Sample size calculation should be performed for design accuracy in diagnostic test studies
Guidelines for conducting studies and reading medical literature on diagnostic tests have been published: Requirements for the selection of cases and controls, and for ensuring a correct reference standard are now clarified. Our objective was to provide tables for sample size determination in this c...
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| Veröffentlicht in: | Journal of clinical epidemiology 2005-08, Vol.58 (8), p.859-862 |
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| container_title | Journal of clinical epidemiology |
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| creator | Flahault, Antoine Cadilhac, Michel Thomas, Guy |
| description | Guidelines for conducting studies and reading medical literature on diagnostic tests have been published: Requirements for the selection of cases and controls, and for ensuring a correct reference standard are now clarified. Our objective was to provide tables for sample size determination in this context.
In the usual situation, where the prevalence Prev of the disease of interest is |
| doi_str_mv | 10.1016/j.jclinepi.2004.12.009 |
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In the usual situation, where the prevalence Prev of the disease of interest is <0.50, one first determines the minimal number
N
cases of cases required to ensure a given precision of the sensitivity estimate. Computations are based on the binomial distribution, for user-specified type I and type II error levels. The minimal number
N
controls of controls is then derived so as to allow for representativeness of the study population, according to
N
controls
=
N
cases [(1 − Prev)/Prev].
Tables give the values of
N
cases corresponding to expected sensitivities from 0.60 to 0.99, acceptable lower 95% confidence limits from 0.50 to 0.98, and 5% probability of the estimated lower confidence limit being lower than the acceptable level.
When designing diagnostic test studies, sample size calculations should be performed in order to guarantee the design accuracy.</description><identifier>ISSN: 0895-4356</identifier><identifier>EISSN: 1878-5921</identifier><identifier>DOI: 10.1016/j.jclinepi.2004.12.009</identifier><identifier>PMID: 16018921</identifier><language>eng</language><publisher>New York, NY: Elsevier Inc</publisher><subject>Accuracy ; Binomial distribution ; Biological and medical sciences ; Biomedical Research - methods ; Confidence intervals ; Diagnostic test ; Diagnostic tests ; Diagnostic Tests, Routine - standards ; Disease ; Epidemiology ; General aspects ; Humans ; Hypotheses ; Medical sciences ; Methodology ; Public health. Hygiene ; Public health. Hygiene-occupational medicine ; Research Design ; Sample Size ; Sensitivity ; Sensitivity and Specificity ; Specificity ; Studies</subject><ispartof>Journal of clinical epidemiology, 2005-08, Vol.58 (8), p.859-862</ispartof><rights>2005 Elsevier Inc.</rights><rights>2005 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c424t-b1ba729360e564efed3b3ad101beca3c8fef3363ccbe451d87e11d83f2b1d3453</citedby><cites>FETCH-LOGICAL-c424t-b1ba729360e564efed3b3ad101beca3c8fef3363ccbe451d87e11d83f2b1d3453</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.proquest.com/docview/1033182146?pq-origsite=primo$$EHTML$$P50$$Gproquest$$H</linktohtml><link.rule.ids>315,781,785,3551,27929,27930,46000,64390,64392,64394,72474</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=17047734$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/16018921$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Flahault, Antoine</creatorcontrib><creatorcontrib>Cadilhac, Michel</creatorcontrib><creatorcontrib>Thomas, Guy</creatorcontrib><title>Sample size calculation should be performed for design accuracy in diagnostic test studies</title><title>Journal of clinical epidemiology</title><addtitle>J Clin Epidemiol</addtitle><description>Guidelines for conducting studies and reading medical literature on diagnostic tests have been published: Requirements for the selection of cases and controls, and for ensuring a correct reference standard are now clarified. Our objective was to provide tables for sample size determination in this context.
In the usual situation, where the prevalence Prev of the disease of interest is <0.50, one first determines the minimal number
N
cases of cases required to ensure a given precision of the sensitivity estimate. Computations are based on the binomial distribution, for user-specified type I and type II error levels. The minimal number
N
controls of controls is then derived so as to allow for representativeness of the study population, according to
N
controls
=
N
cases [(1 − Prev)/Prev].
Tables give the values of
N
cases corresponding to expected sensitivities from 0.60 to 0.99, acceptable lower 95% confidence limits from 0.50 to 0.98, and 5% probability of the estimated lower confidence limit being lower than the acceptable level.
When designing diagnostic test studies, sample size calculations should be performed in order to guarantee the design accuracy.</description><subject>Accuracy</subject><subject>Binomial distribution</subject><subject>Biological and medical sciences</subject><subject>Biomedical Research - methods</subject><subject>Confidence intervals</subject><subject>Diagnostic test</subject><subject>Diagnostic tests</subject><subject>Diagnostic Tests, Routine - standards</subject><subject>Disease</subject><subject>Epidemiology</subject><subject>General aspects</subject><subject>Humans</subject><subject>Hypotheses</subject><subject>Medical sciences</subject><subject>Methodology</subject><subject>Public health. Hygiene</subject><subject>Public health. Hygiene-occupational medicine</subject><subject>Research Design</subject><subject>Sample Size</subject><subject>Sensitivity</subject><subject>Sensitivity and Specificity</subject><subject>Specificity</subject><subject>Studies</subject><issn>0895-4356</issn><issn>1878-5921</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2005</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNqFkE1r3DAQhkVJaLZp_0IQlORmV7Jk2b4lhPQDAjkkvfQi5NE4lfFKrmQH0l8fLbsl0EsuM5fnHd55CDnjrOSMqy9jOcLkPM6urBiTJa9Kxrp3ZMPbpi3qruJHZMPari6kqNUJ-ZDSyBhvWFO_JydcMd5mZkN-3ZvtPCFN7i9SMBOsk1lc8DT9DutkaY90xjiEuEVL86IWk3v01ACs0cAzdZ5aZx59SIsDumBaaFpW6zB9JMeDmRJ-OuxT8vPrzcP19-L27tuP66vbAmQll6LnvWmqTiiGtZI4oBW9MDZ_2SMYAe2AgxBKAPQoa27bBnmeYqh6boWsxSm52N-dY_iz5gJ66xLgNBmPYU1atUwI1skMfv4PHMMafe6meUZ4W3GpMqX2FMSQUsRBz9FtTXzOkN6516P-517v3Gte6ew-B88O59c-23qNHWRn4PwAmJRVD9F4cOmVa5hsGrHrebnnMFt7chh1Aoce0LqIsGgb3FtdXgBRI6aM</recordid><startdate>20050801</startdate><enddate>20050801</enddate><creator>Flahault, Antoine</creator><creator>Cadilhac, Michel</creator><creator>Thomas, Guy</creator><general>Elsevier Inc</general><general>Elsevier</general><general>Elsevier Limited</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>3V.</scope><scope>7QL</scope><scope>7QP</scope><scope>7RV</scope><scope>7T2</scope><scope>7T7</scope><scope>7TK</scope><scope>7U7</scope><scope>7U9</scope><scope>7X7</scope><scope>7XB</scope><scope>88C</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FD</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>C1K</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>H94</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M0T</scope><scope>M1P</scope><scope>M2O</scope><scope>M7N</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>P64</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>Q9U</scope><scope>7X8</scope></search><sort><creationdate>20050801</creationdate><title>Sample size calculation should be performed for design accuracy in diagnostic test studies</title><author>Flahault, Antoine ; Cadilhac, Michel ; Thomas, Guy</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c424t-b1ba729360e564efed3b3ad101beca3c8fef3363ccbe451d87e11d83f2b1d3453</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2005</creationdate><topic>Accuracy</topic><topic>Binomial distribution</topic><topic>Biological and medical sciences</topic><topic>Biomedical Research - methods</topic><topic>Confidence intervals</topic><topic>Diagnostic test</topic><topic>Diagnostic tests</topic><topic>Diagnostic Tests, Routine - standards</topic><topic>Disease</topic><topic>Epidemiology</topic><topic>General aspects</topic><topic>Humans</topic><topic>Hypotheses</topic><topic>Medical sciences</topic><topic>Methodology</topic><topic>Public health. Hygiene</topic><topic>Public health. Hygiene-occupational medicine</topic><topic>Research Design</topic><topic>Sample Size</topic><topic>Sensitivity</topic><topic>Sensitivity and Specificity</topic><topic>Specificity</topic><topic>Studies</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Flahault, Antoine</creatorcontrib><creatorcontrib>Cadilhac, Michel</creatorcontrib><creatorcontrib>Thomas, Guy</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>ProQuest Central (Corporate)</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>Nursing & Allied Health Database</collection><collection>Health and Safety Science Abstracts (Full archive)</collection><collection>Industrial and Applied Microbiology Abstracts (Microbiology A)</collection><collection>Neurosciences Abstracts</collection><collection>Toxicology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Healthcare Administration Database (Alumni)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>Technology Research Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</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>Research Library Prep</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Healthcare Administration Database</collection><collection>Medical Database</collection><collection>Research Library</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Research Library (Corporate)</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 Basic</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of clinical epidemiology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Flahault, Antoine</au><au>Cadilhac, Michel</au><au>Thomas, Guy</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Sample size calculation should be performed for design accuracy in diagnostic test studies</atitle><jtitle>Journal of clinical epidemiology</jtitle><addtitle>J Clin Epidemiol</addtitle><date>2005-08-01</date><risdate>2005</risdate><volume>58</volume><issue>8</issue><spage>859</spage><epage>862</epage><pages>859-862</pages><issn>0895-4356</issn><eissn>1878-5921</eissn><abstract>Guidelines for conducting studies and reading medical literature on diagnostic tests have been published: Requirements for the selection of cases and controls, and for ensuring a correct reference standard are now clarified. Our objective was to provide tables for sample size determination in this context.
In the usual situation, where the prevalence Prev of the disease of interest is <0.50, one first determines the minimal number
N
cases of cases required to ensure a given precision of the sensitivity estimate. Computations are based on the binomial distribution, for user-specified type I and type II error levels. The minimal number
N
controls of controls is then derived so as to allow for representativeness of the study population, according to
N
controls
=
N
cases [(1 − Prev)/Prev].
Tables give the values of
N
cases corresponding to expected sensitivities from 0.60 to 0.99, acceptable lower 95% confidence limits from 0.50 to 0.98, and 5% probability of the estimated lower confidence limit being lower than the acceptable level.
When designing diagnostic test studies, sample size calculations should be performed in order to guarantee the design accuracy.</abstract><cop>New York, NY</cop><pub>Elsevier Inc</pub><pmid>16018921</pmid><doi>10.1016/j.jclinepi.2004.12.009</doi><tpages>4</tpages></addata></record> |
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| ispartof | Journal of clinical epidemiology, 2005-08, Vol.58 (8), p.859-862 |
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| source | MEDLINE; Elsevier ScienceDirect Journals Complete; ProQuest Central UK/Ireland |
| subjects | Accuracy Binomial distribution Biological and medical sciences Biomedical Research - methods Confidence intervals Diagnostic test Diagnostic tests Diagnostic Tests, Routine - standards Disease Epidemiology General aspects Humans Hypotheses Medical sciences Methodology Public health. Hygiene Public health. Hygiene-occupational medicine Research Design Sample Size Sensitivity Sensitivity and Specificity Specificity Studies |
| title | Sample size calculation should be performed for design accuracy in diagnostic test studies |
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