Publication rate and consistency of registered trials of motor-based stroke rehabilitation

Table e1 - Eligible records

A list of registered randomized controlled trials (RCTs) meeting the following criteria:

RCTs of motor-based interventions in individuals with stroke (including transient ischemic attack);

Started on or after 1 July 2005;

Completed before 1 April 2017 (actual or expected end date);

Included human adult participants (≥18 years old);

Included at least one outcome (primary or secondary) related to motor control, mobility, or physical functioning and performance of upper and/or lower extremities or the body as a whole; and

Registered in English.

This list was obtained by searching the following registries between 23 November 2017 and 22 February 2018: the International Clinical Trials Registry Platform, Clinicaltrials.gov (USA), Australian New Zealand Clinical Trial Registry, Chinese Clinical Trial Registry, Clinical Research Information Service (Republic of Korea), Clinical Trial Registry of India, Cuban Public Registry of Clinical Trials, European Union Clinical Trials Register, German Clinical Trials Register, Iranian Registry of Clinical Trials, International Standard Randomised Controlled Trials Number registry (UK), Center for Clinical Trials-Japan Medical Association, University Hospital Medical Information Network-Clinical Trial Registry (Japan), Thai Clinical Trials Registry, Netherlands Trials Registry, Pan African Clinical Trials Registry, Peruvian Clinical Trials Registry, and Sri Lanka Clinical Trials Registry. 

Variable definitions

UIN: Unified identification number (obtained from the trial registry)

Status: whether or not a peer-reviewed publication reporting the trial findings for the primary outcome/outcome was found

Paper available: a publication reporting the trial findings for the primary outcome/objective was found

Paper available (not English): a publication, published in a language other than English, reporting the trial findings for the primary outcome/objective was found

Secondary paper available: a publication reporting study findings is available, but not for the primary objectives/outcome

Results available: trial findings for the primary objective/outcome are available in a non-peer reviewed format (e.g., conference publication, non-peer reviewed journal, or uploaded to the trial registry)

Discontinued: the trial registry record indicates that the trial was discontinued, so no publication is expected

No paper/results: none of the above apply

Source: database or method we used to find the publication reporting the trial findings for the primary objective/outcome

Pubmed: the publication was found by searching for the UIN in Pubmed

EMBASE/OVID: the publication was found by searching for the UIN in Embase or OVID Medline

Google Scholar: the publication was found by searching for the UIN in Google Scholar

Registry: the publication was listed in the trial registry

Internet: the publication was found by a superficial internet search for the UIN

Protocol: the publication was found through a cited reference search for the published protocol

Author: the publication was found by contacting the trial investigators

Other: the publication was found by some other means

None: no publication reporting the trial findings for the primary objective/outcome was found

Table e2 - Published papers consistency

The subset of trials from Table e1 where an English-language publication reporting the trial findings for the primary objective/outcome was found.

Variable definitions

UIN: Unified identification number (obtained from the trial registry)

DOI: digital objective identifier of the publication

First_author: last name of the first author of the publication

Year: year of the publication

Journal: journal of the publication (abbreviated journal names are used, where available)

Reg_Trial_End_Date: end date of the trial, as stated in the trial registry (format DD-MMM-YY)

Date_Submitted: date when the paper was submitted to the journal for publication (where available; format: DD-MMM-YY)

Time_To_Submit: difference, in days, between Reg_Trial_End_Date and Date_Submitted

Date_Published: date when the paper was published, either online or in print, whichever is earlier (format: DD-MMM-YY)

Time_To_Publish: difference, in days, between Reg_Trial_End_Date and Time_To_Publish

UIN_Paper_Location: location of the UIN in the publication

Reg_Pilot: whether the trial was defined as a pilot or feasibility study in the registry record (0=no, 1=yes)

Paper_Pilot: whether the trial was defined as a pilot or feasibility study in the publication (0=no, 1=yes)

Consistency_pilot: whether Reg_Pilot = Paper_Pilot (0=no, 1=yes)

Consistency_Primary_Objective: whether the trial registry record and publication were consistent in terms of the primary objective (0=no, 1=yes)

Consistency_Primary_Outcome: whether the trial registry record and publication were consistent in terms of the primary outcome (0=no, 1=yes)

Target_N: target sample size, as indicated in the trial registry record

Paper_N: number of participants recruited to the study, as indicated in the publication

Consistency_N: whether the trial registry record and publication were consistent in terms of the sample size (i.e., Paper_N is within +/-10% of Target_N; 0=no, 1=yes)

N_direction: for those trials that were inconsistent in terms of the sample size, whether Paper_N was less than (Under) or more then (Over) Target_N

Eligibility_Consistency: whether the trial registry record and publication were consistent in terms of the eligibility criteria

UIN_in_paper: the UIN that was included in the paper, exactly as it was published

UIN_consistency: whether UIN = UIN_in_paper (0=no, 1=yes)

Reg_Type: whether the trial was registered before recruiting the first participant (Prospective), after recruiting the first participant but before the trial was completed (Retro - pre-completion), or after the trial was completed (Retro - post-completion)

Table e3 - Inconsistency details

The subset of trials from Table e2 where the trial registry record and publication were inconsistent on only one of the criteria examined. This table provides further details of these inconsistencies, and details of any explanations for changes to the protocol since registration, if available.