A core outcome set (COS) is a consensus-derived set of two important and interconnected phases. First, determining ''what'' (domains) to measure, (resulting in a Core Domain Set). Second, decisions about ''how'' (instruments) to measure each of the endorsed core domains, Instrument Selection. Together they make a Core Outcome Set that allows researchers to measure a consistent set of clinical endpoints in studies of a health condition. Handbook O. Handbook. OMERACT Handbook. Accessed September 15, 2020. https://omeracthandbook.org/handbookThe COMET Handbook: version 1.0 , Trials , Full Text. Accessed September 15, 2020. https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-017-1978-4#Bib1Cochrane Skin – Core Outcome Set Initiative. Accessed September 15, 2020. http://cs-cousin.org/I’m developing a Core Outcome Set • COSMIN. Accessed September 15, 2020. https://www.cosmin.nl/finding-right-tool/developing-core-outcome-set/

Terminology

The term core domain is a key aspect of health or well-being that is considered essential to define, measure and report in all clinical trials and other research studies related to a specific health condition or disease.These are considered the ‘What’ to measure in Core Outcome Sets. The term core domain should not be confused with the term domain, which refers to any clinical endpoint that can be measured in research, regardless of importance. Similarly, core domains are distinct from core instruments (also known as outcome measures). While core domains provide guidance on what to measure in clinical studies, core instruments provide guidance on how to measure those selected outcomes.COUSIN_guidance_version_5_9_2018.pdf. Accessed September 15, 2020. http://cs-cousin.org/wordpress/wp-content/uploads/2018/11/COUSIN_guidance_version_5_9_2018.pdf

Scope

Core outcome sets are commonly used by clinical investigators who conduct clinical trials for the treatment of a health condition. The patient population associated with a particular core outcome set may vary, as some apply to all patients with that health condition and others apply to a small subset of that population. Core outcome sets are typically used in research, but they may also be used for patient management during routine clinical care. The need to develop core outcome sets was initially identified by methodologists and aggregators of systematic reviews, like Cochrane, who observed that meta-analyses of trials of similar conditions were frequently impeded by the lack of similarity among the outcomes and outcome measures they employed.Schmitt J, Lange T, Kottner J, et al. Cochrane Reviews and Dermatological Trials Outcome Concordance: Why Core Outcome Sets Could Make Trial Results More Usable. ''J Invest Dermatol''. 2019;139(5):1045-1053. doi:10.1016/j.jid.2018.11.019

Methodology

In general, the process for developing a core outcome set requires rigorous methodology in which domains are first generated from all possible sources and then subsequently prioritized during a consensus process.Core Outcome Set-STAndards for Development: The COS-STAD recommendations. Accessed September 15, 2020. https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1002447 A long list of domains is first developed by means of

systematic review A systematic review is a scholarly synthesis of the evidence on a clearly presented topic using critical methods to identify, define and assess research on the topic. A systematic review extracts and interprets data from published studies on t ...

literature review A literature review is an overview of the previously published works on a topic. The term can refer to a full scholarly paper or a section of a scholarly work such as a book, or an article. Either way, a literature review is supposed to provid ...

s, and reviews of patient resources. Additional domains are identified by interviewing those with further personal, professional or scientific knowledge of the health condition, such as patients, representatives of patient support groups, physicians and other clinicians, industry scientists, and healthcare regulators. After a list of potential domains is identified, an international group of experts and patients then select the domains most important to them by a consensus process, commonly the

Delphi technique } The Delphi method or Delphi technique ( ; also known as Estimate-Talk-Estimate or ETE) is a structured communication technique or method, originally developed as a systematic, interactive forecasting method which relies on a panel of experts. The ...

nominal group technique The nominal group technique (NGT) is a group process involving problem identification, solution generation, and decision making. It can be used in groups of many sizes, who want to make their decision quickly, as by a vote, but want everyone's opini ...

. For each of the selected core domains, instruments are identified and then selected through an instrument selection process. The selected list of core domains and instruments is then published and disseminated for use by clinical trialists. Uptake of the core outcome set, or its active use by trialists, is encouraged.

Examples of core outcome set initiatives

The first initiative to standardize outcomes was led in 1970 by the

World Health Organization The World Health Organization (WHO) is a specialized agency of the United Nations responsible for international public health. The WHO Constitution states its main objective as "the attainment by all peoples of the highest possible level o ...

(WHO), which attempted to create a set of domains for clinical trials in cancer. Since then, numerous initiatives have been created to both develop core outcome sets and provide resources for other groups.

Core Outcome Sets in rheumatology

OMERACT

Over 19 core domain sets related to rheumatology have been developed by The Outcome Measures in Rheumatology
OMERACT
collaboration, including those for

fibromyalgia Fibromyalgia (FM) is a medical condition defined by the presence of chronic widespread pain, fatigue, waking unrefreshed, cognitive symptoms, lower abdominal pain or cramps, and depression. Other symptoms include insomnia and a general hype ...

gout Gout ( ) is a form of inflammatory arthritis characterized by recurrent attacks of a red, tender, hot and swollen joint, caused by deposition of monosodium urate monohydrate crystals. Pain typically comes on rapidly, reaching maximal intens ...

, and osteoporosis. In addition to developing core outcome sets in rheumatology, OMERACT publishes resources and handbooks for researchers that can be applied across all specialties.

General initiatives

COMET

The Core Outcome Measures in Effectiveness Trials (COMET) group is an international collaboration that provides extensive methodological support to all groups developing core outcome sets. COMET was first launched in 2010 and is currently led by

Paula Williamson Paula Ruth Williamson is a British medical statistician who specialises in medical statistics and the use of methodology within the field, particularly clinical trials methodology. A graduate from the University of Sheffield, she originally wor ...

Core outcomes in dermatology

CS-COUSIN

The Cochrane Skin - Core Outcome Set Initiative (CS-COUSIN) group was created with the aim of developing core outcome sets in dermatology and providing methodological support to core outcome set developers. CS-COUSIN is affiliated with the development of 18 dermatologic core outcome sets, including those for

vitiligo Vitiligo is a disorder that causes the skin to lose its color. Specific causes are unknown but studies suggest a link to immune system changes. Signs and symptoms The only sign of vitiligo is the presence of pale patchy areas of depigmen ...

eczema Dermatitis is inflammation of the skin, typically characterized by itchiness, redness and a rash. In cases of short duration, there may be small blisters, while in long-term cases the skin may become thickened. The area of skin involved can v ...

, and

acne Acne, also known as ''acne vulgaris'', is a long-term skin condition that occurs when dead skin cells and oil from the skin clog hair follicles. Typical features of the condition include blackheads or whiteheads, pimples, oily skin, and ...

IMPROVED

The Measurement of Priority Outcome Variables in Dermatologic Surgery group (IMPROVED), led by Murad Alam, is an international collaboration of dermatologic surgeons that has developed core outcomes for various dermatologic surgery conditions. Notably, the IMPROVED group has developed core outcome sets for cutaneous squamous cell carcinoma,

basal cell carcinoma Basal-cell carcinoma (BCC), also known as basal-cell cancer, is the most common type of skin cancer. It often appears as a painless raised area of skin, which may be shiny with small blood vessels running over it. It may also present as a rais ...

, and

actinic keratosis Actinic keratosis (AK), sometimes called solar keratosis or senile keratosis, is a pre-cancerous area of thick, scaly, or crusty skin.Freedberg, et al. (2003). ''Fitzpatrick's Dermatology in General Medicine''. (6th ed.). McGraw-Hill. . Actinic k ...

Core outcome in women's health

CROWN

Six core outcome sets have been developed by the Core Outcomes in Women's and Newborn's Health (CROWN) collaboration for various health conditions relevant to women's health. Notable sets include those for diabetes in pregnancy, preterm birth, and maternity care.

Access to core outcome sets

Core outcome sets that are published or are in development can be found in a database maintained by the COMET initiative.COMET Initiative , Search the COMET Database. http://www.comet-initiative.org/Studies The database is refreshed annually by a systematic review of core outcome set studies.

References

{{reflist Clinical research Clinical data management