Restricting alcohol marketing to reduce alcohol consumption: A systematic review of the empirical evidence for one of the 'best buys'.

BACKGROUND AND AIMS: Even though a ban of alcohol marketing has been declared a 'best buy' of alcohol control policy, comprehensive systematic reviews on its effectiveness to reduce consumption are lacking. The aim of this paper was to systematically review the evidence for effects of total and partial bans of alcohol marketing on alcohol consumption. METHODS: This descriptive systematic review sought to include all empirical studies that explored how changes in the regulation of alcohol marketing impact on alcohol consumption. The search was conducted between October and December 2022 considering various scientific databases (Web of Science, PsycINFO, MEDLINE, Embase) as well as Google and Google Scholar. The titles and abstracts of a total of 2572 records were screened. Of the 26 studies included in the full text screening, 11 studies were finally included in this review. Changes in consumption in relation to marketing bans were determined based on significance testing in primary studies. Four risk of bias domains (confounding, selection bias, information bias and reporting bias) were assessed. RESULTS: Seven studies examined changes in marketing restrictions in one location (New Zealand, Thailand, Canadian provinces, Spain, Norway). In the remaining studies, between 17 and 45 locations were studied (mostly high-income countries from Europe and North America). Of the 11 studies identified, six studies reported null findings. Studies reporting lower alcohol consumption following marketing restrictions were of moderate, serious and critical risk of bias. Two studies with low and moderate risk of bias found increasing alcohol consumption post marketing bans. Overall, there was insufficient evidence to conclude that alcohol marketing bans reduce alcohol consumption. CONCLUSIONS: The available empirical evidence does not support the claim of alcohol marketing bans constituting a best buy for reducing alcohol consumption.

GRADE Notes 3: two approaches to assess industry sponsorship bias used by two Dutch guidelines organizations.

OBJECTIVE: Our objective is to develop a step-by-step approach for our institutes to evaluate the influence of the funding body 1. on risk of bias of an individual study and 2. on publication bias in reviews and meta-analyses for guidelines. STUDY DESIGN AND SETTING: Methodologists from guideline organizations in the Netherlands discussed the influence of the funding body in clinical trials researching interventions. Results were discussed in our organizations and presented at the Dutch GRADE Network. RESULTS: Two step-by-step approaches were developed to guide methodologists from our institutes in assessing the influence of the funding body 1. on risk of bias of an individual study and 2. on publication bias in reviews and meta-analyses for guidelines. For risk of bias, the involvement of the funding body in the study is checked as well as the direction of the effect. For publication bias, the exploration by the authors is evaluated, and any difference between industry-funded and non-funded studies in effect is checked. Guiding questions were proposed. CONCLUSION: The step-by-step approaches make the evaluation of the influence of the funding body more objective and transparent in our institutes. The developed approaches will also be brought forward to the Grading of Recommendations Assessment, Development and Evaluation working group.

Ensuring quality control in a COVID-19 clinical trial during the pandemic: The experience of the Inserm C20-15 DisCoVeRy study.

SETTING: Health measures taken during the pandemic deeply modified the clinical research practices. At the same time, the demand for the results of the COVID-19 trials was urgent. Thus, the objective of this article is to share Inserm's experience in ensuring quality control in clinical trials in this challenging context. OBJECTIVES: DisCoVeRy is a phase III randomized study that aimed at evaluating the safety and efficacy of 4 therapeutic strategies in hospitalized COVID-19 adult patients. Between March, 22nd 2020 and January, 20th 2021, 1309 patients were included. In order to guarantee the best quality of data, the Sponsor had to adapt to the current sanitary measures and to their impact on clinical research activity, notably by adapting Monitoring Plan objectives, involving the research departments of the participating hospitals and a network of clinical research assistants (CRAs). RESULTS: Overall, 97 CRAs were involved and performed 909 monitoring visits. The monitoring of 100% of critical data for all patients included in the analysis was achieved, and despite of the pandemic context, a conform consent was recovered for more than 99% of patients. Results of the study were published in May and September 2021. DISCUSSION/CONCLUSION: The main monitoring objective was met thanks to the mobilization of considerable personnel resources, within a very tight time frame and external hurdles. There is a need for further reflection to adapt the lessons learned from this experience to the context of routine practice and to improve the response of French academic research during a future epidemic.

Streamlining clinical research: an ESMO awareness call to improve sponsoring and monitoring of clinical trials.

BACKGROUND: During recent years, the burden of bureaucracy in clinical research has increased dramatically, adversely impacting the activity of investigators and clinical research teams. Although compliance with the Declaration of Helsinki, the guidelines for Good Clinical Practice (GCP), and other applicable regulations remains unquestionable, their overinterpretation and substitution by the internal operating procedures of sponsors and Contract Research Organizations (CROs) have increased the administrative burden. A survey conducted by the European Society for Medical Oncology (ESMO) Clinical Research Observatory (ECRO) among 940 investigators confirmed that they considered that the administrative burden in clinical research is excessive; that administrative procedures could be reduced without affecting the safety and the rights of the patients and the quality of the data; and that bureaucracy represents an obstacle for clinical research. METHODS: A panel of physicians with extensive experience in clinical research, composed by members of the ECRO and the ESMO Scientific Medical and Public Policy divisions, analyzed clinical trial procedures related to administrative workflow, pharmacovigilance, and medical care. RESULTS: The panel identified situations that generate debate between investigators and sponsors/CROs and selected real clinical scenarios that exemplify such situations. The panel discussed and proposed specific recommendations for those situations, based on GCP. CONCLUSIONS: This initiative aspires to streamline clinical research procedures and to become a platform for discussion among all clinical trial stakeholders, with the aim of promoting the sustainability of clinical research and the care of cancer patients.

The Feasibility and Effectiveness of an Online Curriculum for Virtual Onboarding/Orientation of Graduate Medical Education Learners During the COVID-19 Pandemic.

Background: Graduate medical education (GME) orientation/onboarding is conventionally an in-person activity, but the COVID-19 pandemic prompted virtual approaches to learner onboarding. However, online GME onboarding strategies have not been disseminated in the literature. Objective: To determine the usefulness of an online curriculum for GME learner orientation at a large sponsoring institution using an electronic survey. The primary outcome was to discover the usefulness of our online curriculum for GME onboarding, and secondary outcomes included identifying barriers to implementation and weaknesses associated with online GME orientation. Methods: We created an online GME orientation curriculum to onboard incoming learners (from June 1 to August 31, 2020) and electronically surveyed our learners to determine the usefulness of this novel approach. We conducted orientation sessions and electronically recorded questionnaire responses using CarmenCanvas, our institutional learning management system. Linear regression analysis was performed to identify factors predicting satisfaction with virtual GME orientation using IBM SPSS Statistics, Version 26.0 (Armonk, NY, USA). Results: Of 353 trainees, 272 completed the survey for a 77% response rate. 97% of respondents reported that the curriculum supported performance of learner duties. 79% of trainees perceived the overall quality as "very good" or "good", 91% responded that the curriculum provided "effective learning", 94% reported "accessing the course content easily", 92% reported "easily navigating the curriculum", 91% described the curriculum as "well-organized", and 87% reported that the lectures "supported their learning". Conclusion: Online delivery of a comprehensive GME orientation curriculum is useful and facilitates learner education, training, and integration into a large GME institution in the COVID-19 era.

Sponsorship in academic medicine in Switzerland: Push and pull.

INTRODUCTION: Mentorship provides general career guidance in academic medicine. Sponsorship advocates for a sponsee by endorsing this person for a position or role. Sponsorship is less common and originates from the corporate world. The objective was to evaluate current mentorship and sponsorship practices in academic medicine in the German-speaking regions of Switzerland. The aim was to assess to which degree sponsorship is implemented in academic medicine in Switzerland. METHODS: Cross-sectional survey of current and alumni participants of career development programs at two Medical Faculties of Swiss universities. Both programs build on institutionalized mentoring. The anonymous electronic survey was based on a literature review with non-validated questions about mentorship and sponsorship. RESULTS: The overall survey response rate was 37.6% (38/101). The majority of respondents was female (31/38; 81.6%) and between 30 and 40 years of age (22/38; 57.9%). Almost all participants had at least one mentor (37/38; 97.4%), and mentoring addressed all or most (21/38; 55.3%) of the relevant topics regarding academic career development. More than one third of the respondents (13/38; 34.2%) did not have a sponsor, 4/38 (10.5%) were unsure whether they had a sponsor, and 5/38 (13.2%) had not yet heard about sponsorship. DISCUSSION: In Switzerland, mentorship is well-established in academic medicine while awareness for the benefits of sponsorship needs to be fostered in order to further advance academic careers in medicine. CONCLUSION: Mentoring and sponsoring may be considered key instruments for empowerment of junior faculty/physician scientists to become leaders in the field of academic medicine.

Publication rate and research topics of studies in pediatric kidney transplantation.

BACKGROUND: The quality of medical care for pediatric kidney transplant recipients depends on sound evidence from published clinical trials. METHODS: We examined the publication rate, time to publication, and factors associated with publication of studies in pediatric kidney transplantation registered on ClinicalTrials.gov from 1999 to 2020. RESULTS: We identified 136 studies with an overall enrollment of 36255 study participants, of which only 58.8% have been published yet. Unpublished studies included data from 14 350 participants. The median time to publication was 25 months (range, 0-117) with a significantly shorter time to publication in more recent years. The most frequently investigated research topic was immunosuppressants (49.3%), followed by perioperative management (11.0%) and infectiology (10.3%). The percentage of published studies was highest for the topic steroid withdrawal (87.5%), followed by infectiology (78.6%), and nutrition, sports and quality of life (71.4%). Studies, which were co-funded by industry, showed a significantly higher 5-year publication rate (p = 0.019). CONCLUSIONS: In conclusion, nearly half of all studies in pediatric kidney transplantation remain unpublished. Non-publication of studies might lead to a publication bias with a negative impact on clinical decision-making.

Match for Orthopedic Fellowship Programs in the United States: Online Accessibility, Content, and Accreditation Comparison Between Subspecialties and Review of Alternative Resources.

BACKGROUND: Orthopedic surgery is considered among the highly competitive medical specialties to get in as a career in the United States. San Francisco Match (SF Match) is the matching service for orthopedic subspecialty fellowship programs, and the internet is the main source for applicants to obtain program information in the modern era. We aimed to determine and compare the accessibility, content, and accreditation details of the various orthopedic fellowship programs available at the Match website and alternative online resources. METHODS: We studied eight subspecialties (Adult Reconstruction, Musculoskeletal Oncology, Foot and Ankle, Pediatric Orthopedics, Shoulder and Elbow, Orthopedic Spine Surgery, Sports Medicine, and Trauma) in a cross-sectional design during August/September 2019 for programs starting in July/August 2021. We registered the available baseline information at the SF Match site under various categories. We tried to reach the program-specific webpage through SF Match hyperlink and categorized our results into successful (direct and indirect) links and unsuccessful links with subcategorization. We also analyzed the information available at sponsoring society, FREIDA (Fellowship and Residency Electronic Interactive Database), and ACGME (Accreditation Council for Graduate Medical Education) websites. RESULT: We analyzed 465 programs (874 positions) available through the SF Match website. A standardized program description was available for >80% of the programs in each subspecialty. The availability of a successful link for the program-specific webpage ranges from 35% (Pediatric Orthopedics) to 77% (Sports Medicine). Indirect links were almost twice as common as direct links. The success rates through the sponsoring society webpages vary from 3% (Shoulder and Elbow) to 53% (Pediatric Orthopedics). Failure rates after trying both (the Match and Society links) range from 10% (Musculoskeletal Oncology) to 34% (Shoulder and Elbow). FREIDA provides comprehensive information but is limited to accredited programs. ACGME accreditation rate varied from 14.6% (Foot and Ankle) to 98.9% (Sports Medicine). CONCLUSION: The selection of a subspecialty fellowship program is crucial for most applicants. There are plenty of resources for the orthopedic fellowship programs' online presence after two decades since the first orthopedic fellowship match inception. Match website is the primary resource for the applicants. All parties could be benefited if both the programs and the sponsoring societies offer adequate online information to the Match, leading to ideal fellow-program matches and improved educational experiences. Our study may stand as a reference for future comparison possibly due to post-COVID evolution in the Match process. We recommend that consistent availability of direct functional program website links, point-based program description, and filter/comparison options may further improve online accessibility and quality of the content of the Match website.

[A survey on French hospital physicians'certification to the good clinical practices]. / Enquête sur la certification aux bonnes pratiques cliniques en recherche académique.

Good clinical practice (GCP) is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials. Before the start of a clinical trial, investigators commit to perform the research in accordance with GCPs, regulatory dispositions and protocol. The sponsors are responsible for investigators' selection and for controlling their skills. Whereas industrial sponsors systematically require a certificate of GCP training, academic sponsors seem to be less demanding. We have carried out two surveys between April and June 2018. A first questionnaire was sent to the 40 French academic directions of clinical research and innovation in order to determine their requirements about the GCP training of the investigators participating in their trials. The second questionnaire was transmitted to physicians of the "Bretagne recherche clinique hospitalière network": Rennes, Saint-Malo, Saint-Brieuc, Vannes, Lorient and Pontivy hospitals, in order to determine the GCP certification rate, and their needs in terms of clinical research training. Twenty-eight (70%) directions of clinical research answered the first survey, among which 18 (64%) required systematically the investigators' GCP certification in case of category 1 interventional studies. This rate decreased for category 2 (50%) and non-interventional category 3 (18%) studies. A total of 345 physicians answered the second survey, among which 263 (76%) had already been clinical trial investigators. However, only 29% of all physicians and 54% of those who had been principal investigator were certified for GCP training. These results support the need for large campaigns of GCP training in public hospitals.

[Recomendaciones a los cuerpos directivos de las agrupaciones médicas en su relación con la industria].

Continuing medical education activities are often financially supported by pharmaceutical and device companies. With the purpose to ensure ethics and accountability in the management of this assistance, the Committee of Ethics and Transparency in the Physician-Industry Relationship of the National Academy of Medicine of Mexico formulates recommendations to medical associations' leaders in this text.

Las actividades de educación médica continua con frecuencia son apoyadas financieramente por la industria farmacéutica y de implementos médicos. Con el propósito de velar por la ética y rendición de cuentas en el manejo de estos apoyos, en el presente texto el Comité de Ética y Transparencia en la Relación Médico-Industria (Cetremi) de la Academia Nacional de Medicina de México formula recomendaciones a los directivos de agrupaciones médicas.

["Integrity" in the healthcare system : Recognize and avoid risks: on dealing with the Association of Statutory Health Insurance Physicians and the public prosecutors office]. / "Lauterkeit" im Gesundheitswesen : Risiken erkennen und vermeiden: zum Umgang mit Kassenärztlicher Vereinigung und Staatsanwaltschaft.

BACKGROUND: This article describes the introduction of the law to combat corruption in the healthcare system. OBJECTIVE: The effects of the introduced penal regulations on the delivery of medical services is critically scrutinized and the associated procedures as well as indications for the course of action are presented. RESULTS: Knowledge of the relevant regulations and types of procedure is decisive for the penal, social legislative and professional conduct risk minimization.

[Anticorruption Act : A criminal proceedings prophylaxis for urologists]. / Antikorruptionsgesetz : Eine strafrechtliche Prophylaxe für den Urologen.

Since the introduction of the German Act to Combat Corruption in the Healthcare Sector concerns of fear and uncertainty are present. An elementary protection against criminal investigations can be achieved by complying with the physician professional law. Service contracts with the industry can be concluded if the interest in the service is reasonable and the payment is appropriate. There is a restrictive scale for clinical trials with already authorized products regarding any compensation granted which should correspond to the amount determined by the applicable elements of the German scale of medical fees (GOÄ). Invitations to academic training events can be accepted within an appropriate framework.

Comparing mentorship and sponsorship in clinical neuropsychology.

OBJECTIVE: Mentoring is a well-known concept that is widely regarded as beneficial for personal and professional development. The concept of sponsoring is less recognized although it is considered critical by some for career advancement. The purpose of this study was to provide an initial exploration of differences between mentoring and sponsoring within neuropsychology and to learn what sponsors look for in protégés. METHOD: Twenty neuropsychologists with experience in mentorship and sponsorship were interviewed. Topics covered included the number of protégés they had mentored/sponsored, training received in mentoring/sponsoring, characteristics they look for in protégés, expectations of protégés, reasons they mentor/sponsor, and benefits of mentoring/sponsoring. RESULTS: On average, neuropsychologists interviewed had mentored 58 protégés and sponsored 40. None had ever received formal training in mentoring or sponsoring. Key characteristics needed for neuropsychologists to feel comfortable mentoring/sponsoring protégés were similar while those characteristics valued differed slightly with sponsored protégés valued for competence and getting things done and mentored protégés valued for interpersonal qualities. Reasons for and benefits of mentorship/sponsorship were similar, with rewarding feelings, satisfaction, and pride in the protégé's successes at the top of the list. CONCLUSIONS: Neuropsychologists who provide training are in the position to mentor and sponsor individuals; mentoring relationships often entail sponsorship and vice versa such that the two constructs may be considered part of a continuum. Improving knowledge and skills in mentorship and sponsorship will not only advance personal and professional development of protégés but will also positively impact mentors/sponsors and help shape the field of neuropsychology in deliberate ways.

Position paper on current aspects of sponsoring in accredited CME.

This position paper is the result of a collaborative approach of several European Specialty Accreditation Boards (ESABs) and, has been stimulated by their current experience in accreditation regarding roles and responsibilities assumed by sponsors of accredited continuing medical education (CME). The suggestions made in this paper aim to preserve the fundamental principle in CME accreditation that the physician in charge of the programme has sole responsibility for the selection of topics, speakers, content and format, as well as mode of presentation, and that sponsors will under no circumstances interfere with this principle. This is considered as a responsibility of an individual physician (or physicians), which cannot be delegated, even in part, to third parties. This responsibility has been extended to include all communication before and after the event. The paper also identifies undecided issues, about which ESABs are committed to elaborate proposals in the future.

Participações na organização e oficialização de novas sociedades componentes da IPA / Participaciones en la organización y formalización de nuevas sociedades componentes de la IPA / Participations in the organization and formalization of new components societies of IPA

No texto são descritas as participações da Sociedade Psicanalítica de Porto Alegre (SPPA), através do autor, nas tarefas de organização, avaliação e posterior oficialização, pela International Psychoanalytical Association (IPA), de quatro sociedades psicanalíticas latino-americanas. São sumariados os longos processos determinados pela IPA para a consecução de tais objetivos, bem como explicados os motivos de tais exigências. Finalmente, é acentuado o valor dos laços afetivos que derivam de tais trabalhos compartilhados

Based on the author’s experience, the text describes the participation of the Psychoanalytical Society of Porto Alegre (SPPA) in the tasks of organization, evaluation and later formalization by the International Psychoanalytical Association (IPA) of four Latin American psychoanalytic societies. The long processes determined by the IPA to achieve these goals are described and the reasons for these requirements are explained as well. Finally, the value of emotional ties that derive from such shared work is stressed

En el texto son descritas las participaciones de la Sociedad Psicoanalítica de Porto Alegre (SPPA), a través del autor, en las tareas de organización, evaluación y posterior formalización, por la Internatcional Psychoanalytical Association (IPA), de cuatro sociedades psicoanalíticas. Son resumidos los largos procesos determinados por la IPA para la consecución de tales objetivos, así como explicados los motivos de tales exigencias. Finalmente, es acentuado el valor de los lazos afectivos que derivan de tales trabajos compartidos