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
Protocol serial number	SSC Protocol No. 1770 (Revised)
Sponsor	The Wellcome Trust (UK)
Funder	The Wellcome Trust (UK) (grant ref: 084538)

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

Primary study design	Interventional
Study design	Randomised controlled trial and a descriptive case study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study objectives	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(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) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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).
Completion date	30/09/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	40
Key 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.
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/05/2010
Date of final enrolment	30/09/2010

Locations

Countries of recruitment

Kenya

Study participating centre

KEMRI/Wellcome Trust Research Programme

Nairobi
00100
Kenya

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not 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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes