Public Beliefs About Accessibility and Quality of Emergency Departments in Germany.

Background: It is well established that emergency department (ED) crowding leads to worse health outcomes. Although various patient surveys provide information about reasons to visit EDs, less is known in terms of beliefs about EDs among the general population. This study examines public beliefs regarding accessibility and quality of EDs and their associations with social characteristics (gender, age, education, immigration background) as well as knowledge about emergency care services and health literacy. Methods: We conducted a cross-sectional study based on a random sample of 2,404 adults living in Hamburg, Germany, in winter 2021/2022. We developed eight statements regarding accessibility and quality of EDs leading to two scales (Cronbach's α accessibility = 0.76 and quality of care = 0.75). Descriptive statistics of the eight items are shown and linear regression were conducted to determine associations of the two scales with social characteristics as well as knowledge about emergency care services and health literacy (HLS-EU-Q6). Results: Nearly 44% of the respondents agreed that "you can always go to an ED, if you do not get a short-term appointment with a general practitioner or specialist." And 38% agreed with the statement, "If you do not have the time during normal practice hours due to your work, you can always go to an ED." In terms of quality, 38% believed that doctors in EDs are more competent than doctors in general practice, and 25% believed that doctors in EDs are more competent than doctors in specialized practices. In the fully adjusted model, public beliefs about emergency care accessibility and quality of EDs were significantly associated with all social characteristics and knowledge of emergency care options with the strongest associations between knowledge and accessibility (ß = -0.17; P < 0.001) and between education and quality (ß = -0.23; P < 0.001). Conclusion: We found endorsement of public beliefs about accessibility and quality of EDs that can lead to inappropriate utilization. Our results also suggest that knowledge of different emergency services plays an important role. Therefore, after system-related reorganizations of emergency care, information campaigns about such services tailored to socially deprived populations may help alleviate the issue of crowding.

[Intended utilization of health care services in cases of mental illnesses with varying urgency]. / Intendierte Inanspruchnahme von Versorgungsangeboten bei psychischen Erkrankungen mit unterschiedlicher Dringlichkeit.

OBJECTIVE: To investigate variations in intended utilization in cases of an acute psychotic episode, an alcohol related or depressive disorder depending on different case characteristics. METHODS: A telephone survey with case vignettes was conducted (N=1,200). Vignettes varied in terms of urgency of symptoms, daytime, sex of the afflicted person and age/mental disorder. The respondents were asked to indicate whom they would contact first in the described case. RESULTS: Outpatient physicians were named most frequently as the first point of contact (61.1%) while only 6.5% of the respondents named emergency medicine including the medical on call service (8.1% in high urgency cases, i. e. emergencies that did not tolerate any delay). Intended utilization varied by urgency and age/mental illness. CONCLUSION: More Information about the need to seek medical help immediately in cases of mental illnesses with high urgency should be provided.

[Does the Innovation Fund Improve Healthcare Provision? A Critical Assessment of the Status of Implementing Successful Innovation Fund Projects into Healthcare Practice]. / Verbessert der Innovationsfonds die Versorgung? Eine kritische Bestandsaufnahme zum Stand der Implementierung erfolgreicher Innovationsfondsprojekte in die Versorgungspraxis.

INTRODUCTION: Since 2015, the Federal Joint Committee (G-BA)'s Innovation Fund has been supporting projects in health services research and new health service models ("Neue Versorgungsformen", NVF). By the end of 2022, 211 projects in the NVF category had been funded. A key objective is the transfer of successful projects into standard care. This article analyzes previous projects regarding their incorporation into routine care based on transfer recommendations of the Innovation Fund Committee ("Innovationsausschuss" IA). METHOD: Descriptive analysis of all projects completed by August 1, 2023 with transfer recommendations in the "NVF" funding stream. Presentation by topic, project duration, time until IA transfer decision, categorization, and number of institutions and organizations (recipients) addressed per project, their feedback published on the G-BA website, response rates per recipient group, and a content classification and interpretation of exemplary feedback. Recommendations based on the results and their discussion in an expert workshop. RESULTS: Out of 57 NVF projects, 17 had a transfer recommendation. A total of 57 feedback responses were received from a total of 431 recipients addressed by the IA across these projects. Response rates varied significantly. One-third of inquiries to the G-BA and its member organizations received a response (31%), while only every fifth inquiry to federal states (18%) and professional societies (18%) got a response. Less than one in ten inquiries to the Federal Ministry of Health (8%), administrative bodies (6%), and the German Medical Association (0%) received a response. Project-specific feedback within a recipient group was often contradictory or limited to regional scope. DISCUSSION AND CONCLUSION: The transfer process reveals significant structural and procedural obstacles regarding the incorporation of projects evaluated as successful into routine health care. To ensure that funding from the innovation fund is most effectively used, there needs to be a realistic chance of successful transfer of positive project outcomes into routine care. The DNVF recommends stronger involvement of rule-competent institutions, mandatory publication of responses, structured moderation of the transfer process, expanding types of selective contracts, financing of implementation phases and of studies drawing on results across successful NVF projects.

Telephone Health Coaching and Remote Exercise Monitoring (TeGeCoach) in Peripheral Arterial Occlusive Disease­a Randomized Controlled Trial.

BACKGROUND: Supervised exercise programs are commonly used to treat intermittent claudication (IC). Home-based exercise programs have been developed to lower barriers to participation. We studied the effects of one such program (TeGeCoach) on self-reported walking ability in patients with IC. METHODS: In a pragmatic, multicenter, randomized and controlled trial (registration number NCT03496948), 1982 patients with symptomatic IC, insured by one of three German statutory health-insurance carriers, received either telephone health coaching with remote exercise monitoring (TeGeCoach; n = 994) or routine care (n = 988). The primary outcome was the change in Walking Impairment Questionnaire (WIQ) scores 12 and 24 months after the start of the intervention (intention-to-treat analysis). The secondary outcomes were health-related quality of life, symptoms of depression or anxiety, health competence, patient activation, alcohol use, and nicotine dependence. RESULTS: There was a significant difference between arms in favor of TeGeCoach in the WIQ (p<0.0001). Patients in the TeGeCoach arm had WIQ scores that were 6.30 points higher at 12 months (Bonferroni-corrected 95% CI [4.02; 8.59], Cohen's d = 0.26) and 4.55 points higher at 24 months ([2.20; 6.91], d = 0.19). They also fared better in some of the secondary outcomes at 12 months, including physical health-related quality of life and patient activation, with at least small effect sizes (d > 0.20). The average daily step count was no higher in the TeGeCoach group. CONCLUSION: The observed reductions of symptom burden indicate the benefit of home-based exercise programs in the treatment of intermittent claudication. Such programs expand the opportunities for the guideline-oriented treatment of IC. Future studies should address the effect of home-based exercise programs on clinical variables, e.g., the 6-minute walk test.

Multi-staged development and pilot testing of a self-assessment tool for organizational health literacy.

BACKGROUND: Until now a comprehensive, consensus-based tool that can be used by a variety of health care organizations for assessing their organizational health literacy (OHL) is not available. Therefore, we aimed to develop and test a literature- and consensus-based self-assessment tool. METHODS: The study is based on a scoping review that was previously published by the authors. For the development of the self-assessment tool, the criteria identified in the literature were synthesized with criteria gained through group discussions with representatives of different types of health care organizations (N = 27) all based in Hamburg (Germany). Consensus on the criteria was reached by conducting a Delphi process (N = 22). A review by the project's patient advisory council was included in the process. The self-assessment tool was converted into an online tool and refined by a pretest. Finally, the online survey was piloted (N = 53) and the reliability and item loadings for each scale were analyzed. RESULTS: In total, 77 criteria (items) characterizing a health literate health care organization were developed and grouped into five main categories (scales): (1) "easy access and navigation", (2) "integration, prioritization, and dissemination of OHL", (3) "qualification, quality management, evaluation, and needs assessment", (4) "communication with target groups", and (5) "involvement and support of target groups". The results of the online survey showed that the tool is suitable for assessing an organization's status quo on OHL. The psychometric analysis showed good to excellent internal consistency. Item analyses of the developed self-assessment tool was satisfactory. CONCLUSIONS: We were able to define a set of 77 items to characterize OHL, which were integrated into a new, comprehensive, and consensus-based self-assessment tool to identify areas for improvement. We found evidence that the self-assessment tool, based on the identified criteria, consists of the assumed five scales. Further research should analyze the validity of the self-assessment tool on a higher detail level.

Correction: Application of the skills network approach to measure physician competence in shared decision making based on self-assessment.

[This corrects the article DOI: 10.1371/journal.pone.0282283.].

The effect of telephone health coaching and remote exercise monitoring for peripheral artery disease (TeGeCoach) on health care cost and utilization: results of a randomized controlled trial.

BACKGROUND: Peripheral artery disease (PAD) is the third most prevalent atherosclerotic cardiovascular disease. In 2016, costs per patient associated with PAD exceeded even the health-economic burden of coronary heart disease. Although affecting over 200 million people worldwide, a clear consensus on the most beneficial components to be included in home-based exercise programs for patients with peripheral artery disease is lacking. The aim of the study was to examine the health care use and costs caused by the 12-month patient-centered 'Telephone Health Coaching and Remote Exercise Monitoring for Peripheral Artery Disease' (TeGeCoach) program in a randomized controlled trial. METHODS: This is a two-arm, parallel-group, open-label, pragmatic, randomized, controlled clinical trial (TeGeCoach) at three German statutory health insurance funds with follow-up assessments after 12 and 24-months. Study outcomes were medication use (daily defined doses), days in hospital, sick pay days and health care costs, from the health insurers' perspective. Claims data from the participating health insurers were used for analyses. The main analytic approach was an intention-to-treat (ITT) analysis. Other approaches (modified ITT, per protocol, and as treated) were executed additionally as sensitivity analysis. Random-effects regression models were calculated to determine difference-in-difference (DD) estimators for the first- and the second year of follow-up. Additionally, existing differences at baseline between both groups were treated with entropy balancing to check for the stability of the calculated estimators. RESULTS: One thousand six hundred eighty-five patients (Intervention group (IG) = 806; Control group (CG) = 879) were finally included in ITT analyses. The analyses showed non-significant effects of the intervention on savings (first year: - 352€; second year: - 215€). Sensitivity analyses confirmed primary results and showed even larger savings. CONCLUSION: Based on health insurance claims data, a significant reduction due to the home-based TeGeCoach program could not be found for health care use and costs in patients with PAD. Nevertheless, in all sensitivity analysis a tendency became apparent for a non-significant cost reducing effect. TRIAL REGISTRATION: NCT03496948 (www. CLINICALTRIALS: gov), initial release on 23 March 2018.

Application of the skills network approach to measure physician competence in shared decision making based on self-assessment.

Several approaches to and definitions of 'shared decision making' (SDM) exist, which makes measurement challenging. Recently, a skills network approach was proposed, which conceptualizes SDM competence as an organized network of interacting SDM skills. With this approach, it was possible to accurately predict observer-rated SDM competence of physicians from the patients' assessments of the physician's SDM skills. The aim of this study was to assess whether using the skills network approach allows to predict observer-rated SDM competence of physicians from their self-reported SDM skills. We conducted a secondary data analysis of an observational study, in which outpatient care physicians rated their use of SDM skills with the physician version of the 9-item Shared Decision Making Questionnaire (SDM-Q-Doc) during consultations with chronically ill adult patients. Based on the estimated association of each skill with all other skills, an SDM skills network for each physician was constructed. Network parameters were used to predict observer-rated SDM competence, which was determined from audio-recorded consultations using three widely used measures (OPTION-12, OPTION-5, Four Habits Coding Scheme). In our study, 28 physicians rated consultations with 308 patients. The skill 'deliberating the decision' was central in the population skills network averaged across physicians. The correlation between parameters of the skills networks and observer-rated competence ranged from 0.65 to 0.82 across analyses. The use and connectedness of the skill 'eliciting treatment preference of the patient' showed the strongest unique association with observer-rated competence. Thus, we found evidence that processing SDM skill ratings from the physicians' perspective according to the skills network approach offers new theoretically and empirically grounded opportunities for the assessment of SDM competence. A feasible and robust measurement of SDM competence is essential for research on SDM and can be applied for evaluating SDM competence during medical education, for training evaluation, and for quality management purposes. [A plain language summary of the study is available at https://osf.io/3wy4v.].

[Efficiency-Focussed Assessment of Internet-Based Interventions: a Study Protocol]. / Wirksamkeitsfokussierte Bewertung von internetbasierten Interventionen: ein Studienprotokoll.

BACKGROUND: The availability of internet-based interventions for the treatment of mental disorder is steadily growing and is also included in the German health care system. However, there is still room for improvement in terms of the information available to users and practitioners, particularly with regard to the effectiveness of internet-based interventions. OBJECTIVES: To identify and evaluate internet-based interventions for the treatment of mental disorder, listed in the DiGA-Verzeichnis. A user-friendly description of positively evaluated interventions will be made available for interested people at psychenet.de. METHODS: By means of predefined criteria for intervention identification, evaluation and subsequent publication on psychenet.de, a methodological sound and transparent procedure will be established and put into practice. ETHICS AND DISSEMINATION: Ethics approval is not required for this study, as research on secondary data was conducted. Relevant professional, stakeholder and patient associations will be informed about the information offered at psychenet.de.

Multi-organ assessment in mainly non-hospitalized individuals after SARS-CoV-2 infection: The Hamburg City Health Study COVID programme.

AIMS: Long-term sequelae may occur after SARS-CoV-2 infection. We comprehensively assessed organ-specific functions in individuals after mild to moderate SARS-CoV-2 infection compared with controls from the general population. METHODS AND RESULTS: Four hundred and forty-three mainly non-hospitalized individuals were examined in median 9.6 months after the first positive SARS-CoV-2 test and matched for age, sex, and education with 1328 controls from a population-based German cohort. We assessed pulmonary, cardiac, vascular, renal, and neurological status, as well as patient-related outcomes. Bodyplethysmography documented mildly lower total lung volume (regression coefficient -3.24, adjusted P = 0.014) and higher specific airway resistance (regression coefficient 8.11, adjusted P = 0.001) after SARS-CoV-2 infection. Cardiac assessment revealed slightly lower measures of left (regression coefficient for left ventricular ejection fraction on transthoracic echocardiography -0.93, adjusted P = 0.015) and right ventricular function and higher concentrations of cardiac biomarkers (factor 1.14 for high-sensitivity troponin, 1.41 for N-terminal pro-B-type natriuretic peptide, adjusted P ≤ 0.01) in post-SARS-CoV-2 patients compared with matched controls, but no significant differences in cardiac magnetic resonance imaging findings. Sonographically non-compressible femoral veins, suggesting deep vein thrombosis, were substantially more frequent after SARS-CoV-2 infection (odds ratio 2.68, adjusted P < 0.001). Glomerular filtration rate (regression coefficient -2.35, adjusted P = 0.019) was lower in post-SARS-CoV-2 cases. Relative brain volume, prevalence of cerebral microbleeds, and infarct residuals were similar, while the mean cortical thickness was higher in post-SARS-CoV-2 cases. Cognitive function was not impaired. Similarly, patient-related outcomes did not differ. CONCLUSION: Subjects who apparently recovered from mild to moderate SARS-CoV-2 infection show signs of subclinical multi-organ affection related to pulmonary, cardiac, thrombotic, and renal function without signs of structural brain damage, neurocognitive, or quality-of-life impairment. Respective screening may guide further patient management.

Assessment of person-centeredness in healthcare and social support services for women with unintended pregnancy (CarePreg): protocol for a mixed-method study.

INTRODUCTION: For women with unintended pregnancy, access to high-quality care has been found limited due to social stigma and legal restrictions, especially when seeking abortion. To foster person-centeredness (PC), recognising the experiences and needs of women is the first premise. This study aims to (1) identify relevant dimensions of PC (2) evaluate PC in healthcare and social support services, (3) develop recommendations for further actions in healthcare and social support services for women with unintended pregnancy. METHODS AND ANALYSIS: We will use a mixed-methods approach. Phase 1: expert workshops with 10-15 healthcare professionals and counsellors and semistructured interviews with 15-20 women with unintended pregnancy will be conducted to assess the relevance of PC dimensions. Phase 2: quantitative assessment of PC dimensions within healthcare and support services will be conducted. We aim to include 600 women with an unintended pregnancy (1) until 24 weeks of pregnancy or (2) who sought abortion within the past 8 weeks, over three measurement points within 12 months. To deepen the results, semistructured interviews will be conducted. Phase 3: a workshop with 10-15 experts and an online survey with 100-150 experts will be used to indicate recommendations. Participants will be gained through relevant care facilities. An ethical advisory board and an advisory board of affected women will be involved throughout the study. ETHICS AND DISSEMINATION: The study will be carried out in accordance to the latest version of the Helsinki Declaration of the World Medical Association and principles of good scientific practice. The study was approved by the Local Psychological Ethics Committee of the University Medical Center Hamburg-Eppendorf, Germany (LPEK-0260). Written informed consent will be sought prior to study participation. The study results will be disseminated in scientific journals, through collaboration partners and plain language press releases.

[Characteristics of Innovation Fund-supported Intervention Studies: Review and Document Analysis of Study Protocols, Publications and Final Reports]. / Charakteristika von durch den Innovationsfonds geförderten Interventionsstudien: Review und Dokumentenanalyse von Studienprotokollen, Publikationen und Abschlussberichten.

This prospectively registered review characterizes 50 intervention studies from the 1st wave of the Innovation Fund based on study protocols or original articles, among other sources. The mainly (randomized) controlled intervention studies included predominantly adults/seniors in ambulatory care without a regional focus and analyzed treatment processes, clinical and patient outcomes as outcomes. The substantial lack of study protocols and methodological details (e. g., sample size planning) reveals (avoidable) methodological problems regarding the scientific quality of the funded studies.

Association between physicians' and patients' perspectives of shared decision making in primary care settings in Japan: The impact of environmental factors.

PURPOSE: Shared decision-making (SDM) has only lately begun attaining recognition from the Japanese medical community. The purpose of this study was to create a Japanese version of the SDM-Q-Doc, which is a scale that measures SDM from the perspective of physicians, and to clarify its psychometric characteristics and identify the issues and factors that affect SDM. METHODS: The participants were 23 physicians and 130 patients who visited primary care clinics in Japan for the first time. Immediately following physician-patient interviews, the Japanese version of SDM-Q-9 and SDM-Q-Doc were administered to patients and physicians, respectively. For convergent validity, physician confidence in the medical interview (PCMI) was used. After the determination of internal consistency and validity of the SDM-Q-Doc, the relations among each item of SDM-Q-Doc, SDM-Q-9, physicians' sociodemographic attributes, and a presence or absence of nurse's attendance during outpatient consultation were assessed by a multiple regression analysis and structural equation modeling (SEM). RESULTS: A factor analysis confirmed that the Japanese version of the SDM-Q-Doc displays a one-factor structure with a high internal consistency (Cronbach's α = 0.87, ω = 0.88). The correlation between the PCMI and SDM-Q-Doc confirmed an appropriate convergent validity (r = 0.406; p < 0.001). Multiple regression analyses showed that the attendance of a nurse during consultation significantly affected one item of the SDM-Q-Doc, which in turn affected one item of the SDM-Q-9. SEM showed a good fit of model for these three items. CONCLUSION: The Japanese version of the SDM-Q-Doc's internal consistency and validity in the outpatient medical consultations in Japan were confirmed. Further, this study suggests the role of a nurse's attendance during a physician-patient consultation on facilitating the SDM. Further, using the Japanese version of the SDM-Q-Doc will promote communication skills training for medical professionals by checking the quality of SDM.

Interface management concepts in healthcare for rare diseases in Germany: a study protocol for a mixed-methods study to develop best practice recommendations.

INTRODUCTION: Patients and families affected by a rare disease are burdened in multiple ways. Functional interface management can unburden patients or relatives from the need to be solely accountable for the navigation through the healthcare system. This study aims at (1) providing an assessment of approaches and interface management concepts in the care of rare diseases, (2) evaluating selected existing approaches and concepts and (3) developing best practice recommendations for interface management. METHODS AND ANALYSIS: We will conduct a mixed-methods study with three phases. In phase 1, we will develop a tool to assess existing concepts of interface management for rare diseases based on a literature search and an expert workshop. The tool will be applied in a telephone survey with representatives of centres or clinics of expertise for rare diseases (target: n=100) and cooperating practitioners (target: n=60). Based on the results of phase 1, we will select four to six centres of expertise with interface management concepts, which will be evaluated extensively in phase 2. For the evaluation, we will conduct semistructured interviews with practitioners cooperating with centres or clinics for rare diseases (target: n=50), a paper-based survey including patients or parents/legal guardians (target: n=300) from the selected centres or clinics, and semistructured interviews with patients or parents/legal guardians (target: n=50). The final phase of the study will be an integration of results from phases 1 and 2 to develop best practice recommendations for interface management in healthcare of rare diseases. In a concluding expert workshop, recommendations will be presented and finalised. ETHICS AND DISSEMINATION: This study was approved by the Local Psychological Ethics Committee of the Center for Psychosocial Medicine of the University Medical Center Hamburg-Eppendorf (LPEK-0062). The findings of our study will be presented on national and international conferences and published in scientific, peer-reviewed journals. To assure that centres for rare diseases get access to the study results, centres are invited to send a representative to a final expert workshop in phase 3. Moreover, an executive summary will be provided and sent to relevant stakeholders. TRIAL REGISTRATION NUMBER: German Clinical Trials Registry (DRKS00020488).

Cost-effectiveness of guideline-based stepped and collaborative care versus treatment as usual for patients with depression - a cluster-randomized trial.

BACKGROUND: Depression is associated with major patient burden. Its treatment requires complex and collaborative approaches. A stepped care model based on the German National Clinical Practice Guideline "Unipolar Depression" has been shown to be effective. In this study we assess the cost-effectiveness of this guideline based stepped care model versus treatment as usual in depression. METHODS: This prospective cluster-randomized controlled trial included 737 depressive adult patients. Primary care practices were randomized to an intervention (IG) or a control group (CG). The intervention consisted of a four-level stepped care model. The CG received treatment as usual. A cost-utility analysis from the societal perspective with a time horizon of 12 months was performed. We used quality-adjusted life years (QALY) based on the EQ-5D-3L as effect measure. Resource utilization was assessed by patient questionnaires. Missing values were imputed by 'multiple imputation using chained equations' based on predictive mean matching. We calculated adjusted group differences in costs and effects as well as incremental cost-effectiveness ratios. To describe the statistical and decision uncertainty cost-effectiveness acceptability curves were constructed based on net-benefit regressions with bootstrapped standard errors (1000 replications). The complete sample and subgroups based on depression severity were considered. RESULTS: We found no statically significant differences in costs and effects between IG and CG. The incremental total societal costs (+€5016; 95%-CI: [-€259;€10,290) and effects (+ 0.008 QALY; 95%-CI: [- 0.030; 0.046]) were higher in the IG in comparison to the CG. Significantly higher costs were found in the IG for outpatient physician services and psychiatrist services in comparison to the CG. Significantly higher total costs and productivity losses in the IG in comparison to the CG were found in the group with severe depression. Incremental cost-effectiveness ratios for the IG in comparison to the CG were unfavourable (complete sample: €627.000/QALY gained; mild depression: dominated; moderately severe depression: €645.154/QALY gained; severe depression: €2082,714/QALY gained) and the probability of cost-effectiveness of the intervention was low, except for the group with moderate depression (ICER: dominance; 70% for willingness-to-pay threshold of €50,000/QALY gained). CONCLUSIONS: We found no evidence for cost-effectiveness of the intervention in comparison to treatment as usual. TRIAL REGISTRATION: NCT, NCT01731717 . Registered 22 November 2012 - Retrospectively registered.

Telephone health coaching with exercise monitoring using wearable activity trackers (TeGeCoach) for improving walking impairment in peripheral artery disease: study protocol for a randomised controlled trial and economic evaluation.

INTRODUCTION: Peripheral artery disease (PAD) is the third most prevalent cardiovascular disease worldwide, with smoking and diabetes being the strongest risk factors. The most prominent symptom is leg pain while walking, known as intermittent claudication. To improve mobility, first-line treatment for intermittent claudication is supervised exercise programmes, but these remain largely unavailable and economically impractical, which has led to the development of structured home-based exercise programmes. This trial aims to determine the effectiveness and cost advantage of TeGeCoach, a 12-month long home-based exercise programme, compared with usual care of PAD. It is hypothesised that TeGeCoach improves walking impairment and lowers the need of health care resources that are spent on patients with PAD. METHODS AND ANALYSIS: The investigators conduct a prospective, pragmatic randomised controlled clinical trial in a health insurance setting. 1760 patients diagnosed with PAD at Fontaine stage II are randomly assigned to either TeGeCoach or care-as-usual. TeGeCoach consists of telemonitored intermittent walking exercise with medical supervision by a physician and telephone health coaching. Participants allocated to the usual care group receive information leaflets and can access supervised exercise programmes, physical therapy and a variety of programmes for promoting a healthy lifestyle. The primary outcome is patient reported walking ability based on the Walking Impairment Questionnaire. Secondary outcome measures include quality of life, health literacy and health behaviour. Claims data are used to collect total health care costs, healthcare resource use and (severe) adverse events. Outcomes are measured at baseline, 12 and 24 months. ETHICS AND DISSEMINATION: Ethical approval has been obtained from the Medical Association Hamburg. Findings are disseminated through peer-reviewed journals, reports to the funding body, conference presentations and media press releases. Data from this trial are made available to the public and researchers upon reasonable request.NCT03496948 (www.clinicaltrials.gov), Pre-results.

Therapeutic Alliance in Technology-Based Interventions for the Treatment of Depression: Systematic Review.

BACKGROUND: There is growing evidence that technology-based interventions (TBIs) are effective for the treatment of depression. As TBIs are gaining acceptance, a question arises whether good therapeutic alliance, considered a key aspect of psychotherapy, can be established without or with minimal face-to-face contact or rather changes if blended concepts are applied. While therapeutic alliance has been studied extensively in the context of face-to-face therapy, only few studies have reviewed evidence on alliance ratings in TBIs. OBJECTIVE: The purpose of this study was to examine therapeutic alliance in technology-based psychological interventions for the treatment of depression. METHODS: We searched Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, PsycINFO, PSYNDEX, CINAHL, clinical trial registers, and sources of grey literature for randomized controlled trials on TBIs in the treatment of adults with unipolar depression. All publications were selected according to prespecified criteria. Data were extracted by two independent reviewers. RESULTS: A total of eight out of 98 studies (9.5%) included in the review on TBIs for depression considered therapeutic alliance as part of their evaluation. The available data covered eight different treatment conditions, including four stand-alone treatments (face-to-face psychotherapy, email, telephone, and internet program) and four combined treatments (face-to-face psychotherapy plus a smartphone app and an internet program combined with face-to-face psychotherapy, treatment as usual, or email/telephone). On average, patients rated the alliance positively across all groups. Importantly, no relevant group differences regarding therapeutic alliance sum scores were found in any of the studies. Five studies investigated the relationship between patients' alliance ratings and treatment outcome, revealing mixed results. CONCLUSIONS: Our results suggest that it is possible to establish a positive therapeutic alliance across a variety of different TBIs for depression, but this is based on a small number of studies. Future research needs to determine on what basis therapeutic alliance is formed in settings that do not allow for additional nonverbal cues, perhaps with adapted instruments to measure therapeutic alliance. 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.

How does the integration of collaborative care elements in a gatekeeping system affect the costs for mental health care in Germany?

Mental disorders are widespread, debilitating and associated with high costs. In Germany, usual care (UC) for mental disorders is afflicted by poor coordination between providers and long waiting times. Recently, the primary alternative to UC-the gatekeeping-based general practitioners (GP) program-was extended by the collaborative Psychiatry-Neurology-Psychotherapy (PNP) program, which is a selective contract designed to improve mental health care and the allocation of resources. Here, we assess the effects of the GP program and the PNP program on costs for mental health care. We analyzed claims data from 2014 to 2016 of 55,472 adults with a disorder addressed by PNP to compare costs and sick leave days between PNP, the GP program and UC. The individuals were grouped and balanced via entropy balancing to adjust for potentially confounding covariates. We employed a negative binomial model to compare sick leave days and two-part models to compare sick pay, outpatient, inpatient and medication costs over a 12-month period. The PNP program significantly reduced sick pay by 164€, compared to UC, and by 177€, compared to the GP program. Consistently, sick leave days were lower in PNP. We found lower inpatient costs in PNP than in UC (-194€) and in the GP program (-177€), but no reduction in those shares of inpatient costs that accrued in psychiatric or neurological departments. Our results suggest that integrating collaborative care elements in a gatekeeping system can favourably impact costs. In contrast, we found no evidence that the widely implemented GP program reduces costs for mental health care.

Assessment of patient information needs: A systematic review of measures.

BACKGROUND: Providing patient information is a central aspect of patient-centered care. Fulfilling personal information needs has positive effects on several health-related outcomes. Measurement instruments help to identify individual information needs in an effective way. The present study gives an overview of existing information needs measures and further evaluates the quality of their psychometric properties and their psychometric studies. METHODS: We conducted a systematic search on psychometric studies of measures that assess information needs in PubMed and Embase. Furthermore, we carried out a secondary search with reference and citation tracking of the included articles. Title, abstracts and full texts were screened by two independent reviewers for eligibility. We extracted data on content of the measures, validation samples and psychometric properties. In addition we rated the methodological quality with the COSMIN checklist and the quality of psychometric properties with the criteria of Terwee and colleagues. RESULTS: 24 studies on 21 measures were included. Most instruments assessed information needs of patients with cancer or cardiac diseases. The majority of the instruments were in English language and from western countries. Most studies included information on internal consistency and content validity. The ratings showed mixed results with clear deficiencies in the methodological quality of most studies. DISCUSSION: This is the first systematic review that summarized the existing evidence on measures on patient information needs using two instruments for a systematic quality assessment. The results show a need for more psychometric studies on existing measures. In addition, reporting on psychometric studies needs to be improved to be able to evaluate the reliability of the psychometric properties. Furthermore, we were not able to identify any measures on information needs for some frequent chronic diseases. Other methods to elicit information needs (e.g. open-ended interviews, question prompt sheets) could be considered as alternatives if sound measures are missing.

Cost-effectiveness analysis of collaborative treatment of late-life depression in primary care (GermanIMPACT).

BACKGROUND: Late-life depression is a highly prevalent disorder that causes a large economic burden. A stepped collaborative care program was set up in order to improve care for patients with late-life depression in primary care in Germany: GermanIMPACT is the adaption of the Improving Mood-Promoting Access to Collaborative Treatment (IMPACT) program that has already been established in primary care in the USA. The aim of this study was to determine the cost-effectiveness of GermanIMPACT compared with treatment as usual from a societal perspective. METHODS: This study is part of a 12-month bi-centric cluster-randomized controlled trial aiming to assess the effectiveness of GermanIMPACT compared with treatment as usual among patients with late-life depression. A cost-effectiveness analysis using depression-free days (DFDs) was performed. Net-monetary benefit (NMB) regressions adjusted for baseline differences for different willingness-to-pay (WTP) thresholds were conducted and cost-effectiveness acceptability curves were constructed. RESULTS: In total, n = 246 patients (intervention group: n = 139; control group: n = 107) with a mean age of 71 from 71 primary care practices were included in the analysis. After 12 months, adjusted mean differences in costs and DFDs between intervention group and control group were +€354 and +21.4, respectively. Only the difference in DFDs was significant (p = 0.022). According to the unadjusted incremental cost-effectiveness ratio, GermanIMPACT was dominant compared with treatment as usual. The probability of GermanIMPACT being cost-effective was 80%, 90% or 95% if societal WTP per DFD was ≥€70, ≥€110 or ≥€180, respectively. CONCLUSION: Evidence for cost-effectiveness of GermanIMPACT relative to treatment as usual is not clear. Only if societal WTP was ≥€180 for an additional DFD, GermanIMPACT could be considered cost-effective with certainty.