MOMENT – Management of Otitis Media with Effusion in Cleft Palate: protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey

Harman, Nicola; Bruce, Iain; Callery, Peter; Tierney, Stephanie; Sharif, Mohammad Owaise; O’Brien, Kevin; Williamson, Paula

doi:10.1186/1745-6215-14-70

Cited by 166 publications

(170 citation statements)

References 16 publications

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“…Harman et al . proposed five core questions that could be used to assess how transparently researchers had identified and reported their choice of outcomes11, whilst the ORBIT criteria are used to determine whether it is likely that data is missing from the studies report5. The percentage of studies meeting all five of Harman et al .’s core criteria for complete, transparent outcome reporting, and the percentage of studies reporting full data, as described by the ORBIT criteria were calculated for all outcomes investigated.…”

Section: Methodsmentioning

confidence: 99%

Variability of outcome reporting in Hirschsprung’s Disease and gastroschisis: a systematic review

Allin¹,

Irvine

Patni

et al. 2016

Sci Rep

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Heterogeneity in outcome reporting limits identification of gold-standard treatments for Hirschsprung’s Disease(HD) and gastroschisis. This review aimed to identify which outcomes are currently investigated in HD and gastroschisis research so as to counter this heterogeneity through informing development of a core outcome set(COS). Two systematic reviews were conducted. Studies were eligible for inclusion if they compared surgical interventions for primary treatment of HD in review one, and gastroschisis in review two. Studies available only as abstracts were excluded from analysis of reporting transparency. Thirty-five HD studies were eligible for inclusion in the review, and 74 unique outcomes were investigated. The most commonly investigated was faecal incontinence (32 studies, 91%). Seven of the 28 assessed studies (25%) met all criteria for transparent outcome reporting. Thirty gastroschisis studies were eligible for inclusion in the review, and 62 unique outcomes were investigated. The most commonly investigated was length of stay (24 studies, 80%). None of the assessed studies met all criteria for transparent outcome reporting. This review demonstrates that heterogeneity in outcome reporting and a significant risk of reporting bias exist in HD and gastroschisis research. Development of a COS could counter these problems, and the outcome lists developed from this review could be used in that process.

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Section: Methodsmentioning

confidence: 99%

Variability of outcome reporting in Hirschsprung’s Disease and gastroschisis: a systematic review

Allin¹,

Irvine

Patni

et al. 2016

Sci Rep

View full text Add to dashboard Cite

show abstract

“…These components will instead be identified through subsequent literature review; discussion at the consensus meeting; and, if necessary, a separate ‘how to measure’ meeting. The use of systematic reviews to inform phase 1 of a Delphi process is recommended by the COMET Initiative [12] and has previously been used in the development of other COSs, including in the Management of Otitis Media with Effusion in Cleft Palate study [13]. …”

Section: Methodsmentioning

confidence: 99%

NETS1HD: study protocol for development of a core outcome set for use in determining the overall success of Hirschsprung’s disease treatment

Allin

Bradnock

Kenny

et al. 2016

Trials

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BackgroundUse of core outcome sets in research has been proposed as a method for countering the problems caused by heterogeneity of outcome measure reporting. Heterogeneity of outcome measure reporting occurs in Hirschsprung’s disease (HD) research and is limiting the development of a robust evidence base to support clinical practice.MethodsCandidate outcome measures have been identified through a systematic review. These outcome measures will form the starting point for a three-phase online Delphi process to be carried out in parallel by three panels of experts. Panel 1 is a neonatal panel; panel 2 is a non-neonatal panel; and panel 3 is a lay panel. In round 1, experts will be asked to score the previously identified outcome measures from 1 to 9 based on how important they think the measures are in determining the overall success of their/their child’s/their patient’s HD. In round 2, experts will be presented with the same list of outcome measures and graphical representations of how their panel scored that outcome in round 1. They will be asked to re-score the outcome measure, taking into account how important other members of their panel felt it to be. In round 3, experts will again be asked to re-score each outcome measure, but this time they will receive a graphical representation of the distribution of scores from all three panels, which they should take into account when re-scoring. Following round 3 of the Delphi process, 40 experts will be invited to attend a face-to-face consensus meeting. Participants will be invited in a purposive manner to obtain balance between the different panels. Results of the Delphi process will be discussed, and outcomes will be re-scored. Outcome measures where >70% of participants at the meeting scored it 7–9 and <15% scored it 1–3 will form the core outcome set.DiscussionDevelopment of a core outcome set will help to reduce heterogeneity of outcome measure reporting in HD. This will increase the quality of research taking place and ultimately improve care provided to infants with HD.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1693-6) contains supplementary material, which is available to authorized users.

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“…17 One strategy to deal with these issues is development of a core outcome set (COS). [18][19][20] A COS is a list of outcomes that should be measured and reported in all clinical trials. Robust development of a COS ensures that researchers report on outcomes that are relevant to all major stakeholders.…”

Section: Current Selection Of Outcomes For Use In Clinical Trials On mentioning

confidence: 99%

Protocol for the development of a core domain set for hidradenitis suppurativa trial outcomes

et al. 2017

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IntroductionRandomised controlled trials (RCTs) should have well-defined primary and secondary outcomes to answer questions generated by the main hypotheses. However, for the chronic, inflammatory skin disease hidradenitis suppurativa (HS), the reported outcome measures are numerous and diverse. A recent systematic review found a total of 30 outcome measure instruments in 12 RCTs. This use of a broad range of outcome measures can increase difficulties in interpretation and comparison of results and may potentially obstruct appropriate evidence synthesis by causing reporting bias. One strategy for dealing with these problems is to develop a core outcome set (COS). A COS is a list of outcomes that are meant as mandatory and should be measured and reported in all clinical trials. The aim of this study is to develop a COS for the management of HS.Method and analysisAn international steering group of researchers, clinicians and a patient research partner will guide the COS development. 6 stakeholder groups are involved: patients, dermatologists, surgeons, nurses, industry representatives and drug regulatory authorities. A 1:1 ratio of patients:healthcare professionals is aimed for. The initial list of candidate items will be obtained by combining three data sets: (1) a systematic review of the literature, (2) US and Danish qualitative interview studies involving patients with HS and (3) an online healthcare professional (HCP) item generation survey. To reach consensus on the COS, 4 anonymous online Delphi rounds are then planned together with 2 face-to-face consensus meetings (1 in Europe and 1 in the USA) to ensure global representation.Ethics and disseminationThe study will be performed according to the Helsinki declaration. All results from the study, including inconclusive or negative results, will be published in peer-reviewed indexed journals. The study will involve different stakeholder groups to ensure that the developed COS will be suitable and well accepted.

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MOMENT – Management of Otitis Media with Effusion in Cleft Palate: protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey

Cited by 166 publications

References 16 publications

Variability of outcome reporting in Hirschsprung’s Disease and gastroschisis: a systematic review

Variability of outcome reporting in Hirschsprung’s Disease and gastroschisis: a systematic review

NETS1HD: study protocol for development of a core outcome set for use in determining the overall success of Hirschsprung’s disease treatment

Protocol for the development of a core domain set for hidradenitis suppurativa trial outcomes

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