Evidence map›Paper›PMID 32368327›Full record

ArticleWorld journal of gastrointestinal oncology2020

Adjuvant chemotherapy in curatively resected rectal cancer: How valid are the data?

Giulia Manzini, Fabius Hapke, Ian N Hines, Doris Henne-Bruns, Michael Kremer

Abstract read
In one paragraph

Article in World journal of gastrointestinal oncology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Review
  2. Review
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Giulia ManziniDepartment of General and Visceral Surgery, University of Ulm, Ulm 89081, Germany. giulia.manzini@uniklinik-ulm.de.
Fabius HapkeDepartment of General and Visceral Surgery, University of Ulm, Ulm 89081, Germany.
Ian N HinesDepartment of Nutrition Science, College of Allied Health Sciences, East Carolina University, Greenville, NC 27834, United States.
Doris Henne-BrunsDepartment of General and Visceral Surgery, University of Ulm, Ulm 89081, Germany.
Michael KremerDepartment of General and Visceral Surgery, University of Ulm, Ulm 89081, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAccording to the result of the Cochrane review published in 2012, postoperative adjuvant chemotherapy (CTx) is associated with a survival benefit for rectal cancer patients operated for cure in comparison to patients who underwent only the surgical resection.

aimTo analyze the quality of the data supporting the advantage of adjuvant CTx after surgery for rectal cancer. In the times of increasing health care costs, it is imperative to offer the patient an evidence-based therapy that justifies potential side effects as well as costs.

methodsOverall survival was selected as endpoint of interest. Among the 21 included papers which analyzed this endpoint, we identified those three publications which have the highest weights to influence the final result. The validity of these papers was analyzed using the CONSORT checklist for randomized controlled trials. We performed a second meta-analysis excluding the three analyzed studies (

resultsThe detailed analysis of the three most relevant RCTs according to the items of the CONSORT checklist showed several pitfalls. In up to 47% of the items, inappropriate answers were found. Generally, a lack of information regarding the randomization procedure as well as the absence of allocation concealment, blinded set-up, of intention-to-treat analysis and omission of sample size calculation were common problems of the analyzed studies. The exclusion of these three studies from the meta-analysis did not affect the general result of the meta-analysis, still confirming a survival advantage after adjuvant chemotherapy. After exclusion of single studies with a statistically significant outcome improvement, the meta-analysis of the remaining 16 studies again shows a statistically significant result due in part to a large remaining sample size.

conclusionThe three most powerful publications show substantial deficits. We suggest a more critical appraisal regarding the validity of single studies because a meta-analysis cannot overcome the limitations of individual trials by pooling treatment effect estimates to generate a single best estimate.

Indexed as

CONSORT checklistMeta-analysisOverall survivalPostoperative chemotherapyRectal cancerValidity

Identifiers

PMID32368327
PMCPMC7191332

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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 OpenQuestion graph.