What kind of patient education and self-care support do patients with heart failure receive, and by whom? Implementation of the ESC guidelines for heart failure in three European regions.

BACKGROUND: In order to manage Heart Failure (HF) properly, both pharmacological and non-pharmacological interventions including patient education and self-care (SC) support are important. Appropriate health care (HC) professional support is necessary to improve patient SC-skills. However, little is known which HC-professionals deliver specific education and support in daily HF-care. OBJECTIVES: To describe patient-education and SC-support as perceived by different HC-professionals in three neighboring North-West European regions: Maastricht(the Netherlands), Noorder-Kempen(Belgium), Aachen (Germany). METHODS: Semi-structured interviews with cardiologists, HF-nurses and general practitioners (GPs) were performed, followed by qualitative content analysis with a five-step approach: 1) familiarization with data, 2) initial coding with an a-priori code manual, 3) structuring of data in main themes, 4) revision and recoding of initial codes and 5) synthesizing codes in main themes. RESULTS: The sample consisted of 15 cardiologists, 35 GPs and 8 HF-nurses. All interviewed HC-professionals provide HF patient-education, yet, the extent differs between them. Whereas HF-nurses identify patient-education and SC-support as one of their main tasks, physicians report that they provide little education. Moreover, little patient education takes place in primary care; with almost none of the GPs reporting to educate patients about SC. GPs in region 2 refer HF-patients to their practice nurse for education and SC-support. None of the HC-professionals reported to provide patients with all key-topics for patient education and SC-support as defined by the ESC. CONCLUSION: HF nurses consider patient-education and SC-support as one of their main tasks, whereas physicians pay limited attention to education. In none of the three regions, all recommended topics are addressed.

Efficacy of a medication adherence enhancing intervention in transplantation: The MAESTRO-Tx trial.

BACKGROUND: Well-designed randomized controlled trials (RCTs) testing efficacy of post-transplant medication adherence enhancing interventions and clinical outcomes are scarce. METHODS: This randomized controlled trial enrolled adult heart, liver, and lung transplant recipients who were >1 year post-transplant and on tacrolimus twice daily (convenience sample) (visit 1). After a 3-month run-in period, patients were randomly assigned 1:1 to intervention group (IG) or control group (CG) (visit 2), followed by a 6-month intervention (visits 2-4) and a 6-month adherence follow-up period (visit 5). All patients used electronic monitoring for 15 months for adherence measurement, generating a daily binary adherence score per patient. Post-intervention 5-year clinical event-free survival (mortality or retransplantation) was evaluated. The IG received staged multicomponent tailored behavioral interventions (visits 2-4) building on social cognitive theory and trans-theoretical model (e.g., electronic monitoring feedback, motivational interviewing). The CG received usual care and attended visits 1-5 only. Intention-to-treat analysis used generalized estimating equation modeling and Kaplan-Meier survival analysis. RESULTS: Of 247 patients, 205 were randomly assigned (103 IG, 102 CG). At baseline, average daily proportions of patients with correct dosing (82.6% IG, 78.4% CG) and timing adherence (75.8% IG, 72.2% CG) were comparable. The IG had a 16% higher dosing adherence post-intervention (95.1% IG, 79.1% CG; p < 0.001), resulting in odds of adherence being 5 times higher in the IG than in the CG (odds ratio 5.17, 95% confidence interval 2.86-9.38). This effect was sustained at end of follow-up (similar results for timing adherence). In the IG, 5-year clinical event-free survival was 82.5% vs 72.5% in the CG (p = 0.18). CONCLUSION: Our intervention was efficacious in improving adherence and sustainable. Further research should investigate clinical impact, cost-effectiveness, and scalability.

Improving kNowledge Transfer to Efficaciously RAise the level of Contemporary Treatment in Heart Failure (INTERACT-in-HF): Study protocol of a mixed methods study.

Heart failure is a complex disease with poor outcome. This complexity may prevent care providers from covering all aspects of care. This could not only be relevant for individual patient care, but also for care organisation. Disease management programmes applying a multidisciplinary approach are recommended to improve heart failure care. However, there is a scarcity of research considering how disease management programme perform, in what form they should be offered, and what care and support patients and care providers would benefit most. Therefore, the Improving kNowledge Transfer to Efficaciously Raise the level of Contemporary Treatment in Heart Failure (INTERACT-in-HF) study aims to explore the current processes of heart failure care and to identify factors that may facilitate and factors that may hamper heart failure care and guideline adherence. Within a cross-sectional mixed method design in three regions of the North-West part of Europe, patients (n = 88) and their care providers (n = 59) were interviewed. Prior to the in-depth interviews, patients were asked to complete three questionnaires: The Dutch Heart Failure Knowledge scale, The European Heart Failure Self-care Behaviour Scale and The global health status and social economic status. In parallel, retrospective data based on records from these (n = 88) and additional patients (n = 82) are reviewed. All interviews were audiotaped and transcribed verbatim for analysis.

The spectrum of nonadherence with medication in heart, liver, and lung transplant patients assessed in various ways.

Adherence to medication regimes is crucial for transplant patients. Addressing methodological limitations and gaps in the literature, we studied: (i) the prevalence of nonadherence (NA) with immunosuppression (IS) using various measurement methods, (ii) NA prevalence regarding intake and timing, (iii) changes in NA over time, (iv) differences in NA across organ transplant populations, (v) NA regarding co-medication. Using a descriptive, prospective, comparative design over 3 months, we included convenience samples of adult heart (n=79), liver (n=55), and lung (n=104) transplant patients. NA with IS was measured using self-report, collateral report, blood assay, electronic monitoring (Helping Hand™ , Bang and Olufsen Medicom, Denmark), and their combinations. In the overall sample, depending on the method used, IS NA ranged from 23.9% to 70.0%. For co-medication, the overall NA rate was 30.1% using self-report. Nonadherence rates remained stable over time. At inclusion, significant NA differences between organ groups were reported via self- and collateral report; lung transplant patients were less adherent than heart or liver transplant recipients, both to IS and to co-medication.

How to test electronic adherence monitoring devices for use in daily life: a conceptual framework.

Electronic monitoring devices are increasingly used in healthcare to monitor health behaviors on a day-to-day basis. As a prerequisite to their application in clinical studies or daily practice, the performance of those electronic monitoring devices should be tested. Such testing includes a demonstration of technically correct function and of correspondence between the recorded data and the actual patient behavior, that is, objective testing of reliability and validity. Furthermore, from the patient's perspective, the operation of these devices should be easy to learn and to perform, and their use should be acceptable. These aspects of usability need to be tested from a user's subjective point of view. We propose a conceptual framework that builds on existing literature, for example, the framework on "obtrusiveness" of Hensel et al [J Am Med Inform Assoc. 2006;13(4):428-431], the assumptions regarding valid electronic monitoring of Denhaerynck et al [BMC Med Res Methodol. 2008;8:5], and empirical evidence. The framework integrates an objective and a subjective dimension. The objective dimension encompasses both reliability (accuracy and precision) and internal and external validity. The subjective dimension describes the user's perspective on usability along subdimensions of user performance, satisfaction, and acceptability. This framework can be used as a road map to test existing and future electronic monitoring devices before their widespread application in clinical studies or daily practice.

A new electronic monitoring device to measure medication adherence: usability of the Helping Hand™.

The aim of this study was to test the user performance, satisfaction and acceptability of the Helping Hand™ (B&O Medicom) electronic medication adherence monitor. Using a mixed-method design, we studied 11 kidney transplant patients and 10 healthy volunteers during three weeks. Although testing showed positive usability aspects, several areas requiring technical improvement were identified: the most important obstacles to usability and acceptability were the weak sound signal, problems loading the medication, and the fact that only one medication could be used at a time.

How accurate are electronic monitoring devices? A laboratory study testing two devices to measure medication adherence.

In a prospective descriptive laboratory study, 25 Helping Hand(™) (HH) (10 without and 15 with reminder system) and 50 Medication Event Monitoring Systems (MEMS) (25 with 18-month and 25 with 2-year battery life) were manipulated twice daily following a predefined protocol during 3 consecutive weeks. Accuracy was determined using the fixed manipulation scheme as the reference. Perfect functioning (i.e., total absence of missing registrations and/or overregistrations) was observed in 70% of the HH without, 87% of the HH with reminder, 20% MEMS with 18 months, and 100% with 2-year battery life respectively.

Interventions to improve medication-adherence after transplantation: a systematic review.

Reports of interventions to improve adherence to medical regimens in solid organ transplant recipients are scarce. A systematic review identified 12 intervention studies. These studies focused on renal, heart, and liver transplant recipients. Five reports used randomized controlled trial (RCT) designs. Sample sizes varied between 18 and 110 subjects. The interventions are difficult to evaluate and categorize because of brief descriptions of intervention details. Of the 12 studies identified in this review, only five studies found a statistically significant improvement in at least one medication-adherence outcome with the intervention. In general, most included a combination of patient-focused cognitive/educational, counseling/behavioral, and psychologic/affective dimensions. Eight studies intervened at the healthcare provider, healthcare setting or healthcare system level, but showed a limited improvement in adherence. No single intervention proved to be superior at increasing medication-adherence in organ transplantation, but a combination of interventions in a team approach for the chronic disease management of organ transplant patients may be effective in a long-term perspective. In conclusion, finding the most effective combination of interventions to enhance adherence is vital. Utilizing an RCT design and adhering to the CONSORT guidelines can lead to higher quality studies and possibly more effective intervention studies to enhance medication-adherence.

Profile of adults with congenital heart disease having a good, moderate, or poor quality of life: a cluster analytic study.

AIMS: The purpose of the study was to assess the profile of adult patients with congenital heart disease who reported a good, moderate, or poor quality of life. METHODS: We conducted a secondary analysis of data from a large-scale quality-of-life study that included 627 patients. Demographic and clinical variables were retrieved from the medical records and functional status from patient interviews. Overall quality of life was measured using a Linear Analogue Scale. Using K-means cluster analysis, we categorized subjects into a 3-cluster solution: good, moderate, or poor quality of life. RESULTS: Four hundred ninety patients (78.1%) clustered into the good quality-of-life category; 126 patients (20.1%) clustered into the moderate quality-of-life category; and 11 patients (1.8%) clustered into the poor quality-of-life category. Poorer quality of life was associated with lower educational level, unemployment or disability, associated syndromes, instability of the heart disease, and a poorer functional status. CONCLUSION: Over three-quarters of the patients had a good quality of life, whereas only a small proportion had a poor quality of life. Specific demographic and clinical characteristics associated with a poor quality of life could assists in identifying patients at risk for developing a poor quality of life.

Quality of life after kidney transplantation: the bright side of life?

This review describes the state-of-the-art on quality of life (QOL) in kidney transplant (KTx) recipients. More specifically, posttransplant QOL is compared with the pretransplant evaluation, with other chronically ill patient populations, and with healthy subjects. Determinants, consequences, and potential interventions to improve QOL are also summarized. However, because of the methodological diversity of published articles, this review starts with addressing some conceptual and methodological concerns surrounding research on QOL in general and in KTx recipients specifically. The ultimate goal of this review was to identify the gaps in the state-of-the-art evidence and to provide some guidelines for conduct of research in the future.

Development and validation of a care process self-evaluation tool.

Clinical pathways are used as a method of organizing care processes. Although they are used worldwide, the concept remains unclear, with little understanding of what exactly is being implemented. A recent systematic review revealed that, although a tool exists to score the instrumental qualities of clinical pathways, no tools are available to assess how the clinical pathway influences the process of care. These tools are needed for a better understanding of the impact of clinical pathways on the length of hospital stay and patient outcomes. In this study, a Care Process Self-Evaluation Tool (CPSET), based on the clinical pathway concept, for assessing the organization of the process of care has been developed and tested. Qualitative and quantitative methods, involving 885 professionals and patients, were used in the development and validation. The CPSET is a valid and reliable 29-item instrument for assessing how the process of care is organized. The CPSET has five subscales: patient-focused organization, coordination of care, communication with patients and family, cooperation with primary care and monitoring/follow-up of the care process. The CPSET can be used in the audit and accreditation of care processes and will help managers and clinicians to understand better how care processes are organized.

Self-reported physical activities in patients after the Mustard or Senning operation: comparison with healthy control subjects.

BACKGROUND: Some decades ago, the Mustard or Senning operation was used to treat patients who were born with Transposition of the Great Arteries (TGA). Although life expectancy is good, previous studies have demonstrated limitations in exercise capacity. To what extent these limitations affect day-to-day functioning of the patients is not yet known. AIMS: We therefore investigated self-reported physical activities in patients after the Mustard or Senning operation, compared this with those of matched, healthy counterparts, and explored potential associations with age, gender and complexity of the TGA. METHODS: Seventy patients were matched with healthy controls. Habitual physical activity was measured using the Baecke questionnaire, resulting in a work, sports, and leisure time index, which ranges from 1 to 5. RESULTS: The median index scores of patients were 2.63 for work, 2.50 for sports; and 2.75 for leisure time. Only for sports, a significantly lower index score was found in patients. Furthermore, we found that older patients were less frequently engaged in sport activities (Spearman's rho=-0.38; p=0.02). CONCLUSION: The results showed that the level of physical activities of patients after the Mustard and Senning operation is normal, except for sport activities. This indicates that patients after a Mustard or Senning operation tend to partake in all activities that they can comfortably perform.

Sexual functioning and congenital heart disease: Something to worry about?

BACKGROUND: Although sexual problems in cardiac patients are receiving increasing attention, research on sexual functioning of patients with congenital heart disease is very scarce. Therefore, this study investigated sexual functioning in adults with congenital heart disease and compared this with that of matched, healthy control subjects. METHODS: A descriptive, comparative study was conducted, in which 441 adults with congenital heart disease were matched to 441 healthy counterparts, according to age, gender, and marital status. The sample consisted of 53.5% males. Median age was 24 years. Disease-specific determinants of quality of life were assessed using the CHD-TAAQOL. This 77-item instrument includes five items referring to sexual problems. For each item, both the perceived frequency and the associated distress were scored. RESULTS: Sexual problems were perceived by 10% to 20% of the patients. When these problems occurred, they were distressing in 67% to 88% of the patients. Female patients reported significantly more often 'not enjoying having sex', 'being insecure about having sex', and 'not being aroused while having sex', and experienced more distress at 'being insecure about having sex' than male patients. Congenital heart disease patients reported significantly fewer 'not enjoying having sex' and 'worrying about your sex life' than healthy counterparts, but experienced more distress at 'worrying about your sex life'. CONCLUSION: In this study, we found that only a minority of adults with congenital heart disease reported sexual problems. This suggests that sexual functioning in this group of patients is not as problematic as in some other cardiac populations.

Defining pathways.

AIMS AND BACKGROUND: The term 'clinical pathway' is internationally accepted in all settings of healthcare management. The way in which clinical pathways have been developed in the United Kingdom differs from that in the USA. Besides the international differences in the purpose, many alternative names also can be found. These have led to confusion. There is no single, widely accepted definition of a clinical pathway. The aim of the study was to survey the definitions used in describing the concept and to derive key characteristics of clinical pathways. METHOD: Using the PubMed, we conducted a review of literature published between January 2000 and December 2003 using the following terms: critical pathway, clinical pathway, integrated care pathway, care pathway and care map. All reports reviewed had to use the concept, as defined by the Medical Subject Headings term, to be considered. To assess all definitions, the concept analysis method was used. RESULTS: In 82 of the 263 eligible articles, the definition of pathway was given. Totally, we found 84 different definitions. Each definition was rephrased by taking into consideration the following three features inherent to pathways: nouns, characteristics and aims and outcomes. Every feature was further divided into categories. CONCLUSIONS: A clinical pathway is a method for the patient-care management of a well-defined group of patients during a well-defined period of time. A clinical pathway explicitly states the goals and key elements of care based on Evidence Based Medicine (EBM) guidelines, best practice and patient expectations by facilitating the communication, coordinating roles and sequencing the activities of the multidisciplinary care team, patients and their relatives; by documenting, monitoring and evaluating variances; and by providing the necessary resources and outcomes. The aim of a clinical pathway is to improve the quality of care, reduce risks, increase patient satisfaction and increase the efficiency in the use of resources.

Quality of life and health status in adults with congenital heart disease: a direct comparison with healthy counterparts.

INTRODUCTION: Despite having increased life expectancy, patients with congenital heart disease are sometimes presumed to have a diminished quality of life. This study therefore assessed the quality of life and perceived health of adults with congenital heart disease and compared these two measures with those reported by healthy control subjects. METHODS: Using a comparative study design, we examined quality of life and perceived health in 404 patients who were matched for age, sex, educational level, and employment status with 404 healthy counterparts. Quality of life was measured using a linear analog scale and the Satisfaction with Life Scale. Problems and concerns relevant to patients' quality of life were assessed by the Congenital Heart Disease-TNO-AZL Adult Quality of Life scale. Perceived health was also assessed with a linear analog scale. RESULTS: Patients perceived their quality of life (median linear analog scale score 80; median Satisfaction with Life Scale score 28) and health status to be good (median linear analog scale 80). Quality of life was significantly better in patients with congenital heart disease than in healthy peers, with a mean standardized difference of 0.22 on the linear analog scale and 0.34 on the Satisfaction with Life Scale. No group difference was found for perceived health. Problems and concerns in adults with congenital heart disease overlapped to a large extent with those identified by control subjects. Patients reported significantly higher distress scores for 16 of 77 items, whereas control subjects perceived more distress for 20 items. CONCLUSION: Adults with congenital heart disease perceived their quality of life to be better than did their healthy counterparts. This finding refutes the presumed lower quality of life in patients with cardiac anomalies.

Individual quality of life in adults with congenital heart disease: a paradigm shift.

AIMS: During the last decade, a paradigm shift has emerged in the measurement of quality of life, from the use of standard questionnaires towards a more individualized approach. Therefore, this study examined individual quality of life in adults with congenital heart disease and explored potential differences with those reported by matched, healthy control subjects. METHODS AND RESULTS: We examined 579 adults with congenital heart disease. A subsample of 514 of these patients was matched for age, gender, educational level, and employment status with 446 healthy counterparts. Individual quality of life was assessed using the Schedule for the Evaluation of Individual Quality of Life-Direct Weighting (SEIQoL-DW). Twelve domains affecting patients' quality of life were identified. Family, job/education, friends, health, and leisure time were the most prominent quality of life domains. Significantly fewer patients than control subjects considered financial means and material well-being and future to be important determinants of quality of life. CONCLUSION: Assessment of quality of life in adults with congenital heart disease that focusses on the individual is appropriate for obtaining in-depth information on issues relevant for patients' quality of life. This represents a paradigm shift in the measurement of this concept.

Health status, functional abilities, and quality of life after the Mustard or Senning operation.

BACKGROUND: Life expectancy of patients who underwent atrial switch operation for the transposition of the great arteries is relatively good. However, many patients are faced with residua and sequelae, which may hamper their functioning and quality of life. This multicenter study assessed the perceived health status, functional abilities, and quality of life in long-term survivors of the Mustard or Senning operation. METHODS: A group of 89 patients (58% male) were selected from four tertiary care centers, consisting of 37 Mustard and 52 Senning operation patients. Perceived health status was measured using a linear analog scale. The educational level, employment status, New York Health Association classification, ability index, and Baecke questionnaire were used to evaluate functional abilities. Quality of life was assessed with a linear analog scale, the Satisfaction with Life Scale, and the Congenital Heart Disease-TNO/AZL Adult Quality of Life. RESULTS: Patients reported good to very good perceived health, functional capacities, and quality of life. The responses of patients with complex transposition were equivalent to those of patients with simple transposition. The most dominant concerns reported by survivors of the Mustard and Senning operations were experiences about physical limitations and worries about a current or future job or income. CONCLUSIONS: Long-term survivors after atrial inflow correction demonstrated favorable perceived health, functional status, and quality of life; these conditions were, to a large extent, comparable with the status of the general population. These outcome variables were not negatively affected by the complexity of the transposition.

Classifying clinical pathways.

BACKGROUND: Clinical pathways are commonly developed for homogenous patient groups. We were wondering if the traditional patient classification systems could be used for classifying clinical pathways. METHODOLOGY: To examine the utility of patient classification systems for clinical pathways, a sample of 13 clinical pathways was analyzed, involving a total of 412 patients. Three classification systems were tested: International Classification of Diseases, Ninth Revision (ICD9-CM), Clinical Coding System (CCS) data and All-Patient Redefined Diagnosis Related Groups (APR-DRG). RESULTS: Categorization with ICD9-CM and CCS shows rather wide variation. However, when restricting for the principal codes, CCS classification shows an almost homogeneous relationship with clinical pathways. APR-DRG's are already corrected for secondary procedures and are difficult to assess. Categorization with the Risk Of Mortality (ROM) is more homogeneous than with the Severity Of Illness (SOI). CONCLUSION: Patient groups in clinical pathways are rather heterogeneous. When restricting for the principal procedures, the strongest relationship seems to exist between clinical pathways and CCS. Further research is needed to refine this relationship.