Evidence map›Paper›PMID 31455384›Full record

ArticleTrials2019

Project management lessons learned from the multicentre CYCLE pilot randomized controlled trial.

Devin S McCaskell, Alexander J Molloy, Laura Childerhose, F Aileen Costigan, Julie C Reid, Magda McCaughan, France Clarke, Deborah J Cook, Jill C Rudkowski, Christopher Farley and 13 more

Erratum issued Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT02377830 (CYCLE Pilot), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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.

NCT02377830 phase2completednot on this map

CYCLE Pilot: A Pilot Randomized Study of Early Cycle Ergometry Versus Routine Physiotherapy in Mechanically Ventilated Patients

TypeinterventionalSponsorMcMaster UniversityRan2015 to 2018Enrolled113ConditionsIntensive Care Unit Acquired Weakness, Critical Care, Mechanical Ventilation, Respiratory FailureArmsIn-bed cycle ergometer (Restorative Therapies RT300 Supine), Routine physiotherapy
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Article
  2. Article
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

23 authors.

Devin S McCaskellThe Research Institute of St. Joe's Hamilton, 50 Charlton Ave E, Hamilton, ON, L8N 4A6, Canada.
Alexander J MolloyThe Research Institute of St. Joe's Hamilton, 50 Charlton Ave E, Hamilton, ON, L8N 4A6, Canada.
Laura ChilderhoseMcMaster University, School of Rehabilitation Science, Institute of Applied Health Science, Room 403, 1400 Main Street West, Hamilton, ON, L8S 1C7, Canada.
F Aileen CostiganThe Research Institute of St. Joe's Hamilton, 50 Charlton Ave E, Hamilton, ON, L8N 4A6, Canada.
Julie C ReidMcMaster University, School of Rehabilitation Science, Institute of Applied Health Science, Room 403, 1400 Main Street West, Hamilton, ON, L8S 1C7, Canada.
Magda McCaughanDepartment of Physiotherapy, St. Joseph's Healthcare Hamilton, 50 Charlton Ave E, Hamilton, ON, L8N 4A6, Canada.
France ClarkeDepartment of Health Research Methods, Evidence and Impact McMaster University Health Sciences Centre, Room 2C16, 1280 Main St W, Hamilton, ON, L8S 4K1, Canada.
Deborah J CookDepartment of Physiotherapy, St. Joseph's Healthcare Hamilton, 50 Charlton Ave E, Hamilton, ON, L8N 4A6, Canada.
Jill C RudkowskiDepartment of Medicine, McMaster University, 1280 Main St W, Hamilton, ON, L8S 4L8, Canada.
Christopher FarleyJuravinski Hospital, Hamilton, 711 Concession St, Hamilton, ON, L8V 1C3, Canada.
Tim KarachiDepartment of Medicine, McMaster University, 1280 Main St W, Hamilton, ON, L8S 4L8, Canada.
Bram RochwergDepartment of Medicine, McMaster University, 1280 Main St W, Hamilton, ON, L8S 4L8, Canada.
Anastasia NewmanMcMaster University, School of Rehabilitation Science, Institute of Applied Health Science, Room 403, 1400 Main Street West, Hamilton, ON, L8S 1C7, Canada.
Alison Fox-RobichaudDepartment of Medicine, McMaster University, 1280 Main St W, Hamilton, ON, L8S 4L8, Canada.
Margaret S HerridgeToronto General Hospital, 200 Elizabeth St, Toronto, ON, M5G 2C4, Canada.
Vincent LoDepartment of Physical Therapy, University of Toronto, Rehabilitation Sciences Centre, 8th Floor, 500 University Ave, Toronto, ON, M5G 1V7, Canada.
Deanna FeltraccoSt. Michael's Hospital, 30 Bond St, Toronto, ON, M5B 1W8, Canada.
Karen Ea BurnsSt. Michael's Hospital, 30 Bond St, Toronto, ON, M5B 1W8, Canada.
Rebecca PorteousThe Ottawa Hospital, 501 Smyth Rd, Ottawa, ON, K1H 8L6, Canada.
Andrew J E SeelyThe Ottawa Hospital, 501 Smyth Rd, Ottawa, ON, K1H 8L6, Canada.
Ian M BallDepartment of Medicine and Department of Epidemiology and Biostatistics, Western University, Critical Care Trauma Centre, London Health Sciences Centre, 800 Commissioners Rd E, London, ON, N6A 5W9, Canada.
Amy SeczekMcMaster University, School of Rehabilitation Science, Institute of Applied Health Science, Room 403, 1400 Main Street West, Hamilton, ON, L8S 1C7, Canada.
Michelle E KhoThe Research Institute of St. Joe's Hamilton, 50 Charlton Ave E, Hamilton, ON, L8N 4A6, Canada. khome@mcmaster.ca.ORCID http://orcid.org/0000-0003-3170-031X

Funding

Molecular Basis of Berberine-Mediated Antitumor ActivityF05AT002014 · NCCIH · UNIVERSITY OF CHICAGO · PI KANG, QUAN · 2003 to 2007
$183k
Canadian Frailty Network CAT2014-05Institute of Musculoskeletal Health and Arthritis 142327NCCIH NIH HHS F05 AT002014
6 · The paper itself

Abstract

backgroundClinical trials management can be studied using project management theory. The CYCLE pilot randomized controlled trial (RCT) was conducted to determine the feasibility of a future rehabilitation trial of early in-bed cycling in the intensive care unit (ICU). In-bed cycling is a novel intervention, not typically available in ICUs. Implementation of this intervention requires personnel with specialized clinical expertise caring for critically ill patients and use of the in-bed cycle. Our objective was to describe the implementation and conduct of our pilot RCT using a project management approach.

methodsWe retrospectively reviewed activities, timelines, and personnel involved in the trial. We organized activities into four project management phases: initiation, planning, execution, and monitoring and controlling. Data sources included Methods Centre documents used for trial coordination and conduct, and the trial data set. We report descriptive statistics as counts and proportions and also medians and quartiles, and we summarize the lessons learned.

resultsSeven ICUs in Canada participated in the trial. Time from research ethics board and contracts submission to first enrolment was a median (first quartile, third quartile) of 185 (146, 209) and 162 (114, 181) days, respectively. We trained 128 personnel on the CYCLE pilot RCT protocol, and 80 (63%) completed trial-related activities. Four sites required additional training after start-up due to staff turnover and leaves of absence. Over 15 months, we screened 864 patients: 256 were eligible and 66 were enrolled. Despite an 85% consent rate, 74% (190/256) of eligible patients were not randomized, largely (80% [152/190]) due to physiotherapist availability. Thirteen percent of recruitment weeks were lost due to physiotherapist staffing shortages. We highlight five key lessons learned: (1) prepare and anticipate site needs; (2) communicate regularly; (3) proactively analyse and act on process measure data; (4) develop contingency plans; (5) express appreciation to participating sites.

conclusionsOur analysis highlights the scope of relevant activities, rigorous training and monitoring, number and types of required personnel, and time required to conduct a multicentre ICU rehabilitation intervention trial. Our lessons learned can help others interested in implementing complex intervention trials, such as rehabilitation.

trial registrationClinicalTrials.gov, NCT02377830 . Registered prospectively on 4 March 2015.

Indexed as

Research DesignWorkflowData CollectionEndpoint DeterminationHumansMulticenter Studies as TopicPatient SelectionPersonnel Staffing and SchedulingPilot ProjectsRandomized Controlled Trials as TopicResearch PersonnelRetrospective StudiesTime FactorsCritical careProject managementRandomized controlled trialRehabilitationTrial management

Identifiers

PMID31455384
PMCPMC6712681

What OpenQuestion holds

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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.