Reporting of adverse events in randomised controlled trials of antiepileptic drugs using the CONSORT criteria for reporting harms

Epilepsy Research

Volumn 97, Issue 1-2, 2011, Pages 20-29

  Shukralla, Arif A ^a   Tudur Smith, Catrin ^a   Powell, Graham A ^a   Williamson, Paula R ^a   Marson, Anthony G ^a  

^a UNIVERSITY OF LIVERPOOL   (United Kingdom)

Author keywords

Adverse events; Antiepileptic drugs; CONSORT; Harms; Reporting

Indexed keywords

ANTICONVULSIVE AGENT; ETIRACETAM; LAMOTRIGINE; TOPIRAMATE;

ADULT; AGE DISTRIBUTION; ARTICLE; CHILD; COMMERCIAL PHENOMENA; CONSOLIDATED STANDARDS OF REPORTING TRIALS; CONTROLLED STUDY; DATA EXTRACTION; DRUG SURVEILLANCE PROGRAM; HUMAN; INTERRATER RELIABILITY; MAJOR CLINICAL STUDY; OUTCOME ASSESSMENT; PRACTICE GUIDELINE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RISK BENEFIT ANALYSIS; RISK FACTOR;

ADULT; ADVERSE DRUG REACTION REPORTING SYSTEMS; ANTICONVULSANTS; CHILD; EPILEPSY; GUIDELINE ADHERENCE; HUMANS; QUALITY CONTROL; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 81055157670     PISSN: 09201211     EISSN: 18726844     Source Type: Journal    
DOI: 10.1016/j.eplepsyres.2011.06.015     Document Type: Article

References (14)

1. Altman D. Better reporting of randomised controlled trials: the CONSORT statement. BMJ 1996, 313:570-571.
2. Altman D., Schultz K., Moher D., Egger M., Davidoff F., Elbourne D., Gotzsche P., Lang T. The revised CONSORT statement for reporting trials: explanation and elaboration. Ann. Intern. Med. 2001, 134:663-694.
3. Baker G., Jacoby A., Francis P., Chadwick D. The Liverpool adverse event drug profile. Epilepsia 1995, 36(S3):s59-s159.
4. Baker G., Jacoby A. Quality of Life in Epilepsy: Beyond Seizure Counts in Assessment and Treatment 2000, Harwood Academic Publishers.
5. Breau R., Gaboury I., Scales C., Fesperman S., Watterson J., Dahm P. Reporting of harm in randomized controlled trials published in the urological literature. J. Urol. 2010, 183:1693-1697.
6. Chowers M., Gottesman B., Leibovivi L., Pielmeier U., Andreassen S., Paul M. Reporting of adverse events in randomized controlled trials of highly active antiretroviral therapy: systematic review. J. Antimicrob. Chemother. 2009, 64:239-250.
7. Cohen J. Weighted kappa: nominal scale agreement provision for scaled disagreement or partial credit. Psychol. Bull. 1968, 70:213-220.
8. Han C., Kwak K.P., Marks D., Pae C.N., Wu L., Bhatia K., Masand P., Patkar A. The impact of the CONSORT statements on reporting of randomised clinical trials in psychiatry. Contemp. Clin. Trials 2009, 30:116-122.
9. Hopewell S., Clarke M., Moher D., Wager E., Middleton P., Altman D., Schultz K. CONSORT for reporting randomised controlled trials in journals and conference abstracts. PLoS Med. 2008, 5:48-56.
10. Ioannidis J., Evans S., Gotzsche P., O'Neill R., Altman D., Schulz K. Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann. Intern. Med. 2004, 141:781-788.
11. Plint A., Moher D., Morrison A., Schulz K., Altman D., Hill C., Gaboury I. Does the CONSORT checklist improve the quality of reports of randomised controlled trials? A systematic review. Med. J. 2006, 185:263-267.
12. Schringer D., Ouk S., Altman D. The use of the World Wide Web by medical journals in 2003 to 2005: an observational study. Pediatrics 2007, 119:e53-e60.
13. Smith B., Lee H., Lee J., Choi M., Jones D., Bausell R., Broome M. Quality of reporting randomized controlled trials in the nursing literature: application of the consolidated standards of reporting trials (CONSORT). Nurs. Outlook 2008, 56:31-37.
14. Wang Y., Zhou D., Pauli E., Stefan H. Topiramate on ictal seizure semiology: a quantitative randomised, low and medium dose controlled study. Epilepsy Res. 2001, 46:271-277.