A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance

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Abstract

The UK Medical Research Council’s widely used guidance for developing and evaluating complex interventions has been replaced by a new framework, commissioned jointly by the Medical Research Council and the National Institute for Health Research, which takes account of recent developments in theory and methods and the need to maximise the efficiency, use, and impact of research.

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Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK

Merryn Voysey, Sue Ann Costa Clemens, Shabir Madhi … (2022)

Background A safe and efficacious vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), if deployed with high coverage, could contribute to the control of the COVID-19 pandemic. We evaluated the safety and efficacy of the ChAdOx1 nCoV-19 vaccine in a pooled interim analysis of four trials. Methods This analysis includes data from four ongoing blinded, randomised, controlled trials done across the UK, Brazil, and South Africa. Participants aged 18 years and older were randomly assigned (1:1) to ChAdOx1 nCoV-19 vaccine or control (meningococcal group A, C, W, and Y conjugate vaccine or saline). Participants in the ChAdOx1 nCoV-19 group received two doses containing 5 × 1010 viral particles (standard dose; SD/SD cohort); a subset in the UK trial received a half dose as their first dose (low dose) and a standard dose as their second dose (LD/SD cohort). The primary efficacy analysis included symptomatic COVID-19 in seronegative participants with a nucleic acid amplification test-positive swab more than 14 days after a second dose of vaccine. Participants were analysed according to treatment received, with data cutoff on Nov 4, 2020. Vaccine efficacy was calculated as 1 - relative risk derived from a robust Poisson regression model adjusted for age. Studies are registered at ISRCTN89951424 and ClinicalTrials.gov, NCT04324606, NCT04400838, and NCT04444674. Findings Between April 23 and Nov 4, 2020, 23 848 participants were enrolled and 11 636 participants (7548 in the UK, 4088 in Brazil) were included in the interim primary efficacy analysis. In participants who received two standard doses, vaccine efficacy was 62·1% (95% CI 41·0–75·7; 27 [0·6%] of 4440 in the ChAdOx1 nCoV-19 group vs71 [1·6%] of 4455 in the control group) and in participants who received a low dose followed by a standard dose, efficacy was 90·0% (67·4–97·0; three [0·2%] of 1367 vs 30 [2·2%] of 1374; p interaction =0·010). Overall vaccine efficacy across both groups was 70·4% (95·8% CI 54·8–80·6; 30 [0·5%] of 5807 vs 101 [1·7%] of 5829). From 21 days after the first dose, there were ten cases hospitalised for COVID-19, all in the control arm; two were classified as severe COVID-19, including one death. There were 74 341 person-months of safety follow-up (median 3·4 months, IQR 1·3–4·8): 175 severe adverse events occurred in 168 participants, 84 events in the ChAdOx1 nCoV-19 group and 91 in the control group. Three events were classified as possibly related to a vaccine: one in the ChAdOx1 nCoV-19 group, one in the control group, and one in a participant who remains masked to group allocation. Interpretation ChAdOx1 nCoV-19 has an acceptable safety profile and has been found to be efficacious against symptomatic COVID-19 in this interim analysis of ongoing clinical trials. Funding UK Research and Innovation, National Institutes for Health Research (NIHR), Coalition for Epidemic Preparedness Innovations, Bill & Melinda Gates Foundation, Lemann Foundation, Rede D’Or, Brava and Telles Foundation, NIHR Oxford Biomedical Research Centre, Thames Valley and South Midland's NIHR Clinical Research Network, and AstraZeneca.

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Developing and evaluating complex interventions: the new Medical Research Council guidance

Peter Craig, Paul Dieppe, Sally Macintyre … (2008)

Evaluating complex interventions is complicated. The Medical Research Council's evaluation framework (2000) brought welcome clarity to the task. Now the council has updated its guidance

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Process evaluation of complex interventions: Medical Research Council guidance

Graham Moore, Suzanne Audrey, Mary Barker … (2015)

Process evaluation is an essential part of designing and testing complex interventions. New MRC guidance provides a framework for conducting and reporting process evaluation studies

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Author and article information

Contributors

Kathryn Skivington:

ORCID: https://orcid.org/0000-0002-3571-1561

Role: research fellow

Lynsay Matthews:

ORCID: https://orcid.org/0000-0002-5760-1080

Role: research fellow

Sharon Anne Simpson:

ORCID: https://orcid.org/0000-0002-6219-1768

Role: professor of behavioural sciences and health

Peter Craig:

ORCID: https://orcid.org/0000-0002-7653-5832

Role: professor of public health evaluation

Janis Baird:

ORCID: https://orcid.org/0000-0002-4039-4361

Role: professor of public health and epidemiology

Jane M Blazeby:

ORCID: https://orcid.org/0000-0002-3354-3330

Role: professor of surgery

Kathleen Anne Boyd:

ORCID: https://orcid.org/0000-0002-9764-0113

Role: reader in health economics

Neil Craig:

ORCID: https://orcid.org/0000-0002-7370-5541

Role: acting head of evaluation within Public Health Scotland

David P French:

ORCID: https://orcid.org/0000-0002-7663-7804

Role: professor of health psychology

Emma McIntosh:

ORCID: https://orcid.org/0000-0001-6340-3083

Role: professor of health economics

Mark Petticrew:

ORCID: https://orcid.org/0000-0002-6378-5517

Role: professor of public health evaluation

Jo Rycroft-Malone:

ORCID: https://orcid.org/0000-0003-3858-5625

Role: faculty dean

Martin White:

ORCID: https://orcid.org/0000-0002-1861-6757

Role: professor of population health research

Laurence Moore:

ORCID: https://orcid.org/0000-0003-2182-823X

Role: unit director

Journal

Journal ID (nlm-ta): BMJ

Journal ID (iso-abbrev): BMJ

Journal ID (publisher-id): BMJ-UK

Journal ID (hwp): bmj

Title: The BMJ

Publisher: BMJ Publishing Group Ltd.

ISSN (Print): 0959-8138

ISSN (Electronic): 1756-1833

Publication date Collection: 2021

Publication date (Electronic): 30 September 2021

Volume: 374

Electronic Location Identifier: n2061

Affiliations

[1 ]MRC/CSO Social and Public Health Sciences Unit, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK

[2 ]Medical Research Council Lifecourse Epidemiology Unit, University of Southampton, Southampton, UK

[3 ]Medical Research Council ConDuCT-II Hub for Trials Methodology Research and Bristol Biomedical Research Centre, Bristol, UK

[4 ]Health Economics and Health Technology Assessment Unit, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK

[5 ]Public Health Scotland, Glasgow, UK

[6 ]Manchester Centre for Health Psychology, University of Manchester, Manchester, UK

[7 ]London School of Hygiene and Tropical Medicine, London, UK

[8 ]Faculty of Health and Medicine, Lancaster University, Lancaster, UK

[9 ]Medical Research Council Epidemiology Unit, University of Cambridge, Cambridge, UK

Author notes

Correspondence to: K Skivington Kathryn.skivington@ 123456glasgow.ac.uk

Author information

Kathryn Skivington https://orcid.org/0000-0002-3571-1561

Lynsay Matthews https://orcid.org/0000-0002-5760-1080

Sharon Anne Simpson https://orcid.org/0000-0002-6219-1768

Peter Craig https://orcid.org/0000-0002-7653-5832

Janis Baird https://orcid.org/0000-0002-4039-4361

Jane M Blazeby https://orcid.org/0000-0002-3354-3330

Kathleen Anne Boyd https://orcid.org/0000-0002-9764-0113

Neil Craig https://orcid.org/0000-0002-7370-5541

David P French https://orcid.org/0000-0002-7663-7804

Emma McIntosh https://orcid.org/0000-0001-6340-3083

Mark Petticrew https://orcid.org/0000-0002-6378-5517

Jo Rycroft-Malone https://orcid.org/0000-0003-3858-5625

Martin White https://orcid.org/0000-0002-1861-6757

Laurence Moore https://orcid.org/0000-0003-2182-823X

Article

Publisher ID: skik065968

DOI: 10.1136/bmj.n2061

PMC ID: 8482308

PubMed ID: 34593508

SO-VID: 9888d532-0f76-4106-9018-918da25953ad

License:

This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/.

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Date accepted : 09 August 2021

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A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance

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Most cited references 74

Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK

Developing and evaluating complex interventions: the new Medical Research Council guidance

Process evaluation of complex interventions: Medical Research Council guidance

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