Population-Based, Spatial Analysis of Specialised Ambulatory Palliative Care in Mecklenburg-Western Pomerania, Germany, on the Basis of Reimbursement Data.

In rural areas, healthcare providers, patients and relatives have to cover long distances. For specialised ambulatory palliative care (SAPV), a supply radius of max. 30 km is recommended. The aim of this study was to analyse whether there are regional disparities in the supply of SAPV and whether it is associated with the distance between the SAPV team's site and the patient's location. Therefore, anonymised data of the Association of Statutory Health Insurance Physicians of the Federal State of Mecklenburg-Western Pomerania (M-V) were retrospectively analysed for the period of 2014-2017. Identification as a palliative patient was based on palliative-specific items from the ambulatory reimbursement catalogue. In total, 6940 SAPV patients were identified; thereof, 48.9% female. The mean age was 73.3 years. For 28.3% of the identified SAPV patients (n = 1961), the SAPV teams had a travel distance of >30 km. With increasing distance, the average number of treatment days per patient increased. It was found that there are regional disparities in the provision of SAPV services in M-V and that local structures have an important impact on regional supply patterns. The distance between the SAPV team's site and the patient's location is not the only determining factor; other causes must be considered.

Reporting quality of clinical trial protocols: a repeated cross-sectional study about the Adherence to SPIrit Recommendations in Switzerland, CAnada and GErmany (ASPIRE-SCAGE).

OBJECTIVES: Comprehensive protocols are key for the planning and conduct of randomised clinical trials (RCTs). Evidence of low reporting quality of RCT protocols led to the publication of the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist in 2013. We aimed to examine the quality of reporting of RCT protocols from three countries before and after the publication of the SPIRIT checklist. DESIGN: Repeated cross sectional study. SETTING: Swiss, German and Canadian research ethics committees (RECs). PARTICIPANTS: RCT protocols approved by RECs in 2012 (n=257) and 2016 (n=292). PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcomes were the proportion of reported SPIRIT items per protocol and the proportion of trial protocols reporting individual SPIRIT items. We compared these outcomes in protocols approved in 2012 and 2016, and built regression models to explore factors associated with adherence to SPIRIT. For each protocol, we also extracted information on general trial characteristics and assessed whether individual SPIRIT items were reported RESULTS: The median proportion of reported SPIRIT items among RCT protocols showed a non-significant increase from 72% (IQR, 63%-79%) in 2012 to 77% (IQR, 68%-82%) in 2016. However, in a preplanned subgroup analysis, we detected a significant improvement in investigator-sponsored protocols: the median proportion increased from 64% (IQR, 55%-72%) in 2012 to 76% (IQR, 64%-83%) in 2016, while for industry-sponsored protocols median adherence was 77% (IQR 72%-80%) for both years. The following trial characteristics were independently associated with lower adherence to SPIRIT: single-centre trial, no support from a clinical trials unit or contract research organisation, and investigator-sponsorship. CONCLUSIONS: In 2012, industry-sponsored RCT protocols were reported more comprehensively than investigator-sponsored protocols. After publication of the SPIRIT checklist, investigator-sponsored protocols improved to the level of industry-sponsored protocols, which did not improve.

Comparison of survival between patients receiving general outpatient palliative care and patients receiving other palliative care - analysis of data of a statutory health insurance data.

BACKGROUND: The care of palliative patients takes place as non-specialized and specialized care, in outpatient and inpatient settings. However, palliative care is largely provided as General Outpatient Palliative Care (GOPC). This study aimed to investigate whether the survival curves of GOPC patients differed from those of the more intensive palliative care modalities and whether GOPC palliative care was appropriate in terms of timing. METHODS: The study is based on claims data from a large statutory health insurance. The analysis included 4177 patients who received palliative care starting in 2015 and who were fully insured 1 year before and 1 year after palliative care or until death. The probability of survival was observed for 12 months. Patients were classified into group A, which consisted of patients who received palliative care only with GOPC, and group B including patients who received inpatient or specialized outpatient palliative care. Group A was further divided into two subgroups. Patients who received GOPC on only 1 day were assigned to subgroup A1, and patients who received GOPC on two or more days were assigned to subgroup A2. The survival analysis was carried out using Kaplan-Meier curves. The median survival times were compared with the log-rank test. RESULTS: The survival curves differed between groups A and B, except in the first quartile of the survival distribution. The median survival was significantly longer in group A (137 days, n = 2763) than in group B (47 days, n = 1424, p < 0.0001) and shorter in group A1 (35 days, n = 986) than in group A2 (217 days, n = 1767, p < 0.0001). The survival rate during the 12-month follow-up was higher in group A (42%) than in group B (11%) and lower in group A1 (38%) than in group A2 (44%). CONCLUSIONS: The results of the analysis revealed that patients who received the first palliative care shortly before death suspected insufficient care, especially patients who received GOPC for only 1 day and no further palliative care until death or 12-month follow-up. Palliative care should start as early as necessary and be continuous until the end of life.

Nonregistration, discontinuation, and nonpublication of randomized trials: A repeated metaresearch analysis.

BACKGROUND: We previously found that 25% of 1,017 randomized clinical trials (RCTs) approved between 2000 and 2003 were discontinued prematurely, and 44% remained unpublished at a median of 12 years follow-up. We aimed to assess a decade later (1) whether rates of completion and publication have increased; (2) the extent to which nonpublished RCTs can be identified in trial registries; and (3) the association between reporting quality of protocols and premature discontinuation or nonpublication of RCTs. METHODS AND FINDINGS: We included 326 RCT protocols approved in 2012 by research ethics committees in Switzerland, the United Kingdom, Germany, and Canada in this metaresearch study. Pilot, feasibility, and phase 1 studies were excluded. We extracted trial characteristics from each study protocol and systematically searched for corresponding trial registration (if not reported in the protocol) and full text publications until February 2022. For trial registrations, we searched the (i) World Health Organization: International Clinical Trial Registry Platform (ICTRP); (ii) US National Library of Medicine (ClinicalTrials.gov); (iii) European Union Drug Regulating Authorities Clinical Trials Database (EUCTR); (iv) ISRCTN registry; and (v) Google. For full text publications, we searched PubMed, Google Scholar, and Scopus. We recorded whether RCTs were registered, discontinued (including reason for discontinuation), and published. The reporting quality of RCT protocols was assessed with the 33-item SPIRIT checklist. We used multivariable logistic regression to examine the association between the independent variables protocol reporting quality, planned sample size, type of control (placebo versus other), reporting of any recruitment projection, single-center versus multicenter trials, and industry versus investigator sponsoring, with the 2 dependent variables: (1) publication of RCT results; and (2) trial discontinuation due to poor recruitment. Of the 326 included trials, 19 (6%) were unregistered. Ninety-eight trials (30%) were discontinued prematurely, most often due to poor recruitment (37%; 36/98). One in 5 trials (21%; 70/326) remained unpublished at 10 years follow-up, and 21% of unpublished trials (15/70) were unregistered. Twenty-three of 147 investigator-sponsored trials (16%) reported their results in a trial registry in contrast to 150 of 179 industry-sponsored trials (84%). The median proportion of reported SPIRIT items in included RCT protocols was 69% (interquartile range 61% to 77%). We found no variables associated with trial discontinuation; however, lower reporting quality of trial protocols was associated with nonpublication (odds ratio, 0.71 for each 10% increment in the proportion of SPIRIT items met; 95% confidence interval, 0.55 to 0.92; p = 0.009). Study limitations include that the moderate sample size may have limited the ability of our regression models to identify significant associations. CONCLUSIONS: We have observed that rates of premature trial discontinuation have not changed in the past decade. Nonpublication of RCTs has declined but remains common; 21% of unpublished trials could not be identified in registries. Only 16% of investigator-sponsored trials reported results in a trial registry. Higher reporting quality of RCT protocols was associated with publication of results. Further efforts from all stakeholders are needed to improve efficiency and transparency of clinical research.

Telemedicine as a Tool to Improve Medicine Adherence in Patients with Affective Disorders - A Systematic Literature Review.

Affective disorders are a common psychological impairment. A major problem with respect to treatment is medication non-adherence. eHealth interventions are already widely used in the treatment of patients living with affective disorders. The aim of this systematic literature review is to obtain the current scientific evidence to eHealth as a tool to improve medication adherence in patients with affective disorders. A systematic search was performed across PubMed, Cochrane Library, Web of Science and PsycInfo. Studies in English and German published between 2007 and 2020 were included. The review followed the PRISMA guidelines and were performed with the CADIMA online tool. A total of 17 articles were included in this review. Eleven studies were randomized controlled trials, two were controlled clinical trials, and four had a pre-/post-design. Three different types of interventions could be identified: internet-based self-management programs (n=4), multi-faceted interventions addressing different dimensions of medication adherence (n=4), and single-faceted interventions (n=9) comprising four mobile interventions and five telehealth interventions. Eleven interventions addressed patients with (comorbid) depressions and six addressed patients with bipolar disorders. Six interventions showed a statistically significant positive effect on medication adherence. None of the studies showed a statistically significant negative effect. All interventions which had a statistically significant positive effect on medication adherence involved personal contacts between therapists and patients. All included eHealth interventions are at least as effective as control conditions and seems to be effective for patients with depression as well as with bipolar disorders. Personal contacts seem to improve the effectiveness of eHealth interventions. eHealth interventions are an effective way to improve medication adherence in patients with affective disorders. In rural or underserved regions, eHealth can supplement usual care interventions on medication adherence by expanding access. More analyses are needed in order to understand determinants for the effectiveness of eHealth interventions on medication adherence enhancement.

Reporting quality of trial protocols improved for non-regulated interventions but not regulated interventions: A repeated cross-sectional study.

OBJECTIVES: To investigate the adherence of randomised controlled trial (RCT) protocols evaluating non-regulated interventions (including dietary interventions, surgical procedures, behavioural and lifestyle interventions, and exercise programmes) in comparison with regulated interventions to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 Statement. METHODS: We conducted a repeated cross-sectional investigation in a random sample of RCT protocols approved in 2012 (n = 257) or 2016 (n = 292) by research ethics committees in Switzerland, Germany, or Canada. We investigated the proportion of accurately reported SPIRIT checklist items in protocols of trials with non-regulated as compared to regulated interventions. RESULTS: Overall, 131 (24%) of trial protocols tested non-regulated interventions. In 2012, the median proportion of SPIRIT items reported in these protocols (59%, interquartile range [IQR], 53%-69%) was lower than in protocols with regulated interventions (median, 74%, IQR, 66%-80%). In 2016, the reporting quality of protocols with non-regulated interventions (median, 75%, IQR, 62%-83%) improved to the level of regulated intervention protocols, which had not changed on average. CONCLUSIONS: Reporting of RCT protocols evaluating non-regulated interventions improved between 2012 and 2016, although remained suboptimal. SPIRIT recommendations need to be further endorsed by researchers, ethics committees, funding agencies, and journals to optimize reporting of RCT protocols.

Continuity in palliative care - analysis of intersectoral palliative care based on routine data of a statutory health insurance.

BACKGROUND: The goal of palliative care is to prevent and alleviate a suffering of incurable ill patients. A continuous intersectoral palliative care is important. The aim of this study is to analyse the continuity of palliative care, particularly the time gaps between hospital discharge and subsequent palliative care as well as the timing of the last palliative care before the patient's death. METHODS: The analysis was based on claims data from a large statutory health insurance. Patients who received their first palliative care in 2015 were included. The course of palliative care was followed for 12 months. Time intervals between discharge from hospital and first subsequent palliative care as well as between last palliative care and death were analysed. The continuity in palliative care was defined as an interval of less than 14 days between palliative care. Data were analysed using descriptive statistics and Chi-Square. RESULTS: In 2015, 4177 patients with first palliative care were identified in the catchment area of the statutory health insurance. After general inpatient palliative care, 415 patients were transferred to subsequent palliative care, of these 67.7% (n = 281) received subsequent care within 14 days. After a stay in a palliative care ward, 124 patients received subsequent palliative care, of these 75.0% (n = 93) within 14 days. Altogether, 147 discharges did not receive subsequent palliative care. During the 12-months follow-up period, 2866 (68.7%) patients died, of these 78.7% (n = 2256) received palliative care within the last 2 weeks of life. Of these, 1223 patients received general ambulatory palliative care, 631 patients received specialised ambulatory palliative care, 313 patients received their last palliative care at a hospital and 89 patients received it in a hospice. CONCLUSIONS: The majority of the palliative care patients received continuous palliative care. However, there are some patients who did not receive continuous palliative care. After inpatient palliative care, each patient should receive a discharge management for a continuation of palliative care. Readmissions of patients after discharge from inpatients palliative care can be an indication for a lack of support in the ambulatory health care setting and for an insufficient discharge management. Palliative care training and possibilities for palliative care consultations by specialists should strengthen the GPs in palliative care.

[Palliative Care from the Perspective of Providers of General and Specialised Palliative Care - A Cross-Sectional Survey]. / Die allgemeine und spezialisierte Palliativversorgung aus Sicht von Leistungserbringern der Hospiz- und Palliativversorgung ­ eine Querschnittserhebung.

BACKGROUND: Palliative care is a particular challenge in rural regions with low population density. Every patient should have access to palliative care regardless of age, diagnosis, prognosis, place of residence and economic aspects. The aim was to identify problem areas in palliative care in rural regions and to find possible solutions from the perspective of health service providers. METHODS: A standardised written survey was conducted among providers of general and specialised palliative care in the federal state of Mecklenburg-Western Pomerania. In total, 489 service providers were sent a questionnaire. A random sample of general palliative care providers and all specialised palliative care providers in Mecklenburg-Western Pomerania were contacted. For the evaluation of the structure of palliative care and to identify problem areas, the German school grading system was used (1=very good, 6=insufficient). The results of the survey were descriptively analysed. RESULTS: The response rate was 19% (n=93). Identified problems were the interface between outpatient and inpatient care as well as between general and specialised palliative care. The cooperation between specialised outpatient palliative care teams and hospital with a palliative care unit was rated with an average of 1.9. The cooperation between specialised outpatient palliative care teams and hospitals without a palliative care unit was rated with an average of 3.6. The knowledge of palliative care of nurses in nursing homes was graded 4.0; 54.8% (n=51) of the participants could consider providing telemedicine care to palliative patients in addition to conventional care. The establishment of a palliative care coordination unit was rated as highly important by 34.4% of the participants. CONCLUSIONS: The results indicate infrastructural, organisational and quality-related problems in providing palliative care. The provision of palliative care in rural areas could be strengthened through targeted training, outpatient consultation services, coordination units and the integration of telemedicine functionalities.

Task-Sharing Between Pediatricians and Non-Physician Healthcare Professionals in Outpatient Child Health Care in Germany: Assessment of Need and Acceptance for Concept Development.

Although pediatricians in Germany work as general practitioners for children, they are planned and trained as medical specialists. In consequence, distances between practices and residences of patients can be very large. The implementation of task-sharing models is a promising option to sustain pediatric outpatient care in rural regions. In this study we assessed the need for and acceptance of delegation of tasks in outpatient pediatric healthcare to non-physician healthcare professionals and developed a task-sharing concept. A standardized questionnaire was developed and addressed a wide range of healthcare professionals. On the basis of the results of the questionnaire and a subsequent workshop involving representatives of the various fields of pediatric care a delegation-concept was developed. A total of 206 questionnaires were answered (response rate: 17%). About 70% of the respondents (n = 145) agreed with the delegation of counseling on prevention, 66% (n = 135) with the delegation of tasks in the transition process into adult medicine. All proposed tasks were conceivable for at least a third of the respondents. Mostly, pediatricians could envision delegation more than the non-physician health care professionals. A three-dimension-delegation-concept was developed: which tasks can be delegated to whom in which setting. Basically, if nurses or medical practice assistants are adequately qualified, all tasks can be delegated to both. The delegation was approved by most of the respondents. Implementation of task-sharing provides a new option to support pediatricians and create better access to outpatient pediatric health care in rural regions. The next step should be the implementation of the delegation concept in pilot projects.

Rationale and design of repeated cross-sectional studies to evaluate the reporting quality of trial protocols: the Adherence to SPIrit REcommendations (ASPIRE) study and associated projects.

BACKGROUND: Clearly structured and comprehensive protocols are an essential component to ensure safety of participants, data validity, successful conduct, and credibility of results of randomized clinical trials (RCTs). Funding agencies, research ethics committees (RECs), regulatory agencies, medical journals, systematic reviewers, and other stakeholders rely on protocols to appraise the conduct and reporting of RCTs. In response to evidence of poor protocol quality, the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guideline was published in 2013 to improve the accuracy and completeness of clinical trial protocols. The impact of these recommendations on protocol completeness and associations between protocol completeness and successful RCT conduct and publication remain uncertain. OBJECTIVES AND METHODS: Aims of the Adherence to SPIrit REcommendations (ASPIRE) study are to investigate adherence to SPIRIT checklist items of RCT protocols approved by RECs in the UK, Switzerland, Germany, and Canada before (2012) and after (2016) the publication of the SPIRIT guidelines; determine protocol features associated with non-adherence to SPIRIT checklist items; and assess potential differences in adherence across countries. We assembled an international cohort of RCTs based on 450 protocols approved in 2012 and 402 protocols approved in 2016 by RECs in Switzerland, the UK, Germany, and Canada. We will extract data on RCT characteristics and adherence to SPIRIT for all included protocols. We will use multivariable regression models to investigate temporal changes in SPIRIT adherence, differences across countries, and associations between SPIRIT adherence of protocols with RCT registration, completion, and publication of results. We plan substudies to examine the registration, premature discontinuation, and non-publication of RCTs; the use of patient-reported outcomes in RCT protocols; SPIRIT adherence of RCT protocols with non-regulated interventions; the planning of RCT subgroup analyses; and the use of routinely collected data for RCTs. DISCUSSION: The ASPIRE study and associated substudies will provide important information on the impact of measures to improve the reporting of RCT protocols and on multiple aspects of RCT design, trial registration, premature discontinuation, and non-publication of RCTs observing potential changes over time.