Contextualizing the Self-Management of Cardiac Pain in Women: An

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Contextualizing the Self-Management of Cardiac Pain in Women: An Evidence Map

Journal:

BMJ Open

rp Fo Manuscript ID Article Type:

Date Submitted by the Author:

Complete List of Authors:

bmjopen-2017-018549 Research 07-Jul-2017

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Parry, Monica; University of Toronto Lawrence S Bloomberg Faculty of Nursing, Bjornnes, Ann Kristin; Oslo universitetssykehus Ulleval, Clarke, Hance; University Health Network, Pain Research Unit Cooper, Lynn; Canadian Pain Coalition Gordon, Allan; Mount Sinai Hospital, Wasser Pain Management Centre Harvey, Paula; Women's College Hospital Lalloo, Chitra; Hosp Sick Children Leegaard, Marit; Hogskolen i Oslo og Akershus, Department of Nursing and Health Promotion LeFort, Sandra; Memorial University of Newfoundland - School of Nursing McFetridge-Durdle, Judith; Florida State University, College of Nursing McGillion, Michael; McMaster University, Faculty of Health Sciences O'Keefe-McCarthy, Sheila; Brock University, School of Nursing Price, Jennifer; Women's College Hospital Stinson, Jennifer; Toronto SickKids Victor, J. Charles; University of Toronto Watt-Watson, Judy; University of Toronto Lawrence S Bloomberg Faculty of Nursing Cardiovascular medicine

Secondary Subject Heading:

Evidence based practice

Coronary heart disease < CARDIOLOGY, Ischaemic heart disease < CARDIOLOGY, Quality in health care < HEALTH SERVICES ADMINISTRATION & MANAGEMENT, PAIN MANAGEMENT, Coronary intervention < CARDIOLOGY

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Keywords:

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Primary Subject Heading:

For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml

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Full title: Contextualizing the Self-Management of Cardiac Pain in Women: An Evidence Map Authors, Degrees and Affiliations: Parry M NP-Adult PhD1, Bjørnnes AK RN CNM MSc PhD1,7, Clarke H MD PhD FRCPC1,2, Cooper L BSc3, Gordon A MD FRCP(C)1,4, Harvey P BMBS PhD FRACP1,5, Lalloo C BHSc PhD6, Leegaard M RN CRNA PhD 7, LeFort S MN PhD8, McFetridge-Durdle J RN PhD9, McGillion M RN PhD10, O’Keefe-McCarthy S RN PhD11, Price J RN PhD5, Stinson J RN-EC PhD CPNP1,6, Victor JC MSc1, & Watt-Watson J RN MSc PhD1

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University of Toronto, Toronto, ON, Canada

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Pain Research Unit, University Health Network, Toronto, ON, Canada

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Canadian Pain Coalition, Toronto, ON, Canada

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Wasser Pain Management Centre, Mount Sinai Hospital, Toronto, ON, Canada

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Women’s College Hospital, Toronto, ON, Canada

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The Hospital for Sick Children, Toronto, ON, Canada

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Oslo and Akershus University College of Applied Sciences, Oslo, Norway

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Memorial University of Newfoundland, St. John’s, NL, Canada

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Florida State University, Tallahassee, Florida, United States McMaster University, Hamilton, ON, Canada

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Brock University, St, Catherines, ON, Canada

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Corresponding Author: Dr. Monica Parry, Lawrence S. Bloomberg Faculty of Nursing 155 College Street, Suite 130, Toronto, ON, Canada, M5T 1P8

Phone: 416-946-3561, Fax: 416-978-8222, Email: [email protected] Keywords: myocardial ischemia, postoperative pain, pain management, women, self-care Total Word Count: 4952


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Abstract Objective To describe the current evidence related to the self-management of cardiac pain in women using the process and methodology of evidence mapping. Design and setting Literature search of systematic reviews, intervention and non-intervention studies that describe the self-management of cardiac pain in women greater than 18 years of age, managed in community, primary care or outpatient settings. Searches for eligible studies

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published in English or a Scandinavian language between 1 January 1990 and 24 June 2016 (inclusive) were conducted in AMED, CINAHL, ERIC, EMBASE, MEDLINE, Proquest, PsychInfo, the Cochrane Library, Scopus, Swemed+, Web of Science, the Clinical Trials

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Registry, International Register of Controlled Trials, MetaRegister of Controlled Trials, theses and dissertations, published conference abstracts, and relevant websites using GreyNet

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International, ISI proceedings, BIOSIS, and Conference papers index. Two independent

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reviewers screened in two rounds according to predefined eligibility criteria. Included articles were classified according to study design and pain category.

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Interventions Self-management interventions for cardiac pain, or non-interventions studies that

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described views and perspectives of women who self-managed cardiac pain.

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Primary and secondary outcomes measures Outcomes included those related to knowledge, self-efficacy, function, and health related quality of life (HRQL).

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Results The literature search identified 5940 unique articles, of which 288 were included in the evidence map. Seventy percent (n=200) of the studies described cardiac pain related to obstructive CAD, 5% (n=14) non-obstructive CAD, and 14% (n=41) post-PCI/cardiac surgery. The median sample size across studies was 90 and the mean age was 63 years. Only 17% (n=49) were intervention studies.


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Conclusions Our evidence map suggests that while much is known about the differing presentations of obstructive cardiac pain in middle-aged women, little research has focused on young and old women, non-obstructive cardiac pain, or self-management interventions to assist women to manage cardiac pain. Systematic Review Registration Number PROSPERO CRD42016042806.

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Strengths and limitations of this study •

Evidence mapping provides an overview of a broad range of research and identifies evidence gaps and future research needs

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Scope focuses on cardiac pain in women due to obstructive coronary artery disease (CAD), non-obstructive CAD, and post-procedural [percutaneous coronary interventions (PCI) and cardiac surgery]

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This evidence map is based on a systematic search of 20 databases including grey literature sources between 1 January 1990 and 24 June 2016, published in English or a Scandinavian language

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Bubble plots (i.e., weighted by sample size) graphically illustrate the relationships between: 1) study design and type of cardiac pain across years of publication, and 2)

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study design and type of cardiac pain across ages •

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Findings support published Cochrane Reviews, which indicate evidence about risk factors,

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clinical presentations, and symptom experiences in middle-aged women with obstructive CAD are emerging; findings also substantiate a recent Scientific Statement from the

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American Heart Association, which highlights more trials are needed to test interventions tailored for women

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Background

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In 2015, more than 110 million people worldwide were affected by coronary artery disease (CAD),1 and the number is expected to increase over the next decades.2 Coronary artery disease is increasing in women less than 55 years of age due to rising obesity and diabetes rates.3 In 2013, 30% more women died of CAD than cancer (including breast cancer) in the United States (US).4 According to most recent mortality statistics in Europe5 (2015), CAD is the most common cause


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of death and accounts for 20% of all deaths among women. Cardiac pain has been considered the primary indicator of CAD,6 and each year 4.5 million individuals are evaluated for cardiac pain in emergency departments in the US.7 Cardiac pain disproportionately burdens more women than men, and women have a varied pattern and distribution of pain symptoms associated with both obstructive and non-obstructive CAD.8,9

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Women also have a higher prevalence of clinically relevant cardiac pain after percutaneous coronary interventions (PCI) and cardiac surgery and report more persistent pain of moderate to severe intensity up to two years after cardiac surgery.10-12 Poorly controlled acute pain (ischemic and procedural) is a risk factor for persistent pain, a debilitating complication for women

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following cardiac surgery.13,14

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The identification and management of cardiac pain associated with CAD are vital to minimize

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risk of a major adverse cardiac event (MACE). Women with obstructive and non-obstructive CAD have cardiac pain that differs from that of men. Women describe their pain as sharp and

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burning, with additional symptoms of discomfort in the jaw, neck, shoulders, arms, back and

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epigastric area.6,8 Women’s pain and symptoms vary in frequency and distribution, making it

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difficult for them to interpret as cardiac-specific.8,15 Non-obstructive CAD (Cardiac Syndrome X) is angina-like chest discomfort without evidence of coronary artery obstruction.16 Non-

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obstructive CAD is more prevalent in younger, middle-aged women and evidence suggests that more extensive, non-obstructive CAD, hypertension, and diabetes are associated with MACE similar to those with obstructive CAD.9,17 These women suffer from persistent and incapacitating cardiac pain, are at risk for impaired function, depression, poor health-related quality of life (HRQL), and death.18 They are also frequent users of health care services (emergency room, hospitalization, and repeat diagnostic evaluation).19


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The risk of future coronary events for women who present with cardiac pain, additional symptoms and/or cardiac pain equivalents can be classified into low-, intermediate- and high-risk categories.20,21 This risk categorization can be used to guide further assessment and diagnostic evaluation. For example, generally women in the low-risk category do not require diagnostic follow-up. However, if low-risk premenopausal women with cardiac pain symptoms have diabetes, their risk category is elevated to an intermediate risk category suggesting evaluation. All

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women of intermediate- or high-risk of future coronary events benefit from diagnostic evaluation.20 In addition to having difficulty interpreting cardiac pain, women minimize their symptoms, prefer to consult with family and friends, and have caring responsibilities and

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concerns for their family.22 As a result, women with and without known CAD delay seeking appropriate care for their cardiac pain;23 the time from symptom onset to emergency department

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arrival for women is 85 to 320 minutes, and this has not changed in the last decade.24

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The under-recognition of women`s symptoms as well as the difficulty in diagnosing cardiac pain

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in women contribute to poorer outcomes and greater mortality rates in women as compared to

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men.6 Outcomes are also associated with a person’s ability to self-manage their condition in everyday life. A variety of new skills have to be learned; to comply with medication regimes, to

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establish and sustain new and healthier lifestyle routines, monitor and manage symptoms, and

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recognize when to seek help when symptoms occur.25 Self-management programs are designed to allow people to take an active part in the management of their condition through problem solving, decision-making, action planning, self-tailoring, and the formation of patient-provider partnerships.26,27 Due to the complexity of cardiac pain in women, there is an increased need to develop mechanisms to assist women to recognize and manage their pain. We conducted an integrated mixed methods systematic review of the literature to understand the current body of


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knowledge on self-management programs for women with cardiac pain using methods described by the Evidence for Policy and Practice Information (EPPI) and the Coordinating Centre at the Institute of Education.28-32 In this paper we will describe the first step in the EPPI review process, to establish the current evidence related to the self-management of cardiac pain in women using the process and methodology of evidence mapping. Methods

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The main purpose of evidence mapping is to provide an overview of a broad range of research and identify evidence gaps and future research needs.33 The evidence map is broad in scope, and is primarily focused on identifying and describing the characteristics of the evidence base.34 It is

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the first step in conducting an integrated mixed methods systematic review and it does not

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include quality appraisal of the included studies.35 Six steps were used to construct an evidence map of cardiac pain in women.36 1) identify the scope of the evidence map, 2) define the key

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variables, 3) establish a comprehensive search strategy, 4) identify study inclusion and exclusion

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criteria, 5) systematically retrieve, screen and classify the evidence, and 6) report the findings in an evidence map.

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Identify the scope of the evidence map

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The initial scope of the work was established by the research team to focus on three types of

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cardiac pain in women: 1) obstructive CAD, 2) non-obstructive CAD, and 3) post-procedure (PCI and cardiac surgery). The research question and the study eligibility criteria were discussed in a consultation session with health care providers (physicians and nurses) and researchers working in cardiology, cardiac surgery and adult multidisciplinary chronic pain clinics. Additionally, women with cardiac pain provided input into the scope of the evidence map. An overarching review question was established, and purposefully kept broad to ensure a comprehensive review


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of the evidence: What is known about the self-management of cardiac pain in women? This question could be answered by a broad range of quantitative and qualitative evidence, including systematic reviews, randomized controlled trials (RCT), cohort studies, cross-sectional, case control studies and case series/ reports. Define the key variables

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We utilized the PICO framework37 to focus our research question and to facilitate the literature search. The PICO question elements included population, intervention, comparison, and outcomes. Keywords and the National Library of Medicine’s Medical Subject Headings (MeSH) were combined under the three PICO categories: P) women, I) self-management, and O) cardiac

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pain (Table 1). In this instance we did not search using a comparator to maintain breadth of our evidence map.

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- Insert Table 1 -

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Establish a comprehensive search strategy

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The literature on the self-management of cardiac pain in women was systematically searched

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using keywords and MeSH headings in accordance with the search criteria in the bibliographic

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databases. Publications needed to be available in English or a Scandinavian language and published between 1 January 1990 and 24 June 2016 (inclusive). Searches were conducted in July

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2016 using selected databases: AMED (Allied and Complementary Medicine), CINAHL, ERIC, EMBASE, MEDLINE, Proquest, PsychInfo, the Cochrane Library, Scopus, Swemed+ and Web of Science. For ongoing and recently completed clinical trials we searched the Clinical Trials Registry, International Register of Controlled Trials and the MetaRegister of Controlled Trial. Grey literature sources included theses and dissertation, published conference abstracts, and relevant websites using GreyNet International, ISI proceedings, BIOSIS, and Conference papers


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index. Publication citations were exported from electronic search interfaces to Endnote. Identify study inclusion and exclusion criteria The inclusion criteria were kept broad, and studies were included if they focused on the selfmanagement of cardiac pain in women, or described the views and perspectives of women who had cardiac pain independent of the research design. Types of participants included women who

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were greater than 18 years of age with cardiac pain, managed in the community, primary care or outpatient settings. Types of outcomes included those related to knowledge, self-efficacy, physical and mental function, social and role function, and health related quality of life (HRQL). Lastly, the number of women included in the studies needed to be at least 25% to adequately

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represent the ratio of men and women who have cardiac disease4.

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Systematically retrieve, screen and classify the evidence

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Title and abstracts of all identified articles were screened in the first round. Studies were excluded if they were not about the self-management of cardiac pain in women, or described the

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views and perspectives of women who had cardiac pain. A random sample of excluded studies

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(n=50) was discussed between the two reviewers to establish screening accuracy and to confirm

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understanding of the study eligibility criteria. The second round was based on the full text screening and followed all the predefined study eligibility criteria. The articles were single-

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screened due to the large number and time constraints. If the reviewer was unsure about inclusion/exclusion of an article the second reviewer was consulted to confirm inclusion/exclusion. The included articles were classified according to study design as per the hierarchy of evidence (i.e., systematic reviews/meta-analyses, RCTs, cohort studies, case control studies, cross-sectional and case series/reports) and according to pain category (i.e., obstructive CAD, non-obstructive CAD, or pain post procedure (PCI/cardiac surgery).


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Report the findings in an evidence map The characteristics of the included studies (i.e., country, year of publication, study design, sample size, percent women, mean age, and type of cardiac pain) were included in a statistical file. Bubble plots (i.e., weighted scatter plots) were used to graphically illustrate the relationships between: 1) study design and type of cardiac pain across years of publication, weighted by sample size, and 2) study design and type of cardiac pain across ages, weighted by sample size.

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All analyses were performed using STATA 2013.38 Results

Identification of relevant studies

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In total, 6582 eligible citations were identified from searching commercially available

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bibliographic databases and grey literature sources (Figure 1). The most productive of these were MEDLINE, EMBASE, Scopus and Web of Science. After duplicates were removed (n=642),

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most citations were excluded in the first round of title and abstract screening based on scope

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(n=4572) (i.e., focused solely on other diagnoses, children/adolescents or caregivers, medications, diagnostic and surgical procedures).

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In total, 1,368 citations were deemed to meet the eligibility criteria after the first screening. Full

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text reports were obtained and processed for 1,125 (82%) of the citations. Seventy-four percent (n=837) of these did not meet the eligibility criteria, mainly because the outcomes were not related to cardiac pain or the number of women included was less than 25%. A total of 288 unique citations are reported in the evidence map: 20% (n=58) systematic reviews, 4% (n=10) meta-analyses, 17% (n=49) intervention studies, and 59% (n=168) non-intervention studies.


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Twenty-five percent (n=73) of the studies in the evidence map were identified through grey literature sources. A majority of these (n=60, 80%) were dissertations related to obstructive CAD. Study characteristics Seventy percent (n=200) of the included studies on cardiac pain in the evidence map represented obstructive CAD, 5% (n=14) non-obstructive CAD, 14% (n=41) post PCI or cardiac surgery pain,

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and 11% (n=33) of studies were a mixed sample of obstructive CAD and post PCI/cardiac surgery pain. The majority were conducted in North America (n=148, 58%) and in Western Europe (n=98, 34%). No relevant studies from the African continent and only two studies from South-America (i.e., Brazil) were identified. Eleven percent (n=32) of the studies were published

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before year 2000, 46% (n=133) between 2000 and 2010, and 43% (n=123) were published after

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2010. Characteristics of the studies according to pain category are outlined in Table 2. - Insert Table 2 -

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The median sample size across the primary research studies (n=220) was 90 (range 5 to 7093), 53

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(24%) of the studies had less than 30 subjects, and the mean age was 63 years (range 47 to 80

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years). Women comprised approximately 56% of the total sample and 58 (26%) studies included only women. The relationship between sample size, design, number and year of publication are

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depicted in Figure 2, and Figure 3 illustrates the association between mean age and sample size across years of publication and pain categories. - Insert Figure 2 -

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- Insert Figure 3 Characteristics of the systematic reviews/meta-analyses The final sample consisted of ten (4%) systematic reviews with meta-analysis, and nine of these were Cochrane reviews. The latter evaluated 169 studies and 54 (32%) of these included more


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than 25% women. Fifty-eight studies (20%) were systematic reviews without meta-analyses. A majority (n=33, 56%) of the reviews discussed sex/gender differences in cardiac pain with respect to pathophysiology, symptom presentation, response to treatment (i.e., drugs, surgery), and outcomes most often focused on mortality and/or recurrent cardiac pain/angina or cardiac events. Another 32% (n=19) of the reviews addressed biopsychosocial risk factors (e.g., diabetes, hypertension, anxiety or depression) and these factors were mainly discussed as risk factors for

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MACE or adverse outcomes after cardiac surgery or other invasive interventions (e.g., PCI). Seven (10%) reviews and nine (13%) meta-analyses evaluated the effectiveness of selfmanagement interventions/programs. The focus of the reviews and meta-analysis according to

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pain category are summarized in Table 2.

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Characteristics of the intervention studies

Forty-nine (17%) of the studies on cardiac pain focused on interventions, including 35 (72%)

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RCTs with parallel group design, five (10%) RCT-pilots and nine (18%) quasi-experimental

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RCTs. Twenty-six (53%) of the RCTs assessed the effectiveness of interventions targeting men

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and women with obstructive CAD. Three RCTs (6%) included women with non-obstructive CAD. Post-procedural pain was the main or secondary outcome of seven (14% [cardiac surgery: n=4,

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PCI: n=2, mixed: n=1]) RCTs, and 13 (27%) RCTs had a mixed sample of both obstructive and

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post-PCI/cardiac surgery pain. The RCTs evaluated outcomes of different self-management interventions that were broad, and targeted cardiac pain and symptom management through Complementary and Alternative Medicine (CAM) interventions or self-management support delivered in groups, over the Internet, face to face or with help of other educational resources (e.g., information sheets, videos). The median duration of the interventions was 2 months (range < 1 week to 24 months), and the median follow-up time was 4 months (range < 1 week to 9


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years). The interventions and outcomes according to pain category and year of publication are outlined in Table 3. - Insert Table 3 Patient-reported outcomes across the RCTs included cardiac pain frequency and/or intensity, bodily pain, HRQL or other psychosocial factors associated with cardiac pain including fatigue,

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stress, depressive symptoms, anxiety, catastrophizing, coping, self-efficacy, sense of coherence, and personality traits. A majority of the studies also included objective outcomes related to cardiac risk factors (e.g., blood pressure, weight, cholesterol levels, blood glucose, and ischemic stress tests) and patient self-reports about health behaviours (e.g., smoking, activity, and dietary

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habits). The most common data collection methods used in approximately 90% of the

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intervention studies were validated self-reported questionnaires collected on site by the research team or sent out by mail. Outcomes were also extracted from medial charts or registries. Ten

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percent of the studies collected data through telephone surveys or face-to-face interviews using

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standardized interview guides. A combination of quantitative and qualitative methods was found in one study.

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Characteristics of non-intervention studies

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In total, we identified 168 non-intervention studies: 41 (24%) retrospective, 49 (29%) prospective

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and 78 (46%) cross-sectional. In addition, three (1%) studies had a case-control design (Table 2). The majority (n=125, 74%) of the non-intervention studies focused on women with obstructive CAD, 63 (50%) of these were cross-sectional studies. Two (1%) cross-sectional studies investigated cardiac pain and symptoms in women with non-obstructive CAD. Outcomes assessed were similar to those outcomes described for the intervention studies. Validated selfreported questionnaires were used in approximately 75% of the quantitative non-intervention


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studies, and 25% used structural interviews delivered face-to-face or by telephone. In addition, 52 (30%) of the non-intervention studies used qualitative interviews (i.e., semi-structured or in-depth interview), and 11 (7%) used focus group interviews to collect data. A combination of quantitative and qualitative methods was found in 11 (7%) studies. The majority of the qualitative and mixed method studies were related to obstructive CAD (n=54, 73%) that explored women`s cardiac pain and symptom experiences. Cardiac pain appraisal and pain self-management

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strategies were also investigated, primarily with a focus on pre-hospital delays, barriers/challenges (e.g., knowledge deficits) or sequelae after the cardiac event (e.g., anxiety, depression, fatigue) and impact on everyday life. No qualitative study was found to focus on

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women with non-obstructive CAD. Five studies explored women`s experiences after cardiac surgery, and two studies explored women`s experiences with cardiac rehabilitation in mixed

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samples of women after cardiac events (e.g., MI and cardiac surgery).

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Seventeen (10%) studies explored association between ethnicity and obstructive CAD

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descriptions and recognition in women, and most (n=10, 58%) were cross sectional studies. In

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addition, among studies conducted in the US, the sample often included minority ethnic groups (e.g., African-American, Hispanic) but outcomes were rarely reported for these groups separately. Discussion

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The studies included in our evidence map provide a very comprehensive broad overview of the evidence on the self-management of cardiac pain in women published between 1 January 1990 and 24 June 2016. Main results confirm that we have gained knowledge about sex differences in the pathophysiology of CAD, symptom presentation, and clinical outcomes, but most importantly, results indicate there is a general lack of intervention research targeting women with cardiac pain.


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Our results are consistent with previous research39-41 that suggests women are differentially excluded from research. There remains a need to make sex/gender and health more visible in research related to cardiac pain. The lack of intervention studies across all cardiac pain categories suggests that we need to develop mechanisms to assist women to recognize and manage cardiac pain in order to reduce gender inequalities in the outcomes of CAD. It is important to recognise that the terms sex and gender are not interchangeable.42 Sex refers to the anatomy of an

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individual`s reproductive system including chromosomes, gene expression, and levels and function of hormones. Gender refers to socially constructed characteristics of women and men based on behaviours, expressions and identities.43 There is a need to identify and examine the role

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of biological, psychosocial and sociocultural factors in explaining differences in cardiac pain related health outcomes. Researchers need to carefully consider the complex inter-relationship

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between the anatomical and physiological aspects, the psychological processes evident in the

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person, and the person`s interaction within the sociocultural context42. This will require a greater focus on the collection of relevant information when designing studies, engaging women as

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collaborators and partners in research, and looking for opportunities to focus on sex and gender rather than adjusting for it in our analyses.44

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From 1990 to September 2016, we identified 57 (26%) studies that included only women and 84

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(52%) of mixed sex/gender studies that had fewer than 40% of the total sample of women enrolled. Underrepresentation of women (< 25%) was one of the main reasons for exclusion of studies in our second screening, and this was to ensure that we had a representative sample of studies reflecting the ratio of men and women with cardiovascular disease. The gap in the representation of women in mixed sex/gender cardiovascular research has been well documented.45 A review of cardiovascular treatment trials included in Cochrane Reviews


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revealed that only 27% of the total numbers of trial participants in 258 clinical trials were women.40 The included Cochrane reviews in our evidence map had a similar pattern with 68% (n=115) of the studies having either less than 25% women or the authors did not report results by sex/gender. A recent Scientific Statement from the American Heart Association41 highlights that interventions developed specifically for women only are more effective, and more trials are needed to test interventions tailored for women.

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The majority of studies in the evidence map included post-menopausal women. In view of the increasing incidence of CAD and higher death rates in younger women with obstructive CAD compared to men,46,47 this research gap is disturbing. Women`s increased risks for macrovascular

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or obstructive CAD are linked to their higher obesity and diabetes rates.46 However, diabetes also

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concurs an accelerated risk for microvascular or non-obstructive CAD in women, and this has been less well investigated. Non-obstructive CAD is more prevalent in younger, middle-aged

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women,17 and the portion of health care costs attributable to non-obstructive cardiac pain is

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increasing.19 Notably, the lack of recognition and assessment of early symptoms in these younger

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women may be underpinning a negative trajectory.41 The higher age range in women across all studies suggests that gendered aspects of health have not been explored adequately in younger

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women with CAD. Younger women with CAD are more likely to have caregiving responsibilities,

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marital/family dysfunction, and poorer perceived social support compared with men and older women.46 Our results suggest that we need to include more women aged 40 to 54 years in research related to the self-management of cardiac pain. The identified non-pharmacologic interventions women used to self-manage cardiac pain included physical exercise and relaxation, cognitive-behavioural therapy, music, aromatherapy, acupuncture, and peer support. Many of these interventions (e.g., physical exercise) were often


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incorporated as part of rehabilitative treatment approaches. Psychological treatments were generally separated into theoretically based approaches (e.g., acceptance-based and mindfulness therapy) and more specific techniques (e.g., cognitive behaviour therapy, relaxation and hypnosis).48 Non-pharmacologic persistent pain interventions were in general not only about reducing pain intensity but also pain interference and the disability associated with symptoms.48 This was also evident for the studies included in our evidence map, as a majority of the studies

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were secondary pain prevention trials for obstructive CAD. In addition to angina frequency, outcomes emphasised HRQL and other biopsychosocial factors associated with cardiac pain. This is a promising direction for future research, particularly related to women that continue to

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experience angina-like cardiac pain without evidence of coronary artery obstruction, or continue to have cardiac pain despite coronary interventions. For these women, elimination of physical

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causes of pain is not always possible. Creating mechanisms to assist women to recognise and

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manage cardiac pain and symptoms and guide them to seek appropriate and timely care are absolutely necessary in future research studies.20,49

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Cardiac pain is complex, and the need for holistic treatment approaches has been emphasized.50 In total, 19 (7%) studies across cardiac pain categories and designs focused on complementary

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approaches (i.e., CAM) to cardiac pain. These interventions aligned with the complementary

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integrative medicine interventions for persistent pain summarized in a systematic review by Delgado et al.51 Only eight of the studies in our evidence map, including 2% (n=554) of the total trial participants in the 49 intervention studies, assessed the effect of CAM interventions in RCTs. This indicates that we are lacking strong evidence to routinely include CAM interventions in cardiac pain treatment strategies for women.


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One meta-analysis52 suggested that psychological interventions appeared to be effective in treating psychological symptoms of CAD, but there remained uncertainty regarding the characteristics of successful interventions and which patient groups would benefit most.52 A more recent meta-analysis examined psychological interventions for individuals with nonobstructive CAD.53 Only seven of 17 studies (4%) in this meta-analysis included women, and due to small sample sizes, high risk of bias, and heterogeneity in outcomes, the effects of

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psychological interventions for women with non-obstructive CAD remained unclear. Three primary intervention studies in women with non-obstructive CAD included in our evidence map were also characterised by small sample sizes. Additionally, all the original studies related to

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cardiac pain and non-obstructive CAD included women only. Although women are more likely to have cardiac pain in the absence of obstructive CAD, evidence is inconclusive.54 Interestingly, a

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recent Canadian cohort study55 (N=909) found that female gender-related characteristics, not sex

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per se, were associated with recurrent acute coronary syndrome (ACS) and MACE over 12 months. Ørhn et al.56 (N=4849) adds a different perspective by suggesting an association between

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higher pain tolerance and unrecognized MI. They found a higher proportion of unrecognized MIs

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in women, however; when adjusted for confounding factors the association was no longer

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statistically significant.56 Sex and gender differences remain poorly understood. This indicates a need for adequately powered prospective studies with an equal distribution of men and women

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for non-obstructive CAD. Similarly, no qualitative study was found, indicating that little in-depth knowledge exists about how women describe, manage and make decisions about non-obstructive cardiac pain. Addressing this knowledge gap is essential before developing new self-management programs to meet the unique needs of these women.


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Our results indicate that there are few self-management interventions for women with cardiac pain. This is important as women delay seeking medical care for cardiac pain.23 In a recent integrated review57 including 23 studies in 17 different countries, the mean delay times across countries was 3.4 hours, with time to decision to seek treatment reported as the main contributor to this delay. Older age, female gender, ethnicity, lower socioeconomic status, history of chronic disease, symptom knowledge deficits, and underutilization of ambulance services were also

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associated with longer pre-hospital delay times in men and women with and without known CAD. Only three studies in this review57 included a sub-analysis by ethnicity, and these studies reported that Blacks, Asians, Hispanics and South Asians had longer delays in seeking medical care

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compared to Caucasians. Ethnicity and culture affect perceptions of chest pain and aspects of a woman’s life that includes childbearing, caregiving, food preparation, education, employment,

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and health practices.41 Health care providers must recognize that ethnicity and culture affect

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women’s health, and that ethnicity and culture also identify groups of women who have a disproportionate burden of CAD.41 We found 17 studies that focused on ethnicity and symptom

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experience, a majority of these were cross-sectional studies conducted in North-America and

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included women with African or Hispanic origins. Indigenous peoples also experience greater

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cardiovascular disease burden,58 yet only one quasi-experimental RCT targeted indigenous men and women.59 This indicates that we have little research-based information on which to develop

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effective self-management programs for indigenous women. Moreover, interventions to support women of all ethnicities to seek appropriate and timely evaluation for their cardiac pain are needed. Since interventions evaluated in non-indigenous populations may not be generalizable to all women, new interventions need to be appropriately evaluated in specific ethnic groups of women across all cardiac pain categories.


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This evidence map is based on a systematic search of 20 databases including grey literature sources. Despite the high number of potentially eligible studies, many were either not relevant to cardiac pain or the number of women included in the studies was too low. Including only studies published in English or Scandinavian language may be seen as a limitation, however we chose to include a robust search of the grey literature in an attempt to reduce this potential publication bias.60 Moreover, despite having health care providers and researchers involved in establishing

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the scope of the evidence map, our search strategy may not have targeted what women themselves see as the most important aspects of the self-management of cardiac pain. Cardiac pain is a subjective experience, and is associated with physical symptoms (e.g., breathlessness,

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fatigue, sleep problems) and emotional sequelae (e.g., anxiety, depression).61 Additional search terms and keywords related to cardiac pain and symptoms may have increased our probability of

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identifying self-management interventions. The next step in the EPPI review process is to present

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results of this broad mapping and screening exercise to women with cardiac pain (obstructive CAD, non-obstructive CAD and post-procedure [PCI and cardiac surgery]), to re-confirm our

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search terms for a more targeted in-depth search and review including quality appraisal of

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interventions to enhance the self-management of cardiac pain in women. Conclusions

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We aimed to describe the current evidence related to the self-management of cardiac pain in women using the process and methodology of evidence mapping. It was not to present individual study results or synthesis of results, but to describe the process and methodology for creating an evidence map database, using the topic of self-management of cardiac pain in women. Results from this mapping process suggest that evidence about risk factors, clinical presentations, and symptom experiences in women are emerging, particularly for middle-aged women with


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obstructive CAD. Important aspects of cardiac pain in these women focused on the accuracy and interpretation of signs and symptoms, reasons for delays in seeking care, pain interference, persistent pain, treatment compliance, outcomes, and barriers to participation in cardiac rehabilitation. While much is known about the differing presentations of cardiac pain in women, especially for middle-aged women with obstructive CAD, not enough is known about young and old women, and little has been done to help women manage their pain. Self-management

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intervention trials are lacking across all cardiac pain categories (obstructive CAD, nonobstructive CAD and post-procedure [PCI and cardiac surgery]). Further research to develop mechanisms to assist women to recognize and manage cardiac pain is needed.

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References 1.

Steel, Nicholas. Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries, 1990–2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet 2016, 388(10053):1545-1602.

2.

Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med. 2006;3(11):e442.

3.

rp Fo

Balakumar P, Maung-U K, Jagadeesh G. Prevalence and prevention of cardiovascular disease and diabetes mellitus. Pharmacol Res. 2016;113:600-609.

4.

Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, de Ferranti S,

ee

Despres JP, Fullerton HJ, Howard VJ, Huffman MD, Judd SE, Kissela BM, Lackland DT, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Matchar DB, McGuire DK, Mohler ER,

rr

Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L,

ev

Pandey DK, Reeves MJ, Rodriguez CJ, Sorlie P, Stein J, Towfighi A, Turan TN, Virani SS, Willey JZ, Woo D, Yeh RW, Turner MB. Executive Summary: Heart Disease and

ie

Stroke Statistics-2016 Update: A Report From the American Heart Association. Circulation. 2016;133(4):447.

on

5.

w

Townsend N, Wilson L, Bhatnagar P, Wickramasinghe K, Rayner M, Nichols M. Cardiovascular disease in Europe: epidemiological update 2016. Eur Heart J. 2016; 37(42), 3232-3245.

6.

ly

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60

Page 22 of 40

McSweeney J, Cleves MA, Fischer EP, Moser DK, Wei JY, Pettey C, Rojo MO, Armbya N. Predicting Coronary Heart Disease Events in Women A Longitudinal Cohort Study. J Cardiovasc Nurs. 2014;29(6):482-492.

7.

HCUPnet HC. Utilization Project: Agency for Healthcare Research and Quality, Rockville, MD. United States Department of Health & Human Services. 2016.


22

Page 23 of 40

8.

Canto JG, Canto EA, Goldberg RJ. Time to standardize and broaden the criteria of acute coronary syndrome symptom presentations in women. Can J Cardiol. 2014;30(7):721728.

9.

Pepine C, Ferdinand K, Shaw L, Light-McGroary KA, Shah RU, Gulati M, Duvernoy C, Walsh MN, Merz, CN. Emergence of Nonobstructive Coronary Artery Disease: A Woman's Problem and Need for Change in Definition on Angiography. J Am Coll Cardiol.

rp Fo

2015;66(17):1918-1933. 10.

Kok MM, van der Heijden LC, Sen H, Danse PW, Lowik MM, Anthonio RL, Louwerenburg JH, de Man FH, Linssen GC, Ijzerman MJ, Doggen CJ, Maas AH, Mehran

ee

R, von Birgelen C. Sex difference in chest pain after implantation of newer generation coronary drug-eluting stents: a patient-level pooled analysis from the TWENTE and

rr

DUTCH PEERS trials. JACC Cardiovasc Interv. 2016;9(6):553-561. 11.

ev

Choiniere M, Watt-Watson J, Victor JC, Baskett R, Bussieres J, Carrier M, Cogan J, Costello J, Feindel C, Guertin MC, Racine M, Taillefer MC. Prevalence of and risk

ie

factors for persistent postoperative nonanginal pain after cardiac surgery: a 2-year

w

prospective multicentre study. CMAJ. 2014;186(7):E213-223. 12.

on

Katz J, Weinrib A, Fashler S, Katznelzon R, Shah BR, Ladak SJS, Jiang J, Li Q, McMillan K, Santa MD, Wentlandt K, McRae K, Tamir D, Lyn S, de Perrot M, Rao V,

ly

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60

BMJ Open

Grant D, Roche-Nagle G, Cleary SP, Hofer SOP, Gilbert R, Wijeysundera D, Ritvo P, Janmohamed T, O’Leary G, Clarke H. The Toronto General Hospital Transitional Pain Service: development and implementation of a multidisciplinary program to prevent chronic postsurgical pain. J Pain Res. 2015;8:695-702.


23

BMJ Open

13.

King KM, Parry M, Southern D, Faris P, Tsuyuki RT. Women's Recovery from Sternotomy-Extension (WREST-E) study: examining long-term pain and discomfort following sternotomy and their predictors. Heart. 2008;94(4):493-497.

14.

Bjornnes AK, Parry M, Lie I, Fagerland MW, Watt-Watson J, Rustoen T, Stubhaug A, Leegaard M. Pain experiences of men and women after cardiac surgery. J Clin Nurs. 2016;25(19-20):3058-3068.

15.

rp Fo

Kirchberger I, Heier M, Wende R, von Scheidt W, Meisinger C. The patient's interpretation of myocardial infarction symptoms and its role n the decision process to seek treatment: the MONICA/KORA Myocardial Infarction Registry. Clin Res Cardiol. 2012;101:909-916.

Agrawal S, Mehta PK, Bairey Merz CN. Cardiac Syndrome X: Update 2014. Cardiol Clin. 2014;32(3):463-478.

ev

17.

rr

16.

ee

Pizzi C, Xhyheri B, Costa GM, Faustino M, Flacco ME, Gualano MR, Fragassi G, Grigioni F, Manzoli L. Nonobstructive Versus Obstructive Coronary Artery Disease in

ie

Acute Coronary Syndrome: A Meta‐Analysis. J Am Heart Assoc. 2016;5(12):e004185. 18.

w

Altintas E, Yigit F, Taskintuna N. The impact of psychiatric disorders with cardiac

on

syndrome X on quality of life: 3 months prospective study. Int J Clin Exp Med. 2014;7(10):3520-3527. 19.

ly

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60

Page 24 of 40

Arthur H, Campbell P, Harvey P, McGillion M, Oh P, Woodburn E, Hodgson C. Women, Cardiac Syndrome X, and Microvascular Heart Disease. Can J Cardiol. 2012;28:S42-S49.

20.

Mieres J, Gulati M, Merz N, Berman DS, Gerber TC, Hayes SN, Kramer CM, Min JK, Newby LK, Nixon JV, Srichai MB, Pellikka PA, Redberg RF, Wenger NK, Shaw LJ. Role of Noninvasive Testing in the Clinical Evaluation of Women with Suspected


24

Page 25 of 40

Ischemic Heart Disease: A Consensus Statement from the American Heart Association. Circulation. 2014;130(350-379):350-379. 21.

Shaw LJ, Tandon S, Rosen S, Mieres JH. Evaluation of suspected ischemic heart disease in symptomatic women. Can J Cardiol. 2014;30(7):729-737.

22.

Sjostrom-Strand A, Fridlund B. Women's descriptions of symptoms and delay reasons in seeking medical care at the time of a first myocardial infarction: A qualitative study. Int J

rp Fo

Nurs Stud. 2008;45:1003-1010. 23.

von Eisenhart Rothe A, Albarqouni L, Gartner C, Walz L, Smenes K, Ladwig K. Sex specific impact of prodromal chest pain on pre-hospital delay time during an acute

ee

myocardial infarction: Findings from the multicenter MEDEA Study with 619 STEMI patients. Int J Cardiol. 2015;201:581-586. 24.

rr

Sabbag A, Matetzky S, Gottlieb S, Fefer P, Kohanov O, Atar S, Zahger D, Porter A,

ev

Koifman B, Goldenberg I, Segev A. Recent temporal trends in the presentation, management, and outcome of women hospitalized with acute coronary syndromes. The

25.

w

Am J Med. 2015;128(4):380-388.

ie

Jaarsma T, Strömberg A, Mårtensson J, Dracup K. Development and testing of the

on

European Heart Failure Self‐Care Behaviour Scale. Eur J Heart Fail. 2003;5(3):363-370. 26.

Lorig K, Holman H. Self-management education: history, definition, outcomes, and mechanisms. Ann Behav Med. 2003;26(1):1-7.

27.

ly

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60

BMJ Open

Osborne RH, Batterham R, Livingston J. The Evaluation of Chronic Disease SelfManagement Support Across Settings: The International Experience of the Health Education Impact Questionnaire Quality Monitoring System. Nurs Clin North Am. 2011;46(3):255-270.


25

BMJ Open

28.

EPPI. EPPI Centre: Evidence for Policy and Practice Information and Coordinating Centre. http://eppi.ioe.ac.uk/cms/. Accessed April 5, 2015.

29.

Oliver S, Harden A, Rees R. An emerging framework for including different types of evidence in systematic reviews for public policy. Evaluation. 2005;11(4):428-446.

30.

Pope C, Mays N, Popay J. Synthesizing Qualitative and Quantitative Health Evidence. New York: McGraw Open University Press; 2007.

31.

rp Fo

Harden A, Garcia J, Oliver S, Rees R, Shepherd J, Brunton G, Oakley A. Applying systematic review methods to studies of people’s views: an example from public health research. J Epidemiol Community Health. 2004;58(9):794-800.

32.

ee

Thomas J, Harden A, Oakley A, Oliver S, Sutcliffe K, Rees R, Brunton G, Kavanagh J. Integrating qualitative research with trials in systematic reviews. Bmj. 2004;328(7446):1010-1012.

ev

33.

rr

Miake-Lye IM, Hempel S, Shanman R, Shekelle PG. What is an evidence map? A systematic review of published evidence maps and their definitions, methods, and

34.

w

products. Syst Rev. 2016;5(1):1.

ie

Gaarder M. Evidence gap maps -- a tool for promoting evidence-informed policy and

on

prioritizing future research. The World Bank; Vol 625; 2013. 35.

Bragge P, Clavisi O, Turner T, Tavender E, Collie A, Gruen RL. The global evidence

ly

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60

Page 26 of 40

mapping initiative: scoping research in broad topic areas. BMC Med Res Methodol. 2011;11(1):1. 36.

Wang DD, Shams-White M, Bright OJM, Parrott JS, Chung M. Creating a literature database of low-calorie sweeteners and health studies: evidence mapping. BMC Med Res Methodol. 2016;16(1):1.


26

Page 27 of 40

37.

Schardt C, Adams MB, Owens T, Keitz S, Fontelo P. Utilization of the PICO framework to improve searching PubMed for clinical questions. BMC Med Inform Decis Mak. 2007;7(1):1.

38.

Stata S. Release 13. Statistical software College Station Texas, USA: StataCorp LP. 2013.

39.

Mazure CM, Jones DP. Twenty years and still counting: including women as participants and studying sex and gender in biomedical research. BMC Womens Health. 2015;15:94.

40.

rp Fo

Kim ES, Menon V. Status of women in cardiovascular clinical trials. Arterioscler Thromb Vasc Biol. 2009;29(3):279-283.

41.

McSweeney JC, Rosenfeld AG, Abel WM, Braun LT, Burke LE, Daugherty SL, Fletcher

ee

GF, Gulati M, Mehta LS, Pettey C, Reckelhoff JF. Preventing and Experiencing Ischemic Heart Disease as a Woman: State of the Science A Scientific Statement From the

rr

American Heart Association. Circulation. 2016;133(13):1302-1331. 42.

ev

Day S, Mason R, Lagosky S, Rochon PA. Integrating and evaluating sex and gender in health research. Health Res Policy Syst. 2016;14(1):75. Canadian Institutes of Health Research. Definitions of Sex and Gender. 2015.

w

43.

ie

http://www.cihr-irsc.gc.ca/e/47830.html. Accessed 6 Dec. 2016. 44.

on

Gahagan J, Gray K, Whynacht A. Sex and gender matter in health research: addressing health inequities in health research reporting. Int J Equity Health.. 2015;14(1):12.

45.

ly

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60

BMJ Open

Hayes SN, Wood SF, Mieres JH, Campbell SM, Wenger NK. Taking a giant step toward women's heart health: Finding policy solutions to unanswered research questions. Womens Health Issues. 2015;25(5):429-432.

46.

Beckie TM. Biopsychosocial Determinants of Health and Quality of life Among Young Women with Coronary Heart Disease. Curr Cardiovasc Risk Rep. 2014;8(1):1-10.


27

BMJ Open

47.

Wenger NK. Clinical presentation of CAD and myocardial ischemia in women. J Nucl Cardiol. 2016;23(5):976-985.

48.

Turk DC, Wilson HD, Cahana A. Treatment of chronic non-cancer pain. Lancet. 2011;377(9784):2226-2235.

49.

Tashakkor AY, Stone J, Mancini GJ. Is It Time to Update How Suspected Angina Is Evaluated prior to the Use of Specialized Tests? Implications Based on a Systematic

rp Fo

Review. Cardiology. 2015;133(3):181-190. 50.

Webster R, Heeley E. Perceptions of risk: understanding cardiovascular disease. Risk Manag Healthc Policy. 2010;3(4).

51.

ee

Delgado R, York A, Lee C, Crawford C, Buckenmaier C, Schoomaker E, Crawford P. Assessing the quality, efficacy, and effectiveness of the current evidence base of active

rr

self-care complementary and integrative medicine therapies for the management of

ev

chronic pain: a rapid evidence assessment of the literature. Pain Med. 2014;15 Suppl 1:S9-20.

Whalley B, Rees K, Davies P, Bennett P, Ebrahim S, Liu Z, West R, Moxham T,

w

52.

ie

Thompson DR, Taylor RS. Psychological interventions for coronary heart disease. Cochrane Database Syst Rev. 2011(8):CD002902.

Kisely SR, Campbell LA, Yelland MJ, Paydar A. Psychological interventions for

ly

53.

on

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60

Page 28 of 40

symptomatic management of non‐specific chest pain in patients with normal coronary anatomy. Cochrane Database Syst Rev. 2015(6):CD004101. 54.

Tremmel JA. To Define Is to Limit: Is That Good or Bad When it Comes to Chest Pain? JACC Cardiovasc Interv. 2016;9(6):562-564.

55.

Pelletier R, Khan NA, Cox J, Daskalopoulou SS, Eisenberg MJ, Bacon SL, Lavoie KL, Daskupta K, Rabi D, Humphries KH, Norris CM, Thanassoulis G, Behiouli H, Pilote L.


28

Page 29 of 40

Sex versus gender-related characteristics: which predicts outcome after acute coronary syndrome in the young? J Am Coll Cardiol. 2016;67(2):127-135. 56.

Øhrn AM, Nielsen CS, Schirmer H, Stubhaug A, Wilsgaard T, Lindekleiv H. Pain Tolerance in Persons With Recognized and Unrecognized Myocardial Infarction: A Population‐Based, Cross‐Sectional Study. J Am Heart Assoc. 2016;5(12):e003846.

57.

Wechkunanukul K, Grantham H, Clark RA. Global review of delay time in seeking

rp Fo

medical care for chest pain: An integrative literature review. Aust Crit Care. 2016;30(1):13-20 58.

Foulds HJ, Bredin SS, Warburton DE. Greater prevalence of select chronic conditions

ee

among Aboriginal and South Asian participants from an ethnically diverse convenience sample of British Columbians. Appl Physiol, Nutr Metab. 2012;37(6):1212-1221. 59.

rr

Dimer L, Dowling T, Jones J, Cheetham C, Thomas T, Smith J, Mcmanus A, Maiorana

ev

AJ. Build it and they will come: outcomes from a successful cardiac rehabilitation program at an Aboriginal Medical Service. Aust Health Rev. 2013;37(1):79-82. Adams RJ, Smart P, Huff AS. Shades of Grey: Guidelines for Working with the Grey

w

60.

ie

Literature in Systematic Reviews for Management and Organizational Studies. IJMR. 2016;00:1-23.

Bhattacharyya M, Stevenson F, Walters K. Exploration of the psychological impact and

ly

61.

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adaptation to cardiac events in South Asians in the UK: A qualitative study. BMJ Open. 2016;6 (7):e010195.


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Footnotes Contributors: MP formulated the research question. AKB and MP devised the search strategy, in consultation with two experienced information specialists at the Gerstein Science Information Centre at the University of Toronto, Toronto, ON, Canada. AKB conducted the searches. AKB and MP independently doubled screened all titles, abstracts and full text articles. AKB extracted the data in consultation with MP. AKB and MP co-wrote the manuscript. HC, LC, AG, PH, CL,

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ML, SL, JMD, MM, SOM, JP, JS, JCV, and JWW critically reviewed the manuscript and made revisions prior to submission.

Funding: This study was funded by a Canadian Institutes of Health Research (CIHR) Knowledge

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Synthesis Grant 362774. AKB was supported by a Tom Kierans International Post-Doctoral Fellowship from the Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, ON,

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Canada.

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Acknowledgements: The authors would like to thank Ms. Stephanie Xavier who contributed to the search of the grey literature while a student in the Undergraduate Student Summer Research

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Program at the Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, ON, Canada.

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The authors also thank Ms. Ana Patricia Ayala and Ms. Erica Lenton, two experienced

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information specialists at the Gerstein Science Information Centre at the University of Toronto, Toronto, ON, Canada who were available for consultation during the search.

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Competing interests: All authors have completed the Unified Competing Interest forms at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author). There are no disclosures from the authors. Patient consent: No informed consent was required. Ethics approval: Ethics approval was obtained from the Health Sciences Research Ethics Board (REB) at the University of Toronto, ON, Canada (Protocol # 33289).


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Data sharing statement: All data in this evidence map are documented in the manuscript. No additional data are available.

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Table 1. PICO* search strategy.

Population

Intervention

Outcome

“Woman” MeSH terms

“Self-management” MeSH terms

“Cardiac pain” MeSH terms

1:MH “Women+” 

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1:MH “Self Care+” 

1:MH “Angina Pectoris+”

2:MH “Self Concept+” 

2:MH “Myocardial Ischemia+”

3:MH “Gender Identity+”

3:MH “Self-Assessment” 

3:MH “Sternotomy” 

4. MH “Population

4:MH “Pain Management” 

4: MH “Cardiovascular Surgical Procedures+” 

Characteristics+” 

5:MH “Disease Management+” 

5: MH “Chest pain+” 

5: MH “Sex Characteristics” 

6: MH “Health Behavior+” 

6: MH “Acute, Pain” 

6:1 OR 2 OR 3 OR 4 OR 5

7: MH “Activities of Daily Living+” 

2:MH “Female” 

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8: MH “Life Style+” 

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9:MH “Adaption, Psychological+”

7: MH “Pain, Postoperative+”

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8:MH “Chronic Pain” 

Keywords

Keywords

9: (2 OR 3 OR 4) AND (5 OR 6 OR 7 OR 8) 

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10:1 OR 2 OR 3 OR 4 OR 5 OR 5 OR 7 OR 8 OR 9

Combined with OR

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10: 1 OR 5 OR 9 Keywords

1: “women” 

1: “self-manage*” 

1: “angina*” 

2: “woman” 

2: “self-assess*”

3: “female*” 

3: “disease manage*” 

3: “myocardial ischemia*” 

4: “sex diff*” 

4: “lifestyle*” 

4: “heart surgery” 

5: “gender diff*” 

5: “coping” 

5: “chest pain*” 

6: 1 OR 2 OR 3 OR 4 OR 5

6: “self-concept*” 

6: “heart attack” 

7: “(pain* manage*)”

7: “acute pain*” 

8: “self-care” 

8: “postoperative pain*” 

9: “health behavior*” 

9: “(persistent pain* OR chronic pain*)” 

10: 1 OR 2 OR 3 OR 4 OR 5 OR 6 OR 7 OR 8 OR 9

10: (2 OR 3 OR 4 OR 6) AND (5 OR 7 OR 8 OR 9) 

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Table 2. Summary of characteristics of included studies (N=288). Pain Category

Design (n)

Obstructive CAD

Meta-analysis (5)

Age

Sample size

% Women

Mean Median Range

Mean Median Range

Mean Median Range

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Systematic Review (44)

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RCT (19)

63 64 48-76

RCT pilot (4)

RCT quasi-experimental (3)

Prospective Cohort (26)

61 60 55-68 63 57 55-76 64 62 47-77

ee 318 165 53-1343 35 30 10-70 57 67 7-98 176 77 5-1097

48 40 26-100

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63 63 25-100 88 100 64-100 64 54 25-100

Country (n)

Alternative and complementary medicine (1) Clinical presentation (1) eHealth or other educational resources (1) Self-management education programmes (2) Alternative and complementary medicine (1) Clinical presentation (22) eHealth or other educational resources (1) Risk factors (14) Self-management education programmes (1) Symptom experience/description (5) Alternative and complementary medicine (2) eHealth or other educational resources (6) Self-management education programmes (11)

Australia (1), UK (6)

eHealth or other educational resources (3) Self-management education programmes (1)

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Retrospective Cohort (33)

65 64 54-76

249 62 5-1579

51 43 25-100

Case Control (3)

60 60 55-66 62 62 47-76

353 30 70-767 330 83 7-7093

31 30 64-100 59 50 25-100

Cross Sectional (63)

Focus of report (n)


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Clinical presentation (1) eHealth or other educational resources (1) Ethnicity and symptom experience (3) Risk factors (2) Strategies/responses after cardiac events (10) Symptom experience/description (9) Delay in seeking treatment (7) eHealth or other educational resources (1) Ethnicity and symptom experience (5) Self-management education programmes (2) Strategies/responses after cardiac events (8) Symptom experience/description (8) Alternative and complementary medicine (1) Risk factors (1) Strategies/responses after cardiac events (1) Alternative and complementary medicine (3) Delay in seeking treatment (2) Ethnicity and symptom experience (8) Risk factors (4) Self-management education programmes (2) Strategies/responses after cardiac events (18)

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Australia (1), Brazil (1) Canada (3), India (1), Italy (3), Israel (1), Netherlands (1), Portugal (1), Sweden (5), UK (3), US (24) Brazil (1), Canada (2), China (1), Denmark (1), Iran (1), Sweden (1), UK (6), US (6) Canada (1), US (3) Australia (1), Korea (1), US (3) Canada (6), Sweden (4), UK (3), US (13)

Canada (2), Denmark (2), Germany (2), HongKong (1), Norway (1), Korea (1), Oman (2), Poland (1), Sweden (8), UK (3), US (10) Australia (1), Iran (1), Sweden (1) Australia (1), Canada (7), Czech Republic (1), Finland (1), Germany (1), Hong Kong (2), Iran (1), Jordan (1), Norway (2), UK (14),

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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48

NonObstructive CAD

Symptom experience/description (28)

US (31), Across (1)

Meta-analysis (1)

Alternative and complementary medicine (1)

UK (1)

Review (8)

Alternative and complementary medicine (1) Clinical presentation (6) Risk factors (1) Alternative and complementary medicine (1) Self-management education programmes (1) Alternative and complementary medicine (1)

China (1), Italy (1), Netherlands (1), Switzerland (1), US (4) UK (1), Sweden (1) UK (1)

Clinical presentation (1) Risk factors (1) Alternative and complementary medicine (1) eHealth or other educational resources (1) Self-management education programmes (1) Risk factors (4)

Denmark (1), US (1) Germany (1), Netherlands (2),

50 50 28-100 38

Alternative and complementary medicine (2) eHealth or other educational resources (3)

Germany (1), Greece (1), Iran (1), Thailand (1), US (1) Sweden (1)

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Korea (1)

Alternative and complementary medicine (1) eHealth or other educational resources (1) Risk factors (2) Strategies/responses after cardiac events (6) Symptom experience/description (5) Symptom experience/description (2) Strategies/responses after cardiac event (3)

Self-management education programmes (1)

Australia (3), Canada (3), Germany (2), Norway (1) UK (2), US (4) Australia (1), Canada (1), Switzerland (1), US (2) Australia (1), Korea (1), Norway (2), Taiwan (1), Turkey (1), US (1) US (1)

Self-management education programmes (3)

Australia (1), US (1)


Australia (1), Iran (1), Sweden (2), UK (2), US (1) US (2)

RCT (2)

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RCT quasi-experimental (1) Cross Sectional (2) Post PCI/CABG

Meta-analysis (3)

56-57

24-53

100

56

9

100

53-62

159-963

100

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Review (4) RCT (5)

65 66 57-72 56

RCT pilot (1) RCT quasi-experimental (1)

ee 117 100 54-250 34

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64 64 56-72

109 52 6-326

60 37 25-100


69 67 63-80 62 64 56-65

481 57 8-2269 237 100 8-753

55 44 31-100 48 37 26-100

Cross Sectional (7)

Mixed sample

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Meta-analysis (1) Review (2) RCT (7)


64 62 61-67 60

177 196 70-250 47-72

63 40 26-100 28-40

64 64 60-68

126 107 50-240

52 28 28-100

Clinical presentation (1)

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Strategies/responses after cardiac events (6) Symptom experience/description (1)

Alternative and complementary medicine (1) Self-management education programmes (1) Self-management education programmes (4)


Taiwan (1), US (3)

Sweden (1), US (3)

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62 62 49-74

1267 826 31-4204

36 33 28-55


69 69 65-72 60 59 58-63

378 72 39-1024 604 96 10-2798

60 51 30-100 45 35 26-100

Cross Sectional (6)

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Alternative and complementary medicine (1) Clinical presentation (1) Risk factors (2) Self-management education programmes (2) Strategies/responses after cardiac events (1) Symptom experience/description (1) Self-management education programmes (1) Strategies/responses after cardiac event (1) Risk factors (1) Ethnicity and symptom experience (1) Self-management education programmes (1) Strategies/responses after cardiac event (4)

Australia (1), Canada (2), US (5)

Australia (1), Canada (1), Sweden (1) Lithuania (1), UK (1), US (3), Across (1)

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Table 3. Interventions and outcomes in RCTs across years of publication (N=49). Pain Category Design

Alternative and Complementary medicine Intervention → Outcome (Year)

Obstructive CAD RCT parallel Chiropractic treatment → muscle/skeletal pain, HRQL (2012) group

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Topical heat therapy → acute chest pain (2014)

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EHealth or other educational resources

Self-management education programmes

Intervention → Outcome (Year)


Cognitive interactive nursing intervention → risk factors, health behaviours, self-efficacy (1999) Discharge intervention, a self-directed slide presentation → knowledge about disease management (2009) Educational video and information sheets → prehospital delays. Information sheets for patients with chest pain → anxiety, depression, HRQL, patients’ satisfaction (2002) Self-management intervention: sessions, home visit and telephone follow-up → readmission, HRQL, risk factors, health behaviours, depression, illness perception, self-efficacy, symptoms and well-being (2011) Supportive education program → HRQL, symptom selfmanagement (2002)

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Motivational interviewing→ self-care adherence, self-efficacy and symptom burden (2015) Smartphone iOS application → discharge instruction compliance, symptoms changes (2014) Symptom diary intervention → cardiac events, HRQL and self-care maintenance (2012) Individualized nurse coaching intervention → health beliefs, self-care behaviours, and self-efficacy (2003) Mobile phone and Internet intervention → weight loss, risk factors (2012)

RCT-pilot

RCT quasiexperimental Non-Obstructive CAD RCT parallel Autogenic training→ anxiety, depression, and HRQL (2009) group

A cognitive- behavioural nurse-facilitated self-help intervention → angina, mood, knowledge, risk factors, health behaviours, HRQL and Health service utilization (2011) Disease management program→ physical functioning, symptoms and psychosocial status (2000) Lay-facilitated angina management programme→ chest pain, depression, risk factors and health behaviours (2012) Health education in general practice (face to face) → risk factors, health behaviours, chest pain and impact on everyday life. Nurse-led secondary prevention clinics → chest pain, depression and HRQL (1994) Follow-up care intervention in general practice → risk factors, health behaviours, chest pain and HRQL (1990) Self-care intervention→ HRQL, social support, risk factors and health behaviours (2010) Stress management training or exercise training → psychosocial functioning, depression, anxiety, HRQL, risk factors and health behaviours (2005) Home-based psychosocial intervention program → psychosocial distress (2002) Chinese cardiac rehabilitation program → risk factors, health behaviours and chest pain (2004) Stress management program post discharge→ fatigue, depression, risk factors, health behaviours and HRQL (2002) Coaching intervention in a cardiac rehabilitation programme → attendance and rehabilitation intake, self-efficacy (2012)

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Aboriginal cardiac rehabilitation program → risk factors, health behaviours, disease and symptom management (2013)

Physical training and relaxation therapy → exercise capacity, sense of coherence, stress and HRQL (2002)


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RCT quasiexperimental

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Transcendental meditation→ chest symptoms, HRQL and electrocardiographic changes (2012)

Post PCI/ CABG RCT parallel Acupuncture → lung function and postoperative pain (2013) group Guided imagery → pain and anxiety (2015)

Educational audiotape: symptom management post discharge → Symptoms, Depression and HRQL (2010) Symptom management telehealth intervention → cardiac symptoms, HRQL, physical activity (2007)

RCT-pilot


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Aromatherapy → vital signs, anxiety and sleep quality (2013)


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Mixed Sample RCT parallel group

RCT-pilot

Lifestyle intervention, work-book and sessions (diet, smoking cessation and exercise) → cardiac events, depression, risk factors and health behaviours (2016)

Telephone counselling intervention post discharge → psychosocial adjustment, depression, anxiety, perceived control, cardiac events (2003) Web-based cardiac rehabilitation program → angina symptoms, risk factors, depression, and self –efficacy (2014) Work-book and audio tape with relaxation programme → angina symptoms, depression (2002)

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Spiritual retreat → depression, psychological symptoms, stress, hope, gratitude, HRQL, risk factors and health behaviours (2011)

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Behavioural health educational program → stress, HRQL, sense of coherence, anxiety and depression (2012)

Cardiac rehabilitation Family-Centred Empowerment Model→ perceived threat, self-efficacy, self-esteem, HRQL, stress, anxiety, risk factors and health behaviours (2016) Lifestyle modification program → exercise capacity, chest pain, depression, risk factors and health behaviours (2006) Stress management program post discharge→ stress behaviour, social support and depression (2007)

Illness representation intervention → illness perception, depression, social support and HRQL (2007)

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Cardiac rehabilitation and education program→ selfefficacy and activity (1997) Cardiac rehabilitation and education program→ HRQL, risk factors, health behaviours and readmission (2005) Cardiac rehabilitation and education program→ HRQL, risk factors and health behaviours (1997) Cardiac rehabilitation and education program → risk factors, health behaviours, recurrent cardiac events (2000)

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215x279mm (72 x 72 DPI)


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The Self-Management of Cardiac Pain in Women: An Evidence Map

Journal:

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rp Fo Manuscript ID Article Type:

Date Submitted by the Author:

Complete List of Authors:

bmjopen-2017-018549.R1 Research 10-Oct-2017

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Parry, Monica; University of Toronto, Lawrence S. Bloomberg Faculty of Nursing Bjornnes, Ann Kristin; University of Toronto, Lawrence S. Bloomberg Faculty of Nursing; Oslo and Akershus University College of Applied Sciences, Institute of Nursing and Health Promotion Clarke, Hance; University Health Network, Pain Research Unit Cooper, Lynn; Canadian Pain Coalition Gordon, Allan; Mount Sinai Hospital, Wasser Pain Management Centre Harvey, Paula; Women's College Hospital, Department of Medicine; Women's College Hospital, Women’s College Research Institute Lalloo, Chitra; Hosp Sick Children, The Peter Gilgan Centre for Research and Learning Leegaard, Marit; Oslo and Akershus University College of Applied Sciences, Institute of Nursing and Health Promotion LeFort, Sandra; Memorial University of Newfoundland - School of Nursing McFetridge-Durdle, Judith; Florida State University, College of Nursing McGillion, Michael; McMaster University, School of Nursing O'Keefe-McCarthy, Sheila; Brock University, Nursing, Faculty of Applied Sciences Price, Jennifer; Women's College Hospital, Women’s College Research Institute Stinson, Jennifer; Toronto SickKids, The Peter Gilgan Centre for Research and Learning; University of Toronto, Lawrence S. Bloomberg Faculty of Nursing Victor, J. Charles; University of Toronto, Institute of Health Policy, Management and Evaluation Watt-Watson, Judy; University of Toronto Lawrence S Bloomberg Faculty of Nursing

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Primary Subject Heading:

Cardiovascular medicine

Secondary Subject Heading:

Evidence based practice

Keywords:

Coronary heart disease < CARDIOLOGY, Ischaemic heart disease < CARDIOLOGY, Quality in health care < HEALTH SERVICES ADMINISTRATION & MANAGEMENT, PAIN MANAGEMENT, Coronary intervention < CARDIOLOGY


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Full title: The Self-Management of Cardiac Pain in Women: An Evidence Map Authors, Degrees and Affiliations: Parry M NP-Adult PhD1, Bjørnnes AK RN CNM MSc PhD1,8, Clarke H MD PhD FRCPC2, Cooper L BSc3, Gordon A MD FRCP(C)4, Harvey P BMBS PhD FRACP5,6, Lalloo C BHSc PhD7, Leegaard M RN CRNA PhD8, LeFort S MN PhD9, McFetridge-Durdle J RN PhD10, McGillion M RN PhD11, O’Keefe-McCarthy S RN PhD12, Price J RN PhD6, Stinson J RN-EC PhD CPNP1,7, Victor JC MSc13, & Watt-Watson J RN MSc PhD1

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1

Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, Toronto, ON, Canada

2

Pain Research Unit, University Health Network, Toronto, ON, Canada

3

Canadian Pain Coalition, Toronto, ON, Canada

4

Wasser Pain Management Centre, Mount Sinai Hospital, Toronto, ON, Canada

5

Department of Medicine, Women’s College Hospital, Toronto, ON, Canada

6

Women’s College Research Institute, Women’s College Hospital, Toronto, ON, Canada

7

The Peter Gilgan Centre for Research and Learning, The Hospital for Sick Children, Toronto,

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ON, Canada 8

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Institute of Nursing and Health Promotion, Oslo and Akershus University College of Applied

Sciences, Oslo, Norway

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9

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School of Nursing, Memorial University of Newfoundland, St. John’s, NL, Canada

10

College of Nursing, Florida State University, Tallahassee, Florida, United States

11

School of Nursing, McMaster University, Hamilton, ON, Canada

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12

Nursing, Faculty of Applied Sciences, Brock University, St, Catherines, ON, Canada

13

Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON,

Canada Corresponding Author: Dr. Monica Parry, Lawrence S. Bloomberg Faculty of Nursing


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155 College Street, Suite 130, Toronto, ON, Canada, M5T 1P8 Phone: 416-946-3561, Fax: 416-978-8222, Email: [email protected] Keywords: myocardial ischemia, postoperative pain, pain management, women, self-care Total Word Count: 4420

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Abstract Objective To describe the current evidence related to the self-management of cardiac pain in women using the process and methodology of evidence mapping. Design and setting Literature search for studies that describe the self-management of cardiac pain in women greater than 18 years of age, managed in community, primary care or outpatient settings, published in English or a Scandinavian language between 1 January 1990 and 24 June

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2016 using AMED, CINAHL, ERIC, EMBASE, MEDLINE, Proquest, PsychInfo, the Cochrane Library, Scopus, Swemed+, Web of Science, the Clinical Trials Registry, International Register of Controlled Trials, MetaRegister of Controlled Trials, theses and dissertations, published

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conference abstracts, and relevant websites using GreyNet International, ISI proceedings, BIOSIS, and Conference papers index. Two independent reviewers screened using predefined

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eligibility criteria. Included articles were classified according to study design, pain category,

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publication year, sample size, percent women, and mean age. Interventions Self-management interventions for cardiac pain, or non-intervention studies that

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described views and perspectives of women who self-managed cardiac pain.

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Primary and secondary outcomes measures Outcomes included those related to knowledge,

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self-efficacy, function, and health related quality of life (HRQL).

Results The literature search identified 5940 unique articles, of which 220 were included in the

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evidence map. Only 22% (n=49) were intervention studies. Sixty-nine percent (n=151) of the studies described cardiac pain related to obstructive CAD, 2% (n=5) non-obstructive CAD, and 15% (n=34) post-PCI/cardiac surgery. Most were published after 2000, the median sample size was 90 with 25 to 100 percent women, and the mean age was 63 years. Conclusions Our evidence map suggests that while much is known about the differing presentations of obstructive cardiac pain in middle-aged women, little research focused on young


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and old women, non-obstructive cardiac pain, or self-management interventions to assist women to manage cardiac pain. Systematic Review Registration Number PROSPERO CRD42016042806.

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Strengths and limitations of this study •

This evidence map provides a overview of a broad range of research based on a systematic search of 20 databases including grey literature sources published in English or a Scandinavian language between 1 January 1990 and 24 June 2016

•

Including only studies published in English or Scandinavian language may be seen as a limitation, however we chose to include a robust search of the grey literature in an attempt

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to reduce a potential publication bias •

Despite having health care providers and researchers involved in establishing the scope of the evidence map, our search strategy may not have targeted what women themselves see

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as the most important aspects of the self-management of cardiac pain •

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Additional search terms and keywords (e.g., breathlessness, fatigue, sleep problems) and emotional sequelae (e.g., anxiety, depression) may have identified additional self-

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management interventions targeted to cardiac pain and symptoms in women •

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This comprehensive evidence map identified evidence gaps and future research needs specifically focused on the self-management of cardiac pain in women

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Background In 2015, more than 110 million people worldwide were affected by coronary artery disease (CAD),1 and the number is expected to increase over the next decades.2 Coronary artery disease is increasing in women less than 55 years of age due to rising obesity and diabetes rates.3 In 2013, 30% more women died of CAD than cancer (including breast cancer) in the United States (US).4 According to most recent mortality statistics in Europe5 (2015), CAD is the most common

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cause of death and accounts for 20% of all deaths among women. Cardiac pain has been considered the primary indicator of CAD,6 and each year 4.5 million individuals are evaluated for cardiac pain in emergency departments in the US.7 Cardiac pain

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disproportionately burdens more women than men, and women have a varied pattern and

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distribution of pain symptoms associated with both obstructive and non-obstructive CAD.8,9 Women also have a higher prevalence of clinically relevant cardiac pain after percutaneous

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coronary interventions (PCI) and cardiac surgery and report more persistent pain of moderate to

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severe intensity up to two years after cardiac surgery.10-12 Poorly controlled acute pain (ischemic

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and procedural) is a risk factor for persistent pain, a debilitating complication for women following cardiac surgery.13,14

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The identification and management of cardiac pain associated with CAD are vital to minimize

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risk of a major adverse cardiac event (MACE). Women with obstructive and non-obstructive CAD have cardiac pain that differs from that of men. Women describe their pain as sharp and burning, with additional symptoms of discomfort in the jaw, neck, shoulders, arms, back and epigastric area.6,8 Women’s pain and symptoms vary in frequency and distribution, making it difficult for them to interpret as cardiac-specific.8,15 Non-obstructive CAD (Cardiac Syndrome X) is angina-like chest discomfort without evidence of coronary artery obstruction.16 Non-


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obstructive CAD is more prevalent in younger, middle-aged women and evidence suggests that more extensive, non-obstructive CAD, hypertension, and diabetes are associated with MACE similar to those with obstructive CAD.9,17 These women suffer from persistent and incapacitating cardiac pain, are at risk for impaired function, depression, poor health-related quality of life (HRQL), and death.18 They are also frequent users of health care services (emergency room, hospitalization, and repeat diagnostic evaluation).19

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The risk of future coronary events for women who present with cardiac pain, additional symptoms and/or cardiac pain equivalents can be classified into risk categories that can be used to guide further assessment and evaluation.20,21 In addition to having difficulty interpreting

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cardiac pain, women minimize their symptoms, prefer to consult with family and friends, and

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have caring responsibilities and concerns for their family.22 As a result, women delay assessment and diagnostic evaluation;23 the time from symptom onset to emergency department arrival for

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women is 85 to 320 minutes, and this has not changed in the last decade.24 Over 25% of women

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will die within a year of their first myocardial infarction (MI) compare to 19% of men; and 47%

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of women will die within five years of their first MI compared to 36% of men.25

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The under-recognition of women`s symptoms as well as the difficulty in diagnosing cardiac pain in women contribute to poorer outcomes and greater mortality rates in women as compared to

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men.6 Outcomes are also associated with a person’s ability to self-manage their condition in everyday life. A variety of new skills have to be learned; to comply with medication regimes, to establish and sustain new and healthier lifestyle routines, monitor and manage symptoms, and recognize when to seek help when symptoms occur.26 Self-management programs are designed to allow people to take an active part in the management of their condition through problem solving, decision-making, action planning, self-tailoring, and the formation of patient-provider


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partnerships.27 28 Due to the complexity of cardiac pain in women, there is an increased need to develop mechanisms to assist women to recognize and manage their pain. We conducted an comprehensive review of the literature to understand the current body of knowledge on selfmanagement programs for women with cardiac pain using methods described by the Evidence for Policy and Practice Information (EPPI) and the Coordinating Centre at the Institute of Education.29-33 In this paper we will describe the first step in the EPPI review process, to establish

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the current evidence related to the self-management of cardiac pain in women using the process and methodology of evidence mapping. Methods

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The main purpose of evidence mapping is to provide an overview of a broad range of research

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and identify evidence gaps and future research needs.34 The evidence map is broad in scope, and is primarily focused on identifying and describing the characteristics of the evidence base.35 It is

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the first step in conducting an integrated mixed methods systematic review29-33 and it does not

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necessarily include quality appraisal of the included studies.36 Six steps were used to construct an

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evidence map of cardiac pain in women.37 1) identify the scope of the evidence map, 2) define the key variables, 3) establish a comprehensive search strategy, 4) identify study inclusion and

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exclusion criteria, 5) systematically retrieve, screen and classify the evidence, and 6) report the findings in an evidence map.

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Identify the scope of the evidence map The initial scope of the work was established by the research team to focus on three types of cardiac pain in women: 1) obstructive CAD, 2) non-obstructive CAD, and 3) post-procedure (PCI and cardiac surgery). The research question and the study eligibility criteria were discussed in a consultation session with health care providers (physicians and nurses) and researchers working


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in cardiology, cardiac surgery and adult multidisciplinary chronic pain clinics. An overarching review question was established, and purposefully kept broad to ensure a comprehensive review of the evidence: What is known about the self-management of cardiac pain in women? This question could be answered by a broad range of quantitative and qualitative evidence, including systematic reviews, randomized controlled trials (RCT), cohort studies, cross-sectional, case control studies and case series/ reports.

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Define the key variables

We utilized the PICO framework38 to focus our research question and to facilitate the literature search. The PICO question elements included population, intervention, comparison, and

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outcomes. Keywords and the National Library of Medicine’s Medical Subject Headings (MeSH)

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were combined under the three PICO categories: P) women, I) self-management, and O) cardiac pain (Table 1). In this instance we did not search using a comparator to maintain breadth of our

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evidence map.

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- Insert Table 1 Establish a comprehensive search strategy

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The literature on the self-management of cardiac pain in women was systematically searched using keywords and MeSH headings in accordance with the search criteria in the bibliographic

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databases. Publications needed to be available in English or a Scandinavian language and published between 1 January 1990 and 24 June 2016 (inclusive). Searches were conducted in July 2016 using selected databases: AMED (Allied and Complementary Medicine), CINAHL, ERIC, EMBASE, MEDLINE, Proquest, PsychInfo, the Cochrane Library, Scopus, Swemed+ and Web of Science. For ongoing and recently completed clinical trials we searched the Clinical Trials Registry, International Register of Controlled Trials and the MetaRegister of Controlled Trials.


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Grey literature sources included theses and dissertation, published conference abstracts, and relevant websites using GreyNet International, ISI proceedings, BIOSIS, and Conference papers index. Publication citations were exported from electronic search interfaces to Endnote. Identify study inclusion and exclusion criteria The inclusion criteria were kept broad, and studies were included if they focused on the self-

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management of cardiac pain in women, or described the views and perspectives of women who had cardiac pain independent of the research design. Types of participants included women who were greater than 18 years of age with cardiac pain, managed in the community, primary care or outpatient settings. Types of outcomes included those related to knowledge, self-efficacy,

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physical and mental function, social and role function, and health related quality of life (HRQL).

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Lastly, the number of women included in the studies needed to be at least 25% to adequately represent the ratio of men and women who have cardiac disease.4

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Systematically retrieve, screen and classify the evidence

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Title and abstracts of all identified articles were screened in the first round. Studies were

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excluded if they were not about the self-management of cardiac pain in women, or described the

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views and perspectives of women who had cardiac pain. A random sample of excluded studies (n=50) was discussed between the two reviewers to establish screening accuracy and to confirm

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understanding of the study eligibility criteria. The second round was based on the full text screening and followed all the predefined study eligibility criteria. The articles were singlescreened due to the large number and time constraints. If the reviewer was unsure about inclusion/exclusion of an article the second reviewer was consulted to confirm inclusion/exclusion. The included articles were classified and described according to study design as per the hierarchy of evidence (i.e., systematic reviews/meta-analyses, intervention studies


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[randomized controlled trials (RCTs)], and non-intervention studies [prospective, retrospective/case control, and cross-sectional]) and according to pain category (i.e., obstructive CAD, non-obstructive CAD, post procedure [PCI/cardiac surgery] and mixed). To ensure characteristics of primary research studies were not overrepresented, descriptions of the systematic reviews and systematic reviews with meta-analyses were not included in the final evidence map.39

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Report the findings in an evidence map Only characteristics of the primary research studies (i.e., country, study design, pain category, publication year, sample size, percent women, and mean age) were included in the final evidence

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map. Primary research study bubble plots (i.e., weighted scatter plots) were used to graphically

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illustrate the relationships between: 1) percent women, study design and type of cardiac pain across year of publication, weighted by sample size, and 2) age and type of cardiac pain across

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year of publication, weighted by sample size. All analyses were performed using Stata statistical

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software.40

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Results Identification of studies

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In total, 6582 eligible citations were identified from searching commercially available

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bibliographic databases and grey literature sources (Figure 1). After the first screening, a total of 1,368 citations were deemed to meet the eligibility criteria. Full text reports were obtained and processed for 1,125 (82%) of the citations. Seventy-four percent (n=837) of these did not meet the eligibility criteria, mainly because the outcomes were not related to cardiac pain or the number of women included was less than 25%. In addition, 6% (n=68) were excluded because they were systematic reviews or systematic reviews with meta-analyses. Twenty percent (n=220)


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were primary research studies and were included in the final evidence map: 22% (n=49) were intervention studies (RCTs) and 78% (n=171) were non-intervention studies (prospective, retrospective/case control, and cross-sectional). - Insert Figure 1 Thirty-three percent (n=73) of the studies were identified through grey literature sources. The majority of these (n=60, 82%) were dissertations related to obstructive CAD.

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Characteristics of the primary research studies Of the 220 primary research studies, 98 (45%) were conducted in North America and 44 (20%) in Western Europe. No relevant studies from the African continent and only one study from South-

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America (i.e., Brazil) were identified. Thirteen percent (n=29) of the studies were published

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before year 2000, 52% (n=114) between 2000 and 2010, and 35% (n=77) were published after 2010. Sixty-nine percent (n=151) of the included studies on cardiac pain in the evidence map

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represented obstructive CAD, 2% (n=5) non-obstructive CAD, 15% (n=34) post PCI or cardiac

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surgery pain, and 14% (n=30) of studies were a mixed sample of obstructive CAD and post

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PCI/cardiac surgery pain. Characteristics of the primary research studies according to pain category are outlined in Table 2. - Insert Table 2 -

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There were a total of 61,891 participants (29,552 [48%] women) included across studies, and the mean age was 63 years (range 47 to 80 years). The median sample size was 90 (range 7 to 7093), the mean proportion of women was 56%, and 58 (26%) of studies included only women (n=15,071). The relationship between the percent women, study design, type of cardiac pain and year of publication are depicted in Figure 2. Figure 3 illustrates the relation between mean age and sample size across years of publication and pain categories.


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- Insert Figure 2 - Insert Figure 3 Characteristics of the intervention studies Forty-nine (22%) of the studies on cardiac pain focused on interventions, including 33 (67%) RCTs with parallel group design, seven (14%) RCT-pilots and nine (18%) quasi-experimental

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RCTs. Twenty-six (53%) of the RCTs assessed the effectiveness of interventions targeting men and women with obstructive CAD. Three RCTs (6%) included women with non-obstructive CAD. Post-procedural pain was the main or secondary outcome of seven (14% [cardiac surgery: n=4, PCI: n=2, mixed: n=1]) RCTs, and 13 (27%) RCTs had a mixed sample of both obstructive

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and post-PCI/cardiac surgery pain. Interventions investigating cardiac pain related to obstructive

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CAD and post procedure (PCI/CABG) included 25 to 100% of their sample as women. In comparison, interventions targeting cardiac pain due to non-obstructive CAD only included

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women (i.e., no men). The RCTs evaluated outcomes of different self-management interventions

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that were broad, and targeted cardiac pain and symptom management through Complementary

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and Alternative Medicine (CAM) interventions or self-management support delivered in groups, over the Internet, face to face or with help of other educational resources (e.g., information

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sheets, videos). The median duration of the interventions was 2 months (range < 1 week to 24

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months), and the median follow-up time was 4 months (range < 1 week to 9 years). The interventions and outcomes according to pain category and year of publication are outlined in Table 3. - Insert Table 3 Patient-reported outcomes across the RCTs included cardiac pain frequency and/or intensity, bodily pain, HRQL or other psychosocial factors associated with cardiac pain including fatigue,


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stress, depressive symptoms, anxiety, catastrophizing, coping, self-efficacy, sense of coherence, and personality traits. A majority of the studies also included objective outcomes related to cardiac risk factors (e.g., blood pressure, weight, cholesterol levels, blood glucose, and ischemic stress tests) and patient self-reports about health behaviours (e.g., smoking, activity, and dietary habits). The most common data collection methods used in approximately 90% of the intervention studies were validated self-reported questionnaires collected on site by the research

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team or sent out by mail. Outcomes were also extracted from medial charts or registries. Ten percent of the studies collected data through telephone surveys or face-to-face interviews using standardized interview guides. A combination of quantitative and qualitative methods was found in one study.

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Characteristics of non-intervention studies

In total, we identified 171 non-intervention studies: 49 (29%) prospective, 41 (24%)

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retrospective, and 78 (46%) cross-sectional. In addition, three (2%) studies had a case-control

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design (Table 2). The majority (n=125, 73%) of the non-intervention studies focused on women

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with obstructive CAD, 63 (50%) of these were cross-sectional studies. Two (1%) cross-sectional studies investigated cardiac pain and symptoms in women with non-obstructive CAD. Similar to

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the intervention studies, non-interventions studies investigating cardiac pain related to obstructive

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CAD and post procedure (PCI/CABG) included 25 to 100% of their sample as women, and all non-interventions studies in non-obstructive CAD included women only. Outcomes assessed were similar to those outcomes described for the intervention studies. Validated self-reported questionnaires were used in approximately 75% of the quantitative non-intervention studies, and 25% used structural interviews delivered face-to-face or by telephone. In addition, 52 (30%) of the non-intervention studies used qualitative interviews (i.e., semi-structured or in-depth


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interview), and 11 (7%) used focus group interviews to collect data. A combination of quantitative and qualitative methods was found in 11 (7%) studies. The majority of the qualitative and mixed method studies were related to obstructive CAD (n=54, 73%) that explored women`s cardiac pain and symptom experiences. Cardiac pain appraisal and pain self-management strategies were also investigated, primarily with a focus on pre-hospital delays, barriers/challenges (e.g., knowledge deficits) or sequelae after the cardiac event (e.g., anxiety,

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depression, fatigue) and impact on everyday life. Self-management strategies primarily included education and eHealth interventions, and strategies targeted to CAM. No qualitative study was found to focus on women with non-obstructive CAD. Five studies explored women`s experiences

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after cardiac surgery, and two studies explored women`s experiences with cardiac rehabilitation in mixed samples of women after cardiac events (e.g., MI and cardiac surgery).

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Seventeen (10%) studies explored association between ethnicity and obstructive CAD

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descriptions and recognition in women, and most (n=10, 58%) were cross sectional studies. In

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addition, among studies conducted in the US, the sample often included minority ethnic groups

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(e.g., African-American, Hispanic) but outcomes were rarely reported for these groups separately. Discussion

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The studies included in our evidence map provide a very comprehensive broad overview of the evidence on the self-management of cardiac pain in women published between 1 January 1990 and 24 June 2016. Main results confirm those of the Committee on Women’s Health Research41 suggesting there has been some progress in the increased representation of women in cardiovascular health research and increased knowledge about atherosclerotic disease in women, such as sex differences in the pathophysiology of CAD, symptom presentation, and clinical


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outcomes. However, our results are consistent with more recent evidence42,43 that suggest a general lack of research incorporating: 1) sex and gender, 2) women younger than 50 years and older than 75 years, and 3) self-management interventions. Sex and gender terms are not interchangeable.44 Sex refers to the anatomy of an individual`s reproductive system and gender refers to socially constructed characteristics of women and men

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based on behaviours, expressions and identities.45 We identified 57 (26%) studies that included only women (1990 to September 2016) and 84 (38%) studies that had fewer than 40% women in the total sample. Underrepresentation of women (< 25%) was one of the main reasons for exclusion of studies in our second screening, and this was to ensure that we had a representative

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sample of studies reflecting the ratio of men and women with cardiovascular disease. So despite

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the reported progress in the increased representation of women in cardiovascular health research, our results suggest this gap still exists and is supported but more recent evidence.46 In addition to

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sex, there is a need to identify and examine gender differences in self-management interventions

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for cardiac pain. Pilote and Norris reported gender was associated with higher rates of recurrent

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acute coronary syndrome and MACE.47 Other psychosocial factors (e.g., depression) have been linked to adverse outcomes after an MI;48 50% of women less than 50 years of age and 40% of

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women between 50 and 60 years of age have major depression.49 In addition to depression,

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women with premature MI are often from minority groups and have low socioeconomic status and exposure to sexual abuse during childhood.49 Researchers must consider the complex interrelationships between the anatomical/physiological aspects, psychological processes, and the person`s interaction within the sociocultural context44 when designing self-management interventions apriori rather than adjusting for them in the analyses.50


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Over 25% of women will die within a year of their first MI compare to 19% men; and 47% women will die within five years of their first MI compared to 36% men.25 These disparities are associated with age, ethnicity and risk factor burden (e.g., depression).51 These disparities lead to women delaying to seek medical care for their cardiac pain.23 In a recent integrated review including 23 studies in 17 different countries52 older age, female gender, ethnicity, lower socioeconomic status, and symptom knowledge deficits were associated with mean delay times of

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3.4 hours. Only three studies in this review52 included a sub-analysis by ethnicity, and these studies reported that Blacks, Asians, Hispanics and South Asians had longer delays in seeking medical care compared to Caucasians. Ethnicity and culture affect perceptions of chest pain and

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aspects of a woman’s life that includes caregiving, education, employment, and self-management practices.43 We found 17 studies that focused on ethnicity and symptom experience, a majority of

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these were cross-sectional studies conducted in North-America and included women with African

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or Hispanic origins. Indigenous people experience greater cardiovascular disease burden,53 yet only one quasi-experimental RCT targeted indigenous women.54 This indicates that we have little

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research-based information on which to develop effective self-management interventions for nonCaucasians across all cardiac pain categories.

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The majority of studies in the evidence map included women 50 to 75 years of age. In view of the

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increasing incidence of CAD and higher death rates in younger women with obstructive CAD compared to men,55,56 this research gap is disturbing. Women`s increased risks for macrovascular or obstructive CAD are linked to higher obesity and diabetes rates,55 and diabetes also concurs an accelerated risk for microvascular or non-obstructive CAD in younger women.17 Health care costs attributable to non-obstructive cardiac pain is increasing,19 and the lack of recognition and assessment of early symptoms in younger women may underpin a negative trajectory.43 Younger


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women with CAD are more likely to have caregiving responsibilities, marital/family dysfunction, and poorer perceived social support compared with men and older women.55 Our results suggest that we need to include women younger than 50 years and older than 75 years in selfmanagement research related to cardiac pain. A recent Scientific Statement from the American Heart Association43 indicates that self-

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management interventions specifically tailored for women only are more effective. Selfmanagement interventions allow people to take an active part in the management of their own conditions27 and are important predictors of successful behavior change.57 In addition to reducing pain, self-management interventions improve HRQL.58-63 Self-management is one of the six

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components of the Chronic Care Model (CCM);64-66 and personal efforts to engage in self-

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management cannot be made without consideration to other CCM components, such as the community and provider decision supports. We recommend utilizing a strong theoretical model

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to guide the design and evaluation of self-management interventions focused on the sex and

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gendered aspects of cardiac pain in women. For example, the Individual and Family Self-

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Management Theory targets context (condition specific factors, physical and social environments), process (goal setting, self-monitoring, decision making, planning and engaging in

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specific behaviors, collaboration) and outcomes (health status, HRQoL, cost)67,68 and could be used to design tailored interventions for women with cardiac pain.

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Non-pharmacologic interventions women used to self-manage obstructive and post-procedural cardiac pain included physical exercise and relaxation, cognitive-behavioural therapy, music, aromatherapy, acupuncture, and peer support. Many of these interventions were often incorporated as part of rehabilitative treatment approaches. Psychological treatments were generally separated into theoretically based approaches (e.g., acceptance-based and mindfulness


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therapy) and more specific techniques (e.g., cognitive behaviour therapy, relaxation and hypnosis).69 Non-pharmacologic persistent pain interventions were in general not only about reducing pain intensity but also pain interference and the disability associated with symptoms.69 In addition to cardiac pain frequency, outcomes emphasised HRQL and other biopsychosocial factors associated with cardiac pain. This is a promising direction for future research, particularly for women who experience cardiac pain without evidence of coronary artery obstruction, or

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continue to have cardiac pain despite coronary interventions. Creating mechanisms to assist women to recognise and manage cardiac pain and symptoms and guide them to seek appropriate assessment and evaluation are absolutely necessary in future research studies.20,70 And although

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women are more likely to have cardiac pain in the absence of obstructive CAD, the evidence is inconclusive.71 For these women, elimination of physical causes of pain is not always possible.

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We found only five studies addressing cardiac pain in women with non-obstructive CAD; no

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qualitative study was found suggesting little in-depth knowledge exists about how women describe, manage and make decisions about non-obstructive cardiac pain. Addressing this

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knowledge gap is essential before developing self-management interventions to meet the unique

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needs of these women. Cardiac pain is complex, and the need for holistic treatment approaches

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has been emphasized.72 In total, 19 (9%) studies across cardiac pain categories and study designs focused on complementary approaches (i.e., CAM) for cardiac pain. These interventions aligned

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with the complementary integrative medicine interventions for persistent pain summarized in a systematic review by Delgado et al.73 Only eight of the studies in our evidence map, including 2% (n=554) of the total trial participants in the 49 intervention studies, assessed the effect of CAM interventions in RCTs. This indicates that we are lacking strong evidence to routinely include CAM interventions in cardiac pain treatment strategies for women.


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Limitations This evidence map is based on a comprehensive and systematic search of 20 databases including grey literature sources. Despite the high number of potentially eligible studies, many were either not relevant to cardiac pain or the number of women included in the studies was too low. Including only studies published in English or Scandinavian language may be seen as a limitation, however we chose to include a robust search of the grey literature in an attempt to

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reduce this potential publication bias.74 The articles in the second round of full text screening were also single-screened, which may be seen as a limitation. However, if there was uncertainty about an article a second reviewer was consulted to confirm inclusion/exclusion.

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Despite having health care providers and researchers involved in establishing the scope of the

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evidence map, our search strategy may not have targeted what women themselves see as the most important aspects of the self-management of cardiac pain. Cardiac pain is a subjective

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experience, and is associated with physical symptoms (e.g., breathlessness, fatigue, sleep

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problems) and emotional sequelae (e.g., anxiety, depression).75 Additional search terms and

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keywords related to cardiac pain and symptoms may have increased our probability of identifying self-management interventions. The next step in the EPPI review process is to present results of

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this broad mapping and screening exercise to women with cardiac pain (obstructive CAD, non-

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obstructive CAD and post-procedure [PCI and cardiac surgery]), to re-confirm our search terms for a more targeted in-depth search and review including quality appraisal of intervention and non-intevention studies to enhance the self-management of cardiac pain in women. Conclusions We aimed to describe the current evidence related to the self-management of cardiac pain in women using the process and methodology of evidence mapping. It was not to present individual


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study results or synthesis of results, but to describe the process and methodology for creating an evidence map database, using the topic of self-management of cardiac pain in women. Results from this mapping process suggest that evidence about risk factors, clinical presentations, and symptom experiences in women are emerging, particularly for middle-aged women with obstructive CAD. While much is known about the differing presentations of cardiac pain in women, not enough is known about young and old women, women with non-obstructive CAD,

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and little has been done to help women manage their pain. Self-management intervention trials are lacking across all cardiac pain categories (obstructive CAD, non-obstructive CAD and postprocedure [PCI and cardiac surgery]). Further research to develop mechanisms to assist women

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to recognize and manage cardiac pain, utilizing a strong theoretical model to address contextual and process components of self-management, are needed.

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References 1.

Steel, Nicholas. Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries, 1990–2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet 2016, 388(10053):1545-1602.

2.

Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med. 2006;3(11):e442.

3.

rp Fo

Balakumar P, Maung-U K, Jagadeesh G. Prevalence and prevention of cardiovascular disease and diabetes mellitus. Pharmacol Res. 2016;113:600-609.

4.

Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, de Ferranti S,

ee

Despres JP, Fullerton HJ, Howard VJ, Huffman MD, Judd SE, Kissela BM, Lackland DT, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Matchar DB, McGuire DK, Mohler ER,

rr

Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L,

ev

Pandey DK, Reeves MJ, Rodriguez CJ, Sorlie P, Stein J, Towfighi A, Turan TN, Virani SS, Willey JZ, Woo D, Yeh RW, Turner MB. Executive Summary: Heart Disease and

ie

Stroke Statistics-2016 Update: A Report From the American Heart Association. Circulation. 2016;133(4):447.

on

5.

w

Townsend N, Wilson L, Bhatnagar P, Wickramasinghe K, Rayner M, Nichols M. Cardiovascular disease in Europe: epidemiological update 2016. Eur Heart J. 2016; 37(42), 3232-3245.

6.

ly

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60

BMJ Open

McSweeney J, Cleves MA, Fischer EP, Moser DK, Wei JY, Pettey C, Rojo MO, Armbya N. Predicting Coronary Heart Disease Events in Women A Longitudinal Cohort Study. J Cardiovasc Nurs. 2014;29(6):482-492.

7.

HCUPnet HC. Utilization Project: Agency for Healthcare Research and Quality, Rockville, MD. United States Department of Health & Human Services. 2016.


22

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8.

Canto JG, Canto EA, Goldberg RJ. Time to standardize and broaden the criteria of acute coronary syndrome symptom presentations in women. Can J Cardiol. 2014;30(7):721728.

9.

Pepine C, Ferdinand K, Shaw L, Light-McGroary KA, Shah RU, Gulati M, Duvernoy C, Walsh MN, Merz, CN. Emergence of Nonobstructive Coronary Artery Disease: A Woman's Problem and Need for Change in Definition on Angiography. J Am Coll

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Cardiol. 2015;66(17):1918-1933. 10.

Kok MM, van der Heijden LC, Sen H, Danse PW, Lowik MM, Anthonio RL, Louwerenburg JH, de Man FH, Linssen GC, Ijzerman MJ, Doggen CJ, Maas AH, Mehran

ee

R, von Birgelen C. Sex difference in chest pain after implantation of newer generation coronary drug-eluting stents: a patient-level pooled analysis from the TWENTE and

rr

DUTCH PEERS trials. JACC Cardiovasc Interv. 2016;9(6):553-561. 11.

ev

Choiniere M, Watt-Watson J, Victor JC, Baskett R, Bussieres J, Carrier M, Cogan J, Costello J, Feindel C, Guertin MC, Racine M, Taillefer MC. Prevalence of and risk

ie

factors for persistent postoperative nonanginal pain after cardiac surgery: a 2-year

w

prospective multicentre study. CMAJ. 2014;186(7):E213-223. 12.

on

Katz J, Weinrib A, Fashler S, Katznelzon R, Shah BR, Ladak SJS, Jiang J, Li Q, McMillan K, Santa MD, Wentlandt K, McRae K, Tamir D, Lyn S, de Perrot M, Rao V,

ly

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60

Page 24 of 45

Grant D, Roche-Nagle G, Cleary SP, Hofer SOP, Gilbert R, Wijeysundera D, Ritvo P, Janmohamed T, O’Leary G, Clarke H. The Toronto General Hospital Transitional Pain Service: development and implementation of a multidisciplinary program to prevent chronic postsurgical pain. J Pain Res. 2015;8:695-702.


23

Page 25 of 45

13.

King KM, Parry M, Southern D, Faris P, Tsuyuki RT. Women's Recovery from Sternotomy-Extension (WREST-E) study: examining long-term pain and discomfort following sternotomy and their predictors. Heart. 2008;94(4):493-497.

14.

Bjornnes AK, Parry M, Lie I, Fagerland MW, Watt-Watson J, Rustoen T, Stubhaug A, Leegaard M. Pain experiences of men and women after cardiac surgery. J Clin Nurs. 2016;25(19-20):3058-3068.

15.

rp Fo

Kirchberger I, Heier M, Wende R, von Scheidt W, Meisinger C. The patient's interpretation of myocardial infarction symptoms and its role n the decision process to seek treatment: the MONICA/KORA Myocardial Infarction Registry. Clin Res Cardiol. 2012;101:909-916.

Agrawal S, Mehta PK, Bairey Merz CN. Cardiac Syndrome X: Update 2014. Cardiol Clin. 2014;32(3):463-478.

ev

17.

rr

16.

ee

Pizzi C, Xhyheri B, Costa GM, Faustino M, Flacco ME, Gualano MR, Fragassi G, Grigioni F, Manzoli L. Nonobstructive Versus Obstructive Coronary Artery Disease in

ie

Acute Coronary Syndrome: A Meta‐Analysis. J Am Heart Assoc. 2016;5(12):e004185. 18.

w

Altintas E, Yigit F, Taskintuna N. The impact of psychiatric disorders with cardiac

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syndrome X on quality of life: 3 months prospective study. Int J Clin Exp Med. 2014;7(10):3520-3527. 19.

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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60

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Arthur H, Campbell P, Harvey P, McGillion M, Oh P, Woodburn E, Hodgson C. Women, Cardiac Syndrome X, and Microvascular Heart Disease. Can J Cardiol. 2012;28:S42S49.

20.

Mieres J, Gulati M, Merz N, Berman DS, Gerber TC, Hayes SN, Kramer CM, Min JK, Newby LK, Nixon JV, Srichai MB, Pellikka PA, Redberg RF, Wenger NK, Shaw LJ. Role of Noninvasive Testing in the Clinical Evaluation of Women with Suspected


24

BMJ Open

Ischemic Heart Disease: A Consensus Statement from the American Heart Association. Circulation. 2014;130(350-379):350-379. 21.

Shaw LJ, Tandon S, Rosen S, Mieres JH. Evaluation of suspected ischemic heart disease in symptomatic women. Can J Cardiol. 2014;30(7):729-737.

22.

Sjostrom-Strand A, Fridlund B. Women's descriptions of symptoms and delay reasons in seeking medical care at the time of a first myocardial infarction: A qualitative study. Int J

rp Fo

Nurs Stud. 2008;45:1003-1010. 23.

von Eisenhart Rothe A, Albarqouni L, Gartner C, Walz L, Smenes K, Ladwig K. Sex specific impact of prodromal chest pain on pre-hospital delay time during an acute

ee

myocardial infarction: Findings from the multicenter MEDEA Study with 619 STEMI patients. Int J Cardiol. 2015;201:581-586. 24.

rr

Sabbag A, Matetzky S, Gottlieb S, Fefer P, Kohanov O, Atar S, Zahger D, Porter A,

ev

Koifman B, Goldenberg I, Segev A. Recent temporal trends in the presentation, management, and outcome of women hospitalized with acute coronary syndromes. The

25.

Mozaffarian D, Benjamin E, Go A, et al. Heart Disease and Stroke Statistics - 2015

on

Update. Circulation. 2015;131:e1-e294.

Jaarsma T, Strömberg A, Mårtensson J, Dracup K. Development and testing of the

ly

26.

w

Am J Med. 2015;128(4):380-388.

ie

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60

Page 26 of 45

European Heart Failure Self‐Care Behaviour Scale. Eur J Heart Fail. 2003;5(3):363-370. 27.

Lorig K, Holman H. Self-management education: history, definition, outcomes, and mechanisms. Ann Behav Med. 2003;26(1):1-7.

28.

Osborne RH, Batterham R, Livingston J. The Evaluation of Chronic Disease SelfManagement Support Across Settings: The International Experience of the Health


25

Page 27 of 45

Education Impact Questionnaire Quality Monitoring System. Nurs Clin North Am. 2011;46(3):255-270. 29.

EPPI. EPPI Centre: Evidence for Policy and Practice Information and Coordinating Centre. http://eppi.ioe.ac.uk/cms/. Accessed April 5, 2015.

30.

Oliver S, Harden A, Rees R. An emerging framework for including different types of evidence in systematic reviews for public policy. Evaluation. 2005;11(4):428-446.

31.

rp Fo

Pope C, Mays N, Popay J. Synthesizing Qualitative and Quantitative Health Evidence. New York: McGraw Open University Press; 2007.

32.

Harden A, Garcia J, Oliver S, Rees R, Shepherd J, Brunton G, Oakley A. Applying

ee

systematic review methods to studies of people’s views: an example from public health research. J Epidemiol Community Health. 2004;58(9):794-800. 33.

rr

Thomas J, Harden A, Oakley A, Oliver S, Sutcliffe K, Rees R, Brunton G, Kavanagh J.

ev

Integrating qualitative research with trials in systematic reviews. Bmj. 2004;328(7446):1010-1012.

Miake-Lye IM, Hempel S, Shanman R, Shekelle PG. What is an evidence map? A

w

35.

ie

systematic review of published evidence maps and their definitions, methods, and products. Syst Rev. 2016;5(1):1.

Gaarder M. Evidence gap maps -- a tool for promoting evidence-informed policy and prioritizing future research. The World Bank; Vol 625; 2013.

36.

ly

35.

on

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60

BMJ Open

Bragge P, Clavisi O, Turner T, Tavender E, Collie A, Gruen RL. The global evidence mapping initiative: scoping research in broad topic areas. BMC Med Res Methodol. 2011;11(1):1.


26

BMJ Open

37.

Wang DD, Shams-White M, Bright OJM, Parrott JS, Chung M. Creating a literature database of low-calorie sweeteners and health studies: evidence mapping. BMC Med Res Methodol. 2016;16(1):1.

38.

Schardt C, Adams MB, Owens T, Keitz S, Fontelo P. Utilization of the PICO framework to improve searching PubMed for clinical questions. BMC Med Inform Decis Mak. 2007;7(1):1.

39.

rp Fo

Ballard M, Montgomery P. Risk of bias in overviews of reviews: a scoping review of methodological guidance and four-item checklist. Res Synth Methods. 2017;8(1):92-108.

40.

StataCorp. 2013. Stata Statistical Software: Release 13. College Station, TX: StataCorp

ee

LP. 41.

Adler N, Adashi E, Aguilar-Gaxiola S, et al. Women’s Health Research: Progress,

rr

Pitfalls, and Promise. Washington, DC: Institute of Medicine’s Committee on Women’s Health Research 2010

Mazure CM, Jones DP. Twenty years and still counting: including women as participants

ie

42.

ev

and studying sex and gender in biomedical research. BMC Womens Health. 2015;15:94. 43.

w

McSweeney JC, Rosenfeld AG, Abel WM, Braun LT, Burke LE, Daugherty SL, Fletcher

on

GF, Gulati M, Mehta LS, Pettey C, Reckelhoff JF. Preventing and Experiencing Ischemic Heart Disease as a Woman: State of the Science A Scientific Statement From the

ly

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60

Page 28 of 45

American Heart Association. Circulation. 2016;133(13):1302-1331. 44.

Day S, Mason R, Lagosky S, Rochon PA. Integrating and evaluating sex and gender in health research. Health Res Policy Syst. 2016;14(1):75.

45.

Canadian Institutes of Health Research. Definitions of Sex and Gender. 2015. http://www.cihr-irsc.gc.ca/e/47830.html. Accessed 6 Dec. 2016.


27

Page 29 of 45

46.

Hayes SN, Wood SF, Mieres JH, Campbell SM, Wenger NK. Taking a giant step toward women's heart health: Finding policy solutions to unanswered research questions. Womens Health Issues. 2015;25(5):429-432.

47.

Pelletier R, Khan NA, Cox J, Daskalopoulou SS, Eisenberg MJ, Bacon SL, Lavoie KL, Daskupta K, Rabi D, Humphries KH, Norris CM, Thanassoulis G, Behiouli H, Pilote L. Sex versus gender-related characteristics: which predicts outcome after acute coronary

rp Fo

syndrome in the young? J Am Coll Cardiol. 2016;67(2):127-135. 48.

Lichtman J, Froelicher EB, JA., Carney R, et al. Depression is a risk factor for poor prognosis among patients with acute coronary syndrome: systematic review and

ee

recommendations. A scientific statement from the American Heart Association. Circulation. 2014;129:1350-69. 49.

rr

Vaccarino V, Shah A, Rooks C, et al. Sex differences in mental stress-induced myocardial

ev

ischemia in young survivors of an acute myocardial infarction. Psychosom Med. 2014;76:171-80.

Gahagan J, Gray K, Whynacht A. Sex and gender matter in health research: addressing

w

50.

ie

health inequities in health research reporting. Int J Equity Health.. 2015;14(1):12. 51.

on

D'Onofrio G, Safdar B, Lichtman JH, et al. Sex differences in reperfusion in young patients with ST-segment-elevation myocardial infarction: results from the VIRGO study. Circulation. 2015;131(15):1324-32.

52.

ly

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60

BMJ Open

Wechkunanukul K, Grantham H, Clark RA. Global review of delay time in seeking medical care for chest pain: An integrative literature review. Aust Crit Care. 2016;30(1):13-20


28

BMJ Open

53.

Foulds HJ, Bredin SS, Warburton DE. Greater prevalence of select chronic conditions among Aboriginal and South Asian participants from an ethnically diverse convenience sample of British Columbians. Appl Physiol, Nutr Metab. 2012;37(6):1212-1221.

54.

Dimer L, Dowling T, Jones J, Cheetham C, Thomas T, Smith J, Mcmanus A, Maiorana AJ. Build it and they will come: outcomes from a successful cardiac rehabilitation program at an Aboriginal Medical Service. Aust Health Rev. 2013;37(1):79-82.

55.

rp Fo

Beckie TM. Biopsychosocial Determinants of Health and Quality of life Among Young Women with Coronary Heart Disease. Curr Cardiovasc Risk Rep. 2014;8(1):1-10.

56.

Wenger NK. Clinical presentation of CAD and myocardial ischemia in women. J Nucl

ee

Cardiol. 2016;23(5):976-985. 57.

Bandura A. Self-efficacy: toward a unifying theory of behavioral change. Psychol Rev 1977;84(2):191-215.

ev

58.

rr

Johnston L, Foster M, Shennan J, et al. The effectiveness of an acceptance and commitment therapy self-help intervention for chronic pain. Clin J Pain. 2010;26(5):393-

59.

w

402.

ie

Mcgillion M, Arthur H, Victor J, et al. Effectiveness of psychoeducational interventions

on

for improving symptoms, health-related quality of life, and psychological well being in patients with stable angina. Curr Cardiol Rev. 2008;4:1-11. 60.

ly

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60

Page 30 of 45

Perry K, Nicholas M, Middleton J. Multidisciplinary cognitive behavioural pain management programmes for people with a spinal cord injury: design and implementation. Disabil Rehabil. 2011;33(13):1272-80.

61.

Naylor M, Keefe F, Brigidi B, et al. Therapeutic interactive voice response for chronic pain reduction and relapse prevention. Pain 2008;134(3):335-45.


29

Page 31 of 45

62.

Dysvik E, Kvaley J, Stokkeland R, et al. The effectiveness of a multidisciplinary pain management programme managing chronic pain on pain perceptions, health-related quality of life and stages of change - a non-randomized controlled study. Int J Nurs Stud. 2010;47(7):826-35.

63.

Glombiewski J, Hartwich-Tersek J, Rief W. Two psychological interventions are effective in severely disabled, chronic back pain patients: a randomized controlled trial. Int J Behav

rp Fo

Med. 2010;17(2):97-107. 64.

Barr VJ, Robinson S, Marin-Link B, et al. The expanded Chronic Care Model: an integration of concepts and strategies from population health promotion and the Chronic

ee

Care Model. Hosp Q. 2003;7(1):73-82. 65.

Calkins E, Boult C, Wagner EH, et al. New ways to care for older people: Building

rr

systems based on evidence: Springer Publishing Company 2004.

ev

66.

Association OH. Ontario Ministry of Health and Long-Term Care. 2017

67.

Fawcett J, Watson J, Neuman B, et al. On Nursing Theories and Evidence. J Nurs

68.

w

Scholarsh. 2001;33(2):115-19.

ie

Ryan P, Sawin KJ. The Individual and Family Self-Management Theory: Background and

on

Perspectives on Context, Process, and Outcomes. Nurs Outlook. 2009;57(4):217-25. 69.

Turk DC, Wilson HD, Cahana A. Treatment of chronic non-cancer pain. Lancet. 2011;377(9784):2226-2235.

70.

ly

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60

BMJ Open

Tashakkor AY, Stone J, Mancini GJ. Is It Time to Update How Suspected Angina Is Evaluated prior to the Use of Specialized Tests? Implications Based on a Systematic Review. Cardiology. 2015;133(3):181-190.

71.

Tremmel JA. To Define Is to Limit: Is That Good or Bad When it Comes to Chest Pain? JACC Cardiovasc Interv. 2016;9(6):562-564.


30

BMJ Open

72.

Webster R, Heeley E. Perceptions of risk: understanding cardiovascular disease. Risk Manag Healthc Policy. 2010;3(4).

73.

Delgado R, York A, Lee C, Crawford C, Buckenmaier C, Schoomaker E, Crawford P. Assessing the quality, efficacy, and effectiveness of the current evidence base of active self-care complementary and integrative medicine therapies for the management of chronic pain: a rapid evidence assessment of the literature. Pain Med. 2014;15 Suppl

rp Fo

1:S9-20. 74.

Adams RJ, Smart P, Huff AS. Shades of Grey: Guidelines for Working with the Grey Literature in Systematic Reviews for Management and Organizational Studies. IJMR. 2016;00:1-23.

Bhattacharyya M, Stevenson F, Walters K. Exploration of the psychological impact and

rr

75.

ee

adaptation to cardiac events in South Asians in the UK: A qualitative study. BMJ Open. 2016;6 (7):e010195.

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Footnotes Contributors: MP formulated the research question. AKB and MP devised the search strategy, in consultation with two experienced information specialists at the Gerstein Science Information Centre at the University of Toronto, Toronto, ON, Canada. AKB conducted the searches. AKB screened all titles, abstracts and full text articles in consultation with MP. AKB extracted the data in consultation with MP. AKB and MP co-wrote the manuscript. HC, LC, AG, PH, CL, ML, SL,

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JMD, MM, SOM, JP, JS, JCV, and JWW critically reviewed the manuscript and made revisions prior to submission.

Funding: This study was funded by a Canadian Institutes of Health Research (CIHR) Knowledge

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Synthesis Grant 362774. AKB was supported by a Tom Kierans International Post-Doctoral Fellowship from the Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, ON,

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Canada.

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Acknowledgements: The authors would like to thank Ms. Stephanie Xavier who contributed to the search of the grey literature while a student in the Undergraduate Student Summer Research

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Program at the Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, ON, Canada.

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The authors also thank Ms. Ana Patricia Ayala and Ms. Erica Lenton, two experienced

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information specialists at the Gerstein Science Information Centre at the University of Toronto, Toronto, ON, Canada who were available for consultation during the search.

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Competing interests: All authors have completed the Unified Competing Interest forms at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author). There are no disclosures from the authors. Patient consent: No informed consent was required. Ethics approval: Ethics approval was obtained from the Health Sciences Research Ethics Board (REB) at the University of Toronto, ON, Canada (Protocol # 33289).


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Data sharing statement: All data in this evidence map are documented in the manuscript. No additional data are available.

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Figure Legends Figure 1 Flow chart Figure 2 Percent women, study design and type of cardiac pain across year of publication, weighted by sample size Figure 3 Age and type of cardiac pain across year of publication, weighted by sample size

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Table 1. PICO* search strategy.

Population

Intervention

Outcome

“Woman” MeSH terms

“Self-management” MeSH terms

“Cardiac pain” MeSH terms

1:MH “Women+” 

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1:MH “Self Care+” 

1:MH “Angina Pectoris+”

2:MH “Self Concept+” 

2:MH “Myocardial Ischemia+”

3:MH “Gender Identity+”

3:MH “Self-Assessment” 

3:MH “Sternotomy” 

4. MH “Population

4:MH “Pain Management” 

4: MH “Cardiovascular Surgical Procedures+” 

Characteristics+” 

5:MH “Disease Management+” 

5: MH “Chest pain+” 

5: MH “Sex Characteristics” 

6: MH “Health Behavior+” 

6: MH “Acute, Pain” 

6:1 OR 2 OR 3 OR 4 OR 5

7: MH “Activities of Daily Living+” 

2:MH “Female” 

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8: MH “Life Style+” 

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9:MH “Adaption, Psychological+”

7: MH “Pain, Postoperative+”

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8:MH “Chronic Pain” 

Keywords

Keywords

9: (2 OR 3 OR 4) AND (5 OR 6 OR 7 OR 8) 

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10:1 OR 2 OR 3 OR 4 OR 5 OR 5 OR 7 OR 8 OR 9

Combined with OR

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48

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10: 1 OR 5 OR 9 Keywords

1: “women” 

1: “self-manage*” 

1: “angina*” 

2: “woman” 

2: “self-assess*”

3: “female*” 

3: “disease manage*” 

3: “myocardial ischemia*” 

4: “sex diff*” 

4: “lifestyle*” 

4: “heart surgery” 

5: “gender diff*” 

5: “coping” 

5: “chest pain*” 

6: 1 OR 2 OR 3 OR 4 OR 5

6: “self-concept*” 

6: “heart attack” 

7: “(pain* manage*)”

7: “acute pain*” 

8: “self-care” 

8: “postoperative pain*” 

9: “health behavior*” 

9: “(persistent pain* OR chronic pain*)” 

10: 1 OR 2 OR 3 OR 4 OR 5 OR 6 OR 7 OR 8 OR 9

10: (2 OR 3 OR 4 OR 6) AND (5 OR 7 OR 8 OR 9) 

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2: “sternotomy” 

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11: 1 OR 5 OR 10 *Comparison: None

Combined with AND


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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48

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Table 2. Summary of characteristics of primary research studies (N=220). Pain Category

Design (n)

Obstructive CAD

RCT (19)

RCT pilot (4)

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% Women

Mean Median Range

Mean Median Range

63 64 48-76

318 165 53-1343

48 40 26-100

Alternative and complementary medicine (2) eHealth or other educational resources (6) Self-management education programmes (11)

61 60 55-68 63 57 55-76 64 62 47-77

35 30 10-70 57 67 7-98 176 77 5-1097

63 63 25-100 88 100 64-100 64 54 25-100


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Focus of report (n)

Country (n)


Australia (1), Korea (1), US (3) Canada (6), Sweden (4), UK (3), US (13)

Clinical presentation (1) eHealth or other educational resources (1) Ethnicity and symptom experience (3) Risk factors (2) Strategies/responses after cardiac events (10) Symptom experience/description (9) Delay in seeking treatment (7) eHealth or other educational resources (1) Ethnicity and symptom experience (5) Self-management education programmes (2) Strategies/responses after cardiac events (8) Symptom experience/description (8) Alternative and complementary medicine (1) Risk factors (1) Strategies/responses after cardiac events (1) Alternative and complementary medicine (3) Delay in seeking treatment (2) Ethnicity and symptom experience (8) Risk factors (4) Self-management education programmes (2) Strategies/responses after cardiac events (18) Symptom experience/description (28) Alternative and complementary medicine (1) Self-management education programmes (1)

Canada (2), Denmark (2), Germany (2), HongKong (1), Norway (1), Korea (1), Oman (2), Poland (1), Sweden (8), UK (3), US (10) Australia (1), Iran (1), Sweden (1) Australia (1), Canada (7), Czech Republic (1), Finland (1), Germany (1), Hong Kong (2), Iran (1), Jordan (1), Norway (2), UK (14), US (31), Across (1) UK (1), Sweden (1)

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60 60 55-66 62 62 47-76

353 30 70-767 330 83 7-7093

31 30 64-100 59 50 25-100

56-57

24-53

100

56

9

100


UK (1)

Cross Sectional (2)

53-62

159-963

100

RCT (5)

65 66 57-72

117 100 54-250

50 50 28-100

Clinical presentation (1) Risk factors (1) Alternative and complementary medicine (2) eHealth or other educational resources (3)

Denmark (1), US (1) Germany (1), Greece (1), Iran (1), Thailand (1), US (1)

RCT (2)


51 43 25-100

Brazil (1), Canada (2), China (1), Denmark (1), Iran (1), Sweden (1), UK (6), US (6) Canada (1), US (3)

249 62 5-1579

Cross Sectional (63)

Post PCI/CABG

Sample size

65 64 54-76

Case Control (3)

NonObstructive CAD

Age Mean Median Range

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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48

RCT pilot (1)

56

34 56

25


Korea (1)

64 64 56-72

109 52 6-326

60 37 25-100

69 67 63-80 62 64 56-65 64 62 61-67 60

481 57 8-2269 237 100 8-753 177 196 70-250 47-72

55 44 31-100 48 37 26-100 63 40 26-100 28-40

Alternative and complementary medicine (1) eHealth or other educational resources (1) Risk factors (2) Strategies/responses after cardiac events (6) Symptom experience/description (5) Symptom experience/description (2) Strategies/responses after cardiac event (3)

Australia (3), Canada (3), Germany (2), Norway (1) UK (2), US (4) Australia (1), Canada (1), Switzerland (1), US (2) Australia (1), Korea (1), Norway (2), Taiwan (1), Turkey (1), US (1) Australia (1), Iran (1), Sweden (2), UK (2), US (1) US (2)

RCT quasi-experimental (1) Prospective Cohort (15)

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Cross Sectional (7)

Mixed sample

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RCT (7)




Cross Sectional (6)

64 64 60-68 62 62 49-74

69 69 65-72 60 59 58-63

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126 107 50-240 1267 826 31-4204

378 72 39-1024 604 96 10-2798

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52 28 28-100 36 33 28-55

Clinical presentation (1)

Sweden (1)

Strategies/responses after cardiac events (6) Symptom experience/description (1) eHealth or other educational resources (3) Self-management education programmes (4) Alternative and complementary medicine (1) Self-management education programmes (1) Self-management education programmes (4)

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60 51 30-100 45 35 26-100

Alternative and complementary medicine (1) Clinical presentation (1) Risk factors (2) Self-management education programmes (2) Strategies/responses after cardiac events (1) Symptom experience/description (1) Self-management education programmes (1) Strategies/responses after cardiac event (1) Risk factors (1) Ethnicity and symptom experience (1) Self-management education programmes (1) Strategies/responses after cardiac event (4)

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Sweden (1), US (3) Australia (1), Canada (2), US (5)

Australia (1), Canada (1), Sweden (1) Lithuania (1), UK (1), US (3), Across (1)

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Table 3. Interventions and outcomes in RCTs across years of publication (N=49). Pain Category Design

Alternative and Complementary medicine Intervention → Outcome (Year)

Obstructive CAD RCT parallel Chiropractic treatment → muscle/skeletal pain, HRQL (2012) group

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Topical heat therapy → acute chest pain (2014)

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EHealth or other educational resources

Self-management education programmes



Cognitive interactive nursing intervention → risk factors, health behaviours, self-efficacy (1999) Discharge intervention, a self-directed slide presentation → knowledge about disease management (2009) Educational video and information sheets → prehospital delays. Information sheets for patients with chest pain → anxiety, depression, HRQL, patients’ satisfaction (2002) Self-management intervention: sessions, home visit and telephone follow-up → readmission, HRQL, risk factors, health behaviours, depression, illness perception, self-efficacy, symptoms and well-being (2011) Supportive education program → HRQL, symptom selfmanagement (2002)

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Motivational interviewing→ self-care adherence, self-efficacy and symptom burden (2015) Smartphone iOS application → discharge instruction compliance, symptoms changes (2014) Symptom diary intervention → cardiac events, HRQL and self-care maintenance (2012) Individualized nurse coaching intervention → health beliefs, self-care behaviours, and self-efficacy (2003) Mobile phone and Internet intervention → weight loss, risk factors (2012)

RCT-pilot

RCT quasiexperimental Non-Obstructive CAD RCT parallel Autogenic training→ anxiety, depression, and HRQL (2009) group

A cognitive- behavioural nurse-facilitated self-help intervention → angina, mood, knowledge, risk factors, health behaviours, HRQL and Health service utilization (2011) Disease management program→ physical functioning, symptoms and psychosocial status (2000) Lay-facilitated angina management programme→ chest pain, depression, risk factors and health behaviours (2012) Health education in general practice (face to face) → risk factors, health behaviours, chest pain and impact on everyday life. Nurse-led secondary prevention clinics → chest pain, depression and HRQL (1994) Follow-up care intervention in general practice → risk factors, health behaviours, chest pain and HRQL (1990) Self-care intervention→ HRQL, social support, risk factors and health behaviours (2010) Stress management training or exercise training → psychosocial functioning, depression, anxiety, HRQL, risk factors and health behaviours (2005) Home-based psychosocial intervention program → psychosocial distress (2002) Chinese cardiac rehabilitation program → risk factors, health behaviours and chest pain (2004) Stress management program post discharge→ fatigue, depression, risk factors, health behaviours and HRQL (2002) Coaching intervention in a cardiac rehabilitation programme → attendance and rehabilitation intake, self-efficacy (2012)

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Aboriginal cardiac rehabilitation program → risk factors, health behaviours, disease and symptom management (2013)

Physical training and relaxation therapy → exercise capacity, sense of coherence, stress and HRQL (2002)


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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48


Transcendental meditation→ chest symptoms, HRQL and electrocardiographic changes (2012)

Post PCI/ CABG RCT parallel Acupuncture → lung function and postoperative pain (2013) group

Educational audiotape: symptom management post discharge → Symptoms, Depression and HRQL (2010) Symptom management telehealth intervention → cardiac symptoms, HRQL, physical activity (2007)

Guided imagery → pain and anxiety (2015)

RCT-pilot


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Lifestyle intervention, work-book and sessions (diet, smoking cessation and exercise) → cardiac events, depression, risk factors and health behaviours (2016)

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Aromatherapy → vital signs, anxiety and sleep quality (2013)

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Mixed Sample RCT parallel group

RCT-pilot

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Telephone counselling intervention post discharge → psychosocial adjustment, depression, anxiety, perceived control, cardiac events (2003) Web-based cardiac rehabilitation program → angina symptoms, risk factors, depression, and self –efficacy (2014) Work-book and audio tape with relaxation programme → angina symptoms, depression (2002)

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Spiritual retreat → depression, psychological symptoms, stress, hope, gratitude, HRQL, risk factors and health behaviours (2011)

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Behavioural health educational program → stress, HRQL, sense of coherence, anxiety and depression (2012)

Cardiac rehabilitation Family-Centred Empowerment Model→ perceived threat, self-efficacy, self-esteem, HRQL, stress, anxiety, risk factors and health behaviours (2016) Lifestyle modification program → exercise capacity, chest pain, depression, risk factors and health behaviours (2006) Stress management program post discharge→ stress behaviour, social support and depression (2007)

Illness representation intervention → illness perception, depression, social support and HRQL (2007)

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Cardiac rehabilitation and education program→ selfefficacy and activity (1997) Cardiac rehabilitation and education program→ HRQL, risk factors, health behaviours and readmission (2005) Cardiac rehabilitation and education program→ HRQL, risk factors and health behaviours (1997) Cardiac rehabilitation and education program → risk factors, health behaviours, recurrent cardiac events (2000)

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51x67mm (300 x 300 DPI)


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BMJ Open 1 PRISMA 2 3 4 5 Section/topic 6 7 TITLE 8 9 Title 10 11 12 ABSTRACT 13 14 Structured summary 15 16 17 INTRODUCTION 18 19 Rationale 20 Objectives 21 22 23 METHODS 24 Protocol and registration 25 26 27 Eligibility criteria 28 29 Information sources 30 31 32 Search 33 34 35 Study selection 36 37 Data collection process 38 39 40 Data items 41 42 Risk of bias in individual 43 studies 44 45 Summary measures 46 47 48

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2009 Checklist Reported on page #

# Checklist item

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1

Identify the report as a systematic review, meta-analysis, or both.

1 (Evidence Map)

2

Provide a structured summary including, as applicable: background; objectives; data sources; study eligibility criteria, participants, and interventions; study appraisal and synthesis methods; results; limitations; conclusions and implications of key findings; systematic review registration number.

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3

Describe the rationale for the review in the context of what is already known.

4

Provide an explicit statement of questions being addressed with reference to participants, interventions, comparisons, outcomes, and study design (PICOS).

5

Indicate if a review protocol exists, if and where it can be accessed (e.g., Web address), and, if available, provide registration information including registration number.

3

6

Specify study characteristics (e.g., PICOS, length of follow-up) and report characteristics (e.g., years considered, language, publication status) used as criteria for eligibility, giving rationale.

7-8

7

Describe all information sources (e.g., databases with dates of coverage, contact with study authors to identify additional studies) in the search and date last searched.

8-9

8

Present full electronic search strategy for at least one database, including any limits used, such that it could be repeated.

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State the process for selecting studies (i.e., screening, eligibility, included in systematic review, and, if applicable, included in the meta-analysis).

8

(Table 1) 9

10

Describe method of data extraction from reports (e.g., piloted forms, independently, in duplicate) and any processes for obtaining and confirming data from investigators.

9-10

11

List and define all variables for which data were sought (e.g., PICOS, funding sources) and any assumptions and simplifications made.

7-8

12

Describe methods used for assessing risk of bias of individual studies (including specification of whether this was done at the study or outcome level), and how this information is to be used in any data synthesis.

7

13

State the principal summary measures (e.g., risk ratio, difference in means).

10


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BMJ Open

1 PRISMA 2009 Checklist 2 3 4 Synthesis of results 14 Describe the methods of handling data and combining results of studies, if done, including measures of consistency 10 2 5 (e.g., I ) for each meta-analysis. 6 Page 1 of 2 7 8 Reported # Checklist item 9 Section/topic on page # 10 11 Risk of bias across studies 15 Specify any assessment of risk of bias that may affect the cumulative evidence (e.g., publication bias, selective N/A 12 reporting within studies). 13 Additional analyses 16 Describe methods of additional analyses (e.g., sensitivity or subgroup analyses, meta-regression), if done, indicating N/A 14 which were pre-specified. 15 16 RESULTS 17 17 Give numbers of studies screened, assessed for eligibility, and included in the review, with reasons for exclusions at 10-11 18 Study selection each stage, ideally with a flow diagram. 19 20 Study characteristics 18 For each study, present characteristics for which data were extracted (e.g., study size, PICOS, follow-up period) and 11-14, 21 provide the citations. 34-37 22 19 Present data on risk of bias of each study and, if available, any outcome level assessment (see item 12). N/A 23 Risk of bias within studies 24 Results of individual studies 20 For all outcomes considered (benefits or harms), present, for each study: (a) simple summary data for each N/A 25 intervention group (b) effect estimates and confidence intervals, ideally with a forest plot. 26 21 Present results of each meta-analysis done, including confidence intervals and measures of consistency. N/A 27 Synthesis of results 28 Risk of bias across studies 22 Present results of any assessment of risk of bias across studies (see Item 15). N/A 29 23 Give results of additional analyses, if done (e.g., sensitivity or subgroup analyses, meta-regression [see Item 16]). N/A 30 Additional analysis 31 32 DISCUSSION 33 Summary of evidence 24 Summarize the main findings including the strength of evidence for each main outcome; consider their relevance to 14-18 34 key groups (e.g., healthcare providers, users, and policy makers). 35 25 Discuss limitations at study and outcome level (e.g., risk of bias), and at review-level (e.g., incomplete retrieval of 19 36 Limitations identified research, reporting bias). 37 38 Conclusions 26 Provide a general interpretation of the results in the context of other evidence, and implications for future research. 19-20 39 40 FUNDING 41 27 Describe sources of funding for the systematic review and other support (e.g., supply of data); role of funders for the 31 42 Funding systematic review. 43 44 From: Moher D, Liberati A, Tetzlaff J, Altman DG, The PRISMA Group (2009). Preferred Reporting Items for Systematic Reviews and Meta-Analyses: The PRISMA Statement. PLoS Med 6(6): e1000097. 45 doi:10.1371/journal.pmed1000097 For more information, visit: www.prisma-statement.org. 46 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml 47 48

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PRISMA 2009 Checklist Page 2 of 2

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