scholarly journals A Protocol for the Development of Core Outcome Sets in Pelvic Organ Prolapse Research

2019 ◽  
Author(s):  
Stergios Doumouchtsis ◽  
Maria Patricia Rada ◽  
Vasilios Pergialiotis ◽  
Gabriele Falconi ◽  
Jorge Milhem Haddad ◽  
...  

Abstract Background The high prevalence of symptomatic pelvic organ prolapse (POP) and the women's lifetime risk of requiring surgery, as well as the significant impact of POP on women’s health related quality of life has resulted in a variety of studies on POP interventions. A wide variety of outcomes have been reported across randomized trials evaluating interventions for POP and various outcome measures have been used. Such variation leads to a limited value of research to provide reliable evidence-based data for clinical practice guidance. The development and use of a core outcome set (COS) would help to address these issues ensuring outcomes important to all stakeholders, primarily women with POP. We aim to produce, disseminate and implement a COS for POP. Methods A steering group within the CHORUS, an International Collaboration for Harmonising Outcomes, Research and Standards in Urogynaecology and Women’s Health will guide the development of this COS. Systematic reviews of trials that reported outcomes and outcome measures on interventions for POP will form the basis for the creation of an outcome inventory. Core outcome selection process will be performed using an international, multi-perspective, online Delphi survey. The modified Delphi method encourages stakeholder group agreement towards consensus core outcomes through repeated reflection and rescoring of items. Discussion Dissemination and implementation of the resulting COS within an international context will be promoted. An embedded COS for POP within future studies will most likely be reflected by an increased value of research that provides guidance for clinical practice. The paradigm of the COS development could further inform research priorities in POP treatments, and support clinical guidelines development and better patient care. KEYWORDS: core outcome sets, outcome measures, pelvic organ prolapse, Delphi survey, randomized trials.

2021 ◽  
Author(s):  
Stergios D Doumouchtsis ◽  
Vivek Nama ◽  
Gabriele Falconi ◽  
Maria Patricia Rada ◽  
Jittima Manonai ◽  
...  

BACKGROUND Studies evaluating cosmetic gynecological interventions have followed variable methodology and reported a diversity of outcomes. Such variations limit the comparability of studies and the value of research-based evidence. The development of core outcome sets (COS) and core outcome measures sets (COMS) would help address these issues, ensuring outcomes important to all stakeholders, primarily women requesting or with experience of cosmetic gynecological interventions. OBJECTIVE N/A METHODS An international steering group, within the CHORUS Collaboration, including healthcare professionals, researchers and women with experience in cosmetic gynecological interventions will guide the development of COS and COMS. Potential outcome measures and outcomes will be identified through comprehensive literature reviews. COS and COMS will be entered into an international, multi-perspective online Delphi survey. The Delphi survey results will be evaluated in subsequent stakeholder group consensus meetings in the process of establishing ‘core’ outcomes. RESULTS Dissemination and implementation of the resulting COS and COMS within an international context will be promoted and reviewed. CONCLUSIONS Embedding the COS and COMS for cosmetic gynecological interventions within future clinical trials, systematic reviews, and practice guidelines could contribute to the enhancement of the value of research and improving overall patient care. CLINICALTRIAL Core Outcome Measures in Effectiveness Trials [COMET] initiative, registration number 1592


2002 ◽  
Vol 186 (6) ◽  
pp. 1160-1166 ◽  
Author(s):  
Susan L. Hendrix ◽  
Amanda Clark ◽  
Ingrid Nygaard ◽  
Aaron Aragaki ◽  
Vanessa Barnabei ◽  
...  

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Purva Abhyankar ◽  
Joyce Wilkinson ◽  
Karen Berry ◽  
Sarah Wane ◽  
Isabelle Uny ◽  
...  

Abstract Background Pelvic Floor Muscle Training (PFMT) has been shown to be effective for pelvic organ prolapse in women, but its implementation in routine practice is challenging due to lack of adequate specialist staff. It is important to know if PFMT can be delivered by different staff skill mixes, what barriers and facilitators operate in different contexts, what strategies enable successful implementation and what are the underlying mechanisms of their action. PROPEL intervention was designed to maximise the delivery of effective PFMT in the UK NHS using different staff skill mixes. We conducted a realist evaluation (RE) of this implementation to understand what works, for whom, in what circumstances and why. Methods Informed by the Realist and RE-AIM frameworks, the study used a longitudinal, qualitative, multiple case study design. The study took place in five, purposively selected, diverse NHS sites across the UK and proceeded in three phases to identify, test and refine a theory of change. Data collection took place at 4 time points over an 18 month implementation period using focus groups and semi-structured interviews with a range of stakeholders including service leads/managers, senior practitioners, newly trained staff and women receiving care in the new service models. Data were analysed using thematic framework approach adapted to identify Context, Mechanism and Outcome (CMO) configurations of the RE. Results A heightened awareness of the service need among staff and management was a mechanism for change, particularly in areas where there was a shortage of skilled staff. In contrast, the most established specialist physiotherapist-delivered PFMT service activated feelings of role protection and compromised quality, which restricted the reach of PFMT through alternative models. Staff with some level of prior knowledge in women’s health and adequate organisational support were more comfortable and confident in new role. Implementation was seamless when PFMT delivery was incorporated in newly trained staff’s role and core work. Conclusion Roll-out of PFMT delivery through different staff skill mixes is possible when it is undertaken by clinicians with an interest in women’s health, and carefully implemented ensuring adequate levels of training and ongoing support from specialists, multi-disciplinary teams and management.


2020 ◽  
Vol 39 (3) ◽  
pp. 880-889
Author(s):  
Maria Patricia Rada ◽  
Stephanie Jones ◽  
Gabriele Falconi ◽  
Jorge Milhem Haddad ◽  
Cornelia Betschart ◽  
...  

Author(s):  
Mike Armour ◽  
Debra Betts ◽  
Kate Roberts ◽  
Susanne Armour ◽  
Caroline A. Smith

Background: Surveys of acupuncture practitioners worldwide have shown an increase in the use of acupuncture to treat women’s health conditions over the last ten years. Published studies have explored the effectiveness of acupuncture for various conditions such as period pain, fertility, and labor induction. However, it is unclear what role, if any, peer-reviewed research plays in guiding practice. Methods: Acupuncturists with a significant women’s health caseload were interviewed online in three small groups to explore factors that contribute to acupuncturists’ clinical decision made around treatment approaches and research. Results: Eleven practitioners participated in the focus groups. The overarching theme that emerged was one of ‘Not mainstream but a stream.’ This captured two themes relating to acupuncture as a distinct practice: ‘working with what you’ve got’ as well as ‘finding the right lens’, illustrating practitioners’ perception of research needing to be more relevant to clinical practice. Conclusions: Acupuncture practitioners treating women’s health conditions reported a disconnect between their clinical practice and the design of clinical trials, predominantly due to what they perceived as a lack of individualization of treatment. Case histories were popular as a learning tool and could be used to support increasing research literacy.


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