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DOI: 10.1111/j.1471-0528.2008.01842.x

Urogynaecology

www.blackwellpublishing.com/bjog

Experiences and expectations of women with urogenital prolapse: a quantitative and qualitative exploration S Srikrishna, D Robinson, L Cardozo, R Cartwright Department of Urogynaecology, King’s College Hospital, London, UK Correspondence: Dr S Srikrishna, Department of Urogynaecology, King’s College Hospital, Denmark Hill, London SE5 9RS, UK. Email [email protected] Accepted 8 June 2008. Published OnlineEarly 19 August 2008.

Objective To explore the expectations and goals of women

undergoing surgery for urogenital prolapse using both a quantitative quality of life approach exploring symptom bother and a qualitative interview-based approach exploring patient goals and expectations. Design Prospective observational study. Setting Tertiary referral centre for urogynaecology. Population Forty-three women with symptomatic pelvic organ

prolapse were recruited from the waiting list for pelvic floor reconstructive surgery. Methods All women were assessed with a structured clinical interview on an individual basis. The data obtained were transcribed verbatim and then analysed thematically based on the grounded theory. Individual codes and subcodes were identified to develop a coding framework. The prolapse quality-of-life (pQoL) questionnaire was used to determine the impact of pelvic organ prolapse on the woman’s daily life. We arbitrarily classified ‘bother’ as minimal, mild, moderate and marked if scores ranged from 0 to 25, 25–50, 50–75 and 75–100, respectively. The degree of prolapse was objectively quantified using the pelvic organ prolapse quantification (POP-Q) system. Quantitative data were analysed using SPSS. Ethical approval was obtained from the Kings College Hospital Ethics Committee.

Main outcome measures Quantitative data from POP-Q, subjective data from pQoL, qualitative data based on the structured clinical interview. Results Forty-three women were recruited over the first 1 year of the study. Their mean age was 56 years (range 36–78) and mean parity was 2 (range 0–6). The mean ordinal stage of the prolapse was 2 (range stages 1–4). Quantitative analysis of the pQoL data suggested that the main domains affected were prolapse impact on life (mean score 74.71) and personal relationships (mean score 46.66). Qualitative analysis based on the clinical interview suggested that these women were most affected by the actual physical symptoms of prolapse (bulge, pain and bowel problems) as well by the impact prolapse has on their sexual function. Conclusions While disease-specific QoL questionnaires allow

broad comparisons to be made assessing patient bother, they may lack the sensitivity to assess individual symptoms. A qualitative approach may individualise patient care and ultimately improve patient satisfaction and overall outcome when treating women complaining of urogenital prolapse. Keywords Grounded theory, prolapse, qualitative analysis, quality

of life.

Please cite this paper as: Srikrishna S, Robinson D, Cardozo L, Cartwright R. Experiences and expectations of women with urogenital prolapse: a quantitative and qualitative exploration. BJOG 2008;115:1362–1368.

Introduction Urogenital prolapse, while not life threatening, remains an important cause of morbidity in women and the effect on quality of life (QoL) has been extensively documented.1 Increased life expectancy and an expanding elderly population means that urogenital prolapse remains an important condition particularly since the majority of women may now spend one-third of their lives in the postmenopausal state.2

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In a retrospective cohort study of 149 554 women, the lifetime risk of having surgery for urogenital prolapse was 11%, and 29.2% of women required repeat surgery.3 The economic cost of reconstructive pelvic surgery is also considerable. In 1997, the direct costs for pelvic organ prolapse surgery in the USA were estimated as $1012 million with 21% of these procedures being combined with a continence operation.4 When considering outcome measures, there has been a paucity of data regarding patient expectations following

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Experiences and expectations of women with urogenital prolapse

treatment for urogenital prolapse. Expectations regarding outcome are shaped by previous personal experiences, those of friends and relatives and also by the attitude and experience of clinicians caring for these women. Consequently the concept of ‘cure’ is relative. Achieving anatomical restoration of the urogenital tract may not be regarded as a cure if new symptoms related to urinary, sexual and bowel dysfunction are experienced following surgery. QoL has often been used as a surrogate measure of patient satisfaction and success following treatment. Several diseasespecific questionnaires have been developed for use in women complaining of symptoms of urogenital prolapse. Improvement in QoL is seen as a powerful indicator of effective treatment although at present there is little evidence to clarify how QoL evaluation relates to patient expectations and what constitutes a significant or meaningful change.5 An alternative way of examining patient expectations of treatment is that of patient-orientated goals.6 While longterm follow-up studies have revealed that goal achievement is related to general QoL measures,7 there are few data comparing these two measures of outcome and satisfaction. The aim of this study was explore the expectations and goals of women undergoing surgery for urogenital prolapse using both a quantitative QoL approach exploring symptom bother and a qualitative interview-based approach exploring patient goals and expectations.

Methods Women with symptomatic pelvic organ prolapse were recruited from the waiting list for pelvic floor reconstructive surgery at Kings College Hospital, which is a tertiary referral centre for urogynaecology. These data represent part of a larger study investigating the achievement of patient-centred goals in pelvic floor dysfunction surgery. All women fully understood the nature and purpose of the study and written informed consent was obtained prior to study entry. Women were admitted and interviewed in depth 1 day prior to surgery. All women were examined by a single trained investigator in supine and standing position, and the degree of prolapse was objectively quantified using the pelvic organ prolapse quantification (POP-Q) system.8 The same investigator then conducted all patient interviews on an individual basis and these were standardised to be of 30-minute duration, to allow uniformity of data collection. The interview design was semi-structured and based on the ‘jazz musician’ concept proposed by Arksey and Knight.9 This technique likens the role of the interviewer to that of a jazz musician in a jam session –‘the key may have been set and there is an initial theme, thereafter it is improvisation’. The interviews were conducted on the basis of a loose structure consisting of open-ended questions that defined the area

under study, but from which both the interviewer or the interviewee could diverge to pursue an idea in more detail. The aim of the interviewer was to be interactive and sensitive to the language and the ideas used by the interviewee and be flexible through the interview process. An attempt was made to keep all questions open ended, neutral, sensitive and clear in their meaning to the patient. The template of questions used for the semi-structured interview was based on six main types of questions as suggested by Paton10 (Table 1). These were based on behaviour or experience, on opinion or belief, on feeling, on knowledge, on sensory experience and those asking about demographic or background details. The wordings used were not standardised to reflect the woman’s own vocabulary while framing questions. At the end of the interview, women were asked to list up to five personal goals they hoped to achieve following their surgery, although these were not ranked in order of importance to the patient. All the research notes were coded to ensure anonymity and stored securely. The interviews were transcribed verbatim by hand at the time of the interview and then analysed thematically based on the grounded theory.11 This was first described by Glaser and Strauss in 1976. The main premise of this approach is that theory is grounded in and emerges from data. The key to this method is a constant comparison, where data are collected in batches and each batch is compared with the data from previous and subsequent batches. These comparisons see the emergence of themes and subsequent subthemes that summarise the condition being studied. Data were then collated using an inductive approach and the texts were read and reread to identify distinct themes in line with the research aims, until the point of ‘data saturation’.12 These data within identified codes were then compared by two independent reviewers to identify subcodes and develop a coding framework. The principle behind this data analysis

Table 1. Template for semi-structured interview Background information/demographics Patient’s impression of their overall health Women’s impression of how their prolapse affects their overall health How does having a prolapse make them feel on a daily basis? What physical symptoms does their prolapse impose, with regards to multisystem function, for example, bowel, bladder and sexual function? How does having a prolapse impact on their mental health? Are there are any lifestyle limitations imposed on them by their prolapse? Are there any social limitations imposed on them by their prolapse? Are there specific roles/tasks they feel unable to perform as a result of their prolapse? Could they list up to five personal goals they hope to achieve from their treatment

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was to build an explanatory framework to understand the way women with pelvic organ prolapse perceive their symptoms and the effect these had on their QoL. After completion of the in-depth structured interview, the prolapse quality-of-life (pQoL) questionnaire was used to determine the impact of pelvic organ prolapse on the woman’s daily life. This is a validated disease-specific questionnaire used to assess both symptoms and QoL in women with pelvic organ prolapse and is used to determine the impact of urogenital prolapse on daily life.1 The pQoL marks each domain score from 0 to 100. We arbitrarily classified ‘bother’ as minimal, mild, moderate and marked if scores ranged from 0 to 25, 25–50, 50–75 and 75—100, respectively. Statistical analysis of quantitative data generated by analysis of the pQoL was performed using SPSS (version 13; SPSS, Chicago, IL, USA). Descriptive statistics were used to analyse both individual domain scores and total QoL score. Ethical approval for this study was obtained from the Kings College Hospital Ethics Committee.

Results A total of 43 women with symptomatic pelvic organ prolapse were recruited over the first 1 year of the study. These women represent our entire population of patients over the study period, with symptomatic prolapse who wished to undergo pelvic floor surgery as the definitive treatment of their condition. Their mean age was 56 years (range 36–78) and mean parity was 2 (range 0–6). The mean ordinal stage of the prolapse was 2 (range stages 1–4). Their main presenting symptoms were ‘lump’ in the vagina (22), dragging sensation (8), difficulty in defecation (10) and discomfort or pain in the vagina (3).

Quantitative analysis Quantitative analysis of QoL impairment and symptom bother was assessed using the pQoL and the results of each domain are presented below (Table 2).

Qualitative analysis Qualitative analysis of these data showed the emergence of several themes and subthemes (Table 3).

General health judgement Most women, based on the pQoL, found that their prolapse only had a mild impact on their overall QoL. Two women expressed a concern that their general health had been compromised by the presence of their prolapse and hoped that pelvic floor reconstruction would restore their overall sense of wellbeing. Quotes related to general health judgement: it makes me feel worried about myself, I would feel much healthier without it I just feel I would feel so much better in myself once this is sorted

Role limitation Although the pQoL would suggest that most women felt that their prolapse only had a mild impact on their lives, this was not borne out by the qualitative analysis. The majority of women felt limited in their ability to do the housework effectively by the presence of their prolapse (4/5), whereas only one woman felt that her prolapse interfered with her professional work. This may be a reflection of the sedentary nature of most of our women’s occupations compared with the physical exertion of housework. Quotes related to role limitation: all I really want to do is get on with the housework you know, be able to do the washing and the hoovering without feeling this lump I am really fed up of not be able to do look after my house like I used to .before this, my house was always spotless, now I really don’t feel up to it .before all this happened, I really enjoyed my job you know? I looked forward to it, it was important and defined me. Now, it’s so uncomfortable and annoying, I can hardly wait to go home at the end of the day. Sometimes I feel I should give it up, just quit

Table 2. Mean and median pQoL scores and interquartile ranges Domain General health perception Prolapse impact Role limitation Physical limitation Social limitation Personal relationship Emotion Sleep and energy Severity measures

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Mean score

SD

Median score

Percentile 25

Percentile 50

Percentile 75

28.4 74.71 38.50 39.65 25.86 56.66 35.63 43.67 27.01

15.98 26.20 33.36 33.15 31.15 36.51 28.07 32.55 18.31

25 66.66 50 50 22.22 50 33.33 33.33 25

25 66.66 16.66 0 00 16.66 22.22 16.66 16.66

25 66.66 50 50 22.22 50 33.33 33.33 45

50 100 66.66 83.33 55.55 100 55.55 66.66 41.66

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Experiences and expectations of women with urogenital prolapse

Table 3. Qualitative analysis of themes and subthemes Theme 1 2

General health judgement Role limitation

3

Physical/social activity

4 5 6 7

Sexual function Emotions Energy Symptoms

8

Psychological

9

Unclassified

Subtheme

Relating to housework Professional work Sport Travel Social life Depression Fatigue Bulge Pain Smell Bowel problems Confidence Femininity Attractiveness

Quotes related to sexual function: I want to get rid of this balloon in my vagina which keeps pushing my husband’s penis out we hardly do it anymore, my vagina is so loose that it’s not fun. I don’t enjoy it as much I just wish I could have a normal sex life again

Emotions and energy Pelvic organ prolapse appeared to only mildly bother women with regard to their emotional wellbeing, sleep or energy on analysis of the pQoL scores. A minority of women actually felt depressed by the presence of their prolapse or so fatigued that they no longer felt they had any energy left at the end of each day. Quotes related to emotions and energy: I am so fed up with it, I feel really down and out. By the end of the day, I am really quite upset and tearful and that’s not like me I honestly feel worn out by it, I feel like an old woman so tired every day and no energy to get on with anything really

Symptoms Physical/social activity Once again, the pQoL in itself did not seem to reflect the results of our qualitative analysis as the results would suggest only a mild ‘bother’ caused by prolapse symptoms with regard to physical and social limitations. However, on qualitative analysis, a large number of women were found to be extremely concerned about how their condition was limiting them physically or socially. In particular, younger women worried about not being able to exercise regularly or participate in some form of sport they really enjoyed, and in turn this made them worry about becoming overweight or generally unfit. Older women worried about not being able to go away on holiday or meet up with friends as they would have liked to and how this deprived them of a social life. Quotes related to physical/social activity: I just want to get out there, buy myself an active dog and go for long walks again I really miss my weekly 10 pin bowling sessions, they were such fun! Not being able to take my grandchildren out, I hate that I feel that all I want to do is go back to my yoga classes again

Although the pQoL does include a symptom section, these scores are not used to generate the individual domain scores, so despite a large number of women expressing ‘bother’ with prolapse symptoms, this could not be taken into account while calculating the overall effect on individual women’s QoL. However, qualitative analysis of these data showed that nearly half of all affected women had concerns relating to symptoms caused by or exacerbated by their prolapse. The majority of these were to do with the sensation of a ‘bulge’ or ‘lump down below’. The rest were equally divided between defecatory problems (a need to digitate to defecate) and a sensation of dragging discomfort. Quotes related to symptoms: I am just fed of my uterus sitting in my knickers and want rid of it all through the day, no matter what I am doing or where I am, there is always this sensation of a lump down below and it gets worse as the day goes by .especially if I have had a long day or have been on my feet, this egg hanging out gets bigger and bigger

Psychological factors Sexual function Mean pQoL domain scores of 57 would suggest that sexually active women were moderately bothered by the impact of their prolapse on their sexual function. One in five women were dissatisfied with their sex lives as a result of their prolapse. The two common themes were either a sensation of obstruction during penetrative intercourse or of significant vaginal laxity, both of which decreased sexual satisfaction.

The presence of urogenital prolapse symptoms, at least in our population, did not seem to lead to significant psychological issues, in sharp contrast to those caused by incontinence.13 pQoL scores would suggest only a mild degree of emotional bother caused by prolapse. On qualitative analysis of these data as well, very few women were psychologically disturbed by the presence of their prolapse. While this led to issues with lack of confidence in some women, others felt unattractive or less womanly.

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Quotes related to symptoms: how on earth can I feel confident with my bits hanging out of me? Its terrible, I really don’t have the confidence to go out or do anything This just makes me feel ugly, I don’t feel like a woman, certainly not an attractive one at any rate. I just want to feel feminine again

Unclassified Two women were specifically concerned about the durability of the surgery and wished for long-term success with no future recurrences. One woman’s only goal was that she wanted to be able to squeeze her pelvic floor more effectively in the future and another hoped that this surgery would enable her to use her vaginal estrogen cream without any discomfort.

Discussion In the clinical setting, outcome assessment and the definition of ‘cure’ remain poorly defined.14 Generally, while measures of objective ‘cure’ tend to be favoured in the research setting and in the reporting of clinical trials, in everyday clinical practice, more subjective measures of outcome are favoured.15 While the use of objective data allows meaningful comparisons between new techniques and methods of treatment, such outcome measures may lack the subjective sensitivity to assess outcome clinically and in a meaningful way to women. In this study, we have explored the expectations and experiences of women complaining of urogenital prolapse using both a quantitative and qualitative approach. By using multidimensional methodology, we have demonstrated the differences between the more traditional QoL-based patient assessment and that of a qualitative technique. While QoL is essential in assessing ‘bother’ secondary to urogenital prolapse, a structured question may lack the sensitivity to individualise symptom assessment at the patient level. The results from the qualitative analysis in this study would suggest that specific symptoms related to urogenital prolapse are the major factor influencing referral for urogynaecological assessment and consequently women aim for specific goals when seeking help. However, previous work has shown that symptoms of pelvic organ prolapse are only weakly correlated with its severity.16 In addition, a significant proportion of women with urogenital prolapse present with symptoms, such as sexual or bowel dysfunction or generalised ‘tiredness’, which are not necessarily ameliorated with surgery. While there are data to suggest that moving away from traditional levator plication to fascial repair may improve sexual function postoperatively,17 there may be other, more psychological factors involved in sexual dysfunction. Equally, there may be primary bowel problems leading to constipation and therefore, prolapse surgery may not necessarily take away the need

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to ‘digitate to defecate’. In a similar fashion, generalised tiredness or lack of energy is unlikely to be purely related to the presence of prolapse and there may be many other physical or psychological factors at play here. In women who expressly wish to have surgery to relieve these symptoms, there is a high risk of dissatisfaction in the postoperative period. A firm understanding of these goals facilitates an individualised approach to treatment and allows a ‘patient –physician contract’ to be formulated when management is discussed. This in turn should promote a clearer understanding of expectations regarding treatment outcome for both clinicians and patients. An individually tailored plan of management to address specific patient-expressed concerns should optimise treatment outcome and improve satisfaction. There is now a growing wealth of evidence that a subjective approach is important when assessing and counselling women and this is illustrated by previous work investigating the importance of treatment outcomes among women, nurses and medical staff. Visual analogue scales were used to evaluate the relative importance of five clinical outcomes. Overall subjective improvement and improvement in QoL were rated most highly and the authors conclude that these should become primary outcome measures in future clinical trials.18 Similarly, the use of patient-orientated goals has been described as a more sensitive approach to counselling women and also in assessing outcome.19 In addition, there is also considerable evidence that there may be a discrepancy between patient satisfaction and objective outcome measures, meaning that a patient’s goal-driven approach is more clinically meaningful.20 This global approach to individualising patient goals and expectations may ultimately lead to a greater understanding of patient’s expectations and also improve patient satisfaction.21 Our findings, based on the qualitative analysis, would also seem to support the greater sensitivity of a goal-based approach, when compared with QoL assessment, in identifying individual patient needs. Like all qualitative research, the numbers in this study are small and thus quantitative data should be interpreted with caution and is really reported to provide demographic background for the population studied. The QoL questionnaires and qualitative assessments however were robust and, to provide reproducibility, the latter were performed by the same clinician. By using this approach, we have gained insight into those symptoms that actually bother women, which are often missed when examining purely quantitative data. This may allow individual management strategies to be tailored to particular patient requirements. Ultimately, perhaps providing a continuum of outcome measures ranging from the most objective such as urodynamic studies, partially objective such as QoL assessment and entirely subjective, such as symptoms and patient-orientated goals, may lead to the best global assessment of women with urogenital prolapse (Figure 1). In 2008, Lowenstein described this use of patient-reported

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Experiences and expectations of women with urogenital prolapse

Most subjective Patient-orientated goals

Symptoms

Quality of life Most objective POP-Q Figure 1. Continuum of outcome measures.

goals as the fourth dimension in assessing pelvic floor dysfunction.22

Conclusion To the best of our knowledge this is the first reported study to assess women complaining of urogenital prolapse using a combined qualitative and QoL approach. While diseasespecific QoL questionnaires allow broad comparisons to be made assessing patient bother, this study has demonstrated that they may lack the sensitivity to assess individual symptoms. The expectations and goals of women undergoing surgery for urogenital prolapse may therefore not be fully explored using this method alone. Consequently, a qualitative approach may be capable of individualising patient care based on clinical need. A combined approach may identify additional aspects, which are bothersome to women and therefore need to be addressed, which may not necessarily be identified using QoL assessment alone. This may ultimately improve patient satisfaction and overall outcome when treating women complaining of urogenital prolapse.

Disclosure of interest S.S. – None. R.C. has been a paid investigator and received funding for lecturing from UCB Pharma. D.R., is, or has been a paid consultant and received funding for lecturing and research from Astellas, Gynecare, Ferrring, Uroplasty, Q-Med, UCB Pharma, Plethora, Novo Nordisk and Dainippon Sumtomo Pharma. L.C., is, or has been (co) chair of advisory boards for Astellas, Lilly Boehringer Inghelheim and UCB Pharma and principle investigator or researcher in studies funded by Astellas, Lilly Boehringer Ingelheim, Pfizer, UCB Pharma, Gynecare, Plethora, Avera Pharmaceutical and Cook.

Contribution to authorship S.S.: conception and design of the study, data acquisition, analysis and interpretation. Drafting and revising the manu-

script, final approval of the version to be submitted for publication. D.R.: conception and design of the study, supervising the study, drafting and revising the manuscript, final approval of the version to be submitted for publication. L.C.: supervising the study; revising the manuscript and final approval of the version to be submitted for publication. R.C.: conception of study, data analysis and interpretation, revising the manuscript and final approval of the version to be submitted for publication.

Details of ethics approval Ethical approval for this study was obtained from the Kings College Hospital Ethics Committee. Study number 05WH26. j

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20 Mahajan ST, Elkadry EA, Kenton KS, Shott S, Brubaker L. Patient centered surgical outcomes: the impact of goal achievement and urge incontinence on patient satisfaction one year after surgery. Am J Obstet Gynecol 2006;194:722–8. 21 Brubaker L, Shull B. EGGS for patient-centred outcomes. Int Urogynaecol J Pelvic Floor Dysfunct 2005;16:171–3. 22 Lowenstein L, Fitzgerald MP, Kenton K, Dooley Y, Templehof M, Mueller ER, et al. Patient-selected goals: the fourth dimension in assessment of pelvic floor disorders. Int Urogynaecol J Pelvic Floor Dysfunct 2008;19:81–4.

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