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Evans I, Thornton H, Chalmers I, et al. Testing Treatments: Better Research for Better Healthcare. 2nd edition. London: Pinter & Martin; 2011.

Bookshelf ID: NBK66208

References

    Foreword Ben Goldacre

    1.
    Lexchin J, Bero LA, Djulbegovic B, et al. Pharmaceutical industry sponsorship and research outcome and quality: systematic review. BMJ. 2003;326:1167–70. [PMC free article: PMC156458] [PubMed: 12775614]
    2.
    Schwitzer G, Ganapati M, Henry D, et al. What are the roles and responsibilities of the media in disseminating health information? PLoS Med. 2(7):e215. [PMC free article: PMC1181881] [PubMed: 16033311]
    3.
    Wilson PM, Booth AM, Eastwood A, et al. Deconstructing media coverage of trastuzumab (Herceptin): an analysis of national newspaper coverage. Journal of the Royal Society of Medicine. 2008;101:125–32. [PMC free article: PMC2270248] [PubMed: 18344469]
    4.
    Shang A, Huwiler-Müntener K, Nartey L, et al. Are the clinical effects of homoeopathy placebo effects? Comparative study of placebo-controlled trials of homoeopathy and allopathy. Lancet. 2005;366:726–32. [PubMed: 16125589]
    5.
    Bjelakovic G, Nikolova D, Gluud LL, et al. Antioxidant supplements for prevention of mortality in healthy participants and patients with various diseases. Cochrane Database of Systematic Reviews. 2008;(2):CD007176. [PubMed: 18425980]

    Introduction

    1.
    Nolte E, McKee CM. Does health care save lives? Avoidable mortality revisited. London: Nuffield Trust; 2004.
    2.
    Nolte E, McKee CM. Measuring the health of nations: updating an earlier analysis. Health Affairs. 2008;27(1):58–77. [PubMed: 18180480]
    3.
    Gigerenzer G. Reckoning with risk. London: Penguin Books; 2003. Citing Franklin B. Letter to Jean Baptiste Le Roy, 13 November 1789. Writings, vol x.
    4.
    Goldacre B. Bad Science. London: Fourth Estate; 2008. px.
    5.
    Matthews A, Dowswell T, Haas DM, et al. Interventions for nausea and vomiting in early pregnancy. Cochrane Database of Systematic Reviews. 2010;(9):CD007575. [PubMed: 20824863]
    6.
    Irwig L, Irwig J, Trevena L, et al. Smart health choices: making sense of health advice. London: Hammersmith Press; 2008. pdf freely available at: www​.health.usyd.edu.au​/shdg/resources/smart_health_choices​.php and from www​.jameslindlibrary.org.
    7.
    Woloshin S, Schwartz LM, Welch HG. Know your chances: understanding health statistics. Berkeley: University of California Press; 2008. pdf freely available at www​.jameslindlibrary.org.

    Chapter 1. New – but is it better?

    1.
    Vandenbroucke JP. Thalidomide: an unanticipated adverse event. 2003. Available from: www​.jameslindlibrary.org.
    2.
    Stephens T, Brynner R. Dark medicine: the impact of thalidomide and its revival as a vital medicine. Cambridge, Mass: Perseus Publishing; 2001.
    3.
    Thomson D, Capstick T. How a risk management programme can ensure safety in thalidomide use. Pharmaceutical Journal. 2004 Feb;14:194–5.
    4.
    Krumholz HM, Ross JR, Presler AH, et al. What have we learnt from Vioxx? BMJ. 2007;334:120–3. [PMC free article: PMC1779871] [PubMed: 17235089]
    5.
    Merck statements dated 7 December 2009, on Vioxx proceedings in Ontario, Canada, and 4 March 2010 on Vioxx judgment in Australia. available at www​.merck.com.
    6.
    Cohen D. Rosiglitazone what went wrong? BMJ. 2010;341:c4848. [PubMed: 20819889]
    7.
    Lehman R, Yudkin JS, Krumholz HM. Licensing drugs for diabetes: surrogate end points are not enough, robust evidence of benefits and harms is needed. BMJ. 2010;341:c4805. [PubMed: 20819887]
    8.
    Blackstone EH. Could it happen again? The Björk-Shiley convexo-concave heart valve story. Circulation. 2005;111:2717–19. [PubMed: 15927988]
    9.
    Wilson PM, Booth AM, Eastwood A, et al. Deconstructing media coverage of trastuzumab (Herceptin): an analysis of national newspaper coverage. Journal of the Royal Society of Medicine. 2008;101:125–32. [PMC free article: PMC2270248] [PubMed: 18344469]
    10.
    Timmins N. Drugs watchdog gets harsh treatment. Financial Times. 2005 Oct 8;:6.
    11.
    Hawkes N. Wonder drug is “cure” for cancer, say doctors. The Times. 2005 Oct 20;
    12.
    Press MF, Sauter G, Bernstein L, et al. Diagnostic evaluation of HER-2 as a molecular target: an assessment of accuracy and reproducibility of laboratory testing in large, prospective, randomized clinical trials. Clinical Cancer Research. 2005;11(18):6598–607. [PubMed: 16166438]
    13.
    NICE draft guidance on trastuzumab (Herceptin) for early breast cancer (press release) Jun 9, 2006. www​.nice.org.uk/page.aspx?o=328789.
    14.
    Cumming J, Mays N, Daubé J. How New Zealand has contained expenditure on drugs. BMJ. 2010;340:1224–6.
    15.
    NHS NICE Technology Appraisal TA34. Guidance on the use of trastuzumab for the treatment of advanced breast cancer. Issue date March 2002; review date April 2005. www​.nice.org.uk/TA34.

    Chapter 2. Hoped-for effects that don’t materialize

    1.
    Gilbert R, Salanti G, Harden M, et al. Infant sleeping position and the sudden infant death syndrome: systematic review of observational studies and historical review of clinicians’ recommendations from 1940–2000. International Journal of Epidemiology. 2005;34:74–87.
    2.
    Furberg CD. Effect of antiarrhythmic drugs on mortality after myocardial infarction. American Journal of Cardiology. 1983;52:32C–36C.
    3.
    Chalmers I. In the dark. Drug companies should be forced to publish all the results of clinical trials. How else can we know the truth about their products? New Scientist. 2004. Mar 6, p. 19.Moore T. Deadly Medicine. New York: Simon and Schuster; 1995. Citing.
    4.
    Cowley AJ, Skene A, Stainer K, et al. The effect of lorcainide on arrhythmias and survival in patients with acute myocardial infarction: an example of publication bias. International Journal of Cardiology. 1993;40:161–6. [PubMed: 8349379]
    5.
    Chalmers I. Evaluating the effects of care during pregnancy and childbirth. In: Chalmers I, Enkin M, Keirse MJNC, editors. Effective care in pregnancy and childbirth. Oxford; Oxford University Press; 1989. pp. 3–38.
    6.
    Ulfelder H. The stilbestrol disorders in historical perspective. Cancer. 1980;45:3008–11. [PubMed: 6992969]
    7.
    Office of Technology Assessment. Identifying health technologies that work: searching for evidence. Washington, DC: US Government Printing Office; 1994.
    8.
    Hemminki E, McPherson K. Impact of postmenopausal hormone therapy on cardiovascular events and cancer: pooled data from clinical trials. BMJ. 1997;315:149–53. [PMC free article: PMC2127109] [PubMed: 9251544]
    9.
    HRT: update on the risk of breast cancer and long-term safety. Current Problems in Pharmacovigilance. 2003;29:1–3. Citing results of Women’s Health Initiative randomized controlled trial (JAMA 2003;289:3243–53) and Million Women Study (Lancet 2003;362:419–27)
    10.
    Roberts H. Hormone replacement therapy comes full circle. BMJ. 2007;335:219–20. [PMC free article: PMC1939750] [PubMed: 17626055]
    11.
    Williams HC. Evening primrose oil for atopic dermatitis: time to say goodnight (editorial). BMJ. 2003;327:1358–9. [PMC free article: PMC292973] [PubMed: 14670851]
    12.
    Hoare C, Li Wan Po A, Williams H. Systematic review of treatment for atopic eczema. Health Technology Assessment. 2000;4(37):1–191. [PubMed: 11134919]
    13.
    Takwale A, Tan E, Agarwal S, et al. Efficacy and tolerability of borage oil in adults and children with atopic eczema: randomised, double blind, placebo controlled, parallel group trial. BMJ. 2003;327:1385–7. [PMC free article: PMC292992] [PubMed: 14670885]

    Chapter 3. More is not necessarily better

    1.
    Crile G. A plea against blind fear of cancer. Life. 1955 Oct 31;:128–32.
    2.
    Baum M, Houghton J. Contribution of randomised controlled trials to understanding and management of early breast cancer. BMJ. 1999;319:568–71. [PMC free article: PMC1116442] [PubMed: 10463904]
    3.
    Veronesi U, Cascinelli N, Mariani L, et al. Twenty-year follow up of a randomized study comparing breast-conserving surgery with radical mastectomy for early breast cancer. New England Journal of Medicine. 2002;347:1227–32. [PubMed: 12393819]
    4.
    Baum M. Breast beating: a personal odyssey in the quest for an understanding of breast cancer, the meaning of life and other easy questions. London: Anshan; 2010.
    5.
    Japanese Breast Cancer Society. Results of questionnaires concerning breast cancer surgery in Japan 1980–2003. Breast Cancer. 2005;12(1)
    6.
    Early Breast Cancer Trialists’ Collaborative Group. Effects of adjuvant tamoxifen and of cytotoxic therapy on mortality in early breast cancer. An overview of 61 randomized trials among 28,896 women. New England Journal of Medicine. 1988;319:1681–92. [PubMed: 3205265]
    7.
    Clinical Trial Service Unit website. www​.ctsu.ox.ac.uk.
    8.
    The Cochrane Collaboration website. www​.cochrane.org.
    9.
    Kolata G, Eichenwald K. Health business thrives on unproven treatment, leaving science behind, New York Times Special Report. Oct 2, 1999.
    10.
    Farquhar C, Marjoribanks J, Basser R, et al. High dose chemotherapy and autologous bone marrow or stem cell transplantation versus conventional chemotherapy for women with early poor prognosis breast cancer. Cochrane Database of Systematic Reviews. 2005;(3):CD003139. [PubMed: 16034886]
    11.
    Farquhar C, Marjoribanks J, Basser R, et al. High dose chemotherapy and autologous bone marrow or stem cell transplantation versus conventional chemotherapy for women with metastatic breast cancer. Cochrane Database of Systematic Reviews. 2005;(3):CD003142. [PubMed: 16034887]
    12.
    Piccart-Gebhart MJ, Procter M, Leyland-Jones B, et al. Trastuzumab after adjuvant chemotherapy in HER-2-positive breast cancer. New England Journal of Medicine. 2005;353:1659–72. [PubMed: 16236737]
    13.
    Romond EH, Perez EA, Bryant J, et al. Trastuzumab plus adjuvant chemotherapy for operable HER-2-positive breast cancer. New England Journal of Medicine. 2005;353:1673–84. [PubMed: 16236738]
    14.
    Carlson GW, Woods WC. Management of axillary lymph node metastasis in breast cancer: making progress. JAMA. 2011;305:606–7. [PubMed: 21304087]

    Chapter 4. Earlier is not necessarily better

    1.
    Raffle A, Gray M. Screening: evidence and practice. Oxford; Oxford University Press; 2009. rev. repr.
    2.
    Sense About Science. Making sense of screening. London: Sense About Science; 2009. Available from www​.senseaboutscience.org.
    3.
    Goodman MT, Gurney JG, Smith MA, et al. Ries LAG, Smith MA, Gurney JG, et al., editors. Cancer incidence and survival among children and adolescents: United States SEER Program 1975–1995. Bethesda, MD: National Cancer Institute, SEER Program. NIH Pub. No.99-4649; 1999. Sympathetic nervous system tumors. SEER Pediatric Monograph available at http://seer​.cancer.gov​/publications/childhood.
    4.
    Mullassery D, Dominici C, Jesudason EC, et al. Neuroblastoma: contemporary management. Archives of Disease in Childhood – Education and Practice. 2009;94:177–85.
    5.
    Morris JK. Screening for neuroblastoma in children. Journal of Medical Screening. 2002;9:56. [PubMed: 12133921]
    6.
    Raffle A, Gray M. op cit. :89–92.
    7.
    Welch HG. Should I be tested for cancer? Maybe not and here’s why. Berkeley and Los Angeles: University of California Press; 2004. p. 77.
    8.
    Cosford PA, Leng GC, Thomas J. Screening for abdominal aortic aneurysm. Cochrane Database of Systematic Reviews. 2007;(2):CD002945. [PubMed: 17443519]
    9.
    Welch HG. Screening mammography – a long run for a short slide? New England Journal of Medicine. 2010;363:1276–8. [PubMed: 20860510]
    10.
    Heath I. It is not wrong to say no. Why are women told only the benefits of breast screening and none of the possible harms? BMJ. 2009;338:1534.
    11.
    Gøtzsche PC, Nielsen M. Screening for breast cancer with mammography. Cochrane Database of Systematic Reviews. 2011;(1):CD001877. [PubMed: 21249649]
    12.
    Kösters JP, Gøtzsche PC. Regular self-examination or clinical examination for early detection of breast cancer. Cochrane Database of Systematic Reviews. 2003;(2): CD003373. (No change, Update, Issue 3, July 2008.) [PubMed: 12804462]
    13.
    McPherson K. Should we screen for breast cancer? BMJ. 2010;340:c3106. [PubMed: 20576707]
    14.
    Cancer Research UK. Prostate cancer – UK incidence statistics. Updated 23 December 2010. http://info​.cancerresearchuk​.org/cancerstats​/types/prostate/incidence.
    15.
    Chapman S, Barratt A, Stockler M. Let sleeping dogs lie? What men should know before getting tested for prostate cancer. Sydney: Sydney University Press; 2010. pdf available from: http://ses​.library.usyd​.edu.au/bitstream​/2123/6835/3/Let-sleeping-dogs-lie.pdf.
    16.
    Holmström B, Johansson M, Bergh A, et al. Prostate specific antigen for early detection of prostate cancer: longitudinal study. BMJ. 2009;339:b3537. [PMC free article: PMC2751815] [PubMed: 19778969]
    17.
    Djulbegovic M, Beyth RJ, Neuberger MM, et al. Screening for prostate cancer: systematic review and meta-analysis of randomised controlled trials. BMJ. 2010;341:c4543. [PMC free article: PMC2939952] [PubMed: 20843937]
    18.
    Stark JR, Mucci L, Rothman KJ, et al. Prostate cancer screening: the controversy continues. BMJ. 2009;339:b3601. [PubMed: 19778971]
    19.
    National Lung Screening Trial Research Team. Reduced lung-cancer mortality with low-dose computed tomographic screening. New England Journal of Medicine. 2011;365:395–409. [PubMed: 21714641]
    20.
    Moynihan R. Beware the fortune tellers peddling genetic tests. BMJ. 2010;341:c7233.
    21.
    Thornton H. The screening debates: time for a broader approach? European Journal of Cancer. 2003;39:1807–9. [PubMed: 12888377]
    22.
    Wilson JMG, Jungner G. Principles and practice of screening for disease. Geneva: World Health Organization; 1968. Adapted from. Public health paper no 34.
    23.
    COMARE 12th Report: The impact of personally initiated X-ray computed tomography scanning for the health assessment of asymptomatic individuals, Press release, 19 December 2007. www​.comare.org.uk/12thReportPressRelease.htm.
    24.
    Department of Health. Better protection for patients having ‘MOT’ scans. http://webarchive​.nationalarchives​.gov.uk/+/www​.dh.gov.uk/en​/MediaCentre/Pressreleasesarchive​/DH_115243.
    25.
    Food and Drug Administration. Radiation-emitting products: Computed tomography and full-body CT scans – what you need to know. www​.fda.gov/radiation-emittingProducts.

    Chapter 5. Dealing with uncertainty about the effects of treatments

    1.
    Cabello JB, Burls A, Emparanza JI, et al. Oxygen therapy for acute myocardial infarction. Cochrane Database of Systematic Reviews. 2010;(6):CD007160. [PubMed: 20556775]
    2.
    Glasziou P, Chalmers I, Rawlins M, et al. When are randomised trials unnecessary? Picking signal from noise. BMJ. 2007;334:349–51. [PMC free article: PMC1800999] [PubMed: 17303884]
    3.
    Goh CL. Flashlamp-pumped pulsed dye laser (585nm) for the treatment of portwine stains: a study of treatment outcome in 94 Asian patients in Singapore. Singapore Medical Journal. 2000;41:24–28. [PubMed: 10783676]
    4.
    Druker BJ, Talpaz M, Resta DJ, et al. Efficacy and safety of a specific inhibitor of the BCR-ABL tyrosine kinase in chronic myeloid leukemia. New England Journal of Medicine. 2001;344:1031–7. [PubMed: 11287972]
    5.
    Goldman J.for the British Committee for Standards in Haematology. Recommendations for the management of BCR-ABL-positive chronic myeloid leukaemia. London: BSH; 2007.
    6.
    Purohit N, Ray S, Wilson T, et al. The parent’s kiss: an effective way to remove paediatric nasal foreign bodies. Annals of the Royal College of Surgeons of England. 2008;90:420–2. [PMC free article: PMC2645753] [PubMed: 18634742]
    7.
    Sanghavi DM. How should we tell the stories of our medical miracles? Lancet. 2010;375:2068–9. [PubMed: 20549869]
    8.
    Léauté-Labrèze C, Dumas la Roque E, Hubische T, et al. Propranolol for severe hemangiomas of infancy. New England Journal of Medicine. 2008;358:2649–51. [PubMed: 18550886]
    9.
    Huikeshoven M, Koster PHL, de Borgie CAJM, et al. Re-darkening of port-wine stains 10 years after pulsed-dye-laser treatment. New England Journal of Medicine. 2007;356:1235–40. [PubMed: 17377161]
    10.
    Waner M. Recent developments in lasers and the treatment of birthmarks. Archives of Disease in Childhood. 2003;88:372–4. [PMC free article: PMC1719553] [PubMed: 12716698]
    11.
    Anti-Thrombotic Trialists’ (ATT) Collaboration. Clinical Trial Service Unit website. www​.ctsu.ox.ac.uk/projects/att.
    12.
    Lin CWC, Moseley AM, Refshauge KM. Rehabilitation for ankle fractures in adults. Cochrane Database of Systematic Reviews. 2008;(3):CD005595. [PubMed: 18646131]
    13.
    Lindley RI. Personal communication. 2005.
    14.
    Wardlaw JM, Murray V, Berge E, et al. Thrombolysis for acute ischaemic stroke. Cochrane Database of Systematic Reviews. 2009;(4):CD000213. [PubMed: 19821269]
    15.
    Schmidt B, Roberts RS, Davis P, et al. for the Caffeine for Apnea of Prematurity Trial Group. Long-term effects of caffeine therapy for apnea of prematurity. New England Journal of Medicine. 2007;357:1893–902. [PubMed: 17989382]
    16.
    Caffeine citrate (Comment), Neonatal Formulary 5. Available from: www​.blackwellpublishing​.com/medicine/bmj​/nnf5/pdfs/comment/caffeine1.pdf.
    17.
    Kenyon S, Pike K, Jones DR, et al. Childhood outcomes after prescription of antibiotics to pregnant women with preterm rupture of the membranes: 7-year follow-up of the ORACLE I trial. Lancet. 2008;372:1310–18. [PubMed: 18804274]
    18.
    Kenyon S, Pike K, Jones DR, et al. Childhood outcomes after prescription of antibiotics to pregnant women with spontaneous preterm labour: 7-year follow-up of the ORACLE II trial. Lancet. 2008;372:1319–27. [PubMed: 18804276]
    19.
    Erythromycin (Comment), Neonatal Formulary 5. Available from: www​.blackwellpublishing​.com/medicine/bmj​/nnf5/pdfs/commentary/erythromycin.pdf.
    20.
    Giuliano AE, Hunt KK, Ballman KV, et al. Axillary dissection vs no axillary dissection in women with invasive breast cancer and sentinel node metastasis: a randomized clinical trial. JAMA. 2011;305:569–75. [PubMed: 21304082]
    21.
    General Medical Council. Good Medical Practice. London: GMC; 2006. p. 13.
    22.
    Ashcroft R. Giving medicine a fair trial. BMJ. 2000;320:1686. [PMC free article: PMC1127463] [PubMed: 10864526]
    23.
    Pritchard-Jones K, Dixon-Woods M, Naafs-Wilstra M, et al. Improving recruitment to clinical trials for cancer in childhood. Lancet Oncology. 2008;9:392–9. [PubMed: 18374293]
    24.
    Equator network resource centre for good reporting of health research studies. www​.equator-network.org.
    25.
    Smithells RW. Iatrogenic hazards and their effects. Postgraduate Medical Journal. 1975;15:39–52. [PubMed: 1161684]

    Chapter 6. Fair tests of treatments

    1.
    Hopkins WA. Patulin in the common cold. IV. Biological properties: extended trial in the common cold. Lancet. 1943;ii:631–5.
    2.
    Sanders TAB, Woolfe R, Rantzen E. Controlled evaluation of slimming diets: use of television for recruitment. Lancet. 1990;336:918–20. [PubMed: 1976938]
    3.
    Glasziou P, Chalmers I, Rawlins M, et al. When are randomised trials unnecessary? Picking signal from noise. BMJ. 2007;334:349–51. [PMC free article: PMC1800999] [PubMed: 17303884]
    4.
    Pocock SJ. Randomised clinical trials. BMJ. 1977;1:1661. [PMC free article: PMC1607769] [PubMed: 871714]
    5.
    Balfour TG. West C. Lectures on the Diseases of Infancy and Childhood. London: Longman, Brown, Green and Longmans; 1854. p. 600. Quoted in.
    6.
    King G, Gakidou E, Imai K, et al. Public policy for the poor? A randomised assessment of the Mexican universal health insurance programme. Lancet. 2009;373:1447–54. [PubMed: 19359034]
    7.
    Peto J, Eden OB, Lilleyman J, et al. Improvement in treatments for children with acute lymphoblastic leukaemia: The Medical Research Council UKALL Trials, 1972–84. Lancet. 1986;i:408–11.
    8.
    Noseworthy JH, Ebers GC, Vandervoort MK, et al. The impact of blinding on the results of a randomized, placebo-controlled multiple sclerosis clinical trial. Neurology. 1994;44:16–20. [PubMed: 8290055]
    9.
    Moseley JB, O’Malley K, Petersen NJ, et al. A controlled trial of arthroscopic surgery for osteoarthritis of the knee. New England Journal of Medicine. 2002;347:81–8. [PubMed: 12110735]
    10.
    Venning GR. Validity of anecdotal reports of suspected adverse drug reactions: the problem of false alarms. BMJ. 1982;284:249–54. [PMC free article: PMC1495801] [PubMed: 6799125]
    11.
    McLernon DJ, Bond CM, Hannaford PC, et al. on behalf of the Yellow Card Collaborative. Adverse drug reaction reporting in the UK: a retrospective observational comparison of Yellow Card reports submitted by patients and healthcare professionals. Drug Safety. 2010;33:775–88. [PubMed: 20701410]
    12.
    Kocher T. Ueber Kropfexstirpation und ihre Folgen. Archiv für Klinische Chirurgie. 1883;29:254–337.
    13.
    Silverman WA, Andersen DH, Blanc WA, et al. A difference in mortality rate and incidence of kernicterus among premature infants allotted to two prophylactic regimens. Pediatrics. 1956;18:614–25. [PubMed: 13370229]
    14.
    Zhang J, Ding E, Song Y. Adverse effects of cyclooxygenase 2 inhibitors on renal and arrhythmia events: meta-analysis of randomized trials. JAMA. 2006;296:1619–21. [PubMed: 16968832]
    15.
    Vandenbroucke JP, Psaty BM. Benefits and risks of drug treatments: how to combine the best evidence on benefits with the best data about adverse effects. JAMA. 2008;300:2417–9. [PubMed: 19033592]
    16.
    Whittington CJ, Kendall T, Fonagy P, et al. Selective serotonin reuptake inhibitors in childhood depression: systematic review of published versus unpublished data. Lancet. 2004;363:1341–5. [PubMed: 15110490]

    Chapter 7. Taking account of the play of chance

    1.
    Antithrombotic Trialists’ (ATT) Collaboration. Aspirin in the primary and secondary prevention of vascular disease: collaborative meta-analysis of individual participant data from randomised trials. Lancet. 2009;373:1849–60. [PMC free article: PMC2715005] [PubMed: 19482214]
    2.
    CRASH trial collaborators. Final results of MRC CRASH, a randomised placebo-controlled trial of intravenous corticosteroid in adults with head injury – outcomes at 6 months. Lancet. 2005;365:1957–9. [PubMed: 15936423]
    3.
    CRASH-2 trial collaborators. Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomised, placebo-controlled trial. Lancet. 2010;376:23–32. [PubMed: 20554319]
    4.
    Askie LM, Brocklehurst P, Darlow BA, et al. the NeOProM Collaborative Group. NeOProM: Neonatal Oxygenation Prospective Meta-analysis Collaboration study protocol. BMC Pediatrics. 2011;11:6. [PMC free article: PMC3025869] [PubMed: 21235822]

    Chapter 8. Assessing all the relevant, reliable evidence

    1.
    ISIS-2 (Second International Study of Infarct Survival) Collaborative Group. Randomised trial of intravenous streptokinase, oral aspirin, both, or neither among 17,187 cases of suspected acute myocardial infarction: ISIS-2. Lancet. 1988;332:349–60.
    2.
    Reynolds LA, Tansey EM, editors. Prenatal corticosteroids for reducing morbidity and mortality after preterm birth. London: Wellcome Trust Centre for the History of Medicine; 2005.
    3.
    Dickersin K, Chalmers I. Recognising, investigating and dealing with incomplete and biased reporting of clinical research: from Francis Bacon to the World Health Organisation, James Lind Library 2010. www​.jameslindlibrary.org.
    4.
    Cowley AJ, Skene A, Stainer K, et al. The effect of lorcainide on arrhythmias and survival in patients with acute myocardial infarction: an example of publication bias. International Journal of Cardiology. 1993;40:161–6. [PubMed: 8349379]
    5.
    Moore T. Deadly Medicine. New York: Simon and Schuster; 1995.
    6.
    Stjernswärd J. Decreased survival related to irradiation postoperatively in early operable breast cancer. Lancet. 1974;ii:1285–6.
    7.
    Stjernswärd J. Meta-analysis as a manifestation of ‘bondförnuft’ (‘peasant sense’), JLL Bulletin: Commentaries on the history of treatment evaluation. 2009. www​.jameslindlibrary.org.
    8.
    Fugh-Berman AJ. The haunting of medical journals: how ghostwriting sold “HRT” PLoS Medicine. 2010;7(9):e1000335. [PMC free article: PMC2935455] [PubMed: 20838656]
    9.
    Whittington CJ, Kendall T, Fonagy P, et al. Selective serotonin-reuptake inhibitors in childhood depression: systematic review of published versus unpublished data. Lancet. 2004;363:1341–5. [PubMed: 15110490]
    10.
    Spielmans GI, Biehn TL, Sawrey DL. A case study of salami slicing: pooled analysis of duloxetine for depression. Psychotherapy and Psychosomatics. 2010;79:97–106. [PubMed: 20051707]
    11.
    Antman EM, Lau J, Kupelnick B, et al. A comparison of results of meta-analysis of randomized control trials and recommendations of clinical experts. JAMA. 1992;268:240–8. [PubMed: 1535110]
    12.
    Natanson C, Kern SJ, Lurie P, et al. Cell-free hemoglobin-based blood substitutes and risk of myocardial infarction and death: a meta-analysis. JAMA. 2008;299(19):2304–12. [PubMed: 18443023]
    13.
    Chalmers I. TGN1412 and The Lancet’s solicitation of reports of phase 1 trials. Lancet. 2006;368:2206–7. [PubMed: 17189023]
    14.
    Jack A. Call to release human drug trial data. Financial Times. 2006 Aug 8;
    15.
    Kenter MJH, Cohen AF. Establishing risk of human experimentation with drugs: lessons from TGN1412. Lancet. 2006;368:1387–91. [PubMed: 17046471]
    16.
    McLellan F. 1966 and all that – when is a literature search done? Lancet. 2001;358:646. [PubMed: 11530164]
    17.
    Horn J, Limburg M. Calcium antagonists for acute ischemic stroke. Cochrane Database of Systematic Reviews. 2000;(1):CD001928. [PubMed: 10796454]
    18.
    Horn J, de Haan RJ, Vermeulen M, et al. Nimodipine in animal model experiments of focal cerebral ischemia: a systematic review. Stroke. 2001;32:2433–8. [PubMed: 11588338]
    19.
    O’Collins VE, Macleod MR, Donnan GA, et al. 1,026 experimental treatments in acute stroke. Annals of Neurology. 2006;59:467–77. [PubMed: 16453316]
    20.
    CRASH trial collaborators. Final results of MRC CRASH, a randomised placebo-controlled trial of intravenous corticosteroid in adults with head injury – outcomes at 6 months. Lancet. 2005;365:1957–9. [PubMed: 15936423]

    Chapter 9. Regulating tests of treatments: help or hindrance?

    1.
    Emanuel EJ, Menikoff J. Reforming the regulations governing research with human subjects. New England Journal of Medicine. 2011 DOI: 10.1056/ NEJMsb1106942.NEJM.org.
    2.
    Chalmers I, Lindley R. Double standards on informed consent to treatment. In: Doyal L, Tobias JS, editors. Informed consent in medical research. London: BMJ Books; 2001. pp. 266–75.
    3.
    Fallowfield L, Jenkins V, Farewell V, et al. Efficacy of a Cancer Research UK communicating skills training model for oncologists: a randomised controlled trial. Lancet. 2002;359:650–6. [PubMed: 11879860]
    4.
    Chalmers I. Regulation of therapeutic research is compromising the interests of patients. International Journal of Pharmaceutical Medicine. 2007;21:395–404.
    5.
    Roberts I, Prieto-Marino D, Shakur H, et al. Effect of consent rituals on mortality in emergency care research. Lancet. 2011;377:1071–2. [PubMed: 21439634]

    Chapter 10. Research – good, bad, and unnecessary

    1.
    Equator network resource centre for good reporting of health research studies. www​.equator-network.org.
    2.
    European Carotid Surgery Trialists’ Collaborative Group. Randomised trial of endarterectomy for recently symptomatic carotid stenosis: final results of the MRC European Carotid Surgery Trial (ECST). Lancet. 1998;351:1379–87. [PubMed: 9593407]
    3.
    Cina CS, Clase CM, Haynes RB. Carotid endarterectomy for symptomatic carotid stenosis. The Cochrane Database of Systematic Reviews. 1999;(3):CD001081.
    4.
    The Magpie Trial Collaborative Group. Do women with pre-eclampsia, and their babies, benefit from magnesium sulphate? The Magpie Trial: a randomised, placebo-controlled trial. Lancet. 2002;359:1877–90. [PubMed: 12057549]
    5.
    Duley L, Gülmezoglu AM, Henderson-Smart DJ. Magnesium sulphate and other anticonvulsants for women with pre-eclampsia. Cochrane Database of Systematic Reviews. 2003;(2):CD000025. [PubMed: 12804383]
    6.
    Global Report UNAIDS report on the Global AIDS epidemic. 2010. www​.unaids.org/globalreport​/Global_report.htm.
    7.
    Grimwade K, Swingler G. Cotrimoxazole prophylaxis for opportunistic infections in adults with HIV. Cochrane Database of Systematic Reviews. 2003;(3):CD003108. [PubMed: 12917946]
    8.
    Chintu C, Bhat GJ, Walker AS, et al. Co-trimoxazole as prophylaxis against opportunistic infections in HIV-infected Zambian children (CHAP): a double blind randomised placebo-controlled trial. Lancet. 2004;364:1865–71. [PubMed: 15555666]
    9.
    MRC News Release. Antibiotic drug almost halves AIDS-related death in children. London: MRC; Nov 19, 2004.
    10.
    World Health Organization and UNICEF. Co-trimoxazole prophylaxis for HIV-exposed and HIV-infected infants and children: practical approaches to implementation and scale up. WHO and UNICEF; 2009.
    11.
    Soares K, McGrath J, Adams C. Evidence and tardive dyskinesia. Lancet. 1996;347:1696–7. [PubMed: 8642986]
    12.
    Thornley B, Adams C. Content and quality of 2000 controlled trials in schizophrenia over 50 years. BMJ. 1998;317:1181–4. [PMC free article: PMC28699] [PubMed: 9794850]
    13.
    Howell CJ, Chalmers I. A review of prospectively controlled comparisons of epidural with non-epidural forms of pain relief during labour. International Journal of Obstetric Anesthesia. 1992;1:93–110. [PubMed: 15636806]
    14.
    Horn J, Limburg M. Calcium antagonists for acute ischemic stroke. Cochrane Database of Systematic Reviews. 2000;(1):CD001928. [PubMed: 10796454]
    15.
    Horn J, de Haan RJ, Vermeulen RD, Luiten PGM, et al. Nimodipine in animal model experiments of focal cerebral ischemia: a systematic review. Stroke. 2001;32:2433–8. [PubMed: 11588338]
    16.
    Fergusson D, Glass KC, Hutton B, et al. Randomized controlled trials of aprotinin in cardiac surgery: using clinical equipoise to stop the bleeding. Clinical Trials. 2005;2:218–32. [PubMed: 16279145]
    17.
    Tallon D, Chard J, Dieppe P. Relation between agendas of the research community and the research consumer. Lancet. 2000;355:2037–40. [PubMed: 10885355]
    18.
    Cream J, Cayton H. New drugs for Alzheimer’s disease – a consumer perspective. CPD Bulletin Old Age Psychiatry. 2001;2:80–2.
    19.
    Cohen CI, D’Onofrio A, Larkin L, et al. A comparison of consumer and provider preferences for research on homeless veterans. Community Mental Health Journal. 1999;35:273–9. [PubMed: 10401896]
    20.
    Griffiths KM, Jorm AF, Christensen H, et al. Research priorities in mental health, Part 2: an evaluation of the current research effort against stakeholders’ priorities. Australian and New Zealand Journal of Psychiatry. 2002;36:327–39. [PubMed: 12060181]
    21.
    Oliver S, Gray J. A bibliography of research reports about patients’, clinicians’ and researchers’ priorities for new research. London: James Lind Alliance; Dec, 2006.
    22.
    Chalmers I. Current controlled trials: an opportunity to help improve the quality of clinical research, Current Controlled Trials in Cardiovascular Medicine. 2000. pp. 3–8. Available from: http://cvm​.controlled-trials​.com/content/1/1/3.
    23.
    Safeguarding participants in controlled trials. Lancet. 2000;355:1455–63. Editorial.
    24.
    Fugh-Berman A. The haunting of medical journals: how ghostwriting sold “HRT” PLoS Medicine. 2010;7(9):e10000335.
    25.
    Heimans L, van Hylckama V, Dekker FW. Are claims of advertisements in medical journals supported by RCTs? Netherlands Journal of Medicine. 2010;68:46–9. [PubMed: 20103825]
    26.
    Lexchin J, Bero LA, Djulbeovic B, et al. Pharmaceutical industry sponsorship and research outcome and quality: systematic review. BMJ. 2003;326:1167–76. [PMC free article: PMC156458] [PubMed: 12775614]
    27.
    Weatherall D. Academia and industry: increasingly uneasy bedfellows. Lancet. 2000;355:1574. [PubMed: 10821359]
    28.
    Angell M. Is academic medicine for sale? New England Journal of Medicine. 2000;342:1516–8. [PubMed: 10816191]
    29.
    Grant J, Green L, Mason B. From bench to bedside: Comroe and Dripps revisited HERG Research Report No 30. Uxbridge, Middlesex: Brunel University Health Economics Research Group; 2003.
    30.
    Pound P, Ebrahim S, Sandercock P, et al. Reviewing Animal Trials Systematically (RATS) Group. Where is the evidence that animal research benefits humans? BMJ. 2004;328:514–7. [PMC free article: PMC351856] [PubMed: 14988196]
    31.
    Weatherall D. The quiet art revisited. Lancet. 2011;377:1912–13. [PubMed: 21648122]
    32.
    Pirmohamed M. Cited in Mayor S. Fitting the drug to the patient. BMJ. 2007;334:452–3. [PMC free article: PMC1808171] [PubMed: 17332583]
    33.
    The human genome at ten. Nature. 2010;464:649–50. Editorial. [PubMed: 20360688]
    34.
    Mackillop WJ, Palmer MJ, O’Sullivan B, et al. Clinical trials in cancer: the role of surrogate patients in defining what constitutes an ethically acceptable clinical experiment. British Journal of Cancer. 1989;59:388–95. [PMC free article: PMC2247073] [PubMed: 2930704]
    35.
    The Psoriasis Association. www​.psoriasis-association.org.uk.
    36.
    National Psoriasis Association. Statistics about psoriasis. www​.psoriasis.org/netcommunity​/learn_statistics.
    37.
    Jobling R. Therapeutic research into psoriasis: patients’ perspectives, priorities and interests. In: Rawlins M, Littlejohns P, editors. Delivering quality in the NHS 2005. Abingdon: Radcliffe Publishing Ltd; pp. 53–6.

    Chapter 11. Getting the right research done is everybody’s business

    1.
    Oliver S, Clarke-Jones L, Rees R, et al. Involving consumers in research and development agenda setting for the NHS: developing an evidence-based approach. Health Technology Assessment Report. 2004;8(15)
    2.
    NIHR Guy’s and St. Thomas’ and King’s College London’s Biomedical Research Centre. Involving users in the research process: a ‘how to’ guide for researchers. Version 1, April 2010. Available from: www​.biomedicalresearchcentre.org.
    3.
    Cartwright J, Crowe S. Patient and public involvement toolkit. London: Wiley-Blackwell and BMJI Books; 2011.
    4.
    European Science Foundation/EMRC. Implementation of medical research in clinical practice – a growing challenge. Strasbourg: ESF; 2011.
    5.
    Hanley B, Truesdale A, King A, et al. Involving consumers in designing, conducting, and interpreting randomised controlled trials: questionnaire survey. BMJ. 2001;322:519–23. [PMC free article: PMC26555] [PubMed: 11230065]
    6.
    Koops L, Lindley RI. Thrombolysis for acute ischaemic stroke: consumer involvement in design of new randomised controlled trial. BMJ. 2002;325:415–7. [PMC free article: PMC119434] [PubMed: 12193356]
    7.
    Staley K. Exploring impact: public involvement in NHS, public health and social care research. Eastleigh: INVOLVE; 2009. Available from: www​.invo.org.uk.
    8.
    Petit-Zeman S, Firkins L, Scadding JW. The James Lind Alliance: tackling research mismatches. Lancet. 2010;376:667–9. [PubMed: 20801389]
    9.
    Patient Partner Project. An EU programme ‘Identifying the needs for patients partnering in clinical research’. www​.patientpartner-europe.eu.
    10.
    Thornton H, Edwards A, Elwyn G. Evolving the multiple roles of ‘patients’ in health-care research: reflections after involvement in a trial of shared decision-making. Health Expectations. 2003;6:189–97. [PubMed: 12940792]
    11.
    Dixon-Woods M, Agarwal S, Young B, et al. Integrative approaches to qualitative and quantitative evidence. NHS Health Development Agency; 2004.
    12.
    Kushner R. Breast cancer: a personal history and an investigative report. New York: Harcourt Brace Jovanovitch; 1975.
    13.
    Lerner BH. The breast cancer wars: hope, fear, and the pursuit of a cure in twentieth-century America. New York: Oxford University Press; 2003.
    14.
    Institute of Medical Ethics Working Party on the ethical implications of AIDS: AIDS, ethics, and clinical trials. BMJ. 1992;305:699–701. [PMC free article: PMC1882942] [PubMed: 1393120]
    15.
    Thornton H. The patient’s role in research. Health Committee Third Report. Breast cancer services Volume II Minutes of evidence and appendices; Paper given at The Lancet ‘Challenge of Breast Cancer’ Conference; Brugge. April 1994; London: HMSO; Jul, 1995. pp. 112–4.
    16.
    Concorde Coordinating Committee. Concorde: MRC/ANRS randomised double-blind controlled trial of immediate and deferred zidovudine in symptom-free HIV infection. Lancet. 1994;343:871–81. [PubMed: 7908356]
    17.
    Perehudoff K, Alves TL. Patient and consumer organisations at the European Medicines Agency: financial disclosure and transparency. Amsterdam: Health Action International; 2010. Available from www​.haieurope.org.
    18.
    Herxheimer A. Relationships between the pharmaceutical industry and patients’ organisations. BMJ. 2003;326:1208–10. [PMC free article: PMC1126060] [PubMed: 12775627]
    19.
    Consumers’ Association. Who’s injecting the cash, Which? 2003. Apr, pp. 24–25.
    20.
    Koops L, Lindley RI. Thrombolysis for acute ischaemic stroke: consumer involvement in design of new randomised controlled trial. BMJ. 2002;325:415–7. [PMC free article: PMC119434] [PubMed: 12193356]
    21.
    Donovan J, Mills N, Smith M, et al. for the ProtecT Study Group. Quality improvement report: improving design and conduct of randomised trials by embedding them in qualitative research: ProtecT (prostate testing for cancer and treatment) study. BMJ. 2002;325:766–70. [PMC free article: PMC1124277] [PubMed: 12364308]

    Chapter 12. So what makes for better healthcare?

    1.
    Edwards A, Elwyn G, Atwell C, et al. Shared decision making and risk communication in general practice – a study incorporating systematic literature reviews, psychometric evaluation of outcome measures, and quantitative, qualitative and health economic analyses of a cluster randomised trial of professional skill development, Report to Health in Partnership programme, UK Department of Health. Cardiff: Department of General Practice. University of Wales College of Medicine; 2002.
    2.
    Farrell C, editor. Patient and public involvement in health: The evidence for policy implementation. A summary of the results of the Health in Partnership research programme. London: Department of Health Publications; Apr, 2004. Available from: www​.dh.gov.uk/en/Publicationsandstatistics​/Publications/PublicationsPolicyAndGuidance/DH_4082332.
    3.
    Marshall T. Prevention of cardiovascular disease, Risk and benefit calculator. Adapted from. Available from: www​.haps.bham.ac.uk/publichealth​/cardiovascular/index.shtml.
    4.
    Evans I, Thornton H. Transparency in numbers: the dangers of statistical illiteracy. Journal of the Royal Society of Medicine. 2009;102:354–6. [PMC free article: PMC2738764] [PubMed: 19734524]
    5.
    Irwig L, Irwig J, Trevena L, et al. Smart health choices: making sense of health advice. London: Hammersmith Press; 2008.
    6.
    Salzburg Global Seminar website. www​.salzburgglobal.org.
    7.
    Salzburg statement on shared decision making: Salzburg Global Seminar, BMJ. 2011. p. d1745. Available from: www​.bmj.com/content/342/bmj.d1745.full.

    Chapter 13. Research for the right reasons: blueprint for a better future

    1.
    Chalmers 1, Glasziou P. Avoidable waste in the production and reporting of research evidence. Lancet. 2009;374:86–89. [PubMed: 19525005]
    2.
    Roberts I, Yates D, Sandercock P, et al. CRASH trial collaborators. Effect of intravenous corticosteroids on death within 14 days in 10008 adults with clinically significant head injury (MRC CRASH trial): randomised placebo-controlled trial. Lancet. 2004;364:1321–8. [PubMed: 15474134]
    3.
    Cochrane Injuries Group Albumin Reviewers. Human albumin administration in critically ill patients: systematic review of randomised controlled trials. BMJ. 1998;317:235–40. [PMC free article: PMC28613] [PubMed: 9677209]
    4.
    Finfer S, Bellomo R, Bryce N, et al. SAFE Study Investigators. A comparison of albumin and saline for fluid resuscitation in the intensive care unit. New England Journal of Medicine. 2004;350:2247–56. [PubMed: 15163774]
    5.
    Edwards A, Elwyn G, Atwell C, et al. Shared decision making and risk communication in general practice – a study incorporating systematic literature reviews, psychometric evaluation of outcome measures, and quantitative, qualitative and health economic analyses of a cluster randomised trial of professional skill development, Report to Health in Partnership programme, UK Department of Health. Cardiff: Department of General Practice. University of Wales College of Medicine; 2002.
    6.
    Farrell C, editor. Patient and public involvement in health: The evidence for policy implementation. A summary of the results of the Health in Partnership research programme. London: Department of Health Publications; Apr, 2004. Available from: www​.dh.gov.uk/en/Publicationsandstatistics​/Publications/PublicationsPolicyAndGuidance/DH_4082332.
    7.
    Donovan J, Mills N, Smith M, et al. for the ProtecT Study Group. Quality improvement report: improving design and conduct of randomised trials by embedding them in qualitative research: ProtecT (prostate testing for cancer and treatment) study. BMJ. 2002;325:766–70. [PMC free article: PMC1124277] [PubMed: 12364308]
    8.
    Dickersin K, Chalmers I. Recognising, investigating and dealing with incomplete and biased reporting of clinical research: from Francis Bacon to the World Health Organization, James Lind Library. 2010. www​.jameslindlibrary.org.
    9.
    Chan A-W, Hróbjartsson A, Haahr MT, et al. Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles. JAMA. 2004;291:2457–65. [PubMed: 15161896]
    10.
    Chan AW, Altman DG. Epidemiology and reporting of randomised trials published in PubMed journals. Lancet. 2005;365:1159–62. [PubMed: 15794971]
    11.
    Glasziou P, Meats E, Heneghan C, Shepperd S. What is missing from descriptions of treatment in trials and reviews? BMJ. 2008;336:1472–4. [PMC free article: PMC2440840] [PubMed: 18583680]
    12.
    Clarke M, Hopewell S, Chalmers I. Clinical trials should begin and end with systematic reviews of relevant evidence: 12 years and waiting. Lancet. 2010;376:20–21. [PubMed: 20609983]

Copyright © 2011 Imogen Evans, Hazel Thornton, Iain Chalmers and Paul Glasziou.

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Testing Treatments: Better Research for Better Healthcare. 2nd edition.
Evans I, Thornton H, Chalmers I, et al.
London: Pinter & Martin; 2011.
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