Patients' preferences for subcutaneous trastuzumab versus conventional intravenous infusion for the adjuvant treatment of HER2-positive early breast cancer: final analysis of 488 patients in the international, randomized, two-cohort PrefHer study

BACKGROUND: Patients with HER2-positive early breast cancer (EBC) preferred subcutaneous (SC) trastuzumab, delivered via single-use injection device (SID), over the intravenous (IV) formulation (Cohort 1 of the PrefHer study: NCT01401166). Here we report patient preference, healthcare professional satisfaction, and safety data pooled from Cohort 1 and also Cohort 2, where SC trastuzumab was delivered via hand-held syringe. PATIENTS AND METHODS: Patients were randomized to receive 4 adjuvant cycles of 600 mg fixed-dose SC trastuzumab followed by 4 cycles of standard IV trastuzumab, or vice versa. The primary endpoint was overall preference proportions for SC or IV, assessed by patient interviews in the evaluable ITT population. RESULTS: A total of 245 patients were randomized to receive SC followed by IV and 243 received IV followed by SC (evaluable ITT populations: 235 and 232 patients, respectively). SC was preferred by 415/467 (88.9%; 95% CI, 85.7-91.6; P<.0001; two-sided test against null hypothesis of 65% SC preference); 45/467 preferred IV (9.6%; 7-13); 7/467 indicated no preference (1.5%; 1-3). Clinician-reported adverse events occurred in 292/479 (61.0%) and 245/478 (51.3%) patients during the pooled SC and IV periods, respectively (P<.05; 2x2 chi2); 16 patients (3.3%) in each period experienced grade 3 events; none were grade 4/5. CONCLUSION: PrefHer revealed compelling and consistent patient preferences for SC over IV trastuzumab, regardless of SID or hand-held syringe delivery. SC was well tolerated and safety was consistent with previous reports, including the HannaH study (NCT00950300). No new safety signals were identified compared to the known IV profile in EBC. PrefHer and HannaH confirm that SC trastuzumab is a validated and preferred option over IV for improving patients' care in HER2-positive breast cancer

Cardiac rehabilitation for heart failure: Do older people want to attend and are they referred?

Purpose Uptake of cardiac rehabilitation services by older people is suboptimal. Offering suitable services may increase participation. This study investigated older heart failure patients' preferences between hospital, community and home-based service models and sociodemographic and clinical factors associated with these preferences. Rates of referral were examined. Methods Cross-sectional survey of patients aged 65 years and older consecutively admitted to elderly care, cardiology and general medicine wards in a large UK hospital with confirmed heart failure between March-December 2009. A 57-item interview schedule incorporating open and closed questions and standard measures was developed enabling both quantitative and qualitative analysis. Associations between patients' preferences and characteristics including disease severity (New York Heart Association [NYHA] classification) and comorbidity (Charlson comorbidity score) were analysed using Chi-squared tests and one-way ANOVA. Results One hundred and six interviews were completed (mean age 77.8 ± 7.3, 62% male, 47% lived alone). Most patients had moderate-severe heart failure (55% NYHA class III; 34% class II) and co-morbidities (mean Charlson score 3.3 ± 1.7). Most opted for cardiac rehabilitation (72%), preferring hospital to community classes. Those preferring hospital programmes were younger (mean 5.1 years, 95% CI -10.1 to -0.1, P = 0.043) than those preferring not to participate. Neither disease severity nor comorbidity was associated with preferences. Only 21% were referred to any cardiac rehabilitation service. Conclusion Most of these older heart failure patients wanted to attend cardiac rehabilitation, but few were referred. Age was related to preferring certain cardiac rehabilitation service models but not to an overall preference to attend. Referral processes need urgent improvement and offering choice of service models may increase participation. © 2014 Elsevier Masson SAS and European Union Geriatric Medicine Society

A grounded theory study: Exploring health care professionals decision making when managing end stage heart failure care

Aim: To explore how healthcare professionals in an acute medical setting make decisions when managing the care of patients diagnosed with end stage heart failure, and how these decisions impact directly on the patient's end of life experience. Design: A constructivist grounded theory approach was adopted. Method: A purposive sample was used to recruit participants that included 16 registered nurses, 15 doctors and 16 patients. Data were collected using semi-structured interviews and focus groups over a 12-month period of fieldwork concluding in 2017. The interviews were recorded and transcribed and the data were analysed using constant comparison and QSR NVivo. Findings: Four theoretical categories emerged from the data to explain how healthcare professionals and patients negotiated the process of decision making when considering end of life care. These were: signposting symptoms, organizing care, being informed and recognizing dying. The themes revolved around a core category ‘a vicious cycle of heart failure care’. Conclusion: Healthcare professionals need to engage in informed decision making with patients to break this ‘vicious cycle of care’ by identifying key stages in the terminal phase of heart failure and correctly signposting the patient to the most suitable healthcare care professional for intervention. Impact: This study provides a theoretical framework to explain a ‘vicious cycle of care’ for patients diagnosed with end stage heart failure. This theory grounded in data demonstrates the need for both acute and primary care to design an integrative end of life care pathway for heart failure patients which addresses the need for early shared decision making between the healthcare professional, family and the patient when it comes to end of life conversations