Frequency, persistence and relation of disease symptoms, psychosomatic comorbidity and daily life impairment after COVID-19: a cohort study in general practice.

BACKGROUND: Long-lasting symptoms with a possible relation to psychosomatic comorbidity have been described following COVID-19. However, data is sparse in general practice. The trial's objective was to investigate the time-dependent frequency of disease symptoms and relation to psychosomatic comorbidity and daily life impairment (DLI). METHODS: Comparative cohort study of patients reporting a previous SARS-CoV-2 infection and uninfected controls in general practice. Participants were recruited in 14 general practices in the greater Munich area. Data collection was questionnaire based with a 12 months follow-up. Descriptive statistics, multivariable regression and bivariate correlations were used for analysis. RESULTS: A total of n = 204 cases infected up to 42 months ago (n = 141 Omicron, n = 63 earlier variants), and n = 119 controls were included. Disease symptoms were substantially more prevalent in cases (55-79% vs. 43% within one year of infection). This difference also appeared in the multivariable analysis adjusting for socio-demographics and psychosomatic comorbidity with odds ratios (OR) of 4.15 (p < 0.001) and 3.51 (p = 0.054) for the cohorts with Omicron or earlier variants infection (vs. controls), respectively. It was persistent with earlier variants (OR 1.00 per month, p = 0.903), while a decreasing trend was observed for Omicron (OR 0.89 per month, p < 0.001). DLI was especially correlated with fatigue (r = 0.628). CONCLUSION: DLI, psychosomatic comorbidity and independently increased disease symptoms require holistic treatment of the patient in general practice according to the bio-psycho-social model. A key role in restoring the daily life capability may be attributed to the symptom fatigue.

[Physician Numbers and Employment in Bavaria: Trends in statistics of the Bavarian Medical Association and the Association of Statutory Health Insurance Physicians of Bavaria]. / Entwicklung der Ärzt*innenzahlen und Beschäftigungsverhältnisse in Bayern ­ Trends in den Ärzt*innenstatistiken der Bayerischen Landesärztekammer und der Kassenärztlichen Vereinigung Bayerns.

BACKGROUND: Although the number of places at medical schools and physicians in Germany has increased continuously over the past 25 years, there is a threat of a shortage of physicians. Based on data from the Bavarian Medical Association (BLÄK) and the Association of Statutory Health Insurance Physicians of Bavaria (KVB), an analysis of the number of physicians in Bavaria over a longer period of time was carried out in order to understand current developments and possible starting points for the future organization of medical care. The figures were analyzed with regard to the distribution of physicians by outpatient and inpatient sector as well as with regard to the development of the number of employees, the scope of employment and the gender distribution in the outpatient sector. METHODS: Data were taken from the annually published and systematically compiled numbers of physicians from the BLÄK (2000 to 2022) as well as the outpatient billing data of practicing and employed physicians in Bavaria (2010 to 2022), processed by the KVB. Descriptive analyses were performed. RESULTS: Since 2000, the number of physicians in Bavaria has risen by 83% in the inpatient setting and by 35% in the outpatient setting. As a result, more physicians have been working in hospitals than in outpatient care since 2010. In the outpatient setting the trend is moving away from establishing one's own practice and full-time work towards salaried and part-time employment. Employed physicians have lower average working hours than self-employed physicians. The proportion of women among physicians has steadily increased, with female physicians more likely to be employed and working part-time compared with male physicians. Nevertheless, part-time employment is also prominent among male physicians in some specialties today. CONCLUSION: The trend towards practicing in salaried and part-time positions continues unabated and is represented across all specialties, suggesting that more physicians are needed to maintain the number of working hours over time. In addition to incentives and subsidies, this reality must be taken into account when planning care. At the same time, it is questionable whether increasing medical school places without managing them according to need is the right way to address the shortage of physicians in outpatient care when an ever-increasing proportion of physicians is working in inpatient care.

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.

The revision and factor analytic evaluation of the German version of the depression literacy scale (D-Lit-R German).

BACKGROUND: Depression is a common mental health disorder and the second leading cause of disability worldwide. In people with depression, low depression literacy, which could be characterized by a poor recognition of depressive symptoms and less knowledge about the availability of treatment options, can hinder adequate therapy for depression. Nevertheless, questionnaires measuring depression literacy in Germany are rare. Consequently, for the present study, the German Depression Literacy Scale (D-Lit) has been revised and evaluated. METHODS: First, a team of clinical psychologists revised the D-Lit German scale. Next, cognitive interviews were conducted with patients with depression to improve the comprehensibility of the scale items. Our revision of the D-Lit-R German scale was then subjected to an anonymous online study. Finally, the data went through an exploratory factor analysis, and sociodemographic subgroup analyses were performed. RESULTS: N = 524 individuals (age 18-80) completed the D-Lit-R German scale and a questionnaire on their sociodemographic data. Cronbach´s alpha was estimated as α = .72, and McDonald's Omega (categorical) was estimated as ω = .77. The mean Item difficulty was M = .75 (SD = .15). An EFA was performed for a unidimensional model, a 5-factor-model and at last a 3-factor-model. The 5-factorial model showed a good model fit (χ2emp,WLSMV(131) = 92.424, p > .05; CFI = 1, RMSEA = 0, SRMR = .07) but was rejected since the content of the potential 5 factors could not be determined. The 3-factor model showed an arguable model fit. The Chi2 test was significant (χ2emp,WLSMV(168) = 199.912, p < .05), but the CFI and the RMSEA met an acceptable model fit (CFI = .990, RMSEA of .019, 90% CI[.003, .029]). Substantively, the three factors were defined as (1) Distractors and other symptoms, (2) Depressive symptoms, and (3) Pharmacological and psychotherapeutic depression treatment. Furthermore, there were significant differences in sum scores regarding the subgroup's gender, treatment for mental health problems, depression treatment, experience with depression, and different career fields. CONCLUSIONS: The D-Lit-R German scale is a time-efficient scale to assess some aspects of the depression literacy construct that can be easily applied. Since there was no perfect model fit, it is recommended to continue to revise the scale. Further evaluation studies could ask for knowledge of the etiological factors of depression. Future studies could then use this instrument to convey depression literacy. This instrument could assess the growth of knowledge after psychoeducational interventions in different settings. TRIAL REGISTRATION: This trial was preregistered at the platform osf.io ( https://osf.io/49xdh ). REGISTRATION NUMBER: https://doi.org/10.17605/OSF.IO/49XDH Date of registration: 28 April 2022.

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.

Dipsticks and point-of-care Microscopy to reduce antibiotic use in women with an uncomplicated Urinary Tract Infection (MicUTI): protocol of a randomised controlled pilot trial in primary care.

INTRODUCTION: Uncomplicated urinary tract infections (uUTIs) in women are common infections encountered in primary care. Evidence suggests that rapid point-of-care tests (POCTs) to detect bacteria and erythrocytes in urine at presentation may help primary care clinicians to identify women with uUTIs in whom antibiotics can be withheld without influencing clinical outcomes. This pilot study aims to provide preliminary evidence on whether a POCT informed management of uUTI in women can safely reduce antibiotic use. METHODS AND ANALYSIS: This is an open-label two-arm parallel cluster-randomised controlled pilot trial. 20 general practices affiliated with the Bavarian Practice-Based Research Network (BayFoNet) in Germany were randomly assigned to deliver patient management based on POCTs or to provide usual care. POCTs consist of phase-contrast microscopy to detect bacteria and urinary dipsticks to detect erythrocytes in urine samples. In both arms, urine samples will be obtained at presentation for POCTs (intervention arm only) and microbiological analysis. Women will be followed-up for 28 days from enrolment using self-reported symptom diaries, telephone follow-up and a review of the electronic medical record. Primary outcomes are feasibility of patient enrolment and retention rates per site, which will be summarised by means and SDs, with corresponding confidence and prediction intervals. Secondary outcomes include antibiotic use for UTI at day 28, time to symptom resolution, symptom burden, number of recurrent and upper UTIs and re-consultations and diagnostic accuracy of POCTs versus urine culture as the reference standard. These outcomes will be explored at cluster-levels and individual-levels using descriptive statistics, two-sample hypothesis tests and mixed effects models or generalised estimation equations. ETHICS AND DISSEMINATION: The University of Würzburg institutional review board approved MicUTI on 16 December 2022 (protocol n. 109/22-sc). Study findings will be disseminated through peer-reviewed publications, conferences, reports addressed to clinicians and the local citizen's forums. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT05667207.

Impact of pre-existing mental health diagnoses on development of post-COVID and related symptoms: a claims data-based cohort study.

This study aimed to examine the association of prior mental health diagnoses with the onset of Post-COVID-19 condition (PCC). We conducted a retrospective comparative cohort study and secondary analysis of routinely collected claims data from participants in statutory health insurance in Bavaria, Germany, from January 2015 to June 2022. Study participants were 619,560 patients with confirmed COVID-19, 42,969 with other respiratory tract infection (ORI), and 438,023 controls. Using diagnoses coded according to the German modification of the ICD-10, the associations between prior mental health diagnoses and a PCC diagnosis (primary outcome) or associated symptoms (secondary outcomes) were estimated using multiple Cox proportional hazards regression models. Mental disorders (hazard ratio [HR] 1.36, 95% confidence interval [CI] 1.30-1.42), anxiety (HR 1.14, 95% CI 1.07-1.20), depression (HR 1.25, 95% CI 1.19-1.30) and somatoform disorders (HR 1.30, 95% CI 1.24-1.36) were associated with higher risks for PCC. Mental disorders were associated with the same or even greater risk for a diagnosis of malaise and fatigue in the control cohort (HR 1.71, 95% CI 1.52-1.93) and ORI cohort (HR 1.43, 95% CI 1.20-1.72), than in the COVID-19 cohort (HR 1.43, 95% CI 1.35-1.51). In summary, prior mental comorbidity was associated with an increased risk of PCC and its associated symptoms in all cohorts, not specifically in COVID-19 patients.

[Participation in primary care research - From the idea to the constitution of a citizens advisory board]. / Partizipation in der allgemeinmedizinischen Forschung ­ Von der Idee bis zur Gründung eines Bürger*innenbeirats.

INTRODUCTION: Public participation in research processes is becoming increasingly important and is justified with positive effects for research. The first successful initiatives can also be found in general practice and health services research. The transparent presentation of these projects is essential to the discussion about participation. The aim of this article is to present and discuss the conception and implementation of the initiative at the Institute of General Practice and Health Services Research at the Technical University of Munich and the kick-off event for the participation of patients, citizens and patient representatives. METHODS: This article reports the planning, recruitment, implementation, and evaluation of the kick-off event. Frameworks for future events are described. RESULTS: In total, twelve persons were recruited through various recruitment channels to participate in the kick-off event. The participants showed a diverse structure of motives with regard to participation in research. All participants shared the essential goal of improving research and care by adding their perspectives to research processes. However, the specific opportunities for participation and the role of patients and citizens in research processes were unclear. During the event, future workshops were planned to address these challenges. The focus was on strengthening relationships and communicating the basics of primary care research in order to enable sustainable participation. DISCUSSION: The participants' different motivations resulted in the need to explore the concrete possibilities of participation. One of the specific requirements was to focus on role identification and the structure of the initiative. The question of self-description and -identification as a patient and/or citizen seemed crucial. Furthermore, a concise introduction to the topic of participation in research processes, as well as patient and citizen qualifications, is considered necessary. CONCLUSION: Establishing an advisory board for patients and citizens in primary care research is associated with specific requirements. In addition to fundamental necessities such as the joint clarification of the possibilities of participation, defining the role and establishing the identity of the initiative should be promoted.

Expectations of general practitioners on a practice based research network in Germany- a qualitative study within the Bavarian Research Practice Network (BayFoNet).

BACKGROUND: Despite general practitioners' (GPs') key role in Germany`s primary health care, clinical research in general practice is scarce. Clinical research is mainly conducted at inpatient facilities, although their results are rarely transferable. German GPs have no extra time or funding for research, as well as limited research training. To support clinical research in German primary health care, practice-based research networks (PBRNs) are developed. As they will be based on an active involvement of GPs, we need more information on GPs` participation-readiness. The aim of this study was to explore facilitators and barriers to participation in the Bavarian Research Practice Network (BayFoNet) from the GPs`perspective before clinical trials will be performed. METHODS: We have performed semi-structured qualitative interviews with a purposive sample of 20 Bavarian GPs in 2022 under the application of the consolidated framework for implementation research (CFIR). Transcriptions were analysed according to Kuckartz` qualitative content analysis. The five domains of the CFIR framework served as initial deductive codes. RESULTS: N = 14 interviewees already agreed to participate in BayFoNet, whereas n = 6 interviewees opted not to participate in BayFoNet at the time of data collection. Main facilitators to conduct clinical research within BayFoNet were the motivation to contribute to evidence strength and quality in general practice, professional development and training of practice staff, as well as networking. Barriers for an active participation were bad experiences with previous clinical studies and lack of resources. CONCLUSIONS: PBRNS in Germany have to be promoted and the entire practice team has to be involved at an early stage of development. Professional training of general practice staff and a living network might enhance engagement. Participatory approaches could help to develop acceptable and feasible study designs. Furthermore, PBRNs should support patient recruitment and data collection in general practices and disseminate the results of their research projects regularly to maintain GPs` engagement. TRIAL REGISTRATION: DRKS00028805, NCT05667207.

Deconstructing depression by machine learning: the POKAL-PSY study.

Unipolar depression is a prevalent and disabling condition, often left untreated. In the outpatient setting, general practitioners fail to recognize depression in about 50% of cases mainly due to somatic comorbidities. Given the significant economic, social, and interpersonal impact of depression and its increasing prevalence, there is a need to improve its diagnosis and treatment in outpatient care. Various efforts have been made to isolate individual biological markers for depression to streamline diagnostic and therapeutic approaches. However, the intricate and dynamic interplay between neuroinflammation, metabolic abnormalities, and relevant neurobiological correlates of depression is not yet fully understood. To address this issue, we propose a naturalistic prospective study involving outpatients with unipolar depression, individuals without depression or comorbidities, and healthy controls. In addition to clinical assessments, cardiovascular parameters, metabolic factors, and inflammatory parameters are collected. For analysis we will use conventional statistics as well as machine learning algorithms. We aim to detect relevant participant subgroups by data-driven cluster algorithms and their impact on the subjects' long-term prognosis. The POKAL-PSY study is a subproject of the research network POKAL (Predictors and Clinical Outcomes in Depressive Disorders; GRK 2621).

Development and internal validation of an instrument to measure the motivation of residents for family medicine.

BACKGROUND: For several decades, medical school graduates' motivation to specialise in family medicine is decreasing. Therefore, residents in family medicine must be motivated for the profession and finish their residency. OBJECTIVES: Goal of the current study is the development and internal validation of an instrument to measure the residents' motivation for family medicine, which is based on the self-determination theory: STRength mOtivatioN General practitioner (STRONG). METHODS: We used an existing instrument, the 'Strength of Motivation for Medical School,' adapted the 15 items and added a 16th item to make it suitable for residency in family medicine. After a review by experts, the questionnaire was sent to 943 residents of family medicine in Bavaria, Germany, in December 2020. An exploratory factor analysis for the STRONG item scores was carried out. The items were analysed for grouping into subscales by using principal component analysis. Cronbach's alpha for internal consistency was determined for calculating the reliability of the subscales. RESULTS: After analysis, the questionnaire appeared to consist of two subscales: 'Willingness to sacrifice' (eight items, Cronbach's alpha is 0.82) and 'Persuasion' (five items, Cronbach's alpha is 0.61). The factor analysis with Promax rotation resulted in two factors explaining 39.6% of the variance. The Cronbach's alpha of the full scale is 0.73. CONCLUSION: Based on the internal validation, the STRONG Instrument appears to have good reliability and internal validity, assuming a two-factor structure. This may therefore be a helpful instrument for measuring the strength of the motivation of (future) family medicine residents.

Development of a diagnostic score using FeNO and symptoms to predict asthma.

BACKGROUND: Fractional exhaled nitric oxide (FeNO) is known as effective for ruling-in asthma. The diagnostic value might be increased in combination with clinical signs and symptoms (CSS). The aim was to develop a new model for ruling-in and ruling-out asthma. METHODS: Diagnostic multi-centre study in three practices of pneumologists in Germany. Whole-body plethysmography was combined with bronchodilation tests or bronchial provocation as diagnostic reference standard. Follow-up was performed after 3 months. An expert committee evaluated test results, symptoms, and course of disease for the final diagnosis. Relevant CSS known from guidelines were used to enable combinatorial development of decision rules. Outcomes of multiple logistic regression modeling were translated into a diagnostic score and internally validated by ten-fold cross validation. RESULTS: 308 patients with complete follow-up were included. 186 (60.4%) were female, average age was 44.7 years and 161 (52.5%) had asthma. The average area under the receiver operating curve (AUC) of the diagnostic score was 0.755 (interquartile range 0.721-0.814). Allergic rhinitis, wheezing, dyspnea on exertion, coughing attacks at night, and awakening by shortness of breath were leading symptoms for ruling-in asthma. Frequent coughing and frequent respiratory infections were leading symptoms for ruling-out. The combination of FeNO and CSS allowed ruling-in asthma with a probability of up to 99%, and ruling-out with a post-test probability down to 9%. CONCLUSION: The diagnostic scoring model increased the diagnostic value of FeNO in combination with CSS. The new decision rule allowed to rule-in asthma with high certainty, and also to rule-out with acceptable certainty.

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.

Medication Adherence and Healthcare Costs in Chronically Ill Patients Using German Claims Data.

BACKGROUND AND OBJECTIVE: Despite the importance of medication adherence for chronically ill patients and the vast literature on its relationship to costs, this field suffers from methodological limitations. These are caused, amongst others, by the lack of generalizability of data sources, varying definitions of adherence, costs, and model specification. We aim to address this with different modeling approaches and to contribute evidence on the research question. METHODS: We extracted large cohorts of nine chronic diseases (n = 6747-402,898) from German claims data of stationary health insurances between 2012 and 2015 (t0-t3). Defined as the proportion of days covered by medication, we examined the relationship of adherence using several multiple regression models at baseline year t0 with annual total healthcare costs and four sub-categories. Models with concurrent, and differently time-lagged measurements of adherence and costs were compared. Exploratively, we applied non-linear models. RESULTS: Overall, we found a positive association between the proportion of days covered by medication and total costs, a weak association with outpatient costs, positive with pharmacy costs, and frequently negative with inpatient costs. There were major differences by disease and its severity but little between years, provided adherence and costs were not measured concurrently. The fit of linear models was mainly not inferior to that of non-linear models. CONCLUSIONS: The estimated effect on total costs differed from most other studies, which highlights concerns about generalizability, although effect estimates in sub-categories were as expected. Comparison of time lags indicates the importance of avoiding concurrent measurement. A non-linear relationship should be considered. These methodological approaches are valuable in future research on adherence and its consequences.

[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.

HPV vaccination leads to decrease of anogenital warts and precancerous lesions of the cervix uteri in young women with low vaccination rates: a retrospective cohort analysis.

BACKGROUND: Although the human papillomavirus (HPV) vaccine has been recommended in Germany for girls since 2007, no organised vaccination programme was introduced and HPV vaccine coverage remains low. We investigated the HPV vaccination rates from 2008 to 2018 and the effects of HPV vaccination on anogenital warts and precancerous lesions in young women in Bavaria, Germany, a state with low vaccination rates. METHODS: Retrospective analyses of claims data from the Bavarian Association of Statutory Health Insurance Physicians (KVB) on females born between 1990 and 2009 (9 to 28 years old in 2018) were conducted to calculate vaccination rates by birth cohort, proportion of vaccine types administered and incidence of anogenital warts and precancerous lesions of the cervix uteri. 942 841 Bavarian females 9 to 28 years old with available information on HPV vaccination were included to calculate vaccination rates. For the outcome analyses, data from 433 346 females 19 to 28 years old were analysed. Hazard ratios (HR) were computed from univariable and multivariable Cox regression models comparing vaccinated and unvaccinated women, considering type of vaccine used and contraceptive prescription. RESULTS: 40·9% of 18-year-olds and only 13·3% of 12-year-olds were fully vaccinated in 2018 in Bavaria. Gardasil® and Gardasil9® were most commonly administered. Vaccinated compared to unvaccinated women had a lower incidence of anogenital warts and cervical lesions, however only small differences were detected between fully and partially vaccinated women. Fully vaccinated women had a 63% (HR 0·37 (95% confidence interval (CI) 0·34 to 0·40) and 23% (HR 0·77, 95%CI 0·71 to 0·84) lower risk of anogenital warts and cervical lesions, respectively. Women who were prescribed contraceptives prior to vaccination had a 49% higher risk of developing anogenital warts (HR 1·49, 95%CI 1·25 to 1·79) or cervical lesions (HR 1·49, 95%CI 1·27 to 1·75) compared to vaccinated women without contraceptive prescription. CONCLUSIONS: The evaluation of the effects of HPV vaccination in Bavaria showed a promising decline of anogenital warts and precancerous lesions in vaccinated young women. However, an increase in vaccination rates is necessary to achieve a greater population impact in preventing HPV-related diseases.

Identification of target groups and individuals for adherence interventions using tree-based prediction models.

Background: In chronically ill patients, medication adherence during implementation can be crucial for treatment success and can decrease health costs. In some populations, regression models do not show this relationship. We aim to estimate subgroup-specific and personalized effects to identify target groups for interventions. Methods: We defined three cohorts of patients with type 1 diabetes (n = 12,713), type 2 diabetes (n = 85,162) and hyperlipidemia (n = 117,485) from German claims data between 2012 and 2015. We estimated the association of adherence during implementation in the first year (proportion of days covered) and mean total costs in the three following years, controlled for sex, age, Charlson's Comorbidity Index, initial total costs, severity of the disease and surrogates for health behavior. We fitted three different types of models on training data: 1) linear regression models for the overall conditional associations between adherence and costs, 2) model-based trees to identify subgroups of patients with heterogeneous adherence effects, and 3) model-based random forests to estimate personalized adherence effects. To assess the performance of the latter, we conditionally re-estimated the personalized effects using test data, the fixed structure of the forests, and fixed effect estimates of the remaining covariates. Results: 1) our simple linear regression model estimated a positive adherence effect, that is an increase in total costs of 10.73 Euro per PDC-point and year for diabetes type 1, 3.92 Euro for diabetes type 2 and 1.92 Euro for hyperlipidemia (all p ≤ 0.001). 2) The model-based tree detected subgroups with negative estimated adherence effects for diabetes type 2 (-1.69 Euro, 24.4% of cohort) and hyperlipidemia (-0.11 Euro, 36.1% and -5.50 Euro, 5.3%). 3) Our model-based random forest estimated personalized adherence effects with a significant proportion (4.2%-24.1%) of negative effects (up to -8.31 Euro). The precision of these estimates was high for diabetes type 2 and hyperlipidemia patients. Discussion: Our approach shows that tree-based models can identify patients with different adherence effects and the precision of personalized effects is measurable. Identified patients can form target groups for adherence-promotion interventions. The method can also be applied to other outcomes such as hospitalization risk to maximize positive health effects of an intervention.