Wireless pH‐motility capsule for colonic transit: prospective comparison with radiopaque markers in chronic constipation
Background Colon transit (CT) measurements are used in the management of significant constipation. The radiopaque marker (ROM) method provides limited information. Methods We proposed to validate wireless motility capsule (WMC), that measures pH, pressure and temperature, to ROM measurement of CT...
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| Published in | Neurogastroenterology and motility Vol. 22; no. 8; pp. 874 - e233 |
|---|---|
| Main Authors | , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Oxford, UK
Blackwell Publishing Ltd
01.08.2010
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| Subjects | |
| Online Access | Get full text |
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| Abstract | Background Colon transit (CT) measurements are used in the management of significant constipation. The radiopaque marker (ROM) method provides limited information.
Methods We proposed to validate wireless motility capsule (WMC), that measures pH, pressure and temperature, to ROM measurement of CT in patients with symptomatic constipation evaluated at multiple centers. Of 208 patients recruited, 158 eligible patients underwent simultaneous measurement of colonic transit time (CTT) using ROM (Metcalf method, cut off for delay >67 h), and WMC (cutoff for delay >59 h). The study was designed to demonstrate substantial equivalence, defined as diagnostic agreement >65% for patients who had normal or delayed ROM transit.
Key Results Fifty‐nine of 157 patients had delayed ROM CT. Transit results by the two methods differed: ROM median 55.0 h [IQR 31.0–85.0] and WMC (43.5 h [21.7–70.3], P < 0.001. The positive percent agreement between WMC and ROM for delayed transit was ∼80%; positive agreement in 47 by WMC/59 by ROM or 0.796 (95% CI = 0.67–0.98); agreement vs null hypothesis (65%) P = 0.01. The negative percent agreement (normal transit) was ∼91%: 89 by WMC/98 by ROM or 0.908 (95% CI = 0.83–0.96); agreement vs null hypothesis (65%), P = 0.00001. Overall device agreement was 87%. There were significant correlations (P < 0.001) between ROM and WMC transit (CTT [r = 0.707] and between ROM and combined small and large bowel transit [r = 0.704]). There were no significant adverse events.
Conclusions & Inferences The 87% overall agreement (positive and negative) validates WMC relative to ROM in differentiating slow vs normal CT in a multicenter clinical study of constipation. |
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| AbstractList | Background Colon transit (CT) measurements are used in the management of significant constipation. The radiopaque marker (ROM) method provides limited information.
Methods We proposed to validate wireless motility capsule (WMC), that measures pH, pressure and temperature, to ROM measurement of CT in patients with symptomatic constipation evaluated at multiple centers. Of 208 patients recruited, 158 eligible patients underwent simultaneous measurement of colonic transit time (CTT) using ROM (Metcalf method, cut off for delay >67 h), and WMC (cutoff for delay >59 h). The study was designed to demonstrate substantial equivalence, defined as diagnostic agreement >65% for patients who had normal or delayed ROM transit.
Key Results Fifty‐nine of 157 patients had delayed ROM CT. Transit results by the two methods differed: ROM median 55.0 h [IQR 31.0–85.0] and WMC (43.5 h [21.7–70.3], P < 0.001. The positive percent agreement between WMC and ROM for delayed transit was ∼80%; positive agreement in 47 by WMC/59 by ROM or 0.796 (95% CI = 0.67–0.98); agreement vs null hypothesis (65%) P = 0.01. The negative percent agreement (normal transit) was ∼91%: 89 by WMC/98 by ROM or 0.908 (95% CI = 0.83–0.96); agreement vs null hypothesis (65%), P = 0.00001. Overall device agreement was 87%. There were significant correlations (P < 0.001) between ROM and WMC transit (CTT [r = 0.707] and between ROM and combined small and large bowel transit [r = 0.704]). There were no significant adverse events.
Conclusions & Inferences The 87% overall agreement (positive and negative) validates WMC relative to ROM in differentiating slow vs normal CT in a multicenter clinical study of constipation. Colon transit (CT) measurements are used in the management of significant constipation. The radiopaque marker (ROM) method provides limited information. We proposed to validate wireless motility capsule (WMC), that measures pH, pressure and temperature, to ROM measurement of CT in patients with symptomatic constipation evaluated at multiple centers. Of 208 patients recruited, 158 eligible patients underwent simultaneous measurement of CT time (CTT) using ROM (Metcalf method, cut off for delay >67 h), and WMC (cutoff for delay >59 h). The study was designed to demonstrate substantial equivalence, defined as diagnostic agreement >65% for patients who had normal or delayed ROM transit. 59/157 patients had delayed ROM CT. Transit results by the two methods differed: ROM median 55.0h [IQR 31.0–85.0] and WMC (43.5h [21.7–70.3], p<0.001. The positive percent agreement between WMC and ROM for delayed transit was ~80%; positive agreement in 47 by WMC/59 by ROM or 0.796 (95% CI = 0.67–0.98); agreement vs. null hypothesis (65%) p=0.01. The negative percent agreement (normal transit) was ~91%: 89 by WMC/98 by ROM or 0.908 (95% CI = 0.83–0.96); agreement vs null hypothesis (65%), p=0.00001. Overall device agreement was 87%. There were significant correlations (p<0.001) between ROM and WMC transit (CTT [r=0.707] and between ROM and combined small and large bowel transit [r=0.704]). There were no significant adverse events. The 87% overall agreement (positive and negative) validates WMC relative to ROM in differentiating slow versus normal CT in a multicenter clinical study of constipation. Colon transit (CT) measurements are used in the management of significant constipation. The radiopaque marker (ROM) method provides limited information.BACKGROUNDColon transit (CT) measurements are used in the management of significant constipation. The radiopaque marker (ROM) method provides limited information.We proposed to validate wireless motility capsule (WMC), that measures pH, pressure and temperature, to ROM measurement of CT in patients with symptomatic constipation evaluated at multiple centers. Of 208 patients recruited, 158 eligible patients underwent simultaneous measurement of colonic transit time (CTT) using ROM (Metcalf method, cut off for delay >67 h), and WMC (cutoff for delay >59 h). The study was designed to demonstrate substantial equivalence, defined as diagnostic agreement >65% for patients who had normal or delayed ROM transit.METHODSWe proposed to validate wireless motility capsule (WMC), that measures pH, pressure and temperature, to ROM measurement of CT in patients with symptomatic constipation evaluated at multiple centers. Of 208 patients recruited, 158 eligible patients underwent simultaneous measurement of colonic transit time (CTT) using ROM (Metcalf method, cut off for delay >67 h), and WMC (cutoff for delay >59 h). The study was designed to demonstrate substantial equivalence, defined as diagnostic agreement >65% for patients who had normal or delayed ROM transit.Fifty-nine of 157 patients had delayed ROM CT. Transit results by the two methods differed: ROM median 55.0 h [IQR 31.0-85.0] and WMC (43.5 h [21.7-70.3], P < 0.001. The positive percent agreement between WMC and ROM for delayed transit was approximately 80%; positive agreement in 47 by WMC/59 by ROM or 0.796 (95% CI = 0.67-0.98); agreement vs null hypothesis (65%) P = 0.01. The negative percent agreement (normal transit) was approximately 91%: 89 by WMC/98 by ROM or 0.908 (95% CI = 0.83-0.96); agreement vs null hypothesis (65%), P = 0.00001. Overall device agreement was 87%. There were significant correlations (P < 0.001) between ROM and WMC transit (CTT [r = 0.707] and between ROM and combined small and large bowel transit [r = 0.704]). There were no significant adverse events.KEY RESULTSFifty-nine of 157 patients had delayed ROM CT. Transit results by the two methods differed: ROM median 55.0 h [IQR 31.0-85.0] and WMC (43.5 h [21.7-70.3], P < 0.001. The positive percent agreement between WMC and ROM for delayed transit was approximately 80%; positive agreement in 47 by WMC/59 by ROM or 0.796 (95% CI = 0.67-0.98); agreement vs null hypothesis (65%) P = 0.01. The negative percent agreement (normal transit) was approximately 91%: 89 by WMC/98 by ROM or 0.908 (95% CI = 0.83-0.96); agreement vs null hypothesis (65%), P = 0.00001. Overall device agreement was 87%. There were significant correlations (P < 0.001) between ROM and WMC transit (CTT [r = 0.707] and between ROM and combined small and large bowel transit [r = 0.704]). There were no significant adverse events.The 87% overall agreement (positive and negative) validates WMC relative to ROM in differentiating slow vs normal CT in a multicenter clinical study of constipation.CONCLUSIONS & INFERENCESThe 87% overall agreement (positive and negative) validates WMC relative to ROM in differentiating slow vs normal CT in a multicenter clinical study of constipation. Colon transit (CT) measurements are used in the management of significant constipation. The radiopaque marker (ROM) method provides limited information. We proposed to validate wireless motility capsule (WMC), that measures pH, pressure and temperature, to ROM measurement of CT in patients with symptomatic constipation evaluated at multiple centers. Of 208 patients recruited, 158 eligible patients underwent simultaneous measurement of colonic transit time (CTT) using ROM (Metcalf method, cut off for delay >67 h), and WMC (cutoff for delay >59 h). The study was designed to demonstrate substantial equivalence, defined as diagnostic agreement >65% for patients who had normal or delayed ROM transit. Fifty-nine of 157 patients had delayed ROM CT. Transit results by the two methods differed: ROM median 55.0 h [IQR 31.0-85.0] and WMC (43.5 h [21.7-70.3], P < 0.001. The positive percent agreement between WMC and ROM for delayed transit was approximately 80%; positive agreement in 47 by WMC/59 by ROM or 0.796 (95% CI = 0.67-0.98); agreement vs null hypothesis (65%) P = 0.01. The negative percent agreement (normal transit) was approximately 91%: 89 by WMC/98 by ROM or 0.908 (95% CI = 0.83-0.96); agreement vs null hypothesis (65%), P = 0.00001. Overall device agreement was 87%. There were significant correlations (P < 0.001) between ROM and WMC transit (CTT [r = 0.707] and between ROM and combined small and large bowel transit [r = 0.704]). There were no significant adverse events. The 87% overall agreement (positive and negative) validates WMC relative to ROM in differentiating slow vs normal CT in a multicenter clinical study of constipation. AbstractBackground Colon transit (CT) measurements are used in the management of significant constipation. The radiopaque marker (ROM) method provides limited information.Methods We proposed to validate wireless motility capsule (WMC), that measures pH, pressure and temperature, to ROM measurement of CT in patients with symptomatic constipation evaluated at multiple centers. Of 208 patients recruited, 158 eligible patients underwent simultaneous measurement of colonic transit time (CTT) using ROM (Metcalf method, cut off for delay >67 h), and WMC (cutoff for delay >59 h). The study was designed to demonstrate substantial equivalence, defined as diagnostic agreement >65% for patients who had normal or delayed ROM transit.Key Results Fifty-nine of 157 patients had delayed ROM CT. Transit results by the two methods differed: ROM median 55.0 h [IQR 31.0-85.0] and WMC (43.5 h [21.7-70.3], P < 0.001. The positive percent agreement between WMC and ROM for delayed transit was similar to 80%; positive agreement in 47 by WMC-59 by ROM or 0.796 (95% CI = 0.67-0.98); agreement vs null hypothesis (65%) P = 0.01. The negative percent agreement (normal transit) was similar to 91%: 89 by WMC-98 by ROM or 0.908 (95% CI = 0.83-0.96); agreement vs null hypothesis (65%), P = 0.00001. Overall device agreement was 87%. There were significant correlations (P < 0.001) between ROM and WMC transit (CTT [r = 0.707] and between ROM and combined small and large bowel transit [r = 0.704]). There were no significant adverse events.Conclusions & Inferences The 87% overall agreement (positive and negative) validates WMC relative to ROM in differentiating slow vs normal CT in a multicenter clinical study of constipation. |
| Author | Esfandyari, T. Parkman, H. P. Soffer, E. Camilleri, M. Wilding, G. E. Hasler, W. L. Gupta, A. Rao, S. S.c. Kuo, B. Semler, J. R. Thorne, N. K. Scott, S. M. Mccallum, R. W. Ringel, Y. |
| AuthorAffiliation | 13 Department of Biostatistics, State University of New York at Buffalo, Buffalo, New York 9 Cedars-Sinai Medical Center, Los Angeles, California 3 Wake Forest University Medical Center, Winston Salem, North Carolina 5 Department of Medicine, University of Michigan, Ann Arbor, Michigan 2 Department of Medicine, University of Iowa, Iowa City, Iowa 6 University of North Carolina Medical Center, Chapel Hill, North Carolina 7 Department of Medicine, Temple University, Philadelphia, Pennsylvania 1 College of Medicine, Mayo Clinic, Rochester, MN 11 Queen Mary University, London, United Kingdom 10 University of Buffalo VA Medical Center, Buffalo, New York 4 Department of Medicine, Kansas University Medical Center, Kansas City, Kansas 14 SmartPill Corporation, Buffalo, New York 12 Texas Tech University, El Paso, Texas 8 Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts |
| AuthorAffiliation_xml | – name: 4 Department of Medicine, Kansas University Medical Center, Kansas City, Kansas – name: 10 University of Buffalo VA Medical Center, Buffalo, New York – name: 2 Department of Medicine, University of Iowa, Iowa City, Iowa – name: 12 Texas Tech University, El Paso, Texas – name: 13 Department of Biostatistics, State University of New York at Buffalo, Buffalo, New York – name: 5 Department of Medicine, University of Michigan, Ann Arbor, Michigan – name: 3 Wake Forest University Medical Center, Winston Salem, North Carolina – name: 7 Department of Medicine, Temple University, Philadelphia, Pennsylvania – name: 11 Queen Mary University, London, United Kingdom – name: 6 University of North Carolina Medical Center, Chapel Hill, North Carolina – name: 8 Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts – name: 9 Cedars-Sinai Medical Center, Los Angeles, California – name: 1 College of Medicine, Mayo Clinic, Rochester, MN – name: 14 SmartPill Corporation, Buffalo, New York |
| Author_xml | – sequence: 1 givenname: M. surname: Camilleri fullname: Camilleri, M. – sequence: 2 givenname: N. K. surname: Thorne fullname: Thorne, N. K. – sequence: 3 givenname: Y. surname: Ringel fullname: Ringel, Y. – sequence: 4 givenname: W. L. surname: Hasler fullname: Hasler, W. L. – sequence: 5 givenname: B. surname: Kuo fullname: Kuo, B. – sequence: 6 givenname: T. surname: Esfandyari fullname: Esfandyari, T. – sequence: 7 givenname: A. surname: Gupta fullname: Gupta, A. – sequence: 8 givenname: S. M. surname: Scott fullname: Scott, S. M. – sequence: 9 givenname: R. W. surname: Mccallum fullname: Mccallum, R. W. – sequence: 10 givenname: H. P. surname: Parkman fullname: Parkman, H. P. – sequence: 11 givenname: E. surname: Soffer fullname: Soffer, E. – sequence: 12 givenname: G. E. surname: Wilding fullname: Wilding, G. E. – sequence: 13 givenname: J. R. surname: Semler fullname: Semler, J. R. – sequence: 14 givenname: S. S.c. surname: Rao fullname: Rao, S. S.c. |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/20465593$$D View this record in MEDLINE/PubMed |
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| Copyright | 2010 Blackwell Publishing Ltd |
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| Snippet | Background Colon transit (CT) measurements are used in the management of significant constipation. The radiopaque marker (ROM) method provides limited... Background Colon transit (CT) measurements are used in the management of significant constipation. The radiopaque marker (ROM) method provides limited... Colon transit (CT) measurements are used in the management of significant constipation. The radiopaque marker (ROM) method provides limited information. We... Colon transit (CT) measurements are used in the management of significant constipation. The radiopaque marker (ROM) method provides limited... AbstractBackground Colon transit (CT) measurements are used in the management of significant constipation. The radiopaque marker (ROM) method provides limited... Colon transit (CT) measurements are used in the management of significant constipation. The radiopaque marker (ROM) method provides limited information. We... |
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| SubjectTerms | Adult Capsule Endoscopy - methods Capsules Chronic Disease Colon - physiopathology colonic transit time Constipation - diagnosis Constipation - physiopathology Contrast Media - metabolism correlation Female Gastrointestinal Transit - physiology Humans Hydrogen-Ion Concentration Male Middle Aged negative agreement positive agreement radiopaque markers Reproducibility of Results wireless motility capsule |
| Title | Wireless pH‐motility capsule for colonic transit: prospective comparison with radiopaque markers in chronic constipation |
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