Physical function, psychological adjustment, and self-efficacy following sudden cardiac arrest and an initial implantable cardioverter defibrillator (ICD) in a social cognitive theory intervention: secondary analysis of a randomized control trial.

BACKGROUND: Sudden cardiac arrest (SCA) survivorship results in unique issues in return to physical and psychological function. The purpose of the study was to compare recovery across the first year between SCA survivors and other arrhythmia patients who received a first-time implantable cardioverter defibrillator (ICD) for secondary prevention, participating in a social cognitive theory (SCT) intervention. METHODS: 168 (129 males, 39 females) who received an ICD for secondary prevention (SCA N = 65; other arrhythmia N = 103) were randomized to one of two study conditions: SCT intervention (N = 85) or usual care (N = 83). Outcomes were measured at baseline hospital discharge, 1, 3, 6, & 12 months: (1) Physical Function: Patient Concerns Assessment (PCA), SF-36 (PCS); (2) Psychological Adjustment: State Trait Anxiety (STAI), CES-D depression, SF-36 (MCS); (3) Self-Efficacy: Self-Efficacy (SCA-SE), Self-management Behaviors (SMB), Outcome Expectations (OE). Outcomes were compared over 12 months for intervention condition x ICD indication using general estimating equations. RESULTS: Participants were Caucasian (89%), mean age 63.95 ± 12.3 years, EF% 33.95 ± 13.9, BMI 28.19 ± 6.2, and Charlson Index 4.27 ± 2.3. Physical symptoms (PCA) were higher over time for SCA survivors compared to the other arrhythmia group (p = 0.04), ICD shocks were lower in SCA survivors in the SCT intervention (p = 0.01); psychological adjustment (MCS) was significantly lower in SCA survivors in the SCT intervention over 6 months, which improved at 12 months (p = 0.05); outcome expectations (OE) were significantly lower for SCA survivors in the SCT intervention (p = 0.008). CONCLUSIONS: SCA survivors had greater number of physical symptoms, lower levels of mental health and outcome expectations over 12 months despite participation in a SCT intervention. Trial registration Clinicaltrials.gov: NCT04462887.

Treatment Satisfaction Questionnaire for Medication (TSQM version 1.4): Ceiling and Floor Effects, Reliability, and Known-Group Validity in Brazilian Outpatients With Hypertension.

OBJECTIVES: Evaluate the acceptability, ceiling and floor effects, reliability, and known-group validity of the Brazilian version of the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 in patients with hypertension. METHODS: The sample consisted of 300 hypertensive patients undergoing treatment in an outpatient department. The acceptability was evaluated from the items not answered in the TSQM. The reliability of the TSQM was estimated through Cronbach's alpha. Known-group validity tested whether the TSQM discriminates satisfaction between different stages of hypertension, diagnoses of left ventricular hypertrophy, medication adherence, and occurrence of side effects. RESULTS: The TSQM had high acceptability (99% of participants answered all items). A substantial ceiling effect was found in the side effect (89%) and global satisfaction (29%) subscales. Reliability evaluated with Cronbach's alpha showed values >0.76 in all subscales. Known-group validity was supported with a statistically significant difference in patient satisfaction effectiveness between the hypertension groups and those without left ventricular hypertrophy. Regarding medication adherence, the TSQM was able to discriminate satisfaction in the side effect and global satisfaction subscales. A significantly higher satisfaction was found in all subscales of the TSQM in those patients without side effects. CONCLUSIONS: The TSQM is a reliable and valid questionnaire to be used in Brazilians with hypertension.

Left Ventricular Assist Device Caregiver Experiences and Health Outcomes: A Systematic Review of Qualitative and Quantitative Studies.

BACKGROUND: Knowledge synthesis is lacking regarding outcomes and experiences of caregivers of adult patients living with continuous flow left ventricular assist devices (CF-LVAD). The purpose of this systematic review was to summarize qualitative data related to the experience of caregivers of adult patients living with CF-LVAD as well as quantitative data related to health outcomes of caregivers. METHODS AND RESULTS: Multiple databases were systematically queried for studies of qualitative experiences and quantitative health outcomes for caregivers of adult CF-LVAD recipients. Search dates were constrained to articles published between 2004 and August of 2018 because CF-LVADs were not routinely implanted before 2004. Two authors independently screened 683 articles; 15 met predetermined inclusion criteria. Eligible articles reported results from 13 studies. Of those, 8 used either qualitative or mixed methods and 5 used quantitative methods. Caregivers were primarily female (81%) and their mean age was 59 years. Qualitative studies revealed 3 overarching themes related to the caregiver role, coping strategies, and LVAD decisions. Quantitative studies revealed caregiver strain peaked between 1 and 3 months after implantation, anxiety and depression were relatively stable, mental health status improved, and physical health status was stable from before to after implantation. CONCLUSIONS: CF-LVAD caregivers experience significant, sustained emotional strain for 3 months after implantation, reporting considerable stress in meeting their personal needs and those of their loved one.

A Systematic Review of Exercise Training in Patients With Cardiac Implantable Devices.

PURPOSE: This systematic review identified exercise-based intervention studies in patients with cardiac implantable devices (CIDs): implantable cardioverter defibrillator (ICD), cardiac resynchronization pacemaker or defibrillator (cardiac resynchronization therapy [CRT]), or ventricular assist device (VAD) and assessed evidence for the safety and efficacy of exercise-based interventions alone or in combination with psychoeducational components. METHODS: PubMed, EMBASE, CINAHL Plus, Web of Science, Cochrane, and PEDro databases were searched from database inception to September 2016. Data were extracted and validity was assessed by 2 reviewers. Study quality was evaluated using the JADAD scale for randomized controlled trials. A total of 3991 articles for all CIDs (ICD: 1015; pacemaker: 1630; and VAD: 1346) were screened for relevance. Subsequently, 24 full-text articles (ICD: 14; CRT: 4; and VAD: 6) were deemed eligible for this review. RESULTS: Studies of aerobic exercise training demonstrated an average increase in peak oxygen uptake of 2.61 mL/kg/min, (ICD = 2.43, VAD = 2.2, and CRT = 3.2 mL/kg/min). These incremental increases were statistically significant when compared with the usual care or other comparison groups. Adverse event rates were very low at 1.1% to 2.2% for all CIDs. CONCLUSION: Exercise interventions tested to date in the CID population (ICD, CRT, and VAD) indicate that exercise training at moderate to high intensity is safe and effective in improving cardiopulmonary outcomes without adverse events. Future investigations should include a more diverse sample of participants, designs that include translation of exercise to routine practice, the destination therapy VAD population, and measurement of costs and patient-centered outcomes.

Satisfaction with medication in coronary disease treatment: psychometrics of the Treatment Satisfaction Questionnaire for Medication.

OBJECTIVE: to psychometrically test the Brazilian version of the Treatment Satisfaction Questionnaire for Medication - TSQM (version 1.4), regarding ceiling and floor effect, practicability, acceptability, reliability and validity. METHODS: participants with coronary heart disease (n=190) were recruited from an outpatient cardiology clinic at a university hospital in Southeastern Brazil and interviewed to evaluate their satisfaction with medication using the TSQM (version 1.4) and adherence using the Morisky Self-Reported Measure of Medication Adherence Scale and proportion of adherence. The Ceiling and Floor effect were analyzed considering the 15% worst and best possible TSQM scores; Practicability was assessed by time spent during TSQM interviews; Acceptability by proportion of unanswered items and participants who answered all items; Reliability through the Cronbach's alpha coefficient and Validity through the convergent construct validity between the TSQM and the adherence measures. RESULTS: TSQM was easily applied. Ceiling effect was found in the side effects domain and floor effect in the side effects and global satisfaction domains. Evidence of reliability was close to satisfied in all domains. The convergent construct validity was partially supported. CONCLUSIONS: the Brazilian TSQM presents evidence of acceptability and practicability, although its validity was weakly supported and adequate internal consistency was observed for one domain.

Satisfaction with medication in coronary disease treatment: psychometrics of the Treatment Satisfaction Questionnaire for Medication / Satisfação com tratamento medicamentoso no tratamento de doença coronária: psicometria do Treatment Satisfaction Questionnaire for Medication / Satisfacción con medicación en el tratamiento de enfermedad coronaria: propiedades psicométricas del Treatment Satisfaction Questionnaire for Medication

Abstract Objective: to psychometrically test the Brazilian version of the Treatment Satisfaction Questionnaire for Medication - TSQM (version 1.4), regarding ceiling and floor effect, practicability, acceptability, reliability and validity. Methods: participants with coronary heart disease (n=190) were recruited from an outpatient cardiology clinic at a university hospital in Southeastern Brazil and interviewed to evaluate their satisfaction with medication using the TSQM (version 1.4) and adherence using the Morisky Self-Reported Measure of Medication Adherence Scale and proportion of adherence. The Ceiling and Floor effect were analyzed considering the 15% worst and best possible TSQM scores; Practicability was assessed by time spent during TSQM interviews; Acceptability by proportion of unanswered items and participants who answered all items; Reliability through the Cronbach's alpha coefficient and Validity through the convergent construct validity between the TSQM and the adherence measures. Results: TSQM was easily applied. Ceiling effect was found in the side effects domain and floor effect in the side effects and global satisfaction domains. Evidence of reliability was close to satisfied in all domains. The convergent construct validity was partially supported. Conclusions: the Brazilian TSQM presents evidence of acceptability and practicability, although its validity was weakly supported and adequate internal consistency was observed for one domain.

Resumo Objetivos: realizar o teste psicométrico da versão brasileira do Treatment Satisfaction Questionnaire for Medication - TSQM (versão 1.4) [Questionário Satisfação com Tratamento Medicamentoso] com relação aos efeitos de teto e chão, praticidade, aceitabilidade, confiabilidade e validade. Métodos: os participantes com doença cardíaca coronária (n=190) foram recrutados num ambulatório de cardiologia de um hospital universitário no sudeste do Brasil e entrevistados para avaliar satisfação em relação ao tratamento medicamentoso através da TSQM (versão 1.4) e adesão através da Morisky Self-Reported Measure of Medication Adherence Scale [Medida de Auto-Relato de Adesão ao Tratamento Medicamentoso] e proporção de aderência. Os efeitos Teto e Chão foram analisados considerando os 15% piores e 15% melhores escores possíveis obtidos no TSQM; Praticidade foi avaliada pelo tempo gasto na aplicação do TSQM durante a entrevista; Aceitabilidade foi verificada pela proporção de itens não respondidos e participantes que responderam todos os itens; Confiabilidade foi verificada com o coeficiente alfa de Cronbach e Validade através da validade de construto convergente entre o TSQM e as medidas de adesão. Resultados: o TSQM foi facilmente aplicado. O efeito teto foi encontrado no domínio efeitos colaterais e o efeito chão foi encontrado nos domínios efeitos colaterais e satisfação global. Evidência de confiabilidade foi próxima de satisfatória em todos os domínios. A validade de construto convergente foi parcialmente apoiada. Conclusões: a versão brasileira do TSQM apresenta evidência de aceitabilidade e praticidade embora sua validade tenha sido pouco apoiada e consistência interna adequada foi observada em um domínio.

Resumen Objetivos: testar las propiedades psicométricas de la versión brasileña del Treatment Satisfaction Questionnaire for Medication - TSQM (versión 1.4), considerando los efectos techo y suelo, factibilidad, aceptabilidad, confiabilidad y validez. Métodos: participantes con enfermedad coronaria (n=190) fueron reclutados de una clínica ambulatoria de cardiología en un hospital universitario en el sudeste de Brasil y entrevistados para evaluar su satisfacción con la medicación con el TSQM (versión 1.4) y su adhesión con la Morisky Self-Reported Measure of Medication Adherence Scale y proporción de adhesión. Los efectos techo y suelo fueron analizados considerando los 15% peores y mejores puntuaciones en el TSQM; la factibilidad fue evaluada por el tiempo gasto durante las entrevistas de TSQM; la aceptabilidad por la proporción de ítems no respondidos y participantes que contestaron a todos los ítems; la confiabilidad con el coeficiente alfa de Cronbach y la validez de constructo convergente entre el TSQM y las medidas de adhesión. Resultados: el TSQM fue aplicado con facilidad. El efecto de techo fue encontrado en el dominio de los efectos secundarios y el efecto suelo en los dominios de efectos secundarios y satisfacción global. Las evidencias de confiabilidad fueron aproximadamente satisfechas en todos los dominios. La validez de constructo convergente fue parcialmente apoyada. Conclusiones: la versión brasileña del TSQM presenta evidencias de aceptabilidad y factibilidad, a pesar del soporte débil a su validez y de la observación de consistencia interna adecuada para un dominio.