A longitudinal study of patient and surgeon goal achievement 2 years after surgery following pelvic floor dysfunction surgery

Authors


Dr S Srikrishna, Department of Urogynaecology, King’s College Hospital, Denmark Hill London SE5 9RS, UK. Email sushmasrikrishna@hotmail.com

Abstract

Please cite this paper as: Srikrishna S, Robinson D, Cardozo L. A longitudinal study of patient and surgeon goal achievement 2 years after surgery following pelvic floor dysfunction surgery. BJOG 2010;117:1504–1511.

Objective  To compare patient goal achievement in prolapse and continence surgery with objective/subjective outcomes; secondarily, to compare patient goal achievement with overall satisfaction and with that of the surgeon.

Design  Prospective longitudinal observational study, over 2 years.

Setting  Tertiary urogynaecology centre.

Population  Women with prolapse or stress incontinence due for surgery.

Methods  Patients and surgeons listed five goals that they hoped to achieve following surgery. Objective assessment was with Pelvic Organ Prolapse Quantification System (POP-Q) and videocystourethrography (VCU). Quality of life (QoL) was assessed with a Prolapse QoL questionnaire (PQoL), Kings Health questionnaire (KHQ) and Golombok–Rust Inventory of Sexual Satisfaction (GRISS) and satisfaction was assessed with the Patient Global Impression of Improvement (PGI-I).

Main outcome measures  Goal achievement was measured on a 100-mm visual analogue scale (VAS); objective cure of prolapse by POP-Q and of stress incontinence by VCU; QoL was assessed by KHQ, PQoL and GRISS; and satisfaction by PGI-I.

Results  Complete data were available for 112 women. POP-Q scores significantly improved (P < 0.05); objective cure of incontinence (from VCU) was 88.8%. All QoL questionnaires and PGI-I scores showed significant improvement (P < 0.01). Mean goal achievement was 85.1% for patients and 89.6% for surgeons. Patient goal achievement for prolapse surgery was observed sooner and correlated more with other measures of success than continence surgery. Continence-related goals based on symptom relief were achieved more than those based on body image and sexuality. Surgeons reported a high achievement rate in anatomical restoration and functional improvement goals.

Conclusions  Patient goal achievement correlates significantly with other measures of ‘success’ as well as with overall satisfaction. Surgeons and women have varying expectations of the outcome of surgery. Nearly 90% of goals are still achieved 2 years following surgery.

Introduction

Urogenital prolapse and stress urinary incontinence, although not life threatening, remain important causes of morbidity in women. Their adverse effect on quality of life has been extensively documented.1,2 Surgical intervention is one treatment option for these women and the lifetime risk of having surgery for pelvic floor dysfunction is 11%, with 29.2% requiring repeat surgery.3

Traditionally, objective outcome measures have been considered to be more robust and consequently these have been employed in many studies. Despite this, there is no consensus of opinion regarding which method of outcome assessment should be considered more important,4 although previous guidelines regarding outcome assessment have been published.5,6 In addition, there is often a dichotomy of opinion when comparing clinician’s evaluation with that of women; previous work has demonstrated that clinicians tend to underestimate the effects of pelvic floor dysfunction on women’s lives7,8 but be more optimistic when evaluating the outcome of pelvic floor surgery.9

Until relatively recently there has been a paucity of data regarding women’s expectations following treatment for urogenital prolapse or incontinence. Expectations regarding outcome are shaped by previous personal experiences, those of friends and relatives and also by the attitude and experience of the clinicians caring for these women. A woman’s expectations for surgery may be particularly important when surgery is being performed simply to improve quality of life.10,11 Consequently the concept of ‘cure’ is relative. Achieving anatomical restoration of the urogenital tract or being symptomatically ‘dry’ following continence surgery may not be regarded as a cure if new symptoms related to urinary, sexual and bowel dysfunction are experienced following surgery.

As women’s views have been recognised as increasingly important, an alternative way of examining women’s expectations of treatment using patient-orientated goals12 has evolved. There are few studies in the existing surgical literature focusing on women’s expectations for surgery.10–13 Although long-term follow-up studies have revealed that goal achievement is related to general quality of life (QoL) measures,13 there are few data comparing these two measures of outcome and satisfaction.

The aim of this study was to compare patient-centred outcomes in women undergoing continence and pelvic reconstructive surgery with objective outcome measures. The secondary aim was to compare overall satisfaction of women with achievement of these goals and with that of the operating surgeon.

Methods

This was part of an ongoing large prospective longitudinal observational study investigating long-term ‘cure’ following pelvic floor surgery using both subjective and objective outcome assessment tools. Women complaining of symptomatic urogenital prolapse or stress urinary incontinence, who were on the waiting list for pelvic floor surgery were recruited from a tertiary referral urogynaecology centre, over a 2-year period.

All patients fully understood the nature and purpose of the study and written informed consent was obtained before study entry. Ethical approval for this study was obtained from the Kings College Hospital Ethics committee.

Inclusion criteria included women over the age of 18 years, on the list for planned urogenital prolapse repair with or without a concomitant continence procedure. The surgeries for prolapse included abdominal or vaginal hysterectomy and pelvic floor repair with or without vault suspension whereas those for incontinence included tension-free vaginal tape, tension-free vaginal tape-obturator (Gynecare Inc., Johnson and Johnson, Somerville, NJ, USA) and open modified Burch colposuspension. The operating surgeons involved were the two consultant urogynaecologists, the urogynaecology subspecialty trainee and the specialist registrars working with the urogynaecology unit.

At their initial assessment in the urogynaecology outpatients clinic, all women had been extensively counselled with regard to their planned surgery. This included a full discussion of the purpose, risks, benefits, alternatives and complications of the planned surgery. Women were also given written information leaflets with general information about what to expect around the time of surgery, including plans for pain management, and expected bladder and bowel care. If a woman’s expectations from surgery appeared unrealistic in the physician’s opinion (such as cure of urgency/urge incontinence following continence surgery or cure of back ache/constipation post prolapse surgery), these were clarified and a further discussion regarding realistic expectations from surgery was documented.

Women with urogenital prolapse were objectively assessed preoperatively by clinical examination using the Pelvic Organ Prolapse Quantification System (POP-Q).14 All women underwent preoperative videocystourethrography (VCU) to detect the presence of urodynamic stress incontinence and rule out underlying detrusor overactivity or voiding dysfunction.

The impact of urogenital prolapse and urinary incontinence on women’s QoL was assessed using the Prolapse QoL questionnaire (PQoL) and Kings Health questionnaire (KHQ), respectively. These are reliable, validated disease-specific questionnaires that assess the severity of symptoms of prolapse or of urinary incontinence, respectively, and also their impact on the QoL of affected women. The scoring system of these questionnaires has been previously reported.2,15 All sexually active women also completed the female scale of the Golombok Rust Inventory of sexual satisfaction (GRISS),16 which is a short 28-item questionnaire for assessing the existence and severity of sexual problems.

All participating women were asked to list up to five personal goals they hoped to achieve following surgery. These goals were documented verbatim with no further attempt being made by the investigator at this stage to counsel women on whether or not these goals appeared unrealistic. This methodology is based on the technique of Goal Attainment Scaling (GAS), which is a measurement technique that was originally developed in the 1960s17 as part of community mental health evaluation, and since then has had proven utility in assessing the treatment of complex conditions such as interstitial cystitis/painful bladder syndrome18 and rehabilitation.19,20 As GAS has the ability to assess change brought about by any intervention, it can be used as an outcome assessment tool following surgery for pelvic floor dysfunction. However, GAS has only recently been implemented in urogynaecology to evaluate treatment outcomes,10–13 This technique was also applied to evaluate surgeon’s goals. All the operating surgeons were similarly asked to list up to five goals that they hoped to achieve by operating on each woman participating in the study.

Women were reviewed at 6 weeks, 3 months, 6 months, 1 year and 2 years postoperatively. At each review, objective assessment of prolapse was carried out using the POP-Q system. Objective cure of incontinence was determined by repeat VCU at 6 months for all women undergoing continence surgery.

Patient and surgeon goal achievement was measured on a Visual Analogue Scale (VAS). This is an instrument that measures a characteristic such as goal achievement, which is believed to range across a continuum of values. Goal achievement may be at any point on a spectrum that appears continuous from ‘not at all achieved’ to ‘completely achieved’. In our study, we used a horizontal line, 100 mm in length, anchored by word descriptors at each end (Figure 1). The woman or the surgeon marked on the line the point that they felt represented their perception of individual goal fulfilment. The VAS score was determined by measuring in millimetres from the left hand end of the line to the point that the patient marked and converting this into a percentage.

Figure 1.

 Visual analogue scale.

Each woman completed a VAS documenting the degree of goal fulfilment as well as The Patient Global Impression of Improvement questionnaire (PGI-I). This condition-specific global instrument has previously been validated for use in female patients with urinary incontinence21 and more recently also for women with urogenital prolapse.22 The operating surgeons also scored the extent to which their surgical goals had been met, using a VAS at every follow up visit.

Patient goals were categorised as being related primarily to symptom relief, return to physical activity, social activities, sexual function and body image. Surgical goals were categorised as being related to anatomical correction, functional improvement, avoidance of new bladder/bowel symptoms, improvement of sexual function, long-term cure and improvement in QoL. Goals were also classified as unrealistic if it was deemed that they had no association with planned surgery (Table 1). Statistical analysis was performed with spss (V. 17, Chicago IL, USA). Paired t test was used for POP-Q measurement and Wilcoxon Signed Rank for PGI-I and QoL scores. Relationships between noncategorical variables were investigated with the Spearman rank correlation coefficient.

Table 1.   Goal categorisation of patient goals for prolapse surgery and continence surgery
CategoryGoal examples
Goals for prolapse surgery
Physical activityJoin a gym, exercise, exercise to lose weight, go for long walks, do the gardening, do the housework, return to professional occupation
Social activityGo out with my friends/family, go dancing, go ten-pin bowling, travel with friends/family, visit social club
Sexual functionHave normal sex again, have a tighter vagina, sex to feel comfortable again, improve sexual pleasure
Symptom reliefGet rid of bulge, discomfort, dragging sensation, not need to digitate to defaecate or void
Goals for continence surgery
Physical activityNot leak during exercise/at the gym/during sport/while walking/sudden movements/gardening/running for the bus
Social activityNot leak during holidays/travelling/cinema/theatre/dancing. Being able to wear white clothes, visit friends/family
Body imageRestore/improve self esteem/confidence. Feel womanly again/not feel like ‘old smelly woman’
Sexual functionNot leak/smell during sex, sex to feel comfortable again, improve sexual pleasure

Results

In total, 201 women were recruited into the study. A strict per protocol analysis was followed whereby only those women who had attended every postoperative visit and completed all questionnaires were included. Patients who did not fulfil these stringent criteria were still followed up clinically but these data were not included in the analysis. Therefore, completed data sets were available for 112 (56%) women (mean age 64.2 years, range 42–85 years). Seventy-nine patients underwent surgery for urogenital prolapse, 19 underwent continence surgery and 14 underwent combined surgery (see Table S1). Objective assessment using POP-Q showed a statistically significant improvement at 6 weeks, which was maintained at the 2-year review (P < 0.05) (Figure 2). Objective cure of urodynamic stress incontinence on postoperative VCU at 6 months follow-up was 88.8%. All three QoL questionnaires showed an overall significant improvement from preoperative scores to the 2-year review (P < 0.01) (Figures 3 and 4). The PGI-I scores showed a significant improvement from the 6-week score (1.63) to the 2-year follow up (1.51).

Figure 2.

 Pelvic Organ Prolapse Quantification System scores.

Figure 3.

 Quality of Life scores.

Figure 4.

 Golombok–Rust Inventory of Sexual Satisfaction scores.

Women reported a total of 437 goals and surgeons a total of 508 goals. All women and surgeons expressed at least one goal, although surgeons were more likely to document multiple goals (see Table S2) The mean goal achievement for surgeons at 2 years was 89.6%. Surgeons reported a higher achievement rate in anatomical restoration and functional improvement; although lower rates were recorded for goals regarding QoL, sexual function, avoidance of new lower urinary tract symptoms and achieving a long-term cure (Table 2).

Table 2.   Percentage achievement of surgeon’s goals at 2 years
Surgeon’s goals (Numbers expressed)6 weeks3 months6 months1 year2 years
Functional improvement in prolapse (89)86.39187.89193.1
Anatomical restoration (70)91.998.596.298.391.6
Functional improvement in incontinence (32)89.294.797.39792.4
Improve QoL (67)86.592.389.594.689.5
Long-term cure (9)  N/A87.590.597.289.3
Avoid new lower urinary tract symptom/bowel symptoms (124)85.490.191.791.188.7
Improve sexual function (26)26.158.778.180.382.7

The mean patient goal achievement at 2 years was 85.1%. Most women with prolapse achieved the majority of their goals by 12 weeks. Women who underwent continence surgery showed higher goal achievement for symptom relief but lower achievement in goals related to body image, confidence, restoration of sexual function and sexuality (Table 3).

Table 3.   Percentage achievement of patient goals at 2 years
Goals (Numbers expressed)6 weeks3 months6 months1 year2 years
Prolapse goals
Physical activity (49)67.785.898.599.799.5
Social activity (21)48.888.396.510096.3
Symptom relief: [bulge (56), discomfort (35), digitate to defaecate (19)]88.398.895.499.192.1
Sexual function (31)0.546.255.46767.9
Incontinence goals
Symptom relief: [Not need pads (21), not leak (13), not smell (10)]70.178.674.882.794.1
Physical activity (36)75.476.188.787.786.4
Social activity (29)43.869.289.389.376.8
Body image (27)2226253842
Sexual function(14)37.245.155.46769.5
Unrealistic goals
Sleep at night (7)59.27070.374.674.1
Relieve overactive bladder symptoms (18)
Frequency/urgency etc
1213.8141417
Relieve backache (12)2833424446
Relieve constipation (24)1923303132.3

Goal achievement for prolapse surgery compared better with subjective and objective measures of success than continence surgery. There was significant inverse correlation between goal achievement at 2 years with ordinal scores on the POP-Q, QoL scores as well as women’s overall satisfaction with their postoperative condition (Table 4). Goal achievement for continence surgery correlated significantly with KHQ scores and overall satisfaction on PGI-I but not with sexual function scores as measured on GRISS.

Table 4.   Correlation of goal achievement
 POP-QPQoLKHQGRISSPGI-I
Prolapse goalsr = −0.33, P = 0.01r = −0.61, P = 0.01r = −0.47, P = 0.01r = −0.33, P = 0.05r = −0.71, P = 0.01
Incontinence goalsNot applicableNot applicabler = −0.77, P = 0.05r = −0.29, P = 0.09r = −0.56, P = 0.05

Discussion

Our study examines the expectations that women and surgeons have from pelvic floor surgery and the degree to which those expectations are achieved. Previous work suggests that achievement of their own goals is the primary reason why women undergo pelvic floor reconstructive surgery. These goals are highly subjective and personally important to each woman, and despite preoperative counselling sometimes remain ‘unrealistic’. Surgeons tend to express more similar goals as a group compared with woman. Surgical goals are often based on objective measures and these are usually achieved to a greater extent.

Patient-centred goals for women undergoing prolapse surgery were predominantly based on resolution of symptoms and resumption of physical activity, followed by improvement in sexual function and social activities. In addition, the actual physical presence of a ‘bulge’ in the vagina was the most commonly cited reason for curtailment of activities as well as sexual dysfunction. This may explain why reduction of the prolapse and restoration of normal anatomy significantly correlated with QoL improvement and goal achievement as early as the 3-month review. These findings are in agreement with other work that reports the significant association between long-term goal attainment with QoL scores.13,23

However, women with incontinence rated symptom resolution, restoration of physical and social activity along with an improved body image higher than sexual function improvement. Although symptom-based goals were achieved to a greater extent, achievement of goals based on body image, confidence and sexuality were much lower. In addition, some goals such as ‘not needing pads’ were not achieved despite resolution of incontinence as a number of women continued to use pads ‘just in case’. Women who were incontinent appeared to take much longer to recover confidence in their body image, femininity and sexuality than those with prolapse. We hypothesise that this may be because of the profound negative impact of urinary incontinence on self-esteem, which in turn leads to long-term lack of confidence in their sexuality and body image. Previous work has shown that affected women may feel a sense of shame or humiliation that causes them to distance themselves from sexual relationships.24 On the other hand, women undergoing surgery for urodynamic stress incontinence have also been shown to have high expectations regarding outcome, including resolution of urgency and frequency.25 This combination of factors may explain lower goal achievement in this cohort.

Unrealistic expectations and goals related to these play an important role in overall postoperative satisfaction of women. The preoperative counselling visit is essential to identify and clarify a woman’s expectations. However, women’s expectations of goal achievement are so strong that even extensive counselling does not always eliminate unrealistic hopes. Our findings support previous studies that have shown that women ‘hear’ primarily what interests them. Selective attention and interpretation may explain why women remain dissatisfied despite objective evidence of ‘cure’, often stating that ‘no one ever told them’ and that they were not well prepared for surgery.10 This once again highlights the importance of clear information leaflets26 written avoiding medical jargon to reiterate what can and cannot be realistically expected from surgery. Disappointment at not achieving a specific goal, however unrealistic, may overshadow objective cure of stress incontinence and prolapse and therefore does not predict satisfaction. Keeping in mind that patient satisfaction with treatment is directly related to fulfilment of positive expectations, every attempt should be made to keep these expectations realistic and agreed on by patient and physician.

To the best of our knowledge, this is the first study to analyse surgeon’s goals and the extent to which these are attained. This has provided an overview into the reasoning behind a surgeon’s choice of operative intervention and an insight into our motivation for carrying these out. It is reassuring that most surgeons seemed to pay as much importance into improving functional outcomes as they did to anatomic restoration. Improvement of women’s QoL, avoidance of surgical complications and durability of cure were also commonly cited as goals, which once again demonstrate a deeper understanding of issues that are ultimately important to the women. Finally, although surgeon’s goal achievement continued to be higher than that of women at 2 years, this was only a small difference which suggests that, contrary to popular belief, surgeons may now have a more realistic understanding of not only ‘important’ goals from a woman’s point of view but also of the level of their achievement in addition to their own abilities.

Strengths of our study include the prospective design and excellent follow-up rates even at extended follow up of 2 years. Despite following a strict per protocol analysis, whereby only those women who had attended every postoperative visit and completed all questionnaires were included, there was still a 56% follow-up rate at 2 years. All women in this study completed multiple validated indices of bladder, prolapse and sexual function. All objective assessments were also performed using the POP-Q system. As far as we are aware, this is the first study evaluating goals expressed by operating surgeons and how these might differ from patient’s goals both in terms of content and extent of achievement.

We acknowledge however, that our study has some limitations. As per our study methodology, a strict per protocol analysis was followed whereby only those women who had attended every postoperative visit and completed all questionnaires were included. Women who did not fulfil these stringent criteria were still followed up clinically but these data were not included in the analysis. However, we accept that this perhaps could be a source of potential bias. Our method of categorising the goals of women and surgeons was arbitrary and this may be inherently biased. Although we had multiple surgeons performing the procedures, only a single investigator carried out all the postoperative reviews, which also might be a potential source of bias. Finally, we accept that as some of our results are based on bivariable associations, these may not take into account all the potential confounding variables.

We believe that identification of surgeon’s goals provides us with deeper insight into our own motivation for operative intervention. In addition, identification of women’s preoperative goals may lead to improvement in the delivery of care as unmet expectations have been shown to be an integral part of patient dissatisfaction after surgery27 and consequently assessment of their achievement may prove an essential measure of surgical ‘success’.

Conclusion

Surgeons and the women they treat choose different goals and have varying expectations of the outcome of surgery for urogenital prolapse and urinary incontinence. However, of the realistic goals approximately 90% are still achieved 2 years following surgery.

Disclosure of interests

S. Srikrishna has received speaker honoraria from Recordati, Astellas and SEP and is on the advisory board of Astellas. D. Robinson is a consultant for Astellas, Ferring, Gynaecare, Uroplasty, Pfizer, Recordati and Novo-Nordisk; has received speaker honoraria from Astellas, Ferring, Gynaecare, Uroplasty, Pfizer and Recordati and has participated in trials of Astellas and Pfizer. L. Cardozo is a consultant for Astellas, Pfizer, Rottapharm and SEP; has received speaker honorara from Astellas, Pfizer and Rottapharm; has taken part in trials for Astellas and Pfizer; and received a research grant from Pfizer.

Contribution to authorship

S. Srikrishna was responsible for the conception and design of the study, data acquisition, analysis and interpretation, drafting and revising the manuscript, and final approval of the version to be submitted for publication. D. Robinson was responsible for the conception and design of the study, for supervising the study, for drafting and revising the manuscript and for final approval of the version to be submitted for publication. L. Cardozo was resonsible for supervising the study, revising the manuscript and for 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.

Funding

No funding was received for this study.

Journal club

Discussion points

1. Background: Discuss patient-reported outcomes, and whether they are associated with clinical or organisational outcomes (complaints, litigation etc), including but not limited to the field of urogynaecology.

If you have ever been involved in pelvic floor surgery, recall and discuss your personal goals for the operation(s).

Review the literature and explain to your colleagues the Pelvic Organ Prolapse Quantification System.

2. Methods: Describe the technique of Goal Attainment Scaling and compare with Likert scales. If possible, discuss the different statistical methods that would be appropriate for either measure.

How could nonparticipants differ from the women eventually included in the study, and how would this influence the study results?

3. Results and implications: Discuss the difference in goal achievement for prolapse, continence symptoms, body image and sexual function, and possible reasons.

Explain how the findings of this study will affect your counselling of women before pelvic floor surgery. How are you intending to deal with ‘unrealistic’ expectations?

If you could repeat the study with a larger sample, for which confounding factors would you adjust in the multivariate analyses?

D Siassakos

University of Bristol and Southmead Hospital, Bristol, UK
Email jsiasakos@gmail.com

Ancillary