Book contents
- Rethinking Clinical Research
- Rethinking Clinical Research
- Copyright page
- Contents
- Acknowledgments
- Introduction
- Part I Fundamentals
- Part II Rethinking Research
- 4 Asking the Right Questions
- 5 Bias in Randomized Controlled Trials
- 6 Is Bigger Always Better?
- 7 Achieving Transparency
- 8 Understanding and Restraining Study Costs
- 9 Implementation
- 10 Health Outcomes
- 11 Confronting the Crises in Peer Review and Academic Publishing
- 12 Ontologies
- Part III Case Studies
- Index
- References
4 - Asking the Right Questions
from Part II - Rethinking Research
Published online by Cambridge University Press: aN Invalid Date NaN
Book contents
- Rethinking Clinical Research
- Rethinking Clinical Research
- Copyright page
- Contents
- Acknowledgments
- Introduction
- Part I Fundamentals
- Part II Rethinking Research
- 4 Asking the Right Questions
- 5 Bias in Randomized Controlled Trials
- 6 Is Bigger Always Better?
- 7 Achieving Transparency
- 8 Understanding and Restraining Study Costs
- 9 Implementation
- 10 Health Outcomes
- 11 Confronting the Crises in Peer Review and Academic Publishing
- 12 Ontologies
- Part III Case Studies
- Index
- References
Summary
Research is about asking and answering questions. One of the most important investments of time for a research investigator should occur before the study starts. This chapter considers the importance of well-defined research questions that have clear boundaries and scope. The specifics of the research methodologies such as sample size and data analysis are essential for high-quality research. Yet less emphasis is placed on the importance of the research question, the feasibility of the study, and the social impact of the investigation. This chapter argues that clinical research should be person- and community-centered. The population, intervention, comparator, outcome, and timeframe (PICOT) framework encompasses content that may be informative for those who use health care. The feasible, interesting, novel, ethical, and relevant (FINER) framework comes closer to focusing on questions and outcomes of importance to study participants. We offer a BASES (biases, awareness, social, equilibrium, specificity) model that builds on the FINER and PICOT systems to place greater emphasis on social context.
- Type
- Chapter
- Information
- Rethinking Clinical ResearchMethodology and Ethics, pp. 81 - 96Publisher: Cambridge University PressPrint publication year: 2025
References
Kirsch, I, Deacon, BJ, Huedo-Medina, TB, Scoboria, A, Moore, TJ, Johnson, BT. Initial severity and antidepressant benefits: A meta-analysis of data submitted to the Food and Drug Administration. PLoS Med. 2008; 5(2):e45. doi:10.1371/journal.pmed.0050045.CrossRefGoogle ScholarPubMed
Food and Drug Administration. Depression medicines. 2019. www.fda.gov/consumers/womens-health-topics/depression-medicines.Google Scholar
Porzsolt, F, Wiedemann, F, Phlippen, M, et al. The terminology conflict on efficacy and effectiveness in healthcare. J Comp Eff Res. 2020; 9(17):1171–1178. doi:10.2217/cer-2020-0149.CrossRefGoogle ScholarPubMed
Mayo, NE, Ow, N, Asano, M, et al. Reducing research wastage by starting off on the right foot: Optimally framing the research question. Qual Life Res. 2022. doi:10.1007/s11136-022-03117-y.CrossRefGoogle ScholarPubMed
Borgerson, K. Are explanatory trials ethical? Shifting the burden of justification in clinical trial design. Theor Med Bioeth. 2013; 34(4):293–308. doi:10.1007/s11017-013-9262-4.CrossRefGoogle ScholarPubMed
Friedman, LM, DeMets, DL, Furberg, CD, Granger, CB, Reboussin, DM. Fundamentals of Clinical Trials. 5th ed. Springer International Publishing; 2015.CrossRefGoogle Scholar
Szucs, D, Ioannidis, JPA. When null hypothesis significance testing is unsuitable for research: A reassessment. Front Hum Neurosci. 2017; 11:390. doi:10.3389/fnhum.2017.00390.CrossRefGoogle ScholarPubMed
Khan, MS, Lateef, N, Siddiqi, TJ, et al. Level and prevalence of spin in published cardiovascular randomized clinical trial reports with statistically nonsignificant primary outcomes: A systematic review. JAMA Netw Open. 2019; 2(5):e192622–e192622.CrossRefGoogle ScholarPubMed
Freedman, B. Scientific value and validity as ethical requirements for research: A proposed explication. IRB. 1987; 9(6):7–10.CrossRefGoogle ScholarPubMed
Kaplan, RM, Irvin, VL. Likelihood of null effects of large NHLBI clinical trials has increased over time. PloS One. 2015; 10(8):e0132382.CrossRefGoogle ScholarPubMed
Guyatt, G, Rennie, D, Meade, M, Cook, D, American Medical Association. Users’ Guides to the Medical Literature: A Manual for Evidence-Based Clinical Practice. 3rd ed. ed. JAMAevidence. McGraw-Hill Education Medical; 2015.Google Scholar
Hulley, SB. Designing Clinical Research. 4th ed. Wolters Kluwer/Lippincott Williams & Wilkins; 2013.Google Scholar
Potochnik, A. Awareness of our biases is essential to good science. Scientific American. 2020. www.scientificamerican.com/article/awareness-of-our-biases-is-essential-to-good-science/.Google Scholar
Elliott, KC. A Tapestry of Values: An Introduction to Values in Science. Oxford University Press; 2017.CrossRefGoogle Scholar
Kahn, CR. Picking a research problem. The critical decision. N Engl J Med. 1994; 330(21):1530–1533. doi:10.1056/NEJM199405263302113.CrossRefGoogle Scholar
Holland, JL. Making Vocational Choices: A Theory of Vocational Personalities and Work Environments. Psychological Assessment Resources; 1997.Google Scholar
Schwartz, SH, Bilsky, W. Toward a universal psychological structure of human values. J Pers Soc Psychol. 1987; 53(3):550–562.CrossRefGoogle Scholar
Casadevall, A, Fang, FC. Specialized science. Infect Immun. 2014; 82(4):1355–1360. doi:10.1128/IAI.01530-13.CrossRefGoogle ScholarPubMed
Luty, J, Arokiadass, SM, Easow, JM, Anapreddy, JR. Preferential publication of editorial board members in medical specialty journals. J Med Ethics. 2009; 35(3):200–202. doi:10.1136/jme.2008.026740.CrossRefGoogle Scholar
Lakatos, I, Musgrave, A. Criticism and the Growth of Knowledge. Its Proceedings. University Press; 1970.CrossRefGoogle Scholar
DuBois, JM, Antes, AL. Five dimensions of research ethics: A stakeholder framework for creating a climate of research integrity. Acad Med. 2018; 93(4):550–555. doi:10.1097/ACM.0000000000001966.CrossRefGoogle ScholarPubMed
Sobell, MB, Sobell, LC. Second year treatment outcome of alcoholics treated by individualized behavior therapy: Results. Behav Res Ther. 1976; 14(3):195–215. doi:10.1016/0005-7967(76)90013-9.CrossRefGoogle ScholarPubMed
Sobell, MB, Sobell, LC. Individualized behavior therapy for alcoholics – republished article. Behav Ther. 2016; 47(6):937–949. doi:10.1016/j.beth.2016.11.008.CrossRefGoogle ScholarPubMed
Pendery, ML, Maltzman, IM, West, LJ. Controlled drinking by alcoholics? New findings and a reevaluation of a major affirmative study. Science. 1982; 217(4555):169–175. doi:10.1126/science.7089552.CrossRefGoogle Scholar
Norman, C. No fraud found in alcoholism study. Science. 1982; 218(4574):771. doi:10.1126/science.7134972.CrossRefGoogle ScholarPubMed
Marlatt, GA. The controlled-drinking controversy. A commentary. Am Psychol. 1983; 38(10):1097–1110. doi:10.1037//0003-066x.38.10.1097.CrossRefGoogle ScholarPubMed
Paradis, C, Butt, P, Shield, K, et al. Canada’s Guidance on Alcohol and Health: Final Report. 2023. www.ccsa.ca/canadas-guidance-alcohol-and-health-final-report.Google Scholar
Mezue, K, Osborne, MT, Abohashem, S, et al. Reduced stress-related neural network activity mediates the effect of alcohol on cardiovascular risk. J Am Coll Cardiol. 2023; 81(24):2315–2325. doi:10.1016/j.jacc.2023.04.015.CrossRefGoogle ScholarPubMed
Devendorf, AR. Is “me-search” a kiss of death in mental health research? Psychol Serv. 2022; 19(1):49–54. doi:10.1037/ser0000507.CrossRefGoogle Scholar
Buchanan, NT, Perez, M, Prinstein, MJ, Thurston, IB. Upending racism in psychological science: Strategies to change how science is conducted, reported, reviewed, and disseminated. Am Psychol. 2021; 76(7):1097–1112. doi:10.1037/amp0000905.CrossRefGoogle ScholarPubMed
Ayoub, P, Rose, D. Defense of “Me” Studies. Inside Higher Education. 2016. April 14, 2016. www.insidehighered.com/views/2016/04/14/scholarly-importance-studying-issues-related-ones-own-identity-essay.Google Scholar
American Psychological Association. Ethical principles of psychologists and code of conduct. www.apa.org/ethics/code.Google Scholar
Altenmüller, MS, Lange, LL, Gollwitzer, M. When research is me-search: How researchers’ motivation to pursue a topic affects laypeople’s trust in science. PLoS One. 2021; 16(7):e0253911. doi:10.1371/journal.pone.0253911.CrossRefGoogle ScholarPubMed
Rios, K, Roth, ZC. Is “me-search” necessarily less rigorous research? Social and personality psychologists’ stereotypes of the psychology of religion. Self Identity. 2020; 19(7):825–840. doi:10.1080/15298868.2019.1690035.CrossRefGoogle Scholar
Lilford, RJ, Jackson, J. Equipoise and the ethics of randomization. J R Soc Med. 1995; 88(10):552–559.Google ScholarPubMed
Freedman, B. Equipoise and the ethics of clinical research. N Engl J Med. 1987; 317(3):141–115. doi:10.1056/NEJM198707163170304.CrossRefGoogle ScholarPubMed
Lilford, RJ, Jackson, J. Equipoise and the ethics of randomization. J R Soc Med. 1995; 88(10):552.Google ScholarPubMed
National Science Foundation. Broader impacts. https://new.nsf.gov/funding/learn/broader-impacts.Google Scholar
United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont report: Ethical principles and guidelines for the protection of human subjects of research. DHEW Publication no (OS) 78-0012. The Commission; U.S. Govt. Print. Off.; 1978.Google Scholar
Berling, E, McLeskey, C, O’Rourke, M, Pennock, RT. A new method for a virtue-based responsible conduct of research curriculum: Pilot test results. Sci Eng Ethics. 2019; 25(3):899–910. doi:10.1007/s11948-017-9991-2.CrossRefGoogle ScholarPubMed
Pennock, RT, O’Rourke, M. Developing a scientific virtue-based approach to science ethics training. Sci Eng Ethics. 2017; 23(1):243–262. doi:10.1007/s11948-016-9757-2.CrossRefGoogle ScholarPubMed
Collins, SE, Clifasefi, SL, Stanton, J, et al. Community-based participatory research (CBPR): Towards equitable involvement of community in psychology research. Am Psychol. 2018; 73(7):884–898. doi:10.1037/amp0000167.CrossRefGoogle ScholarPubMed
Breault, LJ, Rittenbach, K, Hartle, K, et al. The top research questions asked by people with lived depression experience in Alberta: A survey. CMAJ Open. 2018; 6(3):E398–E405. doi:10.9778/cmajo.20180034.CrossRefGoogle ScholarPubMed