ניסוי מבוקר הקצאה אקראית
הערות שוליים

↑  K. F Schulz, D. G Altman, D. Moher, for the CONSORT Group, CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials, BMJ 340, 2010-03-23, עמ' c332–c332 doi: 10.1136/bmj.c332
↑  "A method for assessing the quality of a randomized control trial". Controlled Clinical Trials. 2 (1): 31–49. 1981. doi:10.1016/0197-2456(81)90056-8. PMID 7261638.
↑  "Randomised controlled trial". National Institute for Health and Care Excellence, London, UK. 2019. נבדק ב-3 ביוני 2019. {{cite web}}:  (עזרה)
1 2  D. Moher, S. Hopewell, K. F Schulz, V. Montori, CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials, BMJ 340, 2010-03-23, עמ' c869–c869 doi: 10.1136/bmj.c869
↑  An-Wen Chan, Jennifer M. Tetzlaff, Douglas G. Altman, Andreas Laupacis, SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials, Annals of internal medicine 158, 2013-02-05, עמ' 200–207 doi: 10.7326/0003-4819-158-3-201302050-00583
1 2 3 4  D. Moher, S. Hopewell, K. F Schulz, V. Montori, CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials, BMJ 340, 2010-03-23, עמ' c869–c869 doi: 10.1136/bmj.c869
↑  "Design and analysis of randomized clinical trials requiring prolonged observation of each patient. I. Introduction and design". Br J Cancer. 34 (6): 585–612. 1976. doi:10.1038/bjc.1976.220. PMC 2025229. PMID 795448.
↑  "Design and analysis of randomized clinical trials requiring prolonged observation of each patient. II. Analysis and examples". Br J Cancer. 35 (1): 1–39. 1977. doi:10.1038/bjc.1977.1. PMC 2025310. PMID 831755.
↑  "Intracoronary autologous bone-marrow cell transfer after myocardial infarction: the BOOST randomised controlled clinical trial". Lancet. 364 (9429): 141–8. 2004-07-10. doi:10.1016/S0140-6736(04)16626-9. PMID 15246726.{{cite journal}}:  תחזוקה - ציטוט: date and year (link)
↑  Dunn PM (בינואר 1997). "James Lind (1716-94) of Edinburgh and the treatment of scurvy". Arch. Dis. Child. Fetal Neonatal Ed. 76 (1): F64–5. doi:10.1136/fn.76.1.f64. PMC 1720613. PMID 9059193. {{cite journal}}:  (עזרה)
↑  Charles Sanders Peirce and Joseph Jastrow (1885). "On Small Differences in Sensation". Memoirs of the National Academy of Sciences. 3: 73–83. http://psychclassics.yorku.ca/Peirce/small-diffs.htm
↑  Hacking, Ian (בספטמבר 1988). "Telepathy: Origins of Randomization in Experimental Design". Isis. A Special Issue on Artifact and Experiment. 79 (3): 427–451. doi:10.1086/354775. JSTOR 234674. MR 1013489. {{cite journal}}:  (עזרה)
↑  Stephen M. Stigler (בנובמבר 1992). "A Historical View of Statistical Concepts in Psychology and Educational Research". American Journal of Education. 101 (1): 60–70. doi:10.1086/444032. {{cite journal}}:  (עזרה)
↑  Trudy Dehue (בדצמבר 1997). "Deception, Efficiency, and Random Groups: Psychology and the Gradual Origination of the Random Group Design". Isis. 88 (4): 653–673. doi:10.1086/383850. PMID 9519574. {{cite journal}}:  (עזרה)
↑  Neyman, Jerzy. 1923 [1990]. "On the Application of Probability Theory to AgriculturalExperiments. Essay on Principles. Section 9." Statistical Science 5 (4): 465–472. Trans. Dorota M. Dabrowska and Terence P. Speed.
↑  Denis Conniffe, R.A. Fisher and the development of statistics - a view in his centerary year, Journal of The Statistical and Social Inquiry Society of Ireland, 1991
↑  Br Med J, Streptomycin Treatment of Pulmonary Tuberculosis: A Medical Research Council Investigation, BMJ 2, 1948-10-30, עמ' 769–782 doi: 10.1136/bmj.2.4582.769
↑  Brown D (1998-11-02). "Landmark study made research resistant to bias". וושינגטון פוסט.
↑  "Comparison of effects in randomized controlled trials with observational studies in digestive surgery". Ann Surg. 244 (5): 668–76. 2006. doi:10.1097/01.sla.0000225356.04304.bc. PMC 1856609. PMID 17060757.
1 2  "Randomized controlled trials". Am J Roentgenol. 183 (6): 1539–44. 2004. doi:10.2214/ajr.183.6.01831539. PMID 15547188.
↑  Meldrum ML (2000). "A brief history of the randomized controlled trial. From oranges and lemons to the gold standard". Hematol Oncol Clin North Am. 14 (4): 745–60, vii. doi:10.1016/S0889-8588(05)70309-9. PMID 10949771.
↑  K. F Schulz, D. G Altman, D. Moher, for the CONSORT Group, CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials, BMJ 340, 2010-03-23, עמ' c332–c332 doi: 10.1136/bmj.c332
↑  Freedman B (1987). "Equipoise and the ethics of clinical research". N Engl J Med. 317 (3): 141–5. doi:10.1056/NEJM198707163170304. PMID 3600702.
↑  Gifford F (1995). "Community-equipoise and the ethics of randomized clinical trials". Bioethics. 9 (2): 127–48. doi:10.1111/j.1467-8519.1995.tb00306.x. PMID 11653056.
↑  "The ethics of randomised controlled trials from the perspectives of patients, the public, and healthcare professionals". Br Med J. 317 (7167): 1209–12. 1998. doi:10.1136/bmj.317.7167.1209. PMC 1114158. PMID 9794861.
↑  Zelen M (1979). "A new design for randomized clinical trials". N Engl J Med. 300 (22): 1242–5. doi:10.1056/NEJM197905313002203. PMID 431682.
↑  "What is Zelen's design?". Br Med J. 316 (7131): 606. 1998. doi:10.1136/bmj.316.7131.606. PMC 1112637. PMID 9518917.
↑  "The therapeutic misconception: informed consent in psychiatric research". Int J Law Psychiatry. 5 (3–4): 319–29. 1982. doi:10.1016/0160-2527(82)90026-7. PMID 6135666.
1 2  "Clinical trials and medical care: defining the therapeutic misconception". PLoS Med. 4 (11): e324. 2007. doi:10.1371/journal.pmed.0040324. PMC 2082641. PMID 18044980.
↑  Jain SL (2010). "The mortality effect: counting the dead in the cancer trial". Public Culture. 21 (1): 89–117. doi:10.1215/08992363-2009-017.
↑  "Clinical trial registration: a statement from the International Committee of Medical Journal Editors". The New England Journal of Medicine. 351 (12): 1250–1. בספטמבר 2004. doi:10.1056/NEJMe048225. PMID 15356289. {{cite journal}}:  (עזרה)
↑  "Despite law, fewer than one in eight completed studies of drugs and biologics are reported on time on ClinicalTrials.gov". Health Aff (Millwood). 30 (12): 2338–45. 2011. doi:10.1377/hlthaff.2011.0172. PMID 22147862.
↑  "Comparison of registered and published primary outcomes in randomized controlled trials". JAMA. 302 (9): 977–84. 2009. doi:10.1001/jama.2009.1242. PMID 19724045.
↑  Bhaumik, S (מרץ 2013). "Editorial policies of MEDLINE indexed Indian journals on clinical trial registration". Indian Pediatr. 50 (3): 339–40. doi:10.1007/s13312-013-0092-2. PMID 23680610. {{cite journal}}:  (עזרה)
1 2  "The quality of reports of randomised trials in 2000 and 2006: comparative study of articles indexed in PubMed". BMJ. 340: c723. 2010. doi:10.1136/bmj.c723. PMC 2844941. PMID 20332510.
↑  Jones, Byron; Kenward, Michael G. (2003). Design and Analysis of Cross-Over Trials (Second ed.). London: Chapman and Hall.
↑  Vonesh, Edward F.; Chinchilli, Vernon G. (1997). "Crossover Experiments". Linear and Nonlinear Models for the Analysis of Repeated Measurements. London: Chapman and Hall. pp. 111–202.
1 2 3 4  Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, Oxman AD, Moher D; CONSORT group; Pragmatic Trials in Healthcare (Practihc) group (2008). "Improving the reporting of pragmatic trials: an extension of the CONSORT statement". BMJ. 337: a2390. doi:10.1136/bmj.a2390. PMC 3266844. PMID 19001484.{{cite journal}}:  תחזוקה - ציטוט: multiple names: authors list (link)
1 2 3 4  Piaggio G, Elbourne DR, Altman DG, Pocock SJ, Evans SJ; CONSORT Group (2006). "Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement" (PDF). JAMA. 295 (10): 1152–60. doi:10.1001/jama.295.10.1152. PMID 16522836.{{cite journal}}:  תחזוקה - ציטוט: multiple names: authors list (link)
1 2 3  "Generation of allocation sequences in randomised trials: chance, not choice" (PDF). Lancet. 359 (9305): 515–9. 2002. doi:10.1016/S0140-6736(02)07683-3. PMID 11853818.
1 2 3 4 5 6 7  "Allocation concealment in randomised trials: defending against deciphering" (PDF). Lancet. 359 (9306): 614–8. 2002. doi:10.1016/S0140-6736(02)07750-4. PMID 11867132.
↑  "In search of justification for the unpredictability paradox". Trials. 15: 480. 2014. doi:10.1186/1745-6215-15-480. PMC 4295227. PMID 25490908.
↑  John M. Lachin, Statistical properties of randomization in clinical trials, Controlled Clinical Trials 9, 1988-12-01, עמ' 289–311 doi: 10.1016/0197-2456(88)90045-1
↑  Rosenberger, James. "STAT 503 - Design of Experiments". Pennsylvania State University. אורכב מ-המקור ב-2013-06-12. נבדק ב-24 בספטמבר 2012. {{cite web}}:  (עזרה)
↑  Avins, A L (1998). ""Can unequal be more fair? Ethics, subject allocation, and randomized clinical trials"". J Med Ethics. 24 (6): 401–408. doi:10.1136/jme.24.6.401. PMC 479141. PMID 9873981.
↑  Buyse ME (1989-12-01). "Analysis of clinical trial outcomes: some comments on subgroup analyses". Controlled Clinical Trials. 10 (4 Suppl): 187S–194S. doi:10.1016/0197-2456(89)90057-3. PMID 2605967.{{cite journal}}:  תחזוקה - ציטוט: date and year (link)
1 2  John M. Lachin, John P. Matts, L. J. Wei, Randomization in clinical trials: Conclusions and recommendations, Controlled Clinical Trials 9, 1988-12-01, עמ' 365–374 doi: 10.1016/0197-2456(88)90049-9
↑  Lachin JM (1988-12-01). "Statistical properties of randomization in clinical trials". Controlled Clinical Trials. 9 (4): 289–311. doi:10.1016/0197-2456(88)90045-1. PMID 3060315.{{cite journal}}:  תחזוקה - ציטוט: date and year (link)
1 2 3 4  John M. Lachin, John P. Matts, L. J. Wei, Randomization in clinical trials: Conclusions and recommendations, Controlled Clinical Trials 9, 1988-12-01, עמ' 365–374 doi: 10.1016/0197-2456(88)90049-9
↑  "The use of response-adaptive designs in clinical trials". Controlled Clinical Trials. 14 (6): 471–84. 1993. doi:10.1016/0197-2456(93)90028-C. PMID 8119063.
↑  "Allocation concealment and blinding: when ignorance is bliss". Med J Aust. 182 (2): 87–9. 2005. PMID 15651970.
↑  "Comparison of descriptions of allocation concealment in trial protocols and the published reports: cohort study". BMJ. 330 (7499): 1049. 2005. doi:10.1136/bmj.38414.422650.8F. PMC 557221. PMID 15817527.
1 2 3  "Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: meta-epidemiological study". BMJ. 336 (7644): 601–5. 2008. doi:10.1136/bmj.39465.451748.AD. PMC 2267990. PMID 18316340.
↑  Glennerster, Rachel; Kudzai Takavarasha (2013). Running randomized evaluations: a practical guide. Princeton: Princeton University Press. ISBN 9780691159249.
↑  "Physician interpretations and textbook definitions of blinding terminology in randomized controlled trials". J Am Med Assoc. 285 (15): 2000–3. 2001. doi:10.1001/jama.285.15.2000. PMID 11308438.
↑  "Who is blinded in randomized clinical trials? A study of 200 trials and a survey of authors". Clin Trials. 3 (4): 360–5. 2006. doi:10.1177/1740774506069153. PMID 17060210.
↑  "The SANAD study of effectiveness of valproate, lamotrigine, or topiramate for generalised and unclassifiable epilepsy: an unblinded randomised controlled trial". Lancet. 369 (9566): 1016–26. 2007. doi:10.1016/S0140-6736(07)60461-9. PMC 2039891. PMID 17382828.
↑  "Oral versus intravenous antibiotics for community acquired lower respiratory tract infection in a general hospital: open, randomised controlled trial". BMJ (חברה). 310 (6991): 1360–2. 1995. doi:10.1136/bmj.310.6991.1360. PMC 2549744. PMID 7787537.
↑  Fukase K, Kato M, Kikuchi S, Inoue K, Uemura N, Okamoto S, Terao S, Amagai K, Hayashi S, Asaka M; Japan Gast Study Group (2008). "Effect of eradication of Helicobacter pylori on incidence of metachronous gastric carcinoma after endoscopic resection of early gastric cancer: an open-label, randomised controlled trial". Lancet. 372 (9636): 392–7. doi:10.1016/S0140-6736(08)61159-9. PMID 18675689.{{cite journal}}:  תחזוקה - ציטוט: multiple names: authors list (link)
↑  "The impact of blinding on the results of a randomized, placebo-controlled multiple sclerosis clinical trial". Neurology. 44 (1): 16–20. 1994. doi:10.1212/wnl.44.1.16. PMID 8290055. אורכב מ-המקור ב-2005-05-10. נבדק ב-2019-06-12.
↑  "What is meant by intention to treat analysis? Survey of published randomised controlled trials". Br Med J. 319 (7211): 670–4. 1999. doi:10.1136/bmj.319.7211.670. PMC 28218. PMID 10480822.
1 2 3  D. Moher, S. Hopewell, K. F Schulz, V. Montori, CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials, BMJ 340, 2010-03-23, עמ' c869–c869 doi: 10.1136/bmj.c869
↑  CONSORT Group. "Welcome to the CONSORT statement Website". נבדק ב-2010-03-29.
↑  Schulz KF, Altman DG, ((Moher D; for the CONSORT Group)) (2010-03-23). "CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials". BMJ (חברה). 340: c332. doi:10.1136/bmj.c332. PMC 2844940. PMID 20332509.{{cite journal}}:  תחזוקה - ציטוט: date and year (link) תחזוקה - ציטוט: multiple names: authors list (link)
↑  "Consort 2010 statement: extension to cluster randomised trials". BMJ (חברה). 345 (e5661): e5661. 2012. doi:10.1136/bmj.e5661. PMID 22951546.
↑  "Extending the CONSORT Statement to randomized trials of nonpharmacologic treatment: explanation and elaboration". Annals of Internal Medicine. 148 (4): 295–309. 2008. doi:10.7326/0003-4819-148-4-200802190-00008. PMID 18283207.
↑  "Methods and Processes of the CONSORT Group: Example of an Extension for Trials Assessing Nonpharmacologic Treatments". Annals of Internal Medicine. 148 (4): W60–6. 2008. doi:10.7326/0003-4819-148-4-200802190-00008-w1. PMID 18283201.
1 2  "A comparison of observational studies and randomized, controlled trials". N Engl J Med. 342 (25): 1878–86. 2000. doi:10.1056/NEJM200006223422506. PMID 10861324.
1 2  "Randomized, controlled trials, observational studies, and the hierarchy of research designs". N Engl J Med. 342 (25): 1887–92. 2000. doi:10.1056/NEJM200006223422507. PMC 1557642. PMID 10861325. אורכב מ-המקור ב-2020-05-21. נבדק ב-2019-06-12.
↑  "Comparison of evidence of treatment effects in randomized and nonrandomized studies". J Am Med Assoc. 286 (7): 821–30. 2001. doi:10.1001/jama.286.7.821. PMID 11497536.
↑  Vandenbroucke JP (2008-03-11). "Observational research, randomised trials, and two views of medical science". PLoS Med. 5 (3): e67. doi:10.1371/journal.pmed.0050067. PMC 2265762. PMID 18336067.{{cite journal}}:  תחזוקה - ציטוט: date and year (link)
↑  Black N (1996). "Why we need observational studies to evaluate the effectiveness of health care". BMJ. 312 (7040): 1215–8. doi:10.1136/bmj.312.7040.1215. PMC 2350940. PMID 8634569.
1 2  "When are randomised trials unnecessary? Picking signal from noise". Br Med J. 334 (7589): 349–51. 2007. doi:10.1136/bmj.39070.527986.68. PMC 1800999. PMID 17303884.
↑  Einhorn LH (2002). "Curing metastatic testicular cancer". Proc Natl Acad Sci U S A. 99 (7): 4592–5. doi:10.1073/pnas.072067999. PMC 123692. PMID 11904381.
↑  Wittes J (2002). "Sample size calculations for randomized controlled trials". Epidemiol Rev. 24 (1): 39–53. doi:10.1093/epirev/24.1.39. PMID 12119854.
↑  "The importance of beta, the type II error and sample size in the design and interpretation of the randomized control trial. Survey of 71 "negative" trials". N Engl J Med. 299 (13): 690–4. 1978. doi:10.1056/NEJM197809282991304. PMID 355881.
↑  "Reporting of sample size calculation in randomised controlled trials: review". Br Med J. 338: b1732. 2009-05-12. doi:10.1136/bmj.b1732. PMC 2680945. PMID 19435763.
↑  Richard Harris (22 דצמ' 2018). "Researchers Show Parachutes Don't Work, But There's A Catch". {{cite news}}:  (עזרה)
↑  National Health and Medical Research Council (1998-11-16). A guide to the development, implementation and evaluation of clinical practice guidelines (PDF). Canberra: Commonwealth of Australia. p. 56. ISBN 978-1-86496-048-8. אורכב מ-המקור (PDF) ב-2009-10-14. נבדק ב-2010-03-28.
1 2  Harris RP, Helfand M, Woolf SH, Lohr KN, Mulrow CD, Teutsch SM, Atkins D; Methods Work Group, Third US Preventive Services Task Force (2001). "Current methods of the US Preventive Services Task Force: a review of the process" (PDF). Am J Prev Med. 20 (3 Suppl): 21–35. doi:10.1016/S0749-3797(01)00261-6. PMID 11306229.{{cite journal}}:  תחזוקה - ציטוט: multiple names: authors list (link)
↑  Guyatt GH, Oxman AD, Kunz R, Vist GE, Falck-Ytter Y, Schünemann HJ; GRADE Working Group (2008). "What is "quality of evidence" and why is it important to clinicians?". BMJ. 336 (7651): 995–8. doi:10.1136/bmj.39490.551019.BE. PMC 2364804. PMID 18456631.{{cite journal}}:  תחזוקה - ציטוט: multiple names: authors list (link)
↑  Oxford Centre for Evidence-based Medicine (2011-09-16). "Levels of evidence". אורכב מ-המקור ב-2020-06-12. נבדק ב-2012-02-15.
1 2 3  "Impact of the Food and Drug Administration approval of flecainide and encainide on coronary artery disease mortality: putting "Deadly Medicine" to the test". Am J Cardiol. 79 (1): 43–7. 1997-01-01. doi:10.1016/S0002-9149(96)00673-X. PMID 9024734.{{cite journal}}:  תחזוקה - ציטוט: date and year (link)
1 2  Rubin R (2006-10-16). "In medicine, evidence can be confusing - deluged with studies, doctors try to sort out what works, what doesn't". USA Today. נבדק ב-2010-03-22.
↑  Cardiac Arrhythmia Suppression Trial (CAST) Investigators (1989-08-10). "Preliminary report: effect of encainide and flecainide on mortality in a randomized trial of arrhythmia suppression after myocardial infarction. The Cardiac Arrhythmia Suppression Trial (CAST) Investigators". N Engl J Med. 321 (6): 406–12. doi:10.1056/NEJM198908103210629. PMID 2473403.{{cite journal}}:  תחזוקה - ציטוט: date and year (link)
↑  Rossouw JE, Anderson GL, Prentice RL, LaCroix AZ, Kooperberg C, Stefanick ML, Jackson RD, Beresford SA, Howard BV, Johnson KC, Kotchen JM, Ockene J; Writing Group for the Women's Health Initiative Investigators (2002-07-17). "Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women's Health Initiative randomized controlled trial". J Am Med Assoc. 288 (3): 321–33. doi:10.1001/jama.288.3.321. PMID 12117397.{{cite journal}}:  תחזוקה - ציטוט: date and year (link) תחזוקה - ציטוט: multiple names: authors list (link)
↑  "Effects of conjugated equine estrogen in postmenopausal women with hysterectomy: the Women's Health Initiative randomized controlled trial". JAMA. 291 (14): 1701–12. 2004-04-14. doi:10.1001/jama.291.14.1701. PMID 15082697.{{cite journal}}:  תחזוקה - ציטוט: date and year (link)
↑  "Understanding the divergent data on postmenopausal hormone therapy". N Engl J Med. 348 (7): 645–50. 2003. doi:10.1056/NEJMsb022365. PMID 12584376.
↑  Vandenbroucke JP (2009). "The HRT controversy: observational studies and RCTs fall in line". Lancet. 373 (9671): 1233–5. doi:10.1016/S0140-6736(09)60708-X. PMID 19362661.
↑  "Changes in postmenopausal hormone replacement therapy use among women with high cardiovascular risk". Am J Public Health. 99 (12): 2184–7. 2009-10-15. doi:10.2105/AJPH.2009.159889. PMC 2775780. PMID 19833984.{{cite journal}}:  תחזוקה - ציטוט: date and year (link)