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Clinical equipoise in idiopathic normal pressure hydrocephalus: a survey of physicians on the need for randomized controlled trials assessing the efficacy of cerebrospinal fluid diversion.

AbstractBACKGROUND:
Idiopathic normal pressure hydrocephalus (iNPH) is a syndrome that may be reversible by diversion of cerebrospinal fluid (CSF). It is increasingly recognized, and accordingly rates of CSF diversion are increasing despite the absence of level I evidence of efficacy, non-neglible rate of complications and an unclear natural history.
METHODS:
A total of 349 neurosurgeons, neurologists, geriatricians and neuropsychiatrists rated the perceived efficacy of CSF diversion, the duration of effect of CSF diversion, and the risk-benefit ratio of CSF diversion in iNPH. These physicians then rated the need for a randomized controlled trial (RCT) of CSF diversion in iNPH. Participants detailed their desired selection criteria and supportive testing for a RCT, and their preferred control group.
RESULTS:
Physicians believe that there is uncertain efficacy of CSF diversion in iNPH, as well as the expected duration of this benefit and the risk-benefit ratio for patients. The greatest degree of uncertainty related to the long-term benefit of surgery. Accordingly, over 75% desire a RCT to determine the efficacy of CSF diversion in iNPH. Only 2.7% of participants believe a RCT of CSF diversion in iNPH is unethical. Patients without a shunt and a programmable valve in the 'off' setting were the preferred control groups.
CONCLUSION:
A RCT of CSF diversion in iNPH is absent from the literature. The majority (>75%) of physicians involved in the diagnosis and treatment of iNPH believe a RCT is required to determine the efficacy, duration of efficacy and risk-benefit ratio of CSF diversion in iNPH.
AuthorsAlexander McGirr, Safraz Mohammed, Roger Kurlan, Michael D Cusimano
JournalJournal of the neurological sciences (J Neurol Sci) Vol. 333 Issue 1-2 Pg. 13-8 (Oct 15 2013) ISSN: 1878-5883 [Electronic] Netherlands
PMID24012011 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
Copyright© 2013.
Topics
  • Attitude of Health Personnel
  • Cerebrospinal Fluid Shunts
  • Humans
  • Hydrocephalus, Normal Pressure (surgery)
  • Middle Aged
  • Physicians
  • Randomized Controlled Trials as Topic
  • Therapeutic Equipoise

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