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Article: Prof. Diana R. Elbourne: CONSORT for Cluster Randomized Trials and CONSORT for Noninferiority and Equivalence Trials.

Du, Kathy J / Li, Grace S / Zhang, Kaiping / Lin, Yao / Yang, Fanghui / Elbourne, Diana R

2022 Volume 10, Issue 18, Page(s) 1033

Language	English
Publishing date	2022-10-03
Publishing country	China
Document type	Editorial
ZDB-ID	2893931-1
ISSN	2305-5847 ; 2305-5839
ISSN (online)	2305-5847
ISSN	2305-5839
DOI	10.21037/atm-2022-42
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Article ; Online: Statistical methods for non-adherence in non-inferiority trials

Matthew Dodd / Diana Elbourne / James R Carpenter / Katherine Fielding / Jennifer A Thompson

BMJ Open, Vol 12, Iss

useful and used? A systematic review

2022 Volume 1

Keywords	Medicine ; R
Language	English
Publishing date	2022-01-01T00:00:00Z
Publisher	BMJ Publishing Group
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Statistical methods for non-adherence in non-inferiority trials: useful and used? A systematic review.

Dodd, Matthew / Fielding, Katherine / Carpenter, James R / Thompson, Jennifer A / Elbourne, Diana

BMJ open

2022 Volume 12, Issue 1, Page(s) e052656

Abstract: Background: In non-inferiority trials with non-adherence to interventions (or non-compliance), intention-to-treat and per-protocol analyses are often performed; however, non-random non-adherence generally biases these estimates of efficacy.: Objective! ...

Abstract	Background: In non-inferiority trials with non-adherence to interventions (or non-compliance), intention-to-treat and per-protocol analyses are often performed; however, non-random non-adherence generally biases these estimates of efficacy. Objective: To identify statistical methods that adjust for the impact of non-adherence and thus estimate the causal effects of experimental interventions in non-inferiority trials. Design: A systematic review was conducted by searching the Ovid MEDLINE database (31 December 2020) to identify (1) randomised trials with a primary analysis for non-inferiority that applied (or planned to apply) statistical methods to account for the impact of non-adherence to interventions, and (2) methodology papers that described such statistical methods and included a non-inferiority trial application. Outcomes: The statistical methods identified, their impacts on non-inferiority conclusions, and their advantages/disadvantages. Results: A total of 24 papers were included (4 protocols, 13 results papers and 7 methodology papers) reporting relevant methods on 26 occasions. The most common were instrumental variable approaches (n=9), including observed adherence as a covariate within a regression model (n=3), and modelling adherence as a time-varying covariate in a time-to-event analysis (n=3). Other methods included rank preserving structural failure time models and inverse-probability-of-treatment weighting. The methods identified in protocols and results papers were more commonly specified as sensitivity analyses (n=13) than primary analyses (n=3). Twelve results papers included an alternative analysis of the same outcome; conclusions regarding non-inferiority were in agreement on six occasions and could not be compared on six occasions (different measures of effect or results not provided in full). Conclusions: Available statistical methods which attempt to account for the impact of non-adherence to interventions were used infrequently. Therefore, firm inferences about their influence on non-inferiority conclusions could not be drawn. Since intention-to-treat and per-protocol analyses do not guarantee unbiased conclusions regarding non-inferiority, the methods identified should be considered for use in sensitivity analyses. Prospero registration number: CRD42020177458.
MeSH term(s)	Bias ; Humans
Language	English
Publishing date	2022-01-12
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Systematic Review
ZDB-ID	2599832-8
ISSN	2044-6055 ; 2044-6055
ISSN (online)	2044-6055
ISSN	2044-6055
DOI	10.1136/bmjopen-2021-052656
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Article ; Online: Impact of maintaining serum potassium concentration ≥ 3.6mEq/L versus ≥ 4.5mEq/L for 120 hours after isolated coronary artery bypass graft surgery on incidence of new onset atrial fibrillation: Protocol for a randomized non-inferiority trial.

Campbell, Niall G / Allen, Elizabeth / Evans, Richard / Jamal, Zahra / Opondo, Charles / Sanders, Julie / Sturgess, Joanna / Montgomery, Hugh E / Elbourne, Diana / O'Brien, Benjamin

PloS one

2024 Volume 19, Issue 3, Page(s) e0296525

Abstract: Background: Atrial Fibrillation After Cardiac Surgery (AFACS) occurs in about one in three patients following Coronary Artery Bypass Grafting (CABG). It is associated with increased short- and long-term morbidity, mortality and costs. To reduce AFACS ... ...

Abstract	Background: Atrial Fibrillation After Cardiac Surgery (AFACS) occurs in about one in three patients following Coronary Artery Bypass Grafting (CABG). It is associated with increased short- and long-term morbidity, mortality and costs. To reduce AFACS incidence, efforts are often made to maintain serum potassium in the high-normal range (≥ 4.5mEq/L). However, there is no evidence that this strategy is efficacious. Furthermore, the approach is costly, often unpleasant for patients, and risks causing harm. We describe the protocol of a planned randomized non-inferiority trial to investigate the impact of intervening to maintain serum potassium ≥ 3.6 mEq/L vs ≥ 4.5 mEq/L on incidence of new-onset AFACS after isolated elective CABG. Methods: Patients undergoing isolated CABG at sites in the UK and Germany will be recruited, randomized 1:1 and stratified by site to protocols maintaining serum potassium at either ≥ 3.6 mEq/L or ≥ 4.5 mEq/L. Participants will not be blind to treatment allocation. The primary endpoint is AFACS, defined as an episode of atrial fibrillation, flutter or tachycardia lasting ≥ 30 seconds until hour 120 after surgery, which is both clinically detected and electrocardiographically confirmed. Assuming a 35% incidence of AFACS in the 'tight control group', and allowing for a 10% loss to follow-up, 1684 participants are required to provide 90% certainty that the upper limit of a one-sided 97.5% confidence interval (CI) will exclude a > 10% difference in favour of tight potassium control. Secondary endpoints include mortality, use of hospital resources and incidence of dysrhythmias not meeting the primary endpoint (detected using continuous heart rhythm monitoring). Discussion: The Tight K Trial will assess whether a protocol to maintain serum potassium ≥ 3.6 mEq/L is non inferior to maintaining serum potassium ≥ 4.5 mEq/L in preventing new-onset AFACS after isolated CABG. Trial registration: ClinicalTrials.gov Identifier: NCT04053816. Registered on 13 August 2019. Last update 7 January 2021.
MeSH term(s)	Humans ; Atrial Fibrillation/epidemiology ; Atrial Fibrillation/etiology ; Atrial Fibrillation/prevention & control ; Coronary Artery Bypass/adverse effects ; Coronary Artery Bypass/methods ; Germany ; Incidence ; Potassium ; Randomized Controlled Trials as Topic ; Equivalence Trials as Topic
Chemical Substances	Potassium (RWP5GA015D)
Language	English
Publishing date	2024-03-13
Publishing country	United States
Document type	Clinical Trial Protocol ; Journal Article
ZDB-ID	2267670-3
ISSN	1932-6203 ; 1932-6203
ISSN (online)	1932-6203
ISSN	1932-6203
DOI	10.1371/journal.pone.0296525
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Article ; Online: Statistical analysis plan for a cluster randomised trial in Madhya Pradesh, India: community health promotion and medical provision and impact on neonates (CHAMPION2).

Magill, Nicholas / Shivalli, Siddharudha / Fazzio, Ila / Elbourne, Diana / Keddie, Suzanne / Reddy, Padmanabh / Nair, Rakhi / Gopal, Madan / Karnati, Sridevi / Reddy, Harshavardhan / Boone, Peter / Frost, Chris

Trials

2024 Volume 25, Issue 1, Page(s) 280

Abstract: Background: Neonatal mortality in India has fallen steadily and was estimated to be 24 per 1000 live births in the year 2017. However, neonatal mortality remains high in rural parts of the country. The Community Health Promotion and Medical Provision ... ...

Abstract	Background: Neonatal mortality in India has fallen steadily and was estimated to be 24 per 1000 live births in the year 2017. However, neonatal mortality remains high in rural parts of the country. The Community Health Promotion and Medical Provision and Impact On Neonates (CHAMPION2) trial investigates the effect of a complex health intervention on neonatal mortality in the Satna District of Madhya Pradesh. Methods/design: The CHAMPION2 trial forms one part of a cluster-randomised controlled trial with villages (clusters) randomised to receive either a health (CHAMPION2) or education (STRIPES2) intervention. Villages receiving the health intervention are controls for the education intervention and vice versa. The primary outcome is neonatal mortality. The effect of the active intervention on the primary outcome (compared to usual care) will be expressed as a risk ratio, estimated using a generalised estimating equation approach with robust standard errors that take account of clustering at village level. Secondary outcomes include maternal mortality, stillbirths, perinatal deaths, causes of death, health care and knowledge, hospital admissions of enrolled women during pregnancy or in the immediate post-natal care period or of their babies (during the neonatal period), maternal blood transfusions, and the cost effectiveness of the intervention. A total of 196 villages have been randomised and over 34,000 women have been recruited in CHAMPION2. Discussion: This update to the published trial protocol gives a detailed plan for the statistical analysis of the CHAMPION2 trial. Trial registration: Registry of India: CTRI/2019/05/019296. Registered on 23 May 2019. https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MzExOTg=&Enc=&userName=champion2.
MeSH term(s)	Humans ; India ; Infant, Newborn ; Infant Mortality ; Health Promotion/methods ; Female ; Randomized Controlled Trials as Topic ; Infant ; Pregnancy ; Data Interpretation, Statistical ; Community Health Services ; Maternal Mortality ; Cost-Benefit Analysis
Language	English
Publishing date	2024-04-25
Publishing country	England
Document type	Journal Article ; Clinical Trial Protocol
ZDB-ID	2040523-6
ISSN	1745-6215 ; 1468-6694 ; 1745-6215
ISSN (online)	1745-6215
ISSN	1468-6694 ; 1745-6215
DOI	10.1186/s13063-024-08056-2
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Article ; Online: Maintenance of Serum Potassium Levels ≥3.6 mEq/L Versus ≥4.5 mEq/L After Isolated Elective Coronary Artery Bypass Grafting and the Incidence of New-Onset Atrial Fibrillation: Pilot and Feasibility Study Results.

Campbell, Niall G / Allen, Elizabeth / Montgomery, Hugh / Aron, Jon / Canter, Ruth R / Dodd, Matthew / Sanders, Julie / Sturgess, Joanna / Elbourne, Diana / O'Brien, Ben

Journal of cardiothoracic and vascular anesthesia

2021 Volume 36, Issue 3, Page(s) 847–854

Abstract: Objective: Serum potassium levels frequently are maintained at high levels (≥4.5 mEq/L) to prevent atrial fibrillation after cardiac surgery (AFACS), with limited evidence. Before undertaking a noninferiority randomized controlled trial to investigate ... ...

Abstract	Objective: Serum potassium levels frequently are maintained at high levels (≥4.5 mEq/L) to prevent atrial fibrillation after cardiac surgery (AFACS), with limited evidence. Before undertaking a noninferiority randomized controlled trial to investigate the noninferiority of maintaining levels ≥3.6 mEq/L compared with this strategy, the authors wanted to assess the feasibility, acceptability, and safety of recruiting for such a trial. Design: Pilot and feasibility study of full trial protocol. Setting: Two university tertiary-care hospitals. Participants: A total of 160 individuals undergoing first-time elective isolated coronary artery bypass grafting. Interventions: Randomization (1:1) to protocols aiming to maintain serum potassium at either ≥3.6 mEq/L or ≥4.5 mEq/L after arrival in the postoperative care facility and for 120 hours or until discharge from the hospital or AFACS occurred, whichever happened first. Measurements and main results: Primary outcomes: (1) whether it was possible to recruit and randomize 160 patients for six months (estimated 20% of those eligible); (2) maintaining supplementation protocol violation rate ≤10% (defined as potassium supplementation being inappropriately administered or withheld according to treatment allocation after a serum potassium measurement); and (3) retaining 28-day follow-up rates ≥90% after surgery. Between August 2017 and April 2018, 723 patients were screened and 160 (22%) were recruited. Potassium protocol violation rate = 9.8%. Follow-up rate at 28 days = 94.3%. Data on planned outcomes for the full trial also were collected. Conclusions: It is feasible to recruit and randomize patients to a study assessing the impact of maintaining serum potassium concentrations at either ≥3.6 mEq/L or ≥4.5 mEq/L on the incidence of AFACS.
MeSH term(s)	Atrial Fibrillation/diagnosis ; Atrial Fibrillation/epidemiology ; Atrial Fibrillation/etiology ; Coronary Artery Bypass/adverse effects ; Feasibility Studies ; Humans ; Incidence ; Postoperative Complications/epidemiology ; Postoperative Complications/prevention & control ; Potassium
Chemical Substances	Potassium (RWP5GA015D)
Language	English
Publishing date	2021-06-24
Publishing country	United States
Document type	Journal Article ; Randomized Controlled Trial
ZDB-ID	1067317-9
ISSN	1532-8422 ; 1053-0770
ISSN (online)	1532-8422
ISSN	1053-0770
DOI	10.1053/j.jvca.2021.06.021
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Article ; Online: Statistical analysis plan for a cluster randomised trial in Madhya Pradesh, India: support to rural India's public education system and impact on numeracy and literacy scores (STRIPES2).

Keddie, Suzanne / Fazzio, Ila / Shivalli, Siddharudha / Magill, Nicholas / Elbourne, Diana / Sharma, Dropti / Shekhawat, Sajjan Singh / Banerji, Rukmini / Karnati, Sridevi / Reddy, Harshavardhan / Eble, Alex / Boone, Peter / Frost, Chris

Trials

2023 Volume 24, Issue 1, Page(s) 469

Abstract: Background: India has made steady progress in improving rates of primary school enrolment but levels of learning achievement remain low. The Support To Rural India's Public Education System (STRIPES) trial provided evidence that an after-school para- ... ...

Abstract	Background: India has made steady progress in improving rates of primary school enrolment but levels of learning achievement remain low. The Support To Rural India's Public Education System (STRIPES) trial provided evidence that an after-school para-teacher intervention improved numeracy and literacy levels in Telangana, India. The STRIPES2 trial investigates whether such an intervention will have a similar effect on the literacy and numeracy of primary school age children in the Satna District of Madhya Pradesh, India. Methods/design: The STRIPES2 trial forms one part of a cluster-randomised controlled trial with villages (clusters) randomised to receive either a health (CHAMPION2) or education (STRIPES2) intervention. Building on the design of the earlier CHAMPION/STRIPES trial, villages receiving the health intervention are controls for the education intervention and vice versa. The primary outcome is a combined literacy and numeracy score. Secondary outcomes include separate scores for literacy and numeracy; caregivers' engagement with child's learning; expenditure on education; enrolment in school; caregiver's report of school attendance and the cost effectiveness of the intervention. Over 7000 primary school age children have been recruited and randomised in STRIPES2. Discussion: This update to the published trial protocol gives a detailed plan for the statistical analysis of the STRIPES 2 trial. Trial registration: Registry of India: CTRI/2019/05/019296. Registered on 23 May 2019. http://www.ctri.nic.in/Clinicaltrials/pdf_generate.php?trialid=31198&EncHid=&modid=&compid=%27,%2731198det%27.
MeSH term(s)	Child ; Humans ; Literacy ; Educational Status ; Schools ; Learning ; India
Language	English
Publishing date	2023-07-22
Publishing country	England
Document type	Randomized Controlled Trial ; Journal Article
ZDB-ID	2040523-6
ISSN	1745-6215 ; 1468-6694 ; 1745-6215
ISSN (online)	1745-6215
ISSN	1468-6694 ; 1745-6215
DOI	10.1186/s13063-023-07453-3
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Article ; Online: Systematic review of the Hawthorne effect: new concepts are needed to study research participation effects.

McCambridge, Jim / Witton, John / Elbourne, Diana R

Journal of clinical epidemiology

2013 Volume 67, Issue 3, Page(s) 267–277

Abstract: Objectives: This study aims to (1) elucidate whether the Hawthorne effect exists, (2) explore under what conditions, and (3) estimate the size of any such effect.: Study design and setting: This systematic review summarizes and evaluates the strength ...

Abstract	Objectives: This study aims to (1) elucidate whether the Hawthorne effect exists, (2) explore under what conditions, and (3) estimate the size of any such effect. Study design and setting: This systematic review summarizes and evaluates the strength of available evidence on the Hawthorne effect. An inclusive definition of any form of research artifact on behavior using this label, and without cointerventions, was adopted. Results: Nineteen purposively designed studies were included, providing quantitative data on the size of the effect in eight randomized controlled trials, five quasiexperimental studies, and six observational evaluations of reporting on one's behavior by answering questions or being directly observed and being aware of being studied. Although all but one study was undertaken within health sciences, study methods, contexts, and findings were highly heterogeneous. Most studies reported some evidence of an effect, although significant biases are judged likely because of the complexity of the evaluation object. Conclusion: Consequences of research participation for behaviors being investigated do exist, although little can be securely known about the conditions under which they operate, their mechanisms of effects, or their magnitudes. New concepts are needed to guide empirical studies.
MeSH term(s)	Behavior ; Human Experimentation ; Humans ; Randomized Controlled Trials as Topic/psychology ; Research Design ; Research Subjects/psychology
Language	English
Publishing date	2013-11-22
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Review ; Systematic Review
ZDB-ID	639306-8
ISSN	1878-5921 ; 0895-4356
ISSN (online)	1878-5921
ISSN	0895-4356
DOI	10.1016/j.jclinepi.2013.08.015
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Article ; Online: Patient and public involvement prior to trial initiation: lessons learnt for rapid partnership in the COVID-19 era.

Jamal, Zahra / Perkins, Alexander / Allen, Christopher / Evans, Richard / Sturgess, Joanna / Snowdon, Claire / Clayton, Tim / Elbourne, Diana

Research involvement and engagement

2021 Volume 7, Issue 1, Page(s) 13

Abstract: Patient and Public Involvement (PPI) describes the active involvement of patients and the public in the research process. Through PPI, patients and members of the public are increasingly involved in the design and conduct of clinical trials. PPI has been ...

Abstract	Patient and Public Involvement (PPI) describes the active involvement of patients and the public in the research process. Through PPI, patients and members of the public are increasingly involved in the design and conduct of clinical trials. PPI has been shown to improve the quality and relevance of research. During the COVID-19 pandemic, clinical trials have been playing a vital role in helping us find ways to prevent and treat the infection and improve our understanding of the virus. It is important that patients and the public are actively involved in deciding how COVID-19 research is carried out. Unfortunately, Research Ethics Committees in the UK have seen far less PPI for COVID-19 research studies compared with research before the pandemic. A key reason for this is that research is being designed much faster than normal and researchers may feel they do not have time to properly involve patients and the public. In this paper, we share our experiences of PPI for a COVID-19 clinical trial. We show that it is possible to rapidly involve patients and the public in COVID-19 clinical trials. We also explain how the design of the clinical trial was changed in response to feedback from public contributors. Lastly, we discuss the wider learning from this process which might be useful for researchers planning PPI activities for COVID-19 clinical trials in the future. Background: Clinical trials are playing a critical role in the global public health response to the COVID-19 pandemic. Despite the increasing recognition of the value of PPI in clinical trials, just 22% of the COVID-19 research proposals reviewed by Research Ethics Committees in the UK at the start of the pandemic reported PPI. There is a perception that PPI might result in delays in delivering research and therefore delays in obtaining important results. In this paper, we report our experience of rapid PPI for a COVID-19 clinical trial. Methods: RAPID-19 is a COVID-19 clinical trial which was planned to be submitted for fast-track ethics review in the United Kingdom. During the development of the trial protocol, the PPI Panel at the London School of Hygiene & Tropical Medicine Clinical Trials Unit was involved in the design of the study. The meeting with the PPI Panel lasted just over 1 h and was conducted by teleconference. Results: Although we only had a short period of time to explore the study with the PPI Panel, we were able to gain valuable insight into how the trial would be perceived by potential trial participants. Substantive changes were made to the trial to improve the acceptability of the research without compromising the study timelines. Having access to public contributors with relevant lived experience is an important resource for a Clinical Trials Unit and is critical for rapid PPI. The move to remote working due to lockdown required virtual discussions which helped to overcome some of the barriers to organising face-to-face meetings at short notice. Conclusions: PPI for clinical trials can be conducted in a time-efficient manner within the pressured environment of a pandemic. Involving PPI contributors at an early stage in protocol development maximised the opportunity to shape and influence the trial as well as limited potential delays which could occur if changes to the protocol had to be made at a later stage.
Language	English
Publishing date	2021-03-08
Publishing country	England
Document type	Journal Article
ZDB-ID	2834246-X
ISSN	2056-7529 ; 2056-7529
ISSN (online)	2056-7529
ISSN	2056-7529
DOI	10.1186/s40900-021-00250-9
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Article ; Online: Teacher Burnout and Contextual and Compositional Elements of School Environment.

Shackleton, Nichola / Bonell, Chris / Jamal, Farah / Allen, Elizabeth / Mathiot, Anne / Elbourne, Diana / Viner, Russell

The Journal of school health

2019 Volume 89, Issue 12, Page(s) 977–993

Abstract: Background: Teachers report higher levels of stress than most occupational groups. Burnout is a specific psychological condition that results from chronic job stress characterized by emotional exhaustion, low personal accomplishment, and ... ...

Abstract	Background: Teachers report higher levels of stress than most occupational groups. Burnout is a specific psychological condition that results from chronic job stress characterized by emotional exhaustion, low personal accomplishment, and depersonalization. This study considers associations between aspects of the school environment and teacher burnout. Methods: Exploratory analysis of baseline data from a cluster randomized controlled trial of 40 schools and 2278 teachers in the United Kingdom. Multilevel methods were used to consider the associations between different compositional and contextual aspects of the school environment and teacher burnout. Results: There was evidence for school effects on teacher burnout, evidenced by ICCs and likelihood ratio tests, supporting the association between school environment and teacher burnout. The factors most consistently associated with teacher burnout in our study were teachers' perceptions of the school's safety and support and student attitudes to learning. Conclusions: The school environment does influence teacher burnout. More research is needed to develop and test causal pathways between the school environment and teacher burnout, and to understand ecological and individual predictors of teacher burnout and the interaction between the two.
MeSH term(s)	Burnout, Professional/diagnosis ; Burnout, Professional/etiology ; Female ; Humans ; Male ; School Teachers/psychology ; Schools ; Stress, Psychological ; Surveys and Questionnaires ; United Kingdom
Language	English
Publishing date	2019-11-01
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	952835-0
ISSN	1746-1561 ; 0022-4391
ISSN (online)	1746-1561
ISSN	0022-4391
DOI	10.1111/josh.12839
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