A comparison of screening methods in two early phase oral leukoplakia clinical trials
Oral Diseases (2012) 18, 720–723 Objectives/Introduction: Clinical trial accrual for oral dysplasia is difficult in the United States and elsewhere. Patients with dysplastic oral leukoplakia progress to frank invasive carcinoma at a rate of 5–37% over 5 years. We compared two clinical trial screeni...
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creator | Rosas, RR Cole, KA Darrah, L Rohrer, MD Rhodus, NL Ondrey, FG |
description | Oral Diseases (2012) 18, 720–723
Objectives/Introduction: Clinical trial accrual for oral dysplasia is difficult in the United States and elsewhere. Patients with dysplastic oral leukoplakia progress to frank invasive carcinoma at a rate of 5–37% over 5 years. We compared two clinical trial screening efforts to hopefully devise better accrual strategies to these types of clinical trials.
Methods: For the first trial, we identified 244 patients with dysplastic oral leukoplakia in our university database and a media campaign. Patients were notified and screened by examination and biopsy. For the second clinical trial, we established a preneoplastic lesions clinic and teaching and communications network with regional oral healthcare professionals.
Results: Only one of 244 patients accrued to the first clinical trial through an organized screening effort based on database/medical records review. The second clinical trial accrued 16/30 screened patients through redirected efforts in teaching, communications, and a preneoplastic lesions clinic.
Conclusion: We conclude that significant difficulties resulted from medical record/database review of leukoplakia patients as a screening method for leukoplakia clinical trial entry. We feel that persistent direct contact and education of healthcare professionals who are likely to examine leukoplakia patients improved accrual to the second clinical trial. |
doi_str_mv | 10.1111/j.1601-0825.2012.01934.x |
format | Article |
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Objectives/Introduction: Clinical trial accrual for oral dysplasia is difficult in the United States and elsewhere. Patients with dysplastic oral leukoplakia progress to frank invasive carcinoma at a rate of 5–37% over 5 years. We compared two clinical trial screening efforts to hopefully devise better accrual strategies to these types of clinical trials.
Methods: For the first trial, we identified 244 patients with dysplastic oral leukoplakia in our university database and a media campaign. Patients were notified and screened by examination and biopsy. For the second clinical trial, we established a preneoplastic lesions clinic and teaching and communications network with regional oral healthcare professionals.
Results: Only one of 244 patients accrued to the first clinical trial through an organized screening effort based on database/medical records review. The second clinical trial accrued 16/30 screened patients through redirected efforts in teaching, communications, and a preneoplastic lesions clinic.
Conclusion: We conclude that significant difficulties resulted from medical record/database review of leukoplakia patients as a screening method for leukoplakia clinical trial entry. We feel that persistent direct contact and education of healthcare professionals who are likely to examine leukoplakia patients improved accrual to the second clinical trial.</description><identifier>ISSN: 1354-523X</identifier><identifier>EISSN: 1601-0825</identifier><identifier>DOI: 10.1111/j.1601-0825.2012.01934.x</identifier><identifier>PMID: 22524155</identifier><language>eng</language><publisher>Oxford, UK: Blackwell Publishing Ltd</publisher><subject>barrier ; cancer ; clinical trial ; Clinical trials ; Clinical Trials as Topic ; Databases, Factual ; dysplasia ; health education ; Health Personnel - education ; Humans ; Leukoplakia, Oral - diagnosis ; Leukoplakia, Oral - drug therapy ; Mass Screening - methods ; Methods ; oral carcinoma ; oral leukoplakia ; Patient Selection ; preneoplasia ; referral clinic ; United States</subject><ispartof>Oral diseases, 2012-10, Vol.18 (7), p.720-723</ispartof><rights>2012 John Wiley & Sons A/S</rights><rights>2012 John Wiley & Sons A/S.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c5404-7ab338cc865b83e0ef04686430aad78419a6becd2bb240842b1dcc516424c8963</citedby><cites>FETCH-LOGICAL-c5404-7ab338cc865b83e0ef04686430aad78419a6becd2bb240842b1dcc516424c8963</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fj.1601-0825.2012.01934.x$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fj.1601-0825.2012.01934.x$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>230,314,777,781,882,1412,27905,27906,45555,45556</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/22524155$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Rosas, RR</creatorcontrib><creatorcontrib>Cole, KA</creatorcontrib><creatorcontrib>Darrah, L</creatorcontrib><creatorcontrib>Rohrer, MD</creatorcontrib><creatorcontrib>Rhodus, NL</creatorcontrib><creatorcontrib>Ondrey, FG</creatorcontrib><title>A comparison of screening methods in two early phase oral leukoplakia clinical trials</title><title>Oral diseases</title><addtitle>Oral Dis</addtitle><description>Oral Diseases (2012) 18, 720–723
Objectives/Introduction: Clinical trial accrual for oral dysplasia is difficult in the United States and elsewhere. Patients with dysplastic oral leukoplakia progress to frank invasive carcinoma at a rate of 5–37% over 5 years. We compared two clinical trial screening efforts to hopefully devise better accrual strategies to these types of clinical trials.
Methods: For the first trial, we identified 244 patients with dysplastic oral leukoplakia in our university database and a media campaign. Patients were notified and screened by examination and biopsy. For the second clinical trial, we established a preneoplastic lesions clinic and teaching and communications network with regional oral healthcare professionals.
Results: Only one of 244 patients accrued to the first clinical trial through an organized screening effort based on database/medical records review. The second clinical trial accrued 16/30 screened patients through redirected efforts in teaching, communications, and a preneoplastic lesions clinic.
Conclusion: We conclude that significant difficulties resulted from medical record/database review of leukoplakia patients as a screening method for leukoplakia clinical trial entry. We feel that persistent direct contact and education of healthcare professionals who are likely to examine leukoplakia patients improved accrual to the second clinical trial.</description><subject>barrier</subject><subject>cancer</subject><subject>clinical trial</subject><subject>Clinical trials</subject><subject>Clinical Trials as Topic</subject><subject>Databases, Factual</subject><subject>dysplasia</subject><subject>health education</subject><subject>Health Personnel - education</subject><subject>Humans</subject><subject>Leukoplakia, Oral - diagnosis</subject><subject>Leukoplakia, Oral - drug therapy</subject><subject>Mass Screening - methods</subject><subject>Methods</subject><subject>oral carcinoma</subject><subject>oral leukoplakia</subject><subject>Patient Selection</subject><subject>preneoplasia</subject><subject>referral clinic</subject><subject>United States</subject><issn>1354-523X</issn><issn>1601-0825</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2012</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkU9v1DAQxS0EoqXwFZAlLlwS_DdxDiBVBbaVVlSqqOA2chxv17tJnNoJ3f32OGxZASd8mZHn955m9BDClOQ0vXebnBaEZkQxmTNCWU5oxUW-e4JOj4OnqedSZJLx7yfoRYwbQmhZcfYcnTAmmaBSnqLbc2x8N-jgou-xX-FogrW96-9wZ8e1byJ2PR4fPLY6tHs8rHW02Afd4tZOWz-0eus0Nq3rnUmfY3C6jS_Rs1Uq9tVjPUO3nz99vbjMlteLq4vzZWakICIrdc25MkYVslbcErsiolCF4ETrplSCVrqorWlYXTNBlGA1bYyRtBBMGFUV_Ax9OPgOU93Zxth-TJvBEFynwx68dvD3pHdruPM_gAtBJK-SwdtHg-DvJxtH6Fw0tm11b_0UgZIECcnLGX3zD7rxU-jTeUClmJeSrEyUOlAm-BiDXR2XoQTm7GADc0QwRwRzdvArO9gl6es_jzkKf4eVgPcH4MG1dv_fxnD98Wrukj476F0c7e6o12ELRclLCd--LIBeEnGzWN5AwX8C-RW3Lw</recordid><startdate>201210</startdate><enddate>201210</enddate><creator>Rosas, RR</creator><creator>Cole, KA</creator><creator>Darrah, L</creator><creator>Rohrer, MD</creator><creator>Rhodus, NL</creator><creator>Ondrey, FG</creator><general>Blackwell Publishing Ltd</general><general>Wiley Subscription Services, Inc</general><scope>BSCLL</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>7QP</scope><scope>K9.</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>201210</creationdate><title>A comparison of screening methods in two early phase oral leukoplakia clinical trials</title><author>Rosas, RR ; Cole, KA ; Darrah, L ; Rohrer, MD ; Rhodus, NL ; Ondrey, FG</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c5404-7ab338cc865b83e0ef04686430aad78419a6becd2bb240842b1dcc516424c8963</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2012</creationdate><topic>barrier</topic><topic>cancer</topic><topic>clinical trial</topic><topic>Clinical trials</topic><topic>Clinical Trials as Topic</topic><topic>Databases, Factual</topic><topic>dysplasia</topic><topic>health education</topic><topic>Health Personnel - education</topic><topic>Humans</topic><topic>Leukoplakia, Oral - diagnosis</topic><topic>Leukoplakia, Oral - drug therapy</topic><topic>Mass Screening - methods</topic><topic>Methods</topic><topic>oral carcinoma</topic><topic>oral leukoplakia</topic><topic>Patient Selection</topic><topic>preneoplasia</topic><topic>referral clinic</topic><topic>United States</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Rosas, RR</creatorcontrib><creatorcontrib>Cole, KA</creatorcontrib><creatorcontrib>Darrah, L</creatorcontrib><creatorcontrib>Rohrer, MD</creatorcontrib><creatorcontrib>Rhodus, NL</creatorcontrib><creatorcontrib>Ondrey, FG</creatorcontrib><collection>Istex</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Oral diseases</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Rosas, RR</au><au>Cole, KA</au><au>Darrah, L</au><au>Rohrer, MD</au><au>Rhodus, NL</au><au>Ondrey, FG</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A comparison of screening methods in two early phase oral leukoplakia clinical trials</atitle><jtitle>Oral diseases</jtitle><addtitle>Oral Dis</addtitle><date>2012-10</date><risdate>2012</risdate><volume>18</volume><issue>7</issue><spage>720</spage><epage>723</epage><pages>720-723</pages><issn>1354-523X</issn><eissn>1601-0825</eissn><abstract>Oral Diseases (2012) 18, 720–723
Objectives/Introduction: Clinical trial accrual for oral dysplasia is difficult in the United States and elsewhere. Patients with dysplastic oral leukoplakia progress to frank invasive carcinoma at a rate of 5–37% over 5 years. We compared two clinical trial screening efforts to hopefully devise better accrual strategies to these types of clinical trials.
Methods: For the first trial, we identified 244 patients with dysplastic oral leukoplakia in our university database and a media campaign. Patients were notified and screened by examination and biopsy. For the second clinical trial, we established a preneoplastic lesions clinic and teaching and communications network with regional oral healthcare professionals.
Results: Only one of 244 patients accrued to the first clinical trial through an organized screening effort based on database/medical records review. The second clinical trial accrued 16/30 screened patients through redirected efforts in teaching, communications, and a preneoplastic lesions clinic.
Conclusion: We conclude that significant difficulties resulted from medical record/database review of leukoplakia patients as a screening method for leukoplakia clinical trial entry. We feel that persistent direct contact and education of healthcare professionals who are likely to examine leukoplakia patients improved accrual to the second clinical trial.</abstract><cop>Oxford, UK</cop><pub>Blackwell Publishing Ltd</pub><pmid>22524155</pmid><doi>10.1111/j.1601-0825.2012.01934.x</doi><tpages>4</tpages><oa>free_for_read</oa></addata></record> |
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subjects | barrier cancer clinical trial Clinical trials Clinical Trials as Topic Databases, Factual dysplasia health education Health Personnel - education Humans Leukoplakia, Oral - diagnosis Leukoplakia, Oral - drug therapy Mass Screening - methods Methods oral carcinoma oral leukoplakia Patient Selection preneoplasia referral clinic United States |
title | A comparison of screening methods in two early phase oral leukoplakia clinical trials |
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