References

ACRE Trial Collaborators and others 2009 Effect of “collaborative requesting” on consent rate for organ donation: Randomised controlled trial (ACRE trial). The BMJ, 339. DOI: https://doi.org/10.1136/bmj.b3911

Adamsen, L, Quist, M, Andersen, C, Møller, T, Herrstedt, J, Kronborg, D, Baadsgaard, M T, Vistisen, K, Midtgaard, J, Christiansen, B, and others 2009 Effect of a multimodal high intensity exercise intervention in cancer patients undergoing chemotherapy: randomised controlled trial. BMJ, 339: 895–899. DOI: https://doi.org/10.1136/bmj.b3410

Ahmed, I, Hudson, J, Innes, K, Hernández, R, Gillies, K, Bruce, R, Bell, V, Avenell, A, Blazeby, J, Brazzelli, M, Cotton, S, Croal, B, Forrest, M, MacLennan, G, Murchie, P, Wileman, S, and Ramsay, C 2023 Effectiveness of conservative management versus laparoscopic cholecystectomy in the prevention of recurrent symptoms and complications in adults with uncomplicated symptomatic gallstone disease (c-GALL trial): Pragmatic, multicentre randomised controlled trial. BMJ, e075383. DOI: https://doi.org/10.1136/bmj-2023-075383

Allan, L, Hays, H, Jensen, N-H, Waroux, B L P de, Bolt, M, Donald, R, and Kalso, E 2001 Randomised crossover trial of transdermal fentanyl and sustained release oral morphine for treating chronic non-cancer pain. BMJ, 322(7295): 1154. DOI: https://doi.org/10.1136/bmj.322.7295.1154

Altman, D G 1998 Confidence intervals for the number needed to treat. BMJ, 317: 1309–1312. DOI: https://doi.org/10.1136/bmj.317.7168.1309

Altman, D G 1991 Practical Statistics for Medical Research. London: Chapman & Hall.

Altman, D G and Bland, M J 2011a Statistics Notes: How to obtain the P value from a confidence interval. BMJ, 343.

Altman, D G and Bland, M J 2011b Statistics Notes: How to obtain the confidence interval from a P value. BMJ, 343.

Altman, D G and Bland, M J 2005 Statistics Notes: Standard deviations and standard errors. BMJ, 331: 903.

Altman, D G and Bland, M J 2003 Statistics Notes: Interaction revisited: the difference between two estimates. BMJ, 326(7382): 219. DOI: https://doi.org/10.1136/bmj.326.7382.219

Altman, D G and Bland, M J 1996a Statistics Notes: Measurement error. BMJ, 313: 744. DOI: https://doi.org/10.1136/bmj.313.7059.744

Altman, D G and Bland, M J 1996b Statistics Notes: Measurement error and correlation coefficients. BMJ, 313: 41–42. DOI: https://doi.org/10.1136/bmj.313.7048.41

Altman, D G and Bland, M J 1996c Statistics Notes: Measurement error proportional to the mean. BMJ, 313: 106. DOI: https://doi.org/10.1136/bmj.313.7049.106

Altman, Douglas G and Bland, M J 1994a Statistics Notes: Diagnostic tests 1: sensitivity and specificity. BMJ, 308: 1552. DOI: https://doi.org/10.1136/bmj.308.6943.1552

Altman, Douglas G and Bland, M J 1994b Statistics Notes: Diagnostic tests 2: predictive values. BMJ, 309: 102. DOI: https://doi.org/10.1136/bmj.309.6947.102

Altman, Douglas G and Bland, M J 1994c Statistics Notes: Diagnostic tests 3: receiver operating characteristic plots. BMJ, 309: 188. DOI: https://doi.org/10.1136/bmj.309.6948.188

Altman, D G, Deeks, J J, and Sackett, D L 1998 Odds ratios should be avoided when events are common. BMJ, 317(7168): 1318. DOI: https://doi.org/10.1136/bmj.317.7168.1318

Altman, D G, Machin, D, Bryant, T N, and Gardner, M J 2000 Statistics with Confidence. Second Edition. BMJ Books.

Anderson, J R, Cain, K C, and Gelber, R D 2008 Analysis of survival by tumor response and other comparisons of time-to-event by outcome variables. Journal of Clinical Oncology, 26(24): 3913–3915. DOI: https://doi.org/10.1200/jco.2008.16.1000

Anderson, J R, Cain, K C, and Gelber, R D 1983 Analysis of survival by tumor response. Journal of Clinical Oncology, 1(11): 710–719. DOI: https://doi.org/10.1200/JCO.1983.1.11.710

Appel, L J, Espeland, M, Whelton, P K, Dolecek, T, Kumanyika, S, Applegate, W B, Ettinger, W H, Kostis, J B, Wilson, A C, Lacy, C, and Miller, S T 1995 Trial of nonpharmacologic intervention in the elderly (TONE). Annals of Epidemiology, 5(2): 119–129. DOI: https://doi.org/10.1016/1047-2797(94)00056-y

Arroll, B, Khin, N, and Kerse, N 2003 Screening for depression in primary care with two verbally asked questions: cross sectional study. BMJ, 327: 1144–1146. DOI: https://doi.org/10.1136/bmj.327.7424.1144

Ballard, C, Margallo-Lana, M, Juszczak, E, Douglas, S, Swann, A, Thomas, A, O’Brien, J, Everratt, A, Sadler, S, Maddison, C, and others 2005 Quetiapine and rivastigmine and cognitive decline in Alzheimer’s disease: randomised double blind placebo controlled trial. BMJ, 330: 1–5. DOI: https://doi.org/10.1136/bmj.38369.459988.8F

Bennewith, O, Stocks, N, Gunnell, D, Peters, T J, Evans, M O, and Sharp, D J 2002 General practice based intervention to prevent repeat episodes of deliberate self harm: cluster randomised controlled trial. BMJ, 324(7348). DOI: https://doi.org/10.1136/bmj.324.7348.1254

Berlin, I, Grangé, G, Jacob, N, and Tanguy, M-L 2014 Nicotine patches in pregnant smokers: randomised, placebo controlled, multicentre trial of efficacy. BMJ, 348: 1–16. DOI: https://doi.org/10.1136/bmj.g1622

Bland, M J 2015 An Introduction to Medical Statistics. Fourth Edition. Oxford University Press.

Bland, M J 2009 The tyranny of power: is there a better way to calculate sample size? BMJ, 339: 1133–1135. DOI: https://doi.org/10.1136/bmj.b3985

Bland, M J and Altman, D G 1999 Measuring agreement in method comparison studies. Statistical Methods in Medical Research, 8(2): 135–160. DOI: https://doi.org/10.1177/096228029900800204

Bland, M J and Altman, D G 1998 Survival probabilities (the Kaplan-Meier method). BMJ, 317(7172): 1572–1580. DOI: https://doi.org/10.1136/bmj.317.7172.1572

Bland, M J and Altman, D G 1996 Statistics notes: Measurement error proportional to the mean. BMJ, 313(7049): 106–106. DOI: https://doi.org/10.1136/bmj.313.7049.106

Bland, M J and Altman, D G 1994a Statistics Notes: Regression towards the mean. BMJ, 308: 1499. DOI: https://doi.org/10.1136/bmj.308.6942.1499

Bland, M J and Altman, D G 1994b Statistics Notes: Some examples of regression towards the mean. BMJ, 309: 780. DOI: https://doi.org/10.1136/bmj.309.6957.780

Bland, M J and Altman, D G 1986 Statistical methods for assessing the agreement between two methods of clinical measurements. Lancet, 1: 307–310. DOI: https://doi.org/10.1016/S0140-6736(86)90837-8

Bland, M J and Kerry, S M 1997 Statistics Notes: Trial randomised in clusters. BMJ, 315: 600. DOI: https://doi.org/10.1136/bmj.315.7108.600

Blue, L, Lang, E, McMurray, J J, Davie, A P, McDonagh, T A, Murdoch, D R, Petrie, M C, Connolly, E, Norrie, J, Round, C E, and others 2001 Randomised controlled trial of specialist nurse intervention in heart failure. BMJ, 323(7315): 715–718. DOI: https://doi.org/10.1136/bmj.323.7315.715

Bombardier, C, Ware, J, Russell, I J, Larson, M, Chalmers, A, Read, J L, Arnold, W, Bennett, R, Caldwell, J, Hench, P K, Lages, W, Liang, M, Ludivico, C, Morgan, G J, O’Hanlan, M, Schur, P, Sheon, R, Taylor, T, McNeil, B, Pauker, S, Torrance, G, and Thompson, M 1986 Auranofin therapy and quality of life in patients with rheumatoid arthritis. Results of a multicenter trial. The American Journal of Medicine, 81(4): 565–578. DOI: https://doi.org/10.1016/0002-9343(86)90539-5

Briel, M, Schuetz, P, Mueller, B, Young, J, Schild, U, Nusbaumer, C, Périat, P, Bucher, H C, and Christ-Crain, M 2008 Procalcitonin-guided antibiotic use vs a standard approach for acute respiratory tract infections in primary care. Archives of internal medicine, 168(18): 2000–2007. DOI: https://doi.org/10.1001/archinte.168.18.2000

Brown, J, Pengas, G, Dawson, K, Brown, L A, and Clatworthy, P 2009 Self administered cognitive screening test (TYM) for detection of Alzheimer’s disease: cross sectional study. BMJ, 338: 1–8. DOI: https://doi.org/10.1136/bmj.b2030

Burgess, I F, Brown, C M, and Lee, P N 2005 Treatment of head louse infestation with 4% dimeticone lotion: Randomised controlled equivalence trial. bmj, 330(7505): 1423. DOI: https://doi.org/10.1136/bmj.38497.506481.8F

Butler, C C, Simpson, S A, Hood, K, Cohen, D, Pickles, T, Spanou, C, McCambridge, J, Moore, L, Randell, E, Alam, M F, and others 2013 Training practitioners to deliver opportunistic multiple behaviour change counselling in primary care: A cluster randomised trial. BMJ, 346. DOI: https://doi.org/10.1136/bmj.f1191

Chan, A-W, Tetzlaff, J M, Altman, D G, Laupacis, A, Gøtzsche, P C, Krleža-Jerić, K, Hróbjartsson, A, Mann, H, Dickersin, K, Berlin, J A, and others 2013a SPIRIT 2013 statement: defining standard protocol items for clinical trials. Annals of Internal Medicine, 158(3): 200–207. DOI: https://doi.org/10.7326/0003-4819-158-3-201302050-00583

Chan, A-W, Tetzlaff, J M, Gøtzsche, P C, Altman, D G, Mann, H, Berlin, J A, Dickersin, K, Hróbjartsson, A, Schulz, K F, Parulekar, W R, and others 2013b SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ, 346. DOI: https://doi.org/10.1136/bmj.e7586

Charig, C R, Webb, D R, Payne, S R, and Wickham, J E 1986 Comparison of treatment of renal calculi by open surgery, percutaneous nephrolithotomy, and extracorporeal shockwave lithotripsy. BMJ, 292: 879–882. DOI: https://doi.org/10.1136/bmj.292.6524.879

Cockayne, S, Hewitt, C, Hicks, K, Jayakody, S, Kang’ombe, A R, Stamuli, E, Turner, G, Thomas, K, Curran, M, Denby, G, Hashmi, F, McIntosh, C, McLarnon, N, Torgerson, D, and Watt, I 2011 Cryotherapy versus salicylic acid for the treatment of plantar warts (verrucae): a randomised controlled trial. BMJ, 344: 1–7. DOI: https://doi.org/10.1136/bmj.d3271

Cockburn, F, Belton, N R, Purvis, R J, Giles, M M, Brown, J K, Turner, T L, Wilkinson, E M, Forfar, J O, Barrie, W J, McKay, G S, and Pocock, S J 1980 Maternal vitamin d intake and mineral metabolism in mothers and their newborn infants. BMJ, 281(6232): 11–14. DOI: https://doi.org/10.1136/bmj.281.6232.11

Coelho, T, Marques, W, Dasgupta, N R, Chao, C-C, Parman, Y, França, M C, Guo, Y-C, Wixner, J, Ro, L-S, Calandra, C R, Kowacs, P A, Berk, J L, Obici, L, Barroso, F A, Weiler, M, Conceição, I, Jung, S W, Buchele, G, Brambatti, M, Chen, J, Hughes, S G, Schneider, E, Viney, N J, Masri, A, Gertz, M R, Ando, Y, Gillmore, J D, Khella, S, Dyck, P J B, Waddington Cruz, M, Mazzeo, A, Papagianni, A, Dimachkie, M, Zaganas, I, Gane, E, Luigetti, M, Galan Davila, L, Mezei, M, Gonzalez Moreno, J, Cintas, P, Pareyson, D, Traub, R, Khoury, J, Estol, C, Needham, M, Adams, D, Polydefkis, M, Brannagan, T, Bril, V, Attarian, S, Rugiero, M, Distad, B, Zamba Papanicolaou, E, Lin, K-P, Benson, M, and Scheinberg, M 2023 Eplontersen for hereditary transthyretin amyloidosis with polyneuropathy. JAMA, 330(15): 1448. DOI: https://doi.org/10.1001/jama.2023.18688

Collett, D 2003 Modelling Survival Data in Medical Research. Second Edition. Chapman & Hall/CRC.

Colorectal Cancer Collaborative Group 2000 Palliative chemotherapy for advanced colorectal cancer: Systematic review and meta-analysis. BMJ, 321(7260): 531–535. DOI: https://doi.org/10.1136/bmj.321.7260.531

Cushny, A R and Peebles, A R 1905 The action of optical isomers: II. hyoscines. The Journal of Physiology, 32(5–6): 501–510. DOI: https://doi.org/10.1113/jphysiol.1905.sp001097

de Fine Olivarius, N, Beck-Nielsen, H, Andreasen, A H, Hørder, M, and Pedersen, P A 2001 Randomised controlled trial of structured personal care of type 2 diabetes mellitus. BMJ, 323(7319). DOI: https://doi.org/10.1136/bmj.323.7319.970

Deeks, J J and Altman, D G 2004 Statistics Notes: Diagnostic tests 4: likelihood ratios. BMJ, 329: 168–169. DOI: https://doi.org/10.1136/bmj.329.7458.168

Dirnagl, Ulrich 1996 Believe it or not! Available at https://dirnagl.com/2018/02/09/believe-it-or-not/

Doyle, J, Alsan, M, Skelley, N, Lu, Y, and Cawley, J 2024 Effect of an intensive food-as-medicine program on health and health care use: A randomized clinical trial. JAMA Internal Medicine, 184(2): 154. DOI: https://doi.org/10.1001/jamainternmed.2023.6670

Durán-Cantolla, J, Aizpuru, F, Montserrat, J M, Ballester, E, Terán-Santos, J, Aguirregomoscorta, J I, Gonzalez, M, Lloberes, P, Masa, J F, De La Peña, M, and others 2010 Continuous positive airway pressure as treatment for systemic hypertension in people with obstructive sleep apnoea: Randomised controlled trial. BMJ, 341. DOI: https://doi.org/10.1136/bmj.c5991

Egger, M, Higgins, J P T, and Smith, G D 2022 Systematic Reviews in Health Research – Meta-Analysis in Context. Third Edition. Hoboken NJ, USA: John Wiley & Sons Ltd.

Fagerström, K, Gilljam, H, Metcalfe, M, Tonstad, S, and Messig, M 2010 Stopping smokeless tobacco with varenicline: randomised double blind placebo controlled trial. BMJ, 341. DOI: https://doi.org/10.1136/bmj.c6549

Fisher, B, Redmond, C, Brown, A, Wickerham, D L, Wolmark, N, Allegra, J, Escher, G, Lippman, M, Savlov, E, and Wittliff, J 1983 Influence of tumor estrogen and progesterone receptor levels on the response to tamoxifen and chemotherapy in primary breast cancer. Journal of Clinical Oncology, 1(4): 227–241. DOI: https://doi.org/10.1200/jco.1983.1.4.227

Fisher, R A 1925 Statistical methods for research workers. Edinburgh: Oliver; Boyd.

Francis Jr, T, Korns, R F, Voight, R B, Boisen, M, Hemphill, F M, Napier, J A, and Tolchinsky, E 1955 An evaluation of the 1954 poliomyelitis vaccine trials. American journal of public health and the nation’s health, 45(5 Pt 2): 1–63.

Frank, B, Serpell, M, Hughes, J, Matthews, J, and Kapur, D 2008 Comparison of analgesic effects and patient tolerability of nabilone and dihydrocodeine for chronic neuropathic pain: Randomised, crossover, double blind study. BMJ, 336(7637): 199–201. DOI: https://doi.org/10.1136/bmj.39429.619653.80

Freedman, S B, Parkin, P C, Willan, A R, and Schuh, S 2011 Rapid versus standard intravenous rehydration in paediatric gastroenteritis: Pragmatic blinded randomised clinical trial. BMJ, 343: 1–12. DOI: https://doi.org/10.1136/bmj.d6976

Futier, E, Jaber, S, Garot, M, Vignaud, M, Panis, Y, Slim, K, Lucet, J-C, Lebuffe, G, Ouattara, A, El Amine, Y, Couderc, P, Dupré, A, De Jong, A, Lasocki, S, Leone, M, Pottecher, J, Pereira, B, and Paugam-Burtz, C 2022 Effect of oral antimicrobial prophylaxis on surgical site infection after elective colorectal surgery: Multicentre, randomised, double blind, placebo controlled trial. BMJ, e071476. DOI: https://doi.org/10.1136/bmj-2022-071476

Gail, M and Simon, R 1985 Testing for qualitative interactions between treatment effects and patient subsets. Biometrics, 41(2): 361–372. DOI: https://doi.org/10.2307/2530862

Giesecke, J 2002 Modern Infectious Disease Epidemiology. Second Edition. London: Hodder Arnold.

Glas, A S, Lijmer, J G, Prins, M H, Bonsel, G J, and Bossuyt, P M M 2003 The diagnostic odds ratio: A single indicator of test performance. Journal of Clinical Epidemiology, 56(11): 1129–1135. DOI: https://doi.org/10.1016/S0895-4356(03)00177-X

Gordon, P M, Diffey, B L, Matthews, J N S, and Farr, P M 1999 A randomized comparison of narrow-band TL-01 phototherapy and PUVA photochemotherapy for psoriasis. Journal of the American Academy of Dermatology, 41(5): 728–732. DOI: https://doi.org/10.1016/s0190-9622(99)70008-3

Hackshaw, A 1998 Lung cancer and passive smoking. Statistical Methods in Medical Research, 7(2): 119–136. DOI: https://doi.org/10.21037/tlcr.2020.02.11

Heal, C F, Buettner, P G, Cruickshank, R, Graham, D, Browning, S, Pendergast, J, Drobetz, H, Gluer, R, and Lisec, C 2009 Does single application of topical chloramphenicol to high risk sutured wounds reduce incidence of wound infection after minor surgery? Prospective randomised placebo controlled double blind trial. BMJ, 338: 1–6. DOI: https://doi.org/10.1136/bmj.a2812

Held, L and Sabanés Bové, D 2020 Likelihood and Bayesian Inference - With Applications in Biology and Medicine. Second Edition. Springer.

Hernán, M A, Wang, W, and Leaf, D E 2022 Target trial emulation: A framework for causal inference from observational data. JAMA, 328(24): 2446. DOI: https://doi.org/10.1001/jama.2022.21383

Hijazi, R, Taylor, D, and Richardson, J 2009 Effect of topical alkane vapocoolant spray on pain with intravenous cannulation in patients in emergency departments: randomised double blind placebo controlled trial. BMJ, 338: 1–5. DOI: https://doi.org/10.1136/bmj.b215

Hill, A B 1937 Principles of medical statistics. London: The Lancet.

Hochberg, Y 1988 A sharper Bonferroni procedure for multiple tests of significance. Biometrika, 75: 800–802. DOI: https://doi.org/10.2307/2336325

Holland, A E, Mahal, A, Hill, C J, Lee, A L, Burge, A T, Cox, N S, Moore, R, Nicolson, C, O’Halloran, P, Lahham, A, and others 2017 Home-based rehabilitation for COPD using minimal resources: a randomised, controlled equivalence trial. Thorax, 72(1): 57–65. DOI: https://doi.org/10.1136/thoraxjnl-2016-208514

Hommel, G 1988 A stagewise rejective multiple test procedure based on a modified bonferroni test. Biometrika, 75: 383–386. DOI: https://doi.org/10.2307/2336190

Hond, A A H de, Steyerberg, E W, and Calster, B van 2022 Interpreting area under the receiver operating characteristic curve. The Lancet Digital Health, 4(12): e853–e855. DOI: https://doi.org/10.1016/s2589-7500(22)00188-1

Hopewell, S, Boutron, I, Chan, A-W, Collins, G S, Beyer, J A de, Hróbjartsson, A, Nejstgaard, C H, Østengaard, L, Schulz, K F, Tunn, R, and Moher, D 2022 An update to SPIRIT and CONSORT reporting guidelines to enhance transparency in randomized trials. Nature Medicine, 28(9): 1740–1743. DOI: https://doi.org/10.1038/s41591-022-01989-8

Hosmer, D W and Lemeshow, S 1989 Applied logistic regression. John Wiley.

Huguenin, P, Beer, K T, Allal, A, Rufibach, K, Friedli, C, Davis, J B, Pestalozzi, B, Schmid, S, Thöni, A, Ozsahin, M, Bernier, J, Töpfer, M, Kann, R, Meier, U R, Thum, P, Bieri, S, Notter, M, Lombriser, N, and Glanzmann, C 2004 Concomitant cisplatin significantly improves locoregional control in advanced head and neck cancers treated with hyperfractionated radiotherapy. Journal of Clinical Oncology, 22(23): 4665–4673. DOI: https://doi.org/10.1200/jco.2004.12.193

ICH Expert Working Group 1999 Statistical principles for clinical trials. Stat Med, 18: 1905–1942.

Ikeda, M, Matsunaga, T, Irabu, N, and Yoshida, S 2002 Using vital signs to diagnose impaired consciousness: cross sectional observational study. BMJ, 325: 1–5. DOI: https://doi.org/10.1136/bmj.325.7368.800

Islami, F, Pourshams, A, Nasrollahzadeh, D, Kamangar, F, Fahimi, S, Shakeri, R, Abedi-Ardekani, B, Merat, S, Vahedi, H, Semnani, S, Abnet, C C, Brennan, P, Møller, H, Saidi, F, Dawsey, S M, Malekzadeh, R, and Boffetta, P 2009 Tea drinking habits and oesophageal cancer in a high risk area in northern Iran: population based case-control study. BMJ, 338: 1–6. DOI: https://doi.org/10.1136/bmj.b929

James, J, Thomas, P, Cavan, D, and Kerr, D 2004 Preventing childhood obesity by reducing consumption of carbonated drinks: cluster randomised controlled trial. BMJ, 328(7450). DOI: https://doi.org/10.1136/bmj.38077.458438.EE

Jen, H-H, Chang, W-J, Hsu, C-Y, Yen, A M-F, Auvinen, A, Chen, T H-H, and Chen, S L-S 2020 Sojourn-time-corrected receiver operating characteristic curve (ROC) for prostate specific antigen (PSA) test in population-based prostate cancer screening. Scientific Reports, 10(1). DOI: https://doi.org/10.1038/s41598-020-77668-w

Johnson, V E 2013 Revised standards for statistical evidence. Proceedings of the National Academy of Sciences, 110(48): 19313–19317. DOI: https://doi.org/10.1073/pnas.1313476110

Jones, B and Kenward, M G 2014 Design and analysis of cross-over trials. Chapman; Hall/CRC. DOI: https://doi.org/10.1201/b17537

Kaur, G, Lakshmi, P V M, Rastogi, A, Bhansali, A, Jain, S, Teerawattananon, Y, Bano, H, and Prinja, S 2020a Diagnostic accuracy of tests for type 2 diabetes and prediabetes: A systematic review and meta-analysis. PLOS ONE, 15(11): e0242415. DOI: https://doi.org/10.1371/journal.pone.0242415

Kaur, G, Lakshmi, P V M, Rastogi, A, Bhansali, A, Jain, S, Teerawattananon, Y, Bano, H, and Prinja, S 2020b Forest plot of HbA1c 6.5. DOI: https://doi.org/10.1371/journal.pone.0242415.g002

Kerry, S M and Bland, M J 1998c Statistics Notes: Sample size in cluster randomisation. BMJ, 316(7130): 549. DOI: https://doi.org/10.1136/bmj.316.7130.549

Kerry, S M and Bland, M J 1998a Statistics Notes: Analysis of a trial randomised in clusters. BMJ, 316: 54. DOI: https://doi.org/10.1136/bmj.316.7124.54

Kerry, S M and Bland, M J 1998b Statistics Notes: The intracluster correlation coefficient in cluster randomisation. BMJ, 316: 1455. DOI: https://doi.org/10.1136/bmj.316.7142.1455

Kinmonth, A L, Woodcock, A, Griffin, S, Spiegal, N, and Campbell, M J 1998 Randomised controlled trial of patient centred care of diabetes in general practice: Impact on current wellbeing and future disease risk. BMJ, 317(7167): 1202–1208. DOI: https://doi.org/10.1136/bmj.317.7167.1202

Kirkwood, B R and Sterne, J A C 2003 Essential Medical Statistics. Second Edition. Blackwell Publishing.

Lee, K J, Moreno‐Betancur, M, Kasza, J, Marschner, I C, Barnett, A G, and Carlin, J B 2019 Biostatistics: A fundamental discipline at the core of modern health data science. Medical Journal of Australia, 211(10): 444. DOI: https://doi.org/10.5694/mja2.50372

Lipsitz, S R, Kim, K, and Zhao, L 1994 Analysis of repeated categorical data using generalized estimating equations. Statistics in Medicine, 13(11): 1149–1163. DOI: https://doi.org/10.1002/sim.4780131106

Little, P, Barnett, J, Barnsley, L, Marjoram, J, Fitzgerald-Barron, A, and Mant, D 2002 Comparison of agreement between different measures of blood pressure in primary care and daytime ambulatory blood pressure. BMJ, 325: 1–6. DOI: https://doi.org/10.1136/bmj.325.7358.254

Loeb, M, Bartholomew, A, Hashmi, M, Tarhuni, W, Hassany, M, Youngster, I, Somayaji, R, Larios, O, Kim, J, Missaghi, B, Vayalumkal, J V, Mertz, D, Chagla, Z, Cividino, M, Ali, K, Mansour, S, Castellucci, L A, Frenette, C, Parkes, L, Downing, M, Muller, M, Glavin, V, Newton, J, Hookoom, R, Leis, J A, Kinross, J, Smith, S, Borhan, S, Singh, P, Pullenayegum, E, and Conly, J 2022 Medical masks versus N95 respirators for preventing COVID-19 among health care workers: A randomized trial. Annals of Internal Medicine, 175(12): 1629–1638. DOI: https://doi.org/10.7326/m22-1966

Loprinzi, C L, Laurie, J A, Wieand, H S, Krook, J E, Novotny, P J, Kugler, J W, Bartel, J, Law, M, Bateman, M, and Klatt, N E 1994 Prospective evaluation of prognostic variables from patient-completed questionnaires. North central cancer treatment group. Journal of Clinical Oncology, 12(3): 601–607. DOI: https://doi.org/10.1200/jco.1994.12.3.601

Lovell, K, Cox, D, Haddock, G, Jones, C, Raines, D, Garvey, R, Roberts, C, and Hadley, S 2006 Telephone administered cognitive behaviour therapy for treatment of obsessive compulsive disorder: Randomised controlled non-inferiority trial. BMJ, 333(7574): 883. DOI: https://doi.org/10.1136/bmj.38940.355602.80

Marion, J D and Althouse, A D 2023 The use of historical controls in clinical trials. JAMA, 330(15): 1484. DOI: https://doi.org/10.1001/jama.2023.16182

Matthews, A A, Danaei, G, Islam, N, and Kurth, T 2022 Target trial emulation: Applying principles of randomised trials to observational studies. BMJ, e071108. DOI: https://doi.org/10.1136/bmj-2022-071108

Matthews, J N S 2006 Introduction to Randomized Controlled Clinical Trials. Second Edition. Chapman & Hall/CRC.

Matthews, J N and Altman, D G 1996 Statistics Notes: Interaction 2: compare effect sizes not P values. BMJ, 313(7060): 808. DOI: https://doi.org/10.1136/bmj.313.7060.808

Meinertz, T, Kasper, W, Schumacher, M, and Just, H 1988 The German multicenter trial of anisoylated plasminogen streptokinase activator complex versus heparin for acute myocardial infarction. Am J Card, 62(7): 347–351. DOI: https://doi.org/10.1016/0002-9149(88)90956-3

Mirpour, S, Fathollah, S, Mansouri, P, Larijani, B, Ghoranneviss, M, Mohajeri Tehrani, M, and Amini, M R 2020 Cold atmospheric plasma as an effective method to treat diabetic foot ulcers: A randomized clinical trial. Scientific Reports, 10(1). DOI: https://doi.org/10.1038/s41598-020-67232-x

Moher, D, Hopewell, S, Schulz, K, Montori, V, Gøtzsche, P, Devereaux, P, Elbourne, D, Egger, M, and Altman, D 2010 CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ, 340. DOI: https://doi.org/https://doi.org/10.1136/bmj.c869

Nab, L, Smeden, M van, Keogh, R H, and Groenwold, R H H 2021 Mecor: An r package for measurement error correction in linear regression models with a continuous outcome. Computer Methods and Programs in Biomedicine, 208: 106238. DOI: https://doi.org/10.1016/j.cmpb.2021.106238

Newcombe, R G 2013 Confidence Intervals for Proportions and Related Measures of Effect Size. Boca Ration, FL: Chapman & Hall/CRC.

Newcombe, R G 1998a Interval estimation for the difference between independent proportions: Comparison of eleven methods. Stat Med, 17(8): 873–890.

Newcombe, R G 1998b Improved confidence intervals for the difference between binomial proportions based on paired data. Stat Med, 17(22): 2635–2650.

O’Brien, P C 1984 Procedures for comparing samples with multiple endpoints. Biometrics, 40: 1079–1087. DOI: https://doi.org/10.2307/2531158

Oakeshott, P, Kerry, S M, and Williams, J E 1994 Randomized controlled trial of the effect of the royal college of radiologists’ guidelines on general practitioners’ referral for radiographic examination. British Journal of General Practice, 44: 197–200. DOI: https://doi.org/10.1046/j.1365-2125.2001.01382.x

Oxford Population Health 1996 The million women study.

Pepe, M S 2003 The Statistical Evaluation of Medical Tests for Classification and Prediction. Oxford University Press.

Pinkney, T D, Calvert, M, Bartlett, D C, Gheorghe, A, Redman, V, Dowswell, G, Hawkins, W, Mak, T, Youssef, H, Richardson, C, and others 2013 Impact of wound edge protection devices on surgical site infection after laparotomy: multicentre randomised controlled trial (ROSSINI Trial). BMJ, 347. DOI: https://doi.org/10.1136/bmj.f4305

Pocock, S J, Henderson, R A, Rickards, A F, Hampton, J R, King, S B, Hamm, C W, Puel, J, Hueb, W, Goy, J-J, and Rodriguez, A 1995 Meta-analysis of randomised trials comparing coronary angioplasty with bypass surgery. The Lancet, 346(8984): 1184–1189. DOI: https://doi.org/10.1016/s0140-6736(95)92897-9

Polack, F P, Thomas, S J, Kitchin, N, Absalon, J, Gurtman, A, Lockhart, S, Perez, J L, Pérez Marc, G, Moreira, E D, Zerbini, C, Bailey, R, Swanson, K A, Roychoudhury, S, Koury, K, Li, P, Kalina, W V, Cooper, D, Frenck, R W, Hammitt, L L, Türeci, Ö, Nell, H, Schaefer, A, Ünal, S, Tresnan, D B, Mather, S, Dormitzer, P R, Şahin, U, Jansen, K U, and Gruber, W C 2020 Safety and efficacy of the BNT162b2 mRNA covid-19 vaccine. New England Journal of Medicine, 383(27): 2603–2615. DOI: https://doi.org/10.1056/nejmoa2034577

Porto, A M F, Coutinho, I C, Correia, J B, and Amorim, M M R 2011 Effectiveness of antenatal corticosteroids in reducing respiratory disorders in late preterm infants: randomised clinical trial. BMJ, 342. DOI: https://doi.org/10.1136/bmj.d1696

Puhan, M A, Suarez, A, Lo Cascio, C, Zahn, A, Heitz, M, and Braendli, O 2005 Didgeridoo playing as alternative treatment for obstructive sleep apnoea syndrome: randomised controlled trial. BMJ, 332: 1–5. DOI: https://doi.org/10.1136/bmj.38705.470590.55

Ravaud, P, Flipo, R, Boutron, I, Roy, C, Mahmoudi, A, Giraudeau, B, and Pham, T 2009 ARTIST (osteoarthritis intervention standardized) study of standardised consultation versus usual care for patients with osteoarthritis of the knee in primary care in France: pragmatic randomised controlled trial. BMJ, 338. DOI: https://doi.org/10.1136/bmj.b421

Redelmeier, D A and Singh, S M 2001 Survival in academy award–winning actors and actresses. Annals of Internal Medicine, 134(10): 955–962. DOI: https://doi.org/10.7326/0003-4819-134-10-200105150-00009

Robertson, D S, Burnett, T, Choodari-Oskooei, B, Dimairo, M, Grayling, M, Pallmann, P, and Jaki, T 2024 Confidence intervals for adaptive trial designs I: A methodological review. DOI: https://doi.org/10.48550/arXiv.2411.08495

Robertson, D S, Choodari‐Oskooei, B, Dimairo, M, Flight, L, Pallmann, P, and Jaki, T 2023 Point estimation for adaptive trial designs I: A methodological review. Statistics in Medicine, 42(2): 122–145. DOI: https://doi.org/10.1002/sim.9605

Roldán Nofuentes, J A, Luna del Castillo, J de D, and Montero Alonso, M Á 2012 Global hypothesis test to simultaneously compare the predictive values of two binary diagnostic tests. Computational Statistics & Data Analysis, 56(5): 1161–1173. DOI: https://doi.org/10.1016/j.csda.2011.06.003

Rothwell, P M 2005 Subgroup analysis in randomised controlled trials: Importance, indications, and interpretation. The Lancet, 365(9454): 176–186. DOI: https://doi.org/10.1016/S0140-6736(05)17709-5

Sackett, D L, Deeks, J J, and Altman, D G 1996 Down with odds ratios! BMJ Evidence-Based Medicine, 1(6): 164–166. DOI: https://doi.org/10.1136/ebm.1996.1.164

Schmid, C H, Stijnen, T, and White, I R 2021 Handbook of Meta-Analysis. Boca Raton FL, USA: CRC Press.

Schulz, K, Altman, D, Moher, D, and the CONSORT group 2010 CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMJ, 340. DOI: https://doi.org/10.1186/1741-7015-8-18

Senn, S 2021 Statistical Issues in Drug Development. Third Edition. Ney York: Wiley.

Senn, S 2011 Francis Galton and regression to the mean. Significance, 8(3): 124–126. DOI: https://doi.org/10.1111/j.1740-9713.2011.00509.x

Senn, S 2002 Cross-over Trials in Clinical Research. Second Edition. Ney York: Wiley.

Simes, R J 1986 An improved Bonferroni procedure for multiple tests of significance. Biometrika, 73: 751–754. DOI: https://doi.org/10.2307/2336545

Spector, T D, Keen, R W, Arden, N K, Morrison, N A, Major, P J, Nguyen, T V, Kelly, P J, Baker, J R, Sambrook, P N, Lanchbury, J S, and Eisman, J A 1995 Influence of vitamin D receptor genotype on bone mineral density in postmenopausal women: a twin study in Britain. BMJ, 310: 1357–1360. DOI: https://doi.org/10.1136/bmj.310.6991.1357

Spiegelhalter, D J, Abrams, K R, and Myles, J P 2004 Bayesian Approaches to Clinical Trials and Health-Care Evaluation. New York: Wiley.

Stolberg, M 2006 Inventing the randomized double-blind trial: The nuremberg salt test of1835. Journal of the Royal Society of Medicine, 99(12): 642–643. DOI: https://doi.org/10.1258/jrsm.99.12.642

Streptomycin in Tuberculosis Trials Committee 1948 Stretomycin treatment of pulmonary tuberculosis. British Medical Journal, 2: 769–782.

Sylvestre, M-P, Huszti, E, and Hanley, J A 2006 Do oscar winners live longer than less successful peers? A reanalysis of the evidence. Annals of internal medicine, 145(5): 361–363. DOI: https://doi.org/10.7326/0003-4819-145-5-200609050-00009

Todd, S, Whitehead, A, Stallard, N, and Whitehead, J 2001 Interim analyses and sequential designs in phase III studies. British Journal of Clinical Pharmacology, 51(5): 394–399. DOI: https://doi.org/10.1046/j.1365-2125.2001.01382.x

Turck, N, Vutskits, L, Sanchez-Pena, P, Robin, X, Hainard, A, Gex-Fabry, M, Fouda, C, Bassem, H, Mueller, M, Lisacek, F, Puybasset, L, and Sanchez, J-C 2010 A multiparameter panel method for outcome prediction following aneurysmal subarachnoid hemorrhage. Intensive Care Med, 36: 107–115. DOI: https://doi.org/10.1007/s00134-009-1641-y

Vadillo-Ortega, F, Perichart-Perera, O, Espino, S, Avila-Vergara, M A, Ibarra, I, Ahued, R, Godines, M, Parry, S, Macones, G, and Strauss, J F 2011 Effect of supplementation during pregnancy with L-arginine and antioxidant vitamins in medical food on pre-eclampsia in high risk population: randomised controlled trial. BMJ, 342. DOI: https://doi.org/10.1136/bmj.d2901

Van den Aardweg, M, Boonacker, C, Rovers, M, Hoes, A, and Schilder, A 2011 Effectiveness of adenoidectomy in children with recurrent upper respiratory tract infections: open randomised controlled trial. BMJ, 343: 1–13. DOI: https://doi.org/10.1136/bmj.d5154

Vickers, A J and Altman, D G 2001 Statistics Notes: Analysing controlled trials with baseline and follow up measurements. BMJ, 323(7321): 1123–1124. DOI: https://doi.org/10.1136/bmj.323.7321.1123

Wen, L M, Baur, L A, Simpson, J M, Rissel, C, Wardle, K, and Flood, V M 2012 Effectiveness of home based early intervention on children’s BMI at age 2: randomised controlled trial. BMJ, 344: 1–11. DOI: https://doi.org/10.1136/bmj.e3732

Wieand, S, Gail, M H, James, B R, and James, K L 1989 A family of nonparametric statistics for comparing diagnostic markers with paired or unpaired data. Biometrika, 76(3): 585–592. DOI: https://doi.org/10.2307/2336123

Zar, H J, Cotton, M F, Strauss, S, Karpakis, J, Hussey, G, Schaaf, H S, Rabie, H, and Lombard, C J 2007 Effect of isoniazid prophylaxis on mortality and incidence of tuberculosis in children with HIV: Randomised controlled trial. BMJ, 334(7585): 136. DOI: https://doi.org/10.1136/bmj.39000.486400.55

Zimmerman, D W 2004 A note on preliminary tests of equality of variances. British Journal of Mathematical and Statistical Psychology, 57(1): 173–181. DOI: https://doi.org/10.1348/000711004849222