Authors' objectives:

This special report will provide information relevant to the evaluation of wireless pH monitoring. This report will summarize information on:

- Diagnostic performance and clinical utility of traditional pH monitoring - Feasibility of wireless pH monitoring - Comparison of performance of traditional and wireless pH monitoring

Authors' results and conclusions: Several case series show that the device is successfully attached and produces pH readings for 24 to 48 hours in over 90% of attempts. Two studies compared wireless and wired monitoring in terms of patient comfort and found that in most measures, wireless monitoring is judged to be more comfortable. One study assesses test positivity in gastroesophageal reflux disease (GERD) subjects and normal controls and found that performance was similar to what has been found with wired monitoring. Although one study shows an 88% concordance in diagnosis of GERD when comparing wireless monitoring to simultaneous wired monitoring, it does not demonstrate that wireless monitoring is better than traditional monitoring in diagnosing or managing GERD. The study does not demonstrate that the wireless monitor is more accurate when the tests are discordant. This degree of concordance between the two methods was achieved only after adjusting test thresholds to maximize concordance. Such a post-hoc adjustment of course cannot be done with the device in use in clinical practice. More experimentation with the device on both GERD patients and normal controls will be needed to better establish appropriate test thresholds that optimize clinical utility of the test. Studies purporting to show improved diagnostic capability of wireless monitoring when used for 48 hours versus 24 hours were fundamentally flawed because there was no gold standard for diagnosis and no control patients were enrolled in the studies.

Authors' recommendations: The following conclusions appear to apply to wireless monitoring: The procedure is successfully performed and produces successful measurement of esophageal acid in a high proportion of cases. The relatively small number of cases reported does not allow for reliable estimation of rare but potentially serious adverse complications. Overall, it is more comfortable than traditional wired monitoring. Measurements correlate fairly closely to wired monitoring after adjusting test thresholds; however, because of the lack of an established gold standard, even when the two devices are discrepant, it cannot be determined which device is "correct". Also, different studies have produced different cutoff values for a normal test. More data are needed to establish appropriate diagnostic thresholds. No studies establish that wireless monitoring is superior to wired monitoring in reaching a GERD diagnosis or optimally managing a patient. There is no evidence linking the use of the wireless device to an improvement in health outcome.

Authors' methods: Review

Project Status: Completed

URL for project: http://www.bcbs.com/blueresources/tec/contact-tec.html

Year Published: 2006

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: United States

Organisation Name: BlueCross BlueShield Association

Contact Address: BlueCross BlueShield Association, Technology Evaluation Center, 225 North Michigan Ave, Chicago, Illinois, USA. Tel: 888 832 4321

Contact Name: tec@bcbsa.com

Contact Email: tec@bcbsa.com

Copyright: BlueCross BlueShield Association (BCBS)