Core Outcome Measures in Effectiveness Trials

Development of recommendations on standard core outcome set for clinical trials of physical rehabilitation in adults across the continuum of solid organ transplantation

General Information

Summary:
Survival rates have been improving in patients that undergo solid organ transplantation (SOT). 1 Therefore, there is a need for interventions that enhance patient’s quality of life and long-term health outcomes. 2 Physical rehabilitation, which includes structured exercise programs and physical activity may benefit recipients of solid organ transplant improving their maximal aerobic capacity (VO2 peak), physical function, body composition and quality of life. 3 However, scientific evidence in this area is still limited. 3 Currently, clinical trials of physical rehabilitation in SOT have small sample sizes and use different and varied outcome measures, 3, 7 which creates difficulties comparing and combining findings, limiting the interpretation of outcomes among studies.4, 5, 6 In a recent review on outcomes in physical rehabilitation and solid organ transplant, the authors identified 126 different outcome measures that have been used. 7 Standardization of outcomes using a core outcome set (COS) across all studies investigating solid organ transplant and physical rehabilitation is key to improve research methodology and to diminish research bias. 4, 5, 8, 9 Consequently, the COS will strengthen randomized clinical trials, improve the ability to combine and compare results across studies and make it possible to draw more powerful conclusions from multiple studies. Hence, the purpose of this study is to develop consensus-based recommendations on standard COS for clinical trials of physical rehabilitation in adult candidates and recipients of solid organ transplant in different phases of SOT (pre-transplant, early post-transplant, late post-transplant). The study will use a systematic Delphi procedure of getting consensus amongst the key stakeholders (patients, clinicians, researchers) in Canada. Ultimately, the results of this study will guide the development of future clinical trials increasing the potential to understand the benefits of physical rehabilitation programs in SOT candidates and recipients.

REFERENCES
1.Lodhi, S. A., Lamb, K. E., & Meier-Kriesche, H. U. (2011). Solid organ allograft survival improvement in the United States: the long-term does not mirror the dramatic short-term success. American Journal of Transplantation: Official Journal of the American Society of Transplantation and the American Society of Transplant Surgeons, 11(6), 1226–35.
2.Mathur, S., Janaudis-Ferreira, T., Wickerson, L., Singer, L. G., Patcai, J., Rozenberg, D., Sonnenday, C. (2014). Meeting report: Consensus recommendations for a research agenda in exercise in solid organ transplantation. In American Journal of Transplantation.
3.Didsbury, M., McGee, R. G., Tong, A., Craig, J. C., Chapman, J. R., Chadban, S., & Wong, G. (2013). Exercise Training in Solid Organ Transplant Recipients. Transplantation Journal, 95(5), 679–687.
4.Clarke, M. (2007). Standardizing outcomes for clinical trials and systematic reviews. Trials, 8(1), 1.
5.Blackwood, B., Marshall, J. C., & Rose, L. (2015). Progress on core outcome sets for critical care research. Current Opinion in Critical Care, 21(5), 439–444.
6.Williamson, P. R., Altman, D. G., Blazeby, J. M., Clarke, M., Devane, D., Gargon, E., & Tugwell, P. (2012). Developing core outcome sets for clinical trials: issues to consider. Trials, 13(1), 132.
7.Janaudis-ferreira, T., Mathur, S., Konidis, S., & Tansey, C. M. (n.d.). Outcomes used in randomized controlled trials of exercise interventions in solid organ transplant recipients: What does the International Classification of Functioning, Disability and Health teach us? (World Journal of Transplantation – in press, Oct 2016. )
8.Prinsen, C. A. C., Vohra, S., Rose, M. R., Boers, M., Tugwell, P., Clarke, M., … Terwee, C. B. (2016). How to select outcome measurement instruments for outcomes included in a “Core Outcome Set” – a practical guideline. Trials, 17(1), 449.
9.Prinsen, C. A. C., Vohra, S., Rose, M. R., King-Jones, S., Ishaque, S., Bhaloo, Z., … Terwee, C. B. (2014). Core Outcome Measures in Effectiveness Trials (COMET) initiative: protocol for an international Delphi study to achieve consensus on how to select outcome measurement instruments for outcomes included in a “core outcome set”. Trials, 15(1), 247.

Contributors:
Principal Investigator:
Tathiana Santana Shiguemoto 1, PT (MSc student)

Faculty Advisor:
Sunita Mathur 1, PT, PhD

Co-Investigators:
Tania Janaudis-Ferreira 2, PhD, Sabrina Figueirido 2, MSc, (PhD candidate)

Affiliations:
1 Dept. of Physical Therapy, University of Toronto
2 School of Physical and Occupational Therapy, McGill University

Further Study Information

Current Stage:
Ongoing
Date:
January 2017 - June 2017
Funding source(s):
There are no funding sources

Health Area

Disease Category
Rehabilitation

Disease Name
Solid Organ Transplant
Transplant surgery

Target Population

Age Range
18 - 100

Sex
Either


Nature / type of Intervention
Rehabilitation

Method(s)

Delphi process
Literature review

This study will use the e-survey Delphi method to get consensus on the most important and relevant areas or outcomes that should be included and measured in all future clinical trials in physical rehabilitation and solid organ transplant (SOT). It is estimated that three rounds of questionnaires will be required to achieve consensus. 1 The questionnaire rounds will be developed based on the literature review of randomized controlled trials examining physical rehabilitation in SOT 2 as well as on suggestions from the panelists on the most important and relevant outcome domains and outcome measures instruments that should be included in the COS. We will use the International Classification of Functioning, Disability and Health (ICF) framework to select and to classify the outcomes and outcome measures instruments and to develop the questionnaires. 3 Data on panelists opinions on the COS for physical rehabilitation in SOT will be collected using a 9-point Likert scale (1-3: not important; 4-6: important but not critical; 7-9: very important – critical), with an option of “don’t know”. 4 In this study, consensus that an outcome should be included in the COS will be defined “a priori” as being achieved if 70% or more participants score 7 to 9 and <15% participants score 1 to 3. Consensus that an outcome should not be included in the COS will occur when 70% or more participants score as 1 to 3 and <15% of participants score as 7 to 9. Anything else will be considered no consensus and uncertainty about the importance of outcome. 5 Once consensus is reached, the results will be used to develop recommendations on standard COS for clinical trials of physical rehabilitation in SOT in adults across the continuum of solid organ transplantation (pre-transplant, early post-transplant and late post-transplant phases).

REFERENCES
1.Prinsen, C. A. C., Vohra, S., Rose, M. R., King-Jones, S., Ishaque, S., Bhaloo, Z., … Terwee, C. B. (2014). Core Outcome Measures in Effectiveness Trials (COMET) initiative: protocol for an international Delphi study to achieve consensus on how to select outcome measurement instruments for outcomes included in a “core outcome set”. Trials, 15(1), 247.
2.Janaudis-ferreira, T., Mathur, S., Konidis, S., & Tansey, C. M. (n.d.). Outcomes used in randomized controlled trials of exercise interventions in solid organ transplant recipients: What does the International Classification of Functioning, Disability and Health teach us? (World Journal of Transplantation – in press, Oct 2016.)
3.International Classification of Functioning, Disability and Health (ICF) manual (2013). World Health Organization website.
4.COMET Initiative website - http://cometinitiative.org/DelphiManager/
5.Harman, N.L, Bruce, I.A, Callery, P., Tierney, S., et al. (2013). MOMENT - Management of otitis media with effusion in cleft palate: protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey. Trials, 14 (70), 1-8.


Stakeholders Involved

Clinical experts
Patient/ support group representatives
Researchers

Study Type

COS for clinical trials or clinical research

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