Study objective

We assess the productivity, outcomes, and experiences of participants in the National Institutes of Health/National Heart, Lung, and Blood Institute-funded K12 institutional research training programs in emergency care research.

Methods

We used a mixed-methods study design to evaluate the 6 K12 programs, including 2 surveys, participant interviews, scholar publications, grant submissions, and funded grants. The training program lasted from July 1, 2011, through June 30, 2017. We tracked scholars for a minimum of 3 years and up to 5 years, beginning with date of entry into the program. We interviewed program participants by telephone using open-ended prompts.

Results

There were 94 participants, including 43 faculty scholars, 13 principal investigators, 30 non-principal investigator primary mentors, and 8 program administrators. The survey had a 74% overall response rate, including 95% of scholars. On entry to the program, scholars were aged a median of 37 years (interquartile range [IQR] 34 to 40 years), with 16 women (37%), and represented 11 disciplines. Of the 43 scholars, 40 (93%) submitted a career development award or research project grant during or after the program; 26 (60%) have secured independent funding as of August 1, 2017. Starting with date of entry into the program, the median time to grant submission was 19 months (IQR 11 to 27 months) and time to funding was 33 months (IQR 27 to 39 months). Cumulative median publications per scholar increased from 7 (IQR 4 to 15.5) at program entry to 21 (IQR 11 to 33.5) in the first post-K12 year. We conducted 57 semistructured interviews and identified 7 primary themes.

Conclusion

This training program produced 43 interdisciplinary investigators in emergency care research, with demonstrated productivity in grant funding and publications.

Background

Long-term follow-up for clinician-scientist training programs is sparse. We describe the outcomes of clinician-scientist scholars in the National Heart Lung and Blood Institute (NHLBI) K12 program in emergency care research up to 8.7 years after matriculation in the program.

Methods

This was a cohort study of faculty clinician-scientist scholars enrolled in a NHLBI K12 research training program at 6 sites across the US, with median follow-up 7.7 years (range 5.7-8.7 years) from the date of matriculation. Scholars completed electronic surveys in 2017 and 2019, with the 2019 survey collecting information for their current work setting, percent time for research, and grant funding from all sources. We used NIH RePorter and online resources to verify federal grants through March 2021. The primary outcome was a funded career development award (CDA) or research project grant (RPG) where the scholar was principal investigator. We included funding from all federal sources and national foundations.

Results

There were 43 scholars, including 16 (37%) women. Over the follow-up period, 32 (74%) received an individual CDA or RPG, with a median of 36 months (range 9-83 months) after entering the program. Of the 43 scholars, 23 (54%) received a CDA and 22 (51%) received an RPG, 7 (16%) of which were R01s. Of the 23 scholars who received a CDA, 13 (56%) subsequently had an RPG funded. Time to CDA or RPG did not differ by sex (women vs. men log-rank test p = 0.27) or specialty training (emergency medicine versus other specialties, p = 0.59).

Conclusions

After 7 years of follow-up for this NHLBI K12 emergency care research training program, three quarters of clinician-scientist scholars had obtained CDA or RPG funding, with no notable differences by sex or clinical training.

Patient-reported outcomes (PROs) are used in clinical trials to provide valuable evidence on the impact of disease and treatment on patients' symptoms, function and quality of life. High-quality PRO data from trials can inform shared decision-making, regulatory and economic analyses and health policy. Recent evidence suggests the PRO content of past trial protocols was often incomplete or unclear, leading to research waste. To address this issue, international, consensus-based, PRO-specific guidelines were developed: the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)-PRO Extension. The SPIRIT-PRO Extension is a 16-item checklist which aims to improve the content and quality of aspects of clinical trial protocols relating to PRO data collection to minimise research waste, and ultimately better inform patient-centred care. This SPIRIT-PRO explanation and elaboration (E&E) paper provides information to promote understanding and facilitate uptake of the recommended checklist items, including a comprehensive protocol template. For each SPIRIT-PRO item, we provide a detailed description, one or more examples from existing trial protocols and supporting empirical evidence of the item's importance. We recommend this paper and protocol template be used alongside the SPIRIT 2013 and SPIRIT-PRO Extension paper to optimise the transparent development and review of trial protocols with PROs.