South African Principal Investigators' perspectives on reducing publication bias of randomized controlled trials
1
Cochrane South Africa, South African Medical Research Council, Cape Town, South Africa
2
Faculty of Medicine and Health Sciences, Stellenbosch University, Stellenbosch, South Africa
3
Health Systems Research Unit, South African Medical Research Council, Cape Town, South Africa
4
Northern Ireland Methodology Hub, Centre for Public Health, Queen’s University Belfast, Belfast, United Kingdom
Popul. Med. 2026;8(Supplement Supplement 1):
ABSTRACT
ABSTRACT:
Non-publication and incomplete reporting of randomised controlled trials (RCTs) are known to harm the evidence ecosystem, such as the synthesis and health decision-making that stem from not having access to RCT findings. We explored principal investigators' views on a consolidated standard of reporting trials (CONSORT) based web writing aid (COBWEB) as an aid to support timely, completed RCT reporting and reduce publication bias (1,2).
METHODS:
Recruitment used purposive and snowball sampling. Two online focus group discussions(FGDs) were conducted with 12 South African PIs of published RCTs. The groups received a COBWEB demonstration, provided feedback, including anticipated implications of adopting COBWEB and incorporated their experiences using CONSORT. Furthermore, they discussed publication bias and shared other means to mitigate publication bias. We performed a thematic analysis using a deductive scaffolding based on the evidence-to-decision domains (3), i.e. values, equity, acceptability and feasibility, with independent coding and consensus.
RESULTS:
PIs strongly agree that it is an ethical duty towards RCT participants to publish, as this benefits the wider evidence ecosystem. Introducing COBWEB at the planning stage of an RCT will reduce cognitive load, improve the report's structure and clarity, thus improving chances of being accepted by peer reviewers. Equity considerations dominated. PIs anticipated greater benefits for authors at historically disadvantaged institutions and non-primary English speakers. Acceptability was seen as being supportive if, but it reduced narrative flexibility and was seen as an added burden if introduced late. Feasibility suggestions included early intervention in the RCT lifecycle and brief training in its use.
CONCLUSIONS:
South African PIs viewed the CONSORT-based aid as a promising approach to strengthening completeness and timeliness of RCT reporting, with potential equity gains if implemented with proportionate support. These mixed-methodsimplemnetation evaluatations should test the impact on reporting quality and non-publication.
Non-publication and incomplete reporting of randomised controlled trials (RCTs) are known to harm the evidence ecosystem, such as the synthesis and health decision-making that stem from not having access to RCT findings. We explored principal investigators' views on a consolidated standard of reporting trials (CONSORT) based web writing aid (COBWEB) as an aid to support timely, completed RCT reporting and reduce publication bias (1,2).
METHODS:
Recruitment used purposive and snowball sampling. Two online focus group discussions(FGDs) were conducted with 12 South African PIs of published RCTs. The groups received a COBWEB demonstration, provided feedback, including anticipated implications of adopting COBWEB and incorporated their experiences using CONSORT. Furthermore, they discussed publication bias and shared other means to mitigate publication bias. We performed a thematic analysis using a deductive scaffolding based on the evidence-to-decision domains (3), i.e. values, equity, acceptability and feasibility, with independent coding and consensus.
RESULTS:
PIs strongly agree that it is an ethical duty towards RCT participants to publish, as this benefits the wider evidence ecosystem. Introducing COBWEB at the planning stage of an RCT will reduce cognitive load, improve the report's structure and clarity, thus improving chances of being accepted by peer reviewers. Equity considerations dominated. PIs anticipated greater benefits for authors at historically disadvantaged institutions and non-primary English speakers. Acceptability was seen as being supportive if, but it reduced narrative flexibility and was seen as an added burden if introduced late. Feasibility suggestions included early intervention in the RCT lifecycle and brief training in its use.
CONCLUSIONS:
South African PIs viewed the CONSORT-based aid as a promising approach to strengthening completeness and timeliness of RCT reporting, with potential equity gains if implemented with proportionate support. These mixed-methodsimplemnetation evaluatations should test the impact on reporting quality and non-publication.
| eISSN: | 2654-1459 |
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