Voting behavior during FDA Medical Device Advisory Committee panel meetings

Objectives During premarket review, the US Food and Drug Administration may ask its Medical Device Advisory Committee (MDAC) Panels to assess the safety and effectiveness of medical devices being considered for approval. The objective of this study is to assess the relationship, if any, between individual votes and Panel recommendations and: (1) the composition of Panels, specifically the expertise and demographic features of individual members; or (2) Panel members’ propensity to speak during Panel deliberations. Methods This was a retrospective cohort study of routinely collected data from voting members of MDAC panels convened between January 2011 to June 2016 to consider premarket approval. Data sources were verbatim transcripts available publicly from the FDA. Number of words spoken, directionality of votes on device approval, profession, and demographics were collected. Results 658,954 words spoken by 536 members during 49 meetings of 11 Panels were analyzed. Based on multivariate analysis, biostatisticians spoke more (+373 words; P = 0.0002), and women (-187 words; P = 0.0184) and other non-physician voting members less (-213 words; P = 0.0306), than physicians. Speaking more was associated with abstaining (P = 0.0179), and with voting against the majority (P = 0.0153). Non-physician, non-biostatistician members (P = 0.0109), and those having attended more meetings as a voting member (P = 0.0249) were more likely to vote against approval. In bivariable analysis, unanimous Panels had a greater proportion of biostatisticians (mean 0.1580; 95% CI 0.1237–0.1923) than non-unanimous Panels (0.1107; 95% CI 0.0912–0.1301; p = 0.0201). Conclusions Panelists likely to vote against the majority include non-physician, non-biostatisticians; experienced Panelists; and more talkative members. The increased presence of biostatisticians on Panels leads to greater voting consensus. Having a diversity of opinions on Panels, including in sufficient numbers those members likely to dissent from majority views, may help ensure that a diversity of opinions are aired before decision-making

Voting behavior during FDA Medical Device Advisory Committee panel meetings

OBJECTIVES: During premarket review, the US Food and Drug Administration may ask its Medical Device Advisory Committee (MDAC) Panels to assess the safety and effectiveness of medical devices being considered for approval. The objective of this study is to assess the relationship, if any, between individual votes and Panel recommendations and: (1) the composition of Panels, specifically the expertise and demographic features of individual members; or (2) Panel members\u27 propensity to speak during Panel deliberations. METHODS: This was a retrospective cohort study of routinely collected data from voting members of MDAC panels convened between January 2011 to June 2016 to consider premarket approval. Data sources were verbatim transcripts available publicly from the FDA. Number of words spoken, directionality of votes on device approval, profession, and demographics were collected. RESULTS: 658,954 words spoken by 536 members during 49 meetings of 11 Panels were analyzed. Based on multivariate analysis, biostatisticians spoke more (+373 words; P = 0.0002), and women (-187 words; P = 0.0184) and other non-physician voting members less (-213 words; P = 0.0306), than physicians. Speaking more was associated with abstaining (P = 0.0179), and with voting against the majority (P = 0.0153). Non-physician, non-biostatistician members (P = 0.0109), and those having attended more meetings as a voting member (P = 0.0249) were more likely to vote against approval. In bivariable analysis, unanimous Panels had a greater proportion of biostatisticians (mean 0.1580; 95% CI 0.1237-0.1923) than non-unanimous Panels (0.1107; 95% CI 0.0912-0.1301; p = 0.0201). CONCLUSIONS: Panelists likely to vote against the majority include non-physician, non-biostatisticians; experienced Panelists; and more talkative members. The increased presence of biostatisticians on Panels leads to greater voting consensus. Having a diversity of opinions on Panels, including in sufficient numbers those members likely to dissent from majority views, may help ensure that a diversity of opinions are aired before decision-making

Factitial panniculitis as a manifestation of self-imposed factitious disorder

Factitious disorder imposed on self is characterized by self-induction. Dermatitis artefacta, the cutaneous subtype of factitious disorder imposed on self, can have a variety of atypical presentations. A 36-year-old woman with an extensive past medical history presented with painful nodules on her abdomen, thighs, and arms. Histologic evaluation identified panniculitis with foreign body material seen under polarization. Chart review from previous hospital visits established a history of factitious disorder imposed on self and upon subsequent search of the hospital room, syringes with an unknown substance were found. Factitial panniculitis should be considered in cases with atypical lesions or locations that do not conform to the presentation of organic causes of panniculitis. Management should include a multidisciplinary approach that prioritizes patient safety and establishes a therapeutic patient-provider relationship

Development of a core outcome set for clinical trials in squamous cell carcinoma: study protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey

Abstract Background Squamous cell carcinoma (SCC) is a common skin cancer that poses a risk of metastasis. Clinical investigations into SCC treatment are common, but the outcomes reported are highly variable, omitted, or clinically irrelevant. The outcome heterogeneity and reporting bias of these studies leave clinicians unable to accurately compare studies. Core outcome sets (COSs) are an agreed minimum set of outcomes recommended to be measured and reported in all clinical trials of a given condition or disease. Although COSs are under development for several dermatologic conditions, work has yet to be done to identify core outcomes specific for SCC. Methods/design Outcome extraction for COS generation will occur via four methods: (1) systematic literature review; (2) patient interviews; (3) other published sources; and (4) input from stakeholders in medicine, pharmacy, and other relevant industries. The list of outcomes will be revaluated by the Measuring PRiority Outcome Variables via Excellence in Dermatologic surgery (IMPROVED) Steering Committee. Delphi processes will be performed separately by expert clinicians and patients to condense the list of outcomes generated. A consensus meeting with relevant stakeholders will be conducted after the Delphi exercise to further select outcomes, taking into account participant scores. At the end of the meeting, members will vote and decide on a final recommended set of core outcomes. The Core Outcome Measures in Effectiveness Trials (COMET) organization and the Cochrane Skin Group - Core Outcome Set Initiative (CSG-COUSIN) will serve as advisers throughout the COS generation process. Discussion Comparison of clinical trials via systematic reviews and meta-analyses is facilitated when investigators study outcomes that are relevant and similar. The aim of this project is to develop a COS to guide use for future clinical trials

Development of a core outcome set for clinical trials in basal cell carcinoma: study protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey

Abstract Background Basal cell carcinoma is the most common skin cancer worldwide. Treatment options include both surgical and topical modalities. Although risk of metastasis is low, basal cell carcinoma can be invasive and infiltrate important underlying structures such as bone or cartilage. While many clinical trials examining therapies for basal cell carcinoma exist, the lack of consensus in outcome reporting across all trials poses a concern. Proper evaluation and comparison of treatment modalities is challenging. In order to address the inconsistencies present, this project aims to determine a core set of outcomes which should be evaluated in all clinical trials of basal cell carcinoma. Methods/design Outcomes will be extracted over four phases: (1) a systematic literature review, (2) patient interviews, (3) other published sources, and (4) stakeholder involvement. Potential outcomes will then be examined by the Steering Committee, who may add or remove outcomes. The Delphi process will then be performed to condense the list of outcomes generated. Two rounds of Delphi surveys will be performed with two groups of participants – physicians and patients. A consensus meeting with relevant stakeholders will be conducted after the Delphi exercise to further select outcomes, taking into account participant scores. By the end of the meeting, members will vote and decide on a final recommended set of core outcomes. For the duration of the study, we will be in collaboration with both the Core Outcome Measures in Effectiveness Trials (COMET) initiative and the Cochrane Skin Group – Core Outcome Set Initiative (CSG-COUSIN). Discussion This study aims to develop a core outcome set to guide assessment in clinical trials on basal cell carcinoma. The end-goal is to improve the consistency of outcome reporting and allow proper evaluation of treatment effectiveness

Development of a core outcome set for basal cell carcinoma

Background: There is variation in the outcomes reported in clinical studies of basal cell carcinoma. This can prevent effective meta-analyses from answering important clinical questions. Objective: To identify a recommended minimum set of core outcomes for basal cell carcinoma clinical trials. Methods: Patient and professional Delphi process to cull a long list, culminating in a consensus meeting. To be provisionally accepted, outcomes needed to be deemed important (score, 7-9, with 9 being the maximum) by 70% of each stakeholder group. Results: Two hundred thirty-five candidate outcomes identified via a systematic literature review and survey of key stakeholders were reduced to 74 that were rated by 100 health care professionals and patients in 2 Delphi rounds. Twenty-seven outcomes were provisionally accepted. The final core set of 5 agreed-upon outcomes after the consensus meeting included complete response; persistent or serious adverse events; recurrence-free survival; quality of life; and patient satisfaction, including cosmetic outcome. Limitations: English-speaking patients and professionals rated outcomes extracted from English language studies. Conclusion: A core outcome set for basal cell carcinoma has been developed. The use of relevant measures may improve the utility of clinical research and the quality of therapeutic guidance available to clinicians. Keywords: basal cell carcinoma; core; measure; outcome; set; skin cancer