Patient partnership in cardiovascular clinical trials.

Patients are ultimately the end-users of medical therapies and need to be actively integrated as contributors and decision-makers in the process of product development throughout product lifecycles. This is increasingly being recognized by patients, investigators, regulators, payers, sponsors, and medical journals. However, cardiovascular research remains behind other fields in terms of the extent of patient involvement and awareness of clinical trials in cardiovascular research. True patient partnerships in cardiovascular therapeutic development may permit more rapid recognition of unmet needs, ensure alignment of product development priorities with patient priorities, improve efficiency of trials (e.g. recruitment), and ensure outcomes of value to patients are being measured in trials (e.g. quality of life). This paper reviews ongoing initiatives and remaining opportunities to accomplish contributive patient involvement in cardiovascular clinical research.

Evaluation of the Patient Request Process for Radiology Imaging in U.S. Hospitals.

Background In the United States, patients have the right to access their protected health information. However, to the knowledge of the authors, no study has evaluated the patient request process and the barriers to patient access of their radiology images. Purpose To assess U.S. hospital compliance with federal regulations and patient ease of access to imaging studies. Materials and Methods In this cross-sectional study conducted from June 6 to December 3, 2018, 80 U.S. hospitals were contacted by telephone to determine their patient request process for imaging studies. A scripted interview was used to simulate the patient experience in requesting imaging studies. Hospitals were compared in terms of formats of release (compact disc [CD] via pick up, CD via mail, e-mail, online patient portal, or other online access), departments from which cine files can be requested, fees, and processing times. Results All 80 hospitals stated that they could provide imaging studies on CDs. Only six (8%) hospitals provided imaging studies via e-mail and three (4%) via an online patient portal. Requests for cine files were fulfilled by a department separate from diagnostic radiology in 47 of 80 (59%) hospitals. Patient charges ranged from $0 to $75 for a single CD, no charge to $6 via e-mail, and no charge via an online patient portal. Fifty-nine (74%) hospitals stated that they could release copies within 24 hours, 10 (13%) within 2-5 days, eight (10%) within 5-10 days, and three (4%) within 10-30 days from request date. Imaging studies from outside of the diagnostic radiology department may need to be requested through the departments that performed the study. Conclusion This study demonstrated that although fees and processing times are compliant with federal regulations, patient access to imaging studies is limited primarily to compact disc format. The request process is also complicated for patients because of dispersion of imaging studies across departments. © RSNA, 2019 Online supplemental material is available for this article.

Assessment of US Hospital Compliance With Regulations for Patients' Requests for Medical Records.

Importance: Although federal law has long promoted patients' access to their protected health information, this access remains limited. Previous studies have demonstrated some issues in requesting release of medical records, but, to date, there has been no comprehensive review of the challenges that exist in all aspects of the request process. Objective: To evaluate the current state of medical records request processes of US hospitals in terms of compliance with federal and state regulations and ease of patient access. Design, Setting, and Participants: A cross-sectional study of medical records request processes was conducted between August 1 and December 7, 2017, in 83 top-ranked US hospitals with independent medical records request processes and medical records departments reachable by telephone. Hospitals were ranked as the top 20 hospitals for each of the 16 adult specialties in the 2016-2017 US News & World Report Best Hospitals National Rankings. Exposures: Scripted interview with medical records departments in a single-blind, simulated patient experience. Main Outcomes and Measures: Requestable information (entire medical record, laboratory test results, medical history and results of physical examination, discharge summaries, consultation reports, physician orders, and other), formats of release (pick up in person, mail, fax, email, CD, and online patient portal), costs, and request processing times, identified on medical records release authorization forms and through telephone calls with medical records departments. Results: Among the 83 top-ranked US hospitals representing 29 states, there was discordance between information provided on authorization forms and that obtained from the simulated patient telephone calls in terms of requestable information, formats of release, and costs. On the forms, as few as 9 hospitals (11%) provided the option of selecting 1 of the categories of information and only 44 hospitals (53%) provided patients the option to acquire the entire medical record. On telephone calls, all 83 hospitals stated that they were able to release entire medical records to patients. There were discrepancies in information given in telephone calls vs on the forms between the formats hospitals stated that they could use to release information (69 [83%] vs 40 [48%] for pick up in person, 20 [24%] vs 14 [17%] for fax, 39 [47%] vs 27 [33%] for email, 55 [66%] vs 35 [42%] for CD, and 21 [25%] vs 33 [40%] for online patient portals), additionally demonstrating noncompliance with federal regulations in refusing to provide records in the format requested by the patient. There were 48 hospitals that had costs of release (as much as $541.50 for a 200-page record) above the federal recommendation of $6.50 for electronically maintained records. At least 6 of the hospitals (7%) were noncompliant with state requirements for processing times. Conclusions and Relevance: The study revealed that there are discrepancies in the information provided to patients regarding the medical records release processes and noncompliance with federal and state regulations and recommendations. Policies focused on improving patient access may require stricter enforcement to ensure more transparent and less burdensome medical records request processes for patients.