Evidence map›Paper›PMID 39020430›Full record

ArticleTrials2024

Reflections on the challenges of conducting an international multicentre randomized controlled trial of balance training in addition to pulmonary rehabilitation and its impact on fall incidence in people with COPD.

Anastasia N L Newman, Marla K Beauchamp, Cindy Ellerton, Roger Goldstein, Jennifer A Alison, Gail Dechman, Kimberley J Haines, Samantha L Harrison, Anne E Holland, Annemarie L Lee and 7 more

Abstract readMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

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

1 citing paper in PubMed.

  1. 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

17 authors.

Anastasia N L NewmanSchool of Rehabilitation Science, Faculty of Health Science, McMaster University, Hamilton, ON, Canada. newmanan@mcmaster.ca.
Marla K BeauchampSchool of Rehabilitation Science, Faculty of Health Science, McMaster University, Hamilton, ON, Canada.
Cindy EllertonDepartment of Respiratory Medicine, West Park Healthcare Centre, Toronto, ON, Canada.
Roger GoldsteinDepartment of Respiratory Medicine, West Park Healthcare Centre, Toronto, ON, Canada.
Jennifer A AlisonSchool of Health Sciences, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.
Gail DechmanSchool of Physiotherapy, Faculty of Health, Dalhousie University, Halifax, NS, Canada.
Kimberley J HainesPhysiotherapy Department, Western Health, Department of Critical Care, The University of Melbourne, Melbourne, VIC, Australia.
Samantha L HarrisonSchool of Health and Life Sciences, Teesside University, Middlesbrough, UK.
Anne E HollandDepartment of Physiotherapy, Alfred Health, Melbourne, VIC, Australia.
Annemarie L LeeInstitute for Breathing and Sleep, Melbourne, VIC, Australia.
Alda MarquesLab3R-Respiratory Research and Rehabilitation Laboratory, School of Health Sciences (ESSUA) and Institute of Biomedicine (iBiMED), University of Aveiro, Aveiro, Portugal.
Lissa SpencerSchool of Health Sciences, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.
Michael K SticklandDivision of Pulmonary Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.
Elizabeth H SkinnerPhysiotherapy Department, Western Health, Department of Critical Care, The University of Melbourne, Melbourne, VIC, Australia.
Pat G CampDepartment of Physical Therapy, University of British Columbia, Vancouver, BC, Canada.
Michelle E KhoSchool of Rehabilitation Science, Faculty of Health Science, McMaster University, Hamilton, ON, Canada.
Dina BrooksSchool of Rehabilitation Science, Faculty of Health Science, McMaster University, Hamilton, ON, Canada.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPulmonary rehabilitation (PR) is accepted as standard care for individuals with COPD. We conducted an international, multi-centred randomized controlled trial (RCT) to determine if adding balance training to PR would reduce the incidence of falls in people with COPD. While there have been many trials investigating the effectiveness of PR, few have involved international collaboration. Successful execution of rehabilitation trials requires a significant investment of time, staffing, and resources. With the recent completion of the Balance Training for Fall Reduction in COPD RCT, we report on the design, implementation, and execution of our trial using project management phases. We also highlight our lessons learned for consideration in future multi-centre rehabilitation trials.

methodsThis was a retrospective review of the planning, preparation, timelines, and personnel training involved in the execution of this study using four of the five project management phases described by Farrell et al. in 2010: (1) initiation, (2) planning, (3) execution, and (4) monitoring and controlling. We report descriptive statistics as percentages and counts and summarize our lessons learned.

resultsTen outpatient PR programs in three continents participated. Thirty-one personnel worked on the trial across all sites. Enrolment began in January 2017 and was suspended in March 2020 due to the COVID-19 pandemic. Approximately 1275 patients were screened, 455 (36%) were eligible, 258 (57%) consented, 243 (53%) participated, and 130 (61%) completed the 12-month follow-up assessment. Lessons learned through our experience included (1) ensuring awareness of funder policies and considering the impact on collaborating sites; (2) preparing for the possibility of human resource and program disruptions; (3) anticipating site dropout and having a contingency plan in place; (4) planning and monitoring process measure data before, during, and after trial initiation; (5) ensuring frequent and consistent communication with and between collaborating sites; (6) maximizing features of database platform to ensure data set completeness and controlled data access; and (7) identifying strategies for increasing patient engagement in a high-demand study.

conclusionsWe identify seven lessons learned through our experience conducting an international, multicentre rehabilitation-based RCT. These lessons can provide guidance to other trialists conducting studies with similar logistics and may assist with future trial planning and implementation.

Indexed as

Accidental FallsPostural BalancePulmonary Disease, Chronic ObstructiveExercise TherapyHumansIncidenceMulticenter Studies as TopicRandomized Controlled Trials as TopicResearch DesignRetrospective StudiesTime FactorsTreatment OutcomeBalance trainingChronic obstructive pulmonary disease (COPD)Project managementPulmonary rehabilitationRandomized controlled trial

Identifiers

PMID39020430
PMCPMC11256496

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.