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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23372813
Publication citations
-
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.