Development of a competency framework for advanced practice nurses: A co-design process.

AIMS: The aim of the study was to develop a comprehensive competency framework for advanced practice nurses in Belgium. DESIGN: A co-design development process was conducted. METHODS: This study consisted of two consecutive stages (November 2020-December 2021): (1) developing a competency framework for advanced practice nurses in Belgium by the research team, based on literature and (2) group discussions or interviews with and written feedback from key stakeholders. 11 group discussions and seven individual interviews were conducted with various stakeholder groups with a total of 117 participants. RESULTS: A comprehensive competency framework containing 31 key competencies and 120 enabling competencies was developed based on the Canadian Medical Education Directions for Specialists Competency Framework. These competencies were grouped into seven roles: clinical expert and therapist, organizer of quality care and leader in innovation, professional and clinical leader, collaborator, researcher, communicator and health promoter. CONCLUSION: The developed competency framework has resemblance to other international frameworks. This framework emphasized the independent role of the advanced practice nurse and provided guidance in a clear task division and delegation to other professionals. It can provide a solid foundation for delivering high-quality, patient-centred care by advanced practice nurses in the years to come. IMPLICATIONS FOR THE PROFESSION: This competency framework can guide further development of advanced practice nursing education in Belgium and represents a starting point for future evaluation of its feasibility and usability in education and clinical practice. Advanced practice nurses and healthcare managers can also use the framework as an instrument for personal and professional development, performance appraisal, and further alignment of these function profiles in clinical practice. Finally, this framework can inform and guide policymakers towards legal recognition of advanced practice nursing in Belgium and inspire the development of advanced practice nursing profiles in countries where these profiles are still emerging. IMPACT: What problem did the study address? The absence of a detailed competency framework for advanced practice nurses complicates legal recognition, role clarification and implementation in practice in Belgium. A rigorously developed competency framework could clarify which competencies to integrate in future advanced practice nursing education, mentorship programs and practice. What were the main findings? The competency framework outlined seven roles for advanced practice nurses: clinical expert and therapist, organizer of quality care and leader in innovation, professional and clinical leader, collaborator, researcher, communicator, and health promoter. Differentiation from other expert nursing profiles and clinical autonomy of advanced practice nurses were pivotal. Where and on whom will the research have impact? The comprehensive competency framework for advanced practice nurses and the collaborative methodology used can inspire other countries where these profiles are still emerging. The competency framework can be used as an instrument for role clarification, performance appraisals, continuous professional development, and professional (e-)portfolios. The competency framework can guide policymakers when establishing Belgian's legal framework for advanced practice nurses. REPORTING METHOD: The authors have adhered to CONFERD-HP: recommendations for reporting COmpeteNcy FramEwoRk Development in health professions. PATIENT OR PUBLIC CONTRIBUTION: No patient or public contribution in the design of the study. A patient advisory panel commented on the developed competency framework.

Trust in the Transplant Team Associated With the Level of Chronic Illness Management-A Secondary Data Analysis of the International BRIGHT Study.

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.

Validation of a Core Patient-Reported Outcome Measure for Life Participation in Kidney Transplant Recipients: the SONG Life Participation Instrument.

Introduction: Life participation has been established as a critically important core for trials in kidney transplantation. We aimed to validate a patient-reported outcome measure for life participation in kidney transplant recipients. Methods: A psychometric evaluation of the Standardized Outcomes in Nephrology life participation (SONG-LP) measure was conducted in adult kidney transplant recipients. The measure includes 4 items of life participation (leisure, family, work, and social) each with a 5-point Likert scale. Each item is scored from 0 (never) to 4 (always) and the summary measure score the average of each item. Results: A total of 249 adult kidney transplant recipients from 20 countries participated. The SONG-LP instrument demonstrated internal consistency (Cronbach's α = 0.87; 95% confidence intervals [CI]: 0.83-0.90, baseline) and test-retest reliability over 1 week (intraclass correlation coefficient of 0.62; 95% CI: 0.54-0.70). There was moderate to high correlation (0.65; 95% CI: 0.57-0.72) with the PROMIS Ability to Participate in Social Roles and Activities Short Form 8a that assessed a similar construct, and moderate correlation with measures that assessed related concepts (i.e., EQ5D 0.57; 95% CI: 0.49-0.65), PROMIS Cognitive Functional Abilities Subset Short Form 4a (0.40; 95% CI: 0.29-0.50). Conclusion: The SONG-LP instrument is a simple, internally consistent, reliable measure for kidney transplant recipients and correlates with similar measures. Routine incorporation in clinical trials will ensure consistent and appropriate assessment of life participation for informed patient-centered decision-making.

Developing a Comprehensive List of Criteria to Evaluate the Characteristics and Quality of eHealth Smartphone Apps: Systematic Review.

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_record.php?ID=CRD42021227064.

Medication adherence in pediatric kidney transplantation: How to build a bridge over troubled water.

Adhering to the immunosuppressive regimen remains one of the biggest challenges for children and adolescents after kidney transplantation. The first paper on nonadherence, co-authored by Dr. Fine, appeared in Pubmed over 45 years ago. Since then, many clinicians and researchers tried to better understand nonadherence and are looking for effective ways to support young people in implementing the complex medication regimen in their daily lives. As a tribute to Dr. Fine, we conducted a comprehensive review providing an overview of adherence-enhancing interventions in the field of pediatric kidney transplantation, thereby focusing on strategies that not only are effective but can also be embedded in daily clinical practice successfully and sustainably. This overview is preceded by a discussion about how to find out who is in need of supportive interventions. We will also argue that interventions should already start before pediatric kidney transplantation and discuss how to decide whether or not a young patient with nonadherence-induced graft loss should undergo retransplantation. We hope this comprehensive overview will rekindle the hope that we can finally turn the tide and beat one of pediatric kidney transplantation's main enemies.

Cultural adaptation and validation of the Brazilian Portuguese version of the PROactive Physical Activity in COPD-clinical visit instrument for individuals with COPD.

OBJECTIVE: To adapt the PROactive Physical Activity in COPD-clinical visit (C-PPAC) instrument to the cultural setting in Brazil and to determine the criterion validity, test-retest reliability agreement, and internal consistency of this version. METHODS: A protocol for cultural adaptation and validation was provided by the authors of the original instrument and, together with another guideline, was applied in a Portuguese-language version developed by a partner research group from Portugal. The adapted Brazilian Portuguese version was then cross-sectionally administered twice within a seven-day interval to 30 individuals with COPD (57% were men; mean age was 69 ± 6 years; and mean FEV1 was 53 ± 18% of predicted) to evaluate internal consistency and test-retest reliability. Participants also completed the International Physical Activity Questionnaire (IPAQ), the modified Medical Research Council scale, the COPD Assessment Test, and Saint George's Respiratory Questionnaire to evaluate criterion validity. RESULTS: The C-PPAC instrument showed good internal consistency and excellent test-retest reliability: "amount" domain = 0.87 (95% CI, 0.73-0.94) and "difficulty" domain = 0.90 (95% CI, 0.76-0.96). Bland & Altman plots, together with high Lin's concordance correlation coefficients, reinforced that agreement. Criterion validity showed moderate-to-strong correlations of the C-PPAC with all of the other instruments evaluated, especially with the IPAQ (rho = -0.63). CONCLUSIONS: The Brazilian Portuguese version of the C-PPAC is a reliable and valid instrument for evaluating the experience of Brazilian individuals with COPD with their physical activity in daily life.

European Society of Organ Transplantation (ESOT) Consensus Statement on Prehabilitation for Solid Organ Transplantation Candidates.

There is increasingly growing evidence and awareness that prehabilitation in waitlisted solid organ transplant candidates may benefit clinical transplant outcomes and improve the patient's overall health and quality of life. Lifestyle changes, consisting of physical training, dietary management, and psychosocial interventions, aim to optimize the patient's physical and mental health before undergoing surgery, so as to enhance their ability to overcome procedure-associated stress, reduce complications, and accelerate post-operative recovery. Clinical data are promising but few, and evidence-based recommendations are scarce. To address the need for clinical guidelines, The European Society of Organ Transplantation (ESOT) convened a dedicated Working Group "Prehabilitation in Solid Organ Transplant Candidates," comprising experts in physical exercise, nutrition and psychosocial interventions, to review the literature on prehabilitation in this population, and develop recommendations. These were discussed and voted upon during the Consensus Conference in Prague, 13-15 November 2022. A high degree of consensus existed amongst all stakeholders including transplant recipients and their representatives. Ten recommendations were formulated that are a balanced representation of current published evidence and real-world practice. The findings and recommendations of the Working Group on Prehabilitation for solid organ transplant candidates are presented in this article.

Patients' acceptance of outcome and experience measurements during hospitalisation for COPD exacerbations: a CICERO Clinical Research Collaboration-European Lung Foundation online patient survey.

Background: The lack of standardised outcome assessments during hospitalisation and follow-up for acute COPD exacerbations has hampered scientific progress and clinical proficiency. The objective of the present study was to evaluate patients' acceptance of selected outcome and experience measurements during hospitalisations for COPD exacerbations and follow-up. Methods: An online survey was held amongst COPD patients in France, Belgium, The Netherlands, Germany and the UK. The European Lung Foundation COPD Patient Advisory Group was involved in the conceptualisation, development and dissemination of the survey. The survey was complementary to a previously obtained expert consensus. We assessed patients' views and acceptance of selected patient-reported outcomes or experiences and corresponding measurement instruments (for dyspnoea, frequent productive cough, health status and hospitalisation experience), and of selected clinical investigations (blood draw, pulmonary function test, 6-min walk test, chest computed tomography, echocardiography). Findings: 200 patients completed the survey. All selected outcomes and experiences were deemed important, and acceptance of their methods of assessment was high. The modified Medical Research Council scale and a numerical rating scale to address dyspnoea, the COPD Assessment Test for quality of life and frequent productive cough, and the Hospital Consumer Assessment of Healthcare Providers and Systems for hospital experiences were the instruments preferred by patients. Consensus on importance of blood draw and spirometry was higher compared with the other investigations. Interpretation: The survey results endorse the use of the selected outcome and experience measurements during hospitalisations for COPD exacerbations. They can be used to optimise standardised and patient-centred care and facilitate multicentric data collection.

Prevalence and Patient-Level Correlates of Intentional Non-Adherence to Immunosuppressive Medication After Heart-Transplantation-Findings From the International BRIGHT Study.

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.

Psychometric Properties of the BAASIS: A Meta-analysis of Individual Participant Data.

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.

Cultural adaptation and validation of the Brazilian Portuguese version of the PROactive Physical Activity in COPD-clinical visit instrument for individuals with COPD / Adaptação cultural e validação da versão brasileira do instrumento PROactive Physical Activity in COPD-clinical visit para indivíduos com DPOC

ABSTRACT Objective: To adapt the PROactive Physical Activity in COPD-clinical visit (C-PPAC) instrument to the cultural setting in Brazil and to determine the criterion validity, test-retest reliability agreement, and internal consistency of this version. Methods: A protocol for cultural adaptation and validation was provided by the authors of the original instrument and, together with another guideline, was applied in a Portuguese-language version developed by a partner research group from Portugal. The adapted Brazilian Portuguese version was then cross-sectionally administered twice within a seven-day interval to 30 individuals with COPD (57% were men; mean age was 69 ± 6 years; and mean FEV1 was 53 ± 18% of predicted) to evaluate internal consistency and test-retest reliability. Participants also completed the International Physical Activity Questionnaire (IPAQ), the modified Medical Research Council scale, the COPD Assessment Test, and Saint George's Respiratory Questionnaire to evaluate criterion validity. Results: The C-PPAC instrument showed good internal consistency and excellent test-retest reliability: "amount" domain = 0.87 (95% CI, 0.73-0.94) and "difficulty" domain = 0.90 (95% CI, 0.76-0.96). Bland & Altman plots, together with high Lin's concordance correlation coefficients, reinforced that agreement. Criterion validity showed moderate-to-strong correlations of the C-PPAC with all of the other instruments evaluated, especially with the IPAQ (rho = −0.63). Conclusions: The Brazilian Portuguese version of the C-PPAC is a reliable and valid instrument for evaluating the experience of Brazilian individuals with COPD with their physical activity in daily life.

RESUMO Objetivo: Adaptar o instrumento PROactive Physical Activity in COPD - clinical visit (C-PPAC) ao contexto cultural brasileiro e determinar a validade de critério, concordância da confiabilidade teste-reteste e consistência interna dessa versão. Métodos: Um protocolo de adaptação cultural e validação foi fornecido pelos autores do instrumento original e, juntamente com outra diretriz, foi aplicado em uma versão em português desenvolvida por um grupo de pesquisa parceiro de Portugal. A versão brasileira adaptada foi então aplicada transversalmente duas vezes, com intervalo de sete dias, em 30 indivíduos com DPOC (57% de homens; média de idade de 69 ± 6 anos; e média do VEF1 de 53 ± 18% do previsto) para avaliação da consistência interna e da confiabilidade teste-reteste. Os participantes também responderam ao International Physical Activity Questionnaire (IPAQ), à escala modificada do Medical Research Council, ao COPD Assessment Test e ao Saint George's Respiratory Questionnaire para avaliação da validade de critério. Resultados: O instrumento C-PPAC apresentou boa consistência interna e excelente confiabilidade teste-reteste: domínio "quantidade" = 0,87 (IC95%: 0,73-0,94) e domínio "dificuldade" = 0,90 (IC95%: 0,76-0,96). As disposições gráficas de Bland-Altman, juntamente com os altos coeficientes de correlação de concordância de Lin, reforçaram essa concordância. A validade de critério mostrou correlações moderadas a fortes do instrumento C-PPAC com todos os outros instrumentos avaliados, principalmente com o IPAQ (rho = −0,63). Conclusões: A versão brasileira do instrumento C-PPAC é uma ferramenta confiável e válida para avaliar a experiência de indivíduos brasileiros com DPOC em relação à sua atividade física na vida diária.

Electronically monitored medication adherence in idiopathic pulmonary fibrosis: prevalence, predictors and outcomes.

Medication adherence studies in idiopathic pulmonary fibrosis (IPF) are limited, use cross-sectional designs and report discontinuation rates. We prospectively investigated adherence to pirfenidone in IPF patients using electronic monitoring, which provides insights on whether and when the medication was taken on a day-by-day basis. We investigated the impact of nonadherence on lung function and selected predictors for nonadherence based on the COM-B behavioural model. The longitudinal statistical analyses included generalised estimation equations and linear mixed effects models. 55 patients initiating pirfenidone were followed-up for 2 years after diagnosis (76.4% men, mean age 71.1 years (range 50-87 years), mean forced vital capacity (FVC) 88% predicted (sd 18.3), mean diffusing capacity of the lung for carbon monoxide (D LCO) 58.1% predicted (sd 14.7)). Our data showed an association (p=0.03) between the proportion of days with three pirfenidone intakes (i.e. dosing adherence) and FVC % predicted, whereby a high dosing adherence seemed necessary to maintain stable or improving FVC % predicted values. 58.2% of the participants were able to implement at least 90% correct dosing days, yet adherence significantly decreased over time. Too short dosing intervals had negative effects on lung function outcomes. Knowledge on IPF and self-reported adherence were significantly associated with electronically measured adherence. In conclusion, nonadherence is prevalent and might negatively affect lung function. Further research is needed on the impact of nonadherence on outcomes and its predictors, so that tailored interventions can be developed. Meanwhile, a self-report questionnaire could be used to identify adherence issues and teams should equip patients with knowledge about their treatment and how to take it.

Patient-Reported Outcomes as Endpoints in Clinical Trials of Kidney Transplantation Interventions.

Patient-reported outcomes (PROs) that assess individuals' perceptions of life participation, medication adherence, disease symptoms, and therapy side effects are extremely relevant in the context of kidney transplantation. All PROs are potentially suitable as primary or secondary endpoints in interventional trials that aim to improve outcomes for transplant recipients. Using PRO measures (PROMs) in clinical trials facilitates assessment of the patient's perspective of their health, but few measures have been developed and evaluated in kidney transplant recipients; robust methodologies, which use validated instruments and established frameworks for reporting, are essential. Establishing a core PROM for life participation in kidney transplant recipients is a critically important need, which is being developed and validated by the Standardized Outcomes in Nephrology (SONG)-Tx Initiative. Measures involving electronic medication packaging and smart technologies are gaining traction for monitoring adherence, and could provide more robust information than questionnaires, interviews, and scales. This article summarizes information on PROs and PROMs that was included in a Broad Scientific Advice request on clinical trial design and endpoints in kidney transplantation. This request was submitted to the European Medicines Agency (EMA) by the European Society for Organ Transplantation in 2016. Following modifications, the EMA provided its recommendations in late 2020.

Multi-level correlates of received social support among heart transplant recipients in the international BRIGHT Study: a secondary analysis.

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.

Behavioural and psychological patterns of patients with idiopathic pulmonary fibrosis: a prospective study.

BACKGROUND: Idiopathic pulmonary fibrosis (IPF) is a chronic and progressive lung condition. Currently, care models predominantly focus on acute medical and pharmacological needs. As a step towards holistic care, the aim of this prospective study was to investigate the psychological and behavioural needs of IPF patients treated with pirfenidone from diagnosis until two years of follow-up. METHODS: The following variables were selected from the literature on patients' needs and the COM-B model, a theoretical model explaining behaviour: medication adherence, barriers to adherence, importance and intentions of medication adherence, anxiety, depression, health literacy, knowledge, reported side effects, adherence to sun protection recommendations, alcohol use, physical activity, quality of life and health status. Linear and generalised linear models for longitudinal data were used to evaluate the evolution since treatment initiation. RESULTS: We included 66 outpatients: 72.7% men, mean age of 70.3 years (range 50-87), predicted mean forced vital capacity of 85.8% (SD 17.4) and predicted mean diffusing capacity for monoxide of 56.9% (SD 15.7). The participants placed considerable importance on following the treatment recommendations. We noticed difficulties regarding health literacy, alcohol use, pirfenidone adherence (decline over time) and adherence to sun protection recommendations (early in follow-up care). There were low levels of physical activity (no effect of time), high body mass indices (decline over time) and moderate levels of depression and anxiety. CONCLUSION: When providing care to IPF patients, behavioural issues, health literacy and psychological well-being should be taken into consideration. There is a need to further explore interventions and care models to tackle these difficulties. Trial registration This study was registered in the ClinicalTrials.gov database (identifier NCT03567785) on May 9th, 2018.

Is degree of chronic illness management in heart transplant centers associated with better patient survival? Findings from the intercontinental BRIGHT study.

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.

Telemedicine based remote monitoring after liver transplantation: Feasible in a select group and a more stringent control of immunosuppression.

Telemedicine gained interest in liver transplant patients but focused until now on the early post-operative period. This prospective cohort study assessed feasibility, safety, and clinical beneficial effects of a telemedicine based remote monitoring program (TRMP) for the chronic follow-up of adult liver transplant recipients. Between November 2017 and August 2019, a total of 87 of the 115 selected patients (76%) started the TRMP. Over the 2 years study period, none of the patients switched to standard follow-up: 39/87 (45%) continued to do this autonomously and 48/87 (55%) stopped to report their data personally but communicated their lab values to the nurse. The other 28/115 (11%) patients who did not accept the TRMP continued the standard follow-up. There was no difference in educational level between the three groups. Remote monitoring did not result in an increase in liver graft rejection and need of hospitalization. TRMP was associated with a higher number of tacrolimus level determinations and tacrolimus blood level concentrations could be kept lower. In conclusion, our results show that in patients with a stable clinical condition there is a high willingness to participate in TRMP and that this approach is safe. Remote monitoring allowed a stringent follow-up of tacrolimus levels.

Medication adherence interventions in transplantation lack information on how to implement findings from randomized controlled trials in real-world settings: A systematic review.

BACKGROUND: Growing numbers of randomized controlled trials (RCTs) are showing the effectiveness of interventions to improve medication adherence in transplantation recipients. However, real-world implementation is still a major challenge. This systematic review assesses the range of information available in RCTs supporting these interventions' clinical adoption in adult transplant populations. METHODS: We included RCTs of interventions that a) targeted any phase of medication adherence in solid organ or allogeneic stem cell transplantation recipients and b) were published between January 2015 and November 2020. We excluded study protocols, conference abstracts and studies focusing only on pediatric populations. We identified relevant database and trial registries as well as traced references backward and citations forward. Implementation-relevant information was evaluated using adapted versions of Peters' ten criteria: 1. healthcare/organizational context; 2. social/economic/policy context; 3. patient involvement; 4. other stakeholder involvement; 5. sample representativeness; 6. trial conducted in a real-world-setting; 7. presence of feasibility study; 8. implementation strategy; 9. process evaluation; 10. implementation outcomes, using a stoplight color-rating system. RESULTS: Screening 17'004 titles/abstracts resulted in 23 eligible RCTs, including 2'339 patients (n = 19-209/study). All included studies focused on the implementation phase of medication adherence. The best-reported criteria were feasibility study (43%), representative sample (17%) and conducted in a real-world-setting (17%). Least reported were context (9%), implementation strategies (4%), process evaluation (4%). CONCLUSIONS: RCTs testing medication adherence interventions tend to report limited implementation-relevant information. This hinders their translation to real-world transplant settings. Integrating implementation science principles early in the conceptualization of RCTs would fuel real-world-translation, reducing research waste.