Modifications to the PREEMPT Protocol for OnabotulinumtoxinA Injections for Chronic Migraine in Clinical Practice
Objective To assess the PREEMPT protocol modifications that have developed in clinical practice over time. Background The United States Food and Drug Administration approved the 155‐unit fixed‐dose, fixed‐site PREEMPT protocol of onabotulinumtoxinA (BoNT‐A) injections for migraine prevention 9 years...
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| Veröffentlicht in: | Headache 2020-07, Vol.60 (7), p.1365-1375 |
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| creator | Begasse de Dhaem, Olivia Gharedaghi, Mohammad Hadi Rizzoli, Paul |
| description | Objective
To assess the PREEMPT protocol modifications that have developed in clinical practice over time.
Background
The United States Food and Drug Administration approved the 155‐unit fixed‐dose, fixed‐site PREEMPT protocol of onabotulinumtoxinA (BoNT‐A) injections for migraine prevention 9 years ago.
Methods
This is an anonymous survey with free text response options of Headache Medicine clinicians.
Results
Out of the 878 contacted Headache Medicine clinicians, 182 (20.7%) completed the survey. Of the 182 respondents, 141 (77.5%) reported that they did not always follow the PREEMPT protocol. Of the 182 respondents, 128 (70%) changed the number of injections, 115 (63%) changed the total units of BoNT‐A injected, 105 (57.7%) altered the location of injection sites (58%); 101 (55.5%) do not aspirate to ensure the absence of blood return; 22 (12.1%) changed the dilution; and 4 (2.2%) added lidocaine. The main reported reasons for changes in number, dose, and location of injections included adapting to the patients’ pain, anatomy, and preferences.
Conclusions
The wide inter‐ and intra‐personal variations in BoNT‐A injections for chronic migraine prevention seen in this survey raise concerns about the standardization of the procedure and suggest that an advisory protocol containing more evidence and discussion of the reasoning behind the recommendations might be more helpful than the current prescriptive protocol. |
| doi_str_mv | 10.1111/head.13823 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2395258925</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2395258925</sourcerecordid><originalsourceid>FETCH-LOGICAL-c3573-46705d4ab544572092ffe66e86d6f4626488c9ea09402891113241f3f81efd693</originalsourceid><addsrcrecordid>eNp90c1OGzEUBWCrApUUuukDVJbYoEoB_4-9jEIKSEREiK4tx2M3jiY22DMC3h6nQ1l0UW-8-e6RfQ8A3zA6x_VcbJxpzzGVhH4CE8yJmDKB0QGYIISbqWyYPAJfStkihJhQ4jM4ooRSrrCcgKdlaoMP1vQhxQL7BPuNg6v7xWK5eoCrnPpkUwd9yvAumnXqhy7EYdenlxBn8CZunR0n92K-ySkGC5fhdzYhOhginFdf47uaZSq17gQcetMV9_X9Pga_fi4e5tfT27urm_nsdmopb2j9QoN4y8yaM8YbghTx3gnhpGiFZ4IIJqVVziDFEJGq7oEShj31EjvfCkWPwdmY-5jT0-BKr3ehWNd1Jro0FE2o4oRLRXilp__QbRpyrK_ThBHJJW0kqurHqGxOpWTn9WMOO5NfNUZ6X4TeF6H_FFHx9_fIYb1z7Qf9u_kK8AieQ-de_xOlrxezyzH0DUhPkWA</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2428583780</pqid></control><display><type>article</type><title>Modifications to the PREEMPT Protocol for OnabotulinumtoxinA Injections for Chronic Migraine in Clinical Practice</title><source>MEDLINE</source><source>Wiley Journals</source><creator>Begasse de Dhaem, Olivia ; Gharedaghi, Mohammad Hadi ; Rizzoli, Paul</creator><creatorcontrib>Begasse de Dhaem, Olivia ; Gharedaghi, Mohammad Hadi ; Rizzoli, Paul</creatorcontrib><description>Objective
To assess the PREEMPT protocol modifications that have developed in clinical practice over time.
Background
The United States Food and Drug Administration approved the 155‐unit fixed‐dose, fixed‐site PREEMPT protocol of onabotulinumtoxinA (BoNT‐A) injections for migraine prevention 9 years ago.
Methods
This is an anonymous survey with free text response options of Headache Medicine clinicians.
Results
Out of the 878 contacted Headache Medicine clinicians, 182 (20.7%) completed the survey. Of the 182 respondents, 141 (77.5%) reported that they did not always follow the PREEMPT protocol. Of the 182 respondents, 128 (70%) changed the number of injections, 115 (63%) changed the total units of BoNT‐A injected, 105 (57.7%) altered the location of injection sites (58%); 101 (55.5%) do not aspirate to ensure the absence of blood return; 22 (12.1%) changed the dilution; and 4 (2.2%) added lidocaine. The main reported reasons for changes in number, dose, and location of injections included adapting to the patients’ pain, anatomy, and preferences.
Conclusions
The wide inter‐ and intra‐personal variations in BoNT‐A injections for chronic migraine prevention seen in this survey raise concerns about the standardization of the procedure and suggest that an advisory protocol containing more evidence and discussion of the reasoning behind the recommendations might be more helpful than the current prescriptive protocol.</description><identifier>ISSN: 0017-8748</identifier><identifier>ISSN: 1526-4610</identifier><identifier>EISSN: 1526-4610</identifier><identifier>DOI: 10.1111/head.13823</identifier><identifier>PMID: 32335918</identifier><language>eng</language><publisher>United States: Wiley Subscription Services, Inc</publisher><subject><![CDATA[Attitude of Health Personnel ; Botulinum toxin type A ; Botulinum Toxins, Type A - administration & dosage ; Chronic Disease ; Clinical medicine ; Clinical Protocols ; Dilution ; Drug dosages ; FDA approval ; Guideline Adherence - statistics & numerical data ; Headache ; Health Care Surveys ; Humans ; Lidocaine ; Medicine ; Migraine ; Migraine Disorders - prevention & control ; Neuromuscular Agents - administration & dosage ; onabotulinumtoxinA ; Pain ; Physicians - statistics & numerical data ; Polls & surveys ; Practice Guidelines as Topic ; PREEMPT protocol ; Prevention ; Standardization]]></subject><ispartof>Headache, 2020-07, Vol.60 (7), p.1365-1375</ispartof><rights>2020 American Headache Society</rights><rights>2020 American Headache Society.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3573-46705d4ab544572092ffe66e86d6f4626488c9ea09402891113241f3f81efd693</citedby><cites>FETCH-LOGICAL-c3573-46705d4ab544572092ffe66e86d6f4626488c9ea09402891113241f3f81efd693</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%2Fhead.13823$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fhead.13823$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,780,784,1417,27924,27925,45574,45575</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32335918$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Begasse de Dhaem, Olivia</creatorcontrib><creatorcontrib>Gharedaghi, Mohammad Hadi</creatorcontrib><creatorcontrib>Rizzoli, Paul</creatorcontrib><title>Modifications to the PREEMPT Protocol for OnabotulinumtoxinA Injections for Chronic Migraine in Clinical Practice</title><title>Headache</title><addtitle>Headache</addtitle><description>Objective
To assess the PREEMPT protocol modifications that have developed in clinical practice over time.
Background
The United States Food and Drug Administration approved the 155‐unit fixed‐dose, fixed‐site PREEMPT protocol of onabotulinumtoxinA (BoNT‐A) injections for migraine prevention 9 years ago.
Methods
This is an anonymous survey with free text response options of Headache Medicine clinicians.
Results
Out of the 878 contacted Headache Medicine clinicians, 182 (20.7%) completed the survey. Of the 182 respondents, 141 (77.5%) reported that they did not always follow the PREEMPT protocol. Of the 182 respondents, 128 (70%) changed the number of injections, 115 (63%) changed the total units of BoNT‐A injected, 105 (57.7%) altered the location of injection sites (58%); 101 (55.5%) do not aspirate to ensure the absence of blood return; 22 (12.1%) changed the dilution; and 4 (2.2%) added lidocaine. The main reported reasons for changes in number, dose, and location of injections included adapting to the patients’ pain, anatomy, and preferences.
Conclusions
The wide inter‐ and intra‐personal variations in BoNT‐A injections for chronic migraine prevention seen in this survey raise concerns about the standardization of the procedure and suggest that an advisory protocol containing more evidence and discussion of the reasoning behind the recommendations might be more helpful than the current prescriptive protocol.</description><subject>Attitude of Health Personnel</subject><subject>Botulinum toxin type A</subject><subject>Botulinum Toxins, Type A - administration & dosage</subject><subject>Chronic Disease</subject><subject>Clinical medicine</subject><subject>Clinical Protocols</subject><subject>Dilution</subject><subject>Drug dosages</subject><subject>FDA approval</subject><subject>Guideline Adherence - statistics & numerical data</subject><subject>Headache</subject><subject>Health Care Surveys</subject><subject>Humans</subject><subject>Lidocaine</subject><subject>Medicine</subject><subject>Migraine</subject><subject>Migraine Disorders - prevention & control</subject><subject>Neuromuscular Agents - administration & dosage</subject><subject>onabotulinumtoxinA</subject><subject>Pain</subject><subject>Physicians - statistics & numerical data</subject><subject>Polls & surveys</subject><subject>Practice Guidelines as Topic</subject><subject>PREEMPT protocol</subject><subject>Prevention</subject><subject>Standardization</subject><issn>0017-8748</issn><issn>1526-4610</issn><issn>1526-4610</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp90c1OGzEUBWCrApUUuukDVJbYoEoB_4-9jEIKSEREiK4tx2M3jiY22DMC3h6nQ1l0UW-8-e6RfQ8A3zA6x_VcbJxpzzGVhH4CE8yJmDKB0QGYIISbqWyYPAJfStkihJhQ4jM4ooRSrrCcgKdlaoMP1vQhxQL7BPuNg6v7xWK5eoCrnPpkUwd9yvAumnXqhy7EYdenlxBn8CZunR0n92K-ySkGC5fhdzYhOhginFdf47uaZSq17gQcetMV9_X9Pga_fi4e5tfT27urm_nsdmopb2j9QoN4y8yaM8YbghTx3gnhpGiFZ4IIJqVVziDFEJGq7oEShj31EjvfCkWPwdmY-5jT0-BKr3ehWNd1Jro0FE2o4oRLRXilp__QbRpyrK_ThBHJJW0kqurHqGxOpWTn9WMOO5NfNUZ6X4TeF6H_FFHx9_fIYb1z7Qf9u_kK8AieQ-de_xOlrxezyzH0DUhPkWA</recordid><startdate>202007</startdate><enddate>202007</enddate><creator>Begasse de Dhaem, Olivia</creator><creator>Gharedaghi, Mohammad Hadi</creator><creator>Rizzoli, Paul</creator><general>Wiley Subscription Services, Inc</general><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>7TK</scope><scope>7U7</scope><scope>C1K</scope><scope>K9.</scope><scope>7X8</scope></search><sort><creationdate>202007</creationdate><title>Modifications to the PREEMPT Protocol for OnabotulinumtoxinA Injections for Chronic Migraine in Clinical Practice</title><author>Begasse de Dhaem, Olivia ; Gharedaghi, Mohammad Hadi ; Rizzoli, Paul</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3573-46705d4ab544572092ffe66e86d6f4626488c9ea09402891113241f3f81efd693</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Attitude of Health Personnel</topic><topic>Botulinum toxin type A</topic><topic>Botulinum Toxins, Type A - administration & dosage</topic><topic>Chronic Disease</topic><topic>Clinical medicine</topic><topic>Clinical Protocols</topic><topic>Dilution</topic><topic>Drug dosages</topic><topic>FDA approval</topic><topic>Guideline Adherence - statistics & numerical data</topic><topic>Headache</topic><topic>Health Care Surveys</topic><topic>Humans</topic><topic>Lidocaine</topic><topic>Medicine</topic><topic>Migraine</topic><topic>Migraine Disorders - prevention & control</topic><topic>Neuromuscular Agents - administration & dosage</topic><topic>onabotulinumtoxinA</topic><topic>Pain</topic><topic>Physicians - statistics & numerical data</topic><topic>Polls & surveys</topic><topic>Practice Guidelines as Topic</topic><topic>PREEMPT protocol</topic><topic>Prevention</topic><topic>Standardization</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Begasse de Dhaem, Olivia</creatorcontrib><creatorcontrib>Gharedaghi, Mohammad Hadi</creatorcontrib><creatorcontrib>Rizzoli, Paul</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Neurosciences Abstracts</collection><collection>Toxicology Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><jtitle>Headache</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Begasse de Dhaem, Olivia</au><au>Gharedaghi, Mohammad Hadi</au><au>Rizzoli, Paul</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Modifications to the PREEMPT Protocol for OnabotulinumtoxinA Injections for Chronic Migraine in Clinical Practice</atitle><jtitle>Headache</jtitle><addtitle>Headache</addtitle><date>2020-07</date><risdate>2020</risdate><volume>60</volume><issue>7</issue><spage>1365</spage><epage>1375</epage><pages>1365-1375</pages><issn>0017-8748</issn><issn>1526-4610</issn><eissn>1526-4610</eissn><abstract>Objective
To assess the PREEMPT protocol modifications that have developed in clinical practice over time.
Background
The United States Food and Drug Administration approved the 155‐unit fixed‐dose, fixed‐site PREEMPT protocol of onabotulinumtoxinA (BoNT‐A) injections for migraine prevention 9 years ago.
Methods
This is an anonymous survey with free text response options of Headache Medicine clinicians.
Results
Out of the 878 contacted Headache Medicine clinicians, 182 (20.7%) completed the survey. Of the 182 respondents, 141 (77.5%) reported that they did not always follow the PREEMPT protocol. Of the 182 respondents, 128 (70%) changed the number of injections, 115 (63%) changed the total units of BoNT‐A injected, 105 (57.7%) altered the location of injection sites (58%); 101 (55.5%) do not aspirate to ensure the absence of blood return; 22 (12.1%) changed the dilution; and 4 (2.2%) added lidocaine. The main reported reasons for changes in number, dose, and location of injections included adapting to the patients’ pain, anatomy, and preferences.
Conclusions
The wide inter‐ and intra‐personal variations in BoNT‐A injections for chronic migraine prevention seen in this survey raise concerns about the standardization of the procedure and suggest that an advisory protocol containing more evidence and discussion of the reasoning behind the recommendations might be more helpful than the current prescriptive protocol.</abstract><cop>United States</cop><pub>Wiley Subscription Services, Inc</pub><pmid>32335918</pmid><doi>10.1111/head.13823</doi><tpages>11</tpages></addata></record> |
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| ispartof | Headache, 2020-07, Vol.60 (7), p.1365-1375 |
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| source | MEDLINE; Wiley Journals |
| subjects | Attitude of Health Personnel Botulinum toxin type A Botulinum Toxins, Type A - administration & dosage Chronic Disease Clinical medicine Clinical Protocols Dilution Drug dosages FDA approval Guideline Adherence - statistics & numerical data Headache Health Care Surveys Humans Lidocaine Medicine Migraine Migraine Disorders - prevention & control Neuromuscular Agents - administration & dosage onabotulinumtoxinA Pain Physicians - statistics & numerical data Polls & surveys Practice Guidelines as Topic PREEMPT protocol Prevention Standardization |
| title | Modifications to the PREEMPT Protocol for OnabotulinumtoxinA Injections for Chronic Migraine in Clinical Practice |
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