Discussion sections in reports of controlled trials published in general medical journals: islands in search of continents?

CONTEXT Several journals have adopted the Consolidated Standards of Reporting Trials (CONSORT) recommendations to make assessment of the quality of randomized controlled trials (RCTs) easier. One of these recommendations is that the trial's results be discussed in light of the totality of the available evidence. OBJECTIVE To assess the extent to which reports of RCTs published in 5 general medical journals have discussed new results in light of all available evidence. DESIGN Assessment of the discussion sections in all 26 reports of RCTs published during May 1997 in Annals of Internal Medicine, BMJ, JAMA, The Lancet, and The New England Journal of Medicine. MAIN OUTCOME MEASURE The inclusion or mention of a systematic review in the discussion section of each article. RESULTS In only 2 articles were the RCT's results discussed in the context of an updated systematic review of earlier trials. In a further 4 articles, references were made to relevant systematic reviews, but no attempts were made to integrate the results of the new trials in updated versions of these reviews. One article was probably the first published trial to address the question studied. The remaining 19 articles included no evidence that any systematic attempt had been made to set the reported trial's results in the context of previous trials. CONCLUSION There is little evidence that journals have adequately implemented the CONSORT recommendation that results of an RCT be discussed in light of the totality of the available evidence.

[1]  Stgrp Capture,et al.  Randomised placebo-controlled trial of abciximab before and during coronary intervention in refractory unstable angina: the CAPTURE study , 1997, The Lancet.

[2]  Dwight Lemon,et al.  Randomised trial of intravenous atenolol among 16,027 cases of suspected acute myocardial infarction: ISIS-1 , 1987 .

[3]  H. Bruining,et al.  p55 Tumor Necrosis Factor Receptor Fusion Protein in the Treatment of Patients With Severe Sepsis and Septic Shock: A Randomized Controlled Multicenter Trial , 1997 .

[4]  K. Malmberg.  Prospective randomised study of intensive insulin treatment on long term survival after acute myocardial infarction in patients with diabetes mellitus , 1997, BMJ.

[5]  F. Wit,et al.  Randomised trial of addition of lamivudine or lamivudine plus loviride to zidovudine-containing regimens for patients with HIV-1 infection: the CAESAR trial , 1997 .

[6]  P. Gøtzsche.  Reference bias in reports of drug trials. , 1987, British medical journal.

[7]  J. Muñoz,et al.  [Lost Science in the Third World]. , 1996, Gaceta medica de Mexico.

[8]  H. Winn,et al.  Administration of Methylprednisolone for 24 or 48 Hours or Tirilazad Mesylate for 48 Hours in the Treatment of Acute Spinal Cord Injury: Results of the Third National Acute Spinal Cord Injury Randomized Controlled Trial , 1998 .

[9]  F. Chan,et al.  Randomised comparison between adrenaline injection alone and adrenaline injection plus heat probe treatment for actively bleeding ulcers , 1997, BMJ.

[10]  M. Bennish,et al.  Treatment of Shigellosis: V. Comparison of Azithromycin and Ciprofloxacin: A Double-Blind, Randomized, Controlled Trial , 1997, Annals of Internal Medicine.

[11]  V. Pérez,et al.  Randomised, double-blind, placebo-controlled trial of pindolol in combination with fluoxetine antidepressant treatment , 1997, The Lancet.

[12]  S G Mize,et al.  An Evaluation of the Quality of Therapeutic Studies in Perinatal Medicine , 1983, The Journal of pediatrics.

[13]  L. Stassen,et al.  Comparison of conventional anterior surgery and laparoscopic surgery for inguinal-hernia repair. , 1997, The New England journal of medicine.

[14]  W. El-Sadr,et al.  Weekly Fluconazole for the Prevention of Mucosal Candidiasis in Women with HIV Infection , 1997, Annals of Internal Medicine.

[15]  M. Grace,et al.  Randomised double-blind placebo-controlled study on adverse effects of rubella immunisation in seronegative women , 1997, The Lancet.

[16]  P. Krogstad,et al.  Combination treatment with zidovudine, didanosine, and nevirapine in infants with human immunodeficiency virus type 1 infection. , 1997, The New England journal of medicine.

[17]  I. Stiell,et al.  A randomized trial comparing octylcyanoacrylate tissue adhesive and sutures in the management of lacerations. , 1997, JAMA.

[18]  R. Warren.  Reasons for writing. , 1973, Archives of surgery.

[19]  Lesley Rushton,et al.  Effect of long term treatment with salmeterol on asthma control: a double blind, randomised crossover study , 1997, BMJ.

[20]  Z Taintor,et al.  An update on software. , 1987, Hospital & community psychiatry.

[21]  F P Rivara,et al.  Effectiveness of a violence prevention curriculum among children in elementary school. A randomized controlled trial. , 1997, JAMA.

[22]  K. Groenier,et al.  Comparison of physiotherapy, manipulation, and corticosteroid injection for treating shoulder complaints in general practice: randomised, single blind study , 1997, BMJ.

[23]  Caroline Leigh Watkins.  The International Stroke Trial (IST): a randomised trial of aspirin, subcutaneous heparin, both, or neither among 19 435 patients with acute ischaemic stroke , 1997 .

[24]  J. Blumberg,et al.  Vitamin E supplementation and in vivo immune response in healthy elderly subjects. A randomized controlled trial. , 1997, JAMA.

[25]  Bill Williams,et al.  Cost effectiveness of day and inpatient psychiatric treatment: results of a randomised controlled trial , 1997, BMJ.

[26]  F M Campbell,et al.  National bias: a comparison of citation practices by health professionals. , 1990, Bulletin of the Medical Library Association.

[27]  S. Ball,et al.  Follow-up study of patients randomly allocated ramipril or placebo for heart failure after acute myocardial infarction: AIRE Extension (AIREX) Study , 1997, The Lancet.

[28]  S. Spruance,et al.  Penciclovir cream for the treatment of herpes simplex labialis. A randomized, multicenter, double-blind, placebo-controlled trial. Topical Penciclovir Collaborative Study Group. , 1997, JAMA.

[29]  A. Pileri,et al.  High-dose chemotherapy and autologous bone marrow transplantation compared with MACOP-B in aggressive B-cell lymphoma. , 1997, The New England journal of medicine.

[30]  I. Olkin,et al.  Improving the quality of reporting of randomized controlled trials. The CONSORT statement. , 1996, JAMA.

[31]  T. Lancet,et al.  Randomised trial of addition of lamivudine or lamivudine plus loviride to zidovudine-containing regimens for patients with HIV-1 infection: the CAESAR trial , 1997, The Lancet.

[32]  ISIS-1 Collaborative Group.  RANDOMISED TRIAL OF INTRAVENOUS ATENOLOL AMONG 16 027 CASES OF SUSPECTED ACUTE MYOCARDIAL INFARCTION: ISIS-1 , 1986, The Lancet.

[33]  T. Chalmers,et al.  Minimizing the three stages of publication bias. , 1990, JAMA.

[34]  Peter Sandercock,et al.  The International Stroke Trial (IST): a randomised trial of aspirin, subcutaneous heparin, both, or neither among 19 435 patients with acute ischaemic stroke , 1997, The Lancet.

[35]  O. D. Del Brutto,et al.  [Lost science in the third world]. , 1996, Revista de neurologia.

[36]  E. Hemminki.  Quality of Clinical Trials — A Concern of Three Decades , 1982, Methods of Information in Medicine.

[37]  K. McPherson,et al.  THE EFFECTS OF HOSPITAL ADMISSION FOR BED REST ON THE DURATION OF TWIN PREGNANCY: A RANDOMISED TRIAL , 1985, The Lancet.

[38]  Randomised placebo-controlled trial of effect of eptifibatide on complications of percutaneous coronary intervention: IMPACT-II. Integrilin to Minimise Platelet Aggregation and Coronary Thrombosis-II. , 1997, Lancet.

[39]  N. Bishop,et al.  Aluminum neurotoxicity in preterm infants receiving intravenous-feeding solutions. , 1997, The New England journal of medicine.

[40]  W. Reinisch,et al.  Intravenous Iron and Erythropoietin for Anemia Associated with Crohn Disease , 1997, Annals of Internal Medicine.

[41]  P. Rochon,et al.  A study of manufacturer-supported trials of nonsteroidal anti-inflammatory drugs in the treatment of arthritis. , 1994, Archives of internal medicine.

[42]  N. Goodman,et al.  The hypertensive response to intubation. Do researchers acknowledge previous work? , 1997, Canadian journal of anaesthesia = Journal canadien d'anesthesie.