Evidence map›Paper›PMID 23311722›Full record

Trial reportTrials2013

Process evaluations for cluster-randomised trials of complex interventions: a proposed framework for design and reporting.

Aileen Grant, Shaun Treweek, Tobias Dreischulte, Robbie Foy, Bruce Guthrie

5 registry-linked trialsOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 5 registered trials, which are not on this map. Cited by 314 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
314citing papers in PubMed, 9 pooled it
55.2field-weighted citation impact, top 1% 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.

NCT01425502 nacompletednot on this map

Data-driven Quality Improvement in Primary Care: Cluster Randomised Controlled Trial to Test the Effectiveness of a Multifaceted Intervention in Reducing High Risk Prescribing of Non-steroidal Anti-inflammatory Drugs and Antiplatelet Agents

TypeinterventionalSponsorUniversity of DundeeRan2012 to 2014Enrolled33ConditionsDrug SafetyArmsDQIP Intervention
NCT05466955 naactive not recruitingnot on this mapstarted 2024, after this paper: background citation

Slashing Two-wheeled Accidents by Leveraging Eyecare: a Stepped-wedge Cluster Randomised Controlled Trial to Assess Impact of Spectacles on Reducing Crash and Near-crash Events Among Myopic Motorcycle Drivers in Ho Chi Minh City Vietnam

TypeinterventionalSponsorQueen's University, BelfastRan2024 to 2027Enrolled158ConditionsMyopiaArmsFree eye glasses for un or under-corrected myopia
NCT05920499 nanot yet recruitingnot on this mapstarted 2025, after this paper: background citation

The Effect of AUDIT and Feedback on Pneumococcal Vaccination Coverage in Adults At Risk in General Practice: a Cluster Randomized Trial

TypeinterventionalSponsorBert VaesRan2025 to 2026Enrolled36ConditionsPneumococcal InfectionsArmsAUDIT and Feedback
NCT06014294 naunknown statusnot on this mapstarted 2023, after this paper: background citation

Effects of High-Intensity Interval Training on Depressive Symptoms in Hong Kong Older Adults With Mild and Moderate Depression: A Cluster-Randomized Controlled Trial

TypeinterventionalSponsorHong Kong Baptist UniversityRan2023 to 2024Enrolled144ConditionsDepressive SymptomsArmsHIIT, Baduanjin, Workshop
NCT06888544 narecruitingnot on this mapstarted 2024, after this paper: background citation

Effects of High-Intensity Interval Training on Bone Health, Physical Fitness and Quality of Life in Elderly Women With Osteopenia: A Pilot Randomized Controlled Trial

TypeinterventionalSponsorHong Kong Baptist UniversityRan2024 to 2026Enrolled48ConditionsOsteopeniaArmsHIIT program for 24 weeks with a frequency of 2 times per week., Non-exercise control
3 · Its place in the literature

Who cites it

314 citing papers in PubMed, 9 syntheses or guidelines pooled it, 582 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Pay for performance for hospitals.The Cochrane database of systematic reviews · 2019
    Pooled it
  9. Childhood Obesity Prevention in Africa: A Systematic Review of Intervention Effectiveness and Implementation.International journal of environmental research and public health · 2019
    Pooled it
  10. Trial
  11. Trial
  12. Trial
  13. Trial
  14. Trial
  15. Trial
  16. Trial
  17. Trial
  18. Trial
  19. Trial
  20. Trial

254 more citing papers are in PubMed but not listed here.

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

5 authors at 3 institutions in 2 countries.

Aileen GrantQuality, Safety and Informatics Research Group, Population Health Sciences, Medical Research Institute, University of Dundee, Mackenzie Building, Dundee DD2 4BF, UK. a.m.grant@dundee.ac.uk
Shaun Treweek
Tobias Dreischulte
Robbie Foy
Bruce Guthrie
University of Dundee · GBQuality Research · USUniversity of Leeds · GB

Funding

Chief Scientist Office ARPG/07/02Chief Scientist Office HSRU1
6 · The paper itself

Abstract

backgroundProcess evaluations are recommended to open the 'black box' of complex interventions evaluated in trials, but there is limited guidance to help researchers design process evaluations. Much current literature on process evaluations of complex interventions focuses on qualitative methods, with less attention paid to quantitative methods. This discrepancy led us to develop our own framework for designing process evaluations of cluster-randomised controlled trials.

methodsWe reviewed recent theoretical and methodological literature and selected published process evaluations; these publications identified a need for structure to help design process evaluations. We drew upon this literature to develop a framework through iterative exchanges, and tested this against published evaluations.

resultsThe developed framework presents a range of candidate approaches to understanding trial delivery, intervention implementation and the responses of targeted participants. We believe this framework will be useful to others designing process evaluations of complex intervention trials. We also propose key information that process evaluations could report to facilitate their identification and enhance their usefulness.

conclusionThere is no single best way to design and carry out a process evaluation. Researchers will be faced with choices about what questions to focus on and which methods to use. The most appropriate design depends on the purpose of the process evaluation; the framework aims to help researchers make explicit their choices of research questions and methods.

trial registrationClinicaltrials.gov NCT01425502.

Indexed as

Evidence-Based MedicineInformation DisseminationOutcome and Process Assessment, Health CareResearch DesignHumansPractice Guidelines as TopicQualitative ResearchTreatment Outcome

Identifiers

PMID23311722
PMCPMC3600672
OpenAlexW2128920447

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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 Socratic graph.