Patient preferences and randomised clinical trials.
Open accessAbstract
Allocating patients to different treatments by randomisation in a controlled trial is now accepted almost without question in accounts of trial design. Randomisation may reasonably be supposed to play a large part in evaluating proposed studies for grant support. The virtue of randomisation is that it reduces some types of systematic error that may interfere with the interpretation of the results of a trial. Allocating patients to treatments in a systematic non-randomised way may introduce bias which destroys comparability. We argue here that despite this advantage random allocation is not always suitable. Though patients play an active part in the outcome of all treatments, we suggest that clinical trials in which they are required to sustain an effortful and demanding role and those in which they are likely to have strong preferences for one treatment need to be considered and conducted differently.
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
Success rates of the three options may be higher than the MIST trial suggests, as women who choose a treatment option are likely to be more motivated to follow their chosen treatment to completion than are women who are randomised.
“Success rates of the three options may be higher than the MIST trial suggests, as women who choose a treatment option are likely to be more motivated to follow their chosen treatment to completion than are women who are randomised.32”
From Management of miscarriage: expectant, medical, or surgical? Results of randomised controlled trial (miscarriage treatment (MIST) trial) (2006) · cites this paper as [32]
The Motivation and Information sections say that treatment preferences can affect patients’ motivation to follow a regimen and that random allocation to a non-preferred treatment can lead to underestimated effectiveness. The paper does not address the MIST trial, its three options, or whether women who choose one are more likely to complete it; applying its general argument to those outcomes is an inference. (LLM, conf=0.85)
Experimental — accuracy not yet measured
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
Cites
No references could be resolved yet.
Research works printed but not linked: 7
- I Pocock SJ. Clinical trials: a practical approach. Chichester: Wiley, 1983.
- Bradlev C. Clinical trials: time for a paradigm shift? Diabetic Med 1988;5: 107-9.
- Beck AT, Rush AJ, Shaw BF, Emery G. Cognitive therapy of depression. New York: Wiley, 1979.
- Schwartz D, Lellouch J. Explanatory and pragmatic attitudes in clinical trials. .7 Chronic Dis 1967;20:637-48.
- Knight G, Boulton AJM, Drury J, et al. A feasibility study of the use of continuous subcutaneous insulin infusion in a diabetic clinic: patients' choice of treatment. Diabetic Med 1984;1:267-72.
- X Bradley C, (iamsu DS, Moses JL, et al. The use of diabetes-specific perceived control and health belief measures to predict treatment choice and efficacy in a feasibility study of continuous subcutaneous insulin infusion pumps. Psvchology and llealth 1987;1:133-46.
- Bradley C, Gamsu DS, Knight G, Boulton AJM, Ward JD. IPredicting risk of diabetic ketoacidosis in patients using continuous subcutaneous insulin infusion. BrAled]7 1986;293:242-3.
Cited by
Sorted by citations
Framework for design and evaluation of complex interventions to improve health
Campbell, M. (2000) · BMJ · doi:10.1136/bmj.321.7262.694 · Cited by 3,474 · see citing works
Why we need observational studies to evaluate the effectiveness of health care
Black, N. (1996) · BMJ · doi:10.1136/bmj.312.7040.1215 · Cited by 1,598 · see citing works
Hierarchy of evidence: a framework for ranking evidence evaluating healthcare interventions
Evans, D. (2003) · Journal of Clinical Nursing · doi:10.1046/j.1365-2702.2003.00662.x · Cited by 993 · see citing works
Understanding controlled trials: Why are randomised controlled trials important?
Sibbald, B., & Roland, M. (1998) · BMJ · doi:10.1136/bmj.316.7126.201 · Cited by 807 · see citing works
The double-blind, randomized, placebo-controlled trial
Kaptchuk, T. J. (2001) · Journal of Clinical Epidemiology · doi:10.1016/s0895-4356(00)00347-4 · Cited by 595 · see citing works
Diabetes distress among adolescents with type 1 diabetes: a systematic review
Hagger, V., Hendrieckx, C., Sturt, J., Skinner, T. C., & Speight, J. (2016) · Current Diabetes Reports · doi:10.1007/s11892-015-0694-2 · Cited by 338 · see citing works
Trinder, J., Brocklehurst, P., Porter, R., Read, M., Vyas, S., & Smith, L. (2006) · BMJ · doi:10.1136/bmj.38828.593125.55 · Cited by 299 · see citing works
Challenges and guidelines for clinical trial of herbal drugs
Ahmad, S., Parveen, A., Parveen, B., & Parveen, R. (2015) · Journal of Pharmacy And Bioallied Sciences · doi:10.4103/0975-7406.168035 · Cited by 259 · see citing works
McCambridge, J., & Kypri, K. (2011) · PLoS ONE · doi:10.1371/journal.pone.0023748 · Cited by 242 · see citing works
Bonell, C. P., Hargreaves, J., Cousens, S., Ross, D., Hayes, R., Petticrew, M., & Kirkwood, B. R. (2011) · Journal of Epidemiology and Community Health · doi:10.1136/jech.2008.082602 · Cited by 223 · see citing works
Pragmatic randomised controlled trials in psychiatry
Hotopf, M., Churchill, R., & Lewis, G. (1999) · British Journal of Psychiatry · doi:10.1192/bjp.175.3.217 · Cited by 165 · see citing works
McCambridge, J., Kypri, K., & Elbourne, D. (2014) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2013.09.004 · Cited by 138 · see citing works
Psychosocial sequelae of breast cancer and its treatment
Moyer, A., & Salovey, P. (1996) · Annals of Behavioral Medicine · doi:10.1007/bf02909583 · Cited by 129 · see citing works
Vercellini, P., Somigliana, E., Consonni, D., Frattaruolo, M. P., De Giorgi, O., & Fedele, L. (2012) · Human Reproduction · doi:10.1093/humrep/des313 · Cited by 129 · see citing works
Oldham, M., Kellett, S., Miles, E., & Sheeran, P. (2012) · Journal of Consulting and Clinical Psychology · doi:10.1037/a0029630 · Cited by 84 · see citing works
“This process ensures that patients with strong preferences do not refuse to enter research trials (Brewin & Bradley, 1989), which would have the potential to skew recruitment and results.”
Ralphs, J. A., de C Williams, A. C., Richardson, P. H., Pither, C. E., & Nicholas, M. K. (1994) · Pain · doi:10.1016/0304-3959(94)90166-x · Cited by 70 · see citing works
The costs of treating miscarriage: a comparison of medical and surgical management
Hughes, J., Ryan, M., Hinshaw, K., Henshaw, R., Rispin, R., & Templeton, A. (1996) · BJOG: An International Journal of Obstetrics & Gynaecology · doi:10.1111/j.1471-0528.1996.tb09632.x · Cited by 58 · see citing works
Series: Pragmatic trials and real world evidence: Paper 5. Usual care and real life comparators
Zuidgeest, M. G. P., Welsing, P. M. J., van Thiel, G. J. M. W., Ciaglia, A., Alfonso-Cristancho, R., Eckert, L., Eijkemans, M. J. C., & Egger, M. (2017) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2017.07.001 · Cited by 59 · see citing works
Randomized study designs for lifestyle interventions: a tutorial
Younge, J. O., Kouwenhoven-Pasmooij, T. A., Freak-Poli, R., Roos-Hesselink, J. W., & Hunink, M. M. (2015) · International Journal of Epidemiology · doi:10.1093/ije/dyv183 · Cited by 57 · see citing works
Scane, K., Alter, D., Oh, P., & Brooks, D. (2012) · Applied Physiology, Nutrition, and Metabolism · doi:10.1139/h11-151 · Cited by 43 · see citing works
Carlisle, S., Ayling, K., Jia, R., Buchanan, H., & Vedhara, K. (2022) · Health Psychology Review · doi:10.1080/17437199.2021.1962386 · Cited by 32 · see citing works
Treatment preference and recruitment to pediatric RCTs: A systematic review
Beasant, L., Brigden, A., Parslow, R. M., Apperley, H., Keep, T., Northam, A., Wray, C., King, H., Langdon, R., Mills, N., et al. (2019) · Contemporary Clinical Trials Communications · doi:10.1016/j.conctc.2019.100335 · Cited by 25 · see citing works
Vercellini, P., Somigliana, E., Cortinovis, I., Bracco, B., de Braud, L., Dridi, D., & Milani, S. (2015) · BMC Women's Health · doi:10.1186/s12905-015-0248-4 · Cited by 22 · see citing works
Jones, S. H., Knowles, D., Tyler, E., Holland, F., Peters, S., Lobban, F., Langshaw, B., Hilton, C., Long, R., Gantt, K., et al. (2018) · Depression and Anxiety · doi:10.1002/da.22781 · Cited by 19 · see citing works
Optimising the psychological benefits of osteopathy
Williams, N. H. (2007) · International Journal of Osteopathic Medicine · doi:10.1016/j.ijosm.2007.05.002 · Cited by 15 · see citing works
- Authors
- Brewin, C. R., & Bradley, C.
- Affiliations
- Medical Research Council (GB)
- Venue
- BMJ
- Publisher
- BMJ
- Published
- 1989-07-29
- Volume
- 299
- Issue
- 6694
- Pages
- 313-315
- ISSN
- 0007-1447 (ISSN-L)
- 0959-8138
- 1468-5833
- PMC
- PMC1837157
- OpenAlex
- W2011294879
- Cited by
- 503
- References
- 0
- Citations by year
- 2026: 4 · 2025: 7 · 2024: 9 · 2023: 10 · 2022: 8 · 2021: 11 · 2020: 14 · 2019: 15 · 2018: 10 · 2017: 21 · 2016: 15 · 2015: 23 · 2014: 23 · 2013: 21 · 2012: 24
- FWCI
- 8.37
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- www.bmj.com/company/legal-information/terms-conditions/legal-information/tdm-licencepolicy (tdm)
- Locations
- BMJ (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- DigitalGeorgetown (Georgetown University Library) (submittedVersion)
- Topics
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Physical Sciences › Mathematics › Statistics and Probability › Advanced Causal Inference Techniques
- Keywords
- patient preferences, randomization, clinical trial design, trial bias, treatment allocation, trial comparability
- MeSH terms
- Attitude to Health, Clinical Trials as Topic, Decision Making, Humans, Patient Compliance, Patient Participation, Random Allocation, Disclosure, Behavioral Research, Research Subjects, Therapeutic Human Experimentation
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
