Evidence map›Paper›PMID 31164158›Full record

ArticleTrials2019

The CHESS trial: protocol for the process evaluation of a randomised trial of an education and self-management intervention for people with chronic headache.

Vivien P Nichols, David R Ellard, Frances E Griffiths, Martin Underwood, Stephanie J C Taylor, Shilpa Patel, CHESS team

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.7field-weighted citation impact, top 31% 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

4 citing papers in PubMed, 14 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Article
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

7 authors at 2 institutions in 1 country.

Vivien P NicholsWarwick Clinical Trials Unit, Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, CV4 7AL, UK.
David R EllardWarwick Clinical Trials Unit, Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, CV4 7AL, UK. d.r.ellard@warwick.ac.uk.ORCID http://orcid.org/0000-0002-2992-048X
Frances E GriffithsDivision of Health Sciences, Warwick Medical School, University of Warwick, Coventry, CV4 7AL, UK.
Martin UnderwoodWarwick Clinical Trials Unit, Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, CV4 7AL, UK.
Stephanie J C TaylorComplex Intervention and Social Practice in Health Care unit, Centre for Primary Care and Public Health, Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, E1 2AB, UK.
Shilpa PatelWarwick Clinical Trials Unit, Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, CV4 7AL, UK.
CHESS team
University of Warwick · GBQueen Mary University of London · GB

Funding

Department of Health RP-PG-1212-20018Programme Grants for Applied Research RP-PG-1212-20018
6 · The paper itself

Abstract

backgroundProcess evaluation is increasingly common alongside complex randomised controlled trials (RCTs). This evaluation helps in understanding the mechanisms of impact and how the study processes were executed, and it includes any contextual factors which may have implications for the trial results and any future implementation. This process evaluation is for the Chronic Headache Education and Self-management Study (CHESS) RCT, which is evaluating an education and self-management group behavioural intervention for people with chronic headache. Chronic headache is defined as headaches which are present for 15 or more days per month. The most common types are chronic migraine and chronic tension type and medication overuse headaches.

methodsWe will use a mixed methods approach. Quantitative data will be taken from routine trial data which will help us to assess the reach of the study; i.e. did we reach those whom we expected and from where? Intervention attendance (dose received) and attrition and qualitative data will augment our understanding about reasons why people may not wish to take part in or failed to attend sessions. Interviews with intervention facilitators and trial participants will gain different perspectives on taking part in the trial. Fidelity will be assessed through listening to audio recordings for adherence to course content and competence of the facilitation of a sample of sessions. DISCUSSION: Our process evaluation will allow us to gain insight into how the trial was delivered, the obstacles and enablers encountered and the possible reasons why the interventions may or may not be effective.

trial registrationISRCTN79708100 . Registered on 16 December 2015.

Indexed as

Patient Education as TopicProcess Assessment, Health CareSelf-ManagementEnglandHeadache DisordersHealth BehaviorHealth Knowledge, Attitudes, PracticeHumansRandomized Controlled Trials as TopicTime FactorsTreatment OutcomeChronic headacheChronic migraineChronic tension type headache and medication overuse headacheProcess evaluationSelf-management

Identifiers

PMID31164158
PMCPMC6549347
OpenAlexW2948037583

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.