Cochrane, AL. Effectiveness and Efficiency: Random Reflections on Health Services. The Rock Carling Fellowship, Nuffield Provincial Hospitals Trust; 1972:xi, p. 92.Google Scholar

Haynes, B. Can it work? Does it work? Is it worth it? The testing of healthcare interventions is evolving. BMJ. 1999; 319(7211):652–653. doi:10.1136/bmj.319.7211.652.CrossRefGoogle Scholar

Porzsolt, F. Comparative effectiveness is the common denominator in health services research: Experimental effects are promising, real-world effects are compelling. J Complement Integr Med. 2023; 21(1):19–25. doi:10.1515/jcim-2023-0179.CrossRefGoogle Scholar

Mentz, RJ, Kaski, JC, Dan, GA, et al. Implications of geographical variation on clinical outcomes of cardiovascular trials. Am Heart J. 2012; 164(3):303–312. doi:10.1016/j.ahj.2012.06.006.CrossRefGoogle ScholarPubMed

World Medical Association. WMA Declaration of Helsinki – Ethical principles for medical research involving human subjects. www.wma.net/what-we-do/medical-ethics/declaration-of-helsinki/.Google Scholar

Manabe, N, Haruma, K, Ito, M, et al. Efficacy of adding sodium alginate to omeprazole in patients with nonerosive reflux disease: A randomized clinical trial. Dis Esophagus. 2012; 25(5):373–380. doi:10.1111/j.1442-2050.2011.01276.x.CrossRefGoogle ScholarPubMed

Bate, CM, Green, JR, Axon, AT, et al. Omeprazole is more effective than cimetidine for the relief of all grades of gastro-oesophageal reflux disease-associated heartburn, irrespective of the presence or absence of endoscopic oesophagitis. Aliment Pharmacol Ther. 1997; 11(4):755–763. doi:10.1046/j.1365-2036.1997.00198.x.CrossRefGoogle ScholarPubMed

Richter, JE, Peura, D, Benjamin, SB, Joelsson, B, Whipple, J. Efficacy of omeprazole for the treatment of symptomatic acid reflux disease without esophagitis. Arch Intern Med. 2000; 160(12):1810–1816. doi:10.1001/archinte.160.12.1810.CrossRefGoogle ScholarPubMed

Hosseini, M, Salari, R, Akbari Rad, M, Salehi, M, Birjandi, B, Salari, M. Comparing the effect of psyllium seed on gastroesophageal reflux disease with oral omeprazole in patients with functional constipation. J Evid Based Integr Med. 2018; 23:2515690X18763294. doi:10.1177/2515690X18763294.CrossRefGoogle ScholarPubMed

Bate, CM, Griffin, SM, Keeling, PW, et al. Reflux symptom relief with omeprazole in patients without unequivocal oesophagitis. Aliment Pharmacol Ther. 1996; 10(4):547–555. doi:10.1046/j.1365-2036.1996.44186000.x.CrossRefGoogle ScholarPubMed

Boeckxstaens, G, El-Serag, HB, Smout, AJ, Kahrilas, PJ. Symptomatic reflux disease: The present, the past and the future. Gut. 2014; 63(7):1185–1193. doi:10.1136/gutjnl-2013-306393.CrossRefGoogle ScholarPubMed

Institute of Medicine (U.S.). Committee on Standards for Developing Trustworthy Clinical Practice Guidelines., Graham R. Clinical Practice Guidelines We Can Trust. National Academies Press; 2011:xxxiv, p. 266.Google Scholar

U.S. Department of Health and Human Services Office of Disease Prevention and Health Promotion. Healthy People 2030. February 4, 2024, https://health.gov/healthypeople/.Google Scholar

Kaplan, RM, Milstein, A. Contributions of health care to longevity: A review of 4 estimation methods. Ann Fam Med. 2019; 17(3):267–272. doi:10.1370/afm.2362.CrossRefGoogle ScholarPubMed

Cockerham, WC. Theoretical approaches to research on the social determinants of obesity. Am J Prev Med. 2022; 63(1 Suppl 1):S8–S17. doi:10.1016/j.amepre.2022.01.030.CrossRefGoogle ScholarPubMed

Lakerveld, J, Mackenbach, J. The upstream determinants of adult obesity. Obes Facts. 2017; 10(3):216–222. doi:10.1159/000471489.CrossRefGoogle ScholarPubMed

Agborsangaya, CB, Majumdar, SR, Sharma, AM, Gregg, EW, Padwal, RS. Multimorbidity in a prospective cohort: Prevalence and associations with weight loss and health status in severely obese patients. Obesity (Silver Spring). 2015; 23(3):707–712. doi:10.1002/oby.21008.CrossRefGoogle Scholar

Jacobson, BC, Somers, SC, Fuchs, CS, Kelly, CP, Camargo, CA. Body-mass index and symptoms of gastroesophageal reflux in women. N Engl J Med. 2006; 354(22):2340–2348. doi:10.1056/NEJMoa054391.CrossRefGoogle ScholarPubMed

de Bortoli, N, Guidi, G, Martinucci, I, et al. Voluntary and controlled weight loss can reduce symptoms and proton pump inhibitor use and dosage in patients with gastroesophageal reflux disease: A comparative study. Dis Esophagus. 2016; 29(2):197–204. doi:10.1111/dote.12319.CrossRefGoogle ScholarPubMed

Yadlapati, R, Pandolfino, JE, Alexeeva, O, et al. The Reflux Improvement and Monitoring (TRIM) program is associated with symptom improvement and weight reduction for patients with obesity and gastroesophageal reflux disease. Am J Gastroenterol. 2018; 113(1):23–30. doi:10.1038/ajg.2017.262.CrossRefGoogle ScholarPubMed

Loudon, K, Treweek, S, Sullivan, F, Donnan, P, Thorpe, KE, Zwarenstein, M. The PRECIS-2 tool: Designing trials that are fit for purpose. BMJ. 2015; 350:h2147. doi:10.1136/bmj.h2147.CrossRefGoogle ScholarPubMed

Janiaud, P, Dal-Ré, R, Ioannidis, JPA. Assessment of pragmatism in recently published randomized clinical trials. JAMA Intern Med. 2018; 178(9):1278–1280. doi:10.1001/jamainternmed.2018.3321.CrossRefGoogle ScholarPubMed

Dal-Ré, R, Janiaud, P, Ioannidis, JPA. Real-world evidence: How pragmatic are randomized controlled trials labeled as pragmatic? BMC Med. 2018; 16(1):49. doi:10.1186/s12916-018-1038-2.CrossRefGoogle ScholarPubMed

Lu, B, Zhang, L, Wang, J, et al. Empirical treatment of outpatients with gastroesophageal reflux disease with proton pump inhibitors: A survey of Chinese patients (the ENLIGHT Study). J Gastroenterol Hepatol. 2018; 33(10):1722–1727. doi:10.1111/jgh.14143.CrossRefGoogle Scholar

Jain, S, Shamrao Kulkarni, S, Mahapatra, JR, et al. Effectiveness of omeprazole in acid peptic disease: A real-world, patient-reported outcome measures study. Cureus. 2023; 15(7):e41994. doi:10.7759/cureus.41994.Google ScholarPubMed

Lanas, A, Rodrigo, L, Márquez, JL, et al. Low frequency of upper gastrointestinal complications in a cohort of high-risk patients taking low-dose aspirin or NSAIDS and omeprazole. Scand J Gastroenterol. 2003; 38(7):693–700. doi:10.1080/00365520310003967.Google ScholarPubMed

Sox, HC, Greenfield, S. Comparative effectiveness research: A report from the Institute of Medicine. Ann Intern Med. 2009; 151(3):203–205. doi:10.7326/0003-4819-151-3-200908040-00125.CrossRefGoogle ScholarPubMed

Elliott, N, Steel, A, Leech, B, Peng, W. Design characteristics of comparative effectiveness trials for the relief of symptomatic dyspepsia: A systematic review. Integr Med Res. 2021; 10(2):100663. doi:10.1016/j.imr.2020.100663.CrossRefGoogle ScholarPubMed

Ware, JE, Snow, KK, Kosinski, M, Gandek, B. SF-36 Health Survey Manual and Interpretation Guide. The Health Institute, New England Medical Center; 1993.Google Scholar

Wiklund, IK, Junghard, O, Grace, E, et al. Quality of Life in Reflux and Dyspepsia patients: Psychometric documentation of a new disease-specific questionnaire (QOLRAD). Eur J Surg Suppl. 1998; (583):41–49.Google ScholarPubMed

Furlong, WJ, Feeny, DH, Torrance, GW, Barr, RD. The Health Utilities Index (HUI) system for assessing health-related quality of life in clinical studies. Ann Med. 2001; 33(5):375–384. doi:10.3109/07853890109002092.CrossRefGoogle ScholarPubMed

El-Dika, S, Guyatt, GH, Armstrong, D, et al. The impact of illness in patients with moderate to severe gastro-esophageal reflux disease. BMC Gastroenterol. 2005; 5:23. doi:10.1186/1471-230X-5-23.CrossRefGoogle ScholarPubMed

Fallone, CA, Guyatt, GH, Armstrong, D, et al. Do physicians correctly assess patient symptom severity in gastro-oesophageal reflux disease? Aliment Pharmacol Ther. 2004; 20(10):1161–1169. doi:10.1111/j.1365-2036.2004.02257.x.CrossRefGoogle ScholarPubMed

Schünemann, HJ, Armstrong, D, Degl’innocenti, A, et al. A randomized multicenter trial to evaluate simple utility elicitation techniques in patients with gastroesophageal reflux disease. Med Care. 2004; 42(11):1132–1142. doi:10.1097/00005650-200411000-00013.CrossRefGoogle ScholarPubMed

Office for Health Improvement and Disparities, National Institute for Health and Care Excellence. Cost utility analysis: Health economic studies. Accessed June 3, 2023, www.gov.uk/guidance/cost-utility-analysis-health-economic-studies.Google Scholar

Mafi, JN, May, FP, Kahn, KL, et al. Low-value proton pump inhibitor prescriptions among older adults at a large academic health system. J Am Geriatr Soc. 2019; 67(12):2600–2604. doi:10.1111/jgs.16117.CrossRefGoogle Scholar

Wilhelm, SM, Rjater, RG, Kale-Pradhan, PB. Perils and pitfalls of long-term effects of proton pump inhibitors. Expert Rev Clin Pharmacol. 2013; 6(4):443–451. doi:10.1586/17512433.2013.811206.CrossRefGoogle ScholarPubMed

Bavishi, C, Dupont, HL. Systematic review: The use of proton pump inhibitors and increased susceptibility to enteric infection. Aliment Pharmacol Ther. 2011; 34(11–12):1269–1281. doi:10.1111/j.1365-2036.2011.04874.x.CrossRefGoogle ScholarPubMed

Ngamruengphong, S, Leontiadis, GI, Radhi, S, Dentino, A, Nugent, K. Proton pump inhibitors and risk of fracture: A systematic review and meta-analysis of observational studies. Am J Gastroenterol. 2011; 106(7):1209–1218; quiz 1219. doi:10.1038/ajg.2011.113.CrossRefGoogle ScholarPubMed

Huber, MA, Nadella, S, Cao, H, et al. Does chronic use of high dose proton pump inhibitors increase risk for pancreatic cancer? Pancreas. 2022; 51(9):1118–1127. doi:10.1097/MPA.0000000000002145.CrossRefGoogle ScholarPubMed

Guo, H, Zhang, R, Zhang, P, et al. Association of proton pump inhibitors with gastric and colorectal cancer risk: A systematic review and meta-analysis. Front Pharmacol. 2023; 14:1129948. doi:10.3389/fphar.2023.1129948.CrossRefGoogle Scholar

Onwuzo, S, Boustany, A, Khaled Abou Zeid, H, et al. Prevalence and risk factors associated with inflammatory bowel disease in patients using proton-pump inhibitors: A population-based study. Cureus. 2023; 15(1):e34088. doi:10.7759/cureus.34088.Google ScholarPubMed

Mc Cord, KA, Ewald, H, Agarwal, A, et al. Treatment effects in randomised trials using routinely collected data for outcome assessment versus traditional trials: Meta-research study. BMJ. 2021; 372:n450. doi:10.1136/bmj.n450.Google ScholarPubMed

Browner, WS. Designing Clinical Research. 5th ed. Wolters Kluwer Health; 2023:1 online resource.Google Scholar

Ray, S, Fitzpatrick, S, Golubic, R, Fisher, S. Oxford Handbook of Clinical and Healthcare Research. 1st ed. Oxford Medical Handbooks. Oxford University Press; 2016:xxi, 580 pages.CrossRefGoogle 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

Morgan, DL, Morgan, RK. Single-participant research design. Bringing science to managed care. Am Psychol. 2001; 56(2):119–127.CrossRefGoogle ScholarPubMed

McDonald, S, Nikles, J. N-of-1 trials in healthcare. Healthcare (Basel). 2021; 9(3). doi:10.3390/healthcare9030330.Google ScholarPubMed

Duan, N, Kravitz, RL, Schmid, CH. Single-patient (n-of-1) trials: A pragmatic clinical decision methodology for patient-centered comparative effectiveness research. J Clin Epidemiol. 2013; 66(8 Suppl):S21–S28. doi:10.1016/j.jclinepi.2013.04.006.CrossRefGoogle ScholarPubMed

Simonsohn, U, Nelson, LD, Simmons, JP. P-curve: A key to the file-drawer. J Exp Psychol Gen. 2014; 143(2):534–547. doi:10.1037/a0033242.CrossRefGoogle Scholar

Kerr, NL. HARKing: Hypothesizing after the results are known. Pers Soc Psychol Rev. 1998; 2(3):196–217. doi:10.1207/s15327957pspr0203_4.CrossRefGoogle ScholarPubMed

Kahn, CR. Picking a research problem: The critical decision. N Engl J Med. 1994; 330(21):1530–1533. doi:10.1056/NEJM199405263302113.CrossRefGoogle Scholar

Savulescu, J, Spriggs, M. The hexamethonium asthma study and the death of a normal volunteer in research. J Med Ethics. 2002; 28(1):3–4. doi:10.1136/jme.28.1.3.CrossRefGoogle ScholarPubMed

Howick, J, Chalmers, I, Glasziou, P, et al. The 2011 Oxford CEBM Levels of Evidence (Introductory Document). www.cebm.ox.ac.uk/resources/levels-of-evidence/levels-of-evidence-introductory-document.Google Scholar

Wensink, MJ, Lu, Y, Tian, L, et al. Preconception antidiabetic drugs in men and birth defects in offspring: A nationwide cohort study. Ann Intern Med. 2022; 175(5):665–673. doi:10.7326/M21-4389.CrossRefGoogle ScholarPubMed

Htay, H, Pascoe, EM, Hawley, CM, et al. Patient and center characteristics associated with kidney transplant outcomes: A binational registry analysis. Transpl Int. 2020; 33(12):1667–1680. doi:10.1111/tri.13681.CrossRefGoogle ScholarPubMed

Crowe, S, Cresswell, K, Robertson, A, Huby, G, Avery, A, Sheikh, A. The case study approach. BMC Med Res Methodol. 2011; 11:100. doi:10.1186/1471-2288-11-100.CrossRefGoogle ScholarPubMed

Iyer, S, Mehta, P, Weith, J, et al. Converting a geriatrics clinic to virtual visits during COVID-19: A case study. J Prim Care Community Health. 2021; 12:21501327211000235. doi:10.1177/21501327211000235.CrossRefGoogle ScholarPubMed

Satoh, K, Okuyama, M, Irie, Y, Kitamura, T, Nakae, H. A case of fatal asthma: Rapid transition to cardiac arrest and rapid recovery of respiratory status. Cureus. 2020; 12(11):e11283. doi:10.7759/cureus.11283.Google ScholarPubMed

Chadwick, P, Trower, P. Cognitive therapy for punishment paranoia: A single case experiment. Behav Res Ther. 1996; 34(4):351–356. doi:10.1016/0005-7967(96)00001-0.CrossRefGoogle ScholarPubMed

Nollace, L, Cravero, C, Abbou, A, et al. Autism and COVID-19: A case series in a neurodevelopmental unit. J Clin Med. 2020; 9(9). doi:10.3390/jcm9092937.CrossRefGoogle Scholar

Patel, NK, Hadley, CJ, Leite, S, et al. Knee arthroplasty with prior ligamentous knee surgery: A matched case-control study. J Knee Surg. 2021; 34(14):1539–1544. doi:10.1055/s-0040-1710375.Google ScholarPubMed

Ma, H, Lin, YH, Dai, LZ, Lin, CS, Huang, Y, Liu, SY. Efficacy and safety of GLP-1 receptor agonists versus SGLT-2 inhibitors in overweight/obese patients with or without diabetes mellitus: A systematic review and network meta-analysis. BMJ Open. 2023; 13(3):e061807. doi:10.1136/bmjopen-2022-061807.CrossRefGoogle ScholarPubMed

Thabane, L, Ma, J, Chu, R, et al. A tutorial on pilot studies: The what, why and how. BMC Med Res Methodol. 2010; 10:1. doi:10.1186/1471-2288-10-1.CrossRefGoogle Scholar

Williams, RJ, Tse, T, DiPiazza, K, Zarin, DA. Terminated trials in the ClinicalTrials.gov results database: Evaluation of availability of primary outcome data and reasons for termination. PLoS One. 2015; 10(5):e0127242. doi:10.1371/journal.pone.0127242.Google ScholarPubMed

Mouw, TJ, Hong, SW, Sarwar, S, et al. Discontinuation of surgical versus nonsurgical clinical trials: An analysis of 88,498 trials. J Surg Res. 2018; 227:151–157. doi:10.1016/j.jss.2018.02.039.CrossRefGoogle Scholar

Bennette, CS, Ramsey, SD, McDermott, CL, Carlson, JJ, Basu, A, Veenstra, DL. Predicting low accrual in the National Cancer Institute’s Cooperative Group clinical trials. J Natl Cancer Inst. 2016; 108(2). doi:10.1093/jnci/djv324.CrossRefGoogle ScholarPubMed

Roddick, AJ, Chan, FTS, Stefaniak, JD, Zheng, SL. Discontinuation and non-publication of clinical trials in cardiovascular medicine. Int J Cardiol. 2017; 244:309–315. doi:10.1016/j.ijcard.2017.06.020.CrossRefGoogle ScholarPubMed

Kasenda, B, von Elm, E, You, J, et al. Prevalence, characteristics, and publication of discontinued randomized trials. JAMA. 2014; 311(10):1045–1051. doi:10.1001/jama.2014.1361.CrossRefGoogle ScholarPubMed

Duggal, M, Sacks, L, Vasisht, KP. Eligibility criteria and clinical trials: An FDA perspective. Contemp Clin Trials. 2021; 109:106515. doi:10.1016/j.cct.2021.106515.CrossRefGoogle ScholarPubMed

Cohen, J. A power primer. Psychol Bull. 1992; 112(1):155–159. doi:10.1037//0033-2909.112.1.155.CrossRefGoogle ScholarPubMed

LeBlanc, TW, Lodato, JE, Currow, DC, Abernethy, AP. Overcoming recruitment challenges in palliative care clinical trials. J Oncol Pract. 2013; 9(6):277–282. doi:10.1200/JOP.2013.000996.CrossRefGoogle ScholarPubMed

Food and Drug Administration. What is a serious adverse event? Accessed July 25, 2023.Google Scholar

Michener, WK. Ten simple rules for creating a good data management plan. PLoS Comput Biol. 2015; 11(10):e1004525. doi:10.1371/journal.pcbi.1004525.CrossRefGoogle ScholarPubMed

National Institutes of Health. Record retention and access. Accessed July 25, 2023, 2023. 8.4.2 Record Retention and Access (nih.gov).Google Scholar

American Psychological Association. Ethical principles of psychologists and code of conduct. www.apa.org/ethics/code.Google Scholar

Gamble, C, Krishan, A, Stocken, D, et al. Guidelines for the content of statistical analysis plans in clinical trials. JAMA. 2017; 318(23):2337–2343. doi:10.1001/jama.2017.18556.CrossRefGoogle Scholar

National Research Council. The Prevention and Treatment of Missing Data in Clinical Trials. The National Academies Press; 2010.Google Scholar

Kaplan, RM, Atkins, CJ. Selective attrition causes overestimates of treatment effects in studies of weight loss. Addictive Behaviors. 1987; 12(3):297–302.CrossRefGoogle ScholarPubMed

Donders, AR, van der Heijden, GJ, Stijnen, T, Moons, KG. Review: A gentle introduction to imputation of missing values. J Clin Epidemiol. 2006; 59(10):1087–1091. doi:10.1016/j.jclinepi.2006.01.014.CrossRefGoogle ScholarPubMed

National Institutes of Health. Protocol templates for clinical trials. Accessed July 25, 2023, 2023. grants.nih.gov.Google Scholar

European Commission. Communication, dissemination and exploitation: Why they all matter and what is the difference? Accessed July 25, 2023. quick-guide_diss-expl_en.pdf (europa.eu).Google Scholar

Clark, T, Davies, H, Mansmann, U. Five questions that need answering when considering the design of clinical trials. Trials. 2014; 15:286. doi:10.1186/1745-6215-15-286.CrossRefGoogle ScholarPubMed

Cascio, MA, Racine, E. Person-oriented research ethics: Integrating relational and everyday ethics in research. Account Res. 2018; 25(3):170–197. doi:10.1080/08989621.2018.1442218.CrossRefGoogle ScholarPubMed

Emanuel, EJ, Grady, C. Four paradigms of clinical research and research oversight. In: Emanuel, EJ, Grady, CC, Crouch, RA, Lie, RK, Miller, FG, Wendler, DD, eds. The Oxford Textbook of Clinical Research Ethics. Oxford University Press; 2008:222–230.CrossRefGoogle Scholar

Weindling, P, von Villiez, A, Loewenau, A, Farron, N. The victims of unethical human experiments and coerced research under National Socialism. Endeavour. 2016; 40(1):1–6. doi:10.1016/j.endeavour.2015.10.005.CrossRefGoogle ScholarPubMed

Shuster, E. Fifty years later: The significance of the Nuremberg Code. N Engl J Med. 1997; 337(20):1436–1440. doi:10.1056/NEJM199711133372006.CrossRefGoogle ScholarPubMed

World Medical Association. WMA Declaration of Helsinki – Ethical principles for medical research involving human subjects. www.wma.net/policies-post/declaration-of-helsinki/.Google Scholar

Brandt, AM. Racism and research: The case of the Tuskegee Syphilis Study. Hastings Cent Rep. 1978; 8(6):21–29.CrossRefGoogle ScholarPubMed

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

Flicker, S, Travers, R, Guta, A, McDonald, S, Meagher, A. Ethical dilemmas in community-based participatory research: Recommendations for institutional review boards. J Urban Health. 2007; 84(4):478–493. doi:10.1007/s11524-007-9165-7.CrossRefGoogle ScholarPubMed

Weinbaum, C, Landree, E, Blumenthal, MS, Piquado, T, Gutierrez, CI. Ethics in scientific research: An examination of ethical principles and emerging topics. 2019. www.rand.org/pubs/research_reports/RR2912.html.CrossRefGoogle Scholar

Sulmasy, LS, Bledsoe, TA, for the ACP Ethics, Profession, and Human Rights Committee. American college of physicians ethics manual: Seventh edition. Ann Intern Med. 2019; 170(2_Suppl):S1–S32. doi:10.7326/M18-2160.Google ScholarPubMed

Kost, RG, Lee, LM, Yessis, J, Coller, BS, Henderson, DK, Subcommittee RPPSFG. Assessing research participants’ perceptions of their clinical research experiences. Clin Transl Sci. 2011; 4(6):403–413. doi:10.1111/j.1752-8062.2011.00349.x.CrossRefGoogle ScholarPubMed

Wendler, D, Krohmal, B, Emanuel, EJ, Grady, C, Group, E. Why patients continue to participate in clinical research. Arch Intern Med. 2008; 168(12):1294–1299. doi:10.1001/archinte.168.12.1294.CrossRefGoogle ScholarPubMed

Grover, S, Fitzpatrick, A, Azim, FT, et al. Defining and implementing patient-centered care: An umbrella review. Patient Educ Couns 2021. doi:10.1016/j.pec.2021.11.004.Google ScholarPubMed

Barlow, DH, Nock, M, Hersen, M. Single Case Experimental Designs: Strategies for Studying Behavior for Change. 3rd ed. Pearson/Allyn and Bacon; 2009:xvi, 393 p.Google Scholar

Mikesell, L, Bromley, E, Khodyakov, D. Ethical community-engaged research: A literature review. Am J Public Health. 2013; 103(12):e7–e14. doi:10.2105/AJPH.2013.301605.CrossRefGoogle ScholarPubMed

Participants in the Community Engagement and Consent Workshop, Kilifi, Kenya, March 2011. Consent and community engagement in diverse research contexts. J Empir Res Hum Res Ethics. 2013; 8(4):1–18. doi:10.1525/jer.2013.8.4.1.CrossRefGoogle Scholar

Newman, SD, Andrews, JO, Magwood, GS, Jenkins, C, Cox, MJ, Williamson, DC. Community advisory boards in community-based participatory research: A synthesis of best processes. Prev Chronic Dis. 2011; 8(3):A70.Google ScholarPubMed

Vasquez, MJ. Psychology and social justice: Why we do what we do. Am Psychol. 2012; 67(5):337–346. doi:10.1037/a0029232.CrossRefGoogle Scholar

Emanuel, EJ, Wendler, D, Grady, C. What makes clinical research ethical? JAMA. 2000; 283(20):2701–2711. doi:10.1001/jama.283.20.2701.CrossRefGoogle ScholarPubMed

Denny, C, Grady, C. Research involving women. In: Emanuel, EJ, Grady, CC, Crouch, RA, Lie, RK, Miller, FG, Wendler, DD, eds. The Oxford Textbook of Clinical Research Ethics. Oxford University Press; 2008:407–422.CrossRefGoogle Scholar

Schmaling, KB. Diversity and inclusion in clinical trials are preconditions for equity. Clinical Psychology: Science and Practice. 2022; 29(2):94–96. doi:10.1037/cps0000068.Google Scholar

Emanuel, EJ, Wendler, D, Killen, J, Grady, C. What makes clinical research in developing countries ethical? The benchmarks of ethical research. J Infect Dis. 2004; 189(5):930–937. doi:10.1086/381709.CrossRefGoogle ScholarPubMed

Rid, A, Emanuel, EJ. Ethical considerations of experimental interventions in the Ebola outbreak. Lancet. 2014; 384(9957):1896–1899. doi:10.1016/S0140-6736(14)61315-5.CrossRefGoogle ScholarPubMed

Hampson, LA, Joffe, S, Fowler, R, Verter, J, Emanuel, EJ. Frequency, type, and monetary value of financial conflicts of interest in cancer clinical research. J Clin Oncol. 2007; 25(24):3609–3614. doi:10.1200/JCO.2006.09.3633.CrossRefGoogle ScholarPubMed

Lexchin, J. Economics and industry do not mean ethical conduct in clinical trials. J Pharm Policy Pract. 2013; 6:11. doi:10.1186/2052-3211-6-11.CrossRefGoogle Scholar

Baraldi, JH, Picozzo, SA, Arnold, JC, Volarich, K, Gionfriddo, MR, Piper, BJ. A cross-sectional examination of conflict-of-interest disclosures of physician-authors publishing in high-impact US medical journals. BMJ Open. 2022; 12(4):e057598. doi:10.1136/bmjopen-2021-057598.CrossRefGoogle ScholarPubMed

Godlee, F, Smith, J, Marcovitch, H. Wakefield’s article linking MMR vaccine and autism was fraudulent. BMJ. 2011; 342:c7452. doi:10.1136/bmj.c7452.Google ScholarPubMed

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

Douglas, BD, McGorray, EL, Ewell, PJ. Some researchers wear yellow pants, but even fewer participants read consent forms: Exploring and improving consent form reading in human subjects research. Psychological Methods. 2021; 26(1):61.CrossRefGoogle ScholarPubMed

Spencer, SP, Stoner, MJ, Kelleher, K, Cohen, DM. Using a multimedia presentation to enhance informed consent in a pediatric emergency department. Pediatr Emerg Care. 2015; 31(8):572–576. doi:10.1097/PEC.0000000000000513.CrossRefGoogle Scholar

Allen, AA, Chen, DT, Bonnie, RJ, et al. Assessing informed consent in an opioid relapse prevention study with adults under current or recent criminal justice supervision. J Subst Abuse Treat. 2017; 81:66–72. doi:10.1016/j.jsat.2017.07.015.CrossRefGoogle ScholarPubMed

Seely, KD, Higgs, JA, Butts, L, et al. The “teach-back” method improves surgical informed consent and shared decision-making: A proof of concept study. Patient Saf Surg. 2022; 16(1):33. doi:10.1186/s13037-022-00342-9.CrossRefGoogle Scholar

Allmark, P, Mason, S. Should desperate volunteers be included in randomised controlled trials? J Med Ethics. 2006; 32(9):548–553. doi:10.1136/jme.2005.014282.CrossRefGoogle ScholarPubMed

Chou, KL, Amick, MM, Brandt, J, et al. A recommended scale for cognitive screening in clinical trials of Parkinson’s disease. Mov Disord. 2010; 25(15):2501–2507. doi:10.1002/mds.23362.CrossRefGoogle ScholarPubMed

Miller, FG, Emanuel, EJ. Quality-improvement research and informed consent. N Engl J Med. 2008; 358(8):765–767. doi:10.1056/NEJMp0800136.CrossRefGoogle ScholarPubMed

American Medical Association. AMA code of medical ethics opinions on research & innovation. www.ama-assn.org/system/files/2019-01/code-of-medical-ethics-chapter-7.pdf.Google Scholar

Oxford Center for Evidence-Based Medicine. Levels of evidence. www.cebm.ox.ac.uk/resources/levels-of-evidence.Google Scholar

Miller, FG. The ethics of placebo-controlled trials. In: Emanuel, EJ, Grady, CC, Crouch, RA, Lie, RK, Miller, FG, Wendler, DD, eds. The Oxford Textbook of Clinical Research Ethics. Oxford University Press; 2008.Google Scholar

Sihvonen, R, Paavola, M, Malmivaara, A, et al. Arthroscopic partial meniscectomy versus sham surgery for a degenerative meniscal tear. N Engl J Med. 2013; 369(26):2515–2524. doi:10.1056/NEJMoa1305189.CrossRefGoogle ScholarPubMed

Kizaki, K, Schwartz, LJ, Ayeni, OR. Evidence first, practice second in arthroscopic surgery: Use of placebo surgery in randomised controlled trial. J Med Ethics. 2019; 45(12):757–760. doi:10.1136/medethics-2019-105598.CrossRefGoogle ScholarPubMed

Joffe, S, Truog, RD. Equipoise and randomization. In: Emanuel, EJ, Grady, CC, Crouch, RA, Lie, RK, Miller, FG, Wendler, DD, eds. The Oxford Textbook of Clinical Research Ethics. Oxford University Press; 2008:245–260.CrossRefGoogle Scholar

Mills, N, Donovan, JL, Smith, M, Jacoby, A, Neal, DE, Hamdy, FC. Perceptions of equipoise are crucial to trial participation: A qualitative study of men in the protect study. Control Clin Trials. 2003; 24(3):272–282. doi:10.1016/s0197-2456(03)00020-5.CrossRefGoogle ScholarPubMed

Ross, S, Grant, A, Counsell, C, Gillespie, W, Russell, I, Prescott, R. Barriers to participation in randomised controlled trials: A systematic review. J Clin Epidemiol. 1999; 52(12):1143–1156. doi:10.1016/s0895-4356(99)00141-9.CrossRefGoogle ScholarPubMed

Borgerson, K. Valuing evidence: Bias and the evidence hierarchy of evidence-based medicine. Perspect Biol Med. 2009; 52(2):218–233. doi:10.1353/pbm.0.0086.CrossRefGoogle ScholarPubMed

National Institutes of Health. Enhanced checks for compliance with clinical trial registration and reporting in RPPR. https://nexus.od.nih.gov/all/2021/11/09/enhanced-checks-for-compliance-with-clinical-trial-registration-and-reporting-in-rppr/.Google Scholar

Brassington, I. The ethics of reporting all the results of clinical trials. Br Med Bull. 2017; 121(1):19–29. doi:10.1093/bmb/ldw058.CrossRefGoogle ScholarPubMed

DeVito, NJ, Bacon, S, Goldacre, B. Compliance with legal requirement to report clinical trial results on ClinicalTrials.gov: A cohort study. Lancet. 2020; 395(10221):361–369. doi:10.1016/S0140-6736(19)33220-9.CrossRefGoogle ScholarPubMed

Williams, RJ, Tse, T, DiPiazza, K, Zarin, DA. Terminated trials in the ClinicalTrials.gov results database: Evaluation of availability of primary outcome data and reasons for termination. PLoS One. 2015; 10(5):e0127242. doi:10.1371/journal.pone.0127242.Google ScholarPubMed

Scherer, RW, Meerpohl, JJ, Pfeifer, N, Schmucker, C, Schwarzer, G, von Elm, E. Full publication of results initially presented in abstracts. Cochrane Database Syst Rev. 2018; 11(11):MR000005. doi:10.1002/14651858.MR000005.pub4.Google ScholarPubMed

Millum, J, Wendler, D, Emanuel, EJ. The 50th anniversary of the declaration of Helsinki: Progress but many remaining challenges. JAMA. 2013; 310(20):2143–2144. doi:10.1001/jama.2013.281632.CrossRefGoogle ScholarPubMed

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

Collaborative Institutional Training Initiative. CITI Program. https://about.citiprogram.org/.Google Scholar

Martinson, BC, Anderson, MS, de Vries, R. Scientists behaving badly. Nature. 2005; 435(7043):737–738. doi:10.1038/435737a.CrossRefGoogle ScholarPubMed

Klitzman, RL, Kleinert, K, Rifai-Bashjawish, H, Leu, CS. The reporting of IRB review in journal articles presenting HIV research conducted in the developing world. Dev World Bioeth. 2011; 11(3):161–169. doi:10.1111/j.1471-8847.2011.00306.x.CrossRefGoogle ScholarPubMed

Hall, DE, Feske, U, Hanusa, BH, et al. Prioritizing Initiatives for Institutional Review Board (IRB) quality improvement. AJOB Empir Bioeth. 2016; 7(4):265–274. doi:10.1080/23294515.2016.1186757.CrossRefGoogle ScholarPubMed

Silberman, G, Kahn, KL. Burdens on research imposed by institutional review boards: The state of the evidence and its implications for regulatory reform. Milbank Q. 2011; 89(4):599–627. doi:10.1111/j.1468-0009.2011.00644.x.CrossRefGoogle ScholarPubMed

Hudson, KL, Lauer, MS, Collins, FS. Toward a new era of trust and transparency in clinical trials. JAMA. 2016; 316(13):1353–1354. doi:10.1001/jama.2016.14668.CrossRefGoogle Scholar

Chalmers, I, Glasziou, P. Avoidable waste in the production and reporting of research evidence. Lancet. 2009; 374(9683):86–89. doi:10.1016/S0140-6736(09)60329-9.CrossRefGoogle ScholarPubMed

Lund, H, Robinson, KA, Gjerland, A, et al. Meta-research evaluating redundancy and use of systematic reviews when planning new studies in health research: A scoping review. Syst Rev. 2022; 11(1):241. doi:10.1186/s13643-022-02096-y.CrossRefGoogle ScholarPubMed

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

Loudon, K, Treweek, S, Sullivan, F, Donnan, P, Thorpe, KE, Zwarenstein, M. The PRECIS-2 tool: Designing trials that are fit for purpose. BMJ. 2015; 350:h2147. doi:10.1136/bmj.h2147.CrossRefGoogle ScholarPubMed

Equator Network. Enhancing the QUAlity and transparency of health research. www.equator-network.org/reporting-guidelines/.Google Scholar