Development and psychometric evaluation of a questionnaire for the assessment of depression in primary care: a cross-sectional study.

OBJECTIVES: To develop a new questionnaire for the diagnostic assessment of depression adapted to the primary care setting by combining psychiatric criteria and heuristics of general practitioners (GPs). Psychometric evaluation of the new questionnaire and first validity evidence. DESIGN: The questionnaire was developed using cognitive interviews with think-aloud technique. Factorial validity was then examined in a cross-sectional study. SETTING: Primary care. Five general practices in Bavaria, Germany. PARTICIPANTS: 15 GPs, 4 psychiatrists/psychotherapists and 13 patients participated in cognitive expert interviews. A primary care sample of N=277 consecutive patients participated in the cross-sectional study. METHODS: After consultation with experts and literature research, the questionnaire contained a self-rating part for patients and an external part for GPs. Items were then iteratively optimised using cognitive interviews. Factorial validity was examined. To estimate internal consistency, Cronbach's α was calculated. Validity was assessed by correlating the new questionnaire and the Patient Health Questionnaire-9 (PHQ-9). RESULTS: The preliminary version of the two-part 'Questionnaire for the assessment of DEpression SYmptoms in Primary Care' (DESY-PC) comprised 52 items for patients (DESY-PAT-1: questions about patient's environment; DESY-PAT-2: questions about depression-specific symptoms) and 21 items for GPs (DESY-GP). The analysis of the DESY-PAT-1 revealed a one-factor solution ('environmental factors') with Cronbach's α of 0.55. The items of the DESY-PAT-2 were assigned to three factors, 'depressive cognitions', 'suicidality' and 'symptoms of fatigue', with Cronbach's α of 0.86, 0.79 and 0.85, respectively. Factorial analysis revealed two factors for the DESY-GP: 'depression symptoms' and 'medical history/external factors'. Cronbach's α was 0.90 and 0.59, respectively. After factorial analysis, the DESY-PAT was reduced to 28 items, and the DESY-GP was reduced to 15 items. Correlations of the DESY-PC with the PHQ-9 were high and significant, indicating convergent validity. CONCLUSIONS: The new questionnaire represents an innovative extension of depression questionnaires and could be particularly suitable for general practices.

Clinical effectiveness of patient-targeted feedback following depression screening in general practice (GET.FEEDBACK.GP): an investigator-initiated, prospective, multicentre, three-arm, observer-blinded, randomised controlled trial in Germany.

BACKGROUND: Screening for depression in primary care alone is not sufficient to improve clinical outcomes. However, targeted feedback of the screening results to patients might result in beneficial effects. The GET.FEEDBACK.GP trial investigated whether targeted feedback of the depression screening result to patients, in addition to feedback to general practitioners (GPs), leads to greater reductions in depression severity than GP feedback alone or no feedback. METHODS: The GET.FEEDBACK.GP trial was an investigator-initiated, multicentre, three-arm, observer-blinded, randomised controlled trial. Depression screening was conducted electronically using the Patient Health Questionnaire-9 (PHQ-9) in 64 GP practices across five regions in Germany while patients were waiting to see their GP. Currently undiagnosed patients (aged ≥18 years) who screened positive for depression (PHQ-9 score ≥10), were proficient in the German language, and had a personal consultation with a GP were randomly assigned (1:1:1) into a group that received no feedback on their depression screening result, a group in which only the GP received feedback, or a group in which both GP and patient received feedback. Randomisation was stratified by treating GP and PHQ-9 depression severity. Trial staff were masked to patient enrolment and study group allocation and GPs were masked to the feedback recieved by the patient. Written feedback, including the screening result and information on depression, was provided to the relevant groups before the consultation. The primary outcome was PHQ-9-measured depression severity at 6 months after randomisation. An intention-to-treat analysis was conducted for patients who had at least one follow-up visit. This study is registered at ClinicalTrials.gov (NCT03988985) and is complete. FINDINGS: Between July 17, 2019, and Jan 31, 2022, 25 279 patients were approached for eligibility screening, 17 150 were excluded, and 8129 patients completed screening, of whom 1030 (12·7%) screened positive for depression. 344 patients were randomly assigned to receive no feedback, 344 were assigned to receive GP-targeted feedback, and 339 were assigned to receive GP-targeted plus patient-targeted feedback. 252 (73%) patients in the no feedback group, 252 (73%) in the GP-targeted feedback group, and 256 (76%) in the GP-targeted and patient-targeted feedback group were included in the analysis of the primary outcome at 6 months, which reflected a follow-up rate of 74%. Gender was reported as female by 637 (62·1%) of 1025 participants, male by 384 (37·5%), and diverse by four (0·4%). 169 (16%) of 1026 patients with available migration data had a migration background. Mean age was 39·5 years (SD 15·2). PHQ-9 scores improved for each group between baseline and 6 months by -4·15 (95% CI -4·99 to -3·30) in the no feedback group, -4·19 (-5·04 to -3·33) in the GP feedback group, and -4·91 (-5·76 to -4·07) in the GP plus patient feedback group, with no significant difference between the three groups (global p=0·13). The difference in PHQ-9 scores when comparing the GP plus patient feedback group with the no feedback group was -0·77 (-1·60 to 0·07, d=-0·16) and when comparing with the GP-only feedback group was -0·73 (-1·56 to 0·11, d=-0·15). No increase in suicidality was observed as an adverse event in either group. INTERPRETATION: Providing targeted feedback to patients and GPs after depression screening does not significantly reduce depression severity compared with GP feedback alone or no feedback. Further research is required to investigate the potential specific effectiveness of depression screening with systematic feedback for selected subgroups. FUNDING: German Innovation Fund. TRANSLATION: For the German translation of the abstract see Supplementary Materials section.

Stress experiences of healthcare assistants in family practice at the onset of the COVID-19 pandemic: a mixed methods study.

Background: At the beginning of the pandemic in 2020, healthcare assistants in general practices were confronted with numerous new challenges. The aim of the study was to investigate the stress factors of healthcare assistants in March/April 2020 as well as in the further course of the pandemic in 2020. Methods: From August to December 2020, 6,300 randomly selected healthcare assistants in four German states were invited to participate in the study. We performed a mixed methods design using semi-structured telephone interviews and a cross-sectional survey with quantitative and open questions. The feeling of psychological burden was assessed on a 6-point likert-scale. We defined stress factors and categorized them in patient, non-patient and organizational stress factors. The results of the three data sets were compared within a triangulation protocol. Results: One thousand two hundred seventy-four surveys were analyzed and 28 interviews with 34 healthcare assistants were conducted. Of the participants, 29.5% reported experiences of a very high or high feeling of psychological burden in March/April 2020. Worries about the patients' health and an uncertainty around the new disease were among the patient-related stress factors. Non-patient-related stress factors were problems with the compatibility of work and family, and the fear of infecting relatives with COVID-19. Organizational efforts and dissatisfaction with governmental pandemic management were reported as organizational stress factors. Support from the employer and team cohesion were considered as important resources. Discussion: It is necessary to reduce stress among healthcare assistants by improving their working conditions and to strengthen their resilience to ensure primary healthcare delivery in future health crises.

Clinical effects of Kneipp hydrotherapy: a systematic review of randomised controlled trials.

OBJECTIVE: Hydrotherapy is a traditional prevention and treatment strategy. This study's aim is to systematically review all available randomised controlled trials (RCTs) investigating clinical effects of hydrotherapy according to Kneipp which is characterised by cold water applications. METHODS: RCTs on disease therapy and prevention with Kneipp hydrotherapy were included. Study participants were patients and healthy volunteers of all age groups. MEDLINE (via PubMed), Scopus, Central, CAMbase, and opengrey.eu were systematically searched through April 2021 without language restrictions and updated by searching PubMed until April 6th 2023. Risk of bias was assessed using the Cochrane tool version 1.ResultsTwenty RCTs (N=4247) were included. Due to high heterogeneity of the RCTs, no meta-analysis was performed. Risk of bias was rated as unclear in most of the domains. Of 132 comparisons, 46 showed significant positive effects in favour of hydrotherapy on chronic venous insufficiency, menopausal symptoms, fever, cognition, emotional function and sickness absenteeism. However, 81 comparisons showed no differences between groups and 5 were in favour of the respective control group. Only half of the studies reported safety issues. CONCLUSION: Although RCTs on Kneipp hydrotherapy seem to show positive effects in some conditions and outcomes, it remains difficult to ascertain treatment effects due to the high risk of bias and heterogeneity of most of the considered studies. Further high-quality RCTs on Kneipp hydrotherapy are urgently warranted. PROSPERO REGISTRATION NUMBER: CRD42021237611.

[General Practitioners' Experiences with COVID-19: a Survey After the First Wave of the Pandemic in March/April 2020]. / Erfahrungen von HausärztInnen mit COVID-19 und der Pandemie ­ ein Survey nach der ersten Pandemiewelle im März/April 2020.

BACKGROUND AND OBJECTIVES: The first wave of the COVID-19 pandemic (Mar-Apr 2020) posed significant challenges for primary care. The goal of this study was to analyse the burden of the crisis situation as experienced by the general practitioners (GPs) at its beginning and over the course of the pandemic and to identify factors predictive of the sense of being overburdened. METHODS: In this cross-sectional study, a total of 6300 randomly selected GPs in four federal states of Germany were contacted per post in order to survey changes in health care they provided and their psychological burden in the context of the pandemic between August and October 2020. RESULTS: The response rate was 23%; 46% of the participants were female. At the beginning of the pandemic, 40% of the participants experienced a high or a very high level of being overburdened; later on, it was only 10%. With increasing numbers of COVID patients, the sense of being overburdened increased, as also their perceived capability to care for COVID patients. Predictors of a sense of being overburdened were, among others, a high level of psychological stress, excessive organising efforts, poor capability to care for COVID patients, and scarce supply of protective equipment. CONCLUSION: Despite a sense of being overburdened initially, GPs felt increasingly capable of caring for COVID patients. To help GPs in future crisis situations like this pandemic, organization of care should be simplified to the extent possible so that they can focus on patient care.

Association between somatic symptom disorder and symptoms with daily life impairment after SARS-CoV-2 infection - results from a population-based cross-sectional study.

BACKGROUND: Post-COVID syndrome (PCS) is defined by symptom persistence accompanied by daily life impairment (DLI). The association of somatic symptom disorder (SSD) and symptoms with DLI after SARS-CoV-2 infection in the general population is unclear to date. The main objective of the study was to investigate the association of possible SSD, depression, anxiety, and participant-reported symptoms with DLI in a local population sample. METHODS: Anonymised cross-sectional study. A symptom questionnaire, including the scales Patient Health Questionnaire PHQ-15 (somatisation module), SSD-12 (psychological distress in SSD), PHQ-2 (depression), GAD-2 (anxiety), and FAS (fatigue assessment scale) was sent in 02/2022 to all adult residents of the district Bad Tölz-Wolfratshausen, Germany, who were registered for SARS-CoV-2-infection between 03/2020 and 11/2021 (8925 delivered). Associations between DLI, symptoms and scales were estimated using binary logistic regression models and network analysis. RESULTS: 2828 questionnaires (31.7%) were complete. 1486 (52.5%) reported persistent symptoms, and 509 (18.0%) perceived DLI. DLI was strongest associated with self-reported fatigue (OR 7.86; 95%CI 5.63-10.97), dyspnea (3.93; 2.73-5.67), impaired concentration (3.05; 2.17-4.30), SSD-12 (4.36; 2.57-7.41), and PHQ-2 (2.48; 1.57-3.92). Self-reported fatigue showed the strongest correlation (rp = 0.248) and closest proximity to DLI in network analysis. CONCLUSION: PCS appears as a complex clinical picture in which SSD might play an important role when DLI is present. The pychological burden might partly be explained by the persistent symptoms, which are difficult to treat up to now. Screening for SSD could help in differential diagnostic decision-making to ensure that patients receive appropriate psychosocial interventions for disease coping.

[Effects of the Risk of Recourse Claims on the Work of General Practitioners and Orthopedists - A Nationwide Survey]. / Auswirkungen der Regressgefahr auf die Tätigkeit von Hausärzt*innen und Orthopäd*innen ­ Bundesweite Befragung.

OBJECTIVE: The aim of this study was to investigate the influence of the perceived risk of recourse claims and the extent of personal recourse experience among general practitioners (GPs) and orthopedists in private practice. METHODS: A four-page questionnaire on the effects and consequences of the threat of recourse or recourse actually experienced was sent to a nationwide random sample of 1000 GPs and 1000 orthopedists. RESULTS: The response rate was 41% for GPs and 39% for orthopedists; 47% of the participating GPs and 55% of the orthopedists stated that the risk of recourse was a heavy burden in everyday practice, 37/47% that it had a strong influence on their medical practice. 51/25% stated that they referred to a (different) specialist at least occasionally despite the indication of a prescription. 72% of GPs and 59% of orthopedists had recourse at least once, 36 and 19%, respectively more than 3 times. 18% of GPs and 26% of orthopedists had experienced recourse claims of more than € 5000. The emotional burden caused by the worst regress was perceived by 72 and 78%, respectively of those affected by recourse as severe or very severe. CONCLUSION: The risk of recourse can have a strong impact on the work of GPs and orthopedists in private practice. Recourse is often felt to be emotionally stressful and sometimes seen as inhibiting establishing a practice.

Implementation of an internet-based asthma patient education program in primary care: results of a single-arm trial.

Asthma education programs (AEPs) for patients are known to be important to provide skills to effectively manage the disease. We developed an electronic AEP (eAEP) and assessed the extent to which patients with asthma in primary care are capable to use the eAEP and whether asthma knowledge improved after eAEP.A single-arm pilot study was performed between November 2019 and December 2020 in 12 general practices in Upper Bavaria, Germany. Asthma knowledge was assessed by the Asthma Knowledge Test (AKT) at baseline, 2 weeks after completion of the eAEP, as well as after 3 and 6 months. AKT sum scores at baseline and follow-up were compared with each other using the Wilcoxon test.In total, 72 patients with asthma were included, of whom all participated in the 2-week follow-up, while data on the 3- and 6-month follow-up was available in 62 and 51 patients, respectively. The eAEP was well accepted and positively evaluated by participants. The mean AKT score significantly (p < .001) increased from 22.8 ± 11.0 at baseline to 44.6 ± 8.3 two weeks after completion of the eAEP. After 3 months, the mean score was still 41.8 ± 7.6, and after 6 months it was 40.2 ± 9.3 (p < .001 each compared to baseline).The internet-based asthma education program was well accepted by primary care patients and resulted in a major increase of asthma knowledge. Thus, it has the potential to be an important adjunct in the treatment of patients with asthma in general practice.

Lessons learned from applying established cut-off values of questionnaires to detect somatic symptom disorders in primary care: a cross-sectional study.

Introduction: Based on two diagnostic accuracy studies in high-prevalence settings, two distinctly different combinations of cut-off values have been recommended to identify persons at risk for somatic symptom disorder (SSD) with the combination of the Patient-Health Questionnaire-15 (PHQ-15) and the Somatic Symptom Disorder-B Criteria Scale (SSD-12). We investigated whether the reported sensitivity and specificity of both recommended cut-off combinations are transferable to primary care. Methods: In a cross-sectional study, 420 unselected adult primary care patients completed PHQ-15 and SSD-12. Patients scoring ≥9 and ≥ 23 (recommended cut-off combination #1) or ≥ 8 and ≥ 13 (recommended cut-off combination #2) were considered test-positive for SSD, respectively. To assess the validity of the reported sensitivity and specificity in different low- to high-prevalence settings, we compared correspondingly expected proportions of test positives to the proportion observed in our sample. Results: Based on combination #1, 38 participants (9%) were found to be test positive, far fewer than expected, based on the reported values for sensitivity and specificity (expected minimum frequency 30% with a true prevalence ≥1%). This can only be explained by a lower sensitivity and higher specificity in primary care. For combination #2, 98 participants (23%) were test positive, a finding consistent with a true prevalence of SSD of 15% or lower. Discussion: Our analyzes strongly suggest that the sensitivity and specificity estimates reported for combination #1 are not applicable to unselected primary care patients and that the cut-off for the SSD (≥23) is too strict. Cut-off combination #2 seems more applicable but still needs to be tested in studies that compare screening findings by questionnaires with validated diagnostic interviews as reference standards in primary care populations.

Effectiveness of an online education program for asthma patients in general practice: study protocol for a cluster randomized controlled trial.

BACKGROUND: Asthma education programs (AEPs) have been shown to increase quality of life and reduce emergency treatments and hospital admissions. Despite the proven benefits, only a minority of asthma patients attend such programs. To increase the number of educated patients, an online education program (electronic AEP, eAEP) for asthma patients has been developed. The present study aims to investigate the effectiveness of the eAEP in terms of asthma knowledge, asthma control and emergency treatments in general practice settings. METHODS: This is a cluster randomized controlled trial including 100 patients with bronchial asthma from 20 general practices in Bavaria, Germany. General practices will be randomly assigned to either the intervention or control group. Patients in the intervention group will receive access to the eAEP and instructions to complete this program within two weeks. Patients in the control group will receive usual care including a referral to face-to-face AEP (fAEP) by a certified primary care physician or a pulmonologist according to guideline recommendations. Furthermore, patients of both the intervention and control groups will be invited to a follow-up consultation in their general practice after completion of the eAEP and fAEP (three weeks and twelve weeks after study inclusion, respectively) to discuss any open issues. Outcomes for both groups will be assessed at baseline (t0), after two weeks (t1), three months (t2) and six months (t3). The primary outcome is the comparison of asthma knowledge gain between intervention and control groups after completion of the eAEP (two weeks after study inclusion) and fAEP (twelve weeks after study inclusion), respectively. Secondary outcomes include asthma control, frequency of emergency treatments, patient autonomy as well as attitudes towards asthma medication. DISCUSSION: The results of the present trial will provide knowledge about the effectiveness of an online education program for asthma patients compared to usual care in primary care. TRIAL REGISTRATION: German Clinical Trials Register (DRKS), DRKS00028805 . Registered 22 April 2022.

Incidence of post-COVID syndrome and associated symptoms in outpatient care in Bavaria, Germany: a retrospective cohort study using routinely collected claims data.

OBJECTIVES: To estimate the treatment incidence of post-COVID syndrome (postinfectious sequelae present at least 12 weeks following infection) in the context of ambulatory care in Bavaria, Germany, and to establish whether related diagnoses occur more frequently than in patients with no known history of COVID-19. DESIGN: Retrospective cohort analysis of routinely collected claims data. SETTING: Ambulatory care in Bavaria, Germany, observed from January 2020 to March 2022 (data accessed May 2022). PARTICIPANTS: 391 990 patients with confirmed COVID-19 diagnosis, 62 659 patients with other respiratory infection and a control group of 659 579 patients with no confirmed or suspected diagnosis of COVID-19. PRIMARY AND SECONDARY OUTCOME MEASURES: Primary outcome is diagnosis of post-COVID syndrome documented in ambulatory care. Secondary outcomes are: chronic fatigue syndrome, psychological disorder, fatigue, mild cognitive impairment, disturbances of taste and smell, dyspnoea, pulmonary embolism and myalgia. RESULTS: Among all patients with confirmed COVID-19, 14.2% (95% CI 14.0% to 14.5%) received a diagnosis of a post-COVID syndrome, and 6.7% (95% CI 6.5% to 6.9%) received the diagnosis in at least two quarterly periods during a 2-year follow-up. Compared with patients with other respiratory infections and with controls, patients with COVID-19 more frequently received a variety of diagnoses including chronic fatigue syndrome (1.6% vs 0.6% and 0.3%, respectively), fatigue (13.3% vs 9.2% and 6.0%), dyspnoea (9.9% vs 5.1% and 3.2%) and disturbances of taste and smell (3.2% vs 1.2% and 0.5%). The treatment incidence of post-COVID syndrome was highest among adults aged 40-59 (19.0%) and lowest among children aged below 12 years (2.6%). CONCLUSIONS: Our results demonstrate a moderately high incidence of post-COVID syndrome 2 years after COVID-19 diagnosis. There is an urgent need to find efficient and effective solutions to help patients with dyspnoea, fatigue, cognitive impairment and loss of smell. Guidelines and treatment algorithms, including referral criteria, and occupational and physical therapy, require prompt and coherent implementation.

[Experiences with Regional Medical Coordinators in Ambulatory Care in the Early COVID-19 Phase 2020 in Bavaria: Survey of Regional Ambulatory Coordinators and General Practitioners]. / Erfahrungen mit Versorgungsärzt*innen in der frühen COVID-19-Phase 2020 in Bayern ­ Befragung von Versorgungs- und Hausärzt*innen.

BACKGROUND: During the state of emergency in Bavaria in the early Corona phase 2020, some physicians in ambulatory care were appointed as regional medical coordinators (RMCs). The aim of the present study was to evaluate this newly introduced but temporary position. METHODS: In November 2020, a paper-based questionnaire was sent out to all 85 RMCs who could be identified through an internet research and to all 197 teaching practices of the Institute of General Practice and Health Services Research at the Technical University of Munich. The data analysis was descriptive and anonymised. RESULTS: Overall, 75 (88%) RMCs and 156 (79%) general practitioners (GPs) were included. 97% of the RMCs and 67% of the GPs assessed the introduction of RMCs in ambulatory care as reasonable, but also as an intervention concerning the self-administration of physicians (RMCs: 59% and GPs: 42%). 37% of the GPs stated that RMCs should be avoided as far as possible in future pandemic situations. Overall, GPs with more intensive contact to an RMC showed higher levels of agreement. Both groups rated the collaboration and communication strategies of politics, authorities and the Bavarian Association of Statutory Health Insurance Physicians as difficult and often contradictory. However, most of the RMCs assessed the cooperation with politics and authorities at the local level as positive. The lack of medical protective equipment at the beginning of the pandemic was judged critically by both groups of the respondents. CONCLUSIONS: The establishment of RMCs in the early Corona phase 2020 in Bavaria was considered sensible by almost all RMCs and the majority of the surveyed GPs. For the future, it seems necessary to involve primary care physicians more intensively and permanently in decision-making processes and to strengthen existing structures.

COVID-19 vaccine hesitancy in people with migratory backgrounds: a cross-sectional study among Turkish- and German-speaking citizens in Munich.

BACKGROUND: This study aimed to investigate the knowledge, attitudes, behaviors, and COVID-19 vaccine hesitancy of people with migratory backgrounds among Turkish- and German-speaking patients in Munich. METHODS: Primary outcomes were the intention to get vaccinated for COVID-19 and COVID-19 knowledge levels (25 true/false items). Other variables included demographics, attitudes to COVID-19 and vaccination (7 items), and behaviors regarding COVID-19 (7 items). The attitude and behavior questions had 5-point Likert scales. Of the 10 Turkish-speaking family physicians in Munich, six agreed to administer Turkish or German questionnaires to consecutive patients in February 2021. Furthermore, participants with either citizenship, country of origin, native language, or place of birth being non-German were categorized as "Having a migratory background." Data from 420 respondents were analyzed. RESULTS: Women constituted 41.4% (n = 174), the mean age was 42.2 ± 15.5 years, 245 (58.3%) preferred the Turkish questionnaire, 348 (82.9%) had a migratory background, and 197 (47.9%) intended to be vaccinated. The mean knowledge, attitude, and behavioral scores were 21.5 ± 3.2 (max = 25), 3.7 ± 0.8 (max = 5), and 4.0 ± 0.5 (max = 5). While 42.3% (n = 145) of the participants with a migratory background considered getting vaccinated, this proportion was 76.5% (n = 52) for non-immigrant Germans (Chi-square = 26.818, p < 0.001). Non-migratory background (odds ratio (OR): 3.082), high attitude scores (OR: 2.877), male sex (OR: 2.185), years of schooling (OR: 1.064), and age (OR: 1.022) were positively associated with vaccination intention. CONCLUSIONS: We suggest initiating or supporting projects run by persons or groups with immigrant backgrounds to attempt to elaborate and change their vaccination attitudes.

COVID-19 assessment in family practice-A clinical decision rule based on self-rated symptoms and contact history.

The study aimed to evaluate the diagnostic accuracy of contact history and clinical symptoms and to develop decision rules for ruling-in and ruling-out SARS-CoV-2 infection in family practice. We performed a prospective diagnostic study. Consecutive inclusion of patients coming for COVID-PCR testing to 19 general practices. Contact history and self-reported symptoms served as index test. PCR testing of nasopharyngeal swabs served as reference standard. Complete data were available from 1141 patients, 605 (53.0%) female, average age 42.2 years, 182 (16.0%) COVID-PCR positive. Multivariable logistic regression showed highest odds ratios (ORs) for "contact with infected person" (OR 9.22, 95% CI 5.61-15.41), anosmia/ageusia (8.79, 4.89-15.95), fever (4.25, 2.56-7.09), and "sudden disease onset" (2.52, 1.55-4.14). Patients with "contact with infected person" or "anosmia/ageusia" with or without self-reported "fever" had a high probability of COVID infection up to 84.8%. Negative response to the four items "contact with infected person, anosmia/ageusia, fever, sudden disease onset" showed a negative predictive value (NPV) of 0.98 (95% CI 0.96-0.99). This was present in 446 (39.1%) patients. NPV of "completely asymptomatic," "no contact," "no risk area" was 1.0 (0.96-1.0). This was present in 84 (7.4%) patients. To conclude, the combination of four key items allowed exclusion of SARS-CoV-2 infection with high certainty. With the goal of 100% exclusion of SARS-CoV-2 infection to prevent the spread of SARS-CoV-2 to the population level, COVID-PCR testing could be saved only for patients with negative response in all items. The decision rule might also help for ruling-in SARS-CoV-2 infection in terms of rapid assessment of infection risk.

SARS-CoV-2 infection and cardiovascular or pulmonary complications in ambulatory care: A risk assessment based on routine data.

BACKGROUND: Risk factors of severe COVID-19 have mainly been investigated in the hospital setting. We investigated pre-defined risk factors for testing positive for SARS-CoV-2 infection and cardiovascular or pulmonary complications in the outpatient setting. METHODS: The present cohort study makes use of ambulatory claims data of statutory health insurance physicians in Bavaria, Germany, with polymerase chain reaction (PCR) test confirmed or excluded SARS-CoV-2 infection in first three quarters of 2020. Statistical modelling and machine learning were used for effect estimation and for hypothesis testing of risk factors, and for prognostic modelling of cardiovascular or pulmonary complications. RESULTS: A cohort of 99 811 participants with PCR test was identified. In a fully adjusted multivariable regression model, dementia (odds ratio (OR) = 1.36), type 2 diabetes (OR = 1.14) and obesity (OR = 1.08) were identified as significantly associated with a positive PCR test result. Significant risk factors for cardiovascular or pulmonary complications were coronary heart disease (CHD) (OR = 2.58), hypertension (OR = 1.65), tobacco consumption (OR = 1.56), chronic obstructive pulmonary disease (COPD) (OR = 1.53), previous pneumonia (OR = 1.53), chronic kidney disease (CKD) (OR = 1.25) and type 2 diabetes (OR = 1.23). Three simple decision rules derived from prognostic modelling based on age, hypertension, CKD, COPD and CHD were able to identify high risk patients with a sensitivity of 74.8% and a specificity of 80.0%. CONCLUSIONS: The decision rules achieved a high prognostic accuracy non-inferior to complex machine learning methods. They might help to identify patients at risk, who should receive special attention and intensified protection in ambulatory care.

The diversity of opinion among general practitioners regarding the threat and measures against COVID-19 - Cross-sectional survey.

BACKGROUND: After the 'first wave' in spring 2020, opinions regarding the threat and measures against COVID-19 seemed to vary among German general practitioners (GPs). OBJECTIVES: To systematically investigate opinions and to identify subgroups of GPs sharing similar views. METHODS: A questionnaire was sent to all 210 practices accredited for undergraduate teaching of family medicine at the Medical Faculty of the Technical University of Munich. Questions addressed personal opinions regarding risks, dilemmas, restrictions and their relaxation associated with COVID-19, and personal fears, symptoms of depression and anxiety. Patterns of strong opinions ('archetypes') were identified using archetypal analysis, a statistical method seeking extremal points in the multidimensional data. RESULTS: One hundred and sixty-one GPs sent back a questionnaire (response rate 77%); 143 (68%) with complete data for all 38 relevant variables could be included in the analysis. We identified four archetypes with subgroups of GPs tending in the direction of these archetypes: a small group of 'Sceptics' (n = 12/8%) considering threats of COVID-19 as overrated and measures taken as exaggerated; 'Hardliners' (n = 34/24%) considering threats high and supporting strong measures; 'Balancers' (n = 77/54%) who also rated the threats high but were more critical about potentially impairing the quality of life of elderly people and children; and 'Anxious' GPs (n = 20/14%) tending to report more fear, depressive and anxiety symptoms. CONCLUSION: Among the participants in this survey, opinions regarding the threat and the measures taken against COVID-19 during the 'first wave' in Germany in spring 2020 varied greatly.

Ambulatory specialist costs and morbidity of coordinated and uncoordinated patients before and after abolition of copayment: A cohort analysis.

To strengthen the coordinating function of general practitioners (GPs) in the German healthcare system, a copayment of €10 was introduced in 2004. Due to a perceived lack of efficacy and a high administrative burden, it was abolished in 2012. The present cohort study investigates characteristics and differences of GP-coordinated and uncoordinated patients in Bavaria, Germany, concerning morbidity and ambulatory specialist costs and whether these differences have changed after the abolition of the copayment. We performed a retrospective routine data analysis, using claims data of the Bavarian Association of the Statutory Health Insurance Physicians during the period 2011-2012 (with copayment) and 2013-2016 (without copayment), covering 24 quarters. Coordinated care was defined as specialist contact only with referral. Multinomial regression modelling, including inverse probability of treatment weighting, was used for the cohort analysis of 500 000 randomly selected patients. Longitudinal regression models were calculated for cost estimation. Coordination of care decreased substantially after the abolition of the copayment, accompanied by increasing proportions of patients with chronic and mental diseases in the uncoordinated group, and a corresponding decrease in the coordinated group. In the presence of the copayment, uncoordinated patients had €21.78 higher specialist costs than coordinated patients, increasing to €24.94 after its abolition. The results indicate that patients incur higher healthcare costs for specialist ambulatory care when their care is uncoordinated. This effect slightly increased after abolition of the copayment. Beyond that, the abolition of the copayment led to a substantial reduction in primary care coordination, particularly affecting vulnerable patients. Therefore, coordination of care in the ambulatory setting should be strengthened.

Nonpharmacological Interventions for Pediatric Migraine: A Network Meta-analysis.

CONTEXT: Migraine is a common neurologic disorder in children and adolescents. However, a comparison of multiple nonpharmacological treatments is lacking. OBJECTIVE: To examine whether nonpharmacological treatments are more effective than waiting list and whether there are differences between interventions regarding efficacy. DATA SOURCES: Systematic review and network meta-analysis of studies in Medline, Cochrane, Embase, and PsycINFO published through August 5, 2019. STUDY SELECTION: Randomized controlled trials of nonpharmacological treatments in children and adolescents diagnosed with episodic migraine. DATA EXTRACTION: Effect sizes, calculated as standardized mean differences (SMDs) for the primary outcome efficacy, were assessed in a random-effects model. RESULTS: Twelve studies (N = 576) were included. When interventions were classified into groups on the basis of similarity of treatment components, self-administered treatments, biofeedback, relaxation, psychological treatments, and psychological placebos were significantly more effective than waiting list with effect sizes ranging between SMD = 1.14 (95% confidence interval, 0.09 to 2.19) for long-term psychological placebos to SMD = 1.44 (95% confidence interval, 0.26 to 2.62) for short-term self-administered treatments. However, when all interventions were examined individually (ie, 1 node per intervention), none were significantly more effective compared with waiting list, mainly because of lack of statistical power. LIMITATIONS: Because of our focus on pediatric migraine, only a small number of studies could be included. CONCLUSIONS: Our findings reveal that components of nonpharmacological interventions are effective in treating pediatric migraine. Some effects have to be interpreted carefully because they are based on small studies. Future researchers should identify factors associated with individual responses in large, multicentered studies.

Health literacy and eHealth among adult asthma patients - results of a cross sectional survey.

Background: To investigate HL (health literacy) and eHealth literacy (eHL) among two groups of asthma outpatients, those with prior asthma education and those without. In addition, we aimed to compare two shortened versions of a HL measure instrument.Methods: A cross-sectional survey was conducted with a sample of adult asthma patients (n = 129). Half of them had received asthma patient education prior to the study (n = 64). The study collected demographic data, questions on HL (HLS-EU-Q16) and eHL (eHEALS).Results: In the main analysis respondents' mean HL values were almost identical in both groups, 11.9 (SD = 3.1) among trained and 11.8 (SD = 3.5) among untrained patients, demonstrating a problematic level of HL, according to the instrument. In the subdivision of sum scores, the HL level of trained patients was categorized more often as problematic (43%) than among untrained patients (20%). Bland-Altman plots of the 6-item and 16-item versions of the HLS-EU suggest only limited agreement between the versions. In terms of eHL, trained patients showed a mean of 3.0 (SD = 1.1) and untrained patients a mean of 3.2 (SD = 1.0). Analysis of HL and eHL showed no difference between groups.Conclusions: No consistent differences between groups were found, suggesting that trained patients did not benefit from asthma education regarding HL and eHL. The 6-item and 16-item versions of the HLS-EU were not easily interchangeable, limiting its use in a busy outpatient practice.AbbreviationseHEALSElectronic Health Literacy ScaleeHLElectronic Health Literacy HLS-EUEuropean Health Literacy Survey.

Identifying patients with chronic pain who respond to acupuncture: results from an individual patient data meta-analysis.

BACKGROUND: In a recent individual patient data meta-analysis, acupuncture was found to be superior to sham and non-sham controls in patients with chronic pain. It has been suggested that a subgroup of patients has an exceptional response to acupuncture. We hypothesized the presence of exceptional acupuncture responders would lead to a different distribution of pain scores in acupuncture versus control groups, with the former being skewed to the right. METHODS: This individual patient data meta-analysis included 39 high-quality randomized trials of acupuncture for chronic headache, migraine, osteoarthritis, low back pain, neck pain and shoulder pain published before December 2015 (n = 20,827). In all, 25 involved sham acupuncture controls (n = 7097) and 25 non-acupuncture controls (n = 16,041). We analyzed the distribution of change scores and calculated the difference in the skewness statistic-which assesses asymmetry in the data distribution-between acupuncture and either sham or non-acupuncture control groups. We then entered the difference in skewness along with standard error into a meta-analysis. FINDINGS: Control groups were more right-skewed than acupuncture groups, although this difference was very small. The difference in skew was 0.124 for non-acupuncture-controlled trials (p = 0.047) and 0.141 for sham-controlled trials (p = 0.029). In a pre-specified sensitivity analysis excluding three trials with outlying results known a priori, the difference in skew between acupuncture and sham was no longer statistically significant (p = 0.2). CONCLUSION: We did not find evidence to support the notion that there are exceptional acupuncture responders. The challenge remains to identify features of chronic pain patients that can be used to distinguish those that have a good response to acupuncture treatment.