Strategies to enhance recruitment methods in phantom limb pain clinical trials
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.
Ziegler-Graham K, MacKenzie E, Ephraim P, Travison T, Brookmeyer R. Estimating the prevalence of limb loss in the United States: 2005 to 2050. Arch Phys Med Rehabil. 2008;89(3):422-9.
Dillingham TR, Pezzin LE, Mackenzie EJ. Limb Amputation and Limb Deficiency : Epidemiology and Recent Trends in the United States. South Med J. 2002;95(8):875-84.
Flor H. Phantom-limb pain: Characteristics, causes, and treatment. Lancet Neurol. 2002;1(3):182-9.
Rao A, Sharma N, Gajra A. Management of lung cancer in the elderly. In: Cancer Treatment and Research. Volume 170. 2016: 251-84.
Volkow ND, McLellan AT. Opioid Abuse in Chronic Pain - Misconceptions and Mitigation Strategies. N Engl J Med. 2016;374(13):1253-63.
Bell SA, Tudur Smith C. A comparison of interventional clinical trials in rare versus non-rare diseases: an analysis of ClinicalTrials.gov. Orphanet J Rare Dis. 2014;9:170.
Jonker AH, Mills A, Lau LPL, Ando Y, Baroldi P, Bretz F, Burman CF, Collignon O, et.al. Small Population Clinical Trials: Challenges in the Field of Rare Diseases. Scientific Secretariat of the IRDiRC. 2016.
ISR Reports. The Expanding Web of Clinical Trial Patient Recruitment, 2014. Available at http://www.isrreports.com/wp-content/uploads/
/04/ISR-The-Expanding-Web-of-Clinical-Trial-Patient-Recruitment-Whitepaper.pdf. Accessed 4 February 2017.
Rosner BMH, Fervenza FC, Bunchman TE. Randomized Clinical Trials : Why is Nephrology so Far Behind? Nephrology Times. 2008;1(2):5-6.
Strippoli GFM. The Number, Quality, and Coverage of Randomized Controlled Trials in Nephrology. J Am Soc Nephrol. 2004;15(2):411-9.
McDonald AM, Knight RC, Campbell MK. What influences recruitment to randomised controlled trials? A review of trials funded by two UK funding agencies. Trials. 2006;7:9.
Pinto CB, Saleh Velez FG, Bolognini N, Crandell D, Merabet LB, Fregni F. Optimizing Rehabilitation for Phantom Limb Pain Using Mirror Therapy and Transcranial Direct Current Stimulation: A Randomized, Double-Blind Clinical Trial Study Protocol. JMIR Res Protoc. 2016;5(3):138.
Frandsen M, Thow M, Ferguson SG. The Effectiveness Of Social Media (Facebook) Compared With More Traditional Advertising Methods for Recruiting Eligible Participants To Health Research Studies: A Randomized, Controlled Clinical Trial. JMIR Res Protoc. 2016;5(3):161.
Miller EG, Nowson CA, Dunstan DW, Kerr DA, Solah V, Menzies D, et al. Recruitment of older adults with type 2 diabetes into a community-based exercise and nutrition randomised controlled trial. Trials. 2016;17:12.
Nanji A. Newspaper Readership Trends by Platform and Age. marketingprofs.
Hapca A, Jennings CG, Wei L, Wilson A, Macdonald TM, Mackenzie IS. Effectiveness of newspaper advertising for patient recruitment into a clinical trial. Br J Clin Pharmacol. 2014;77(6):1064-72.
Amputee Coalition. inMotion Magazine. http://www.amputee-coalition.org/limb-loss-resource-center/publications/inmotion/.Acessed 5 February 2017.
New england amputee association. New England Amputee Association 2013. Available at: http://www.newenglandamputeeassociation.com. Accessed 10 February 2017.
Social Networking Use. Pew Research Center. Available at http://www.pewresearch.org/data-trend/media-and-technology/social-networking-use/. Accessed 25 January 2017.
Frandsen M, Walters J, Ferguson SG. Exploring the viability of using online social media advertising as a recruitment method for smoking cessation clinical trials. Nicotine Tob Res. 2014;16(2):247-51.
Ben eld JA, Szlemko WJ. Internet- based data collection: Promises and realities. J Res Pract. 2006;2(2).
Topolovec-Vranic J, Natarajan K. Use of Social Media in Recruitment for Medical Research Studies: A Scoping Review. J Med Internet Res. 2016;18(11):286.
Graham AL, Milner P, Saul JE PL. Online Advertising as a Public Health and Recruitment Tool: Comparison of Different Media Campaigns to Increase Demand for Smoking Cessation Interventions. J Med Internet Res. 2008;10(5):50.
Thoma A, Farrokhyar F, McKnight L, Bhandari M. How to optimize patient recruitment. Canadian J Surg. 2010;53(3):205-10.
Hondras M a, Long CR, Haan AG, Spencer LB, Meeker WC. Recruitment and enrollment for the simultaneous conduct of 2 randomized controlled trials for patients with subacute and chronic low back pain at a CAM research center. J Altern Complement Med. 2008;14(8):983-92.
Kelechi TJ, Watts A WJ. Recruitment strategy effectiveness for a Ostomy, cryotherapy intervention for a venous leg ulcer prevention study. J Wound Ostomy Cont Nurs. 2010;37(1):39-4.
Rahlyn Gossen. How Clinical Research Sites Can Engage Patients Using Facebook, 2014. Available at: https://rebarinteractive.com/clinical-research-sites-engage-patients-facebook/. Accessed 29 January 2017.
Ramo DE, Rodriguez TMS, Chavez K, Sommer MJ, Prochaska JJ. Facebook recruitment of young adult smokers for a cessation trial: Methods, metrics, and lessons learned. Internet Interv. 2014;1(2):58-64.
DiGuiseppi C, Goss C, Xu S, Magid D, Graham A. Telephone screening for hazardous drinking among injured patients seen in acute care clinics: feasibility study. Alcohol Alcohol. 2006;41(4):438-445.
Harris LE Tierney WM WM. Assessing inner-city patients’ hospital experiences. A controlled trial of telephone interviews versus mailed surveys. Med Care. 1997;35(1):70.
Akhtar S, Gladson B. Type 2 Diabetes CommunityBased Recruitment Strategies. Appl Clin Trials. 2013;22(6):.
Cheng KF, Leung PC, Wong LY, Fong YS. Patient recruitment for clinical trials on traditional Chinese medicine: Challenges, barriers, and strategies. Patient Prefer Adherence. 2008;2:207-13.
Goodman L, Sia C, Carnes R, et al. Advocacy recruiting for Huntington’s disease clinical trials. PLoS Curr. 2011.
Merkel PA, Manion M, Gopal-Srivastava R, Groft S, Jinnah HA, Robertson Det al. The partnership of patient advocacy groups and clinical investigators in the rare diseases clinical research network. Orphanet J Rare Dis. 2016;11(1):66.
Blanton S, Morris DM, Prettyman MG, McCulloch K, Redmond S. Lessons learned in participant recruitment and retention: the EXCITE trial. Phys Ther. 2006;86(11):1520-1533.
Scianni A, Teixeira-Salmela LF, Ada L. Challenges in recruitment, attendance and adherence of acute stroke survivors to a randomized trial in Brazil: a feasibility study. Rev Bras Fisioter. 2012;16(1):40-5.
Kenyon S, Rhodes A TD. A recipe for successful recruitment to a randomised controlled trial. MDIRS Midwifery Dig. 2005;15:16-9.
Albrecht TL, Eggly SS, Gleason MEJ, et al. Influence of clinical communication on patients’ decision making on participation in clinical trials. J Clin Oncol. 2008;26(16).
Wade J, Donovan JL, Lane JA, Neal DE, Hamdy FC. It’s not just what you say, it’s also how you say it: opening the “black box” of informed consent appointments in randomised controlled trials. Soc Sci Med. 2009;68(11):2018-28.
Fletcher B, Gheorghe A, Moore D, Wilson S, Damery S. Improving the recruitment activity of clinicians in randomised controlled trials: a systematic review. BMJ Open. 2012;2(1):e000496.
Newington L, Metcalfe A. Factors influencing recruitment to research: qualitative study of the experiences and perceptions of research teams. BMC Med Res Methodol. 2014;14(1):10.
Comis RL, Miller JD, Colaizzi DD, Kimmel LG. Physician-related factors involved in patient decisions to enroll onto cancer clinical trials. J Oncol Pract. 2009;5(2):50-6.
Picillo M, Kou N, Barone P, Fasano A. Recruitment strategies and patient selection in clinical trials for Parkinson’s disease: Going viral and keeping science and ethics at the highest standards. Park Relat Disord. 2015;21(9):1041-8.
Peindl KS, Wisner KL. Successful recruitment strategies for women in postpartum mental health trials. J Psychiatr Res. 2003;37(2):117-25.
Carter A, Humphreys L, Snowdon N, et al. Participant recruitment into a randomised controlled trial of exercise therapy for people with multiple sclerosis. Trials. 2015;16(1).
Shimizu R, Ogata K, Tamaura A, et al. Clinical trial network for the promotion of clinical research for rare diseases in Japan: muscular dystrophy clinical trial network. BMC Health Serv Res. 2016;16(1):241.
Harmsworth S, Turpin S. Creating an Effective Dissemination Strategy: An Expanded Interactive Workbook for Educational Development Projects. TQEF Natl Co-ord Team. 2000: 1-33.
National Conference. Amputee coalition, 2017. Available at: http://www.amputee-coalition.org/
events-programs/national-conference/. Accessed 15 January 2017.
Neuromodulation in Clinical Practice. Massachusetts Neurologic Association, 2017. Available at: http://massneuro.org/event-2407981.Accessed 10 February 2017.
Hawkathon Digital Health. Hawkathon Digital Health Available at: http://www.hawkathon.org/. Accessed 10 January 2017.
Education & training. Spaulding rehabilitation hospital network, 2016. Available at: http://spauldingrehab.org/
education-and-training/hackathon/. Accessed 28 January.
2017 Annual Meeting. American Academy of Neurology. Available at https://www.aan.com/
conferences/2017-annual-meeting/. Accessed 15 February 2017.
Vakratsas D, Ambler T. How Advertising Works : What Do We Really Know ? J Mark. 1999;63(1):26-43.