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The role of previously undocumented data in the assessment of medical trainees in clinical competency committees.

ABSTRACT: INTRODUCTION:The clinical competency committee (CCC) comprises a group of clinical faculty tasked with assessing a medical trainee's progress from multiple data sources. The use of previously undocumented data, or PUD, during CCC deliberations remains controversial. This study explored the use of previously undocumented data in conjunction with documented data in creating a meaningful assessment in a CCC. METHODS:An instrumental case study of a CCC that uses previously undocumented data was conducted. A single CCC meeting was observed, followed by semi-structured individual interviews with all CCC members (n?=?7). Meeting and interview transcripts were analyzed iteratively. RESULTS:Documented data were perceived as limited by inaccurate or superficial data, but sometimes served as a starting point for invoking previously undocumented data. Previously undocumented data were introduced as summary impressions, contextualizing factors, personal anecdotes and, rarely, hearsay. The purpose was to raise a potential issue for discussion, enhance and elaborate an impression, or counter an impression. Various mechanisms allowed for the responsible use of previously undocumented data: embedding these data within a structured format; sharing relevant information without commenting beyond one's scope of experience; clarifying allowable disclosure of personal contextual factors with the trainee pre-meeting; excluding previously undocumented data not widely agreed upon in decision-making; and expecting these data to have been provided as direct feedback to trainees pre-meeting. DISCUSSION:Previously undocumented data appear to play a vital part of the group conversation in a CCC to create meaningful, developmentally focused trainee assessments that cannot be achieved by documented data alone. Consideration should be given to ensuring the thoughtful incorporation of previously undocumented data as an essential part of the CCC assessment process.

SUBMITTER: Tam J

PROVIDER: S-EPMC7550499 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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The role of previously undocumented data in the assessment of medical trainees in clinical competency committees.

Tam Jennifer J Wadhwa Anupma A Martimianakis Maria Athina MA Fernando Oshan O Regehr Glenn G

Perspectives on medical education 20201006 5

<h4>Introduction</h4>The clinical competency committee (CCC) comprises a group of clinical faculty tasked with assessing a medical trainee's progress from multiple data sources. The use of previously undocumented data, or PUD, during CCC deliberations remains controversial. This study explored the use of previously undocumented data in conjunction with documented data in creating a meaningful assessment in a CCC.<h4>Methods</h4>An instrumental case study of a CCC that uses previously undocumente ...[more]

PMID: 33025382

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Project description:BackgroundHuman papillomavirus (HPV) infection is the most common sexually transmitted infection in the United States. High-risk HPV strains are associated with cancer of the cervix, oropharynx, anus, rectum, penis, vagina, and vulva. To combat increasing HPV-related cancers, the 9-valent HPV vaccine Gardasil was developed. Recommendation of the HPV vaccine by a health care provider has been cited as the number one factor affecting vaccine uptake among adolescents and young adults. Physician assistants, nurse practitioners, and pharmacists have been enlisted to bridge the gap.ObjectiveThe specific aim of this research study was to develop a reliable and valid HPV vaccine communication scale that can be used to measure the competency of primary care providers when recommending the need for vaccination to parents and patients.MethodsUsing a descriptive study, we collected data via a literature review, focus groups, and an expert panel to inform the scale domains and blueprint design. Pretesting (cognitive interviews) was used to inform item revision decisions. An item analysis was also conducted for the responses provided in the cognitive interviews. Item statistics (means and SDs), interitem correlations, and reliability were examined. Data were analyzed using SPSS (IBM Corp) software.ResultsA valid and reliable 42-item HPV vaccine communication competency scale was developed. The scale included 6 domains of interest. Scale items were moderately to strongly correlated with one another, and Cronbach α indicated good internal consistency with each scale. Scale items included were related to provider introduction or rapport (α=.796), patient respect or empathy (α=.737), provider interview or intake (α=.9), patient counseling or education (α=.935), provider communication closure (α=.896), and provider knowledge (α=.824).ConclusionsPharmacists, nurse practitioners, and physician assistants should be trained to be competent in HPV vaccine communication and recommendation due to their expanded roles. Interdisciplinary collaboration is important to account for the trainee's individual differences and ensure the best health care outcomes for patients. A standardized HPV communication scale can be used to ensure effective and consistent recommendation by health care providers, thus affecting immunization rates.

Project description:The role and use of independent data monitoring committees (IDMCs) has evolved over the past decades. The Food and Drug Administration and European Medicines Agency have issued guidelines on the role and functioning of such committees. In general, data monitoring committees are recommended for large, often randomised clinical trials involving life-threatening diseases, studies performed in vulnerable populations or where the experimental intervention can potentially harm the trial participant. Such committees play an important role in trials evaluating treatments with the potential to prolong life or reduce the risk of major adverse health outcomes.Typically, oncology clinical trials fall within these recommendations, as they are often large, randomised, multicentric protocols aiming at improving survival outcomes by exploring the use of study treatments that may be associated with a significant risk of serious, even life-threatening adverse events. IDMCs are required for National Cancer Institute phase III randomised trials, European Organisation for Research and Treatment of Cancer phase II/III trials with formal interim analyses, early-stopping rules or adaptive studies. The primary role of an IDMC of ensuring the safety of study participants and maintaining clinical trial integrity is particularly important in oncology trials, due to the nature of the disease, the potential for treatment toxicity and for instilling confidence that the clinical trial data are reliable. A clear understanding by IDMC members of the natural course of the disease, treatment landscape, importance and relevance of certain adverse events in trial participants, clinical trial methodology in general and stopping rules for oncology trials in particular, is crucial for the functioning of an IDMC.It is recommended that IDMC members should be experienced trialists, have a track record of strong clinical, statistical and/or methodological expertise and the required level of independence, as they play a highly important role in the protection of study participants, and in commercially and strategically important go/no decisions. Ideally, IDMC members should have relevant experience or have some training, mentorship or guidelines.

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Project description:Background/aims Use of data monitoring committees to oversee clinical trials was first proposed nearly 50 years ago. Since then, data monitoring committee use in clinical trials has increased and evolved. Nonetheless, there are no well-defined criteria for determining the need for a data monitoring committee, and considerable variability exists in data monitoring committee composition and conduct. To understand and describe the role and function of data monitoring committees, and establish best practices for data monitoring committee trial oversight, the Clinical Trials Transformation Initiative-a public-private partnership to improve clinical trials-launched a multi-stakeholder project. Methods The data monitoring committee project team included 16 individuals charged with (1) clarifying the purpose of data monitoring committees, (2) identifying best practices for independent data monitoring committee conduct, (3) describing effective communication practices, and (4) developing strategies for training data monitoring committee members. Evidence gathering included a survey, a series of focus group discussions, and a 2-day expert meeting aimed at achieving consensus opinions that form the foundation of our data monitoring committee recommendations. Results We define the role of the data monitoring committee as an advisor to the research sponsor on whether to continue, modify, or terminate a trial based on periodic assessment of trial data. Data monitoring committees should remain independent from the sponsor and be composed of members with no relevant conflicts of interest. Representation on a data monitoring committee generally should include at least one clinician with expertise in the therapeutic area being studied, a biostatistician, and a designated chairperson who has experience with clinical trials and data monitoring. Data monitoring committee meetings are held periodically to evaluate the unmasked data from ongoing trials, but the content and conduct of meetings may vary depending on specific goals or topics for deliberation. To guide data monitoring committee conduct and communication plans, a charter consistent with the protocol's research design and statistical analysis plan should be developed and agreed upon by the sponsor and the data monitoring committee prior to patient enrollment. We recommend concise and flexible charters that explain roles, responsibilities, operational issues, and how data monitoring committee recommendations are generated and communicated. The demand for data monitoring committee members appears to exceed the current pool of qualified individuals. To prepare a new generation of trained data monitoring committee members, we encourage a combination of didactic educational programs, practical experience, and skill development through apprenticeships and mentoring by experienced data monitoring committee members. Conclusion Our recommendations address data monitoring committee use, conduct, communication practices, and member preparation and training. Furthermore recommendations form the foundation for ongoing efforts to improve clinical trial oversight and enhance the safety and integrity of clinical research. These recommendations serve as a call to action for implementation of best practices that benefit study participants, study sponsors, and society.

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The role of previously undocumented data in the assessment of medical trainees in clinical competency committees.

Publications

The role of previously undocumented data in the assessment of medical trainees in clinical competency committees.

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