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Purpose: eHealth-facilitated integrated care models (eICMs) have proved effective in improving outcomes for chronically ill patients. However, evidence on cost-effectiveness of eICMs is scarce so far. Allogeneic stem cell transplantation (alloSCT) recipients' post-discharge treatment costs and mortality are greatly influenced by complications. Within the international, multicentric SMILe implementation science project, the eHealth-facilitated SMILe integrated care model (SMILe-ICM) was developed to support patients minimize complications' effects within the first year post-alloSCT. Using initial effectiveness findings from the first center that implemented the SMILe-ICM, this study provides a cost and cost-effectiveness evaluation considering one-year and long-term survival effects, post-discharge costs, and patient-related factors., Methods: A single-center hybrid effectiveness implementation randomized controlled trial was conducted at a German university hospital from 2/2020 to 8/2022. Eligible alloSCT patients were randomized to the SMILe-ICM or usual care, i.e., one pre-transplant educational nursing visit followed by a physician-led follow-up. The intervention group received usual care plus the SMILe-ICM's four intervention modules (i.e., monitoring of medical/symptom-related parameters, medication adherence, infection prevention, physical activity). All modules were delivered by Advanced Practice Nurses (APNs) in face-to-face visits, combined with continuous online support. Daily, patients entered seventeen medical and symptom-related parameters to the SMILe App, so that APNs could monitor for and investigate possible pre-complication signs. Healthcare utilization costs were assessed at eight time-points (d+30 post-alloSCT-d365) on fourteen self-reported cost indicators and validated against health records. To calculate costs, we applied German standardized unit costs. Cost- and cost-effectiveness were analyzed in five steps: 1.) Calculate total costs, including for the alloSCT inpatient stay and post-discharge follow-up. 2.) Determine life-years gained (survival) as a health benefit unit. 3.) Calculate overall and rehospitalization-free survival estimates. 4.) Calculate the intervention's long-term cost-effectiveness, including extended follow-up, rate of survival until day 1000, and restricted mean survival time. 5.) Contrast these long-term estimates to current post-discharge costs with comparable patient-related factors (age ≥ or < 65, living alone, gender)., Results: Seventy-two patients participated (n = 36/group). Total intergroup healthcare utilization and post-discharge costs differed, but non-significantly. Survival rates improved with the SMILe-ICM (88% vs. 80%) at least until day +1000. Rehospitalization-free survival showed improvement (38% vs. 30%); however, considering this sample size, both findings were nonsignificant. Cost-effectiveness analysis showed an overall post-discharge cost-effectiveness of 35,364.01€/patient and 6,742€/life year gained - a mean of 79.21 additional days of life for an intervention investment of 1.464€/patient in the first year post-alloSCT. One-year cost-effectiveness was highest for patients living alone. Younger age correlated with longer survival but higher costs., Conclusion: The SMILe-ICM appears to offer survival and rehospitalization benefits, particularly for vulnerable groups, e.g., patients living alone. Larger, adequately powered studies are needed to validate these findings., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Lynn Leppla reports financial support was provided by German José Carreras Foundation for Leukemia. Robert Zeiser reports a relationship with Novartis PharmaSAS that includes: speaking and lecture fees. Sabina De Geest reports a relationship with University of Basel that includes: board membership, consulting or advisory, and equity or stocks. The other authors, declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

The EBMT (European Blood and Marrow Transplantation Society) aims to connect patients, the scientific community, and other stakeholders to improve hematopoietic stem cell transplantation and cellular therapy outcomes. We performed a cross-sectional online survey to understand the perceptions regarding Patient Reported Outcomes (PROs) and Patient Active Involvement in Research (PAIR) in over 800 stakeholders (n = 813). Patients (n = 278) and health care professionals (HCPs) (n = 351) were compared. We observed high openness for EBMT PRO collection (n = 680, 84.5% across stakeholders' groups; patients n = 256, 93.1% versus HCPs n = 273, 78.4% [p < 0.001]) and PAIR (n = 702, 87.3% across stakeholder groups; patients n = 256, 92.4% versus HCPs n = 296, 85.8% [p = 0.009]), with a significantly higher proportion of patients expressing interest compared to HCPs. Priority domains for PROs data-collection identified were the assessment of symptom experience, psychosocial and cognitive functioning. The most important issues for patients specifically were the data-collection of PROs reflecting cognitive function, the option of reporting data at home, the importance of identifying actionable targets to improve their recovery, and receiving feedback on their input when participating in research projects. Our multistakeholder approach suggests an added value to embracing patient engagement in the development of meaningful research and service design within the transplantation and cellular therapy community., (© 2024. The Author(s), under exclusive licence to Springer Nature Limited.)

Non-adherence to immunosuppressive medication among transplant patients is associated with poor clinical outcomes and higher economic costs. Barriers to immunosuppressives are a proximal determinant of non-adherence. So far, international variability of barriers to adherence in transplantation has not been studied. As part of the cross-sectional multi-country and multi-center BRIGHT study, barriers to adherence were measured in 1,382 adult heart transplant recipients of 11 countries using the 28-item self-report questionnaire "Identifying Medication Adherence Barriers" (IMAB). Barriers were ranked by their frequency of occurrence for the total sample and by country. Countries were also ranked the by recipients' total number of barriers. Intra-class correlations were calculated at country and center level. The five most frequently mentioned barriers were sleepiness (27.1%), being away from home (25.2%), forgetfulness (24.5%), interruptions to daily routine (23.6%) and being busy (22.8%), fairly consistently across countries. The participants reported on average three barriers, ranging from zero up to 22 barriers. The majority of the variability among reported barriers frequency was situated at the recipient level (94.8%). We found limited international variability in primarily person-level barriers in our study. Understanding of barriers in variable contexts guides intervention development to support adherence to the immunosuppressive regimen in real-world settings., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Denhaerynck, Berger Wermuth, Dobbels, Berben, Russell and De Geest.)

Background: Quality of life (QoL) is a measure to evaluate kidney transplant (KT) results., Aim: To describe the QoL profile in a larger sample of Brazilian patients who underwent KT according to age, sex, and access to KT., Methods: We conducted a secondary data analysis of the ADHERE BRAZIL multicenter cross-sectional study including 1105 patients from 20 centers, considering KT access region and transplant activity. QoL was assessed by the WHOQOL-BREF. Data was compared using Generalized Estimating Equations., Results: Overall, 58.5 % of the patients were men, mean age of 47.6 ± 12.6 years. The general QoL score was 81 ± 15.1, 58.6 ± 11.6 for physical, 65.5 ± 11.4 for psychological, 68.3 ± 17.1 for social relationships, and 64.2 ± 13.3 for environmental domain. Higher QoL scores were observed in men compared to women in three WHOQOL-BREF domains: psychological (OR:2.62; CI, 1.29 ̶ 3.95, p < 0.0001), social relationships (OR:3.21; CI, 1.2 ̶ 5.23, p = 0.002) and environmental (OR:3.79; CI:2.23 ̶ 5.35, p < 0.0001). Younger patients (18-44 years) had higher scores in the psychological (OR:-2.69; CI, -4.13 ̶ -1.25; p < 0.001; OR:-3.52; CI, -5.39 ̶ -1.66; p < 0.001) and social (OR:-3.46; CI, -5.64 ̶ -1.27; p = 0.002; OR:-7.17; CI, -10 ̶ -4.35; p < 0.0001) domains than older ones (45-59 and > 60 years, respectively). Patients from higher KT access region had higher scores in environmental domain (OR:3.53; CI, 0.28 ̶ 6.78; p = 0.033)., Conclusions: Featuring the results of KT under patient view, the physical and social relationships domains were the most and least affected, respectively. Lower QoL subgroups (females and age > 45 years) should be targeted in future multi-professional interventions., Competing Interests: Declaration of competing interest The authors declare that they have no competing interests., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Objective: Physical activity is recommended for recipients of a kidney transplant. However, ADHERE BRAZIL study found a high prevalence (69%) of physical inactivity in Brazilian recipients of a kidney transplant. To tackle this behavior, a broad analysis of barriers is needed. This study aimed to identify factors (patient and transplant center levels) associated with physical inactivity among recipients of a kidney transplant., Methods: This was a subproject of the ADHERE BRAZIL study, a cross-sectional, multicenter study of 1105 recipients of a kidney transplant from 20 kidney transplant centers. Using a multistage sampling method, patients were proportionally and randomly selected. Applying the Brief Physical Activity Assessment questionnaire, patients were classified as physically active (≥150 min/wk) or physically inactive (<150 min/wk). On the basis of an ecological model, 34 factors associated with physical inactivity were analyzed by sequential logistic regression., Results: At the patient level, physical inactivity was associated with smoking (odds ratio = 2.43; 95% CI = 0.97-6.06), obesity (odds ratio = 1.79; 95% CI = 1.26-2.55), peripheral vascular disease (odds ratio = 3.18; 95% CI = 1.20-8.42), >3 posttransplant hospitalizations (odds ratio = 1.58; 95% CI = 1.17-2.13), family income of >1 reference salary ($248.28 per month; odds ratio = 0.66; 95% CI = 0.48-0.90), and student status (odds ratio = 0.58; 95% CI = 0.37-0.92). At the center level, the correlates were having exercise physiologists in the clinical team (odds ratio = 0.54; 95% CI = 0.46-0.64) and being monitored in a teaching hospital (undergraduate students) (odds ratio = 1.47; 95% CI = 1.01-2.13)., Conclusions: This study identified factors associated with physical inactivity after kidney transplantation that may guide future multilevel behavioral change interventions for physical activity., Impact: In a multicenter sample of recipients of a kidney transplant with a prevalence of physical inactivity of 69%, we found associations between this behavior and patient- and center-level factors. At the patient level, the chance of physical inactivity was positively associated with smoking, obesity, and patient morbidity (peripheral vascular disease and hospitalization events after kidney transplantation). Conversely, a high family income and a student status negatively correlated with physical inactivity. At the center level, the presence of a dedicated professional to motivate physical activity resulted in a reduced chance of physical inactivity. A broad knowledge of barriers associated with physical inactivity can allow us to identify patients at a high risk of not adhering to the recommended levels of physical activity., (© The Author(s) 2024. Published by Oxford University Press on behalf of the American Physical Therapy Association. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: As the number of nursing home residents with multiple healthcare needs grows, the demand for nursing expertise increases. The implementation of new care models involving nurses with expanded roles is crucial for ensuring quality care in nursing homes., Objectives: To investigate the characteristics and activities of nurses employed in nursing homes in expanded roles and the factors associated with variation in the activities performed., Methods: This multicentre cross-sectional survey in Switzerland collected data from a convenience sample of 118 nursing homes between September 2018 and October 2019. From a subsample of 62 nursing homes, we analysed the characteristics and activities of 104 nurses in expanded roles. Associations between the activities performed and the educational background of the nurses in expanded roles, their direct supervisors' positions and the presence of physicians in the nursing homes were examined., Results: Most Registered Nurses in expanded roles were diploma educated (48%), with fewer having a bachelor's (35%) or master's degree (17%). Overall, direct clinical practice and guidance and coaching activities were conducted monthly to weekly; consultation, evidence-based practice, collaboration and ethical decision-making activities were conducted monthly. We saw variations where a higher educational background was associated with more frequent evidence-based practice activities (z = 3.47, p < 0.001), and if direct supervisors were ward managers, nurses in expanded roles worked more frequently below their scope of practice (z = 4.10, p < 0.001)., Conclusion: This is the first study to use Hamric's integrative Advanced Practice Nursing model to examine the activities of nurses in expanded roles in nursing homes. We found considerable variation in their activities, where nursing homes seem to adapt their roles to their educational background and the local context., Implications for Practice: Our findings show the importance of clarifying role expectations for Registered Nurses in expanded roles, allowing them to practice at the top of the licence to meet residents' complex healthcare needs., (© 2024 The Author(s). International Journal of Older People Nursing published by John Wiley & Sons Ltd.)

A trustful relationship between transplant patients and their transplant team (interpersonal trust) is essential in order to achieve positive health outcomes and behaviors. We aimed to 1) explore variability of trust in transplant teams; 2) explore the association between the level of chronic illness management and trust; 3) investigate the relationship of trust on behavioral outcomes. A secondary data analysis of the BRIGHT study (ID: NCT01608477; https://clinicaltrials.gov/ct2/show/NCT01608477?id=NCT01608477&rank=1) was conducted, including multicenter data from 36 heart transplant centers from 11 countries across four different continents. A total of 1,397 heart transplant recipients and 100 clinicians were enrolled. Trust significantly varied among the transplant centers. Higher levels of chronic illness management were significantly associated with greater trust in the transplant team (patients: AOR= 1.85, 95% CI = 1.47-2.33, p < 0.001; clinicians: AOR = 1.35, 95% CI = 1.07-1.71, p = 0.012). Consultation time significantly moderated the relationship between chronic illness management levels and trust only when clinicians spent ≥30 min with patients. Trust was significantly associated with better diet adherence (OR = 1.34, 95%CI = 1.01-1.77, p = 0.040). Findings indicate the relevance of trust and chronic illness management in the transplant ecosystem to achieve improved transplant outcomes. Thus, further investment in re-engineering of transplant follow-up toward chronic illness management, and sufficient time for consultations is required., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Mielke, Cajita, Denhaerynck, Valenta, Dobbels, Russell, De Geest and the BRIGHT study team.)

Clinical and health services researchers seek to discover effective programs, practices, and interventions to improve people's health. The current paradigm for evidence generation is incremental and misaligned to translate evidence-based discoveries into real-world settings. This persistent challenge are "valleys of death" that represent missed opportunities and preventable missteps to actually use scientific advancements in real-world clinical settings where they can improve health and well-being (De Geest S, Zúñiga F, Brunkert T et al. Powering Swiss health care for the future: implementation science to bridge "the valley of death". 2020;150:w20323). Only one in seven of evidence-based interventions is ever implemented. It is after an average of 17 years. We propose embedding the principles of implementation science throughout the research pipeline, from discovery to adoption, to efficiently translate discoveries into real-world contexts (Balas EA, Boren SA. Managing clinical knowledge for health care improvement. 2000;9:65-70). We outline implications for capacity building, including composition of the research team, study design, and competencies that could bolster the value proposition of implementation science. We describe a research paradigm that recognizes scientists' responsibility to ensure their discoveries be translated into real-world settings., (Published by Oxford University Press on behalf of the Society of Behavioral Medicine 2023.)

Background: The field of eHealth is growing rapidly and chaotically. Health care professionals need guidance on reviewing and assessing health-related smartphone apps to propose appropriate ones to their patients. However, to date, no framework or evaluation tool fulfills this purpose., Objective: Before developing a tool to help health care professionals assess and recommend apps to their patients, we aimed to create an overview of published criteria to describe and evaluate health apps., Methods: We conducted a systematic review to identify existing criteria for eHealth smartphone app evaluation. Relevant databases and trial registers were queried for articles. Articles were included that (1) described tools, guidelines, dimensions, or criteria to evaluate apps, (2) were available in full text, and (3) were written in English, French, German, Italian, Portuguese, or Spanish. We proposed a conceptual framework for app evaluation based on the dimensions reported in the selected articles. This was revised iteratively in discussion rounds with international stakeholders. The conceptual framework was used to synthesize the reported evaluation criteria. The list of criteria was discussed and refined by the research team., Results: Screening of 1258 articles yielded 128 (10.17%) that met the inclusion criteria. Of these 128 articles, 30 (23.4%) reported the use of self-developed criteria and described their development processes incompletely. Although 43 evaluation instruments were used only once, 6 were used in multiple studies. Most articles (83/128, 64.8%) did not report following theoretical guidelines; those that did noted 37 theoretical frameworks. On the basis of the selected articles, we proposed a conceptual framework to explore 6 app evaluation dimensions: context, stakeholder involvement, features and requirements, development processes, implementation, and evaluation. After standardizing the definitions, we identified 205 distinct criteria. Through consensus, the research team relabeled 12 of these and added 11 more-mainly related to ethical, legal, and social aspects-resulting in 216 evaluation criteria. No criteria had to be moved between dimensions., Conclusions: This study provides a comprehensive overview of criteria currently used in clinical practice to describe and evaluate apps. This is necessary as no reviewed criteria sets were inclusive, and none included consistent definitions and terminology. Although the resulting overview is impractical for use in clinical practice in its current form, it confirms the need to craft it into a purpose-built, theory-driven tool. Therefore, in a subsequent step, based on our current criteria set, we plan to construct an app evaluation tool with 2 parts: a short section (including 1-3 questions/dimension) to quickly disqualify clearly unsuitable apps and a longer one to investigate more likely candidates in closer detail. We will use a Delphi consensus-building process and develop a user manual to prepare for this undertaking., Trial Registration: PROSPERO International Prospective Register of Systematic Reviews CRD42021227064; https://www.crd.york.ac.uk/prospero/display&#95;record.php?ID=CRD42021227064., (©Janette Ribaut, Annette DeVito Dabbs, Fabienne Dobbels, Alexandra Teynor, Elisabeth Veronica Mess, Theresa Hoffmann, Sabina De Geest. Originally published in JMIR mHealth and uHealth (https://mhealth.jmir.org), 15.01.2024.)

Background: Cardiometabolic conditions including acute coronary syndrome (ACS) and type 2 diabetes (T2D) require comprehensive care and patient engagement in self-care behaviors, and the drivers of those behaviors at the individual and health system level are still poorly understood., Objective: We aim to gain insights into self-care behaviors of individuals with cardiometabolic conditions., Methods: A convenience sample of 98 adult patients with ACS and T2D was recruited in the United States, Germany, and Taiwan to participate in a mixed methods study using ethnographic methods. All participants completed 7-day web-based diaries tracking their level of engagement, and 48 completed 90-minute web-based semistructured interviews between February 4, 2021, and March 27, 2021, focusing on themes including moments of engagement. Qualitative analysis identified factors influencing self-care practices and a Patient Mind States Model prototype., Results: Patient reports indicate that many patients feel social pressure to adhere to treatment. Patients' experience can be understood within 5 categories defined in terms of their degree of engagement and adherence ("ignoring," "struggling," "juggling," "controlling," and "reframing")., Conclusions: For people living with ACS and T2D, the self-care journey is defined by patterns of patient experiences, which can identify areas that tailored digital health care interventions may play a meaningful role., (©Jan Liska, Marie Mical, Christophe Maillard, Cécile Dessapt, Europa Bendig, Daniel Mai, John D Piette, Sabina De Geest, Guillaume Fontaine. Originally published in JMIR Formative Research (https://formative.jmir.org), 12.01.2024.)

Frailty is increasingly recognized as a salient condition in patients with heart failure (HF) as previous studies have determined that frailty is highly prevalent and prognostically significant, particularly in those with advanced HF. Definitions of frailty have included a variety of domains, including physical performance, sarcopenia, disability, comorbidity, and cognitive and psychological impairments, many of which are common in advanced HF. Multiple groups have recently recommended incorporating frailty assessments into clinical practice and research studies, indicating the need to standardize the definition and measurement of frailty in advanced HF. Therefore, the purpose of this consensus statement is to provide an integrated perspective on the definition of frailty in advanced HF and to generate a consensus on how to assess and manage frailty. We convened a group of HF clinicians and researchers who have expertise in frailty and related geriatric conditions in HF, and we focused on the patient with advanced HF. Herein, we provide an overview of frailty and how it has been applied in advanced HF (including potential mechanisms), present a definition of frailty, generate suggested assessments of frailty, provide guidance to differentiate frailty and related terms, and describe the assessment and management in advanced HF, including with surgical and nonsurgical interventions. We conclude by outlining critical evidence gaps, areas for future research, and clinical implementation., (Copyright © 2023 International Society for the Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Background: Nonadherence to immunosuppressives, a risk factor for poor posttransplant outcomes, can be assessed by self-report using the Basel Assessment of Adherence to Immunosuppressive Medications Scale (BAASIS). Available in written and interview versions, and previously validated on content, the BAASIS is widely used in research and clinical practice. The aim of this study was to investigate its psychometric properties., Methods: Using a literature search and our BAASIS database, this meta-analysis identified completed studies in adult transplant recipients whose data were usable to examine the BAASIS' reliability and 3 validity aspects: (1) relationships with other variables (electronic monitoring, other self-report scales, tacrolimus blood-level variability, collateral report, depressive symptoms, psycho-behavioral constructs, and interventions); (2) response processes; and (3) internal structure. Testing used random-effects logistic regressions., Results: Our sample included 12 109 graft recipients from 26 studies. Of these 26, a total of 20 provided individual participant data. Evidence of the BAASIS' stability over time supports its reliability. Validity testing of relationships with other variables showed that BAASIS-assessed nonadherence was significantly associated with the selected variables: electronically monitored nonadherence ( P < 0.03), other self- and collaterally-reported nonadherence ( P < 0.001), higher variability in tacrolimus concentrations ( P = 0.02), higher barriers ( P < 0.001), lower self-efficacy ( P < 0.001), lower intention ( P < 0.001), and higher worries ( P = 0.02). Nonadherence also decreased after regimen change interventions ( P = 0.03). Response process evaluation indicated good readability and slightly higher nonadherence with the written version. Structurally, items on taking and timing shared variability., Conclusions: The BAASIS shows good validity and reliability as a self-report instrument to assess medication nonadherence in transplantation., Competing Interests: S.D.G. consults for Sanofi and Novartis—activities unrelated to the current work. The other authors declare no conflicts of interest. The BAASIS is copyright the University of Basel (Switzerland) but is freely available for academic and clinical purposes after registration on the BAASIS website ( https://baasis.nursing.unibas.ch/ )., (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc.)

After heart transplantation (HTx), non-adherence to immunosuppressants (IS) is associated with poor outcomes; however, intentional non-adherence (INA) is poorly understood regarding its international variability in prevalence, contributing factors and impact on outcomes. We investigated (1) the prevalence and international variability of INA, (2) patient-level correlates of INA, and (3) relation of INA with clinical outcomes. Secondary analysis of data from the BRIGHT study-an international multi-center, cross-sectional survey examining multi-level factors of adherence in 1,397 adult HTx recipients. INA during the implementation phase, i.e., drug holiday and dose alteration, was measured using the Basel Assessment of Adherence to Immunosuppressive Medications Scale © (BAASIS © ). Descriptive and inferential analysis was performed with data retrieved through patient interview, patient self-report and in clinical records. INA prevalence was 3.3% ( n = 46/1,397)-drug holidays: 1.7% ( n = 24); dose alteration: 1.4% ( n = 20); both: 0.1% ( n = 2). University-level education (OR = 2.46, CI = 1.04-5.83), insurance not covering IS costs (OR = 2.21, CI = 1.01-4.87) and barriers (OR = 4.90, CI = 2.73-8.80) were significantly associated with INA; however, clinical outcomes were not. Compared to other single-center studies, this sample's INA prevalence was low. More than accessibility or financial concerns, our analyses identified patient-level barriers as INA drivers. Addressing patients' IS-related barriers, should decrease INA., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Marston, Berben, Dobbels, Russell and de Geest.)

Background: Although there are already success stories, population health management in Belgium is still in its infancy. A health system transformation approach such as population health management may be suited to address the public health issue of atherosclerotic cardiovascular disease, as this is one of the main causes of mortality in Belgium. This article aims to raise awareness about population health management in Belgium by: (a) eliciting barriers and recommendations for its implementation as perceived by local stakeholders; (b) developing a population health management approach to secondary prevention of atherosclerotic cardiovascular disease; and (c) providing a roadmap to introduce population health management in Belgium., Methods: Two virtual focus group discussions were organized with 11 high-level decision makers in medicine, policy and science between October and December 2021. A semi-structured guide based on a literature review was used to anchor discussions. These qualitative data were studied by means of an inductive thematic analysis., Results: Seven inter-related barriers and recommendations towards the development of population health management in Belgium were identified. These related to responsibilities of different layers of government, shared responsibility for the health of the population, a learning health system, payment models, data and knowledge infrastructure, collaborative relationships and community involvement. The introduction of a population health management approach to secondary prevention of atherosclerotic cardiovascular disease may act as a proof-of-concept with a view to roll out population health management in Belgium., Conclusions: There is a need to instill a sense of urgency among all stakeholders to develop a joint population-oriented vision in Belgium. This call-to-action requires the support and active involvement of all Belgian stakeholders, both at the national and regional level., (© 2023. The Author(s).)

Aim: Nurse-led care aims to optimize the discharge preparation with a focus on increasing patients' independency and self-care abilities. This study compared patients' improvements of self-care abilities and frequency of readmission rate between nurse-led care and regular nursing care within the acute hospital setting., Design: A quasi-experimental design within a real-world setting was used for this work., Methods: We included a pool of 2501 patients from a control group (medically stable in usual care) and 420 patients from an intervention group (nurse-led care). After propensity score matching, the study cohort consisted of 612 patients., Results: From admission to discharge, nurse-led care patients showed superior improvements of total self-care abilities compared to usual care patients. In particular, we found improvements in the following categories: mobility, grooming and excretion. Patients with nurse-led care were furthermore less frequently readmitted to hospital compared with the control group patients., Patient or Public Contribution: No patient or public contribution., (© 2023 The Authors. Nursing Open published by John Wiley & Sons Ltd.)

Background: Identification of differences in medication adherence by sex or organ type may help in planning interventions to optimize outcomes. We compared immunosuppressive medication adherence between males and females, and between kidney, liver and heart transplant recipients., Methods: This multicenter study of prevalent kidney, liver and heart transplant recipients 14-25 years assessed adherence 3 times (0, 3, 6 months post-enrollment) with the BAASIS self-report tool. At each visit, participants were classified as adherent if they missed no doses in the prior 4 weeks and non-adherent otherwise. Adherence was also assessed using the coefficient of variation (CV) of tacrolimus trough levels; CV < 30% was classified as adherent. We used multivariable mixed effects logistic regression models adjusted for potential confounders to compare adherence by sex and by organ., Results: Across all visits, males (n = 150, median age 20.4 years, IQR 17.2-23.3) had lower odds of self-reported adherence than females (n = 120, median age 19.8 years, IQR 17.1-22.7) (OR 0.41, 95% CI 0.21-0.80) but higher odds of adherence by tacrolimus CV (OR 2.50, 95% CI 1.30-4.82). No significant differences in adherence (by self-report or tacrolimus CV) were noted between the 184 kidney, 58 liver, and 28 heart recipients., Conclusion: Females show better self-reported adherence than males but greater variability in tacrolimus levels. Social desirability bias, more common in females than males, may contribute to better self-reported adherence among females. Higher tacrolimus variability among females may reflect biologic differences in tacrolimus metabolism between males and females rather than sex differences in adherence. There were no significant differences in adherence by organ type., (© 2022 Wiley Periodicals LLC.)

A valid and reliable instrument that can measure adherence is needed to identify nonadherent patients and to improve adherence. However, there is no validated Japanese self-report instrument to evaluate adherence to immunosuppressive medications for transplant patients. The purpose of this study was to determine the reliability and validity of the Japanese version of the Basel Assessment of Adherence to Immunosuppressive Medications Scale (BAASIS)., Methods: We translated the BAASIS into Japanese and developed the Japanese version of the BAASIS (J-BAASIS) according to the International Society of Pharmacoeconomics and Outcomes Research task force guidelines. We analyzed the reliability (test-retest reliability and measurement error) and validity of the J-BAASIS (concurrent validity with the medication event monitoring system and the 12-item Medication Adherence Scale) referring to the COSMIN Risk of Bias checklist., Results: A total of 106 kidney transplant recipients were included in this study. In the analysis of test-retest reliability, Cohen's kappa coefficient was found to be 0.62. In the analysis of measurement error, the positive and negative agreement were 0.78 and 0.84, respectively. In the analysis of concurrent validity with the medication event monitoring system, sensitivity and specificity were 0.84 and 0.90, respectively. In the analysis of concurrent validity with the 12-item Medication Adherence Scale, the point-biserial correlation coefficient for the "medication compliance" subscale was 0.38 ( P  < 0.001)., Conclusions: The J-BAASIS was determined to have good reliability and validity. Using the J-BAASIS to evaluate adherence can help clinicians to identify medication nonadherence and institute appropriate corrective measures to improve transplant outcomes., Competing Interests: The authors declare no conflicts of interest., (Copyright © 2023 The Author(s). Transplantation Direct. Published by Wolters Kluwer Health, Inc.)

Background: Contextually adapting complex interventions and tailoring their implementation strategies is key to a successful and sustainable implementation. While reporting guidelines for adaptations and tailoring exist, less is known about how to conduct context-specific adaptations of complex health care interventions., Aims: To describe in methodological terms how the merging of contextual analysis results (step 1) with stakeholder involvement, and considering overarching regulations (step 2) informed our adaptation of an Integrated Care Model (ICM) for SteM cell transplantatIon faciLitated by e Health (SMIL e ) and the tailoring of its implementation strategies (step 3)., Methods: Step 1: We used a mixed-methods design at University Hospital Basel, guided by the Basel Approach for coNtextual ANAlysis (BANANA). Step 2: Adaptations of the SMILe-ICM and tailoring of implementation strategies were discussed with an interdisciplinary team ( n  = 28) by considering setting specific and higher-level regulatory scenarios. Usability tests were conducted with patients ( n  = 5) and clinicians ( n  = 4). Step 3: Adaptations were conducted by merging our results from steps 1 and 2 using the Framework for Reporting Adaptations and Modifications-Enhanced (FRAME). We tailored implementation strategies according to the Expert Recommendations for Implementing Change (ERIC) compilation., Results: Step 1: Current clinical practice was mostly acute-care-driven. Patients and clinicians valued eHealth-facilitated ICMs to support trustful patient-clinician relationships and the fitting of eHealth components to context-specific needs. Step 2 : Based on information from project group meetings, adaptations were necessary on the organizational level (e.g., delivery of self-management information). Regulations informed the tailoring of SMILe-ICM`s visit timepoints and content; data protection management was adapted following Swiss regulations; and steering group meetings supported infrastructure access. The usability tests informed further adaptation of technology components. Step 3: Following FRAME and ERIC, SMILe-ICM and its implementation strategies were contextually adapted and tailored to setting-specific needs., Discussion: This study provides a context-driven methodological approach on how to conduct intervention adaptation including the tailoring of its implementation strategies. The revealed meso-, and macro-level differences of the contextual analysis suggest a more targeted approach to enable an in-depth adaptation process. A theory-guided adaptation phase is an important first step and should be sufficiently incorporated and budgeted in implementation science projects., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2023 Valenta, Ribaut, Leppla, Mielke, Teynor, Koehly, Gerull, Grossmann, Witzig-Brändli and De Geest.)

Background: HRQoL is an indicator of individuals' perception of their overall health, including social and environmental aspects. As a multidimensional concept, HRQoL can be influenced by a multitude of factors. Studies of HRQoL and factors associated with it among home-dwelling older adults have often been limited to inpatient settings or to a sub-population with a chronic disease. Studying HRQoL and its correlating factors among this population, by providing an ecological lens on factors beyond the individual level, can provide a better understanding of the construct and the role of the environment on how they perceive their HRQoL. Thus, we aimed to assess the HRQoL and investigate the correlates of HRQOL among home-dwelling older adults, guided by the levels of the ecological model., Methods: This is a cross-sectional population survey conducted in 2019 in Canton Basel-Landschaft, in northwestern Switzerland, and includes a sample of 8786 home-dwelling older adults aged 75 and above. We assessed HRQoL by using the EQ-index and the EQ-VAS. The influence of independent variables at the macro, meso and micro level on HRQoL was tested using Tobit multiple linear regression modelling., Results: We found that having a better socio-economic status as denoted by higher income, having supplementary insurance and a higher level of education were all associated with a better HRQoL among home-dwelling older adults. Furthermore, being engaged in social activities was also related to an improved HRQoL. On the other hand, older age, female gender, presence of multimorbidity and polypharmacy as well as social isolation and loneliness were found to all have a negative impact on HRQoL., Conclusions: Understanding factors related to HRQoL by using an ecological lens can help identify factors beyond the individual level that impact the HRQoL of home-dwelling older adults. Our study emphasises the importance of social determinants of health and potential disparities that exists, encouraging policymakers to focus on policies to reduce socio-economic disparities using a life-course approach, which consequently could also impact HRQoL in later stages of life., (© 2022. The Author(s).)

Background: Evaluations of integrated care models for home-dwelling frail older adults have shown inconclusive results on health and service outcomes. However, limited research has focused on the implementation of integrated care models. Applying implementation science methods may facilitate uptake of integrated care models, thus generating positive outcomes e.g., reduced hospital admissions. This paper describes the protocol to assess the feasibility of an integrated care model (featuring a four-step comprehensive geriatric assessment: screening, a multi-dimensional assessment, a coordinated individualized care plan and follow-up) designed for a new community-based center for home-dwelling older adults in Switzerland. The study includes the following objectives: 1) to assess implementation by a) monitoring respondents to the outreach strategies and describing the Center's visitors; b) assessing implementation outcomes related to the care model (i.e., adoption, acceptability, feasibility, fidelity) and implementation processes related to collaboration; and 2) assessing implementation costs., Methods: For objective 1a, we will use a descriptive design to assess respondents to the outreach strategies and describe the Center's visitors. We will use a parallel convergent mixed methods design for objective 1b. Implementation outcomes data will be collected from meetings with the Center's staff, interviews with older adults and their informal caregivers, and reviewing older adults' health records at the Center. Implementation processes related to collaboration will be assessed through a questionnaire to external collaborators (e.g., GPs) towards the end of the study. For objective 2, implementation costs will be calculated using time-driven activity-based costing methods. Data collection is anticipated to occur over approximately six months., Discussion: This study of a contextually adapted integrated care model will inform adaptations to the outreach strategies, care model and implementation strategies in one community center, prior to evaluating the care model effectiveness and potentially scaling out the intervention., Trial Registration: Feasibility study registration ID with clinicaltrials.gov: NCT05302310; registration ID with BMC: ISRCTN12324618., Competing Interests: Unrelated to the current work, LZ consults for Novartis and MB received unrestricted grants from Moderna. This does not alter our adherence to PLOS ONE policies on sharing data and materials., (Copyright: This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 public domain dedication.)

Background: Within implementation science studies, contextual analysis is increasingly recognized as foundational to interventions' successful and sustainable implementation. However, inconsistencies between methodological approaches currently limit progress in studying context and guidance to standardize the use of those approaches is scant. Therefore, this study's objective was to systematically review and map current methodological approaches to contextual analysis in intervention implementation studies. The results would help us both to systematize the process of contextual analysis and identify gaps in the current evidence., Methods: We conducted an evidence gap map (EGM) based on literature data via a stepwise approach. First, using an empirically developed search string, we randomly sampled 20% of all intervention implementation studies available from PubMed per year (2015-2020). Second, we assessed included studies that conducted a contextual analysis. Data extraction and evaluation followed the Basel Approach for CoNtextual ANAlysis (BANANA), using a color-coded rating scheme. Also based on BANANA and on the Context and Implementation of Complex Interventions (CICI) framework-an implementation framework that pays ample attention to context- we created visual maps of various approaches to contextual analysis., Results: Of 15, 286 identified intervention implementation studies and study protocols, 3017 were screened for inclusion. Of those, 110 warranted close examination, revealing 22% that reported on contextual analysis. Only one study explicitly applied a framework for contextual analysis. Data were most commonly collected via surveys (n = 15) and individual interviews (n = 13). Ten studies reported mixed-methods analyses. Twenty-two assessed meso-level contextual and setting factors, with socio-cultural aspects most commonly studied. Eighteen described the use of contextual information for subsequent project phases (e.g., intervention development/adaption, selecting implementation strategies). Nine reported contextual factors' influences on implementation and/or effectiveness outcomes., Conclusions: This study describes current approaches to contextual analysis in implementation science and provides a novel framework for evaluating and mapping it. By synthesizing our findings graphically in figures, we provide an initial evidence base framework that can incorporate new findings as necessary. We strongly recommend further development of methodological approaches both to conduct contextual analysis and to systematize the reporting of it. These actions will increase the quality and consistency of implementation science research., (© 2022. The Author(s).)

Purpose: To explore the association between the degree of Chronic illness management and survival rates at 1-, 3-, 5-years post heart transplantation., Methods: Exploratory secondary analysis of a cross-sectional, international study (Building Research Initiative Group study). Latent profile analysis was performed to classify 36 heart transplant centers according to the degree of chronic illness management., Results: The analysis resulted in 2 classes with 29 centers classified as "low-degree chronic illness management" and 7 centers as "high-degree chronic illness management". After 1-year posttransplantation, the high-degree chronic illness management class had a significantly greater mean survival rate compared to the low-degree chronic illness management class (88.4% vs 84.2%, p  = 0.045) and the difference had a medium effect size (η2 = .06). No difference in survival for the other time points was observed. Patients in high-degree chronic illness management centers had 52% lower odds of moderate to severe drinking (95% confidence interval .30-.78, p  = 0.003). No significant associations between degree of chronic illness management and the other recommended health behaviors were observed., Conclusions: The findings from this exploratory study offer preliminary insight into a system-level pathway (chronic illness management) for improving outcomes for heart transplant recipients. The signals observed in our data support further investigation into the effectiveness of chronic illness management-based interventions in heart transplant follow-up care.

Aims: Social support is critical in follow-up of patients after heart transplant (HTx) and positively influences well-being and clinical outcomes such as medication adherence. The purpose of this study was to (i) explore received social support variation (emotional and practical) in HTx recipients at country and centre level and (ii) to assess multi-level correlates., Methods and Results: Secondary data analysis of the multi-level cross-sectional BRIGHT study was conducted in 36 HTx centres in 11 countries. Received social support related to medication adherence was measured with emotional and practical sub-scales. The Conceptual Model of Social Networks and Health guided selection of patient, micro (interpersonal and psychosocial), meso (HTx centre) and macro-level (country health system) factors. Descriptive statistics, intraclass correlations, and sequential multiple ordinal mixed logistic regression analysis were used. A total of 1379 adult HTx recipients were included. Patient level correlates (female sex, living alone, and fewer depressive symptoms) and micro-level correlates (higher level of chronic disease management and trust in the healthcare team) were associated with better emotional social support. Similarly, patient level (living alone, younger age, and male sex), micro-level and meso-level (patient and clinician-rated higher level of chronic disease management) were associated with better practical social support. Social support varied at country and centre levels for emotional and practical dimensions., Conclusions: Social support in HTx recipients varies by country, centre, and was associated with multi-level correlates. Qualitative and longitudinal studies are needed to understand influencing factors of social support for intervention development, improvement of social support, and clinical outcomes., Competing Interests: Conflict of interest: None declared., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Background: Home-dwelling frail older adults are often faced with multimorbidity and complex care needs, requiring health and social care systems that support frail older adults to age in place. The objective of this paper was to investigate the types of formal health and social care as well as informal care and social support used by home-dwelling frail older adults; whether they perceive their support as sufficient; and their experience with and preferences for care and support., Methods: Using an explanatory sequential mixed methods design, we first conducted a secondary analysis of a subset of cross-sectional data from the ImplemeNtation of a community-baSed care Program for home dwelling senIoR citizEns (INSPIRE) population survey using descriptive analysis. Subsequently, we analyzed existing data from interviews in the parent study to help explain the survey results using applied thematic analysis. Results were organized according to adapted domains and concepts of the SELFIE framework and integrated via a joint display table., Results: Of the parent population survey respondents, 2314 older adults indicating frailty were included in the quantitative arm of this study. Interview data was included from 7 older adults who indicated frailty. Support from health and social, formal and informal caregivers is diverse and anticipated to increase (e.g., for 'care and assistance at home' and 'meal services'). Informal caregivers fulfilled various roles and while some older adults strongly relied on them for support, others feared burdening them. Most participants (93.5%) perceived their overall support to meet their needs; however, findings suggest areas (e.g., assessment of overall needs) which merit attention to optimize future care., Conclusions: Given the anticipated demand for future care and support, we recommend efforts to prevent fragmentation between health and social as well as formal and informal care., (© 2022. The Author(s).)

Background: Transplantoux's MVT exercise intervention prepares organ transplant recipients to cycle or hike up France's Mont Ventoux. We aimed to assess (i) MVT's effects on patient-reported outcomes (PROs) and (ii) perceived barriers and facilitators to physical activity., Methods: Using a hybrid design, a convenience sample of transplant recipients participating in MVT (n = 47 cycling (TxCYC); n = 18 hiking (TxHIK)), matched control transplant recipients (TxCON, n = 213), and healthy MVT participants (HCON, n = 91) completed surveys to assess physical activity (IPAQ), health-related quality of life (HRQOL; SF-36 and EuroQol VAS), mental health (GHQ-12), and depressive symptomatology, anxiety, and stress (DASS-21) at baseline, then after 3, 6 (Mont Ventoux climb), 9, and 12 months. TxCYC and TxHIK participated in a 6-month intervention of individualized home-based cycling/hiking exercise and a series of supervised group training sessions. Barriers and facilitators to physical activity (Barriers and Motivators Questionnaire) were measured at 12 months., Results: Regarding PROs, except for reducing TxHIK stress levels, MVT induced no substantial intervention effects. For both TxCYC and TxHIK, between-group comparisons at baseline showed that physical activity, HRQOL, mental health, depressive symptomatology and stress were similar to those of HCON. In contrast, compared to TxCYC, TxHIK, and HCON, physical activity, HRQOL and mental health were lower in TxCON. TxCON also reported greater barriers, lower facilitators, and different priority rankings concerning physical activity barriers and facilitators., Conclusion: Barely any of the PROs assessed in the present study responded to Transplantoux's MVT exercise intervention. TxCON reported distinct and unfavorable profiles regarding PROs and barriers and facilitators to physical activity. These findings can assist tailored physical activity intervention development., Trial Registration: Clinical trial notation: The study was approved by the University Hospitals Leuven's Institutional Review Board (B322201523602)., Competing Interests: The authors have declared that no competing interests exist.

Background and objective: Non-adherence to tacrolimus commonly manifests as low drug concentrations and/or high intra-patient variability (IPV) of concentrations across multiple measurements. We aimed to compare several methods of tacrolimus IPV calculation and evaluate how well each reflects blood concentration variation due to medication non-adherence in kidney transplant recipients. Methods: This Czech single-center retrospective longitudinal study was conducted in 2019. All outpatients ≥18 years of age, ≥3 months post-transplant, and on tacrolimus-based regimens were approached. After collecting seven consecutive tacrolimus concentrations we asked participating patients to self-report adherence to immunosuppressants (BAASIS © scale). The IPV of tacrolimus was calculated as the medication level variability index (MLVI), the coefficient of variation (CV), the time-weighted CV, and via nonlinearly modeled dose-corrected trough levels. These patient-level variables were analyzed using regression analysis. Detected nonlinearities in the dose-response curve were controlled for by adding tacrolimus dosing and its higher-order terms as covariates, along with self-reported medication adherence levels. Results: Of 243 patients using tacrolimus, 42% ( n = 102) reported medication non-adherence. Non-adherence was associated with higher CVs, higher time-weighted CVs, and lower dose-corrected nonlinearly modeled trough levels; however, it was not associated with MLVIs. All of the significant operationalizations suggested a weak association that was similar across the applied methods. Discussion and conclusion: Implementation non-adherence was reflected by higher CV or time-weighted CV and by lower blood concentrations of tacrolimus. As an additional tool for identifying patients at risk for non-adherence, simple IPV calculations incorporated into medical records should be considered in everyday clinical practice., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Kostalova, Mala-Ladova, Sulkova, Denhaerynck, De Geest and Maly.)

Background: Designing intervention and implementation strategies with careful consideration of context is essential for successful implementation science projects. Although the importance of context has been emphasized and methodology for its analysis is emerging, researchers have little guidance on how to plan, perform, and report contextual analysis. Therefore, our aim was to describe the Basel Approach for coNtextual ANAlysis (BANANA) and to demonstrate its application on an ongoing multi-site, multiphase implementation science project to develop/adapt, implement, and evaluate an integrated care model in allogeneic SteM cell transplantatIon facILitated by eHealth (the SMILe project)., Methods: BANANA builds on guidance for assessing context by Stange and Glasgow (Contextual factors: the importance of considering and reporting on context in research on the patient-centered medical home, 2013). Based on a literature review, BANANA was developed in ten discussion sessions with implementation science experts and a medical anthropologist to guide the SMILe project's contextual analysis. BANANA's theoretical basis is the Context and Implementation of Complex Interventions (CICI) framework. Working from an ecological perspective, CICI acknowledges contextual dynamics and distinguishes between context and setting (the implementation's physical location)., Results: BANANA entails six components: (1) choose a theory, model, or framework (TMF) to guide the contextual analysis; (2) use empirical evidence derived from primary and/or secondary data to identify relevant contextual factors; (3) involve stakeholders throughout contextual analysis; (4) choose a study design to assess context; (5) determine contextual factors' relevance to implementation strategies/outcomes and intervention co-design; and (6) report findings of contextual analysis following appropriate reporting guidelines. Partly run simultaneously, the first three components form a basis both for the identification of relevant contextual factors and for the next components of the BANANA approach., Discussion: Understanding of context is indispensable for a successful implementation science project. BANANA provides much-needed methodological guidance for contextual analysis. In subsequent phases, it helps researchers apply the results to intervention development/adaption and choices of contextually tailored implementation strategies. For future implementation science projects, BANANA's principles will guide researchers first to gather relevant information on their target context, then to inform all subsequent phases of their implementation science project to strengthen every part of their work and fulfill their implementation goals., (© 2022. The Author(s).)

Importance: Whether interprofessional collaboration is effective and safe in decreasing hospital length of stay remains controversial., Objective: To evaluate the outcomes and safety associated with an electronic interprofessional-led discharge planning tool vs standard discharge planning to safely reduce length of stay among medical inpatients with multimorbidity., Design, Setting, and Participants: This multicenter prospective nonrandomized controlled trial used interrupted time series analysis to examine medical acute hospitalizations at 82 hospitals in Switzerland. It was conducted from February 2017 through January 2019. Data analysis was conducted from March 2021 to July 2022., Intervention: After a 12-month preintervention phase (February 2017 through January 2018), an electronic interprofessional-led discharge planning tool was implemented in February 2018 in 7 intervention hospitals in addition to standard discharge planning., Main Outcomes and Measures: Mixed-effects segmented regression analyses were used to compare monthly changes in trends of length of stay, hospital readmission, in-hospital mortality, and facility discharge after the implementation of the tool with changes in trends among control hospitals., Results: There were 54 695 hospitalizations at intervention hospitals, with 27 219 in the preintervention period (median [IQR] age, 72 [59-82] years; 14 400 [52.9%] men) and 27 476 in the intervention phase (median [IQR] age, 72 [59-82] years; 14 448 [52.6%] men) and 438 791 at control hospitals, with 216 261 in the preintervention period (median [IQR] age, 74 [60-83] years; 109 770 [50.8%] men) and 222 530 in the intervention phase (median [IQR] age, 74 [60-83] years; 113 053 [50.8%] men). The mean (SD) length of stay in the preintervention phase was 7.6 (7.1) days for intervention hospitals and 7.5 (7.4) days for control hospitals. During the preintervention phase, population-averaged length of stay decreased by -0.344 hr/mo (95% CI, -0.599 to -0.090 hr/mo) in control hospitals; however, no change in trend was observed among intervention hospitals (-0.034 hr/mo; 95% CI, -0.646 to 0.714 hr/mo; difference in slopes, P = .09). Over the intervention phase (February 2018 through January 2019), length of stay remained unchanged in control hospitals (slope, -0.011 hr/mo; 95% CI, -0.281 to 0.260 hr/mo; change in slope, P = .03), but decreased steadily among intervention hospitals by -0.879 hr/mo (95% CI, -1.607 to -0.150 hr/mo; change in slope, P = .04, difference in slopes, P = .03). Safety analyses showed no change in trends of hospital readmission, in-hospital mortality, or facility discharge over the whole study time., Conclusions and Relevance: In this nonrandomized controlled trial, the implementation of an electronic interprofessional-led discharge planning tool was associated with a decline in length of stay without an increase in hospital readmission, in-hospital mortality, or facility discharge., Trial Registration: isrctn.org Identifier: ISRCTN83274049.

Background: While effectiveness outcomes of eHealth-facilitated integrated care models (eICMs) in transplant and oncological populations are promising, implementing and sustaining them in real-world settings remain challenging. Allogeneic stem cell transplant (alloSCT) patients could benefit from an eICM to enhance health outcomes. To combat health deterioration, integrating chronic illness management, including continuous symptom and health behaviour monitoring, can shorten reaction times. We will test the 1st-year post-alloSCT effectiveness and evaluate bundled implementation strategies to support the implementation of a newly developed and adapted eICM in allogeneic stem cell transplantation facilitated by eHealth (SMILe-ICM). SMILe-ICM has been designed by combining implementation, behavioural, and computer science methods. Adaptions were guided by FRAME and FRAME-IS. It consists of four modules: 1) monitoring & follow-up; 2) infection prevention; 3) physical activity; and 4) medication adherence, delivered via eHealth and a care coordinator (an Advanced Practice Nurse). The implementation was supported by contextually adapted implementation strategies (e.g., creating new clinical teams, informing local opinion leaders)., Methods: Using a hybrid effectiveness-implementation randomised controlled trial, we will include a consecutive sample of 80 adult alloSCT patients who were transplanted and followed by University Hospital Basel (Switzerland). Inclusion criteria are basic German proficiency; elementary computer literacy; internet access; and written informed consent. Patients will be excluded if their condition prevents the use of technology, or if they are followed up only at external centres. Patient-level (1:1) stratified randomisation into a usual care group and a SMILe-ICM group will take place 10 days pre-transplantation. To gauge the SMILe-ICM's effectiveness primary outcome (re-hospitalisation rate), secondary outcomes (healthcare utilization costs; length of inpatient re-hospitalizations, medication adherence; treatment and self-management burden; HRQoL; Graft-versus-Host Disease rate; survival; overall survival rate) and implementation outcomes (acceptability, appropriateness, feasibility, fidelity), we will use multi-method, multi-informant assessment (via questionnaires, interviews, electronic health record data, cost capture methods)., Discussion: The SMILe-ICM has major innovative potential for reengineering alloSCT follow-up care, particularly regarding short- and medium-term outcomes. Our dual focus on implementation and effectiveness will both inform optimization of the SMILe-ICM and provide insights regarding implementation strategies and pathway, understudied in eHealth-facilitated ICMs in chronically ill populations., Trial Registration: ClinicalTrials.gov. Identifier: NCT04789863 . Registered April 01, 2021., (© 2022. The Author(s).)

Competing Interests: Author MO was employed by the company Novartis Pharma AG. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Background: Unplanned rehospitalizations occur frequently in older patients. Drug-related problems constitute a major and largely preventable cause with inappropriate prescribing being a substantial culprit. Solutions are needed to reduce this risk by targeting pharmacotherapy both during and after hospital stay. Therefore, we aim to perform a randomized controlled trial in geriatric inpatients to investigate the impact of a multifaceted clinical pharmacy intervention on health-related outcomes., Methods/design: The study concerns a monocenter, non-blinded, randomized controlled trial that will take place at the acute geriatric wards of a large academic hospital. Patients being in a palliative stage with active therapy withdrawal or patients discharged to another ward within the same hospital or another hospital are excluded. In total, 828 patients will be randomized (1:1) to the usual care or intervention group. The multifaceted clinical pharmacy intervention comprises medication reconciliation at admission and discharge, medication review, patient/caregiver education, intensified communication with primary care providers and post-discharge follow-up, which also includes a telepharmacology service. The primary endpoint is defined as the time to an all-cause, unplanned hospital revisit within six months after discharge. Other health-related outcomes such as drug-related readmissions, quality of life and number of potentially inappropriate medications will be analyzed as secondary endpoints. Patient inclusion started in February 2021., Discussion: This study will provide useful insights regarding the impact of clinical pharmacy interventions on geriatric wards with the goal to optimize health-related outcomes such as hospital revisits., Trial Registration: ClinicalTrials.gov Identifier: NCT04617340., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Context in implementation science includes not only characteristics of a setting in which an intervention will be delivered, but also social systems (e.g., interrelationships). Context is dynamic and interacts with both, the intervention and its implementation. Therefore, contextual analysis is recognized as an indispensable part of implementation science methodology: it provides the foundation for successful and sustainable implementation projects. Yet, driven by the prevailing post-positivist understanding of context, contextual analysis typically focuses on individual characteristics of context i.e., contextual dynamics and interactions go unnoticed. Conducting contextual analysis from a constructivist perspective promotes a multilayered approach, building a more comprehensive understanding of context, and thus facilitating successful implementation. In this article, we highlight the limitations of prevailing perspectives on context and approaches to contextual analysis. We then describe how contextual analysis can be enriched by working from a constructivist perspective. We finish with a discussion of the methodological and practical implications the proposed changes would entail. Emerging literature attempts to address both the concept of context and methods for contextual analysis. Various theories, models and frameworks consider context, however, many of these are reductionistic and do not acknowledge the dynamic nature of context or interactions within it. To complement recent conceptualizations of context, we suggest consider the following five constructivist concepts: 1) social space; 2) social place; 3) agency; 4) sensation; and 5) embodiment. We demonstrate the value of these concepts using COVID-19 vaccination uptake as an example and integrate the concepts in the Context and Implementation of Complex Interventions (CICI) framework- an implementation science framework that pays ample attention to context. To study context from a constructivist perspective, we also suggest additional considerations in view of methodologies for data collection and analysis, e.g., rapid ethnographic methods. A constructivist perspective contributes to a stronger conceptualization of contextual analysis. Considering the five constructivist concepts helps to overcome contextual analysis' current shortcomings, while revealing complex dynamics that usually go unnoticed. Thus, more comprehensive understanding of context can be developed to inform subsequent phases of an implementation project, thereby maximizing an intervention's uptake and sustainability., (Copyright © 2022 Mielke, De Geest, Zúñiga, Brunkert, Zullig, Pfadenhauer and Staudacher.)

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).)