Economic evaluation of surgical treatments for women with stress urinary incontinence: a cost-utility and value of information analysis.

OBJECTIVES: Stress urinary incontinence (SUI) and stress-predominant mixed urinary incontinence (MUI) are common conditions that can have a negative impact on the quality of life of patients and serious cost implications for healthcare providers. The objective of this study was to assess the cost-effectiveness of nine different surgical interventions for treatment of SUI and stress-predominant MUI from a National Health Service and personal social services perspective in the UK. METHODS: A Markov microsimulation model was developed to compare the costs and effectiveness of nine surgical interventions. The model was informed by undertaking a systematic review of clinical effectiveness and network meta-analysis. The main clinical parameters in the model were the cure and incidence rates of complications after different interventions. The outcomes from the model were expressed in terms of cost per quality-adjusted life-years (QALYs) gained. In addition, expected value of perfect information (EVPI) analyses were conducted to quantify the main uncertainties facing decision-makers. RESULTS: The base-case results suggest that retropubic mid-urethral sling (retro-MUS) is the most cost-effective surgical intervention over a 10-year and lifetime time horizon. The probabilistic results show that retro-MUS and traditional sling are the interventions with the highest probability of being cost-effective across all willingness-to-pay thresholds over a lifetime time horizon. The value of information analysis results suggest that the largest value appears to be in removing uncertainty around the incidence rates of complications, the relative treatment effectiveness and health utility values. CONCLUSIONS: Although retro-MUS appears, at this stage, to be a cost-effective intervention, research is needed on possible long-term complications of all surgical treatments to provide reassurance of safety, or earlier warning of unanticipated adverse effects. The value of information analysis supports the need, as a first step, for further research to improve our knowledge of the actual incidence of complications.

Surgical treatments for women with stress urinary incontinence: a systematic review of economic evidence.

BACKGROUND: Surgical interventions for the treatment of stress urinary incontinence (SUI) in women are commonly employed following the failure of minimally invasive therapies. Due to the limited information available on the relative cost-effectiveness of available surgeries for treating SUI, a de novo economic analysis was conducted to assess costs and effects of all relevant surgeries. To inform the economic analysis, the objective of this review was to identify and assess the quality of existing economic evaluation studies on different surgical interventions for the treatment of SUI in women. METHODS: The following databases were searched during the review process: Medical Literature Analysis and Retrieval System Online (MEDLINE), MEDLINE In-Process, Excerpta Medica Database (Embase), National Health Service Economic Evaluation Database (NHS EED), and Health Management Information Consortium and Cost-Effectiveness Analysis Registry (CEA registry). The key criteria for inclusion were that the study population included women with SUI and that the surgical interventions considered were utilised as either a primary or a follow-up surgery. The review included only full economic evaluations. Studies were quality assessed using the Drummond checklist for economic evaluations. No quantitative synthesis of the results by meta-analysis was conducted due to the high methodological heterogeneity. RESULTS: Twenty-six economic evaluations were included, of which 13 were model-based analyses. Surgical treatments assessed most frequently were mid-urethral slings and open and laparoscopic colposuspension. There were some differences in the methodological approaches taken, including differences in type of economic analysis, perspective, time horizon, types of resource use, and costs and outcomes that were included in the analysis. The majority of studies conducted a cost-utility analysis from a health system perspective and applied a time horizon of between 1 and 5 years. The cost-effectiveness results suggest that single-incision mini-sling and mid-urethral slings are among the most cost-effective options. CONCLUSIONS: The review has shown that methods used for the economic evaluation of surgical treatments for SUI vary widely in terms of study design, analysis type, compared alternatives, time horizon, costing methodologies and effect outcomes. Future economic evaluation studies on surgical treatments for SUI may be improved by the application of available guidelines. SYSTEMATIC REVIEW REGISTRATION: Registered in PROSPERO in 2016, CRD42016049339.

Traditional suburethral sling operations for urinary incontinence in women.

BACKGROUND: Stress urinary incontinence constitutes a significant health and economic burden to society. Traditional suburethral slings are surgical operations used to treat women with symptoms of stress urinary incontinence. OBJECTIVES: To assess the effectiveness of traditional suburethral sling procedures for treating stress urinary incontinence in women; and summarise the principal findings of relevant economic evaluations. SEARCH METHODS: We searched the Cochrane Incontinence Specialised Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), as well as MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP); we handsearched journals and conference proceedings (searched 27 February 2017) and the reference lists of relevant articles. On 23 January 2019, we updated this search; as a result, several additional reports of studies are awaiting classification. SELECTION CRITERIA: Randomised or quasi-randomised trials that assessed traditional suburethral slings for treating stress or mixed urinary incontinence. DATA COLLECTION AND ANALYSIS: At least two review authors independently extracted data from included trials and assessed risk of bias. When appropriate, a summary statistic was calculated: risk ratio (RR) for dichotomous data, odds ratio (OR) for continence and cure rates that were expected to be high, and mean difference (MD) for continuous data. We adopted the GRADE approach to assess the quality of evidence. MAIN RESULTS: A total of 34 trials involving 3244 women were included. Traditional slings were compared with 10 other treatments and with each other. We did not identify any trials comparing suburethral slings with no treatment or sham treatment, conservative management, anterior repair, or laparoscopic retropubic colposuspension. Most trials did not distinguish between women having surgery for primary or recurrent incontinence. One trial compared traditional slings with bladder neck needle suspension, and another trial compared traditional slings with single-incision slings. Both trials were too small to be informative. Traditional suburethral sling operation versus drugs One small trial compared traditional suburethral sling operations with oxybutynin to treat women with mixed urinary incontinence. This trial did not report any of our GRADE-specific outcomes. It is uncertain whether surgery compared with oxybutynin leads to more women being dry (83% vs 0%; OR 195.89, 95% confidence interval (CI) 9.91 to 3871.03) or having less urgency urinary incontinence (13% vs 43%; RR 0.29, 95% CI 0.09 to 0.94) because the quality of this evidence is very low. Traditional suburethral sling versus injectables One small trial compared traditional slings with suburethral injectable treatment. The impact of surgery versus injectables is uncertain in terms of the number of continent women (100% were dry with a traditional sling versus 71% with the injectable after the first year; OR 11.57, 95% CI 0.56 to 239.74), the need for repeat surgery for urinary incontinence (RR 0.52, 95% CI 0.05 to 5.36) or the occurrence of perioperative complications (RR 1.57, 95% CI 0.29 to 8.49), as the quality of evidence is very low. Traditional suburethral sling versus open abdominal retropubic colposuspension Eight trials compared slings with open abdominal retropubic colposuspension. Moderate-quality evidence shows that the traditional suburethral sling probably leads to more continent women in the medium term (one to five years) (69% vs 59% after colposuspension: OR 1.70, 95% CI 1.22 to 2.37). High-quality evidence shows that women were less likely to need repeat continence surgery after a traditional sling operation than after colposuspension (RR 0.15, 95% CI 0.05 to 0.42). We found no evidence of a difference in perioperative complications between the two groups, but the CI was very wide and the quality of evidence was very low (RR 1.24, 95% CI 0.83 to 1.86). Traditional suburethral sling operation versus mid-urethral slings Fourteen trials compared traditional sling operations and mid-urethral sling operations. Depending on judgements about what constitutes a clinically important difference between interventions with regard to continence, traditional suburethral slings are probably no better, and may be less effective, than mid-urethral slings in terms of number of women continent in the medium term (one to five years) (67% vs 74%; OR 0.67, 95% CI 0.44 to 1.02; n = 458; moderate-quality evidence). One trial reported more continent women with the traditional sling after 10 years (51% vs 32%: OR 2.22, 95% CI 1.07 to 4.61). Mid-urethral slings may be associated with fewer perioperative complications (RR 1.74, 95% CI 1.16 to 2.60; low-quality evidence). One type of traditional sling operation versus another type of traditional sling operation Nine trials compared one type of traditional sling operation with another. The different types of traditional slings, along with the number of different materials used, mean that trial results could not be pooled due to clinical heterogeneity. Complications were reported by two trials - one comparing non-absorbable Goretex with a rectus fascia sling, and the second comparing Pelvicol with a rectus fascial sling. The impact was uncertain due to the very low quality of evidence. AUTHORS' CONCLUSIONS: Low-quality evidence suggests that women may be more likely to be continent in the medium term (one to five years) after a traditional suburethral sling operation than after colposuspension. It is very uncertain whether there is a difference in urinary incontinence after a traditional suburethral sling compared with a mid-urethral sling in the medium term. However, these findings should be interpreted with caution, as long-term follow-up data were not available from most trials. Long-term follow-up of randomised controlled trials (RCTs) comparing traditional slings with colposuspension and mid-urethral slings is essential. Evidence is insufficient to suggest whether traditional suburethral slings may be better or worse than other management techniques. This review is confined to RCTs and therefore may not identify all of the adverse effects that may be associated with these procedures. A brief economic commentary (BEC) identified three eligible economic evaluations, which are not directly comparable due to differences in methods, time horizons, and settings. End users of this review will need to assess the extent to which methods and results of identified economic evaluations may be applicable (or transferable) to their own setting.

Surgical treatments for women with stress urinary incontinence: the ESTER systematic review and economic evaluation.

BACKGROUND: Urinary incontinence in women is a distressing condition that restricts quality of life and results in a large economic burden to both the NHS and women themselves. OBJECTIVE: To evaluate the clinical effectiveness, safety and cost-effectiveness of surgical treatment for stress urinary incontinence (SUI) in women and explore women's preferences. DESIGN: An evidence synthesis, a discrete choice experiment (DCE) and an economic decision model, with a value-of-information (VOI) analysis. Nine surgical interventions were compared. Previous Cochrane reviews for each were identified and updated to include additional studies. Systematic review methods were applied. The outcomes of interest were 'cure' and 'improvement'. Both a pairwise and a network meta-analysis (NMA) were conducted for all available surgical comparisons. A DCE was undertaken to assess the preferences of women for treatment outcomes. An economic model assessed the cost-effectiveness of alternative surgeries and a VOI analysis was undertaken. RESULTS: Data from 175 studies were included in the effectiveness review. The majority of included studies were rated as being at high or unclear risk of bias across all risk-of-bias domains. The NMA, which included 120 studies that reported data on 'cure' or 'improvement', showed that retropubic mid-urethral sling (MUS), transobturator MUS, traditional sling and open colposuspension were more effective than other surgical procedures for both primary outcomes. The results for other interventions were variable. In general, rate of tape and mesh exposure was higher after transobturator MUS than after retropubic MUS or single-incision sling, whereas the rate of tape or mesh erosion/extrusion was similar between transobturator MUS and retropubic MUS. The results of the DCE, in which 789 women completed an anonymous online questionnaire, indicate that women tend to prefer surgical treatments associated with no pain or mild chronic pain and shorter length of hospital stay as well as those treatments that have a smaller risk for urinary symptoms to reoccur after surgery. The cost-effectiveness results suggest that, over a lifetime, retropubic MUS is, on average, the least costly and most effective surgery. However, the high level of uncertainty makes robust estimates difficult to ascertain. The VOI analysis highlighted that further research around the incidence rates of complications would be of most value. LIMITATIONS: Overall, the quality of the clinical evidence was low, with limited data available for the assessment of complications. Furthermore, there is a lack of robust evidence and significant uncertainty around some parameters in the economic modelling. CONCLUSIONS: To our knowledge, this is the most comprehensive assessment of published evidence for the treatment of SUI. There is some evidence that retropubic MUS, transobturator MUS and traditional sling are effective in the short to medium term and that retropubic MUS is cost-effective in the medium to long term. The VOI analysis highlights the value of further research to reduce the uncertainty around the incidence rates of complications. There is a need to obtain robust clinical data in future work, particularly around long-term complication rates. STUDY REGISTRATION: This study is registered as PROSPERO CRD42016049339. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

Urinary incontinence, defined as involuntary leakage of urine, is a common condition that varies in type and severity and can have a huge impact on the quality of life of women. The aim of this project was to summarise the evidence on the clinical effectiveness, safety and cost-effectiveness of nine surgical operations for stress urinary incontinence in women and assess the need for further research. Women's preferences for surgery were also explored. Currently there is no agreement among decision-makers, doctors and patients about which of the available surgical operations is best. Based on previous Cochrane reviews, the effects and safety of each operation were systematically reviewed and analysed. Their cost-effectiveness and the value of conducting further research were also evaluated. To better understand the preference of women, an online survey containing a discrete choice experiment was conducted. Finally, patient representatives were consulted to help us to understand the consequences of the findings from a patient's perspective. The evidence on surgical operations was predominantly short to medium term (up to 12 months). This analysis found that the quality of the evidence varied, with the majority of trials being subject to high or unclear risk of bias, making the conclusions that can be drawn less robust. The findings of the clinical evidence review suggest that retropubic sling procedures, transobturator sling procedures and traditional sling procedures are more effective than other surgical procedures for both 'cure' and 'improvement' of stress urinary incontinence. The results of the economic analyses support these findings, suggesting that retropubic mid-urethral sling is the most cost-effective surgical operation. However, data on complications were lacking, limiting any strong conclusions. The results suggest that there is value in undertaking further research to reduce the uncertainty around the medium- to long-term complications of all surgical treatments and this was reflected in patients' views.

Pointers to earlier diagnosis of endometriosis: a nested case-control study using primary care electronic health records.

BACKGROUND: Endometriosis is a condition with relatively non-specific symptoms, and in some cases a long time elapses from first-symptom presentation to diagnosis. AIM: To develop and test new composite pointers to a diagnosis of endometriosis in primary care electronic records. DESIGN AND SETTING: This is a nested case-control study of 366 cases using the Practice Team Information database of anonymised primary care electronic health records from Scotland. Data were analysed from 366 cases of endometriosis between 1994 and 2010, and two sets of age and GP practice matched controls: (a) 1453 randomly selected females and (b) 610 females whose records contained codes indicating consultation for gynaecological symptoms. METHOD: Composite pointers comprised patterns of symptoms, prescribing, or investigations, in combination or over time. Conditional logistic regression was used to examine the presence of both new and established pointers during the 3 years before diagnosis of endometriosis and to identify time of appearance. RESULTS: A number of composite pointers that were strongly predictive of endometriosis were observed. These included pain and menstrual symptoms occurring within the same year (odds ratio [OR] 6.5, 95% confidence interval [CI] = 3.9 to 10.6), and lower gastrointestinal symptoms occurring within 90 days of gynaecological pain (OR 6.1, 95% CI = 3.6 to 10.6). Although the association of infertility with endometriosis was only detectable in the year before diagnosis, several pain-related features were associated with endometriosis several years earlier. CONCLUSION: Useful composite pointers to a diagnosis of endometriosis in GP records were identified. Some of these were present several years before the diagnosis and may be valuable targets for diagnostic support systems.