Evaluating alternative approaches to packaging evidence and exploring the influence of context in guideline development in Kenya

ISRCTN ISRCTN05154264
DOI https://doi.org/10.1186/ISRCTN05154264
Secondary identifying numbers SSC Protocol No. 1770 (Revised)
Submission date
01/03/2011
Registration date
16/03/2011
Last edited
22/03/2013
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Opiyo Newton
Scientific

KEMRI/Wellcome Trust Research Programme
P.O. Box 43640-00100, GPO
Nairobi
00100
Kenya

Phone +254 (0)20 271 0672 / 272 0163
Email nopiyo@nairobi.kemri-wellcome.org

Study information

Study designRandomised controlled trial and a descriptive case study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleEvaluating 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
Study objectivesStudy 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(s)Ethics approval received from the Kenya Medical Research Institute National Ethical Review Committee on the 2nd March 2010 [ref. SSC Protocol No 1770 (Revised)].
Health condition(s) or problem(s) studiedChild health: evidence-informed guidelines
InterventionStudy 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 typeOther
Primary outcome measureStudy 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 measuresWe 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 study start date01/05/2010
Completion date30/09/2010

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants36-40 technical experts, practitioners and policy makers
Key inclusion criteriaParticipants 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.
Key exclusion criteriaDoes not meet inclusion criteria
Date of first enrolment01/05/2010
Date of final enrolment30/09/2010

Locations

Countries of recruitment

  • Kenya

Study participating centre

KEMRI/Wellcome Trust Research Programme
Nairobi
00100
Kenya

Sponsor information

The Wellcome Trust (UK)
Charity

Wellcome Trust, Gibbs Building, 215 Euston Road
London
NW1 2BE
United Kingdom

Phone +44 (0)20 7611 8888
Email contact@wellcome.ac.uk
Website http://www.wellcome.ac.uk/
ROR logo "ROR" https://ror.org/029chgv08

Funders

Funder type

Charity

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/02/2013 Yes No