Changes in the pattern of suicides and suicide attempt admissions in relation to the COVID-19 pandemic.

The consequences of the current COVID-19 pandemic for mental health remain unclear, especially regarding the effects on suicidal behaviors. To assess changes in the pattern of suicide attempt (SA) admissions and completed suicides (CS) in association with the COVID-19 pandemic. As part of a longitudinal study, SA admissions and CS are systematically documented and analyzed in all psychiatric hospitals in Frankfurt/Main (765.000 inhabitants). Number, sociodemographic factors, diagnoses and methods of SA and CS were compared between the periods of March-December 2019 and March-December 2020. The number of CS did not change, while the number of SA significantly decreased. Age, sex, occupational status, and psychiatric diagnoses did not change in SA, whereas the percentage of patients living alone while attempting suicide increased. The rate and number of intoxications as a SA method increased and more people attempted suicide in their own home, which was not observed in CS. Such a shift from public places to home is supported by the weekday of SA, as the rate of SA on weekends was significantly lower during the pandemic, likely because of lockdown measures. Only admissions to psychiatric hospitals were recorded, but not to other institutions. As it seems unlikely that the number of SA decreased while the number of CS remained unchanged, it is conceivable that the number of unreported SA cases increased during the pandemic. Our data suggest that a higher number of SA remained unnoticed during the pandemic because of their location and the use of methods associated with lower lethality.

[SaxoForN-a transregional primary care research network in Dresden and Frankfurt am Main : Design of a practice-based research infrastructure]. / SaxoForN ­ Transregionales allgemeinmedizinisches Forschungspraxennetz Dresden und Frankfurt am Main : Konzept einer innovativen Forschungspraxeninfrastruktur.

Establishing primary care research networks (PCRNs) makes it easier to conduct clinical trials and health services research in a general-practice setting. Since February 2020, the German Federal Ministry of Education and Research (BMBF) has sponsored the development of six PCRNs and a coordination unit throughout Germany, with the aim of setting up a sustainable outpatient research infrastructure to raise the quantity and quality of primary care.The present article describes the design of a PCRN in Dresden and Frankfurt am Main - SaxoForN - and explains its structure and how it operates. The network is a transregional alliance between the two regional PCRNs named "SaxoN" (Dresden/Saxony) and "ForN" (Frankfurt am Main/Hesse), both of which run transregional and local research projects. For this purpose, joint standards and harmonized structures, for example with respect to the data infrastructure, qualifications, participation, and accreditation, were agreed upon and implemented at both sites.A critical success factor will be whether and to what extent the standards and structures, as well as resource planning, can be designed sustainably enough to permit the PCRNs to carry out high-quality research over the long term. To achieve this, the PCRNs will have to attract new practices and build up lasting relationships with them, qualify the research practices in order to standardize processes as far as possible, and regularly document their basic information and healthcare data.

Care practices of specialized outpatient pediatric palliative care teams in collaboration with parents: Results of participatory observations.

BACKGROUND: Collaboration between parents and professional care providers is an essential part of pediatric palliative care. As children are embedded in family systems and many of the patients are not able to communicate verbally, their parents are the primary interaction partners for palliative care providers. International standards for pediatric palliative care in Europe state that parents should be supported, acknowledged as the primary carers and involved as partners in all care and decisions. AIM: To find out through which care practices pediatric palliative care teams shape collaboration with parents in everyday care. DESIGN: Ethnographic method of participatory observations. Field notes were analyzed using thematic analysis. SETTING/PARTICIPANTS: Researchers accompanied three pediatric palliative care teams on home visits to eight different families caring for a child with life-limiting conditions. RESULTS: Care practices of palliative care teams were characterized by familiarity, a resource-oriented attitude, empowerment of parents, shared decision-making and support for parents. Palliative care teams not only provided palliative medical treatment for the children, but also developed a trusting care partnership with parents. The teams employed a sensitive and multifaceted communication style in their collaboration with parents. CONCLUSIONS: Care practices in pediatric palliative care require time, communication skills, and a high level of psychosocial competence, to develop a trusting, collaborative relationship with parents. This should be taken into consideration when establishing pediatric palliative care structures, preparing guidelines, training staff, and deciding upon appropriate remuneration.

Evaluation of a collaborative ambulatory orthopedic care program for patients with hip and knee osteoarthritis: a comparative observational cohort study.

BACKGROUND: In 2014, the novel orthopedic care program was established by the AOK health insurance fund in southern Germany to improve ambulatory care for patients with musculoskeletal disorders. The program offers extended consultation times, structured collaboration between general practitioners and specialists, as well as a renewed focus on guideline-recommended therapies and patient empowerment. The aim of this study was to assess the impact of the program on health service utilization in patients with hip and knee osteoarthritis (OA). METHODS: This retrospective cohort study, which is based on claims data, evaluated health service utilization in patients with hip and knee OA from 2014 to 2017. The intervention group comprised OA patients enrolled in collaborative ambulatory orthopedic care, and the control group received usual care. The outcomes were participation in exercise interventions, prescription of physical therapy, OA-related hospitalization, and endoprosthetic surgery rates. Generalized linear regression models were used to analyze the effect of the intervention. RESULTS: Claims data for 24,170 patients were analyzed. Data for the 23,042 patients in the intervention group were compared with data for the 1,128 patients in the control group. Participation in exercise interventions (Odds Ratio (OR): 1.781; 95% Confidence Interval (CI): 1.230-2.577; p = 0.0022), and overall prescriptions of physical therapy (Rate Ratio (RR): 1.126; 95% CI: 1.025-1.236; p = 0.0128) were significantly higher in the intervention group. The intervention group had a significantly lower risk of OA -related hospitalization (OR: 0.375; 95% CI: 0.290-0.485; p < 0.0001). Endoprosthetic surgery of the knee was performed in 53.8% of hospitalized patients in the intervention group vs. 57.5% in the control group; 27.7% of hospitalized patients underwent endoprosthetic surgery of the hip in the intervention group versus 37.0% in the control group. CONCLUSIONS: In patients with hip and knee OA, collaborative ambulatory orthopedic care is associated with a lower risk of OA-related hospitalization, higher participation in exercise interventions, and more frequently prescribed physical therapy.

[Family Health Teams in Ontario: Ideas for Germany from a Canadian Primary Care Model]. / Family Health Teams in Ontario ­ Vorstellung eines kanadischen Primärversorgungsmodells und Anregungen für Deutschland.

The German healthcare system is struggling with fragmentation of care in the face of an increasing shortage of general practitioners and allied health professionals, and the time-demanding healthcare needs of an aging, multimorbid patient population. Innovative interprofessional, intersectoral models of care are required to ensure adequate access to primary care across a variety of rural and urban settings into the foreseeable future. A team approach to care of the complex multimorbid patient population appears particularly suitable in attracting and retaining the next generation of healthcare professionals, including general practitioners. In 2014, the German Advisory Council on the Assessment of Developments in the Health Care System highlighted the importance of regional, integrated care with community-based primary care centres at its core, providing comprehensive, population-based, patient-centred primary care with adequate access to general practitioners for a given geographical area. Such centres exist already in Ontario, Canada; within Family Health Teams (FHT), family physicians work hand-in-hand with pharmacists, nurses, nurse practitioners, social workers, and other allied health professionals. In this article, the Canadian model of FHT will be introduced and we will discuss which components could be adapted to suit the German primary care system.

Short-acting insulin analogues versus regular human insulin for adult, non-pregnant persons with type 2 diabetes mellitus.

BACKGROUND: The use of short-acting insulin analogues (insulin lispro, insulin aspart, insulin glulisine) for adult, non-pregnant people with type 2 diabetes is still controversial, as reflected in many scientific debates. OBJECTIVES: To assess the effects of short-acting insulin analogues compared to regular human insulin in adult, non-pregnant people with type 2 diabetes mellitus. SEARCH METHODS: For this update we searched CENTRAL, MEDLINE, Embase, the WHO ICTRP Search Portal, and ClinicalTrials.gov to 31 October 2018. We placed no restrictions on the language of publication. SELECTION CRITERIA: We included all randomised controlled trials with an intervention duration of at least 24 weeks that compared short-acting insulin analogues to regular human insulin in the treatment of people with type 2 diabetes, who were not pregnant. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and assessed the risk of bias. We assessed dichotomous outcomes by risk ratios (RR), and Peto odds ratios (POR), with 95% confidence intervals (CI). We assessed continuous outcomes by mean differences (MD) with 95% CI. We assessed trials for certainty of the evidence using the GRADE approach. MAIN RESULTS: We identified 10 trials that fulfilled the inclusion criteria, randomising 2751 participants; 1388 participants were randomised to receive insulin analogues and 1363 participants to receive regular human insulin. The duration of the intervention ranged from 24 to 104 weeks, with a mean of about 41 weeks. The trial populations showed diversity in disease duration, and inclusion and exclusion criteria. None of the trials were blinded, so the risk of performance bias and detection bias, especially for subjective outcomes, such as hypoglycaemia, was high in nine of 10 trials from which we extracted data. Several trials showed inconsistencies in the reporting of methods and results.None of the included trials defined all-cause mortality as a primary outcome. Six trials provided Information on the number of participants who died during the trial, with five deaths out of 1272 participants (0.4%) in the insulin analogue groups and three deaths out of 1247 participants (0.2%) in the regular human insulin groups (Peto OR 1.66, 95% CI 0.41 to 6.64; P = 0.48; moderate-certainty evidence). Six trials, with 2509 participants, assessed severe hypoglycaemia differently, therefore, we could not summarise the results with a meta-analysis. Overall, the incidence of severe hypoglycaemic events was low, and none of the trials showed a clear difference between the two intervention arms (low-certainty evidence).The MD in glycosylated haemoglobin A1c (HbA1c) change was -0.03% (95% CI -0.16 to 0.09; P = 0.60; 9 trials, 2608 participants; low-certainty evidence). The 95% prediction ranged between -0.31% and 0.25%. The MD in the overall number of non-severe hypoglycaemic episodes per participant per month was 0.08 events (95% CI 0.00 to 0.16; P = 0.05; 7 trials, 2667 participants; very low-certainty evidence). The 95% prediction interval ranged between -0.03 and 0.19 events per participant per month. The results provided for nocturnal hypoglycaemic episodes were of questionable validity. Overall, there was no clear difference between the two short-acting insulin analogues and regular human insulin. Two trials assessed health-related quality of life and treatment satisfaction, but we considered the results for both outcomes to be unreliable (very low-certainty evidence).No trial was designed to investigate possible long term effects (all-cause mortality, microvascular or macrovascular complications of diabetes), especially in participants with diabetes-related complications. No trial reported on socioeconomic effects. AUTHORS' CONCLUSIONS: Our analysis found no clear benefits of short-acting insulin analogues over regular human insulin in people with type 2 diabetes. Overall, the certainty of the evidence was poor and results on patient-relevant outcomes, like all-cause mortality, microvascular or macrovascular complications and severe hypoglycaemic episodes were sparse. Long-term efficacy and safety data are needed to draw conclusions about the effects of short-acting insulin analogues on patient-relevant outcomes.

Changes in prescribed medicines in older patients with multimorbidity and polypharmacy in general practice.

BACKGROUND: Treatment complexity rises in line with the number of drugs, single doses, and administration methods, thereby threatening patient adherence. Patients with multimorbidity often need flexible, individualised treatment regimens, but alterations during the course of treatment may further increase complexity. The objective of our study was to explore medication changes in older patients with multimorbidity and polypharmacy in general practice. METHODS: We retrospectively analysed data from the cluster-randomised PRIMUM trial (PRIoritisation of MUltimedication in Multimorbidity) conducted in 72 general practices. We developed an algorithm for active pharmaceutical ingredients (API), strength, dosage, and administration method to assess changes in physician-reported medication data during two intervals (baseline to six-months: ∆1; six- to nine-months: ∆2), analysed them descriptively at prescription and patient levels, and checked for intervention effects. RESULTS: Of 502 patients (median age 72 years, 52% female), 464 completed the study. Changes occurred in 98.6% of patients (changes were 19% more likely in the intervention group): API changes during ∆1 and ∆2 occurred in 414 (82.5%) and 338 (67.3%) of patients, dosage alterations in 372 (74.1%) and 296 (59.2%), and changes in API strength in 158 (31.5%) and 138 (27.5%) respectively. Administration method changed in 79 (16%) of patients in both ∆1 and ∆2. Simvastatin, metformin and aspirin were most frequently subject to alterations. CONCLUSION: Medication regimens in older patients with multimorbidity and polypharmacy changed frequently. These are mostly due to discontinuations and dosage alterations, followed by additions and restarts. These findings cast doubt on the effectiveness of cross-sectional assessments of medication and support longitudinal assessments where possible. TRIAL REGISTRATION: 1. Prospective registration: Trial registration number: NCT01171339 ; Name of registry: ClinicalTrials.gov; Date of registration: July 27, 2010; Date of enrolment of the first participant to the trial: August 12, 2010. 2. Peer reviewed trial registration: Trial registration number: ISRCTN99526053 ; Name of registry: Controlled Trials; Date of registration: August 31, 2010; Date of enrolment of the first participant to the trial: August 12, 2010.

Study protocol: evaluation of specialized outpatient palliative care (SOPC) in the German state of Hesse (ELSAH study) - work package II: palliative care for pediatric patients.

BACKGROUND: In 2007, the European Association of Palliative Care (EAPC) provided a comprehensive set of recommendations and standards for the provision of adequate pediatric palliative care. A number of studies have shown deficits in pediatric palliative care compared to EAPC standards. In Germany, pediatric palliative care patients can be referred to specialized outpatient palliative care (SOPC) services, which are known to enhance quality of life, e.g. by avoiding hospitalization. However, current regulations for the provision of SOPC in Germany do not account for the different circumstances and needs of children and their families compared to adult palliative care patients. The "Evaluation of specialized outpatient palliative care (SOPC) in the German state of Hesse (ELSAH)" study aims to perform a needs assessment for pediatric patients (children, adolescents and young adults) receiving SOPC. This paper presents the study protocol for this assessment (work package II). METHODS/DESIGN: The study uses a sequential mixed-methods study design with a focus on qualitative research. Data collection from professional and family caregivers and, as far as possible, pediatric patients, will involve both a written questionnaire based on European recommendations for pediatric palliative care, and semi-structured interviews. Additionally, professional caregivers will take part in focus group discussions and participatory observations. Interviews and focus groups will be tape- or video-recorded, transcribed verbatim and analyzed in accordance with the principles of grounded theory (interviews) and content analysis (focus groups). A structured field note template will be used to record notes taken during the participatory observations. Statistical Package for Social Sciences (SPSS, version 22 or higher) will be used for descriptive statistical analyses. The qualitative data analyses will be software-assisted by MAXQDA (version 12 or higher). DISCUSSION: This study will provide important information on what matters most to family caregivers and pediatric patients receiving SOPC. The results will add valuable knowledge to the criteria that distinguish SOPC for pediatric from SOPC for adult patients, and will provide an indication of how the German SOPC rule of procedure can be optimized to satisfy the special needs of pediatric patients. TRIAL REGISTRATION: Internet Portal of the German Clinical Trials Register ( www.germanctr.de , DRKS-ID: DRKS00012431).

Frequency of a positive family history of colorectal cancer in general practice: a cross-sectional study.

BACKGROUND: Evidence on the frequency of a positive family history of colorectal cancer (CRC) among individuals aged <55 years is lacking. General practice setting might be well suited for the identification of individuals in this above-average risk group. OBJECTIVE: To determine the frequency of a reported positive family history of CRC among patients aged 40 to 54 years in a general practice setting. METHODS: We conducted a cross-sectional study in 21 general practices in Germany. Patients aged 40 to 54 years were identified by means of the practice software and interviewed by health care assistants using a standardized four-item questionnaire. Outcome was occurrence of a positive family history of CRC, defined as at least one first-degree relative (FDR: parents, siblings, or children) with CRC. Further measurements were FDRs with CRC / colorectal polyps (adenomas) diagnosed before the age of 50 and occurrence of three or more relatives with colorectal, stomach, cervical, ovarian, urethel or renal pelvic cancer. RESULTS: Out of 6723 participants, 7.2% (95% confidence interval [CI] 6.6% to 7.8%) reported at least one FDR with CRC and 1.2% (95% CI 0.9% to 1.5%) reported FDRs with CRC diagnosed before the age of 50. A further 2.6% (95% CI 2.3% to 3.0%) reported colorectal polyps in FDRs diagnosed before the age of 50 and 2.1% (95% CI 1.8% to 2.5%) reported three or more relatives with entities mentioned above. CONCLUSION: One in 14 patients reported at least one FDR with CRC. General practice should be considered when defining requirements of risk-adapted CRC screening.

Does a complex intervention increase patient knowledge about oral anticoagulation? - a cluster-randomised controlled trial.

BACKGROUND: Oral anticoagulation therapy (OAT) is a challenge in general practice, especially for high-risk groups such as the elderly. Insufficient patient knowledge about safety-relevant aspects of OAT is considered to be one of the main reasons for complications. The research question addressed in this manuscript is whether a complex intervention that includes practice-based case management, self-management of OAT and additional patient and practice team education improves patient knowledge about anticoagulation therapy compared to a control group of patients receiving usual care (as a secondary objective of the Primary Care Management for Optimised Antithrombotic Treatment (PICANT) trial). METHODS: The cluster-randomised controlled PICANT trial was conducted in 52 general practices in Germany, between 2012 and 2015. Trial participants were patients with a long-term indication for oral anticoagulation. A questionnaire was used to assess knowledge at baseline, after 12, and after 24 months. The questionnaire consists of 13 items (with a range of 0 to 13 sum-score points) covering topics related to intervention. Differences in the development of patient knowledge between intervention and control groups compared to baseline were assessed for each follow-up by means of linear mixed-effects models. RESULTS: Seven hundred thirty-six patients were included at baseline, of whom 95.4% continued to participate after 12 months, and 89.3% after 24 months. The average age of patients was 73.5 years (SD 9.4), and they mainly suffered from atrial fibrillation (81.1%). Patients in the intervention and control groups had similar knowledge about oral anticoagulation at baseline (5.6 (SD 2.3) in both groups). After 12 months, the improvement in the level of knowledge (compared to baseline) was significantly larger in the intervention group than in the control group (0.78 (SD 2.5) vs. 0.04 (SD 2.3); p = 0.0009). After 24 months, the difference between both groups was still statistically significant (0.6 (SD 2.6) vs. -0.3 (SD 2.3); p = 0.0001). CONCLUSION: Since this intervention was effective, it should be established in general practice as a means of improving patient knowledge about oral anticoagulation. TRIAL REGISTRATION: Current controlled trials ISRCTN41847489 ; Date of registration: 13/04/2012.

Medical Assistant-Based Care Management for High-Risk Patients in Small Primary Care Practices: A Cluster Randomized Clinical Trial.

BACKGROUND: Patients with multiple chronic conditions are at high risk for potentially avoidable hospitalizations, which may be reduced by care coordination and self-management support. Medical assistants are an increasingly available resource for patient care in primary care practices. OBJECTIVE: To determine whether protocol-based care management delivered by medical assistants improves care in patients at high risk for future hospitalization in primary care. DESIGN: Two-year cluster randomized clinical trial. (Current Controlled Trials: ISRCTN56104508). SETTING: 115 primary care practices in Germany. PATIENTS: 2076 patients with type 2 diabetes, chronic obstructive pulmonary disease, or chronic heart failure and a likelihood of hospitalization in the upper quartile of the population, as predicted by an analysis of insurance data. INTERVENTION: Protocol-based care management, including structured assessment, action planning, and monitoring delivered by medical assistants, compared with usual care. MEASUREMENTS: All-cause hospitalizations at 12 months (primary outcome) and quality-of-life scores (12-Item Short Form Health Survey [SF-12] and EuroQol instrument [EQ-5D]). RESULTS: Included patients had an average of 4 co-occurring chronic conditions. All-cause hospitalizations did not differ between groups at 12 months (risk ratio [RR], 1.01 [95% CI, 0.87 to 1.18]) and 24 months (RR, 0.98 [CI, 0.85 to 1.12]). Quality of life (differences, 1.16 [CI, 0.24 to 2.08] on SF-12 physical component and 1.68 [CI, 0.60 to 2.77] on SF-12 mental component) and general health (difference on EQ-5D, 0.03 [CI, 0.00 to 0.05]) improved significantly at 24 months. Intervention costs totaled $10 per patient per month. LIMITATION: Small number of primary care practices and low intensity of intervention. CONCLUSION: This low-intensity intervention did not reduce all-cause hospitalizations but showed positive effects on quality of life at reasonable costs in high-risk multimorbid patients. PRIMARY FUNDING SOURCE: AOK Baden-Württemberg and AOK Bundesverband.

[Primary and secondary data on dementia care as an example of regional health planning]. / Planung einer kleinräumigen Versorgung unter Nutzung von Primär- und Sekundärdaten am Beispiel von Demenzerkrankten.

BACKGROUND: Health service planning that takes into account as far as possible the regional needs and regional discrepancies is a controversial health issue in Germany. OBJECTIVES: In a pilot scheme, we tested a planning process for regional healthcare services, based on the example of dementia care. The aim of this article is to present the strengths and limitations of this planning process. MATERIALS AND METHODS: We developed an indicator set for dementia care based on routine regional data obtained from two German statutory health insurance companies. Additionally, primary data based on a questionnaire sent to all GPs in the area were evaluated. These data were expanded through the addition of official socio-demographic population data. Procedures and evaluation strategies, discussion of the results and the derivation of planning measures followed, in close agreement with a group of local experts. RESULTS: Few epidemiological data on regional variations in health care planning are publicly available. Secondary data from statutory health insurance companies can be assessed to support the estimation of regional health care needs, but interpretation is difficult. The use of surveys to collect primary data, and the assessment of results by the local health board may facilitate interpretation and may contribute towards more valid statements regarding regional health planning. CONCLUSIONS: Despite the limited availability of data and the considerable efforts involved in data analysis, the project demonstrates how needs-based health service planning can be carried out in a small region, taking into account the increasing demands of the local health care providers and the special local features.

Short-acting insulin analogues versus regular human insulin for adults with type 1 diabetes mellitus.

BACKGROUND: Short-acting insulin analogue use for people with diabetes is still controversial, as reflected in many scientific debates. OBJECTIVES: To assess the effects of short-acting insulin analogues versus regular human insulin in adults with type 1 diabetes. SEARCH METHODS: We carried out the electronic searches through Ovid simultaneously searching the following databases: Ovid MEDLINE(R), Ovid MEDLINE(R) In-Process & Other Non-Indexed Citations, Ovid MEDLINE(R) Daily and Ovid OLDMEDLINE(R) (1946 to 14 April 2015), EMBASE (1988 to 2015, week 15), the Cochrane Central Register of Controlled Trials (CENTRAL; March 2015), ClinicalTrials.gov and the European (EU) Clinical Trials register (both March 2015). SELECTION CRITERIA: We included all randomised controlled trials with an intervention duration of at least 24 weeks that compared short-acting insulin analogues with regular human insulins in the treatment of adults with type 1 diabetes who were not pregnant. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and assessed trials for risk of bias, and resolved differences by consensus. We graded overall study quality using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) instrument. We used random-effects models for the main analyses and presented the results as odds ratios (OR) with 95% confidence intervals (CI) for dichotomous outcomes. MAIN RESULTS: We identified nine trials that fulfilled the inclusion criteria including 2693 participants. The duration of interventions ranged from 24 to 52 weeks with a mean of about 37 weeks. The participants showed some diversity, mainly with regard to diabetes duration and inclusion/exclusion criteria. The majority of the trials were carried out in the 1990s and participants were recruited from Europe, North America, Africa and Asia. None of the trials was carried out in a blinded manner so that the risk of performance bias, especially for subjective outcomes such as hypoglycaemia, was present in all of the trials. Furthermore, several trials showed inconsistencies in the reporting of methods and results.The mean difference (MD) in glycosylated haemoglobin A1c (HbA1c) was -0.15% (95% CI -0.2% to -0.1%; P value < 0.00001; 2608 participants; 9 trials; low quality evidence) in favour of insulin analogues. The comparison of the risk of severe hypoglycaemia between the two treatment groups showed an OR of 0.89 (95% CI 0.71 to 1.12; P value = 0.31; 2459 participants; 7 trials; very low quality evidence). For overall hypoglycaemia, also taking into account mild forms of hypoglycaemia, the data were generally of low quality, but also did not indicate substantial group differences. Regarding nocturnal severe hypoglycaemic episodes, two trials reported statistically significant effects in favour of the insulin analogue, insulin aspart. However, due to inconsistent reporting in publications and trial reports, the validity of the result remains questionable.We also found no clear evidence for a substantial effect of insulin analogues on health-related quality of life. However, there were few results only based on subgroups of the trial populations. None of the trials reported substantial effects regarding weight gain or any other adverse events. No trial was designed to investigate possible long-term effects (such as all-cause mortality, diabetic complications), in particular in people with diabetes related complications. AUTHORS' CONCLUSIONS: Our analysis suggests only a minor benefit of short-acting insulin analogues on blood glucose control in people with type 1 diabetes. To make conclusions about the effect of short acting insulin analogues on long-term patient-relevant outcomes, long-term efficacy and safety data are needed.

Positive family history of colorectal cancer in a general practice setting [FRIDA.Frankfurt]: study protocol of a of a cross-sectional study.

BACKGROUND: Although the risk of developing colorectal cancer (CRC) is 2-4 times higher in case of a positive family history, risk-adapted screening programs for family members related to CRC- patients do not exist in the German health care system. CRC screening recommendations for persons under 55 years of age that have a family predisposition have been published in several guidelines. The primary aim of this study is to determine the frequency of positive family history of CRC (1st degree relatives with CRC) among 40-54 year old persons in a general practitioner (GP) setting in Germany. Secondary aims are to detect the frequency of occurrence of colorectal neoplasms (CRC and advanced adenomas) in 1st degree relatives of CRC patients and to identify the variables (e.g. demographic, genetic, epigenetic and proteomic characteristics) that are associated with it. This study also explores whether evidence-based information contributes to informed decisions and how screening participation correlates with anxiety and (anticipated) regret. METHODS/DESIGN: Prior to the beginning of the study, the GP team (GP and one health care assistant) in around 50 practices will be trained, and about 8,750 persons that are registered with them will be asked to complete the "Network against colorectal cancer" questionnaire. The 10% who are expected to have a positive family history will then be invited to give their informed consent to participate in the study. All individuals with positive family history will be provided with evidence-based information and prevention strategies. We plan to examine each participant's family history of CRC in detail and to collect information on further variables (e.g. demographics) associated with increased risk. Additional stool and blood samples will be collected from study-participants who decide to undergo a colonoscopy (n ~ 350) and then analyzed at the German Cancer Research Center (DKFZ) Heidelberg to see whether further relevant variables are associated with an increased risk of CRC. One screening list and four questionnaires will be used to collect the data, and a detailed statistical analysis plan will be provided before the database is closed (expected to be June 30, 2015). DISCUSSION: It is anticipated that when persons with a family history of colorectal cancer have been provided with professional advice by the practice team, there will be an increase in the availability of valid information on the frequency of affected individuals and an increase in the number of persons making informed decisions. We also expect to identify further variables that are associated with colorectal cancer. This study therefore has translational relevance from lab to practice. TRIAL REGISTRATION: German Clinical Trials Register DRKS00006277.

Colorectal cancer stage at diagnosis in migrants versus non-migrants (KoMigra): study protocol of a cross-sectional study in Germany.

BACKGROUND: In Germany, about 20% of the total population have a migration background. Differences exist between migrants and non-migrants in terms of health care access and utilisation. Colorectal cancer is the second most common malignant tumour in Germany, and incidence, staging and survival chances depend, amongst other things, on ethnicity and lifestyle. The current study investigates whether stage at diagnosis differs between migrants and non-migrants with colorectal cancer in an area of high migration and attempts to identify factors that can explain any differences. METHODS/DESIGN: Data on tumour and migration status will be collected for 1,200 consecutive patients that have received a new, histologically verified diagnosis of colorectal cancer in a high migration area in Germany in the previous three months. The recruitment process is expected to take 16 months and will include gastroenterological private practices and certified centres for intestinal diseases. Descriptive and analytical analysis will be performed: the distribution of variables for migrants versus non-migrants and participants versus non-participants will be analysed using appropriate χ2-, t-, F- or Wilcoxon tests. Multivariable, logistic regression models will be performed, with the dependent variable being the dichotomized stage of the tumour (UICC stage I versus more advanced than UICC stage I). Odds ratios and associated 95%-confidence intervals will be calculated. Furthermore, ordered logistic regression models will be estimated, with the exact stage of the tumour at diagnosis as the dependent variable. Predictors used in the ordered logistic regression will be patient characteristics that are specific to migrants as well as patient characteristics that are not. Interaction models will be estimated in order to investigate whether the effects of patient characteristics on stage of tumour at the time of the initial diagnosis is different in migrants, compared to non-migrants. DISCUSSION: An association of migration status or other socioeconomic variables with stage at diagnosis of colorectal cancer would be an important finding with respect to equal health care access among migrants. It would point to access barriers or different symptom appraisal and, in the long term, could contribute to the development of new health care concepts for migrants. TRIAL REGISTRATION: German Clinical Trials Register DRKS00005056.

The German version of the mHealth App Usability Questionnaire (GER-MAUQ): Translation and validation study in patients with cardiovascular disease.

Objective: In Germany, only a few standardized evaluation tools for assessing the usability of mobile Health apps exist so far. This study aimed to translate and validate the English patient version for standalone apps of the mHealth App Usability Questionnaire (MAUQ) into a German version. Methods: Following scientific guidelines for translation and cross-cultural adaptation, the patient version for standalone apps was forward and back-translated from English into German by an expert panel. In total, 53 participants who were recruited as part of the beta testing process of the recently developed mHealth app HerzFit, answered the questions of the German version of the MAUQ (GER-MAUQ) and the System Usability Scale. Subsequently, a descriptive as well as a psychometric analysis was performed to test validity and reliability. Results: After conducting three cognitive interviews, five items were modified. The values for Cronbach alpha for the entire questionnaire and the three subscales (0.966, 0.814, 0.910, and 0.909) indicate strong internal consistency. The correlation analysis revealed that the scores of the GER-MAUQ, the subscales and the SUS were strongly correlated with each other. The correlation coefficient of the SUS and the GER-MAUQ overall score was r = 0.854, P < 0.001 and the coefficients of the subscales and the SUS were r = 0.642, P < 0.001; r = 0.866, P < 0.001 and r = 0.643, P < 0.001. Conclusions: We have developed a novel German version of the MAUQ and demonstrated it as a reliable and valid measurement tool for assessing the usability of standalone mHealth apps from the patients' perspective. The GER-MAUQ allows a new form of standardized assessment of usability of mHealth apps for patients with cardiovascular disease in Germany. Further research with a larger sample and other samples is recommended.

[17 years of the critical incident reporting and learning system "jeder-fehler-zaehlt.de" for primary care: Analysis of reports]. / 17 Jahre hausärztliches Fehlerberichts- und Lernsystem "jeder-fehler-zaehlt.de" ­ Analyse des Berichtsbestandes.

BACKGROUND: The topic of patient safety has been a subject of much discussion since the end of the last millennium. Ensuring patient safety is a central challenge in health care. An important tool to raise awareness for and learn from adverse events and thus promote patient safety are error-reporting and learning systems (Critical Incident Reporting System = CIRS). METHODS: More than 17 years after its establishment, the CIRS "jeder-fehler-zaehlt.de" (JFZ) for German primary care has undergone a revision in terms of content and technology. The revised web-based system can be used for reporting as well as for classifying and analyzing incident reports. During this process, a descriptive analysis of the current report inventory was carried out, with a focus on serious medication errors. This included all 781 valid incident reports received between September 2004 and December 2021. RESULTS: In 576 of the 781 reports (73.8%), the GP practice was directly involved in the critical incident. Among error types, process errors predominated (79.8% of the classifications, 99.1% of the reports) compared with knowledge and skills errors (20.2% of the classifications, 39.7% of the reports). Communication errors (63.0%) were the most common contributing factor to critical incidents, followed by flaws in tasks and measures (39.7%). Serious and permanent patient harm was rarely reported (8.3% of the reports), whereas temporary patient harm was more common (40.3% of the reports). Incident reports about medication errors with at least serious patient harm included, in particular, substances that affected blood clotting, corticosteroids, and opiates. DISCUSSION: Our results complement the rates that are reported internationally for error types, patient harm, and contributing factors. Serious but preventable adverse events, so-called never events, are frequently associated with the medication process in both JFZ reports and the literature. CONCLUSION: Critical incident reporting systems cannot provide accurate information about the frequency of errors in health care, but they can offer important insights into, for example, serious medication errors. Therefore, they offer both employees and healthcare institutions an opportunity for individual and institutional learning.

Supporting Error Management and Safety Climate in Ambulatory Care Practices: The CIRSforte Study.

BACKGROUND: To improve patient safety, it is important that healthcare facilities learn from critical incidents. Tools such as reporting and learning systems and team meetings structure error management and promote learning from incidents. To enhance error management in ambulatory care practices, it is important to promote a climate of safety and ensure personnel share views on safety policies and procedures. In contrast to the hospital sector, little research has been dedicated to developing feasible approaches to supporting error management and safety climate in ambulatory care. In this study, we developed, implemented, and evaluated a multicomponent intervention to address how error management and safety climate can be improved in ambulatory care practices. METHODS: In a prospective 1-group pretest-posttest implementation study, we sought to encourage teams in German ambulatory practices to use proven methods such as guidelines, workshops, e-learning, (online) meetings, and e-mail newsletters. A pretest-posttest questionnaire was used to evaluate level and strength of safety climate and psychological behavioral determinants for systematic error management. Using 3 short surveys, we also assessed the state of error management in the participating practices. In semistructured interviews, we asked participants for their views on our intervention measures. RESULTS: Overall, 184 ambulatory care practices nationwide agreed to participate. Level of safety climate and safety climate strength (rwg) improved significantly. Of psychological behavioral determinants, significant improvements could be seen in "action/coping planning" and "action control." Seventy-six percent of practices implemented a new reporting and learning system or modified their existing system. The exchange of information between practices also increased over time. Interviews showed that the introductory workshop and provided materials such as report forms or instructions for team meetings were regarded as helpful. CONCLUSIONS: A significant improvement in safety climate level and strength, as well as participants' knowledge of how to analyze critical incidents, derive preventive measures and develop concrete plans suggest that it is important to train practice teams, to provide practical tips and tools, and to facilitate the exchange of information between practices. Future randomized and controlled intervention trials should confirm the effectiveness of our multicomponent intervention.Trial registration: Retrospectively registered on 18. November 2019 in German Clinical Trials Register No. DRKS00019053.

Cost-effectiveness of depression case management in small practices.

BACKGROUND: Case management undertaken by healthcare assistants in small primary care practices is effective in improving depression symptoms and adherence in patients with major depression. AIMS: To evaluate the cost-effectiveness of depression case management by healthcare assistants in small primary care practices. METHOD: Cost-effectiveness analysis on the basis of a pragmatic randomised controlled trial (2005-2008): practice-based healthcare assistants in 74 practices provided case management to 562 patients with major depression over 1 year. Our primary outcome was the incremental cost-effectiveness ratio (ICER) calculated as the ratio of differences in mean costs and mean number of quality-adjusted life-years (QALYs). Our secondary outcome was the mean depression-free days (DFDs) between the intervention and control group at 24-month follow-up. The study was registered at the International Standard Randomised Controlled Trial Number Registry: ISRCTN66386086. RESULTS: Intervention v. control group: no significant difference in QALYs; significantly more DFDs (mean: 373 v. 311, P<0.01); no significant difference in mean direct healthcare costs (€4495 v. €3506, P = 0.16); considerably lower mean indirect costs (€5228 v. €7539, P = 0.06), resulting in lower total costs (€9723 v. €11 045, P = 0.41). The point estimate for the cost-utility ratio was €38 429 per QALY gained if only direct costs were considered, and 'dominance' of the intervention if total costs were considered. Yet, regardless of decision makers' willingness to pay per QALY, the probability of the intervention being cost-effective was never above 90%. CONCLUSIONS: In small primary care practices, 1 year of case management did not increase the number of QALYs but it did increase the number of DFDs. The intervention was likely to be cost-effective.

Impact of individual and team features of patient safety climate: a survey in family practices.

PURPOSE: Knowledge about safety climate is fundamental to improving patient safety in health care organizations. Because individual and organizational factors influence the safety climate, we conducted a health care survey of German family practices so we could analyze the impact of the professional group, the professional experience of practice staff, and practice characteristics on perceptions of the safety climate. METHODS: We wrote to health care assistants and doctors in 1,800 randomly selected family practices in Germany and asked them to complete a newly developed and validated Frankfurt Patient Safety Climate Questionnaire. We conducted a descriptive analyses of items and climate factors, as well as regression analysis, to identify potential predictors of the safety climate in family practice. RESULTS: The response rate from the participating practices was 36.1%. Safety climate was perceived to be generally positive with the exception of the factors of error management and perception of the causes of errors. We discovered that whether or not the entire team had taken part in the survey had a positive influence on most factors. Doctors had more positive perceptions of 4 of 7 factors addressed to both professions. Male participants and doctors showed the most willingness to admit they had made an error. CONCLUSIONS: Though the safety climate in German family practices was positive overall, health care professionals' use of incident reporting and a system's approach to errors was fairly rare. When evaluating the safety climate in primary health care practices, respondents' individual characteristics, as well as organizational features, should be taken into account.