Development and validation of clinical implementation methods for patient-reported outcomes in Japanese multi-center palliative care units.

BACKGROUND: Patient-Reported Outcomes (PROs) are recommended for use in clinical oncology. However, they are not routinely used in professional palliative care practices in Japan. The reasons include both patient and healthcare provider factors and the implementation of PROs. This study aimed to develop and validate clinical implementation methods for PROs in Japanese palliative care units. METHODS: The Consolidated Framework for Implementation Research (CFIR) was conducted with four palliative care units in Japan. The study was conducted in six steps: unit assessment, development and implementation of a PRO implementation plan, PRO post-implementation survey and analysis of its utilization, a review of the PRO implementation process, creation of a PRO implementation method in a palliative care unit, and use and verification of the implementation method. Steps 1-5 were the development phase, and step 6 was the verification phase. RESULTS: Interviews were conducted with healthcare providers prior to PRO implementation. Intervention characteristics, patient needs in the palliative care unit, and factors related to the organization were identified as barriers. The implementation plan was developed, and the core members were selected. The implementation procedures were created in the above mentioned steps. PROs were used in the palliative care units. The same was true in the validation phase. CONCLUSIONS: This study guided PROs in specialized palliative care unit in a clinical setting. The method was developed and validated for the implementation of PROs in the palliative care unit. In the PRO implementation process, it was important to assess the unit, address the barriers to implementation, and reduce the burden on healthcare providers. Furthermore, healthcare providers had to be supported by the champion, a person responsible for the implementation of PROs in the palliative care unit.

Cancer Pain Management in Patients Receiving Inpatient Specialized Palliative Care Services.

CONTEXT: Cancer pain is a common complication that is frequently undertreated in patients with cancer. OBJECTIVES: This study is aimed at assessing the time needed to achieve cancer pain management goals through specialized palliative care (SPC). METHODS: This was a multicenter, prospective, longitudinal study of inpatients with cancer pain who received SPC. Patients were continuously followed up until they considered cancer pain management successful, and we estimated this duration using the Kaplan-Meier method. We investigated the effectiveness of pain management using multiple patient-reported outcomes (PROs) and quantitative measures, including pain intensity change in the Brief Pain Inventory. A paired-sample t-test was used to compare the pain intensity at the beginning and end of the observation period. RESULTS: Cancer pain management based on the PROs was achieved in 87.9% (385/438) of all cases. In 94.5% (364/385) of these cases, cancer pain management was achieved within 1 week, and the median time to pain management was 3 days (95% confidence interval [CI], 2-3). The mean worst pain intensity in the last 24 h at the start and end of observation were 6.9 ± 2.2 and 4.0 ± 2.3, respectively, with a difference of -2.9 (95% CI, -3.2 to -2.6; p < 0.01). Overall, 81.6% of the patients reported satisfaction with cancer pain management, and 62 adverse events occurred. CONCLUSION: SPC achieved cancer pain management over a short period with a high level of patient satisfaction resulting in significant pain reduction and few documented adverse events.

Prevalence of opioid-induced adverse events across opioids commonly used for analgesic treatment in Japan: a multicenter prospective longitudinal study.

PURPOSE: Although opioids have been shown to be effective for cancer pain, opioid-induced adverse events (AEs) are common. To date, little is known about the differences in risks of AEs by opioid type. This study was performed to compare the prevalence of AEs across opioids commonly used for analgesic treatment in Japan. METHODS: This study was conducted as a preplanned secondary analysis of a multicenter prospective longitudinal study of inpatients with cancer pain who received specialized palliative care for cancer pain relief. We assessed daily AEs until termination of follow-up. We rated the severity of AEs based on the Common Terminology Criteria for Adverse Events version 5.0. We computed adjusted odds ratios for each AE (constipation, nausea and vomiting, delirium, and drowsiness) with the following variables: opioid, age, sex, renal dysfunction, and primary cancer site. RESULTS: In total, 465 patients were analyzed. Based on the descriptive analysis, the top four most commonly used opioids were included in the analysis: oxycodone, hydromorphone, fentanyl, and tramadol. With respect to the prevalence of AEs among all analyzed patients, delirium (n = 25, 6.3%) was the most frequent, followed by drowsiness (n = 21, 5.3%), nausea and vomiting (n = 19, 4.8%), and constipation (n = 28, 4.6%). The multivariate logistic analysis showed that no single opioid was identified as a statistically significant independent predictor of any AE. CONCLUSION: There was no significant difference in the prevalence of AEs among oxycodone, fentanyl, hydromorphone, and tramadol, which are commonly used for analgesic treatment in Japan.