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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.

Studies from general practitioner (GP) populations from various European countries show a high prevalence of burnout, yet data from Germany are scarce and there are no data comparing GPs from solo versus group practices. This cross-sectional survey addressed all GPs from a German network of family medicine practices comprising 185 practices. Participants were asked to fill in a self-administered questionnaire addressing socio-demographic and job-related characteristics. The German version of the Maslach Burnout Inventory was used to measure the dimensions emotional exhaustion (EE), depersonalization (DP), and personal accomplishment (PA). Each participant was categorized as having high EE, high DP and low PA following pre-defined cut-offs. A total of 214 GPs from 129 practices participated: 65.9% male, 24.8% solo practice. Of all GPs, 34.1% (n = 73) scored high for EE, 29.0% (n = 62) high for DP, 21.5% (n = 46) low for PA and 7.5% (n = 16) for all three dimensions. A higher risk for EE was found among female physicians, those unsatisfied with their job, those using few stress-regulating measures regularly and those reporting bad work-life balance. Burnout prevalence was higher in GPs in group than in solo practices (37.9% vs. 28.8% had high EE, 33.1% vs. 18.9% had high DP and 22.8% vs. 18.9% had low PA). A significantly higher prevalence of burnout symptoms was found in group practice employees compared to group practice owners. Burnout prevalence was higher among physicians in group practices compared to solo practices. In group practices, employed, young, female and part-time working physicians showed a higher burnout risk.

The majority of studies investigating stress in primary care have focused either on general practitioners (GPs) or practice assistants (PAs), but did not measure stress on a practice level. We analyzed the prevalence of chronic stress for both professional groups and on a practice level and investigated personal, practice, and regional characteristics. Chronic stress was measured in GPs and PAs from 136 German practices using the standardized, self-administered TICS-SSCS questionnaire (12 items). Based on a sum-score, participants per professional group were categorized as having low or high strain due to chronic stress (≤ 25th and ≥ 75th percentile of the study population´s distribution, respectively). For a cluster-level analysis, the mean of all practice means was used to categorize low- and high-stress practices. The intra-class correlation coefficient (ICC) was calculated using ANOVA. Prevalence Ratios (PR) were used to compare low versus high strain due to stress, stratified for personal, practice and regional characteristics. The response rate was 74.1% (n = 137/185). Data from 214 GPs (34.1% female), 500 PAs (99.4% female), and 50 PAs in training (98.0% female) were analyzed. Chronic stress was highest in female GPs (median 19, IQR (interquartile range) 11.5), followed by PAs (16, IQR 12.25) and male GPs (15, IQR 10). On a practice level, 26.3% of the practice personnel reported a high stress level. We observed an overall ICC of 0.25, with higher ICCs when stratifying by professional group (PAs: ICC 0.36, GPs in group practices: ICC 0.51). High chronic stress was observed as the number of working hours per week increased (GPs: PR 2.03, 95% CI 1.16-3.56; PAs: PR 2.02, 95% CI 1.22-3.35). There were no differences for practice type (solo/group) and the various regional characteristics. Personal and practice characteristics were associated with chronic stress in GPs, PAs, and on a practice level. The high ICCs indicate a need for stress-reduction strategies geared at both professions on a practice level.

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. 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). 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]). 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.

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. 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). 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]). 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.

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. 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. 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%. 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.

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.

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 12 th , 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.

IntroductionWith 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 analysisThis 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 disseminationEthics 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 numberCore Outcome Measures in Effectiveness Trials Initiative (registration number: 1685).

Background Regular physical activity improves physical health and mental well-being and reduces the risk of falling in older adults. The randomized controlled “ P revention by lay-assisted O utdoor- W alking in the E lderly at R isk” 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.