Pragmatic randomised controlled trials in psychiatry
Abstract
BACKGROUND: Randomised controlled trials (RCTs) are the most important method of evaluating new treatments and treatment policies. Despite this, there are relatively few large pragmatic RCTs in psychiatry. AIMS: To explore the main advantages of large pragmatic RCTs and the obstacles to performing them in psychiatry. METHOD: A narrative review of literature on pragmatic RCTs with examples drawn from psychiatry and other medical specialities. RESULTS: Obstacles to performing pragmatic RCTs in psychiatry include the complexity of psychiatric interventions, the complexity of outcomes used in psychiatry and the difficulties of blinding subjects and investigators to some psychiatric interventions. CONCLUSIONS: Researchers need to frame questions in a form that is relevant to clinicians and to convince clinicians to cooperate in simple large pragmatic trials.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
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?
Conducting clinical trials in real-world health system practice can be challenging, especially in psychiatry.
“Conducting clinical trials in real-world health system practice can be challenging, especially in psychiatry (18).”
From Total Sleep Deprivation Followed by Bright Light Therapy as Rapid Relief for Depression: A Pragmatic Randomized Controlled Trial (2021) · cites this paper as [18]
Cites
Hamilton, M. (1960) · Journal of Neurology, Neurosurgery & Psychiatry · doi:10.1136/jnnp.23.1.56 · Cited by 32,817 · see citing works
Improving the Quality of Reporting of Randomized Controlled Trials: The CONSORT Statement
Begg, C. (1996) · JAMA · doi:10.1001/jama.1996.03540080059030 · Cited by 3,127 · see citing works
The number needed to treat: a clinically useful measure of treatment effect
Cook, R. J., & Sackett, D. L. (1995) · BMJ · doi:10.1136/bmj.310.6977.452 · Cited by 1,885 · 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
Explanatory and Pragmatic Attitudes in Therapeutical Trials
Schwartz, D., & Lellouch, J. (2009) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2009.01.012 · Cited by 1,253 · see citing works
Explanatory and pragmatic attitudes in therapeutical trials
Schwartz, D., & Lellouch, J. (1967) · Journal of Chronic Diseases · doi:10.1016/0021-9681(67)90041-0 · Cited by 1,185 · see citing works
Confidence intervals for the number needed to treat.
Altman, D. G. (1998) · BMJ · doi:10.1136/bmj.317.7168.1309 · Cited by 938 · see citing works
Rogers, S. L., & Friedhoff, L. T. (1996) · Dementia and Geriatric Cognitive Disorders · doi:10.1159/000106895 · Cited by 743 · see citing works
Costing psychiatric interventions.
Beecham, J. K., & Knapp, M. R. J. (1992) · Kent Academic Repository (University of Kent) · Cited by 710 · see citing works
Slade, M., & Thornicroft, G. (2025) · doi:10.1093/med/9780198898818.003.0007 · Cited by 679 · see citing works
Statistical Problems in the Reporting of Clinical Trials
Pocock, S., Hughes, M. D., & Lee, R. J. (1987) · New England Journal of Medicine · doi:10.1056/nejm198708133170706 · Cited by 660 · see citing works
The Coronary Drug Project Research Group (1980) · New England Journal of Medicine · doi:10.1056/nejm198010303031804 · Cited by 659 · see citing works
Patient preferences and randomised clinical trials.
Brewin, C. R., & Bradley, C. (1989) · BMJ · doi:10.1136/bmj.299.6694.313 · Cited by 503 · see citing works
Prevention of suicide: aspirations and evidence
Gunnell, D., & Frankel, S. (1994) · BMJ · doi:10.1136/bmj.308.6938.1227 · Cited by 468 · see citing works
Psychiatric Consultation in Somatization Disorder
Smith, G. R., Monson, R. A., & Ray, D. C. (1986) · New England Journal of Medicine · doi:10.1056/nejm198605293142203 · Cited by 459 · see citing works
Gøtzsche, P. C. (1989) · Controlled Clinical Trials · doi:10.1016/0197-2456(89)90017-2 · Cited by 339 · see citing works
The intracluster correlation coefficient in cluster randomisation
Kerry, S., & Bland, J. M. (1998) · BMJ · doi:10.1136/bmj.316.7142.1455 · Cited by 296 · see citing works
Simon, G. E. (1996) · JAMA · doi:10.1001/jama.275.24.1897 · Cited by 294 · see citing works
Statistical Issues in Drug Development
Ziegel, E. R., & Senn, S. J. (1999) · Technometrics · doi:10.2307/1271380 · Cited by 224 · see citing works
Takahashi, A. (1998) · International Clinical Psychopharmacology · doi:10.1097/00004850-199801000-00048 · Cited by 185 · see citing works
Initial Antidepressant Choice in Primary Care
Simon, G. E. (1996) · JAMA · doi:10.1001/jama.1996.03530480039038 · Cited by 173 · see citing works
Appleby, L., Dennehy, J. A., Thomas, C. S., Faragher, E. B., & Lewis, G. (1999) · The Lancet · doi:10.1016/s0140-6736(98)10014-4 · Cited by 172 · see citing works
Self-citationHotopf, M. H., Hardy, R., & Lewis, G. (1997) · The British Journal of Psychiatry · doi:10.1192/bjp.170.2.120 · Cited by 142 · see citing works
Self-citationUse of antidepressants among people committing suicide in Sweden
Isaccsson, G., Holmgren, P., Wasserman, D., & Bergman, U. (1994) · BMJ · doi:10.1136/bmj.308.6927.506 · Cited by 135 · see citing works
Hotopf, M., Lewis, G., & Normand, C. (1997) · Journal of Epidemiology and Community Health · doi:10.1136/jech.51.4.354 · Cited by 130 · see citing works
Self-citationEveritt, B. J. (1998) · The British Journal of Psychiatry · doi:10.1192/bjp.172.1.7 · Cited by 116 · see citing works
Are SSRIs a Cost-Effective Alternative to Tricyclics?
Hotopf, M. H., Lewis, G., & Normand, C. E. M. (1996) · The British Journal of Psychiatry · doi:10.1192/bjp.168.4.404 · Cited by 104 · see citing works
Self-citationEvaluation of quality of life in clinical trials of cardiovascular disease
FLETCHER, A. E., Hunt, B. M., & Bulpitt, C. J. (1987) · Journal of Chronic Diseases · doi:10.1016/0021-9681(87)90014-2 · Cited by 84 · see citing works
Generalisability of results from randomised drug trials
Licht, R. W., Gouliaev, G., Vestergaard, P., & Frydenberg, M. (1997) · The British Journal of Psychiatry · doi:10.1192/bjp.170.3.264 · Cited by 78 · see citing works
Statistical Issues in Drug Development
(1999) · Technometrics · doi:10.1080/00401706.1999.10485963 · Cited by 77 · see citing works
Cost-effectiveness of antidepressant treatment reassessed
Woods, S. W., & Rizzo, J. A. (1997) · The British Journal of Psychiatry · doi:10.1192/bjp.170.3.257 · Cited by 58 · see citing works
Problems in conducting economic evaluations alongside clinical trials
Gray, A. M., Marshall, M., Lockwood, A., & Morris, J. K. (1997) · The British Journal of Psychiatry · doi:10.1192/bjp.170.1.47 · Cited by 56 · see citing works
Thornicroft, G., Gooch, C., & Dayson, D. (1992) · BMJ · doi:10.1136/bmj.305.6860.996 · Cited by 53 · see citing works
Predictors of a Medical-Offset Effect Among Patients Receiving Antidepressant Therapy
Thompson, D., Hylan, T. R., McMullen, W., Romeis, M. E., Buesching, D. P., & Oster, G. (1998) · American Journal of Psychiatry · doi:10.1176/ajp.155.6.824 · Cited by 48 · see citing works
Potential Mechanisms of Worsening
Dávalos, A., & Castillo, J. (2007) · Cerebrovascular Diseases · doi:10.1159/000108271 · Cited by 35 · see citing works
Research Methods in Psychiatry: A Beginner's Guide
Wise, T. N. (1990) · Psychosomatics · doi:10.1016/s0033-3182(90)72147-0 · Cited by 33 · see citing works
How Reliable Are Simple Questions in Assessing Outcome after Stroke?
Dennis, M. S., Wellwood, I., O'Rourke, S., MacHale, S., & Warlow, C. P. (1997) · Cerebrovascular Diseases · doi:10.1159/000108158 · Cited by 29 · see citing works
Stevens, L., Kinmonth, A., Peveler, R., & Thompson, C. M. (1997) · Medical Education · doi:10.1046/j.1365-2923.1997.00670.x · Cited by 21 · see citing works
Sample size of randomized double-blind trials 1976-1991.
Mulward, S., & Gøtzsche, P. C. (1996) · PubMed · Cited by 17 · see citing works
Predictors of a medical-offset effect among patients receiving antidepressant therapy.
Thompson, Hylan, Mcmullen, & Romeis (1998) · American Journal of Psychiatry · Cited by 15 · see citing works
Flagged first, then by citations
2 of the 42 references couldn’t be matched to a known paper.
Cited by
Sorted by citations
Improving the reporting of pragmatic trials: An extension of the CONSORT statement
Zwarenstein, M., Treweek, S., Gagnier, J. J., Altman, D. G., Tunis, S., Haynes, B., Oxman, A. D., Moher, D., & groups, F. T. C. A. P. T. I. H. (. (2008) · BMJ · doi:10.1136/bmj.a2390 · Cited by 1,813 · see citing works
Stroup, T., Mcevoy, J., Swartz, M., Byerly, M., Glick, I., Cañive, J., McGee, M., Simpson, G., Stevens, M., & Lieberman, J. (2003) · Schizophrenia bulletin · doi:10.1093/oxfordjournals.schbul.a006986 · Cited by 647 · see citing works
Godwin, M. S., Rühland, L., Casson, I., MacDonald, S., Delva, D., Birtwhistle, R., Lam, M., & Seguin, R. (2003) · BMC Medical Research Methodology · doi:10.1186/1471-2288-3-28 · Cited by 507 · see citing works
Making trials matter: pragmatic and explanatory trials and the problem of applicability
Treweek, S. P., & Zwarenstein, M. (2009) · Trials · doi:10.1186/1745-6215-10-37 · Cited by 482 · see citing works
Personalized Medicine for Depression: Can We Match Patients With Treatments?
Simon, G. E., & Perlis, R. H. (2010) · American Journal of Psychiatry · doi:10.1176/appi.ajp.2010.09111680 · Cited by 365 · see citing works
Compulsory community and involuntary outpatient treatment for people with severe mental disorders
Kisely, S. R., & Campbell, L. A. (2014) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd004408.pub4 · Cited by 320 · see citing works
Wells, M., Williams, B., Treweek, S., Coyle, J., & Taylor, J. (2012) · Trials · doi:10.1186/1745-6215-13-95 · Cited by 297 · see citing works
Martín, J. L. R., Barbanoj, M., Schlaepfer, T., Thompson, E., Pérez, V., & Kulisevsky, J. (2003) · The British journal of psychiatry : the journal of mental science · doi:10.1192/bjp.182.6.480 · Cited by 315 · see citing works
Systematic meta-review of depot antipsychotic drugs for people with schizophrenia
Adams, C. E., Fenton, M., Quraishi, S. N., & David, A. S. (2001) · The British Journal of Psychiatry · doi:10.1192/bjp.179.4.290 · Cited by 286 · see citing works
Casacalenda, N., Perry, J. C., & Looper, K. J. (2002) · American Journal of Psychiatry · doi:10.1176/appi.ajp.159.8.1354 · Cited by 247 · see citing works
Constraint-induced movement therapy for upper extremities in people with stroke
Corbetta, D., Sirtori, V., Castellini, G., Moja, L., & Gatti, R. (2015) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd004433.pub3 · Cited by 248 · see citing works
The case for practical clinical trials in psychiatry.
March, J. S., Silva, S. G., Compton, S., Shapiro, M., Califf, R., & Krishnan, R. (2005) · American Journal of Psychiatry · doi:10.1176/appi.ajp.162.5.836 · Cited by 240 · see citing works
Constraint-induced movement therapy for upper extremities in stroke patients
Sirtori, V., Corbetta, D., Moja, L., & Gatti, R. (2009) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd004433.pub2 · Cited by 206 · see citing works
Schene, A. H., Koeter, M. W. J., Kikkert, M., Swinkels, J. A., & McCrone, P. (2006) · Psychological Medicine · doi:10.1017/s0033291706009366 · Cited by 203 · see citing works
Methodological issues in research on web-based behavioral interventions
Danaher, B. G., & Seeley, J. R. (2009) · Annals of Behavioral Medicine · doi:10.1007/s12160-009-9129-0 · Cited by 193 · see citing works
Assessing effectiveness of treatment of depression in primary care
Bedi, N., Chilvers, C. E. D., Churchill, D., Dewey, M. E., Duggan, C. F., Fielding, K., Gretton, V., Miller, P., Harrison, G. L., Lee, A., et al. (2000) · The British Journal of Psychiatry · doi:10.1192/bjp.177.4.312 · Cited by 193 · see citing works
Manchikanti, L. (2009) · Pain Physician · doi:10.36076/ppj.2009/12/35 · Cited by 186 · see citing works
The pragmatic randomised controlled trial
Hotopf, M. H. (2002) · Advances in Psychiatric Treatment · doi:10.1192/apt.8.5.326 · Cited by 189 · see citing works
Self-citationMorrell, C., Warner, R., Slade, P., Dixon, S., Walters, S. J., Paley, G., & Brugha, T. S. (2009) · Health Technology Assessment · doi:10.3310/hta13300 · Cited by 174 · see citing works
Manchikanti, L. (2009) · Pain Physician · doi:10.36076/ppj.2009/12/819 · Cited by 168 · see citing works
Manchikanti, L. (2010) · Pain Physician · doi:10.36076/ppj.2010/13/343 · Cited by 162 · see citing works
How is affective instability defined and measured? A systematic review
Marwaha, S., He, Z., Broome, M. R., Singh, S. P., Scott, J. L., Eyden, J., & Dieter Wolke, C. (2013) · Psychological Medicine · doi:10.1017/s0033291713002407 · Cited by 160 · see citing works
Parr, A. T. (2012) · Pain Physician · doi:10.36076/ppj.2012/15/e159 · Cited by 160 · see citing works
Sumathipala, A. (2007) · Psychosomatic Medicine · doi:10.1097/psy.0b013e31815b5cf6 · Cited by 151 · see citing works
Manchikanti, L., Cash, K. A., McManus, C. D., Pampati, V., & Abdi, S. (2008) · PubMed · Cited by 146 · see citing works
Manchikanti, L. (2009) · Pain Physician · doi:10.36076/ppj.2009/12/e341 · Cited by 131 · see citing works
Selective serotonin re-uptake inhibitors (SSRIs) for preventing migraine and tension-type headaches
Moja, L., Cusi, C., Sterzi, R., & Canepari, C. (2005) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd002919.pub2 · Cited by 136 · see citing works
Srihari, V. H., Tek, C., Küçükgöncü, S., Phutane, V. H., Breitborde, N. J. K., Pollard, J., Özkan, B., Saksa, J. R., Walsh, B. C., & Woods, S. W. (2015) · Psychiatric Services · doi:10.1176/appi.ps.201400236 · Cited by 136 · see citing works
Compulsory community and involuntary outpatient treatment for people with severe mental disorders
Kisely, S. R., Campbell, L. A., & Preston, N. J. (2011) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd004408.pub3 · Cited by 133 · see citing works
Transcranial magnetic stimulation for treating depression.
Rodriguez-Martin, J. L., Barbanoj, J. M., Schlaepfer, T., Clos, S., Perez, V., Kulisevsky, J., & Gironell, A. (2001) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd003493 · Cited by 146 · see citing works
SUMATHIPALA, A., HEWEGE, S., HANWELLA, R., & MANN, A. H. (2000) · Psychological Medicine · doi:10.1017/s0033291799002160 · Cited by 129 · see citing works
Manchikanti, L. (2009) · Pain Physician · doi:10.36076/ppj.2009/12/73 · Cited by 117 · see citing works
Benyamin, R. M., Manchikanti, L., Parr, A. T., Diwan, S. A., Singh, V. P., Falco, F. J. E., Datta, S., Abdi, S., & Hirsch, J. A. (2012) · PubMed · Cited by 124 · see citing works
Lewis, G., Duffy, L., Ades, A., Amos, R., Araya, R., Brabyn, S., Button, K. S., Churchill, R., Derrick, C., Dowrick, C., et al. (2019) · The Lancet Psychiatry · doi:10.1016/s2215-0366(19)30366-9 · Cited by 120 · see citing works
Self-citationNaturopathic care for anxiety: a randomized controlled trial ISRCTN78958974
Cooley, K., Szczurko, O., Perri, D., Mills, E. J., Bernhardt, B., Zhou, Q., & Seely, D. (2009) · PLoS ONE · doi:10.1371/journal.pone.0006628 · Cited by 114 · see citing works
Transforming the Treatment of Schizophrenia in the United States: The RAISE Initiative
Dixon, L. B., Goldman, H. H., Srihari, V. H., & Kane, J. M. (2018) · Annual Review of Clinical Psychology · doi:10.1146/annurev-clinpsy-050817-084934 · Cited by 112 · see citing works
Social problem-solving plus psychoeducation for adults with personality disorder
Huband, N., McMurran, M., Evans, C., & Duggan, C. F. (2007) · The British Journal of Psychiatry · doi:10.1192/bjp.bp.106.023341 · Cited by 105 · see citing works
Dell’Osso, B., Camuri, G., Castellano, F., Vecchi, V., Benedetti, M., Bortolussi, S., & Altamura, A. C. (2011) · Clinical Practice & Epidemiology in Mental Health · doi:10.2174/1745017901107010167 · Cited by 105 · see citing works
Reininghaus, U., Depp, C. A., & Myin‐Germeys, I. (2015) · Schizophrenia Bulletin · doi:10.1093/schbul/sbv193 · Cited by 102 · see citing works
The European First Episode Schizophrenia Trial (EUFEST): Rationale and design of the trial
Fleischhacker, W. W., Keet, I. P. M., & Kahn, R. S. (2005) · Schizophrenia Research · doi:10.1016/j.schres.2005.06.004 · Cited by 100 · see citing works
Outcomes research in mental health
Gilbody, S. M., House, A. O., & Sheldon, T. (2002) · The British Journal of Psychiatry · doi:10.1192/bjp.181.1.8 · Cited by 98 · see citing works
Manchikanti, L., Cash, K. A., McManus, C. D., Pampati, V., & Smith, H. S. (2008) · PubMed · Cited by 99 · see citing works
Manchikanti, L., Singh, V. P., Cash, K. A., Pampati, V., & Datta, S. (2009) · PubMed · Cited by 98 · see citing works
Compulsory community and involuntary outpatient treatment for people with severe mental disorders
Kisely, S. R., Campbell, L. A., & Preston, N. J. (2005) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd004408.pub2 · Cited by 93 · see citing works
Is Early Intervention for Psychosis Feasible and Effective?
Srihari, V. H., Shah, J. L., & Keshavan, M. S. (2012) · Psychiatric Clinics of North America · doi:10.1016/j.psc.2012.06.004 · Cited by 80 · see citing works
The 2 “Es” of Research: Efficacy and Effectiveness Trials
Streiner, D. L. (2002) · The Canadian Journal of Psychiatry · doi:10.1177/070674370204700607 · Cited by 79 · see citing works
Effects of NMDA receptor antagonist memantine on mismatch negativity
Korostenskaja, M., Nikulin, V. V., Kičić, D., Nikulina, A. V., & Kähkönen, S. (2007) · Brain Research Bulletin · doi:10.1016/j.brainresbull.2007.01.007 · Cited by 77 · see citing works
Serotonergic modulation of mismatch negativity
Kähkönen, S., Mäkinen, V. T., Jääskeläinen, I. P., Pennanen, S., Liesivuori, J., & Ahveninen, J. (2005) · Psychiatry Research Neuroimaging · doi:10.1016/j.pscychresns.2004.09.006 · Cited by 77 · see citing works
A systematic evaluation of the therapeutic effectiveness of sacroiliac joint interventions.
Hansen, H., Manchikanti, L., Simopoulos, T. T., Christo, P. J., Gupta, S., Smith, H. S., Hameed, H., & Cohen, S. P. (2012) · PubMed · Cited by 75 · see citing works
Manchikanti, L., Singh, V., Cash, K. A., Pampati, V., & Datta, S. (2008) · PubMed · Cited by 75 · see citing works
Study control, violators, inclusion criteria and defining explanatory and pragmatic trials
McMahon, A. D. (2002) · Statistics in Medicine · doi:10.1002/sim.1120 · Cited by 74 · see citing works
Banzi, R., Cusi, C., Randazzo, C., Sterzi, R., Tedesco, D., & Moja, L. (2015) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd002919.pub3 · Cited by 69 · see citing works
Banzi, R., Cusi, C., Randazzo, C., Sterzi, R., Tedesco, D., & Moja, L. (2015) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd011681 · Cited by 66 · see citing works
Kisely, S. R., Campbell, L. A., Scott, A., Preston, N. J., & Xiao, J. (2006) · Psychological Medicine · doi:10.1017/s0033291706008592 · Cited by 63 · see citing works
Mood swings in patients with anxiety disorders compared with normal controls
Bowen, R., Clark, M., & Baetz, M. (2002) · Journal of Affective Disorders · doi:10.1016/s0165-0327(02)00304-x · Cited by 63 · see citing works
Manchikanti, L., Cash, K. A., Pampati, V., Wargo, B. W., & Malla, Y. (2010) · PubMed · Cited by 59 · see citing works
Depression in palliative care: a systematic review. Part 2. Treatment
Ly, K. L., Chidgey, J., Addington-Hall, J. M., & Hotopf, M. H. (2002) · Palliative Medicine · doi:10.1191/0269216302pm570oa · Cited by 59 · see citing works
Self-citationMartín, J. L. R., Pérez, V., Sacristán, M., Rodríguez‐Artalejo, F., Martínez, C., & Álvarez, E. (2005) · European Psychiatry · doi:10.1016/j.eurpsy.2005.09.009 · Cited by 58 · see citing works
Clinical trials for antipsychotic drugs: design conventions, dilemmas and innovations
Stroup, T. S., Alves, W. M., Hamer, R. M., & Lieberman, J. A. (2006) · Nature Reviews Drug Discovery · doi:10.1038/nrd1956 · Cited by 58 · see citing works
Manchikanti, L. (2009) · Pain Physician · doi:10.36076/ppj.2009/12/e1 · Cited by 52 · see citing works
Randomized controlled trials in schizophrenia: a critical perspective on the literature
Gilbody, S. M., Wahlbeck, K., & Adams, C. E. (2002) · Acta Psychiatrica Scandinavica · doi:10.1034/j.1600-0447.2002.00242.x · Cited by 56 · see citing works
Evidence-based mental health policy: Acritical appraisal
OGUIBENINE, B. (2003) · British Journal of Psychiatry · doi:10.1192/bjp.183.2.105 · Cited by 49 · see citing works
An Update of Evaluation of Therapeutic Thoracic Facet Joint Interventions
Falco, F. J. E. (2012) · Pain Physician · doi:10.36076/ppj.2012/15/e463 · Cited by 51 · see citing works
Patterson, S., Kramo, K., Soteriou, T., & Crawford, M. (2010) · Journal of Mental Health · doi:10.3109/09638237.2010.520367 · Cited by 51 · see citing works
Evidence‐based psychiatry: understanding the limitations of a method
Maier, T. (2006) · Journal of Evaluation in Clinical Practice · doi:10.1111/j.1365-2753.2006.00604.x · Cited by 50 · see citing works
Korostenskaja, M., Kičić, D., & Kähkönen, S. (2008) · Psychopharmacology · doi:10.1007/s00213-007-1065-8 · Cited by 50 · see citing works
Outcome measurement in mental health – welcome to the revolution
Holloway, F. A. (2002) · The British Journal of Psychiatry · doi:10.1192/bjp.181.1.1 · Cited by 47 · see citing works
Patient‐reported outcomes and health‐related quality of life in effectiveness studies: pros and cons
Marquis, P., Arnould, B., Acquadro, C., & Roberts, W. M. (2006) · Drug Development Research · doi:10.1002/ddr.20077 · Cited by 47 · see citing works
Compulsory community mental health treatment: Literature review
O'Brien, A. J., McKenna, B. G., & Kydd, R. R. (2009) · International Journal of Nursing Studies · doi:10.1016/j.ijnurstu.2009.02.006 · Cited by 46 · see citing works
An update of the effectiveness of therapeutic lumbar facet joint interventions.
Falco, F. J. E., Manchikanti, L., Datta, S., Sehgal, N., Geffert, S., Onyewu, O., Zhu, J., Coubarous, S., Hameed, M., Ward, S. P., et al. (2012) · PubMed · Cited by 46 · see citing works
Durand, M. A., & King, M. (2003) · Europe PMC (PubMed Central) · Cited by 45 · see citing works
The Child and Adolescent Psychiatry Trials Network (CAPTN)
March, J. S., Silva, S. G., Compton, S. N., Anthony, G., DeVeaugh-Geiss, J., Califf, R. M., & Krishnan, R. R. (2004) · Journal of the American Academy of Child & Adolescent Psychiatry · doi:10.1097/00004583-200405000-00004 · Cited by 45 · see citing works
Fagiolini, A. M., Rocca, P., Giorgi, S. D., Spina, E., Amodeo, G., & Amore, M. (2016) · Psychiatry Research · doi:10.1016/j.psychres.2016.11.044 · Cited by 44 · see citing works
Huf, G., Coutinho, E. S. F., & Adams, C. E. (2002) · BMC Psychiatry · doi:10.1186/1471-244x-2-11 · Cited by 44 · see citing works
Research methods, statistics and evidence-based practice
McIntosh, A. M., Sharpe, M., & Lawrie, S. M. (2010) · Elsevier eBooks · doi:10.1016/b978-0-7020-3137-3.00009-7 · Cited by 44 · see citing works
Cognitive-behavioural therapy for bipolar disorder
Scott, J. L., Paykel, E. S., Morriss, R. K., Bentall, R. P., Kinderman, P., Johnson, T. L., Abbott, R., & Hayhurst, H. (2006) · The British Journal of Psychiatry · doi:10.1192/bjp.188.5.488 · Cited by 40 · see citing works
Effectiveness of Involuntary Outpatient Commitment
SZMUKLER, G., & HOTOPF, M. (2001) · American Journal of Psychiatry · doi:10.1176/appi.ajp.158.4.653-a · Cited by 39 · see citing works
Self-citationCrawford, M., Weaver, T. D., Rutter, D., Sensky, T., & Tyrer, P. J. (2002) · International Review of Psychiatry · doi:10.1080/09540260120114005 · Cited by 39 · see citing works
Andreoli, P. B. D. A., Cítero, V. D. A., & Mari, J. D. J. (2003) · Psychosomatics · doi:10.1176/appi.psy.44.6.499 · Cited by 37 · see citing works
Randomized Controlled Trials in Psychiatry. Part II: Their Relationship to Clinical Practice
Mulder, R., Frampton, C. M., Joyce, P. R., & Porter, R. (2003) · Australian & New Zealand Journal of Psychiatry · doi:10.1046/j.1440-1614.2003.01176.x · Cited by 36 · see citing works
Huf, G. (2003) · Cited by 35 · see citing works
ADME pharmacogenetics: current practices and future outlook
Grossman, I. (2009) · Expert Opinion on Drug Metabolism & Toxicology · doi:10.1517/17425250902902322 · Cited by 34 · see citing works
Fulford, D., Mote, J., Gard, D. E., Mueser, K. T., Gill, K., Leung, L., & Dillaway, K. (2020) · Journal of Behavioral and Cognitive Therapy · doi:10.1016/j.jbct.2020.03.016 · Cited by 31 · see citing works
Werneck, A. P., Hallak, J. E. C., Nakano, E. Y., & Elkis, H. (2011) · Psychiatry Research · doi:10.1016/j.psychres.2011.04.004 · Cited by 31 · see citing works
Lasalvia, A., & Ruggeri, M. (2007) · Acta Psychiatrica Scandinavica · doi:10.1111/j.1600-0447.2007.01089.x · Cited by 31 · see citing works
Cook, W. L., Khan, K. M., Bech, M. H., Brasher, P. M. A., Brown, R. A., Bryan, S., Donaldson, M. G., Guy, P., Hanson, H. M., Leia, C., et al. (2011) · BMC Geriatrics · doi:10.1186/1471-2318-11-30 · Cited by 30 · see citing works
Srihari, V. H., Breitborde, N. J. K., Pollard, J., Tek, C., Hyman, L., Frisman, L. K., McGlashan, T. H., Jacobs, S., & Woods, S. W. (2009) · Psychiatric Services · doi:10.1176/appi.ps.60.11.1426 · Cited by 30 · see citing works
Chadwick, D. W., & Marson, A. G. (2007) · Epilepsia · doi:10.1111/j.1528-1167.2007.01086.x · Cited by 27 · see citing works
A new generation of pragmatic trials of psychosocial interventions is needed
Ruggeri, M., Lasalvia, A., & Bonetto, C. (2013) · Epidemiology and Psychiatric Sciences · doi:10.1017/s2045796013000127 · Cited by 27 · see citing works
Neuroleptic Malignant Syndrome After Addition of Haloperidol to Atypical Antipsychotic
Mujica, R., & Weiden, P. J. (2001) · American Journal of Psychiatry · doi:10.1176/appi.ajp.158.4.650-a · Cited by 25 · see citing works
Does placebo help establish equivalence in trials of new antidepressants?
Barbui, C., Violante, A., & Garattini, S. K. (2000) · European Psychiatry · doi:10.1016/s0924-9338(00)00233-9 · Cited by 25 · see citing works
Cross-sectional Database Analysis of Antidepressant Prescribing in Italy
Barbui, C., Broglio, E., Laia, A. C., D’Agostino, S., Enrico, F., Ferraro, L., Fiorio, E., Miletti, F., Pietraru, C., Poggio, L., et al. (2003) · Journal of Clinical Psychopharmacology · doi:10.1097/00004714-200302000-00006 · Cited by 26 · see citing works
Mari, J. D. J., de Lima, M. S., Costa, A. N., Alexandrino, N., Filho, S. R., de Oliveira, I. R., & Tollefson, G. D. (2004) · European Archives of Psychiatry and Clinical Neuroscience · doi:10.1007/s00406-004-0514-1 · Cited by 24 · see citing works
Catts, S. V., O’Toole, B. I., Carr, V. J., Lewin, T. J., Neil, A. L., Harris, M., Frost, A. D. J., Crissman, B., Eadie, K., & Evans, R. W. (2010) · Australian & New Zealand Journal of Psychiatry · doi:10.3109/00048670903487167 · Cited by 22 · see citing works
Xiao, J., Preston, N. J., & Kisely, S. R. (2004) · Australian & New Zealand Journal of Psychiatry · doi:10.1080/j.1440-1614.2004.01429.x · Cited by 23 · see citing works
March, J. S., Chrisman, A. K., Breland‐Noble, A. M., Clouse, K., D'Alli, R., EGGER, H. L., Gammon, P., Gazzola, M., Lin, A., Mauro, C., et al. (2005) · Child and Adolescent Psychiatric Clinics of North America · doi:10.1016/j.chc.2004.05.001 · Cited by 22 · see citing works
The Current View of Evidence and Evidence‐Based Practice
Bower, P., & Gilbody, S. M. (2010) · Wiley eBooks · doi:10.1002/9780470687994.ch1 · Cited by 21 · see citing works
Pragmatic design in randomized controlled trials
Purgato, M., Barbui, C., Stroup, S., & Adams, C. (2015) · Psychological Medicine · doi:10.1017/s0033291714001275 · Cited by 19 · see citing works
Drug treatments for schizophrenia
Adams, C. E. (2000) · Quality in Health Care · doi:10.1136/qhc.9.1.73 · Cited by 18 · see citing works
Falloon, I. R. H., Economou, M. P., Palli, A., Malm, U., Mizuno, M., Murakami, M., & Optimal Treatment Project Collaborative Group (2005) · Psychiatric Services · doi:10.1176/appi.ps.56.12.1584 · Cited by 17 · see citing works
- Authors
- Hotopf, M., Churchill, R., & Lewis, G.
- Affiliations
- Guy's Hospital (GB)
- Cardiff University (GB)
- Corresponding author
- Hotopf, Matthew
- Venue
- British Journal of Psychiatry
- Publisher
- Royal College of Psychiatrists
- Published
- 1999-09
- Volume
- 175
- Issue
- 3
- Pages
- 217-223
- ISSN
- 0007-1250 (ISSN-L)
- 1472-1465
- OpenAlex
- W2058332740
- Cited by
- 165
- References
- 42
- Citations by year
- 2025: 2 · 2024: 2 · 2022: 2 · 2021: 3 · 2020: 3 · 2019: 2 · 2018: 2 · 2017: 1 · 2016: 2 · 2015: 7 · 2014: 2 · 2013: 5 · 2012: 9
- FWCI
- 2.23
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The British Journal of Psychiatry (publishedVersion)
- PubMed (publishedVersion)
- UCL Discovery (University College London) (submittedVersion)
- DigitalGeorgetown (Georgetown University Library) (submittedVersion)
- Topics
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Health Sciences › Health Professions › General Health Professions › Health Policy Implementation Science
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Keywords
- pragmatic randomized controlled trial, psychiatry, mental health outcomes, clinician involvement in research, research question formulation
- MeSH terms
- Mental Disorders, Costs and Cost Analysis, Ethics, Medical, Humans, Prognosis, Random Allocation, Observer Variation, Cluster Analysis, Randomized Controlled Trials as Topic, Patient Satisfaction, Patient Selection
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
