Evidence map›Paper›PMID 33316128›Full record

ArticleHealth expectations : an international journal of public participation in health care and health policy2021

Stakeholder involvement in the development of trial material for a clinical trial.

Jacqueline Rix, Jonathan Branney, Alexander C Breen, Philip Sewell, Sharon Docherty

Open access · goldAbstract read
In one paragraph

Article in Health expectations : an international journal of public participation in health care and health policy, 2021. 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
0.5field-weighted citation impact, top 26% 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, 4 citations in OpenAlex.

  1. A public and patient consultation process as an aid to design a person-centred randomized clinical trial.Health expectations : an international journal of public participation in health care and health policy · 2021
    Trial
  2. Article
  3. Article
  4. Stakeholder involvement in the development of trial material for a clinical trial.Health expectations : an international journal of public participation in health care and health policy · 2021
    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

5 authors at 2 institutions in 1 country.

Jacqueline RixDepartment of Design and Engineering, Faculty of Science and Technology, Bournemouth University, Poole, UK.ORCID 0000-0002-7442-4565
Jonathan BranneyDepartment of Nursing Science, Faculty of Health and Social Science, Bournemouth University, Poole, UK.ORCID 0000-0003-2102-8435
Alexander C BreenCentre for Biomechanics Research, AECC University College, Bournemouth, UK.ORCID 0000-0001-9983-5363
Philip SewellDepartment of Design and Engineering, Faculty of Science and Technology, Bournemouth University, Poole, UK.ORCID 0000-0003-3260-6931
Sharon DochertyDepartment of Medical Science & Public Health, Faculty of Health & Social Sciences, Bournemouth University, Poole, UK.ORCID 0000-0003-3209-1560
Bournemouth University · GBHealth Sciences University · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundStakeholder involvement includes not just patients and public, but also those delivering treatment for example clinicians and students. Each stakeholder brings unique experiences to the process. The aim of this stakeholder exercise was to explore readability and understanding of the trial material for the future trial to be conducted by the authors: Biomechanical Effects of Manual Therapy-A Feasibility Study.

designVolunteers from identified stakeholder groups were provided with trial material which included the information sheet, consent form, questionnaires and home management booklet. They provided feedback on content (readability, understanding) and style (font, layout). An additional document was provided with genres of pictures to choose the most appropriate style to be used in the booklet. Readability formulas were used to calculate reading age before and after feedback to objectively measure ease of reading.

resultsThe public group provided a layperson's perspective to clarify the information sheet for patients, whereas practitioner and intern groups indicated where information could be clarified. The reading age of all documentation decreased following feedback; however, templated sections of the documentation did not. The majority (87%) of volunteers chose coloured classic cartoons for the booklet.

conclusionThis process highlighted the importance of involving different stakeholder groups in the development of research materials as each group made a unique contribution. Readability and understanding of the trial material were improved, feeding back into the consent process contributing towards fully informed consent. PATIENT OR PUBLIC CONTRIBUTION: Public helped develop materials for a future trial but not with manuscript preparation.

Indexed as

Consent FormsInformed ConsentComprehensionHumansclinical trialinformed consentPatient and Public InvolvementResearch CollaborationStakeholder Involvement

Identifiers

PMID33316128
PMCPMC8077147
OpenAlexW3112801242

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.