Core outcome set implementation supported by the <i>BJD</i>
نویسندگان
چکیده
A core outcome set (COS) is an agreed minimum of outcomes that should be measured globally in all clinical trials or other specified settings, such as routine practice quality assurance, for a particular condition.1 COS consists primarily domains (what to measure) and eventually measurement instruments (how measure). The universal uptake suitable critical advancing patient-centred care reducing research waste, through enabling comparative effectiveness limiting reporting bias.2, 3 Nonuniformity blights the dermatology literature, demonstrated by studies eczema, hidradenitis suppurativa, acne, vitiligo, vulval disorders psoriasis. Moreover, meta-analyses are frequently missing from Cochrane reviews due incomparable outcomes.4 This results obstruction clear therapeutic recommendations5 ultimately suboptimal patient care. BJD has prioritized publication related papers, recognizing their pivotal role However, editorial team have, at times, observed either partial absent utilization submitted trial manuscripts, despite existence published field. observation supported findings recent systematic review examining uptake, which high variability, ranging zero gout 82% rheumatoid arthritis, with full typically found fewer than 25% trials.6 Gains have been made Harmonising Outcome Measures Eczema (HOME) initiative, increase use three four (signs, symptoms life) period 2005–2018, 33% 2018.7 measure instrument (OMI) domain signs (Eczema Area Severity Index) widely adopted (92% trials), whereas OMI (Patient-Oriented Measure, POEM) was used only 17% trials; consensus latter reached 2017.7 lack POEM confirmed living network meta-analysis investigating systemic immunomodulatory therapy atopic dermatitis.8 comprising six psoriasis 2018,9 developed International Dermatology Measure group. ‘skin manifestations’ ‘investigator global assessment’ routinely reported primary publications using Psoriasis Index Investigator’s Global Assessment, accepted regulatory bodies US Food Drug Administration (FDA). these do not reflect experience defined COS. Specifically, assessment, symptoms, health-related life treatment satisfaction often omitted. concluded effective data synthesis limited harmonization.10 Beyond eczema there nine COSs within domains, including keratinocyte carcinoma, vascular malformations uncertain levels uptake.1 Broad implementation critical, otherwise itself danger being wasteful. requires multicomponent interventions targeting awareness, acceptance adherence (Table 1). There myriad ways build utility medical curricula conference programming decision making. Core Effectiveness Trials (COMET) initiative1 provides database ongoing completed promotes awareness engagement partnering agencies Cochrane, National Institute Health Care Excellence (NICE) Research (NIHR). Adherence facilitated more stringent funding, regulation requirements, mandating inclusion (or explanation exclusion) ethics submissions, funding applications, protocols registries. Endorsement FDA European Medicines Agency essential, considered partly responsible rates arthritis (82%).11 Progress made, illustrated ISRCTN registry guideline Standard Protocol Items: Recommendations Interventional (SPIRIT), now advise COS, direct designers COMET information on available field.12 In addition, also required, where available, NIHR approval NICE. success measures improving depends entirely building deeper community, turn wide genuinely representative stakeholder involvement, total transparency demonstration methodological rigour. numerous resources facilitate standards development, namely HOME roadmap13 conjunction Skin – Set Initiative (CS-COUSIN; http://cs-cousin.org) COMET. Kirkham et al. devised standard methodology (COS-STAD)14 accompanying checklists (COS-STAP)15 (COS-STAR).16 Journals important play both disseminating development encouraging uptake. frontrunner showcasing research. next step require investigators report publications, provide its absence example, if protocol written before specific domain. will encouraged become compulsory medium term. Emma Veysey: Conceptualization (lead); Writing-original draft Writing-review & editing (lead). John R Ingram: (supporting); (supporting). Christian Apfelbacher: Aaron M Drucker:
منابع مشابه
A survey of core outcome set developers
Background A systematic review of core outcome sets (COS) identified 250 reports relating to 198 studies [1]. The review showed that a range of methods have been used, in a variety of ways, to develop core outcome sets. Furthermore, we found that of the 178 studies that described the methods they used to determine the core outcome set, 164 (92%) did not provide an explanation regarding their ch...
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ژورنال
عنوان ژورنال: British Journal of Dermatology
سال: 2021
ISSN: ['1365-2133', '0007-0963']
DOI: https://doi.org/10.1111/bjd.20050