PMID- 15689300
OWN - NLM
STAT- MEDLINE
DCOM- 20050504
LR  - 20220330
IS  - 0949-2321 (Print)
IS  - 0949-2321 (Linking)
VI  - 9
IP  - 12
DP  - 2004 Dec 22
TI  - An internal standard for verifying the accuracy of serious adverse event 
      reporting: the example of an acupuncture study of 190,924 patients.
PG  - 545-51
AB  - BACKGROUND: Reporting of all serious adverse events (SAEs) is a requirement for 
      regulatory approval of a drug. Can equally rigorous reporting standards be 
      expected in studies of non-drug treatments and how can underreporting, if any, be 
      detected and proven? Using data from our large-scale prospective cohort study of 
      acupuncture on outpatients, we examine the use of an internal standard, a 
      principle taken from laboratory medicine, to quantify real event rates. METHODS: 
      A total of 190,924 patients (68.6% women) seeking treatment for chronic pain 
      (headache, low back pain, coxarthrosis or gonarthrosis) from 12,000 physicians in 
      private practice in Germany were observed during a six-month period ending in May 
      2002. Most received ten sessions of body acupuncture. Mean treatment time was six 
      weeks. All practitioners were certified in acupuncture and received written 
      instructions on completing forms for basic patient data and SAE monitoring. They 
      were also informed that payment by insurers would be made only upon return of the 
      completed form. All SAEs occurring between start of the first acupuncture session 
      and end of the last one were to be reported, whether causally related to the 
      treatment or not. Multiple minor adverse events (AEs) per single patient were to 
      be reported only once. As the internal standard we chose the expected number of 
      deaths, based on the death rate for the German population, adjusted for age, sex 
      distribution and mean observation time of our study patients. RESULTS: 45 SAEs 
      and 14,404 AEs were reported (i.e. 2.4 SAEs and 754 AEs per 10,000 patients). The 
      number of reported deaths (9) was only 5% of the statistically expected number 
      (180). Applying the resulting correction factor of 20 to all reported SAEs, 
      resulted in 900 expected SAEs (versus 45 reported) or 47 per 10,000 patients. 
      CONCLUSIONS: Without verifying the accuracy of a measurement, results remain 
      speculative. Our internal standard for the first time provides a means of 
      verifying the accuracy of the reported SAE rate and correcting it to the 
      statistically expected SAE rate.
FAU - Endres, H G
AU  - Endres HG
AD  - Department of Medical Informatics, Statistics and Epidemiology, Ruhr University 
      Bochum, D-44801 Bochum, Germany. heinz.endres@ruhr-uni-bochum.de
FAU - Molsberger, A
AU  - Molsberger A
FAU - Lungenhausen, M
AU  - Lungenhausen M
FAU - Trampisch, H J
AU  - Trampisch HJ
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Eur J Med Res
JT  - European journal of medical research
JID - 9517857
SB  - IM
MH  - Acupuncture Therapy/*adverse effects
MH  - Adolescent
MH  - Adult
MH  - Adverse Drug Reaction Reporting Systems/standards
MH  - Aged
MH  - Aged, 80 and over
MH  - Child
MH  - Child, Preschool
MH  - Female
MH  - Humans
MH  - Infant
MH  - Male
MH  - Middle Aged
MH  - Reference Standards
EDAT- 2005/02/04 09:00
MHDA- 2005/05/05 09:00
CRDT- 2005/02/04 09:00
PHST- 2005/02/04 09:00 [pubmed]
PHST- 2005/05/05 09:00 [medline]
PHST- 2005/02/04 09:00 [entrez]
PST - ppublish
SO  - Eur J Med Res. 2004 Dec 22;9(12):545-51.