Healthcare professionals' perspectives on use of PCSK9 inhibitors in cardiovascular disease: an in-depth qualitative study.

AIM: Injectable medicines such as PCSK-9 inhibitors are increasingly used to manage risk factors for cardiovascular events with little information around the perceptions of healthcare professionals (HCPs) on the administrative and clinical practicalities. The aim was to identify the facilitators and barriers on the use of injectable therapies with CV benefits through interviews with HCPs. METHODS AND RESULTS: Qualitative interviews were conducted in the United Kingdom (London and Leeds) and Italy (Rome and Milan) in 2021. Coding was undertaken using NVivo and thematic analysis performed. A total of 38 HCPs were interviewed, 19 in each country composing of physicians (n = 18), pharmacists (n = 10), nurses (n = 9) and pharmacy technician (n = 1). Four themes emerged: (i) Clinicians' previous experiences with injectable therapies (ii) Challenges with patients' behaviours and beliefs (iii) Clinicians' knowledge of injectable therapies and therapeutic inertia and (iv) Organisational and governance issues. The behaviour and beliefs from healthcare professionals focused on facilitating behaviour change as well as the poor interdisciplinary working and collaboration. Therapeutic inertia was raised where physicians either lacked awareness of injectable therapies or were unwilling to prescribe them. The importance of facilitating patient education on injection techniques was highlighted while organisational and governance issues identified the lack of guidance to inform practice. Clear pathways are required to identify those who were eligible for injectable therapies as well as on how injectables should be prescribed. CONCLUSION: If medicine optimisation is to be achieved, there needs to be structured processes in place to identify eligible patients and the development of educational material.

The relationship between caregiver contribution to self-care and patient quality of life in heart failure: A longitudinal mediation analysis.

BACKGROUND: Patients with heart failure may experience poor quality of life due to a variety of physical and psychological symptoms. Quality of life can improve if patients adhere to consistent self-care behaviors. Patient outcomes (i.e., quality of life) are thought to improve as a result of caregiver contribution to self-care. However, uncertainty exists on whether these outcomes improve as a direct result of caregiver contribution to self-care or whether this improvement occurs indirectly through the improvement of patient heart failure self-care behaviors. AIMS: To investigate the influence of caregiver contribution to self-care on quality of life of heart failure people and explore whether patient self-care behaviors mediate such a relationship. METHODS: This is a secondary analysis of the MOTIVATE-HF randomized controlled trial (Clinicaltrials.gov registration number: NCT02894502). Data were collected at baseline and 3 months. An autoregressive longitudinal path analysis model was conducted to test our hypotheses. RESULTS: We enrolled a sample of 510 caregivers [mean age = 54 (±15.44), 24% males)] and 510 patients [mean age = 72.4 (±12.28), 58% males)]. Patient self-care had a significant and direct effect on quality of life at three months (ß = 0.20, p < .01). Caregiver contribution to self-care showed a significant direct effect on patient self-care (ß = 0.32, p < .01), and an indirect effect on patient quality of life through the mediation of patient self-care (ß = 0.07, p < .001). CONCLUSION: Patient quality of life is influenced by self-care both directly and indirectly, through the mediation of caregiver contribution to self-care. These findings improve our understanding on how caregiver contribution to self-care improves patient outcomes.

Improving adherence to rehabilitation for heart failure patients through immersive virtual reality (VIRTUAL-HF): A protocol for a randomized controlled trial.

BACKGROUND: To improve symptoms and reduce poor outcomes related to heart failure (HF), international guidelines recommend cardiac rehabilitation (CR), particularly for those with a reduced ejection fraction. Unfortunately, patient adherence to rehabilitation programs remains suboptimal, with dropouts ranging from 15.4 to 63.3%. An innovative and promising intervention that could improve adherence to rehabilitation is virtual reality (VR). This study aims to evaluate the effects of VR in patients with HF who undergo CR using this technology in terms of adherence (primary outcome), functional capacity, perceived exertion, angina, quality of life, heart rate, oxygen saturation, blood pressure, maximum oxygen uptake, minute ventilation/carbon dioxide production slope, oxygen pulse, blood values of NT-proBNP and HF related rehospitalization rates (secondary outcomes). METHODS: A randomized controlled trial will be conducted in a sample of 80 patients referred to CR. Participants will be enrolled in a cardiological rehabilitation unit of a large university hospital in Italy and randomized (1:1) to the experimental intervention consisting of CR performed with high-quality immersive VR with PICO 4® Head Mounted Display headset and TREADMILL XR® software (Arm 1) or standard CR (Arm 2). Patients, according to guidelines, will perform 30-min of CR sessions with moderate intensity, twice a week for one month. RESULTS: Significant improvements in primary and secondary outcomes are expected in patients in the intervention group. CONCLUSIONS: If proven to be effective, VR could be an innovative, safe, and easy digital health intervention to improve adherence to CR in patients with HF, as well as important clinical outcomes.

Patients' perceptions on the facilitators and barriers using injectable therapies in dyslipidaemia: An empirical qualitative descriptive international study.

BACKGROUND: Injectable medicines are increasingly used to manage abnormal levels of lipids, which is a major risk factor for cardiovascular events. Enhancing our understanding of patients' perceptions of these injectables, can inform practice with the aim of increasing uptake and medication adherence. AIM: To explore patient's experiences of using injectables and to identify potential facilitators and barriers to using injectable therapies in dyslipidaemia. DESIGN: A qualitative descriptive study using semi-structured interviews was conducted with patients who were using injectables to manage their cardiovascular conditions. METHODS: A total of 56 patients, 30 from the United Kingdom and 26 from Italy, were interviewed online from November 2020 to June 2021. Interviews were transcribed and schematic content analysis performed. RESULTS: Four distinct themes emerged from interviews with patients and caregivers: (i) Their behaviours and personal beliefs; (ii) Knowledge and education about injectable medication; (iii) Clinical skills and previous experiences and (iv) Organizational and governance. Participants expressed initial fears such as needle phobia, and their concerns about commencing therapy were compounded by a lack of accessible information. However, patients' pre-existing knowledge of lipid lowering medication, previous experience with statins and history of adverse side effects informed their decision-making regarding using injectables. Organization and governance-related issues were primarily around the distribution and management of medication supply within primary care, and the lack of a standardized clinical support monitoring system. CONCLUSION: Changes are needed in clinical practice to better educate and support patients to improve the uptake of injectables and optimize their use of these medications in the management of dyslipidaemia. IMPACT: This study suggests that injectable therapies were acceptable to people with cardiovascular disease. However, healthcare professionals need to play a key role in improving education and providing support to aid patients' decision-making regarding commencing and adhering to injectable therapies. REPORTING METHOD: The study adhered to the Consolidated Criteria for Reporting Qualitative Research. PATIENT OR PUBLIC CONTRIBUTION: There was no patient or public contribution.

Effectiveness of transitional care interventions in patients with serious illness and their caregivers: a systematic review protocol.

OBJECTIVE: The objective of this review is to evaluate the effectiveness of transitional care interventions for seriously ill patients and their caregivers. INTRODUCTION: Seriously ill patients and their caregivers may have complex health and social care needs that require services from numerous providers across multiple sectors. Transitional care interventions have been designed to enhance a collaborative approach among providers to facilitate the care transition process. However, the effectiveness of transitional care interventions for seriously ill patients and their caregivers, and the effects of such interventions on their outcomes, remain unclear. INCLUSION CRITERIA: Randomized controlled trials with adult patients (≥18 years old) with serious illness and their caregivers involved in transitional care programs will be considered for inclusion. The patients' outcomes will include mortality and/or survival, symptoms (eg, pain, nausea), and health-related quality of life. The caregivers' outcomes will include caregiver burden, preparedness, and well-being. METHODS: The JBI methodology for systematic reviews of effectiveness will be followed. The search strategy will aim to locate published and unpublished studies. Electronic databases, including PubMed, Embase, CINAHL, and the Cochrane Central Register of Controlled Trials, will be systematically searched from 2003 to the present. Studies in English, Italian, Spanish, French, and German will be included. Critical appraisal and data extraction will be conducted using standardized tools. Quantitative data will be pooled in statistical meta-analysis or, if statistical pooling is not possible, the findings will be reported narratively. Certainty of the evidence will be assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. SYSTEMATIC REVIEW REGISTRATION NUMBER: PROSPERO CRD42022319848.

Effectiveness of Motivational Interviewing on contribution to self-care, self-efficacy, and preparedness in caregivers of patients with heart failure: a secondary outcome analysis of the MOTIVATE-HF randomized controlled trial.

AIMS: Caregiver characteristics and behaviours are associated with patients' and caregivers' outcomes. However, there is scarce evidence on interventions aimed at improving caregiver contribution (CC) to patient self-care, caregiver self-efficacy, and caregiver preparedness in heart failure (HF). This study aims to evaluate the effect of Motivational Interviewing (MI) on CC to patient self-care, caregiver self-efficacy, and caregiver preparedness in HF. METHODS AND RESULTS: This is a secondary outcome analysis of MOTIVATE-HF randomized controlled trial. Caregivers of patients with HF were randomized into three arms: Arm 1 (MI for patients), Arm 2 (MI for patients and caregivers), and Arm 3 (standard care). The intervention consisted of one MI session plus three telephone contacts. Data were collected at baseline and after 3, 6, 9, and 12 months. A total of 510 patient and caregiver (median age 54 years, 76% females) dyads were enrolled, 235 caregivers and 238 patients completed the study until 12 months. Caregiver contribution to self-care maintenance and management and caregiver preparedness significantly improved over time, but without significant differences among the three arms. At 9 months, caregiver self-efficacy improved more in Arm 2 than Arm 3 [difference: 8.36, 95% confidence interval (CI) (3.13; 13.59), P = 0.001]. This improvement remained significant also at linear mixed model [ß^ = 1.39, 95% CI (0.02; 2.75), P = 0.046]. CONCLUSION: Motivational Interviewing did not improve CC to patient self-care and caregiver preparedness. However, it increased caregiver self-efficacy, which is known to be a powerful mediator of CC to self-care. REGISTRATION: Clinicaltrials.gov: NCT02894502.

A Motivational Interviewing Intervention Improves Physical Symptoms in Patients with Heart Failure: A Secondary Outcome Analysis of the Motivate-HF Randomized Controlled Trial.

CONTEXT: Heart failure (HF) patients experience high burden of physical symptoms during their disease trajectory. OBJECTIVE: To evaluate the effects of Motivational Interviewing (MI) on the burden of physical symptoms in HF patients. METHODS: We performed a secondary analysis of data from the MOTIVATE-HF randomized controlled trial. A sample of 510 patients (median 74 years, 58% male) and their caregivers (median 55 years, 75.5% female) was randomly allocated to Arm 1 (MI only for patients), Arm 2 (MI for patients and caregivers), and Arm 3 (standard of care). The MI intervention consisted of one face-to-face session plus three telephone calls conducted within two months from enrollment. Symptoms' burden was assessed with the Heart Failure Somatic Perception Scale (HFSPS) with the dimensions of Chest Discomfort, Dyspnea, Early and subtle and Edema. Data were collected at baseline and at 3, 6, 9, and 12 months after enrollment. RESULTS: At 12 months, Chest Discomfort improved in Arms 1 and 2 vs Arm 3 (Δ: -8.13, 95% CI: -14.61; -1.65). Dyspnea improved in Arms 1 and 2 vs Arm 3 both at 9 and 12 months (Δ: -7, 95% CI: -13.18; -0.82 and -6.78, 95% CI: -13.19; -0.38); HFSPS total score improved in Arm 1 and Arm 2 vs Arm 3 at 9 months (Δ: -4.55, 95% CI: -9.05; -0.05). Over 1 year, Chest Discomfort and HFSPS total score in Arm 2 improved compared to Arm 3 (ß= -2.61, 95% CI: -4.21; -1.00, P = 0.0015 and ß=-1.35, 95% CI: -2.50; -0.21, P = 0.02). CONCLUSION: MI reduces the burden of physical HF symptoms, particularly when caregivers are involved in the intervention.

Effectiveness of motivational interviewing on health-service use and mortality: a secondary outcome analysis of the MOTIVATE-HF trial.

AIMS: Intense health-care service use and high mortality are common in heart failure (HF) patients. This secondary analysis of the MOTIVATE-HF trial investigates the effectiveness of motivational interviewing (MI) in reducing health-care service use (e.g. emergency service use and hospitalizations) and all-cause mortality. METHODS AND RESULTS: This study used a randomized controlled trial. Patients and caregivers were randomized to Arm 1 (MI for patients), Arm 2 (MI for patients and caregivers), or Arm 3 (control group). Data were collected at baseline and at 3, 6, 9, and 12 months. Face-to-face MI plus three telephone calls were performed in Arms 1 and 2. The sample consisted of 510 patient (median age 74 years, 58% male patients) and caregiver dyads (median age 55 years, 75% female patients). At 12 months, 16.1%, 17%, and 11.2% of patients used health-care services at least once in Arms 1, 2, and 3, respectively, without significant difference. At 3 months, 1.9%, 0.6%, and 5.1% of patients died in Arms 1, 2, and 3, respectively. Mortality was lower in Arm 2 vs. Arm 3 at 3 months [hazard ratio (HR) = 0.112, 95% CI: 0.014-0.882, P = 0.04]; no difference was found at subsequent follow-ups. Mortality was lower in Arm 1 vs. Arm 3 at 3 months but did not reach statistical significance (HR = 0.38, 95% CI: 0.104-1.414, P = 0.15). CONCLUSION: This study suggests that MI reduces mortality in patients with HF if caregivers are included in the intervention. Further studies with a stronger intervention and longer follow-up are needed to clarify the benefits of MI on health-care service use and mortality.

Motivational interviewing to improve self-care in heart failure patients (MOTIVATE-HF): a randomized controlled trial.

AIMS: Self-care, an essential component of heart failure (HF) treatment, is inadequate in most patients. We evaluated if motivational interviewing (MI) (i) improves patient self-care maintenance (primary endpoint; e.g. taking medications), self-care management (e.g. responding to symptoms) and self-care confidence (or self-efficacy) 3 months after enrolment; (ii) changes self-care over 1 year, and (iii) augments patient self-care if informal caregivers are involved. METHODS AND RESULTS: Parallel randomized controlled trial (1:1:1). A sample of 510 patients (median 74 years, 58% male) and caregivers (median 55 years, 75% female) was randomized to Arm 1 (MI only for patients), Arm 2 (MI for patients and caregivers), or Arm 3 (usual care). The intervention in Arms 1 and 2 consisted of one face-to-face MI session with three telephone contacts. Self-care was evaluated with the Self-Care of HF Index measuring self-care maintenance, management, and confidence. Scores on each scale range from 0 to 100 with higher scores indicating better self-care; ≥70 is considered adequate. At 3 months, self-care maintenance improved 6.99, 7.42 and 2.58 points in Arms 1, 2, and 3, respectively (P = 0.028). Self-care maintenance was adequate in 18.4%, 19.4%, and 9.2% of patients in Arms 1, 2 and 3, respectively (P = 0.016). Over 1 year, self-care maintenance, management, and confidence scores in Arms 1 and 2 were significantly higher than in Arm 3 in several follow-ups. Over 1 year, Arm 2 had the best scores in self-care management. CONCLUSIONS: MI significantly improved self-care in HF patients. Including caregivers may potentiate the effect, especially in self-care management. ClinicalTrial.gov, identifier: NCT02894502.

Men's experiences of deciding about treatment for localized prostate cancer: a meta-synthesis.

BACKGROUND: Prostate cancer is the most common cancer in men worldwide and nowadays several treatments are available, each presenting risks and benefits. Therefore, deciding on the most appropriate treatment is particularly challenging for men at the time of the diagnosis. AIM: This review was aimed at identifying, analyzing, and synthesizing the qualitative evidence on the experience of deciding about treatment after a diagnosis of localized Prostate cancer (LPC) METHODS: A meta-synthesis according to the meta-aggregation approach of the Joanna Briggs Institute (JBI) was used. The CINAHL, MEDLINE, and PsycINFO databases were searched for qualitative studies published from January 1998 to August 2018 in English and Italian. Qualita- tive Assessment and Review Instrument of JBI was used. RESULTS: From the identified sixteen studies two synthesized findings were derived that describe the decision-making as a complex process made in condition of emotional distress and influenced by internal and external factors; men evaluate differently the possible risks and benefits of cancer treatment, and after deciding they try to cope with their choice. CONCLUSION: The review provides evidence that men with LPC's need to receive emotional support and comprehensive information about the treatment options to facilitate their decision. The healthcare team should refer men to a multidisciplinary cancer service to permit access to all the treatment options.