10,568
Views
0
CrossRef citations to date
0
Altmetric
Research Articles

Assessing the Overall Validity of Randomised Controlled Trials

References

  • Andrew, E., A. Anis, T. Chalmers, M. Cho, M. Clarke, D. Felson, P. Gøtzsche, et al. 1994. “A Proposal for Structured Reporting of Randomized Controlled Trials.” JAMA 272 (24): 1926–1931.
  • Ankeny, R. 2014. “The Overlooked Role of Cases in Casual Attribution in Medicine.” Philosophy of Science 81 (5): 999–1011.
  • Banerjee, A. 2007. Making Aid Work. Cambridge: MIT Press.
  • Banerjee, A., and Esther Duflo. 2009. “The Experimental Approach to Development Economics.” Annual Review of Economics 1 (1): 151–178.
  • Barbour, Rosaline. 1999. “The Case for Combining Qualitative and Quantitative Approaches in Health Services Research.” Journal of Health Services Research & Policy 4 (1): 39–43.
  • Black, N. 1996. “Why we Need Observational Studies to Evaluate the Effectiveness of Health Care.” BMJ 312 (7040): 1215–1218.
  • Campbell, D. 1957. “Factors Relevant to the Validity of Experiments in Social Settings.” Psychological Bulletin 54: 297–312.
  • Campbell, D., and J. Stanley. 1963. Experimental and Quasi-Experimental Designs for Research. Chicago: Rand McNally and Company.
  • Cartwright, N. 1989. Nature’s Capacities and Their Measurement. Oxford: Clarendon Press.
  • Cartwright, N. 2007a. Hunting Causes and Using Them. Cambridge: Cambridge University Press.
  • Cartwright, N. 2007. “Are RCTs the Gold Standard?” Biosocieties 2 (1): 11–20.
  • Cartwright, N. 2010. “What are Randomised Controlled Trials Good for?” Philosophical Studies 147: 59. https://doi.org/https://doi.org/10.1007/s11098-009-9450-2.
  • Chan, A., and D. Altman. 2005. “Epidemiology and Reporting of Randomised Trials Published in PubMed Journals.” Lancet 365: 1159–1162.
  • Clarke, B., D. Gillies, P. Illari, F. Russo, and J. Williamson. 2014. “Mechanisms and the Evidence Hierarchy.” Topoi 33: 339–360.
  • Cochrane Library. 2021. Cochrane Library. London, https://www.cochranelibrary.com/central.
  • Cook, T., and D. Campbell. 1979. Quasi-Experimentation: Design & Analysis Issues for Field Settings. Boston: Houghton Mifflin Company.
  • Deaton, A. 2009. Instruments of Development: Randomization in the Tropics, and the Search for the Elusive Keys to Economic Development. NBER Working Papers 14690, National Bureau of Economic Research, Inc.
  • Diabetes Control and Complications Trial Research Group (DCC). 1993. “The Effect of Intensive Treatment of Diabetes on the Development and Progression of Long-Term Complications in Insulin-Dependent Diabetes Mellitus.” New England Journal of Medicine 329 (14): 977–986.
  • Djulbegovic, B., A. Kumar, P. Glasziou, B. Miladinovic, and I. Chalmers. 2013. “Medical Research: Trial Unpredictability Yields Predictable Therapy Gains.” Nature 500: 395–396.
  • Duflo, E., R. Glennerster, and M. Kremer. 2007. “Using Randomization in Development Economics Research: a Toolkit.” In Handbook of Development Economics. Vol. 4, 3895–3962. Elsevier.
  • Dwan, K., D. G. Altman, J. A. Arnaiz, J. Bloom, A. W. Chan, E. Cronin, E. Decullier, et al. 2008. “Systematic Review of the Empirical Evidence of Study Publication Bias and Outcome Reporting Bias.” PLoS One 3 (8): e3081.
  • Fallis, D. 2000. “The Reliability of Randomized Algorithms.” The British Journal for the Philosophy of Science 51 (2): 255–271.
  • Favereau, Judith, and Michiru Nagatsu. 2020. “Holding Back from Theory: Limits and Methodological Alternatives of Randomized Field Experiments in Development Economics.” Journal of Economic Methodology 27 (3): 191–211.
  • Fuller, J. 2018. “The Confounding Question of Confounding Causes in Randomized Trials.” The British Journal for the Philosophy of Science 70 (3): 901–926.
  • Goldacre, B. 2016. “Make Journals Report Clinical Trials Properly.” Nature 530 (7588): 7.
  • Gorard, Stephen, and Chris Taylor. 2004. Combining Methods in Educational and Social Research. Columbus, OH; Open University Press: McGraw-Hill.
  • Harrison, G. 2011. “Randomization and Its Discontents.” Journal of African Economies 20 (4): 626–652.
  • Heckman, J. 2001. Econometrics, counterfactuals and causal models. Keynote Address, International Statistical Institute, Seoul, Korea.
  • Heckman, J. 2020. Randomization and Social Policy Evaluation Revisited. Institute of Labor Economics, IZA Discussion Papers, No. 12882, Bonn.
  • Heukelom, F. 2009. Origin and Interpretation of Internal and External Validity in Economics. Nijmegen Center for Economics; NiCE Working Paper 09-111.
  • Holland, P., and D. Rubin. 1988. “Causal Inference in Retrospective Studies.” Evaluation Review 12: 203–231.
  • Holman, B. 2017. “Philosophers on Drugs.” Synthese 196: 4363–4390.
  • Holman, B. 2018. “In Defense of Meta-Analysis.” Synthese 196: 3189–3211.
  • Holman, B., and J. Bruner. 2017. “Experimentation by Industrial Selection.” Philosophy of Science 84 (5): 1008–1019.
  • Howick, J. 2011. “Exposing the Vanities - and a Qualified Defense - of Mechanistic Reasoning in Health Care Decision Making.” Philosophy of Science 78 (5): 926–940.
  • Howick, J. 2017. “The Relativity of ‘Placebos’: Defending a Modified Version of Grünbaum’s Definition.” Synthese 194: 1363–1396.
  • Hurwitz, H., L. Fehrenbacher, W. Novotny, T. Cartwright, J. Hainsworth, W. Heim, J. Berlin, et al. 2004. “Bevacizumab Plus Irinotecan, Fluorouracil, and Leucovorin for Metastatic Colorectal Cancer.” New England Journal of Medicine 350: 2335–2342.
  • Jiménez-Buedo, María, and Luis Miller. 2010. “Why a Trade-off? The Relationship Between the External and Internal Validity of Experiments.” Theoria. Revista de Teoría, Historia y Fundamentos de la Ciencia 25 (3): 301–321.
  • Kane, R. 2006. Understanding Health Care Outcomes Research. Burlington: Jones & Bartlett.
  • Kannisto, K. A., J. Korhonen, C. E. Adams, M. H. Koivunen, T. Vahlberg, and M. A. Välimäki. 2017. “Factors Associated With Dropout During Recruitment and Follow-Up Periods of a MHealth-Based Randomized Controlled Trial for Mobile.Net to Encourage Treatment Adherence for People With Serious Mental Health Problems.” Journal of Medical Internet Research 19 (2): e46.
  • Kelly, A., R. Lesh, and J. Baek. 2014. Handbook of Design Research Methods in Education: Innovations in Science, Technology, Engineering, and Mathematics Learning and Teaching. New York: Routledge.
  • Knowler, W., Barrett-Connor E., Fowler S., Hamman R., Lachin J., Walker E., Nathan D. 2002. “Reduction in the Incidence of Type 2 Diabetes with Lifestyle Intervention or Metformin.” New England Journal of Medicine 346 (6): 393–403.
  • Krauss, Alexander. 2018. “Why all Randomised Controlled Trials Produce Biased Results.” Annals of Medicine 50: 312–322.
  • Marcellesi, A. 2015. “External Validity: Is There Still a Problem?” Philosophy of Science 82 (5): 1308–1317.
  • Marler, J. 1995. “Tissue Plasminogen Activator for Acute Ischemic Stroke.” New England Journal of Medicine 333: 1581–1588.
  • Moher, D., S. Hopewell, K. F. Schulz, V. Montori, P. C. Gøtzsche, P. J. Devereaux, D. Elbourne, M. Egger, and D. G. Altman. 2010. “CONSORT 2010 Explanation and Elaboration: Updated Guidelines for Reporting Parallel Group Randomised Trials.” BMJ 340: c869.
  • Moher, D., A. Jones, D. J. Cook, A. R. Jadad, M. Moher, P. Tugwell, and T. P. Klassen. 1998. “Does Quality of Reports of Randomised Trials Affect Estimates of Intervention Efficacy Reported in Meta-Analyses?” Lancet 352: 609–613.
  • Papineau, D. 1994. “The Virtues of Randomization.” The British Journal for the Philosophy of Science 45: 437–450.
  • Ravallion, Martin. 2009. “Evaluation in the Practice of Development.” The World Bank Research Observer 24 (1): 29–53.
  • Reiss, Julian. 2019. “Against External Validity.” Synthese 196: 3103–3121.
  • Rennie, D. 2001. “CONSORT Revised – Improving the Reporting of Randomized Trials.” JAMA 285: 2006–2007.
  • Richards, D. A., P. Bazeley, G. Borglin, P. Craig, R. Emsley, J. Frost, J. Hill, et al. 2019. “ Integrating Quantitative and Qualitative Data and Findings When Undertaking Randomised Controlled Trials.” BMJ Open 9 (11): e032081.
  • Rossouw, J. E., G. L. Anderson, R. L. Prentice, A. Z. LaCroix, C. Kooperberg, M. L. Stefanick, R. D. Jackson, et al. 2002. “Risks and Benefits of Estrogen Plus Progestin in Healthy Postmenopausal Women: Principal Results from the Women's Health Initiative Randomized Controlled Trial.” JAMA 288:321–333.
  • Russo, F., and J. Williamson. 2011. “Epistemic Causality and Evidence-Based Medicine.” History and Philosophy of the Life Sciences 33 (4): 563–581.
  • Sackett, D. L., W. M. Rosenberg, J. M. Gray, R. B. Haynes, and W. S. Richardson. 1996. "Evidence-based Medicine: What it is and What it Isn’t.” British Medical Journal 312: 71–72.
  • Scandinavian Simvastatin Survival Study Group (SSSSG). 1994. “Randomised Trial of Cholesterol Lowering in 4444 Patients with Coronary Heart Disease: the Scandinavian Simvastatin Survival Study.” Lancet 344: 1383–1389.
  • Seligman, M. 1996. “Science as an Ally of Practice.” American Psychology 51 (10): 1072–1079.
  • Shepherd, J., S. M. Cobbe, I. Ford, C. G. Isles, A. R. Lorimer, P. W. Macfarlane, J. H. McKillop, and C. J. Packard. 1995. “Prevention of Coronary Heart Disease with Pravastatin in men with Hypercholesterolemia.” New England Journal of Medicine 333: 1301–1308.
  • Slamon, D. J., B. Leyland-Jones, S. Shak, H. Fuchs, V. Paton, A. Bajamonde, T. Fleming, et al. 2001. “Use of Chemotherapy Plus a Monoclonal Antibody Against her2 for Metastatic Breast Cancer That Overexpresses HER2.” New England Journal of Medicine 344: 783–792.
  • Stegenga, J. 2011. “Is Meta-Analysis the Platinum Standard of Evidence?” Studies in History and Philosophy of Biological and Biomedical Sciences 42 (4): 497–507.
  • Suppes, P. 1970. A Probabilistic Theory of Causality. Amsterdam: North-Holland.
  • Teira, David. 2010. “Frequentist Versus Bayesian Clinical Trials.” In Philosophy of Medicine [Handbook of Philosophy of Science, vol. 16], edited by Fred Gifford, 255–297. Amsterdam: Elsevier.
  • Teira, D. 2013. “Blinding and the Non-Interference Assumption in Medical and Social Trials.” Philosophy of the Social Sciences 43 (3): 358–372.
  • Turner, R. 1998. “Intensive Blood-Glucose Control with Sulphonylureas or Insulin Compared with Conventional Treatment and Risk of Complications in Patients with Type 2 Diabetes.” Lancet 352: 837–853.
  • Van den Berghe, G., P. Wouters, F. Weekers, C. Verwaest, F. Bruyninckx, M. Schetz, D. Vlasselaers, P. Ferdinande, P. Lauwers, and R. Bouillon. 2001. “Intensive Insulin Therapy in Critically ill Patients.” New England Journal of Medicine 345: 1359–1367.
  • Ward, A., and P. Johnson. 2008. “Addressing Confounding Errors When Using non-Experimental, Observational Data to Make Causal Claims.” Synthese 163 (3): 419–432.
  • Waters, E., B. Swinburn, J. Seidell, and R. Uauy. 2010. Preventing Childhood Obesity: Evidence Policy and Practice. New Jersey: Wiley-Blackwell; BMJ books.
  • Woodward, J. 2003. Making Things Happen. Oxford: Oxford University Press.
  • Worrall, J. 2007a. “Evidence in Medicine and Evidence-Based Medicine.” Philosophy Compass 2 (6): 981–1022.
  • Worrall, J. 2007. “Why There’s no Cause to Randomize.” The British Journal for the Philosophy of Science 58 (3): 451–488.
  • Worrall, J. 2010. “Evidence: Philosophy of Science Meets Medicine.” Journal of Evaluation in Clinical Practice 16 (2): 356–362.