Quality of Life and Patient Reported Outcomes

Urogenital prolapse and urinary incontinence, whilst not life threatening, remain important causes of morbidity in women. Their adverse effect on quality of life (QoL) has been extensively documented.^{1, 2}

As there is no standard validated definition of urogenital prolapse, it is difficult to determine prevalence in the female population. However, four large population studies suggest that the prevalence of stage 3–4 prolapse is in the range of 2–11%.^{3, 4, 5, 6} Whilst the prevalence of urinary incontinence has been found to vary widely as well, depending on the definition used, a large scale epidemiological study found that approximately 25% of women complain of urinary leakage.⁷ Stress incontinence accounted for 50% of cases, urgency incontinence 11% and mixed incontinence 36%.

Pelvic floor dysfunction can be successfully managed with a range of conservative or behavioral treatments including lifestyle modification, bladder retraining, pelvic floor muscle training, and as well as the use of pessaries. These treatments may be used alone, but are typically offered in combination. Pharmacological intervention is frequently required for women with an overactive bladder (OAB), whilst the lifetime risk of having surgery for urogenital prolapse or stress incontinence is 11%, with 29.2% requiring repeat surgery.⁸

When comparing results of intervention for pelvic floor dysfunction, traditionally, objective outcome measures have been considered to be more robust and consequently these have been employed in many studies. Although previous guidelines regarding outcome assessment have been published,^{9, 10} currently there is no consensus of opinion regarding which method of outcome assessment is most appropriate.¹¹ In addition, there is often a dichotomy of opinion when comparing clinician’s evaluation with that of patients; previous work has demonstrated that clinicians tend to underestimate the effects of pelvic floor dysfunction on patient’s lives,^{12, 13} but be more optimistic when evaluating the outcome of their pelvic floor surgery.¹⁴

Until relatively recently there has been a paucity of data regarding patient expectations following treatment for urogenital prolapse or incontinence. Expectations are shaped by previous personal experiences, those of friends and relatives and also by the attitude and experience of clinicians caring for these women. Patient expectations of surgery may be particularly important when surgery is being performed simply to improve QoL.^{15, 16} 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 patient’s views have been recognized as increasingly important, an alternative way of examining patient expectations of treatment is to use patient-reported outcomes.

A patient-reported outcome (PRO) is 'any report of the status of a patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else'.¹⁷ PROs measure different aspects of disease and therapeutic impact such as symptom frequency or symptom bother, health-related quality of life (HRQL), treatment satisfaction, or work productivity measures. The past decade has been one of tremendous growth in the area of PROs with influences from scientific and regulatory communities. As there are many available PROs, it is of utmost importance to select the PRO measure that is relevant and applicable to one’s desired outcome. In addition, issues of staff and participant burden, time constraints, and resources should be considered in the selection of a PRO measure. In general, the growing trend has been to include condition-specific outcome measures in clinical trials owing to their enhanced sensitivity to change and the need to minimize participant burden. In practice, clinical trials that include PROs usually incorporate a combination of PRO measures most relevant to the study population and intervention, if applicable, being mindful of resource constraints and staff and participant burden.

The aim of this review article is to consider the development and current usage of PROs as outcome assessment tools in urogynecology, with focus on urogenital prolapse and stress urinary incontinence.

The World Health Organization has defined health as ‘not merely the absence of disease, but complete physical, mental and social wellbeing’.¹⁸ QoL includes a combination of patient assessed measures of health including physical function, role function, social function, emotional or mental state, burden of symptoms and sense of well-being.¹⁹ QoL has been defined as including ‘those attributes valued by patients including their resultant comfort or sense of well-being; the extent to which they were able to maintain reasonable physical, emotional, and intellectual function; the degree to which they retain their ability to participate in valued activities within the family and the community.²⁰ This helps to emphasize the multidimensional nature of QoL and the importance of considering patients' perception of their own situation with regard to non-health related aspects of their life.²¹

Research has often concentrated on the prevalence, etiology, diagnosis and management of pelvic floor dysfunction with little work being performed on the effects of chronic conditions, or their treatment, on QoL. Over the past few decades interest in the incorporation of patient assessed health status or QoL measures into the evaluation of the management has increased.²²

The views of clinicians and patients regarding QoL and the effects of therapy differ considerably. Traditionally, surgeons have considered objective outcome measures to be more robust and, consequently, these have been employed in many studies. Despite this currently there is no consensus of opinion regarding which method of outcome assessment should be considered more important,²³ although previous guidelines regarding outcome assessment have been published.^{24, 25} QoL has often been used as a surrogate marker of patient satisfaction and success following treatment. The evaluation of QoL allows the quantification of morbidity, treatment efficacy and also acts as a measure of how lives are affected and coping strategies adopted. It is estimated that 20% of adult women suffer some degree of life disruption secondary to lower urinary tract dysfunction.²⁶

Whilst QoL is highly subjective, it has now been acknowledged that it is as important as physical disease state in the management of women with pelvic floor dysfunction.²⁷ Consequently the success of treatment can no longer be judged on clinical parameters alone and QoL needs to be considered in both clinical and research settings (Table 1).²⁸

Table 1  Applications of quality of life questionnaires

There are many validated questionnaires available, although all have the same structure consisting of a series of sections (domains) designed to gather information regarding particular aspects of health (Table 2). There are two types of QoL questionnaires, generic and disease or condition specific.

 Table 2 Quality of life domains

More recently the International Consultation on Incontinence (ICI) has published levels of recommendation for both generic and disease specific questionnaire(Table 3).²⁹

Table 3 Criteria for the recommendation of questionnaires (based on the Oxford Scale)

GENERIC QoL QUESTIONNAIRES

Generic questionnaires are designed as general measures of QoL and are therefore applicable to a wide range of populations and clinical conditions. Many different validated generic questionnaires have been developed, although not all are suitable for the assessment of urogenital prolapse. They are not specific to a particular disease, treatment or age group and hence allow broad comparisons to be made. Consequently they lack sensitivity when applied to women with urogenital prolapse and may be unable to detect clinically important improvement.

Generic quality of life questionnaires (grade A) include:

DISEASE-SPECIFIC QUALITY OF LIFE QUESTIONNAIRES

International Consultation on Incontinence (ICIQ) modular questionnaire

The ICIQ modular questionnaire²⁹ was developed to meet the need for a universally applicable standard guide for the selection of questionnaires for use in clinical practice and clinical research. The decision to develop standard questionnaire modules was taken by the Committee after the first ICI meeting in 1998, and resulted in the development of the ICIQ core questionnaire. The aims of the ICIQ project are as follows:

1. To provide a series of questionnaire modules to assess pelvic problems;
2. To develop fully validated international standard questionnaires for lower urinary tract dysfunction, vaginal symptoms and lower bowel dysfunction;
3. To form consensus over the most suitable questionnaires for use;
4. To facilitate wide use of the questionnaires.

Fourteen ICIQ modules/questionnaires are currently available for use, with further modules in development. The Grade A recommended questionnaires that are specific to women with pelvic floor dysfunction (pelvic organ prolapse (POP) and stress urinary incontinence (SUI)) are discussed in the following sections.

The ICIQ modular questionnaire project (www.iciq.net) provides a series of standardized questionnaires for the patient reported assessment of pelvic dysfunction symptoms and their impact on patients lives. The ICIQ provides clarity over the selection of questionnaires by recommending only those with evidence of high quality and robust psychometric validation including validity, reliability and sensitivity to change.

QoL and pelvic organ prolapse

In the past, an attempt has been made to use generalized questions in an effort to evaluate sexual function in women undergoing surgery for pelvic floor disorders.³⁴ More recently, disease-specific QoL questionnaires have been developed to specifically address urogenital prolapse more accurately and in greater detail. The questions are designed to focus on key aspects associated with pelvic floor dysfunction whilst scoring is performed so that clinically important changes can be detected. However, there are only a few validated questionnaires available which record both symptom distress and QoL in women with POP.

In general questionnaires for POP tend to focus more on the symptoms related to the lower bowel and prolapse probably because of the wider availability of questionnaires to assess lower urinary tract symptoms (LUTS). The three broad categories of instruments for POP are:

1. Presence of symptoms and their severity;
2. Health related quality of life (HRQL)
3. Sexual function.

Disease-specific quality of life questionnaires (grade A) include:

Prolapse QoL questionnaire

The Prolapse QoL questionnaire is a reliable and validated questionnaire which assesses both the severity of symptoms of prolapse and their impact on the QoL of affected women. It includes 20 questions representing nine quality of life domains covering general health, prolapse impact, role, physical and social limitations, personal relationships, emotional problems, sleep/energy disturbance as well as measurements of symptom severity. Questions regarding bladder, bowel and sexual function are also separately included and validated for reproducibility and internal consistency (Tables 4 and 5). The scoring system of the PQoL has been previously reported.³⁵ It is a simple, valid, reliable questionnaire which has been translated and validated into many languages around the world.^{36, 37, 38, 39, 40, 41, 42}

Table 4 Prolapse QoL domains

Table 5 Prolpapse QoL symptoms questions

Pelvic Floor Distress Inventory and the Pelvic Floor Impact Questionnaire

The Pelvic Floor Distress Inventory (PFDI) and the Pelvic Floor Impact Questionnaire (PFIQ)⁴³ address symptom distress and QoL impact respectively in women with urogenital prolapse. These two instruments are based on the structure and content of two widely used condition-specific HRQoL questionnaires for women with lower urinary tract dysfunction, the Urinary Distress Inventory (UDI) and the Incontinence Impact Questionnaire (IIQ).⁴⁴ The PFDI was designed to assess symptom distress in women with pelvic floor dysfunction and includes all of the items in the original UDI instrument plus items relating to POP and lower bowel dysfunction. The PFIQ was designed to assess life impact in women with pelvic floor disorders and, like the PFDI, contains all of the items included in the original IIQ, as well as items related to other pelvic floor disorders.

The PFDI has 46 items and contains three scales, the UDI, the Pelvic Organ Prolapse Distress Inventory (POPDI), and the Colorectal–anal Distress Inventory (CRADI) (Table 6). Respondents are asked whether they experience symptoms and, if so, to indicate on a scale from 1 (not at all) to 4 (quite a bit) the degree to which they are bothersome. The UDI scale of the PFDI is a modified and expanded version of the original instrument with nine additional questions related to lower urinary tract symptoms that are common in women with other pelvic floor disorders. The original three subscales of the UDI (Obstructive, Irritative/discomfort, and Stress) are retained. The POPDI consists of 16 symptoms related to POP and has three subscales (General, Anterior, and Posterior). The CRADI consists of 17 items related to lower gastrointestinal tract dysfunction and has four subscales (Obstructive, Incontinence, Pain/irritation, and Rectal prolapse).

The PFIQ has a total of 93 items and contains three scales, the Urinary Impact Questionnaire (UIQ), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ), and the Colo-Rectal-Anal Impact Questionnaire (CRAIQ), each with 31 items (Table 7). Thirty of the 31 items in each of the PFIQ scales are identical to those described in the original IIQ with an additional question regarding the effect of bladder, bowel, or vaginal symptoms on the patient’s relationship with her husband or intimate partner. Responses regarding the degree to which bladder, bowel, or vaginal symptoms affect each activity or feeling range from 1 (not at all) to 4 (quite a bit). The four subscales of the IIQ (Travel, Social, Emotional, and Physical activity) were retained and applied to all three scales of the PFIQ.¹³ Because of the relatively large number of items in the PFIQ, the questionnaire was structured to maximize efficiency and encourage discrimination between the impact of bowel, bladder, and vaginal symptoms.

Table 6 Scales and subscales of the PFDI

NA, not applicable

Table 7  Scales and subscales of the PFDI

The UDI, CRADI and POPDI are each scored similarly. All subscales score a common range of 0–100. The total scale score is then calculated by summing the subscale scores. This gives a total possible score of 0–300 for the UDI and the POPDI, each with three subscales, and 0–400 for the CRADI, which has four subscales. The UIQ, POPIQ, and CRAIQ are scored in the same manner with total scores ranging from 0 to 400. Together, these two instruments provide a measurement of the extent to which pelvic floor disorders affect the lives of the women who have them.

QUALITY OF LIFE AND LOWER URINARY TRACT DYSFUNCTION

Disease-specific QoL questionnaires

To improve the sensitivity of QoL questionnaires disease-specific tools have been developed to assess particular medical conditions more accurately and in greater detail. The questions are designed to focus on key aspects associated with lower urinary tract symptoms whilst scoring is performed so that clinically important changes can be detected. There are several Grade A recommended disease specific QoL questionnaires that can be used in women with lower urinary tract dysfunction.

 Disease-specific QoL questionnaires (grade A) include:

In general, perhaps the best solution when assessing women with urinary incontinence is to use a generic and a disease-specific questionnaire in combination, both of which have been validated and used previously.

The King’s Health Questionnaire (KHQ)

The King’s Health Questionnaire (KHQ) was developed in the department of Urogynaecology at King’s College Hospital (Table 8).⁴⁵ It is a disease-specific, self-administered questionnaire designed to assess the impact of urinary incontinence on QoL in women. The instrument contains 21 questions that are scored in nine domains (general health perception, incontinence impact, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep/energy, severity of urinary symptoms).⁴³ Importantly, the KHQ is designed to sensitively measure the effect that symptoms of urinary incontinence have on QoL, and can be used to grade improvement after treatment. The KHQ is easy to complete, valid and a reliable instrument for the assessment of women with urinary incontinence so it continues to be used for clinical and research purposes. In addition it has been utilized in many major clinical trials and has now been modified for a number of different cultures and languages. It has been translated into a total of 44 languages including French, German, Greek, Spanish, Swiss, Italian, French and English Canadian and US English, and has been validated in men.

QoL and sexual function

Sexual health is a state of physical, emotional, mental, and social well-being in relation to sexuality; it is not merely the absence of disease, dysfunction, or infirmity.⁵² Pelvic floor disorders (PFD), including urinary (UI) and pelvic organ prolapse (POP), often adversely affect sexual health.^{53, 54} Up to 60% of sexually active women attending urogynecology clinics report sexual dysfunction.⁵⁴ Questionnaires play an integral role in the evaluation of female sexual function. Although there are several questionnaires available now which deal with female sexual dysfunction, only two have a grade A recommendation, having demonstrated not only reliability and validity, but also that content was derived with patient input and responsiveness to treatment has been shown.

Disease-specific QoL questionnaires (grade A) include:

Golombok Rust Inventory of Sexual satisfaction (GRISS)

The Golombok Rust Inventory of Sexual Satisfaction (GRISS) is a short 28-item questionnaire for assessing the existence and severity of sexual problems. The design, construction and item analysis of the GRISS are described. It has been shown to have high reliability and good validity for both the overall scales and the subscales.⁵⁵ The GRISS is used by sexual dysfunction clinics and relationship counsellors to monitor the state of their patient’s sexual function. It has also been used in clinical trials of new treatment approaches and pharmacological products designed for treatment of sexual dysfunction. It is particularly useful in identifying the extent of any change in sexual function as a result of therapy. The female version of the GRISS produces a total score as well as subscales of:

• Infrequency – number of times a week (or less) on which sexual intercourse takes place
• Avoidance – extent to which a female partner is actively avoiding having sex
• Anorgasmia – extent to which a woman is able to attain orgasm
• Non-communication – extent to which a couple are able to talk about any sexual problems
• Non-sensuality – extent to which a female partner gains pleasure from touching and caressing
• Dissatisfaction – extent to which a woman is dissatisfied with her sexual partner
• Vaginismus – extent of any tightness around the vagina that interferes with sex

The Female Sexual Function Index (FSFI)

The FSFI⁵⁶ was developed as a brief, multidimensional self-report instrument for assessing key dimensions of sexual function in women. It is a valid, and reliable self-report measure of female sexual function, which can be easily administered to women across a wide age range, including postmenopausal women.

The FSFI was designed to be a clinical trials assessment instrument that addresses the multidimensional nature of female sexual function. The scale consists of 19 items that assess sexual function over the previous 4 weeks and yield domain scores in six areas: sexual desire, arousal, lubrication, orgasm, satisfaction, and pain. The authors have also proposed a cut-off total scale score of 26 for diagnostic classification. Any individual woman who scores 26 or less on the total score should be considered at risk for sexual dysfunction and be evaluated further. Additionally, increased pain scores can be viewed as evidence for a sexual pain disorder, and decreased lubrication scores may be associated with a sexual arousal disorder. The FSFI has now been validated in several languages.

From a clinical perspective, FSFI can be used as a screening tool and potential aid in diagnostic assessment.  However, its main limitations are that it cannot be used as the sole basis for diagnostic classification. In addition to the psychometric issues and the assessment is limited to the previous 4 weeks. No information is provided regarding the onset or duration of the problem, nor does the scale offer information on the role of etiological or maintaining factors.

Psychological and relationship factors are also not adequately addressed. Additionally, the scale is not designed to assess potential interactions among domains or to differentiate primary from secondary or situational causes of

sexual dysfunction in women.

When comparing results of intervention for pelvic floor dysfunction, traditionally, objective outcome measures have been considered to be more robust and, consequently, these have been employed in many studies. Although previous guidelines regarding outcome assessment have been published,^{57, 58} currently there is no consensus of opinion regarding which method of outcome assessment is most appropriate.⁵⁹ As patient’s views have been recognized as increasingly important, an alternative way of examining patient expectations of treatment using patient orientated goals⁶⁰ has evolved. This still remains an emerging field and there are only a few studies in the existing surgical literature focusing on patient expectations for surgery.^{15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 61, 57, 58, 59, 60, 62} Some studies have revealed that goal achievement is related to general QoL measures,⁶² although few data compare these with satisfaction.

Patient satisfaction and Goal Attainment Scaling are two important but separate types of PROs that allow for individualised assessment of disease impact and treatment. Patient satisfaction is the subjective, individual evaluation of treatment effectiveness and/or the service provided by the healthcare system. Goal attainment scaling (GAS) is a method developed to ascertain individual patient treatment goals and using those to facilitate patient–provider interaction and tailor the treatment plan based on those individual’s goals.

Measures of patient satisfaction can include evaluation of accessibility/convenience, availability of resources, continuity of care, efficacy, finances, humaneness, information gathering and giving processes, pleasantness of surroundings and perceived quality/competence of health care personnel.⁶³ At its most basic level, satisfaction is a comprehensive evaluation of several dimensions of health care based on patient expectations and provider and treatment performance. As an outcomes measure, patient satisfaction allows health care providers to assess the appropriateness of treatment according to patient expectations. In chronic diseases, where patients must live with treatment, patient satisfaction may be the distinguishing outcome among treatments with comparable efficacy.

HISTORY AND DEVELOPMENT OF PATIENT GOALS AS AN OUTCOME MEASURE

Goal attainment scaling (GAS) was originally developed in the 1960s.⁶⁴ It is a measurement technique that was pioneered in community mental health evaluation, and since then been used in other complex conditions such as interstitial cystitis/painful bladder syndrome⁶⁵ and rehabilitation.^{66, 67} 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 urogynecology to evaluate treatment outcome^{15, 16, 60, 62}.

GAS has been linked to several possible benefits compared with traditional outcome measures, such as improved clarity concerning treatment objectives for both the healthcare provider and the patient, active involvement of the patient in problem-solving efforts, establishment of realistic patient and healthcare provider expectations of treatment, and increased motivation of patients toward improving their health condition. The end result of GAS is to clarify patients’ expectations for their treatment, document goal achievement, and eventually increase patient satisfaction and improve therapeutic outcomes.

Patient selected goals are now increasingly used as an alternative approach to measuring improvements in symptoms and QoL. The term 'EGGS' has been coined⁶⁸ in relation to patient-centered treatment outcomes – E expectations, G goal setting, G goal achievement, S satisfaction. Lowenstein et al.¹⁶ have even suggested that, in addition to the three established dimensions for pelvic floor disorders in the assessment of women with pelvic floor dysfunction (physical findings, symptoms, and QoL assessment), patient centered goals should be integrated as the fourth dimension. However, these goals may need frequent review and reassessment as previous work has shown that urogynecological consultation affects patients' goals.⁶⁹

The use of such goals in urogynecology was first demonstrated in the surgical management of prolapse. Here, such goals have been shown to be both responsive to change and stable over time.^{15, 60, 62}

Subsequently, patient goals have been used as an outcome assessment tool in other urogynecological disorders, including stress incontinence,¹⁶ overactive bladder⁷⁰and painful bladder syndrome⁶². Goal achievement has also been assessed with a variety of interventions, including pessary use,^{71, 72} pelvic floor training,⁷³ antimuscarinic therapy⁷⁴ and intravesical botulinum toxin.⁷⁵

PATIENTS GOALS IN UROGENITAL PROLAPSE

The first published account of patient goals in the setting of urogenital prolapse was by Hullfish et al. in 2002.⁶⁰ This paper attempted to define the 'meaning of success' from the patient’s perspective following pelvic floor surgery. Women who underwent a pelvic floor operation defined their own personal goals that they hoped to achieve from surgery and assessed the achievement of those postoperatively. Women with pelvic floor dysfunction were found to have widely varying expectations for reconstructive surgery and most women met their goals by 12 weeks postoperatively, and this achievement persisted 1–3 years after surgery. The findings of this and subsequent follow-up studies⁷⁶ by this group suggested that goal achievement is related to, but not identical to, overall measures of QoL and symptom distress.

Similar findings were subsequently reported by other authors. Elkadry et al.¹⁵ demonstrated the importance of achieving patient expectations particularly when surgical intervention was being considered simply to improve QoL. Women’s goals for pelvic floor surgery were shown to be personal and highly subjective with lifestyle factors playing a large role in goal determination. Another study by Mahajan et al.⁷⁷ also found that symptoms of urgency incontinence and reduced achievement of subjective surgical goals were associated with decreased long-term patient satisfaction after reconstructive pelvic surgery.

Srikrishna et al.⁷⁸compared patient centered outcomes in women undergoing continence and pelvic reconstructive surgery with objective outcome measures. They also compared patient overall satisfaction with achievement of these goals and with that of the operating surgeon. The findings of this study suggested that patient centered goals for women having 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. Overall, reduction of the prolapse and restoration of normal anatomy significantly correlated with QoL improvement and goal achievement.

Unrealistic expectations and goals related to these were deemed to play an important role in overall postoperative patient satisfaction. This was also the first reported study of surgeon’s goals which provided an overview into the reasoning behind a surgeon’s choice of operative intervention and an insight into the motivation for carrying these out. Most surgeons paid as much attention into improving functional outcomes as they did to anatomic restoration. Improvement of patient’s QoL, avoidance of surgical complications and durability of cure were also commonly cited as goals. Interestingly, recent work has suggested that patient’s goals may also vary with the stage of prolapse.⁷⁹ However, resolution of urinary symptoms, ability to perform daily activities, and sexual function goals were demonstrated to be as important as resolution of prolapse symptoms.

Goal achievement has also been assessed for nonsurgical interventions, including pessary use and pelvic floor training. Patient goals amongst pessary users were found to be variable and subjective. However, achievement of these goals was associated with pessary continuation.⁷¹ Pelvic floor muscle training alone was associated with lower patient goal attainment and satisfaction scores at 1 year compared to patients undergoing surgery. Goal achievement correlated with disease specific QoL.⁷²

PATIENTS GOALS IN STRESS URINARY INCONTINENCE

The traditional focus in the management of stress urinary incontinence (SUI) has been to provide an objective cure for this distressing condition. For those patients who do not have adequate symptom relief with conservative treatment, surgery is often required. However, objective cure rate cannot be the only consideration when comparing different treatments for SUI, as this is a condition which principally impairs QoL. The degree of patient satisfaction with treatment outcome after all incontinence therapy has been poorly studied.

Previous studies using goal attainment scaling as an outcome assessment tool have found goal achievement following conservative treatment was poor. GAS was not thought to be a feasible outcome measure as women readily identified personal goals but could not grade levels of attainment for each goal.⁸⁰

Colposuspension and traditional slings have been reported to be associated with high objective success, but in the few studies using patient perceptions of outcome, the subjective results are less optimistic than those measured by objective outcome assessment.⁸¹

Insertion of a retropubic mid-urethral tape has increasingly become the new 'gold standard' in the surgical management of SUI. A recent multicenter randomized controlled trial comparing retropubic versus trans-obturator mid-urethral slings for urodynamic stress incontinence was the first to use patient reported outcomes as the primary outcome measure.⁸² The results of this study showed that although the transobdurator tape (TOT) was not inferior to the tension-free transvaginal tape (TVT), success rates were less than those of studies using objective measures. Subjective ‘cure’ was seen in 66% and 63% of TVT and TOT patients, respectively. Despite this, patient satisfaction was high, which suggests that complete continence may not be as important for patient satisfaction as achievement of their personal goals. Davis et al.⁸³ reported on a cohort of patients who had undergone a TVT procedure, 1 year after surgery. They found that dissatisfied patients complained of incontinence, storage symptoms or voiding dysfunction after surgery much more frequently than those satisfied with surgical outcome. Therefore, they concluded that normal bladder storage and emptying function were important patient goals which predicted satisfaction after surgery.

Improvement of stress urinary incontinence was perceived as the most important goals of treatment⁸⁴ in a study comparing perspectives by patients and physicians on outcomes of mid-urethral sling surgery. Development of de novo detrusor overactivity, voiding dysfunction needing self-catheterization and dyspareunia were considered to be the most important complications by patients. Patient goals have also been found to be useful in assessing less invasive forms of surgical treatment for SUI. Chapple et al. found there was a willingness to trade a lower success rate in favor of a more minor treatment procedure such as peri-urethral injection therapy.⁸⁵

Although these QoL instruments are a vital part of outcome assessment, they are relatively long and require calculation of a score, making them difficult to use in a busy clinical setting. In contrast, global indices that ask a patient to rate the response of her condition to intervention (such as surgery in pelvic organ prolapse) are much more simple and easy to use and interpret in trials comparing interventions in the management of urogenital prolapse.

The goal of a global scale is to gain an overall appraisal of a complex phenomenon, not to evaluate each of its component parts. Therefore, there may be uncertainty regarding precise aspects of improvement which results in an individual rating chosen by the patient.⁸⁶ However, a global index is completed by the patient and represents her own unique personal perception. This is in direct contrast to the total scores that can be calculated from multiple question condition specific QoL instruments, as these are derived from questions set by clinicians rather than patients themselves.⁸⁷ In addition, global indices have been shown to be precise when applied by the same person over time.

The Patient Global Impression of Improvement (PGI-I) has been previously validated for use in female patients with urinary incontinence,⁸⁸ but more recently its use has also been validated in women with urogenital prolapse.^89, The PGI-I scale was originally modelled after psychopharmacological scales described in 1976 (Clinical Global Impression).⁹⁰ It is a seven point scale that requires the patient to assess how much her condition has improved or worsened relative to a baseline state prior to the start of the intervention (Figure 1). The advantage of using a global index such as the PGI-I is that it provides a single measure of significance of change from the individual perspective.⁹¹

A global index can assess clinically meaningful change by taking into account more information that may affect health related QoL (HRQOL). It shares the advantage with other self administered questionnaires that it avoids physician bias. It is also a single question assessment which makes it easy for the patient to complete and is less time consuming than a more detailed multiple question condition specific QoL instrument. This, in turn, makes it an ideal instrument to be used in the clinical setting of a busy urogynecology unit. From a research point of view, its versatility in terms of application in both urogenital prolapse and urinary incontinence and simplicity of usage should make it an ideal outcome assessment tool.^{88, 89}

In essence, the PGI-I encompasses all outcome measures: subjective, quality of life and patient-centered goals. It is simple, pragmatic and easy to use whilst being sensitive to change. It is a true reflection of  'success' following surgery for urogenital prolapse as it reflects a woman’s overall appraisal of her response to treatment. Consequently, this global index may be a valuable addition not only in clinical practice to evaluate response to prolapse treatment, but also an outcome assessment tool in trials comparing interventions in the management of urogenital prolapse.

The use of PROs has been now established as integral in outcome assessment women with pelvic floor dysfunction. In general, the growing trend has been to include condition-specific outcome measures in clinical trials owing to their enhanced sensitivity to change and the need to minimize participant burden. Importantly, the type of instruments selected for inclusion in a research study will depend on the goals of the intervention and the specific research questions to be addressed. In practice, clinical trials that include PROs usually incorporate a combination of PRO measures most relevant to the study population and intervention, if applicable, being mindful of resource constraints and staff and participant burden.

PROs have been shown to be a useful adjunct in the investigation and management of women with pelvic floor dysfunction. They provide an objective measure of the impact of prolapse and incontinence which is essential to the accurate investigation and evaluation of patients and new treatment protocols. In addition they have an important role in research, both in pharmacological and surgical trials, and audit activities allowing accurate assessment of new and established treatments and their impact on QoL.

QoL assessment has been established as an integral outcome assessment tool in the management of women with pelvic floor dysfunction. However, there are only a few validated questionnaires available which record both symptom distress and QoL in women with pelvic floor dysfunction. In addition, most are lengthy thereby limiting their use in the clinical setting.

Patient expectations for surgery may be particularly important when surgery is being performed simply to improve QoL. Evidence shows that achievement of their own goals is the primary reason for which patients undergo pelvic floor reconstruction surgery. These goals are highly subjective and personally important to each patient. However, it remains difficult to compare results across studies, limiting their generalizability. There are also limited data comparing goal achievement with other measures of outcome and satisfaction.

Global indices are more simple and easy to use and interpret, and give an overall appraisal of a complex phenomenon. However, these do not evaluate specific component parts, therefore, there may be uncertainty regarding precise aspects of improvement which results in an individual rating chosen by the patient.

As each method has its own advantages and disadvantages they need to be applied on an individualized basis and frequently several outcome measures are used in conjunction to provide a holistic measurement of disease impact on the patients’ lives as well as the 'success' of intervention from the patients' perspective.

Use of PROs allows patient care to be tailored based on clinical need and enables clinicians to focus on those specific and often very personal symptoms that bother patients most. This may ultimately improve patient satisfaction and overall outcome.