Evaluating alternative approaches to packaging evidence and exploring the influence of context in guideline development in Kenya
ISRCTN | ISRCTN05154264 |
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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
Scientific
KEMRI/Wellcome Trust Research Programme
P.O. Box 43640-00100, GPO
Nairobi
00100
Kenya
Phone | +254 (0)20 271 0672 / 272 0163 |
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nopiyo@nairobi.kemri-wellcome.org |
Study information
Study design | Randomised controlled trial and a descriptive case study |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Other |
Study type | Quality of life |
Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/05/2010 |
Completion date | 30/09/2010 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 36-40 technical experts, practitioners and policy makers |
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
00100
Kenya
Sponsor information
The Wellcome Trust (UK)
Charity
Charity
Wellcome Trust, Gibbs Building, 215 Euston Road
London
NW1 2BE
United Kingdom
Phone | +44 (0)20 7611 8888 |
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contact@wellcome.ac.uk | |
Website | http://www.wellcome.ac.uk/ |
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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 01/02/2013 | Yes | No |