A systematic review of outcome reporting in early phase studies of colorectal cancer surgical innovation


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Christin Hoffmann1,Kerry NL Avery1,Shelley Potter2,Nicholas Wilson1,Rhiannon Macefield1,Natalie Blencowe3,Sean Cousins1,Jane M Blazeby1,Angus GK McNair4
1Centre for Surgical Research, Bristol Medical School: Population Health Sciences, University of Bristol,21 Centre for Surgical Research, Bristol Medical School: Population Health Sciences, University of Bristol; 2 Bristol Breast Care Centre, North Bristol NHS Trust, Bristol, UK,31 Centre for Surgical Research, Bristol Medical School: Population Health Sciences, University of Bristol; 2 Division of Surgery Head and Neck, University Hospitals Bristol NHS Foundation Trust, Bristol, UK,41 Centre for Surgical Research, Bristol Medical School: Population Health Sciences, University of Bristol; 2 Department of Gastrointestinal Surgery, North Bristol NHS Trust, Bristol, UK

Abstract

Background

Early phase studies of surgical innovation are essential to evaluate new technologies prior to definitive randomised evaluation. Evaluation may be limited, however, by inconsistent measurement and reporting of outcomes. This study provides an in-depth analysis of outcomes of early phase interventions for the surgical treatment of colorectal cancer.

Method

A systematic search identified early phase studies (first in human to pre-definitive trial) of patients who have undergone an invasive procedure to treat primary colorectal adenocarcinoma published between 2018-19. Sixty-eight search terms were combined using Boolean operators and applied to Medline and Embase databases. Included were studies where authors reported a surgical device/techniques as ‘new’ or ‘modified’. Excluded were studies of established devices/techniques. Line-by-line coding was used to identify outcomes from a random sample of included articles. Outcomes were extracted, grouped into domains, and categorised as ‘measured’, where data were collected, or ‘mentioned’, when no data were collected.

Results

An initial 8373 records were screened, of which 816 were eligible. A random sample of 51 studies were included of which 17 self-identified as evaluating ‘new’ and 34 ‘modified’ surgical devices/techniques. Most studies were case series (25%), conducted in a single-centre setting (90%) evaluating techniques (82%). Interventions most commonly involved laparoscopic (47%) or trans-anal (27%) approaches.

Some 2429 outcomes were identified, of which 1111 (46%) were measured and 1318 (54%) only mentioned. Post-operative complications were most frequently measured (502 outcomes, 20%) and measures of intra-operative resource use least measured (3, <1%). Intra-operative advantages were frequently mentioned (170, 13%) but rarely measured (15, 1%), as were surgeon’s perception and/or experience of performing the innovative intervention (222, 15% mentioned; 19, 2% measured).

Conclusion

There is outcome reporting heterogeneity in studies of early phase colorectal cancer surgery, and discrepancies between outcomes mentioned and measured. This may delay effective evaluation of new technology and create research waste.