ArticleBMJ open2024
How pragmatic are randomised controlled trials evaluating minimally invasive surgery for oesophageal cancer? A methodological review of trial design using the Pragmatic-Explanatory Continuum Indicator Summary-2 (PRECIS-2) tool.
Article in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Clinical utility of randomized controlled trials of regional anesthesia for lower-extremity surgery: a systematic review.Regional anesthesia and pain medicine · 2026Pooled it
- Clinical decision-making frameworks for pandemic preparedness and response: A scoping review.Health promotion perspectives · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundSurgical interventions are inherently complex and designing and conducting surgical randomised controlled trials (RCTs) can be challenging. Trial design impacts the applicability of trial results to clinical practice. Given the recent growth in numbers of surgical RCTs, there is a need to better understand the validity and applicability of trials in this field.
objectivesTo examine the applicability and validity of RCTs comparing minimally invasive and open surgery for oesophageal cancer and to delineate areas for future research. ELIGIBILITY CRITERIA: RCTs comparing open with minimal invasive oesophagectomy, published January 2012-June 2023. Abstracts, pilot and feasibility studies, and systematic reviews were excluded. SOURCES OF EVIDENCE: Three sequential searches of Ovid MEDLINE, Embase and CENTRAL electronic databases and clinical trials registry databases. CHARTING
methodsTwo independent reviewers screened the articles and used appropriate, validated tools (Pragmatic-Explanatory Continuum Indicator Summary-2 (PRECIS-2) and Risk of Bias 2) to assess study quality. Trials were considered pragmatic if they were conducted in multiple centres and had a mean score of four or above on the PRECIS-2.
resultsNine RCTs were identified. One was judged to be pragmatic. The remaining eight were limited by narrow eligibility criteria, being single-centred or having strict intervention protocols. Two studies were low risk of bias, of which one was pragmatic, and three high, due to unblinded outcome assessment. The remaining four studies were of 'some concern' due to poor reporting.
conclusionsOnly one trial identified in this review was considered pragmatic. More lenient criteria, as used in other reviews, may increase the proportion. There is a need for clearer guidance on the cut-off values that define a trial as pragmatic. It is recommended that the intended purpose of the trial, whether explanatory or pragmatic, receives more attention during surgical trial study design and conduct.
Indexed as
Identifiers
What Socratic holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.