A systematic review of reported outcomes and outcome measures in randomized trials evaluating surgical interventions for posterior vaginal prolapse to aid development of a core outcome set

Lourenço, Thais R M; Pergialiotis, Vasilis; Durnea, Constantin M.; Elfituri, Abdullatif; Haddad, Jorge Milhem; Betschart, Cornelia; Falconi, Gabriele; Nygaard, Christiana Campani; Bergstrom, Lina; Pattel, Mittal; Doumouchtsis, Stergios K.; Urogynaecology, Standards in

doi:10.1002/ijgo.13079

Cited by 14 publications

(16 citation statements)

References 44 publications

(47 reference statements)

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“…Dyspareunia has been reported after transvaginal rectocele repair [9] However, no dyspareunia was observed in this study, although the number of patients who performed sexual intercourse was small. This might be due to the level of approximation of levator muscles.…”

Section: Discussioncontrasting

confidence: 65%

“…Patients with symptomatic rectocele sometimes need digitation on defecation, and these symptoms often decrease the patients' quality of life [3]. Rectocele is considered to be due to rectovaginal septum weakness, and several procedures, such as transanal [3][4][5], transperineal [6][7][8], transvaginal [2,9], laparoscopic repairs with or without mesh [10], stapler repairs [11,12], and a combination of the abovementioned procedures, have been used for rectocele repair [5,9,10]. However, rectocele repair does not always alleviate symptoms [11,13].…”

Section: Introductionmentioning

confidence: 99%

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Outcomes of Transvaginal Anterior Levatorplasty with Posterior Colporrhaphy for Symptomatic Rectocele

Maeda

Honda²,

Koide

et al. 2021

J Anus Rectum Colon

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Section: Discussioncontrasting

confidence: 65%

Section: Introductionmentioning

confidence: 99%

Outcomes of Transvaginal Anterior Levatorplasty with Posterior Colporrhaphy for Symptomatic Rectocele

Maeda

Honda²,

Koide

et al. 2021

J Anus Rectum Colon

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“…We followed a standardised methodological approach in line with previous experience and expertise developed within CHORUS as well as recommended COMET guidelines in relation to systematic reviews and the development of COS 10–16 …”

Section: Methodsmentioning

confidence: 99%

A systematic review on reported outcomes and outcome measures in female idiopathic chronic pelvic pain for the development of a core outcome set

Ghai

Subramanian

Jan

et al. 2020

BJOG

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Background A core outcome set (COS) is required to address inconsistencies in outcome reporting in chronic pelvic pain (CPP) trials. Objectives Evaluation of reported outcomes and selected outcome measures in CPP trials by producing a comprehensive inventory to inform a COS. Search strategy Systematic review of randomised controlled trials (RCTs) identified from Cochrane Central Register of Controlled Trials (CENTRAL), Embase and MEDLINE databases. Selection criteria RCTs assessing efficacy and safety of medical, surgical and psychological interventions for women with idiopathic CPP. Data collection and analysis Two independent researchers extracted outcomes and outcome measures. Similar outcomes were grouped and classified into domains to produce a structured inventory. Main results Twenty‐four trials were identified including 136 reported outcomes and outcome measures. Rates of reporting outcomes varied (4–100%) and pelvic pain was the most frequently reported outcome (100%). All trials reported the pain domain; however, only half reported quality of life, clinical effectiveness and adverse events. No differences in outcome reporting were observed in five high‐quality trials (21%). Univariate analysis demonstrated an association between quality of outcome reporting and methodological quality of studies (rs = 0.407, P = 0.048). Conclusion There is wide variation in reported outcomes and applied outcome measures in CPP trials. While a COS is being developed and implemented, we propose the interim use of commonly reported outcomes in each domain: pain (pelvic pain, dyspareunia, dysmenorrhoea), life impact (quality of life, emotional functioning, physical functioning), clinical effectiveness (efficacy, satisfaction, cost effectiveness, return to daily activities) and adverse events (surgical, perioperative observations, nonsurgical). Tweetable abstract There is significant variation in outcome reporting in CPP trials. Our systematic review forms the basis for the development of a core outcome set.

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“…This study has been performed by a working group of CHORUS, an International Collaboration for Harmonizing Outcomes, Research and Standards in Urogynaecology and Women's Health (https://i-chorus.org), aiming to address outcome reporting, research quality and research and clinical standards in the areas of urogynaecology, female pelvic medicine and reconstructive surgery [14][15][16]. This project is part of a wider initiative to develop core outcome sets (COS) in therapeutic interventions for female CPP that has been prospectively registered with the Core Outcome Measures in Effectiveness Trials (COMET initiative), number 981.…”

Section: Methodsmentioning

confidence: 99%

A meta-synthesis of qualitative literature on female chronic pelvic pain for the development of a core outcome set: a systematic review

et al. 2021

Self Cite

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Introduction and hypothesis Qualitative research has an increasing role in the development of core outcome sets (COS) adding patient perspectives to the considerations of core outcomes. We aimed to identify priorities of women with experience of chronic pelvic pain (CPP). Methods The search strategy was a systematic review of qualitative studies identified from Cochrane Central Register of Controlled Trials (CENTRAL), CINAHL, EMBASE, MEDLINE and PsycInfo databases. Selection criteria were qualitative studies exploring the experience of women with CPP. Two independent researchers extracted data and summarized findings using thematic analysis. A CERQual assessment was performed to assess the confidence of review findings. Results We identified pertinent issues affecting women with CPP including the lack of holistic care, influence of psychosocial factors and the impact of pain on quality of life. Five meta-themes central to delivering a patient-centred approach were highlighted: acceptance of pain, quality of life, management of CPP, communication and support. Management of CPP was the most commonly reported meta-theme across seven studies and half of studies reported quality of life, management, communication and support. Quality appraisal of included studies identified only a single study that met all CASP (Critical Appraisal Skills Programme) criteria. There was high confidence in the evidence for acceptance of pain, quality of life and communication meta-themes. Conclusion Meta-themes revealed by this review should be considered as a priority and reflected in outcomes reported by future studies evaluating interventions for CPP. In addition, these themes should be considered by clinicians managing women with CPP.

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A systematic review of reported outcomes and outcome measures in randomized trials evaluating surgical interventions for posterior vaginal prolapse to aid development of a core outcome set

Cited by 14 publications

References 44 publications

Outcomes of Transvaginal Anterior Levatorplasty with Posterior Colporrhaphy for Symptomatic Rectocele

Outcomes of Transvaginal Anterior Levatorplasty with Posterior Colporrhaphy for Symptomatic Rectocele

A systematic review on reported outcomes and outcome measures in female idiopathic chronic pelvic pain for the development of a core outcome set

A meta-synthesis of qualitative literature on female chronic pelvic pain for the development of a core outcome set: a systematic review

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