Use of a novel electronic data collection system in multicenter studies of irritable bowel syndrome
Background: The reliability of symptom data collected during efficacy studies in irritable bowel syndrome (IBS) is paramount to the proper assessment of potential therapeutic agents. Historically, data have been collected on paper diary cards, which patients were requested to fill out at a specified...
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| Veröffentlicht in: | Alimentary pharmacology & therapeutics 1997-12, Vol.11 (6), p.1073-1076 |
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| container_title | Alimentary pharmacology & therapeutics |
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| creator | HARDING, J. P. HAMM, L. R. EHSANULLAH, R. S. B. HEATH, A. T. SORRELLS, S. C. HAW, J. DUKES, G. E. WOLFE, S. G. MANGEL, A. W. NORTHCUTT, A. R. |
| description | Background:
The reliability of symptom data collected during efficacy studies in irritable bowel syndrome (IBS) is paramount to the proper assessment of potential therapeutic agents. Historically, data have been collected on paper diary cards, which patients were requested to fill out at a specified interval. However, with paper diary cards it is not possible to determine whether the cards are filled out as required, or at random times. To circumvent this problem, a novel electronic data collection system that ensures the reliability and security of data entry was used.
Methods:
Data were collected from 640 patients during the 2‐week screening and 12‐week treatment phases of two multicentre trials of IBS. The electronic data collection system used was based upon a touchtone telephone system.
Results:
The electronic data collection system had a potential 8135 up‐time hours during the study. An up‐time of 8040 h and down‐time of 95 h was observed. This corresponds to an up‐time of approximately 99%. Patient compliance for data entry in the two studies was 81% and 83%, respectively. On a single random day during their daily telephone call, patients were asked questions to assess satisfaction with the system. On aggregate, 79% of patients were satisfied or very satisfied with the system, only 10% were dissatisfied or very dissatisfied.
Conclusion:
A unique electronic data collection system was tested for use in clinical studies in IBS. This system provided 100% reliability as to the date of data entry, and data were not subject to modification once entered. This methodology represents a marked advancement in clinical studies of IBS. |
| doi_str_mv | 10.1046/j.1365-2036.1997.00256.x |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_79607984</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>79607984</sourcerecordid><originalsourceid>FETCH-LOGICAL-c4446-87bd9a0c9cdc0ec7668fa6933922b24ff230f9ff31465f7ce0ddc882ce574f923</originalsourceid><addsrcrecordid>eNqNkE1r3DAQhkVpSbdpf0JBh9Kb3bGklS3oJYR-QaA9JGchj0egRbZSyW6y_752d9lzTxr0PvMOPIzxBuoGlP50qBup95UAqevGmLYGEHtdP79gu0vwku1AaFOJrpGv2ZtSDgCgWxBX7MpoLTspdgwfCvHkueNT-kORUyScc5oC8sHNjmOK209IEy_HMtPIw8THJc4BaZop8zIvQ6CydYScw-z6SLxPT2tXOU5DTiO9Za-8i4Xend9r9vD1y_3t9-ru57cftzd3FSqldNW1_WAcoMEBgbDVuvNOGymNEL1Q3gsJ3ngvG6X3vkWCYcCuE0j7Vnkj5DX7eOp9zOn3QmW2YyhIMbqJ0lJsazS0plMr2J1AzKmUTN4-5jC6fLQN2M2vPdhNo9002s2v_efXPq-r7883ln6k4bJ4FrrmH865K-iiz27CUC6YAGMaBSv2-YQ9hUjH_z5vb37dr4P8C5Vkl3I</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>79607984</pqid></control><display><type>article</type><title>Use of a novel electronic data collection system in multicenter studies of irritable bowel syndrome</title><source>MEDLINE</source><source>Wiley Journals</source><source>IngentaConnect Free/Open Access Journals</source><source>EZB-FREE-00999 freely available EZB journals</source><source>Wiley Online Library (Open Access Collection)</source><creator>HARDING, J. P. ; HAMM, L. R. ; EHSANULLAH, R. S. B. ; HEATH, A. T. ; SORRELLS, S. C. ; HAW, J. ; DUKES, G. E. ; WOLFE, S. G. ; MANGEL, A. W. ; NORTHCUTT, A. R.</creator><creatorcontrib>HARDING, J. P. ; HAMM, L. R. ; EHSANULLAH, R. S. B. ; HEATH, A. T. ; SORRELLS, S. C. ; HAW, J. ; DUKES, G. E. ; WOLFE, S. G. ; MANGEL, A. W. ; NORTHCUTT, A. R.</creatorcontrib><description>Background:
The reliability of symptom data collected during efficacy studies in irritable bowel syndrome (IBS) is paramount to the proper assessment of potential therapeutic agents. Historically, data have been collected on paper diary cards, which patients were requested to fill out at a specified interval. However, with paper diary cards it is not possible to determine whether the cards are filled out as required, or at random times. To circumvent this problem, a novel electronic data collection system that ensures the reliability and security of data entry was used.
Methods:
Data were collected from 640 patients during the 2‐week screening and 12‐week treatment phases of two multicentre trials of IBS. The electronic data collection system used was based upon a touchtone telephone system.
Results:
The electronic data collection system had a potential 8135 up‐time hours during the study. An up‐time of 8040 h and down‐time of 95 h was observed. This corresponds to an up‐time of approximately 99%. Patient compliance for data entry in the two studies was 81% and 83%, respectively. On a single random day during their daily telephone call, patients were asked questions to assess satisfaction with the system. On aggregate, 79% of patients were satisfied or very satisfied with the system, only 10% were dissatisfied or very dissatisfied.
Conclusion:
A unique electronic data collection system was tested for use in clinical studies in IBS. This system provided 100% reliability as to the date of data entry, and data were not subject to modification once entered. This methodology represents a marked advancement in clinical studies of IBS.</description><identifier>ISSN: 0269-2813</identifier><identifier>EISSN: 1365-2036</identifier><identifier>DOI: 10.1046/j.1365-2036.1997.00256.x</identifier><identifier>PMID: 9663832</identifier><language>eng</language><publisher>Oxford, UK: Blackwell Science Ltd</publisher><subject>Biological and medical sciences ; Clinical trial. Drug monitoring ; Colonic Diseases, Functional ; Data Collection - methods ; Databases, Factual ; Digestive system ; Electronic Data Processing ; Europe ; General pharmacology ; Humans ; Medical sciences ; Patient Compliance ; Patient Satisfaction ; Pharmacology. Drug treatments ; Telephone ; United States</subject><ispartof>Alimentary pharmacology & therapeutics, 1997-12, Vol.11 (6), p.1073-1076</ispartof><rights>1998 INIST-CNRS</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4446-87bd9a0c9cdc0ec7668fa6933922b24ff230f9ff31465f7ce0ddc882ce574f923</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1046%2Fj.1365-2036.1997.00256.x$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1046%2Fj.1365-2036.1997.00256.x$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,780,784,1417,1433,27924,27925,45574,45575,46409,46833</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=2099140$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/9663832$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>HARDING, J. P.</creatorcontrib><creatorcontrib>HAMM, L. R.</creatorcontrib><creatorcontrib>EHSANULLAH, R. S. B.</creatorcontrib><creatorcontrib>HEATH, A. T.</creatorcontrib><creatorcontrib>SORRELLS, S. C.</creatorcontrib><creatorcontrib>HAW, J.</creatorcontrib><creatorcontrib>DUKES, G. E.</creatorcontrib><creatorcontrib>WOLFE, S. G.</creatorcontrib><creatorcontrib>MANGEL, A. W.</creatorcontrib><creatorcontrib>NORTHCUTT, A. R.</creatorcontrib><title>Use of a novel electronic data collection system in multicenter studies of irritable bowel syndrome</title><title>Alimentary pharmacology & therapeutics</title><addtitle>Aliment Pharmacol Ther</addtitle><description>Background:
The reliability of symptom data collected during efficacy studies in irritable bowel syndrome (IBS) is paramount to the proper assessment of potential therapeutic agents. Historically, data have been collected on paper diary cards, which patients were requested to fill out at a specified interval. However, with paper diary cards it is not possible to determine whether the cards are filled out as required, or at random times. To circumvent this problem, a novel electronic data collection system that ensures the reliability and security of data entry was used.
Methods:
Data were collected from 640 patients during the 2‐week screening and 12‐week treatment phases of two multicentre trials of IBS. The electronic data collection system used was based upon a touchtone telephone system.
Results:
The electronic data collection system had a potential 8135 up‐time hours during the study. An up‐time of 8040 h and down‐time of 95 h was observed. This corresponds to an up‐time of approximately 99%. Patient compliance for data entry in the two studies was 81% and 83%, respectively. On a single random day during their daily telephone call, patients were asked questions to assess satisfaction with the system. On aggregate, 79% of patients were satisfied or very satisfied with the system, only 10% were dissatisfied or very dissatisfied.
Conclusion:
A unique electronic data collection system was tested for use in clinical studies in IBS. This system provided 100% reliability as to the date of data entry, and data were not subject to modification once entered. This methodology represents a marked advancement in clinical studies of IBS.</description><subject>Biological and medical sciences</subject><subject>Clinical trial. Drug monitoring</subject><subject>Colonic Diseases, Functional</subject><subject>Data Collection - methods</subject><subject>Databases, Factual</subject><subject>Digestive system</subject><subject>Electronic Data Processing</subject><subject>Europe</subject><subject>General pharmacology</subject><subject>Humans</subject><subject>Medical sciences</subject><subject>Patient Compliance</subject><subject>Patient Satisfaction</subject><subject>Pharmacology. Drug treatments</subject><subject>Telephone</subject><subject>United States</subject><issn>0269-2813</issn><issn>1365-2036</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>1997</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkE1r3DAQhkVpSbdpf0JBh9Kb3bGklS3oJYR-QaA9JGchj0egRbZSyW6y_752d9lzTxr0PvMOPIzxBuoGlP50qBup95UAqevGmLYGEHtdP79gu0vwku1AaFOJrpGv2ZtSDgCgWxBX7MpoLTspdgwfCvHkueNT-kORUyScc5oC8sHNjmOK209IEy_HMtPIw8THJc4BaZop8zIvQ6CydYScw-z6SLxPT2tXOU5DTiO9Za-8i4Xend9r9vD1y_3t9-ru57cftzd3FSqldNW1_WAcoMEBgbDVuvNOGymNEL1Q3gsJ3ngvG6X3vkWCYcCuE0j7Vnkj5DX7eOp9zOn3QmW2YyhIMbqJ0lJsazS0plMr2J1AzKmUTN4-5jC6fLQN2M2vPdhNo9002s2v_efXPq-r7883ln6k4bJ4FrrmH865K-iiz27CUC6YAGMaBSv2-YQ9hUjH_z5vb37dr4P8C5Vkl3I</recordid><startdate>19971201</startdate><enddate>19971201</enddate><creator>HARDING, J. P.</creator><creator>HAMM, L. R.</creator><creator>EHSANULLAH, R. S. B.</creator><creator>HEATH, A. T.</creator><creator>SORRELLS, S. C.</creator><creator>HAW, J.</creator><creator>DUKES, G. E.</creator><creator>WOLFE, S. G.</creator><creator>MANGEL, A. W.</creator><creator>NORTHCUTT, A. R.</creator><general>Blackwell Science Ltd</general><general>Blackwell</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>19971201</creationdate><title>Use of a novel electronic data collection system in multicenter studies of irritable bowel syndrome</title><author>HARDING, J. P. ; HAMM, L. R. ; EHSANULLAH, R. S. B. ; HEATH, A. T. ; SORRELLS, S. C. ; HAW, J. ; DUKES, G. E. ; WOLFE, S. G. ; MANGEL, A. W. ; NORTHCUTT, A. R.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4446-87bd9a0c9cdc0ec7668fa6933922b24ff230f9ff31465f7ce0ddc882ce574f923</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>1997</creationdate><topic>Biological and medical sciences</topic><topic>Clinical trial. Drug monitoring</topic><topic>Colonic Diseases, Functional</topic><topic>Data Collection - methods</topic><topic>Databases, Factual</topic><topic>Digestive system</topic><topic>Electronic Data Processing</topic><topic>Europe</topic><topic>General pharmacology</topic><topic>Humans</topic><topic>Medical sciences</topic><topic>Patient Compliance</topic><topic>Patient Satisfaction</topic><topic>Pharmacology. Drug treatments</topic><topic>Telephone</topic><topic>United States</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>HARDING, J. P.</creatorcontrib><creatorcontrib>HAMM, L. R.</creatorcontrib><creatorcontrib>EHSANULLAH, R. S. B.</creatorcontrib><creatorcontrib>HEATH, A. T.</creatorcontrib><creatorcontrib>SORRELLS, S. C.</creatorcontrib><creatorcontrib>HAW, J.</creatorcontrib><creatorcontrib>DUKES, G. E.</creatorcontrib><creatorcontrib>WOLFE, S. G.</creatorcontrib><creatorcontrib>MANGEL, A. W.</creatorcontrib><creatorcontrib>NORTHCUTT, A. R.</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Alimentary pharmacology & therapeutics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>HARDING, J. P.</au><au>HAMM, L. R.</au><au>EHSANULLAH, R. S. B.</au><au>HEATH, A. T.</au><au>SORRELLS, S. C.</au><au>HAW, J.</au><au>DUKES, G. E.</au><au>WOLFE, S. G.</au><au>MANGEL, A. W.</au><au>NORTHCUTT, A. R.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Use of a novel electronic data collection system in multicenter studies of irritable bowel syndrome</atitle><jtitle>Alimentary pharmacology & therapeutics</jtitle><addtitle>Aliment Pharmacol Ther</addtitle><date>1997-12-01</date><risdate>1997</risdate><volume>11</volume><issue>6</issue><spage>1073</spage><epage>1076</epage><pages>1073-1076</pages><issn>0269-2813</issn><eissn>1365-2036</eissn><abstract>Background:
The reliability of symptom data collected during efficacy studies in irritable bowel syndrome (IBS) is paramount to the proper assessment of potential therapeutic agents. Historically, data have been collected on paper diary cards, which patients were requested to fill out at a specified interval. However, with paper diary cards it is not possible to determine whether the cards are filled out as required, or at random times. To circumvent this problem, a novel electronic data collection system that ensures the reliability and security of data entry was used.
Methods:
Data were collected from 640 patients during the 2‐week screening and 12‐week treatment phases of two multicentre trials of IBS. The electronic data collection system used was based upon a touchtone telephone system.
Results:
The electronic data collection system had a potential 8135 up‐time hours during the study. An up‐time of 8040 h and down‐time of 95 h was observed. This corresponds to an up‐time of approximately 99%. Patient compliance for data entry in the two studies was 81% and 83%, respectively. On a single random day during their daily telephone call, patients were asked questions to assess satisfaction with the system. On aggregate, 79% of patients were satisfied or very satisfied with the system, only 10% were dissatisfied or very dissatisfied.
Conclusion:
A unique electronic data collection system was tested for use in clinical studies in IBS. This system provided 100% reliability as to the date of data entry, and data were not subject to modification once entered. This methodology represents a marked advancement in clinical studies of IBS.</abstract><cop>Oxford, UK</cop><pub>Blackwell Science Ltd</pub><pmid>9663832</pmid><doi>10.1046/j.1365-2036.1997.00256.x</doi><tpages>4</tpages><oa>free_for_read</oa></addata></record> |
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| identifier | ISSN: 0269-2813 |
| ispartof | Alimentary pharmacology & therapeutics, 1997-12, Vol.11 (6), p.1073-1076 |
| issn | 0269-2813 1365-2036 |
| language | eng |
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| source | MEDLINE; Wiley Journals; IngentaConnect Free/Open Access Journals; EZB-FREE-00999 freely available EZB journals; Wiley Online Library (Open Access Collection) |
| subjects | Biological and medical sciences Clinical trial. Drug monitoring Colonic Diseases, Functional Data Collection - methods Databases, Factual Digestive system Electronic Data Processing Europe General pharmacology Humans Medical sciences Patient Compliance Patient Satisfaction Pharmacology. Drug treatments Telephone United States |
| title | Use of a novel electronic data collection system in multicenter studies of irritable bowel syndrome |
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