Strategies to enhance recruitment methods in phantom limb pain clinical trials

Authors

  • Camila Bonin Pinto Laboratory of Neuromodulation & Center for Clinical Research Learning, Physics and Rehabilitation Department, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, USA; Department of Neuroscience and Behavior, Psychology Institute, University of São Paulo, São Paulo, Brazil http://orcid.org/0000-0003-2820-8703
  • Faddi Ghassan Saleh Vélez Laboratory of Neuromodulation & Center for Clinical Research Learning, Physics and Rehabilitation Department, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, USA http://orcid.org/0000-0002-2626-6259
  • Melanie N. French Laboratory of Neuromodulation & Center for Clinical Research Learning, Physics and Rehabilitation Department, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, USA
  • Dian Zeng Laboratory of Neuromodulation & Center for Clinical Research Learning, Physics and Rehabilitation Department, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, USA
  • David Crandell Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, USA http://orcid.org/0000-0002-4832-4587
  • Nadia Bolognini 1.Department of Psychology, Milan Center for Neuroscience - NeuroMi, University of Milano-Bicocca, Milano, Italy 2. Neuropsychological Laboratory, IRCCS Istituto Auxologico Italiano, Milano, Italy http://orcid.org/0000-0002-2921-8658
  • Lotfi B. Merabet The Laboratory for Visual Neuroplasticity, Department of Ophthalmology, Massachusetts Eye and Ear Infirmary, Harvard Medical School, Boston, USA. http://orcid.org/0000-0002-8094-9536
  • Felipe Fregni Laboratory of Neuromodulation & Center for Clinical Research Learning, Physics and Rehabilitation Department, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, USA. http://orcid.org/0000-0002-1703-7526

DOI:

https://doi.org/10.18203/2349-3259.ijct20171917

Keywords:

Phantom limp pain, Randomized clinical trials, Recruitment methods

Abstract

Phantom limp pain (PLP) was first described in 1551. To date, its mechanisms and novel interventions remain mostly untested. Only limited conclusions can be drawn from few and small sized randomized clinical trials (RCTs) on PLP. In this scenario, enhanced recruitment strategies are crucial in order to overcome inherent challenges to recruit and enroll PLP subjects for clinical trials. Although there are many general methods to enhance recruitment and also retention, in this article we discuss these methods based on a common topic; dissemination. We summarize and discuss ten strategies of recruitment related to the dissemination of information based on the notion that increased trial awareness may lead to both improved recruitment and also external generalizability. In addition, we include insights based on our experience recruiting PLP patients for the purposes of a large-scale and on-going NIH-sponsored clinical trial. Although specific regulatory considerations need to be considered when choosing the methods of recruitment (which may vary across different countries and Institutional Review Boards (IRBs)), these strategies may be applicable to most research settings.

Author Biographies

Camila Bonin Pinto, Laboratory of Neuromodulation & Center for Clinical Research Learning, Physics and Rehabilitation Department, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, USA; Department of Neuroscience and Behavior, Psychology Institute, University of São Paulo, São Paulo, Brazil

Research Fellow at Spaulding Neuromodulation Center, Harvard Medical School

Faddi Ghassan Saleh Vélez, Laboratory of Neuromodulation & Center for Clinical Research Learning, Physics and Rehabilitation Department, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, USA

Post-Doctoral Research Fellow at Spaulding Neuromodulation Center, Harvard Medical School

Melanie N. French, Laboratory of Neuromodulation & Center for Clinical Research Learning, Physics and Rehabilitation Department, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, USA

Research Coordinator at Spaulding Neuromodulation Center, Harvard Medical School

Dian Zeng, Laboratory of Neuromodulation & Center for Clinical Research Learning, Physics and Rehabilitation Department, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, USA

Research Fellow at Spaulding Neuromodulation Center, Harvard Medical School

David Crandell, Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, USA

Medical Director Limb Loss Clinic,Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital, Harvard Medical School

Lotfi B. Merabet, The Laboratory for Visual Neuroplasticity, Department of Ophthalmology, Massachusetts Eye and Ear Infirmary, Harvard Medical School, Boston, USA.

Associate Scientist, Schepens Eye Research InstituteAssociate Professor  of Ophthalmology, Harvard Medical SchoolDirector, the Laboratory for Visual Neuroplasticity, 
Mass. Eye and Ear

Felipe Fregni, Laboratory of Neuromodulation & Center for Clinical Research Learning, Physics and Rehabilitation Department, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, USA.

Associate Professor of Physical Medicine & Rehabilitation, Harvard Medical School

Associate Professor of Neurology, Harvard Medical School

Director, Clinical Research Collaborative Learning Training Program - Principles and Practice of Clinical Research (PPCR), ECPE, Harvard T.H. Chan School of Public Health

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Published

2017-04-26

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Review Articles