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An integrative review of standardized clinical evaluation tool utilization in anticholinergic drug trials for neurogenic lower urinary tract dysfunction
Study design: To review prospective and randomized trials studying anticholinergic therapy for neurogenic bladder in SCI to identify whether trials included standardized clinical evaluation tools and reporting measures now recognized to enhance clinical trial data. Methods: A systematic search via E...
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| Published in: | Spinal cord 2016-12, Vol.54 (12), p.1114-1120 |
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| container_title | Spinal cord |
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| creator | Stothers, L Tsang, B Nigro, M Lazare, D Macnab, A |
| description | Study design:
To review prospective and randomized trials studying anticholinergic therapy for neurogenic bladder in SCI to identify whether trials included standardized clinical evaluation tools and reporting measures now recognized to enhance clinical trial data.
Methods:
A systematic search via EMBASE, MEDLINE, CENTRAL, CINAHL (Cumulative Index to Nursing and Allied Health Literature), HTA (Health Technology Assessment), CMR (Comprehensive Microbial Resource), HAPI (Health and Psychosocial Instruments) and PsycINFO using the key term spinal cord injury crossed with oxybutynin, tolterodine, darifenacin, solifenacin, fesoterodine, trospium chloride, propiverine, propantheline and anticholinergic(s) for 1946–2015 inclusive. We then collated whether standardized clinical tools, measures and descriptors were used within each study identified: American Spine Injury Association (ASIA) impairment scale; symptom scores validated in SCI; technical methodology for urodynamics/video urodynamics; urinary diaries; and standardized urologic terminology.
Results:
A total of 1225 entries with 610 unique articles were identified, 14 randomized and 16 prospective studies. In 6/30 the population comprised SCI patients with neurogenic bladder alone; the remainder included mixed neurogenic etiologies. Classification using the ASIA impairment scale was used in |
| doi_str_mv | 10.1038/sc.2016.63 |
| format | article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_5308214</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>4269571541</sourcerecordid><originalsourceid>FETCH-LOGICAL-c475t-71a101201f631bff1dafac2b6ca771c29a50f6b1983b090d8dc382ce608d0f4e3</originalsourceid><addsrcrecordid>eNplkVtrFTEUhQdRbK2--AMk4Isoc8xlJpN5EUrxBgVf9Dlkkp1pSk5Sczml_SX-XHM4tVR9Ssj-svZarK57SfCGYCbeZ72hmPANZ4-6YzJMvB85HR63O-O0H9jMjrpnOV9ijGcyi6fdEZ3oQIaRHne_TgNyocCaVHE7QAl2Dq5RtCgXFYxKxt2CQdq74LTyCHbK14bGgEqMHtXivLs9PLiAVChOX8RGQ1qdRibVFZXklM_IxoQC1BRXaFrIx2tIqCYXVLppjNIFmZtsa9B7tefdE9t-wYu786T78enj97Mv_fm3z1_PTs97PUxj6SeiCCYtvuWMLNYSo6zSdOFaTRPRdFYjtnxpsdmCZ2yE0UxQDRwLg-0A7KT7cNC9qssWjIbQrHh5ldy2-ZJROfn3JLgLucadHBkWlAxN4M2dQIo_K-Qity5r8F4FiDVLIrhgTPB5aujrf9DLWFNo8Ro1jNM0iok06u2B0inmnMDemyFY7guXWct94ZKzBr96aP8e_dNwA94dgNxGYYX0YOf_cr8Bu1W6LA</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1845775871</pqid></control><display><type>article</type><title>An integrative review of standardized clinical evaluation tool utilization in anticholinergic drug trials for neurogenic lower urinary tract dysfunction</title><source>Springer Nature</source><creator>Stothers, L ; Tsang, B ; Nigro, M ; Lazare, D ; Macnab, A</creator><creatorcontrib>Stothers, L ; Tsang, B ; Nigro, M ; Lazare, D ; Macnab, A</creatorcontrib><description>Study design:
To review prospective and randomized trials studying anticholinergic therapy for neurogenic bladder in SCI to identify whether trials included standardized clinical evaluation tools and reporting measures now recognized to enhance clinical trial data.
Methods:
A systematic search via EMBASE, MEDLINE, CENTRAL, CINAHL (Cumulative Index to Nursing and Allied Health Literature), HTA (Health Technology Assessment), CMR (Comprehensive Microbial Resource), HAPI (Health and Psychosocial Instruments) and PsycINFO using the key term spinal cord injury crossed with oxybutynin, tolterodine, darifenacin, solifenacin, fesoterodine, trospium chloride, propiverine, propantheline and anticholinergic(s) for 1946–2015 inclusive. We then collated whether standardized clinical tools, measures and descriptors were used within each study identified: American Spine Injury Association (ASIA) impairment scale; symptom scores validated in SCI; technical methodology for urodynamics/video urodynamics; urinary diaries; and standardized urologic terminology.
Results:
A total of 1225 entries with 610 unique articles were identified, 14 randomized and 16 prospective studies. In 6/30 the population comprised SCI patients with neurogenic bladder alone; the remainder included mixed neurogenic etiologies. Classification using the ASIA impairment scale was used in <10% of studies; none used symptom scores validated in SCI; <50% reported urodynamic test methodology fully, incorporated urinary diaries or used International Continence Society Standardization Subcommittee urinary tract terminology.
Conclusion:
Integrative review of trials from 1946 to 2015 identified infrequent use of standardized clinical evaluation tools and reporting measures. Data from future trials evaluating therapies for neurogenic bladder would likely be more applicable to specific SCI patients if current standardized classification and descriptors now available were used consistently: for example, the ASIA scale, symptom scores validated in SCI, standardized urodynamic methodology, urinary diaries and urinary tract terminology. Studies recruiting SCI patients exclusively would also provide additional benefit.</description><identifier>ISSN: 1362-4393</identifier><identifier>EISSN: 1476-5624</identifier><identifier>DOI: 10.1038/sc.2016.63</identifier><identifier>PMID: 27241452</identifier><identifier>CODEN: SPCOFM</identifier><language>eng</language><publisher>London: Nature Publishing Group UK</publisher><subject>692/308/409 ; Anatomy ; Biomedical and Life Sciences ; Biomedicine ; Cholinergic Antagonists - therapeutic use ; Human Physiology ; Humans ; Neurochemistry ; Neuromuscular Agents - therapeutic use ; Neuropsychology ; Neurosciences ; Original ; original-article ; Randomized Controlled Trials as Topic ; Spinal Cord Injuries - complications ; Spinal Cord Injuries - drug therapy ; Spinal Cord Injuries - physiopathology ; Urinary Bladder, Neurogenic - drug therapy ; Urinary Bladder, Neurogenic - etiology ; Urinary Bladder, Neurogenic - physiopathology</subject><ispartof>Spinal cord, 2016-12, Vol.54 (12), p.1114-1120</ispartof><rights>The Author(s) 2016</rights><rights>Copyright Nature Publishing Group Dec 2016</rights><rights>Copyright © 2016 International Spinal Cord Society 2016 International Spinal Cord Society</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c475t-71a101201f631bff1dafac2b6ca771c29a50f6b1983b090d8dc382ce608d0f4e3</citedby><cites>FETCH-LOGICAL-c475t-71a101201f631bff1dafac2b6ca771c29a50f6b1983b090d8dc382ce608d0f4e3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,780,784,885,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27241452$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Stothers, L</creatorcontrib><creatorcontrib>Tsang, B</creatorcontrib><creatorcontrib>Nigro, M</creatorcontrib><creatorcontrib>Lazare, D</creatorcontrib><creatorcontrib>Macnab, A</creatorcontrib><title>An integrative review of standardized clinical evaluation tool utilization in anticholinergic drug trials for neurogenic lower urinary tract dysfunction</title><title>Spinal cord</title><addtitle>Spinal Cord</addtitle><addtitle>Spinal Cord</addtitle><description>Study design:
To review prospective and randomized trials studying anticholinergic therapy for neurogenic bladder in SCI to identify whether trials included standardized clinical evaluation tools and reporting measures now recognized to enhance clinical trial data.
Methods:
A systematic search via EMBASE, MEDLINE, CENTRAL, CINAHL (Cumulative Index to Nursing and Allied Health Literature), HTA (Health Technology Assessment), CMR (Comprehensive Microbial Resource), HAPI (Health and Psychosocial Instruments) and PsycINFO using the key term spinal cord injury crossed with oxybutynin, tolterodine, darifenacin, solifenacin, fesoterodine, trospium chloride, propiverine, propantheline and anticholinergic(s) for 1946–2015 inclusive. We then collated whether standardized clinical tools, measures and descriptors were used within each study identified: American Spine Injury Association (ASIA) impairment scale; symptom scores validated in SCI; technical methodology for urodynamics/video urodynamics; urinary diaries; and standardized urologic terminology.
Results:
A total of 1225 entries with 610 unique articles were identified, 14 randomized and 16 prospective studies. In 6/30 the population comprised SCI patients with neurogenic bladder alone; the remainder included mixed neurogenic etiologies. Classification using the ASIA impairment scale was used in <10% of studies; none used symptom scores validated in SCI; <50% reported urodynamic test methodology fully, incorporated urinary diaries or used International Continence Society Standardization Subcommittee urinary tract terminology.
Conclusion:
Integrative review of trials from 1946 to 2015 identified infrequent use of standardized clinical evaluation tools and reporting measures. Data from future trials evaluating therapies for neurogenic bladder would likely be more applicable to specific SCI patients if current standardized classification and descriptors now available were used consistently: for example, the ASIA scale, symptom scores validated in SCI, standardized urodynamic methodology, urinary diaries and urinary tract terminology. Studies recruiting SCI patients exclusively would also provide additional benefit.</description><subject>692/308/409</subject><subject>Anatomy</subject><subject>Biomedical and Life Sciences</subject><subject>Biomedicine</subject><subject>Cholinergic Antagonists - therapeutic use</subject><subject>Human Physiology</subject><subject>Humans</subject><subject>Neurochemistry</subject><subject>Neuromuscular Agents - therapeutic use</subject><subject>Neuropsychology</subject><subject>Neurosciences</subject><subject>Original</subject><subject>original-article</subject><subject>Randomized Controlled Trials as Topic</subject><subject>Spinal Cord Injuries - complications</subject><subject>Spinal Cord Injuries - drug therapy</subject><subject>Spinal Cord Injuries - physiopathology</subject><subject>Urinary Bladder, Neurogenic - drug therapy</subject><subject>Urinary Bladder, Neurogenic - etiology</subject><subject>Urinary Bladder, Neurogenic - physiopathology</subject><issn>1362-4393</issn><issn>1476-5624</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><recordid>eNplkVtrFTEUhQdRbK2--AMk4Isoc8xlJpN5EUrxBgVf9Dlkkp1pSk5Sczml_SX-XHM4tVR9Ssj-svZarK57SfCGYCbeZ72hmPANZ4-6YzJMvB85HR63O-O0H9jMjrpnOV9ijGcyi6fdEZ3oQIaRHne_TgNyocCaVHE7QAl2Dq5RtCgXFYxKxt2CQdq74LTyCHbK14bGgEqMHtXivLs9PLiAVChOX8RGQ1qdRibVFZXklM_IxoQC1BRXaFrIx2tIqCYXVLppjNIFmZtsa9B7tefdE9t-wYu786T78enj97Mv_fm3z1_PTs97PUxj6SeiCCYtvuWMLNYSo6zSdOFaTRPRdFYjtnxpsdmCZ2yE0UxQDRwLg-0A7KT7cNC9qssWjIbQrHh5ldy2-ZJROfn3JLgLucadHBkWlAxN4M2dQIo_K-Qity5r8F4FiDVLIrhgTPB5aujrf9DLWFNo8Ro1jNM0iok06u2B0inmnMDemyFY7guXWct94ZKzBr96aP8e_dNwA94dgNxGYYX0YOf_cr8Bu1W6LA</recordid><startdate>20161201</startdate><enddate>20161201</enddate><creator>Stothers, L</creator><creator>Tsang, B</creator><creator>Nigro, M</creator><creator>Lazare, D</creator><creator>Macnab, A</creator><general>Nature Publishing Group UK</general><general>Nature Publishing Group</general><scope>C6C</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>3V.</scope><scope>7QL</scope><scope>7RV</scope><scope>7T7</scope><scope>7TK</scope><scope>7U9</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8FD</scope><scope>8FE</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>C1K</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>H94</scope><scope>HCIFZ</scope><scope>K9.</scope><scope>KB0</scope><scope>LK8</scope><scope>M0S</scope><scope>M1P</scope><scope>M7N</scope><scope>M7P</scope><scope>NAPCQ</scope><scope>P64</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>5PM</scope></search><sort><creationdate>20161201</creationdate><title>An integrative review of standardized clinical evaluation tool utilization in anticholinergic drug trials for neurogenic lower urinary tract dysfunction</title><author>Stothers, L ; Tsang, B ; Nigro, M ; Lazare, D ; Macnab, A</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c475t-71a101201f631bff1dafac2b6ca771c29a50f6b1983b090d8dc382ce608d0f4e3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>692/308/409</topic><topic>Anatomy</topic><topic>Biomedical and Life Sciences</topic><topic>Biomedicine</topic><topic>Cholinergic Antagonists - therapeutic use</topic><topic>Human Physiology</topic><topic>Humans</topic><topic>Neurochemistry</topic><topic>Neuromuscular Agents - therapeutic use</topic><topic>Neuropsychology</topic><topic>Neurosciences</topic><topic>Original</topic><topic>original-article</topic><topic>Randomized Controlled Trials as Topic</topic><topic>Spinal Cord Injuries - complications</topic><topic>Spinal Cord Injuries - drug therapy</topic><topic>Spinal Cord Injuries - physiopathology</topic><topic>Urinary Bladder, Neurogenic - drug therapy</topic><topic>Urinary Bladder, Neurogenic - etiology</topic><topic>Urinary Bladder, Neurogenic - physiopathology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Stothers, L</creatorcontrib><creatorcontrib>Tsang, B</creatorcontrib><creatorcontrib>Nigro, M</creatorcontrib><creatorcontrib>Lazare, D</creatorcontrib><creatorcontrib>Macnab, A</creatorcontrib><collection>Springer Nature OA Free Journals</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Nursing & Allied Health Database</collection><collection>Industrial and Applied Microbiology Abstracts (Microbiology A)</collection><collection>Neurosciences Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Technology Research Database</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni)</collection><collection>ProQuest Central</collection><collection>ProQuest Central Essentials</collection><collection>Biological Science Collection</collection><collection>ProQuest Central</collection><collection>Natural Science Collection</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central</collection><collection>Engineering Research Database</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>SciTech Premium Collection (Proquest) (PQ_SDU_P3)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>ProQuest Biological Science Collection</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>PML(ProQuest Medical Library)</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Biological Science Database</collection><collection>Nursing & Allied Health Premium</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Spinal cord</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Stothers, L</au><au>Tsang, B</au><au>Nigro, M</au><au>Lazare, D</au><au>Macnab, A</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>An integrative review of standardized clinical evaluation tool utilization in anticholinergic drug trials for neurogenic lower urinary tract dysfunction</atitle><jtitle>Spinal cord</jtitle><stitle>Spinal Cord</stitle><addtitle>Spinal Cord</addtitle><date>2016-12-01</date><risdate>2016</risdate><volume>54</volume><issue>12</issue><spage>1114</spage><epage>1120</epage><pages>1114-1120</pages><issn>1362-4393</issn><eissn>1476-5624</eissn><coden>SPCOFM</coden><abstract>Study design:
To review prospective and randomized trials studying anticholinergic therapy for neurogenic bladder in SCI to identify whether trials included standardized clinical evaluation tools and reporting measures now recognized to enhance clinical trial data.
Methods:
A systematic search via EMBASE, MEDLINE, CENTRAL, CINAHL (Cumulative Index to Nursing and Allied Health Literature), HTA (Health Technology Assessment), CMR (Comprehensive Microbial Resource), HAPI (Health and Psychosocial Instruments) and PsycINFO using the key term spinal cord injury crossed with oxybutynin, tolterodine, darifenacin, solifenacin, fesoterodine, trospium chloride, propiverine, propantheline and anticholinergic(s) for 1946–2015 inclusive. We then collated whether standardized clinical tools, measures and descriptors were used within each study identified: American Spine Injury Association (ASIA) impairment scale; symptom scores validated in SCI; technical methodology for urodynamics/video urodynamics; urinary diaries; and standardized urologic terminology.
Results:
A total of 1225 entries with 610 unique articles were identified, 14 randomized and 16 prospective studies. In 6/30 the population comprised SCI patients with neurogenic bladder alone; the remainder included mixed neurogenic etiologies. Classification using the ASIA impairment scale was used in <10% of studies; none used symptom scores validated in SCI; <50% reported urodynamic test methodology fully, incorporated urinary diaries or used International Continence Society Standardization Subcommittee urinary tract terminology.
Conclusion:
Integrative review of trials from 1946 to 2015 identified infrequent use of standardized clinical evaluation tools and reporting measures. Data from future trials evaluating therapies for neurogenic bladder would likely be more applicable to specific SCI patients if current standardized classification and descriptors now available were used consistently: for example, the ASIA scale, symptom scores validated in SCI, standardized urodynamic methodology, urinary diaries and urinary tract terminology. Studies recruiting SCI patients exclusively would also provide additional benefit.</abstract><cop>London</cop><pub>Nature Publishing Group UK</pub><pmid>27241452</pmid><doi>10.1038/sc.2016.63</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
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| source | Springer Nature |
| subjects | 692/308/409 Anatomy Biomedical and Life Sciences Biomedicine Cholinergic Antagonists - therapeutic use Human Physiology Humans Neurochemistry Neuromuscular Agents - therapeutic use Neuropsychology Neurosciences Original original-article Randomized Controlled Trials as Topic Spinal Cord Injuries - complications Spinal Cord Injuries - drug therapy Spinal Cord Injuries - physiopathology Urinary Bladder, Neurogenic - drug therapy Urinary Bladder, Neurogenic - etiology Urinary Bladder, Neurogenic - physiopathology |
| title | An integrative review of standardized clinical evaluation tool utilization in anticholinergic drug trials for neurogenic lower urinary tract dysfunction |
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