Quantifying cancer risk from exposures to medical imaging in the Risk of Pediatric and Adolescent Cancer Associated with Medical Imaging (RIC) Study: research methods and cohort profile.

PURPOSE: The Risk of Pediatric and Adolescent Cancer Associated with Medical Imaging (RIC) Study is quantifying the association between cumulative radiation exposure from fetal and/or childhood medical imaging and subsequent cancer risk. This manuscript describes the study cohorts and research methods. METHODS: The RIC Study is a longitudinal study of children in two retrospective cohorts from 6 U.S. healthcare systems and from Ontario, Canada over the period 1995-2017. The fetal-exposure cohort includes children whose mothers were enrolled in the healthcare system during their entire pregnancy and followed to age 20. The childhood-exposure cohort includes children born into the system and followed while continuously enrolled. Imaging utilization was determined using administrative data. Computed tomography (CT) parameters were collected to estimate individualized patient organ dosimetry. Organ dose libraries for average exposures were constructed for radiography, fluoroscopy, and angiography, while diagnostic radiopharmaceutical biokinetic models were applied to estimate organ doses received in nuclear medicine procedures. Cancers were ascertained from local and state/provincial cancer registry linkages. RESULTS: The fetal-exposure cohort includes 3,474,000 children among whom 6,606 cancers (2394 leukemias) were diagnosed over 37,659,582 person-years; 0.5% had in utero exposure to CT, 4.0% radiography, 0.5% fluoroscopy, 0.04% angiography, 0.2% nuclear medicine. The childhood-exposure cohort includes 3,724,632 children in whom 6,358 cancers (2,372 leukemias) were diagnosed over 36,190,027 person-years; 5.9% were exposed to CT, 61.1% radiography, 6.0% fluoroscopy, 0.4% angiography, 1.5% nuclear medicine. CONCLUSION: The RIC Study is poised to be the largest study addressing risk of childhood and adolescent cancer associated with ionizing radiation from medical imaging, estimated with individualized patient organ dosimetry.

Do Work Condition Interventions Affect Quality and Errors in Primary Care? Results from the Healthy Work Place Study.

BACKGROUND: While primary care work conditions are associated with adverse clinician outcomes, little is known about the effect of work condition interventions on quality or safety. DESIGN: A cluster randomized controlled trial of 34 clinics in the upper Midwest and New York City. PARTICIPANTS: Primary care clinicians and their diabetic and hypertensive patients. INTERVENTIONS: Quality improvement projects to improve communication between providers, workflow design, and chronic disease management. Intervention clinics received brief summaries of their clinician and patient outcome data at baseline. MAIN MEASURES: We measured work conditions and clinician and patient outcomes both at baseline and 6-12 months post-intervention. Multilevel regression analyses assessed the impact of work condition changes on outcomes. Subgroup analyses assessed impact by intervention category. KEY RESULTS: There were no significant differences in error reduction (19 % vs. 11 %, OR of improvement 1.84, 95 % CI 0.70, 4.82, p = 0.21) or quality of care improvement (19 % improved vs. 44 %, OR 0.62, 95 % CI 0.58, 1.21, p = 0.42) between intervention and control clinics. The conceptual model linking work conditions, provider outcomes, and error reduction showed significant relationships between work conditions and provider outcomes (p ≤ 0.001) and a trend toward a reduced error rate in providers with lower burnout (OR 1.44, 95 % CI 0.94, 2.23, p = 0.09). LIMITATIONS: Few quality metrics, short time span, fewer clinicians recruited than anticipated. CONCLUSIONS: Work-life interventions improving clinician satisfaction and well-being do not necessarily reduce errors or improve quality. Longer, more focused interventions may be needed to produce meaningful improvements in patient care. CLINICAL TRIAL REGISTRATION NUMBER: ClinicalTrials.gov # NCT02542995.

A Cluster Randomized Trial of Interventions to Improve Work Conditions and Clinician Burnout in Primary Care: Results from the Healthy Work Place (HWP) Study.

BACKGROUND: Work conditions in primary care are associated with physician burnout and lower quality of care. OBJECTIVE: We aimed to assess if improvements in work conditions improve clinician stress and burnout. SUBJECTS: Primary care clinicians at 34 clinics in the upper Midwest and New York City participated in the study. STUDY DESIGN: This was a cluster randomized controlled trial. MEASURES: Work conditions, such as time pressure, workplace chaos, and work control, as well as clinician outcomes, were measured at baseline and at 12-18 months. A brief worklife and work conditions summary measure was provided to staff and clinicians at intervention sites. INTERVENTIONS: Diverse interventions were grouped into three categories: 1) improved communication; 2) changes in workflow, and 3) targeted quality improvement (QI) projects. ANALYSIS: Multilevel regressions assessed impact of worklife data and interventions on clinician outcomes. A multilevel analysis then looked at clinicians whose outcome scores improved and determined types of interventions associated with improvement. RESULTS: Of 166 clinicians, 135 (81.3%) completed the study. While there was no group treatment effect of baseline data on clinician outcomes, more intervention clinicians showed improvements in burnout (21.8% vs 7.1% less burned out, p = 0.01) and satisfaction (23.1% vs 10.0% more satisfied, p = 0.04). Burnout was more likely to improve with workflow interventions [Odds Ratio (OR) of improvement in burnout 5.9, p = 0.02], and with targeted QI projects than in controls (OR 4.8, p = 0.02). Interventions in communication or workflow led to greater improvements in clinician satisfaction (OR 3.1, p = 0.04), and showed a trend toward greater improvement in intention to leave (OR 4.2, p = 0.06). LIMITATIONS: We used heterogeneous intervention types, and were uncertain how well interventions were instituted. CONCLUSIONS: Organizations may be able to improve burnout, dissatisfaction and retention by addressing communication and workflow, and initiating QI projects targeting clinician concerns.