Opioid Use Disorder: A Qualitative Exploratory Analysis of Potential Misunderstandings in Patients with Chronic Non-Cancer Pain.

Purpose: Substance use disorders (SUD) are a challenging comorbidity in patients with chronic non-cancer pain (CNCP) as they complicate diagnosis and therapy, especially when opioids are part of the therapeutic regimen. A definite diagnosis of opioid use disorder (OUD) in patients with CNCP on long-term opioid therapy (LTOT) is a prerequisite for effective and targeted therapy but may be complicated as some criteria of OUD might be attributed to the desire of the patient to relieve the pain. For instance, the desire to increase the dose can be based on both a SUD as well as inadequate pain therapy. Many scientific studies use standardized questions. Therefore, potential misunderstandings due to possible diagnostic overlaps often cannot be clarified. Methods: 14 qualitative guided interviews were conducted and analyzed (Kuckartz content analysis), with the intention to verify if patient's initial response to simple questions based on the wording of the DSM-5, as commonly used in research and practice, were consistent with the results of a more in-depth inquiry. Results: The results suggest that without in-depth investigation, there is a particular risk of false-positive assessment of the DSM-5 criteria for OUD when opioids are prescribed, especially when the questions are considered independently of chronic pain. The risk of a false-negative assessment has also been shown in isolated cases. Conclusion: Only after asking for and describing specific situations it was possible to determine whether the patient's positive or negative answers were based on a misunderstanding of the question. To avoid misdiagnosis, staff conducting DSM-5 interviews should be trained in pain-specific follow-up questions that may help to uncover diagnostic confounding.

[Interface Communication and Information Transfer in Medical Care for People with Intellectual Disabilities: Qualitative Expert Interviews]. / Schnittstellenkommunikation und Informationstransfer in der medizinischen Versorgung von Menschen mit intellektueller Entwicklungsstörung: Qualitative Expert*innen-Interviews.

BACKGROUND: The aim of this study was to investigate the experiences, barriers, and solutions in communication during the provision of care for people with intellectual developmental disabilities in Germany. As there are approximately 350,000 people living with intellectual or developmental disabilities in Germany, who rely on assistance when communicating with healthcare providers, this study was conducted to examine the communication challenges and potential solutions in this population. The analysis especially focused on the potentials of digital applications facilitating information transfer. METHODS: Thirteen expert interviews were conducted using a structured interview guide with caregivers and medical providers to people with intellectual developmental disabilities. The interviews were analyzed using an inductive and deductive content analysis approach, according to Meuser and Nagel. RESULTS: The results revealed that the provision of care for people with intellectual developmental disabilities was characterized by time constraints and uncertainty when caregivers lack experience in caring for this population. Additionally, information transfer increased in complexity due to an overload of individual information provided by caregivers verbally or paper-based as well due to the passive role of patients who were usually not actively involved in the communication process. With regard to the potential for integrating digital applications for information transfer, a controversy between opportunity and risk emerged. CONCLUSION: The findings demonstrate that there is a need to implement training programs for professionals to enable them to offer improved health care for people with intellectual developmental disabilities. It is essential that caregivers are given sufficient time to communicate with patients, and that digital applications are utilized to support information transfer. Moreover, other research shows that digital applications offer new possibilities to communicate with people with intellectual developmental disabilities, such as the use of simplified or pictorial language. By addressing these communication challenges, healthcare professionals may be able to provide more effective and efficient care to this population. However, this requires further research, which addresses the controversial results regarding digital applications outlined in this paper.

[Physician assistants as a future model in primary care: Experiences, needs, potentials and barriers]. / Physician Assistants als Zukunftsmodell in der hausärztlichen Versorgung ­ Erfahrungen, Bedarfe, Potenziale und Hürden.

INTRODUCTION: In the coming decades, demographic change will dramatically increase health care needs, especially for general practitioners (GPs). However, there is a shortage of young primary care physicians, with signs of (impending) underuse already becoming apparent in rural and structurally weak areas. Innovative care concepts are needed to counteract this development and ensure the future of primary care. In addition to medical assistants (MFA), academically trained physician assistants (PAs) could be considered for more demanding delegation tasks and be involved in direct patient care under the responsibility of a physician in the practice team. In England, the Netherlands and the USA, PAs have been a part of the health care systems for many years. RESEARCH QUESTIONS: 1) What are the potentials for delegation/possibilities for PAs working in primary care practices in contrast to medical assistants? 2) What structural requirements are necessary to regularly integrate PAs in primary care practices? METHODS: After preliminary interviews with PA experts and primary care researchers and practitioners (n=29), four expert interviews (n=4) with GPs and PAs were performed in a case analysis in order to elicit experiences with PAs in family practice. Based on this, three focus groups were conducted with GPs and practice staff (n=15) to discuss the extent, the need and the willingness to delegate physician services to PAs, as well as existing barriers. After transcription, analyses were performed using qualitative content analysis according to Mayring. RESULTS: The participants acknowledged the potential to reduce physician workloads and showed a high willingness to delegate tasks. Practical examples suggest that a clearly defined delegation of medical tasks to PAs, e.g. participation in infection consultations, is possible after only a few weeks working in family practices. Thus, the cooperation between GPs, PAs and medical assistants can be successful. Uncertainties exist regarding the legal possibilities and limits of delegation as well as the current and future financial reimbursement of PAs. DISCUSSION: The legal and financial framework for the utilization of PAs in ambulatory care should be reliably clarified as well as transparently communicated so that the considerable potentials of delegating tasks to academically trained staff, e.g. PAs, especially in the GP sector, can be exploited in the future. CONCLUSION: Participation of PAs in the GP team could be key to overcoming the often threatening or already existing under-provision of medical care in structurally weak regions.

Experiences of participants of a volunteer-supported walking intervention to improve physical function of nursing home residents - a mixed methods sub-study of the POWER-project.

BACKGROUND: Regular physical activity improves physical health and mental well-being and reduces the risk of falling in older adults. The randomized controlled "Prevention by lay-assisted Outdoor-Walking in the Elderly at Risk" POWER-study investigates whether volunteer-supported outdoor-walking improves physical function and quality of life in older people living independently or in nursing homes. This sub-study explores the experiences of older participants and volunteers in relation to their physical and psychosocial well-being as well as the challenges faced by both groups. A further aim was to explore volunteers' experience with people living in nursing homes during the first pandemic lockdown (spring 2020). METHODS: The sub-study was designed as mixed-methods approach consisting of 11 individual semi-structured guide-based interviews (nursing home residents), two focus group interviews (volunteers), and a cross-sectional questionnaire survey (volunteers). The interviews were audiotaped, transcribed verbatim, and analyzed by content analysis as described by Kuckartz. Topics addressed in the interviews were triangulated by means of a questionnaire. The quantitative data were analyzed using descriptive statistics. RESULTS: Participants' evaluation of the intervention was generally positive. Nursing home residents appreciated the social interaction associated with the assisted walking, which motivated them to take part regularly, provided a sense of safety, and caused pleasure on both sides. The impact on physical health status of the nursing home residents of this sub-study varied to a large degree as reported in interviews: in some cases, an improvement in physical performance, a decrease in physical complaints, and an improvement in gait or independence was reported. If not, reference was made to previous or sudden illnesses and the advanced age of the participants. Despite the COVID-19-lockdown and the associated restrictions, about 60% of contacts were still possible and participants planned to continue the assisted walks after the lockdown. CONCLUSION: Volunteers have a positive effect on the quality of life, mobility, and general health of nursing home residents. Even more than the improvement of physical performance, social interaction was seen as helpful. Despite their advanced age, the nursing home residents were curious and open to new contacts. When removing the identified barriers, it might be possible to integrate this program into the long-term everyday life of nursing homes. TRIAL REGISTRATION: DRKS-ID: DRKS00015188, date of registration: 31.08.2018.

Suitability of accelerometry as an objective measure for upper extremity use in stroke patients.

BACKGROUND: Upper limb (UL) paresis is one of the most common stroke consequences and significantly restricts patients in everyday life. Instruments objectively measuring direct arm use in stroke patients are lacking, but might be helpful to understand patients' impairment. Aiming to examine whether accelerometry is a suitable objective measure for everyday UL use in stroke patients, we conducted a systematic review on the association between accelerometer-derived measurements and clinical scales. METHODS: Articles were systematically searched in PubMed, Scopus, Cochrane Library, PeDro and LIVIVO through December 12th, 2021, screened for inclusion by AH, and subsequently independently screened by CK and MK. Disagreements were discussed until consensus. We included English and German peer-reviewed articles dealing with the validity of accelerometers as a measurement of UL use in stroke patients and eligible systematic reviews. Studies exclusively using accelerometry as an outcome parameter, book contributions, conference abstracts and case studies were excluded. Data extraction was conducted by AH and confirmed by CK focussing on study type, objective, accelerometer device, sample size, stroke status, assessments conducted, measurement method, wearing time and key results. We analysed all eligible articles regarding the correlation between accelerometry and other clinical assessments and the validity in accordance with the type of accelerometer. RESULTS: Excluding duplicates, the initial search yielded 477 records. In the 34 eligible studies accelerometers was used with a predominance of tri-axial accelerometery (n = 12) and only few with two-axial application (n = 4). Regarding measures to examine association to accelerometer data different clinical scales were applied depending on the setting, the degree of impairment and/or the status of stroke. Cut-off values to determine correlations varied largely; most significant correlations are reported for the MAL [Range 0.31- 0.84] and the ARAT [Range 0.15-0.79]. CONCLUSIONS: Accelerometers can provide reliable data about daily arm use frequency but do not supply information about the movements´ quality and restrictions on everyday activities of stroke patients. Depending on the context, it is advisable to use both, accelerometry and other clinical measures. According to the literature there is currently no accelerometer device most suitable to measure UL activity. High correlations indicate that multi-dimensional accelerometers should be preferred.

General practitioners treating their own family members: a cross-sectional survey in Germany.

BACKGROUND: In Germany, there are neither guidelines provided by the medical associations nor a public discussion about general practitioners (GPs) treating their family members. Only few studies on this topic from the primary care setting exist. The aim of this study is to describe GPs' treatment of family members and to generate empirical data on the most common reasons for this. METHODS: In June 2018 we conducted a postal survey among GPs in the North Rhine region of Germany. The questionnaire was developed in a stepwise process including initial expert panels, interviews with GPs, item construction workshops, cognitive pre-tests and pilot testing with 40 questionnaires. The final questionnaire addressed: type and frequency of treatment, documentation and place of treatment, engagement as the official GP as well as reasons for and against the treatment. For data evaluation, descriptive and explorative statistical analyses were conducted. RESULTS: Overall, 393 questionnaires were returned (response rate 39.8%). 96.7% of the GPs had treated at least one family member during the last 12 months. Services that were provided frequently (more than three times in the last 12 months) included the prescription or dispensing of medication (partner 45%, children 37%, parents 43%, partner's parents 26%), physical examinations (partner 18%, children 24%, parents 25%, partner's parents 15%), and the arrangement or provision of laboratory tests (partner 14%, children 7%, parents 16%, partner's parents 9%). Less than one third of the study participants always treated their relatives in their office. Male GPs more often provided care to family members (except children) registered in their practice. Senior male GPs treated their relatives more often than junior female GPs. Family members were most commonly treated for practical reasons. CONCLUSION: The subject of GPs treating their relatives is of high everyday relevance, since nearly all GPs are involved in the treatment of their family members. Frequent at-home treatments and low documentation rates may indicate risks due to deviating from the professional routine.

Patients' perspective on supposedly patient-relevant process and outcome parameters: a cross-sectional survey within the 'PRO patients study'.

BACKGROUND: To be able to make informed choices based on their individual preferences, patients need to be adequately informed about treatment options and their potential outcomes. This implies that studies measure the effects of care based on parameters that are relevant to patients. In a previous scoping review, we found a wide variety of supposedly patient-relevant parameters that equally addressed processes and outcomes of care. We were unable to identify a consistent understanding of patient relevance and therefore aimed to develop an empirically based concept including a generic set of patient-relevant parameters. As a first step we evaluated the process and outcome parameters identified in the scoping review from the patients' perspective. METHODS: We conducted a cross-sectional survey among German general practice patients. Ten research practices of Witten/Herdecke University supported the study. During a two-week period in the fall of 2020, patients willing to participate self-administered a short questionnaire. It evaluated the relevance of the 32 parameters identified in the scoping review on a 5-point Likert scale and offered a free-text field for additional parameters. These free-text answers were inductively categorized by two researchers. Quantitative data were analyzed using descriptive statistics. Bivariate analyses were performed to determine whether there are any correlations between rating a parameter as highly relevant and patients' characteristics. RESULTS: Data from 299 patients were eligible for analysis. All outcomes except 'sexuality' and 'frequency of healthcare service utilization' were rated important. 'Confidence in therapy' was rated most important, followed by 'prevention of comorbidity' and 'mobility'. Relevance ratings of five parameters were associated with patients' age and gender, but not with their chronic status. The free-text analysis revealed 15 additional parameters, 12 of which addressed processes of care, i.e., 'enough time in physician consultation'. CONCLUSION: Patients attach great value to parameters addressing processes of care. It appears as though the way in which patients experience the care process is not less relevant than what comes of it. Relevance ratings were not associated with chronic status, but few parameters were gender- and age-related. TRIAL REGISTRATION: Core Outcome Measures in Effectiveness Trials Initiative, registration number: 1685.

[Patient and Public Involvement in Family Medicine Research]. / Aktive Patient*innen- und Bürger*innen-Beteiligung in der allgemeinmedizinischen Forschung: Methodische Ansätze und Konzepte in den Netzen der Initiative Deutscher Forschungspraxennetze ­ DESAM-ForNet.

Patient and Public Involvement (PPI) has gained importance in Germany and is also increasingly implemented in research in family medicine. Internationally, diverse frameworks give recommendations on how to successfully design and implement PPI in specific contexts. However, it is crucial to share experiences on PPI in specific settings such as family medicine in order to learn from each other. Thus, this article provides an overview of PPI concepts in the practice-based research networks (PBRNs) of the Initiative of German Practice-Based Research Networks - DESAM-ForNet. In the PBRNs patients and the public are involved in the research process by repeated group meetings in "public forums" (BayFoNet), "round tables" (FoPraNet-BW) or "patient advisory boards" (HAFO.NRW, RESPoNsE, SaxoForN) with a special focus on the planning and dissemination phase of projects. The most successful recruitment strategies so far have encompassed individual patient contacts of family physicians, postings/posters, local self-help organizations and standardized patient programs. Evaluation of PPI is currently being designed in most PBRNS. Overall, the PBRN-specific PPI concepts represent diverse possibilities to create long-term collaborative partnerships with patients and the public. These exemplary concepts are meant to encourage the further development and implementation of adapted PPI-concepts in family medicine research.

Burden Associated with Telephone Calls on COVID-19: Results of a Flash Mob Study in Family Practices.

Background: Family practices are the primary contact for inquiries relating to COVID-19. This study reveals the reasons why German family practices are called during the pandemic and which burden is associated with patients' inquiries related to COVID-19 among practice assistants (PAs). Methods: On April 28, 2021 a cross-sectional flash mob study was conducted in family practices across Germany. The study material and invitation were disseminated via social media and postal or electronic mails. During half a day, participating practices counted every incoming call. For calls addressing COVID-19, the reason, duration, and perceived stress level were documented. Descriptive statistics and regression analyses were performed using SPSS. Results: 5,646 calls, 1,826 of which were related to COVID-19 (32.3%), were documented by 73 practices (practice average: 25.0 ± 17.7) within a single Wednesday morning. Most calls addressed vaccination (n = 1,050, 59.0%). During 22.0% (n = 388) of COVID-19-related calls, PAs felt stressed, which was mainly influenced by the call duration (calls of 5 minutes and longer were perceived significantly more stressful [OR 8.94, 95% CI 6.47-12.37]). Feeling well-prepared to meet patients' inquiries relating to COVID-19 was a protective factor for the average stress perceived per PA. Overall, less than 10% of calls on COVID-19 were transferred to a physician. Conclusions: Family practice teams experience a high volume of partly stressful phone calls about COVID-19 but are often able to handle the pandemic challenges. PAs play a central role in advising the practice population on issues related to COVID-19. This deserves greater recognition.

Optimizing blood pressure control by an Information Communication Technology-supported case management (PIA study): study protocol for a cluster-randomized controlled trial of a delegation model for general practices.

BACKGROUND: Longitudinal hypertension control prevents heart attacks, strokes, and other cardiovascular diseases. However, 49% of patients in German family medicine practices do not reach blood pressure (BP) targets (< 140/90 mmHg). Drawing on successful international approaches, the PIA study introduces the PIA information and communication technology system (PIA-ICT) for hypertension management in primary care. The PIA-ICT comprises the PIA-App for patients and the PIA practice management center for practices. Case management includes electronic communication with patients, recall, and stepwise medication adjustments following guidelines. The system supports a physician-supervised delegation model to practice assistants. General practitioners are qualified by eLearning. Patients learn how to obtain reliable BP readings, which they communicate to the practice using the PIA-App. METHODS: The effectiveness of the PIA-Intervention is evaluated in a cluster-randomized study with 60 practices, 120 practice assistants, and 1020 patients. Patients in the intervention group receive the PIA-Intervention; the control group receives usual care. The primary outcome is the BP control rate (BP < 140/90 mmHg) after 12 months. Using a mixed methods approach, secondary outcomes address the acceptance on behalf of physicians, practice assistants, and patients. This includes an evaluation of the delegation model. DISCUSSION: It is hypothesized that the PIA-Intervention will improve the quality of BP care. Perspectively, it may constitute an important health service model for primary care in Germany. TRIAL REGISTRATION: German Clinical Trials Register DRKS00012680. Registered on May 10, 2019.

Mixed-methods approach to develop an agreed concept on patient relevance: study protocol for the 'PRO patients study'.

INTRODUCTION: With respect to patient-centred care and shared decision-making, measuring care effects based on outcomes relevant to patients is becoming increasingly important. Recently, a scoping review of the international literature revealed a wide range of supposedly patient-relevant outcomes and found that there is neither a sound definition of patient relevance nor a consistent set of outcomes relevant to patients. To close this gap, this study aims to develop an agreed concept on patient relevance including a set of outcomes relevant to patients irrespective of diseases, which grades outcomes according to their importance. METHODS AND ANALYSIS: This prospective mixed-methods study will integrate the perspectives of patients across diseases, healthcare professionals and researchers. The consensus process will consist of four phases. Based on the results of the recent scoping review, a patient survey will be conducted first, followed by a multiprofessional group discussion. Finally, a two-round online Delphi approach based on data from the previous phases will be applied to agree on a concept. ETHICS AND DISSEMINATION: Ethics approval for the study was granted on 26 August 2020 by the Ethics Commission of Witten/Herdecke University (reference number: 156/2020). In the long run, the implementation of an agreed concept on patient relevance will help improve the comparability of study results regarding the patient benefit and thereby strengthen the role of patients in the decision-making process. Also, the experiences regarding grading outcomes according to importance will help to develop a method on how to individualise clinical trial outcomes according to each patient's individual specifics and priorities in order to more adequately represent the patient perspective in clinical research. TRIAL REGISTRATION NUMBER: Core Outcome Measures in Effectiveness Trials Initiative (registration number: 1685).

Correction to: IMPROVEjob - Participatory intervention to improve job satisfaction of general practice teams: a model for structural and behavioural prevention in small and medium-sized enterprises - a study protocol of a cluster-randomised controlled trial.

An amendment to this paper has been published and can be accessed via the original article.

Practice assistants´ perceived mental workload: A cross-sectional study with 550 German participants addressing work content, stressors, resources, and organizational structure.

INTRODUCTION: Practice assistants represent a highly relevant occupational group in Germany and one of the most popular training professions in Germany. Despite this, most research in the health care sector has focused on secondary care settings, but has not addressed practice assistants in primary care. Knowledge about practice assistants' workplace-related stressors and resources is particularly scarce. This cross-sectional study addresses the mental workload of practice assistants working in primary care practices. METHODS: Practice assistants from a network of 185 German primary care practices were invited to participate in this cross-sectional study. The standardized `Short Questionnaire for Workplace Analysis' (German: Kurzfragebogen zur Arbeitsanalyse) was used to assess practice assistants´ mental workload. It addresses eleven workplace factors in 26 items: versatility, completeness of task, scope of action, social support, cooperation, qualitative work demands, quantitative work demands, work disruptions, workplace environment, information and participation, and benefits. Sociodemographic and work characteristics were also obtained. A descriptive analysis was performed for sociodemographic data and "Short Questionnaire for Workplace Analysis" factors. The one-sided t-test and Cohen´s d were calculated for a comparison with data from 23 professional groups (n = 8,121). RESULTS: A total of 550 practice assistants from 130 practices participated. The majority of practice assistants was female (99.3%) and worked full-time (66.5%) in group practices (50.6%). Compared to the other professional groups, practice assistants reported higher values for the factor social support (4.0 versus 3.7 [d 0.44; p<0.001]), information and participation (3.6 versus 3.3 [d 0.38; p<0.001] as well as work disruptions (2.7 vs. 2.4 [d 0.42; p<0.001]), while practice assistants showed lower values regarding scope of action (3.4 versus 3.8 [d 0.43; p<0.001]). CONCLUSIONS: Our study identified social support and participation within primary care practices as protective factors for mental workload, while work disruptions and scope of action were perceived as stressors.

Patient-relevant outcomes: what are we talking about? A scoping review to improve conceptual clarity.

BACKGROUND: With respect to patient-centered care, measuring care effects based on patient-relevant outcomes is becoming increasingly important. There is some uncertainty about what outcomes are particularly relevant to patients and who determines their relevance. To determine this, we conducted a scoping review of the international literature with the aim to improve the conceptual clarity regarding (1) the terminology used for supposedly patient-relevant outcomes, (2) the variety of outcomes considered patient-relevant, and (3) justifications for the choice of these specific outcomes. METHODS: We conducted a systematic search in Embase, PubMed (including Medline), Cochrane Central, Scopus, and Google Scholar with a special focus on article titles. Search terms included patient-relevant, patient-important, patient-preferred, and outcome(s), endpoint(s), parameter(s), indicator(s). We limited the search period from January 2000 to July 2019. Full-text articles reporting outcomes that were described as patient-relevant met the inclusion criteria. Two researchers independently analyzed all eligible articles applying quantitative and structuring content analysis. RESULTS: We identified 155 articles, 44 of which met the inclusion criteria. A content analysis revealed 35 different terms used with regard to patient-relevant outcomes. However, authors predominantly referred to patient-important outcomes (23 articles, 52.3%) and patient-relevant outcomes (17 articles, 38.6%). A structuring content analysis of all extracted outcomes revealed a total of 281 codes, pooled in 32 inductive categories. Among these, the following categories dominated: symptoms, adverse events/complications, survival/mortality, pain. In just 16 of the articles (36.4%), authors provided justifications for the choice of the outcome being based either on patient and/or expert opinions. In another 13 articles (29.5%), no justification was provided. CONCLUSION: This scoping review on patient-relevant outcomes was driven by the questions (1) what outcomes are particularly relevant to patients, and (2) who determines their relevance. We found a wide range of supposedly patient-relevant outcomes, with only one third of articles involving patients in the justification of the outcome selection. In view of this conceptual uncertainty it appears difficult to determine or even to compare a particular patient benefit of interventions. A set of generic outcomes relevant to patients would be helpful to contribute to a consistent understanding of patient relevance.

IMPROVEjob - Participatory intervention to improve job satisfaction of general practice teams: a model for structural and behavioural prevention in small and medium-sized enterprises - a study protocol of a cluster-randomised controlled trial.

BACKGROUND: Perceived high chronic stress is twice as prevalent among German general practitioners (GPs) and non-physician medical staff compared to the general population. The reasons are multi-factorial and include patient, practice, healthcare system and societal factors, such as multi-morbidity, the diversity of populations and innovations in medical care. Also, practice-related factors, like stressful patient-staff interactions, poor process management of waiting times and lack of leadership, play a role. This publicly funded study evaluates the effectiveness of the newly developed participatory, interdisciplinary, and multimodal IMPROVEjob intervention on improving job satisfaction among general practice personnel. The intervention aims at structural stress prevention with regard to working conditions and behavioural stress prevention for leaders and other practice personnel. METHODS: In this cluster-randomised controlled trial, a total of 56 general practices will be assigned to either (1) participation in the IMPROVEjob intervention or (2) the waiting-list control group. The IMPROVEjob intervention consists of the following elements: three workshops, a toolbox with supplemental material and an implementation period with regular contact to so-called IMPROVEjob facilitators. The first workshop, addressing leadership issues, is designed for physicians with leadership responsibilities only. The two subsequent workshops target all GP and non-physician personnel; they address issues of communication (with patients and within the team), self-care and team-care and practice organisation. During the 9-month implementation period, practices will be contacted by IMPROVEjob facilitators to enhance motivation. Additionally, the practices will have access to the toolbox materials online. All participants will complete questionnaires at baseline and follow up. The primary outcome is the change in job satisfaction as measured by the respective scale of the validated German version of the Copenhagen Psychosocial Questionnaire (COPSOQ, version 2018). Secondary outcomes obtained by questionnaires and - qualitatively - by facilitators comprise psychosocial working conditions including leadership aspects, expectations and experiences of the workshops, team and individual efforts and organisational changes. DISCUSSION: It is hypothesised that participation in the IMPROVEjob intervention will improve job satisfaction and thus constitute a structural and behavioural prevention strategy for the promotion of psychological wellbeing of personnel in general practices and prospectively in other small and medium sized enterprises. TRIAL REGISTRATION: German Clinical Trials Register: DRKS00012677. Registered on 16 October 2019. Retrospectively, https://www.drks.de/drks_web/navigate.do?navigationId=trial. HTML&TRIAL_ID = DRKS00012677.

No difference in medication regimes and dosing in study participants with and without blood pressure control: longitudinal data of the population-based Heinz Nixdorf Recall Study.

BACKGROUND: To achieve blood pressure (BP) control adequate dosing of first-line antihypertensive medications is recommended in addition to life-style changes. Given observations that dosing of antihypertensive agents is frequently insufficient, we compared the changes of BP control rates and antihypertensive drug regimens in a prospective German population using a new strategy to analyze medication dosing. METHODS: This analysis is based on data of the baseline (2000-2003) and the first follow-up examination (2005-2008) of the population-based Heinz Nixdorf Recall study. Participants with hypertension at baseline (BP ≥140/90 mmHg or at least one antihypertensive agent) who participated in both examinations were included. RESULTS: Of the 4157 participants, 2289 (55.1%) had hypertension at baseline. The prevalence of participants on antihypertensive agents was 60.3% at baseline and increased to 75.1% at follow-up. The mean number of antihypertensive agents was 2 [±1 SD (standard deviation)] initially and at follow-up. The prevalence of medication-controlled BP did not improve over time (baseline: 54.5%, follow-up: 56.5%). When stratifying by medication-controlled BP, the medication dosing rate slightly increased over time without differences between groups [controlled versus uncontrolled BP: 40.9 versus 46.2% (baseline); 50.1 versus 51.9% (follow-up)]. CONCLUSION: Although the prevalence of antihypertensive medication use increased in the study period, the BP control rate did not. In contrast to clinical reasoning, participants with uncontrolled BP did neither receive more agents nor higher dosing despite outcome-relevant hypertension. Our approach to analyze medication dosing suggests a potential to improve cardiovascular outcomes by increasing dosages of antihypertensive agents.

Vaccine cold chain in general practices: A prospective study in 75 refrigerators (Keep Cool study).

INTRODUCTION: Protecting vaccines from freeze damage is considered one of the most poorly addressed problems in vaccine management. Freezing may impair the potency especially of adsorbed vaccines. The Keep Cool study aims at ensuring optimal vaccine storage conditions in general practices. This publication analyses the baseline data using standardised temperature recordings. METHODS: This prospective study in German general practices analysed 7-day temperature recordings of refrigerators used for vaccine storage. Temperatures were recorded continuously using a standardised data logger with an accuracy of ±0.4 °C. The prevalence rates of refrigerators within the target range (2 to 8 °C) and of those reaching critically low temperatures (≤0 °C) were calculated. In addition, the cumulative time and the duration of single episodes beyond the target range were computed. To assess for structural deficits, the prevalence of refrigerators with a cycling of >5 °C was determined. Generalised linear mixed models were applied to analyse correlating factors between the dependent variables 'within temperature range' and 'reaching critically low temperatures' with practice characteristics. RESULTS: The study included 64 of 168 practices (38.1% response rate) with 75 refrigerators. The prevalence of refrigerators with temperatures within the target range was 32.0% (n = 24), and 14.7% (n = 11) reached critically low temperatures <0 °C. 44.0% of refrigerators (n = 33) showed temperatures >8 °C and 28.0% (n = 21) <2 °C. Of the 168 hours recorded per refrigerator, the average cumulative time >8 °C was 49 hours, <2 °C 75 hours and ≤0 °C 74 hours. The longest consecutive period of critically low temperatures was 168 hours (mean: 39±53). The prevalence of refrigerators with a cycling range of >5 °C was 29.3%. CONCLUSION: Given the importance of immunisation, the results of our study call for action, as two-thirds of the refrigerators exhibited cold chain breaches and 15% reached critically low temperatures threatening vaccine potency.

Chronic stress, work-related daily challenges and medicolegal investigations: a cross-sectional study among German general practitioners.

BACKGROUND: The prevalence of chronic stress among German general practitioners (GPs) was shown to be twice as high as in the general population. Because chronic stress negatively influences well-being and poor physician well-being is associated with poor patient outcomes, targeted strategies are needed. This analysis focuses on work-related factors associated with high chronic stress in GPs. METHODS: This cross-sectional study measured chronic stress among German GPs using the validated and standardized Trier Inventory for the Assessment of Chronic Stress (TICS-SSCS). Based on the TICS, GPs were categorized as either having low strain (≤ 25th percentile) or high strain (≥ 75th percentile) due to chronic stress. Questions on work-related challenges assessed the frequency and the subjectively perceived strain of single challenges. For exploratory analyses, these items were combined to dichotomous variables reflecting challenges that are common and that cause high strain. Variables significant in bivariate analyses were included in a multivariate logistic regression model analyzing their association with high chronic stress. RESULTS: Data of 109 GPs categorized as having low strain (n = 53) or high strain (n = 56) due to chronic stress were analyzed. Based on bivariate analyses, challenges regarding personnel matters, practice software, complexity of patients, difficult patients, care facilities, scheduling of appointments, keeping medical records up-to-date, fee structures, and expectations versus reality of care were included in the regression model. Keeping medical records up-to-date had the strongest association with high chronic stress (odds ratio 4.95, 95% confidence interval 1.29-19.06). A non-significant trend showed that medicolegal investigations were more common among GPs with high chronic stress. CONCLUSIONS: This exploratory research shows that chronic stress is predominantly associated with administrative challenges. Treatment documentation, which represents a legal safeguard and is closely linked to existential concerns, has the strongest influence.

Evaluating the Feasibility of a Software Prototype Supporting the Management of Multimorbid Seniors: Mixed Methods Study in General Practices.

BACKGROUND: Longitudinal, patient-centered care represents a challenge for general practices. Decision support and reminder systems can offer targeted support. OBJECTIVE: The objective of this study was to follow a user-oriented, stepwise approach to develop an add-on for German electronic health record (EHR) systems, which aims to support longitudinal care management of multimorbid seniors, using a flag system displaying patient-centered information relevant for comprehensive health care management. This study evaluated the prototype's feasibility from both a technical and users' perspective. METHODS: The study was conducted with 18 general practitioners (GPs) and practice assistants (PAs) from 9 general practices using a mixed methods approach. In all practices, 1 GP and 1 PA tested the software each for 4 multimorbid seniors selected from the practice patient data. Technical feasibility was evaluated by documenting all technical problems. To evaluate the feasibility from the users' perspective, participants' responses during the software test were documented. In addition, they completed a self-administered questionnaire, including the validated System Usability Scale (SUS). Data were merged by transforming qualitative data into quantitative data. Analyses were performed using univariate statistics in IBM SPSS statistics. RESULTS: From a technical perspective, the new software was easy to install and worked without problems. Difficulties during the installation occurred in practices lacking a 64-bit system or a current version of Microsoft .NET. As EHRs used in German practices do not provide an interface to extract the data needed, additional software was required. Incomplete flags for some laboratory data occurred, although this function was implemented in our software as shown in previous tests. From the users' perspective, the new add-on provided a better overview of relevant patient information, reminded more comprehensively about upcoming examinations, and better supported guideline-based care when compared with their individual practice strategies. A total of 14 out of 18 participants (78%) were interested in using the software long-term. Furthermore, 8 of 9 GPs were willing to pay 5 to 25 Euros (mean 14.75, SD 5.93) monthly for its use. The usability was rated as 75% (43%-95%). CONCLUSIONS: The new EHR add-on was well accepted and achieved a good usability rating measured by the validated SUS. In perspective, the legally consolidated, standardized interface to German EHRs will facilitate the technical integration. In view of the high feasibility, we plan to study the software's effectiveness in everyday primary care. TRIAL REGISTRATION: German Clinical Trials Register DRKS00008777; https://www.drks.de/drks_web/navigate.do? navigationId=trial.HTML&TRIAL_ID=DRKS00008777.