The importance of piloting an RCT intervention

Canadian Journal of Nursing Research

Volumn 41, Issue 2, 2009, Pages 84-99

  Feeley, Nancy ^a,b   Cossette, Sylvie ^c   Cǒté, José ^d,e   Héon, Marjolaine ^d   Stremler, Robyn ^f,g   Martorella, Géraldine ^d   Purden, Margaret ^a,b  

^a MCGILL UNIVERSITY   (Canada)

^b MCGILL UNIVERSITY   (Canada)

^c MONTREAL HEART INSTITUTE   (Canada)

^d UNIVERSITÉ DE MONTRÉAL   (Canada)

^e CENTRE HOSPITALIER DE L UNIVERSITÉ DE MONTRÉAL   (Canada)

^f UNIVERSITY OF TORONTO   (Canada)

^g HOSPITAL FOR SICK CHILDREN   (Canada)

Author keywords

Acceptability; Feasibility; Methods; Pilot studies; Randomized controlled trials

Indexed keywords

EQUIPMENT; EVIDENCE BASED PRACTICE; FEASIBILITY STUDY; HUMAN; INFORMATION PROCESSING; METHODOLOGY; NEEDS ASSESSMENT; NURSING; NURSING RESEARCH; ORGANIZATION; ORGANIZATION AND MANAGEMENT; PILOT STUDY; PUBLISHING; QUALITY CONTROL; RANDOMIZED CONTROLLED TRIAL; REVIEW; SAMPLE SIZE;

BENCHMARKING; DATA COLLECTION; EFFECT MODIFIERS (EPIDEMIOLOGY); EVIDENCE-BASED PRACTICE; FEASIBILITY STUDIES; HUMANS; NEEDS ASSESSMENT; NURSING RESEARCH; ORGANIZATIONAL OBJECTIVES; PILOT PROJECTS; PLANNING TECHNIQUES; PUBLISHING; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN; SAMPLE SIZE;

EID: 68149145741     PISSN: 08445621     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (38)

1. Acceptableness. (2008). In Wiktionary: A Wiki-based open content dictionary. Retrieved August 15, 2008, from http://en.wiktionary.org/wiki/ acceptableness.
2. Becker, H., Roberts, G., & Voelmeck, W. (2003). Explanations for improvement in both experimental and control groups. Western Journal of Nursing Research, 25, 746-755.
3. Bennett, J. A. (2005). The consolidated standards of reporting trials (CONSORT): Guidelines for reporting randomized trials. Nursing Research, 54, 128-132.
4. Bruckenthal, P., & Broderick, J. E. (2007). Assessing treatment fidelity in pilot studies assists in designing clinical trials: An illustration from a nurse practitioner community-based intervention for pain. Advances in Nursing Science, 30, E72-E84.
5. Campbell, N. C., Murray, E., Darbyshire, J., Emery, J., Farmer, A., Griffiths, F., et al. (2007). Designing and evaluating complex interventions to improve health care. British Medical Journal, 334, 455-459.
6. Conn, V. S., Rantz, M. J., Wipke-Tevis, D. D., & Maas, M. L. (2001). Focus on research methods: Designing effective nursing interventions. Research in Nursing and Health, 24, 433-442.
7. Dennis, C.-L. (2003). The effect of peer support on postpartum depression: A pilot randomized controlled trial. Canadian Journal of Psychiatry, 48, 115-124.
8. DiCenso, A., Guyatt, G., & Ciliska, D. (2005). Evidence-based nursing: A guide to clinical practice. Toronto: Elsevier Mosby.
9. Feeley, N., Zelkowitz, P., Charbonneau, L., Cormier, C., Lacroix, A., Ste. Marie, C., et al. (2008). Promoting mothers' ability to interact sensitively with their very-low birthweight infant: A pilot study. Advances in Neonatal Care, 8 (5), 276-284.
10. Fogg, L., & Gross, D. (2000). Threats to validity in randomized clinical trials. Research in Nursing and Health, 23, 79-87.
11. Freedman, B. (1987). Equipoise and the ethics of clinical research. New England Journal of Medicine, 317, 141-145.
12. Friedman, L. M., Furberg, C. D., & DeMets, D. L. (1998). Recruitment of study participants. In Fundamentals of Clinical Trials, 3rd ed. (pp. 141-155). New York: Springer.
13. Gardner, G., Gardner, A., MacLellan, L., & Osborne, S. (2003). Reconceptualising the objectives of a pilot study for clinical research. International Journal of Nursing Studies, 40, 719-724.
14. Gross, D., & Fogg, L. (2001). Clinical trials in the 21st century:The case for participant-centered research. Research in Nursing and Health, 24, 530-539.
15. Habermann, B., & Davis, L. L. (2006). Lessons learned from a Parkinson's disease caregiver intervention pilot study. Applied Nursing Research, 19, 212-215.
16. Hertzog, M. A. (2008). Considerations in determining sample size for pilot studies. Research in Nursing and Health, 31, 180-191.
17. Hinds, P. S., & Gattuso, J. S. (1991). From pilot work to a major study in cancer nursing research. Cancer Nursing, 14, 132-135.
18. Homer, C. S. (2002). Using the Zelen design in randomized controlled trials: Debates and controversies. Journarl of Advanced Nursing, 38, 200-207.
19. InfoPOEMS. (2007). Levels of evidence: From the Centre for Evidence-Based Medicine (POEM). InfoPOEMS, the Clinical Awareness System. [Online.] Available: http://www.infopoems.com/concept/ebm-loe.cfm.
20. Jairath, N., Hogerney, M., & Parsons, C. (2000). The role of the pilot study: A case illustration from cardiac nursing research. Applied Nursing Research, 13, 92-96.
21. Kraemer, H. C., Mintz, J., Noda, A., Tinklenberg, J., & Yesavage, J. A. (2006). Caution regarding the use of pilot studies to guide power calculations for study proposals. Archives of General Psychiatry, 63, 484-489.
22. Lancaster, G. A., Dodd, S., & Williamson, P. R. (2004). Design and analysis of pilot studies: Recommendations for good practice. Journal of Evaluation in Clinical Practice, 10, 307-312.
23. Melnyk, B. M., & Fineout-Overholt, E. (2005). Evidence-based practice in nursing and healthcare: A guide to best practice. New York: Lippincott Williams & Wilkins.
24. Mills, N., Donovan, J. L., Smith, M., Jacoby, A., Neal, D. E., & Hamdy, F. C. (2003). Perceptions of equipoise are crucial to trial participation: A qualitative study of men in the Protec T study. Controlled Clinical Trials, 24, 272-282.
25. Miranda, J. (2004). An exploration of participants' treatment preferences in a partial RCT. CJNR, 36, 100-114.
26. Oakley, A., Strange, V., Bonell, C., Allen, E., Stephenson, J., & RIPPLE study team. (2006). Process evaluation in randomized control trials of complex interventions. British Medical Journal, 332, 413-416.
27. Perry, S. E. (2001). Appropriate use of pilot studies. Journal of Nursing Scholarship, 33, 107.
28. Pridham, K. A., Krolikowski, M. M., Limbo, R. K., Paradowski, J., Rudd, N., Meurer, J. R., et al. (2006). Guiding mothers' management of health problems of very low birth-weight infants. Public Health Nursing, 23, 205-215.
29. Santacroce, S. J., Maccarelli, L. M., & Grey, M. (2004). Intervention fidelity. Nursing Research, 53, 63-66.
30. Schulz, K. F., & Grimes, D. A. (2002). Generation of allocation sequences in randomised trials: Chance, not choice. Lancet, 359, 515-519.
31. Sidani, S., & Braden, C. J. (1998). Evaluating nursing interventions: A theory-driven approach. Thousand Oaks, CA: Sage.
32. Sidani, S., Epstein, D. R., & Moritz, P. (2003). An alternative paradigm for clinical nursing research: An exemplar. Research in Nursing and Health, 26, 244-255.
33. Soanes, C., & Stevenson, A. (Eds.). (2005). The Oxford dictionary of English, rev. ed. Oxford Reference Online. Retrieved August 15, 2008, from http://www.oxfordreference.com/views/ENTRY.html?subview=Main&entry= tl40.e27054.
34. Stremler, R., Hodnett, E., Lee, K., MacMillan, S., Mill, C., Ongcangco, L., et al. (2006). A behavioral-educational intervention to promote maternal and infant sleep: A pilot randomized, controlled trial. Sleep, 29, 1609-1615.
35. Vandelanotte, C., & De Bourdeaudhuij, I. (2003). Acceptability and feasibility of a computer-tailored physical activity intervention using stages of change: Project FAITH. Health Education Research, 18, 304-317.
36. van Meijel, B., Gamel, C., van Swieten-Duijfjes, B., & Grypdonck, M. H. (2004). The development of evidence-based nursing interventions: Methodological considerations. Journal of Advanced Nursing, 48, 84-92.
37. van Teijlingen, E., & Hundley, V. (2002). The importance of pilot studies. Nursing Standard, 16, 33-36.
38. Watson, R., Atkinson, I., & Rose, K. (2007). Pilot studies:To publish or not? Journal of Clinical Nursing, 16, 619-620.