Relevant Publications

This list contains publications from members of our group and other papers highly relevant to our work. This list is only the begining. Please send others you have found useful and would like to see added to Su Golder at spg3@york.ac.uk

General Guidance/ Discussion Papers

• Cochrane Handbook for Systematic Reviews of Interventions (formerly the Reviewers' Handbook).
• Loke  YK, Price D, Herxheimer A. Systematic reviews of adverse effects: framework for a structured approach    BMC Med Res Methodol 2007;7:32.
• Chou R, Helfand M. Challenges in systematic reviews that assess treatment harms. Ann Intern Med 2005;142:1090-9.
• Etminan M, Carleton B, Rochon PA. Quantifying adverse drug events - are systematic reviews the answer? Drug Safety 2004;27:757-61.
• McIntosh H, Woolacott N, Bagnall A-M. Assessing harmful effects in systematic reviews. BMC Med Res Methodol 2004;4:6.
• Special Issue: Balancing benefits and harms in health care. BMJ 2004;329:1-60.

Current Practice

• Golder S, Loke Y, McIntosh HM. Room for improvement? A survey of the methods used in systematic reviews of adverse effects. BMC Med Res Methodol 2006;6.

Information Retrieval

• Golder S, McIntosh H, Duffy S, Glanville J. Developing efficient search strategies to identify reports of adverse effects in MEDLINE and EMBASE. Health Info Libr J 2006;23:3-12.
• Derry S, Loke YK, Aronson K. Incomplete evidence: the inadeqacy of databases in tracing published adverse drug reactions in clinical trials. BMC Med Res Methodol 2001;1.

Sources of Evidence

• Ioannidis JPA, Mulrow CD, Goodman SG. Adverse events: the more you search, the more you find. Ann Intern Med 2006;144:298-300.
• Scharf O, Colevas AD. Adverse event reporting in publications compared with sponsor database for cancer clinical trials. J Clin Oncol 2006;24:3933-8
• Als-Nielsen B, Chen W, Gluud C, Kjaergard LL. Association of funding and conclusions in randomized drug trials: a reflection of treatment effect or adverse events? JAMA 2003;290:921-28.
• Ross SD. Drug-related adverse events: a readers' guide to assessing literature reviews and meta-analyses. Arch Intern Med 2001;161:1041-6.

Spontaneous Reports

• Ahmad SR, Goetsch GA, Marks NS. Spontaneous Reporting in the United States. In: Strom BE, editor. Pharmacoepidemiology. 4th ed. West Sussex, England: Wiley and Sons; 2005. p. 135-59.
• Ahmad SR. Adverse Drug Event Monitoring at the Food and Drug Administration:  Your Report Can Make a Difference. J Gen Intern Med 2003;18:57-60.

Types of Evidence

• Aronson JK, Hauben M.  Anecdotes that provide definitive evidence. BMJ 2006;16:1267-9. 
• Aronson JK. Monitoring for harms of therapy. Br J Clin Pharmacol 2006;61:365-6. 
• Loke YK, Price D, Derry S, Aronson JK.  Case reports of suspected adverse drug reactions--systematic literature survey of follow-up. BMJ 2006;332:335-9. 
• Vandenbroucke JP. What is the best evidence for determining harms of medical treatment? CMAJ 2006;174:645-6. 
• Loke YK, Derry S, Aronson JK. A comparison of three different sources of data in assessing the frequencies of adverse reactions to amiodarone. Br J Clin Pharmacol 2004;57:616-21.
• Papanikolaou PN, Ioannidis JPA. Availability of large-scale evidence on specific harms from systematic reviews of randomized trials. Am J Med 2004;117:582-9.

Study Quality

• Chou R, Fu R, Carson S, Saha S, Helfand M. Methodological shortcomings predicted lower harm estimates in one of two sets of studies of clinical interventions. J Clin Epidemiol 2007;60:18-28.
• Martin RC, Brennan MF, Jaques DP. Quality of complication reporting in the surgical literature. Ann Surg 2002;235:803-13.
• Levine M, Walter S, Lee H, Haines T, Holbrook A, Moyer V. How to use an article about harm. Centre for Health Evidence, Canada; 2001.

Reporting

• Golder S, Loke Y. Is there evidence for biased reporting of published adverse effects data in pharmaceutical industry-funded studies? British Journal of Clinical Pharmacology 2008: 66(6): 767-73.
• Ioannidis JP, Evans S, Gøtzsche PC, O'Neil RT, Altman DG, Schulz K, et al. Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med 2004;141:781-8.
• Gøtzsche PC, CONSORT-gruppen. [Better reporting of harms in randomized trials: an extension of the CONSORT statement][Article in Danish]. Ugeskr Laeger 2005;167:1520-2.
• Papanikolaou PN, Churchill R, Wahlbeck K, Ioannidis JPA, Project TE-P. Safety reporting in RCTs of mental health interventions Am J Psychiatry 2004;161:1692-97.
• Ioannidis JPA, Lau J. Improving safety reporting from randomised trials. Drug Safety 2002;25:77-84.
•  Loke YK, Derry S. Reporting of adverse drug reactions in randomised controlled trials - a systematic survey. BMC Clin Pharmacol 2001;1.

Evidence Synthesis

• Ashby D, Smyth RL, Brown PJ. Statistical issues in pharmaco-epidemiological case-control studies.  Stats Med 1998;17:1839-1850.
• Smyth RL, Ashby D, O'Hea U, Burrows E, Lewis P, van Velzen D, Dodge JA. (1995) Fibrosing colonopathy in cystic fibrosis: results of a case-control study.  Lancet 1995;346:1247-1251.
• Sutton AJ, Cooper NJ, Lambert PC, Jones DR, Abrams KR, Sweeting MJ. Meta-analysis of rare and adverse event data. Expert Review of Pharmacoeconomics and Outcomes Research 2002;2:367-79.
   

Communicating about Risks and Harms

• Herxheimer A.  Side effects: freedom of information and the communication of doubt. (Side Effects of Drugs Essay) In: Side Effects of Drugs Annual 19, ed Aronson J. Amsterdam: Elsevier;1996, p xix-xxvii.
• Herxheimer A.  Communicating with patients about risks and harms.  PLoS Medicine 2005; 2(2):e42-43.