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A core outcome set for post-COVID-19 condition in adults for use in clinical practice and research: an international Delphi consensus study.

ABSTRACT: Health consequences that persist beyond the acute infection phase of COVID-19, termed post-COVID-19 condition (also commonly known as long COVID), vary widely and represent a growing global health challenge. Research on post-COVID-19 condition is expanding but, at present, no agreement exists on the health outcomes that should be measured in people living with the condition. To address this gap, we conducted an international consensus study, which included a comprehensive literature review and classification of outcomes for post-COVID-19 condition that informed a two-round online modified Delphi process followed by an online consensus meeting to finalise the core outcome set (COS). 1535 participants from 71 countries were involved, with 1148 individuals participating in both Delphi rounds. Eleven outcomes achieved consensus for inclusion in the final COS: fatigue; pain; post-exertion symptoms; work or occupational and study changes; survival; and functioning, symptoms, and conditions for each of cardiovascular, respiratory, nervous system, cognitive, mental health, and physical outcomes. Recovery was included a priori because it was a relevant outcome that was part of a previously published COS on COVID-19. The next step in this COS development exercise will be to establish the instruments that are most appropriate to measure these core outcomes. This international consensus-based COS should provide a framework for standardised assessment of adults with post-COVID-19 condition, aimed at facilitating clinical care and research worldwide.

SUBMITTER: Munblit D

PROVIDER: S-EPMC9197249 | biostudies-literature | 2022 Jul

REPOSITORIES: biostudies-literature

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A core outcome set for post-COVID-19 condition in adults for use in clinical practice and research: an international Delphi consensus study.

Munblit Daniel D Nicholson Timothy T Akrami Athena A Apfelbacher Christian C Chen Jessica J De Groote Wouter W Diaz Janet V JV Gorst Sarah L SL Harman Nicola N Kokorina Alisa A Olliaro Piero P Parr Callum C Preller Jacobus J Schiess Nicoline N Schmitt Jochen J Seylanova Nina N Simpson Frances F Tong Allison A Needham Dale M DM Williamson Paula R PR

The Lancet. Respiratory medicine 20220614 7

Health consequences that persist beyond the acute infection phase of COVID-19, termed post-COVID-19 condition (also commonly known as long COVID), vary widely and represent a growing global health challenge. Research on post-COVID-19 condition is expanding but, at present, no agreement exists on the health outcomes that should be measured in people living with the condition. To address this gap, we conducted an international consensus study, which included a comprehensive literature review and c ...[more]

PMID: 35714658

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Project description:ObjectivesTo reach an international expert consensus on the diagnosis, prognosis and management of fetal lower urinary tract obstruction (LUTO) by means of a Delphi procedure, and to use this to define a core outcome set (COS).MethodsA three-round Delphi procedure was conducted among an international panel of experts in fetal LUTO. The panel was provided with a list of literature-based parameters to consider for the diagnosis, prognosis, management and outcomes of LUTO. A parallel procedure was conducted with patient groups during the development of the COS.ResultsA total of 168 experts were approached, of whom 99 completed the first round and 80/99 (80.8%) completed all three rounds of the study questionnaires. Consensus was reached that, in the first trimester, an objective measurement of longitudinal bladder diameter of ≥ 7 mm should be used to suspect LUTO. In the second trimester, imaging parameters suggestive of LUTO could include enlarged bladder, keyhole sign, bladder wall thickening, bilateral hydronephrosis, bilateral hydroureteronephrosis and male sex. There was 79% agreement that the current prognostic scoring systems in the literature should not be used clinically. However, experts agreed on the value of amniotic fluid volume (at < 24 weeks) to predict survival and that the value of fetal intervention is to improve the chance of neonatal survival. Experts endorsed sonographic parameters suggestive of renal dysplasia, at least one vesicocentesis, and renal biochemistry for prognosis and counseling, but these items did not reach a consensus for determining candidacy for fetal intervention. On the other hand, imaging parameters suggestive of LUTO, absence of life-limiting structural or genetic anomalies, gestational age of ≥ 16 weeks and oligohydramnios (defined as deepest vertical pocket < 2 cm) should be used as candidacy criteria for fetal intervention based on expert consensus. If bladder refill was evaluated, it should be assessed subjectively. Vesicoamniotic shunt should be the first line of fetal intervention. In the presence of suspected fetal renal failure, serial amnioinfusion should be offered only as an experimental procedure under research protocols. A COS for future LUTO studies was agreed upon.ConclusionInternational consensus on the diagnosis, prognosis and management of fetal LUTO, as well as the COS, should inform clinical care and research to optimize perinatal outcomes. © 2024 The Author(s). Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.

Project description:ObjectivesA core outcome set (COS) describes a minimum set of outcomes to be reported by all clinical trials of one healthcare condition. Delphi surveys are frequently used to achieve consensus on core outcomes. International input is important to achieve global COS uptake. We aimed to investigate participant representation in international Delphi surveys, with reference to the inclusion of patients and participants from low and middle income countries as stakeholders (LMICs).DesignSystematic review.Data sourcesEMBASE, Medline, Web of Science, COMET database and hand-searching.Eligibility criteriaProtocols and studies describing Delphi surveys used to develop an international COS for trial reporting, published between 1 January 2017 and 6 June 2019.Data extraction and synthesisDelphi participants were grouped as patients or healthcare professionals (HCPs). Participants were considered international if their country of origin was different to that of the first or senior author. Data extraction included participant numbers, country of origin, country income group and whether Delphi surveys were translated. We analysed the impact these factors had on outcome prioritisation.ResultsOf 90 included studies, 69% (n=62) were completed and 31% (n=28) were protocols. Studies recruited more HCPs than patients (median 60 (IQR 30-113) vs 30 (IQR 14-66) participants, respectively). A higher percentage of HCPs was international compared with patients (57% (IQR 37-78) vs 20% (IQR 0-68)). Only 31% (n=28) studies recruited participants from LMICs. Regarding recruitment from LMICs, patients were under-represented (16% studies; n=8) compared with HCPs (22%; n=28). Few (7%; n=6) studies translated Delphi surveys. Only 3% studies (n=3) analysed Delphi responses by geographical location; all found differences in outcome prioritisation.ConclusionsThere is a disproportionately lower inclusion of international patients, compared with HCPs, in COS-development Delphi surveys, particularly within LMICs. Future international Delphi surveys should consider exploring for geographical and income-based differences in outcome prioritisation.Prospero registration numberCRD42019138519.

Project description:BackgroundDisease outbreaks significantly affect maternal and neonatal health. Variability in reporting health outcomes hinder evidence generation. We aimed to develop a core outcome set (COS) for maternal and neonatal health research and surveillance during emerging and ongoing epidemic threats and to agree on outcomes' definitions.MethodsWe conducted a systematic review of observational and experimental studies related to epidemics to identify outcomes, and a four-stage modified-Delphi consensus. 150 international stakeholders participated in online surveys, and 24 representatives in consensus meetings. The panels were diverse, with balanced representation of professional background, gender, and geography, including civil society representatives. Outcome were included if ≥ 80% of participants scored them as critically important and ≤10% rated them as not important.FindingsThe final COS includes seven main maternal outcomes-pregnancy outcome, maternal death, suspected symptomatic infection, confirmed infection, severe disease, preterm delivery, mode of birth; seven complementary maternal outcomes-antepartum haemorrhage, postpartum haemorrhage, hypertensive disorders of pregnancy, maternal sepsis, admission to intensive care unit/special units, respiratory support, depression and anxiety; 11 main neonatal outcomes-neonatal death, neonatal suspected symptomatic infection, confirmed infection, severe disease, vertical transmission, low birth weight, prematurity, congenital disorder, respiratory support, skin-to-skin contact, breastfeeding; and, four complementary neonatal outcomes-admission to neonatal intensive care unit/special units, respiratory failure, birth asphyxia, sepsis.InterpretationThis COS could contribute to standardize maternal and neonatal outcomes selection and reporting in observational and experimental studies, facilitating efficient data comparison and timely evidence-based decision-making in the context of ongoing and emerging epidemic threats.FundingBill & Melinda Gates Foundation (grant INV-041181) and the UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), a cosponsored programme executed by the World Health Organization (HQHRP2422779).

Dataset Information

A core outcome set for post-COVID-19 condition in adults for use in clinical practice and research: an international Delphi consensus study.

Publications

A core outcome set for post-COVID-19 condition in adults for use in clinical practice and research: an international Delphi consensus study.

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