15 research outputs found
A protocol for developing, disseminating, and implementing a core outcome set for stress urinary incontinence.
INTRODUCTION: Randomized trials evaluating interventions for stress urinary incontinence (SUI) have been using variable outcome measures, reporting a variety of outcomes. Alongside this variation across studies, outcome-reporting flaws contribute to a limited use of research to inform clinical practice. The development and use of core outcome sets (COSs) in future trials would ensure that outcomes important to different stakeholders and primarily women with SUI are reported more consistently and comprehensively. METHODS: An international steering group including healthcare professionals, researchers, and women with urinary incontinence will guide the development of this COS. Potential outcomes will be identified through comprehensive literature reviews. These outcomes will be entered into an international, multiperspective online Delphi survey. All key stakeholders, including healthcare professionals, researchers, and women with urinary incontinence, will be invited to participate. The modified Delphi method encourages stakeholder group convergence toward collective agreement, also referred as consensus, core outcomes. DISCUSSION: Dissemination and implementation of the resulting COS within an international context will be promoted and reviewed. Embedding the COS for SUI within future clinical trials, systematic reviews and clinical practice guidelines could make a significant contribution to advancing the value of research in informing clinical practice, enhancing patient care and improving outcomes. The infrastructure created by developing a COS for SUI could be leveraged in other settings, for example, selecting research priorities and clinical practice guideline development
A systematic review on reporting outcomes and outcome measures in trials on synthetic mesh procedures for pelvic organ prolapse: Urgent action is needed to improve quality of research.
The use of synthetic mesh in pelvic organ prolapse surgery is being closely scrutinized because of serious concerns regarding life-changing complications such as erosion, pain, infection, bleeding, dyspareunia, organ perforation, and urinary problems. Randomized trials and their syntheses in meta-analysis offer a unique opportunity to assess efficacy and safety. However, outcomes and outcome measures need to be consistently selected, collected, and reported across randomized trials to be effectively combined in systematic reviews. AIMS: We evaluated outcome and outcome measure reporting across randomized controlled trials on surgical interventions using synthetic mesh for pelvic organ prolapse. METHODS: Systematic review of randomized controlled trials using synthetic mesh for the treatment of pelvic organ prolapse. The selected studies were evaluated using Jadad and MOMENT criteria. Outcomes and outcome measures were systematically identified and categorized. RESULTS: Seventy-one randomized trials were included. Twenty-four different types of mesh were identified. Included trials reported 110 different outcomes and 60 outcome measures. Erosion (40 trials, 78%), pain (29 trials, 56%), bleeding (31 trials, 61%), and dyspareunia (25 trials, 49%) were the most frequently reported outcomes. The longest follow up was 74 months. CONCLUSIONS: Most randomized trials evaluating surgical interventions using synthetic mesh for pelvic organ prolapse failed to report on clinically important outcomes and to evaluate efficacy and safety over the medium- and long-term. Developing and implementing a minimum data set, known as a core outcome set, in future vaginal prolapse trials could help address these issues
Variations in bladder pain syndrome/interstitial cystitis (IC) definitions, pathogenesis, diagnostics and treatment: a systematic review and evaluation of national and international guidelines
INTRODUCTION AND HYPOTHESIS
Interstitial cystitis (IC) and bladder pain syndrome (BPS) are challenging and encompassing hypersensitivity disorders of the lower urinary tract. A variety of national and international guidelines have been published including guidance on nomenclature, definitions, etiopathology, diagnostics and treatment. A lack of universally established clinical guidance is apparent. The aim of this review is to evaluate key guidelines on this area of practice, identify variations, compare their recommendations and grade them using AGREE II.
METHODS
Literature searches were performed using the PUBMED and CINAHL database from January 1, 1983, to December 1, 2018, referring to the search strategy of AUA. Ten national and international guidelines were included into the analysis. We assessed the guidelines with the updated AGREE II.
RESULTS
Symptoms congruent in all guidelines are: pain, pressure, discomfort and frequency, urgency and nocturia. Urinalysis is a prerequisite for diagnostics, cystoscopy for most and urodynamics not part of the routine assessment. Treatment options are recommended stepwise. The highest level of evidence and consensus was identified for oral therapies. Nine guidelines had an overall quality score ≥ 50% and three scored ≥ 70% (AUA, GG, RCOG).
CONCLUSIONS
The guidelines are congruent in symptom reporting, quite congruent in diagnostics and vary to a high degree on treatment recommendations. The complexity of BPS and emerging evidence indicate the need for regular updating of the guidelines and a wider consensus
A systematic review on reporting outcomes and outcome measures in trials on synthetic mesh procedures for pelvic organ prolapse: Urgent action is needed to improve quality of research
The use of synthetic mesh in pelvic organ prolapse surgery is being closely scrutinized because of serious concerns regarding life-changing complications such as erosion, pain, infection, bleeding, dyspareunia, organ perforation, and urinary problems. Randomized trials and their syntheses in meta-analysis offer a unique opportunity to assess efficacy and safety. However, outcomes and outcome measures need to be consistently selected, collected, and reported across randomized trials to be effectively combined in systematic reviews. Aims: We evaluated outcome and outcome measure reporting across randomized controlled trials on surgical interventions using synthetic mesh for pelvic organ prolapse. Methods: Systematic review of randomized controlled trials using synthetic mesh for the treatment of pelvic organ prolapse. The selected studies were evaluated using Jadad and MOMENT criteria. Outcomes and outcome measures were systematically identified and categorized. Results: Seventy-one randomized trials were included. Twenty-four different types of mesh were identified. Included trials reported 110 different outcomes and 60 outcome measures. Erosion (40 trials, 78%), pain (29 trials, 56%), bleeding (31 trials, 61%), and dyspareunia (25 trials, 49%) were the most frequently reported outcomes. The longest follow up was 74 months. Conclusions: Most randomized trials evaluating surgical interventions using synthetic mesh for pelvic organ prolapse failed to report on clinically important outcomes and to evaluate efficacy and safety over the medium- and long-term. Developing and implementing a minimum data set, known as a core outcome set, in future vaginal prolapse trials could help address these issues. © 2018 Wiley Periodicals, Inc
A systematic review of reported outcomes and outcome measures in randomized controlled trials on apical prolapse surgery
Background Evidence on efficacy and safety of pelvic organ prolapse
interventions is variable, and methodological flaws preclude meaningful
synthesis of primary research data. Objective To evaluate variations in
reported outcomes and outcome measures in randomized controlled trials
(RCTs) on apical prolapse surgical interventions. Search strategy We
searched Cochrane, EMBASE, MEDLINE, and Scopus for English-language
articles published from inception to September 30, 2017, using the terms
“management”, “repair”, “operation”, and “pelvic organ
prolapse”. Selection criteria RCTs on apical prolapse surgical
treatment. Data collection and analysis Outcomes and outcome measures
were identified and categorized into domains. Studies were evaluated for
quality of outcomes. Descriptive statistics were used to calculate
frequencies. Main results Forty-three RCTs were included. Seventy-six
outcomes and 66 outcome measures were identified. Bladder and ureteric
injury were the most commonly reported intraoperative complications
(19/31 studies; 61%). Quality of life was assessed by 19 different
instruments and questionnaires. Fourteen (45%) of 31 studies used
recurrence of prolapse as a postoperative anatomical outcome.
Conclusions Substantial variation in reported outcomes and outcome
measures was confirmed, precluding comparisons across trials and
synthesis of the results. Development of a core outcome set will enable
high-quality meta-analyses to be performed in the future
Quality assessment of outcome reporting, publication characteristics and overall methodological quality in trials on synthetic mesh procedures for the treatment of pelvic organ prolapse for development of core outcome sets
Introduction and hypothesis Variations in outcome measures and reporting
of outcomes in trials on surgery for pelvic organ prolapse (POP) using
synthetic mesh have been evaluated and reported. However, the quality of
outcome reporting, methodology of trials and their publication
parameters are important considerations in the process of development of
Core Outcome Sets. We aimed to evaluate these characteristics in
randomized controlled trials on surgery for POP using mesh. Methods
Secondary analysis of randomized controlled trials on surgical
treatments using synthetic mesh for POP previously included in a
systematic review developing an inventory of reported outcomes and
outcome measures. The methodological quality was investigated with the
modified Jadad criteria. Outcome reporting quality was evaluated with
the MOMENT criteria. Publication parameters included publishing journal,
impact factor and year of publication. Results Of the 71 previously
reviewed studies published from 2000 to 2017, the mean JADAD score was
3.59 and the mean MOMENT score was 4.63. Quality of outcomes (MOMENT)
was related to methodological quality (JADAD) (rho = 0.662; p = 0.000)
and to year of publication (rho = 0.262; p = 0.028). Conclusions
Methodological quality and outcome reporting quality appear correlated.
However, publication characteristics do not have strong associations
with the methodological quality of the studies. Evaluation of the
quality of outcomes, methodology and publication characteristics are all
an indispensable part of a staged process for the development of Core
Outcome and Outcome Measure Sets