Survey indicated that core outcome set development is increasingly including patients, being conducted internationally and using Delphi surveys

Biggane, Alice M; Brading, Lucy; Ravaud, Philippe; Young, Bridget; Williamson, Paula

doi:10.1186/s13063-018-2493-y

Cited by 54 publications

(46 citation statements)

References 19 publications

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“…Heterogeneity in methodology and specifically in reported outcomes in randomized trials prohibits the use of data in systematic reviews and meta‐analyses, thus preventing firm conclusions and consensus in the clinical application of the research evidence. Variation in outcome measures renders this task even more challenging …”

Section: Introductionmentioning

confidence: 99%

“…Variation in outcome measures renders this task even more challenging. 6,7 We aimed to identify and classify all the reported outcomes and outcome measures in randomized controlled trials on apical prolapse interventions. We used the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guideline to report the search and selection of studies.…”

Section: Introductionmentioning

confidence: 99%

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A systematic review of reported outcomes and outcome measures in randomized controlled trials on apical prolapse surgery

Lourenço

Pergialiotis

Durnea

et al. 2019

Intl J Gynecology & Obste

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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. PROSPERO registration: CRD42017062456.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

A systematic review of reported outcomes and outcome measures in randomized controlled trials on apical prolapse surgery

Lourenço

Pergialiotis

Durnea

et al. 2019

Intl J Gynecology & Obste

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“…This is reflective of COSs in general and is not a methodological problem specific to cancer. Recent research has shown an improvement in patient participation in more recently published COSs [6,11]. Although thirteen studies did include patients in COS development, there is still great variability in the level of participation of patients in COS development.…”

Section: Discussionmentioning

confidence: 99%

Improvement was needed in the standards of development for cancer core outcome sets

Gargon

Williamson

Blazeby

et al. 2019

Journal of Clinical Epidemiology

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Objective: The Core Outcome SeteSTAndards for Development (COS-STAD) contains 11 standards (12 criteria) that are deemed to be the minimum design recommendations for all core outcome set (COS) development projects. Cancer is currently the disease area with the highest number of published COSs and is a major cause of worldwide morbidity and mortality. The aim of this study was to provide a baseline of cancer COS standards. Study Design and Setting: Systematic reviews of COSs have identified 307 published COS studies. Cancer COSs were eligible for inclusion. Two reviewers independently assessed each of the COSs against the 12 criteria. Results: Forty-nine cancer COSs were included; none met all 12 criteria representing the 11 minimum standards assessed in this study (range 5 4e11 criteria, median 5 6 criteria). All studies met the four scope standards, eight (16%) met all three standards for stakeholders involved, and two (4%) met all four standards for consensus process standards. Conclusion: With the exception of ''scope'' specification, there is much need for improvement. Poor reporting often made it challenging to assess whether minimum standards were met. The consensus process criteria were most difficult to assess, particularly those that required an assessment of being a priori. This is the first application of COS-STAD criteria to studies that have developed COSs and provides a baseline of cancer COS standards of development.

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“…however, the most appropriate way to facilitate inclusion remains largely unknown [2,7]. Participation in Delphi surveys is the most popular method used for patient inclusion by COS developers, but mixed methods techniques are becoming increasingly popular [7,8]. COS developers using mixed method techniques often conduct patient interviews as an adjunct to a systematic review of the literature to identify an initial list of potential outcomes for inclusion in a Delphi consensus survey [9].…”

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confidence: 99%

Methodology in core outcome set (COS) development: the impact of patient interviews and using a 5-point versus a 9-point Delphi rating scale on core outcome selection in a COS development study.

Remus

Smith

Wuytack

2020

Preprint

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Background: As the development of core outcome sets (COS) increases, guidance for developing and reporting high-quality COS continues to evolve; however, a number of methodological uncertainties still remain. The objectives of this study were: (1) to explore the impact of including patient interviews in developing a COS, (2) to examine the impact of using a 5-point versus a 9-point rating scale during Delphi consensus methods on outcome selection and the COS and (3) to inform and contribute to COS development methodology by advancing the evidence base on COS development techniques.Methods: Semi-structured patient interviews and a nested randomised controlled parallel group trial as part of the Pelvic Girdle Pain Core Outcome Set project (PGP-COS). Patient interviews, as an adjunct to a systematic review of outcomes reported in previous studies, were undertaken to identify preliminary outcomes for including in a Delphi consensus survey. In the Delphi survey, participants were randomised (1:1) to a 5-point or 9-point scale for rating the importance of the list of preliminary outcomes.Results: None of the outcomes identified from the patient interviews were included in the final PGP-COS. The 5-point rating scale resulted in twice as many outcomes reaching consensus after the 3-round Delphi survey compared to the 9-point scale. Consensus on all five outcomes included in the final PGP-COS was achieved by participants allocated the 5-point rating scale, whereas consensus on four of these was achieved by those using the 9-point scale.Conclusions: Using patient interviews to identify preliminary outcomes as an adjunct to conducting a systematic review of outcomes measured in the literature does not appear to influence outcome selection in developing a COS. The use of different rating scales in a Delphi survey, however, does appear to impact on outcome selection. The 5-point scale demonstrated greater congruency than the 9-point scale with the outcomes included in the final PGP-COS. Use of a 5-point scale might be considered for Delphi surveys in COS development studies. Future research to substantiate our findings and to explore the impact of other rating scales on outcome selection during COS development, however, is still warranted.

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Survey indicated that core outcome set development is increasingly including patients, being conducted internationally and using Delphi surveys

Cited by 54 publications

References 19 publications

A systematic review of reported outcomes and outcome measures in randomized controlled trials on apical prolapse surgery

A systematic review of reported outcomes and outcome measures in randomized controlled trials on apical prolapse surgery

Improvement was needed in the standards of development for cancer core outcome sets

Methodology in core outcome set (COS) development: the impact of patient interviews and using a 5-point versus a 9-point Delphi rating scale on core outcome selection in a COS development study.

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