The Impact of a Line Probe Assay Based Diagnostic Algorithm on Time to Treatment Initiation and Treatment Outcomes for Multidrug Resistant TB Patients in Arkhangelsk Region, Russia
In the Arkhangelsk region of Northern Russia, multidrug-resistant (MDR) tuberculosis (TB) rates in new cases are amongst the highest in the world. In 2014, MDR-TB rates reached 31.7% among new cases and 56.9% among retreatment cases. The development of new diagnostic tools allows for faster detectio...
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| Veröffentlicht in: | PloS one 2016-04, Vol.11 (4), p.e0152761-e0152761 |
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| creator | Eliseev, Platon Balantcev, Grigory Nikishova, Elena Gaida, Anastasia Bogdanova, Elena Enarson, Donald Ornstein, Tara Detjen, Anne Dacombe, Russell Gospodarevskaya, Elena Phillips, Patrick P J Mann, Gillian Squire, Stephen Bertel Mariandyshev, Andrei |
| description | In the Arkhangelsk region of Northern Russia, multidrug-resistant (MDR) tuberculosis (TB) rates in new cases are amongst the highest in the world. In 2014, MDR-TB rates reached 31.7% among new cases and 56.9% among retreatment cases. The development of new diagnostic tools allows for faster detection of both TB and MDR-TB and should lead to reduced transmission by earlier initiation of anti-TB therapy.
The PROVE-IT (Policy Relevant Outcomes from Validating Evidence on Impact) Russia study aimed to assess the impact of the implementation of line probe assay (LPA) as part of an LPA-based diagnostic algorithm for patients with presumptive MDR-TB focusing on time to treatment initiation with time from first-care seeking visit to the initiation of MDR-TB treatment rather than diagnostic accuracy as the primary outcome, and to assess treatment outcomes. We hypothesized that the implementation of LPA would result in faster time to treatment initiation and better treatment outcomes.
A culture-based diagnostic algorithm used prior to LPA implementation was compared to an LPA-based algorithm that replaced BacTAlert and Löwenstein Jensen (LJ) for drug sensitivity testing. A total of 295 MDR-TB patients were included in the study, 163 diagnosed with the culture-based algorithm, 132 with the LPA-based algorithm.
Among smear positive patients, the implementation of the LPA-based algorithm was associated with a median decrease in time to MDR-TB treatment initiation of 50 and 66 days compared to the culture-based algorithm (BacTAlert and LJ respectively, p |
| doi_str_mv | 10.1371/journal.pone.0152761 |
| format | Article |
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The PROVE-IT (Policy Relevant Outcomes from Validating Evidence on Impact) Russia study aimed to assess the impact of the implementation of line probe assay (LPA) as part of an LPA-based diagnostic algorithm for patients with presumptive MDR-TB focusing on time to treatment initiation with time from first-care seeking visit to the initiation of MDR-TB treatment rather than diagnostic accuracy as the primary outcome, and to assess treatment outcomes. We hypothesized that the implementation of LPA would result in faster time to treatment initiation and better treatment outcomes.
A culture-based diagnostic algorithm used prior to LPA implementation was compared to an LPA-based algorithm that replaced BacTAlert and Löwenstein Jensen (LJ) for drug sensitivity testing. A total of 295 MDR-TB patients were included in the study, 163 diagnosed with the culture-based algorithm, 132 with the LPA-based algorithm.
Among smear positive patients, the implementation of the LPA-based algorithm was associated with a median decrease in time to MDR-TB treatment initiation of 50 and 66 days compared to the culture-based algorithm (BacTAlert and LJ respectively, p<0.001). In smear negative patients, the LPA-based algorithm was associated with a median decrease in time to MDR-TB treatment initiation of 78 days when compared to the culture-based algorithm (LJ, p<0.001). However, several weeks were still needed for treatment initiation in LPA-based algorithm, 24 days in smear positive, and 62 days in smear negative patients. Overall treatment outcomes were better in LPA-based algorithm compared to culture-based algorithm (p = 0.003). Treatment success rates at 20 months of treatment were higher in patients diagnosed with the LPA-based algorithm (65.2%) as compared to those diagnosed with the culture-based algorithm (44.8%). Mortality was also lower in the LPA-based algorithm group (7.6%) compared to the culture-based algorithm group (15.9%). There was no statistically significant difference in smear and culture conversion rates between the two algorithms.
The results of the study suggest that the introduction of LPA leads to faster time to MDR diagnosis and earlier treatment initiation as well as better treatment outcomes for patients with MDR-TB. These findings also highlight the need for further improvements within the health system to reduce both patient and diagnostic delays to truly optimize the impact of new, rapid diagnostics.</description><identifier>ISSN: 1932-6203</identifier><identifier>EISSN: 1932-6203</identifier><identifier>DOI: 10.1371/journal.pone.0152761</identifier><identifier>PMID: 27055269</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>Adult ; Algorithms ; Biology and Life Sciences ; Care and treatment ; Clinical outcomes ; Clinics ; Complications and side effects ; Culture ; Diagnosis ; Diagnostic software ; Diagnostic systems ; Disease transmission ; Drug resistance ; Drug sensitivity testing ; Female ; Humans ; Lung diseases ; Male ; Medical diagnosis ; Medicine ; Medicine and Health Sciences ; Microbial drug resistance ; Middle Aged ; Mortality ; Multidrug resistance ; Multidrug resistant organisms ; Patient outcomes ; Patients ; People and Places ; Physical Sciences ; Public health ; Research and Analysis Methods ; Russia - epidemiology ; Smear ; Statistical analysis ; Studies ; Tuberculosis ; Tuberculosis, Multidrug-Resistant - diagnosis ; Tuberculosis, Multidrug-Resistant - epidemiology ; Tuberculosis, Multidrug-Resistant - therapy</subject><ispartof>PloS one, 2016-04, Vol.11 (4), p.e0152761-e0152761</ispartof><rights>COPYRIGHT 2016 Public Library of Science</rights><rights>2016 Eliseev et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2016 Eliseev et al 2016 Eliseev et al</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c692t-2a75c436c1e68c6736cbacb1b32a7ffdb98fa534fbd2e842341112078641b45d3</citedby><cites>FETCH-LOGICAL-c692t-2a75c436c1e68c6736cbacb1b32a7ffdb98fa534fbd2e842341112078641b45d3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4824472/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4824472/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,864,885,2102,2928,23866,27924,27925,53791,53793,79600,79601</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27055269$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><contributor>García-García, José-María</contributor><creatorcontrib>Eliseev, Platon</creatorcontrib><creatorcontrib>Balantcev, Grigory</creatorcontrib><creatorcontrib>Nikishova, Elena</creatorcontrib><creatorcontrib>Gaida, Anastasia</creatorcontrib><creatorcontrib>Bogdanova, Elena</creatorcontrib><creatorcontrib>Enarson, Donald</creatorcontrib><creatorcontrib>Ornstein, Tara</creatorcontrib><creatorcontrib>Detjen, Anne</creatorcontrib><creatorcontrib>Dacombe, Russell</creatorcontrib><creatorcontrib>Gospodarevskaya, Elena</creatorcontrib><creatorcontrib>Phillips, Patrick P J</creatorcontrib><creatorcontrib>Mann, Gillian</creatorcontrib><creatorcontrib>Squire, Stephen Bertel</creatorcontrib><creatorcontrib>Mariandyshev, Andrei</creatorcontrib><title>The Impact of a Line Probe Assay Based Diagnostic Algorithm on Time to Treatment Initiation and Treatment Outcomes for Multidrug Resistant TB Patients in Arkhangelsk Region, Russia</title><title>PloS one</title><addtitle>PLoS One</addtitle><description>In the Arkhangelsk region of Northern Russia, multidrug-resistant (MDR) tuberculosis (TB) rates in new cases are amongst the highest in the world. In 2014, MDR-TB rates reached 31.7% among new cases and 56.9% among retreatment cases. The development of new diagnostic tools allows for faster detection of both TB and MDR-TB and should lead to reduced transmission by earlier initiation of anti-TB therapy.
The PROVE-IT (Policy Relevant Outcomes from Validating Evidence on Impact) Russia study aimed to assess the impact of the implementation of line probe assay (LPA) as part of an LPA-based diagnostic algorithm for patients with presumptive MDR-TB focusing on time to treatment initiation with time from first-care seeking visit to the initiation of MDR-TB treatment rather than diagnostic accuracy as the primary outcome, and to assess treatment outcomes. We hypothesized that the implementation of LPA would result in faster time to treatment initiation and better treatment outcomes.
A culture-based diagnostic algorithm used prior to LPA implementation was compared to an LPA-based algorithm that replaced BacTAlert and Löwenstein Jensen (LJ) for drug sensitivity testing. A total of 295 MDR-TB patients were included in the study, 163 diagnosed with the culture-based algorithm, 132 with the LPA-based algorithm.
Among smear positive patients, the implementation of the LPA-based algorithm was associated with a median decrease in time to MDR-TB treatment initiation of 50 and 66 days compared to the culture-based algorithm (BacTAlert and LJ respectively, p<0.001). In smear negative patients, the LPA-based algorithm was associated with a median decrease in time to MDR-TB treatment initiation of 78 days when compared to the culture-based algorithm (LJ, p<0.001). However, several weeks were still needed for treatment initiation in LPA-based algorithm, 24 days in smear positive, and 62 days in smear negative patients. Overall treatment outcomes were better in LPA-based algorithm compared to culture-based algorithm (p = 0.003). Treatment success rates at 20 months of treatment were higher in patients diagnosed with the LPA-based algorithm (65.2%) as compared to those diagnosed with the culture-based algorithm (44.8%). Mortality was also lower in the LPA-based algorithm group (7.6%) compared to the culture-based algorithm group (15.9%). There was no statistically significant difference in smear and culture conversion rates between the two algorithms.
The results of the study suggest that the introduction of LPA leads to faster time to MDR diagnosis and earlier treatment initiation as well as better treatment outcomes for patients with MDR-TB. These findings also highlight the need for further improvements within the health system to reduce both patient and diagnostic delays to truly optimize the impact of new, rapid diagnostics.</description><subject>Adult</subject><subject>Algorithms</subject><subject>Biology and Life Sciences</subject><subject>Care and treatment</subject><subject>Clinical outcomes</subject><subject>Clinics</subject><subject>Complications and side effects</subject><subject>Culture</subject><subject>Diagnosis</subject><subject>Diagnostic software</subject><subject>Diagnostic systems</subject><subject>Disease transmission</subject><subject>Drug resistance</subject><subject>Drug sensitivity testing</subject><subject>Female</subject><subject>Humans</subject><subject>Lung diseases</subject><subject>Male</subject><subject>Medical diagnosis</subject><subject>Medicine</subject><subject>Medicine and Health Sciences</subject><subject>Microbial drug resistance</subject><subject>Middle 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Academic</collection><collection>ProQuest Engineering Collection</collection><collection>ProQuest Biological Science Collection</collection><collection>Agricultural Science Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Biological Science Database</collection><collection>Engineering Database</collection><collection>Nursing & Allied Health Premium</collection><collection>Advanced Technologies & Aerospace Database</collection><collection>ProQuest Advanced Technologies & Aerospace Collection</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>Environmental Science Database</collection><collection>Materials Science Collection</collection><collection>Publicly Available Content Database</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>Engineering Collection</collection><collection>Environmental Science Collection</collection><collection>Genetics Abstracts</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>PloS one</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Eliseev, Platon</au><au>Balantcev, Grigory</au><au>Nikishova, Elena</au><au>Gaida, Anastasia</au><au>Bogdanova, Elena</au><au>Enarson, Donald</au><au>Ornstein, Tara</au><au>Detjen, Anne</au><au>Dacombe, Russell</au><au>Gospodarevskaya, Elena</au><au>Phillips, Patrick P J</au><au>Mann, Gillian</au><au>Squire, Stephen Bertel</au><au>Mariandyshev, Andrei</au><au>García-García, José-María</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>The Impact of a Line Probe Assay Based Diagnostic Algorithm on Time to Treatment Initiation and Treatment Outcomes for Multidrug Resistant TB Patients in Arkhangelsk Region, Russia</atitle><jtitle>PloS one</jtitle><addtitle>PLoS One</addtitle><date>2016-04-07</date><risdate>2016</risdate><volume>11</volume><issue>4</issue><spage>e0152761</spage><epage>e0152761</epage><pages>e0152761-e0152761</pages><issn>1932-6203</issn><eissn>1932-6203</eissn><abstract>In the Arkhangelsk region of Northern Russia, multidrug-resistant (MDR) tuberculosis (TB) rates in new cases are amongst the highest in the world. In 2014, MDR-TB rates reached 31.7% among new cases and 56.9% among retreatment cases. The development of new diagnostic tools allows for faster detection of both TB and MDR-TB and should lead to reduced transmission by earlier initiation of anti-TB therapy.
The PROVE-IT (Policy Relevant Outcomes from Validating Evidence on Impact) Russia study aimed to assess the impact of the implementation of line probe assay (LPA) as part of an LPA-based diagnostic algorithm for patients with presumptive MDR-TB focusing on time to treatment initiation with time from first-care seeking visit to the initiation of MDR-TB treatment rather than diagnostic accuracy as the primary outcome, and to assess treatment outcomes. We hypothesized that the implementation of LPA would result in faster time to treatment initiation and better treatment outcomes.
A culture-based diagnostic algorithm used prior to LPA implementation was compared to an LPA-based algorithm that replaced BacTAlert and Löwenstein Jensen (LJ) for drug sensitivity testing. A total of 295 MDR-TB patients were included in the study, 163 diagnosed with the culture-based algorithm, 132 with the LPA-based algorithm.
Among smear positive patients, the implementation of the LPA-based algorithm was associated with a median decrease in time to MDR-TB treatment initiation of 50 and 66 days compared to the culture-based algorithm (BacTAlert and LJ respectively, p<0.001). In smear negative patients, the LPA-based algorithm was associated with a median decrease in time to MDR-TB treatment initiation of 78 days when compared to the culture-based algorithm (LJ, p<0.001). However, several weeks were still needed for treatment initiation in LPA-based algorithm, 24 days in smear positive, and 62 days in smear negative patients. Overall treatment outcomes were better in LPA-based algorithm compared to culture-based algorithm (p = 0.003). Treatment success rates at 20 months of treatment were higher in patients diagnosed with the LPA-based algorithm (65.2%) as compared to those diagnosed with the culture-based algorithm (44.8%). Mortality was also lower in the LPA-based algorithm group (7.6%) compared to the culture-based algorithm group (15.9%). There was no statistically significant difference in smear and culture conversion rates between the two algorithms.
The results of the study suggest that the introduction of LPA leads to faster time to MDR diagnosis and earlier treatment initiation as well as better treatment outcomes for patients with MDR-TB. These findings also highlight the need for further improvements within the health system to reduce both patient and diagnostic delays to truly optimize the impact of new, rapid diagnostics.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>27055269</pmid><doi>10.1371/journal.pone.0152761</doi><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1932-6203 |
| ispartof | PloS one, 2016-04, Vol.11 (4), p.e0152761-e0152761 |
| issn | 1932-6203 1932-6203 |
| language | eng |
| recordid | cdi_plos_journals_1779457570 |
| source | MEDLINE; DOAJ Directory of Open Access Journals; Public Library of Science (PLoS) Journals Open Access; EZB-FREE-00999 freely available EZB journals; PubMed Central; Free Full-Text Journals in Chemistry |
| subjects | Adult Algorithms Biology and Life Sciences Care and treatment Clinical outcomes Clinics Complications and side effects Culture Diagnosis Diagnostic software Diagnostic systems Disease transmission Drug resistance Drug sensitivity testing Female Humans Lung diseases Male Medical diagnosis Medicine Medicine and Health Sciences Microbial drug resistance Middle Aged Mortality Multidrug resistance Multidrug resistant organisms Patient outcomes Patients People and Places Physical Sciences Public health Research and Analysis Methods Russia - epidemiology Smear Statistical analysis Studies Tuberculosis Tuberculosis, Multidrug-Resistant - diagnosis Tuberculosis, Multidrug-Resistant - epidemiology Tuberculosis, Multidrug-Resistant - therapy |
| title | The Impact of a Line Probe Assay Based Diagnostic Algorithm on Time to Treatment Initiation and Treatment Outcomes for Multidrug Resistant TB Patients in Arkhangelsk Region, Russia |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-03T22%3A11%3A30IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-gale_plos_&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=The%20Impact%20of%20a%20Line%20Probe%20Assay%20Based%20Diagnostic%20Algorithm%20on%20Time%20to%20Treatment%20Initiation%20and%20Treatment%20Outcomes%20for%20Multidrug%20Resistant%20TB%20Patients%20in%20Arkhangelsk%20Region,%20Russia&rft.jtitle=PloS%20one&rft.au=Eliseev,%20Platon&rft.date=2016-04-07&rft.volume=11&rft.issue=4&rft.spage=e0152761&rft.epage=e0152761&rft.pages=e0152761-e0152761&rft.issn=1932-6203&rft.eissn=1932-6203&rft_id=info:doi/10.1371/journal.pone.0152761&rft_dat=%3Cgale_plos_%3EA453451906%3C/gale_plos_%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=1779457570&rft_id=info:pmid/27055269&rft_galeid=A453451906&rft_doaj_id=oai_doaj_org_article_72267107569445e4a08002411276157f&rfr_iscdi=true |