This list contains publications from members of our group and other resources and papers highly relevant to our work. This list is only the beginning. Please send others you have found useful and would like to see added to Su Golder at email@example.com
- General Guidance/ Discussion Papers
- Current Practice in Systematic Reviews
- Search Strategies to Identify Adverse Effects
- Sources of Evidence
- Study Design
- Spontaneous Reports
- Study Quality
- Reporting in RCTs
- Evidence Synthesis
- Communicating about Risks and Harms
General Guidance/ Discussion Papers
- Zorzela L, Loke YK, Ioannidis JP, Golder S, Santaguida P, Altman DG, Moher D, Vohra S. PRISMA harms checklist: improving harms reporting in systematic reviews. BMJ 2016;352:i157.
- Berlin JA, Crowe BJ, Whalen E, Xia HA, Koro CE, and Kuebler J. Meta-analysis of clinical trial safety data in a drug development program: Answers to frequently asked questions. Clin Trials 2013;10 20-31.
- Loke YK, Golder SP, Vandenbrouche JP. Comprehensive evaluations of the adverse effects of drugs: importance of appropriate study selection and data sources. Therapeutic Advances in Drug Safety. 2011; 2(2) 59-68.
- Chou R, Aronsonb N, Atkinsc D, Ismailad AS, Santaguidad P, Smithe DH, et al. AHRQ Series Paper 4: Assessing harms when comparing medical interventions: AHRQ and the Effective Health-Care Program Journal of Clinical Epidemiology 2010;63:502-12.
- 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.
- Etminan M, Carleton B, Rochon PA. Quantifying adverse drug events : are systematic reviews the answer? Drug Saf 2004;27:757-61.
- Ross SD. Drug-related adverse events: a readers' guide to assessing literature reviews and meta-analyses. Arch Intern Med 2001;161:1041-6.
Current Practice in Systematic Reviews
- Cooney L, Loke YK, Golder S, Kirkham J, Jorgensen A, Sinha I, Hawcutt D.Overview of systematic reviews of therapeutic ranges: methodologies and recommendations for practice. BMC Med Res Methodol. 2017 Jun 2;17(1):84. doi: 10.1186/s12874-017-0363-z.
- Golder S, Loke YK, Wright K, Sterrantino C. Most systematic reviews of adverse effects did not included unpublished data. J Clin Epidemiology. 2016.
- Saini P, Loke YK, Gamble C, Altman DG, Williamson PR, Kirkham JJ. Selective reporting bias of harm outcomes within studies: findings from a cohort of systematic reviews. BMJ. 2014 Nov 21;349.
- Golder S, Loke YK, Zorzela L. Comparison of search strategies in systematic reviews of adverse effects to other systematic reviews. Health Info Libr J 2014;31(2):92-105.
- Zorzela L, Golder S, Liu Y, Pilkington K, Hartling L, Joffe A, Loke Y, Vohra S. Quality of reporting in systematic reviews of adverse events: systematic review. BMJ. 2014: 348.
- Golder S, Loke YK, Zorzela L. Some improvements are apparent in identifying adverse effects in systematic reviews from 1994 to 2011.J Clin Epidemiol 2013;66(3):253-60.
- Alves C, Batel-Marques F, Filipa Macedo A. Data sources on drug safety evaluation: a review of recent published meta-analyses. Pharmacoepidemiol Drug Saf 2012;21: 21-33.
- Pilkington K, Boshnakova A. Complementary medicine and safety: A systematic investigation of design and reporting of systematic reviews.Complement Ther Med 2012;20:73-82.
- Warren FC, Abrams KR, Golder S, Sutton AJ. Systematic review of methods used in meta-analyses where a primary outcome is an adverse or unintended event. BMC Medical Research Methodology 2012;12:64.
- Cornelius VR, Perrio MJ, Shakir SAW, Smith LA. Systematic reviews of adverse effects of drug interventions: a survey of their conduct and reporting quality. Pharmacoepidemiol Drug Saf 2009;18:1223-31.
- Golder S, Loke Y, McIntosh HM. Poor reporting and inadequate searches were apparent in systematic reviews of adverse effects.J Clin Epidemiol2008;61(5):440-8.
- Bastian H, Schultheis A. Good news about bad news: Improvements in attention to adverse effects in Cochrane reviews (1997-2007).15th Cochrane Colloquium; 23-27 October 2007; Sao Paulo, Brazil.
- 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.
- Papanikolaou PN, Ioannidis JP. Availability of large-scale evidence on specific harms from systematic reviews of randomized trials. Am J Med 2004;117:582-9.
- Price D, Jefferson T, Demicheli V. Methodological issues arising from systematic reviews of the evidence of safety of vaccines. Vaccine 2004;22:2080-4.
- Ernst E, Pittler MH. Assessment of therapeutic safety in systematic reviews: literature review.BMJ2001;323:546.
- Ernst E, Pittler MH. Systematic reviews neglect safety issues.Arch Intern Med2001;161:125-6.
- Cosmi B, Castelvetri C, Milandri M, Rubboli A, Conforti A. The evaluation of rare adverse drug events in Cochrane reviews: the incidence of thrombotic thrombocytopenic purpura after ticlopidine plus aspirin for coronary stenting.8th Annual Cochrane Colloquium; October 2000; Cape Town; South Africa.
Search Strategies to Identify Adverse Effects
- Golder S, Wright K, Rodgers M. Failure or success of search strategies to identify adverse effects of medical devices: a feasibility study using a systematic review. Systematic Reviews 2014, 3:113.
- Golder S, Loke YK, Zorzela L. Comparison of search strategies in systematic reviews of adverse effects to other systematic reviews.Health Information and Libraries Journal.. 2014;31(2):92-105.
- Golder S, Loke YK, Zorzela L. Optimising the retrieval of information on adverse drug effects.Health Info Libr J.2013;30(4):327-31.
- Golder S, Loke YK Failure or success of electronic search strategies to identify adverse effects data.J Med Libr Assoc 2012;100(2):130-4.
- Golder S, Loke YK. The performance of adverse effects search filters in MEDLINE and EMBASE.Health Info Libr J 2012;29(2):141-51.
- Golder S, Loke YK. Sensitivity and precision of adverse effects search filters in MEDLINE and EMBASE: a case study of fractures with thiazolidinediones. Health Info Libr J 2012;29(1):28-38.
- Golder S, Loke YK. The contribution of different information sources for adverse effects data.Int J Technol Assess Health Care. 2012;28(2):133-7.
- Golder S, Loke YK. Sources of information on adverse effects: a systematic review.Health Info Libr J 2010;27(3):176-90.
- Golder S, Loke YK. Search strategies to identify information on adverse effects: a systematic review. Journal of the Medical Library Association 2009:97(2): 84–92.
- 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.
- Ioannidis JP, Mulrow CD, Goodman SN. Adverse events: the more you search, the more you find. Ann Intern Med 2006;144:298-300.
- Golder S, McIntosh HM, Loke Y. Identifying systematic reviews of the adverse effects of health care interventions.BMC Med Res Methodol 2006;8;6:22.
- 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.
Golder S, Loke YK, Wright K, Norman G. Reporting of Adverse Events in Published and Unpublished Studies of Health Care Interventions: A Systematic Review. Plos Med. 2016;13(9).
- Golder S, Wright K, Rodgers M. The contribution of different information sources to identify adverse effects of a medical device: a case study using a systematic review of spinal fusion. International Journal of Health Technology Assessment in Health Care 2014, 30:4,1-7.
- Golder S, Loke YK. The contribution of different information sources for adverse effects data.International Journal of Technology Assessment in Health Care 2012;28(2):133-7.
- Golder S, Loke YK. Sources of information on adverse effects: a systematic review. Health Information and Libraries Journal 2010;27(3):176-90.
- Golder S, Loke YK, Bland M. Unpublished data can be of value in systematic reviews of adverse effects: methodological overview. Journal of Clinical Epidemiology 2010;63(10):1071-1081.
- 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 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.
- Golder S, Loke YK, Bland M.Comparison of pooled risk estimates for adverse effects from different observational study designs: methodological overview.PLoS One. 2013 Aug 20;8(8):e71813. doi: 10.1371/journal.pone.0071813.
- Golder SP, Loke YK, Bland M. Meta-analyses of Adverse Effects Data Derived from Randomised Controlled Trials as Compared to Observational Studies: Methodological Overview. PLOS Medicine 2011;8(5) e1001026.
- 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, Christidi GD, Ioannidis JPA. Comparison of evidence on harms of medical interventions in randomized and nonrandomized studies. CMAJ 2006;174:635-41.
- 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.
- Schroll JB, Maund E, Gøtzsche PC (2012) Challenges in coding adverse events in clinical trials: a systematic review. PLoS ONE 7(7):e41174
- Jefferson T, Jones MA, Doshi P, Del Mar CB, Heneghan CJ, Hama R, Thompson MJ. Neuraminidase inhibitors for preventing and treating influenza in healthy adults and children. Cochrane Database of Systematic Reviews 2012, Issue 1. Art. No.: CD008965. DOI: 10.1002/14651858.CD008965.pub3
This will contain an evolution of methods to extract appraise and synthesize harms evidence from clinical study reports
- 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 in RCTs
- Favier R, Crépin S. The reporting of harms in publications on randomized controlled trials funded by the "Programme Hospitalier de Recherche Clinique," a French academic funding scheme. Clin Trials. 2018 Feb 1
- Loke YK, Mattishent K. If nothing happens, is everything all right? Distinguishing genuine reassurance from a false sense of security. CMAJ. 2015 Jan 6;187(1):15-6.
- Hodkinson A, Kirkham JJ, Tudur-Smith C, Gamble C. Reporting of harms data in RCTs: a systematic review of empirical assessments against the CONSORT harms extension. BMJOpen 2013;3:e003436. doi:10.1136/bmjopen-2013-003436
- Schroll JB, Maund E, Gøtzsche PC (2012) Challenges in coding adverse events in clinical trials: a systematic review. PLoS ONE 7(7):e41174. http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0041174
- Bolland MJ, Barber A, Doughty RN, Grey A, Gamble G, Reid IR. Differences between self-reported and verified adverse cardiovascular events in a randomised clinical trial. BMJ Open 2013;3.
- Cornelius VR, Sauzet O, Williams JE, Ayis S, Farquhar-Smith P, Ross JR, et al. Adverse event reporting in randomised controlled trials of neuropathic pain: Considerations for future practice.Pain 2013;154:213-20.
- Bagul NB, Kirkham JJ. The reporting of harms in randomized controlled trials of hypertension using the CONSORT criteria for harm reporting. Clin Exp Hypertens 2012;34:548-54.
- Haidich A, Birtsou C, Dardavessis T, Tirodimos I, Arvanitidou M. The quality of safety reporting in trials is still suboptimal: Survey of major general medical journals. J Clin Epidemiol 2011;64:124-35
- Pezo RC, Seruga B, Krzyzanowska MK, Bedard P. Quality of safety reporting in oncology-randomized controlled trials (RCTs).J Clin Oncol 2011;1
- Shukralla AA, Tudur-Smith C, Powell GA, Williamson PR, Marson AG. Reporting of adverse events in randomised controlled trials of antiepileptic drugs using the CONSORT criteria for reporting harms.Epilepsy Res 2011;97:20-9.
- Capili B, Anastasi JK, Geiger JN. Adverse event reporting in acupuncture clinical trials focusing on pain.Clin J Pain 2010;26:43-8.
- Shukralla A, Powell G, Tudor Smith C, Marson A. Reporting of adverse events is poor in epilepsy trials and has not improved following CONSORT guidance.Epilepsia 2010;51:15-6.
- Smith LM, Srighanthan J, Poon KKY, Levesque LE. Quality of reporting of harms in randomized controlled trials: An example using human papillomavirus (HPV) vaccines. Pharmacoepidemiol Drug Saf 2010;19:S82.
- De Vries TW, Van Roon EN. Low quality of reporting adverse drug reactions in paediatric randomised controlled trials.Arch Dis Child 2010;95:1023-6.
- Chowers MY, Gottesman BS, Leibovici L, Pielmeier U, Andreassen S, Paul M. Reporting of adverse events in randomized controlled trials of highly active antiretroviral therapy: systematic review.J Antimicrob Chemother2009;64:239-50.
- Ioannidis J. Adverse events in randomized trials.Arch Intern Med 2009;169:1737-9.
- Pitrou I, Boutron I, Ahmad N, Ravaud P. Reporting of safety results in published reports of randomized controlled trials.Arch Intern Med 2009;169:1756-61.Gartlehner G, Thieda P, Hansen RA, Morgan LC, Shumate JA, Nissman DB. Inadequate reporting of trials compromises the applicability of systematic reviews. Int J Technol Assess Health Care 2009;25:323-30.
- Yazici Y. Safety reporting in randomized clinical trials - a need for improvement.Bull NYU Hosp Jt Dis2009;67:209-10.
- Cheng C-W, Bian Z-X, Li Y-P, Moher D, Wu T-X, Dagenais S, et al. Transparently reporting adverse effects of traditional Chinese medicine interventions in randomized controlled trials.Zhong Xi Yi Jie He Xue Bao/Journal of Chinese Integrative Medicine 2008;6:881-6.
- Bauer KA, Hammerman S, Rapoport B, Lacouture ME. Completeness in the reporting of dermatologic adverse drug reactions associated with monoclonal antibody epidermal growth factor receptor inhibitors in phase II and III colorectal cancer clinical trials.Clin Colorectal Cancer 2008;7:309-14.
- Lee PE, Fischerb HD, Rochonb PA, Gillb SS, Herrmanng N, Bellb CM, et al. Published randomized controlled trials of drug therapy for dementia often lack complete data on harm. J Clin Epidemiol 2008;61:1152-60.
- Nuovo J, Sather C. Reporting adverse events in randomized controlled trials.Pharmacoepidemiol Drug Saf 2007;16:349-51.
- Woodworth T, Furst DE, Alten R, Bingham C, Yocum D, Sloan V, et al. Standardizing assessment and reporting of adverse effects in rheumatology clinical trials II: the Rheumatology Common Toxicity Criteria v.2.0.J Rheumatol 2007;34:1401-14.
- 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.
- Extermann M. More thoughts on the reporting of adverse events in cancer clinical trials.J Clin Oncol 2007;25:918.
- Burfeind DB. Streamlining adverse event reporting in trials.Dermatol Nurs 2006;18:381-2.
- Toenders WGM. Better reporting of adverse effects in clinical trials.Nederlands Tijdschrift voor Geneeskunde 2006;150:2838.
- Ethgen M, Boutron I, Baron G, Giraudeau B, Sibilia J, Ravaud P. Reporting of harm in randomized, controlled trials of nonpharmacologic treatment for rheumatic disease.Ann Intern Med 2005;143:20-5.
- Yiannakopoulou E, Damianou C, Bamia C, Papdopulos JS. Adequacy of safety data reporting in randomized clinical trials comparing coxibs with non selective NSAIDs.Epitheorese Klinikes Farmakologias Kai Farmakokinetikes2005;23:42-3.
- Sather C, Nuovo J. Reporting methods of adverse events in randomized controlled trials.International Congress on Peer Review and Biomedical Publication; 2005 Sept 16-18; Chicago, Illinois, USA.
- Lassere MND, Johnson KR, Woodworth TG, Furst DE, Fries JF, Kirwan JR, et al. Challenges and progress in adverse event ascertainment and reporting in clinical trials.J Rheumatol 2005;32:2030-2.
- Trotti A, Bentzen SM. The need for adverse effects reporting standards in oncology clinical trials.J Clin Oncol 2004;22:19-22.
- 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.
- Keech AC, Wonders SM, Cook DI, Gebski VJ. Balancing the outcomes: Reporting adverse events.Med J Aust 2004;181:215-18.
- 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.Liauw WS, Day RO. Adverse event reporting in clinical trials: room for improvement.Med J Aust 2003;179:426-8.
- Martin PJ, Antin JH, Weisdorf DJ, Paton V, Horowitz MM. Reporting of adverse event data in hematopoietic stem cell transplantation clinical trials involving investigational new drugs or devices: a report from the William Guy Forbeck Foundation 2001 focus meeting on clinical trials in hematopoietic stem cell transplantation.Biol Blood Marrow Transplant 2002;8:295-302.
- Loke YK, Derry S. Lack of detail and uniformity in the reporting of adverse drug reactions in randomized controlled trials: important implications for systematic reviews.9th Annual Cochrane Colloquium; October 2001; Lyon, France.
- Ethgen M, Boutron I, Steg PG, Roy C, Ravaud P. Reporting of harm in randomized controlled trials evaluating stents for percutaneous coronary intervention.Trials [Electronic Resource]2009;10:29.
- Ethgen M, Boutron I, Baron G, Giraudeau B, Sibilia J, Ravaud P. Reporting of harm in randomized controlled trials evaluating pharmacological and nonpharmacological treatments.13th Cochrane Colloquium; 22-26 October 2005; Melbourne, Australia.
- Papanikolaou P, Churchill R, Wahlbeck K, Ioannidis J. Reporting of harms in randomized trials of mental health interventions.12th Cochrane Colloquium: Bridging the Gaps; 2-6 October 2004; Ottawa, Ontario, Canada.
- Ioannidis JPA, Lau J. Improving safety reporting from randomised trials. Drug Safety 2002;25:77-84.
- Kohl KS, Bonhoeffer J, Steering Committee of The Brighton C. Safety reporting in clinical trials.JAMA 2001;285:2076-7.
- Loke YK, Derry S. Reporting of adverse drug reactions in randomised controlled trials - a systematic survey. BMC Clin Pharmacol 2001;1.
- Neidig JL, Koletar SL. Safety reporting in clinical trials.JAMA 2001;285:2077-8.
- Edwards JE, McQuay HJ, Moore RA, Collins SL. Reporting of adverse effects in clinical trials should be improved: lessons from acute postoperative pain. J Pain Symptom Manage 1999;18:427-37.
- Ioannidis JP, Contopoulos-Ioannidis DG. Reporting of safety data from randomised trials. Lancet 1998;352:1752-3.
- 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.
- Pirmohamed M, Darbyshire J. Collecting and sharing information about harms: appropriate strategies to communicate this information are essential. BMJ 2004;329:6-7.
Medicines are not just a commodity
Medicines are not just a commodity: the International Society of Drug Bulletins (ISDB), the Medicines in Europe Forum (MiEF) and the Nordic Cochrane Centre (NCC) welcome the decision to leave responsibility for medicinal products with Health Commissioner (joint press release).
PROTECT project (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium): a consortium of 33 public and private participants coordinated by the European Medicines Agency, aiming to strengthen the monitoring of the benefit-risk of medicines in Europe.