Perspectives Regarding Methodological Considerations and Challenges of Conducting Randomized Controlled Trials (RCTs) in Nursing Research

Nour Ali  Alrida; Amal Mohammad Tayseer  Ababneh; Basheer Mahmoud Al-Zu'bi

doi:10.25159/2520-5293/15071

Authors

Nour Ali Alrida Yarmouk University https://orcid.org/0000-0002-2825-2539
Amal Mohammad Tayseer Ababneh Jerash University https://orcid.org/0000-0002-4698-0679
Basheer Mahmoud Al-Zu'bi Irbid University College https://orcid.org/0009-0006-4596-3523

DOI:

https://doi.org/10.25159/2520-5293/15071

Keywords:

Challenges, Randomized Controlled Trials (RCTs), Nursing research, Methodology

Abstract

Randomised Control Trials (RCT) serve as the gold standard in research design, offering valuable insights into evaluating the impact of nursing interventions on patient health outcomes. This paper explores the methodological considerations and challenges inherent in designing and conducting RCTs within the nursing context. The inclusion criteria involved a thorough search across reputable databases, including CEINAHL, EBSCO, Scopus, Google Scholar, and Cochrane Library, spanning any period due to the scarcity of relevant material. Articles were selected based on their alignment with key considerations such as randomisation, blinding, sample size calculations, outcome measures, and ethical aspects. Data extraction involved findings related to methodological considerations and challenges faced by nurse researchers in RCT design and implementation. Various challenges arise when applying these considerations due to the nature of nursing interventions and ethical concerns. Proposed solutions include comprehensive informed consent, mixed-methods approaches, and the cluster-randomization process. This paper underscores the role of nurse researchers in overcoming challenges and fostering evidence-based practice. Integrating robust methodological strategies and ethical considerations ensures the validity and reliability of nursing RCTs, contributing to improved patient care.

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Author Biographies

Amal Mohammad Tayseer Ababneh, Jerash University

School of Nursing

Basheer Mahmoud Al-Zu'bi, Irbid University College

Allied Medical Professions Department

References

Al Dalbhi, Sultan, Abdulaziz Alodhayani, Yasser Alghamdi, Salma Alrasheed, Alyah Alshehri, and Noura Alotaibi. 2019. "Difficulties in Conducting Clinical Research among Healthcare Practitioners in Saudi Arabia: A Cross-Sectional Survey" Journal of Family Medicine and Primary Care 8: 1877. https://doi.org/10.4103/jfmpc.jfmpc_317_19 DOI: https://doi.org/10.4103/jfmpc.jfmpc_317_19

Bench, Suzanne, Tina Day, and Alison Metcalfe. 2013. "Randomised Controlled Trials: An Introduction for Nurse Researchers" Nurse Researcher 20. https://doi.org/10.7748/nr2013.05.20.5.38.e312 DOI: https://doi.org/10.7748/nr2013.05.20.5.38.e312

Bounds, Dawn T, Colleen Stiles‐Shields, Stephen M Schueller, Candice L Odgers, and Niranjan S Karnik. 2023. "Ethical Considerations for Developing Pediatric mHealth Interventions For Teens With Socially Complex Needs" Journal of Child and Adolescent Psychiatric Nursing 36: 7–16. https://doi.org/10.1111/jcap.12396 DOI: https://doi.org/10.1111/jcap.12396

Christie, Janice, Peter O'Halloran, and Mike Stevenson. 2009. "Planning a Cluster Randomized Controlled Trial: Methodological Issues" Nursing Research 58: 128–134. https://doi.org/10.1097/NNR.0b013e3181900cb5 DOI: https://doi.org/10.1097/NNR.0b013e3181900cb5

Friedman, Lawrence M, Curt D Furberg, David L DeMets, David M Reboussin, Christopher B Granger, and Lawrence M Friedman Curt D Furberg. 2015. "Fundamentals of Clinical Trials (PDFDrive)" Cham: Springer International Publishing. https://doi.org/10.1007/978-3-319-18539-2 DOI: https://doi.org/10.1007/978-3-319-18539-2

Gao, Qian. 2020. "The Relationship between Hand Washing and Hospital-Acquired Infections" MSN Capstone Projects 1.

Gul, Raisa B, and Parveen A Ali. 2010. "Clinical Trials: The Challenge of Recruitment and Retention of Participants" Journal of Clinical Nursing 19: 227–233. https://doi.org/10.1111/j.1365-2702.2009.03041.x DOI: https://doi.org/10.1111/j.1365-2702.2009.03041.x

Gustafsson, Markus, Doris M Bohman, and Gunilla Borglin. 2014. "Challenges of Conducting Experimental Studies within a Clinical Nursing Context" Applied Nursing Research 27: 133–136. https://doi.org/10.1016/j.apnr.2013.11.013 DOI: https://doi.org/10.1016/j.apnr.2013.11.013

Hasan, Nazmul, Rashed Ullah Rana, Sharmin Chowdhury, Afrin Jahan Dola, and Moustaq Karim Khan Rony. 2021. "Ethical Considerations in Research" Journal of Nursing Research, Patient Safety and Practise (JNRPSP 2799–1210) 1: 1–4. https://doi.org/10.55529/jnrpsp.11.1.4 DOI: https://doi.org/10.55529/jnrpsp.11.1.4

Karimi, Zohreh, Mohammad Behnammoghadam, Hossein Rafiei, Naeem Abdi, Mohammad Zoladl, Mohammad Sharif Talebianpoor, Arash Arya, and Maryam Khastavaneh. 2019. "Impact of Olive Oil and Honey on Healing of Diabetic Foot: A Randomized Controlled Trial" Clinical, Cosmetic and Investigational Dermatology: 347–354. https://doi.org/10.2147/CCID.S198577 DOI: https://doi.org/10.2147/CCID.S198577

King, Rachel, Bethany Taylor, Ashfaque Talpur, Carolyn Jackson, Kim Manley, Nichola Ashby, Angela Tod, Tony Ryan, Emily Wood, and Michaela Senek. 2021. "Factors that Optimise the Impact of Continuing Professional Development in Nursing: A Rapid Evidence Review" Nurse Education Today 98: 104652. https://doi.org/10.1016/j.nedt.2020.104652 DOI: https://doi.org/10.1016/j.nedt.2020.104652

Kozier, Barbara, Glenora Lea Erb, Audrey Berman, Shirlee Snyder, Tracy Levett-Jones, Trudy Dwyer, Majella Hales, Nicole Harvey, Lorna Moxham, and Tanya Park. 2015. Kozier and Erb's Fundamentals of Nursing [3rd Australian edition]. Australia: Pearson.

Leung, Alice WY, Ruth SM Chan, Mandy MM Sea, and Jean Woo. 2017. "An Overview of Factors Associated with Adherence to Lifestyle Modification Programs for Weight Management in Adults" International Journal of Environmental Research and Public Health 14: 922. https://doi.org/10.3390/ijerph14080922 DOI: https://doi.org/10.3390/ijerph14080922

Liodden, Ingrid, and Anne Moen. 2012. "Knowledge Development in Nursing–Pragmatic, Randomized Controlled Trial as a Methodological Approach to Support Evidence Based Practice" Nordisk Sygeplejeforskning 2: 233–246. https://doi.org/10.18261/ISSN1892-2686-2012-03-07 DOI: https://doi.org/10.18261/ISSN1892-2686-2012-03-07

Makhlouf, Mai M, Eric Robles Garibay, Brooke N Jenkins, Zeev N Kain, and Michelle A Fortier. 2019. "Postoperative Pain: Factors and Tools to Improve Pain Management in Children" Pain Management 9: 389–397. https://doi.org/10.2217/pmt-2018-0079 DOI: https://doi.org/10.2217/pmt-2018-0079

Markle-Reid, Maureen, Carrie McAiney, Kathryn Fisher, Rebecca Ganann, Alain P Gauthier, Gail Heald-Taylor, Janet E McElhaney, Fran McMillan, Penelope Petrie, and Jenny Ploeg. 2021. "Effectiveness of a Nurse-Led Hospital-To-Home Transitional Care Intervention for Older Adults with Multimorbidity and Depressive Symptoms: A Pragmatic Randomized Controlled Trial" Plos One 16: e0254573. https://doi.org/10.1371/journal.pone.0254573 DOI: https://doi.org/10.1371/journal.pone.0254573

Martorella, Géraldine, José Côté, Mélanie Racine, and Manon Choinière. 2012. "Web-Based Nursing Intervention for Self-Management of Pain After Cardiac Surgery: Pilot Randomized Controlled Trial" Journal of Medical Internet Research 14: e2070. https://doi.org/10.2196/jmir.2070 DOI: https://doi.org/10.2196/jmir.2070

Pocock, Stuart J. 2013. Clinical trials: a practical approach. John Wiley & Sons. https://doi.org/10.1002/9781118793916 DOI: https://doi.org/10.1002/9781118793916

Schliep, Megan E, Crystle N Alonzo, and Megan A Morris. 2017. "Beyond RCTs: Innovations in Research Design and Methods to Advance Implementation Science" Evidence-Based Communication Assessment and Intervention 11: 82–98. https://doi.org/10.1080/17489539.2017.1394807 DOI: https://doi.org/10.1080/17489539.2017.1394807

Seal, Karen H, Brian Borsari, Jennifer Tighe, Beth E Cohen, Kevin Delucchi, Benjamin J Morasco, Yongmei Li, Emily Sachs, Linda Abadjian, and Erin C Watson. 2019. "Optimizing Pain Treatment Interventions (OPTI): A Pilot Randomized Controlled Trial of Collaborative Care to Improve Chronic Pain Management and Opioid Safety—Rationale, Methods, and Lessons Learned" Contemporary clinical trials 77: 76–85. https://doi.org/10.1016/j.cct.2018.12.006 DOI: https://doi.org/10.1016/j.cct.2018.12.006

Shamley, Delva, and Brenda Wright. 2017. A comprehensive and practical guide to clinical trials. Academic Press.

Siraneh, Yibeltal, Mirkuzie Woldie, and Zewdie Birhanu. 2021. "Effectiveness of Positive Deviance Approach to Promote Exclusive Breastfeeding Practice: A Cluster Randomized Controlled Trial" Risk Management and Healthcare Policy: 3483–3503. https://doi.org/10.2147/RMHP.S324762 DOI: https://doi.org/10.2147/RMHP.S324762

Tam, Wilson, Kenneth Lo, and Brigitte Woo. 2020. "Reporting Sample Size Calculations for Randomized Controlled Trials Published in Nursing Journals: A Cross-Sectional Study" International Journal of Nursing Studies 102: 103450. https://doi.org/10.1016/j.ijnurstu.2019.103450 DOI: https://doi.org/10.1016/j.ijnurstu.2019.103450

Toyon, Mohammad Abu Sayed. 2021. "Explanatory Sequential Design of Mixed Methods Research: Phases and Challenges" International Journal of Research in Business and Social Science (2147–4478) 10: 253–260. https://doi.org/10.20525/ijrbs.v10i5.1262 DOI: https://doi.org/10.20525/ijrbs.v10i5.1262

van Meijel, van B, C Gamel, B van Swieten‐Duijfjes, and MHF Grypdonck. 2004. "The Development of Evidence‐Based Nursing Interventions: Methodological Considerations" Journal of Advanced Nursing 48: 84–92. https://doi.org/10.1111/j.1365-2648.2004.03171.x DOI: https://doi.org/10.1111/j.1365-2648.2004.03171.x

Webb, Stephen A. 2001. "Some Considerations on the Validity of Evidence-Based Practice in Social Work" British Journal of Social Work 31: 57–79. https://doi.org/10.1093/bjsw/31.1.57 DOI: https://doi.org/10.1093/bjsw/31.1.57