Actual Number Of Participants Research Articles

The initial assessment of expert panel performance in core hospitals for cancer genomic medicine in Japan

BackgroundSince June 2019, cancer genomic profiling (CGP) tests have been reimbursed by the National Health Insurance system in Japan, with restrictions for government-designated hospitals with a molecular tumor board composed of multidisciplinary specialists, known as an expert panel (EP). The standardization of EPs is a critical challenge for implementing precision oncology in the clinical setting.MethodsData on consecutive cases who underwent the CGP tests at 11 core hospitals between June 2019 and January 2020 were collected. We evaluated the proportions of cases that received genomically matched treatments, including investigational new drugs (INDs) based on CGP results, and/or for which genetic counseling was recommended. Two simulated cases were annotated by each EP. The annotated reports were then centrally assessed.ResultsEach EP mainly discussed the applicability to genomically matched treatments and the necessity of performing genetic counseling. A pre-review of the report by key members in each EP reportedly made the EP conference more interactive and efficient, and thereby saved time. A total of 747 cases underwent CGP tests, 28 cases (3.7%) received genomically matched treatment, and 17 cases (2.3%) were referred for genetic counseling. Annotated reports for the simulated cases varied across the EPs, particularly the number of recommended IND trials, which seemed to be associated with the actual number of participants in IND trials.ConclusionsThis investigation provides reference data for the application of precision oncology in a clinical setting. Further investigations on the standardization of clinical annotations are warranted.

Multifaceted remediation program: experience of a residency program to rescue residents who failed the American Board of Anesthesiology basic examination.

ProblemPassing the American Board of Anesthesiology (ABA) basic examination is required to progress through anesthesiology training in USA. Failing the test may be related to medical knowledge gaps, presence of negative psychosocial factors, and/or individual approaches to learning. This article describes the experience of development and implementation of a multifaceted remediation program (MRP) in residents who failed the ABA basic test.InterventionThis is a retrospective analysis of four cases of residents who failed the ABA basic test between 2016 and 2017. The MRP is described. Pedagogical diagnosis, objectives, teaching strategies and assessment, and their constructive alignment are presented. Information regarding test performance is also presented.ContextThis study involves accredited anesthesiology residency program in USA. Outcomes: Four subjects (11% of program residents) failed the ABA basic test. Superficial approach to learning was observed in 100% of cases. The total possible number of participants was 4. The actual number of participants was 4, and the response rate was 100%. Four residents fell under 10th percentile on the first attempt, and 100% passed the test on the second attempt. There was 38% improvement in the number of failed keywords between the two attempts.Lessons learnedImplementation of the MRP developed at our institution is successful to remediate anesthesiology residents who fail the ABA basic examination. We learned that the deep analysis of learning approaches, psychosocial factors, and medical knowledge gaps can be used to develop a remediation program based on the constructive alignment between objectives, curriculum, and assessment.

Sample size re-estimation in paired comparative diagnostic accuracy studies with a binary response

BackgroundThe sample size required to power a study to a nominal level in a paired comparative diagnostic accuracy study, i.e. studies in which the diagnostic accuracy of two testing procedures is compared relative to a gold standard, depends on the conditional dependence between the two tests - the lower the dependence the greater the sample size required. A priori, we usually do not know the dependence between the two tests and thus cannot determine the exact sample size required. One option is to use the implied sample size for the maximal negative dependence, giving the largest possible sample size. However, this is potentially wasteful of resources and unnecessarily burdensome on study participants as the study is likely to be overpowered. A more accurate estimate of the sample size can be determined at a planned interim analysis point where the sample size is re-estimated.MethodsThis paper discusses a sample size estimation and re-estimation method based on the maximum likelihood estimates, under an implied multinomial model, of the observed values of conditional dependence between the two tests and, if required, prevalence, at a planned interim. The method is illustrated by comparing the accuracy of two procedures for the detection of pancreatic cancer, one procedure using the standard battery of tests, and the other using the standard battery with the addition of a PET/CT scan all relative to the gold standard of a cell biopsy. Simulation of the proposed method illustrates its robustness under various conditions.ResultsThe results show that the type I error rate of the overall experiment is stable using our suggested method and that the type II error rate is close to or above nominal. Furthermore, the instances in which the type II error rate is above nominal are in the situations where the lowest sample size is required, meaning a lower impact on the actual number of participants recruited.ConclusionWe recommend multinomial model maximum likelihood estimation of the conditional dependence between paired diagnostic accuracy tests at an interim to reduce the number of participants required to power the study to at least the nominal level.Trial registrationISRCTN ISRCTN73852054. Registered 9th of January 2015. Retrospectively registered.

Initial Comparison of Resident and Attending Milestones Evaluations in Plastic Surgery

Graduate medical education has recently undergone a major archetypal shift toward competency-based evaluations of residents' performance. The implementation of the Milestones program by the Accreditation Council for Graduate Medical Education (ACGME) is a core component of the shift, designed to ensure uniformity in measuring residency knowledge using a series of specialty-specific achievements. This study evaluates the correlation between residents' self-evaluations and program directors' assessments of their performance. The study population comprised 12 plastic surgery residents, ranging from postgraduate year 1 to postgraduate year 6, enrolled in an integrated residency program at a single institution. Overall, average attending scores were lower than average resident scores at all levels except postgraduate year 6. Correlation between resident and attending evaluations ranged from 0.417 to 0.957, with the correlation of average scores of Patient Care (0.854) and Medical Knowledge (0.816) Milestones significantly higher than those of professional skillsets (0.581). "Patient care, facial esthetics" was the Milestone with the lowest average scores from both groups. Residents scored themselves notably higher than their attendings' evaluations in Practice-based Learning and Improvement categories (+0.958) and notably lower in Medical Knowledge categories such as "Cosmetic Surgery, Trunk and Lower Extremities" (-0.375) and "Non-trauma hand" (-0.208). The total possible number of participants in this study was 12. The actual number of participants was 12 (100%). The remarkable range of correlations suggests that expectations for performance standards may vary widely between residents and program directors. Understanding gaps between expectations and performance is vital to inform current and future residents as the restructuring of the accreditation process continues.

Engagement in Play Activities as a Means for Youth in Detention to Acquire Life Skills

This study describes how occupational therapists in a community-based programme, Occupational Therapy Training Program (OTTP), use play activities to facilitate the acquisition of life skills by youth in detention. This pilot study explored the extent of engagement of male and female inmates aged 14 to 18 years old in structured play activities on topics such as interpersonal relationships, self-awareness, cultural celebrations and the transition to community. Retrospective analysis of data collected from surveys using the Engagement in OTTP Activities Questionnaire (EOAQ), completed by youth participants at the end of each group session, was used to measure the extent of occupational engagement. Worksheets and artworks produced by OTTP participants during those group sessions were also analysed. The participants reported very high engagement in OTTP. Engagement scores for male participants were higher than those for female participants, and male and female participants had higher engagement scores for different activities. Over 90% of the worksheets and artworks were found to be complete and relevant to the topic of the session. Play activities could be an appropriate way for occupational therapists to encourage youth in detention to acquire life skills. Demographic information and the actual number of participants are unknown because of how the existing data were collected. Future studies examining the potential gender-related preferences for specific topics deserve further investigation as well as research comparing the youth's engagement in OTTP interventions using play activities to other group interventions. Copyright © 2016 John Wiley & Sons, Ltd.

Abstract A39: GMaP Region 4 clinical trials outreach for Latinos

Abstract Background: One of the National Cancer Institute's (NCI) Center to Reduce Cancer Health Disparities (CRCHD) Transdisciplinary Geographical Management of Cancer Health Disparities Program (GMAP) focuses is to connect underrepresented communities with research, training and outreach efforts. GMaP Region 4 composed of 9 states (Arizona, Colorado, Kansas, Nebraska, New Mexico, Oklahoma, Texas Utah and Wyoming), developed Clinical Trials Outreach for Latinos (CTOL) and educational module to help close the gap of clinical trial and biospecimen information within our minority community. Although clinical trials are operational in some of our sites, the overall number of eligible clinical trial participants per site is much higher than the number of actual participants in clinical trials. Drawing on the Region 4 Implementation Plan, which identified the need for CT accrual especially among low income English- and Spanish-speaking Latinos, we developed an intervention to test a CT education and outreach project in at least five different sites in Region 4. CTOL Program Purpose: Increase Latinos' informed decision-making about joining clinical trials and donating biospecimens.Highlight the importance of participating in trials and donating biospecimens.Discuss risks and benefits of participation in trials and donating biospecimens.Provide resources for available local and national trials and biobanks. Methodology: The CTOL involved the design and testing of a pilot CT education program through focus groups to implementation of the module. The project coordinator/health educator identified community organizations to the introduce CTOL and arranged for the educational sessions. The outreach strategy was to conduct a 20 to 30 minute session “piggy backed” into regularly scheduled group meetings. Prior to the presentation participants were asked to provide demographic information in a sign-in sheet. The presentations contained 4 pre-evaluation questions in which participants were asked to raise their hand if they agreed with the statement. After the session, participants asked questions and then answered several post-evaluation questions. Results: Seventy-two education sessions were conducted at five sites: 1) The University of Texas Health Science Center San Antonio, 2) New Mexico State University, 3) University of Arizona Cancer Center, 4) Good Samaritan Hospital (NE), and 5) Penrose Cancer Center (CO). The GMaP program in Region 4 included over 1200 participants in 12 different cities in 5 states (AZ, CO, NE, NM, and TX). Participants represented 155 different zip codes with the majority being Hispanic white females. At the beginning of the sessions, about 60% had heard about clinical trials however not many people really understood how they worked (33%) and fewer people neither understood nor knew about biospecimens or biobanks (17%). At the end of the sessions most participants gained knowledge about clinical trials and biospecimens with most post questions receiving over 80% “yes” responses. Sixty percent indicated they would be interested in future participation in clinical trials and biospecimen collection. Conclusions: Tailoring the form, content and delivery of education materials to an intended audience are essential for an effective program or intervention. We found that participants were not very informed about clinical trials or biospecimens but indicated that their knowledge and attitudes towards these issues increased or improved after exposure to our CTOL. Based on our findings we continued to refine the program and created “The Clinical Trials Outreach for Latinos: Program Replication Manual”, which we believe could assist other communities and stakeholders to disseminate this information and program in their own communities. Citation Format: Rose A. Treviño-Whitaker, Amelie G. Ramirez, Kipling Gallion, Mary O'Connell. GMaP Region 4 clinical trials outreach for Latinos. [abstract]. In: Proceedings of the Seventh AACR Conference on The Science of Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; Nov 9-12, 2014; San Antonio, TX. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2015;24(10 Suppl):Abstract nr A39.

Number of participants

I am often asked by novice researchers how many participants they should include in their studies. What is the ideal number? ‘Well, it depends,’ I always answer. And then we have a conversation about what it depends on. Top of the list is probably the purpose of the study. If, for example, a study aims to describe the language learning history of a particular learner, giving full, rich contextual details of learning over time, then obviously just that one learner would be the focus of the study. The purpose of such a study would be to present an in-depth analysis of learning that readers would make sense of by transferring the findings to their own teaching and learning (and research) contexts. If, on the other hand, a study aims to show broad trends about a population of learners or teachers, appropriate design and statistics would be used to ensure such generalization. Statistics demand that the sample population in this case be sufficiently large to ensure that the conditions of the specific inferential statistics being used have been satisfied. These are questions of both epistemology and methodology. There are cases, however, where it is not always easy to decide what the actual number of participants should be. In ethnographic studies, for example, what difference does it make if five or eight or 12 participants are interviewed? Should three schools be investigated or just two? In a large-scale questionnaire-based study, how much difference would it make if 190 instead of 250 respondents completed the questionnaire? Sometimes answers to questions such as these depend more on practical matters, such as accessibility to participants (Does the researcher have permission to enter a school site? Does the desired site even exist?), their availability (Do participants have time to take part in the study? Do they wish to?), and who they are (teachers, learners, policy-makers). Choosing the most appropriate number of participants, therefore, requires finding the right balance between achieving the research goals, meeting the requirements of the relevant research methodological procedures, and managing constraints set by practical and human circumstances. The number of participants in the studies in this issue varies from 1 to 135 (see Table 1). Cross’s article reports on a case study of one Japanese learner of English as a foreign language (EFL) who was guided through metacognitive instruction to deepen her knowledge of herself as a listener in second language contexts and her understanding of the challenges of second language listening. The aim was to develop the autonomous use of podcasts outside the classroom in order ultimately to increase listening ability. The study employed a combination of written reflective journal entries and interviews with the 510447 LTR18110.1177/1362168813510447Language Teaching ResearchEditorial research-article2014

Partner selections in public goods games with constant group size

Most of previous studies concerning the public goods game assume either participation is unconditional or the number of actual participants in a competitive group changes over time. How the fixed group size, prescribed by social institutions, affects the evolution of cooperation is still unclear. We propose a model where individuals with heterogeneous social ties might well engage in differing numbers of public goods games, yet with each public goods game being constant size during the course of evolution. To do this, we assume that each focal individual unidirectionally selects a constant number of interaction partners from his immediate neighbors with probabilities proportional to the degrees or the reputations of these neighbors, corresponding to degree-based partner selection or reputation-based partner selection, respectively. Because of the stochasticity the group formation is dynamical. In both selection regimes, monotonical dependence of the stationary density of cooperators on the group size was found, the latter over the whole range but the former over a restricted range of the renormalized enhancement factor. Moreover, the reputation-based regime can substantially improve cooperation. To interpret these differences, the microscopic characteristics of individuals are probed. We later extend the degree-based partner selection to general cases where focal individuals have preferences toward their neighbors of varying social ties to form groups. As a comparison, we as well investigate the situation where individuals locating on the degree regular graphs choose their coplayers at random. Our results may give some insights into better understanding the widespread teamwork and cooperation in the real world.

The Social Structure of the Hospice Decision

Two complementary studies examined social structural dimensions of discussions and decisions to enter hospice care. In Study 1, intensive interviews were conducted with caregivers, patients, “other” decision makers, and physicians for 150 hospice cases. In Study 2, survivors of cancer deaths were surveyed by mail. Data from Study 1 showed that the discussion was likely to be initiated by a professional outside the patient’s household, that the number of actual participants in the discussion was small, that social network—friends and relatives—were important during the communication and discussion processes, and that the decision to enter hospice care was likely to be made by the caregiver. Data from Study 2 showed the importance of the timing of communications about hospice. Both studies revealed high levels of awareness of hospice care, as well as how social networks, particularly friends and relatives, serve to communicate information about hospice. Implications for the timing of communications related to hospice care, as well as for future research and models of decision-making are discussed.

The Social Structure of the Hospice Decision

Two complementary studies examined social structural dimensions of discussions and decisions to enter hospice care. In Study 1, intensive interviews were conducted with caregivers, patients, "other" decision makers, and physicians for 150 hospice cases. In Study 2, survivors of cancer deaths were surveyed by mail. Data from Study 1 showed that the discussion was likely to be initiated by a professional outside the patient's household, that the number of actual participants in the discussion was small, that social network--friends and relatives--were important during the communication and discussion processes, and that the decision to enter hospice care was likely to be made by the caregiver. Data from Study 2 showed the importance of the timing of communications about hospice. Both studies revealed high levels of awareness of hospice care, as well as how social networks, particularly friends and relatives, serve to communicate information about hospice. Implications for the timing of communications related to hospice care, as well as for future research and models of decision-making are discussed.