Navigating the landscape of core outcome set development in dermatology

Prinsen, Cecilia A.C.; Spuls, Phyllis I.; Kottner, Jan; Kim, Thomas; Apfelbacher, Christian; Chalmers, Joanne R; Deckert, Stefanie; Furue, Masutaka; Gerbens, L. A. A.; Kirkham, Jamie J; Simpson, Eric L.; Alam, Murad; Balzer, Katrin; Beeckman, Dimitri; Eleftheriadou, Viktoria; Ezzedine, Khaled; Horbach, Sophie E.R.; Ingram, John R.; Layton, Alison; Weller, Karsten; Wild, T. Cameron; Wolkerstorfer, Albert; Williams, Hywel C; Schmitt, Jochen

doi:10.1016/j.jaad.2019.03.009

Cited by 49 publications

(49 citation statements)

References 40 publications

(41 reference statements)

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“…Moreover, standardization of outcome measures is imperative for enabling comparisons between studies. Increased awareness of the importance of (high-quality) outcome measures has led to a rise in outcome measure research, especially in dermatology [13] (in particular for psoriasis [14], atopic dermatitis [15], and more recently vitiligo [16]).…”

Section: Introductionmentioning

confidence: 99%

Clinical outcome measures and scoring systems used in prospective studies of port wine stains: A systematic review

et al. 2020

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Background Valid and reliable outcome measures are needed to determine and compare treatment results of port wine stain (PWS) studies. Besides, uniformity in outcome measures is crucial to enable inter-study comparisons and meta-analyses. This study aimed to assess the heterogeneity in reported PWS outcome measures by mapping the (clinical) outcome measures currently used in prospective PWS studies. Methods OVID MEDLINE, OVID Embase, and CENTRAL were searched for prospective PWS studies published from 2005 to May 2020. Interventional studies with a clinical efficacy assessment were included. Two reviewers independently evaluated methodological quality using a modified Downs and Black checklist. Results In total, 85 studies comprising 3,310 patients were included in which 94 clinician/observerreported clinical efficacy assessments had been performed using 46 different scoring systems. Eighty-one-studies employed a global assessment of PWS appearance/improvement, of which-82% was expressed as percentage improvement and categorized in 26 different scoring systems. A wide variety of other global and multi-item scoring systems was identified. As a result of outcome heterogeneity and insufficient data reporting, only 44% of studies could be directly compared. A minority of studies included patient-reported or objective outcomes. Thirteen studies of good quality were found.

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Section: Introductionmentioning

confidence: 99%

Clinical outcome measures and scoring systems used in prospective studies of port wine stains: A systematic review

et al. 2020

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“…Accordingly, it is only possible to generalise towards this. However, previous literature has identified similar barriers to COS uptake for osteoarthritis, 13 sepsis, 14 and dermatology 15 trials. Third, pre-survey work based on Smith et al’.s 7 COS uptake analysis and piloting of this study’s survey suggested that awareness of the COS may be a major reason for non-adoption.…”

Section: Discussionmentioning

confidence: 83%

Barriers to uptake of the hip fracture core outcome set: An international survey of 80 hip fracture trialists

2020

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Background: Core outcome sets are an agreed recommendation to inform the selection of outcome measures in clinical trials. There has been low uptake of the 2014 hip fracture core outcome set. The reasons for this remain unclear. The aim of this study was to understand the reasons for the non-adoption and approaches to increase adoption of the hip fracture core outcome set. Methods: Randomised controlled trials from PubMed (2017–2019) and ClinicalTrials.gov (2015–2019) were identified. Corresponding authors for each identified trial (n = 302) were surveyed using five questions on awareness of the hip fracture core outcome set, reasons for non-adoption and approaches to increase adoption. Data were analysed descriptively using frequencies, mean values and standard deviations. Results: Fifty-four percent of the respondents (n = 43) were aware of the concept of core outcome set. Only 15% (n = 12) based the outcome measure selection on the 2014 hip fracture core outcome set. Key reasons for non-adoption included the following: authors being unaware and perceived inappropriateness to their trial design. Eighty-six percent (n = 69) of respondents agreed to the need for increased awareness of core outcome sets through research training, academic and clinical journal requirements, and funding or publication stipulations. Eighty-eight percent (n = 70) of respondents indicated the current core outcome set required revision to focus on trials investigating people with cognitive impairment, caregivers, rehabilitation, surgical interventions and anaesthetic trial designs. Conclusion: Barriers to the adoption of the hip fracture core outcome set centre on education, awareness of the core outcome sets and applicability to the breath of hip fracture trial designs. Further consideration should be made to address these, to improve the harmonisation of outcome measures across hip fracture trials.

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“…In 2016 the International Consortium for Health Outcomes Measurement (ICHOM) published a standard set of outcome measures to evaluate value in maternity care [12]. Standard sets are the same as core outcome sets but have a clear focus on clinical practice [13]. An ICHOM working party comprising two consumers and nineteen international experts convened to identify outcomes and measurement instruments for inclusion in their set [14].…”

Section: Introductionmentioning

confidence: 99%

Comparison of screening accuracy of the Patient Health Questionnaire-2 using two case-identification methods during pregnancy and postpartum

Slavin

Creedy

Gamble

2020

BMC Pregnancy Childbirth

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Background: Variation exists regarding perinatal depression screening. A two-step screening method has been recommended. According to a maternity-focused core outcome set developed by the International Consortium for Health Outcomes Measurement, women who score 3 or more on the PHQ-2 then complete the Edinburgh Postnatal Depression Scale (EPDS). Limited evidence exists regarding the screening accuracy of the PHQ-2 in childbearing women. An alternative case-identification method may be more sensitive for perinatal women. We aimed to [1] evaluate the screening accuracy of the PHQ-2 during the perinatal period using two case-identification methods, and [2] measure the variability of accuracy over four time-points during pregnancy and postpartum. Methods: A prospective, longitudinal cohort study was conducted with 309 consecutive women who completed the PHQ-2 and EPDS during pregnancy (booking, 36-weeks) and postpartum (6-, 26-weeks). EPDS was the reference standard using cutoff scores for 'at least probable minor depression' during pregnancy (≥ 13) and postpartum (≥ 10) and for 'probable major depression' during pregnancy (≥ 15) and postpartum (≥ 13). PHQ-2 was analysed using two methods: [1] scored (cut-points ≥ 2 and ≥ 3), [2] dichotomous yes/no (positive response to either question) against EPDS cut-points for at least probable minor and probable major depression. Receiver operating characteristic analyses determined accuracy. Results: Probable major depression: Over four timepoints PHQ-2 ≥ 3 revealed lowest sensitivity (36-79%) but highest specificity (94-98%). An alternative case-identification method revealed high sensitivity (93-100%), but lowest specificity (58-71%). Minor depression: PHQ-2 ≥ 3 revealed the lowest sensitivity (19-50%) but highest specificity (95-98%). An alternative case-identification method revealed the highest sensitivity (81-100%) and moderate specificity (60-74%).

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Navigating the landscape of core outcome set development in dermatology

Abstract:  CS-COUSIN provides methodological support for dermatology-specific core outcome set initiatives to ensure high quality across core outcome sets in dermatology.

Cited by 49 publications

References 40 publications

Clinical outcome measures and scoring systems used in prospective studies of port wine stains: A systematic review

Clinical outcome measures and scoring systems used in prospective studies of port wine stains: A systematic review

Barriers to uptake of the hip fracture core outcome set: An international survey of 80 hip fracture trialists

Comparison of screening accuracy of the Patient Health Questionnaire-2 using two case-identification methods during pregnancy and postpartum

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