Analysis bias

Biases can be introduced when knowledge of the results of studies influences analysis and reporting decisions, for example, when studies stop earlier than planned, or with biased selection of the treatment outcomes measured.

33 RECORDS
9 ARTICLES

The need to address treatment uncertainties

Principles of Testing

Treatment comparisons are essential

Treatment comparisons must be fair

Biases

Double dummy

The play of chance

Bringing it all together for the benefit of patients and the public

James Lind LibraryIllustrating the development of fair tests of treatments in health care

Analysis bias

Biases can be introduced when knowledge of the results of studies influences analysis and reporting decisions, for example, when studies stop earlier than planned, or with biased selection of the treatment outcomes measured.

SORT date ▲ author

33 RECORDS

9 ARTICLES

Mainland D (1952) Intercurrent Events. In: Elementary Medical Statistics: the principles of quantitative medicine. London: WB Saunders Company, p 109. [Facimile copy printed and bound in India. Pranava Books. 2- LB100151138852 -301 -4 sa.]

Herdan G (1955) Statistics of Therapeutic Trials. Amsterdam: Elsevier.

Sutherland I (1958) Statistical aspects of clinical trials. In: Dodds C, ed. Report of a Symposium on Clinical Trials held at The Royal Society of Medicine, London, 25 April, p 53, pp 50-55.

Laurence DR, ed. (1959) Quantitative Methods in Human Pharmacology and Therapeutics. London: Pergamon Press.

Lasagna L, Meier P (1959) Experimental Design and Statistical Problems. In: Waife SO, Shapiro AP, eds. The Clinical Evaluation of New Drugs. New York: Hoeber. pp 37-60.

Knowelden J (1959) Prophylactic trials. In: Witts LJ ed. Medical Surveys and Clinical Trials. London: Oxford University Press. pp 118-133.

Knowelden J (1960) The analysis and presentation of results. In: Hill AB, ed. Controlled Clinical Trials. In: Hill AB, ed. Controlled Clinical Trials. Oxford: Blackwell Scientific Publications, 155-159.

Bywaters E (1960) Rheumatoid arthritis. Treatment and illustrative answers. In: Hill AB ed. Controlled Clinical Trials. Oxford: Blackwell Scientific Publications, pp 75-83.

Mainland D (1963) Elementary medical statistics: 2nd edn. Philadelphia: WB Saunders Co.

Pocock SJ, Hughes MD, Lee RJ (1987) Statistical problems in the reporting of clinical trials. A survey of three medical journals. New England Journal of Medicine 317:426-32.

Gøtzsche PC (1987) Reference bias in reports of drug trials. BMJ 295:654-656.

Newcombe RG (1988) Explanatory and pragmatic estimates of the treatment effect when deviations from allocated treatment occur. . Statistics in Medicine Volume 7, Issue 11 p. 1179-1186.

Gøtzsche PC (1989) Methodology and overt and hidden bias in reports of 196 double-blind trials of nonsteroidal antiinflammatory drugs in rheumatoid arthritis. Control Clinical Trials 10:31-56.

Hill AB, Hill ID (1991) Differential exclusions. In: Bradford Hill’s Principles of Medical Statistics. 12th edition. London: Edward Arnold. pp 226-228.

Counsell CE, Clarke MJ, Slattery J, Sandercock PAG (1994) The miracle of DICE therapy for acute stroke: fact or fictional product of subgroup analysis? BMJ 309:1677-1681.

Hollis S, Campbell F (1999) What is meant by intention-to-treat analysis? Survey of published randomised controlled trials. BMJ 319:670-674.

Yusuf S (2000) Challenges in the conduct and interpretation of phase II (pilot) randomized trials. . American Heart Journal 139:S136-42.

Ruiz-Canela M, Martinez-Gonzalez MA, de Irala-Estevez J (2000) Intention-to-treat analysis is related to methodological quality. BMJ 320:107-108.

Davidson I, Hillier VF (2002) Comparison of four methods of allocation for clinical trials with small sample sizes. Physiotherapy 88;12:722-729, ISSN 0031-9406.

Trotta F, Apolone G, Garattini S, Tafuri G (2008) Stopping a trial early in oncology: for patients or for industry? Annals of Oncology Feb 29; doi:10.1093/annonc/mdn042.

Kramer MS, Martin RM, Sterne JA, Shapiro S, Mourad D, Platt RW (2009) The double jeopardy of clustered measurement and cluster randomisation. BMJ 339:503-505.

Bassler D, Briel M, Montori VM, Lane M, Glasziou P, Zhou Q, Heels-Ansdell D, Walter SD, Guyatt GH; STOPIT-2 Study Group (2010) Stopping randomized trials early for benefit and estimation of treatment effects: systematic review and meta-regression analysis. JAMA. 303:1180-7.

Montedori A, Cherubini A, Bonacini MI, Casazza G, Luchetta ML, Duca P, Cozzolino F, Abraha I (2011) Modified versus standard intention-to-treat reporting: Are there differences in methodological quality, sponsorship, and findings in randomised trials? A cross-sectional study. Trials 12:58.

White IR, Carpenter J, Horton NJ (2012) Including all individuals is not enough: lessons for intention-to-treat analysis. Clinical Trials 9:396-407.

Page MJ, McKenzie JE, Kirkham J, Dwan K, Kramer S, Green S, Forbes A (2014) Bias due to selective inclusion and reporting of outcomes and analyses in systematic reviews of randomised trials of healthcare interventions. Cochrane Database of Systematic Reviews 2014;(10):MR000035.

Abraha I, Cherubini A, Cozzolino F, De Florio R, Luchetta ML, Rimland JM, Folletti I, Marchesi M, Germani A, Orso M, Eusebi P, Montedori A (2015) Deviation from intention to treat analysis in randomised trials and treatment effect estimates: meta-epidemiological study. BMJ 2015;350:h2445.

Misemer BS, Platts-Mills TF, Jones CW (2016) Citation bias favoring positive clinical trials of thrombolytics for acute ischemic stroke: a cross-sectional analysis. Trials 17:473.

Imberger G, Thorlund K, Gluud C, Wetterslev J (2016) False-positive findings in Cochrane meta-analyses with and without application of trial sequential analysis: an empirical review. BMJ Open 6(8):e011890.

Ristl R, Urach S, Rosenkranz G, Posch M (2018) Methods for the analysis of multiple endpoints in small populations: A review. Journal of Biopharmaceutical Statistics 29:1-29.

Bradley SH, DeVito NJ, Lloyd KE, Richards GC, Rombey T, Wayant C, Gill PJ (2020) Reducing bias and improving transparency in medical research: a critical overview of the problems, progress and suggested next steps. Journal of the Royal Society of Medicine 113:433-443.

Bradley VC, Kuriwaki S, Isakov M, Sejdinovic D, Meng X, Flaxman S (2021) Unrepresentative big surveys significantly overestimated US vaccine uptake. Nature 600, 695–700. https://doi.org/10.1038/s41586-021-04198-4.

Show ALL ARTICLES Brief histories Commentaries Biographies Personal reflections Doctoral theses

Schlesselman JJ (2015).Jerome Cornfield’s Bayesian approach to assessing interim results in clinical trials. JLL Bulletin: Commentaries on the history of treatment evaluation.

Zwarenstein M (2016).‘Pragmatic’ and ‘Explanatory’ attitudes to randomized trials. JLL Bulletin: Commentaries on the history of treatment evaluation.

Altman DG† (2017).Donald Mainland: anatomist, educator, thinker, medical statistician, trialist, rheumatologist. JLL Bulletin: Commentaries on the history of treatment evaluation.

Jefferson T (2019).Sponsorship bias in clinical trials – growing menace or dawning realisation? JLL Bulletin: Commentaries on the history of treatment evaluation.

Tröhler U (2020)Probabilistic thinking and the evaluation of therapies, 1700-1900. JLL Bulletin: Commentaries on the history of treatment evaluation.

Gøtzsche PC (2021).Citation bias: questionable research practice or scientific misconduct? JLL Bulletin: Commentaries on the history of treatment evaluation.

Ritskes-Hoitinga M, Pound P (2022).The role of systematic reviews in identifying the limitations of preclinical animal research, 2000 – 2022. JLL Bulletin: Commentaries on the history of treatment evaluation.

Chalmers I, Matthews R, Glasziou P, Boutron I, Armitage P† (2023).Analysis of clinical trial by Treatment Allocated or by Treatment Received? Applying ‘the intention-to-treat principle’. JLL Bulletin: Commentaries on the history of treatment evaluation.

Glasziou P, Matthews R, Boutron I, Chalmers I, Armitage P† (2023)The differences and overlaps between ‘explanatory’ and ‘pragmatic’ controlled trials: a historical perspective. JLL Bulletin: Commentaries on the history of treatment evaluation.

Topics

BROWSE

ABOUT

COPYRIGHT

FEEDBACK

James Lind Library
Illustrating the development of fair tests of treatments in health care

Mainland D (1952)
Intercurrent Events. In: Elementary Medical Statistics: the principles of quantitative medicine. London: WB Saunders Company, p 109. [Facimile copy printed and bound in India. Pranava Books. 2- LB100151138852 -301 -4 sa.]

Herdan G (1955)
Statistics of Therapeutic Trials. Amsterdam: Elsevier.

Sutherland I (1958)
Statistical aspects of clinical trials. In: Dodds C, ed. Report of a Symposium on Clinical Trials held at The Royal Society of Medicine, London, 25 April, p 53, pp 50-55.

Laurence DR, ed. (1959)
Quantitative Methods in Human Pharmacology and Therapeutics. London: Pergamon Press.

Lasagna L, Meier P (1959)
Experimental Design and Statistical Problems. In: Waife SO, Shapiro AP, eds. The Clinical Evaluation of New Drugs. New York: Hoeber. pp 37-60.

Knowelden J (1959)
Prophylactic trials. In: Witts LJ ed. Medical Surveys and Clinical Trials. London: Oxford University Press. pp 118-133.

Knowelden J (1960)
The analysis and presentation of results. In: Hill AB, ed. Controlled Clinical Trials. In: Hill AB, ed. Controlled Clinical Trials. Oxford: Blackwell Scientific Publications, 155-159.

Bywaters E (1960)
Rheumatoid arthritis. Treatment and illustrative answers. In: Hill AB ed. Controlled Clinical Trials. Oxford: Blackwell Scientific Publications, pp 75-83.

Mainland D (1963)
Elementary medical statistics: 2nd edn. Philadelphia: WB Saunders Co.

Pocock SJ, Hughes MD, Lee RJ (1987)
Statistical problems in the reporting of clinical trials. A survey of three medical journals. New England Journal of Medicine 317:426-32.

Gøtzsche PC (1987)
Reference bias in reports of drug trials. BMJ 295:654-656.

Newcombe RG (1988)
Explanatory and pragmatic estimates of the treatment effect when deviations from allocated treatment occur. . Statistics in Medicine Volume 7, Issue 11 p. 1179-1186.

Gøtzsche PC (1989)
Methodology and overt and hidden bias in reports of 196 double-blind trials of nonsteroidal antiinflammatory drugs in rheumatoid arthritis. Control Clinical Trials 10:31-56.

Hill AB, Hill ID (1991)
Differential exclusions. In: Bradford Hill’s Principles of Medical Statistics. 12th edition. London: Edward Arnold. pp 226-228.

Counsell CE, Clarke MJ, Slattery J, Sandercock PAG (1994)
The miracle of DICE therapy for acute stroke: fact or fictional product of subgroup analysis? BMJ 309:1677-1681.

Hollis S, Campbell F (1999)
What is meant by intention-to-treat analysis? Survey of published randomised controlled trials. BMJ 319:670-674.

Yusuf S (2000)
Challenges in the conduct and interpretation of phase II (pilot) randomized trials. . American Heart Journal 139:S136-42.

Ruiz-Canela M, Martinez-Gonzalez MA, de Irala-Estevez J (2000)
Intention-to-treat analysis is related to methodological quality. BMJ 320:107-108.

Davidson I, Hillier VF (2002)
Comparison of four methods of allocation for clinical trials with small sample sizes. Physiotherapy 88;12:722-729, ISSN 0031-9406.

Trotta F, Apolone G, Garattini S, Tafuri G (2008)
Stopping a trial early in oncology: for patients or for industry? Annals of Oncology Feb 29; doi:10.1093/annonc/mdn042.

Kramer MS, Martin RM, Sterne JA, Shapiro S, Mourad D, Platt RW (2009)
The double jeopardy of clustered measurement and cluster randomisation. BMJ 339:503-505.

Bassler D, Briel M, Montori VM, Lane M, Glasziou P, Zhou Q, Heels-Ansdell D, Walter SD, Guyatt GH; STOPIT-2 Study Group (2010)
Stopping randomized trials early for benefit and estimation of treatment effects: systematic review and meta-regression analysis. JAMA. 303:1180-7.

Montedori A, Cherubini A, Bonacini MI, Casazza G, Luchetta ML, Duca P, Cozzolino F, Abraha I (2011)
Modified versus standard intention-to-treat reporting: Are there differences in methodological quality, sponsorship, and findings in randomised trials? A cross-sectional study. Trials 12:58.

White IR, Carpenter J, Horton NJ (2012)
Including all individuals is not enough: lessons for intention-to-treat analysis. Clinical Trials 9:396-407.

Page MJ, McKenzie JE, Kirkham J, Dwan K, Kramer S, Green S, Forbes A (2014)
Bias due to selective inclusion and reporting of outcomes and analyses in systematic reviews of randomised trials of healthcare interventions. Cochrane Database of Systematic Reviews 2014;(10):MR000035.

Abraha I, Cherubini A, Cozzolino F, De Florio R, Luchetta ML, Rimland JM, Folletti I, Marchesi M, Germani A, Orso M, Eusebi P, Montedori A (2015)
Deviation from intention to treat analysis in randomised trials and treatment effect estimates: meta-epidemiological study. BMJ 2015;350:h2445.

Misemer BS, Platts-Mills TF, Jones CW (2016)
Citation bias favoring positive clinical trials of thrombolytics for acute ischemic stroke: a cross-sectional analysis. Trials 17:473.

Imberger G, Thorlund K, Gluud C, Wetterslev J (2016)
False-positive findings in Cochrane meta-analyses with and without application of trial sequential analysis: an empirical review. BMJ Open 6(8):e011890.

Ristl R, Urach S, Rosenkranz G, Posch M (2018)
Methods for the analysis of multiple endpoints in small populations: A review. Journal of Biopharmaceutical Statistics 29:1-29.

Bradley SH, DeVito NJ, Lloyd KE, Richards GC, Rombey T, Wayant C, Gill PJ (2020)
Reducing bias and improving transparency in medical research: a critical overview of the problems, progress and suggested next steps. Journal of the Royal Society of Medicine 113:433-443.

Bradley VC, Kuriwaki S, Isakov M, Sejdinovic D, Meng X, Flaxman S (2021)
Unrepresentative big surveys significantly overestimated US vaccine uptake. Nature 600, 695–700. https://doi.org/10.1038/s41586-021-04198-4.

Show

Schlesselman JJ (2015).
Jerome Cornfield’s Bayesian approach to assessing interim results in clinical trials. JLL Bulletin: Commentaries on the history of treatment evaluation.

Zwarenstein M (2016).
‘Pragmatic’ and ‘Explanatory’ attitudes to randomized trials. JLL Bulletin: Commentaries on the history of treatment evaluation.

Altman DG† (2017).
Donald Mainland: anatomist, educator, thinker, medical statistician, trialist, rheumatologist. JLL Bulletin: Commentaries on the history of treatment evaluation.

Jefferson T (2019).
Sponsorship bias in clinical trials – growing menace or dawning realisation? JLL Bulletin: Commentaries on the history of treatment evaluation.

Tröhler U (2020)
Probabilistic thinking and the evaluation of therapies, 1700-1900. JLL Bulletin: Commentaries on the history of treatment evaluation.

Gøtzsche PC (2021).
Citation bias: questionable research practice or scientific misconduct? JLL Bulletin: Commentaries on the history of treatment evaluation.

Ritskes-Hoitinga M, Pound P (2022).
The role of systematic reviews in identifying the limitations of preclinical animal research, 2000 – 2022. JLL Bulletin: Commentaries on the history of treatment evaluation.

Chalmers I, Matthews R, Glasziou P, Boutron I, Armitage P† (2023).
Analysis of clinical trial by Treatment Allocated or by Treatment Received? Applying ‘the intention-to-treat principle’. JLL Bulletin: Commentaries on the history of treatment evaluation.

Glasziou P, Matthews R, Boutron I, Chalmers I, Armitage P† (2023)
The differences and overlaps between ‘explanatory’ and ‘pragmatic’ controlled trials: a historical perspective. JLL Bulletin: Commentaries on the history of treatment evaluation.