Background The Utrecht Symptom Diary (USD) is a Dutch and adapted version of the Edmonton Symptom Assessment System, a patient‐reported outcome measurement (PROM) tool to asses and monitor symptoms in cancer patients. This study analyses the validity and responsiveness of the USD and the cutoff points to determine the clinical significance of a symptom score. Methods Observational longitudinal cohort study including adult in‐ and outpatients treated in an academic hospital in the Netherlands who completed at least one USD as part of routine care (2012‐2019). The distress thermometer and problem checklist (DT&PC) was used as a reference PROM. Content, construct and criterion validity, responsiveness, and cutoff points are shown with prevalences, area under receiver operating characteristic (ROC) curve, Chi‐squared test, Wilcoxon signed‐rank test, and positive and negative predictive values, respectively. Results A total of 3913 patients completed 22 400 USDs. Content validity was confirmed for all added USD items with prevalences of ≥22%. All USD items also present on the DT&PC demonstrated a good criterion validity (ROC >0.8). Construct validity was confirmed for the USD as a whole and for the items dry mouth, dysphagia and well‐being (P < .0001). USD scores differed significantly for patients when improving or deteriorating on the DT&PC which confirmed responsiveness. Optimal cutoff points (3 or 4) differed per symptom. Conclusion The USD is a valid 12‐item PROM for the most prevalent symptoms in cancer patients, which has content, criterion, and construct validity, and detects clinically important changes over time, in both curative and palliative phase.

BackgroundThe nationwide integration of palliative care best practices into general care settings is challenging but important in improving the quality of palliative care. This is why the Dutch National Quality Improvement Programme for Palliative Care has recently been launched. This four-year programme consists of about 70 implementation trajectories of best practices. A large evaluation study has been set up to evaluate this national programme and separate implementation trajectories.Methods/DesignThis paper presents the protocol of the evaluation study consisting of a quantitative effect evaluation and a qualitative process evaluation. The effect evaluation has a pre-test post-test design, with measurements before implementation (month 0) and after implementation (month 9) of a best practice. Patients are eligible if they have a life expectancy of less than six months and/or if they are undergoing palliative treatment and provided they are physically and mentally capable of responding to questionnaires. Bereaved relatives are eligible if they have been involved in the care of a deceased patient who died after a sickbed between six weeks and six months ago. Three types of measurement instruments are used: (1) numerical rating scales for six symptoms (pain, fatigue, breathlessness, obstipation, sadness and anxiety), (2) the Consumer Quality Index Palliative Care - patient version and (3) the version for bereaved relatives.The process evaluation consists of analysing implementation plans and reports of the implementation, and individual and group interviews with healthcare professionals. This will be done nine to eleven months after the start of the implementation of a best practice.DiscussionThis mixed-method evaluation study gives more insight into the effects of the total programme and the separate implementation trajectories. However, evaluation of large quality improvement programmes is complicated due to changing, non-controlled environments. Therefore, it is important that an effect evaluation is combined with a process evaluation.Trial registrationNTR-4085

203 Background: Radiotherapy (RT) is an effective treatment for painful bone metastases, although pain is not always sufficiently controlled. Pain management education may improve patient empowerment and, consequently, reduce pain intensity. The effect of nurse-led education (NLE) in patients undergoing RT for painful bone metastases was investigated as compared to care as usual (CAU). Primary endpoint was pain intensity at 12 weeks, secondary outcome was quality of life (QoL). Methods: In this multicentre, randomised phase 3 study, patients referred for short schedule RT, with uncontrolled pain (a score of ≥5 on a 0-10 numeric rating scale (NRS)), were randomised between NLE or CAU before start of RT. The NLE consisted of a structured interview including assessment of pain knowledge, verbal and written education on all aspects of pain and follow-up phone calls at 1, 4, 8 & 12 weeks to address pain-related questions. Patients in CAU received leaflets on RT, cancer pain and opioid use. Patient characteristics were assessed at baseline. Pain intensity and QoL were evaluated with the Brief Pain Inventory, EORTC QLQ-C15-PAL and EORTC QLQ-BM22 at baseline, and week 1, 4, 8 & 12. Power calculation showed that there were 89 patients per arm needed to detect a 10% difference in number of patients with a NRS < 5 at 12 weeks(1-sided α = 0.05; β 0.8). Results: Between May 2011-April 2016, 354 patients were randomised (176 NLE, 178 CAU), 38 were excluded (30 NRS < 5 at baseline, 7 no short schedule RT, 1 missing informed consent). At twelve weeks, 185 (NLE 95) had completed follow-up (72 stopped filling out questionnaires, 59 died prematurely). Baseline characteristics were similar in both groups; mean age 65 years, 56% men. At week 12, more patients in NLE than in CAU had controlled pain (NRS < 5; respectively 66% and 52%, p = 0.036). Moreover, patients in NLE reached faster a pain score < 5 than patients in CAU (31 versus 54 days respectively, p = 0.026). On all time points, no significant differences in QoL were found between both groups. Conclusions: Controlled pain, i.e. a pain intensity < 5, was reached faster and by more patients with painful bone metastases undergoing RT by the addition of nurse-led pain education. Clinical trial information: NCT01358539.