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Which outcomes are most important to measure in patients with COVID-19 and how and when should these be measured? Development of an international standard set of outcomes measures for clinical use in patients with COVID-19: a report of the International Consortium for Health Outcomes Measurement (ICHOM) COVID-19 Working Group.
Seligman, William H; Fialho, Luz; Sillett, Nick; Nielsen, Christina; Baloch, Farhala M; Collis, Philip; Demedts, Ingel K M; Fleck, Marcelo P; Floriani, Maiara A; Gabriel, Lucinda E K; Gagnier, Joel J; Keetharuth, Anju; Londral, Ana; Ludwig, Ingvar I L; Lumbreras, Carlos; Moscoso Daza, Alejandro; Muhammad, Nasreen; Nader Bastos, Gisele A; Owen, Christine W; Powers, John H; Russell, Anne-Marie; Smith, Michaela K; Wang, Tracy Y-P; Wong, Evan K; Woodhouse, Douglas C; Zimlichman, Eyal; Brinkman, Kees.
  • Seligman WH; International Consortium for Health Outcomes Measurement, Boston, Massachusetts, USA w.seligman@ichom.org.
  • Fialho L; International Consortium for Health Outcomes Measurement, Boston, Massachusetts, USA.
  • Sillett N; International Consortium for Health Outcomes Measurement, Boston, Massachusetts, USA.
  • Nielsen C; International Consortium for Health Outcomes Measurement, Boston, Massachusetts, USA.
  • Baloch FM; The Aga Khan University Hospital, Karachi, Pakistan.
  • Collis P; NIHR, London, UK.
  • Demedts IKM; AZ Delta Campus Brugsesteenweg, Roeselare, West-Vlaanderen, Belgium.
  • Fleck MP; Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil.
  • Floriani MA; Hospital Moinhos de Vento, Porto Alegre, Brazil.
  • Gabriel LEK; King's Health Partners, London, London, UK.
  • Gagnier JJ; University of Michigan, Ann Arbor, Michigan, USA.
  • Keetharuth A; The University of Sheffield, Sheffield, UK.
  • Londral A; Value for Health CoLAB, Lisboa, Portugal.
  • Ludwig IIL; Hospital do Coracao, Sao Paulo, Brazil.
  • Lumbreras C; Universidad Complutense de Madrid, Madrid, Spain.
  • Moscoso Daza A; Clinica del Country, Bogota, Colombia.
  • Muhammad N; The Aga Khan University Hospital, Karachi, Pakistan.
  • Nader Bastos GA; Hospital Moinhos de Vento, Porto Alegre, Brazil.
  • Owen CW; NHS Wales, Cardiff, UK.
  • Powers JH; The George Washington University School of Medicine and Health Sciences, Washington, District of Columbia, USA.
  • Russell AM; University of Exeter, Exeter, UK.
  • Smith MK; Mediclinic Southern Africa, Stellenbosch, South Africa.
  • Wang TY; Duke University School of Medicine, Durham, North Carolina, USA.
  • Wong EK; Providence Health Care, Seattle, Washington, USA.
  • Woodhouse DC; University of Calgary, Calgary, Alberta, Canada.
  • Zimlichman E; Sheba Medical Center, Tel Hashomer, Israel.
  • Brinkman K; OLVG, Amsterdam, The Netherlands.
BMJ Open ; 11(11): e051065, 2021 11 15.
Article in English | MEDLINE | ID: covidwho-1518146
ABSTRACT

OBJECTIVES:

The COVID-19 pandemic has resulted in widespread morbidity and mortality with the consequences expected to be felt for many years. Significant variation exists in the care even of similar patients with COVID-19, including treatment practices within and between institutions. Outcome measures vary among clinical trials on the same therapies. Understanding which therapies are of most value is not possible unless consensus can be reached on which outcomes are most important to measure. Furthermore, consensus on the most important outcomes may enable patients to monitor and track their care, and may help providers to improve the care they offer through quality improvement. To develop a standardised minimum set of outcomes for clinical care, the International Consortium for Health Outcomes Measurement (ICHOM) assembled a working group (WG) of 28 volunteers, including health professionals, patients and patient representatives.

DESIGN:

A list of outcomes important to patients and professionals was generated from a systematic review of the published literature using the MEDLINE database, from review of outcomes being measured in ongoing clinical trials, from a survey distributed to patients and patient networks, and from previously published ICHOM standard sets in other disease areas. Using an online-modified Delphi process, the WG selected outcomes of greatest importance.

RESULTS:

The outcomes considered by the WG to be most important were selected and categorised into five domains (1) functional status and quality of life, (2) mental functioning, (3) social functioning, (4) clinical outcomes and (5) symptoms. The WG identified demographic and clinical variables for use as case-mix risk adjusters. These included baseline demographics, clinical factors and treatment-related factors.

CONCLUSION:

Implementation of these consensus recommendations could help institutions to monitor, compare and improve the quality and delivery of care to patients with COVID-19. Their consistent definition and collection could also broaden the implementation of more patient-centric clinical outcomes research.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Quality of Life / COVID-19 Type of study: Observational study / Prognostic study / Reviews / Systematic review/Meta Analysis Limits: Humans Language: English Journal: BMJ Open Year: 2021 Document Type: Article Affiliation country: Bmjopen-2021-051065

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Quality of Life / COVID-19 Type of study: Observational study / Prognostic study / Reviews / Systematic review/Meta Analysis Limits: Humans Language: English Journal: BMJ Open Year: 2021 Document Type: Article Affiliation country: Bmjopen-2021-051065