Evidence map›Paper›PMID 25267774›Full record

SynthesisCMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne2014

Outcomes for patients with the same disease treated inside and outside of randomized trials: a systematic review and meta-analysis.

Natasha Fernandes, Dianne Bryant, Lauren Griffith, Mohamed El-Rabbany, Nisha M Fernandes, Crystal Kean, Jacquelyn Marsh, Siddhi Mathur, Rebecca Moyer, Clare J Reade and 3 more

Abstract readMeta-AnalysisSystematic Review
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 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

13 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Trial
  4. Review
  5. Article
  6. Benefits of Participation in Clinical Trials: An Umbrella Review.International journal of environmental research and public health · 2022
    Review
  7. Observational
  8. Article
  9. Review
  10. Article
  11. Observational
  12. Article
  13. 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

13 authors.

Natasha FernandesFaculty of Medicine (Natasha Fernandes, Mathur), University of Ottawa, Ottawa, Ont.; Faculty of Health Sciences (Bryant, Marsh, Moyer) and Schulich School of Medicine and Dentistry (Bryant), The University of Western Ontario, London, Ont.; Department of Clinical Epidemiology and Biostatistics (Bryant, Griffith), Department of Medicine (Nisha Fernandes), Health Sciences Library (Bhatnagar), Department of Family Medicine (Riva) and Division of Gynecologic Oncology (Reade), McMaster University, Hamilton, Ont.; Faculty of Dentistry (El-Rabbany), University of Toronto, Toronto, Ont.; School of Medical and Applied Sciences (Kean), Central Queensland University, Rockhampton, Australia; Department of Orthopaedic Surgery (Somerville), London Health Sciences Centre, London, Ont. natasha.fernandes31@gmail.com.
Dianne BryantFaculty of Medicine (Natasha Fernandes, Mathur), University of Ottawa, Ottawa, Ont.; Faculty of Health Sciences (Bryant, Marsh, Moyer) and Schulich School of Medicine and Dentistry (Bryant), The University of Western Ontario, London, Ont.; Department of Clinical Epidemiology and Biostatistics (Bryant, Griffith), Department of Medicine (Nisha Fernandes), Health Sciences Library (Bhatnagar), Department of Family Medicine (Riva) and Division of Gynecologic Oncology (Reade), McMaster University, Hamilton, Ont.; Faculty of Dentistry (El-Rabbany), University of Toronto, Toronto, Ont.; School of Medical and Applied Sciences (Kean), Central Queensland University, Rockhampton, Australia; Department of Orthopaedic Surgery (Somerville), London Health Sciences Centre, London, Ont.
Lauren GriffithFaculty of Medicine (Natasha Fernandes, Mathur), University of Ottawa, Ottawa, Ont.; Faculty of Health Sciences (Bryant, Marsh, Moyer) and Schulich School of Medicine and Dentistry (Bryant), The University of Western Ontario, London, Ont.; Department of Clinical Epidemiology and Biostatistics (Bryant, Griffith), Department of Medicine (Nisha Fernandes), Health Sciences Library (Bhatnagar), Department of Family Medicine (Riva) and Division of Gynecologic Oncology (Reade), McMaster University, Hamilton, Ont.; Faculty of Dentistry (El-Rabbany), University of Toronto, Toronto, Ont.; School of Medical and Applied Sciences (Kean), Central Queensland University, Rockhampton, Australia; Department of Orthopaedic Surgery (Somerville), London Health Sciences Centre, London, Ont.
Mohamed El-RabbanyFaculty of Medicine (Natasha Fernandes, Mathur), University of Ottawa, Ottawa, Ont.; Faculty of Health Sciences (Bryant, Marsh, Moyer) and Schulich School of Medicine and Dentistry (Bryant), The University of Western Ontario, London, Ont.; Department of Clinical Epidemiology and Biostatistics (Bryant, Griffith), Department of Medicine (Nisha Fernandes), Health Sciences Library (Bhatnagar), Department of Family Medicine (Riva) and Division of Gynecologic Oncology (Reade), McMaster University, Hamilton, Ont.; Faculty of Dentistry (El-Rabbany), University of Toronto, Toronto, Ont.; School of Medical and Applied Sciences (Kean), Central Queensland University, Rockhampton, Australia; Department of Orthopaedic Surgery (Somerville), London Health Sciences Centre, London, Ont.
Nisha M FernandesFaculty of Medicine (Natasha Fernandes, Mathur), University of Ottawa, Ottawa, Ont.; Faculty of Health Sciences (Bryant, Marsh, Moyer) and Schulich School of Medicine and Dentistry (Bryant), The University of Western Ontario, London, Ont.; Department of Clinical Epidemiology and Biostatistics (Bryant, Griffith), Department of Medicine (Nisha Fernandes), Health Sciences Library (Bhatnagar), Department of Family Medicine (Riva) and Division of Gynecologic Oncology (Reade), McMaster University, Hamilton, Ont.; Faculty of Dentistry (El-Rabbany), University of Toronto, Toronto, Ont.; School of Medical and Applied Sciences (Kean), Central Queensland University, Rockhampton, Australia; Department of Orthopaedic Surgery (Somerville), London Health Sciences Centre, London, Ont.
Crystal KeanFaculty of Medicine (Natasha Fernandes, Mathur), University of Ottawa, Ottawa, Ont.; Faculty of Health Sciences (Bryant, Marsh, Moyer) and Schulich School of Medicine and Dentistry (Bryant), The University of Western Ontario, London, Ont.; Department of Clinical Epidemiology and Biostatistics (Bryant, Griffith), Department of Medicine (Nisha Fernandes), Health Sciences Library (Bhatnagar), Department of Family Medicine (Riva) and Division of Gynecologic Oncology (Reade), McMaster University, Hamilton, Ont.; Faculty of Dentistry (El-Rabbany), University of Toronto, Toronto, Ont.; School of Medical and Applied Sciences (Kean), Central Queensland University, Rockhampton, Australia; Department of Orthopaedic Surgery (Somerville), London Health Sciences Centre, London, Ont.
Jacquelyn MarshFaculty of Medicine (Natasha Fernandes, Mathur), University of Ottawa, Ottawa, Ont.; Faculty of Health Sciences (Bryant, Marsh, Moyer) and Schulich School of Medicine and Dentistry (Bryant), The University of Western Ontario, London, Ont.; Department of Clinical Epidemiology and Biostatistics (Bryant, Griffith), Department of Medicine (Nisha Fernandes), Health Sciences Library (Bhatnagar), Department of Family Medicine (Riva) and Division of Gynecologic Oncology (Reade), McMaster University, Hamilton, Ont.; Faculty of Dentistry (El-Rabbany), University of Toronto, Toronto, Ont.; School of Medical and Applied Sciences (Kean), Central Queensland University, Rockhampton, Australia; Department of Orthopaedic Surgery (Somerville), London Health Sciences Centre, London, Ont.
Siddhi MathurFaculty of Medicine (Natasha Fernandes, Mathur), University of Ottawa, Ottawa, Ont.; Faculty of Health Sciences (Bryant, Marsh, Moyer) and Schulich School of Medicine and Dentistry (Bryant), The University of Western Ontario, London, Ont.; Department of Clinical Epidemiology and Biostatistics (Bryant, Griffith), Department of Medicine (Nisha Fernandes), Health Sciences Library (Bhatnagar), Department of Family Medicine (Riva) and Division of Gynecologic Oncology (Reade), McMaster University, Hamilton, Ont.; Faculty of Dentistry (El-Rabbany), University of Toronto, Toronto, Ont.; School of Medical and Applied Sciences (Kean), Central Queensland University, Rockhampton, Australia; Department of Orthopaedic Surgery (Somerville), London Health Sciences Centre, London, Ont.
Rebecca MoyerFaculty of Medicine (Natasha Fernandes, Mathur), University of Ottawa, Ottawa, Ont.; Faculty of Health Sciences (Bryant, Marsh, Moyer) and Schulich School of Medicine and Dentistry (Bryant), The University of Western Ontario, London, Ont.; Department of Clinical Epidemiology and Biostatistics (Bryant, Griffith), Department of Medicine (Nisha Fernandes), Health Sciences Library (Bhatnagar), Department of Family Medicine (Riva) and Division of Gynecologic Oncology (Reade), McMaster University, Hamilton, Ont.; Faculty of Dentistry (El-Rabbany), University of Toronto, Toronto, Ont.; School of Medical and Applied Sciences (Kean), Central Queensland University, Rockhampton, Australia; Department of Orthopaedic Surgery (Somerville), London Health Sciences Centre, London, Ont.
Clare J ReadeFaculty of Medicine (Natasha Fernandes, Mathur), University of Ottawa, Ottawa, Ont.; Faculty of Health Sciences (Bryant, Marsh, Moyer) and Schulich School of Medicine and Dentistry (Bryant), The University of Western Ontario, London, Ont.; Department of Clinical Epidemiology and Biostatistics (Bryant, Griffith), Department of Medicine (Nisha Fernandes), Health Sciences Library (Bhatnagar), Department of Family Medicine (Riva) and Division of Gynecologic Oncology (Reade), McMaster University, Hamilton, Ont.; Faculty of Dentistry (El-Rabbany), University of Toronto, Toronto, Ont.; School of Medical and Applied Sciences (Kean), Central Queensland University, Rockhampton, Australia; Department of Orthopaedic Surgery (Somerville), London Health Sciences Centre, London, Ont.
John J RivaFaculty of Medicine (Natasha Fernandes, Mathur), University of Ottawa, Ottawa, Ont.; Faculty of Health Sciences (Bryant, Marsh, Moyer) and Schulich School of Medicine and Dentistry (Bryant), The University of Western Ontario, London, Ont.; Department of Clinical Epidemiology and Biostatistics (Bryant, Griffith), Department of Medicine (Nisha Fernandes), Health Sciences Library (Bhatnagar), Department of Family Medicine (Riva) and Division of Gynecologic Oncology (Reade), McMaster University, Hamilton, Ont.; Faculty of Dentistry (El-Rabbany), University of Toronto, Toronto, Ont.; School of Medical and Applied Sciences (Kean), Central Queensland University, Rockhampton, Australia; Department of Orthopaedic Surgery (Somerville), London Health Sciences Centre, London, Ont.
Lyndsay SomervilleFaculty of Medicine (Natasha Fernandes, Mathur), University of Ottawa, Ottawa, Ont.; Faculty of Health Sciences (Bryant, Marsh, Moyer) and Schulich School of Medicine and Dentistry (Bryant), The University of Western Ontario, London, Ont.; Department of Clinical Epidemiology and Biostatistics (Bryant, Griffith), Department of Medicine (Nisha Fernandes), Health Sciences Library (Bhatnagar), Department of Family Medicine (Riva) and Division of Gynecologic Oncology (Reade), McMaster University, Hamilton, Ont.; Faculty of Dentistry (El-Rabbany), University of Toronto, Toronto, Ont.; School of Medical and Applied Sciences (Kean), Central Queensland University, Rockhampton, Australia; Department of Orthopaedic Surgery (Somerville), London Health Sciences Centre, London, Ont.
Neera BhatnagarFaculty of Medicine (Natasha Fernandes, Mathur), University of Ottawa, Ottawa, Ont.; Faculty of Health Sciences (Bryant, Marsh, Moyer) and Schulich School of Medicine and Dentistry (Bryant), The University of Western Ontario, London, Ont.; Department of Clinical Epidemiology and Biostatistics (Bryant, Griffith), Department of Medicine (Nisha Fernandes), Health Sciences Library (Bhatnagar), Department of Family Medicine (Riva) and Division of Gynecologic Oncology (Reade), McMaster University, Hamilton, Ont.; Faculty of Dentistry (El-Rabbany), University of Toronto, Toronto, Ont.; School of Medical and Applied Sciences (Kean), Central Queensland University, Rockhampton, Australia; Department of Orthopaedic Surgery (Somerville), London Health Sciences Centre, London, Ont.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIt is unclear whether participation in a randomized controlled trial (RCT), irrespective of assigned treatment, is harmful or beneficial to participants. We compared outcomes for patients with the same diagnoses who did ("insiders") and did not ("outsiders") enter RCTs, without regard to the specific therapies received for their respective diagnoses.

methodsBy searching the MEDLINE (1966-2010), Embase (1980-2010), CENTRAL (1960-2010) and PsycINFO (1880-2010) databases, we identified 147 studies that reported the health outcomes of "insiders" and a group of parallel or consecutive "outsiders" within the same time period. We prepared a narrative review and, as appropriate, meta-analyses of patients' outcomes.

resultsWe found no clinically or statistically significant differences in outcomes between "insiders" and "outsiders" in the 23 studies in which the experimental intervention was ineffective (standard mean difference in continuous outcomes -0.03, 95% confidence interval [CI] -0.1 to 0.04) or in the 7 studies in which the experimental intervention was effective and was received by both "insiders" and "outsiders" (mean difference 0.04, 95% CI -0.04 to 0.13). However, in 9 studies in which an effective intervention was received only by "insiders," the "outsiders" experienced significantly worse health outcomes (mean difference -0.36, 95% CI -0.61 to -0.12).

interpretationWe found no evidence to support clinically important overall harm or benefit arising from participation in RCTs. This conclusion refutes earlier claims that trial participants are at increased risk of harm.

Indexed as

Outcome Assessment, Health CarePatient ParticipationRandomized Controlled Trials as TopicResearch SubjectsHumansResearch DesignRisk

Identifiers

PMID25267774
PMCPMC4216275

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.