German Health Care Context Research Articles

Fostering Shared Decision-Making Between Patients and Health Care Professionals in Clinical Practice Guidelines: Protocol for a Project to Develop and Test a Tool for Guideline Developers.

Clinical practice guidelines (CPGs) are designed to assist health care professionals in medical decision-making, but they often lack effective integration of shared decision-making (SDM) principles to reflect patient values and preferences, particularly in the context of preference-sensitive CPG recommendations. To address this shortcoming and foster SDM through CPGs, the integration of patient decision aids (PDAs) into CPGs has been proposed as an important strategy. However, methods for systematically identifying and prioritizing CPG recommendations relevant to SDM and related decision support tools are currently lacking. The aim of the project is to develop (1) a tool for systematically identifying and prioritizing CPG recommendations for which SDM is considered particularly relevant and (2) a platform for PDAs to support practical SDM implementation. The project consists of 6 work packages (WPs). It is embedded in the German health care context but has an international focus. In WP 1, we will conduct a scoping review in bibliographic databases and gray literature sources to identify methods used to foster SDM via PDAs in the context of CPGs. In WP 2, we will conduct semistructured interviews with CPG experts to better understand the concepts of preference sensitivity and identify strategies for fostering SDM through CPGs. WP 3, a modified Delphi study including surveys and focus groups with SDM experts, aims to define and operationalize preference sensitivity. Based on the results of the Delphi study, we will develop a methodology for prioritizing key questions in CPGs. In WP 4, the tool will be developed. A list of relevant items to identify CPG recommendations for which SDM is most relevant will be created, tested, and iteratively refined, accompanied by the development of a user manual. In WP 5, a platform for creating and digitizing German-language PDAs will be developed to support the practical application of SDM during clinical encounters. WP 6 will conclude the project by testing the tool with newly developed and revised CPGs. The Brandenburg Medical School Ethics Committee approved the project (165122023-ANF). An international multidisciplinary advisory board is involved to guide the tool development on CPGs and SDM. Patient partners are involved throughout the project, considering the essential role of the patient perspective in SDM. As of February 20, 2024, we are currently assessing literature references to determine eligibility for inclusion in the scoping review (WP 1). We expect the project to be completed by December 31, 2026. The tool will enable CPG developers to systematically incorporate aspects of SDM into CPG development, thereby providing guideline-based support for the patient-practitioner interaction. Together, the tool for CPGs and the platform for PDAs will create a systematic link between CPGs, SDM, and PDAs, which may facilitate SDM in clinical practice. DERR1-10.2196/57611.

Hypothalamic obesity: Epidemiology in rare sellar/suprasellar tumors-A German claims database analysis.

Hypothalamic obesity (HO) is defined as abnormal weight gain resulting in severe persistent obesity due to physical, tumor- and/or treatment-related damage to the hypothalamus. HO epidemiology is poorly understood. We developed a database algorithm supporting the standardized identification of tumor/treatment-related HO (TTR-HO) patients. The algorithm is used to estimate incidence rates of TTR-HO patients in the German healthcare context from a representative claims database (n = 5.42 million) covering 2010-2020. Patients were identified based on surgery/radiotherapy procedures and HO-associated tumor diagnoses (n = 3976). HO was defined by incident obesity and validated based on incident diabetes insipidus diagnoses and desmopressin prescription within a 12-month period after surgery/radiotherapy. Uncertainty due to algorithm definitions is explored in sensitivity analyses. Estimated annual incidence of TTR-HO in Germany is between 0.7 and 1.7 cases per 1,000,000 persons (2019 prevalence: n = 1262 patients). With observed cases in all age groups, two HO-incidence peaks are identified: children/young adults aged 10-24 years and adults aged 40-44 years. Most frequent HO-validated tumor diagnoses are benign sellar/suprasellar tumors (6.1/1,000,000 persons over 9 years), including tumors of the craniopharyngeal duct (1.3/1,000,000), neoplasms of the pituitary gland (4.1/1,000,000), and nonspecific brain tumors of endocrine glands (2.4/1,000,000). This is the first real-world database analysis of TTR-HO epidemiology, refining current estimates of HO epidemiology and early patient identification. A more comprehensive characterization of patients with HO as well as a better understanding of clinical implications will be crucial in developing optimal treatment strategies to improve patient outcomes.

Ten years of hypoglossal nerve stimulation in obstructive sleep apnea: a systematic literature review

To show the importance of hypoglossal nerve stimulation (HGNS) as a treatment method for obstructive sleep apnea (OSA) in the German healthcare context and to better assess the way patients who do not receive adequate care could benefit from HGNS. A systematic literature review in the Medline and Cochrane Library literature database was conducted, including publications using different stimulation technologies for HGNS. The efficacy of HGNS was assessed based on patient-relevant outcomes (daytime sleepiness, quality of life), treatment adherence and the apnea-hypopnea index (AHI) and oxygen desaturation index (ODI). The safety of the treatment method was assessed based on adverse events (AEs). Inclusion and analysis of 33 publications: 2 randomized controlled trials (RCTs, level Ib), 1 level IIb trial (n = 1) and 30 level IV trials with a study duration of up to 60 months. The RCTs showed better values for daytime sleepiness and quality of life when using HGNS than in the control group. AHI and ODI showed a deterioration under placebo stimulation or therapy withdrawal in the RCTs. Consistently high adherence was also reported in the long-term course. Severe AEs under HGNS were rare and could usually be resolved by repositioning electrodes or replacing device components. Other AEs were mostly transient or could be resolved by non-invasive measures. All investigated parameters showed similar results in the evaluated studies. The results of different stimulation systems are comparable in type and extent. The comprehensive review of the literature shows consistent data that highlight the importance of HGNS as an effective and safe treatment for OSA after unsuccessful CPAP treatment. The evaluation also shows that the different stimulation systems make it possible to better tailor the therapy to the patient's individual requirements. A future systematic evaluation of real-world data on the use of HGNS would help gain additional insights into the relevance of the method in routine clinical practice.

Ethical Challenges in Oral Healthcare Services Provided by Non-Governmental Organizations for Refugees in Germany.

Oral healthcare is attracting much attention after decades of neglect from policymakers. Recent studies have shown a strong association between oral and overall health, which can lead to serious health problems. Availability of oral healthcare services is an essential part of ensuring universal healthcare coverage. More importantly, current gaps in its accessibility by minority or marginalized population groups are crucial public health as well as ethical concerns. One notable effort to address this issue comes from Non-Governmental Organizations (NGOs), which offer oral healthcare services for non-insured refugees. However, the challenge remains that these care services are not comprehensive, which has implications for the refugees' oral and general health. In this article, we discuss this complex issue in the German healthcare context by including ethical reflections. Therefore, the purpose of this article is to discuss the ethical challenges related to oral healthcare services provided by NGOs for refugees in Germany. First, we will introduce the general oral healthcare context worldwide and in Germany. Second, we will provide a general description of the oral healthcare services provided by NGOs for refugees in Germany, as well as an overview of existing gaps. This will provide us with the context for our third and most important task-discussing the ethical implications of the gaps. In doing so, and since the ethical implications can be several, we demarcate the scope of our analysis by focusing on the specific ethical issues of justice, harm, and autonomy. Finally, we offer some recommendations for how to move forward.

Experiences with a patient-oriented navigation program in Germany from the navigators' perspectives

Abstract Background The German healthcare system has a distinct separation of outpatient and inpatient care, with no coordination along a patient's care trajectory between these sectors. Additionally, support offers are often unknown by patients and providers. To address these barriers, we developed a patient-oriented navigation program for people with chronic conditions in Germany, which mainly focus on the patients' individual needs. Methods In a mixed methods study our navigation program for people with lung cancer and stroke is being evaluated in the German healthcare context. Patient navigators support study participants in their individual healthcare organization and coordination for 13 months. Qualitative interviews are conducted regularly with the navigators to capture their experiences with the navigation program. Results In our study, three navigators support a total of 122 study participants. Their activities include emotional support, help with bureaucratic matters, organizing outpatient care and gathering specialized information. There is a high overlap in navigation tasks between the two groups of patients. Interviews show that the navigators perceive their work as meaningful and find the exchange within the team and the offer of supervision very important. Conclusions For navigation of chronic conditions that require complex care, such as lung cancer and stroke, it appears important to ensure that patients' emotional, social and coordination needs are met in a way that suits their individual wishes. The experiences of the navigators as providers of the navigation intervention can be used for a practice-oriented optimization of the navigation program. Key messages • Navigation tasks overlap to a large extent in both groups of patients despite the differences in disease trajectories. • We suggest that a patient-oriented navigation program focusing on social and coordination needs does not have to be disease-specific but can cover general needs of people with complex care situations.

Effectiveness of evidence-based decision aids for women with pathogenic BRCA1 or BRCA2 variants in the german health care context: results from a randomized controlled trial

BackgroundWomen with pathogenic BRCA1 or BRCA2 variants are at high risk for breast and ovarian cancer. Preventive options include risk-reducing breast and ovarian surgeries and intensified breast surveillance. However, individual decision-making is often associated with decisional conflicts. Two evidence-based decision aids have recently been developed for these women (healthy or with unilateral breast cancer) for the German context to support them in their decision-making process. This study evaluated their effectiveness.MethodsIn a randomized controlled study, women (aged 18–70 years) with pathogenic BRCA1 or BRCA2 variants were randomly assigned 1:1 to the intervention (IG, n = 230) or control (CG, n = 220) group. All participants received usual care. After baseline survey (t0), IG participants additionally received the DAs. Follow-up surveys were at three (t1) and six (t2) months. Primary outcome was decisional conflict at t1. Secondary analyses included decision status, decision regret, knowledge on risks and preventive options, self-reported psychological symptoms, acceptability of DAs, and preparation for decision-making.ResultsOf 450 women recruited, 417 completed t0, 398 completed t1 and 386 completed t2. Compared to CG, IG participants had lower decisional conflict scores at t1 (p = 0.049) and t2 (p = 0.006) and higher scores for knowledge (p = 0.004), acceptability (p = 0.000), and preparation for decision-making (p < 0.01).ConclusionsThese DAs can help improve key parameters of decision-making in women with pathogenic BRCA1 and BRCA2 variants and, thus, provide a useful add-on to the current counseling and care concept for these women in Germany.Trial registrationGerman Clinical Trials Register, DRKS-ID: DRKS00015823, retrospectively registered 14/06/2019.

Cultural adaptation of the Integrated Palliative care Outcome Scale for neurological symptoms.

Standardized measures for assessing neurological patients needing palliative care remain scarce. The Integrated Palliative care Outcome Scale for neurological patients in its short form (IPOS Neuro-S8) helps assess and identify patients' symptom burden and needs early but has not yet been validated in German. The aim was to culturally adapt and translate the IPOS Neuro-S8 into the German health-care context and evaluate its face and content validity. Cultural adaptation study following the first 6 out of 8 phases of the Palliative care Outcome Scale measures manual: (1) conceptual definition, (2) forward translation to German, (3) backward translation to English, (4) expert review, (5) cognitive debriefing, (6) proofreading. Neurological patients needing palliative care and clinical staff of the Department of Palliative Medicine or Neurology of the University Hospital of Cologne were included. Data were analyzed using thematic content analysis and descriptive statistics. A total of 13 patients and 16 clinical staff participated in this study. The expert review panel (phase 4) consisted of 11 additional members. While patients (n=9) and clinical staff (n=11) confirmed that the IPOS Neuro-S8 is an intelligible tool that is well accepted (phase 5), some linguistic and cultural differences were found between the original English and German versions. These mainly concerned the items mouth problems and spasms. The German version of the IPOS Neuro-S8 has demonstrated face and content validity and captures relevant symptoms of neurological patients needing palliative care. Its psychometric properties, including construct and criterion validity, will be investigated next.

Measuring continuity of ambulatory cardiovascular care: a cross-sectional study on the applicability of the Nijmegen Continuity Questionnaire in Germany

BackgroundChronic cardiovascular diseases demand continuous care from general practitioners and medical specialists. Especially in fragmented healthcare systems, such as in Germany, a large body of research is devoted to the improvement of care continuity. Meanwhile, measuring continuity of care itself has been a challenge due to the absence of validated instruments. In 2011, the Dutch Nijmegen Continuity Questionnaire (NCQ) was developed and validated to measure continuity of care across care settings from the patients’ perspectives in the Netherlands. Its applicability in other countries and health systems, however, has rarely been tested. We therefore aimed at assessing the applicability of the Nijmegen Continuity Questionnaire to the German health care context. MethodsWe translated and applied the original NCQ to an ambulatory cardiovascular care setting in Germany. Qualitative interview data and quantitative survey data on our adaptation were collected from patients in 27 general practices within the German states of Baden-Wuerttemberg and Rhineland-Palatinate. Qualitative data on understandability and clearness of the questionnaire was obtained using semi-structured telephone interviews and think aloud-protocols. Quantitative data was obtained through an anonymous written questionnaire containing the translated NCQ items to assess applicability of our translation. We performed confirmatory and exploratory factor analyses based on the original NCQ-structure mapped to general practitioners and an aggregated analysis of general practitioners and cardiologists combined.ResultsA total of 6 patients participated in the interviews and a total of 435 patients participated in the written survey. The interviews showed that, overall, patients had little difficulties comprehending and answering to our translation of the NCQ. The confirmatory factor analyses then showed that the structure of the original NCQ with 12 items and 3 latent factors can also be found in the German context. However, a simpler 2-factor-structure would also fit well with the data.ConclusionA German translation of the NCQ yielded a factor structure comparable to the original version and proved to be understandable for patients.Trial registrationThe project underlying the study was registered on November 7, 2019 in the German Clinical Trials Register (www.drks.de) under ID: DRKS00019219.

1323P Towards the development of a German instrument to measure financial effects of a tumor disease: First results

Cancer diagnosis and therapy can be associated with patients' physical, emotional and financial burdens. While much attention is being paid to physical and emotional distress, there is only limited data about financial effects on cancer patients in countries with universal healthcare system. In order to tailor support for financial distress to patient reported outcomes it is crucial to better model and understand financial effects. This study aims to define a conceptual model of financial effects of a tumor disease for the German health care context.

Development of a patient-oriented navigation model for patients with lung cancer and stroke in Germany

BackgroundThe concept of patient navigation was first established in the USA to support vulnerable patient groups in receiving timely and comprehensive access to cancer care. It has recently gained increasing interest in Germany to support patients with chronic diseases in a fragmented healthcare system. The aim of this paper is to present the development of such a model adapted to the German context based on the results of mixed-methods studies investigating the need for and barriers to patient-oriented care.MethodsIn a process adapted from Delphi rounds, we conducted regular structured workshops with investigators of the project to discuss results of their studies and identify content and structure of the model based on the data. Workshop discussions were structured along seven core components of a navigation model including target patient groups, navigator tasks, occupational background and education of navigators, and patient-navigator interaction mode.ResultsUsing an approach based on empirical data of current care practices with special focus on patients’ perspectives, we developed a patient-oriented navigation model for patients who have experienced stroke and lung cancer in the German healthcare context. Patients without personal social support were viewed as struggling most with the healthcare system, as well as multimorbid and elderly patients. Navigators should serve as a longer-term contact person with a flexible contact mode and timing based on the individual situation and preferences of patients. Navigator tasks include the provision of administrative and organizational support as well as referral and guidance to available resources and beneficial health programs with special forms of knowledge. Implementation of the navigator should be flexibly located to ensure a reliable outreach to vulnerable patients for first contact in settings like specialized in-patient and out-patient settings, while navigation itself focuses on care coordination in the out-patient setting.ConclusionFlexibility of navigator tasks needed to be a core characteristic of a navigation model to be perceived as supportive from patients’ perspectives. In a subsequent feasibility study, an intervention based on the model will be evaluated according to its acceptance, demand, and practicality.

Device activism and material participation in healthcare: retracing forms of engagement in the #WeAreNotWaiting movement for open-source closed-loop systems in type 1 diabetes self-care

The #WeAreNotWaiting movement is a global digital health phenomenon in which people with diabetes, mainly type 1 diabetes (T1D), engage in the development and usage of open-source closed-loop technology for the improvement of their “chronic living” (Wahlberg et al. 2021). The characteristics of a digitally enabled and technologically engaged global activist patient collective feed into existing narratives of user-led and open-source innovation. They also call for more exploration of what it actually means to be locally involved in this kind of technologically mediated and global form of patient engagement. Building on empirical research conducted in the German healthcare context, we explore the different forms of material participation encountered among a group of people with T1D (who describe themselves as loopers), who are engaged in the development and usage of this open-source technology. Introducing the concept of device activism, we retrace three different device-centered narratives that show how a globally shared concern and political participation through technology use varies with local practices. Hereby we stress that the engagement in the #WeAreNotWaiting movement is both shaped by and is shaping the matters of concerns: devices in, on, and with bodies.

Evaluation of two evidence-based decision aids for female BRCA1/2 mutation carriers in Germany: study protocol for a randomised controlled parallel-group trial

BackgroundWomen with BRCA1/2 mutations have a higher risk of developing breast and ovarian cancer compared to women of the general population. Various preventive options are available to deal with the increased risk of developing cancer. These include intensified breast cancer screening and risk-reducing bilateral mastectomy and salpingo-oophorectomy. The choice of a preventive option can lead to increased decisional conflict. To support these women in their decision-making process, two evidence-based decision aids were developed in an upstream research process and adapted to the German healthcare context. These will be evaluated within a randomised controlled trial (RCT) in terms of their effects on decision-making, women’s level of information and psychological outcome variables.MethodsA sample of 310 women carrying BRCA1/2 mutations (A) without a history of cancer or (B) with a history of unilateral breast cancer who have received post-test genetic counselling will be enrolled. Upon study consent, women will be randomly assigned to either the intervention or the control group. All participants will receive standard care including a physician’s letter summarising the counselling content. After baseline data collection (t0), the intervention group receives the respective decision aid while the control group receives standard care only. The primary outcome variable assessed at a 3-month follow-up (t1) is the change of extent in decisional conflict (measured with the Decisional Conflict Scale). Secondary outcome variables comprise the stage of decision-making, self-reported symptoms of anxiety, depression and stress due to the genetic test result, and knowledge regarding cancer risks and preventive options. At t1, the extent of preparation for decision-making and acceptability of the decision aids will also be examined. Another secondary outcome variable assessed at 6-month follow-up (t2) is the extent of decision regret.DiscussionThese will be the first decision aids available for BRCA1/2 mutation carriers in Germany to be evaluated regarding their effectiveness and acceptability in clinical use within an RCT. Subsequently, they are to be integrated into the care concept of the centres of the German Consortium for Hereditary Breast and Ovarian Cancer and the affiliated breast centres.Trial registration {2a}DRKS DRKS00015823. Retrospectively registered on 14 June 2019

Do guidelines for care practice address the stability of home-based care arrangements for people with dementia?-A document analysis

The care of people with dementia (PwD) living at home is mainly provided by family carers who intend to maintain care at home for as long as possible. In the DZNE-SoCA project, amiddle range theory of stability of home-based care arrangements for people living with dementia (SoCA-Dem theory) has been developed. The theory helps to understand the complex phenomenon of stability, provides atheoretical framework that can guide future research and can be used for the (further) development of home care structures. The aim of this substudy of the SoCA project was to examine whether the SoCA-Dem theory can guide German health and social care practice in dealing with family carers of PwD. The two guidelines for healthcare professionals, the concept of the Centre for Quality in Care (ZQP) "Quality framework for counselling in care" and the DEGAM guidelines for general practitioners "Family carers of adults", were evaluated using acontent analysis with respect to the SoCA-Dem theory. Most concepts that constitute stability are addressed in both guidelines. The SoCA-Dem theory illustrates the importance of the interaction between the different concepts for the stability of home-based care arrangements. In the guidelines, the dynamic interplay remains unclear. The SoCA-Dem theory seems to be compatible with the German health care context and can support afuture shift from astress-oriented view of giving care to amore comprehensive one.

PRO104 Risk Factors for NOVEL Pharmaceutical Products of Being Imposed with a Registry during the German Benefit Assessment

In Germany, novel drugs must pass a comprehensive benefit assessment process by the Federal Joint Committee (G-BA), after approval is granted by the European Medicine Agency (EMA). Since 2019, a German law intends to include real-world evidence in benefit assessments initially based on insufficient evidence. In this study, time-limited G-BA procedures with a registry requirement serving as an additional evidence base in the re-assessment were evaluated. Using the SKC MAIS-database, which is based on publicly available German benefit assessment and pricing data, time-limited benefit assessments in combination with registry requirements were identified until June 2020 and related constraints, justifications, and deadlines were analysed. For a total of 73 benefit assessments, the G-BA resolution was time-limited so far. 30 of these procedures (41%) concerned orphan drugs. In five of these orphan drug assessments, all of which received a non-quantifiable benefit, the G-BA requested for additional data collection based on a registry to close an existing evidence gap. The first benefit re-assessment of asfotase alfa was completed in April 2020 (price negotiations ongoing), whereas the other four assessments are still pending up to 2022. In all cases, the EMA previously required a patient registry in connection with the approval to gather additional evidence for long-term safety and efficacy of the drug. However, our analysis shows that EMA registry requirements differ from those by the G-BA. In 3/5 cases (60%) the G-BA requested additional registry data on patient-relevant endpoints specific for the German healthcare context. Approval and benefit assessment of orphan drugs are often based on low evidence due to small target populations. The likelihood of being imposed with a registry requirement by the G-BA for generation of additional evidence increases with a registry requested by the EMA, although methodological requirements differ considerably between the HTA authorities.

Challenges in the cultural adaptation of the German Myeloma Patient Outcome Scale (MyPOS): an outcome measure to support routine symptom assessment in myeloma care

BackgroundPatients with multiple myeloma report more problems with quality of life (QoL) than other haematological malignancies over the course of their incurable illness. The patient-centred Myeloma Patient Outcome Scale (MyPOS) was developed to assess and monitor symptoms and supportive care factors in routine care. Our aim was to translate and culturally adapt the outcome measure to the German context, and to explore its face and content validity.MethodsTranslation and cultural adaptation following established guidelines used an exploratory, sequential mixed method study design. Steps included: (1) forward translation to German; (2) backward translation to English; (3) expert review; (4) focus groups with the target population (patients, family members, healthcare professionals) to achieve conceptual equivalence; (5) cognitive interviews using Tourangeau’s model with think-aloud technique to evaluate comprehension and acceptability; (6) final review. Results were analysed using thematic analysis.ResultsCultural and linguistic differences were noted between the German and English original version. The focus groups (n = 11) and cognitive interviews (n = 9) both highlighted the need for adapting individual items and their answer options to the German healthcare context. Greater individuality regarding need for information with the right to not be informed was elaborated by patients. While the comprehensive nature of the tool was appreciated, item wording regarding satisfaction with healthcare was deemed not appropriate in the German context. Before implementation into routine care, patients’ concerns about keeping their MyPOS data confidential need to be addressed as a barrier, whereas the MyPOS itself was perceived as a facilitator/prompt for a patient-centred discussion of QoL issues.ConclusionWith adaptations to answer options and certain items, the German version of the MyPOS can help monitor symptoms and problems afflicting myeloma patients over the course of the disease trajectory. It can help promote a model of comprehensive supportive and patient-centred care for these patients.

Chronic heart failure patients’ experiences of German healthcare services: a protocol for a scoping review

IntroductionChronic heart failure (CHF) is a heterogeneous condition requiring complex treatment from diverse healthcare services. An increasingly holistic understanding of healthcare has resulted in contextual factors such as perceived quality...

Prioritization not Rationing in Cancer Care.

Conditions of scarcity impact healthcare services for cancer patients. This is the unpleasant reality for nations, local governments, hospitals, and even individual doctors. This means that medical services judged by objective standards as potentially effective by medical professionals are limited because of financial or access scarcity. With this situation of scarcity as premise, one must raise the ethical question of how to deal with scarcity while respecting fundamental principles of human dignity and human rights. This chapter focuses on the German healthcare context where dignity and rights form the basis and framework for medical ethics. Accordingly, in Germany, rationing medical services for life-threatening diseases has been traditionally and appropriately criticized and prohibited. Granting a situation of scarcity, however, some prioritization becomes increasingly necessary. Thus, there is present need for careful ethical analysis of non-emergency regulatory prioritization principles and protocols. Above all, analysis and conclusions must preserve and foster society's deepest moral commitments.

The Impact Of Patient Preference Studies In The German Healthcare System

Patients commonly have to deal with healthcare-related decisions based on their personal preferences. Preference studies could help informing on relevance of patient-related outcomes which are of paramount importance in the regulatory AMNOG process. IQWIG also already performed preference studies on the impact of adverse events of pharmaceuticals for the AMNOG process. Aim of this study was to assess the current impact of preference studies in the German healthcare context. A systematic literature search was performed in PubMed and Scopus. Search terms comprised the different preference elicitation methods. The search included all studies conducted in/for Germany up to March 2017 with respect to the applied approach, year of publication, and indication. The search yielded n=511 hits (n=122 in PubMed, n=389 in Scopus, respectively) with n=94 publications being included and stratified by approach, publication year, and indication. Six categories of preference methods were determined: Analytic Hierarchy Process (AHP), Best-Worst-Scaling (BWS), Conjoint Analysis (CA), Contingent Valuation/Willingness to pay (WTP), Discrete Choice Experiment (DCE), and others. Most publications (64.9%) used DCEs, followed by AHP (11.7%) and CA (9.6%) with the first study dating back to 2001. Since 2011, numbers significantly increased with a peak in 2016 (24.5%). 80.9% of the preference studies were conducted for specific disease areas being led by psychological disorders (16.0%), metabolic disorders (10.6%), and infections (9.6%). Patient preference studies have become an important research area when considering the increasing number of patient preference studies in Germany over recent years. Out of the identified methods of preference elicitation, the DCE is the most commonly applied method in Germany. Patient preference studies were adapted over a wide range of diseases suggesting that an inclusion of such evidence in many cases might constitute a feasible option of identifying patient-relevant outcomes offering a separate component of value also during the regulatory AMNOG process.

Potential analysis for research on occupational therapy-led physical exercise programmes and home environment adaptation programmes to prevent falls for elderly people living at home / Potenzialanalyse zu ergotherapeutischen körperlichen Trainingsprogrammen und Wohnraumanpassungen zur Vermeidung von Stürzen bei zu Hause lebenden älteren Menschen

Abstract Background In Germany, four to five million community-dwelling people aged 65 years or older fall every year. The presented potential analysis evaluates the potential of occupational therapy-led physical exercise programs and home environment adaptations to reduce the frequency of falling and as well as intrinsic and extrinsic risk factors for falling of older people living at home. Methods The potential analysis was compiled according to a method guideline (p.11-22) available as follows: http://www.cochrane. de/news/leitfaden-f%C3%BCr-gesundheitsfachberufe-mai-2013. The research question of fall prevention was considered as very relevant for health care and specified according to the PICOS-system. A Cochrane review was systematically searched and the body of evidence was assessed using the GRADE-system. In addition, studies after the search period of the Cochrane review were identified using the search strategy of this review. Both the studies within and after the review were assessed regarding their transferability to the German health care context. Corpus of evidence A Cochrane review from 2012 revealed that occupational therapy-led physical exercise programs reduced the frequency of falling of older people living at home (7 studies, 951 participants, 0.68 RaR; 95%-KI [0.58-0.80]), the number of fallers (6 studies, 714 participants, 0.78 RaR, 95%-KI [0.64-0.94]) and the fractures (6 studies, 810 participants, 0.34 RaR, 95%-KI [0.18-0.63]). Further studies showed that home environment adaptation programs significantly reduced the number of falls (4 studies, 1443 participants, 0.69 RaR, 95%-KI [0.55-0.86]) and the number of fallers (5 studies, 1153 participants, 0.79 RaR, 95%-KI [0.70-0.91]). However, direct implementation into the German healthcare context is not recommendable. Implication for research It is recommended (1) to manualise identified home environment adaptation programmes for the German healthcare context and (2) to pilot-test the physical exercise programmes ‘LiFE’ with regard to theoretical framework, acceptance, applicability and feasibility and to examine both interventions as part of a feasibility study. If this trial results in a feasible treatment programme well accepted by patients and their treating occupational therapists, a large-scaled randomized clinical trial in terms of comparative effectiveness research may follow.

A brief patient-reported outcome instrument for primary care: German translation and validation of the Measure Yourself Medical Outcome Profile (MYMOP).

BackgroundMeasure Yourself Medical Outcome Profile (MYMOP) is a patient-generated outcome instrument capable of measuring effects from a wide range of health care interventions. This paper reports the translation of this instrument into German (MYMOP-D) and the assessment of validity and sensitivity to change for the MYMOP-D. The instrument was piloted in a German primary care context.MethodsThe translation process was conducted according to international guidelines. Recruited patients of both general practitioners and non-medical Complementary and Alternative Medicine (CAM) practitioners (“Heilpraktiker”) in the German state of Baden-Wuerttemberg completed a questionnaire comprised of the MYMOP-D and the EQ-5D. Responses were analysed to assess construct validity. For assessing the instrument’s sensitivity to change, patients received the MYMOP-D again after four weeks at which point they were also asked for their subjective views on change of symptoms. Correlation between MYMOP-D and EQ-5D and sensitivity to change as gradient in score change and as standardized response mean (SRM) were calculated.Results476 patients from general practices and 91 patients of CAM practitioners were included. Construct validity of the MYMOP-D was given with a correlation of r = .47 with the EQ-5D. Sensitivity to change for subjective change of symptoms could only be analysed for improvement or no change of symptoms, as only 12 patients reported deterioration of symptoms. Results showed the expected smooth gradient with 2.2, 1.3, and 0.5 points of change for large, little improvement and no change, respectively. SRM for MYMOP-D Profile Score was 0.88.ConclusionsThe MYMOP-D shows excellent construct validity. It is able to detect changes when symptoms in patients improve or remain unchanged. Deterioration of symptoms could not be evaluated due to too few data. With its brevity and simplicity, it might be an important tool for enhancing patient-centred care in the German health care context.Electronic supplementary materialThe online version of this article (doi:10.1186/s12955-014-0112-5) contains supplementary material, which is available to authorized users.