ORIGINAL CONTRIBUTIONS
A Patient-Centered Approach to Developing a Comprehensive Symptom and Quality of Life Assessment of Anal Incontinence Nikki Cotterill, B.Sc.(Hons.), R.N.,1 Christine Norton, Ph.D., M.A., R.N.,2 Kerry N. L. Avery, Ph.D.,3 Paul Abrams, M.D., F.R.C.S.,1 Jenny L. Donovan, Ph.D.3 1 Bristol Urological Institute, Southmead Hospital, Westbury-on-Trym, Bristol, United Kingdom 2 The Burdett Institute of Gastrointestinal Nursing, St. Mark’s Hospital, Watford Road, Harrow, Middlesex, United Kingdom 3 Department of Social Medicine, Canynge Hall, University of Bristol, Whiteladies Road, Bristol, United Kingdom
PURPOSE: This study was designed to identify question items required for a comprehensive symptom and quality of life assessment for individuals with anal incontinence. METHODS: Three substudies addressed the goals: 1)
convenience sample of clinical experts was asked to identify symptom items essential to characterize anal incontinence; 2) free-text comments by patients involved in a treatment intervention trial (Norton et al., Gastroenterology 2003;125:1320–9) underwent content analysis to highlight themes regarding life restriction caused by anal incontinence; and 3) qualitative interviews were conducted by using a grounded theory approach with symptomatic patients to identify issues causing impact on quality of life. Terminology for this condition was explored in the interviews to identify the most acceptable phraseology. Finally, the capability of existing anal incontinence questionnaires to capture and assess issues identified as important by patients was assessed. RESULTS: Seven clinical experts reached consensus that
assessment should include the type, frequency and severity of incontinence, whether passive or associated with urgency, ability to delay and discriminate stool type, and “normal” bowel pattern. A total of 284 patients’ comments were reviewed and 31 patients were interviewed, highlighting five key issues: unpredictability, toilet location, coping strategies, embarrassment, and social activity restriction. Assessment of available questionnaires for their inclusion of these themes indicates that none currently captures comprehensive information on these issues identified as important by patients.
Presented at the meeting of the International Continence Society, Montreal, Canada, August 31 to September 2, 2005.
CONCLUSIONS: Fundamental issues as identified by patients are not currently represented in one overall comprehensive measure. The mixed method approach identified key issues to be assessed to ensure accurate symptomatic assessment and a comprehensive assessment of quality of life impact associated with anal incontinence. KEY WORDS: Fecal incontinence; Quality of life;
Qualitative research; Questionnaires; Terminology; Outcome assessment. he assessment of anal incontinence has traditionally been clinician-centered and dependent on symptom and physiologic parameters, such as frequency and type of incontinence and anal sphincter pressure measurements.2–4 This approach fails to capture the patients’ lived experience and thereby offers little appreciation of the impact of symptoms on quality of life (QOL).5 In addition, patients often are reluctant to volunteer symptoms of anal incontinence because of embarrassment and the expectation that they have to live with these symptoms.6–11 Clinicianadministered instruments often are used, which can significantly underestimate the symptoms experienced by patients and the subsequent impact on their lives.5 Currently there is no fully validated assessment instrument for individuals with anal incontinence— developed by collaboration between clinicians and patients from the initial developmental stages—that is applicable to a general adult population.5 Existing studies have incorporated patient input at cognitive debriefing stages12–17 when draft instruments have already been created. The value of changing this process and asking individuals first has not been explored.
T
Reprints are not available.
MATERIALS AND METHODS
Address of correspondence: Nikki Cotterill, B.Sc.(Hons.), R.N., Bristol Urological Institute, Southmead Hospital, Westbury-on-Trym, Bristol BS10 5NB, United Kingdom. E-mail:
[email protected]
Three substudies were undertaken to identify items, and these were then compared with items included in existing
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DOI: 10.1007/s10350-007-9069-3 VOLUME 51: 82–87 (2008) ©THE ASCRS. 2007
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questionnaires. Standard methodology incorporating mixed methods was used for this study to elicit information from both clinicians and patients to capture the most pertinent elements of this condition. Clinical Experts’ Opinion Opinions were gathered from clinical experts in the field comprising a convenience sample of seven multidisciplinary professionals. The group of experts were invited purposively to incorporate varying aspects of the clinical field in which anal incontinence can occur.18 All items related to symptoms in existing questionnaires12,13,15,17,19–31 were collated in an attempt to produce an exhaustive list of currently available assessment. In a modified Delphi technique18 clinicians were approached via email and the list circulated electronically with instructions to comment on the need to include or exclude items to achieve an accurate symptomatic assessment of anal incontinence. Clinicians also were encouraged to suggest new items for inclusion that would enable a thorough evaluation. Responses were analyzed to find areas of agreement or disagreement between the clinicians and the list recirculated for clarification where consensus was not achieved, until a clear set of items were identified for inclusion. Patients’ Opinion: Free-Text Comments Patients’ perspectives were sought by using two approaches. First, free-text comments made in a randomized, controlled trial comparing different methods of biofeedback treatment for anal incontinence1 were analyzed for content and emerging themes.18 Within the trial, patients were asked to complete a set of questions about bowel symptoms and an open-ended question also was included as the only question item on impact of anal incontinence: If your bowel control does restrict your life, please briefly describe in what way(s).
A coding frame for these responses was devised and all freetext coded according to methods described by Bowling.18 Patients’ Opinion: Qualitative Interviews Audio-taped patient interviews using qualitative methods18,32–34 also were undertaken to explore the condition in depth, as perceived by patients, and to ascertain the impact on quality of life that the condition imposed. Participant recruitment initially commenced with individuals who had presented to an inflammatory bowel disease specialist nurse or to a urology clinic, to interview patients without anal incontinence as their presenting condition, and to explore wider bowel terminology and possible symptoms in those who were not familiar with the field of anal incontinence. Subsequent interviews involved patients with anal incontinence to focus more
specifically on the area of interest.34 The interviews were semistructured, although the key areas of the type of symptoms experienced and how they affected participants, was used as the focus, with encouragement given to freely discuss these and other points.18,34 The description of symptoms by individuals with anal incontinence was important to provide an alternative angle to the symptom assessment items identified by clinical experts and to ensure that symptoms that were significant to patients were not overlooked. In addition, the most appropriate terminology for this area was explored, including terms that currently appear in self-completion questionnaires along with more familiar conversational terms. The individuals who had not presented with anal incontinence were particularly informative at this stage because they were less familiar with medical terms used in this field. A written list of all known terms was used as a visual prompt during interviews to avoid discrepancies between written and verbal acceptability and patients were asked to explain their understanding of the terms and to indicate which words would be most acceptable. In addition, alternative terms were sought for incorporation into further interviews in an iterative manner.18 Interview audiotapes were transcribed verbatim by using Microsoft Word and a coding frame devised for analysis, according to emerging themes. Randomly selected transcripts were coded by an independent researcher (KA) for comparison of highlighted themes and content analysis was performed.18,35 A grounded theory approach was used with reviews of interview findings being conducted after each round and used to inform the focus of subsequent interviews until saturation was achieved and no new themes were identified.35,36 Responses regarding terminology were analyzed by using content analysis. Comparisons were made between the findings of the interviews and free-text comments and the content of existing questionnaires12–17,19–31 to establish whether current assessment methods were adequately describing the problems of these individuals. The key issues that were identified within the qualitative studies were used as a simple coding frame on which to evaluate current assessment instruments with regard to the inclusion or absence of these issues. Ethics approval was granted from Southmead and Harrow Local Research Ethics Committees. Informed, written consent was obtained from all patients involved in the study.
RESULTS Clinical Experts’ Opinion The first round of feedback from the clinical experts (1 colorectal surgeon, 2 gastroenterologists, 1 nurse consultant, 2 nurse specialists, and 1 physiotherapist with particular interest in incontinence) was made by four members of the group, therefore, opinions regarding the
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TABLE 1. Essential anal incontinence assessment areas as defined by clinical experts
Assessment areas to be addressed Type, amount, and frequency of fecal incontinence episodes (day and night) Ability to delay/control passage of flatus and stool Straining to evacuate Incomplete evacuation Ability to discriminate between flatus and stool Passive and urgent episodes of fecal incontinence Sensation, if any, experienced during incontinence episodes “Normal” bowel pattern for the individual
preliminary findings and further clarification was sought. The second round of feedback comprised all the members listed, after which a clear consensus was achieved. Assessment of wider gastrointestinal symptoms that appear in some of the available instruments were considered by the panel to be unnecessary in a questionnaire intended to specifically address anal incontinence. Table 1 summarizes the areas deemed to be essential to symptom evaluation in patients with anal incontinence to summarize symptoms and indicate functional abnormalities. Patients’ Opinion: Free-Text Comments A total of 420 patients participated in the randomized, controlled trial comparing biofeedback methods for anal incontinence.1 In total, 68 percent of patients (n=284) made comments with regard to the restrictions imposed on their lives as a result of poor bowel control, which alludes to the impact on quality of life. This subgroup of patients consisted of 42 (15 percent) males and 242
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Patients’ Opinion: Qualitative Interviews Qualitative interviews were conducted with 31 patients (8 males and 23 females) during four rounds of interviews. Twenty-five individuals had presented with anal incontinence, whereas the remaining six patients had urologic symptoms (n=3) or inflammatory bowel disease (n=3). Interestingly, of the six patients who had not presented with anal incontinence, four had experienced anal incontinence, and of these, three patients were unable to control flatus on a frequent basis. “Anal soreness” was identified for assessment as, in addition to two of the clinical experts who had suggested it for inclusion, eight interviewees had reported significant distress caused by this symptom. “Unpredictability” was a key issue in these interviews and put forward by 25 of 26 individuals with symptomatic anal incontinence, including unpredictability of the type of event and its magnitude, in addition to the timing of incontinence episodes. The variability of symptom severity and subsequent life restriction also was highlighted with wide variation existing in the extent of symptoms between individuals but within the same individual at different times: But there’s no telling when [anal incontinence will occur], it just goes from day to day really. It happened to me when I was in the kitchen one day. I was cooking the tea, I passed wind and it (stool) just went all over the kitchen floor.
Percentage of Overall Patient Comments 12 10 8 6 4 2 Fear Hygiene/ Coping Odor Strategies Issues FIGURE 1. Restrictions imposed by poor bowel control (questionnaire study). Social Life
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(85 percent) females (median age, 54 (range, 23–86) years). Analysis of these responses highlighted the most frequently occurring comments (Fig. 1).
Distribution of most frequent free-text patient comments
Toilet Location
IN
Physical Activities
EmbarBowel rassment Unpredictability
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Coping strategies were a key area of discussion, with patients detailing ways of minimizing the impact of symptoms because they were unable to control symptoms:
TABLE 3. Current questionnaire assessment of the key issues identified by patients with anal incontinence
Issue identified by patient I have an emergency bag with me as well—spare pants, spare pads and a plastic bag—like your makeup bag. If I know I’m going out for the day, I’ve got to take extreme caution and know where loos (toilet) are and things. Or, if I’m going on a coach trip somewhere, I need to know there’s a loo on board. I’m alright on a train because there [are] loos on the trains.
Although only mentioned by a minority of the interviewees (n=5), the importance placed on sexual matters by these individuals was considerable: My symptoms in the beginning, I found terribly embarrassing, more so than average I think, because the first thing I found was I had bowel incontinence during sex...I was horrified and terrified...it took nearly five years I think (to bring it to the attention of a health professional) by which time I’d made myself quite ill with like an anxiety problem, which I went to the doctor’s about, but I knew what was causing the anxiety problem, which I couldn’t tell the doctor.
Terminology A group of core terms that most people found acceptable emerged (Table 2). The most unambiguous terms were deemed to be socially unacceptable and not appropriate for use in a questionnaire, for example “fart” (passing flatus).
TABLE 2. Terminology findings
Patientacceptable term Bowel movement Back passage Wind Stool Accident Leakage Staining
Consensus definition Actual process of opening bowels General anal canal area from which stool passes Air or gas from back passage Product of opening bowels (when used in context of bowels) Uncontrolled loss of stool, indicates formed stool Gradual seepage of stool, indicates liquid or soft stool Marking of underwear or clothes caused by bowel events
Proportion of group supporting use (%) 74 100 88 100 95 88 86
Unpredictability Coping strategies (other than dietary restriction) Embarrassment Reluctance to leave the house Fear of incontinence Toilet location Hygiene, including smell, cleanliness, and pad use Physical activities Social activities Sexual matters
No. of current questionnaires *) assessing issue (n=16*) 0 114 213,14 214,16 116 412,14,16,28 812–14,16,20,23,28,31 613,14,19,20,22,23 712–14,16,19,20,23 712–14,16,20,22,23
** Four instruments that were identified for anal incontinence were excluded from this review because they were symptom-specific assessments and did not intend to include any of the above issues
Comparison with Existing Measures Four assessment instruments24,26,27,29 were excluded from the comparison between patients’ opinions of the key issues and the issues addressed by existing questionnaires, because they were designed as symptom grading instruments and therefore did not intend to include any of the QOL issues identified. Of the remaining 16 questionnaires evaluated (Table 3),12–17,19–23,25,28,30,31 “unpredictability” appeared in none of the existing measures, whereas “coping strategies” appeared in one questionnaire14 and “fear of incontinence” appeared in one other questionnaire.16 “Embarrassment” and “reluctance to leave the house” appeared in two questionnaires each,13,14,16 one of which assessed both issues,14 whereas “toilet location” was covered in four existing measures.12,14,16,28 This comparison highlights these issues as the most poorly represented in current assessment tools compared with issues, such as hygiene, physical and social activities, and sexual matters, which are represented in six to eight questionnaires each.12–14,16,19,20,22,23,28,31
DISCUSSION This study explored the pertinent elements as defined by patients and clinicians for the assessment of anal incontinence symptoms and their impact on QOL. Involvement of expert clinicians in this process was essential to define the clinical perspective and to ensure that symptom assessment would accurately and adequately summarize the experience of the patients while also providing indicators of the mechanism of incontinence for diagnostic and treatment purposes. By way of free-text comments and qualitative interviews, patients themselves highlighted the most crucial aspects for individuals with this condition. This method is essential because only those who experience anal incon-
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tinence can report on the more subjective elements33 and recent guidance from the Food and Drug Administration suggests that patient involvement is imperative in the design of outcome measures used in applications for drug labeling (Center for drug evaluation and research FDA. Unpublished data, 2006). Issues highlighted included toilet location, unpredictability, devised coping strategies, fear of incontinence, embarrassment, reluctance to leave the house, and subsequent impact on social life. Similar findings have been reported recently in a much larger qualitative study of patients with neuropathic fecal incontinence who were asked to identify areas of impact caused by their symptoms and rate them in terms of their importance.37 Patients in our current study placed considerable emphasis on the unpredictable nature of anal incontinence, in particular not knowing whether they will safely pass flatus or whether they will lose fecal material, and also, when it may happen and whether they will be able to control it. This can cause patients great consternation and impacts what they feel they can and cannot do. The measurement of these issues may provide more sensitive indicators of condition status and subsequent improvements or deterioration in their condition, because these are the issues that cause the most “bother” to patients. A treatment strategy that reduces the unpredictability of incontinence or enables individuals to resume normal daily activities, such as going out of the house without having to restrict their food intake to the point of not eating, will more likely be perceived as an improvement in condition status than any measured physiologic parameter. The apparent emphasis on coping strategies is of critical importance, because such strategies may actually mask the true severity of anal incontinence when measured by incontinence episodes alone, as has been the trend with early instruments. The event of one anal incontinence episode per month does not adequately reflect the day-to-day issues that surround living with the potential occurrence of an incontinence episode at any time, as summarized by study participants. It’s [anal incontinence] always there at the back of your mind so it puts a bit of a dampener on your life. ...it was [a problem] just not being able to relax and it [anal incontinence] just being on your mind constantly.
Sexual matters also were highlighted as having a significant impact on quality of life for some of these patients. These taboo subjects of anal incontinence and sex combined make disclosure of symptoms very difficult. Therefore, assessment instruments enabling an individual to reveal this issue without having to verbalize it may assist considerably in accurate identification and assessment of these individuals. The comparison of key patient issues included in currently available assessment instruments, highlighted
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that the most important areas identified—unpredictability, coping strategies, embarrassment, reluctance to leave the house, fear of incontinence, and toilet location—were the most poorly represented in current assessment tools. Some instruments came close to capturing patientidentified issues13,14,16; the Fecal Incontinence Quality of Life Scale (FIQL)16 incorporates an “embarrassment” domain consisting of items addressing “unawareness of leakage,” “worries of others smelling stool,” and “shame.” Although these issues are no doubt associated with embarrassment, a specific feeling of embarrassment was identified in the qualitative interviews undertaken in addition to these issues, as a recurring distinct theme, and therefore, it was felt that the FIQL did not fully capture this sentiment as described by patients. This has been recognized and incorporated as a separate item in the adaptation of the FIQL created for postpartum females,14 which also was based on qualitative interviews. This adaptation is the nearest to achieving the objectives of our study. However, this questionnaire has been developed and validated for a specific patient population and is not utilizable in the general population. Of greater importance from this evaluation is that none of the available instruments contains all of the important issues for patients. Therefore, no overall comprehensive assessment of these fundamental issues for patients exists. The issues highlighted are the key areas that enable normal day-to-day functioning, which when limited by the presence, or potential, of anal incontinence emphasizes how restrictive this condition can be. The identification of a core group of acceptable terms for patients in England will enable the development of a new instrument that is acceptable to people with or at risk of anal incontinence. The information gathered in these studies has enabled the commencement of extensive psychometric validation studies of a new instrument: the International Consultation on Incontinence Questionnaire for anal incontinence (ICIQ-B). The ICIQ-B was designed to provide a widely applicable, robust, selfcompletion questionnaire for the assessment of symptoms and QOL of patients with anal incontinence, as described by clinicians and patients themselves. Because of the international intentions of the project, particular care will be required with regard to terminology in future translations and linguistic validations. This will be essential to ensure that the most appropriate terms that are socially and culturally acceptable are used in any given country.
ACKNOWLEDGMENTS
The authors thank the patients who participated in this study, the clinical experts involved, and the staff at St.
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