The rehabilitation treatment beliefs questionnaire-revised: assessing adolescents' treatment beliefs.

OBJECTIVE: While there are several studies on children's and adolescents' beliefs about illness and medication treatment, there is limited research on their treatment beliefs in the context of rehabilitation. The Rehabilitation Treatment Beliefs Questionnaire (RTBQ) was the first instrument available to assess pediatric patients' rehabilitation-related treatment beliefs. However, the RTBQ had some limitations that we aimed to address in this study: We revised the content of the RTBQ to include previously unaddressed dimensions of rehabilitation-related treatment beliefs, and we thoroughly tested its psychometric properties based on a sizeable, multicenter sample of adolescents with different chronic diseases. METHODS: Across 11 pediatric rehabilitation clinics throughout Germany, eligible patients aged 12-18 years with any chronic physical or mental health condition were invited to participate in an online survey. Psychometric evaluation included item analysis, exploratory factor analysis, internal consistency and construct validity. RESULTS: The sample comprised N = 294 adolescents (M = 14.2 years) with various chronic conditions. Psychometric testing demonstrated a coherent factor structure with 6 interpretable scales covering process and outcome expectations, expectations of one's own role in the treatment process, structural expectations, concerns, and emotions, the latter three representing previously unaddressed dimensions of rehabilitation-related treatment beliefs. Internal consistency was acceptable to good. Construct validity analyses showed mostly hypotheses-consistent correlations with related constructs. CONCLUSIONS: The revised RTBQ provides a psychometrically well-tested, adolescent-specific, and disease-generic instrument that captures multiple dimensions of rehabilitation-related treatment beliefs. Practical implications include identifying adolescents' beliefs about rehabilitation treatment in order to actively involve them in their illness management.

The economic impact of a local, collaborative, stepped, and personalized care management for older people with chronic diseases: results from the randomized comparative effectiveness LoChro-trial.

BACKGROUND: Within the ageing population of Western societies, an increasing number of older people have multiple chronic conditions. Because multiple health problems require the involvement of several health professionals, multimorbid older people often face a fragmented health care system. To address these challenges, in a two-group parallel randomized controlled trial, a newly developed care management approach (LoChro-Care) was compared with usual care. METHODS: LoChro-Care consists of individualized care provided by chronic care managers with 7 to 16 contacts over 12 months. Patients aged 65 + with chronic conditions were recruited from inpatient and outpatient departments. Healthcare utilization costs are calculated by using an adapted version of the generic, self-reporting FIMA©-questionnaire with the application of standardized unit costs. Questionnaires were given at 3 time points (T0 baseline, T1 after 12 months, T2 after 18 months). The primary outcome was overall 3-month costs of healthcare utilization at T1 and T2. The data were analyzed using generalized linear models with log-link and gamma distribution and adjustment for age, sex, level of care as well as the 3-month costs of care at T0. RESULTS: Three hundred thirty patients were analyzed. The results showed no significant difference in the costs of healthcare utilization between participants who received LoChro-Care and those who received usual care, regardless of whether the costs were evaluated 12 (adjusted mean difference € 130.99, 95%CI €-1477.73 to €1739.71, p = 0.873) or 18 (adjusted mean difference €192.99, 95%CI €-1894.66 to €2280.65, p = 0.856) months after the start of the intervention. CONCLUSION: This study revealed no differences in costs between older people receiving LoChro-Care or usual care. Before implementing the intervention, further studies with larger sample sizes are needed to provide robust evidence on the cost effects of LoChro-Care. TRIAL REGISTRATION: German Clinical Trials Register (DRKS): DRKS00013904, https://drks.de/search/de/trial/DRKS00013904 ; date of first registration 02/02/2018.

The Effect of Interactivity, Tailoring, and Use Intensity on the Effectiveness of an Internet-Based Smoking Cessation Intervention Over a 12-Month Period: Randomized Controlled Trial.

BACKGROUND: eHealth approaches show promising results for smoking cessation (SC). They can improve quit rates, but rigorous research is sparse regarding their effectiveness and the effects of their interactivity, tailoring, and use intensity. OBJECTIVE: We examined the effectiveness of Techniker Krankenkasse Smoking Cessation Coaching (TK-SCC), an internet-based, tailored, and interactive SC intervention. Our hypotheses were as follows: hypothesis 1, in the intervention group (IG; access to TK-SCC), a clinically relevant number of participants will be abstinent at the 12-month follow-up (T3); hypothesis 2, the number of abstinent participants will be significantly greater in the IG than the control group (CG) at T3; and hypothesis 3, in the IG, more intense use of TK-SCC will be positively associated with abstinence. METHODS: Individuals who smoke were randomized into the IG (563/1115, 50.49%) or CG (552/1115, 49.51%), which received a noninteractive, nontailored, and information-only web-based intervention. Data were collected before the intervention, at the postintervention time point (T1), at the 4-month follow-up (T2), and at T3. We tested hypothesis 1 through equivalence tests between the IG's success rate and success rates of comparable effective interventions reported in 2 current meta-analyses. For hypothesis 2, we conducted binary logistic regressions. For hypothesis 3, we assigned the IG participants to 1 of 4 user types and used binary logistic regressions with user types as the independent variable and smoking abstinence as the dependent variable. RESULTS: In the IG, 11.5% (65/563) and 11.9% (67/563) of participants were smoke free at T1 and T3, respectively. These values were statistically equivalent to the effects in the 2 meta-analyses, which reported 9% (z score=0.64, P=.74) and 10.9% (z score=-0.71, P=.24) success rates, respectively. In the CG, 6.2% (34/552) of the participants were smoke free at T1, which increased up to 8.2% (45/552) at T3. The difference between the IG and CG was statistically significant only at T1 (odds ratio [OR] 2.0, 99% CI 1.1 to 3.6; P=.002), whereas the effect was nonsignificant following α error corrections at T3 (OR 1.6, 99% CI 0.9 to 2.7; P=.02). In the IG, constant users of the program became smoke free significantly more often than rare users of the program (T1: OR 15.0, 99% CI 6.1 to 36.9; P<.001; T3: OR 6.5, 99% CI 2.8 to 15.5; P<.001). CONCLUSIONS: TK-SCC is effective for SC. However, its superiority compared with a minimal SC intervention could not be confirmed in the long term. Insufficient implementation of the techniques used and cotreatment bias could explain this outcome. Higher use intensity of TK-SCC was positively related to abstinence. Therefore, additional efforts to motivate users to adhere to intervention use as intended could improve the intervention's effectiveness. TRIAL REGISTRATION: German Clinical Trials Register DRKS00020249, Universal Trial Number U1111-1245-0273; https://drks.de/search/de/trial/DRKS00020249. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s13063-021-05470-8.

The concept of treatment beliefs in children and adolescents with chronic health conditions: a scoping review.

Children and adolescents with chronic health conditions are faced with ongoing challenges, making self-regulation crucial. As children grow up, they gradually develop differentiated beliefs about illness and treatment. While research indicates treatment beliefs as relevant factor on outcomes like adherence, the specific contents and dimensions of children's and adolescents' treatment beliefs remained unclear. This scoping review therefore aimed at the identification of treatment beliefs dimensions in children and adolescents with chronic health conditions, the underlying theoretical frameworks, and methodological operationalisation. Published literature was examined by applying systematic searches in electronic databases (Medline, PsycINFO, CINAHL) and comprehensive selection criteria, resulting in 49 included studies. The predominant treatment beliefs dimensions were necessity, concerns, perceived benefits and costs/barriers, and expectations. The latter can be differentiated into outcome, social, process, and structural expectations, and expectations of one's own role in the treatment process. In addition, dimensions that cover emotions and reasons for treatment were identified. The results are related to the methods and theoretical models applied, which were often adapted from adult research. However, additional and possibly more child-specific dimensions such as social expectations and emotions were found. This scoping review indicates several research gaps and discusses practical implications.

Analysis of the key themes in the healthcare of older people with multimorbidity in Germany: a framework analysis as part of the LoChro trial.

OBJECTIVES: Multimorbidity challenges healthcare systems. In Germany, coordination of healthcare for older multimorbid patients remains unstructured.This study aims to identify key themes in the healthcare of these patients and the inter-relationships between them. DESIGN: Framework analysis of six cases based on 1-year data of primary and secondary care, patient-answered questionnaires and video material. SETTING: Southern Germany. PARTICIPANTS: Six multimorbid older patients participating in a randomised controlled trial that compared usual care with a local, collaborative, stepped and personalised care management approach for older people with chronic diseases (LoChro-trial). The LoChro care intervention involved a care manager who assisted participants in self-management. The primary outcome was a composite of functional health and depressive symptoms at 12 and 18 months. The LoChro-intervention had no effect on the primary outcome. PRIMARY OUTCOME MEASURE: Key themes in the healthcare of older patients with multimorbidity and the inter-relationships between them. METHODS: One-year data included diagnoses, treatment plans, examinations, assessments and discharge reports. Patient perspectives were assessed using the Patient Assessment of Chronic Illness Care. In three cases, videos of the LoChro intervention showed patients describing their health needs. These data were evaluated by three doctors and public health researchers. Using framework analysis, recurring themes influencing the healthcare situation of multimorbid older patients and their inter-relationships were identified. RESULTS: Participants had an average age of 77, with 13 diagnoses, taking eight medications regularly. The five key themes describing the healthcare situation of these multimorbid patients were as follows: insufficient coordination, overuse and underuse of medical care, doctor and patient roles. Each theme covered three to four subcategories. The most significant inter-relationships between these themes were a lack of coordination leading to overuse and underuse of medical care. These were characterised by redundant inpatient stays, potential prescribing omissions and missed examinations. Deficiencies in vaccinations and secondary prevention were also demonstrated. CONCLUSION: Coordination of care for multimorbid older patients in Germany is still deficient. Future healthcare arrangements should be explored with the participation of physicians and patients. TRIAL REGISTRATION NUMBER: LoChro trial: DRKS00013904.

Exploring communication preferences of trans and gender diverse individuals-A qualitative study.

BACKGROUND: Trans and gender-diverse individuals experience adverse health outcomes that might be due, in addition to other factors, to stigma and discrimination in the health care sector. At the same time, the concept of person-centred care acknowledges the role of patient-physician communication in health care outcomes. This study aims to explore patient-physician communication preferences in trans and gender-diverse individuals. METHOD: A qualitative interview study was conducted, including N = 10 participants between February and March 2022. Participants were interviewed using a semi-structured interview guideline, based on previous knowledge in person-centred care and sample specific communication. Participants were asked about their experiences and wishes in patient-physician centeredness. Analyses were conducting using a qualitative content analysis strategy. RESULTS: Mean age was 29.3 years; n = 6 participants identified themselves within the binary gender concept, while n = 4 identified themselves with a non-binary gender. Communication preferences for patient-physician communication were categorised into four themes: general communication aspects (e.g. active listening); the role of gender during appointments (e.g. appropriate/inappropriate addressing); gender-neutral language (e.g. experiences use of gender neutral language by physicians); own communication style (e.g. early outing and justification). Furthermore, possible contextual factors of patient-physician communication where found (e.g. trusting relationship). CONCLUSION: Adding knowledge to communication preferences of trans and gender-diverse individuals, this study was able to identify preferences that are specific to the sample as well as preferences that differ from the cis-gendered population. However, it remains unclear how the patient-physician communication preferences affects health care utilization and outcomes. TRIAL REGISTRATION: German Clinical Trial Register (DRKS00026249).

Local, collaborative, stepped, and personalized care management for older people with chronic diseases - results from the randomized controlled LoChro-trial.

BACKGROUND: In the aging population of Western societies, an increasing number of older adults have multiple chronic diseases. As multifaceted health problems imply the involvement of several healthcare professionals, multimorbid older people frequently face a fragmentation of health care. Addressing these challenges, we developed a local, collaborative, stepped, and personalized care management approach (LoChro-Care) and evaluated its effectiveness. METHODS: A two-group, parallel randomized controlled trial was conducted comparing LoChro-Care recipients (IG) to participants with usual care (CG). Patients aged 65 + with chronic conditions were recruited at inpatient and outpatient departments of the Medical Center, University of Freiburg. Participants were allocated using block randomization (nIG = 261, nCG = 263). LoChro-Care comprised individualized care provided by chronic care managers with 7 to 13 contacts over 12 months. Questionnaires were given at 3 time points (T0: baseline, T1: after 12 months, T2: after 18 months). The primary outcome was the physical, psychological, and social health status represented by a composite score of functional health and depressive symptoms. Secondary outcomes were the participants' evaluation of their health care situation, health-related quality of life (HRQL), and life-satisfaction (LS). The data were analyzed using linear mixed modelling. RESULTS: We analyzed N = 491 participants (nIG = 244, nCG = 247), aged M = 76.78 years (SD = 6.35). For the composite endpoint, neither a significant difference between IG and CG (p = .88) nor a group-time interaction (p = .52; p = .88) could be observed. Participants in both groups showed a significant decline on the primary outcome between T0 and T2 (p < .001). Post hoc analyses revealed a decline in both functional health (p < .001) and depressive symptoms (p = .02). Both groups did not differ in their evaluation of their health care situation (p = .93), HRQL (p = .44) or LS (p = .32). Relevant confounding variables were female gender and multimorbidity. CONCLUSION: Supporting patients' self-management in coordinating their individual care network through LoChro-Care did not result in any significant effect on the primary and secondary outcomes. A decline of functional health and depressive symptoms was observed among all participants. Potential future intervention adaptations are discussed, such as a more active case management through direct referral to (in-)formal support, an earlier treatment initiation, and the consideration of specific sociodemographic factors in care management planning. TRIAL REGISTRATION: German Clinical Trials Register (DRKS): DRKS00013904 (02.02.2018), https://drks.de/search/de/trial/DRKS00013904.

Treatment Beliefs of Children and Adolescents With Chronic Diseases: Development of the Rehabilitation Treatment Beliefs Questionnaire for Children and Adolescents.

OBJECTIVE: Rehabilitation is an important component in the health care of children and adolescents with chronic diseases and aims at supporting patients' self-regulation for dealing with the disease. Patients' beliefs about illness and treatment are core elements in the self-regulation process. While questionnaires measuring illness beliefs for children and adolescents exist, questionnaires about their rehabilitation-related treatment beliefs are lacking. We therefore developed a questionnaire to assess the rehabilitation-related treatment beliefs of children and adolescents with chronic diseases (Rehabilitation Treatment Beliefs Questionnaire, RTBQ) and tested its psychometric properties. METHODS: Ahead of their rehabilitation, children and adolescents, aged 12-17 years, answered 129 items, which were developed based on previous qualitative findings exploring children and adolescents' rehabilitation-related treatment beliefs. Psychometric testing included item analyses, exploratory factor analysis, internal consistency and bivariate correlations of the extracted scales, and the discriminatory power and difficulty of the final items. RESULTS: The sample consisted of 170 participants with a mean age of 14.3 years (SD = 1.6); 53.5% were female. After item analyses, 47 items remained for the exploratory factor analysis which revealed 22 items allocated to 4 scales: "expectations of communication and interaction," "expectations of the treatment process," "expectations of treatment success and sustainability," and "expectations of one's own role in the rehabilitation process." The psychometric properties were acceptable to good. CONCLUSIONS: The RTBQ assesses various dimensions of rehabilitation-related treatment beliefs of children and adolescents with chronic diseases. While first psychometric results are promising, further psychometric testing is needed.

Psychometric properties of the rehabilitation treatment beliefs questionnaire for psychosomatic rehabilitation.

PURPOSE: Treatment beliefs play a crucial role for patient satisfaction and the treatment outcome in psychosomatic rehabilitation. The aim of this study was the development and the psychometric evaluation of an indication-specific questionnaire of beliefs about psychosomatic rehabilitation. MATERIALS AND METHODS: The study was conducted at a psychosomatic rehabilitation clinic. The primary item list comprised k = 125 items. After a descriptive item analysis, we conducted an exploratory factor analysis. Furthermore, we tested reliability via McDonald's Omega and construct validity by analyzing correlations of the scales with related constructs. RESULTS: Of the N = 264 participants, 50% were female and the mean age was 50.4 (SD = 9.8) years. K = 85 items were suitable for factor analysis, which resulted in k = 30 items constituting six scales, explaining of 57% the overall variance. The corrected item-total correlations were between r = 0.48 and r = 0.83. Internal consistency ranged from ω = 0.81 to ω = 0.86. CONCLUSION: The newly developed questionnaire assesses specific treatment beliefs about inpatient psychosomatic rehabilitation. The psychometric properties of the six scales are acceptable. Further studies should confirm the psychometric results, such as the factorial structure of the questionnaire.IMPLICATIONS FOR REHABILITATIONTreatment beliefs are known to play an important role for the adherence, therapy outcome and satisfaction in psychosomatic rehabilitation.We developed and tested a indication-specific questionnaire assessing treatment beliefs in psychosomatic rehabilitation.The questionnaire can be used to explore patient's rehabilitation-related treatment beliefs, predict treatment outcomes, and to develop interventions attempting to modify these.

Over- and under-prescribing, and their association with functional disability in older patients at risk of further decline in Germany - a cross-sectional survey conducted as part of a randomised comparative effectiveness trial.

BACKGROUND: Older patients at risk of functional decline are frequently affected by polypharmacy. This is associated with a further loss of independence. However, a relationship between functional disability and medications, such as 'Potentially Inappropriate Medications' (PIMs) and 'Potential Prescribing Omissions' (PPOs), as itemised for (de) prescribing in practice-orientated medication lists, has yet to be established. METHODS: As part of a randomised comparative effectiveness trial, LoChro, we conducted a cross-sectional analysis of the association between PIMs and PPOs measured using the 'Screening Tool of Older Persons' Prescription Criteria / Screening Tool To Alert to Right Treatment' (STOPP/START) Version 2, with functional disability assessed using the 'World Health Organization Disability Assessment Schedule 2.0' (WHODAS). Individuals aged 65 and older at risk of loss of independence were recruited from the inpatient and outpatient departments of the local university hospital. Multiple linear regression analysis was used to model the potential prediction of functional disability using the numbers of PIMs and PPOs, adjusted for confounders including multimorbidity. RESULTS: Out of 461 patients, both the number of PIMs and the number of PPOs were significantly associated with an increase in WHODAS-score (Regression coefficients B 2.7 [95% confidence interval: 1.5-3.8] and 1.5 [95% confidence interval: 0.2-2.7], respectively). In WHODAS-score prediction modelling the contribution of the number of PIMs exceeded the one of multimorbidity (standardised coefficients beta: PIM 0.20; multimorbidity 0.13; PPO 0.10), whereas no significant association between the WHODAS-score and the number of medications was seen. 73.5 % (339) of the participants presented with at least one PIM, and 95.2% (439) with at least one PPO. The most common PIMs were proton pump inhibitors and analgesic medication, with frequent PPOs being pneumococcal and influenza vaccinations, as well as osteoporosis prophylaxis. CONCLUSIONS: The results indicate a relationship between inappropriate prescribing, both PIMs and PPOs, and functional disability, in older patients at risk of further decline. Long-term analysis may help clarify whether these patients benefit from interventions to reduce PIMs and PPOs.

Evaluation of a cross-sectoral care intervention for families with psychosocial burden: a study protocol of a controlled trial.

BACKGROUND: Family risk factors, e.g. low socioeconomic status or parental mental health disorders, can affect children's health and development. Thus, targeted preventive services for families with psychosocial burden are crucial. The German Early Childhood Intervention (ECI) program is a preventive approach that aims to strengthen parent's resources by supportive services. However, research has revealed that only a proportion of the families considered to have substantial risk factors access the ECI program. To increase pediatricians' skills in identifying risk factors, and to improve the cross-sectoral collaboration between relevant professionals and the referral of families to supportive services, the PATH-intervention (Pediatric Attention To Help) was developed. The PATH-intervention includes interprofessional quality circles and a one-day training program for the pediatricians. This study aims to evaluate this complex cross-sectoral care intervention for families with psychosocial burden. METHODS: Using a prospective quasi-experimental, controlled (matched-pair), longitudinal mixed-method design, we will compare families under treatment of pediatricians trained in the PATH-intervention with families under treatment of a control group of pediatricians. Participating families are asked to complete online-surveys. As a primary outcome, we will examine the use of supportive services of the ECI by burdened families. Secondary outcomes are the proportion of correctly identified families with psychosocial burden by the pediatricians, as well as information provision and motivation of the families to use the supportive services. Additionally, the cost-effectiveness ratio will be investigated. In the process evaluation, we will qualitatively explore the acceptance of the PATH-intervention of all involved stakeholders and the treatment fidelity of the trained pediatricians. DISCUSSION: This study will determine whether the PATH-intervention enables the pediatricians to identify and recommend supportive services to burdened families, as well as the families' use of the supportive services of the ECI. Qualitative data will give insight into the acceptance of the intervention from the perspective of all stakeholders and the treatment fidelity. Results of this study could be the starting point for the broader implementation of the PATH-intervention as standard care. TRIAL REGISTRATION: German Clinical Trials Register (DRKS): DRKS00023461 (3rd December 2020); WHO UTN: U1111- 260-6575.

Rehabilitation-related treatment beliefs in adolescents: A qualitative study.

BACKGROUND: Medical rehabilitation plays an important role in the health care of chronically ill children and adolescents. During medical rehabilitation, supporting illness-related self-regulation is a central goal. Beliefs about illness and beliefs about treatment are core elements of patients' self-regulation, and there is evidence that these beliefs are relevant predictors of different health- and treatment-related outcomes such as adherence. However, little is known about adolescents' beliefs about rehabilitation. This study therefore explores adolescents' treatment beliefs in the context of inpatient medical rehabilitation. METHODS: A qualitative study was conducted in a German rehabilitation clinic for children and adolescents. Using a purposive sampling method, 13 adolescents (12-16 years old) were recruited. Semi-structured, audiotaped interviews were conducted and analysed using content analysis. RESULTS: Results demonstrate that adolescents have differentiated rehabilitation-related treatment beliefs. Twelve themes, with various subthemes, emerged, which include access to and knowledge about rehabilitation, the rehabilitation-related individual position and normative aspects, expectations of oneself, as well as in respect of the social context (fellow patients, contact with family and friends), expectations of the structure, process and outcome of rehabilitation, concerns and barriers and emotional aspects. CONCLUSIONS: Our explorative study revealed a broad range of rehabilitation-related treatment beliefs in adolescents, indicating parallels, but also differences, to research results with adults. Treatment beliefs are assumed to be an influencing factor for various health- and treatment-related outcomes. Thus, implications of our findings for clinical practice and further research are discussed.

[Relevance of different study types in benefit assessment: Results from expert interviews]. / Bedeutung verschiedener Studientypen in der Nutzenbewertung: Ergebnisse aus Experteninterviews.

BACKGROUND: Careful evaluation of new interventions is essential. Randomized controlled trials (RCTs) and systematic reviews of RCTs provide the most reliable evidence base in comparative evaluations of treatments and interventions. Observational study designs are found at the lower levels of the classical evidence hierarchy. In light of policy efforts to accelerate the availability of innovations, the use of evidence from non-randomized studies for reimbursement decisions is being discussed. The present study addresses the question of the value and feasibility of RCTs and observational studies for benefit assessment after an intervention has been introduced into practice. METHODS: Experts from German-speaking countries were interviewed using qualitative, semi-structured interviews. Participants included experts in health economics, health services and health services research, health communication, ethics, and health policy. The interviews were conducted by one researcher and then analyzed using a deductive approach. Main categories and subcategories were extracted. RESULTS: Twenty-six experts were invited to participate, and 15 agreed to be interviewed. The duration of the individual interviews varied between 35 and 80minutes. The interviewed experts considered it possible and necessary to conduct RCTs when an intervention is already available in care in order to demonstrate that an intervention is more effective than existing alternatives. Experts considered good study design, methodological knowledge of those conducting the study, infrastructure, and funding as underlying conditions. They emphasized that the benefit of an intervention cannot be conclusively clarified on the basis of observational studies and that RCTs can therefore only be dispensed with in exceptional cases. Therefore, observational studies do not represent an alternative to RCTs in benefit assessment in general. In the opinion of the experts, the requirements for observational studies included sensible criteria and quality assurance measures. As alternatives to RCTs, the experts named studies based on routine data or high-quality, prospective, comparative cohort studies. Individual experts were very critical of studies based on data from registries. DISCUSSION AND CONCLUSION: The results of the interviews are underlined by findings from the scientific literature. For example, international scientists advocate for conducting RCTs instead of observational studies and for a reduction in hurdles and barriers for conducting RCTs. In international methodological standards for the preparation of health technology assessments, RCTs are also generally preferred for benefit assessment. Nevertheless, there is still a need for research about the optimal use of observational studies, alternative RCT designs and the use of data from routine care or registries, as policy makers, among others, believe that observational studies should be used for benefit assessment. The results show that experts still adhere to the established principles of clinical epidemiology. Observational studies should only be used as an alternative to RCTs in exceptional cases to examine whether one intervention is more effective than existing alternatives.

Effectiveness of an interactive web-based health program for adults: a study protocol for three concurrent controlled-randomized trials (EVA-TK-Coach).

BACKGROUND: A healthy lifestyle can help prevent diseases that impair quality of life and lead to premature death. The Techniker health insurance fund offers a comprehensive online health program to support users in achieving their health goals of Increasing Fitness, Losing and Maintaining Weight, or Smoking Cessation. METHODS: The aim of this study is to test the long-term effectiveness of the web-based TK-HealthCoach with regard to the primary outcomes of increased physical activity, sustainable weight reduction, and smoking abstinence. We are conducting three interconnected, randomized controlled trials (RCT), one for each health goal, within which participants are allocated to an intervention group (interactive online health program) or a control group (non-interactive online health program). The effects of the intervention groups compared to the control groups will be analyzed by multi-level models for change. Participants' data are captured via online questionnaires before the program starts (baseline t0), again when it ends (t1), and later at two follow-up surveys (t2 and t3); the latter 12 months after t1. We are documenting socio-demographic, health-related, and psychological variables as well as usage behavior data of the programs. According to our sample size calculation, we have to enroll 1114 participants in each Losing and Maintaining Weight and Increasing Fitness RCT and 339 participants in the Smoking Cessation RCT. Additionally, 15-20 participants in the interactive smoking-cessation program will be invited to qualitative telephone interviews with the aim to obtain detailed information concerning utilization, compliance, and satisfaction. The online RCTs' inclusion criteria are: adults of each gender regardless of whether they are insured with Techniker health insurance fund. Persons with impairments or pre-existing conditions require a medical assessment as to whether the program is suitable for them. Specific exclusion criteria apply to each program/RCT. DISCUSSION: We assume that study participants will improve their health behavior by using the offered online health programs and that each health goal's intervention group will reveal advantages regarding the outcome variables compared to the control groups. Study enrollment started on January 1, 2020. TRIAL REGISTRATION: German Clinical Trials Register, Universal Trial Number (UTN): U1111-1245-0273 . Registered on 11 December 2019.

[Integrated care management for older people with chronic diseases in domesticity: evidence from Cochrane reviews]. / Integriertes Versorgungsmanagement für chronisch erkrankte ältere Menschen in der eigenen Häuslichkeit: Evidenz aus Cochrane-Reviews.

BACKGROUND: The number of multiple chronically ill older people is increasing and multimorbidity is associated with high utilization of health services. Integrated care management is increasingly used to address this problem; however, there is a substantial lack of reliable data on its effectiveness in this target group. OBJECTIVE: To assess the effectiveness of components of integrated care management in adults of all ages and to estimate the transferability to older, multimorbid people in Germany. METHODS: A systematic search was carried out in the Cochrane Library for Cochrane reviews (CR) on (a) the 13 most frequent health problems in old age, which (b) evaluated components of integrated care management in (c) adults of all ages. Experts assessed the transferability of the included CR to multiple chronically ill older people in Germany. RESULTS: Out of 1412 hits 126 CR were included. Regarding independence and functional health outcomes, 25 CR showed clinically relevant results with at least a moderate level of evidence. The following intervention components were estimated to be transferable and could be adapted to be part of an effective integrated care management for multimorbid chronically ill older people, specified by indications and taking identified barriers into account: (1) physical activation, (2) multidisciplinary interventions (3) interventions that enhance self-management, (4) cognitive therapy modalities, (5) telemedical interventions and (6) disease management programs. CONCLUSION: The effectiveness of the identified components in frail older patients should be assessed in care-related and patient-related randomized controlled studies.

Contextual factors of self-regulation in children and adolescents with chronic diseases - a qualitative analysis.

BACKGROUND: In recent decades, the prevalence of chronic diseases in children and adolescents has increased significantly. Contextual factors play a central role in the self-regulation of chronic diseases. They influence illness and treatment representations, disease management, and health outcomes. While previous studies have investigated the influence of contextual factors on children's beliefs about their illness, little is known about subjective contextual factors of treatment representations of children and adolescents with chronic diseases, especially in the context of rehabilitation. Therefore, the aim of this qualitative analysis was to examine the contextual factors reported by chronically ill children and adolescents in relation to their treatment representations. Furthermore, we aimed to assign the identified themes to classifications of environmental and personal contextual factors in the context of the International Classification of Functioning, Disability and Health (ICF). METHODS: Between July and September 2018, semi-structured interviews were conducted with N = 13 children and adolescents in rehabilitation to explore their rehab-related treatment representations and associated contextual factors. The interviews started with an open narrative question about expectations and beliefs about rehabilitation, followed by further detailed questions. The interviews were recorded on audio tape, transcribed, and analysed using thematic content analysis. RESULTS: Participants raised six themes associated with their rehab-related treatment representations that were interpreted as contextual factors: the living situation before rehabilitation, the idea of rehabilitation, previous solution attempts, rehab pre-experiences, information that the children and adolescents received from the clinic or sought themselves, and the assumed attitudes of their parents concerning rehabilitation. All the themes could be assigned to the classification of environmental and personal factors in the context of the ICF for children and youth. CONCLUSIONS: Although contextual factors have an important impact on self-regulation, little attention is paid to their investigation. Personal and environmental factors probably influence patients' treatment representations in terms of expectations and concerns as well as emotions regarding the treatment. Considering contextual factors could lead to the more appropriate allocation of medical care and the better customisation of treatment.

Local, collaborative, stepped and personalised care management for older people with chronic diseases (LoChro): study protocol of a randomised comparative effectiveness trial.

BACKGROUND: Multimorbid older adults suffering from a long-term health condition like depression, diabetes mellitus type 2, dementia or frailty are at high risk of losing their autonomy. Disability and multimorbidity in the older population are associated with social inequality and lead to soaring costs. Our local, collaborative, stepped and personalised care management for older people with chronic diseases (LoChro-Care) aims at improving outcomes for older multimorbid patients with chronic conditions whose social and medical care must be improved. METHODS: The study will evaluate the effects of LoChro-Care on functional health, depressive symptoms and satisfaction with care, resource utilisation as well as health costs in older persons with long-term conditions. The trial will compare the effectiveness of LoChro-Care and usual care in a cross-sectoral setting from hospital to community care. We will recruit 606 older adults (65+) admitted to local hospital inpatient or outpatient departments who are at risk of loss of independence. Half of them will be randomised to receive the LoChro-Care intervention, comprising seven to 16 contacts with chronic care managers (CCM) within 12 months. The hypothesis that LoChro-Care will result in better patient-centred outcomes will be tested through mixed-method process and outcome evaluation and valid measures completed at baseline and at 12 and 18 months. Cost-effectiveness analyses from the healthcare perspective will include incremental cost-effectiveness ratios. DISCUSSION: The trial will provide evidence about the effectiveness of local, collaborative, stepped and personalised care management for multimorbid patients with more than one functional impairment or chronic condition. Positive results will be a first step towards the implementation of a systematic cross-sectoral chronic care management to facilitate the appropriate use of available medical and nursing services and to enhance self-management of older people. TRIAL REGISTRATION: German Clinical Trials Register (DRKS): DRKS00013904 ; Trial registration date: 02. February 2018.

[Patients' Narratives as a Tool to Prepare for Medical Rehabilitation: The Website "Medical Rehabilitation (Medizinische Reha)" at www.krankheitserfahrungen.de]. / Patientennarrative als Instrument zur Vorbereitung auf eine medizinische Rehabilitation: Der Erfahrungsbereich "Medizinische Reha" auf der Website www.krankheitserfahrungen.de.

OBJECTIVE: The website "medical rehabilitation (Medizinische Reha)" at www.krankheitserfahrungen.de presents patients' experiences concerning medical rehabilitation and aims at supporting people in preparation for medical rehabilitation. METHODS: Using purposeful sampling 38 former rehabilitation patients were selected. They took part in a guided narrative interview about their experiences concerning medical rehabilitation. Interview transcripts were coded and systematically aggregated based on Grounded Theory. RESULTS: Under the heading "individuals (Personen)" individual experiences of each patient are portrayed on the website. Analysis revealed 8 categories of specific issues and subtopics. These topics are illustrated by original excerpts of the interviews as video, audio or text on the website. Topics are the way to and daily routine in rehabilitation, therapies and other offers of the clinic, family, profession, profits of the rehabilitation, the time afterwards, messages and recommendations. Patients mentioned obstacles and challenges as well as supporting experiences and advice. CONCLUSION: The website provides free and barrier-free information about medical rehabilitation for prospective patients and professionals, exclusively focusing on patients' perspectives.