Changing indications for keratoplasty: monocentric analysis of the past two decades.

PURPOSE: Over the past two decades, lamellar keratoplasty procedures, such as Descemet's Stripping Automated Endothelial Keratoplasty (DSAEK) and Descemet's Membrane Endothelial Keratoplasty (DMEK) as well as Deep Anterior Lamellar Keratoplasty (DALK), have become an integral part of clinical practice. With advances in contact lens fitting for keratoconus management and the implementation of UVA-Riboflavin Crosslinking (CXL), the landscape of keratoplasty indications is undergoing changes. Procedures and indications in a single tertiary care center over the past two decades are reviewed in this retrospective analysis. METHODS: Retrospective analysis utilized anonymized electronic data from the LIONS cornea bank Baden-Württemberg, Eye Center Freiburg, spanning from beginning of 2004 to end of 2023. The primary focus was on surgical procedures and indications for keratoplasty. RESULTS: The study encompassed a comprehensive analysis of 7130 corneal transplants. Penetrating keratoplasty (PK) exhibited a significant decline from 95% (n = 206, 2004) to 11% (n = 46, 2023), while DMEK increased from 48% (n = 157, 2012) to 82% (n = 347, 2023). Fuchs endothelial dystrophy (FED) emerged as the dominant indication, witnessing a significant increase from 24% (2004, n = 39) to 72% (2023, n = 288). Conversely, keratoconus (KC) showed a reciprocal change from 25% (2004, n = 40) to 4% (2023, n = 17). PK demonstrated a noteworthy indication shift in descending order from Bullous Keratopathy (BK), FED, and KC in 2004 to KC, graft failure, corneal scars, and ulcers in 2023. Repeat keratoplasty following DMEK remained rare, but a discernible upward trend was observed for PK. CONCLUSION: This retrospective analysis highlights significant changes in both keratoplasty indications and techniques over the past two decades. DMEK has emerged as a successful intervention for treating endothelial diseases, while PK retains its qualitative indispensability for a wide range of indications. Modern corneal banks are urged to maintain a robust supply of grafts for all surgical techniques in anticipation of potential increased demand in the future, particularly for repeat keratoplasties. KEY MESSAGES: What is known • Over the past two decades, lamellar keratoplasty procedures such as DSAEK and DMEK have increasingly replaced penetrating keratoplasty (PK) in clinical practice due to their improved outcomes and reduced complications for certain indications. New Findings • Our study reveals a significant shift in keratoplasty indications, with Fuchs endothelial dystrophy (FED) emerging as the predominant indication, increasing from 24% in 2004 to 72% in 2023, while keratoconus (KC) declined from 25 to 4% during the same period. • Penetrating keratoplasty (PK) has shown a marked decline in use, dropping from 95% of keratoplasties in 2004 to 11% in 2023, whereas DMEK has grown to represent 82% of procedures in 2023. • Despite the rise of DMEK, PK remains vital for a broad spectrum of indications, highlighting the necessity for corneal banks to maintain a versatile supply of grafts to meet diverse clinical needs, particularly in cases of repeat keratoplasties.

Theories used to develop or evaluate social prescribing in studies: a scoping review.

OBJECTIVE: This scoping review aims to provide an overview of how theories were used in the development or evaluation of social prescribing (SP) intervention studies. BACKGROUND: SP describes a patient pathway where general practitioners (GPs) connect patients with community activities through referrals to link workers. This review seeks to understand the explanations provided for the outcomes and implementation process of SP. INCLUSION CRITERIA: Studies using a defined theory to develop or evaluate a specific SP intervention in primary care and the community sector. METHODS: This scoping review was conducted in accordance with JBI methodology. The following databases were searched on 8th of July 2022: PubMed, ASSIA, Cochrane, Cinahl, PsycINFO, Social Care Online, Sociological Abstracts, Scopus, and Web of Science. The search only considered English language texts. Additional literature was identified by searching relevant web pages and by contacting experts. The selection of sources and the data extraction was done by two reviewers independently. RESULTS: The search resulted in 4240 reports, of which 18 were included in the scoping review. Of these, 16 were conducted in the UK, one in Canada and one in Australia. The majority of reports employed a qualitative approach (11/18). Three were study protocols. 11 distinct theories were applied to explain outcomes (4 theories), differences in outcomes (3 theories), and the implementation of the intervention (4 theories). In terms of practical application, the identified theories were predominantly used to explain and understand qualitative findings. Only one theory was used to define variables for hypothesis testing. All theories were used for the evaluation and none for the development of SP. CONCLUSION: The theories influenced which outcomes the evaluation assessed, which causal pathway was expected to generate these outcomes, and which methodological approaches were used. All three groups of theories that were identified focus on relevant aspects of SP: fostering positive patient/community outcomes, addressing inequalities by considering the context of someone's individual circumstances, and successfully implementing SP by collaboratively working across professions and institutional boundaries. Additional insight is required regarding the optimal use of theories in practical applications.

[Influence of health care crises on the treatment of cancer pain: a presentation using the example of the COVID-19 pandemic from the provider's perspective]. / Einfluss von Versorgungskrisen auf die Behandlung von Tumorschmerzen: eine Darstellung am Beispiel der COVID-19-Pandemie aus Versorgersicht.

BACKGROUND: The COVID-19 pandemic led to significantly restricted access to pain medicine services. Patients with cancer-related pain are considered a vulnerable group in terms of care deficits. A questionnaire among providers providing treatment to this group was used to assess limitations and solutions in this critical situation. MATERIALS AND METHODS: The online survey, developed by the 'Tumour Pain Working Group' of the German Pain Society using the Delphi method, included questions on site structure, pandemic-related care problems, and burdens experienced by those treating patients. It was distributed several times via the mailing lists of the German Pain Society and the 'Palliative Medicine Working Group' of the German Society of Anaesthesiology and Intensive Care Medicine. RESULTS: In all, 175 fully completed questionnaires were analysed. Over 75% of participants reported pandemic-related staff shortages and closures of pain medicine facilities, with 32% of facilities temporarily not treating elective pain patients and 13% not treating any emergencies. Care was hampered by numerous logistical problems such as very frequent pandemic-related cancellations by patients or in the transmission of prescriptions. Alternative forms of consultation by telephone or telemedicine, rarely used before the pandemic, were reported by 79 and 31% of respondents respectively, but deficiencies were noted. In addition, 52.1% of respondents complained of severe and 26.8% of moderate psychological stress due to the pandemic, and 74.1% evaluated working conditions as moderately to severely difficult. Medical training was still possible for 86% through format changes. CONCLUSION: The COVID-19 pandemic revealed numerous deficits in the care of patients with cancer-related pain, as well as burdens on healthcare providers. The development of new concepts could help to ensure better care in future crisis situations.

[Current data on rheumatological care: annual report from the National database (NDB) of the regional collaborative arthritis centres in Germany]. / Aktuelle Zahlen zur rheumatologischen Versorgung ­ Jahresbericht aus der Kerndokumentation der regionalen kooperativen Rheumazentren.

In the National database (NDB) of the German regional collaborative arthritis centres, annual data on the rheumatological care of patients with inflammatory rheumatic diseases have been collected since 1993. This first annual report presents current cross-sectional data on medication and patient-reported outcomes gathered in 2022.

Unsupervised learning for medical data: A review of probabilistic factorization methods.

We review popular unsupervised learning methods for the analysis of high-dimensional data encountered in, for example, genomics, medical imaging, cohort studies, and biobanks. We show that four commonly used methods, principal component analysis, K-means clustering, nonnegative matrix factorization, and latent Dirichlet allocation, can be written as probabilistic models underpinned by a low-rank matrix factorization. In addition to highlighting their similarities, this formulation clarifies the various assumptions and restrictions of each approach, which eases identifying the appropriate method for specific applications for applied medical researchers. We also touch upon the most important aspects of inference and model selection for the application of these methods to health data.

Centering Public Perceptions on Translating AI Into Clinical Practice: Patient and Public Involvement and Engagement Consultation Focus Group Study.

BACKGROUND: Artificial intelligence (AI) is widely considered to be the new technical advancement capable of a large-scale modernization of health care. Considering AI's potential impact on the clinician-patient relationship, health care provision, and health care systems more widely, patients and the wider public should be a part of the development, implementation, and embedding of AI applications in health care. Failing to establish patient and public engagement and involvement (PPIE) can limit AI's impact. OBJECTIVE: This study aims to (1) understand patients' and the public's perceived benefits and challenges for AI and (2) clarify how to best conduct PPIE in projects on translating AI into clinical practice, given public perceptions of AI. METHODS: We conducted this qualitative PPIE focus-group consultation in the United Kingdom. A total of 17 public collaborators representing 7 National Institute of Health and Care Research Applied Research Collaborations across England participated in 1 of 3 web-based semistructured focus group discussions. We explored public collaborators' understandings, experiences, and perceptions of AI applications in health care. Transcripts were coanalyzed iteratively with 2 public coauthors using thematic analysis. RESULTS: We identified 3 primary deductive themes with 7 corresponding inductive subthemes. Primary theme 1, advantages of implementing AI in health care, had 2 subthemes: system improvements and improve quality of patient care and shared decision-making. Primary theme 2, challenges of implementing AI in health care, had 3 subthemes: challenges with security, bias, and access; public misunderstanding of AI; and lack of human touch in care and decision-making. Primary theme 3, recommendations on PPIE for AI in health care, had 2 subthemes: experience, empowerment, and raising awareness; and acknowledging and supporting diversity in PPIE. CONCLUSIONS: Patients and the public can bring unique perspectives on the development, implementation, and embedding of AI in health care. Early PPIE is therefore crucial not only to safeguard patients but also to increase the chances of acceptance of AI by the public and the impact AI can make in terms of outcomes.

Transitional care of older ethnic minority patients: An integrative review.

AIMS: To critically synthesize the empirical literature on practice in transitional care and how to meet the care needs of older ethnic minority populations who discharged from hospital to community. DESIGN: An integrative literature review integrating empirical studies using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. DATA SOURCES: PubMed, Web of Science, PsycINFO, EBSCO (including CINAHL and MEDLINE) and Scopus were searched for papers published between 2012 and September 2022. REVIEW METHODS: Full-text papers were screened against inclusion and exclusion criteria subsequent to screening titles and abstracts. All included papers were evaluated for methodological quality using the Critical Appraisal Skills Programme Checklists. After extracting findings, themes were created by critically examining and synthesizing of findings. RESULTS: The search yielded a total of 1180 studies, 1153 after removing duplicates and 27 papers meeting the inclusion criteria and exclusion criteria were included in the review. The main findings were categorized into four themes: (i) intervention-related outcomes; (ii) unmet needs of older minority people; (iii) transitional care-related characteristics of older minority people and (iv) challenges for healthcare providers. Findings indicated that the transitional care experience of ethnic minority older populations differed from natives to some extent which revealed unmet needs addressing how to provide culturally appropriate transitional care for this population. CONCLUSION: This review gave insight into facilitators in the transitional care of ethnic minority older adults. Future transitional care interventions should incorporate needs of ethnic minority population. IMPACT: This review highlighted the defined gaps between existing transitional care programmes and transitional care needs of older ethnic minority. Increasing follow-up completion, evidence defining deeply of ethnic phenomenon in the transitional care process, developing interventions that meet transitional care needs and increasing healthcare providers' cultural competency were featured headlines. No Patient or Public Contribution.

[PHARAO study: drug treatment of inflammatory rheumatic diseases : Guideline-conform treatment with biologics follows availability of biosimilars]. / PHARAO-Studie: Arzneimittelversorgung entzündlich rheumatischer Erkrankungen : Leitliniengerechte Versorgung mit Biologika folgt Verfügbarkeit von Biosimilars.

BACKGROUND: With the introduction of tumor necrosis factor (TNF) alpha inhibitors, the treatment of inflammatory rheumatic diseases (IRD) has undergone a fundamental change. Several of the originally high-priced biologics are now accessible as lower cost biosimilars, removing a significant impediment to prescription. OBJECTIVE: The present study investigated whether the availability of biosimilars is associated with an improvement in the care of IRD. Moreover, the subjective acceptance of biosimilars by physicians and patients was investigated and compared with objectifiable parameters. MATERIAL AND METHODS: Pseudonymized claims data of the Bavarian Association of Statutory Health Insurance Physicians from 2014 to 2019 as well as a paper and pencil survey of patients and rheumatologists formed the data basis of the study. RESULTS: During the observation period, the proportion of diagnosed patients receiving drug therapy increased from 38.5% to 43.2%. Also, the care changed in terms of the prescribed agents. Conventional drug therapy declined overall and, in particular, glucocorticoid prescriptions decreased from 39.3% in 2014 to 34.3% in 2019. At the same time, the proportion of targeted treatments increased from 12.3% to 20.4%. The median duration of basic treatment before first-time bDMARD use dropped from 3.15 years in 2014 to 2.17 years in 2019. CONCLUSION: Over the observation period, in which three biosimilars entered the market, the care of patients with IRD improved both quantitatively and qualitatively. The market share of biosimilars increased in parallel with this development. With an overall high acceptance of biosimilars, the assessment of the disease course by physicians and patients indicates a slight subjectively perceived advantage of therapy with originals compared to biosimilars, which, however, is not confirmed when standardized scores are applied. A possible explanation for this might be a nocebo effect, which could be minimized by suitable communication strategies.

Stability of individual dementia diagnoses in routine care: Implications for epidemiological studies.

PURPOSE: Epidemiological and health care research frequently rely on diagnoses from routine care, but the intra-individual stability of diagnoses of Alzheimer's disease (AD), vascular dementia (VD) or other forms of dementia (oD) in patients over time is understudied. More data on the diagnostic stability is needed to appraise epidemiological findings from such studies. METHODS: Using health claims data of the years 2004-2016 from the German Pharmacoepidemiological Research Database, 160 273 patients aged ≥50 with incident dementia were identified and followed for 4 years. According to the incident ICD-10 codes patients were assigned to the categories AD, VD or oD. Changes between categories during follow-up were calculated. RESULTS: Overall, 18.8% had incident AD (VD: 21.5%, oD: 59.7%). Fifteen thousand eight hundred forty-two patients had only one dementia diagnosis during 4 years (AD: 7.4%, VD: 12.4%, oD: 9.8%). Among those with more than one diagnosis, the incident diagnosis matched the last diagnosis in 65.1% (AD), 53.9% (VD) and 73.8% (oD) of patients. Changes in the diagnostic category were higher in patients with AD (mean: 5.1) than in patients with VD (3.6) or oD (3.3). Patients with stable AD diagnoses during the observation period were younger (median: 76 vs. 79 years) and had less inpatient treatment days (median: 14 days) than patients with changes from an AD diagnosis to another category or from another category to AD (27 days). CONCLUSIONS: While health claims data are feasible for estimating the incidence of dementia in general, the substantial number of changes in dementia diagnoses during the course of the disease warrant caution on the interpretation of epidemiological data on specific dementia types.

Complex skills are required for new primary health care researchers: a training program responds.

BACKGROUND: Current dimensions of the primary health care research (PHC) context, including the need for contextualized research methods to address complex questions, and the co-creation of knowledge through partnerships with stakeholders - require PHC researchers to have a comprehensive set of skills for engaging effectively in high impact research. MAIN BODY: In 2002 we developed a unique program to respond to these needs - Transdisciplinary Understanding and Training on Research - Primary Health Care (TUTOR-PHC). The program's goals are to train a cadre of PHC researchers, clinicians, and decision makers in interdisciplinary research to aid them in tackling current and future challenges in PHC and in leading collaborative interdisciplinary research teams. Seven essential educational approaches employed by TUTOR-PHC are described, as well as the principles underlying the curriculum. This program is unique because of its pan-Canadian nature, longevity, and the multiplicity of disciplines represented. Program evaluation results indicate: 1) overall program experiences are very positive; 2) TUTOR-PHC increases trainee interdisciplinary research understanding and activity; and 3) this training assists in developing their interdisciplinary research careers. Taken together, the structure of the program, its content, educational approaches, and principles, represent a complex whole. This complexity parallels that of the PHC research context - a context that requires researchers who are able to respond to multiple challenges. CONCLUSION: We present this description of ways to teach and learn the advanced complex skills necessary for successful PHC researchers with a view to supporting the potential uptake of program components in other settings.

Socioeconomic Disparity Trends in Cancer Screening Among Women After Introduction of National Quality Indicators.

PURPOSE: Primary care physicians have an important role in encouraging adequate cancer screening. Disparities in cancer screening by socioeconomic status (SES) may affect presentation stage and cancer survival. This study aimed to examine whether breast, colorectal, and cervical cancer screening rates in women differed by SES and age, and whether screening rates and SES disparities changed after introduction of a primary care-based national quality indicator program. METHODS: This repeated cross-sectional study spanning 2002-2017 included all female Israeli residents in age ranges appropriate for each cancer screening assessed. SES was measured both as an individual-level variable based on exemption from copayments and as an area-level variable using census data. RESULTS: In 2017, the most recent year in the study period, screening rates among 1,529,233 women were highest for breast cancer (70.5%), followed by colorectal cancer (64.3%) and cervical cancer (49.6%). Women in the highest area-level SES were more likely to undergo cervical cancer screening compared with those in the lowest (odds ratio = 3.56; 99.9% CI, 3.47-3.65). Temporal trends showed that after introduction of quality indicators for breast and colorectal cancer screening in 2004 and 2005, respectively, rates of screening for these cancers increased, with greater reductions in disparities for the former. The quality indicator for cervical cancer screening was introduced in 2015, and no substantial changes have occurred yet for this screening. CONCLUSIONS: We found increased uptake and reduced socioeconomic disparities after introduction of cancer screening indicators. Recent introduction of a cervical cancer screening indicator may increase participation and reduce disparities, as has occurred for breast and colorectal cancer screening. These findings related to Israel's quality indicators program highlight the importance of primary care clinicians in increasing cancer screening rates to improve outcomes and reduce disparities.

STARD Adherence in an Interventional Radiology Guideline for Diagnostic Arteriography.

Objective: To assess the quality of reporting in diagnostic accuracy studies (DAS) referenced by the Quality Improvement Guidelines for Diagnostic Arteriography and their adherence to the Standards for Reporting of Diagnostic Accuracy (STARD) statement.Materials and Methods: Citations specific to the Society of Interventional Radiology's Quality Improvement Guidelines for Diagnostic Arteriography were collected. Using the 34-item STARD checklist, two authors in a duplicate and blinded fashion documented the number of items reported per diagnostic accuracy study. Authors met, and any discrepancies were resolved in a resolution meeting.Results: Of the 26 diagnostic accuracy studies included, the mean number of STARD items reported was 17.8 (SD ± 3.1). The median adherence was 18 (IQR, 17-19) items. Ten articles were published prior to 2003, the original date of STARD publication, and 16 articles were published after 2003. The mean number of reported items for the articles published prior to STARD 2003, and after STARD 2003 was 17.4 (SD ± 2.4) and 18.1 (SD ± 3.5), respectively. There were 14 STARD items that demonstrated an adherence of < 25%, and 13 an adherence > 75%.Conclusion: The dichotomous distribution of adherence to the STARD statement by DAS investigated demonstrates that areas of deficient reporting may be present and require attention to ensure complete and transparent reporting in the future.

Organizing work in local service implementation: an ethnographic study of nurses' contributions and competencies in implementing a municipal acute ward.

BACKGROUND: The increased prevalence of chronic diseases and an ageing population challenge healthcare delivery, particularly hospital-based care. To address this issue, health policy aims to decentralize healthcare by transferring responsibility and introducing new services in primary healthcare. In-depth knowledge of associated implementation processes is crucial for health care managers, policymakers, and the health care personnel involved. In this article, we apply an ethnographic approach in a study of nurses' contributions to the implementation of a new inpatient service in an outpatient primary care emergency clinic and explore the competencies involved. The approach allowed us to explore the unexpressed yet significant effort, knowledge and competence of nurses that shaped the new service. METHODS: The study combines observations (250 h) and several in situ interviews with healthcare personnel and individual in-depth interviews with nurses (n = 8) at the emergency clinic. In our analysis, we draw on a sociological perspective on healthcare work and organization that considers nursing a practice within the boundaries of clinical patient work, organizational structures, and managerial and professional requirements. RESULTS: We describe the following three aspects of nurses' contributions to the implementation of the new service: (1) anticipating worst-case scenarios and taking responsibility for preventing them, (2) contributing coherence in patient care by ensuring that new and established procedures are interconnected, and (3) engaging in "invisible work". The nurses draw on their own experiences from their work as emergency nurses and knowledge of the local and regional contexts. They utilize their knowledge, competence, and organizing skills to influence the implementation process and ensure high-quality healthcare delivery in the extended service. CONCLUSIONS: Our study illustrates that nurses' contributions are vital to coordinating and adjusting extended services. Organizing work, in addition to clinical work, is a crucial aspect of nursing work. It 'glues' the complex and varied components of the individual patient's services into coherent and holistic care trajectories. It is this organizing competence that nurses utilize when coordinating and adjusting extended services. We believe that nurses' organizing work is generally invaluable in implementing new services, although it has not been well emphasized in practice and research.

[Psycho-oncological care in private practices: a survey among psychotherapists with and without licence for reimbursement with public health insurance]. / Psychoonkologische Versorgung bei niedergelassenen Psychotherapeuten: eine Befragung von Therapeuten mit und ohne Kassensitz.

Psycho-oncological care in private practices: a survey among psychotherapists with and without licence for reimbursement with public health insurance Objective: This study examined how certified psychotherapist working in an outpatient setting organise their practice to be able to treat cancer patients and what specific problems they encounter. We differentiated between therapists with and without licence. Methods: Out of the list of psychotherapists held by the German Cancer Information Service, a random sample of practices was selected. They received a mailed questionnaire. Per practice, only one therapist was selected. The questionnaire was developed by a group of psychotherapists from two psycho-oncological associations in Germany. Practices with and without licence were compared using chi-square, ranksum tests and multivariate regression analyses (adjusting for professional qualification and school of therapy). Results: Of 257 contacted practices, 160 therapists participated, and 144 were certified and could be included (62 without and 82 with licence). Waiting times for a first consultation for cancer patients were on average 10 days in practices of therapists without licence and 18 days with licence (p < 0.01). Crisis intervention within 3 days was possible for 62 % of the therapists without and for 44 % with licence (p = 0.08). There was no evidence for differences in what treatment options both types of therapists offered. Both groups reported that more than half of the cancer patients (60 % without and 58 % with licence) had to cancel their appointments at least once every 3 months, and 64 % of the therapists did not ask a fee for that. Financing of the treatment happened most frequently via compensation from health insurance companies via their licence in therapists with licence and via private payment or so called "Kostenerstattung" in therapists without licence. Discussion: In psycho-oncological practices, waiting times for a first consultation for cancer patients are on average 4 weeks shorter than in general, especially short in practices without licence. Cancellation of appointments by patients are relatively frequent in both groups of therapists, which bears financial risks for them. Special methods of compensation for services such as selective contracts are infrequently used..

Rare genital malformations in women's health research: sociodemographic, regional, and disease-related characteristics of patients with Mayer-Rokitansky-Küster-Hauser syndrome.

BACKGROUND: The Mayer-Rokitansky-Küster-Hauser syndrome, MRKHS, is a rare (orphan) disease characterized by the aplasia or hypoplasia of the uterus and the vagina. In women's health research, little is known as to how much care provision for patients with MRKHS takes into account their socio-demographic together with their clinical characteristics. This work examines the patients' socio-demographic characteristics, highlighting issues of inappropriate and deficient provision of care. METHODS: The study was carried out as part of the larger TransCareO project and included a group of N=129 MRKHS patients who underwent surgery between 2008 and 2012. Using a specially developed questionnaire, we analyzed MRKHS patients' data found both in the clinical documentation of the Department for Women's Health, University Hospital of Tübingen and the patient surveys of the Center for Rare Genital Malformations (CRGM/ ZSGF). Patients who took part in interviews were compared with non-respondents. RESULTS: Patient respondents and non-respondents did not differ as to the parameters of interest. In most cases, primary amenorrhea was reported as an admission reason. In 24% of patients, a medical intervention (hymenal incision or hormone treatment) already occurred before admission to the Center in Tübingen and proper diagnosis of MRKHS. About one third received in advance inappropriate treatment. During the therapy, more than half of the patients were in a solid partnership. 10% of the family anamneses documented the occurrence of urogenital malformations. CONCLUSIONS: Care provision for MRKHS patients is largely characterized by delayed proper diagnosis and in part, by inappropriate treatment attempts; there are also indications of regional differences. Anamnestic clues such as an asymptomatic amenorrhea or renal abnormalities of unclear origin still fail to result early enough in referral to a center on the basis of suspected MRKHS diagnosis. Urogenital malformations in the family are more common in patients than in the general population. For patients, a wide range of burdens are associated with the diagnosis. Abnormalities compared to their female peers occur, for instance, in the partnership status: MRKHS patients have more rarely a partner.

Acute neurological care in north-east Germany with telemedicine support (ANNOTeM): protocol of a multi-center, controlled, open-label, two-arm intervention study.

BACKGROUND: Both diagnosis and treatment of neurological emergencies require neurological expertise and are time-sensitive. The lack of fast neurological expertise in regions with underserved infrastructure poses a major barrier for state-of-the-art care of patients with acute neurological diseases and leads to disparity in provision of health care. The main purpose of ANNOTeM (acute neurological care in North East Germany with telemedicine support) is to establish effective and sustainable support structures for evidence based treatments for stroke and other neurological emergencies and to improve outcome for acute neurological diseases in these rural regions. METHODS: A "hub-and-spoke" network structure was implemented connecting three academic neurological centres ("hubs") and rural hospitals ("spokes") caring for neurological emergencies. The network structure includes (1) the establishment of a 24/7 telemedicine consultation service, (2) the implementation of standardized operating procedures (SOPs) in the network hospitals, (3) a multiprofessional training scheme, and (4) a quality management program. Data from three major health insurance companies as well as data from the quality management program are being collected and evaluated. Primary outcome is the composite of first time of receiving paid outpatient nursing care, first time of receiving care in a nursing home, or death within 90 days after hospital admission. DISCUSSION: Beyond stroke only few studies have assessed the effects of telemedically supported networks on diagnosis and outcome of neurological emergencies. ANNOTeM will provide information whether this approach leads to improved outcome. In addition, a health economic analysis will be performed. STUDY REGISTRATION: German Clinical Trials Register DRKS00013067, date of registration: November 16 th, 2017, URL: http://www.drks.de/DRKS00013068.

How do 66 European institutional review boards approve one protocol for an international prospective observational study on traumatic brain injury? Experiences from the CENTER-TBI study.

BACKGROUND: The European Union (EU) aims to optimize patient protection and efficiency of health-care research by harmonizing procedures across Member States. Nonetheless, further improvements are required to increase multicenter research efficiency. We investigated IRB procedures in a large prospective European multicenter study on traumatic brain injury (TBI), aiming to inform and stimulate initiatives to improve efficiency. METHODS: We reviewed relevant documents regarding IRB submission and IRB approval from European neurotrauma centers participating in the Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury (CENTER-TBI). Documents included detailed information on IRB procedures and the duration from IRB submission until approval(s). They were translated and analyzed to determine the level of harmonization of IRB procedures within Europe. RESULTS: From 18 countries, 66 centers provided the requested documents. The primary IRB review was conducted centrally (N = 11, 61%) or locally (N = 7, 39%) and primary IRB approval was obtained after one (N = 8, 44%), two (N = 6, 33%) or three (N = 4, 23%) review rounds with a median duration of respectively 50 and 98 days until primary IRB approval. Additional IRB approval was required in 55% of countries and could increase duration to 535 days. Total duration from submission until required IRB approval was obtained was 114 days (IQR 75-224) and appeared to be shorter after submission to local IRBs compared to central IRBs (50 vs. 138 days, p = 0.0074). CONCLUSION: We found variation in IRB procedures between and within European countries. There were differences in submission and approval requirements, number of review rounds and total duration. Research collaborations could benefit from the implementation of more uniform legislation and regulation while acknowledging local cultural habits and moral values between countries.

Caring for frail older patients in the last phase of life : Challenges for general practitioners in the integration of geriatric and palliative care.

BACKGROUND: The best possible care for frail older patients at the end of life can require the integration of geriatric and palliative approaches, possibly with different accentuations at different times. General practitioners (GP) are particularly important in this context: they provide patients with low-threshold primary care close to their homes and provide both general palliative care and geriatric services. OBJECTIVE: What are the challenges for GPs in caring for frail older patients at the end of their lives? MATERIAL AND METHODS: A secondary data analysis of 52 qualitative interviews was carried out, which were serially obtained at 4 points in time over a period of 18 months with 14 family doctors. In addition, one focus group with five GPs took place. The analysis was carried out according to the principles of grounded theory. RESULTS: The results show that GPs see the care of frail older patients at the end of their lives through a) the growing number of older people, b) multimorbidity and complexity of the problem areas, c) the integration of geriatric and palliative approaches, d) the high average age of general practitioners and the lack of junior staff and e) the problem of ensuring care in rural areas as a major challenge. The practical transition between geriatric and palliative care is considered by GPs to be fluid and there is a desire for more integration of both disciplines. CONCLUSION: In this study GPs perceived a large overlap between geriatric and palliative care. Both approaches should be offered for a selection of patients as a combined service. In the future a systematic network between GPs and geriatricians in practices, clinics, and day clinics will be necessary.

LearnOvation: an intervention to foster exploration and exploitation behaviour in health care management in daily practice.

BACKGROUND: Innovation has been identified as an important engine for improving the quality, productivity and efficiency of health care. Little is known about how to stimulate innovation capacity in primary health care in general; even less is known about how specific interventions should be designed to support managements' work with practice-based innovations. Research has shown that if managers and teams are excellent at handling the challenges of production (exploitation) and development (exploration), they are better at innovation. The aim of the study is to develop a dynamic management support programme to increase innovation leadership skills in daily practice. METHODS: The study has an interactive approach that allows the need for empirical and theoretical knowledge to emerge and merge, and a quasi-experimental cross-over design. Eight primary health care centres will participate in the study. In the first phase, the management teams at four health care centres will participate in the intervention, and the other four centres will serve as a control group. Thereafter, the units will switch places and the control group will experience the intervention. All staff at the 8 units will answer questionnaires at four points in time (before, during, after, 6 months later) to evaluate the effects of the intervention. DISCUSSION: The study will contribute to knowledge on how to organize processes of innovation and support exploitation and exploration behaviours by co-producing and testing a tailor-made management support programme for innovation work in primary health care. An expected long-term effect is that the support system will be disseminated to other centres both within and beyond the participating organizations.

[Quality assurance in specialized palliative home care (QUAPS): a questionnaire's feasibility]. / Qualitätssicherung in der spezialisierten ambulanten Palliativversorgung (QUAPS) ­ Praktikabilität eines Fragebogens.

BACKGROUND: Structure and process parameters are not sufficient for adequate quality assurance in specialized palliative home care (SAPV). Asking the patients and their relatives for their assessment is crucial. A focus group in Jena, Germany, developed the quality assurance in specialized palliative home care (QUAPS) questionnaire for this assessment of outcome parameters, which was tested in two studies. OBJECTIVES: The aim of the study was to evaluate the feasibility of a questionnaire for patients, relatives and SAPV teams. MATERIAL AND METHODS: The questionnaire collects outcome parameters on a Likert scale as well as the distress of respondents using the numeric rating scale (NRS). In the pilot study, QUAPS I was tested in three SAPV teams. The survey was simplified in the follow-up study, QUAPS II, where 17 teams were included. Both studies were conducted with an ex-post-facto design. RESULTS: In QUAPS I, complete datasets could be obtained for 43 out of 308 surveyed cases. In QUAPS II, 169 complete datasets resulted from 371 surveyed cases. The SAPV staff assessed the QUAPS II survey as being organizationally feasible. The questionnaire shows good internal consistency and high approval for the surveyed aspects of SAPV care. Ceiling effects occurred. More than 70% of respondents reported a distress score >5. CONCLUSIONS: The simplified survey in QUAPS II resulted in a higher rate of complete datasets. The detected ceiling effects restrict the conclusions of the survey. Biases like social desirability cannot be ruled out. In the future, a combination of different questionnaires (e. g. integrated palliative outcome score [IPOS] and QUAPS) should be explored.