A multicenter study for the evaluation of the reference interval for TSH in Italy (ELAS TSH Italian Study)
Background The aims of this study were: (1) to calculate reliable thyroid stimulating hormone (TSH) reference intervals using laboratory databases; (2) to evaluate the relationship between TSH, sex and age values in different large Italian populations. Methods The TSH values stored in the laboratory...
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| Veröffentlicht in: | Clinical chemistry and laboratory medicine 2019-02, Vol.57 (2), p.259-267 |
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| creator | Clerico, Aldo Trenti, Tommaso Aloe, Rosalia Dittadi, Ruggero Rizzardi, Sara Migliardi, Marco Musa, Roberta Dipalo, Mariella Prontera, Concetta Masotti, Silvia Musetti, Veronica Tozzoli, Renato Padoan, Andrea Bagnasco, Marcello |
| description | Background The aims of this study were: (1) to calculate reliable thyroid stimulating hormone (TSH) reference intervals using laboratory databases; (2) to evaluate the relationship between TSH, sex and age values in different large Italian populations. Methods The TSH values stored in the laboratory information system of clinical laboratories of four Italian city hospitals, including 146,801 TSH measurements (with the respective age and sex data of individuals) were taken in consideration. Assuming a log-normal distribution, to log-transformed TSH values were applied the Dixon's iterative principle in order to exclude the outliers. At the end of this iterative process 142,821 log-transformed TSH results remained. The four clinical laboratories measured serum TSH concentrations using the same TSH immunoassay method (Access TSH 3rd IS, using UniCel DxI platform). Results The TSH reference interval calculated in the present study (0.362-5.280 mIU/L) is similar to that suggested by the manufacturer for the Access TSH 3rd IS assay (0.45-5.33 mIU/L). TSH values in females were significantly higher than in males (females: mean=2.06 mIU/L; standard deviation [SD]=1.26 mIU/L; n=101,243; males: mean=1.92 mIU/L; SD=1.19 mIU/L; n=41,578; p |
| doi_str_mv | 10.1515/cclm-2018-0541 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2071574071</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2168515675</sourcerecordid><originalsourceid>FETCH-LOGICAL-c442t-988d856b3cd0ba4bf8bc3f1e1652e7f12fa39d75437828aaab317aa783ad8a963</originalsourceid><addsrcrecordid>eNptkUtLAzEUhYMotla3LiXgRhejk3cKboqoFQouqutwJ5PRKfPQZEbpvzfT-gBxk9zcfDlJzkHomKQXRBBxaW1VJzQlOkkFJztoTDhTCWeM7G5qnkhJyQgdhLBKUyIEV_toxGIpqZJjtJrhuq-60rqmcx6Hrs_XuGg97l4cdu9Q9dCVbYPbYtPxrnDeNdbhcuDj_gZ-XM5jA993UK3x2c1itty0hnUJDV4OqueHaK-AKrijr3mCnm5vHq_nyeLh7v56tkgs57RLplrnWsiM2TzNgGeFziwriCNSUKcKQgtg01yJ-E9NNQBkjCgApRnkGqaSTdDZVvfVt2-9C52py2BdVUHj2j4YmioiFI9jRE__oKu29018naFE6miwVCJSF1vK-jaEaIF59WUNfm1IaoYUzJCCGVIwQwrxwMmXbJ_VLv_Bv22PwNUW-IAq2pi7Z9-vY_F7_f_KQlEqpuwTsPOVTw</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2168515675</pqid></control><display><type>article</type><title>A multicenter study for the evaluation of the reference interval for TSH in Italy (ELAS TSH Italian Study)</title><source>De Gruyter journals</source><creator>Clerico, Aldo ; Trenti, Tommaso ; Aloe, Rosalia ; Dittadi, Ruggero ; Rizzardi, Sara ; Migliardi, Marco ; Musa, Roberta ; Dipalo, Mariella ; Prontera, Concetta ; Masotti, Silvia ; Musetti, Veronica ; Tozzoli, Renato ; Padoan, Andrea ; Bagnasco, Marcello</creator><creatorcontrib>Clerico, Aldo ; Trenti, Tommaso ; Aloe, Rosalia ; Dittadi, Ruggero ; Rizzardi, Sara ; Migliardi, Marco ; Musa, Roberta ; Dipalo, Mariella ; Prontera, Concetta ; Masotti, Silvia ; Musetti, Veronica ; Tozzoli, Renato ; Padoan, Andrea ; Bagnasco, Marcello ; Italian Section of the European Ligand Assay Society (ELAS)</creatorcontrib><description>Background The aims of this study were: (1) to calculate reliable thyroid stimulating hormone (TSH) reference intervals using laboratory databases; (2) to evaluate the relationship between TSH, sex and age values in different large Italian populations. Methods The TSH values stored in the laboratory information system of clinical laboratories of four Italian city hospitals, including 146,801 TSH measurements (with the respective age and sex data of individuals) were taken in consideration. Assuming a log-normal distribution, to log-transformed TSH values were applied the Dixon's iterative principle in order to exclude the outliers. At the end of this iterative process 142,821 log-transformed TSH results remained. The four clinical laboratories measured serum TSH concentrations using the same TSH immunoassay method (Access TSH 3rd IS, using UniCel DxI platform). Results The TSH reference interval calculated in the present study (0.362-5.280 mIU/L) is similar to that suggested by the manufacturer for the Access TSH 3rd IS assay (0.45-5.33 mIU/L). TSH values in females were significantly higher than in males (females: mean=2.06 mIU/L; standard deviation [SD]=1.26 mIU/L; n=101,243; males: mean=1.92 mIU/L; SD=1.19 mIU/L; n=41,578; p<0.0001). Moreover, a negative linear relationship was observed between TSH throughout all interval age values (from 0 to 105 years). Conclusions The results of the present multicenter study confirm that data mining techniques can be used to calculate clinically useful reference intervals for TSH. From a pathophysiological point of view, our results suggest that some Northern populations of Italy might still suffer some harmful effects on the thyroid gland due to mild to moderate iodine intake deficiency. Specific clinical trials are needed to confirm these results.</description><identifier>ISSN: 1434-6621</identifier><identifier>EISSN: 1437-4331</identifier><identifier>DOI: 10.1515/cclm-2018-0541</identifier><identifier>PMID: 30016276</identifier><language>eng</language><publisher>Germany: De Gruyter</publisher><subject>Age ; Clinical trials ; Data mining ; data mining technique ; Data processing ; Females ; Immunoassay ; immunoassay methods ; Information systems ; Intervals ; Iodine ; Laboratories ; Males ; Mathematical analysis ; Medical research ; Normal distribution ; Outliers (statistics) ; population study ; Populations ; reference intervals ; Sex ; Thyroid ; Thyroid gland ; thyroid stimulating hormone (TSH) ; Thyroid-stimulating hormone</subject><ispartof>Clinical chemistry and laboratory medicine, 2019-02, Vol.57 (2), p.259-267</ispartof><rights>2019 Walter de Gruyter GmbH, Berlin/Boston</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c442t-988d856b3cd0ba4bf8bc3f1e1652e7f12fa39d75437828aaab317aa783ad8a963</citedby><cites>FETCH-LOGICAL-c442t-988d856b3cd0ba4bf8bc3f1e1652e7f12fa39d75437828aaab317aa783ad8a963</cites><orcidid>0000-0003-1284-7885</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.degruyter.com/document/doi/10.1515/cclm-2018-0541/pdf$$EPDF$$P50$$Gwalterdegruyter$$H</linktopdf><linktohtml>$$Uhttps://www.degruyter.com/document/doi/10.1515/cclm-2018-0541/html$$EHTML$$P50$$Gwalterdegruyter$$H</linktohtml><link.rule.ids>314,776,780,27901,27902,66497,68281</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30016276$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Clerico, Aldo</creatorcontrib><creatorcontrib>Trenti, Tommaso</creatorcontrib><creatorcontrib>Aloe, Rosalia</creatorcontrib><creatorcontrib>Dittadi, Ruggero</creatorcontrib><creatorcontrib>Rizzardi, Sara</creatorcontrib><creatorcontrib>Migliardi, Marco</creatorcontrib><creatorcontrib>Musa, Roberta</creatorcontrib><creatorcontrib>Dipalo, Mariella</creatorcontrib><creatorcontrib>Prontera, Concetta</creatorcontrib><creatorcontrib>Masotti, Silvia</creatorcontrib><creatorcontrib>Musetti, Veronica</creatorcontrib><creatorcontrib>Tozzoli, Renato</creatorcontrib><creatorcontrib>Padoan, Andrea</creatorcontrib><creatorcontrib>Bagnasco, Marcello</creatorcontrib><creatorcontrib>Italian Section of the European Ligand Assay Society (ELAS)</creatorcontrib><title>A multicenter study for the evaluation of the reference interval for TSH in Italy (ELAS TSH Italian Study)</title><title>Clinical chemistry and laboratory medicine</title><addtitle>Clin Chem Lab Med</addtitle><description>Background The aims of this study were: (1) to calculate reliable thyroid stimulating hormone (TSH) reference intervals using laboratory databases; (2) to evaluate the relationship between TSH, sex and age values in different large Italian populations. Methods The TSH values stored in the laboratory information system of clinical laboratories of four Italian city hospitals, including 146,801 TSH measurements (with the respective age and sex data of individuals) were taken in consideration. Assuming a log-normal distribution, to log-transformed TSH values were applied the Dixon's iterative principle in order to exclude the outliers. At the end of this iterative process 142,821 log-transformed TSH results remained. The four clinical laboratories measured serum TSH concentrations using the same TSH immunoassay method (Access TSH 3rd IS, using UniCel DxI platform). Results The TSH reference interval calculated in the present study (0.362-5.280 mIU/L) is similar to that suggested by the manufacturer for the Access TSH 3rd IS assay (0.45-5.33 mIU/L). TSH values in females were significantly higher than in males (females: mean=2.06 mIU/L; standard deviation [SD]=1.26 mIU/L; n=101,243; males: mean=1.92 mIU/L; SD=1.19 mIU/L; n=41,578; p<0.0001). Moreover, a negative linear relationship was observed between TSH throughout all interval age values (from 0 to 105 years). Conclusions The results of the present multicenter study confirm that data mining techniques can be used to calculate clinically useful reference intervals for TSH. From a pathophysiological point of view, our results suggest that some Northern populations of Italy might still suffer some harmful effects on the thyroid gland due to mild to moderate iodine intake deficiency. Specific clinical trials are needed to confirm these results.</description><subject>Age</subject><subject>Clinical trials</subject><subject>Data mining</subject><subject>data mining technique</subject><subject>Data processing</subject><subject>Females</subject><subject>Immunoassay</subject><subject>immunoassay methods</subject><subject>Information systems</subject><subject>Intervals</subject><subject>Iodine</subject><subject>Laboratories</subject><subject>Males</subject><subject>Mathematical analysis</subject><subject>Medical research</subject><subject>Normal distribution</subject><subject>Outliers (statistics)</subject><subject>population study</subject><subject>Populations</subject><subject>reference intervals</subject><subject>Sex</subject><subject>Thyroid</subject><subject>Thyroid gland</subject><subject>thyroid stimulating hormone (TSH)</subject><subject>Thyroid-stimulating hormone</subject><issn>1434-6621</issn><issn>1437-4331</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><recordid>eNptkUtLAzEUhYMotla3LiXgRhejk3cKboqoFQouqutwJ5PRKfPQZEbpvzfT-gBxk9zcfDlJzkHomKQXRBBxaW1VJzQlOkkFJztoTDhTCWeM7G5qnkhJyQgdhLBKUyIEV_toxGIpqZJjtJrhuq-60rqmcx6Hrs_XuGg97l4cdu9Q9dCVbYPbYtPxrnDeNdbhcuDj_gZ-XM5jA993UK3x2c1itty0hnUJDV4OqueHaK-AKrijr3mCnm5vHq_nyeLh7v56tkgs57RLplrnWsiM2TzNgGeFziwriCNSUKcKQgtg01yJ-E9NNQBkjCgApRnkGqaSTdDZVvfVt2-9C52py2BdVUHj2j4YmioiFI9jRE__oKu29018naFE6miwVCJSF1vK-jaEaIF59WUNfm1IaoYUzJCCGVIwQwrxwMmXbJ_VLv_Bv22PwNUW-IAq2pi7Z9-vY_F7_f_KQlEqpuwTsPOVTw</recordid><startdate>20190201</startdate><enddate>20190201</enddate><creator>Clerico, Aldo</creator><creator>Trenti, Tommaso</creator><creator>Aloe, Rosalia</creator><creator>Dittadi, Ruggero</creator><creator>Rizzardi, Sara</creator><creator>Migliardi, Marco</creator><creator>Musa, Roberta</creator><creator>Dipalo, Mariella</creator><creator>Prontera, Concetta</creator><creator>Masotti, Silvia</creator><creator>Musetti, Veronica</creator><creator>Tozzoli, Renato</creator><creator>Padoan, Andrea</creator><creator>Bagnasco, Marcello</creator><general>De Gruyter</general><general>Walter De Gruyter & Company</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QO</scope><scope>7T7</scope><scope>7TK</scope><scope>7U7</scope><scope>8FD</scope><scope>C1K</scope><scope>FR3</scope><scope>P64</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0003-1284-7885</orcidid></search><sort><creationdate>20190201</creationdate><title>A multicenter study for the evaluation of the reference interval for TSH in Italy (ELAS TSH Italian Study)</title><author>Clerico, Aldo ; Trenti, Tommaso ; Aloe, Rosalia ; Dittadi, Ruggero ; Rizzardi, Sara ; Migliardi, Marco ; Musa, Roberta ; Dipalo, Mariella ; Prontera, Concetta ; Masotti, Silvia ; Musetti, Veronica ; Tozzoli, Renato ; Padoan, Andrea ; Bagnasco, Marcello</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c442t-988d856b3cd0ba4bf8bc3f1e1652e7f12fa39d75437828aaab317aa783ad8a963</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Age</topic><topic>Clinical trials</topic><topic>Data mining</topic><topic>data mining technique</topic><topic>Data processing</topic><topic>Females</topic><topic>Immunoassay</topic><topic>immunoassay methods</topic><topic>Information systems</topic><topic>Intervals</topic><topic>Iodine</topic><topic>Laboratories</topic><topic>Males</topic><topic>Mathematical analysis</topic><topic>Medical research</topic><topic>Normal distribution</topic><topic>Outliers (statistics)</topic><topic>population study</topic><topic>Populations</topic><topic>reference intervals</topic><topic>Sex</topic><topic>Thyroid</topic><topic>Thyroid gland</topic><topic>thyroid stimulating hormone (TSH)</topic><topic>Thyroid-stimulating hormone</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Clerico, Aldo</creatorcontrib><creatorcontrib>Trenti, Tommaso</creatorcontrib><creatorcontrib>Aloe, Rosalia</creatorcontrib><creatorcontrib>Dittadi, Ruggero</creatorcontrib><creatorcontrib>Rizzardi, Sara</creatorcontrib><creatorcontrib>Migliardi, Marco</creatorcontrib><creatorcontrib>Musa, Roberta</creatorcontrib><creatorcontrib>Dipalo, Mariella</creatorcontrib><creatorcontrib>Prontera, Concetta</creatorcontrib><creatorcontrib>Masotti, Silvia</creatorcontrib><creatorcontrib>Musetti, Veronica</creatorcontrib><creatorcontrib>Tozzoli, Renato</creatorcontrib><creatorcontrib>Padoan, Andrea</creatorcontrib><creatorcontrib>Bagnasco, Marcello</creatorcontrib><creatorcontrib>Italian Section of the European Ligand Assay Society (ELAS)</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>Biotechnology Research Abstracts</collection><collection>Industrial and Applied Microbiology Abstracts (Microbiology A)</collection><collection>Neurosciences Abstracts</collection><collection>Toxicology Abstracts</collection><collection>Technology Research Database</collection><collection>Environmental Sciences and Pollution Management</collection><collection>Engineering Research Database</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>Clinical chemistry and laboratory medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Clerico, Aldo</au><au>Trenti, Tommaso</au><au>Aloe, Rosalia</au><au>Dittadi, Ruggero</au><au>Rizzardi, Sara</au><au>Migliardi, Marco</au><au>Musa, Roberta</au><au>Dipalo, Mariella</au><au>Prontera, Concetta</au><au>Masotti, Silvia</au><au>Musetti, Veronica</au><au>Tozzoli, Renato</au><au>Padoan, Andrea</au><au>Bagnasco, Marcello</au><aucorp>Italian Section of the European Ligand Assay Society (ELAS)</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A multicenter study for the evaluation of the reference interval for TSH in Italy (ELAS TSH Italian Study)</atitle><jtitle>Clinical chemistry and laboratory medicine</jtitle><addtitle>Clin Chem Lab Med</addtitle><date>2019-02-01</date><risdate>2019</risdate><volume>57</volume><issue>2</issue><spage>259</spage><epage>267</epage><pages>259-267</pages><issn>1434-6621</issn><eissn>1437-4331</eissn><abstract>Background The aims of this study were: (1) to calculate reliable thyroid stimulating hormone (TSH) reference intervals using laboratory databases; (2) to evaluate the relationship between TSH, sex and age values in different large Italian populations. Methods The TSH values stored in the laboratory information system of clinical laboratories of four Italian city hospitals, including 146,801 TSH measurements (with the respective age and sex data of individuals) were taken in consideration. Assuming a log-normal distribution, to log-transformed TSH values were applied the Dixon's iterative principle in order to exclude the outliers. At the end of this iterative process 142,821 log-transformed TSH results remained. The four clinical laboratories measured serum TSH concentrations using the same TSH immunoassay method (Access TSH 3rd IS, using UniCel DxI platform). Results The TSH reference interval calculated in the present study (0.362-5.280 mIU/L) is similar to that suggested by the manufacturer for the Access TSH 3rd IS assay (0.45-5.33 mIU/L). TSH values in females were significantly higher than in males (females: mean=2.06 mIU/L; standard deviation [SD]=1.26 mIU/L; n=101,243; males: mean=1.92 mIU/L; SD=1.19 mIU/L; n=41,578; p<0.0001). Moreover, a negative linear relationship was observed between TSH throughout all interval age values (from 0 to 105 years). Conclusions The results of the present multicenter study confirm that data mining techniques can be used to calculate clinically useful reference intervals for TSH. From a pathophysiological point of view, our results suggest that some Northern populations of Italy might still suffer some harmful effects on the thyroid gland due to mild to moderate iodine intake deficiency. Specific clinical trials are needed to confirm these results.</abstract><cop>Germany</cop><pub>De Gruyter</pub><pmid>30016276</pmid><doi>10.1515/cclm-2018-0541</doi><tpages>9</tpages><orcidid>https://orcid.org/0000-0003-1284-7885</orcidid></addata></record> |
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| subjects | Age Clinical trials Data mining data mining technique Data processing Females Immunoassay immunoassay methods Information systems Intervals Iodine Laboratories Males Mathematical analysis Medical research Normal distribution Outliers (statistics) population study Populations reference intervals Sex Thyroid Thyroid gland thyroid stimulating hormone (TSH) Thyroid-stimulating hormone |
| title | A multicenter study for the evaluation of the reference interval for TSH in Italy (ELAS TSH Italian Study) |
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