{"doc_desc":{"title":"Cohorte d\u2019enfants atteints d\u2019une forme bilat\u00e9rale s\u00e9v\u00e8re de paralysie c\u00e9r\u00e9brale: incidence et \u00e9volution des complications orthop\u00e9diques et des douleurs en lien avec ces complications","idno":"FRESH-PEF5282-fr","producers":[{"name":"Isabelle POIROT","affiliation":"HOSPICES CIVILS DE LYON (HCL)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF5282-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"5282"},{"agency":"FReSH","code":"FRESH-PEF5282"}]},"title":"Cohorte d\u2019enfants atteints d\u2019une forme bilat\u00e9rale s\u00e9v\u00e8re de paralysie c\u00e9r\u00e9brale: incidence et \u00e9volution des complications orthop\u00e9diques et des douleurs en lien avec ces complications","alternate_title":"Cohorte PC"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Isabelle;POIROT","PILabo":"Groupement Hospitalier Est, Hospices Civils de \/ Service \u00ab L\u2019Escale \u00bb, R\u00e9\u00e9ducation Fonctionnelle Infantile","affiliationName":"HOSPICES CIVILS DE LYON (HCL)","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"060599790","role":"pi id"},{"title":"SIREN","uri":"266900273","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"isabelle.poirot@chu-lyon.fr","isContact":"Oui"}],"oth_id":[{"name":"R\u00e9union des investigateurs annuelle lors des journ\u00e9es d'Etude SFERHE (Soci\u00e9t\u00e9 Francophone d'Etudes et de Recherche sur les Handicaps de l'Enfance)","type":"collaboration"}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"HOSPICES CIVILS DE LYON (HCL)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01502ca60","role":"sponsor id"},{"title":"SIREN","uri":"266900273","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"MINISTERE DU TRAVAIL, DE LA SANTE, DES SOLIDARITES ET DES FAMILLES","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01wp0c315"},{"title":"SIREN","uri":"130016546"}]},{"name":"SOCIETE FRANCOPHONE D ETUDES ET DE RECHERCHES SUR LES HANDICAPS DE L ENFANCE (S.F.E.R.H.E)","extlink":[{"title":"SIREN","uri":"494451883"}]},{"name":"","extlink":[]}]},"distribution_statement":{"contact":[{"name":"Isabelle;POIROT","email":"isabelle.poirot@chu-lyon.fr","type":"contact","affiliationName":"HOSPICES CIVILS DE LYON (HCL)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/01502ca60","role":"organisation id","title":"ROR"},{"uri":"266900273","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"Douleur"},{"keyword":"Enfant"},{"keyword":"Cohorte"},{"keyword":"Complications orthop\u00e9diques"},{"keyword":"Epid\u00e9miologie"},{"keyword":"Paralysie c\u00e9r\u00e9brale"}],"topics":[{"topic":"M\u00e9decine physique et de r\u00e9adaptation","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/38e57437-b2cc-4d26-a46e-c5b639c01e5f"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D010810"}]},{"topic":"Neurologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/c4793dfe-e80e-49dd-9fcc-a1a742de1b25"},{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/00a5c4f4-b7ee-41a4-bcdf-3a02e6be1660"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D009462"}]},{"topic":"Paralysie c\u00e9r\u00e9brale","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/76906748","title":"CIM-11"}]},{"topic":"D\u00e9terminants socio-d\u00e9mographiques et \u00e9conomiques","vocab":"health determinant"}],"purpose":"L'objectif principal de cette \u00e9tude de cohorte est d'\u00e9tablir l'incidence des complications orthop\u00e9diques (scoliose et excentration de hanche) en fonction de l\u2019\u00e2ge des patients. Les objectifs secondaires vient \u00e0 d\u00e9crire la s\u00e9quence temporelle de survenue de ces complications et de la douleur associ\u00e9e, d'explorer l'impact de l\u2019\u00e9tat nutritionnel, du traitement chirurgical, des postures asym\u00e9triques et des facteurs environnementaux, et de d\u00e9crire le suivi m\u00e9dical et r\u00e9\u00e9ducatif dont font l\u2019objet ces patients.","abstract":"","coll_dates":[{"start":"2009-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","analysis_unit":"Individus","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Masculin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"F\u00e9minin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D005260\"\n            }\n        }\n    ],\n    \"level_age_clusion_I\": [\n        {\n            \"value\": \"Petite enfance (2 \u00e0 5 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002675\"\n            }\n        },\n        {\n            \"value\": \"Enfance (6 \u00e0 12 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002648\"\n            }\n        },\n        {\n            \"value\": \"Adolescence (13 \u00e0 18 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000293\"\n            }\n        },\n        {\n            \"value\": \"Adulte (19 \u00e0 24 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \" Enfants \u00e2g\u00e9s de 2 \u00e0 10 ans \u00e0 l\u2019inclusion - Paralysie c\u00e9r\u00e9brale (l\u00e9sion ou anomalie c\u00e9r\u00e9brale survenue avant l\u2019\u00e2ge de 2 ans), avec atteinte bilat\u00e9rale et s\u00e9v\u00e8re (stade IV ou V de la  GMFCS [Gross Motor Function Classification System]).  - Atteinte c\u00e9r\u00e9brale non \u00e9volutive\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es paracliniques','Donn\u00e9es paracliniques (hors biologiques) : Imagerie']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Ev\u00e9nements de sant\u00e9\/morbidit\u00e9\r\nEv\u00e9nements de sant\u00e9\/mortalit\u00e9"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":"['Via des structures (services ou \u00e9tablissements de sant\u00e9, \u00e9coles, entreprises\u2026)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Transcription et saisie d\u2019informations dans un enregistrement structur\u00e9\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"< 500 individus","response_rate":"322 patients inclus au 07\/02\/2018"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]},{"subject":"observational study method","values":["Cohorte"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"A d\u00e9finir\",\"extLink\":[]}"},"dataset_use":{"restrictions":"","conditions":"","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"imported","creationDate":"03-01-2013","lastUpdatedAuto":null,"lastUpdatedManual":"07-02-2018","isContributorPI":"Non","contributorName":"Isabelle POIROT","contributorAffiliation":"HOSPICES CIVILS DE LYON (HCL)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"Physiopathological hypothesis of hip excentration in cerebral palsy, from a field experience","link":"http:\/\/www.em-consulte.com\/en\/article\/855582"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Priv\u00e9 \u00e0 but non lucratif","Priv\u00e9 \u00e0 but non lucratif"],"otherFundingAgentType":["","",""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":"Oui"},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Oui","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Les donn\u00e9es sont recueillies sur un cahier d'observation \u00e9lectronique (e-CRF) par les m\u00e9decins investigateurs de l'\u00e9tude, au cours de chaque visite annuelle des patients. Ces visites entrent dans le cadre du suivi habituel du patient. Les donn\u00e9es recueillies se basent sur l'interrogatoire des parents, l'examen clinique du patient, les radiographies de l'enfant, et le dossier m\u00e9dical s'il y a lieu (ant\u00e9c\u00e9dents m\u00e9dicaux, donn\u00e9es cliniques et paracliniques,...).","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"France (englobant l'\u00cele de la R\u00e9union, la Martinique et la Polyn\u00e9sie)."},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"","isDataInBiobank":"Non","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}