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Background: Electronic monitoring (EM) is used increasingly to measure medication non-adherence. Unbiased EM assessment requires fulfillment of assumptions. The purpose of this study was to determine assumptions needed for internal and external validity of EM measurement. To test internal validity, we examined if (1) EM equipment functioned correctly, (2) if all EM bottle openings corresponded to actual drug intake, and (3) if EM did not influence a patient's normal adherence behavior. To assess external validity, we examined if there were indications that using EM affected the sample representativeness.Methods: We used data from the Supporting Medication Adherence in Renal Transplantation (SMART) study, which included 250 adult renal transplant patients whose adherence to immunosuppressive drugs was measured during 3 months with the Medication Event Monitoring System (MEMS). Internal validity was determined by assessing the prevalence of nonfunctioning EM systems, the prevalence of patient-reported discrepancies between cap openings and actual intakes (using contemporaneous notes and interview at the end of the study), and by exploring whether adherence was initially uncharacteristically high and decreased over time (an indication of a possible EM intervention effect). Sample representativeness was examined by screening for differences between participants and non-participants or drop outs on non-adherence.Results: Our analysis revealed that some assumptions were not fulfilled: 1) one cap malfunctioned (0.4%), 2) self-reported mismatches between bottle openings and actual drug intake occurred in 62% of the patients (n = 155), and 3) adherence decreased over the first 5 weeks of the monitoring, indicating that EM had a waning intervention effect.Conclusion: The validity assumptions presented in this article should be checked in future studies using EM as a measure of medication non-adherence. [ABSTRACT FROM AUTHOR]

Background: Homecare client services are often distributed across several interdependent healthcare providers, making proper care coordination essential. However, as studies exploring care coordination in the homecare setting are scarce, serious knowledge gaps exist regarding how various factors influence coordination in this care sector. To fill such gaps, this study's central aim was to explore how external factors (i.e., financial and regulatory mechanisms) and homecare agency characteristics (i.e., work environment, workforce, and client characteristics) are related to care coordination in homecare., Methods: This analysis was part of a national multicentre, cross-sectional study in the Swiss homecare setting that included a stratified random sample of 88 Swiss homecare agencies. Data were collected between January and September 2021 through agency and employee questionnaires. Using our newly developed care coordination framework, COORA, we modelled our variables to assess the relevant components of care coordination on the structural, process, and outcome levels. We conducted both descriptive and multilevel regression analyses-with the latter adjusting for dependencies within agencies-to explore which key factors are associated with coordination., Results: The final sample size consisted of 1450 employees of 71 homecare agencies. We found that one explicit coordination mechanism ("communication and information exchange" (beta = 0.10, p <.001)) and four implicit coordination mechanisms-"knowledge of the health system" (beta = -0.07, p <.01), "role clarity" (beta = 0.07, p <.001), "mutual respect and trust" (beta = 0.07, p <.001), and "accountability, predictability, common perspective" (beta = 0.19, p <.001)-were significantly positively associated with employee-perceived coordination. We also found that the effects of agency characteristics and external factors were mediated through coordination processes., Conclusion: Implicit coordination mechanisms, which enable and enhance team communication, require closer examination. While developing strategies to strengthen implicit mechanisms, the involvement of the entire care team is vital to create structures (i.e., explicit mechanisms) that enable communication and information exchange. Appropriate coordination processes seem to mitigate the association between staffing and coordination. This suggests that they support coordination even when workload and overtime are higher., (© 2024. The Author(s).)

Background: Symptom perception is an important process of heart failure (HF) self-care that persons with HF need in order to master self-care management. It also leads to better patient outcomes. Symptom perception consists of body observation and analysis, which are both challenging. We aimed to test the feasibility, acceptability, and outcome responsiveness of a novel intervention (SYMPERHEART) delivered to persons with HF with their informal caregiver., Methods: We designed SYMPERHEART as a complex evidence-informed education and support intervention targeting body observation and analysis. We conducted a feasibility quasi-experimental study with a single group pre-post-test design. We included three subsamples: persons with HF receiving home-based care, their informal caregivers exposed to SYMPERHEART, and home-care nurses who delivered SYMPERHEART during 1 month. We assessed feasibility by recruitment time, time to deliver SYMPERHEART, eligibility rate, and intervention fidelity. We assessed acceptability by consent rate, retention rate, persons with HF engagement in body observation, and treatment acceptability. Outcome responsiveness was informed by patient-reported (PRO) and clinical outcomes: HF self-care and the informal caregivers' contribution to HF self-care, perception of HF symptom burden, health status, caregivers' burden, and HF events. We performed descriptive analyses for quantitative data and calculated Cohen's d for PROs. A power analysis estimated the sample size for a future full-scale effectiveness study., Results: We included 18 persons with HF, 7 informal caregivers, and 9 nurses. Recruitment time was 112.6 h. The median time to deliver SYMPERHEART for each participant was 177.5 min. Eligibility rate was 55% in persons with HF. Intervention fidelity revealed that 16 persons with HF were exposed to body observation and analysis. Consent and retention rates in persons with HF were 37.5% and 100%, respectively. Participants engaged actively in symptom and weight monitoring. Treatment acceptability scores were high. Symptom perception and informal caregivers' contribution to symptom perception were found to be responsive to SYMPERHEART. We estimate that a sample size of 50 persons with HF would be needed for a full-scale effectiveness study., Conclusions: SYMPERHEART was found to be feasible and acceptable. This feasibility study provides information for a subsequent effectiveness study., Trial Registration: ISRCTN. ISRCTN18151041 , retrospectively registered on 4 February 2021, ICTRP Search Portal., (© 2023. BioMed Central Ltd., part of Springer Nature.)

Background: Heart failure (HF) is a progressive disease associated with a high burden of symptoms, high morbidity and mortality, and low quality of life (QoL). This study aimed to evaluate the feasibility and potential outcomes of a novel multicomponent complex intervention, to inform a future full-scale randomized controlled trial (RCT) in Switzerland., Methods: We conducted a pilot RCT at a secondary care hospital for people with HF hospitalized due to decompensated HF or with a history of HF decompensation over the past 6 months. We randomized 1:1; usual care for the control (CG) and intervention group (IG) who received the intervention as well as usual care. Feasibility measures included patient recruitment rate, study nurse time, study attrition, the number and duration of consultations, intervention acceptability and intervention fidelity. Patient-reported outcomes included HF-specific self-care and HF-related health status (KCCQ-12) at 3 months follow-up. Clinical outcomes were all-cause mortality, hospitalization and days spent in hospital., Results: We recruited 60 persons with HF (age mean = 75.7 years, ± 8.9) over a 62-week period, requiring 1011 h of study nurse time. Recruitment rate was 46.15%; study attrition rate was 31.7%. Follow-up included 2.14 (mean, ± 0.97) visits per patient lasting a total of 166.96 min (mean, ± 72.55), and 3.1 (mean, ± 1.7) additional telephone contacts. Intervention acceptability was high. Mean intervention fidelity was 0.71. We found a 20-point difference in mean self-care management change from baseline to 3 months in favour of the IG (Cohens' d = 0.59). Small effect sizes for KCCQ-12 variables; less IG participants worsened in health status compared to CG participants. Five deaths occurred (IG = 3, CG = 2). There were 13 (IG) and 18 (CG) all-cause hospital admissions; participants spent 8.90 (median, IQR = 9.70, IG) and 15.38 (median, IQR = 18.41, CG) days in hospital. A subsequent full-scale effectiveness trial would require 304 (for a mono-centric trial) and 751 participants (for a ten-centre trial) for HF-related QoL (effect size = 0.3; power = 0.80, alpha = 0.05)., Conclusion: We found the intervention, research methods and outcomes were feasible and acceptable. We propose increasing intervention fidelity strategies for a full-scale trial., Trial Registration: ISRCTN10151805 , retrospectively registered 04/10/2019., (© 2023. The Author(s).)

Background: Implementation fidelity assesses the degree to which an intervention is delivered as it should be. Fidelity helps to determine if the outcome(s) of an intervention are attributed to the intervention itself or to a failure of its implementation. Little is known about how fidelity impacts the intended outcome(s) and what elements or moderators can affect the fidelity trajectory over time. We exemplify the meaning of implementation fidelity with INTERCARE, a nurse-led care model that was implemented in eleven Swiss nursing homes (NHs) and showed effectiveness in reducing unplanned hospital transfers. INTERCARE comprises six core elements, including advance care planning and tools to support inter- and interprofessional communication, which were introduced with carefully developed implementation strategies., Methods: A mixed-methods convergent/triangulation design was used to investigate the influence of implementation fidelity on unplanned transfers. A fidelity questionnaire measuring the degree of fidelity to INTERCARE's core components was fielded at four time points in the participating NHs. Two-monthly meetings were conducted with NHs (September 2018-January 2020) and structured notes were used to determine moderators affecting fidelity (e.g., participant responsiveness). We used the fidelity scores and generalized linear mixed models to analyze the quantitative data. The Framework method was used for the qualitative analysis. The quantitative and qualitative findings were integrated using triangulation., Results: A higher overall fidelity score showed a decreasing rate of unplanned hospital transfers post-intervention (OR: 0.65 (CI = 0.43-0.99), p = 0.047). A higher fidelity score to advance care planning was associated with lower unplanned transfers (OR = 0.24 (CI 0.13-0.44), p = < 0.001) and a lower fidelity score for communication tools (e.g., ISBAR) to higher rates in unplanned transfers (OR = 1.69 (CI 1.30-2.19), p = < 0.003). In-house physicians with a collaborative approach and staff's perceived need for nurses working in extended roles, were important moderators to achieve and sustain high fidelity., Conclusion: Implementation fidelity is challenging to measure and report, especially in complex interventions, yet is crucial to better understand how such interventions may be tailored for scale-up. This study provides both a detailed description of how fidelity can be measured and which ingredients highly contributed to reducing unplanned NH transfers., Trial Registration: The INTERCARE study was registered at clinicaltrials.gov Protocol Record NCT03590470., (© 2023. The Author(s).)

Background: Health economic evaluations of the implementation of evidence-based interventions (EBIs) into practice provide vital information but are rarely conducted. We evaluated the health economic impact associated with implementation and intervention of the INTERCARE model-an EBI to reduce hospitalisations of nursing home (NH) residents-compared to usual NH care., Methods: The INTERCARE model was conducted in 11 NHs in Switzerland. It was implemented as a hybrid type 2 effectiveness-implementation study with a multi-centre non-randomised stepped-wedge design. To isolate the implementation strategies' costs, time and other resources from the NHs' perspective, we applied time-driven activity-based costing. To define its intervention costs, time and other resources, we considered intervention-relevant expenditures, particularly the work of the INTERCARE nurse-a core INTERCARE element. Further, the costs and revenues from the hotel and nursing services were analysed to calculate the NHs' losses and savings per resident hospitalisation. Finally, alongside our cost-effectiveness analysis (CEA), a sensitivity analysis focused on the intervention's effectiveness-i.e., regarding reduction of the hospitalisation rate-relative to the INTERCARE costs. All economic variables and CEA were assessed from the NHs' perspective., Results: Implementation strategy costs and time consumption per bed averaged 685CHF and 9.35 h respectively, with possibilities to adjust material and human resources to each NH's needs. Average yearly intervention costs for the INTERCARE nurse salary per bed were 939CHF with an average of 1.4 INTERCARE nurses per 100 beds and an average employment rate of 76% of full-time equivalent per nurse. Resident hospitalisation represented a total average loss of 52% of NH revenues, but negligible cost savings. The incremental cost-effectiveness ratio of the INTERCARE model compared to usual care was 22'595CHF per avoided hospitalisation. As expected, the most influential sensitivity analysis variable regarding the CEA was the pre- to post-INTERCARE change in hospitalisation rate., Conclusions: As initial health-economic evidence, these results indicate that the INTERCARE model was more costly but also more effective compared to usual care in participating Swiss German NHs. Further implementation and evaluation of this model in randomised controlled studies are planned to build stronger evidential support for its clinical and economic effectiveness., Trial Registration: clinicaltrials.gov ( NCT03590470 )., (© 2022. The Author(s).)

Background: Rare disease patient-reported outcome measures (PROMs) require linguistic adaptation to overcome the challenge of geographically dispersed patient populations. Importantly, PROMs such as health-related quality of life (HRQoL) should accurately capture responses to patient-identified concerns. The Systemic Sclerosis Quality of Life Questionnaire (SScQoL) is a 29-item tool validated in six languages. Previous evaluation of the German version revealed problems with dichotomous responses. This study aimed to revise the German SScQoL, extend the response structure, and evaluate content and construct validity, reliability and unidimensionality., Methods: The instrument validation study involved revising the German SScQoL response structure, cognitive debriefing with patients and validation using Rasch analysis. The revised SScQoL was completed by Swiss-German-speaking patients with SSc within the Swiss MANagement Of Systemic Sclerosis (MANOSS) study. Rasch analysis was employed to test the validity, reliability and unidimensionality of the revised instrument., Results: Based on cognitive debriefing with patients (n = 6) dichotomous items were extended to a polytomous 4-point response structure. A total of 78 patients completed the revised SScQoL. Initial analysis of the 29 items suggested the scale lacked fit to the model (χ 2  = 51.224, df = 29, p = 0.007). Grouping items into five domains resulted in an adequate fit to the Rasch model (χ 2  = 5.343, df = 5, p = 0.376) and unidimensionality (proportion of significant independent t tests: 0.045, 95% CI 0.016-0.114). Overall, the scale was well targeted, had high internal consistency (Person Separation Index, PSI = 0.931) and worked consistently in patients with different demographic and clinical characteristics., Conclusions: The revised German SScQoL has a 4-point response structure and is a valid, reliable measure. Rasch analysis is useful for validating continuous response structure of quality of life measures. Further evaluation of measurement equivalence with other German-speaking cultures is required for multinational comparisons and data pooling., (© 2021. The Author(s).)

Background: DOPPS reported that thousands of life-years could be gained in the US and Europe over 5 years by correcting six modifiable haemodialysis practices. We estimated potential life-years gained across 10 European countries using MONITOR-CKD5 study data., Methods: The DOPPS-based target ranges were used, except for haemoglobin due to label changes, as well as DOPPS-derived relative mortality risks. Percentages of MONITOR-CKD5 patients outside targets were calculated. Consistent with the DOPPS-based analyses, we extrapolated life-years gained for the MONITOR-CKD5 population over 5 years if all patients were within targets., Results: Bringing the 10 MONITOR-CKD5 countries' dialysis populations into compliance on the six practices results in a 5-year gain of 97,428 patient-years. In descending order, survival impact was the highest for albumin levels, followed by phosphate levels, vascular access, haemoglobin, dialysis adequacy, and interdialytic weight gain., Conclusions: Optimal management of the six modifiable haemodialysis practices may achieve 6.2% increase in 5-year survival., Trial Registration: NCT01121237 . Clinicaltrials.gov registration May 12, 2010 (retrospectively registered).

Background: The Emergency Severity Index (ESI) is an English language emergency department patient triage tool. After translation, it has been adapted for use to triage patients in growing numbers of emergency departments in non-English-speaking countries. Few reports of the proficiency of triage nurses to score an ESI exist. We sought to determine accuracy, inter-rater reliability, and subjective confidence of triage nurses at four hospitals to determine an ESI from standardized ESI scenarios., Methods: Triage nurses assigned an ESI score to each of 30 standard ESI (ESI Implementation Handbook Version 4) translated teaching case scenarios. Accuracy and Inter-rater reliability (Krippendorff's alpha) of the ESI scoring was measured. Nurses' subjective confidence applying the ESI algorithm was obtained by a Likert scale., Results: Sixty-nine nurses from four EDs participated in the study. They scored 59.6 % of the case scenarios correctly. Inter-rater reliability was 0.78 (Krippendorff's alpha). Most (54/69, 78 %) felt confident in their ability to apply the ESI., Conclusions: Low accuracy of ESI score assignment was observed when nurses scored an ESI for 30 standard written case scenarios, translated into nurses' native language, despite a good inter-rater reliability and high nurse confidence in their ability to apply the ESI. Although feasible, using standard written case scenarios to determine ESI triage scoring effectiveness may not be the optimum means to rate nurses' triage skills.

Background: Language barriers have a major impact on both the quality and the costs of health care. While there is a growing body of evidence demonstrating the detrimental effects of language barriers on the quality of health care provision, less is known about their impact on costs. This purpose of this study was to investigate the association between language barriers and the costs of health care., Methods: The data source was a representative set of asylum seekers whose health care was provided by a Swiss Health Maintenance Organisation (HMO). A cross-sectional survey was conducted: data was collected on all the asylum seekers' health care costs including consultations, diagnostic examinations, medical interventions, stays in the clinic, medication, and interpreter services. The data were analysed using path analysis., Results: Asylum seekers showed higher health care costs if there were language barriers between them and the health professionals. Most of these increased costs were attributable to those patients who received interpreter services: they used more health care services and more material. However, these patients also had a lower number of visits to the HMO than patients who faced language barriers but did not receive interpreter services., Conclusion: Language barriers impact health care costs. In line with the limited literature, the results of this study seem to show that interpreter services lead to more targeted health care, concentrating higher health care utilisation into a smaller number of visits. Although the initial costs are higher, it can be posited that the use of interpreter services prevents the escalation of long-term costs. A future study specially designed to examine this presumption is needed.