Condition category
Not Applicable
Date applied
01/03/2011
Date assigned
16/03/2011
Last edited
22/03/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Opiyo Newton

ORCID ID

Contact details

KEMRI/Wellcome Trust Research Programme
P.O. Box 43640-00100
GPO
Nairobi
00100
Kenya
+254 (0)20 271 0672 / 272 0163
nopiyo@nairobi.kemri-wellcome.org

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

SSC Protocol No. 1770 (Revised)

Study information

Scientific title

Evaluating approaches to packaging evidence and exploring the influence of context in the process of developing evidence-informed guidelines for newborn care in rural hospitals in Kenya

Acronym

Study hypothesis

Study 1 (randomised controlled trial) tests the null hypothesis that presenting research evidence using graded-entry summaries is not useful to those involved in national guideline development.

Study 2 (descriptive case study) involves description of deliberative processes involved in guideline development – statement of a null hypothesis is consequently inappropriate.

Ethics approval

Ethics approval received from the Kenya Medical Research Institute National Ethical Review Committee on the 2nd March 2010 [ref. SSC Protocol No 1770 (Revised)].

Study design

Randomised controlled trial and a descriptive case study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Child health: evidence-informed guidelines

Intervention

Study 1. Randomised controlled trial

Participants will be randomly allocated to receive the following ‘graded-entry’ evidence summary formats.

A = Technical reviews + Systematic reviews (TR+SR)
B = Technical reviews + Systematic reviews + GRADE Summary of Findings table (TR+SR+SoF)
C = Technical reviews + Systematic reviews + Locally prepared mini-reviews with ‘user- friendly front-ends’ (e.g. GRADE Summary of Findings table or SUPPORT-type summaries) placed under the abstract (TR+SR+MR+SoF)

The different evidence summary formats will be provided to participants as pre-reading materials one month before the national guideline development workshop.

Study 2. Descriptive case study

The usefulness of the ‘linkage-exchange’ forum will be explored by conducting follow-up interviews with a sub-sample of the experts representing the spectrum of interest groups to, among other reasons, generate information on the opinions that shape stakeholder views on research evidence among different audiences for the guidelines.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Study 1. Randomised controlled trial

We will measure the impact of graded-entry evidence packs on participants’ understanding of key messages resulting from the evidence (tracer topic) summaries e.g. issues around persistent dilemmas on the timing (‘early’ or ‘delayed’) and rate of advancement (‘rapid’ or ‘slow’) of feeding volumes in prematurely born sick infants.

Study 2. Descriptive case study

Data collection will focus on documenting processes involved in knowledge exchange and in the application of GRADE grid in guideline development. Emerging themes following the application of GRADE grid will be presented to all the participants for further discussions to promote consensus on draft essential newborn care (ENC) recommendations.

Secondary outcome measures

We will measure the impact of graded-entry evidence packs on participants’ rating of their experience / satisfaction with the use of provided evidence packs.

Rating will be done using a 5-point Likert scale tool (used successfully in previous studies measuring 3 domains of their experience: usability (ease of use as indicated by average time spent looking for information), practical value (e.g. in tailoring research evidence) and barriers to use of evidence pack (accessibility).

Overall trial start date

01/05/2010

Overall trial end date

30/09/2010

Reason abandoned

Eligibility

Participant inclusion criteria

Participants will consist of a purposive sample of technical experts, practitioners and policy makers gathered to develop consensus guidelines during a planned 1 week neonatal stakeholder workshop.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

36-40 technical experts, practitioners and policy makers

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/05/2010

Recruitment end date

30/09/2010

Locations

Countries of recruitment

Kenya

Trial participating centre

KEMRI/Wellcome Trust Research Programme
Nairobi
00100
Kenya

Sponsor information

Organisation

The Wellcome Trust (UK)

Sponsor details

Wellcome Trust
Gibbs Building
215 Euston Road
London
NW1 2BE
United Kingdom
+44 (0)20 7611 8888
contact@wellcome.ac.uk

Sponsor type

Charity

Website

http://www.wellcome.ac.uk/

Funders

Funder type

Charity

Funder name

The Wellcome Trust (UK) (grant ref: 084538)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23372813

Publication citations

  1. Results

    Opiyo N, Shepperd S, Musila N, Allen E, Nyamai R, Fretheim A, English M, Comparison of alternative evidence summary and presentation formats in clinical guideline development: a mixed-method study., PLoS ONE, 2013, 8, 1, e55067, doi: 10.1371/journal.pone.0055067.

Additional files

Editorial Notes