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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.
Newman, Anastasia N L; Beauchamp, Marla K; Ellerton, Cindy; Goldstein, Roger; Alison, Jennifer A; Dechman, Gail; Haines, Kimberley J; Harrison, Samantha L; Holland, Anne E; Lee, Annemarie L; Marques, Alda; Spencer, Lissa; Stickland, Michael K; Skinner, Elizabeth H; Camp, Pat G; Kho, Michelle E; Brooks, Dina.
Afiliación
  • Newman ANL; School of Rehabilitation Science, Faculty of Health Science, McMaster University, Hamilton, ON, Canada. newmanan@mcmaster.ca.
  • Beauchamp MK; School of Rehabilitation Science, Faculty of Health Science, McMaster University, Hamilton, ON, Canada.
  • Ellerton C; Department of Respiratory Medicine, West Park Healthcare Centre, Toronto, ON, Canada.
  • Goldstein R; Department of Respiratory Medicine, West Park Healthcare Centre, Toronto, ON, Canada.
  • Alison JA; Department of Respiratory Medicine, West Park Healthcare Centre, Toronto, ON, Canada.
  • Dechman G; Department of Physical Therapy, Faculty of Medicine, University of Toronto, Toronto, ON, Canada.
  • Haines KJ; Rehabilitation Sciences Institute, School of Graduate Studies, University of Toronto, Toronto, ON, Canada.
  • Harrison SL; Department of Medicine, Faculty of Medicine, University of Toronto, Toronto, ON, Canada.
  • Holland AE; School of Health Sciences, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.
  • Lee AL; Allied Health, Sydney Local Health District, Sydney, Australia.
  • Marques A; School of Physiotherapy, Faculty of Health, Dalhousie University, Halifax, NS, Canada.
  • Spencer L; Physiotherapy Department, Western Health, Department of Critical Care, The University of Melbourne, Melbourne, VIC, Australia.
  • Stickland MK; School of Health and Life Sciences, Teesside University, Middlesbrough, UK.
  • Skinner EH; Department of Physiotherapy, Alfred Health, Melbourne, VIC, Australia.
  • Camp PG; Respiratory Research, Monash University, Melbourne, VIC, Australia.
  • Kho ME; Institute for Breathing and Sleep, Melbourne, VIC, Australia.
  • Brooks D; Institute for Breathing and Sleep, Melbourne, VIC, Australia.
Trials ; 25(1): 487, 2024 Jul 17.
Article en En | MEDLINE | ID: mdl-39020430
ABSTRACT

BACKGROUND:

Pulmonary 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.

METHODS:

This 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.

RESULTS:

Ten 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.

CONCLUSIONS:

We 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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Accidentes por Caídas / Enfermedad Pulmonar Obstructiva Crónica / Equilibrio Postural Límite: Humans Idioma: En Revista: Trials Asunto de la revista: MEDICINA / TERAPEUTICA Año: 2024 Tipo del documento: Article País de afiliación: Canadá Pais de publicación: Reino Unido
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Accidentes por Caídas / Enfermedad Pulmonar Obstructiva Crónica / Equilibrio Postural Límite: Humans Idioma: En Revista: Trials Asunto de la revista: MEDICINA / TERAPEUTICA Año: 2024 Tipo del documento: Article País de afiliación: Canadá Pais de publicación: Reino Unido