Improving diversity in study participation: Patient perspectives on barriers, racial differences and the role of communities.

INTRODUCTION: The lack of racial/ethnic diversity in research potentially limits the generalizability of findings to a broader population, highlighting the need for greater diversity and inclusion in clinical research. Qualitative research (i.e., focus groups) was conducted to identify (i) the potential motivators and barriers to study participation across different races and ethnicities; (ii) preferred delivery of education and information to support healthcare decision-making and the role of the community. METHODS: Patient focus groups were conducted with 26 participants from the sponsor's Patient Engagement Research Councils selected through subjective sampling. Recruitment prioritized adequate representation across different race/ethnic groups. Participation was voluntary and participants underwent a confidential interview process before selection. Narrative analysis was used to identify themes and draw insights from interactions. Experienced research specialists identified emerging concepts, and these were tested against new observations. The frequency of each concept was examined to understand its importance. RESULTS: Based on self-selected race/ethnicity, participants were divided into five focus groups (Groups: African American/Black: 2; Hispanic/Latino, Asian American, and white: 1 each) and were asked to share their experiences/opinions regarding the stated objectives. Barriers to study participation included: limited awareness of opportunities to participate in research, fears about changes in standard therapy, breaking cultural norms/stigma, religion-related concerns and mistrust of clinical research. Participants identified the importance of transparency by pharmaceutical companies and other entities to build trust and partnership and cited key roles that communities can play. The perceptions of the African American group regarding diversity/inclusion in research studies appeared to be different from other groups; a lack of trust in healthcare providers, concerns about historical instances of research abuse and the importance of prayer were cited. CONCLUSION: This study provided insights into barriers to study participation, and also highlighted the need for pharmaceutical companies and other entities to authentically engage in strategies that build trust within communities to enhance recruitment among diverse populations. PATIENT OR PUBLIC CONTRIBUTION: The data collected in the present study was provided by the participants in the focus groups.

Research: Evaluation of Orthopedic Hip Device Recalls by the FDA from 2007 to 2017.

BACKGROUND: Medical device recalls have increased in the previous two decades. Orthopedic devices are estimated to constitute 12% of all medical devices recalled. Medical devices enter the market via the Food and Drug Administration's (FDA's) premarket approval (PMA) or 510(k) pathways. This article evaluates orthopedic hip device recalls between Jan. 1, 2007, and Dec. 31, 2017. We hypothesized that the 510(k) approval process would have substantially higher recall rates for defective devices. METHODS: The FDA's device recall database was queried for all orthopedic hip devices from Jan. 1, 2007, to Dec. 31, 2017. Each recall included product description, recall number, device class, date of recall posting, date of recall termination, manufacturer, FDA-determined cause for recall, number of recalled units, distribution, product classification, and method of approval [510(k), PMA, or unspecified]. RESULTS: In total, 774 orthopedic hip devices were recalled between Jan. 1, 2007, and Dec. 31, 2017. The 510(k) approval process constituted 85% of hip device recalls. The most common FDA-determined cause of hip device recalls was device design, which constituted 37% of 510(k)-approved device recalls but only 6% of PMA-approved device recalls. The most recalled hip devices were hip prostheses. Orthopedic hip device recalls have shown a decrease of about 10 recalls per year during the 11-year period of analysis. CONCLUSION: Devices approved through the 510(k) process, compared with the PMA process, were more likely to be recalled for design defects. Although device design is the most common reason for device recall, many recalls are due to suboptimally standardized processes (e.g., packaging, process controls, device labeling). Overall, orthopedic hip device recalls decreased during the period of analysis (2007-17).

Patient perceptions of copay card utilization and policies.

BACKGROUND: Copay cards are intended to mitigate patient out-of-pocket (OOP) expenses. This qualitative, exploratory focus group study aimed to capture patient perceptions of copay cards and copay adjustment programs (CAPs; insurers' accumulator and maximizer policies), which redirect the copay card utilization benefits intended for patients' OOP expenses. METHODS: Patients with chronic conditions were recruited through Janssen's Patient Engagement Research Council program. They completed a survey and attended a live virtual session to provide feedback on copay cards. RESULTS: Among 33 participants (median age, 49 years [range, 24-78]), the most frequent conditions were cardiovascular-metabolic disease and inflammatory bowel disease. Patients associated copay cards with lessening financial burden, improving general and mental health, and enabling medication adherence. An impact on medication adherence was identified by 10 (63%) White and nine (100%) Black respondents. Some patients were unaware of CAPs despite having encountered them; they recommended greater copay card education and transparency about CAPs. CONCLUSION: Patients relied on copay cards to help afford their prescribed medication OOP expenses and maintain medication adherence. Use of CAPs may increase patient OOP expenses. Patients would benefit from awareness programs and industry - healthcare provider partnerships that facilitate and ensure access to copay cards.

Primary Arthrodesis Versus Open Reduction and Internal Fixation Outcomes for Lisfranc Injuries: An Analysis of Conflicting Meta-analyses Results.

INTRODUCTION: The superiority of primary arthrodesis (PA) versus open reduction and internal fixation (ORIF) in Lisfranc injuries has been debated. Meta-analyses comparing these surgical options have reached contradicting conclusions. The goal of this article is to determine why different conclusions were reached and provide clarity on the comparable outcomes of PA and ORIF in Lisfranc injuries. METHODS: A systematic literature review was conducted by searching for "meta-analysis" AND "Lisfranc" with keywords such as "ORIF" OR "open reduction" OR "arthrodesis" OR "fusion." Five meta-analysis articles discussing PA and ORIF in Lisfranc injuries were identified. Study outcomes were extracted from each article, and contradicting conclusions were identified for analysis. RESULTS: PA had lower rates of hardware removal. There was no difference between PA and ORIF when considering revision surgery, anatomic reduction, postoperative infection, total complications, and patient satisfaction. However, contradicting conclusions were reached for return to duty, the American Orthopaedic Foot and Ankle Society (AOFAS) score, and visual analogue scale (VAS) score. Conclusions. There was no difference in PA and ORIF for return to work and VAS score. Repeat meta-analysis with truly equivocal outcomes would be necessary to reach a valid conclusion for return to full activity and AOFAS midfoot scores. LEVELS OF EVIDENCE: Level II: Therapeutic studies.

The safety of foot and ankle procedures at an ambulatory surgery center.

BACKGROUND: This study evaluates the safety of foot and ankle outpatient surgeries at a freestanding ambulatory surgery centers. METHODS: A total of 1352 cases were evaluated for adverse events in a retrospective review of all foot and ankle cases performed over a 5-year period at a single center. RESULTS: The rate of adverse events was 2.3%, with 31 identified over the 5-year period (23 infections, 5 symptomatic thromboembolisms, 3 postoperative hospital transfers). DISCUSSION: The rate of postoperative adverse events in outpatient foot and ankle procedures is low. These surgeries can be performed safely in an outpatient setting at an ASC. LEVEL OF EVIDENCE: Level IV, Case Series.