{"doc_desc":{"title":"Communication entre la patiente et le centre d'Assistance M\u00e9dicale \u00e0 la Procr\u00e9ation (AMP) pour la f\u00e9condation in vitro (FIV): v\u00e9cu et attentes des patientes","idno":"FRESH-PEF73357-fr","producers":[{"name":"Laurie LEVY-BACHELOT","affiliation":"MSD FRANCE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73357-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"73357"},{"agency":"FReSH","code":"FRESH-PEF73357"}]},"title":"Communication entre la patiente et le centre d'Assistance M\u00e9dicale \u00e0 la Procr\u00e9ation (AMP) pour la f\u00e9condation in vitro (FIV): v\u00e9cu et attentes des patientes","alternate_title":"EVASTIM"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Maja;VELKOVSKI-ROUYER","PILabo":"MSD","affiliationName":"MSD FRANCE","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"","uri":"","role":"pi id"},{"title":"SIREN","uri":"417890589","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"","isContact":"Non"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"MSD FRANCE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00kt5kp12","role":"sponsor id"},{"title":"SIREN","uri":"417890589","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"MSD FRANCE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00kt5kp12"},{"title":"SIREN","uri":"417890589"}]}]},"distribution_statement":{"contact":[{"name":"","type":"contact"}]},"study_info":{"keywords":[],"topics":[{"topic":"G\u00e9riatrie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/d37e4d8c-a978-40c7-ba4f-eee841851073"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D005853"}]}],"purpose":"Evaluer le ressenti des patientes vis-\u00e0-vis de leur prise en charge (informations g\u00e9n\u00e9rales, consignes pratiques, r\u00e9alisation des injections) dans le cadre d'une FIV.","abstract":"","coll_dates":[{"start":"","end":""}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","analysis_unit":"Individus","universe":"{\n    \"level_sex_clusion_I\": [\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\": \"Adulte (19 \u00e0 24 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adulte (25 \u00e0 44 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Adulte (45 \u00e0 64 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        },\n        {\n            \"value\": \"Personne \u00e2g\u00e9e (65 \u00e0 79 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        },\n        {\n            \"value\": \"Grand \u00e2ge (80 ans et plus)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Population g\u00e9n\u00e9rale\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Premi\u00e8re phase Seules les patientes qui r\u00e9pondent aux crit\u00e8res d'inclusion suivants lors de la visite d'inclusion seront incluses dans cette \u00e9tude:  \u2022Patientes b\u00e9n\u00e9ficiant d'une 1\u00e8re tentative de FIV ou d'ICSI dans un centre d'AMP \u2022Patientes capables de renseigner un auto-questionnaire seules \u2022Patientes acceptant de participer \u00e0 l'\u00e9tude et ne participant pas \u00e0 un essai th\u00e9rapeutique Seconde phase Un crit\u00e8re d'inclusion suppl\u00e9mentaire doit \u00eatre pris en compte pour l'inclusion dans la 2\u00e8me phase de l'\u00e9tude : \u2022Patientes disposant d'un Smartphone depuis au moins 3 mois et habitu\u00e9es \u00e0 utiliser des applications (questionnaire de screening)  \",\n    \"clusion_E\": \"Les patientes ayant d\u00e9j\u00e0 re\u00e7u un traitement injectable pour l'infertilit\u00e9 dans un centre d'AMP (c'est-\u00e0-dire pr\u00e9c\u00e9demment trait\u00e9es par des injections de FSH pour l'infertilit\u00e9) ne pourront pas \u00eatre incluses dans cette \u00e9tude\"\n}","data_kind":"['Donn\u00e9es rapport\u00e9es par le participant de l&#x27;\u00e9tude']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":""}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Transcription et saisie d\u2019informations dans un enregistrement structur\u00e9\"}","{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Entretien avec le participant (dont clinique)\"}"],"research_instrument":"Pas d\u2019acc\u00e8s","sources":[],"target_sample_size":"< 500 individus","response_rate":"390"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]}]},"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":"----","lastUpdatedAuto":null,"lastUpdatedManual":"29-10-2020","isContributorPI":"Non","contributorName":"Laurie LEVY-BACHELOT","contributorAffiliation":"MSD 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