How novice, skilled and advanced clinical researchers include variables in a case report form for clinical research: a qualitative study

Abstract

ObjectivesDespite varying degrees in research training, most academic clinicians are expected to conduct clinical research. The objective of this research was to understand how clinical researchers of different skill levels include variables in a case report form for their clinical research.SettingThe setting for this research was a major academic institution in Beijing, China.ParticipantsThe target population was clinical researchers with three levels of experience, namely, limited clinical research experience, clinicians with rich clinical research experience and clinical research experts.MethodsUsing a qualitative approach, we conducted 13 individual interviews (face to face) and one group interview (n=4) with clinical researchers from June to September 2016. Based on maximum variation sampling to identify researchers with three levels of research experience: eight clinicians with limited clinical research experience, five clinicians with rich clinical research experience and four clinical research experts. These 17 researchers had diverse hospital-based medical specialties and or specialisation in clinical research.ResultsOur analysis yields a typology of three processes developing a case report form that varies according to research experience level. Novice clinician researchers often have an incomplete protocol or none at all, and conduct data collection and publication based on a general framework. Experienced clinician researchers include variables in the case report form based on previous experience with attention to including domains or items at risk for omission and by eliminating unnecessary variables. Expert researchers consider comprehensively in advance data collection and implementation needs and plan accordingly.ConclusionThese results illustrate increasing levels of sophistication in research planning that increase sophistication in selection for variables in the case report form. These findings suggest that novice and intermediate-level researchers could benefit by emulating the comprehensive planning procedures such as those used by expert clinical researchers.

The structure of qualitative studies: a bibliometric pattern of biomedical literature

“…Thus, the rationale regarding the techniques used for the sample and analysis strategies will be better thought out. The improved structuring of a qualitative research extends the effective communication between health professionals andresearchers, and support in the management of clinical situations 26,29 . Finally, criticisms regarding the lack of rigor and validity in qualitative health studies can be responded to by making the study results clearer for the biomedical literature 30 .…”