Evidence map›Paper›PMID 26975720›Full record

Trial reportTrials2016

Contacting authors to retrieve individual patient data: study protocol for a randomized controlled trial.

Areti Angeliki Veroniki, Sharon E Straus, Huda Ashoor, Lesley A Stewart, Mike Clarke, Andrea C Tricco

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02569411 (Contacting Authors to Retrieve Individual Patient Data), which is not on this map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
2.1field-weighted citation impact, top 11% of its field
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.

NCT02569411 nacompletednot on this map

Contacting Authors to Retrieve Individual Patient Data: Protocol for a Randomized Controlled Trial

TypeinterventionalSponsorUnity Health TorontoRan2016 to 2018Enrolled129ConditionsResponse RatesArmsFinancial Incentive
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 19 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Review
  5. Article
  6. 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 at 4 institutions in 2 countries.

Areti Angeliki VeronikiLi Ka Shing Knowledge Institute of St. Michael's Hospital, 209 Victoria Street, East Building, Toronto, ON, M5B 1T8, Canada.
Sharon E StrausLi Ka Shing Knowledge Institute of St. Michael's Hospital, 209 Victoria Street, East Building, Toronto, ON, M5B 1T8, Canada.
Huda AshoorLi Ka Shing Knowledge Institute of St. Michael's Hospital, 209 Victoria Street, East Building, Toronto, ON, M5B 1T8, Canada.
Lesley A StewartCentre for Reviews and Dissemination, University of York, York, UK.
Mike ClarkeNorthern Ireland Hub for Trials Methodology Research, Queen's University Belfast, Belfast, UK.
Andrea C TriccoLi Ka Shing Knowledge Institute of St. Michael's Hospital, 209 Victoria Street, East Building, Toronto, ON, M5B 1T8, Canada. triccoa@smh.ca.
St. Michael's Hospital · CAUniversity of Toronto · CAQueen's University Belfast · GBUniversity of York · GB

Funding

Medical Research Council G0801402Medical Research Council G0901530
6 · The paper itself

Abstract

backgroundIndividual patient data (IPD) meta-analysis is considered the "gold standard" for exploring the effectiveness of interventions in different subgroups of patients. However, obtaining IPD is time-consuming and contact with the researchers responsible for the original trials is usually required. To date, there are no studies evaluating different strategies to optimize the process for retrieval of IPD from such researchers. Our aim is to examine the impact of providing incentives to the researchers responsible for the trials eligible for a meta-analysis to submit their IPD. METHODS/

designWe updated our previously published systematic reviews for type 1 diabetes mellitus comparing long- and intermediate-acting insulin regimens (from January 2013 to June 2015) and for Alzheimer's dementia comparing cognitive enhancers (from January 2015 to May 2015). Eligible were randomized controlled trials (RCTs) fulfilling the eligibility criteria of the systematic reviews. We will randomly allocate authors of the reports of these RCTs into an intervention or control group. Those allocated to the intervention group will be contacted by email, mail, and phone, and will be asked to provide the IPD from their RCT and will be given a financial incentive. Those allocated to the control group will be contacted by email, mail, and phone, but will not receive a financial incentive. Our primary outcome will be the proportion of authors who provide the IPD. The secondary outcomes will be the time to return the dataset (defined as the period between the information request and the authors' response with the dataset), and completeness of data. We will compare the response rates in the two groups using the odds ratio and the corresponding 95 % confidence interval. We will also use binary logistic regression and cox regression analyses to examine whether different RCT characteristics, such as study size and sponsor information, influence the probability of providing IPD and the time needed to share the data. DISCUSSION: This study will determine whether a financial incentive affects response rates when seeking IPD from the original researchers. We will disseminate our findings in an open access scientific journal and present results at national and international conferences.

trial registrationThis trial is registered in Clinical Trials.gov, ID number NCT02569411 . Date of registration 5 October 2015.

Indexed as

AuthorshipCommunicationCompensation and RedressMeta-Analysis as TopicMotivationElectronic MailHumansInformation Storage and RetrievalResearch DesignTelephoneData collectionData retrievalIncentiveIndividual participant dataIndividual patient dataMeta-analysisPatient-level dataResponse rate

Identifiers

PMID26975720
PMCPMC4791799
OpenAlexW2298788870

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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 OpenQuestion graph.