Evidence map›Paper›PMID 30474552›Full record

SynthesisBMC musculoskeletal disorders2018

Pilot randomized controlled trials in the orthopaedic surgery literature: a systematic review.

Bijal Desai, Veeral Desai, Shivani Shah, Archita Srinath, Amr Saleh, Nicole Simunovic, Andrew Duong, Sheila Sprague, Mohit Bhandari

Abstract readSystematic Review
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in BMC musculoskeletal disorders, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 2 pooled it
–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

7 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Article
  5. Article
  6. Randomized controlled trials in neurosurgery.Surgical neurology international · 2022
    Review
  7. 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

9 authors.

Bijal DesaiFaculty of Health Sciences, McMaster University, Hamilton, ON, Canada.
Veeral DesaiFaculty of Health Sciences, McMaster University, Hamilton, ON, Canada.
Shivani ShahSchulich School of Medicine and Dentistry, Western University, London, ON, Canada.
Archita SrinathFaculty of Medicine, University of Toronto, Toronto, ON, Canada.
Amr SalehFaculty of Health Sciences, McMaster University, Hamilton, ON, Canada.
Nicole SimunovicDepartment of Health Research Methods, Evidence, and Impact (HEI), Division of Orthopaedic Surgery, McMaster University, Hamilton, ON, Canada. simunon@mcmaster.ca.
Andrew DuongDepartment of Surgery, Division of Orthopaedic Surgery, McMaster University, Hamilton, ON, Canada.
Sheila SpragueDepartment of Health Research Methods, Evidence, and Impact (HEI), Division of Orthopaedic Surgery, McMaster University, Hamilton, ON, Canada.
Mohit BhandariDepartment of Health Research Methods, Evidence, and Impact (HEI), Division of Orthopaedic Surgery, McMaster University, Hamilton, ON, Canada.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe primary objective of this systematic review is to examine the characteristics of pilot randomized controlled trials (RCTs) in the orthopaedic surgery literature, including the proportion framed as feasibility trials and those that lead to definitive RCTs. This review aim to answer the question of whether pilot RCTs lead to definitive RCTs, whilst investigating the quality, feasibility and overall publication trends of orthopaedic pilot trials.

methodsPilot RCTs in the orthopaedic literature were identified from three electronic databases (EMBASE, MEDLINE, and Pubmed) searched from database inception to January 2018. Search criteria included the evaluation of at least one orthopaedic surgical intervention, research on humans, and publication in English. Two reviewers independently screened the pool of pilot trials, and conducted a search for corresponding definitive trials. Screened pilot RCTs were assessed for feasibility outcomes related to efficiency, cost, and/or timeliness of a large-scale clinical trial involving a surgical intervention. The quality of the pilot and definitive trials were assessed using the Checklist to Evaluate a Report of a Non-Pharmacological Trial (CLEAR NPT).

resultsThe initial search for pilot RCTs yielded 3857 titles, of which 49 articles were relevant for this review. 73.5% (36/49) of the orthopaedic pilot RCTs were framed as feasibility trials. Of these, 5 corresponding definitive trials (10.2%) were found, of which four were published and one ongoing. Based on author responses, the lack of a definitive RCT following the pilot trial was attributed to a lack of funding, inadequacies in recruitment, and belief that the pilot RCT sufficiently answered the research question.

conclusionsBased on this systematic review, most pilot RCTs were characterized as feasibility trials. However, the majority of published pilot RCTs did not lead to definitive trials. This discrepancy was mainly attributed to poor feasibility (e.g. poor recruitment) and lack of funding for an orthopaedic surgical definitive trial. In recent years this discrepancy may be due to researchers saving on time and cost by rolling their pilot patients into the definitive RCT rather than publish a separate pilot trial.

Indexed as

Feasibility StudiesHumansOrthopedic ProceduresPilot ProjectsRandomized Controlled Trials as TopicDefinitive trialFeasibilityOrthopaedicPilot studyRCTSurgery

Identifiers

PMID30474552
PMCPMC6260657

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.