Development of a Core Outcome Set for Clinical Trials in Non-infectious Uveitis of the Posterior Segment
To develop an agreed upon set of outcomes known as a “core outcome set” (COS) for noninfectious uveitis of the posterior segment (NIU-PS) clinical trials. Mixed-methods study design comprising a systematic review and qualitative study followed by a 2-round Delphi exercise and face-to-face consensus...
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creator | Tallouzi, Mohammad O. Mathers, Jonathan M. Moore, David J. Bucknall, Nicholas Calvert, Melanie J. Murray, Philip I. Denniston, Alastair K. Okada, Annabelle Vasconcelos-Santos, Daniel Jabs, Douglas A. Davis, Janet Smith, Justine Zierhut, Manfred de Smet, Marc D. Maese, David Hollis, Gaynor M. Roberts, Graham Emerson, Joanna Quigley, Joseph Cave, Katie Twigge, Kenneth McCarthy, Maxine Davis, Ruth Twigge, Eileen Roberts, Helen Emerson, Martin Maese, Racheal Mohammed, Bashar Bunce, Catey Damato, Erika Stanford, Miles Poonit, Natraj Lee, Richard Sharma, Srilakshmi M. |
description | To develop an agreed upon set of outcomes known as a “core outcome set” (COS) for noninfectious uveitis of the posterior segment (NIU-PS) clinical trials.
Mixed-methods study design comprising a systematic review and qualitative study followed by a 2-round Delphi exercise and face-to-face consensus meeting.
Key stakeholders including patients diagnosed with NIU-PS, their caregivers, and healthcare professionals involved in decision-making for patients with NIU-PS, including ophthalmologists, nurse practitioners, and policymakers/commissioners.
A long list of outcomes was developed based on the results of (1) a systematic review of clinical trials of NIU-PS and (2) a qualitative study of key stakeholders including focus groups and interviews. The long list was used to generate a 2-round Delphi exercise of stakeholders rating the importance of outcomes on a 9-point Likert scale. The proportion of respondents rating each item was calculated, leading to recommendations of “include,” “exclude,” or “for discussion” that were taken to a face-to-face consensus meeting of key stakeholders at which they agreed on the final COS.
Items recommended for inclusion in the COS for NIU-PS.
A total of 57 outcomes grouped in 11 outcome domains were presented for evaluation in the Delphi exercise, resulting in 9 outcomes directly qualifying for inclusion and 15 outcomes being carried forward to the consensus meeting, of which 7 of 15 were agreed on for inclusion. The final COS contained 16 outcomes organized into 4 outcome domains comprising visual function, health-related quality of life, treatment side effects, and disease control.
This study builds on international work across the clinical trials community and our qualitative research to construct the world’s first COS for NIU-PS. The COS provides a list of outcomes that represent the priorities of key stakeholders and provides a minimum set of outcomes for use in all future NIU-PS clinical trials. Adoption of this COS can improve the value of future uveitis clinical trials and reduce noninformative research. Some of the outcomes identified do not yet have internationally agreed upon methods for measurement and should be the subject of future international consensus development. |
doi_str_mv | 10.1016/j.ophtha.2021.01.022 |
format | Article |
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Mixed-methods study design comprising a systematic review and qualitative study followed by a 2-round Delphi exercise and face-to-face consensus meeting.
Key stakeholders including patients diagnosed with NIU-PS, their caregivers, and healthcare professionals involved in decision-making for patients with NIU-PS, including ophthalmologists, nurse practitioners, and policymakers/commissioners.
A long list of outcomes was developed based on the results of (1) a systematic review of clinical trials of NIU-PS and (2) a qualitative study of key stakeholders including focus groups and interviews. The long list was used to generate a 2-round Delphi exercise of stakeholders rating the importance of outcomes on a 9-point Likert scale. The proportion of respondents rating each item was calculated, leading to recommendations of “include,” “exclude,” or “for discussion” that were taken to a face-to-face consensus meeting of key stakeholders at which they agreed on the final COS.
Items recommended for inclusion in the COS for NIU-PS.
A total of 57 outcomes grouped in 11 outcome domains were presented for evaluation in the Delphi exercise, resulting in 9 outcomes directly qualifying for inclusion and 15 outcomes being carried forward to the consensus meeting, of which 7 of 15 were agreed on for inclusion. The final COS contained 16 outcomes organized into 4 outcome domains comprising visual function, health-related quality of life, treatment side effects, and disease control.
This study builds on international work across the clinical trials community and our qualitative research to construct the world’s first COS for NIU-PS. The COS provides a list of outcomes that represent the priorities of key stakeholders and provides a minimum set of outcomes for use in all future NIU-PS clinical trials. Adoption of this COS can improve the value of future uveitis clinical trials and reduce noninformative research. Some of the outcomes identified do not yet have internationally agreed upon methods for measurement and should be the subject of future international consensus development.</description><identifier>ISSN: 0161-6420</identifier><identifier>EISSN: 1549-4713</identifier><identifier>DOI: 10.1016/j.ophtha.2021.01.022</identifier><identifier>PMID: 33515595</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Clinical trials ; Consensus method ; Core outcome set ; Delphi technique/exercise ; Domain ; Key stakeholders ; Macular edema ; Outcomes ; Uveitis</subject><ispartof>Ophthalmology (Rochester, Minn.), 2021-08, Vol.128 (8), p.1209-1221</ispartof><rights>2021 American Academy of Ophthalmology</rights><rights>Copyright © 2021 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c474t-ca01041dc9db4d715f05346a8a11993d4074f4ad25dd77389e73da5f8b3dfa1c3</citedby><cites>FETCH-LOGICAL-c474t-ca01041dc9db4d715f05346a8a11993d4074f4ad25dd77389e73da5f8b3dfa1c3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.ophtha.2021.01.022$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,780,784,3550,27924,27925,45995</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33515595$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Tallouzi, Mohammad O.</creatorcontrib><creatorcontrib>Mathers, Jonathan M.</creatorcontrib><creatorcontrib>Moore, David J.</creatorcontrib><creatorcontrib>Bucknall, Nicholas</creatorcontrib><creatorcontrib>Calvert, Melanie J.</creatorcontrib><creatorcontrib>Murray, Philip I.</creatorcontrib><creatorcontrib>Denniston, Alastair K.</creatorcontrib><creatorcontrib>Okada, Annabelle</creatorcontrib><creatorcontrib>Vasconcelos-Santos, Daniel</creatorcontrib><creatorcontrib>Jabs, Douglas A.</creatorcontrib><creatorcontrib>Davis, Janet</creatorcontrib><creatorcontrib>Smith, Justine</creatorcontrib><creatorcontrib>Zierhut, Manfred</creatorcontrib><creatorcontrib>de Smet, Marc D.</creatorcontrib><creatorcontrib>Maese, David</creatorcontrib><creatorcontrib>Hollis, Gaynor M.</creatorcontrib><creatorcontrib>Roberts, Graham</creatorcontrib><creatorcontrib>Emerson, Joanna</creatorcontrib><creatorcontrib>Quigley, Joseph</creatorcontrib><creatorcontrib>Cave, Katie</creatorcontrib><creatorcontrib>Twigge, Kenneth</creatorcontrib><creatorcontrib>McCarthy, Maxine</creatorcontrib><creatorcontrib>Davis, Ruth</creatorcontrib><creatorcontrib>Twigge, Eileen</creatorcontrib><creatorcontrib>Roberts, Helen</creatorcontrib><creatorcontrib>Emerson, Martin</creatorcontrib><creatorcontrib>Maese, Racheal</creatorcontrib><creatorcontrib>Mohammed, Bashar</creatorcontrib><creatorcontrib>Bunce, Catey</creatorcontrib><creatorcontrib>Damato, Erika</creatorcontrib><creatorcontrib>Stanford, Miles</creatorcontrib><creatorcontrib>Poonit, Natraj</creatorcontrib><creatorcontrib>Lee, Richard</creatorcontrib><creatorcontrib>Sharma, Srilakshmi M.</creatorcontrib><creatorcontrib>COSUMO Working Group</creatorcontrib><title>Development of a Core Outcome Set for Clinical Trials in Non-infectious Uveitis of the Posterior Segment</title><title>Ophthalmology (Rochester, Minn.)</title><addtitle>Ophthalmology</addtitle><description>To develop an agreed upon set of outcomes known as a “core outcome set” (COS) for noninfectious uveitis of the posterior segment (NIU-PS) clinical trials.
Mixed-methods study design comprising a systematic review and qualitative study followed by a 2-round Delphi exercise and face-to-face consensus meeting.
Key stakeholders including patients diagnosed with NIU-PS, their caregivers, and healthcare professionals involved in decision-making for patients with NIU-PS, including ophthalmologists, nurse practitioners, and policymakers/commissioners.
A long list of outcomes was developed based on the results of (1) a systematic review of clinical trials of NIU-PS and (2) a qualitative study of key stakeholders including focus groups and interviews. The long list was used to generate a 2-round Delphi exercise of stakeholders rating the importance of outcomes on a 9-point Likert scale. The proportion of respondents rating each item was calculated, leading to recommendations of “include,” “exclude,” or “for discussion” that were taken to a face-to-face consensus meeting of key stakeholders at which they agreed on the final COS.
Items recommended for inclusion in the COS for NIU-PS.
A total of 57 outcomes grouped in 11 outcome domains were presented for evaluation in the Delphi exercise, resulting in 9 outcomes directly qualifying for inclusion and 15 outcomes being carried forward to the consensus meeting, of which 7 of 15 were agreed on for inclusion. The final COS contained 16 outcomes organized into 4 outcome domains comprising visual function, health-related quality of life, treatment side effects, and disease control.
This study builds on international work across the clinical trials community and our qualitative research to construct the world’s first COS for NIU-PS. The COS provides a list of outcomes that represent the priorities of key stakeholders and provides a minimum set of outcomes for use in all future NIU-PS clinical trials. Adoption of this COS can improve the value of future uveitis clinical trials and reduce noninformative research. Some of the outcomes identified do not yet have internationally agreed upon methods for measurement and should be the subject of future international consensus development.</description><subject>Clinical trials</subject><subject>Consensus method</subject><subject>Core outcome set</subject><subject>Delphi technique/exercise</subject><subject>Domain</subject><subject>Key stakeholders</subject><subject>Macular edema</subject><subject>Outcomes</subject><subject>Uveitis</subject><issn>0161-6420</issn><issn>1549-4713</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><recordid>eNp9kEtLazEURoNc0fr4ByIZOjk1z_OYCJf6BFFBHYc02bEp55zUJC34702p1-GFDZms79vZC6EzSqaU0PpyOQ2rRV7oKSOMTkkZxvbQhErRVaKh_A-aFIxWtWDkEB2ltCSE1DUXB-iQc0ml7OQELa5hA31YDTBmHBzWeBYi4Od1NmEA_AoZuxDxrPejN7rHb9HrPmE_4qcwVn50YLIP64TfN-CzT9uOvAD8ElKG6Ev0FT625Sdo35UknP68x-j99uZtdl89Pt89zP4-VkY0IldGE0oEtaazc2EbKh2RXNS61ZR2HbeCNMIJbZm0tml420HDrZaunXPrNDX8GF3selcxfK4hZTX4ZKDv9Qjln4qJlre0JYwUVOxQE0NKEZxaRT_o-KUoUVvHaql2jtXWsSJlGCux858N6_kA9jf0T2oBrnYAlDs3HqJKxsNowPpYdCkb_P83fAMxJY9i</recordid><startdate>20210801</startdate><enddate>20210801</enddate><creator>Tallouzi, Mohammad O.</creator><creator>Mathers, Jonathan M.</creator><creator>Moore, David J.</creator><creator>Bucknall, Nicholas</creator><creator>Calvert, Melanie J.</creator><creator>Murray, Philip I.</creator><creator>Denniston, Alastair K.</creator><creator>Okada, Annabelle</creator><creator>Vasconcelos-Santos, Daniel</creator><creator>Jabs, Douglas A.</creator><creator>Davis, Janet</creator><creator>Smith, Justine</creator><creator>Zierhut, Manfred</creator><creator>de Smet, Marc D.</creator><creator>Maese, David</creator><creator>Hollis, Gaynor M.</creator><creator>Roberts, Graham</creator><creator>Emerson, Joanna</creator><creator>Quigley, Joseph</creator><creator>Cave, Katie</creator><creator>Twigge, Kenneth</creator><creator>McCarthy, Maxine</creator><creator>Davis, Ruth</creator><creator>Twigge, Eileen</creator><creator>Roberts, Helen</creator><creator>Emerson, Martin</creator><creator>Maese, Racheal</creator><creator>Mohammed, Bashar</creator><creator>Bunce, Catey</creator><creator>Damato, Erika</creator><creator>Stanford, Miles</creator><creator>Poonit, Natraj</creator><creator>Lee, Richard</creator><creator>Sharma, Srilakshmi M.</creator><general>Elsevier Inc</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20210801</creationdate><title>Development of a Core Outcome Set for Clinical Trials in Non-infectious Uveitis of the Posterior Segment</title><author>Tallouzi, Mohammad O. ; Mathers, Jonathan M. ; Moore, David J. ; Bucknall, Nicholas ; Calvert, Melanie J. ; Murray, Philip I. ; Denniston, Alastair K. ; Okada, Annabelle ; Vasconcelos-Santos, Daniel ; Jabs, Douglas A. ; Davis, Janet ; Smith, Justine ; Zierhut, Manfred ; de Smet, Marc D. ; Maese, David ; Hollis, Gaynor M. ; Roberts, Graham ; Emerson, Joanna ; Quigley, Joseph ; Cave, Katie ; Twigge, Kenneth ; McCarthy, Maxine ; Davis, Ruth ; Twigge, Eileen ; Roberts, Helen ; Emerson, Martin ; Maese, Racheal ; Mohammed, Bashar ; Bunce, Catey ; Damato, Erika ; Stanford, Miles ; Poonit, Natraj ; Lee, Richard ; Sharma, Srilakshmi M.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c474t-ca01041dc9db4d715f05346a8a11993d4074f4ad25dd77389e73da5f8b3dfa1c3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Clinical trials</topic><topic>Consensus method</topic><topic>Core outcome set</topic><topic>Delphi technique/exercise</topic><topic>Domain</topic><topic>Key stakeholders</topic><topic>Macular edema</topic><topic>Outcomes</topic><topic>Uveitis</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Tallouzi, Mohammad O.</creatorcontrib><creatorcontrib>Mathers, Jonathan M.</creatorcontrib><creatorcontrib>Moore, David J.</creatorcontrib><creatorcontrib>Bucknall, Nicholas</creatorcontrib><creatorcontrib>Calvert, Melanie J.</creatorcontrib><creatorcontrib>Murray, Philip I.</creatorcontrib><creatorcontrib>Denniston, Alastair K.</creatorcontrib><creatorcontrib>Okada, Annabelle</creatorcontrib><creatorcontrib>Vasconcelos-Santos, Daniel</creatorcontrib><creatorcontrib>Jabs, Douglas A.</creatorcontrib><creatorcontrib>Davis, Janet</creatorcontrib><creatorcontrib>Smith, Justine</creatorcontrib><creatorcontrib>Zierhut, Manfred</creatorcontrib><creatorcontrib>de Smet, Marc D.</creatorcontrib><creatorcontrib>Maese, David</creatorcontrib><creatorcontrib>Hollis, Gaynor M.</creatorcontrib><creatorcontrib>Roberts, Graham</creatorcontrib><creatorcontrib>Emerson, Joanna</creatorcontrib><creatorcontrib>Quigley, Joseph</creatorcontrib><creatorcontrib>Cave, Katie</creatorcontrib><creatorcontrib>Twigge, Kenneth</creatorcontrib><creatorcontrib>McCarthy, Maxine</creatorcontrib><creatorcontrib>Davis, Ruth</creatorcontrib><creatorcontrib>Twigge, Eileen</creatorcontrib><creatorcontrib>Roberts, Helen</creatorcontrib><creatorcontrib>Emerson, Martin</creatorcontrib><creatorcontrib>Maese, Racheal</creatorcontrib><creatorcontrib>Mohammed, Bashar</creatorcontrib><creatorcontrib>Bunce, Catey</creatorcontrib><creatorcontrib>Damato, Erika</creatorcontrib><creatorcontrib>Stanford, Miles</creatorcontrib><creatorcontrib>Poonit, Natraj</creatorcontrib><creatorcontrib>Lee, Richard</creatorcontrib><creatorcontrib>Sharma, Srilakshmi M.</creatorcontrib><creatorcontrib>COSUMO Working Group</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Ophthalmology (Rochester, Minn.)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Tallouzi, Mohammad O.</au><au>Mathers, Jonathan M.</au><au>Moore, David J.</au><au>Bucknall, Nicholas</au><au>Calvert, Melanie J.</au><au>Murray, Philip I.</au><au>Denniston, Alastair K.</au><au>Okada, Annabelle</au><au>Vasconcelos-Santos, Daniel</au><au>Jabs, Douglas A.</au><au>Davis, Janet</au><au>Smith, Justine</au><au>Zierhut, Manfred</au><au>de Smet, Marc D.</au><au>Maese, David</au><au>Hollis, Gaynor M.</au><au>Roberts, Graham</au><au>Emerson, Joanna</au><au>Quigley, Joseph</au><au>Cave, Katie</au><au>Twigge, Kenneth</au><au>McCarthy, Maxine</au><au>Davis, Ruth</au><au>Twigge, Eileen</au><au>Roberts, Helen</au><au>Emerson, Martin</au><au>Maese, Racheal</au><au>Mohammed, Bashar</au><au>Bunce, Catey</au><au>Damato, Erika</au><au>Stanford, Miles</au><au>Poonit, Natraj</au><au>Lee, Richard</au><au>Sharma, Srilakshmi M.</au><aucorp>COSUMO Working Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Development of a Core Outcome Set for Clinical Trials in Non-infectious Uveitis of the Posterior Segment</atitle><jtitle>Ophthalmology (Rochester, Minn.)</jtitle><addtitle>Ophthalmology</addtitle><date>2021-08-01</date><risdate>2021</risdate><volume>128</volume><issue>8</issue><spage>1209</spage><epage>1221</epage><pages>1209-1221</pages><issn>0161-6420</issn><eissn>1549-4713</eissn><abstract>To develop an agreed upon set of outcomes known as a “core outcome set” (COS) for noninfectious uveitis of the posterior segment (NIU-PS) clinical trials.
Mixed-methods study design comprising a systematic review and qualitative study followed by a 2-round Delphi exercise and face-to-face consensus meeting.
Key stakeholders including patients diagnosed with NIU-PS, their caregivers, and healthcare professionals involved in decision-making for patients with NIU-PS, including ophthalmologists, nurse practitioners, and policymakers/commissioners.
A long list of outcomes was developed based on the results of (1) a systematic review of clinical trials of NIU-PS and (2) a qualitative study of key stakeholders including focus groups and interviews. The long list was used to generate a 2-round Delphi exercise of stakeholders rating the importance of outcomes on a 9-point Likert scale. The proportion of respondents rating each item was calculated, leading to recommendations of “include,” “exclude,” or “for discussion” that were taken to a face-to-face consensus meeting of key stakeholders at which they agreed on the final COS.
Items recommended for inclusion in the COS for NIU-PS.
A total of 57 outcomes grouped in 11 outcome domains were presented for evaluation in the Delphi exercise, resulting in 9 outcomes directly qualifying for inclusion and 15 outcomes being carried forward to the consensus meeting, of which 7 of 15 were agreed on for inclusion. The final COS contained 16 outcomes organized into 4 outcome domains comprising visual function, health-related quality of life, treatment side effects, and disease control.
This study builds on international work across the clinical trials community and our qualitative research to construct the world’s first COS for NIU-PS. The COS provides a list of outcomes that represent the priorities of key stakeholders and provides a minimum set of outcomes for use in all future NIU-PS clinical trials. Adoption of this COS can improve the value of future uveitis clinical trials and reduce noninformative research. Some of the outcomes identified do not yet have internationally agreed upon methods for measurement and should be the subject of future international consensus development.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>33515595</pmid><doi>10.1016/j.ophtha.2021.01.022</doi><tpages>13</tpages><oa>free_for_read</oa></addata></record> |
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subjects | Clinical trials Consensus method Core outcome set Delphi technique/exercise Domain Key stakeholders Macular edema Outcomes Uveitis |
title | Development of a Core Outcome Set for Clinical Trials in Non-infectious Uveitis of the Posterior Segment |
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