EU's Medical Device Expert Panels: Analysis of Membership and Published Clinical Evaluation Consultation Procedure (CECP) Results.

BACKGROUND: The new EU Medical Device Regulation (MDR) places greater importance on the role of clinical evidence to establish safety and performance. Article 54 of the MDR calls for expert committees to independently review the scientific, technical, and clinical evidence supporting the market authorization of certain novel devices independently from the established process of Notified Body reviews. These experts provide a review and opinion that ultimately is taken into consideration alongside the information reviewed by the Notified Body during the review process. Four expert committees (General and Plastic Surgery and Dentistry; Orthopaedics, Traumatology, Rehabilitation, Rheumatology; Circulatory System; and Neurology) have published at least one Scientific Opinion (SO) under the Clinical Evaluation Consultation Procedure (CECP) in 2021-2022. METHODS: The four expert committees with published CECP opinions were reviewed to assess the academic backgrounds and professional expertise of each member with respect to clinical, technical, and biological domains on a 0-2 scale for each domain. A content review was conducted on the 10 CECP opinions published by these committees to assess their consistency with the goals and outcome expectations set by the MDR. The extent of content related to each of the clinical, technical, and biological domains was also assessed on a 0-2 scale. RESULTS: All committees were composed primarily by members with strong clinical expertise, but only a few had strong technical and biological expertise. Across committees, the average scores of members related to academic background and professional expertise both ranged from 1.64 to 2.00 in the clinical domain, but only 0-0.15 and 0.15-0.69, respectively, in the biological domain, and 0.12-0.55 and 0.23-0.73, respectively, in the technical domain. A content review for the 10 SOs showed that all opinions focused exclusively or primarily on the clinical evidence. Three contained a modest amount of additional text directed at technical/engineering issues and five at biological issues. CONCLUSION: Expert committees are composed predominantly of expert clinical reviewers but have many fewer members with significant technical or biological expertise. This may limit the ability of the committees to evaluate the significant technical and biological risks that are often best understood by preclinical testing. Broadening the expertise across the committees may improve the depth of their benefit/risk critiques.

Cost of start-up activities to implement a community-level opioid overdose reduction intervention in the HEALing Communities Study.

BACKGROUND: Communities That HEAL (CTH) is a novel, data-driven community-engaged intervention designed to reduce opioid overdose deaths by increasing community engagement, adoption of an integrated set of evidence-based practices, and delivering a communications campaign across healthcare, behavioral-health, criminal-legal, and other community-based settings. The implementation of such a complex initiative requires up-front investments of time and other expenditures (i.e., start-up costs). Despite the importance of these start-up costs in investment decisions to stakeholders, they are typically excluded from cost-effectiveness analyses. The objective of this study is to report a detailed analysis of CTH start-up costs pre-intervention implementation and to describe the relevance of these data for stakeholders to determine implementation feasibility. METHODS: This study is guided by the community perspective, reflecting the investments that a real-world community would need to incur to implement the CTH intervention. We adopted an activity-based costing approach, in which resources related to hiring, training, purchasing, and community dashboard creation were identified through macro- and micro-costing techniques from 34 communities with high rates of fatal opioid overdoses, across four states-Kentucky, Massachusetts, New York, and Ohio. Resources were identified and assigned a unit cost using administrative and semi-structured-interview data. All cost estimates were reported in 2019 dollars. RESULTS: State-level average and median start-up cost (representing 8-10 communities per state) were $268,657 and $175,683, respectively. Hiring and training represented 40%, equipment and infrastructure costs represented 24%, and dashboard creation represented 36% of the total average start-up cost. Comparatively, hiring and training represented 49%, purchasing costs represented 18%, and dashboard creation represented 34% of the total median start-up cost. CONCLUSION: We identified three distinct CTH hiring models that affected start-up costs: hospital-academic (Massachusetts), university-academic (Kentucky and Ohio), and community-leveraged (New York). Hiring, training, and purchasing start-up costs were lowest in New York due to existing local infrastructure. Community-based implementation similar to the New York model may have lower start-up costs due to leveraging of existing infrastructure, relationships, and support from local health departments.

The implementation & sustainment facilitation (ISF) strategy: Cost and cost-effectiveness results from a 39-site cluster randomized trial integrating substance use services in community-based HIV service organizations.

Background: As part of the Substance Abuse Treatment to HIV Care Project, the Implementation & Sustainment Facilitation (ISF) strategy was found to be an effective adjunct to the Addiction Technology Transfer Center (ATTC) strategy for integrating a motivational interviewing-based brief intervention (MIBI) for substance use disorders. This study presents the cost and cost-effectiveness results. Methods: Thirty-nine HIV service organizations were randomized to receive the ATTC-only condition or the ATTC + ISF condition. Two staff from each organization received the ATTC-training. In ATTC + ISF organizations, the same two staff and additional support staff participated in facilitation sessions to support MIBI implementation. We estimated costs using primary data on the time spent in each strategy and the time spent delivering 409 MIBIs to clients. We estimated staff-level cost-effectiveness for the number of MIBIs delivered, average MIBI quality scores, and total client days abstinent per staff. We used sensitivity analyses to test how changes to key variables affect the results. Results: Adjusted per-staff costs were $2,915 for the ATTC strategy and $5,371 for ATTC + ISF, resulting in an incremental cost of $2,457. ATTC + ISF significantly increased the number of MIBIs delivered (3.73) and the average MIBI quality score (61.45), yielding incremental cost effectiveness ratios (ICERs) of $659 and $40. Client days abstinent increased by 59 days per staff with a quality-adjusted life-year ICER of $40,578 (95% confidence interval $29,795-$61,031). Conclusions: From the perspective of federal policymakers, ISF as an adjunct to the ATTC strategy may be cost-effective for improving the integration of MIBIs within HIV service organizations, especially if scaled up to reach more clients. Travel accounted for nearly half of costs, and virtual implementation may further increase value. We also highlight two considerations for cost-effectiveness analysis with hybrid trials: study protocols kept recruitment low and modeling choices affect how we interpret the effects on client-level outcomes.

The inconspicuous nature of COVID-19 and its impact to dentistry.

To state that the new coronavirus SARS-CoV-2 has broadly and deeply impacted our lives is an understatement. Since it first showed up on our radar in December 2019, the new coronavirus has wreaked havoc on virtually all businesses and industries across the globe. The impact is equally felt in developing, developed, industrialized, rural, rich, and poor countries and communities, irrespective of how well-prepared those countries and communities felt they were 9 months ago. To this day we are still learning to prepare for, respond to, and adapt to the broad and deep impact of this virus. This essay presents different perspectives on the impact of the novel coronavirus to dentistry, through the lenses of a private practice-based general dentist, a nursing home-based public health dentist, and a school of dentistry clinical director. The goal of the essay is to share our experiences and challenges, as well as highlight our capacity to respond to a crisis with resilience, determination, creativity, inventivity, and, most importantly, humility and altruism.

Outbreak of pneumonia associated with emergent human adenovirus serotype 14--Southeast Alaska, 2008.

BACKGROUND: In September 2008, an outbreak of pneumonia associated with an emerging human adenovirus (human adenovirus serotype 14 [HAdV-14]) occurred on a rural Southeast Alaska island. Nine patients required hospitalization, and 1 patient died. METHODS: To investigate the outbreak, pneumonia case patients were matched to control participants on the basis of age, sex, and community of residence. Participants in the investigation and their household contacts were interviewed, and serum samples and respiratory tract specimens were collected. Risk factors were evaluated by means of conditional logistic regression. RESULTS: Among 32 pneumonia case patients, 21 (65%) had confirmed or probable HAdV-14 infection. None of 32 matched control participants had evidence of HAdV-14 infection (P<.001 for the difference). Factors independently associated with pneumonia included contact with a known HAdV-14-infected case patient (odds ratio [OR], 18.3 [95% confidence interval {CI}, >or=2.0]), current smoking (OR, 6.7 [95% CI, >or=0.9]), and having neither traveled off the island nor attended a large public gathering (OR, 14.7 [95% CI, >or=2.0]). Fourteen (67%) of 21 HAdV-14-positive case patients belonged to a single network of people who socialized and often smoked together and infrequently traveled off the island. HAdV-14 infection occurred in 43% of case-patient household contacts, compared with 5% of control-participant household contacts (P = .005). CONCLUSIONS: During a community outbreak in Alaska, HAdV-14 appeared to have spread mostly among close contacts and not widely in the community. Demographic characteristics and illness patterns among the case patients were similar to those observed in other recent outbreaks of HAdV-14 infection in the United States.