Publicação
Interpretation of chronic pain clinical trial outcomes : IMMPACT recommended considerations
| Resumo: | Interpreting randomized clinical trials (RCTs) is crucial to making decisions regarding the use of analgesic treatments in clinical practice. In this article, we report on an Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) consensus meeting organized by the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks, the purpose of which was to recommend approaches that facilitate interpretation of analgesic RCTs. We review issues to consider when drawing conclusions from RCTs, as well as common methods for reporting RCT results and the limitations of each method. These issues include the type of trial, study design, statistical analysis methods, magnitude of the estimated beneficial and harmful effects and associated precision, availability of alternative treatments and their benefit-risk profile, clinical importance of the change from baseline both within and between groups, presentation of the outcome data, and the limitations of the approaches used. |
|---|---|
| Autores principais: | Smith, Shannon M. |
| Outros Autores: | Dworkin, Robert H.; Turk, Dennis C.; McDermott, Michael P.; Eccleston, Christopher; Farrar, John T.; Rowbotham, Michael C.; Bhagwagar, Zubin; Burke, Laurie B.; Cowan, Penney; Ellenberg, Susan S.; Evans, Scott R.; Freeman, Roy L.; Garrison, Louis P.; Iyengar, Smriti; Jadad, Alejandro; Jensen, Mark P.; Junor, Roderick; Kamp, Cornelia; Katz, Nathaniel P.; Kesslak, James Patrick; Kopecky, Ernest A.; Lissin, Dmitri; Markman, John D.; Mease, Philip J.; O'Connor, Alec B.; Patel, Kushang V.; Raja, Srinivasa N.; Sampaio, Cristina; Schoenfeld, David; Singh, Jasvinder; Steigerwald, Ilona; Strand, Vibeke; Tive, Leslie A.; Tobias, Jeffrey; Wasan, Ajay D.; Wilson, Hilary D. |
| Assunto: | Randomized clinical trials Pain Interpretation Analgesic Analysis |
| Ano: | 2020 |
| País: | Portugal |
| Tipo de documento: | artigo |
| Tipo de acesso: | acesso restrito |
| Instituição associada: | Universidade de Lisboa |
| Idioma: | inglês |
| Origem: | Repositório da Universidade de Lisboa |
| _version_ | 1865920851388399616 |
|---|---|
| author | Smith, Shannon M. |
| author2 | Dworkin, Robert H. Turk, Dennis C. McDermott, Michael P. Eccleston, Christopher Farrar, John T. Rowbotham, Michael C. Bhagwagar, Zubin Burke, Laurie B. Cowan, Penney Ellenberg, Susan S. Evans, Scott R. Freeman, Roy L. Garrison, Louis P. Iyengar, Smriti Jadad, Alejandro Jensen, Mark P. Junor, Roderick Kamp, Cornelia Katz, Nathaniel P. Kesslak, James Patrick Kopecky, Ernest A. Lissin, Dmitri Markman, John D. Mease, Philip J. O'Connor, Alec B. Patel, Kushang V. Raja, Srinivasa N. Sampaio, Cristina Schoenfeld, David Singh, Jasvinder Steigerwald, Ilona Strand, Vibeke Tive, Leslie A. Tobias, Jeffrey Wasan, Ajay D. Wilson, Hilary D. |
| author2_role | author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author |
| author_facet | Smith, Shannon M. Smith, Shannon M. Dworkin, Robert H. Turk, Dennis C. McDermott, Michael P. Eccleston, Christopher Farrar, John T. Rowbotham, Michael C. Bhagwagar, Zubin Burke, Laurie B. Cowan, Penney Ellenberg, Susan S. Evans, Scott R. Freeman, Roy L. Garrison, Louis P. Iyengar, Smriti Jadad, Alejandro Jensen, Mark P. Junor, Roderick Kamp, Cornelia Katz, Nathaniel P. Kesslak, James Patrick Kopecky, Ernest A. Lissin, Dmitri Markman, John D. Mease, Philip J. O'Connor, Alec B. Patel, Kushang V. Raja, Srinivasa N. Sampaio, Cristina Schoenfeld, David Singh, Jasvinder Steigerwald, Ilona Strand, Vibeke Tive, Leslie A. Tobias, Jeffrey Wasan, Ajay D. Wilson, Hilary D. Dworkin, Robert H. Turk, Dennis C. McDermott, Michael P. Eccleston, Christopher Farrar, John T. Rowbotham, Michael C. Bhagwagar, Zubin Burke, Laurie B. Cowan, Penney Ellenberg, Susan S. Evans, Scott R. Freeman, Roy L. Garrison, Louis P. Iyengar, Smriti Jadad, Alejandro Jensen, Mark P. Junor, Roderick Kamp, Cornelia Katz, Nathaniel P. Kesslak, James Patrick Kopecky, Ernest A. Lissin, Dmitri Markman, John D. Mease, Philip J. O'Connor, Alec B. Patel, Kushang V. Raja, Srinivasa N. Sampaio, Cristina Schoenfeld, David Singh, Jasvinder Steigerwald, Ilona Strand, Vibeke Tive, Leslie A. Tobias, Jeffrey Wasan, Ajay D. Wilson, Hilary D. |
| author_role | author |
| contributor_name_str_mv | Repositório Científico de Acesso Aberto da ULisboa |
| country_str | PT |
| creators_json_str | [{\"Person.name\":\"Smith, Shannon M.\"},{\"Person.name\":\"Dworkin, Robert H.\"},{\"Person.name\":\"Turk, Dennis C.\"},{\"Person.name\":\"McDermott, Michael P.\"},{\"Person.name\":\"Eccleston, Christopher\"},{\"Person.name\":\"Farrar, John T.\"},{\"Person.name\":\"Rowbotham, Michael C.\"},{\"Person.name\":\"Bhagwagar, Zubin\"},{\"Person.name\":\"Burke, Laurie B.\"},{\"Person.name\":\"Cowan, Penney\"},{\"Person.name\":\"Ellenberg, Susan S.\"},{\"Person.name\":\"Evans, Scott R.\"},{\"Person.name\":\"Freeman, Roy L.\"},{\"Person.name\":\"Garrison, Louis P.\"},{\"Person.name\":\"Iyengar, Smriti\"},{\"Person.name\":\"Jadad, Alejandro\"},{\"Person.name\":\"Jensen, Mark P.\"},{\"Person.name\":\"Junor, Roderick\"},{\"Person.name\":\"Kamp, Cornelia\"},{\"Person.name\":\"Katz, Nathaniel P.\"},{\"Person.name\":\"Kesslak, James Patrick\"},{\"Person.name\":\"Kopecky, Ernest A.\"},{\"Person.name\":\"Lissin, Dmitri\"},{\"Person.name\":\"Markman, John D.\"},{\"Person.name\":\"Mease, Philip J.\"},{\"Person.name\":\"O'Connor, Alec B.\"},{\"Person.name\":\"Patel, Kushang V.\"},{\"Person.name\":\"Raja, Srinivasa N.\"},{\"Person.name\":\"Sampaio, Cristina\",\"Person.identifier.orcid\":\"0000-0002-7052-9079\"},{\"Person.name\":\"Schoenfeld, David\"},{\"Person.name\":\"Singh, Jasvinder\"},{\"Person.name\":\"Steigerwald, Ilona\"},{\"Person.name\":\"Strand, Vibeke\"},{\"Person.name\":\"Tive, Leslie A.\"},{\"Person.name\":\"Tobias, Jeffrey\"},{\"Person.name\":\"Wasan, Ajay D.\"},{\"Person.name\":\"Wilson, Hilary D.\"}] |
| datacite.contributors.contributor.contributorName.fl_str_mv | Repositório Científico de Acesso Aberto da ULisboa |
| datacite.creators.creator.creatorName.fl_str_mv | Smith, Shannon M. Dworkin, Robert H. Turk, Dennis C. McDermott, Michael P. Eccleston, Christopher Farrar, John T. Rowbotham, Michael C. Bhagwagar, Zubin Burke, Laurie B. Cowan, Penney Ellenberg, Susan S. Evans, Scott R. Freeman, Roy L. Garrison, Louis P. Iyengar, Smriti Jadad, Alejandro Jensen, Mark P. Junor, Roderick Kamp, Cornelia Katz, Nathaniel P. Kesslak, James Patrick Kopecky, Ernest A. Lissin, Dmitri Markman, John D. Mease, Philip J. O'Connor, Alec B. Patel, Kushang V. Raja, Srinivasa N. Sampaio, Cristina Schoenfeld, David Singh, Jasvinder Steigerwald, Ilona Strand, Vibeke Tive, Leslie A. Tobias, Jeffrey Wasan, Ajay D. Wilson, Hilary D. |
| datacite.date.Accepted.fl_str_mv | 2020-11-01T00:00:00Z |
| datacite.date.available.fl_str_mv | 2020-11-09T15:41:02Z |
| datacite.date.embargoed.fl_str_mv | 2020-11-09T15:41:02Z |
| datacite.rights.fl_str_mv | http://purl.org/coar/access_right/c_16ec |
| datacite.subjects.subject.fl_str_mv | Randomized clinical trials Pain Interpretation Analgesic Analysis |
| datacite.titles.title.fl_str_mv | Interpretation of chronic pain clinical trial outcomes : IMMPACT recommended considerations |
| dc.contributor.none.fl_str_mv | Repositório Científico de Acesso Aberto da ULisboa |
| dc.creator.none.fl_str_mv | Smith, Shannon M. Dworkin, Robert H. Turk, Dennis C. McDermott, Michael P. Eccleston, Christopher Farrar, John T. Rowbotham, Michael C. Bhagwagar, Zubin Burke, Laurie B. Cowan, Penney Ellenberg, Susan S. Evans, Scott R. Freeman, Roy L. Garrison, Louis P. Iyengar, Smriti Jadad, Alejandro Jensen, Mark P. Junor, Roderick Kamp, Cornelia Katz, Nathaniel P. Kesslak, James Patrick Kopecky, Ernest A. Lissin, Dmitri Markman, John D. Mease, Philip J. O'Connor, Alec B. Patel, Kushang V. Raja, Srinivasa N. Sampaio, Cristina Schoenfeld, David Singh, Jasvinder Steigerwald, Ilona Strand, Vibeke Tive, Leslie A. Tobias, Jeffrey Wasan, Ajay D. Wilson, Hilary D. |
| dc.date.Accepted.fl_str_mv | 2020-11-01T00:00:00Z |
| dc.date.available.fl_str_mv | 2020-11-09T15:41:02Z |
| dc.date.embargoed.fl_str_mv | 2020-11-09T15:41:02Z |
| dc.format.none.fl_str_mv | application/pdf |
| dc.identifier.none.fl_str_mv | http://hdl.handle.net/10451/44811 |
| dc.language.none.fl_str_mv | eng |
| dc.publisher.none.fl_str_mv | LWW Journals |
| dc.rights.none.fl_str_mv | http://purl.org/coar/access_right/c_16ec |
| dc.subject.none.fl_str_mv | Randomized clinical trials Pain Interpretation Analgesic Analysis |
| dc.title.fl_str_mv | Interpretation of chronic pain clinical trial outcomes : IMMPACT recommended considerations |
| dc.type.none.fl_str_mv | http://purl.org/coar/resource_type/c_6501 |
| description | Interpreting randomized clinical trials (RCTs) is crucial to making decisions regarding the use of analgesic treatments in clinical practice. In this article, we report on an Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) consensus meeting organized by the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks, the purpose of which was to recommend approaches that facilitate interpretation of analgesic RCTs. We review issues to consider when drawing conclusions from RCTs, as well as common methods for reporting RCT results and the limitations of each method. These issues include the type of trial, study design, statistical analysis methods, magnitude of the estimated beneficial and harmful effects and associated precision, availability of alternative treatments and their benefit-risk profile, clinical importance of the change from baseline both within and between groups, presentation of the outcome data, and the limitations of the approaches used. |
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| format | article |
| fulltext.url.fl_str_mv | https://repositorio.ulisboa.pt/bitstreams/b6f66ca8-96ec-48fd-90cb-b4dc646aa6b7/download |
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| identifier.url.fl_str_mv | http://hdl.handle.net/10451/44811 |
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| institution | Universidade de Lisboa |
| instname_str | Universidade de Lisboa |
| language | eng |
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| network_name_str | Repositório da Universidade de Lisboa |
| oai_identifier_str | oai:repositorio.ulisboa.pt:10451/44811 |
| organization_str_mv | urn:organizationAcronym:ul |
| person_str_mv | Smith, Shannon M. Dworkin, Robert H. Turk, Dennis C. McDermott, Michael P. Eccleston, Christopher Farrar, John T. Rowbotham, Michael C. Bhagwagar, Zubin Burke, Laurie B. Cowan, Penney Ellenberg, Susan S. Evans, Scott R. Freeman, Roy L. Garrison, Louis P. Iyengar, Smriti Jadad, Alejandro Jensen, Mark P. Junor, Roderick Kamp, Cornelia Katz, Nathaniel P. Kesslak, James Patrick Kopecky, Ernest A. Lissin, Dmitri Markman, John D. Mease, Philip J. O'Connor, Alec B. Patel, Kushang V. Raja, Srinivasa N. Sampaio, Cristina Sampaio, Cristina http://orcid.org/0000-0002-7052-9079 0000-0002-7052-9079 Schoenfeld, David Singh, Jasvinder Steigerwald, Ilona Strand, Vibeke Tive, Leslie A. Tobias, Jeffrey Wasan, Ajay D. Wilson, Hilary D. |
| publishDate | 2020 |
| publisher.none.fl_str_mv | LWW Journals |
| reponame_str | Repositório da Universidade de Lisboa |
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| spelling | engLWW Journalspt_PTInterpreting randomized clinical trials (RCTs) is crucial to making decisions regarding the use of analgesic treatments in clinical practice. In this article, we report on an Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) consensus meeting organized by the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks, the purpose of which was to recommend approaches that facilitate interpretation of analgesic RCTs. We review issues to consider when drawing conclusions from RCTs, as well as common methods for reporting RCT results and the limitations of each method. These issues include the type of trial, study design, statistical analysis methods, magnitude of the estimated beneficial and harmful effects and associated precision, availability of alternative treatments and their benefit-risk profile, clinical importance of the change from baseline both within and between groups, presentation of the outcome data, and the limitations of the approaches used.application/pdfpt_PTInterpretation of chronic pain clinical trial outcomes : IMMPACT recommended considerationsSmith, Shannon M.Dworkin, Robert H.Turk, Dennis C.McDermott, Michael P.Eccleston, ChristopherFarrar, John T.Rowbotham, Michael C.Bhagwagar, ZubinBurke, Laurie B.Cowan, PenneyEllenberg, Susan S.Evans, Scott R.Freeman, Roy L.Garrison, Louis P.Iyengar, SmritiJadad, AlejandroJensen, Mark P.Junor, RoderickKamp, CorneliaKatz, Nathaniel P.Kesslak, James PatrickKopecky, Ernest A.Lissin, DmitriMarkman, John D.Mease, Philip J.O'Connor, Alec B.Patel, Kushang V.Raja, Srinivasa N.PersonalSampaio, CristinaDSpacehttp://dspace.org/items/cb8e1445-bca9-4565-be74-e23dd4f191c1DSpacehttp://dspace.org/items/cb8e1445-bca9-4565-be74-e23dd4f191c1SampaioCristinaORCIDhttp://orcid.org0000-0002-7052-9079Schoenfeld, DavidSingh, JasvinderSteigerwald, IlonaStrand, VibekeTive, Leslie A.Tobias, JeffreyWasan, Ajay D.Wilson, Hilary D.HostingInstitutionOrganizationalRepositório Científico de Acesso Aberto da ULisboae-mailmailto:repositorio@reitoria.ulisboa.ptrepositorio@reitoria.ulisboa.ptISSNIsPartOf0304-3959DOIIsPartOf10.1097/j.pain.00000000000019522020-11-09T15:41:02Z2020-112020-11-01T00:00:00ZHandlehttp://hdl.handle.net/10451/44811http://purl.org/coar/access_right/c_16ecrestricted accessRandomized clinical trialsPainInterpretationAnalgesicAnalysis463899 bytesliteraturehttp://purl.org/coar/resource_type/c_6501journal articlehttp://purl.org/coar/access_right/c_16ecapplication/pdffulltexthttps://repositorio.ulisboa.pt/bitstreams/b6f66ca8-96ec-48fd-90cb-b4dc646aa6b7/downloadPain1611124462461 |
| spellingShingle | Interpretation of chronic pain clinical trial outcomes : IMMPACT recommended considerations Interpretation of chronic pain clinical trial outcomes : IMMPACT recommended considerations Smith, Shannon M. Randomized clinical trials Pain Interpretation Analgesic Analysis Smith, Shannon M. Randomized clinical trials Pain Interpretation Analgesic Analysis |
| status | SINGLETON |
| subject.fl_str_mv | Randomized clinical trials Pain Interpretation Analgesic Analysis |
| title | Interpretation of chronic pain clinical trial outcomes : IMMPACT recommended considerations |
| title_full | Interpretation of chronic pain clinical trial outcomes : IMMPACT recommended considerations |
| title_fullStr | Interpretation of chronic pain clinical trial outcomes : IMMPACT recommended considerations Interpretation of chronic pain clinical trial outcomes : IMMPACT recommended considerations |
| title_full_unstemmed | Interpretation of chronic pain clinical trial outcomes : IMMPACT recommended considerations Interpretation of chronic pain clinical trial outcomes : IMMPACT recommended considerations |
| title_short | Interpretation of chronic pain clinical trial outcomes : IMMPACT recommended considerations |
| title_sort | Interpretation of chronic pain clinical trial outcomes : IMMPACT recommended considerations |
| topic | Randomized clinical trials Pain Interpretation Analgesic Analysis |
| topic_facet | Randomized clinical trials Pain Interpretation Analgesic Analysis |
| url | http://hdl.handle.net/10451/44811 |
| visible | 1 |