Evidence map›Paper›PMID 35688484›Full record

ArticleBMJ global health2022

Strengthening causal inference from randomised controlled trials of complex interventions.

Jef L Leroy, Edward A Frongillo, Bezawit E Kase, Silvia Alonso, Mario Chen, Ian Dohoo, Lieven Huybregts, Suneetha Kadiyala, Naomi M Saville

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ global health, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 4 pooled it
11.5field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 4 syntheses or guidelines pooled it, 44 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 7 institutions in 4 countries.

Jef L Leroy *Poverty, Health, and Nutrition Division, International Food Policy Research Institute, Washington, District of Columbia, USA j.leroy@cgiar.org.ORCID 0000-0001-9371-3832
Edward A Frongillo *Department of Health Promotion, Education, and Behavior, University of South Carolina, Columbia, South Carolina, USA.ORCID 0000-0002-8265-9815
Bezawit E KaseDepartment of Health Promotion, Education, and Behavior, University of South Carolina, Columbia, South Carolina, USA.
Silvia AlonsoAnimal and Human Health Porgram, International Livestock Research Institute, Nairobi, Kenya.
Mario ChenBiostatistics and Data Sciences, FHI 360, Durham, North Carolina, USA.
Ian DohooHealth Management, University of Prince Edward Island, Charlottetown, Prince Edward Island, Canada.
Lieven HuybregtsPoverty, Health, and Nutrition Division, International Food Policy Research Institute, Washington, District of Columbia, USA.
Suneetha KadiyalaThe London School of Hygiene & Tropical Medicine, London, UK.
Naomi M SavilleInstitute for Global Health, University College London, London, UK.
International Food Policy Research Institute · USUniversity of South Carolina · USFamily Health International 360 · USInternational Livestock Research Institute · KELondon School of Hygiene & Tropical Medicine · GBUniversity College London · GBUniversity of Prince Edward Island · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Researchers conducting randomised controlled trials (RCTs) of complex interventions face design and analytical challenges that are not fully addressed in existing guidelines. Further guidance is needed to help ensure that these trials of complex interventions are conducted to the highest scientific standards while maximising the evidence that can be extracted from each trial. The key challenge is how to manage the multiplicity of outcomes required for the trial while minimising false positive and false negative findings. To address this challenge, we formulate three principles to conduct RCTs: (1) outcomes chosen should be driven by the intent and programme theory of the intervention and should thus be linked to testable hypotheses; (2) outcomes should be adequately powered and (3) researchers must be explicit and fully transparent about all outcomes and hypotheses before the trial is started and when the results are reported. Multiplicity in trials of complex interventions should be managed through careful planning and interpretation rather than through post hoc analytical adjustment. For trials of complex interventions, the distinction between primary and secondary outcomes as defined in current guidelines does not adequately protect against false positive and negative findings. Primary outcomes should be defined as outcomes that are relevant based on the intervention intent and programme theory, declared (ie, registered), and adequately powered. The possibility of confirmatory causal inference is limited to these outcomes. All other outcomes (either undeclared and/or inadequately powered) are secondary and inference relative to these outcomes will be exploratory.

Indexed as

Randomized Controlled Trials as TopicHumansintervention studyrandomised control trial

Identifiers

PMID35688484
PMCPMC9189821
OpenAlexW4281748809

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.