Category | Theme | Relevance to risk of bias |
---|---|---|
Barriers | Â | Â |
Individual | Knowledge | - Little formal training in research methods, therefore bias is likely due to a lack of knowledge of how it is introduced. |
Institutional | Clinical care vs. clinical research | - Decisions made clinically rather than per the trial design can lead to protocol deviations, e.g. interference with randomization sequence. |
Culture | - Research is often viewed negatively in the clinical setting, leading to little value placed on following the trial protocol when it deviates from usual care. | |
Logistics | - Demands on time and space can put research at a low priority and tasks may not be done according to protocol, e.g. ensuring safeguards are in place to maintain blinding. | |
Policy | Administration | - Budget constraints can limit hiring external methodological expertise if necessary; ethics requirements for methodology are inconsistent, leaving protocols subject to change. |
 | Pediatric-specific challenges | - Blinding parents; investigators are less willing to inconvenience families with strict protocols; fewer trials has meant less competition for developing the best methodology. |
Facilitators | Â | Â |
Individual | Ownership | - The trial will be more successful when the investigators take responsibility for generating support and ensuring rigor. |
Institutional | Acceptance | - Researcher understanding of the clinical setting facilitates the acceptance of research methods by the practitioners. |
Cohesive study team | - Consulting experienced trialists and methodologists contributes to a more rigorous and well thought out study, in terms of both validity and feasibility. | |
Infrastructure | - Protected research time and dedicated research staff facilitate trial design and conduct. | |
 | Verification | - Checks on the science facilitate high quality, e.g., reliable review processes and guidance from trusted third parties. |