Completeness and consistency of primary outcome reporting in COVID-19 publications in the early pandemic phase: a descriptive study.

BACKGROUND: The COVID-19 pandemic saw a steep increase in the number of rapidly published scientific studies, especially early in the pandemic. Some have suggested COVID-19 trial reporting is of lower quality than typical reports, but there is limited evidence for this in terms of primary outcome reporting. The objective of this study was to assess the prevalence of completely defined primary outcomes reported in registry entries, preprints, and journal articles, and to assess consistent primary outcome reporting between these sources. METHODS: This is a descriptive study of a cohort of registered interventional clinical trials for the treatment and prevention of COVID-19, drawn from the DIssemination of REgistered COVID-19 Clinical Trials (DIRECCT) study dataset. The main outcomes are: 1) Prevalence of complete primary outcome reporting; 2) Prevalence of consistent primary outcome reporting between registry entry and preprint as well as registry entry and journal article pairs. RESULTS: We analyzed 87 trials with 116 corresponding publications (87 registry entries, 53 preprints and 63 journal articles). All primary outcomes were completely defined in 47/87 (54%) registry entries, 31/53 (58%) preprints and 44/63 (70%) journal articles. All primary outcomes were consistently reported in 13/53 (25%) registry-preprint pairs and 27/63 (43%) registry-journal article pairs. No primary outcome was specified in 13/53 (25%) preprints and 8/63 (13%) journal articles. In this sample, complete primary outcome reporting occurred more frequently in trials with vs. without involvement of pharmaceutical companies (76% vs. 45%), and in RCTs vs. other study designs (68% vs. 49%). The same pattern was observed for consistent primary outcome reporting (with vs. without pharma: 56% vs. 12%, RCT vs. other: 43% vs. 22%). CONCLUSIONS: In COVID-19 trials in the early phase of the pandemic, all primary outcomes were completely defined in 54%, 58%, and 70% of registry entries, preprints and journal articles, respectively. Only 25% of preprints and 43% of journal articles reported primary outcomes consistent with registry entries.

[Public Health Education in Health-Related Study Programs in Germany: Perspectives from Course Coordinators]. / Lehre von Public Health in gesundheitsbezogenen Studiengängen in Deutschland: die Sicht von Studiengangsverantwortlichen.

INTRODUCTION: Public health education in Germany takes place in public health courses and in health-related study courses. We aim to provide data and knowledge on structure and content of health-related study courses and on cooperation between universities and/or Universities of Applied Sciences. METHODS: We conducted an online-based cross-sectional study (01.6. - 15.9.2015), involving 93 universities and Universities of Applied Sciences in Germany. Herewith we addressed 351 study course coordinators. We included course coordinators from universities and Universities of Applied Sciences who were members of the German Association of Social Medicine and Prevention (DGSMP) or in the Association Universities for Health (HOGE). RESULTS: 104 course coordinators responded to the survey (43% men, 57% women). Among others, global health and environmental health are primarily taught in public health courses; ethics and psychology primarily in health-related study courses. Financial support for teaching and research is highly needed at universities and at universities of applied sciences. Furthermore, there is a high need of cooperation between institutions. Additionally, course coordinators from universities of applied sciences indicated a need for cooperative doctoral programs. CONCLUSION: In Germany, competence criteria for teaching public health are missing. Additionally, cooperation between study courses needs to be developed further.

Drivers of poor medical care.

The global ubiquity of overuse and underuse of health-care resources and the gravity of resulting harms necessitate an investigation of drivers to inform potential solutions. We describe the network of influences that contribute to poor care and suggest that it is driven by factors that fall into three domains: money and finance; knowledge, bias, and uncertainty; and power and human relationships. In each domain the drivers operate at the global, national, regional, and individual level, and are modulated by the specific contexts within which they act. We discuss in detail drivers of poor care in each domain.

Consequences of early thyroid ultrasound on subsequent tests, morbidity and costs: an explorative analysis of routine health data from German ambulatory care.

OBJECTIVES: This study aims to evaluate whether the use of thyroid ultrasound (US) early in the work-up of suspected thyroid disorders triggers cascade effects of medical procedures and to analyse effects on morbidity, healthcare usage and costs. STUDY DESIGN: Retrospective analysis of claims data from ambulatory care (2012-2017). SETTING: Primary care in Bavaria, Germany, 13 million inhabitants. PARTICIPANTS: Patients having received a thyroid stimulating hormone (TSH) test were allocated to (1) observation group: TSH test followed by an early US within 28 days or (2) control group: TSH test, but no early US. Propensity score matching was used adjusting for socio-demographic characteristics, morbidity and symptom diagnosis (N=41 065 per group after matching). PRIMARY AND SECONDARY OUTCOME MEASURES: Using cluster analysis, groups were identified regarding frequency of follow-up TSH tests and/or US and compared. RESULTS: Four subgroups were identified: cluster 1: 22.8% of patients, mean (M)=1.6 TSH tests; cluster 2: 16.6% of patients, M=4.7 TSH tests; cluster 3: 54.4% of patients, M=3.3 TSH tests, 1.8 US; cluster 4: 6.2% of patients, M=10.9 TSH tests, 3.9 US. Overall, reasons that explain the tests could rarely be found. An early US was mostly found in clusters 3 and 4 (83.2% and 76.1%, respectively, were part of the observation group). In cluster 4 there were more women, thyroid-specific morbidity and costs were higher and the early US was more likely to be performed by specialists in nuclear medicine or radiologists. CONCLUSION: Presumably unnecessary tests in the field of suspected thyroid diseases seem to be frequent, contributing to cascades effects. Neither German nor international guidelines provide clear recommendations for or against US screening. Therefore, guidelines on when to apply US and when not are urgently needed.

Moving towards patient-centered care and shared decision-making in Germany.

The main focus of this paper is to describe the development and current state of policy, research and implementation of patient-centered care (PCC) and shared decision-making (SDM) in Germany. What is the current state in health policy? Since 2013, the Law on Patients' Rights has standardized all rights and responsibilities regarding medical care for patients in Germany. This comprises the right to informed decisions, comprehensive and comprehensible information, and decisions based on a clinician-patient partnership. In addition, reports and action plans such as the German Ethics Council's report on patient well-being, the National Health Literacy Action Plan, or the National Cancer Plan emphasize and foster PCC and SDM on a policy level. There are a number of public organizations in Germany that support PCC and SDM. How are patients and the public involved in health policy and research? Publishers and funding agencies increasingly demand patient and public involvement. Numerous initiatives and organizations are involved in publicizing ways to engage patients and the public. Also, an increasing number of public and research institutions have established patient advisory boards. How is PCC and SDM taught? Great progress has been made in introducing SDM into the curricula of medical schools and other health care providers' (HCPs) schools (e.g., nursing, physical therapy). What is the German research agenda? The German government and other public institutions have constantly funded research programs in which PCC and SDM are important topics. This yielded several large-scale funding initiatives and helped to develop SDM training programs for HCPs in different fields of health care and information materials. Recently, two implementation studies on SDM have been conducted. What is the current uptake of PCC and SDM in routine care, and what implementation efforts are underway? Compared to the last country report from 2017, PCC and SDM efforts in policy, research and education have been intensified. However, many steps are still needed to reliably implement SDM in routine care in Germany. Specifically, the further development and uptake of decision tools and countrywide SDM trainings for HCPs require further efforts. Nevertheless, an increasing number of decision support tools - primarily with support from health insurance funds and other public agencies - are to be implemented in routine care. Also, recent implementation efforts are promising. For example, reimbursement by health insurance companies of hospital-wide SDM implementation is being piloted. A necessary next step is to nationally coordinate the gathering and provision of the many PCC and SDM resources available.

Perimenopause and Postmenopause - Diagnosis and Interventions. Guideline of the DGGG and OEGGG (S3-Level, AWMF Registry Number 015-062, September 2020).

Aim The aim of the interdisciplinary S3-guideline Perimenopause and Postmenopause - Diagnosis and Interventions is to provide help to physicians as they inform women about the physiological changes which occur at this stage of life and the treatment options. The guideline should serve as a basis for decisions taken during routine medical care. This short version lists the statements and recommendations given in the long version of the guideline together with the evidence levels, the level of recommendation, and the strength of consensus. Methods The statements and recommendations are largely based on methodologically high-quality publications. The literature was evaluated by experts and mandate holders using evidence-based medicine (EbM) criteria. The search for evidence was carried out by the Essen Research Institute for Medical Management (EsFoMed). To some extent, this guideline also draws on an evaluation of the evidence used in the NICE guideline on Menopause and the S3-guidelines of the AWMF and has adapted parts of these guidelines. Recommendations Recommendations are given for the following subjects: diagnosis and therapeutic interventions for perimenopausal and postmenopausal women, urogynecology, cardiovascular disease, osteoporosis, dementia, depression, mood swings, hormone therapy and cancer risk, as well as primary ovarian insufficiency.

Quantity and quality of conflict of interest policies at German medical schools: a cross-sectional study and survey.

OBJECTIVES: To assess the quantity and evaluate the quality of policies and curricula focusing on conflicts of interests (COI) at medical schools across Germany. DESIGN: Cross-sectional study, survey of medical schools, standardised web search. SETTING: Medical schools, Germany. PARTICIPANTS: 38 German medical schools. INTERVENTIONS: We collected relevant COI policies, including teaching activities, by conducting a search of the websites of all 38 German medical schools using standardised keywords for COI policies and teaching. Further, we surveyed all medical schools' dean's offices. Finally, we adapted a scoring system for results we obtained with 13 categories based on prior similar studies. MAIN OUTCOMES AND MEASURES: Presence or absence of COI-related policies, including teaching activities at medical school. The secondary outcome was the achieved score on a scale from 0 to 26, with high scores representing restrictive policies and sufficient teaching activities. RESULTS: We identified relevant policies for one medical school via the web search. The response rate of the deans' survey was 16 of 38 (42.1%). In total, we identified COI-related policies for 2 of 38 (5.3%) German medical schools, yet no policy was sufficient to address all COI-related categories that were assessed in this study. The maximum score achieved was 12 of 26. 36 (94.7%) schools scored 0. No medical school reported curricular teaching on COI. CONCLUSIONS: Our results indicate a low level of action by medical schools to protect students from undue commercial influence. No participating dean was aware of any curriculum or instruction on COI at the respective school and only two schools had policies in place. The German Medical Students Association and international counterparts have called for a stronger focus on COI in the classroom. We conclude that for German medical schools, there is still a long way to go.

Defining Criteria for Guiding Cancer Patients to Find a Reputable Complementary Medicine Provider: Results of a Literature Review and a Consensus Procedure.

PURPOSE: Even in cases of positive evidence for complementary medicine (CM) therapies, it is still difficult for cancer patients to identify reputable providers. The aim of this study was to develop and evaluate a criteria list to provide guidance to cancer patients seeking a reputable CM provider. METHODS: The design combined a literature review, an expert consensus procedure (n=15) and an assessment from three stakeholder perspectives (patients (n=18), CM providers (n=26) and oncology physicians (n=20)). RESULTS: A total of 30 existing CM criteria were extracted from the literature, and 12 more were added by the experts. The main challenge was to define criteria that could easily be applied by the patients. A final comprehensive list of 8 criteria guiding cancer patients to find a reputable CM provider was developed. CONCLUSION: Health professionals and cancer information services might find the criteria list helpful when aiming to strengthen patients' awareness of quality-related factors associated with CM providers. The criteria developed might be helpful when standards are established for quality assurance in CM in oncology.

The long way of implementing patient-centered care and shared decision making in Germany.

The main focus of the paper is on the description of the development and current state of research and implementation of patient-centered care (PCC) and shared decision making (SDM) after fifteen years of substantial advances in health policy and health services research. What is the current state of SDM in health policy? The "Patients' Rights Act" from 2013 standardizes all rights and responsibilities within the framework of medical treatment for German citizens and legal residents. This comprises the right to informed decisions, comprehensive and comprehensible information for patients, and decisions based on a clinician-patient-partnership. What is the current state of SDM interventions and patient decision support tools? SDM training programs for healthcare professionals have been developed. Their implementation in medical schools has been successful. Several decision support tools - primarily with support from health insurance funds and other public agencies - are to be implemented in routine care, specifically for national cancer screening programs. What is the current state of research and routine implementation? The German government and other public institutions are constantly funding research programs in which patient-centered care and shared decision-making are important topics. The development and implementation of decision tools for patients and professionals as well as the implementation of CME trainings for healthcare professionals require future efforts. What does the future look like? With the support of health policy and scientific evidence, transfer of PCC and SDM to practice is regarded as meaningful. Research can help to assess barriers, facilitators, and needs, and subsequently to develop and evaluate corresponding strategies to successfully implement PCC and SDM in routine care, which remains challenging.

When Choosing Wisely meets clinical practice guidelines.

The American Board of Internal Medicine (ABIM) Foundation launched the Choosing Wisely campaign in 2012 and until today convinced more than 50 US specialist societies to develop lists of interventions that may not improve people's health but are potentially harmful. We suggest combining these new efforts with the already existing efforts in clinical practice guideline development. Existing clinical practice guidelines facilitate a more participatory and evidence-based approach to the development of top 5 lists. In return, adding top 5 lists (for overuse and underuse) to existing clinical practice guidelines nicely addresses a neglected dimension to clinical practice guideline development, namely explicit information on which Do or Don't do recommendations are frequently disregarded in practice.

[How to bring quality into the focus of health care--results of a delphi and stakeholder survey]. / Wie rückt Qualität in den Fokus der Gesundheitsversorgung? Ergebnisse einer Delphi- und Akteurbefragung.

Although plenty of statutory requirements, concepts and tools to promote the quality of health care exist, Germany's health care system seems far from being pervaded by a vivid quality culture. In order to show ways how to succeed in developing and implementing such a quality culture in the German health care system, the Bertelsmann foundation conducted a delphi survey of seven quality of care experts and an online survey of 239 stakeholders, encompassing health care providers and representatives of the self administration of the health care system, politicians, the health care industry, and patient representatives. Based on the delphi results 31 theses within 12 subject areas have been formulated and assessed, which describe building blocks to put quality in the center of Germany's health care system. After dichotomizing the answers (school grades 1-6 into 1-2 = best, and 3-6 = worse) > 66% of the stakeholders rated 28 of 31 theses with grades 1-2. The ten most accepted theses received grades 1 or 2 from more than 85% of the stakeholders. Following the main results of the surveys, establishing a vivid quality culture requires outcome oriented quality goals and quality indicators to be defined, quality management to be embedded better into the education of all health care providers, and quality promotion to be introduced which is build on quality incentives and objective quality transparency. Since experts and stakeholders agree to such a high degree in the steps necessary to establish a quality culture in the German health care system, the realization of these steps seems to be possible.