Conducting high-quality randomized clinical trials (RCTs) is challenging and resource-demanding. Trials are often not conducted as planned or are even prematurely discontinued, eg, for reasons of unexpected harm from the intervention, early superiority, futility, administrative problems, or poor recruitment of participants. Trial discontinuation poses ethical concerns, particularly if results remain unreported, and may represent a considerable waste of scarce research resources.^1-3

Purpose: The Prospective Oral Mucositis Audit assessed the incidence, duration, and determinants of severe oral mucositis (OM; WHO oral toxicity scale grades 3 to 4) in patients with multiple myeloma (MM) or non-Hodgkin's lymphoma (NHL) receiving high-dose conditioning chemotherapy before autologous stem-cell transplantation. Patients and Methods: Patients with MM (n = 109; mean age, 57 ± 8 years) or NHL (n = 88; mean age, 50 ± 13 years) were treated with high-dose melphalan (200 mg/m²) or carmustine 300 mg/m², etoposide 800 mg/m², cytarabine 800 to 1,600 mg/m², and melphalan 140 mg/m² chemotherapy, respectively, in 25 European centers. OM assessments were made daily until 30 days after transplantation or hospital discharge. High quality of OM assessment was ensured by an intensive training program. Results: Severe OM occurred in 46% (95% CI, 36% to 56%) of patients with MM and 42% (95% CI, 32% to 53%) of patients with NHL, with a mean duration of 5.3 days (95% CI, 4.4 to 6.1 days) and 5.5 days (95% CI, 4.5 to 6.7 days), respectively. Time from start of conditioning to peak OM score was 12.1 ± 2.6 and 14.6 ± 2.4 days. Severe OM risk and/or duration was significantly associated with higher chemotherapy dose per kilogram of body weight and poor performance status, but in contrast with some previous reports, this was not related to age. Conclusion: Severe OM is more common in the transplantation setting than previously reported, justifying effective preventative and therapeutic measures.

Patient ratings of satisfaction with their postoperative pain treatment tend to be high even in those with substantial pain. Determinants are poorly understood and have not previously been studied in large-scale, international datasets. PAIN OUT, a European Union-funded acute pain registry and research project, collects patient-reported outcome data on postoperative day 1 using the self-reported International Pain Outcome Questionnaire (IPO), and patient, clinical, and treatment characteristics. We investigated correlates of satisfaction and consistency of effects across centres and countries using multilevel regression modelling. Our sample comprised 16,868 patients (median age 55 years; 55% female) from 42 centres in 11 European countries plus Israel, USA, and Malaysia, who underwent a wide range of surgical procedures, for example, joint, limb, and digestive tract surgeries. Median satisfaction was 9 (interquartile range 7-10) on a 0-10 scale. Three IPO items showed strong associations and explained 35% of the variability present in the satisfaction variable: more pain relief received, higher allowed participation in pain treatment decisions, and no desire to have received more pain treatment. Patient factors and additional IPO items reflecting pain experience (eg, worst pain intensity), pain-related impairment, and information on pain treatment added little explanatory value, partially due to covariate correlations. Effects were highly consistent across centres and countries. We conclude that satisfaction with postoperative pain treatment is associated with the patients' actual pain experience, but more strongly with impressions of improvement and appropriateness of care. To the degree they desire, patients should be provided with information and involved in pain treatment decisions.