Abstract

Abstract Background The UK has one of the highest rates of oesophageal adenocarcinoma worldwide. Surgical resection, with peri-operative chemotherapy, is the cornerstone of curative treatment. The evidence base for which surgical approach is best (including open, hybrid, totally laparoscopic/thoracoscopic, and robotic surgery) is negatively affected by heterogeneous reporting of outcomes. This study examines the degree to which outcomes deemed critically important to patients and healthcare professionals (a core outcome set - COS) are reported by studies in this field. Methods We undertook a mapping review of prospective cohort studies, randomized controlled trials (RCTs), and published protocols in the field of oesophageal cancer surgery. Evidence Based Medicine Reviews, MEDLINE, EMBASE, and CINAHL were searched for relevant studies conducted over a 10-year period (2011-2021). We mapped the reporting of 10 core outcomes during this period as described by a COS for oesophagectomy trials (overall survival; in-hospital mortality; inoperability; the need for additional intervention; respiratory complications; conduit necrosis and anastomotic leak; severe nutritional problems; the ability to eat and drink; problems with acid indigestion or heartburn and overall quality of life). Results Initial searches identified 8944 potentially eligible records, which, after exclusion of duplicates, abstract screening and full paper reviews, yielded 57 eligible studies that recruited 10,561 patients (36 prospective cohort studies, 16 RCT’s and 5 published protocols). No study reported all core outcomes. The median number of outcomes reported was 4 (IQR 3). ‘In-hospital mortality’ (86%), ‘conduit necrosis/leak’ (81%) and ‘respiratory complications’ (79%) were reported by most studies. ‘Quality of life’ (26%), reflux symptoms’ (21%) and 'severe nutritional effects' (19%) were rarely reported alongside ‘need for reintervention’ (16%). No improvement in reporting rates was seen during the study period. Conclusions The reporting of core outcomes in surgical research for oesophageal cancer does not adequately reflect the priorities of patients and healthcare professionals. Further work is therefore needed to significantly improve the reporting of these core outcomes and increase the methodological quality of studies in this field. The results from this study suggest that there is a need for further high-quality prospective studies and RCTs which encompass the reporting of core outcomes.

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