Longitudinal Clusters of Long-Term Trajectories in Patients with Early-Onset Chronic Depression: 2 Years of Naturalistic Follow-Up after Extensive Psychological Treatment.

INTRODUCTION: In clinical trials, mostly group-level treatment effects of repeated cross-sectional measures are analyzed. However, substantial heterogeneity regarding individual symptom profiles and the variability of treatment effects are often neglected, especially over the long-term course. To provide effective personalized treatments, investigations of these characteristics are urgently needed. METHODS: Depression severity ratings over 104 weeks of follow-up after year-long treatment with the Cognitive Behavioral Analysis System of Psychotherapy (CBASP) or Supportive Psychotherapy (SP) were analyzed. Longitudinal cluster analysis and multinomial logistic regression analysis were conducted to investigate intraindividual trajectories from one of the largest psychotherapy trials in early-onset chronic depression. RESULTS: Two-year post-study-treatment trajectories of N = 188 patients with early-onset chronic depression were grouped into four prototypical clusters. Overall, 16.0% of patients remitted (cluster 1) and most of them did not receive any treatment during the 2-year follow-up. However, 84.0% of patients continued to experience subthreshold (37.2% cluster 2) or major depressive symptoms (46.8% clusters 3-4) and spent on average more than half of the follow-up in pharmacological and psychological treatment. Hierarchical regression analysis indicated that previous study treatment with CBASP or SP did not significantly predict cluster allocation, while baseline variables accounted for a large proportion of explained variance (R2 N = 0.64). CONCLUSION: While some patients experienced stable remission over 2 years of follow-up, the majority of patients experienced subthreshold or major depressive symptoms regardless of former study treatment with CBASP or SP. This calls for a long-term perspective implementing staging and innovative treatment approaches such as the sequential model or modular psychotherapy.

Effects of a shared decision-making implementation programme on patient-centred communication in oncology-Secondary analysis of a randomised controlled trial.

BACKGROUND: There is a need for better implementation of patient-centred (PC) communication and shared decision-making (SDM) in routine cancer care. OBJECTIVE: The aim of this study was to assess whether a programme to implement SDM in oncology had effects on PC communication in clinical encounters. DESIGN: This study constitutes a secondary analysis of data derived from an implementation trial applying a stepped wedge design that, among other strategies, incorporated training and coaching to enhance the PC communication skills of physicians. SETTING AND PARTICIPANTS: We analysed audio recordings of clinical encounters collected in three departments of a comprehensive cancer centre in Germany before and after rolling out the implementation programme. MAIN VARIABLES STUDIED: We assessed the PC communication skills of physicians. MAIN OUTCOME MEASURES: Each recording was rated by two researchers using the German version of the Four Habits Coding Scheme (4HCS), an observer-based measure of PC communication. Interrater reliability of the outcome measure was acceptable but moderate. Demographic data of patients participating in audio recordings were analysed. METHODS: Data were analysed using descriptive statistics and linear mixed-effects models. RESULTS: In total, 146 encounters, 74 before and 72 after implementation, were evaluated. The mean age of patients was 57.1 years (SD = 13.8), 70.3% were female, the largest portion of patients had medium formal education (32.4%) and were (self-) employed (37.8%). No statistically significant effect of the implementation programme on the physicians' PC communication skills was found. DISCUSSION: The results indicate that the investigated programme to implement SDM in oncology, including training and coaching, had no effects on PC communication in clinical encounters. These results are in contrast to other studies that report the effects of specific training or coaching on PC communication. Reasons for the lack of effect include the short duration of our training compared to other studies, limited reliability and moderate interrater reliability of the 4HCS scale, limited reach of the intervention programme as well as the inclusion of physicians regardless of their exposure to the interventions. CONCLUSION: Further research is needed to develop implementation strategies that improve physicians' PC communication skills. PATIENT CONTRIBUTION: Data on patients and clinical encounters with patients and physicians were analysed. There was no other patient or public involvement.

Methodological and Statistical Practices of Using Symptom Networks to Evaluate Mental Health Interventions: A Review and Reflections.

The network approach to psychopathology, which assesses associations between individual symptoms, has recently been applied to evaluate treatments for mental disorders. While various options for conducting network analyses in intervention research exist, an overview and an evaluation of the various approaches are currently missing. Therefore, we conducted a review on network analyses in intervention research. Studies were included if they constructed a symptom network, analyzed data that were collected before, during or after treatment of a mental disorder, and yielded information about the treatment effect. The 56 included studies were reviewed regarding their methodological and analytic strategies. About half of the studies based on data from randomized trials conducted a network intervention analysis, while the other half compared networks between treatment groups. The majority of studies estimated cross-sectional networks, even when repeated measures were available. All but five studies investigated networks on the group level. This review highlights that current methodological practices limit the information that can be gained through network analyses in intervention research. We discuss the strength and limitations of certain methodological and analytic strategies and propose that further work is needed to use the full potential of the network approach in intervention research.

Evaluation of a patient-centered communication skills training for nurses (KOMPAT): study protocol of a randomized controlled trial.

BACKGROUND: To ensure high quality of nurses' communication as part of patient-centered care, training of communication skills is essential. Previous studies indicate that communication skills trainings can improve communication skills of nurses and have a positive effect on emotional and psychological burden. However, most show methodological limitations, are not specifically developed for nurses or were developed for oncological setting only. METHODS: This study aims to evaluate the effectiveness of a needs-based communication skills training for nursing professionals and to derive indications for future implementation. A two-armed randomized controlled trial including components from both effectiveness and implementation research will be applied. Additionally, a comprehensive process evaluation will be carried out to derive indications for future implementation. Nurses (n=180) of a university medical center in Germany will be randomized to intervention or waitlist-control group. The intervention was developed based on the wishes and needs of nurses, previously assessed via interviews and focus groups. Outcomes to measure effectiveness were selected based on Kirkpatrick's four levels of training evaluation and will be assessed at baseline, post-training and at 4-weeks follow-up. Primary outcome will be nurses' self-reported self-efficacy regarding communication skills. Secondary outcomes include nurses' communication skills assessed via standardized patient assessment, knowledge about patient-centered communication, mental and work-related burden, and participants' satisfaction with training. DISCUSSION: To our knowledge, this is the first study systematically evaluating the effectiveness of a patient-centered communication skills training for nursing professionals in Germany. Results will yield insight whether a needs-based intervention can improve nurses' self-efficacy regarding communication skills and other secondary outcomes. TRIAL REGISTRATION: Clinical trial registration number: NCT05700929, trial register: ClinicalTrials.gov (date of registration: 16 November 2022).

Symptom-specific improvement across therapies and their putative mediators: A mediation network intervention analysis.

OBJECTIVE: We evaluated differential treatment effects on specific symptoms and their mediators for Cognitive Behavioral Analysis System of Psychotherapy (CBASP) and Supportive Psychotherapy (SP) in persistently depressed patients. METHOD: We conducted a Bayesian mediation network intervention analysis with data from a randomized controlled trial comparing CBASP and SP. Three networks were calculated to investigate (1) differential treatment effects on specific symptoms, (2) differential treatment effects on the potential mediators interpersonal problems and social functioning, and (3) associations between change in symptoms and change in the potential mediators. RESULTS: First, we found no evidence that CBASP more strongly improves most depressive symptoms specifically, except minimal evidence of symptom-specific effects on sleeping problems and self-esteem. Second, no and minimal evidence for differential treatment effects on interpersonal problems and social functioning was shown, respectively. Third, interpersonal problems and social functioning were strongly related to depressive symptoms. CONCLUSION: While CBASP showed superior treatment effects for overall symptom severity, this treatment might not be superior in improving specific symptoms and the potential mediators interpersonal problems and social functioning. Still, interpersonal problems and social functioning seem to play an important role for depression symptoms. Future research needs to further investigate potential working mechanisms of CBASP.Trial registration: ClinicalTrials.gov identifier: NCT00970437.

Factorial, Construct, and Predictive Validity of the Motivation for Treatment Scale in Alcohol-Use Disorder Withdrawal Treatment.

INTRODUCTION: The aim of the present study was to examine for the first time the factorial, construct, and predictive validity of the motivation for treatment (MfT) scale in a cohort of patients undergoing inpatient-qualified alcohol withdrawal treatment with the goal of referring patients to further treatment. The MfT scale has previously been evaluated in different settings of substance abuse treatment, revealing factorial ambiguity. To the best of our knowledge, the present study is the first study that conducted comprehensive factor analyses versus separate analyses of the factors conducted in prior studies in order to clarify the aforementioned factorial ambiguity. METHODS: A total of 249 patients (mean age 45.2 years (SD = 10.3); 34.4% females) with alcohol dependence were assessed. Data were obtained from four inpatient clinics specialized in qualified alcohol withdrawal treatment in Germany. First, confirmatory factor analyses were carried out to examine the fit of the four models discussed in the literature. Second, an exploratory factor analysis was conducted. Correlations of the new factors with other motivational constructs and referral to a subsequent treatment were investigated as measures of construct and predictive validity. RESULTS: None of the four models showed an acceptable fit to the data in confirmatory analyses. The exploratory analysis suggested to eliminate seven items because of inappropriate factor loadings and resulted in a shortened MfT scale, which consists of three factors based on 17 items. For the latent variables "problem recognition," "desire for help," and "treatment readiness," satisfactory composite reliability was found with 0.82, 0.80, and 0.78, respectively. Evidence for predictive validity was found in the correlation between "treatment readiness" and referral to a subsequent treatment. DISCUSSION/CONCLUSION: The new shortened MfT scale exhibited remarkable parsimony, which is desirable in settings such as withdrawal treatment, where patients frequently are cognitively or physically impaired. Despite its briefness, construct and predictive validity were better than in the original version of the MfT scale. The factorial validity of the suggested scale needs to be corroborated in further research.

Patient-centered placement matching of alcohol-dependent patients based on a standardized intake assessment: process evaluation within an exploratory randomized controlled trial.

BACKGROUND: In the implementation of placement matching guidelines, feasibility has been concerned in previous research. Objectives of this process evaluation were to investigate whether the patient-centered matching guidelines (PCPM) are consistently applied in referral decision-making from an inpatient qualified withdrawal program to a level of care in aftercare, which factors affect whether patients actually receive matched aftercare according to PCPM, and whether its use is feasible and accepted by clinic staff. METHODS: The study was conducted as process evaluation within an exploratory randomized controlled trial in four German psychiatric clinics offering a 7-to-21 day qualified withdrawal program for patients suffering from alcohol dependence, and with measurements taken during detoxification treatment and six months after the initial assessment. PCPM were used with patients in the intervention group by feeding back to them a recommendation for a level of care in aftercare that had been calculated from Measurements in the Addictions for Triage and Evaluation (MATE) and discussed with the staff on the treatment unit. As measurements, The MATE, the Client Socio-Demographic and Service Receipt Inventory-European Version, a documentation form, the Control Preference Scale, and the Motivation for Treatment Scale were administered. A workshop for the staff at the participating trial sites was conducted after data collection was finished. RESULTS: Among 250 patients participating in the study, 165 were interviewed at follow-up, and 125 had received aftercare. Although consistency in the application of PCPM was moderate to substantial within the qualified withdrawal program (Cohen's kappa ≥ .41), it was fair from discharge to follow-up. In multifactorial multinomial regression, the number of foregoing substance abuse treatments predicted whether patients received more likely undermatched (Odds Ratio=1.27; p=.018) or overmatched (Odds Ratio=0.78; p=.054) treatment. While the implementation process during the study was evaluated critically by the staff, they stated a potential of quality assurance, more transparency and patient-centeredness in the use of PCPM. CONCLUSIONS: While the use of PCPM has the potential to enhance the quality of referral decision making within treatment, it may not be sufficient to determine referral decisions for aftercare. TRIAL REGISTRATION: German Clinical Trials Register DRKS00005035 . Registered 03/06/2013.

Development and content validity of the Experienced Patient-Centeredness Questionnaire (EPAT)-A best practice example for generating patient-reported measures from qualitative data.

INTRODUCTION: To effectively foster patient-centeredness (PC), it is crucial to measure its implementation. So far, there is no German measure to assess PC comprehensively. The aim of this study is to develop and select items for the Experienced Patient-Centeredness (EPAT) Questionnaire, a patient-reported experience measure (PREM). The EPAT intends to assess PC from the perspective of adult patients treated for different chronic diseases in inpatient and outpatient settings in Germany. Furthermore, we aim at providing a best-practice example for developing PREMs from qualitative data. METHODS: The development process comprised a three-phase mixed-method design: (1) preparation, (2) item generation and (3) item selection and testing of content validity. We generated items using qualitative content analysis based on information from focus groups, key informant interviews and literature search. We selected items using relevance rating and cognitive interviews. Participants were patients from four chronic disease groups (cancer, cardiovascular disease, mental disorder, musculoskeletal disorder) and healthcare experts (e.g., clinicians, researchers, patient representatives). RESULTS: We conducted six focus groups with a total of 40 patients, key informant interviews with 10 experts and identified 48 PREMs from international literature. After team discussion, we reached a preliminary pool of 152 items. We conducted a relevance rating with 32 experts and 34 cognitive interviews with 21 patients. We selected 125 items assessing 16 dimensions of PC and showed high relevance and comprehensibility. CONCLUSIONS: The EPAT questionnaire is currently undergoing psychometric testing. The transparent step-by-step report provides a best practice example that other researchers may consider for developing PREMs. Integrating literature and experts with a strong focus on patient feedback ensured good content validity. The EPAT questionnaire will be helpful in assessing PC in routine clinical practice in inpatient and outpatient settings for research and quality improvement. PATIENT OR PUBLIC CONTRIBUTION: Patients were not involved as active members of the research team. While developing the funding proposal, we informally reached out to several patient organizations who all gave us positive feedback on the study aims, thereby confirming their relevance. Those patient organizations endorsed the funding proposal with formal letters of support and supported recruitment by disseminating advertisements for study participation.

Implementability of collecting patient-reported outcome data in stroke unit care - a qualitative study.

BACKGROUND: Patient-reported outcome measures (PROMs) assess patient-relevant effects of medical treatments. We aimed to evaluate the implementation of the International Consortium for Health Outcomes Measurement Standard Set for Stroke (ICHOM-SSS) into routine inpatient care of a stroke unit. METHODS: The ICHOM-SSS was administered in a certified stroke unit during and after inpatient care. Semi-structured interviews with medical staff (n = 5) and patients or their proxies (n = 19) about their experience were audio-recorded and analysed using thematic analyses. Implementation outcomes were chosen in advance and adhered to current standards of implementation science. RESULTS: Patients perceived the ICHOM-SSS to be relevant and feasible. They reported limited understanding of why the assessment was introduced. The overall acceptance of using PROMs was high. While medical staff, too, perceived the assessment to be appropriate and relevant, their appraisal of feasibility, sustainability, and their acceptance of the implementation were low. CONCLUSIONS: For a sustainable implementation of PROMs in clinical practice, IT resources need to be adapted, medical care needs to be reorganized, and additional clinical resources are required. Future research should investigate benefits of the ICHOM-SSS and a simpler, automated implementation in stroke care. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03795948 , retrospectively registered on 8 January 2019.

Editor's Choice - The GermanVasc Score: A Pragmatic Risk Score Predicts Five Year Amputation Free Survival in Patients with Peripheral Arterial Occlusive Disease.

OBJECTIVE: Patients with peripheral arterial occlusive disease (PAOD) face an increased risk of both lower limb amputation and death. To date, it has been challenging to predict the long term outcomes for PAOD. The aim was to develop a risk score to predict worse five year amputation free survival (AFS). METHODS: In this retrospective analysis of claims data, symptomatic PAOD patients were split into training and validation sets. Variables in the model were patient age and sex, Elixhauser comorbidities, and the 190 most common secondary diagnoses. Penalised Cox regression (least absolute shrinkage and selection operator [LASSO]) with tenfold cross validation for variable selection was performed and patients were categorised into five risk groups using the ten most important variables. All analyses were stratified by intermittent claudication (IC) and chronic limb threatening ischaemia (CLTI). RESULTS: In total, 87 293 patients with PAOD (female 45.3%, mean age 71.4 ± 11.1 years) were included in the analysis. The most important variable predicting worse five year AFS was patient age >80 years. The GermanVasc score exhibited good predictive accuracy both for IC (c statistic = 0.70, 95% confidence interval [CI] 0.69-0.71) and CLTI (c statistic = 0.69, 95% CI 0.68-0.70) with adequate calibration due largely to alignment of observed and expected risk. Depending on the cumulative point score, the five year risk of amputation or death ranged from 9% (low risk) to 48% (high risk) for IC, and from 25% to 88% for CLTI. CONCLUSION: The GermanVasc score predicts worse five year AFS stratified for inpatients suffering from IC and CLTI, with good predictive accuracy. By separating low from high risk patients, the GermanVasc score may support patient centred consent.

Effectiveness and Acceptance of Technology-Based Psychological Interventions for the Acute Treatment of Unipolar Depression: Systematic Review and Meta-analysis.

BACKGROUND: Evidence on technology-based psychological interventions (TBIs) for the acute treatment of depression is rapidly growing. Despite extensive research in this field, there is a lack of research determining effectiveness and acceptance of TBIs considering different application formats in people with a formally diagnosed depressive disorder. OBJECTIVE: The goal of the review was to investigate the effectiveness and acceptance of TBIs in people with diagnosed depression with particular focus on application formats (stand-alone interventions, blended treatments, collaborative and/or stepped care interventions). METHODS: Studies investigating adults with diagnosed unipolar depressive disorders receiving any kind of psychotherapeutic treatment delivered (at least partly) by a technical medium and conducted as randomized controlled trials (RCTs) were eligible for inclusion. We searched CENTRAL (Cochrane Central Register of Controlled Trials; August 2020), MEDLINE, PsycINFO, PSYNDEX, CINAHL (January 2018), clinical trial registers, and sources of grey literature (January 2019). Two independent authors decided about study inclusion and extracted data. We performed random effects meta-analyses to synthesize the data. RESULTS: Database searches resulted in 15,546 records of which 78 completed studies were included. TBIs delivered as stand-alone interventions showed positive effects on posttreatment depression severity when compared to treatment as usual (SMD -0.44, 95% CI -0.73 to -0.15, k=10; I²=86%), attention placebo (SMD -0.51, 95% CI -0.73 to -0.30; k=12; I²=66%), and waitlist controls (SMD -1.01, 95% CI -1.23 to -0.79; k=19; I²=73%). Superior long-term effects on depression severity were shown when TBIs were compared to treatment as usual (SMD -0.24, 95% CI -0.41 to -0.07; k=6; I²=48%) attention placebo (SMD -0.23, 95% CI -0.40 to -0.07; k=7; I²=21%) and waitlist controls (SMD -0.74, 95% CI -1.31 to -0.18; k=3; I²=79%). TBIs delivered as blended treatments (providing a TBI as an add-on to face-to-face treatment) yielded beneficial effects on posttreatment depression severity (SMD -0.27, 95% CI -0.48 to -0.05; k=8; I²=53%) compared to face-to-face treatments only. Additionally, TBIs delivered within collaborative care trials were more effective in reducing posttreatment (SMD -0.20, 95% CI -0.36 to -0.04; k=2; I²=0%) and long-term (SMD -0.23, 95% CI -0.39 to -0.07; k=2; I²=0%) depression severity than usual care. Dropout rates did not differ between the intervention and control groups in any comparison (all P≥.09). CONCLUSIONS: We found that TBIs are effective not only when delivered as stand-alone interventions but also when they are delivered as blended treatments or in collaborative care trials for people with diagnosed depression. Our results may be useful to inform routine care, since we focused specifically on different application formats, formally diagnosed patients, and the long-term effectiveness of TBIs. TRIAL REGISTRATION: PROSPERO International Prospective Register of Systematic Reviews CRD42016050413; https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42016050413. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2018-028042.

Adapting the patient and physician versions of the 9-item shared decision making questionnaire for other healthcare providers in Japan.

BACKGROUND: In Japan, the number of older people with various health problems and difficulties in living is increasing. In order to practice patient-centered care for them, not only medical professionals but also multidisciplinary teams including care professionals and patients need to practice shared decision making (SDM) in the context of long-term care. For this reason, a measure of SDM in consultations with healthcare professionals (HCPs) other than physicians is needed. Therefore, this study aimed at adapting the patient and physician versions of the 9-item Shared Decision Making Questionnaire (SDM-Q-9, SDM-Q-Doc) for consultations with HCPs other than physicians in Japan. METHODS: A pair of SDM measures that can be used by HCPs other than physicians, "Care SDM-Questionnaire for care receivers (SDM-C-patient)" and "Care SDM-Questionnaire for care providers (SDM-C-provider)" were prepared based on the Japanese versions of the SDM-Q-9 and SDM-Q-Doc. The internal consistency and conceptual structure of these measures were tested by secondary analysis of data from 496 participants from a workshop on SDM for different HCPs. Measurement invariance were tested by multigroup confirmatory factor analysis (CFA) for the patient (SDM-C-patient and SDM-Q-9) and provider (SDM-C-provider vs. SDM-Q-Doc) versions. RESULTS: Both the Japanese SDM-C-patient and SDM-C-provider demonstrated high internal consistencies (Cronbach's α coefficient was 0.90 and McDonald's ω coefficient was 0.90 for both measures). CFA showed one-factor structures for both measures and original measures for physicians. Moreover, multigroup CFA showed configural and metric invariance between the novel care measures and original physician's measures. CONCLUSIONS: Thus, the novel SDM measures for care providers in Japan as well as the original physician's measures could be used in training setting. As these measures were tested only in a training setting, their reliability and validity as new measures for care should be tested in a clinical setting in future.

Efficacy of the Managing Cancer and Living Meaningfully (CALM) individual psychotherapy for patients with advanced cancer: A single-blind randomized controlled trial.

OBJECTIVE: We aimed to determine whether the Managing Cancer and Living Meaningfully (CALM) therapy is superior to a non-manualized supportive psycho-oncological counselling intervention (SPI). METHODS: Adult patients with advanced cancer and ≥9 points on the PHQ-9 and/or ≥5 points on the DT were randomized to CALM or SPI. We hypothesized that CALM patients would report significantly less depression (primary outcome) on the BDI-II and the PHQ-9 6 months after baseline compared to SPI patients. RESULTS: From 329 eligible patients, 206 participated (61.2% female; age: M = 57.9 [SD = 11.7]; 84.5% UICC IV stage). Of them, 99 were assigned to CALM and 107 to SPI. Intention-to-treat analyses revealed significantly less depressive symptoms at 6 months than at baseline (P < .001 for BDI-II and PHQ-9), but participants in the CALM and SPI group did not differ in depression severity (BDI-II: P = .62, PHQ-9: P = .998). Group differences on secondary outcomes were statistically not significant either. CONCLUSIONS: CALM therapy was associated with reduction in depressive symptoms over time but this improvement was not statistically significant different than that obtained within SPI group.

Editor's Choice - Comorbidity Patterns Among Patients with Peripheral Arterial Occlusive Disease in Germany: A Trend Analysis of Health Insurance Claims Data.

OBJECTIVE: Patients suffering from peripheral arterial occlusive disease (PAOD) are a central target population for multidisciplinary vascular medicine. This study aimed to highlight trends in treatment patterns and comorbidities using up to date longitudinal patient related data from Germany. METHODS: This study is a retrospective health insurance claims data analysis of patients insured by the second largest health insurance provider in Germany, BARMER. All PAOD patient hospitalisations between 2008 and 2016 were included. The comorbidities were categorised with Elixhauser groups using WHO ICD-10 codes and summarised as the linear van Walraven score (vWS). A trend analysis of the comorbidities was performed after standardisation by age and sex. RESULTS: A total of 156 217 patients underwent 202 961 hospitalisations (49.4% for chronic limb threatening ischaemia in 2016) with PAOD during the study period. Although the estimated annual incidence of PAOD among the BARMER cohort decreased slightly (- 4.4%), an increase was observed in the prevalence of PAOD (+ 23.1%), number of hospitalisations (+ 25.1%), peripheral vascular interventions (PVI, + 61.1%), and disease related reimbursement costs (+ 31%) from 2008 to 2016. Meanwhile, the number of major amputations decreased (- 15.1%). The proportion of patients aged 71-80 years increased about +10% among PAOD patients and the mean vWS also increased by two points during the study period. Considerable increases were found in the rates of hypertension, renal failure, and hypothyroidism, whereas the rates of diabetes and congestive heart failure decreased over time. CONCLUSION: Increasing numbers of PVI performed on these ageing and sicker patients lead to rising costs but correlate with decreasing major amputation rates.

Predictive accuracy of a hierarchical logistic model of cumulative SARS-CoV-2 case growth until May 2020.

BACKGROUND: Infectious disease predictions models, including virtually all epidemiological models describing the spread of the SARS-CoV-2 pandemic, are rarely evaluated empirically. The aim of the present study was to investigate the predictive accuracy of a prognostic model for forecasting the development of the cumulative number of reported SARS-CoV-2 cases in countries and administrative regions worldwide until the end of May 2020. METHODS: The cumulative number of reported SARS-CoV-2 cases was forecasted in 251 regions with a horizon of two weeks, one month, and two months using a hierarchical logistic model at the end of March 2020. Forecasts were compared to actual observations by using a series of evaluation metrics. RESULTS: On average, predictive accuracy was very high in nearly all regions at the two weeks forecast, high in most regions at the one month forecast, and notable in the majority of the regions at the two months forecast. Higher accuracy was associated with the availability of more data for estimation and with a more pronounced cumulative case growth from the first case to the date of estimation. In some strongly affected regions, cumulative case counts were considerably underestimated. CONCLUSIONS: With keeping its limitations in mind, the investigated model may be used for the preparation and distribution of resources during the initial phase of epidemics. Future research should primarily address the model's assumptions and its scope of applicability. In addition, establishing a relationship with known mechanisms and traditional epidemiological models of disease transmission would be desirable.

Cancer patients' preferred and perceived level of involvement in treatment decision-making: an epidemiological study.

Background: We aimed to analyze preferred and perceived levels of patients' involvement in treatment decision-making in a representative sample of cancer patients.Material and Methods: We conducted a multicenter, epidemiological cross-sectional study with a stratified random sample based on the incidence of cancer diagnoses in Germany. Data were collected between January 2008 and December 2010. Analyses were undertaken between 2017 and 2019. We included 5889 adult cancer patients across all cancer entities and disease stages from 30 acute care hospitals, outpatient facilities, and cancer rehabilitation clinics in five regions in Germany. We used the Control Preferences Scale to assess the preferred level of involvement and the nine-item Shared Decision-Making Questionnaire to assess the perceived level of involvement.Results: About 4020 patients (mean age of 58 years, 51% female) completed the survey. Response rate was 68.3%. About a third each preferred patient-led, shared, or physician-led decision-making. About 50.7% perceived high levels, about a quarter each reported moderate (26.0%) or low (24.3%) levels of shared decision-making. Sex, age, relationship status, education, health care setting, and tumor entity were linked to preferred and/or perceived decision-making. Of those patients who preferred active involvement, about 50% perceived high levels of shared decision-making.Conclusion: The majority of patients with cancer wanted to be involved in medical decisions. Many patients perceived a high level of shared decision-making. However, many patients' level of involvement did not fit their preference. This study provides a solid basis for efforts to improve shared decision-making in German cancer care.

A skills network approach to physicians' competence in shared decision making.

BACKGROUND: Measurement of physicians' competence in shared decision making (SDM) remains challenging with frequent disagreement between assessment methods. OBJECTIVE: To conceptualize and measure physicians' SDM competence as an organized network of behavioural skills and to determine whether processing patient-reported data according to this model can be used to predict observer-rated competence. DESIGN: Secondary analysis of an observational study. SETTING AND PARTICIPANTS: Primary and specialty outpatient care physicians and consecutively recruited adult patients with a chronic condition who faced a treatment decision with multiple acceptable choices. MEASURES: Network parameters constructed from patients' assessment of physicians' SDM skills as measured by the 9-item Shared Decision Making Questionnaire (SDM-Q-9) and observer-rated SDM competence of physicians measured by three widely used observer-rated instruments. RESULTS: 29 physicians (12 female, 17 male; mean age 50.3 years) recruited 310 patients (59.4% female, 40.6% male; mean age 54.0 years) facing a decision mainly regarding type 2 diabetes (36.4%), chronic back pain (32.8%) or depressive disorder (26.8%). Although most investigated skills were interrelated, elicitation of the patient's treatment preferences showed the strongest associations with the other skills. Network parameters of this skill were also decisive in predicting observer-rated competence. Correlation between predicted competence scores and observer-rated measurements ranged from 0.710 to 0.785. CONCLUSIONS: Conceptualizing physicians' SDM competence as a network of interacting skills enables the measurement of observer-rated competence using patient-reported data. In addition to theoretical implications for defining and training medical competences, the findings open a new way to measure physicians' SDM competence under routine conditions.

Patient-Centered Placement Matching of Alcohol-Dependent Patients Based on a Standardized Intake Assessment: Primary Outcomes of an Exploratory Randomized Controlled Trial.

BACKGROUND: Placement matching guidelines are promising means to optimize patient-centered care and to match patients' treatment needs. Despite considerable research regarding placement matching approaches to optimize alcohol abuse treatment, findings are inconclusive. OBJECTIVES: To investigate whether the use of patient-centered placement matching (PCPM) guidelines is more effective in reducing heavy drinking and costs 6 months after discharge from an inpatient alcohol withdrawal treatment compared to usual referral to aftercare. Secondary aims were to investigate whether age, gender, trial site or level of care (LOC) are moderators of efficacy and whether patients who were actually referred to the recommended LOC had better treatment outcomes compared to patients who were treated under- or overmatched. METHODS: Design. Exploratory randomized controlled trial with measurements during withdrawal treatment and 6 months after initial assessment. SETTING: Four German psychiatric clinics offering a 7-21 day inpatient qualified withdrawal program for patients suffering from alcohol dependence. PARTICIPANTS: From 1,927 patients who had a primary diagnosis of alcohol dependence and did not have organized aftercare when entering withdrawal treatment, 299 were invited to participate. Of those, 250 were randomized to the intervention group (IG, n = 123) or the control group (CG, n = 127). INTERVENTION: The PCPM were applied to patients of the IG by feeding back a recommendation to a LOC for aftercare that was calculated from the Measurements in the Addictions for Triage and Evaluation (MATE) and discussed with the staff of the treatment unit. Patients of the CG received a general feedback regarding their MATE interview on request. MEASUREMENTS: The MATE, the Client Socio-Demographic and Service Receipt Inventory--European Version and the MATE-Outcomes were administered. Data were analyzed using generalized linear models. RESULTS: In the intention-to-treat analysis, there were no significant differences between IG and CG regarding days of heavy drinking (incident risk ratio [IRR] 1.09; p = 0.640), direct (IRR 1.06; p = 0.779), indirect (IRR 0.77; p = 0.392) and total costs (IRR 0.89; p = 0.496). Furthermore, none of the investigated moderator variables affected statistically significant drinking or cost-related primary outcomes. Regardless of group allocation, patients who received matched aftercare reported significantly fewer days of heavy drinking than undermatched patients (IRR 2.09; p = 0.004). For patients who were overmatched, direct costs were significantly higher (IRR 1.79; p = 0.024), but with no additional effects on alcohol consumption compared to matched patients. CONCLUSIONS: While the use of PCPM failed to affect the actual referral to aftercare, our findings suggest that treating patients on the recommended LOC may have the potential to reduce days of heavy drinking compared to undertreatment and costs compared to overtreatment.

Data Privacy Compliant Validation of Health Insurance Claims Data: the IDOMENEO Approach.

Recently, health insurance claims have regained the attention of the scientific community as a source of real-world evidence in health care research and quality improvement. To date, very few studies are available which investigate the validity of health insurance claims; these may be affected by bias from several sources, such as possible upcoding of co-morbidities and complications for reimbursement advantages. The IDOMENEO study investigates the inpatient treatment of peripheral arterial disease (PAD) comprehensively using various data sources with a consortium involving experts from health care research and data privacy, a large health insurance fund, biostatisticians, jurists, and computer scientists. Prospective registry data were collected from 30-40 vascular centres in Germany using the GermanVasc registry. In addition, health insurance claims data were prospectively collected from BARMER, the second largest health insurance fund in Germany. The consortium is currently developing a data privacy compliant method of health insurance claims data validation, the methodological foundations of which are described here.

Adverse events during a disorder-specific psychotherapy compared to a nonspecific psychotherapy in patients with chronic depression.

OBJECTIVES: A recent trial comparing Cognitive Behavioral Analysis System of Psychotherapy (CBASP) and supportive psychotherapy in chronic depression found CBASP to be more effective in treating depressive symptoms. We aimed to evaluate adverse events that occurred during this trial. MATERIALS AND METHOD: A randomized trial of chronically depressed outpatients was performed. The treatment included 32 sessions of CBASP or supportive psychotherapy. Therapists asked patients about adverse events and their intensity in each session using a standardized checklist. We analyzed the mean number of (severe) adverse events per patient up to Session 32 with gamma frailty recurrent event models. RESULTS: Two hundred and sixty patients were included in the analyses (66% female, mean age 45 years). Patients in the supportive psychotherapy group reported less severe adverse events in general, and less severe adverse events related to personal life and to occupational life than patients in the CBASP group. Less adverse events related to suicidal thoughts were reported in the CBASP compared with the supportive psychotherapy group. CONCLUSIONS: Differences in the adverse events profile may be explained by the treatment elements. Adverse events related to personal and occupational life for example might be considered a necessary and expected yet temporary adverse treatment outcome of an effective CBASP treatment.