Evidence map›Paper›PMID 31324209›Full record

Trial reportTrials2019

Development of the IRIS-AR strategy: an intervention to improve rates of accrual and retention for the VTE-PRO randomized controlled trial.

Christine Fahim, Danielle Hylton, Marko Simunovic, John Agzarian, Christian Finley, Wael C Hanna, Yaron Shargall

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02334007 (Extended Low-Molecular Weight Heparin VTE Prophylaxis in the Thoracic Surgery Population, a Prospective, Randomized Controlled Study), which is not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
0.4field-weighted citation impact, top 33% 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.

NCT02334007 phase1 / phase2completednot on this map

Extended Low-Molecular Weight Heparin VTE Prophylaxis in the Thoracic Surgery Population, a Prospective, Randomized Controlled Study

TypeinterventionalSponsorMcMaster UniversityRan2015 to 2018Enrolled102ConditionsVenous Thromboembolism, Lung Neoplasms, Pulmonary EmbolismArmsLMWH: Dalteparin, Placebo
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Review
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

7 authors at 2 institutions in 2 countries.

Christine FahimBloomberg School of Public Health, Johns Hopkins University, Hampton House, Room 663, 624 N Broadway, Baltimore, MD, 21205, USA. cfahim1@jhu.edu.
Danielle HyltonDepartment of Surgery, McMaster University, Hamilton, ON, Canada.
Marko SimunovicDepartment of Surgery, McMaster University, Hamilton, ON, Canada.
John AgzarianDepartment of Surgery, McMaster University, Hamilton, ON, Canada.
Christian FinleyDepartment of Surgery, McMaster University, Hamilton, ON, Canada.
Wael C HannaDepartment of Surgery, McMaster University, Hamilton, ON, Canada.
Yaron ShargallDepartment of Surgery, McMaster University, Hamilton, ON, Canada.
McMaster University · CAJohns Hopkins University · US

Funding

McMaster University McMaster Surgical Associates Grant
6 · The paper itself

Abstract

backgroundThe Venous Thromboembolism Prophylaxis (VTE-PRO) randomized trial is a pilot study evaluating the impact of extended-duration prophylaxis on venous thromboembolic events in patients undergoing lung cancer resection. Enrolled VTE-PRO participants self-inject either low-molecular weight heparin or a saline placebo for 30 days postoperatively. Study outcomes include feasibility, incidence of venous thromboembolism, and venous thromboembolism-related morbidity and mortality. Initial analyses demonstrated low rates of accrual and retention for the VTE-PRO pilot. Therefore, the purpose of the current study was to develop a knowledge translation intervention to improve VTE-PRO pilot trial accrual and retention.

methodsEligible participants were surveyed to identify the barriers to VTE-PRO participation. The Theoretical Domains Framework was used to categorize these barriers. Barriers were mapped to the capabilities, opportunities, and behavior (COM-B) behavioral change wheel to identify potential interventions to support trial accrual and retention. The resulting knowledge translation intervention was titled Inform, Remind, Involve and Support to improve Accrual and Retention (IRIS-AR). Key informant interviews with patients were held to refine and confirm the validity of identified barriers and perceived acceptability of the proposed IRIS-AR intervention. Institutional Review Board approval was granted for this study.

resultsThe resulting intervention included: information booklets and counseling sessions to identify unique participant challenges to trial participation (Inform); daily reminders to administer injections (Remind); involvement of family/caregivers in study processes (Involve); and leverage of an existing home-care nursing program to provide injection support when needed (Support). Twenty-six key informant participants were interviewed. The most common barriers to trial participation included lack of social support and fear of needle injection. Participants generally supported use of information booklets, involvement of family/caregivers, and support by a home-care nursing program; however, not all supported the use of daily reminders.

conclusionDeveloped using theory and integrated knowledge translation, the IRIS-AR presents a patient-centered intervention that leverages existing programs to promote trial engagement. The proposed strategy can likely be adapted to improve compliance with other patient-directed interventions.

trial registrationClinicalTrials.gov, NCT02334007 . Registered on 8 January 2015.

Indexed as

Patient SelectionAnticoagulantsChoice BehaviorDrug Administration ScheduleHealth Knowledge, Attitudes, PracticeHeparin, Low-Molecular-WeightHumansInjectionsLung NeoplasmsPatient Education as TopicPilot ProjectsPneumonectomyResearch SubjectsSample SizeSelf AdministrationTime FactorsAnticoagulantsHeparin, Low-Molecular-WeightAccrualBehavior change wheelRandomized trialsRetentionTheoretical domains framework

Identifiers

PMID31324209
PMCPMC6642524
OpenAlexW2964344180

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.