Beth Hodshon

A Historic Moment for Open Science: The Yale University Open Data Access Project and Medtronic

Two systematic reviews on rhBMP-2 in this issue are based on patient-level data from all clinical trials conducted by Medtronic, which were shared through the YODA Project—an unprecedented step in ...

Association of Discharge Summary Quality With Readmission Risk for Patients Hospitalized With Heart Failure Exacerbation

Patients admitted with heart failure have disproportionately high readmission rates, most recently ranging from 17.5% to 30.3% nationally.1 The Affordable Care Act penalizes hospitals with higher than average readmission rates after admissions for heart failure. However, clinicians remain uncertain, which strategies are associated with reducing readmissions in this population.2 Experts have proposed that the creation and transmission of a high-quality discharge summary to outpatient clinicians may improve the transition from hospital to home. Discharge summaries may facilitate safer transitions in care by informing outpatient clinicians about the course of hospitalization, identifying pending studies requiring follow-up, suggesting further follow-up testing, and clarifying changes in medications and treatments after discharge. Nonetheless, despite widespread enthusiasm for improving the quality of discharge summaries, there have been few studies of the effectiveness of discharge summaries in helping to avoid readmissions, and those few have found no association of timeliness,3,4 transmission,5,6 or content5 with readmission. To determine the association of discharge quality and readmission in a large national sample, we examined discharge summaries of patients enrolled in the Telemonitoring to Improve Heart Failure Outcomes (Tele-HF) randomized controlled trial. ### Study Cohort and Setting The Tele-HF study included patients living at home and hospitalized for heart failure in the previous 30 days.7 Patients in Tele-HF were recruited from 33 cardiology practices in 21 states and the District of Columbia. We obtained discharge summaries for the index hospitalization. Wherever possible, we obtained …

Do Non-Clinical Factors Improve Prediction of Readmission Risk?: Results From the Tele-HF Study.

OBJECTIVES This study sought to determine whether a model that included self-reported socioeconomic, health status, and psychosocial characteristics obtained from patients recently discharged from hospitalizations for heart failure substantially improved 30-day readmission risk prediction compared with a model that incorporated only clinical and demographic factors. BACKGROUND Existing readmission risk models have poor discrimination and it is unknown whether they would be markedly improved by the inclusion of patient-reported information. METHODS As part of the Tele-HF (Telemonitoring to Improve Heart Failure Outcomes) trial, we conducted medical record abstraction and telephone interviews in a sample of 1,004 patients recently hospitalized for heart failure to obtain clinical, functional, and psychosocial information within 2 weeks of discharge. Candidate risk factors included 110 variables divided into 2 groups: demographic and clinical variables generally available from the medical record; and socioeconomic, health status, adherence, and psychosocial variables from patient interview. RESULTS The 30-day readmission rate was 17.1%. Using the 3-level risk score derived from the restricted medical record variables, patients with a score of 0 (no risk factors) had a readmission rate of 10.9% (95% confidence interval [CI]: 8.2% to 14.2%), and patients with a score of 2 (all risk factors) had a readmission rate of 32.1% (95% CI: 22.4% to 43.2%), a C-statistic of 0.62. Using the 5-level risk score derived from all variables, patients with a score of 0 (no risk factors) had a readmission rate of 9.6% (95% CI: 6.1% to 14.2%), and patients with a score of 4 (all risk factors) had a readmission rate of 55.0% (95% CI: 31.5% to 76.9%), a C-statistic of 0.65. CONCLUSIONS Self-reported socioeconomic, health status, adherence, and psychosocial variables are not dominant factors in predicting readmission risk for patients with heart failure. Patient-reported information improved model discrimination and extended the predicted ranges of readmission rates, but the model performance remained poor. (Telemonitoring to Improve Heart Failure Outcomes [Tele-HF]; NCT00303212).

Sea Change in Open Science and Data Sharing Leadership by Industry

With remarkable speed, the landscape of open science and data sharing is changing. Fueled by recent evidence that the results of many clinical trials of interventions in common use are never published or reported and that these studies are not missing at random, a persuasive argument has been made that all data from human trials should be available to inform clinical practice.1–6 This would also promote higher quality and higher integrity science, although some urge caution as a result of concerns about unintended adverse consequences.7 In response to these calls for action, some companies have stepped forward and demonstrated leadership. GlaxoSmithKline, in coordination with other companies such as Roche and ViiV, committed early to data sharing.8 Medtronic contracted with our research team, the Yale University Open Data Access Project,9 to conduct external reviews of its clinical trial data for a single product. In addition, we developed policies and procedures to share these data with other investigators. Importantly, Medtronic fully transferred the decision-making authority on how to share the data and who could receive the data to the Yale University Open Data Access Project. Janssen, the pharmaceutical companies of Johnson & Johnson, has now contracted to do the same for the trials under its auspices. Increasingly, other companies are announcing their intention to share data from all published and unpublished clinical trials. On July 24, 2013, the …

Hospital Variation in Quality of Discharge Summaries for Patients Hospitalized With Heart Failure Exacerbation

Background— Single-site studies have demonstrated inadequate quality of discharge summaries in timeliness, transmission, and content, potentially contributing to adverse outcomes. However, degree of hospital-level variation in discharge summary quality for patients hospitalized with heart failure (HF) is uncertain. Methods and Results— We analyzed discharge summaries of patients enrolled in the Telemonitoring to Improve Heart Failure Outcomes (Tele-HF) study. We assessed hospital-level performance on timeliness (fraction of summaries completed on the day of discharge), documented transmission to the follow-up physician, and content (presence of components suggested by the Transitions of Care Consensus Conference). We obtained 1501 discharge summaries from 1640 (91.5%) patients discharged alive from 46 hospitals. Among hospitals contributing ≥10 summaries, the median hospital dictated 69.2% of discharge summaries on the day of discharge (range, 0.0%–98.0%; P<0.001); documented transmission of 33.3% of summaries to the follow-up physician (range, 0.0%–75.7%; P<0.001); and included 3.6 of 7 Transitions of Care Consensus Conference elements (range, 2.9–4.5; P<0.001). Hospital course was typically included (97.2%), but summaries were less likely to include discharge condition (30.7%), discharge volume status (16.0%), or discharge weight (15.7%). No discharge summary included all 7 Transitions of Care Consensus Conference–endorsed content elements, was dictated on the day of discharge, and was sent to a follow-up physician. Conclusions— Even at the highest performing hospital, discharge summary quality is insufficient in terms of timeliness, transmission, and content. Improvements in all aspects of discharge summary quality are necessary to enable the discharge summary to serve as an effective transitional care tool.

Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey.

Background In the US, once a medical device is made available for use, several requirements have been established by the US Food and Drug Administration (FDA) to ensure ongoing post-market surveillance of device safety and effectiveness. Our objective was to determine how commonly medical device manufacturers initiate post-market clinical studies or augment FDA post-market surveillance requirements for higher-risk devices that are most often approved via the FDA’s pre-market approval (PMA) pathway. Methods and results We conducted a cross-sectional survey of 47 manufacturers with operations in California, Minnesota, and Massachusetts who market devices approved via the PMA pathway. Among 22 respondents (response rate =47%), nearly all self-reported conducting post-market clinical research studies, commonly between 1 and 5; only 1 respondent reported never conducting post-market clinical research studies. While manufacturers most often engaged in these studies to satisfy FDA requirements, other reasons were reported, including performance monitoring and surveillance and market acceptance initiatives. Risks of conducting and not conducting post-market clinical research studies were described through open-ended response to questions. Conclusion Medical device manufacturers commonly initiate post-market clinical studies at the request of the FDA. Clinical data from these studies should be integrated into national post-market surveillance initiatives.

A taxonomy and cultural analysis of intra-hospital patient transfers

Existing research on intra-hospital patient transitions focuses chiefly on handoffs, or exchanges of information, between clinicians. Less is known about patient transfers within hospitals, which include but extend beyond the exchange of information. Using participant observations and interviews at a 1,541-bed, academic, tertiary medical center, we explored the ways in which staff define and understand patient transfers between units. We conducted observations of staff (n = 16) working in four hospital departments and interviewed staff (n = 29) involved in transfers to general medicine floors from either the Emergency Department or the Medical Intensive Care Unit between February and September 2015. The collected data allowed us to understand transfers in the context of several hospital cultural microsystems. Decisions were made through the lens of the specific unit identity to which staff felt they belonged; staff actively strategized to manage workload; and empty beds were treated as a scarce commodity. Staff concepts informed the development of a taxonomy of intra-hospital transfers that includes five categories of activity: disposition, or determining the right floor and bed for the patient; notification to sending and receiving staff of patient assignment, departure and arrival; preparation to send and receive the patient; communication between sending and receiving units; and coordination to ensure that transfer components occur in a timely and seamless manner. This taxonomy widens the study of intra-hospital patient transfers from a communication activity to a complex cultural phenomenon with several categories of activity and views them as part of multidimensional hospital culture, as constructed and understood by staff.

Impact of Telemonitoring on Health Status

Background— Although noninvasive telemonitoring in patients with heart failure does not reduce mortality or hospitalizations, less is known about its effect on health status. This study reports the results of a randomized clinical trial of telemonitoring on health status in patients with heart failure. Methods and Results— Among 1521 patients with recent heart failure hospitalization randomized in the Tele-HF trial (Telemonitoring to Improve Heart Failure Outcomes), 756 received telephonic monitoring and 765 usual care. Disease-specific health status was measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ) within 2 weeks of discharge and at 3 and 6 months. Repeated measures linear regression models were used to assess differences in KCCQ scores between patients assigned to telemonitoring and usual care over 6 months. The baseline characteristics of the 2 treatment arms were similar (mean age, 61 years; 43% female and 39% black). Over the 6-month follow-up period, there was a statistically significant, but clinically small, difference between the 2 groups in their KCCQ overall summary and subscale scores. The average KCCQ overall summary score for those receiving telemonitoring was 2.5 points (95% confidence interval, 0.38–4.67; P=0.02) higher than usual care, driven primarily by improvements in symptoms (3.5 points; 95% confidence interval, 1.18–5.82; P=0.003) and social function (3.1 points; 95% confidence interval, 0.30–6.00; P=0.03). Conclusions— Telemonitoring results in statistically significant, but clinically small, improvements in health status when compared with usual care. Given that the KCCQ was a secondary outcome, the benefits should be confirmed in future studies. Clinical Trial Registration— URL: https://www.clinicaltrials.gov/. Unique identifier: NCT00303212.