Serveur d'exploration sur les relations entre la France et l'Australie

Attention, ce site est en cours de développement !
Attention, site généré par des moyens informatiques à partir de corpus bruts.
Les informations ne sont donc pas validées.

OARSI Clinical Trials Recommendations: Design and conduct of clinical trials for hand osteoarthritis.

Identifieur interne : 002C85 ( PubMed/Curation ); précédent : 002C84; suivant : 002C86

OARSI Clinical Trials Recommendations: Design and conduct of clinical trials for hand osteoarthritis.

Auteurs : M. Kloppenburg [Pays-Bas] ; E. Maheu [France] ; V B Kraus [États-Unis] ; F. Cicuttini [Australie] ; M. Doherty [Royaume-Uni] ; R-L Dreiser [France] ; Y. Henrotin [Belgique] ; G-L Jiang [États-Unis] ; L. Mandl [États-Unis] ; J. Martel-Pelletier [Canada] ; A E Nelson [États-Unis] ; T. Neogi [États-Unis] ; J-P Pelletier [Canada] ; L. Punzi [Italie] ; R. Ramonda [Italie] ; L S Simon [États-Unis] ; S. Wang [États-Unis]

Source :

RBID : pubmed:25952348

Descripteurs français

English descriptors

Abstract

Hand osteoarthritis (OA) is a very frequent disease, but yet understudied. However, a lot of works have been published in the past 10 years, and much has been done to better understand its clinical course and structural progression. Despite this new knowledge, few therapeutic trials have been conducted in hand OA. The last OARSI recommendations for the conduct of clinical trials in hand OA dates back to 2006. The present recommendations aimed at updating previous recommendations, by incorporating new data. The purpose of this expert opinion, consensus driven exercise is to provide evidence-based guidance on the design, execution and analysis of clinical trials in hand OA, where published evidence is available, supplemented by expert opinion, where evidence is lacking, to perform clinical trials in hand OA, both for symptom and for structure-modification. They indicate core outcome measurement sets for studies in hand OA, and list the methods and instruments that should be used to measure symptoms or structure. For both symptom- and structure-modification, at least pain, physical function, patient global assessment, HR-QoL, joint activity and hand strength should be assessed. In addition, for structure-modification trials, structural progression should be measured by radiographic changes. We also provide a research agenda listing many unsolved issues that seem to most urgently need to be addressed from the perspective of performing "good" clinical trials in hand OA. These updated OARSI recommendations should allow for better standardizing the conduct of clinical trials in hand OA in the next future.

DOI: 10.1016/j.joca.2015.03.007
PubMed: 25952348

Links toward previous steps (curation, corpus...)


Links to Exploration step

pubmed:25952348

Le document en format XML

<record>
<TEI>
<teiHeader>
<fileDesc>
<titleStmt>
<title xml:lang="en">OARSI Clinical Trials Recommendations: Design and conduct of clinical trials for hand osteoarthritis.</title>
<author>
<name sortKey="Kloppenburg, M" sort="Kloppenburg, M" uniqKey="Kloppenburg M" first="M" last="Kloppenburg">M. Kloppenburg</name>
<affiliation wicri:level="1">
<nlm:affiliation>Departments of Rheumatology, Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands.</nlm:affiliation>
<country xml:lang="fr">Pays-Bas</country>
<wicri:regionArea>Departments of Rheumatology, Clinical Epidemiology, Leiden University Medical Center, Leiden</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Maheu, E" sort="Maheu, E" uniqKey="Maheu E" first="E" last="Maheu">E. Maheu</name>
<affiliation wicri:level="1">
<nlm:affiliation>Department of Rheumatology, Saint-Antoine Hospital - AP-HP, and Private Office, Paris, France. Electronic address: emaheu@wanadoo.fr.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>Department of Rheumatology, Saint-Antoine Hospital - AP-HP, and Private Office, Paris</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Kraus, V B" sort="Kraus, V B" uniqKey="Kraus V" first="V B" last="Kraus">V B Kraus</name>
<affiliation wicri:level="1">
<nlm:affiliation>Duke Molecular Physiology Institute and Division of Rheumatology, Duke University School of Medicine, Durham, NC, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Duke Molecular Physiology Institute and Division of Rheumatology, Duke University School of Medicine, Durham, NC</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Cicuttini, F" sort="Cicuttini, F" uniqKey="Cicuttini F" first="F" last="Cicuttini">F. Cicuttini</name>
<affiliation wicri:level="1">
<nlm:affiliation>School of Public Health and Preventive Medicine, Monash University, Alfred Hospital, Melbourne, 3004, Australia.</nlm:affiliation>
<country xml:lang="fr">Australie</country>
<wicri:regionArea>School of Public Health and Preventive Medicine, Monash University, Alfred Hospital, Melbourne, 3004</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Doherty, M" sort="Doherty, M" uniqKey="Doherty M" first="M" last="Doherty">M. Doherty</name>
<affiliation wicri:level="1">
<nlm:affiliation>Division of Rheumatology, Orthopaedics and Dermatology, School of Medicine, University of Nottingham, Nottingham, UK.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Division of Rheumatology, Orthopaedics and Dermatology, School of Medicine, University of Nottingham, Nottingham</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Dreiser, R L" sort="Dreiser, R L" uniqKey="Dreiser R" first="R-L" last="Dreiser">R-L Dreiser</name>
<affiliation wicri:level="1">
<nlm:affiliation>Department of Rheumatology, Bichat Hospital, AP-HP, Paris, France.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>Department of Rheumatology, Bichat Hospital, AP-HP, Paris</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Henrotin, Y" sort="Henrotin, Y" uniqKey="Henrotin Y" first="Y" last="Henrotin">Y. Henrotin</name>
<affiliation wicri:level="1">
<nlm:affiliation>Bone and Cartilage Research Unit, Arthropôle Liège, University of Liège, CHU Sart-Tilman, 4000 Liège and Department of Physical Therapy and Rehabilitation, Princess Paola Hospital, Marche-en-Famenne, Belgium.</nlm:affiliation>
<country xml:lang="fr">Belgique</country>
<wicri:regionArea>Bone and Cartilage Research Unit, Arthropôle Liège, University of Liège, CHU Sart-Tilman, 4000 Liège and Department of Physical Therapy and Rehabilitation, Princess Paola Hospital, Marche-en-Famenne</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Jiang, G L" sort="Jiang, G L" uniqKey="Jiang G" first="G-L" last="Jiang">G-L Jiang</name>
<affiliation wicri:level="1">
<nlm:affiliation>Neurology & Pain Clinical Development, Allergan, Inc., 2525 Dupont Dr., Irvine, CA, 92612, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Neurology & Pain Clinical Development, Allergan, Inc., 2525 Dupont Dr., Irvine, CA, 92612</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Mandl, L" sort="Mandl, L" uniqKey="Mandl L" first="L" last="Mandl">L. Mandl</name>
<affiliation wicri:level="1">
<nlm:affiliation>Hospital for Special Surgery, Weil Cornell Medical School, Division of Rheumatology, New York City, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Hospital for Special Surgery, Weil Cornell Medical School, Division of Rheumatology, New York City</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Martel Pelletier, J" sort="Martel Pelletier, J" uniqKey="Martel Pelletier J" first="J" last="Martel-Pelletier">J. Martel-Pelletier</name>
<affiliation wicri:level="1">
<nlm:affiliation>Osteoarthritis Research Unit, University of Montreal Hospital Research Centre (CRCHUM), University of Montreal, Montreal, Quebec, Canada. Electronic address: jm@martelpelletier.ca.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Osteoarthritis Research Unit, University of Montreal Hospital Research Centre (CRCHUM), University of Montreal, Montreal, Quebec</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Nelson, A E" sort="Nelson, A E" uniqKey="Nelson A" first="A E" last="Nelson">A E Nelson</name>
<affiliation wicri:level="1">
<nlm:affiliation>Thurston Arthritis Research Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Thurston Arthritis Research Center, University of North Carolina at Chapel Hill, Chapel Hill, NC</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Neogi, T" sort="Neogi, T" uniqKey="Neogi T" first="T" last="Neogi">T. Neogi</name>
<affiliation wicri:level="1">
<nlm:affiliation>Section of Clinical Epidemiology Research and Training Unit, Boston University School of Medicine, Boston, USA; Section of Rheumatology, Boston University School of Medicine, Boston, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Section of Clinical Epidemiology Research and Training Unit, Boston University School of Medicine, Boston, USA; Section of Rheumatology, Boston University School of Medicine, Boston</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Pelletier, J P" sort="Pelletier, J P" uniqKey="Pelletier J" first="J-P" last="Pelletier">J-P Pelletier</name>
<affiliation wicri:level="1">
<nlm:affiliation>Osteoarthritis Research Unit, University of Montreal Hospital Research Centre (CRCHUM), University of Montreal, Montreal, Quebec, Canada. Electronic address: dr@jppelletier.ca.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Osteoarthritis Research Unit, University of Montreal Hospital Research Centre (CRCHUM), University of Montreal, Montreal, Quebec</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Punzi, L" sort="Punzi, L" uniqKey="Punzi L" first="L" last="Punzi">L. Punzi</name>
<affiliation wicri:level="1">
<nlm:affiliation>Rheumatology Unit, Department of Medicine DIMED, University of Padova, Padova, Italy.</nlm:affiliation>
<country xml:lang="fr">Italie</country>
<wicri:regionArea>Rheumatology Unit, Department of Medicine DIMED, University of Padova, Padova</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Ramonda, R" sort="Ramonda, R" uniqKey="Ramonda R" first="R" last="Ramonda">R. Ramonda</name>
<affiliation wicri:level="1">
<nlm:affiliation>Rheumatology Unit, Department of Medicine DIMED, University of Padova, Padova, Italy.</nlm:affiliation>
<country xml:lang="fr">Italie</country>
<wicri:regionArea>Rheumatology Unit, Department of Medicine DIMED, University of Padova, Padova</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Simon, L S" sort="Simon, L S" uniqKey="Simon L" first="L S" last="Simon">L S Simon</name>
<affiliation wicri:level="1">
<nlm:affiliation>SDG LLC, Cambridge, MA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>SDG LLC, Cambridge, MA</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Wang, S" sort="Wang, S" uniqKey="Wang S" first="S" last="Wang">S. Wang</name>
<affiliation wicri:level="1">
<nlm:affiliation>Immunology Development, Global Pharmaceutical R&D, Abbvie, North Chicago, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Immunology Development, Global Pharmaceutical R&D, Abbvie, North Chicago</wicri:regionArea>
</affiliation>
</author>
</titleStmt>
<publicationStmt>
<idno type="wicri:source">PubMed</idno>
<date when="2015">2015</date>
<idno type="RBID">pubmed:25952348</idno>
<idno type="pmid">25952348</idno>
<idno type="doi">10.1016/j.joca.2015.03.007</idno>
<idno type="wicri:Area/PubMed/Corpus">002D60</idno>
<idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">002D60</idno>
<idno type="wicri:Area/PubMed/Curation">002C85</idno>
<idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Curation">002C85</idno>
</publicationStmt>
<sourceDesc>
<biblStruct>
<analytic>
<title xml:lang="en">OARSI Clinical Trials Recommendations: Design and conduct of clinical trials for hand osteoarthritis.</title>
<author>
<name sortKey="Kloppenburg, M" sort="Kloppenburg, M" uniqKey="Kloppenburg M" first="M" last="Kloppenburg">M. Kloppenburg</name>
<affiliation wicri:level="1">
<nlm:affiliation>Departments of Rheumatology, Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands.</nlm:affiliation>
<country xml:lang="fr">Pays-Bas</country>
<wicri:regionArea>Departments of Rheumatology, Clinical Epidemiology, Leiden University Medical Center, Leiden</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Maheu, E" sort="Maheu, E" uniqKey="Maheu E" first="E" last="Maheu">E. Maheu</name>
<affiliation wicri:level="1">
<nlm:affiliation>Department of Rheumatology, Saint-Antoine Hospital - AP-HP, and Private Office, Paris, France. Electronic address: emaheu@wanadoo.fr.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>Department of Rheumatology, Saint-Antoine Hospital - AP-HP, and Private Office, Paris</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Kraus, V B" sort="Kraus, V B" uniqKey="Kraus V" first="V B" last="Kraus">V B Kraus</name>
<affiliation wicri:level="1">
<nlm:affiliation>Duke Molecular Physiology Institute and Division of Rheumatology, Duke University School of Medicine, Durham, NC, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Duke Molecular Physiology Institute and Division of Rheumatology, Duke University School of Medicine, Durham, NC</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Cicuttini, F" sort="Cicuttini, F" uniqKey="Cicuttini F" first="F" last="Cicuttini">F. Cicuttini</name>
<affiliation wicri:level="1">
<nlm:affiliation>School of Public Health and Preventive Medicine, Monash University, Alfred Hospital, Melbourne, 3004, Australia.</nlm:affiliation>
<country xml:lang="fr">Australie</country>
<wicri:regionArea>School of Public Health and Preventive Medicine, Monash University, Alfred Hospital, Melbourne, 3004</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Doherty, M" sort="Doherty, M" uniqKey="Doherty M" first="M" last="Doherty">M. Doherty</name>
<affiliation wicri:level="1">
<nlm:affiliation>Division of Rheumatology, Orthopaedics and Dermatology, School of Medicine, University of Nottingham, Nottingham, UK.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Division of Rheumatology, Orthopaedics and Dermatology, School of Medicine, University of Nottingham, Nottingham</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Dreiser, R L" sort="Dreiser, R L" uniqKey="Dreiser R" first="R-L" last="Dreiser">R-L Dreiser</name>
<affiliation wicri:level="1">
<nlm:affiliation>Department of Rheumatology, Bichat Hospital, AP-HP, Paris, France.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>Department of Rheumatology, Bichat Hospital, AP-HP, Paris</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Henrotin, Y" sort="Henrotin, Y" uniqKey="Henrotin Y" first="Y" last="Henrotin">Y. Henrotin</name>
<affiliation wicri:level="1">
<nlm:affiliation>Bone and Cartilage Research Unit, Arthropôle Liège, University of Liège, CHU Sart-Tilman, 4000 Liège and Department of Physical Therapy and Rehabilitation, Princess Paola Hospital, Marche-en-Famenne, Belgium.</nlm:affiliation>
<country xml:lang="fr">Belgique</country>
<wicri:regionArea>Bone and Cartilage Research Unit, Arthropôle Liège, University of Liège, CHU Sart-Tilman, 4000 Liège and Department of Physical Therapy and Rehabilitation, Princess Paola Hospital, Marche-en-Famenne</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Jiang, G L" sort="Jiang, G L" uniqKey="Jiang G" first="G-L" last="Jiang">G-L Jiang</name>
<affiliation wicri:level="1">
<nlm:affiliation>Neurology & Pain Clinical Development, Allergan, Inc., 2525 Dupont Dr., Irvine, CA, 92612, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Neurology & Pain Clinical Development, Allergan, Inc., 2525 Dupont Dr., Irvine, CA, 92612</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Mandl, L" sort="Mandl, L" uniqKey="Mandl L" first="L" last="Mandl">L. Mandl</name>
<affiliation wicri:level="1">
<nlm:affiliation>Hospital for Special Surgery, Weil Cornell Medical School, Division of Rheumatology, New York City, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Hospital for Special Surgery, Weil Cornell Medical School, Division of Rheumatology, New York City</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Martel Pelletier, J" sort="Martel Pelletier, J" uniqKey="Martel Pelletier J" first="J" last="Martel-Pelletier">J. Martel-Pelletier</name>
<affiliation wicri:level="1">
<nlm:affiliation>Osteoarthritis Research Unit, University of Montreal Hospital Research Centre (CRCHUM), University of Montreal, Montreal, Quebec, Canada. Electronic address: jm@martelpelletier.ca.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Osteoarthritis Research Unit, University of Montreal Hospital Research Centre (CRCHUM), University of Montreal, Montreal, Quebec</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Nelson, A E" sort="Nelson, A E" uniqKey="Nelson A" first="A E" last="Nelson">A E Nelson</name>
<affiliation wicri:level="1">
<nlm:affiliation>Thurston Arthritis Research Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Thurston Arthritis Research Center, University of North Carolina at Chapel Hill, Chapel Hill, NC</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Neogi, T" sort="Neogi, T" uniqKey="Neogi T" first="T" last="Neogi">T. Neogi</name>
<affiliation wicri:level="1">
<nlm:affiliation>Section of Clinical Epidemiology Research and Training Unit, Boston University School of Medicine, Boston, USA; Section of Rheumatology, Boston University School of Medicine, Boston, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Section of Clinical Epidemiology Research and Training Unit, Boston University School of Medicine, Boston, USA; Section of Rheumatology, Boston University School of Medicine, Boston</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Pelletier, J P" sort="Pelletier, J P" uniqKey="Pelletier J" first="J-P" last="Pelletier">J-P Pelletier</name>
<affiliation wicri:level="1">
<nlm:affiliation>Osteoarthritis Research Unit, University of Montreal Hospital Research Centre (CRCHUM), University of Montreal, Montreal, Quebec, Canada. Electronic address: dr@jppelletier.ca.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Osteoarthritis Research Unit, University of Montreal Hospital Research Centre (CRCHUM), University of Montreal, Montreal, Quebec</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Punzi, L" sort="Punzi, L" uniqKey="Punzi L" first="L" last="Punzi">L. Punzi</name>
<affiliation wicri:level="1">
<nlm:affiliation>Rheumatology Unit, Department of Medicine DIMED, University of Padova, Padova, Italy.</nlm:affiliation>
<country xml:lang="fr">Italie</country>
<wicri:regionArea>Rheumatology Unit, Department of Medicine DIMED, University of Padova, Padova</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Ramonda, R" sort="Ramonda, R" uniqKey="Ramonda R" first="R" last="Ramonda">R. Ramonda</name>
<affiliation wicri:level="1">
<nlm:affiliation>Rheumatology Unit, Department of Medicine DIMED, University of Padova, Padova, Italy.</nlm:affiliation>
<country xml:lang="fr">Italie</country>
<wicri:regionArea>Rheumatology Unit, Department of Medicine DIMED, University of Padova, Padova</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Simon, L S" sort="Simon, L S" uniqKey="Simon L" first="L S" last="Simon">L S Simon</name>
<affiliation wicri:level="1">
<nlm:affiliation>SDG LLC, Cambridge, MA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>SDG LLC, Cambridge, MA</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Wang, S" sort="Wang, S" uniqKey="Wang S" first="S" last="Wang">S. Wang</name>
<affiliation wicri:level="1">
<nlm:affiliation>Immunology Development, Global Pharmaceutical R&D, Abbvie, North Chicago, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Immunology Development, Global Pharmaceutical R&D, Abbvie, North Chicago</wicri:regionArea>
</affiliation>
</author>
</analytic>
<series>
<title level="j">Osteoarthritis and cartilage</title>
<idno type="eISSN">1522-9653</idno>
<imprint>
<date when="2015" type="published">2015</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
</fileDesc>
<profileDesc>
<textClass>
<keywords scheme="KwdEn" xml:lang="en">
<term>Clinical Trials as Topic (standards)</term>
<term>Disease Management</term>
<term>Hand Joints</term>
<term>Humans</term>
<term>Osteoarthritis (therapy)</term>
<term>Practice Guidelines as Topic</term>
</keywords>
<keywords scheme="KwdFr" xml:lang="fr">
<term>Arthrose ()</term>
<term>Articulations de la main</term>
<term>Essais cliniques comme sujet (normes)</term>
<term>Guides de bonnes pratiques cliniques comme sujet</term>
<term>Humains</term>
<term>Prise en charge de la maladie</term>
</keywords>
<keywords scheme="MESH" qualifier="normes" xml:lang="fr">
<term>Essais cliniques comme sujet</term>
</keywords>
<keywords scheme="MESH" qualifier="standards" xml:lang="en">
<term>Clinical Trials as Topic</term>
</keywords>
<keywords scheme="MESH" qualifier="therapy" xml:lang="en">
<term>Osteoarthritis</term>
</keywords>
<keywords scheme="MESH" xml:lang="en">
<term>Disease Management</term>
<term>Hand Joints</term>
<term>Humans</term>
<term>Practice Guidelines as Topic</term>
</keywords>
<keywords scheme="MESH" xml:lang="fr">
<term>Arthrose</term>
<term>Articulations de la main</term>
<term>Guides de bonnes pratiques cliniques comme sujet</term>
<term>Humains</term>
<term>Prise en charge de la maladie</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front>
<div type="abstract" xml:lang="en">Hand osteoarthritis (OA) is a very frequent disease, but yet understudied. However, a lot of works have been published in the past 10 years, and much has been done to better understand its clinical course and structural progression. Despite this new knowledge, few therapeutic trials have been conducted in hand OA. The last OARSI recommendations for the conduct of clinical trials in hand OA dates back to 2006. The present recommendations aimed at updating previous recommendations, by incorporating new data. The purpose of this expert opinion, consensus driven exercise is to provide evidence-based guidance on the design, execution and analysis of clinical trials in hand OA, where published evidence is available, supplemented by expert opinion, where evidence is lacking, to perform clinical trials in hand OA, both for symptom and for structure-modification. They indicate core outcome measurement sets for studies in hand OA, and list the methods and instruments that should be used to measure symptoms or structure. For both symptom- and structure-modification, at least pain, physical function, patient global assessment, HR-QoL, joint activity and hand strength should be assessed. In addition, for structure-modification trials, structural progression should be measured by radiographic changes. We also provide a research agenda listing many unsolved issues that seem to most urgently need to be addressed from the perspective of performing "good" clinical trials in hand OA. These updated OARSI recommendations should allow for better standardizing the conduct of clinical trials in hand OA in the next future.</div>
</front>
</TEI>
<pubmed>
<MedlineCitation Status="MEDLINE" Owner="NLM">
<PMID Version="1">25952348</PMID>
<DateCreated>
<Year>2015</Year>
<Month>05</Month>
<Day>08</Day>
</DateCreated>
<DateCompleted>
<Year>2016</Year>
<Month>02</Month>
<Day>02</Day>
</DateCompleted>
<DateRevised>
<Year>2016</Year>
<Month>10</Month>
<Day>18</Day>
</DateRevised>
<Article PubModel="Print">
<Journal>
<ISSN IssnType="Electronic">1522-9653</ISSN>
<JournalIssue CitedMedium="Internet">
<Volume>23</Volume>
<Issue>5</Issue>
<PubDate>
<Year>2015</Year>
<Month>May</Month>
</PubDate>
</JournalIssue>
<Title>Osteoarthritis and cartilage</Title>
<ISOAbbreviation>Osteoarthr. Cartil.</ISOAbbreviation>
</Journal>
<ArticleTitle>OARSI Clinical Trials Recommendations: Design and conduct of clinical trials for hand osteoarthritis.</ArticleTitle>
<Pagination>
<MedlinePgn>772-86</MedlinePgn>
</Pagination>
<ELocationID EIdType="doi" ValidYN="Y">10.1016/j.joca.2015.03.007</ELocationID>
<ELocationID EIdType="pii" ValidYN="Y">S1063-4584(15)00845-6</ELocationID>
<Abstract>
<AbstractText>Hand osteoarthritis (OA) is a very frequent disease, but yet understudied. However, a lot of works have been published in the past 10 years, and much has been done to better understand its clinical course and structural progression. Despite this new knowledge, few therapeutic trials have been conducted in hand OA. The last OARSI recommendations for the conduct of clinical trials in hand OA dates back to 2006. The present recommendations aimed at updating previous recommendations, by incorporating new data. The purpose of this expert opinion, consensus driven exercise is to provide evidence-based guidance on the design, execution and analysis of clinical trials in hand OA, where published evidence is available, supplemented by expert opinion, where evidence is lacking, to perform clinical trials in hand OA, both for symptom and for structure-modification. They indicate core outcome measurement sets for studies in hand OA, and list the methods and instruments that should be used to measure symptoms or structure. For both symptom- and structure-modification, at least pain, physical function, patient global assessment, HR-QoL, joint activity and hand strength should be assessed. In addition, for structure-modification trials, structural progression should be measured by radiographic changes. We also provide a research agenda listing many unsolved issues that seem to most urgently need to be addressed from the perspective of performing "good" clinical trials in hand OA. These updated OARSI recommendations should allow for better standardizing the conduct of clinical trials in hand OA in the next future.</AbstractText>
<CopyrightInformation>Copyright © 2015 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.</CopyrightInformation>
</Abstract>
<AuthorList CompleteYN="Y">
<Author ValidYN="Y">
<LastName>Kloppenburg</LastName>
<ForeName>M</ForeName>
<Initials>M</Initials>
<AffiliationInfo>
<Affiliation>Departments of Rheumatology, Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Maheu</LastName>
<ForeName>E</ForeName>
<Initials>E</Initials>
<AffiliationInfo>
<Affiliation>Department of Rheumatology, Saint-Antoine Hospital - AP-HP, and Private Office, Paris, France. Electronic address: emaheu@wanadoo.fr.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Kraus</LastName>
<ForeName>V B</ForeName>
<Initials>VB</Initials>
<AffiliationInfo>
<Affiliation>Duke Molecular Physiology Institute and Division of Rheumatology, Duke University School of Medicine, Durham, NC, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Cicuttini</LastName>
<ForeName>F</ForeName>
<Initials>F</Initials>
<AffiliationInfo>
<Affiliation>School of Public Health and Preventive Medicine, Monash University, Alfred Hospital, Melbourne, 3004, Australia.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Doherty</LastName>
<ForeName>M</ForeName>
<Initials>M</Initials>
<AffiliationInfo>
<Affiliation>Division of Rheumatology, Orthopaedics and Dermatology, School of Medicine, University of Nottingham, Nottingham, UK.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Dreiser</LastName>
<ForeName>R-L</ForeName>
<Initials>RL</Initials>
<AffiliationInfo>
<Affiliation>Department of Rheumatology, Bichat Hospital, AP-HP, Paris, France.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Henrotin</LastName>
<ForeName>Y</ForeName>
<Initials>Y</Initials>
<AffiliationInfo>
<Affiliation>Bone and Cartilage Research Unit, Arthropôle Liège, University of Liège, CHU Sart-Tilman, 4000 Liège and Department of Physical Therapy and Rehabilitation, Princess Paola Hospital, Marche-en-Famenne, Belgium.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Jiang</LastName>
<ForeName>G-L</ForeName>
<Initials>GL</Initials>
<AffiliationInfo>
<Affiliation>Neurology & Pain Clinical Development, Allergan, Inc., 2525 Dupont Dr., Irvine, CA, 92612, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Mandl</LastName>
<ForeName>L</ForeName>
<Initials>L</Initials>
<AffiliationInfo>
<Affiliation>Hospital for Special Surgery, Weil Cornell Medical School, Division of Rheumatology, New York City, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Martel-Pelletier</LastName>
<ForeName>J</ForeName>
<Initials>J</Initials>
<AffiliationInfo>
<Affiliation>Osteoarthritis Research Unit, University of Montreal Hospital Research Centre (CRCHUM), University of Montreal, Montreal, Quebec, Canada. Electronic address: jm@martelpelletier.ca.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Nelson</LastName>
<ForeName>A E</ForeName>
<Initials>AE</Initials>
<AffiliationInfo>
<Affiliation>Thurston Arthritis Research Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Neogi</LastName>
<ForeName>T</ForeName>
<Initials>T</Initials>
<AffiliationInfo>
<Affiliation>Section of Clinical Epidemiology Research and Training Unit, Boston University School of Medicine, Boston, USA; Section of Rheumatology, Boston University School of Medicine, Boston, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Pelletier</LastName>
<ForeName>J-P</ForeName>
<Initials>JP</Initials>
<AffiliationInfo>
<Affiliation>Osteoarthritis Research Unit, University of Montreal Hospital Research Centre (CRCHUM), University of Montreal, Montreal, Quebec, Canada. Electronic address: dr@jppelletier.ca.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Punzi</LastName>
<ForeName>L</ForeName>
<Initials>L</Initials>
<AffiliationInfo>
<Affiliation>Rheumatology Unit, Department of Medicine DIMED, University of Padova, Padova, Italy.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Ramonda</LastName>
<ForeName>R</ForeName>
<Initials>R</Initials>
<AffiliationInfo>
<Affiliation>Rheumatology Unit, Department of Medicine DIMED, University of Padova, Padova, Italy.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Simon</LastName>
<ForeName>L S</ForeName>
<Initials>LS</Initials>
<AffiliationInfo>
<Affiliation>SDG LLC, Cambridge, MA, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Wang</LastName>
<ForeName>S</ForeName>
<Initials>S</Initials>
<AffiliationInfo>
<Affiliation>Immunology Development, Global Pharmaceutical R&D, Abbvie, North Chicago, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<CollectiveName>OARSI Hand Clinical Trial Recommendations Work Group</CollectiveName>
</Author>
</AuthorList>
<Language>eng</Language>
<PublicationTypeList>
<PublicationType UI="D016428">Journal Article</PublicationType>
<PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType>
<PublicationType UI="D016454">Review</PublicationType>
</PublicationTypeList>
</Article>
<MedlineJournalInfo>
<Country>England</Country>
<MedlineTA>Osteoarthritis Cartilage</MedlineTA>
<NlmUniqueID>9305697</NlmUniqueID>
<ISSNLinking>1063-4584</ISSNLinking>
</MedlineJournalInfo>
<CitationSubset>IM</CitationSubset>
<MeshHeadingList>
<MeshHeading>
<DescriptorName UI="D002986" MajorTopicYN="N">Clinical Trials as Topic</DescriptorName>
<QualifierName UI="Q000592" MajorTopicYN="Y">standards</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D019468" MajorTopicYN="N">Disease Management</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D050823" MajorTopicYN="Y">Hand Joints</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D010003" MajorTopicYN="N">Osteoarthritis</DescriptorName>
<QualifierName UI="Q000628" MajorTopicYN="Y">therapy</QualifierName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D017410" MajorTopicYN="Y">Practice Guidelines as Topic</DescriptorName>
</MeshHeading>
</MeshHeadingList>
<KeywordList Owner="NOTNLM">
<Keyword MajorTopicYN="N">Clinical tools</Keyword>
<Keyword MajorTopicYN="N">Clinical trials guidelines</Keyword>
<Keyword MajorTopicYN="N">Hand osteoarthritis</Keyword>
<Keyword MajorTopicYN="N">Methodology</Keyword>
<Keyword MajorTopicYN="N">Radiological assessment</Keyword>
<Keyword MajorTopicYN="N">Recommendations osteoarthritis</Keyword>
</KeywordList>
</MedlineCitation>
<PubmedData>
<History>
<PubMedPubDate PubStatus="received">
<Year>2015</Year>
<Month>01</Month>
<Day>28</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="revised">
<Year>2015</Year>
<Month>03</Month>
<Day>04</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="accepted">
<Year>2015</Year>
<Month>03</Month>
<Day>09</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="entrez">
<Year>2015</Year>
<Month>5</Month>
<Day>9</Day>
<Hour>6</Hour>
<Minute>0</Minute>
</PubMedPubDate>
<PubMedPubDate PubStatus="pubmed">
<Year>2015</Year>
<Month>5</Month>
<Day>9</Day>
<Hour>6</Hour>
<Minute>0</Minute>
</PubMedPubDate>
<PubMedPubDate PubStatus="medline">
<Year>2016</Year>
<Month>2</Month>
<Day>3</Day>
<Hour>6</Hour>
<Minute>0</Minute>
</PubMedPubDate>
</History>
<PublicationStatus>ppublish</PublicationStatus>
<ArticleIdList>
<ArticleId IdType="pubmed">25952348</ArticleId>
<ArticleId IdType="pii">S1063-4584(15)00845-6</ArticleId>
<ArticleId IdType="doi">10.1016/j.joca.2015.03.007</ArticleId>
</ArticleIdList>
</PubmedData>
</pubmed>
</record>

Pour manipuler ce document sous Unix (Dilib)

EXPLOR_STEP=$WICRI_ROOT/Wicri/Asie/explor/AustralieFrV1/Data/PubMed/Curation
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 002C85 | SxmlIndent | more

Ou

HfdSelect -h $EXPLOR_AREA/Data/PubMed/Curation/biblio.hfd -nk 002C85 | SxmlIndent | more

Pour mettre un lien sur cette page dans le réseau Wicri

{{Explor lien
   |wiki=    Wicri/Asie
   |area=    AustralieFrV1
   |flux=    PubMed
   |étape=   Curation
   |type=    RBID
   |clé=     pubmed:25952348
   |texte=   OARSI Clinical Trials Recommendations: Design and conduct of clinical trials for hand osteoarthritis.
}}

Pour générer des pages wiki

HfdIndexSelect -h $EXPLOR_AREA/Data/PubMed/Curation/RBID.i   -Sk "pubmed:25952348" \
       | HfdSelect -Kh $EXPLOR_AREA/Data/PubMed/Curation/biblio.hfd   \
       | NlmPubMed2Wicri -a AustralieFrV1 

Wicri

This area was generated with Dilib version V0.6.33.
Data generation: Tue Dec 5 10:43:12 2017. Site generation: Tue Mar 5 14:07:20 2024