Patient-Reported Outcome Results From the Open-Label, Randomized Phase III Myeloma X Trial Evaluating Salvage Autologous Stem-Cell Transplantation in Relapsed Multiple Myeloma.

PURPOSE: Salvage autologous stem-cell transplantation (sASCT) in patients with multiple myeloma (MM) relapsing after a prior autologous stem-cell transplantation leads to increased remission duration and overall survival. We report a comprehensive study on patient-reported outcomes, including quality of life (QoL) and pain in sASCT. METHODS: Patients were randomly assigned to either sASCT or nontransplantation consolidation (NTC). Pain and QoL were assessed as secondary outcomes using validated QoL instruments (European Organisation for Research and Treatment of Cancer QLQ-C30 and myeloma-specific module, QLQ-MY20; the Brief Pain Inventory [Short Form]; and the Leeds Assessment of Neuropathic Symptoms and Signs [Self-Assessment] scale). RESULTS: A total of 288 patients (> 96%) consented to the QoL substudy. The median follow-up was 52 months. The European Organisation for Research and Treatment of Cancer QLQ-C30 Global health status scores were higher (better) in the NTC group at 100 days after random assignment (P = .0496), but not at later time points. Pain interference was higher (worse) in the sASCT group than in the NTC group at 6 months after random assignment (P = .0267), with patients with sASCT reporting higher scores for Pain interference with daily living for up to 2 years after random assignment. Patients reporting lower concerns about adverse effects of treatment after sASCT had a time to progression advantage. CONCLUSION: Patients with sASCT with relapsed MM demonstrated a comparative reduction in QoL and greater impact of treatment adverse effects lasting for 6 months and up to 2 years for pain, after which patients who had received sASCT reported better outcomes. Patients who experienced lower adverse effects after sASCT had longer time to progression and overall survival, showing the need to improve symptom management peritransplantation. To our knowledge, this study provides the most comprehensive picture of QoL before and after sASCT in patients with relapsed MM.

The impact of cytogenetics on duration of response and overall survival in patients with relapsed multiple myeloma (long-term follow-up results from BSBMT/UKMF Myeloma X Relapse [Intensive]): a randomised, open-label, phase 3 trial.

The Myeloma X trial (ISCRTN60123120) registered patients with relapsed multiple myeloma. Participants were randomised between salvage autologous stem cell transplantation (ASCT) or weekly cyclophosphamide following re-induction therapy. Cytogenetic analysis performed at trial registration defined t(4;14), t(14;16) and del(17p) as high-risk. The effect of cytogenetics on time to progression (TTP) and overall survival was investigated. At 76 months median follow-up, ASCT improved TTP compared to cyclophosphamide (19 months (95% confidence interval [95% CI] 16-26) vs. 11 months (9-12), hazard ratio [HR]: 0·40, 95% CI: 0·29-0·56, P < 0·001), on which the presence of any single high-risk lesion had a detrimental impact [likelihood ratio test (LRT): P = 0·011]. ASCT also improved OS [67 months (95% CI 59-not reached) vs. 55 months (44-67), HR: 0·64, 95% CI: 0·42-0·99, P = 0·0435], with evidence of a detrimental impact with MYC rearrangement (LRT: P = 0·021). Twenty-one (24·7%) cyclophosphamide patients received an ASCT post-trial, median OS was not reached (95% CI: 39-not reached) for these participants compared to 31 months (22-39), in those who did not receive a post-trial ASCT. The analysis further supports the benefit of salvage ASCT, which may still be beneficial after second relapse in surviving patients. There is evidence that this benefit reduces in cytogenetic high-risk patients, highlighting the need for targeted study in this patient group.

Developing nurse medication safety training in a health partnership in Mozambique using behavioural science.

BACKGROUND: Globally, safe and effective medication administration relies on nurses being able to apply strong drug calculation skills in their real-life practice, in the face of stressors and distractions. These may be especially prevalent for nurses in low-income countries such as Mozambique and Continuing Professional Development post-registration may be important. This study aimed to 1) explore the initial impact of an international health partnership's work to develop a drug calculation workshop for nurses in Beira, Mozambique and 2) reflect upon the role of health psychologists in helping educators apply behavioural science to the training content and evaluation. METHODS: In phase one, partners developed a training package, which was delivered to 87 Portuguese-speaking nurses. The partnership's health psychologists coded the training's behaviour change content and recommended enhancements to content and delivery. In phase two, the refined training, including an educational game, was delivered to 36 nurses in Mozambique and recoded by the health psychologists. Measures of participant confidence and intentions to make changes to healthcare practice were collected, as well as qualitative data through post-training questions and 12 short follow-up participant interviews. RESULTS: In phase one six BCTs were used during the didactic presentation. Most techniques targeted participants' capability to calculate drug doses accurately; recommendations aimed to increase participants' motivation and perceived opportunity, two other drivers of practice change. Phase two training included an extra seven BCTs, such as action planning and further skills practice. Participants reported high confidence before and after the training (p = 0.25); intentions to use calculators to check drug calculations significantly increased (p = 0.031). Qualitative data suggested the training was acceptable, enjoyable and led to practice changes, through improved capability, opportunity and motivation. Opportunity barriers to medication safety were highlighted. CONCLUSIONS: Reporting and measuring medication errors and related outcomes is a complex challenge affecting global efforts to improve medication safety. Through strong partnership working, a multi-disciplinary team of health professionals including health psychologists developed, refined and begin to evaluate a locally-led drug calculation CPD workshop for nurses in a low-resource setting. Applying behavioural science helped to collect feasible evaluation data and hopefully improved impact and sustainability.