Table 4

Interview themes and relevance to risk of bias
Category Theme Relevance to risk of bias
Barriers
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
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.

Hamm et al.

Hamm et al. BMC Medical Research Methodology 2012 12:158   doi:10.1186/1471-2288-12-158

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