Study within a trial of electronic versus paper-based Patient-Reported oUtcomes CollEction (SPRUCE): study protocol for a partially randomised patient preference study.

INTRODUCTION: Patient-reported outcomes (PRO) are currently collected from trial participants using paper questionnaires by the Clinical Trials and Statistics Unit at The Institute of Cancer Research (ICR-CTSU). Streamlining PRO collection using electronic questionnaires (ePRO) may improve data collection and patient experience. Here, we outline our protocol for a Study within a trial of electronic versus paper-based Patient-Reported oUtcomes CollEction (SPRUCE), which investigates the acceptability of ePRO in oncology clinical trials. METHODS AND ANALYSIS: SPRUCE was developed alongside patient and public contributors. SPRUCE runs in multiple host trials with a partially randomised patient preference design, allowing participants to be randomised or choose their preference of electronic or paper questionnaires. Questionnaires are scheduled in accordance with host trial follow-up. The primary objective will assess differences in return rates (compliance) between ePRO and paper PROs at the first timepoint post-host trial intervention in the randomised group. Paper PRO compliance is expected to be 90%. 244 randomised participants are required to exclude ≤80% compliance rates with ePRO (10% non-inferiority margin, with 80% power and one-sided alpha=0.05). SPRUCE aims to assess acceptability of ePRO in oncology clinical trials, establish whether ePRO is acceptable to ICR-CTSU trial participants and can capture complete PRO data, consistent with paper PROs. ETHICS AND DISSEMINATION: The SPRUCE protocol (ICR-CTSU/2021/10074) was approved by the Coventry and Warwick Central Research Ethics Committee (21/WM/0223) on 21 October 2021. Results will be disseminated via presentations, publications and lay summaries. No participant identifiable data will be included. TRIAL REGISTRATION: SWAT169.

PEARLS - A multicentre phase II/III trial of extended field radiotherapy for androgen sensitive prostate cancer patients with PSMA-avid pelvic and/or para-aortic lymph nodes at presentation.

PEARLS is a multi-stage randomised controlled trial for prostate cancer patients with pelvic and/or para-aortic PSMA-avid lymph node disease at presentation. The aim of the trial is to determine whether extending the radiotherapy field to cover the para-aortic lymph nodes (up to L1/L2 vertebral interspace) can improve outcomes for this patient group.

The impact of new cancer drug therapies on site specialised cancer treatment activity in a UK cancer network 2014-2018.

INTRODUCTION: Drug treatment for cancer has changed dramatically over the past decade with many new drugs often with multiple applications. More recently, the detailed pathway for approval from the National Institute for Health and Care Excellence (NICE) in the UK has been simplified. To explore how these changes have impacted on systemic anti-cancer therapy tumour site-specific prescribing and workload activities, we have reviewed the prescribing records for 2014-2018 in a UK cancer network. METHODS: Information about the numbers of new systemic anti-cancer therapy drugs and NICE approvals were obtained from print editions of the British National Formulary (BNF) and the NICE website. Data on the numbers of new chemotherapy courses and individual treatment-related attendances were obtained from the cancer network Chemocare electronic prescribing system. RESULTS: During the five-year study period, there were 49 new systemic anti-cancer therapy drugs for all tumour types, and a total of 65 NICE technology approvals for solid tumour indications. Overall numbers of treatment courses increased by 40.7% and total treatment-related visits by 80.6%. There was a wide variation across tumour types with the highest number of increased visits seen for melanoma (349.3%) and prostate cancer (242.3%), but in contrast, no appreciable increases were seen for lower gastrointestinal cancers or small cell lung cancer. CONCLUSION: The study confirms the major impact of the arrival of new drug technology and positive NICE appraisals on increasing systemic anti-cancer therapy prescribing and chemotherapy unit activity. The data in this study may be of help in planning for future service delivery planning and workforce configurations.

Breastfeeding after cesarean delivery: a systematic review and meta-analysis of world literature.

BACKGROUND: The rate of exclusive breastfeeding remains low in many countries. Furthermore, cesarean delivery (CD) is increasing and may affect breastfeeding success. OBJECTIVE: The objective was to conduct a systematic review and meta-analysis of observational studies to determine whether CD (prelabor or in-labor) is associated with a lower rate of breastfeeding compared with vaginal delivery (VD). DESIGN: Studies published before January 2011 that reported breastfeeding up to 6 mo postpartum and compared outcomes after CD or VD, including foreign language publications, were identified through PubMed and bibliographic review. Prespecified data were extracted independently by multiple observers. The types of CD [prelabor (elective/scheduled) or in-labor (emergency)] were compared by subgroup analyses. Potential sources of study-level bias were analyzed by using meta-regression and sensitivity analyses. RESULTS: The systematic review included 53 studies (554,568 subjects, 33 countries); 25 authors contributed additional data (245,455 subjects), and 48 studies (553,306 subjects, 31 countries) were included in the meta-analysis. Rates of early breastfeeding (any initiation or at hospital discharge) were lower after CD compared with after VD (pooled OR: 0.57; 95% CI: 0.50, 0.64; P < 0.00001) and lower after prelabor but not after in-labor CD (prelabor OR: 0.83; 95% CI: 0.80, 0.86; P < 0.00001; in-labor OR: 1.00; 95% CI: 0.97, 1.04; P = 0.86). In mothers who initiated breastfeeding, CD had no significant effect on any breastfeeding at 6 mo (OR: 0.95; 95% CI: 0.89, 1.01; P = 0.08). CONCLUSIONS: There was a negative association between prelabor CD and early breastfeeding. If breastfeeding is initiated, mode of delivery has no apparent effect on the number of mothers still breastfeeding at 6 mo. Women and health care workers should be aware of the negative associations between CD and early breastfeeding and consequent implications for infants' well-being.