Introduction:
A core outcome set (COS) is a minimal list of consensus outcomes that should be used in all intervention research in a specific domain. COS enhance the ability to undertake meaningful comparisons and to understand the benefits or harms of different treatments. A first step
in developing a COS is to identify outcomes that have been used previously. We did this global systematic review to provide the foundation for development of a region-specific COS for snakebite envenomation.
Methods:
We searched 15 electronic databases, eight trial registries, and reference lists of included studies to identify reports of relevant trials, protocols, registry records and systematic reviews. We extracted verbatim data on outcomes, their definitions, measures, and timepoints. Outcomes were classified as per an existing outcome taxonomy, and we identified unique outcomes based on similarities in the definition and measurement of the verbatim outcomes.
Results:
We included 107 records for 97 studies which met our inclusion criteria. These reported 538 outcomes, with a wide variety of outcome measures, definitions, and time points for measurement. We consolidated these into 88 unique outcomes, which we classified into
core areas of mortality (1, 1.14 %), life impact (6, 6.82%), resource use (15, 17.05%), adverse events (7, 7.95%), physiological/clinical (51, 57.95%), and composite (8, 9.09%) outcomes. The types of outcomes varied by the type of intervention, and by geographic region. Only 15 of the 97 trials (17.04%) listed Patient Related Outcome Measures (PROMS).
Conclusion:
Trials evaluating interventions for snakebite demonstrate heterogeneity on outcomes and often omit important information related to outcome measurement (definitions, instruments, and time points). Developing high quality, region-specific COS for snakebite could inform the design of future trials and improve outcome reporting. Measurement of PROMS, resource use and life impact outcomes in trials on snakebite remains a gap.
The objective of this study is to identify what outcomes have been used in intervention research on snakebite through a global systematic review of outcomes. This conduct of a robust and comprehensive systematic review of outcomes is an essential first step in the development of a COS.
ContributorsSoumyadeep Bhaumik, Deepti Beri, Jyoti Tyagi, Mike Clarke, Sanjib Kumar Sharma, Paula R Williamson, Jagnoor Jagnoor
Disease Category: Other
Disease Name: Snakebite
Age Range: Unknown
Sex: Either
Nature of Intervention: Any
- Systematic review of outcomes measured in trials
- Systematic review
We searched 15 electronic databases (PubMed, EMBASE, CINAHL, Cochrane Database of Systematic Reviews, ACP Journal Club, Database of Abstracts of Reviews of Effects, Cochrane Clinical Answers, Cochrane Central Register of Controlled Trials, Cochrane Methodology Register, Health Technology Assessment, NHS Economic Evaluation
Database, Campbell Library, Epistemonikos, Scielo and Open dissertations) on 29th October 2021, with no language restrictions.
We hand-searched nine trial registries (Australia New Zealand Trial Clinical Registry, Brazilian Clinical Trials Registry, Clinical Trial Registry of India, US trial registry (clinicaltrials.gov), Iranian Registry of Clinical Trials, Thai Clinical Trials Registry, Peruvian Clinical Trial Registry, Sri Lanka Clinical Trials Registry, and WHO International Clinical Trial
Registry Platform) in November 2021. We also screened the reference lists of included studies and contacted snakebite experts to identify additional eligible studies.