Feasibility, acceptability, and outcome responsiveness of the SYMPERHEART intervention to support symptom perception in persons with heart failure and their informal caregivers: a feasibility quasi-experimental study.

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

A multicomponent complex intervention for supportive follow-up of persons with chronic heart failure: a randomized controlled pilot study (the UTILE project).

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

The use of nurse-led care intervention to improve self-care abilities subsequently decreasing readmission in multimorbid hospitalized patients: A quasi-experimental study in a real-world setting.

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.

SYMPERHEART: an intervention to support symptom perception in persons with heart failure and their informal caregiver: a feasibility quasi-experimental study protocol.

INTRODUCTION: Symptom perception in heart failure (HF) has been identified as crucial for effective self-care, and is related to patient and health system outcomes. There is uncertainty regarding the feasibility and acceptability of symptom perception support and doubts regarding how to include informal caregivers. This study aims to test the feasibility, acceptability and outcome responsiveness of an intervention supporting symptom perception in persons with HF and their informal caregiver. METHODS AND ANALYSIS: A feasibility study with a quasi-experimental pretest and post-test single group design is conducted. The convenience sample consists of 30 persons with HF, their informal caregivers and six nurses. SYMPERHEART is an evidence-informed intervention that targets symptom perception by educational and support components. Feasibility is measured by time-to-recruit; time-to-deliver; eligibility rate; intervention delivery fidelity rate. Acceptability is measured by rate of consent, retention rate, treatment acceptability and the engagement in the intervention components. Outcome responsiveness includes: HF self-care (via the Self-care of Heart Failure Index V.7.2); perception of HF symptom burden (via the Heart Failure Somatic Perception Scale V.3); health status (via the Kansas City Cardiomyopathy Questionnaire-12); caregivers' contribution to HF self-care (via the Caregiver Contribution to Self-Care of Heart Failure Index 2); caregivers' burden (via the Zarit Burden Interview). Clinical outcomes include HF events, hospitalisation reason and length of hospital stay. Descriptive statistics will be used to report feasibility, acceptability, patient-reported outcomes (PRO) and clinical outcomes. PRO and caregiver-reported outcome responsiveness will be reported with mean absolute change and effect sizes. ETHICS AND DISSEMINATION: The study is conducted according to the Declaration of Helsinki. The Human Research Ethics Committee of the Canton of Vaud, Switzerland, has approved the study. Written informed consent from persons with HF and informal caregivers are obtained. Results will be published via peer reviewed and professional journals, and further disseminated via congresses. TRIAL REGISTRATION NUMBER: ISRCTN18151041.

Self-care, symptom experience, needs, and past health-care utilization in individuals with heart failure: results of a cross-sectional study.

AIMS: Self-care in heart failure (HF) is generally sub-optimal and impacts morbidity and mortality. To describe self-care prevalence and explore its relationships with symptom experience, patient needs, and health-care utilization in a Swiss hospital providing regional secondary care. METHODS AND RESULTS: Cross-sectional study, convenience sample of individuals with HF from four campuses of one regional Swiss hospital. Self-care was assessed via the Self-Care of Heart Failure Index (SCHFI) and the European Heart Failure Self-care Behaviour Scale (EHFScBS), symptom experience via the M.D. Anderson Symptom Inventory-HF (MDASI-HF) and needs via the Heart Failure Needs Assessment Questionnaire (HFNAQ). Healthcare utilization reflected the preceding year's hospitalization incidence. A cut-off level of ≥70% indicated adequate self-care. We analysed SCHFI, EHFScBS, MDASI-HF and HFNAQ scores' relationships with hospitalizations using Spearman's rho correlation; no prior hypotheses were stated. Sample of 310 individuals with HF (37.4% female; mean age 76.8; 55% NYHA III). Adequate self-care maintenance, management, and confidence were reported by 24%, 10%, and 61%. respectively. The sample's mean number of experienced symptoms was 12.8 (SD 4.0) and 14.0 (SD 5.8) for needs. Over the previous year, 269 hospitalizations had occurred (median: 0, IQR 1). Hospitalizations positively correlated with self-care; symptom experience with needs. Neither symptom experience nor needs correlated with hospitalizations. CONCLUSION: The findings indicated low self-care levels and suggest a need for increased support to maintain physiological stability, manage symptoms and prevent hospitalizations. This study is the first of its kind in Switzerland and among few studies worldwide to report on self-care, symptom experience, needs, and health-care utilization. Interventional studies are warranted considering baseline self-care capabilities, symptoms, and needs of individuals with HF.

Symptom perception in heart failure - Interventions and outcomes: A scoping review.

BACKGROUND: Symptom perception in heart failure has recently been described as essential in the self-care process bridging self-care maintenance and self-care management. Accordingly, symptom perception appears to be critical for improving patient outcomes such as decreased hospital readmission and increased survival. OBJECTIVES: To explore what interventions have been reported on heart failure symptom perception and to describe outcomes responsive to symptom perception. DESIGN: We conducted a scoping review using PRISMA Extension for Scoping Reviews. DATA SOURCES: Structured searches of Medline, PubMed, Embase, CINAHL, PsychINFO, Web of Science, Cochrane, Joanna Briggs Institute and Grey literature databases. REVIEW METHODS: Two authors independently screened references for eligibility. Eligible articles were written in English, French, German, Swedish, Italian or Spanish and concerned symptom perception in adults with heart failure. Data were extracted and charted in tables by three reviewers. Results were narratively summarized. RESULTS: We identified 99 eligible studies from 3055 references. Seven interventional studies targeted symptom perception as the single intervention component. Mixed results have been found: while some reported decreased symptom frequency, intensity and distress, enhanced health-related quality of life, improved heart failure self-care maintenance and management as well as a greater ability to mention heart failure symptoms, others found more contacts with healthcare providers or no impact on anxiety, heart failure self-care nor a number of diary reported symptoms. Additional interventional studies included symptom perception as one component of a multi-faceted intervention. Outcomes responsive to symptom perception were improved general and physical health, decreased mortality, heart failure decompensation, as hospital/emergency visits, shorter delays in seeking care, more consistent weight monitoring, improved symptom recognition as well as self-care management, decreased hospital length of stay and decreased costs. CONCLUSIONS: While many studies allowed to map a comprehensive overview of interventions supporting symptom perception in heart failure as well as responsiveness to outcomes, only a few single component intervention studies targeting symptom perception have been reported and study designs preclude assessing intervention effectiveness. With regard to multiple component interventions, the specific impact of symptom perception interventions on outcomes remains uncertain to date. Well-designed studies are needed to test the effectiveness of symptom perception interventions and to elucidate relationships with outcomes.

Symptom perception in heart failure: a scoping review on definition, factors and instruments.

BACKGROUND: Symptom perception in heart failure has been identified as crucial for effective self-care that is a modifiable factor related to decreased hospital readmission and improved survival. AIMS: To review systematically the heart failure symptom perception literature and synthesise knowledge on definition, description, factors and instruments. METHODS: We conducted a scoping review including studies reporting patient-reported symptom perception in adults with heart failure. Structured searches were conducted in Medline, PubMed, Embase, CINAHL, PsychINFO, Web of Science, Cochrane, JBI and grey literature. Two authors independently reviewed references for eligibility. Data were charted in tables and results narratively summarised. RESULTS: The search yielded 3057 references, of which 106 were included. The definition of heart failure symptom perception comprised body listening, monitoring signs, recognising, interpreting and labelling symptoms, and furthermore awareness of and assigning meaning to the change. Symptom monitoring, recognition and interpretation were identified as challenging. Symptom perception facilitators include prior heart failure hospitalisation, heart failure self-care maintenance, symptom perception confidence, illness uncertainty and social support. Barriers include knowledge deficits, symptom clusters and lack of tools/materials. Factors with inconsistent impact on symptom perception include age, sex, education, experiences of living with heart failure, comorbidities, cognitive impairment, depression and symptom progression. One instrument measuring all dimensions of heart failure symptom perception was identified. CONCLUSION: Heart failure symptom perception definition and description have been elucidated. Several factors facilitating or hampering symptom perception are known. Further research is needed to determine a risk profile for poor symptom perception - which can then be taken into consideration when supporting heart failure self-care.

Prediction of post-acute care demand in medical and neurological inpatients: diagnostic assessment of the post-acute discharge score - a prospective cohort study.

BACKGROUND: Early identification of patients requiring transfer to post-acute care (PAC) facilities shortens hospital stays. With a focus on interprofessional assessment of biopsychosocial risk, this study's aim was to assess medical and neurological patients' post-acute care discharge (PACD) scores on days 1 and 3 after hospital admission regarding diagnostic accuracy and effectiveness as an early screening tool. The transfer to PAC facilities served as the outcome ("gold standard"). METHODS: In this prospective cohort study, registered at ClinicalTrial.gov (NCT01768494) on January 2013, 1432 medical and 464 neurological patients (total n = 1896) were included consecutively between February and October 2013. PACD scores and other relevant data were extracted from electronic records of patient admissions, hospital stays, and interviews at day 30 post-hospital admission. To gauge the scores' accuracy, we plotted receiver operating characteristic (ROC) curves, calculated area under the curve (AUC), and determined sensitivity and specificity at various cut-off levels. RESULTS: Medical patients' day 1 and day 3 PACD scores accurately predicted discharge to PAC facilities, with respective discriminating powers (AUC) of 0.77 and 0.82. With a PACD cut-off of ≥8 points, day 1 and 3 sensitivities were respectively 72.6% and 83.6%, with respective specificities of 66.5% and 70.0%. Neurological patients' scores showed lower accuracy both days: using the same cut-off, respective day 1 and day 3 AUCs were 0.68 and 0.78, sensitivities 41.4% and 68.7% and specificities 81.4% and 83.4%. CONCLUSION: PACD scores at days 1 and 3 accurately predicted transfer to PAC facilities, especially in medical patients on day 3. To confirm and refine these results, PACD scores' value to guide discharge planning interventions and subsequent impact on hospital stay warrants further investigation. TRIAL REGISTRATION: ClinialTrials.gov Identifier, NCT01768494 .

[Daily routine of informal caregivers-needs and concerns with regard to the discharge of their elderly family members from the hospital setting-a qualitative study]. / Der Alltag pflegender Angehöriger - Was sie während des Spitalaufenthalts ihres Familienmitglieds beschäftigt im Hinblick auf den Austritt und was sie diesbezüglich für sich benötigen: eine qualitative Studie.

BACKGROUND: The care of an elderly frail and ill family member places a great responsibility on informal caregivers. Following discharge of the older person from the hospital setting it can be observed that caregivers are often inadequately informed about aspects such as health status, prognosis, complications, and care interventions. Concerns and needs of caregivers regarding their daily living and routine following hospital discharge has not been investigated and is considered important for an optimized discharge management. AIM: To explore personal needs and concerns of informal caregivers with regard to daily living prior to discharge of their family member. METHOD: Eight narrative interviews were conducted with caregivers and were analysed using Mayring's content analysing method. RESULTS: All caregivers had concerns regarding the maintenance of a functional daily routine. As well as caring and household duties, this functional daily routine included negotiating one's own personal time off duties, the reality of the deteriorating health status of the family member and the associated sense of hope. The intensity of family ties affected the functional daily routine. Caregivers had different expectations with regard to their integration during the hospital period. CONCLUSIONS: To support caregivers in their situation it is advisable to assess the functional daily routine of caregivers. Their need for time off their household and caring duties and their informational and educational needs to pertaining to disease progression, possible sources of support and symptom management should be recognised. Further inquiries into caregiver's involvement and responsibilities in the discharge process are needed.

A mixed-method study to explore patients' perspective of self-management tasks in the early phase after kidney transplant.

CONTEXT: Patients' perspectives of posttransplant self-management tasks have not been explored.OBJECTIVE-To explore the concept and the presence of self-management tasks mastered by patients in the early phase after kidney transplant. DESIGN: Mixed-method study using semistructured interviews and a structured questionnaire.Setting-Outpatient Division of Nephrology at University Hospital Zurich, Switzerland. PATIENTS: Twelve patients (median age, 52 years, interquartile range, 42.25-65.25 years; median time after kidney transplant, 6.5 months; interquartile range, 2.25-15.75 months) were included.Analysis-Qualitative data were analyzed according to Corbin and Strauss' 3 self-management tasks with content analysis procedures. In the quantitative analysis, the presence of each self-management task is expressed as a frequency. RESULTS: -The qualitative findings showed that patients were greatly challenged by the effort to manage the upcoming instability, which has a persistent broad impact on their lives. Managing emotions comprised dealing with uncertainty, disappointment, and frustration. Additionally, patients had to manage changes in self-perception. Managing life roles mainly involved an adaptation of relationships, occupational changes, and interactions with health care providers. Taking medications, managing symptoms, integrating new behaviors, and understanding one's course of disease were further tasks. Quantitatively, self-management tasks that were perceived as a challenge by at least half of the patients were primarily tasks from the questionnaire section "managing stressful emotions and self-perception." The synthesis of qualitative and quantitative findings indicates that self-management programs for kidney transplant recipients should focus on strengthening patients' self-management of emotional tasks and on regaining stability in daily life.

Optimizing triage and hospitalization in adult general medical emergency patients: the triage project.

BACKGROUND: Patients presenting to the emergency department (ED) currently face inacceptable delays in initial treatment, and long, costly hospital stays due to suboptimal initial triage and site-of-care decisions. Accurate ED triage should focus not only on initial treatment priority, but also on prediction of medical risk and nursing needs to improve site-of-care decisions and to simplify early discharge management. Different triage scores have been proposed, such as the Manchester triage system (MTS). Yet, these scores focus only on treatment priority, have suboptimal performance and lack validation in the Swiss health care system. Because the MTS will be introduced into clinical routine at the Kantonsspital Aarau, we propose a large prospective cohort study to optimize initial patient triage. Specifically, the aim of this trial is to derive a three-part triage algorithm to better predict (a) treatment priority; (b) medical risk and thus need for in-hospital treatment; (c) post-acute care needs of patients at the most proximal time point of ED admission. METHODS/DESIGN: Prospective, observational, multicenter, multi-national cohort study. We will include all consecutive medical patients seeking ED care into this observational registry. There will be no exclusions except for non-adult and non-medical patients. Vital signs will be recorded and left over blood samples will be stored for later batch analysis of blood markers. Upon ED admission, the post-acute care discharge score (PACD) will be recorded. Attending ED physicians will adjudicate triage priority based on all available results at the time of ED discharge to the medical ward. Patients will be reassessed daily during the hospital course for medical stability and readiness for discharge from the nurses and if involved social workers perspective. To assess outcomes, data from electronic medical records will be used and all patients will be contacted 30 days after hospital admission to assess vital and functional status, re-hospitalization, satisfaction with care and quality of life measures. We aim to include between 5000 and 7000 patients over one year of recruitment to derive the three-part triage algorithm. The respective main endpoints were defined as (a) initial triage priority (high vs. low priority) adjudicated by the attending ED physician at ED discharge, (b) adverse 30 day outcome (death or intensive care unit admission) within 30 days following ED admission to assess patients risk and thus need for in-hospital treatment and (c) post acute care needs after hospital discharge, defined as transfer of patients to a post-acute care institution, for early recognition and planning of post-acute care needs. Other outcomes are time to first physician contact, time to initiation of adequate medical therapy, time to social worker involvement, length of hospital stay, reasons for discharge delays, patient's satisfaction with care, overall hospital costs and patients care needs after returning home. DISCUSSION: Using a reliable initial triage system for estimating initial treatment priority, need for in-hospital treatment and post-acute care needs is an innovative and persuasive approach for a more targeted and efficient management of medical patients in the ED. The proposed interdisciplinary , multi-national project has unprecedented potential to improve initial triage decisions and optimize resource allocation to the sickest patients from admission to discharge. The algorithms derived in this study will be compared in a later randomized controlled trial against a usual care control group in terms of resource use, length of hospital stay, overall costs and patient's outcomes in terms of mortality, re-hospitalization, quality of life and satisfaction with care. TRIAL REGISTRATION: ClinicalTrials.gov Identifier, NCT01768494.

[In-patient education after renal transplantation]. / Patientenedukation während des stationären Aufenthalts nach Nierentransplantation.

Patients with end-stage renal disease who receive a kidney through transplantation enter a new phase in their illness trajectory. The question emerged which knowledge and skills are essential for a safe self-management immediately after the transplantation. The aim of this project was to develop an evidence-based in-patient education programme for renal transplant recipients. A participative action research approach was chosen. An interprofessional group, led by an advanced practice nurse, initiated the project. Based on a systematic literature review and on qualitative interviews with both patients and experts, an in-patient educational programme was developed and implemented. The main elements of the programme focused on taking medications appropriately and on the observation and interpretation of symptoms. The content of the programme was documented in a brochure for patients. The structure of the programme was documented in a guideline with a standardised procedure. The procedure was based on patients' needs and preferences, and therefore provides tailored education. Besides the support received in gaining relevant knowledge, patients are supported in developing practical skills, problem solving, and decision making. An initial evaluation revealed that patients with cognitive impairment have special needs for education that exceeds what exists in the developed programme. As the programme is revised, additional contents on psychosocial issues will be included and the programme will be planned along the clinical pathway. Furthermore, it should begin during the pre-transplant period and continue in a longterm follow-up.

[Medication non adherence - predictive factors and diagnostics]. / Medikamentöse Nicht-Adhärenz - Prädiktive Faktoren und Diagnostik.

There are many complex reasons for medication non adherence and a gold standard to assess medication non adherence does not exist. We present factors associated with medication non adherence using the five adherence dimensions suggested by the World Health Organization as well as the subjective appraisal regarding medication intake of the patient as suggested by the National Institute of Health and Clinical Excellence in the UK. Based on current research based knowledge, we suggest a two step adherence assessment for the clinical setting: 1) a routine assessment (screening) using patient self-report complemented by non adherence evidence from other methods; 2) in-depth adherence assessment for patients with positive non adherence evidence via interview. The adherence assessment turns then into adherence support. Adherence is the result of a skilled collaborative partnership between patients and health professionals. In complex cases adherence has to be regarded as an aim to be achieved in several stages.

Clinical consequences of non adherence to immunosuppressive medication in kidney transplant patients.

Little is known of the long-term clinical effects of non adherence on transplanted kidneys, especially regarding newer immunosuppressive regimens. In a study of 356 adult Swiss kidney transplant patients, non adherence was measured at inclusion by means of self-reporting, electronic monitoring, collateral reporting and blood assay. Long-term clinical outcomes regarding graft loss and creatinine levels were collected prospectively over a period of 5 years. A Cox proportional hazards model and mixed regression analysis were used, respectively, to examine the effects of non adherence on kidney survival and kidney function. The majority of patients (62%) were on immunosuppressive regimens that included mycophenolate mofetil, tacrolimus or sirolimus. No associations were found between non adherence and kidney graft survival or graft function. Notwithstanding weaknesses of this study, this negative result suggests that high adherence may protect patients against detrimental clinical outcomes, and/or that immunosuppressive regimens containing newer drugs allow wider non adherence margins than those based on previous generation medications such as cyclosporine, azathioprine and corticosteroids.

Computerized patient education in kidney transplantation: testing the content validity and usability of the Organ Transplant Information System (OTIS).

OBJECTIVE: To test content validity and usability of the Organ Transplant Information System (OTIS). METHODS: This study used qualitative methods. The purposive sample consisted of 8 clinicians and 14 patients. Clinicians rated the content's congruence with current medical practice. We used the clinicians' evaluations to revise the OTIS content; then each patient evaluated the revised OTIS modules using the thinking-aloud method and via structured interviews. Descriptive statistics were applied for demographic and clinical data, and for the clinicians' ratings. Content data usability and validity were analyzed using Content Analysis. RESULTS: Clinicians identified deviations from current medical practice regarding content, language, and information structure of OTIS. Seven rated OTIS as non-relevant for implementation into clinical practice. Five rated the program's content--with the stipulated adaptations--as important for patients. All patients encountered usability problems, mostly regarding the program's interface. Emerging categories from the patients' perspectives vis à vis content were knowledge acquisition, illness management, and partnership forming. CONCLUSION: Problems arose regarding OTIS's initial content validity and usability, demonstrating the need to establish the presented material's content validity and usability by involving clinicians and patients before its clinical implementation. PRACTICE IMPLICATIONS: High quality computer-learning-software is needed to enhance patient self-management.

Examining assumptions regarding valid electronic monitoring of medication therapy: development of a validation framework and its application on a European sample of kidney transplant patients.

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

Supporting medication adherence in renal transplantation (SMART): a pilot RCT to improve adherence to immunosuppressive regimens.

BACKGROUND: Although non-adherence to an immunosuppressive regimen (NAH) is a major risk factor for poor outcome after renal transplantation (RTx), very few studies have examined non-adherence intervention in this context. This pilot randomized controlled trial (RCT) tested the efficacy of an educational-behavioural intervention to increase adherence in non-adherent RTx patients. We also assessed how NAH evolves over time. METHODS: Eighteen RTx non-adherent patients (age: 45.6 +/- 1.2 yr; 78.6% male) were randomly assigned to either an intervention group (IG) (n = 6) or an enhanced usual care group (EUCG) (n = 12), the latter receiving the usual clinical care. The IG received one home visit and three telephone interviews. We assessed NAH through electronic monitoring (EM) of medication intake during a nine-month period (three months intervention, six months follow-up). RESULTS: Five of 18 patients withdrew. Inclusion in the study resulted in a remarkable decrease in NAH in both groups over the first three months (IG chi(2) = 3.97, df = 1, p = 0.04; EUCG chi(2) = 3.40, df = 1, p = 0.06). The IG showed the greatest decrease in NAH after three months, although this did not reach statistical significance (at 90 d, chi(2) = 1.05, df = 1, p = 0.31). Thereafter, NAH increased gradually in both groups, reaching comparable levels at the end of the six-month follow-up (i.e. at nine months). CONCLUSION: Our findings suggest an inclusion effect. Although the intervention in this pilot RCT appeared to add further benefit in medication compliance, a lack of statistical power prevented us from making a strong statistical statement.