Abstract
Aim
Early phase studies are essential to evaluate new technologies prior to randomised evaluation. Evaluation is limited, however, by inconsistent measurement and reporting of outcomes. This study examines outcome reporting in studies of innovative colorectal cancer surgery.
Methods
Systematic searches identified studies of invasive procedures treating primary colorectal adenocarcinoma. Included were a random sample of studies which authors reported as ‘new’ or ‘modified’. Outcomes were extracted verbatim and categorised using an existing framework of 32 domains relevant to early phase studies. Outcomes were classified as ‘measured’ (where there was an explicit statement to that effect or evidence that data collection had occurred) or ‘mentioned but not measured’ (where outcomes were discussed but data collection was not evident). Patterns of identified outcomes are described.
Results
Of 8,373 records, 816 were potentially eligible. Full‐text review of a random sample of 218 studies identified 51 for inclusion of which 34 (66%) were ‘new’ and 17(33%) were ‘modified’. Some 2073 outcomes were identified, and all mapped to domains. “Anticipated disadvantages” were most frequently identified (660(32%) outcomes identified across 50(98%) studies). No domain was represented in all studies. Under half (944, 46%) of outcomes were ‘measured’. “Surgeon/operator’s experience of the innovation” were more frequently ‘mentioned but not measured’ (207(18%) outcomes across 46(90%) studies) than ‘measured’ (17(2%) outcomes, 11(22%) studies).
Conclusion
There is outcome reporting heterogeneity in studies of early phase colorectal cancer surgery. The adoption of core outcome sets may help to resolve these inconsistencies and enable efficient evaluation of surgical innovations.
Early phase studies are essential to evaluate new technologies prior to randomised evaluation. Evaluation is limited, however, by inconsistent measurement and reporting of outcomes. This study examines outcome reporting in studies of innovative colorectal cancer surgery.
Methods
Systematic searches identified studies of invasive procedures treating primary colorectal adenocarcinoma. Included were a random sample of studies which authors reported as ‘new’ or ‘modified’. Outcomes were extracted verbatim and categorised using an existing framework of 32 domains relevant to early phase studies. Outcomes were classified as ‘measured’ (where there was an explicit statement to that effect or evidence that data collection had occurred) or ‘mentioned but not measured’ (where outcomes were discussed but data collection was not evident). Patterns of identified outcomes are described.
Results
Of 8,373 records, 816 were potentially eligible. Full‐text review of a random sample of 218 studies identified 51 for inclusion of which 34 (66%) were ‘new’ and 17(33%) were ‘modified’. Some 2073 outcomes were identified, and all mapped to domains. “Anticipated disadvantages” were most frequently identified (660(32%) outcomes identified across 50(98%) studies). No domain was represented in all studies. Under half (944, 46%) of outcomes were ‘measured’. “Surgeon/operator’s experience of the innovation” were more frequently ‘mentioned but not measured’ (207(18%) outcomes across 46(90%) studies) than ‘measured’ (17(2%) outcomes, 11(22%) studies).
Conclusion
There is outcome reporting heterogeneity in studies of early phase colorectal cancer surgery. The adoption of core outcome sets may help to resolve these inconsistencies and enable efficient evaluation of surgical innovations.
| Original language | English |
|---|---|
| Pages (from-to) | 1862-1873 |
| Number of pages | 12 |
| Journal | Colorectal Disease |
| Volume | 22 |
| Issue number | 12 |
| Early online date | 23 Oct 2020 |
| DOIs | |
| Publication status | Published - 29 Dec 2020 |
Bibliographical note
Funding Information:This work was funded by an NIHR Clinician Scientist fellowship (NIHR‐CS‐2017‐17‐010). Further support was provided through funding received by the National Institute for Health Research (NIHR) Biomedical Research Centre (BRC) at the University Hospitals Bristol and Weston NHS Foundation Trust and the University of Bristol, the Royal College of Surgeons of England Bristol Surgical Trials Centre and the Medical Research Council (MRC) ConDuCT‐II (Collaboration and innovation for Difficult and Complex randomized controlled Trials In Invasive procedures) Hub for Trials Methodology Research, MR/K025643/1. The views and opinions expressed therein are those of the authors and not necessarily those of the UK National Health Service, the National Institute for Health Research, the Department of Health and Social Care, the Royal College of Surgeons of England or the MRC.
Funding Information:
This work was funded by an NIHR Clinician Scientist fellowship (NIHR-CS-2017-17-010). Further support was provided through funding received by the National Institute for Health Research (NIHR) Biomedical Research Centre (BRC) at the University Hospitals Bristol and Weston NHS Foundation Trust and the University of Bristol, the Royal College of Surgeons of England Bristol Surgical Trials Centre and the Medical Research Council (MRC) ConDuCT-II (Collaboration and innovation for Difficult and Complex randomized controlled Trials In Invasive procedures) Hub for Trials Methodology Research, MR/K025643/1. The views and opinions expressed therein are those of the authors and not necessarily those of the UK National Health Service, the National Institute for Health Research, the Department of Health and Social Care, the Royal College of Surgeons of England or the MRC.
Publisher Copyright:
© 2020 The Association of Coloproctology of Great Britain and Ireland