Choosing Important Health Outcomes for Comparative Effectiveness Research: A Systematic Review
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{"title"=>"Choosing important health outcomes for comparative effectiveness research: A systematic review", "type"=>"generic", "authors"=>[{"first_name"=>"Elizabeth", "last_name"=>"Gargon", "scopus_author_id"=>"35745919700"}, {"first_name"=>"Binu", "last_name"=>"Gurung", "scopus_author_id"=>"57200779075"}, {"first_name"=>"Nancy", "last_name"=>"Medley", "scopus_author_id"=>"56226478000"}, {"first_name"=>"Doug G.", "last_name"=>"Altman", "scopus_author_id"=>"7201380947"}, {"first_name"=>"Jane M.", "last_name"=>"Blazeby", "scopus_author_id"=>"7003664999"}, {"first_name"=>"Mike", "last_name"=>"Clarke", "scopus_author_id"=>"55559031600"}, {"first_name"=>"Paula R.", "last_name"=>"Williamson", "scopus_author_id"=>"55559027000"}], "year"=>2014, "source"=>"PLoS ONE", "identifiers"=>{"issn"=>"19326203", "scopus"=>"2-s2.0-84903141537", "pui"=>"373381735", "doi"=>"10.1371/journal.pone.0099111", "isbn"=>"1932-6203 (Electronic) 1932-6203 (Linking)", "sgr"=>"84903141537", "pmid"=>"24932522"}, "id"=>"b9f290e0-a5c7-3e80-90be-7aa97a1201c5", "abstract"=>"BACKGROUND: A core outcome set (COS) is a standardised set of outcomes which should be measured and reported, as a minimum, in all effectiveness trials for a specific health area. This will allow results of studies to be compared, contrasted and combined as appropriate, as well as ensuring that all trials contribute usable information. The COMET (Core Outcome Measures for Effectiveness Trials) Initiative aims to support the development, reporting and adoption of COS. Central to this is a publically accessible online resource, populated with all available COS. The aim of the review we report here was to identify studies that sought to determine which outcomes or domains to measure in all clinical trials in a specific condition and to describe the methodological techniques used in these studies.\\n\\nMETHODS: We developed a multi-faceted search strategy for electronic databases (MEDLINE, SCOPUS, and Cochrane Methodology Register). We included studies that sought to determine which outcomes/domains to measure in all clinical trials in a specific condition.\\n\\nRESULTS: A total of 250 reports relating to 198 studies were judged eligible for inclusion in the review. Studies covered various areas of health, most commonly cancer, rheumatology, neurology, heart and circulation, and dentistry and oral health. A variety of methods have been used to develop COS, including semi-structured discussion, unstructured group discussion, the Delphi Technique, Consensus Development Conference, surveys and Nominal Group Technique. The most common groups involved were clinical experts and non-clinical research experts. Thirty-one (16%) studies reported that the public had been involved in the process. The geographic locations of participants were predominantly North America (n = 164; 83%) and Europe (n = 150; 76%).\\n\\nCONCLUSIONS: This systematic review identified many health areas where a COS has been developed, but also highlights important gaps. It is a further step towards a comprehensive, up-to-date database of COS. In addition, it shows the need for methodological guidance, including how to engage key stakeholder groups, particularly members of the public.", "link"=>"http://www.mendeley.com/research/choosing-important-health-outcomes-comparative-effectiveness-research-systematic-review-4", "reader_count"=>40, "reader_count_by_academic_status"=>{"Unspecified"=>1, "Professor > Associate Professor"=>4, "Librarian"=>1, "Researcher"=>11, "Student > Doctoral Student"=>1, "Student > Ph. D. Student"=>10, "Student > Postgraduate"=>1, "Other"=>2, "Student > Master"=>1, "Student > Bachelor"=>4, "Lecturer > Senior Lecturer"=>1, "Professor"=>3}, "reader_count_by_user_role"=>{"Unspecified"=>1, "Professor > Associate Professor"=>4, "Librarian"=>1, "Researcher"=>11, "Student > Doctoral Student"=>1, "Student > Ph. D. Student"=>10, "Student > Postgraduate"=>1, "Other"=>2, "Student > Master"=>1, "Student > Bachelor"=>4, "Lecturer > Senior Lecturer"=>1, "Professor"=>3}, "reader_count_by_subject_area"=>{"Unspecified"=>4, "Nursing and Health Professions"=>7, "Biochemistry, Genetics and Molecular Biology"=>1, "Medicine and Dentistry"=>18, "Psychology"=>5, "Computer Science"=>1, "Immunology and Microbiology"=>1, "Economics, Econometrics and Finance"=>3}, "reader_count_by_subdiscipline"=>{"Medicine and Dentistry"=>{"Medicine and Dentistry"=>18}, "Psychology"=>{"Psychology"=>5}, "Immunology and Microbiology"=>{"Immunology and Microbiology"=>1}, "Economics, Econometrics and Finance"=>{"Economics, Econometrics and Finance"=>3}, "Computer Science"=>{"Computer Science"=>1}, "Nursing and Health Professions"=>{"Nursing and Health Professions"=>7}, "Biochemistry, Genetics and Molecular Biology"=>{"Biochemistry, Genetics and Molecular Biology"=>1}, "Unspecified"=>{"Unspecified"=>4}}, "reader_count_by_country"=>{"United States"=>1, "Uruguay"=>1, "Italy"=>1, "United Kingdom"=>2}, "group_count"=>3}

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  • {"files"=>["https://ndownloader.figshare.com/files/1536188"], "description"=>"<p><i>* clinical experts includes multiple descriptions.</i></p><p><i>**16 studies, participants described as ‘researchers/investigators’ or ‘academic researchers’.</i></p><p><i>*** 54 studies with clinical input but unclear about involvement of other stakeholders.</i></p><p><i>**** Workshop/meeting participants (*5), subcommittee/committee (*2), guidelines panel, military personnel, moderator and audience, representatives from EORTC, members with expertise in information technologies, informatics, clinical registries, data-standards development, expertise in vaccine safety, malaria control and representatives from funding agencies/registration authorities, and donor organisation, members of the Rheumatology Section of the American Academy of Pediatrics, the Pediatric Section of the ACR, and the Arthritis Foundation, the diagnostic radiology and basic science communities, and from individuals conversant with functional and quality of life (QOL) assessments, comparative effectiveness research, and cost/benefit analysis.</i></p>", "links"=>[], "tags"=>["Clinical medicine", "clinical trials", "Research assessment", "Systematic reviews", "research design", "Clinical research design", "groups", "selecting"], "article_id"=>1058477, "categories"=>["Biological Sciences"], "users"=>["Elizabeth Gargon", "Binu Gurung", "Nancy Medley", "Doug G. Altman", "Jane M. Blazeby", "Mike Clarke", "Paula R. Williamson"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0099111.t004", "stats"=>{"downloads"=>1, "page_views"=>7, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Participant_groups_involved_in_selecting_outcomes_/1058477", "title"=>"Participant groups involved in selecting outcomes.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-06-16 03:09:40"}
  • {"files"=>["https://ndownloader.figshare.com/files/1536183"], "description"=>"<p>Year of first publication of each study (N = 198).</p>", "links"=>[], "tags"=>["Clinical medicine", "clinical trials", "Research assessment", "Systematic reviews", "research design", "Clinical research design"], "article_id"=>1058472, "categories"=>["Biological Sciences"], "users"=>["Elizabeth Gargon", "Binu Gurung", "Nancy Medley", "Doug G. Altman", "Jane M. Blazeby", "Mike Clarke", "Paula R. Williamson"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0099111.g002", "stats"=>{"downloads"=>1, "page_views"=>3, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Year_of_first_publication_of_each_study_N_8202_8202_198_/1058472", "title"=>"Year of first publication of each study (N = 198).", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2014-06-16 03:09:40"}
  • {"files"=>["https://ndownloader.figshare.com/files/1536192"], "description"=>"<p><i>*Although these studies are relevant to the development of a core outcome set (and therefore suitable for inclusion in the COMET database), they did not meet the review inclusion criteria.</i></p><p><i>*<sup>1</sup>These studies included qualitative studies describing the impact of a treatment or condition on a patient's quality of life, studies to determine particular domains of quality of life, and single patient narratives of the impact of a condition or treatment on their quality of life. The focus of these studies was on quality of life only.</i></p><p><i>*<sup>2</sup>Although the ICF is widely comprehensive </i><a href=\"http://www.plosone.org/article/info:doi/10.1371/journal.pone.0099111#pone.0099111-Kostanjsek1\" target=\"_blank\">[<i>13</i>]</a><i>, it is not all inclusive. For example, the ICF does not include outcomes such as death, an outcome that is often relevant to measure in clinical trials. Furthermore, as the ICF focuses on the individual only, caregiver outcomes would not be included. While for many health areas this may not be relevant, for some (e.g. dementia), caregiver outcomes may be core to measure.</i></p><p><i>*<sup>3</sup>These studies assessed quality or efficiency of care (clinical practice), or the performance of an individual institution. Indicators were often specific to that scenario/environment of care only.</i></p><p><i>*<sup>4</sup>These studies described the development of registries, each with its own purpose, often to evaluate management of patients, identify best practices or to describe therapeutic strategies.</i></p><p><i>*<sup>5</sup>599 of these (90%) had no abstract to assess (title only), so had to be reviewed at full paper due to potential eligibility based on the title alone.</i></p>", "links"=>[], "tags"=>["Clinical medicine", "clinical trials", "Research assessment", "Systematic reviews", "research design", "Clinical research design", "exclusion"], "article_id"=>1058481, "categories"=>["Biological Sciences"], "users"=>["Elizabeth Gargon", "Binu Gurung", "Nancy Medley", "Doug G. Altman", "Jane M. Blazeby", "Mike Clarke", "Paula R. Williamson"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0099111.t001", "stats"=>{"downloads"=>0, "page_views"=>1, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Reasons_for_exclusion_at_stage_2_assessment_of_full_text_reports_/1058481", "title"=>"Reasons for exclusion at stage 2 (assessment of full text reports).", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-06-16 03:09:40"}
  • {"files"=>["https://ndownloader.figshare.com/files/1536191"], "description"=>"<p><b><i>*Procedure descriptions –</i></b>.</p><p><i>Procedure - Uterine artery embolization</i>.</p><p><i>Procedure - Aortic valve stenosis (AS) - transcatheter aortic valve implantation</i>.</p><p><i>Procedure - Aortic valve stenosis (AS)</i>.</p><p><i>Procedure - pulp treatments of primary teeth</i>.</p><p><i>Procedure - drug-eluting coronary stents (DES)</i>.</p><p><b><i>**Device descriptions –</i></b>.</p><p><i>Device – Compression (n = 2)</i>.</p><p><i>Device - Mechanical circulatory support (MCS)</i>.</p><p><b><i>***Other descriptions –</i></b>.</p><p><i>Coronary angiogenesis</i>.</p><p><i>Hip protectors</i>.</p><p><i>Neuro-protective therapy (aka Neuroprotection)</i>.</p><p><i>Non-surgical treatment (no other detail given)</i>.</p><p><i>Operative and non-operative management</i>.</p><p><i>Oral care products</i>.</p><p><i>Ascorbic acid</i>.</p><p><i>Exercise/physical activity</i>.</p><p><i>Fall injury prevention interventions</i>.</p><p><i>Behavioural therapies or other kinds of nonpharmacologic therapies</i>.</p><p><i>Psychological & behavioural: Psychosocial</i>.</p><p><i>Rehabilitation (vocational)</i>.</p><p><i>Maternity care</i>.</p>", "links"=>[], "tags"=>["Clinical medicine", "clinical trials", "Research assessment", "Systematic reviews", "research design", "Clinical research design", "included", "studies"], "article_id"=>1058480, "categories"=>["Biological Sciences"], "users"=>["Elizabeth Gargon", "Binu Gurung", "Nancy Medley", "Doug G. Altman", "Jane M. Blazeby", "Mike Clarke", "Paula R. Williamson"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0099111.t002", "stats"=>{"downloads"=>0, "page_views"=>4, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_The_Scope_of_included_studies_N_8202_8202_198_/1058480", "title"=>"The Scope of included studies (N = 198).", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-06-16 03:09:40"}
  • {"files"=>["https://ndownloader.figshare.com/files/1536189"], "description"=>"<p>The methods used to develop core outcome sets (N = 198).</p>", "links"=>[], "tags"=>["Clinical medicine", "clinical trials", "Research assessment", "Systematic reviews", "research design", "Clinical research design", "methods", "sets"], "article_id"=>1058478, "categories"=>["Biological Sciences"], "users"=>["Elizabeth Gargon", "Binu Gurung", "Nancy Medley", "Doug G. Altman", "Jane M. Blazeby", "Mike Clarke", "Paula R. Williamson"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0099111.t003", "stats"=>{"downloads"=>0, "page_views"=>4, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_The_methods_used_to_develop_core_outcome_sets_N_8202_8202_198_/1058478", "title"=>"The methods used to develop core outcome sets (N = 198).", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-06-16 03:09:40"}
  • {"files"=>["https://ndownloader.figshare.com/files/1536187"], "description"=>"<p><i>Besides the lead contact or participating authors, other participants' locations were not stated/known (<sup>1</sup> – 15 studies, <sup>2</sup> - 9 studies, <sup>3</sup> - 7 studies, <sup>4</sup> - 2 studies, <sup>5</sup> - 1 study).</i></p><p><i>* In 6 studies, OMERACT participants' information was extracted from the introductory paper.</i></p><p><i>** In 1 study, participants' location was based on where they had graduated from.</i></p>", "links"=>[], "tags"=>["Clinical medicine", "clinical trials", "Research assessment", "Systematic reviews", "research design", "Clinical research design", "geographical"], "article_id"=>1058475, "categories"=>["Biological Sciences"], "users"=>["Elizabeth Gargon", "Binu Gurung", "Nancy Medley", "Doug G. Altman", "Jane M. Blazeby", "Mike Clarke", "Paula R. Williamson"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0099111.t005", "stats"=>{"downloads"=>0, "page_views"=>4, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Participants_geographical_location_/1058475", "title"=>"Participants' geographical location.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-06-16 03:09:40"}
  • {"files"=>["https://ndownloader.figshare.com/files/1536185"], "description"=>"<p><i>*COS had already been developed without patient input, so this work done to elicit patient opinion.</i></p><p><b><i>**</i></b><i> Patient core set.</i></p>", "links"=>[], "tags"=>["Clinical medicine", "clinical trials", "Research assessment", "Systematic reviews", "research design", "Clinical research design"], "article_id"=>1058474, "categories"=>["Biological Sciences"], "users"=>["Elizabeth Gargon", "Binu Gurung", "Nancy Medley", "Doug G. Altman", "Jane M. Blazeby", "Mike Clarke", "Paula R. Williamson"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0099111.t006", "stats"=>{"downloads"=>0, "page_views"=>3, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Public_involvement_detail_N_8202_8202_20_/1058474", "title"=>"Public involvement detail (N = 20).", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-06-16 03:09:40"}
  • {"files"=>["https://ndownloader.figshare.com/files/1536180"], "description"=>"<p>Identification of studies.</p>", "links"=>[], "tags"=>["Clinical medicine", "clinical trials", "Research assessment", "Systematic reviews", "research design", "Clinical research design"], "article_id"=>1058469, "categories"=>["Biological Sciences"], "users"=>["Elizabeth Gargon", "Binu Gurung", "Nancy Medley", "Doug G. Altman", "Jane M. Blazeby", "Mike Clarke", "Paula R. Williamson"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0099111.g001", "stats"=>{"downloads"=>1, "page_views"=>4, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Identification_of_studies_/1058469", "title"=>"Identification of studies.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2014-06-16 03:09:40"}
  • {"files"=>["https://ndownloader.figshare.com/files/1536193", "https://ndownloader.figshare.com/files/1536194", "https://ndownloader.figshare.com/files/1536195"], "description"=>"<div><p>Background</p><p>A core outcome set (COS) is a standardised set of outcomes which should be measured and reported, as a minimum, in all effectiveness trials for a specific health area. This will allow results of studies to be compared, contrasted and combined as appropriate, as well as ensuring that all trials contribute usable information. The COMET (Core Outcome Measures for Effectiveness Trials) Initiative aims to support the development, reporting and adoption of COS. Central to this is a publically accessible online resource, populated with all available COS. The aim of the review we report here was to identify studies that sought to determine which outcomes or domains to measure in all clinical trials in a specific condition and to describe the methodological techniques used in these studies.</p><p>Methods</p><p>We developed a multi-faceted search strategy for electronic databases (MEDLINE, SCOPUS, and Cochrane Methodology Register). We included studies that sought to determine which outcomes/domains to measure in all clinical trials in a specific condition.</p><p>Results</p><p>A total of 250 reports relating to 198 studies were judged eligible for inclusion in the review. Studies covered various areas of health, most commonly cancer, rheumatology, neurology, heart and circulation, and dentistry and oral health. A variety of methods have been used to develop COS, including semi-structured discussion, unstructured group discussion, the Delphi Technique, Consensus Development Conference, surveys and Nominal Group Technique. The most common groups involved were clinical experts and non-clinical research experts. Thirty-one (16%) studies reported that the public had been involved in the process. The geographic locations of participants were predominantly North America (n = 164; 83%) and Europe (n = 150; 76%).</p><p>Conclusions</p><p>This systematic review identified many health areas where a COS has been developed, but also highlights important gaps. It is a further step towards a comprehensive, up-to-date database of COS. In addition, it shows the need for methodological guidance, including how to engage key stakeholder groups, particularly members of the public.</p></div>", "links"=>[], "tags"=>["Clinical medicine", "clinical trials", "Research assessment", "Systematic reviews", "research design", "Clinical research design", "outcomes", "comparative", "systematic"], "article_id"=>1058482, "categories"=>["Biological Sciences"], "users"=>["Elizabeth Gargon", "Binu Gurung", "Nancy Medley", "Doug G. Altman", "Jane M. Blazeby", "Mike Clarke", "Paula R. Williamson"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0099111.s001", "https://dx.doi.org/10.1371/journal.pone.0099111.s002", "https://dx.doi.org/10.1371/journal.pone.0099111.s003"], "stats"=>{"downloads"=>1, "page_views"=>6, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Choosing_Important_Health_Outcomes_for_Comparative_Effectiveness_Research_A_Systematic_Review_/1058482", "title"=>"Choosing Important Health Outcomes for Comparative Effectiveness Research: A Systematic Review", "pos_in_sequence"=>0, "defined_type"=>4, "published_date"=>"2014-06-16 03:09:40"}

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  • {"unique-ip"=>"13", "full-text"=>"16", "pdf"=>"2", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"3", "supp-data"=>"2", "cited-by"=>"0", "year"=>"2019", "month"=>"10"}

Relative Metric

{"start_date"=>"2014-01-01T00:00:00Z", "end_date"=>"2014-12-31T00:00:00Z", "subject_areas"=>[{"subject_area"=>"/Medicine and health sciences/Clinical medicine", "average_usage"=>[282]}, {"subject_area"=>"/Medicine and health sciences/Pharmacology", "average_usage"=>[286]}, {"subject_area"=>"/People and places", "average_usage"=>[302]}]}
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