Evidence map›Paper›PMID 29173262›Full record

ArticleCanadian journal of surgery. Journal canadien de chirurgie2017

Users' guide to the surgical literature: how to assess a noninferiority trial.

Achilleas Thoma, Forough Farrokhyar, Daniel Waltho, Luis H Braga, Sheila Sprague, Charlie H Goldsmith

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Canadian journal of surgery. Journal canadien de chirurgie, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Trial
  2. 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

6 authors.

Achilleas ThomaHamilton, Ont. (Thoma); the Surgical Outcomes Research Center, Department of Surgery, Faculty of Health Sciences, McMaster University, Hamilton, Ont. (Thoma, Farrokhyar, Braga, Goldsmith); the Department of Clinical Epidemiology and Biostatistics, Faculty of Health Sciences, McMaster University, Hamilton, Ont. (Thoma, Farrokhyar, Sprague, Goldsmith); the Faculty of Medicine, University of Ottawa, Ottawa, Ont. (Waltho); the Division of Urology, Department of Surgery, Faculty of Health Sciences, McMaster University, Hamilton, Ont. (Braga); the Faculty of Health Sciences, Simon Fraser University, Burnaby, BC (Goldsmith); and the Division of Orthopedic Surgery, Department of Surgery, Faculty of Health ciences, McMaster University, Hamilton, Ont. (Sprague).
Forough FarrokhyarHamilton, Ont. (Thoma); the Surgical Outcomes Research Center, Department of Surgery, Faculty of Health Sciences, McMaster University, Hamilton, Ont. (Thoma, Farrokhyar, Braga, Goldsmith); the Department of Clinical Epidemiology and Biostatistics, Faculty of Health Sciences, McMaster University, Hamilton, Ont. (Thoma, Farrokhyar, Sprague, Goldsmith); the Faculty of Medicine, University of Ottawa, Ottawa, Ont. (Waltho); the Division of Urology, Department of Surgery, Faculty of Health Sciences, McMaster University, Hamilton, Ont. (Braga); the Faculty of Health Sciences, Simon Fraser University, Burnaby, BC (Goldsmith); and the Division of Orthopedic Surgery, Department of Surgery, Faculty of Health ciences, McMaster University, Hamilton, Ont. (Sprague).
Daniel WalthoHamilton, Ont. (Thoma); the Surgical Outcomes Research Center, Department of Surgery, Faculty of Health Sciences, McMaster University, Hamilton, Ont. (Thoma, Farrokhyar, Braga, Goldsmith); the Department of Clinical Epidemiology and Biostatistics, Faculty of Health Sciences, McMaster University, Hamilton, Ont. (Thoma, Farrokhyar, Sprague, Goldsmith); the Faculty of Medicine, University of Ottawa, Ottawa, Ont. (Waltho); the Division of Urology, Department of Surgery, Faculty of Health Sciences, McMaster University, Hamilton, Ont. (Braga); the Faculty of Health Sciences, Simon Fraser University, Burnaby, BC (Goldsmith); and the Division of Orthopedic Surgery, Department of Surgery, Faculty of Health ciences, McMaster University, Hamilton, Ont. (Sprague).
Luis H Braga
Sheila SpragueHamilton, Ont. (Thoma); the Surgical Outcomes Research Center, Department of Surgery, Faculty of Health Sciences, McMaster University, Hamilton, Ont. (Thoma, Farrokhyar, Braga, Goldsmith); the Department of Clinical Epidemiology and Biostatistics, Faculty of Health Sciences, McMaster University, Hamilton, Ont. (Thoma, Farrokhyar, Sprague, Goldsmith); the Faculty of Medicine, University of Ottawa, Ottawa, Ont. (Waltho); the Division of Urology, Department of Surgery, Faculty of Health Sciences, McMaster University, Hamilton, Ont. (Braga); the Faculty of Health Sciences, Simon Fraser University, Burnaby, BC (Goldsmith); and the Division of Orthopedic Surgery, Department of Surgery, Faculty of Health ciences, McMaster University, Hamilton, Ont. (Sprague).
Charlie H GoldsmithHamilton, Ont. (Thoma); the Surgical Outcomes Research Center, Department of Surgery, Faculty of Health Sciences, McMaster University, Hamilton, Ont. (Thoma, Farrokhyar, Braga, Goldsmith); the Department of Clinical Epidemiology and Biostatistics, Faculty of Health Sciences, McMaster University, Hamilton, Ont. (Thoma, Farrokhyar, Sprague, Goldsmith); the Faculty of Medicine, University of Ottawa, Ottawa, Ont. (Waltho); the Division of Urology, Department of Surgery, Faculty of Health Sciences, McMaster University, Hamilton, Ont. (Braga); the Faculty of Health Sciences, Simon Fraser University, Burnaby, BC (Goldsmith); and the Division of Orthopedic Surgery, Department of Surgery, Faculty of Health ciences, McMaster University, Hamilton, Ont. (Sprague).

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

summaryA well-planned randomized controlled trial (RCT) is the most optimal study design to determine if a novel surgical intervention is any different than a prevailing one. Traditionally, when we want to show that a new surgical intervention is superior to a standard one, we analyze data from an RCT to see if the null hypothesis of "no difference" can be rejected (i.e., the 2 surgical interventions have the same effect). A noninferiority RCT design seeks to determine whether a new intervention is not worse than a prevailing (standard) one within an acceptable margin of risk or benefit, referred to as the "noninferiority margin." In the last decade, we have observed an increase in the publication of noninferiority RCTs. This article explores this type of study design and discusses the tools that can be used to appraise such a study.

Indexed as

Equivalence Trials as TopicSurgical Procedures, OperativeGuidelines as TopicHumansResearch DesignReview Literature as Topic

Identifiers

PMID29173262
PMCPMC5726973

What OpenQuestion holds

Textmetadata
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.