Ipilimumab in a real-world population: A prospective Phase IV trial with long-term follow-up.

Ipilimumab was the first treatment that improved survival in advanced melanoma. Efficacy and toxicity in a real-world setting may differ from clinical trials, due to more liberal eligibility criteria and less intensive monitoring. Moreover, high costs and lack of biomarkers have raised cost-benefit concerns about ipilimumab in national healthcare systems and limited its use. Here, we report the prospective, interventional study, Ipi4 (NCT02068196), which aimed to investigate the toxicity and efficacy of ipilimumab in a real-world population with advanced melanoma. This national, multicentre, phase IV trial included 151 patients. Patients received ipilimumab 3 mg/kg intravenously and were followed for at least 5 years or until death. Treatment interruption or cessation occurred in 38%, most frequently due to disease progression (19%). Treatment-associated grade 3 to 4 toxicity was observed in 28% of patients, and immune-related toxicity in 56%. The overall response rate was 9%. Median overall survival was 12.1 months (95% CI: 8.3-15.9); and progression-free survival 2.7 months (95% CI: 2.6-2.8). After 5 years, 20% of patients were alive. In a landmark analysis from 6 months, improved survival was associated with objective response (HR 0.16, P = .001) and stable disease (HR 0.49, P = .005) compared to progressive disease. Poor performance status, elevated lactate dehydrogenase and C-reactive protein were identified as biomarkers. This prospective trial represents the longest reported follow-up of a real-world melanoma population treated with ipilimumab. Results indicate safety and efficacy comparable to phase III trials and suggest that the use of ipilimumab can be based on current cost-benefit estimates.

Adapting an Australian question prompt list in oncology to a Norwegian setting-a combined method approach.

PURPOSE: A question prompt list (QPL) is an inexpensive communication aid that has been proved effective in encouraging patients to ask questions during medical consultations. The aim of this project was to develop a QPL for Norwegian cancer patients. METHODS: A multimethod approach was chosen combining literature review, focus groups, and a survey in the process of culturally adjusting an Australian QPL for the Norwegian setting. Participants were recruited from the University Hospital of North Norway. They were asked to review and comment on iterative drafts of the QPL. RESULTS: Eighteen patients, mean age 54, participated in the focus groups, and 31 patients, mean age 55, participated in the survey. Focus groups suggested that topics related to accompanying relatives, children as next of kin, and rehabilitation were important and should be added to the original QPL. The survey revealed that most questions from the original QPL were considered both useful and understandable. Although half of the patients found some questions about prognosis unpleasant, the vast majority considered the same questions useful. Questions regarding clinical studies, multidisciplinary teams, and public versus private hospitals had lower ratings of usefulness. CONCLUSION: QPLs require some adjustment to the local cultural context, and a mixed method approach may provide a useful model for future cultural adaptation of QPLs. The present QPL has been adjusted to the needs of oncology patients in the Norwegian health care setting.

Is patient behavior during consultation associated with shared decision-making? A study of patients' questions, cues and concerns in relation to observed shared decision-making in a cancer outpatient clinic.

OBJECTIVES: To explore how cancer patients actively participate in consultations by asking questions and expressing emotional cues/concerns and to what extent this is associated with physician shared decision making (SDM) behavior. METHODS: This observational study included audio recordings of 31 primary consultation with patients at the Oncology Outpatient Clinic at the University Hospital of North Norway. The content (topics) and frequency of health related questions from patients/caregivers were registered along with emotional cues and concerns (VR-CoDES) and observed shared decision-making (OPTION). Patient reported outcomes were measured before and one week after the consultation. RESULTS: On average, 17 (SD 15) questions were asked, and 1.9 (SD 1.9) emotional cues and concerns were expressed by patients per consultation. The questions mainly pertained to treatment and practical issues. The mean OPTION score was 12 (SD 7.9) and was neither associated with questions nor emotional cues and concerns from patients. CONCLUSION: Although patients were active by asking questions, observed physician SDM behavior measured by OPTION was low and not associated with patient behavior during consultation. PRACTICE IMPLICATIONS: Further research on patients influence on physician SDM behavior is needed.

Supporting doctor-patient communication: Providing a question prompt list and audio recording of the consultation as communication aids to outpatients in a cancer clinic.

OBJECTIVE: To document the effect of a cancer specific question prompt list (QPL) on patients question asking and shared decision-making (SDM), and to evaluate the combined effect of the QPL and consultation audio recording (CAR) on patient outcomes. METHOD: This exploratory study compared two groups of patients receiving either a QPL or combined QPL/CAR, to a control group. Measurements included number/types of questions asked, and physician SDM behavior (OPTION score). Questionnaire data included anxiety/depression and quality of life (QoL). RESULTS: A total of 93 patients participated (31 Control, 30 QPL and 32 Combined). Patients in the intervention groups asked more questions concerning prognosis (p < .0001), the disease (p = .006) and quality of treatment (p < .001) than patients in the control group, but no impact was found on the OPTION score. An increase in mean consultation length was observed in the intervention groups compared to the control group (44 vs. 36 min; p = .028). Patients rated both interventions positively. CONCLUSION: Provision of the QPL facilitates patients to ask a broader range of questions, but does not increase physician SDM behavior. PRACTICAL IMPLEMENTATION: The combination of QPL and CAR seems feasible and should be tested in an implementation study following the disease trajectory.