Reactogenicity and safety of COVID-19 primary immunisation and booster vaccination regimens: a comparative observational cohort study.

BACKGROUND: Since the beginning of the COVID-19 vaccination campaigns, recommendations regarding the vaccination have been very dynamic. Although the safety and efficacy of different vaccines have been analysed, data were scarce for vaccine regimens combining different vaccines. We therefore aimed to evaluate and compare the perceived reactogenicity and need for medical consultation after the most frequently applied homologous and heterologous COVID-19 vaccination regimens. METHODS: In an observational cohort study, reactogenicity and safety were assessed within a maximum follow-up time of 124 days using web-based surveys. Reactogenicity was assessed for different vaccination regimens 2 weeks after a vaccination (short-term survey). The following surveys, long-term and follow-up surveys, focused on the utilisation of medical services, including those that were not suspected to be vaccine-related. RESULTS: Data of 17,269 participants were analysed. The least local reactions were seen after a ChAdOx1 - ChAdOx1 regimen (32.6%, 95% CI [28.2, 37.2]) and the most after the first dose with mRNA-1273 (73.9%, 95% CI [70.5, 77.2]). Systemic reactions were least frequent in participants with a BNT162b2 booster after a homologous primary immunisation with ChAdOx1 (42.9%, 95% CI [32.1, 54.1]) and most frequent after a ChAdOx1 - mRNA-1273 (85.5%, 95% CI [82.9, 87.8]) and mRNA-1273/mRNA-1273 regimen (85.1%, 95% CI [83.2, 87.0]). In the short-term survey, the most common consequences were medication intake and sick leave (after local reactions 0% to 9.9%; after systemic reactions 4.5% to 37.9%). In the long-term and follow-up surveys, between 8.2 and 30.9% of participants reported consulting a doctor and between 0% and 5.4% seeking hospital care. The regression analyses 124 days after the first and after the third dose showed that the odds for reporting medical consultation were comparable between the vaccination regimens. CONCLUSIONS: Our analysis revealed differences in reactogenicity between the COVID-19 vaccines and vaccination regimens in Germany. The lowest reactogenicity as reported by participants was seen with BNT162b2, especially in homologous vaccination regimens. However, in all vaccination regimens reactogenicity rarely led to medical consultations. Small differences in seeking any medical consultation after 6 weeks diminished during the follow-up period. In the end, none of the vaccination regimens was associated with a higher risk for medical consultation. TRIAL REGISTRATION: DRKS DRKS00025881 ( https://drks.de/search/de/trial/DRKS00025373 ). Registered on 14 October 2021. DRKS DRKS00025373 ( https://drks.de/search/de/trial/DRKS00025881 ). Registered on 21 May 2021. Registered retrospectively.

Patient-reported reactogenicity and safety of COVID-19 vaccinations vs. comparator vaccinations: a comparative observational cohort study.

BACKGROUND: In the course of the SARS-CoV-2 pandemic, multiple vaccines were developed. Little was known about reactogenicity and safety in comparison to established vaccines, e.g. influenza, pneumococcus, or herpes zoster. Therefore, the present study aimed to compare self-reported side effects in persons vaccinated against SARS-CoV-2 with the incidence of side effects in persons receiving one of the established vaccines. METHODS: A longitudinal observational study was conducted over a total of 124 days using web-based surveys. Persons receiving either a vaccination against SARS-CoV-2 or one of the established vaccines (comparator group) were included. In the first questionnaire (short-term survey), 2 weeks after vaccination, mainly local and systemic complaints were evaluated. The long-term survey (42 days after vaccination) and follow-up survey (124 weeks after vaccination) focused on medical consultations for any reason. Multivariate analyses were conducted to determine the influence of the vaccine type (SARS-CoV-2 vs. comparator) and demographic factors. RESULTS: In total, data from 16,636 participants were included. Self-reported reactogenicity was lowest in the comparator group (53.2%) and highest in the ChAdOx1 group (85.3%). Local reactions were reported most frequently after mRNA-1273 (73.9%) and systemic reactions mainly after vector-based vaccines (79.8%). Almost all SARS-CoV-2 vaccines showed increased odds of reporting local or systemic reactions. Approximately equal proportions of participants reported medical consultations. None in the comparator group suspected a link to vaccination, while this was true for just over one in 10 in the mRNA-1273 group. The multivariate analysis showed that people with SARS-CoV-2 vaccination were not more likely to report medical consultations; patients who had received a regimen with at least one ChAdOx1 were even less likely to report medical consultations. Younger age, female gender and higher comorbidity were mostly associated with higher odds of medical consultations. CONCLUSION: The rate of adverse reactions after established vaccinations was roughly comparable to previous studies. Two weeks after vaccination, participants in the SARS-CoV-2 vaccination group reported more local and systemic local reactions than participants in the comparator group. In the further course, however, there were no higher odds of medical consultations in either of the two groups. Thus, altogether, we assume comparable safety. TRIAL REGISTRATION: DRKS-ID DRKS00025881 and DRKS-ID DRKS00025373.

Reactogenicity after heterologous and homologous COVID-19 prime-boost vaccination regimens: descriptive interim results of a comparative observational cohort study.

BACKGROUND: Due to safety signals after vaccination with COVID-19 vector vaccines, several states recommended to complete the primary immunization series in individuals having received one dose of ChAdOx1 (AstraZeneca) with an mRNA vaccine. However, data on safety and reactogenicity of this heterologous regimen are still scarce. The aim of this study was therefore to compare the reactogenicity and the frequency of medical consultations after boost vaccination in a heterologous regimen with ChAdOx1 and mRNA-vaccines (BNT162b2, BioNTech/Pfizer or mRNA-1273, Moderna) to homologous regimens with ChAdOx1 or mRNA-vaccines, respectively. METHODS: In an observational cohort study reactogenicity and safety were assessed 14-19 days (short-term) and 40 to 56 days (long-term) after the boost vaccination using web-based surveys. In the short-term survey solicited and unsolicited reactions were assessed, while the long-term survey focussed on health problems leading to medical consultation after the vaccination, including those that were not suspected to be vaccine-related. RESULTS: In total, 9146 participants completed at least one of the surveys (ChAdOx1/ChAdOx1: n = 552, ChAdOx1/mRNA: n = 2382, mRNA/mRNA: n = 6212). In the short-term survey, 86% with ChAdOx1/mRNA regimen reported at least one reaction, in the ChAdOx1/ChAdOx1 and mRNA/mRNA cohorts 58% and 76%, respectively (age and sex adjusted p < 0.0001). In the long-term survey, comparable proportions of individuals reported medical consultation (ChAdOx1/ChAdOx1 vs. ChAdOx1/mRNA vs. mRNA/mRNA: 15% vs. 18% vs. 16%, age and sex adjusted p = 0.398). Female gender was associated with a higher reactogenicity and more medical consultations. Younger age was associated with a higher reactogenicity, whereas elderly people reported more medical consultations. CONCLUSION: Although the short-term reactogenicity was higher with the heterologous regimen than with the homologous regimens, other factors such as higher efficacy and limited resources during the pandemic may prevail in recommending specific regimens.

Vitamin-K-antagonist phenprocoumon versus low-dose direct oral anticoagulants (DOACs) in patients with atrial fibrillation: a real-world analysis of German claims data.

BACKGROUND: For stroke prevention in patients with atrial fibrillation (AF), direct oral anticoagulants (DOACs) have been increasingly prescribed instead of vitamin-K-antagonists (VKA). For some patients a lower dosage of DOACs (ld-DOACs) is recommended. Ld-DOAC prescribing seems to be common, although previous studies did not show clear superiority of ld-DOACs over warfarin. In Germany, phenprocoumon is used almost exclusively as VKA. Randomized controlled trials comparing DOACs and phenprocoumon in the general population of patients with AF do not exist. Therefore, we aimed to compare ld-DOACs and phenprocoumon in a real-world setting in Germany. METHODS: In a retrospective observational cohort study, claims data from a group of small to medium-sized health insurance companies were analysed. Risks for the outcomes thromboembolism, death and major bleeding were estimated by Cox regression. Out of 93,685 patients with atrial fibrillation and a first prescription of an oral anticoagulant, 20,179 receiving VKA and 21,724 ld-DOACs (29.6% of all DOAC patients) were included. For the sensitivity analysis phenprocoumon was compared to the five ld-DOAC groups (ld-apixaban, ld-dabigatran, ld-edoxaban, ld-rivaroxaban, and the composite of all ld-DOACs) after propensity-score matching. RESULTS: Phenprocoumon was associated with statistically significant fewer thromboembolic events (HR = 1.29, 95% CI [1.13, 1.48], p < .001) and deaths (HR = 1.52, 95% CI [1.41, 1.63], p < .001) and a non-significant higher bleeding risk (HR = 0.89, 95% CI [0.79, 1.00], p = .051) than composite ld-DOAC. Regarding the subgroups, only patients with ld-apixaban had a statistically significant higher risk for thromboembolic events (HR = 1.42, 95% CI [1.21, 1.65], p < .001) and a lower bleeding risk (HR = 0.75, 95% CI [0.65, 0.86], p < .001). Ld-apixaban, ld-edoxaban, and ld-rivaroxaban were associated with a higher risk of death. The sensitivity analysis confirmed these associations. CONCLUSION: Phenprocoumon seems to be superior to ld-DOACs for patients with AF. As a hypothesis phenprocoumon might turn out to be the wiser choice for high-risk patients with AF as compared to ld-DOACs, especially regarding thromboembolic events and death. Therefore, RCTs comparing ld-DOACs with phenprocoumon are needed.

What do people know and think about medical overuse? an online questionnaire study in Germany.

BACKGROUND: Medical overuse is defined as health care services that exceed the individual needs of patients and when the potential harms of medical interventions exceed their benefits. It has impacts on patients as well as on health care resources. To address medical overuse, it is important to understand the knowledge and experiences of overuse on the side of patients. RESEARCH QUESTIONS: What is the citizens' understanding of overuse? How do they assess its relevance, causes, consequences and potential solutions? METHODS: A quantitative online survey was conducted. The participants were asked to state what they understand by medical overuse. Statements on causes, consequences and possible solutions were evaluated. Recruitment was carried out via a panel of a market research institute (Schlesinger Group). RESULTS: The survey was completed by 406 participants. In terms of age and gender, the sample corresponded to the distribution in the German population. The majority had never heard of medical overuse (58%). About 60% assumed that medical overuse means "too much medicine including overtreatment and overtesting". Medical overuse was mainly suspected for services not covered by the public health insurance system (56%), surgical interventions (45%) and medication prescriptions (37%). Reasons for medical overuse were seen in uncoordinated care and financial incentives, but also in the expectations of patients. The main problem with medical overuse was seen in rising health care costs, while harmful physical and mental consequences for patients were mentioned less often. In order to reduce medical overuse, little importance was attributed to a primary care based system or higher financial contribution of patients. Instead, stricter cost control on the side of physicians and better coordination between care providers were suggested as solutions. Differences in socio-demographic characteristics hardly showed any differences in response behavior. CONCLUSION: More than half of the respondents had never heard of medical overuse. Overuse was mainly associated with financial causes and consequences. It was not seen that overuse can be harmful for patients directly. The limited awareness of the problem of overuse probably is a barrier to tackling it effectively. Communicating the topic to the public might therefore be an effective start to mitigate medical overuse. TAKE HOME MESSAGE: Many citizens seem not to be familiar with the concept of medical overuse, especially not with the fact that it may directly cause harm to patients. Informing citizens about the harms of medical overuse might be helpful in mitigating it.

Vitamin-K-antagonist phenprocoumon versus direct oral anticoagulants in patients with atrial fibrillation: a real-world analysis of German claims data.

OBJECTIVES: Direct oral anticoagulants (DOACs) were introduced based on randomised controlled trials (RCTs) comparing them to vitamin-K-antagonist (VKA) warfarin. In Germany, almost exclusively phenprocoumon is used as VKA. RCTs with phenprocoumon being absent we analysed the benefits and harms of DOACs and phenprocoumon for patients with atrial fibrillation (AF) in a real-world setting. DESIGN: In a retrospective observational cohort study, claims data covering inpatient and outpatient care from 2015 to 2019 were analysed by Cox regression and propensity score matching (PSM). SETTING: Data from a group of small-sized to medium-sized health insurance companies in Germany. PARTICIPANTS: We analysed datasets of 71 961 patients with AF and first prescription of phenprocoumon (n=20 179) or DOAC in standard dose (n=51 782). Patients with reduced dose of DOACs were excluded (n=21 724). OUTCOME MEASURES: Outcomes were thromboembolic events, major bleeding and death during a 12-month follow-up period. RESULTS: The regression analysis widely showed similarity between phenprocoumon and standard dose DOACs regarding effectiveness and safety. There were only three statistically significant differences: a lower bleeding risk with composite DOACs and apixaban (HR (95% CI) = 0.67 (0.59 to 0.76) and 0.54 (0.46 to 0.63), respectively) and a higher risk of death with rivaroxaban (1.21 (1.10 to 2.34)). The analysis after PSM was consistent with the first two results regarding composite DOACs and apixaban (number needed to treat, NNT 101 and 78) and showed a lower bleeding risk with rivaroxaban (NNT 156). Absolute differences were small. CONCLUSIONS: The small superiority or non-inferiority of DOACs over warfarin seen in the RCTs might not translate into relevant advantages of DOACs over phenprocoumon. To confirm the hypothesis, an RCT with phenprocoumon is needed. Next to the safety and effectiveness assessments other factors might also play a substantial role in the decision on the right OAC for stroke prevention.

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.

"The measures taken by the government overburdened the daily practice" - insights of the PRICOV-19 study on German general practitioners in times of COVID-19.

BACKGROUND: The international study PRICOV-19 aims to assess the impact of the COVID-19 pandemic on the organisation of primary health care. The German part focuses on German general practitioners during the second wave of the COVID-19 pandemic. This paper addresses the following research questions: (1) How were changes in tasks on primary care and patient treatment perceived by GPs?, (2) What was the role of GPs during the pandemic, and how was their wellbeing?, (3) How did GPs perceive health policy measures?, and, (4) What influenced the attitudes of GPs on health policy measures? METHODS: This study pursues a multi-country cross-sectional design. Data collection took place throughout Germany from 01.02. to 28.02.2021 with a quantitative online questionnaire consisting of 53 items. The questionnaire was analysed through descriptive and inferential analyses using correlation and multiple regression models. RESULTS: The response rate was 20.4% (n = 349). The respondents were mainly GPs (59.6%) in single practices (62.5%) with a mean work experience of 15 to 20 years. GPs experienced a change in their work and practice organisation (80.3%). They felt a high responsibility (70.6%) and found their work has become more meaningful to them (76%). They also saw a lack of political support (75.2%) and that the measures taken by the government overburdened the daily practice (66.4%). Not many GPs were at risk of being distressed (53.4%) but rated the health policies rather negatively (60%). The multiple regression showed, the more GPs were exposed to risk of distress, the worse they assessed the government's measures. CONCLUSION: GPs perceived their work as relevant and felt confident they could fulfil their tasks, but noticed that health policy initially hardly supported the outpatient sector. Health policies should increase their competence in relation to primary care, ensure its needs and consider an active inclusion of GPs in preparedness plans.

Active monitoring of adverse reactions following COVID-19 and other vaccinations: a feasibility study as part of the CoVaKo project.

BACKGROUND: The Corona-Vakzin-Konsortium project (CoVaKo) analyses the efficacy and safety of COVID-19 vaccines in a real-world setting, as well as breakthrough infections in Bavaria, Germany. A subproject of CoVaKo aims to identify adverse reactions of the COVID-19 vaccine and compare these to adverse reactions of other vaccines in an online survey. In a preceding feasibility study, the study materials were tested for comprehensibility, visual design, and motivation to participate, as well as for their ability to be implemented and carried out in primary care practices and vaccination centres. METHODS: We used a mixed-methods research design. First, three focus groups consisting of general population participants were organised to evaluate the study materials and survey. Second, a test roll-out was conducted in vaccination centres and primary care practices that involved implementing and quantitatively evaluating the online survey. Third, interviews were conducted with participating general practitioners and heads of vaccination centres four weeks after the test roll-out. RESULTS: Parts of the information and registration form proved incomprehensible, specifically regarding the recruitment material and/or online survey. For example, headings were misleading given that, relative to other vaccinations, the COVID-19 vaccination was overemphasised in the title. Participants requested additional information regarding the procedure and completion time. Within 31 days, 2199 participants, who received either a COVID-19 vaccination (99%) or at least one of the control vaccinations (1%), registered for the study. Participants (strongly) agreed that the registration process was easy to understand, that the completion time was reasonable, and that the technical setup was straightforward. Physicians and heads of the vaccination centres perceived the study as easy to integrate into their workflow. The majority expressed willingness to participate in the main study. CONCLUSIONS: Our study indicated that identifying and documenting adverse reactions following vaccinations using an online survey is feasible. Testing materials and surveys provided valuable insight, enabling subsequent improvements. Participation from health professionals proved essential in ensuring the practicality of procedures. Lastly, adapting the study's organisation to external fluctuating structures and requirements confirmed necessary for a successful implementation, especially due to dynamic changes in the nation's COVID-19 vaccination strategies. TRIAL REGISTRATION: The trial was retrospectively registered at the "Deutsches Register Klinischer Studien" (DRKS-ID: DRKS00025881 ) on Oct 14, 2021.

Short- and medium-term cost effects of non-indicated thyroid diagnostics: empirical evidence from German claims data.

This paper contributes to the discussion of whether non-indicated ultrasound examinations of the thyroid gland contribute to overtreatment and excess health care expenditures. Using two sources of claims data from Germany, we analyzed data from patients who underwent a TSH blood test which is the initial diagnostic measure to check for possible presence of thyroid dysfunction. In a matching analysis, we compared health costs of two groups of patients. One consisted of patients who underwent an early thyroid ultrasound that according to medical guidelines-at this point-was probably not indicated. The other group consisted of patients, who underwent no ultrasound examination at all or later in the course of the disease, making probable a correct indication. Both groups were made comparable by the means of a matching procedure. Average thyroid-specific health costs were substantially higher for the first group in the quarter in which the ultrasound examination took place. Some deviation in these specific costs persisted over a substantial period of time, with drug expenditures exhibiting the biggest difference. If, however, total health costs were considered, difference in costs was only found in the initial quarter. We conclude that non-indicated ultrasound examination of the thyroid gland may have some moderate effects on thyroid-specific costs. Yet the data do not suggest that long-lasting overtreatment and excess health expenditures are initiated by non-indicated ultrasound in Germany.

Laying the foundation for a primary care core set of the International Classification of Functioning, Disability and Health (ICF) for community-dwelling older adults: A qualitative study.

OBJECTIVE: To explore relevant areas of functioning from the perspective of community-dwelling adults aged 75 years and over, in order to develop a Core Set of the International Classification of Functioning, Disability and Health (ICF) for community-dwelling older adults for use in primary care. DESIGN: Qualitative study using semi-structured interviews and focus groups. PARTICIPANTS: A total of 27 community-dwelling older adults participated in the interviews and 24 of them in the focus groups. METHODS: Following the proposed methodology of the ICF Research Branch, this is 1 of 4 preparatory studies in the Core Set development process. Within the transcripts, concepts of functioning were identified, based on Mayring's qualitative content analysis using deductive category assignment with the ICF being the category system. RESULTS: Overall 6,667 concepts were identified. Most were linked to the Activities and Participation component. The most frequently identified categories were "recreation and leisure" and "family relationships". CONCLUSION: Categories from all ICF chapters were identified, demonstrating the complexity and multidimensionality of the ageing process, with a special emphasis on the component Activities and Participation. This qualitative study provides a list of relevant categories from the perspective of community--dwelling elderly people, which will be used to develop a Core Set for older primary care patients.

Laying the foundation for a Core Set of the International Classification of Functioning, Disability and Health for community-dwelling older adults in primary care: relevant categories of their functioning from the research perspective, a scoping review.

OBJECTIVES: The objective of this study was to find relevant concepts of functioning in community-dwelling older adults within frequently used assessment instruments published in the scientific literature. This was part of a larger project to develop an International Classification of Functioning, Disability and Health (ICF) Core Set for use in primary care. DESIGN: A scoping review was conducted. Articles dealing with functioning in older adults were searched and assessed for eligibility. The study population included community-dwelling adults (≥75 years) without dementia, living in high-resource countries. Relevant concepts were extracted from assessment instruments and linked to the ICF using standardised linking rules. Finally, a frequency analysis was conducted. SETTING: Home, primary care. PARTICIPANTS: Community-dwelling adults aged 75 years and above. RESULTS: From 5060 identified publications, 68 were included and 30 assessment instruments extracted. Overall, 1182 concepts were retrieved. Most were linked to the 'activities and participation' component. The most frequently identified categories were 'memory functions', 'dressing' and 'changing basic body position'. CONCLUSIONS: This review provides a list of relevant ICF categories from the research perspective that will be used for developing an ICF Core Set for older primary care patients. TRIAL REGISTRATION NUMBERS: PROSPERO (CRD42017067784), Versorgungsforschung Deutschland Datenbank (VfD_17_003833) and ClinicalTrials.gov (NCT03384732).

Is it really always only the others who are to blame? GP's view on medical overuse. A questionnaire study.

BACKGROUND: Medical overuse is a common problem in health care. Preventing unnecessary medicine is one of the main tasks of General Practice, so called quaternary prevention. We aimed to capture the current opinion of German General Practitioners (GPs) to medical overuse. METHODS: A quantitative online study was conducted. The questionnaire was developed based on a qualitative study and literature search. GPs were asked to estimate prevalence of medical overuse as well as to evaluate drivers and solutions of medical overuse. GPs in Bavaria were recruited via email (750 addresses). A descriptive data analysis was performed. Additionally the association between doctors' attitudes and (1) demographic variables and (2) interest in campaigns against medical overuse was assessed. RESULTS: Response rate was 18%. The mean age was 54 years, 79% were male and 68% have worked as GP longer than 15 years. Around 38% of medical services were considered as medical overuse and nearly half of the GPs (47%) judged medical overuse to be the more important problem than medical underuse. Main drivers were seen in "patients´ expectations" (76%), "lack of a primary care system" (61%) and "defensive medicine" (53%), whereas "disregard of evidence/guidelines" (15%) and "economic pressure on the side of the doctor" (13%) were not weighted as important causes. Demographic variables did not have an important impact on GPs´ response pattern. GPs interested in campaigns like "Choosing Wisely" showed a higher awareness for medical overuse, although these campaigns were only known by 50% of the respondents. DISCUSSION: Medical overuse is an important issue for GPs. Main drivers were searched and found outside their own sphere of responsibility. Campaigns as "Choosing Wisely" seem to have a positive effect on GPs attitude, but knowledge is still limited.

Do guidelines help us to deviate from their recommendations when appropriate for the individual patient? A systematic survey of clinical practice guidelines.

RATIONALE, AIMS, AND OBJECTIVES: Clinical practice guidelines (CPG) were introduced to summarize the best scientific evidence available. Thereby, CPG were meant to support evidence-based medicine (EBM). However, besides evidence, EBM also asks for patients' preferences and physicians' experiences to be considered when coming to therapeutic decisions. Thus, deviations from CPG recommendations are sometimes necessary when practicing EBM. We wanted to examine whether CPG support deviations from their recommendations when appropriate. For operationalization, we asked whether absolute effect sizes (AES) for benefit and/or harm of suggested therapies were provided along with the respective CPG recommendation. METHODS: This systematic survey comprised the most common CPG on chronic coronary heart disease (CCHD) and type 2 diabetes mellitus (T2DM) from English- and German-speaking countries. Only CPG recommendations on pharmacotherapy were evaluated. If AES of a recommended therapy were reported, we rated how easily findable they were within the CPG. Moreover, we assessed whether the CPG provided patient information material and whether this material supplied AES allowing patients to determine the effects to be expected. RESULTS: In the 13 CPG surveyed, 144 recommendations on pharmacotherapy were identified. For 108 recommendations (75%), no AES for benefit and/or harm were reported. Thirty-one recommendations (22%) were accompanied by one or more AES for either benefit or harm. Along with five recommendations (3%), one or more AES for both benefit and harm were given. AES were considered easy to find for three of these 36 recommendations (8%). Patient information material was provided in three of the 13 CPG (23%) accounting for AES in one occasion only. CONCLUSION: Current CPG on T2DM and CCHD do not sufficiently offer AES for benefits and harms of recommended therapies. Thus, they lack satisfactory information to support deviations from CPG recommendations. Consequently, CPG in their present form do not adequately facilitate EBM.

How confident are medical students about making clinical decisions relying on the evidence? A cross-sectional questionnaire study.

Objective: Giving information and providing advice on diagnostic tests is one of the tasks physicians must carry out personally. To do so, they must evaluate the evidence and integrate their findings into everyday practice. Clinical decisions should be based on evidence. How well current medical education prepares for such evidence-based clinical decision-making is largely unclear. Therefore, it was examined how confident medical students are in clinical decision-making based on evidence using epidemiological data. It was examined whether the decision-making confidence increases the higher the semester. Further questions were whether scientifically active medical students show higher decision-making confidence and whether the representation of figures as pictograms rather than tables positively influences the decision-making confidence. Methods: An online survey of the medical students of the Friedrich-Alexander-University Erlangen-Nürnberg was carried out. Respondents were presented with three clinical decision-making situations in random order for evaluation in the form of screening scenarios. In each case, the decision-making confidence also had to be specified. The scenarios contained only epidemiological data on existing screening tests. For each scenario, the numbers were presented as a table or a pictogram in a random fashion. In order to avoid false confidence resulting from preconceived opinions neither the illnesses nor the screening tests were mentioned by name. Results: Answers from 171 students were evaluated. Decision-making confidence in dealing with the numbers does not increase in higher semesters (rPearson =0.018, p=0.41). Scientific work is not associated with a higher decision-making confidence (t(169)=-1.26, p=0.11, d=-0.19). Presentation as a pictogram leads to a higher decision-making confidence compared to tables (Pictogram: M=2.33, SD=1.07, Table with numbers: M=2.64, SD=1.11, t(511)=3.21, p<0.01, d=0.28). Conclusions: Medical students from higher semesters show no higher decision-making confidence compared to medical students from lower semesters. Curricular events and scientific work, such as a doctoral thesis, do not seem to strengthen the required skills sufficiently. If evidence is presented in the form of pictograms, this seems to improve student confidence in decision-making.

Referrals for uncomplicated lower back pain: a cluster parallel randomised trial of patient-centred communication to improve the management of acute back pain in primary care. A study protocol.

INTRODUCTION: Low back pain (LBP) is one of the most frequent encounters in General Practice. Investigation and referral remain common despite the self-limiting character of episodes that are not largely attributable to specific underlying injuries. Identifying patients' ideas, concerns and expectations (ICE) is a well-established element within consultation skills training and has been shown to improve prescribing. It can be a powerful communication tool setting the base for transferring and adjusting adequate clinical information. This study aims to evaluate whether ICE can decrease unnecessary medicine in the management of acute LBP in primary care. METHODS AND ANALYSIS: Research question: Does ICE training intervention have an effect on doctors' referrals of patients suffering from acute LBP? Population: Recruitment to this parallel cluster randomised trial will take place among general practitioners belonging to four independent practice networks in Northern Bavaria/Germany. Intervention: At baseline, 24 out of 48 doctors will be randomly assigned to take part in a 1-day training session covering theoretical background and clinical implementation of patient-centred communication by stimulating ICE. They will also be given access to a web-based supporting tool for reflective practice on their communication skills. Comparison: GPs in the control group will continue consultations as usual. Outcome: Outcome measures are referrals to diagnostic imaging, physiotherapy and specialists obtained from routine practice data, compared between intervention and control group. Time: Referrals of patients consulting their doctors for documented LBP will be monitored up to 3 months after the ICE training intervention. ETHICS AND DISSEMINATION: Ethical approval for the study was obtained by the Ethics Committee of the University Erlangen-Nuremberg (296_17B). Results will be disseminated by conference presentations and journal publications. TRIAL REGISTRATION NUMBER: The trial is registered in clinicaltrials.gov (NCT03711071).

[Evidence and practice: How do primary care physicians evaluate screening interventions? A questionnaire study]. / Zwischen Evidenz und Praxis: Wie bewerten Hausärzte Früherkennungsmaßnahmen? Eine Fragebogenstudie.

BACKGROUND: Patients receiving a screening intervention have to be informed about risks and benefits. On the part of the physician, it requires the understanding of statistical evidence and statistical literacy. OBJECTIVES: Do general practitioners (GPs) make different recommendations on screening interventions if they only rely on statistics compared to their decisions in everyday practice? Are the decisions relying on statistics and the decisions made in everyday practice consistent with official recommendations? Does the way of presenting the numbers (table versus pictogram) affect the decision? METHODS: Online survey among German GPs. The GPs were asked to make recommendations for three different screening scenarios which were based on statistical evidence of existing screening interventions. To avoid bias, statistics were not presented in relation to the actual diseases. The numbers were presented in either a table or a pictogram. Afterwards, the GPs were asked for their recommendations on the same screening interventions in everyday practice. RESULTS: Forty-three GPs were surveyed. Compared to everyday medical practice, participants were less likely to recommend a screening intervention when being confronted with the underlying statistical evidence (F (1, 3)=104.83, p=.002, ηpartial2=.97). Most of the decisions in everyday practice were consistent with official recommendations, while their decisions relying on statistics were more likely to deviate from them (everyday practice, M=1.79, SD=0.77; scenario, M=1.44, SD=0.80; t (42)=-2.29, p=.03). The way the numbers were presented did not affect the decision (t (127)=-1.83, p=.07). CONCLUSIONS: In everyday practice, GPs' screening recommendations do not seem to be based on statistical evidence. Presumably they would be more reluctant to recommend screening interventions if they knew the statistical evidence.

Laying the foundation for a core set of the International Classification of Functioning, Disability and Health for community-dwelling adults aged 75 years and above in general practice: a study protocol.

INTRODUCTION: With the medical focus on disease, the problem of overdiagnosis inevitably increases with ageing. Considering the functional health of patients might help to discriminate between necessary and unnecessary medicine. The International Classification of Functioning, Disability and Health (ICF) is an internationally recognised tool for describing functional health. However, it is too detailed to be used in primary care practices. Consequently, the aim of this study is to identify relevant codes for an ICF core set for community-dwelling older adults (75 years and above) in primary care. METHODS AND ANALYSIS: The study will follow the methodology proposed by the ICF Research Branch to identify relevant concepts from different perspectives: (1) Research perspective: A systematic review of studies focusing on functional health in old age will be conducted in different databases. Relevant concepts will be extracted from the publications. (2) Patients' perspective: Relevant areas of functioning and disability will be identified conducting qualitative interviews and focus groups with community-dwelling older persons. The interviews will be transcribed verbatim and analysed using the documentary method of interpretation. (3) Experts' perspective: An online survey with open-ended questions will be conducted. Answers will be analysed using the qualitative content analysis of Mayring. (4) Clinical perspective: A cross-sectional empirical study will be performed to assess the health status of community-dwelling older adults using the extended ICF checklist and other measurement tools.Relevant concepts identified in each study will be linked to ICF categories resulting in four preliminary core sets. ETHICS AND DISSEMINATION: Ethical approval for the study was obtained (90_17B). All participants will provide written informed consent. Data will be pseudonymised for analysis. Results will be disseminated by conference presentations and journal publications. TRIAL REGISTRATION NUMBER: Projektdatenbank Versorgungsforschung Deutschland: VfD_17_003833,Clinicaltrials.gov: NCT03384732 and PROSPERO: CRD42017067784.

"What they see is what you get": Prescribing antibiotics for respiratory tract infections in primary care: Do high prescribers diagnose differently? An analysis of German routine data.

BACKGROUND: Characteristics of high and low prescribers of antibiotics in German primary care were analysed using population data. We aimed to evaluate differences in prescribing rates and factors being associated with high prescribing, and whether high prescribers made the diagnosis of perceived bacterial infections more often. METHODS: Routine data were provided by the Bavarian Association of Statutory Health Insurance Physicians. Routine data are delivered by primary care practices on a quarterly basis. We analysed data from 2011 and 2012. Patients older than 15 years with respiratory tract infections consulting a primary care physician were selected (6.647 primary care practices). Patient and physician characteristics associated with high prescribing were identified using stepwise logistic regression. RESULTS: Mean prescribing rate of antibiotics was 24.9%. Prescribing rate for high prescribers was 43.5% compared to 8.5% for low prescribers. High prescribers made the diagnosis of perceived bacterial infections more often (Mhigh = 64.5%, Mlow = 45.2%). In the adjusted regression model, perceived bacterial infections were strongly associated with high prescribing (OR = 13.9, 95% CI [10.2, 18.8]). Treating patients with comorbidities was associated with lower prescribing of antibiotics (OR = 0.6, 95% CI [0.4, 0.8]). High prescribers had a higher practice volume, a higher degree of prescribing dominance, and were situated more often in deprived areas and in rural settings. INTERPRETATION: Compared to findings of studies in other European countries, prescribing rates were low. There was a considerable difference between prescribing rates of high and low prescribers. Diagnostic labelling was the best predictor for high prescribing. Current guidelines recommend considering antibiotic treatment for patients with co-morbidities. In our study, treating a large number of high-risk patients was not associated with high prescribing.