Validity of the ≥50% Response Threshold in Treatment With NASHA/Dx Injection Therapy for Fecal Incontinence.
Identifieur interne : 000F83 ( Main/Corpus ); précédent : 000F82; suivant : 000F84Validity of the ≥50% Response Threshold in Treatment With NASHA/Dx Injection Therapy for Fecal Incontinence.
Auteurs : Jaime E. Sanchez ; Darren M. Brenner ; Howard Franklin ; Jing Yu ; Andrew C. Barrett ; Craig PatersonSource :
- Clinical and translational gastroenterology [ 2155-384X ] ; 2015.
Abstract
OBJECTIVES
Many fecal incontinence (FI) studies define primary efficacy outcome as a decrease from baseline of ≥50% in the number of FI episodes; this threshold has never been validated. We aimed to establish the validity and responsiveness of ≥50% reduction in FI episodes (responder50) as the threshold indicative of clinically meaningful response.
METHODS
Adults with a Cleveland Clinic Florida fecal incontinence score ≥10 were randomized to receive nonanimal stabilized hyaluronic acid/dextranomer (NASHA/Dx) injection or sham treatment in a 6-month trial. Validity and responsiveness of the primary end point were evaluated post hoc. The data were compared using different thresholds for defining a responder for a number of end points.
RESULTS
Data from 206 patients (NASHA/Dx, n=136; sham, n=70) were evaluated. Incremental patient response threshold increases showed that although the percentage of patients who achieved response decreased with increasing threshold, the difference between treatments remained significant up to an 80% response threshold (NASHA/Dx, 23%; sham, 10%; P=0.02). Response thresholds between 40% and 80% demonstrated evidence for convergent validity, with the strongest correlation with the number of FI episodes, the number of FI episodes when the patient was awake, and the number of FI-free days observed at ≥40% and ≥50% thresholds. Further examination of the responder50 threshold indicated that, regardless of treatment (NASHA/Dx or sham), responders performed significantly better than nonresponders on nearly all secondary efficacy end points.
CONCLUSION
This study demonstrates the responsiveness, validity, and clinical applicability of the ≥50% response threshold in clinical studies of patients with FI receiving treatment with NASHA/Dx.
DOI: 10.1038/ctg.2014.20
PubMed: 25588523
PubMed Central: PMC4418408
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Validity of the ≥50% Response Threshold in Treatment With NASHA/Dx Injection Therapy for Fecal Incontinence.</title><author><name sortKey="Sanchez, Jaime E" sort="Sanchez, Jaime E" uniqKey="Sanchez J" first="Jaime E" last="Sanchez">Jaime E. Sanchez</name><affiliation><nlm:affiliation>Division of Colon and Rectal Surgery, University of South Florida Morsani College of Medicine, Tampa, Florida, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Brenner, Darren M" sort="Brenner, Darren M" uniqKey="Brenner D" first="Darren M" last="Brenner">Darren M. Brenner</name><affiliation><nlm:affiliation>Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Franklin, Howard" sort="Franklin, Howard" uniqKey="Franklin H" first="Howard" last="Franklin">Howard Franklin</name><affiliation><nlm:affiliation>Salix Pharmaceuticals Inc., Raleigh, North Carolina, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Yu, Jing" sort="Yu, Jing" uniqKey="Yu J" first="Jing" last="Yu">Jing Yu</name><affiliation><nlm:affiliation>Salix Pharmaceuticals Inc., Raleigh, North Carolina, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Barrett, Andrew C" sort="Barrett, Andrew C" uniqKey="Barrett A" first="Andrew C" last="Barrett">Andrew C. Barrett</name><affiliation><nlm:affiliation>Salix Pharmaceuticals Inc., Raleigh, North Carolina, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Paterson, Craig" sort="Paterson, Craig" uniqKey="Paterson C" first="Craig" last="Paterson">Craig Paterson</name><affiliation><nlm:affiliation>Salix Pharmaceuticals Inc., Raleigh, North Carolina, USA.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2015">2015</date><idno type="RBID">pubmed:25588523</idno><idno type="pmid">25588523</idno><idno type="doi">10.1038/ctg.2014.20</idno><idno type="pmc">PMC4418408</idno><idno type="wicri:Area/Main/Corpus">000F83</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Corpus" wicri:corpus="PubMed">000F83</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Validity of the ≥50% Response Threshold in Treatment With NASHA/Dx Injection Therapy for Fecal Incontinence.</title><author><name sortKey="Sanchez, Jaime E" sort="Sanchez, Jaime E" uniqKey="Sanchez J" first="Jaime E" last="Sanchez">Jaime E. Sanchez</name><affiliation><nlm:affiliation>Division of Colon and Rectal Surgery, University of South Florida Morsani College of Medicine, Tampa, Florida, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Brenner, Darren M" sort="Brenner, Darren M" uniqKey="Brenner D" first="Darren M" last="Brenner">Darren M. Brenner</name><affiliation><nlm:affiliation>Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Franklin, Howard" sort="Franklin, Howard" uniqKey="Franklin H" first="Howard" last="Franklin">Howard Franklin</name><affiliation><nlm:affiliation>Salix Pharmaceuticals Inc., Raleigh, North Carolina, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Yu, Jing" sort="Yu, Jing" uniqKey="Yu J" first="Jing" last="Yu">Jing Yu</name><affiliation><nlm:affiliation>Salix Pharmaceuticals Inc., Raleigh, North Carolina, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Barrett, Andrew C" sort="Barrett, Andrew C" uniqKey="Barrett A" first="Andrew C" last="Barrett">Andrew C. Barrett</name><affiliation><nlm:affiliation>Salix Pharmaceuticals Inc., Raleigh, North Carolina, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Paterson, Craig" sort="Paterson, Craig" uniqKey="Paterson C" first="Craig" last="Paterson">Craig Paterson</name><affiliation><nlm:affiliation>Salix Pharmaceuticals Inc., Raleigh, North Carolina, USA.</nlm:affiliation></affiliation></author></analytic><series><title level="j">Clinical and translational gastroenterology</title><idno type="ISSN">2155-384X</idno><imprint><date when="2015" type="published">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p><b>OBJECTIVES</b></p><p>Many fecal incontinence (FI) studies define primary efficacy outcome as a decrease from baseline of ≥50% in the number of FI episodes; this threshold has never been validated. We aimed to establish the validity and responsiveness of ≥50% reduction in FI episodes (responder50) as the threshold indicative of clinically meaningful response.</p></div><div type="abstract" xml:lang="en"><p><b>METHODS</b></p><p>Adults with a Cleveland Clinic Florida fecal incontinence score ≥10 were randomized to receive nonanimal stabilized hyaluronic acid/dextranomer (NASHA/Dx) injection or sham treatment in a 6-month trial. Validity and responsiveness of the primary end point were evaluated post hoc. The data were compared using different thresholds for defining a responder for a number of end points.</p></div><div type="abstract" xml:lang="en"><p><b>RESULTS</b></p><p>Data from 206 patients (NASHA/Dx, n=136; sham, n=70) were evaluated. Incremental patient response threshold increases showed that although the percentage of patients who achieved response decreased with increasing threshold, the difference between treatments remained significant up to an 80% response threshold (NASHA/Dx, 23%; sham, 10%; P=0.02). Response thresholds between 40% and 80% demonstrated evidence for convergent validity, with the strongest correlation with the number of FI episodes, the number of FI episodes when the patient was awake, and the number of FI-free days observed at ≥40% and ≥50% thresholds. Further examination of the responder50 threshold indicated that, regardless of treatment (NASHA/Dx or sham), responders performed significantly better than nonresponders on nearly all secondary efficacy end points.</p></div><div type="abstract" xml:lang="en"><p><b>CONCLUSION</b></p><p>This study demonstrates the responsiveness, validity, and clinical applicability of the ≥50% response threshold in clinical studies of patients with FI receiving treatment with NASHA/Dx.</p></div></front></TEI><pubmed><MedlineCitation Status="PubMed-not-MEDLINE" Owner="NLM"><PMID Version="1">25588523</PMID><DateCompleted><Year>2015</Year><Month>01</Month><Day>15</Day></DateCompleted><DateRevised><Year>2018</Year><Month>11</Month><Day>13</Day></DateRevised><Article PubModel="Electronic"><Journal><ISSN IssnType="Print">2155-384X</ISSN><JournalIssue CitedMedium="Print"><Volume>6</Volume><PubDate><Year>2015</Year><Month>Jan</Month><Day>15</Day></PubDate></JournalIssue><Title>Clinical and translational gastroenterology</Title><ISOAbbreviation>Clin Transl Gastroenterol</ISOAbbreviation></Journal><ArticleTitle>Validity of the ≥50% Response Threshold in Treatment With NASHA/Dx Injection Therapy for Fecal Incontinence.</ArticleTitle><Pagination><MedlinePgn>e70</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1038/ctg.2014.20</ELocationID><Abstract><AbstractText Label="OBJECTIVES" NlmCategory="OBJECTIVE">Many fecal incontinence (FI) studies define primary efficacy outcome as a decrease from baseline of ≥50% in the number of FI episodes; this threshold has never been validated. We aimed to establish the validity and responsiveness of ≥50% reduction in FI episodes (responder50) as the threshold indicative of clinically meaningful response.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">Adults with a Cleveland Clinic Florida fecal incontinence score ≥10 were randomized to receive nonanimal stabilized hyaluronic acid/dextranomer (NASHA/Dx) injection or sham treatment in a 6-month trial. Validity and responsiveness of the primary end point were evaluated post hoc. The data were compared using different thresholds for defining a responder for a number of end points.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">Data from 206 patients (NASHA/Dx, n=136; sham, n=70) were evaluated. Incremental patient response threshold increases showed that although the percentage of patients who achieved response decreased with increasing threshold, the difference between treatments remained significant up to an 80% response threshold (NASHA/Dx, 23%; sham, 10%; P=0.02). Response thresholds between 40% and 80% demonstrated evidence for convergent validity, with the strongest correlation with the number of FI episodes, the number of FI episodes when the patient was awake, and the number of FI-free days observed at ≥40% and ≥50% thresholds. Further examination of the responder50 threshold indicated that, regardless of treatment (NASHA/Dx or sham), responders performed significantly better than nonresponders on nearly all secondary efficacy end points.</AbstractText><AbstractText Label="CONCLUSION" NlmCategory="CONCLUSIONS">This study demonstrates the responsiveness, validity, and clinical applicability of the ≥50% response threshold in clinical studies of patients with FI receiving treatment with NASHA/Dx.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Sanchez</LastName><ForeName>Jaime E</ForeName><Initials>JE</Initials><AffiliationInfo><Affiliation>Division of Colon and Rectal Surgery, University of South Florida Morsani College of Medicine, Tampa, Florida, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Brenner</LastName><ForeName>Darren M</ForeName><Initials>DM</Initials><AffiliationInfo><Affiliation>Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Franklin</LastName><ForeName>Howard</ForeName><Initials>H</Initials><AffiliationInfo><Affiliation>Salix Pharmaceuticals Inc., Raleigh, North Carolina, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Yu</LastName><ForeName>Jing</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Salix Pharmaceuticals Inc., Raleigh, North Carolina, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Barrett</LastName><ForeName>Andrew C</ForeName><Initials>AC</Initials><AffiliationInfo><Affiliation>Salix Pharmaceuticals Inc., Raleigh, North Carolina, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Paterson</LastName><ForeName>Craig</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Salix Pharmaceuticals Inc., Raleigh, North Carolina, USA.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2015</Year><Month>01</Month><Day>15</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Clin Transl Gastroenterol</MedlineTA><NlmUniqueID>101532142</NlmUniqueID><ISSNLinking>2155-384X</ISSNLinking></MedlineJournalInfo></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2014</Year><Month>08</Month><Day>05</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2014</Year><Month>11</Month><Day>17</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2015</Year><Month>1</Month><Day>16</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2015</Year><Month>1</Month><Day>16</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2015</Year><Month>1</Month><Day>16</Day><Hour>6</Hour><Minute>1</Minute></PubMedPubDate></History><PublicationStatus>epublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">25588523</ArticleId><ArticleId IdType="pii">ctg201420</ArticleId><ArticleId IdType="doi">10.1038/ctg.2014.20</ArticleId><ArticleId IdType="pmc">PMC4418408</ArticleId></ArticleIdList><ReferenceList><Reference><Citation>Br Med J. 1980 Nov 15;281(6251):1336-8</Citation><ArticleIdList><ArticleId IdType="pubmed">7437789</ArticleId></ArticleIdList></Reference><Reference><Citation>Health Qual Life Outcomes. 2013 Apr 19;11:64</Citation><ArticleIdList><ArticleId IdType="pubmed">23601140</ArticleId></ArticleIdList></Reference><Reference><Citation>Dis Colon Rectum. 2000 Jan;43(1):9-16; 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