Development and initial psychometric properties of the Research Complexity Index.

Objective: Research study complexity refers to variables that contribute to the difficulty of a clinical trial or study. This includes variables such as intervention type, design, sample, and data management. High complexity often requires more resources, advanced planning, and specialized expertise to execute studies effectively. However, there are limited instruments that scale study complexity across research designs. The purpose of this study was to develop and establish initial psychometric properties of an instrument that scales research study complexity. Methods: Technical and grammatical principles were followed to produce clear, concise items using language familiar to researchers. Items underwent face, content, and cognitive validity testing through quantitative surveys and qualitative interviews. Content validity indices were calculated, and iterative scale revision was performed. The instrument underwent pilot testing using 2 exemplar protocols, asking participants (n = 31) to score 25 items (e.g., study arms, data collection procedures). Results: The instrument (Research Complexity Index) demonstrated face, content, and cognitive validity. Item mean and standard deviation ranged from 1.0 to 2.75 (Protocol 1) and 1.31 to 2.86 (Protocol 2). Corrected item-total correlations ranged from .030 to .618. Eight elements appear to be under correlated to other elements. Cronbach's alpha was 0.586 (Protocol 1) and 0.764 (Protocol 2). Inter-rater reliability was fair (kappa = 0.338). Conclusion: Initial pilot testing demonstrates face, content, and cognitive validity, moderate internal consistency reliability and fair inter-rater reliability. Further refinement of the instrument may increase reliability thus providing a comprehensive method to assess study complexity and related resource quantification (e.g., staffing requirements).

Effectiveness and cost of recruiting healthy volunteers for clinical research studies using an electronic patient portal: A randomized study.

INTRODUCTION: It is not clear how to effectively recruit healthy research volunteers. METHODS: We developed an electronic health record (EHR)-based algorithm to identify healthy subjects, who were randomly assigned to receive an invitation to join a research registry via the EHR's patient portal, letters, or phone calls. A follow-up survey assessed contact preferences. RESULTS: The EHR algorithm accurately identified 858 healthy subjects. Recruitment rates were low, but occurred more quickly via the EHR patient portal than letters or phone calls (2.7 vs. 19.3 or 10.4 d). Effort and costs per enrolled subject were lower for the EHR patient portal (3.0 vs. 17.3 or 13.6 h, $113 vs. $559 or $435). Most healthy subjects indicated a preference for contact via electronic methods. CONCLUSIONS: Healthy subjects can be accurately identified from EHR data, and it is faster and more cost-effective to recruit healthy research volunteers using an EHR patient portal.

Ambulance clinical placements--a pilot study of students' experience.

BACKGROUND: Undergraduate paramedic students undertake clinical placements in a variety of locations. These placements are considered an essential element for paramedic pre-employment education. However, anecdotal evidence suggests some students have not had positive experiences on their emergency ambulance placements. The objective of this study was to identify the type of experiences had by students during ambulance clinical placements and to provide feedback to the ambulance services. METHODS: In this pilot study we employed a cross-sectional study methodology, using a convenience sample of undergraduate paramedic students available in semester one of 2007 to ascertain the students' views on their reception by on-road paramedics and their overall experience on emergency ambulance clinical placements. Ethics approval was granted. RESULTS: There were 77 students who participated in the survey, 64% were females, with 92% of students < 25 years of age and 55% < 65 Kg in weight. There was a statistically significant difference in average height between the genders (Male 179 cm vs Female 168 cm, p < 0.001). Clinical instructors were available to 44% of students with 30% of students excluded from patient management. Thirty percent of students felt there was a lot of unproductive down time during the placement. Paramedics remarked to 40% of students that they doubted their ability to perform the physical role of a paramedic, of this group 36% were advised this more than once. CONCLUSION: This study demonstrates that for a small group of students, emergency ambulance clinical placements were not a positive experience clinically or educationally. Some qualified paramedics doubt if a number of female students can perform the physical role of a paramedic.