{"id":"https://openalex.org/W7201831765","doi":"https://doi.org/10.1016/j.chstcc.2026.100311","title":"Writing, Reviewing, and Reading Standard and Pragmatic Clinical Trial Protocol Papers","display_name":"Writing, Reviewing, and Reading Standard and Pragmatic Clinical Trial Protocol Papers","publication_year":2026,"publication_date":"2026-08-01","ids":{"openalex":"https://openalex.org/W7201831765","doi":"https://doi.org/10.1016/j.chstcc.2026.100311","pmid":"https://pubmed.ncbi.nlm.nih.gov/42985288","pmcid":"https://www.ncbi.nlm.nih.gov/pmc/articles/13733615"},"language":"en","primary_location":{"id":"doi:10.1016/j.chstcc.2026.100311","doi":"https://doi.org/10.1016/j.chstcc.2026.100311","is_oa":true,"landing_page_url":"https://doi.org/10.1016/j.chstcc.2026.100311","pdf_url":"https://www.chestcc.org/article/S2949-7884(26)00078-X/pdf","source":{"id":"https://openalex.org/S4387286741","display_name":"CHEST Critical Care","issn_l":"2949-7884","issn":["2949-7884"],"is_oa":true,"is_in_doaj":true,"is_core":true,"listed_in":["cwts-core","doaj","ki-jl-1"],"host_organization":"https://openalex.org/P4310320990","host_organization_name":"Elsevier BV","host_organization_lineage":["https://openalex.org/P4310320990"],"host_organization_lineage_names":["Elsevier BV"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"CHEST Critical Care","raw_type":"journal-article"},"volume":null,"type":"article","is_traditional":true,"indexed_in":["crossref","doaj","pubmed"],"open_access":{"is_oa":true,"oa_status":"gold","oa_url":"https://www.chestcc.org/article/S2949-7884(26)00078-X/pdf","any_repository_has_fulltext":true},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5088505419","display_name":"Elizabeth S. Munroe","orcid":"https://orcid.org/0000-0003-3353-612X","observed_orcids":["https://orcid.org/0000-0003-3353-612X"]},"institutions":[{"id":"https://openalex.org/I108785884","display_name":"Intermountain Healthcare","ror":"https://ror.org/04mvr1r74","country_code":"US","type":"healthcare","lineage":["https://openalex.org/I108785884"]}],"countries":["US"],"is_corresponding":true,"raw_author_name":"Elizabeth S. Munroe","raw_affiliation_strings":["Department of Pulmonary and Critical Care, Intermountain Health, Salt Lake City, UT"],"raw_orcid":"https://orcid.org/0000-0003-3353-612X","affiliations":[{"raw_affiliation_string":"Department of Pulmonary and Critical Care, Intermountain Health, Salt Lake City, UT","institution_ids":["https://openalex.org/I108785884"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5021860043","display_name":"Bhakti K. Patel","orcid":"https://orcid.org/0000-0002-6517-2175","observed_orcids":["https://orcid.org/0000-0002-6517-2175"]},"institutions":[{"id":"https://openalex.org/I40347166","display_name":"University of Chicago","ror":"https://ror.org/024mw5h28","country_code":"US","type":"education","lineage":["https://openalex.org/I40347166"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Bhakti K. Patel","raw_affiliation_strings":["Section of Pulmonary and Critical Care, Department of Medicine, University of Chicago, Chicago, IL"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Section of Pulmonary and Critical Care, Department of Medicine, University of Chicago, Chicago, IL","institution_ids":["https://openalex.org/I40347166"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5108133935","display_name":"Ithan D. Peltan","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I108785884","display_name":"Intermountain Healthcare","ror":"https://ror.org/04mvr1r74","country_code":"US","type":"healthcare","lineage":["https://openalex.org/I108785884"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Ithan Peltan","raw_affiliation_strings":["Department of Pulmonary and Critical Care, Intermountain Health, Salt Lake City, UT"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Pulmonary and Critical Care, Intermountain Health, Salt Lake City, UT","institution_ids":["https://openalex.org/I108785884"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":2,"corresponding_author_ids":["https://openalex.org/A5088505419"],"corresponding_institution_ids":["https://openalex.org/I108785884"],"apc_list":{"value":2500,"currency":"USD","value_usd":2500},"apc_paid":{"value":2500,"currency":"USD","value_usd":2500},"fwci":0.0,"has_fulltext":true,"cited_by_count":0,"citation_normalized_percentile":{"value":0.55012637,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":null,"biblio":{"volume":null,"issue":null,"first_page":"100311","last_page":"100311"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T10206","display_name":"Meta-analysis and systematic reviews","score":0.8740000128746033,"subfield":{"id":"https://openalex.org/subfields/1804","display_name":"Statistics, Probability and Uncertainty"},"field":{"id":"https://openalex.org/fields/18","display_name":"Decision Sciences"},"domain":{"id":"https://openalex.org/domains/2","display_name":"Social Sciences"}},"topics":[{"id":"https://openalex.org/T10206","display_name":"Meta-analysis and systematic reviews","score":0.8740000128746033,"subfield":{"id":"https://openalex.org/subfields/1804","display_name":"Statistics, Probability and Uncertainty"},"field":{"id":"https://openalex.org/fields/18","display_name":"Decision Sciences"},"domain":{"id":"https://openalex.org/domains/2","display_name":"Social Sciences"}},{"id":"https://openalex.org/T11235","display_name":"Statistical Methods in Clinical Trials","score":0.0608999989926815,"subfield":{"id":"https://openalex.org/subfields/2613","display_name":"Statistics and Probability"},"field":{"id":"https://openalex.org/fields/26","display_name":"Mathematics"},"domain":{"id":"https://openalex.org/domains/3","display_name":"Physical Sciences"}},{"id":"https://openalex.org/T12664","display_name":"Clinical practice guidelines implementation","score":0.02280000038444996,"subfield":{"id":"https://openalex.org/subfields/2739","display_name":"Public Health, Environmental and Occupational Health"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/pragmatic-clinical-trials","display_name":"pragmatic trials","score":0.7329999804496765},{"id":"https://openalex.org/keywords/randomized-controlled-trials","display_name":"randomized controlled trials","score":0.7720000147819519},{"id":"https://openalex.org/keywords/critical-care-research","display_name":"critical care research","score":0.7310000061988831},{"id":"https://openalex.org/keywords/reporting-guidelines","display_name":"reporting guidelines","score":0.8199999928474426},{"id":"https://openalex.org/keywords/trial-design","display_name":"trial design","score":0.5600000023841858},{"id":"https://openalex.org/keywords/electronic-health-record-data","display_name":"electronic health record data","score":0.8299999833106995},{"id":"https://openalex.org/keywords/interpretation-of-trial-results","display_name":"trial interpretation","score":0.5189999938011169}],"concepts":[{"id":"https://openalex.org/C2780385302","wikidata":"https://www.wikidata.org/wiki/Q367158","display_name":"Protocol (science)","level":3,"score":0.6446999907493591},{"id":"https://openalex.org/C554936623","wikidata":"https://www.wikidata.org/wiki/Q199657","display_name":"Reading (process)","level":2,"score":0.6087999939918518},{"id":"https://openalex.org/C535046627","wikidata":"https://www.wikidata.org/wiki/Q30612","display_name":"Clinical trial","level":2,"score":0.5848000049591064},{"id":"https://openalex.org/C509550671","wikidata":"https://www.wikidata.org/wiki/Q126945","display_name":"Medical education","level":1,"score":0.42480000853538513},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.42149999737739563},{"id":"https://openalex.org/C15744967","wikidata":"https://www.wikidata.org/wiki/Q9418","display_name":"Psychology","level":0,"score":0.41130000352859497},{"id":"https://openalex.org/C19527891","wikidata":"https://www.wikidata.org/wiki/Q1120908","display_name":"Medical physics","level":1,"score":0.36039999127388},{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.33379998803138733},{"id":"https://openalex.org/C2779473830","wikidata":"https://www.wikidata.org/wiki/Q1540899","display_name":"MEDLINE","level":2,"score":0.29409998655319214},{"id":"https://openalex.org/C133112747","wikidata":"https://www.wikidata.org/wiki/Q7251931","display_name":"Protocol analysis","level":2,"score":0.2858000099658966},{"id":"https://openalex.org/C68122502","wikidata":"https://www.wikidata.org/wiki/Q764527","display_name":"Informed consent","level":3,"score":0.28519999980926514},{"id":"https://openalex.org/C2779318504","wikidata":"https://www.wikidata.org/wiki/Q1438035","display_name":"Research design","level":2,"score":0.2847000062465668}],"mesh":[],"locations_count":3,"locations":[{"id":"doi:10.1016/j.chstcc.2026.100311","doi":"https://doi.org/10.1016/j.chstcc.2026.100311","is_oa":true,"landing_page_url":"https://doi.org/10.1016/j.chstcc.2026.100311","pdf_url":"https://www.chestcc.org/article/S2949-7884(26)00078-X/pdf","source":{"id":"https://openalex.org/S4387286741","display_name":"CHEST Critical Care","issn_l":"2949-7884","issn":["2949-7884"],"is_oa":true,"is_in_doaj":true,"is_core":true,"listed_in":["cwts-core","doaj","ki-jl-1"],"host_organization":"https://openalex.org/P4310320990","host_organization_name":"Elsevier BV","host_organization_lineage":["https://openalex.org/P4310320990"],"host_organization_lineage_names":["Elsevier BV"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"CHEST Critical Care","raw_type":"journal-article"},{"id":"pmh:oai:pubmedcentral.nih.gov:13733615","doi":null,"is_oa":true,"landing_page_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC13733615/","pdf_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC13733615/pdf/nihms-2215685.pdf","source":{"id":"https://openalex.org/S2764455111","display_name":"PubMed Central","issn_l":null,"issn":null,"is_oa":true,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"CHEST Crit Care","raw_type":"Text"},{"id":"pmid:42985288","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/42985288","pdf_url":null,"source":{"id":"https://openalex.org/S4306525036","display_name":"PubMed","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"CHEST critical care","raw_type":"Journal Article"}],"best_oa_location":{"id":"doi:10.1016/j.chstcc.2026.100311","doi":"https://doi.org/10.1016/j.chstcc.2026.100311","is_oa":true,"landing_page_url":"https://doi.org/10.1016/j.chstcc.2026.100311","pdf_url":"https://www.chestcc.org/article/S2949-7884(26)00078-X/pdf","source":{"id":"https://openalex.org/S4387286741","display_name":"CHEST Critical Care","issn_l":"2949-7884","issn":["2949-7884"],"is_oa":true,"is_in_doaj":true,"is_core":true,"listed_in":["cwts-core","doaj","ki-jl-1"],"host_organization":"https://openalex.org/P4310320990","host_organization_name":"Elsevier BV","host_organization_lineage":["https://openalex.org/P4310320990"],"host_organization_lineage_names":["Elsevier BV"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"CHEST Critical Care","raw_type":"journal-article"},"sustainable_development_goals":[{"score":0.4043000042438507,"id":"https://metadata.un.org/sdg/3","display_name":"Good health and well-being"}],"study_designs":[],"awards":[{"id":"https://openalex.org/G9000897275","display_name":"Measuring and Learning from Care Variation in Sepsis","funder_award_id":"R35GM151147","funder_id":"https://openalex.org/F4320337354","funder_display_name":"National Institute of General Medical Sciences"}],"funders":[{"id":"https://openalex.org/F4320311600","display_name":"Regeneron Pharmaceuticals","ror":"https://ror.org/02f51rf24"},{"id":"https://openalex.org/F4320332161","display_name":"National Institutes of Health","ror":"https://ror.org/01cwqze88"},{"id":"https://openalex.org/F4320332162","display_name":"Centers for Disease Control and Prevention","ror":"https://ror.org/042twtr12"},{"id":"https://openalex.org/F4320337338","display_name":"National Heart, Lung, and Blood Institute","ror":"https://ror.org/012pb6c26"},{"id":"https://openalex.org/F4320337354","display_name":"National Institute of General Medical Sciences","ror":"https://ror.org/04q48ey07"}],"has_content":{"pdf":true,"grobid_xml":true},"content_urls":{"pdf":"https://content.openalex.org/works/W7201831765.pdf","grobid_xml":"https://content.openalex.org/works/W7201831765.grobid-xml"},"referenced_works_count":48,"referenced_works":["https://openalex.org/W1788491752","https://openalex.org/W1931781407","https://openalex.org/W2052666601","https://openalex.org/W2055690472","https://openalex.org/W2061149030","https://openalex.org/W2101584773","https://openalex.org/W2102330235","https://openalex.org/W2108153775","https://openalex.org/W2122959806","https://openalex.org/W2128659393","https://openalex.org/W2145555293","https://openalex.org/W2152445141","https://openalex.org/W2167165853","https://openalex.org/W2274125232","https://openalex.org/W2396727790","https://openalex.org/W2411024165","https://openalex.org/W2581059334","https://openalex.org/W2610369259","https://openalex.org/W2770291148","https://openalex.org/W2903775789","https://openalex.org/W2943308955","https://openalex.org/W2943492071","https://openalex.org/W2980378683","https://openalex.org/W2984947744","https://openalex.org/W2990895485","https://openalex.org/W3021640810","https://openalex.org/W3047950129","https://openalex.org/W3157944437","https://openalex.org/W3200190241","https://openalex.org/W3209293982","https://openalex.org/W4205374244","https://openalex.org/W4241014756","https://openalex.org/W4281479985","https://openalex.org/W4283011822","https://openalex.org/W4288068352","https://openalex.org/W4288724240","https://openalex.org/W4307179271","https://openalex.org/W4311249208","https://openalex.org/W4317677052","https://openalex.org/W4386924182","https://openalex.org/W4387638731","https://openalex.org/W4392367320","https://openalex.org/W4396509781","https://openalex.org/W4399624094","https://openalex.org/W4409417738","https://openalex.org/W4409875165","https://openalex.org/W4410556676","https://openalex.org/W4417137712"],"related_works":["https://openalex.org/W97884202","https://openalex.org/W7124289004","https://openalex.org/W2312359799","https://openalex.org/W4286592300","https://openalex.org/W3158013573","https://openalex.org/W4256022567","https://openalex.org/W7165009322","https://openalex.org/W4285819585","https://openalex.org/W395551815","https://openalex.org/W4225292519"],"abstract_inverted_index":{"Randomized":[0],"controlled":[1],"trials":[2,17,127],"provide":[3,77],"foundational":[4],"evidence":[5,13],"in":[6,48,84,132,155],"clinical":[7,16,62,156],"medicine.":[8],"However,":[9],"the":[10,20,42,58,93,103,115],"quality":[11,21],"of":[12,22,41,57,98,170],"generated":[14],"by":[15],"depends":[18],"on":[19,193],"their":[23,135],"design,":[24],"conduct,":[25],"and":[26,39,76,108,118,158,177,183],"analysis.":[27],"A":[28],"comprehensive":[29],"protocol":[30,43,59,80,99,171,187],"is":[31,44],"essential":[32],"for":[33,60,105,181],"conducting":[34],"a":[35,61,110,190],"rigorous,":[36],"high-quality":[37],"trial,":[38],"publication":[40],"an":[45,69],"important":[46],"step":[47],"transparent":[49],"trial":[50,85,95,117,143,148,153],"reporting.":[51],"Protocol":[52],"papers":[53,65,100],"summarize":[54],"key":[55,179],"elements":[56],"audience.":[63],"Such":[64],"afford":[66],"trialists":[67],"with":[68,189],"opportunity":[70],"to":[71,113,122,141],"explain":[72],"study":[73],"design":[74,144],"choices":[75],"details":[78],"about":[79],"execution":[81],"that":[82,146],"aid":[83],"interpretation":[86],"but":[87],"do":[88],"not":[89],"necessarily":[90],"fit":[91],"within":[92],"main":[94],"manuscript.":[96],"Consumers":[97],"should":[101],"understand":[102],"standards":[104],"adequate":[106],"reporting":[107,175],"use":[109],"systematic":[111],"approach":[112],"evaluate":[114],"planned":[116],"identify":[119],"potential":[120],"threats":[121],"its":[123],"quality.":[124],"As":[125],"pragmatic":[126,194],"have":[128],"become":[129],"increasingly":[130],"common":[131],"critical":[133,185],"care,":[134],"protocols":[136],"merit":[137],"special":[138],"consideration":[139],"due":[140],"unique":[142],"features":[145],"impact":[147],"interpretation,":[149],"such":[150],"as":[151],"embedding":[152],"operations":[154],"practice":[157],"using":[159],"electronic":[160],"health":[161],"record":[162],"data.":[163],"In":[164],"this":[165],"perspective,":[166],"we":[167],"review":[168],"components":[169],"papers,":[172,188],"discuss":[173],"current":[174],"guidelines,":[176],"highlight":[178],"considerations":[180],"writing":[182],"reading":[184],"care":[186],"specific":[191],"focus":[192],"trials.":[195]},"counts_by_year":[],"updated_date":"2026-11-09T13:22:03.289127","created_date":"2026-08-08T00:00:00"}