The Supervisor's Toolkit: Strategies of Supervisors to Entrust and Regulate Autonomy of Residents in the Operating Room.

OBJECTIVE: To identify what strategies supervisors use to entrust autonomy during surgical procedures and to clarify the consequences of each strategy for a resident's level of autonomy. BACKGROUND: Entrusting autonomy is at the core of teaching and learning surgical procedures. The better the level of autonomy matches the learning needs of residents, the steeper their learning curves. However, entrusting too much autonomy endangers patient outcome, while entrusting too little autonomy results in expertise gaps at the end of training. Understanding how supervisors regulate autonomy during surgical procedures is essential to improve intraoperative learning without compromising patient outcome. METHODS: In an observational study, all the verbal and nonverbal interactions of 6 different supervisors and residents were captured by cameras. Using the iterative inductive process of conversational analysis, each supervisor initiative to guide the resident was identified, categorized, and analyzed to determine how supervisors affect autonomy of residents. RESULTS: In the end, all the 475 behaviors of supervisors to regulate autonomy in this study could be classified into 4 categories and nine strategies: I) Evaluate the progress of the procedure: inspection (1), request for information (2), and expressing their expert opinion (3); II) Influence decision-making: explore (4), suggest (5), or declare the next decision (6); III) Influence the manual ongoing action: adjust (7), or stop the resident's manual activity (8); IV) take over (9). CONCLUSIONS: This study provides new insights into how supervisors regulate autonomy in the operating room. This insight is useful toward analyzing whether supervisors meet learning needs of residents as effectively as possible.

Validación en español de un cuestionario para la evaluación de la calidad de la mentoría en investigación en ciencias de la salud / Spanish validation of a questionnaire for the quality evaluation of research mentoring in health sciences

Introducción. Es relevante contar con un cuestionario breve y auto-administrado para evaluar la calidad de los procesos de mentoría en investigación en la comunidad científica hispanohablante. Objetivos. Validar una versión abreviada, auto-administrada y en español del cuestionario multidimensional Evaluación de las competencias de mentoría. Métodos.1) Traducción y adaptación transcultural; 2) Reducción de la versión traducida; 3) Validación de la versión abreviada en una muestra local de 159 participantes respecto de su validez de constructo (análisis factorial confirmatorio) y de criterio (correlación de su puntaje total con el de una pregunta agregada y con la versión extensa del cuestionario). Resultados. Obtuvimos un cuestionario abreviado, en español y auto-aministrado de 17 ítems divididos en cinco dimensiones: 1) Mantenimiento de una comunicación efectiva, 2) Alineación de expectativas, 3) Evaluación del conocimiento,4) Promoción de la independencia, 5) Promoción del desarrollo profesional. El modelo hipotetizado ajustó de manera aceptable a los datos de nuestra muestra de validación (RMSEA=0,045; CFI=0,992; TLI=0,99 y WRMR=0,564). Todos los parámetros estimados para los ítems individuales tuvieron significancia estadística, oscilando las cargas factoriales estandarizadas entre 0,571 y 0,936. La fiabilidad compuesta de los diferentes dominios estuvo comprendida entre 0,764 y0,865, y la varianza media extractada, entre 0,522 y 0,644, en concordancia con lo recomendado. La validez convergente fue adecuada ya que las cargas factoriales estandarizadas de 94 % de los ítems del modelo final fueron mayores a 0,6 y con significancia estadística (valor t>1,96). La correlación entre los cinco factores fue alta (0,740 a 0,944). En la mayoría de las comparaciones, el cuadrado de dichas correlaciones fue superior a la varianza media extractada, lo que refleja una validez divergente o discriminante baja. El puntaje de la versión abreviada tuvo una correlación positiva y alta (Coeficiente de Pearson 0,847; p<0,001) con la pregunta agregada como criterio externo concurrente de validación y muy alta correlación (coeficiente de Pearson: 0,988;p<0,001) con el puntaje de la versión original traducida de 26 ítems. Conclusiones. La versión abreviada en español del cuestionario Evaluación de las competencias de mentoría tiene adecuadas propiedades psicométricas y puede ser aplicada en forma auto-administrada, lo que la vuelve la primera herramienta en español para evaluar procesos de mentoría en investigación. (AU)

Introduction. It is relevant to have a short and self-administered questionnaire to assess research mentoring processquality in the Spanish-speaking scientific community. Objectives. To validate a short and self-administered version in Spanish of the multidimensional questionnaire Mentoring Competency Assessment. Methods.1) Translation and cross-cultural adaptation; 2) Reduction of the translated version; 3) Validation of the shortenedversion in a local sample of 159 participants regarding its construct validity (confirmatory factor analysis) and its criterion validity (correlation of its total score with that of an additional question and with the long version of the questionnaire). Results. We obtained an abbreviated (17 items) and self-administered questionnaire in Spanish, divided into five constructs: 1) Maintaining effective communication, 2) Aligning expectations, 3) Addressing knowledge, 4) Promoting independence, 5) Promoting professional development. The hypothesized model fit acceptably to the data from our validation sample (RMSEA=0.045; CFI=0.992; TLI=0.99 and WRMR=0.564).All the parameters estimated for the individual items were statistically significant, with their standardized factor loads ranging from 0.571 to 0.936. The composite reliability of the different domains ranged between 0.764 and 0.865, and the mean extracted variance, between 0.522 and 0.644, in accordance with the recommended range. Convergent validity was adequate since the standardized factor loads of 94 % of the items in the final model were greater than 0.6 and with statistical significance (t-value >1,96). The correlation between the five factors was high (0.740 to 0.944) and in most of the comparisons, the square of these correlations was higher than the average variance extracted, reflecting low divergent or discriminant validity. The score of the shortened version had a positive and high correlation (Pearson coefficient 0.847;p <0.001) with the additional question as a concurrent external validation criterion and a very high correlation (Pearson coefficient: 0.988; p <0.001) with the score of the original 26-item translated version. Conclusions. The shortened Spanish version of the Mentoring Competency Assessment questionnaire has adequate psychometric properties and can be applied in a self-administered way, which makes it the first tool in Spanish to assessresearch mentoring processes. (AU)

The Complexity of Conducting a Multicenter Clinical Trial: Taking It to the Next Level Stipulated by the Federal Agencies.

Randomized controlled trials are becoming increasingly difficult to organize and conduct efficiently. This, in turn, hinders the ability to derive the highest level of evidence. Often, investigators forget or remain unaware of essential practices that will help them fulfill their study goals. This article emphasizes the common issues that a study team experiences during the planning and conducting of randomized controlled trials. The authors sought to share remedies to overcome these issues with the experience garnered in conducting several multicenter clinical trials and observational studies. In addition, the authors list resources from sponsors such as the National Institutes of Health and the U.S. Food and Drug Administration that study teams can apply to undertake studies effectively.

Scientific production indicators and researchers training in the Brazilian Collective Health / Indicadores de la producción científica y la formación de investigadores en la Salud Colectiva Brasileña / Indicadores de produção científica e formação de pesquisadores na Saúde Coletiva brasileira

ABSTRACT Objective: To evaluate the scientific production, generation of patents and researchers training among Brazilian Collective Health professors who were awarded a Pq/CNPq productivity scholarship from 2000 to 2012 and to verify the existence of an association between these production modalities and the characteristics of the professors, such as gender, training and origin. Method: An analytical cross-sectional study was carried out from 2000 to 2012, and the Prevalence Ratio was calculated using Poisson regression. For the statistical analyzes, the SPSS® program was used. Results: Of particular note are regional and institutional concentration, consistent scientific output, important researchers training, and a primordial but still timid generation of patents. We found an association between the "scientific production", "researchers training" outcomes, and the gender characteristics, such as the formation and origin of the Pq professor. Conclusion: These findings can guide the decision-making aimed at the deconcentration of scientific production and researchers training in the Brazilian Collective Health.

RESUMEN El objetivo del trabajo fue evaluar la producción científica, la generación de patentes y la formación de investigadores entre docentes de la Salud Colectiva brasileña que fueron contemplados con becas de productividad Pq/CNPq en el período de verano y verificar la existencia de la asociación entre estas modalidades de producción; y las características de los docentes, como el género, la formación y el origen. Método: Se realizó un estudio transversal analítico en el período de referencia y se calculó la razón de prevalencia por medio de la regresión de Poisson. Para los análisis estadísticos se utilizó el programa SPSS®. Resultados: Se destacan la concentración regional e institucional, la consistente producción científica, la importante formación de investigadores; y la significativa, pero aún tímida, generación de patentes. Se encontró una asociación entre los resultados de la producción científica, la formación de investigadores y las características género, formación y origen del docente Pq. Conclusión: Esos hallazgos pueden orientar la toma de decisiones dirigidas a la desconcentración de la producción científica y la formación de investigadores en Salud Colectiva en Brasil.

RESUMO Objetivo: Avaliar a produção científica, geração de patentes e formação de pesquisadores entre docentes da Saúde Coletiva brasileira que foram contemplados com bolsas de produtividade Pq/CNPq no período 2000-2012 e verificar a existência de associação entre estas modalidades de produção e características dos docentes, como gênero, formação e origem. Método: Foi realizado um estudo transversal analítico no período 2000-2012 e foi calculada a razão de prevalência por meio da regressão de Poisson. Para as análises estatísticas, utilizou-se o programa SPSS®. Resultados: Destacam-se a concentração regional e institucional, consistente produção científica, importante formação de pesquisadores e primordial, mas ainda tímida geração de patentes. Foi encontrada associação entre os desfechos "produção científica", "formação de pesquisadores", e as características de gênero, como formação e origem do docente Pq. Conclusão: Estes achados podem orientar a tomada de decisões voltadas para a desconcentração da produção científica e formação de pesquisadores em Saúde Coletiva no Brasil.

Improving transparency and scientific rigor in academic publishing.

Progress in basic and clinical research is slowed when researchers fail to provide a complete and accurate report of how a study was designed, executed, and the results analyzed. Publishing rigorous scientific research involves a full description of the methods, materials, procedures, and outcomes. Investigators may fail to provide a complete description of how their study was designed and executed because they may not know how to accurately report the information or the mechanisms are not in place to facilitate transparent reporting. Here, we provide an overview of how authors can write manuscripts in a transparent and thorough manner. We introduce a set of reporting criteria that can be used for publishing, including recommendations on reporting the experimental design and statistical approaches. We also discuss how to accurately visualize the results and provide recommendations for peer reviewers to enhance rigor and transparency. Incorporating transparency practices into research manuscripts will significantly improve the reproducibility of the results by independent laboratories. SIGNIFICANCE: Failure to replicate research findings often arises from errors in the experimental design and statistical approaches. By providing a full account of the experimental design, procedures, and statistical approaches, researchers can address the reproducibility crisis and improve the sustainability of research outcomes. In this piece, we discuss the key issues leading to irreproducibility and provide general approaches to improving transparency and rigor in reporting, which could assist in making research more reproducible.

Participatory action research, mixed methods, and research teams: learning from philosophically juxtaposed methodologies for optimal research outcomes.

BACKGROUND: Workplace health interventions incorporating qualitative and quantitative components (mixed methods) within a Participatory Action Research approach can increase understanding of contextual issues ensuring realistic interventions which influence health behaviour. Mixed methods research teams, however, face a variety of challenges at the methodological and expertise levels when designing actions and interventions. Addressing these challenges can improve the team's functionality and lead to higher quality health outcomes. In this paper we reflect on the data collection, implementation and data analysis phases of a mixed methods workplace health promotion project and discuss the challenges which arose within our multidisciplinary team. METHODS: This project used mixed methods within a Participatory Action Research approach to address workers' sun safety behaviours in 14 outdoor workplaces in Queensland, Australia, and elucidate why certain measures succeeded (or failed) at the worker and management level. The project integrated qualitative methods such as policy analysis and interviews, with a range of quantitative methods - including worker surveys, ultraviolet radiation (UVR) exposure measurement, and implementation cost analyses. RESULTS: The research team found the integration of qualitative and quantitative analyses within the Participatory Action Research process to be challenging and a cause of tensions. This had a negative impact on the data analysis process and reporting of results, and the complexity of qualitative analysis was not truly understood by the quantitative team. Once all researchers recognised qualitative and quantitative data would be equally beneficial to the Participatory Action Research process, methodological bias was overcome to a degree to which the team could work cooperatively. CONCLUSIONS: Mixed methods within a Participatory Action Research approach may allow a research team to discuss, reflect and learn from each other, resulting in broadened perspectives beyond the scope of any single research methodology. However, cohesive and supportive teams take constant work and adjustment under this approach, as knowledge and understanding is gained and shared. It is important researchers are cognisant of, and learn from, potential tensions within research teams due to juxtaposed philosophies, methodologies and experiences, if the team is to function efficiently and positive outcomes are to be achieved.

Variable participation of knowledge users in cancer health services research: results of a multiple case study.

BACKGROUND: Integrated knowledge translation (IKT) is a research approach in which knowledge users (KUs) co-produce research. The rationale for IKT is that it leads to research that is more relevant and useful to KUs, thereby accelerating uptake of findings. The aim of the current study was to evaluate IKT activities within a cancer health services research network in Ontario, Canada. METHODS: An embedded multiple case study design was used. The cases were 5 individual studies within an overarching cancer health services research network. These studies focused on one of the following topics: case costing of cancer treatment, lung cancer surgery policy analysis, patient and provider-reported outcomes, colorectal cancer screening, and a team approach to women's survivorship. We conducted document reviews and held semi-structured interviews with researchers, KUs, and other stakeholders within a cancer system organization. The analysis examined patterns across and within cases. RESULTS: Researchers and their respective knowledge users from 4 of the 5 cases agreed to participate. Eighteen individuals from 4 cases were interviewed. In 3 of 4 cases, there were mismatched expectations between researchers and KUs regarding KU role; participants recommended that expectations be made explicit from the beginning of the collaboration. KUs perceived that frequent KU turnover may have affected both KU engagement and the uptake of study results within the organization. Researchers and KUs found that sharing research results was challenging because the organization lacked a framework for knowledge translation. Uptake of research findings appeared to be related to the researcher having an embedded role in the cancer system organization and/or close alignment of the study with organizational priorities. Document reviews found evidence of planned IKT strategies in 3 of 4 cases; however, actual KU role/engagement on research teams was variable. CONCLUSIONS: Barriers to KU co-production of cancer health services research include mismatched expectations of KU role and frequent KU turnover. When a research study directly aligns with organizational priorities, it appears more likely that results will be considered in programming. Research teams that take an IKT approach should consider specific strategies to address barriers to KU engagement.

So You Want to Be a Principal Investigator.

Therapeutic trials represent the front line of clinical progress, where the rubber meets the road. The conduct of clinical trials requires unique skills, innate as well as learned, on the part of the investigators who conduct these studies. Often such skills are acquired on the job and are passed on from mentor to junior investigator. However, over the years, the role of the principal investigator (PI) has evolved into a vast list of roles and responsibilities that cannot readily be conveyed through a hands-on approach alone. The fast-paced tempo of drug discovery and development, and the ever-increasing numbers of therapeutic trials being conducted in the United States, combined with a decline in the number of new clinical investigators, have exposed a gap between the expectations placed on the PI and the training and experience of today's young clinicians, who are being asked to take on the responsibilities outlined in Food and Drug Administration Form 1572. This article aims to begin an exploration of the role and increasing responsibilities of a PI and the growing need for structured investigator training. We propose options to better equip the PI to achieve compliance with Good Clinical Practice.

Agreement between core laboratory and study investigators for imaging scores in a thrombectomy trial.

PURPOSE: We aimed to assess the agreement between study investigators and the core laboratory (core lab) of a thrombectomy trial for imaging scores. METHODS: The Alberta Stroke Program Early CT Score (ASPECTS), the European Collaborative Acute Stroke Study (ECASS) hemorrhagic transformation (HT) classification, and the Thrombolysis In Cerebral Infarction (TICI) scores as recorded by study investigators were compared with the core lab scores in order to assess interrater agreement, using Cohen's unweighted and weighted kappa statistics. RESULTS: There were frequent discrepancies between study sites and core lab for all the scores. Agreement for ASPECTS and ECASS HT classification was less than substantial, with disagreement occurring in more than one-third of cases. Agreement was higher on MRI-based scores than on CT, and was improved after dichotomization on both CT and MRI. Agreement for TICI scores was moderate (with disagreement occurring in more than 25% of patients), and went above the substantial level (less than 10% disagreement) after dichotomization (TICI 0/1/2a vs 2b/3). CONCLUSION: Discrepancies between scores assessed by the imaging core lab and those reported by study sites occurred in a significant proportion of patients. Disagreement in the assessment of ASPECTS and day 1 HT scores was more frequent on CT than on MRI. The agreement for the dichotomized TICI score (the trial's primary outcome) was substantial, with less than 10% of disagreement between study sites and core lab. TRIAL REGISTRATION NUMBER: NCT02523261, Post-results.

An Evolving Story of Translational Research: A Decade after the Jacobson Promising Investigator Award.

THE THIRD JOAN L AND JULIUS H JACOBSON PROMISING INVESTIGATOR AWARDEE, MARK PUDER, MD, PHD, FACS: In 2005, the Surgical Research Committee (SRC) of the American College of Surgeons was tasked with selecting the recipient of a newly established award, "The Joan L and Julius H Jacobson Promising Investigator Award." According to the Jacobsons, the award, funded by Dr Jacobson, should be given at least once every 2 years to a surgeon investigator at "the tipping point," who can demonstrate that his or her research shows the promise of leading to a significant contribution to the practice of surgery and patient safety. Every year, the SRC receives many excellent nominations and has the difficult task of selecting 1 awardee. The first awardee was Michael Longaker, MD, FACS, who, 10 years later, reflected on the award and the impact it had on his career.1 This year, Mark Puder, MD, PhD FACS, the third Jacobson awardee, reflects on his 10-year journey after receiving the award. Dr Puder is now a national and international figure in the field of intestinal failure-associated liver disease and has studied the effect of intravenous lipid emulsions on the etiology and treatment of a once fatal disease in children. Kamal MF Itani, MD, FACS and Brian S Zuckerbraun, MD, FACS, on behalf of the Research Committee of the American College of Surgeons.

Presenting comparative study PRO results to clinicians and researchers: beyond the eye of the beholder.

PURPOSE: Patient-reported outcome (PRO) results from clinical trials can inform clinical care, but PRO interpretation is challenging. We evaluated the interpretation accuracy and perceived clarity of various strategies for displaying clinical trial PRO findings. METHODS: We conducted an e-survey of oncology clinicians and PRO researchers (supplemented by one-on-one clinician interviews) that randomized respondents to view one of the three line-graph formats (average scores over time for two treatments on four domains): (1) higher scores consistently indicating "better" patient status; (2) higher scores indicating "more" of what was being measured (better for function, worse for symptoms); or (3) normed scores. Two formats displayed proportions changed (pie/bar charts). Multivariate modeling was used to analyze interpretation accuracy and clarity ratings. RESULTS: Two hundred and thirty-three clinicians and 248 researchers responded; ten clinicians were interviewed. Line graphs with "better" directionality were more likely to be interpreted accurately than "normed" line graphs (OR 1.55; 95% CI 1.01-2.38; p = 0.04). No significant differences were found between "better" and "more" formats. "Better" formatted graphs were also more likely to be rated "very clear" versus "normed" formatted graphs (OR 1.91; 95% CI 1.44-2.54; p < 0.001). For proportions changed, respondents were less likely to make an interpretation error with pie versus bar charts (OR 0.35; 95% CI 0.2-0.6; p < 0.001); clarity ratings did not differ between formats. Qualitative findings informed the interpretation of the survey findings. CONCLUSIONS: Graphic formats for presenting PRO data differ in how accurately they are interpreted and how clear they are perceived to be. These findings will inform the development of best practices for optimally reporting PRO findings.

Can cancer researchers accurately judge whether preclinical reports will reproduce?

There is vigorous debate about the reproducibility of research findings in cancer biology. Whether scientists can accurately assess which experiments will reproduce original findings is important to determining the pace at which science self-corrects. We collected forecasts from basic and preclinical cancer researchers on the first 6 replication studies conducted by the Reproducibility Project: Cancer Biology (RP:CB) to assess the accuracy of expert judgments on specific replication outcomes. On average, researchers forecasted a 75% probability of replicating the statistical significance and a 50% probability of replicating the effect size, yet none of these studies successfully replicated on either criterion (for the 5 studies with results reported). Accuracy was related to expertise: experts with higher h-indices were more accurate, whereas experts with more topic-specific expertise were less accurate. Our findings suggest that experts, especially those with specialized knowledge, were overconfident about the RP:CB replicating individual experiments within published reports; researcher optimism likely reflects a combination of overestimating the validity of original studies and underestimating the difficulties of repeating their methodologies.

New European Clinical Trial Regulation: perception and expectations in Italy.

BACKGROUND: In July 2012, the European Commission formalized the proposal for a European Clinical Trial Regulation that should replace the European Clinical Trials Directive 2001/20/CE. The new Regulation 536/2014 entered into force in June 2014 and it was expected to be applied not earlier than May 2016. Indeed, at the time, all required central tools are not yet available and new forecasts indicate it will become effective at the end of 2018. The aims of the Regulation are the promotion of higher standards in patient's safety and increasing transparency in Clinical Trials, also by changing the application process. METHODS: An online survey was conducted among the Italian's Clinical Research Coordinators and Clinical Investigators to examine the perception and knowledge about the upcoming changes in Clinical Trials. A total of 190 Clinical Research Coordinators and 80 Clinical Investigators were surveyed. RESULTS: Clinicians are less aware of the content of the Regulation than Clinical Research Coordinators, who demonstrate an extensive expertise on the topic (84.4%), mainly reached through self-training. The majority of the Investigators (74%) believes that their site's facilities and staff already met all the requirements imposed by the Regulation while Clinical Research Coordinators are less optimistic: 65.2% of them believes that the site staff is not yet fully aware of changes associated to its implementation. CONCLUSIONS: The general opinion of the interviewed is that the new Regulation will strongly affect the trial management regardless of their type and phase, and the fulfillment of the imposed requirements represents an opportunity that Italy should not miss to increase its attractiveness to the pharmaceutical market.

What specifications for a centre or network of excellence in clinical research?

The Giens 2015 Workshop Round Table entitled "What specifications for a centre or network of excellence in clinical research?" took a viewpoint distinct from earlier work and studies on changes in clinical research activities in France. The purpose of the present work was to identify, starting from concrete examples, the main strengths and advantages of clinical research activity in France related, in part, to the background environment and also to the specific characteristics of the investigation centres considered to be among the most high-performance units in activity. The criteria retained were grouped into a set of specifications that could be used to establish a "label of excellence" upon which the different teams and clinical research centres could model themselves. It was thus considered that belonging to a centre or structured network with at least a national configuration, when this is possible for the medial topic in question, constitutes a real advantage. Four benchmarks were identified: the scientific and clinical expertise of the head investigator, as well as the qualification and operational capacity of the centre's team; definition and measurement of performance using clearly displayed indicators and evaluation procedures; the quality of the overall trial "process" and of each of its component steps; communication, because know-how and promotion go hand in hand, with the main objective of informing the professional and general public about the value of the research centre meeting the above-mentioned criteria, about its networks of competencies, and more generally, about the important assets of the background of clinical research in France. This sector of research is funded by the public authorities via calls for public grants, financial aids for structures supporting clinical research in the University Hospital Centres and other healthcare institutions allowing for a professionalization of the research occupations, and the national public health plans (cancer, rare disease, HIV).