Factors influencing deceased organ donation rates in OECD countries: a panel data analysis.

OBJECTIVES: This study aims to investigate factors with a significant influence on deceased organ donation rates in Organisation for Economic Co-operation and Development (OECD) countries and determine their relative importance. It seeks to provide the necessary data to facilitate the development of more efficient strategies for improving deceased organ donation rates. DESIGN: Retrospective study. SETTING: Publicly available secondary annual data. PARTICIPANTS: The study includes 36 OECD countries as panel members for data analysis. OUTCOME MEASURES: Multivariable panel data regression analysis was employed, encompassing data from 2010 to 2018 for all investigated variables in the included countries. RESULTS: The following variables had a significant influence on deceased organ donation rates: 'opt-in' system (ß=-4.734, p<0.001, ref: 'opt-out' system), only donation after brain death (DBD) donors allowed (ß=-4.049, p=0.002, ref: both DBD and donation after circulatory death (DCD) donors allowed), number of hospital beds per million population (pmp) (ß=0.002, p<0.001), total healthcare employment pmp (ß=-0.00012, p=0.012), World Giving Index (ß=0.124, p=0.008), total tax revenue as a percentage of gross domestic product (ß=0.312, p=0.009) and percentage of population aged ≥65 years (ß=0.801, p<0.001) as well as high education population in percentage (ß=0.118, p=0.017). CONCLUSIONS: Compared with the promotion of socioeconomic factors with a positive significant impact on deceased organ donation rates, the following policies have been shown to significantly increase rates of deceased organ donation, which could be further actively promoted: the adoption of an 'opt-out' system with presumed consent for deceased organ donation and the legal authorisation of both DBD and DCD for transplantation.

Effect of the addition of a mental health specialist for evaluation of undiagnosed patients in centres for rare diseases (ZSE-DUO): a prospective, controlled trial with a two-phase cohort design.

Background: People with complex symptomatology but unclear diagnosis presenting to a centre for rare diseases (CRD) may present with mental (co-)morbidity. We hypothesised that combining an expert in somatic medicine with a mental health specialist working in tandem will improve the diagnostic outcome. Methods: Patients aged 12 years and older who presented to one of the 11 participating German CRDs with an unknown diagnosis were recruited into this prospective cohort trial with a two-phase cohort design. From October 1, 2018 to September 30, 2019, participants were allocated to standard care (SC, N = 684), and from October 1, 2019 to January 31, 2021 to innovative care (IC, N = 695). The cohorts consisted mainly of adult participants with only a minority of children included (N = 67). IC included the involvement of a mental health specialist in all aspects of care (e.g., assessing medical records, clinic visits, telehealth care, and case conferences). Clinicaltrials.gov identifier: NCT03563677. Findings: The proportion of patients with diagnoses established within 12 months after the first visit to the CRD explaining the entire symptomatology (primary outcome) was 19% (N = 131 of 672) in the SC and 42% (N = 286 of 686) in the IC cohort (OR adjusted for centre effects 3.45 [95% CrI: 1.99-5.65]). The difference was mainly due to a higher prevalence of mental disorders and non-rare somatic diseases in the IC cohort. The median time to explaining diagnoses was one month shorter with IC (95% CrI: 1-2), and significantly more patients could be referred to local regular care in the IC (27.5%; N = 181 of 659) compared to the SC (12.3%; N = 81 of 658) cohort (OR adjusted for centre effects 2.70 [95% CrI: 2.02-3.60]). At 12-month follow-up, patient satisfaction with care was significantly higher in the IC compared to the SC cohort, while quality of life was not different between cohorts. Interpretation: Our findings suggested that including a mental health specialist in the entire evaluation process of CRDs for undiagnosed adolescents and adults should become an integral part of the assessment of individuals with a suspected rare disease. Funding: The study was funded by the Global Innovation Fund from the Joint Federal Committee in Germany (Innovationsfonds des Gemeinsamen Bundesausschusses), grant number 01NVF17031.

Is there a place for sigmoidoscopy in colorectal cancer screening? A systematic review and critical appraisal of cost-effectiveness models.

INTRODUCTION: Screening for colorectal cancer (CRC) is effective in reducing both incidence and mortality. Colonoscopy and stool tests are most frequently used for this purpose. Sigmoidoscopy is an alternative screening measure with a strong evidence base. Due to its distinct characteristics, it might be preferred by subgroups. The aim of this systematic review is to analyze the cost-effectiveness of sigmoidoscopy for CRC screening compared to other screening methods and to identify influencing parameters. METHODS: A systematic literature search for the time frame 01/2010-01/2023 was conducted using the databases MEDLINE, Embase, EconLit, Web of Science, NHS EED, as well as the Cost-Effectiveness Registry. Full economic analyses examining sigmoidoscopy as a screening measure for the general population at average risk for CRC were included. Incremental cost-effectiveness ratios were calculated. All included studies were critically assessed based on a questionnaire for modelling studies. RESULTS: Twenty-five studies are included in the review. Compared to no screening, sigmoidoscopy is a cost-effective screening strategy for CRC. When modelled as a single measure strategy, sigmoidoscopy is mostly dominated by colonoscopy or modern stool tests. When combined with annual stool testing, sigmoidoscopy in 5-year intervals is more effective and less costly than the respective strategies alone. The results of the studies are influenced by varying assumptions on adherence, costs, and test characteristics. CONCLUSION: The combination of sigmoidoscopy and stool testing represents a cost-effective screening strategy that has not received much attention in current guidelines. Further research is needed that goes beyond a narrow focus on screening technology and models different, preference-based participation behavior in subgroups.

Determinants for participation in a prevention and early detection programme for children and adolescents in Germany: does social background play a role?

Early detection examinations and prevention are particularly important in childhood and adolescence, as certain diseases are already developing and health-related attitudes and behaviour patterns are formed and implemented. Despite the importance of screening and prevention, not all families use the available services and programmes. The aim of this study is to identify factors associated with participation in an early detection and prevention programme for children and adolescents, as well as factors associated with actual uptake of an examination. The analyses are based on questionnaire data of an online survey of participants and non-participants. Descriptive analyses and logistic regression models are conducted on a defined sample (n = 1,289). The results show that both groups differ with regard to several factors: age, chronic diseases, federal state, living space, number of siblings, country of birth, migration background, language spoken at home, mother's occupational status, household income, treatment duration, and trust in treating physician. Regression I shows that participation in the programme is significantly associated with higher age, language spoken at home, mother's occupational status and greater trust in the treating physician. The latter demonstrates the highest predictive power. Regression II indicates that the actual uptake of an examination among participants is significantly affected by age, federal state and father's occupational status. Overall, the results of this study show that social background partly plays a role in participation, but that factors such as trust in the treating physician also have a significant impact. For the future, further research on the factors influencing participation in screening and prevention services or programmes for children and adolescents is important in order to develop strategies to overcome existing barriers and thus reach groups that have not been reached yet. In this context, trust in the treating physician and his or her influence on decision-making should in particular be considered.

Lifestyle interventions for patients with non-alcoholic steato-hepatitis-Design, rationale and protocol of the study "target group-specific optimisation of lifestyle interventions for behavior change in non-alcoholic steato-hepatitis (OPTI-NASH)".

BACKGROUND: Non-alcoholic steato-hepatitis (NASH) is the inflammatory, progressive form of non-alcoholic fatty liver disease (NAFLD). A delayed diagnose interval is typical for the majority of the patients because of the asymptomatic natural course. However, serious sequelae may develop such as cirrhosis or hepatocellular carcinoma. NASH is also associated with an increased risk of metabolic diseases. Obesity developed due to a lack of exercise or a disadvantageous diet often leads to NAFLD or NASH, thereby interventions including enhanced physical activity and calorie reduction form the actual gold standard of treatment. To date, patients rarely use these. The project aims to model lifestyle interventions based on the preferences of the NASH patients. METHODS: Based on a systematic review and focus group discussions, two discrete choice experiments (DCE) will be designed, one on aspects influencing successful uptake of lifestyle interventions and one to analyses parameters contributing to long-term participation. An online survey will be used to elicit patient's preferences on program design and on motivational aspects in a cross-sectional design. The recruitment will take place in nine certified specialist practices and hospital outpatient clinics aiming to reach a sample size of n = 500 which is also required for the DCE design. DISCUSSION: The results will provide an overview of the NASH patient's preferences regarding the successful uptake and long-term implementation of lifestyle interventions. Recommendations for optimized lifestyle change programs will be derived and an intervention manual will be developed to facilitate target group-specific inclusion in programs in practice.

Evaluation of a multimodal pain therapy approach with relapse prophylaxis for back pain (MMS-RFP study): a study protocol for a cluster randomised controlled trial.

INTRODUCTION: The need for an interdisciplinary multimodal approach to the treatment of back pain has already been demonstrated by various studies. However, when considering the periods of incapacity to work in the longitudinal course after the multimodal pain therapy (MPT), limits in terms of its sustainable effect become clear. Patients who receive MPT subsequently return to standard outpatient care, which is associated with a risk of relapse. A 12-month relapse prophylaxis (RP) programme, intended to follow a 4-week MPT, was developed to help patients make the transition to health-conscious and physically active behaviour in everyday life and to identify and prevent impending relapses at an early stage. The evaluation, based on a cluster randomised controlled trial, seeks to provide information on the benefits of early and intensive RP as part of MPT, examine whether it is cost effective, reduces the days of incapacity to work and increases functional capacity, as well as to examine other parameters. METHODS AND ANALYSIS: The study population comprises members of a regional statutory health insurance fund in Germany, who are ≤62 years old, gainfully employed and have been incapacitated for work for at least 21 days due to a diagnosis of back pain. Over a recruitment period of 24 months, a maximum of 368 individuals can potentially be included in the MPT. The intervention group (IG) and control group (CG) will both receive MPT, after randomisation IG will receive RP and CG will receive no further therapy or support as part of the trial. The evaluation is carried out on the following levels: structural, process and results quality. Cost effectiveness is also assessed by means of a health economic evaluation. In addition to the collection of qualitative and quantitative primary data, claims data from the regional health insurance fund are also included in the analysis. ETHICS AND DISSEMINATION: This study has received approval by the ethics committee of the Hannover Medical School (reference number: 8548_BO_S_2019). The study results will be disseminated in national and international journals and conference presentations. TRIAL REGISTRATION NUMBER: DRKS00017654.

Systematic review on the involvement and engagement of patients as advisers for the organisation of organ transplantation services.

OBJECTIVES: This systematic review aims to derive practical lessons from publications on patient involvement and engagement in the organisation of organ transplantation services. DESIGN: This systematic review was conducted according to the Preferred Reporting Items for Systematic reviews and Meta-Analyses. Inclusion criteria for the analysis of publications in English cited in the databases PubMed and Web of Science until 6 December 2022 required that patients participated as advisers in the organisation of organ transplantation services. Quality assessment was performed using the Guidance for Reporting Involvement of Patients and the Public (GRIPP) 2 small form and the Critical Appraisal Skills Programme (CASP) tool for the assessment of the risks of bias. RESULTS: Deployed search strings identified 2263 records resulting in a total of 11 articles. The aims and strategies, deployed methods, observed effects, observed barriers and proposed improvements for the future varied vastly. All reported that well-developed programmes involving and engaging patients at an organisational level provide additional benefits for patients and foster patient-centred care. Lessons learnt include: (1) to empower patients, the information provided to them should be individualised to prioritise their needs; (2) financial as well as organisational resources are important to successfully implement patient involvement and engagement; (3) systematic feedback from patients in organisational structures to health providers is required to improve clinical workflows and (4) the consideration of ethical issues and the relationship between investigators and participating patients should be clarified and reported. CONCLUSIONS: Actionable management recommendations could be derived. The quantitative impact on clinical outcome and economic clinical process improvements remains to be investigated. Study quality can be improved using the GRIPP 2 guidance and the CASP tool. PROSPERO REGISTRATION NUMBER: CRD42022186467.

The effectiveness of additional screening examinations for children and adolescents in Germany: a longitudinal retrospective cohort study.

BACKGROUND: Continuous medical care is particularly important in childhood and adolescence. Since there are gaps in regular care in Germany, various health insurance providers offer to cover additional examinations (e.g., U10, U11, J2) to ensure ongoing paediatrician visits. However, the question arises as to whether these examinations are effective. Thus, the main objective of this study is to determine whether participation in the U10, U11 or J2 examinations leads to more frequent and earlier diagnosis and treatment of age-specific diseases. METHODS: The analyses are based on administrative claims data from a statutory health insurance fund. For each examination, an intervention group (IG) is formed and matched with a corresponding control group (CG). Descriptive analyses include proportion with diagnosis and treatment, average age of diagnosis and treatment initiation. Hypothesis testing is performed using methods appropriate to each. In addition, subgroup analyses and binominal logistic regression models are conducted. RESULTS: More diagnoses are detected in IG, irrespective of subgroups. Additionally, diagnoses are made slightly earlier on average in IG. In the total samples, more therapies are initiated in IG, and slightly earlier. Considering only diagnosed cases, more therapies are initiated in CG but continue to be started earlier in IG. Regression models show that participation in the examinations has the highest predictive power for detecting a diagnosis. The presence of a chronic disease and sex - male at the U10 and U11 and female at the J2 - are also significantly associated. The models further show that nationality, unemployment of parents and region also have a significant influence in some cases, whereas school-leaving qualification, vocational qualification and income of parents do not. Considering the initiation of treatment in overall samples, the models show similar results, but here the presence of a chronic illness has the highest predictive power. CONCLUSION: The results indicate that participation in the examinations leads to significantly more diagnoses and, in the overall samples, significantly more treatments. In addition, diagnoses were made somewhat earlier and therapies were initiated somewhat earlier. In the future, it would be useful to investigate the U10, U11 and J2 examinations over a longer time horizon to determine whether the statistically significant difference found is also clinically relevant, i.e., earlier diagnosis and initiation of therapy lead to prevention of manifestation or progression of the diagnosed diseases and to avoidance of secondary diseases. TRIAL REGISTRATION: German Clinical Trials Register (DRKS), DRKS-ID: DRKS00015280. Prospectively registered on 18 March 2019.

Setting Organ Allocation Priorities: A Discrete Choice Experiment with German Patients and Their Relatives.

Purpose: Organ transplantation systems benefit from guidelines that are harmonious with the preferences of the people involved. Discrete choice experiments are useful tools for eliciting preferences. Patients and Methods: This study evaluated the preferences of patients and their relatives (n=285) to identify their priorities in organ allocation using a discrete choice experiment. In eight hypothetical allocation decisions, the participants were asked to select the candidate they considered the most suitable The candidates differed in years of life gained after transplantation, quality of life after transplantation, waiting time until transplantation, age, compliance and social support. Results: The most important aspects for setting priority in organ allocation were lack of compliance (ß= -2.5, p<0.001) and good quality of life after transplantation (ß = +1.4, p<0.001). The lack of social support (ß = -0.8, p<0.05) and the more years of life gained after transplantation (ß = +0.5, p<0.001) had less but still a significant amount of influence on this decision, while the waiting list was not considered significantly important (ß = 0.1, p>0.05). The comparison of the different relations to transplantation showed that life years gained after transplantation was of high relevance to posttransplant patients (+10 years: ß = +0.709, p<0.001 / +15 years: ß = +0.700, p<0.001) and of no importance to waitlisted patients (+10 years: ß = +0.345, p>0.05 / + 15 years: ß = +0.173, p>0.05) and relatives (+ 10 years: ß = +0.063, p>0.05 / +15 years: ß = +0.304, p>0.05). Conclusion: This study provides useful insights into the unique perspective of patients and their relatives on priority-setting in the allocation of donor organs that should be reflected in improved donor organ allocation rules.

Synchronous online focus groups in health research: application and further development of methodology based on experiences from two mixed-methods research projects.

OBJECTIVES: Focus groups used for data collection in health research are increasingly conducted online. In two multi-center health research projects, we applied available methodological instructions for synchronous online focus groups (SOFGs). We describe necessary changes and specifications regarding the planning (recruitment, technology, ethics, appointments) and conduct (group composition, moderation, interaction, didactics) to enhance knowledge about the planning and conduct of SOFGs. RESULTS: Recruiting online proved to be challenging and necessitated direct and analogue recruiting, too. To ensure participation, less digital and more individual formats may be offered, e.g. telephone calls. Explaining verbally the specifics of data protection and anonymity in an online setting can foster participants' confidence to actively engage in the discussion. Two moderators, one moderating, one supporting technically, are advisable in SOFGs, however, due to limited nonverbal communication, roles and tasks need to be defined beforehand. Participant interaction is central to focus groups in general, but sometimes difficult to achieve online. Hence, smaller group size, sharing of personal information and moderators increased attention to individual reactions appeared helpful. Lastly, digital tools such as surveys and breakout rooms should be used with caution, as they easily inhibit interaction.

Assessment of health-related quality of life in individuals with depressive symptoms: validity and responsiveness of the EQ-5D-3L and the SF-6D.

BACKGROUND: The EQ-5D and the SF-6D are examples of commonly used generic preference-based instruments for assessing health-related quality of life (HRQoL). However, their suitability for mental disorders has been repeatedly questioned. OBJECTIVE: To assess the responsiveness and convergent validity of the EQ-5D-3L and SF-6D in patients with depressive symptoms. METHODS: The data analyzed were from cardiac patients with depressive symptoms and were collected as part of the SPIRR-CAD (Stepwise Psychotherapy Intervention for Reducing Risk in Coronary Artery Disease) trial. The EQ-5D-3L and SF-6D were compared with the HADS (Hospital Anxiety and Depression Scale) and PHQ-9 (Patient Health Questionnaire) as disease-specific instruments. Convergent validity was assessed using Spearman's rank correlation. Effect sizes were calculated and ROC analysis was performed to determine responsiveness. RESULTS: Data from 566 patients were analysed. The SF-6D correlated considerably better with the disease-specific instruments (|rs|= 0.63-0.68) than the EQ-5D-3L (|rs|= 0.51-0.56). The internal responsiveness of the SF-6D was in the upper range of a small effect (ES: - 0.44 and - 0.47), while no effect could be determined for the EQ-5D-3L. Neither the SF-6D nor the EQ-5D-3L showed acceptable external responsiveness for classifying patients' depressive symptoms as improved or not improved. The ability to detect patients whose condition has deteriorated was only acceptable for the EQ-5D-3L. CONCLUSION: Overall, both the convergent validity and responsiveness of the SF-6D are better than those of the EQ-5D-3L in patients with depressive symptoms. The SF-6D appears, therefore, more recommendable for use in studies to evaluate interventions for this population.

Real-world experience for the outcomes and costs of treating hepatitis C patients: Results from the German Hepatitis C-Registry (DHC-R).

BACKGROUND & AIMS: With long-term consequences like the development of liver cirrhosis and hepatocellular carcinoma, chronic hepatitis C virus (HCV) infection is associated with a significant health burden. Information on HCV treatment outcomes and costs in routine care is still rare, especially for subgroups. The aim of this study was to analyse the treatment outcomes and costs of subgroups in routine care and to compare them over time with previous analyses. METHODS: Data were derived from a noninterventional study including a subset of 10298 patients receiving DAAs with genotypes 1 and 3. Sociodemographic, clinical parameters and costs were collected using a web-based data recording system. The total sample was subdivided according to treatment regimen, cirrhosis status as well as present HIV infection and opioid substitution treatment (OST). RESULTS: 95% of all patients achieved SVR. Currently used DAA showed higher SVR-rates and less adverse events (AE) compared to former treatments. Concerning subgroups, cirrhotic patients, HIV-coinfected patients and OST patients showed lower but still high SVR-rates. In comparison, cirrhotic had considerably longer treatment duration and more frequent (serious) AE. Overall, average treatment costs were €48470 and costs per SVR were €51129; for currently used DAAs costs amounted to €30330 and costs per SVR to €31692. After the end of treatment, physical health is similar to the general population in all patients except cirrhotic. Mental health remains far behind in all subgroups, even for currently used DAA. CONCLUSIONS: Over time, some relevant factors developed positively (SVR-rates, costs, treatment duration, adverse events, health-related quality of life (HRQoL)). Further research on HRQoL, especially on mental health, is necessary to evaluate the differences between subgroups and HRQoL over time and to identify influencing factors.

Heterogeneous Preferences for Colorectal Cancer Screening in Germany: Results of a Discrete Choice Experiment.

OBJECTIVES: Colorectal cancer (CRC) screening tests differ in benefits, harms, and processes, making individual informed decisions preference based. The objective was to analyze the preferences of insurees in Germany for characteristics of CRC screening modalities. METHODS: A generic discrete choice experiment with 2-alternative choice sets and 6 attributes (CRC mortality, CRC incidence, complications, preparation, need for transportation, and follow-up; 3 levels each) depicting characteristics of fecal testing, sigmoidoscopy, and colonoscopy was generated. Participants completed 8 choice tasks. Internal validity was tested using a within-set dominated pair. Between June and October 2020, written questionnaires were sent to a stratified random sample (n = 5000) of 50-, 55-, and 60-year-old insurees of the AOK (Allgemeine Ortskrankenkasse) Lower Saxony, who had previously received an invitation to participate in the organized screening program including evidence-based information. Preferences were analyzed using conditional logit, mixed logit, and latent-class model. RESULTS: From 1282 questionnaires received (26% [1282 of 4945]), 1142 were included in the analysis. Approximately 42% of the respondents chose the dominated alternative in the internal validity test. Three heterogeneous preference classes were identified. Most important attributes were preparation (class 1; n = 505, 44%), CRC mortality (class 2; n = 347, 30%), and CRC incidence (class 3; n = 290, 25%). Contrary to a priori expectations, a higher effort was preferred for bowel cleansing (class 1) and accompaniment home (classes 1 and 2). CONCLUSION: Internal validity issues of choice data need further research and warrant attention in future discrete choice experiment surveys. The observed preference heterogeneity suggests different informational needs, although the underlying reasons remained unclear.

Do task and item difficulty affect overestimation of one's hand hygiene compliance? A cross-sectional survey of physicians and nurses in surgical clinics of six hospitals in Germany.

BACKGROUND: One barrier to hand hygiene compliance is overestimation of one's own performance. Overconfidence research shows that overestimation tends to be higher for difficult tasks, which suggests that the magnitude of overestimation also depends on how it is assessed. Thus, we tested the hypothesis that overestimation was stronger for hand hygiene indications with low compliance (i.e., high difficulty), and the hypothesis that self-reported overall compliance based on a single item is higher than based on "5 Moments of Hand Hygiene" (WHO-5) items, since the single item implies an aggregation across indications. METHODS: In the WACH trial (German Clinical Trials Register [DRKS] ID: DRKS00015502), a questionnaire survey was conducted among physicians and nurses in nine surgical clinics (general/visceral surgery or orthopedics/trauma surgery) of six German hospitals. Self-reported compliance was assessed both by a single item and the WHO-5-items using percentage scales. These were compared with each other and with direct observations. Relative frequencies of the WHO-5 indications used to calculate the WHO-5-based self-reported overall compliance rate were estimated by a systematized review of the literature (see appendix). In analysis, t-tests, Chi2-tests and multiple linear regressions were used. RESULTS: Ninety-three physicians (response rate: 28.4%) and 225 nurses (30.4%) participated. Significant compliance differences between physicians and nurses were found for direct observations and were in favor of nurses, while no such differences were found for self-reports. Across the WHO-5, overestimation showed inverse correlations with observed compliance (physicians: r = -0.88, p = 0.049; nurses: r = -0.81, p = 0.093). Support for the hypothesis that the self-reported overall compliance based on one item is higher than that based on WHO-5 items was found for physicians (M = 87.2 vs. 84.1%, p = 0.041; nurses: 84.4 vs. 85.5%, p = 0.296). Exploratory analyses showed that this effect was confined to orthopedic/trauma surgeons (89.9 vs. 81.7%, p = 0.006). CONCLUSION: Among physicians, results indicate stronger hand hygiene overestimation for low-compliance indications, and when measurements are based on a single item versus the five WHO-5 items. For practice, results contribute to infection prevention and control's understanding of overestimation as a psychological mechanism that is relevant to professional hand hygiene.

How Should Deceased Donor Organs Be Allocated? The Patient's Perspective Derived from Semi-Structured Interviews.

Purpose: The gap between the supply and demand for deceased donor organs is increasing worldwide, while patients on waiting lists for organ transplantation die. This situation requires ethical donor organ allocation rules. The patients' perspective on donor organ allocation rules offers a highly relevant and unique perspective that may differ from the perspectives of physicians and the general public. Patients and Methods: Semi-structured telephone interviews were conducted with the regional group coordinators of the federal self-help organization for organ transplanted patients and their relatives in Germany in early 2021. Twelve interviews were conducted with patients and relatives of transplantation patients who received transplants for the affected organs including the lungs, heart, kidney, and liver. Transcripts were analyzed using the deductive framework method which was based on an earlier study. All criteria were reported following the COREQ statement. Results: Participants emphasized aspects of "medical urgency" and "effectiveness/benefit" of transplantation and associated trade-offs as well as the recipient's responsibility for organ failure ("own fault"), the appreciation for the gifted graft and the patient's capability of taking care of it ("appreciation/responsibility"). Patients acknowledged that urgent patients should be prioritized and they showed a clear preference toward allocation rules that strive to maximize both the life years and quality of life gained by transplantation. Conclusion: The patients' perspective is unique in that patients agree on certain rules for allocation and share many preferences, but also have a hard time finding clear cutoff points when considering selecting a participant for allocation. Patient representatives should therefore be consulted in the debate on donor organ allocation rules.

Attributes in stated preference elicitation studies on colorectal cancer screening and their relative importance for decision-making among screenees: a systematic review.

INTRODUCTION: The SIGMO study (Sigmoidoscopy as an evidence-based colorectal cancer screening test - a possible option?) examines screening eligible populations' preferences for colorectal cancer (CRC) screening in Germany using a discrete choice experiment (DCE). Attribute identification and selection are essential for the construction of choice tasks and should be evidence-based. As a part of the SIGMO study this systematic review provides an overview of attributes included in studies eliciting stated preferences for CRC screening tests and their relative importance for decision-making. METHODS: Systematic search (November 2021) for English-language studies published since January 2000 in PubMed, Embase, Web of Science, Biomedical Reference Collection: Corporate Edition, LIVIVO and PsycINFO. DCEs and conjoint analysis ranking or rating tasks on screening eligible populations' preferences for stool testing, sigmoidoscopy, and/or colonoscopy were included. Attributes were extracted and their relative importance was calculated and ranked. Risk of bias (RoB) of included studies was assessed using a modified GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach. Study selection and RoB rating were carried out independently by two reviewers. Data were extracted by one reviewer and checked by another one. RESULTS: A total of 23 publications on 22 studies were included. Overall RoB was rated as serious/critical for 21 studies and as moderate for 2 studies. Main reasons for high RoB were non-random sampling, low response rates, lack of non-responder analyses, and, to a lesser extent, weaknesses in the measurement instrument and data analysis. Extracted attributes (n = 120) referred to procedure-related characteristics (n = 42; 35%), structural characteristics of health care (n = 24; 20%), test characteristics (n = 23; 19%), harms (n = 16; 13%), benefits (n = 13; 11%), and level of evidence (n = 2; 2%). Most important attributes were reduction in CRC mortality (and incidence) (n = 7), test sensitivity (n = 7), out-of-pocket costs (n = 4), procedure (n = 3), and frequency (n = 2). CONCLUSIONS: Health preference studies on CRC were found to have a high RoB. The composition of choice tasks revealed a lack of attributes on patient-important outcomes (like incidence reduction), while attributes not considered relevant for individual screening decisions (like sensitivity) were frequently used. Future studies eliciting stated preferences in cancer screening should apply the principles of informed decision-making in attribute identification and selection.

Attributes Characterizing Colorectal Cancer Screening Tests That Influence Preferences of Individuals Eligible for Screening in Germany: A Qualitative Study.

Purpose: This qualitative study is part of the SIGMO study, which evaluates general populations' preferences for colorectal cancer (CRC) screening in Germany using a discrete choice experiment. Attribute identification and selection are essential in the construction of choice tasks and should be evidence-based ensuring that attributes are relevant to potential beneficiaries and contribute to overall utility. Therefore, this qualitative study aims to identify relevant attributes characterizing CRC screening tests from the perspective of those eligible for screening in Germany. Patients and Methods: Individuals aged 50 to 60 were purposively selected. A questioning route was developed and piloted. Four focus groups (FG) (n=20) were conducted (November 2019) with two moderators and one observer each. FGs were audio recorded, transcribed, and analyzed using qualitative content analysis. Attributes were deductively assigned based on a priori identified attribute categories, and inductively derived. Results: Across FGs, 24 attributes (n=293 codes) were discussed, five of which (sedation, inability to work, transportation home, predictive values, waiting time for screening colonoscopy) were inductively derived (n=76 codes). Four attributes identified a priori were not addressed in any FG. The most frequently discussed attribute category was procedural characteristics, followed by measures of screening test validity, benefits, harms, and structural characteristics of health care. The most commonly addressed attributes were preprocedural bowel cleansing, kind of procedure, and predictive values. Conclusion: Newly identified attributes characterizing CRC screening tests from an individual's perspective, and a priori identified attributes not addressed by any FG stress the added value of qualitative research and thereby the importance of applying a mix of methods in identifying and selecting attributes for the construction of choice tasks. This study meets the requirements for a transparent and detailed presentation of the qualitative methods used in this process, which has rarely been the case before.

Dual guidance structure for evaluation of patients with unclear diagnosis in centers for rare diseases (ZSE-DUO): study protocol for a controlled multi-center cohort study.

BACKGROUND: In individuals suffering from a rare disease the diagnostic process and the confirmation of a final diagnosis often extends over many years. Factors contributing to delayed diagnosis include health care professionals' limited knowledge of rare diseases and frequent (co-)occurrence of mental disorders that may complicate and delay the diagnostic process. The ZSE-DUO study aims to assess the benefits of a combination of a physician focusing on somatic aspects with a mental health expert working side by side as a tandem in the diagnostic process. STUDY DESIGN: This multi-center, prospective controlled study has a two-phase cohort design. METHODS: Two cohorts of 682 patients each are sequentially recruited from 11 university-based German Centers for Rare Diseases (CRD): the standard care cohort (control, somatic expertise only) and the innovative care cohort (experimental, combined somatic and mental health expertise). Individuals aged 12 years and older presenting with symptoms and signs which are not explained by current diagnoses will be included. Data will be collected prior to the first visit to the CRD's outpatient clinic (T0), at the first visit (T1) and 12 months thereafter (T2). OUTCOMES: Primary outcome is the percentage of patients with one or more confirmed diagnoses covering the symptomatic spectrum presented. Sample size is calculated to detect a 10 percent increase from 30% in standard care to 40% in the innovative dual expert cohort. Secondary outcomes are (a) time to diagnosis/diagnoses explaining the symptomatology; (b) proportion of patients successfully referred from CRD to standard care; (c) costs of diagnosis including incremental cost effectiveness ratios; (d) predictive value of screening instruments administered at T0 to identify patients with mental disorders; (e) patients' quality of life and evaluation of care; and f) physicians' satisfaction with the innovative care approach. CONCLUSIONS: This is the first multi-center study to investigate the effects of a mental health specialist working in tandem with a somatic expert physician in CRDs. If this innovative approach proves successful, it will be made available on a larger scale nationally and promoted internationally. In the best case, ZSE-DUO can significantly shorten the time to diagnosis for a suspected rare disease. Trial registration ClinicalTrials.gov; Identifier: NCT03563677; First posted: June 20, 2018, https://clinicaltrials.gov/ct2/show/NCT03563677 .

Additional offer of sigmoidoscopy in colorectal cancer screening in Germany: rationale and protocol of the decision-analytic modelling approach in the SIGMO study.

INTRODUCTION: In Germany, statutory insured persons are entitled to a stool test (faecal immunochemical test (FIT)) or colonoscopy for colorectal cancer (CRC) screening, depending on age and sex, yet participation rates are rather low. Sigmoidoscopy is a currently not available screening measure that has a strong evidence base for incidence and mortality reduction. Due to its distinct characteristics, it might be preferred by some, who now reject colonoscopy. The objective of this study is to estimate the economic consequences of the additional offer of sigmoidoscopy for CRC screening in Germany compared with the present screening practice while considering the preferences of the general population. METHODS AND ANALYSIS: A decision-analytic modelling approach will be developed that compares the present CRC screening programme in Germany (FIT, colonoscopy) with a programme extended by sigmoidoscopy from a societal perspective. A decision tree and Markov model will be combined to assess both short-term and long-term effects, such as CRC and adenoma detection rates, the number of CRC cases, CRC mortality as well as complications. The incremental cost per quality-adjusted life year gained for each alternative will be calculated. The model will incorporate the general population's preferences based on a discrete choice experiment. Further, input parameters will be taken from the literature, the German cancer registry and health insurance claims data. ETHICS AND DISSEMINATION: Ethical approval for the study was obtained from the Ethics Committee of Hannover Medical School (ID: 8671_BO_K_2019). The findings of the study will be published in peer-reviewed journals and presented at national and/or international conferences. TRIAL REGISTRATION NUMBER: DRKS00019010.

Public Preferences for Exit Strategies From COVID-19 Lockdown in Germany-A Discrete Choice Experiment.

Objectives: To decrease the rapid growth of SARS-CoV-2 in Germany, a stepped lockdown was conducted. Acceptance and compliance regarding entering and exiting lockdown measures are key for their success. The aim of the present study was to analyse the population's preferences for exiting lockdown measures. Methods: To evaluate population's preferences and identify trade-offs between different exit strategies, a discrete choice experiment was conducted on 28-29 April (n = 1,020). Overall, six attributes and 16 choice sets (fractional-factorial design) without an opt-out were chosen. Conditional logit and latent class models were conducted. Results: Most attributes proved to be significant. Two attributes dominated all others: Avoiding a mandatory tracing app, and providing sufficient intensive care capacities. Preventing a high long-term unemployment rate and avoiding the isolation of persons aged 70+, were relevant, though utilities were comparatively lower. We identified subgroups (elderly persons and persons with school children) with different utilities, which indicates specific attributes affecting them dissimilarly. Conclusions: The population prefers cautious re-opening strategies and is at least sceptical about the adoption of severe protection measures. Government should balance interests between subgroups.