RESUMEN
Importance: Chronic breathlessness is common in people with chronic obstructive pulmonary disease (COPD). Regular, low-dose, extended-release morphine may relieve breathlessness, but evidence about its efficacy and dosing is needed. Objective: To determine the effect of different doses of extended-release morphine on worst breathlessness in people with COPD after 1 week of treatment. Design, Setting, and Participants: Multicenter, double-blind, placebo-controlled randomized clinical trial including people with COPD and chronic breathlessness (defined as a modified Medical Research Council score of 3 to 4) conducted at 20 centers in Australia. People were enrolled between September 1, 2016, and November 20, 2019, and followed up through December 26, 2019. Interventions: People were randomized 1:1:1 to 8 mg/d or 16 mg/d of oral extended-release morphine or placebo during week 1. At the start of weeks 2 and 3, people were randomized 1:1 to 8 mg/d of extended-release morphine, which was added to the prior week's dose, or placebo. Main Outcomes and Measures: The primary outcome was change in the intensity of worst breathlessness on a numerical rating scale (score range, 0 [none] to 10 [being worst or most intense]) using the mean score at baseline (from days -3 to -1) to the mean score after week 1 of treatment (from days 5 to 7) in the 8 mg/d and 16 mg/d of extended-release morphine groups vs the placebo group. Secondary outcomes included change in daily step count measured using an actigraphy device from baseline (day -1) to the mean step count from week 3 (from days 19 to 21). Results: Among the 160 people randomized, 156 were included in the primary analyses (median age, 72 years [IQR, 67 to 78 years]; 48% were women) and 138 (88%) completed treatment at week 1 (48 in the 8 mg/d of morphine group, 43 in the 16 mg/d of morphine group, and 47 in the placebo group). The change in the intensity of worst breathlessness at week 1 was not significantly different between the 8 mg/d of morphine group and the placebo group (mean difference, -0.3 [95% CI, -0.9 to 0.4]) or between the 16 mg/d of morphine group and the placebo group (mean difference, -0.3 [95%, CI, -1.0 to 0.4]). At week 3, the secondary outcome of change in mean daily step count was not significantly different between the 8 mg/d of morphine group and the placebo group (mean difference, -1453 [95% CI, -3310 to 405]), between the 16 mg/d of morphine group and the placebo group (mean difference, -1312 [95% CI, -3220 to 596]), between the 24 mg/d of morphine group and the placebo group (mean difference, -692 [95% CI, -2553 to 1170]), or between the 32 mg/d of morphine group and the placebo group (mean difference, -1924 [95% CI, -47â¯699 to 921]). Conclusions and Relevance: Among people with COPD and severe chronic breathlessness, daily low-dose, extended-release morphine did not significantly reduce the intensity of worst breathlessness after 1 week of treatment. These findings do not support the use of these doses of extended-release morphine to relieve breathlessness. Trial Registration: ClinicalTrials.gov Identifier: NCT02720822.
Asunto(s)
Disnea , Morfina , Enfermedad Pulmonar Obstructiva Crónica , Fármacos del Sistema Respiratorio , Anciano , Femenino , Humanos , Masculino , Preparaciones de Acción Retardada/uso terapéutico , Método Doble Ciego , Disnea/tratamiento farmacológico , Disnea/etiología , Morfina/administración & dosificación , Morfina/uso terapéutico , Enfermedad Pulmonar Obstructiva Crónica/complicaciones , Enfermedad Pulmonar Obstructiva Crónica/tratamiento farmacológico , Fármacos del Sistema Respiratorio/administración & dosificación , Fármacos del Sistema Respiratorio/uso terapéutico , Enfermedad Crónica , Resultado del TratamientoRESUMEN
PURPOSE: To determine whether provision of a question prompt list (QPL) influences advanced cancer patients'/caregivers' questions and discussion of topics relevant to end-of-life care during consultations with a palliative care (PC) physician. PATIENTS AND METHODS: This randomized controlled trial included patients randomly assigned to standard consultation or provision of QPL before consultation, with endorsement of the QPL by the physician during the consultation. Consecutive eligible patients with advanced cancer referred to 15 PC physicians from nine Australian PC services were invited to participate. Consultations were audiotaped, transcribed, and analyzed by blinded coders; patients completed questionnaires before, within 24 hours, and 3 weeks after the consultation. RESULTS: A total of 174 patients participated (92 QPL, 82 control). Compared with controls, QPL patients and caregivers asked twice as many questions (for patients, ratio, 2.3; 95% CI, 1.7 to 3.2; P < .0001), and patients discussed 23% more issues covered by the QPL (95% CI, 11% to 37%; P < .0001). QPL patients asked more prognostic questions (ratio, 2.3; 95% CI, 1.3 to 4.0; P = .004) and discussed more prognostic (ratio, 1.43; 95% CI, 1.1 to 1.8, P = .003) and end-of-life issues (30% v 10%; P = .001). Fewer QPL patients had unmet information needs about the future (21 = 4.14; P = .04), which was the area of greatest unmet information need. QPL consultations (average, 38 minutes) were longer (P = .002) than controls (average, 31 minutes). No differences between groups were observed in anxiety or patient/physician satisfaction. CONCLUSION: Providing a QPL and physician endorsement of its use assists terminally ill cancer patients and their caregivers to ask questions and promotes discussion about prognosis and end-of-life issues, without creating patient anxiety or impairing satisfaction.
Asunto(s)
Planificación Anticipada de Atención , Neoplasias/psicología , Neoplasias/terapia , Cuidados Paliativos , Participación del Paciente , Cuidado Terminal/organización & administración , Adulto , Anciano , Anciano de 80 o más Años , Actitud Frente a la Muerte , Cuidadores , Comunicación , Femenino , Humanos , Masculino , Persona de Mediana Edad , Neoplasias/diagnóstico , Variaciones Dependientes del Observador , Relaciones Médico-Paciente , Pronóstico , Derivación y Consulta , Sistemas Recordatorios/instrumentación , Encuestas y Cuestionarios , Enfermo TerminalRESUMEN
Palliative care teams have made an important contribution to improving the care of patients with incurable illnesses in Australian hospitals over the past 20 years. Co-location of hospital-based palliative medicine specialists with other specialties allows communication and exchange of ideas on issues relevant to the medical care of such patients. Shared management of complex cases maximises comprehension of patient distress and optimises the support provided during hospitalisation. Tensions arising across the interface provide opportunities for both groups to improve the relief of suffering in the acute-care setting. Palliative medicine in the private sector has some advantages, but specialists also face specific challenges, including the cost of certain drugs, access to the multidisciplinary team and reimbursement issues.