Ako sa RWD a RWE uplat\u0148uj\u00fa v zdravotnej starostlivosti?<\/h1>\n\n\n\n
Na individu\u00e1lnej \u00farovni sa RWD vyskytuje vo forme osobn\u00fdch zdravotn\u00fdch meran\u00ed, napr\u00edklad sledovan\u00edm fyzickej aktivity alebo hladiny cukru v krvi prostredn\u00edctvom nosite\u013en\u00fdch zariaden\u00ed. Na klinickej \u00farovni s\u00fa EHR syst\u00e9my \u0161tandardom \u2013 v roku 2017 pou\u017e\u00edvalo EHR syst\u00e9m takmer 86 % ambulantn\u00fdch lek\u00e1rov v USA v porovnan\u00ed so 42 % v roku 2008. Navy\u0161e, digitaliz\u00e1cia zr\u00fdchlen\u00e1 pand\u00e9miou COVID-19 podporila vzdialen\u00fa \u00fa\u010das\u0165 pacientov v klinick\u00fdch \u0161t\u00fadi\u00e1ch prostredn\u00edctvom telemedic\u00edny a prepojen\u00fdch senzorov.<\/p>\n\n\n\n Regula\u010dn\u00e9 org\u00e1ny, ako je Americk\u00fd \u00fadar pre kontrolu potrav\u00edn a lie\u010div (FDA), uzn\u00e1vaj\u00fa hodnotu RWD a RWE. Aj ke\u010f RCT zost\u00e1vaj\u00fa zlat\u00fdm \u0161tandardom pri schva\u013eovan\u00ed liekov a zdravotn\u00fdch pom\u00f4cok, RWE sa za\u010d\u00edna uplat\u0148ova\u0165 pri posudzovan\u00ed niektor\u00fdch regula\u010dn\u00fdch \u017eiadost\u00ed. RWD pon\u00faka jedine\u010dn\u00fa mo\u017enos\u0165 z\u00edska\u0165 d\u00e1ta o zdravotn\u00fdch slu\u017eb\u00e1ch, zariadeniach a lie\u010div\u00e1ch z r\u00f4znych pacientsk\u00fdch popul\u00e1ci\u00ed, ktor\u00e9 nemusia by\u0165 v RCT dostato\u010dne zast\u00fapen\u00e9.<\/p>\n\n\n\n Aj ke\u010f m\u00f4\u017ee RWE poskytn\u00fa\u0165 cenn\u00e9 doplnenie klinick\u00fdch \u0161t\u00fadi\u00ed, existuj\u00fa ur\u010dit\u00e9 obmedzenia, ktor\u00e9 je potrebn\u00e9 zv\u00e1\u017ei\u0165:<\/p>\n\n\n\n Je d\u00f4le\u017eit\u00e9, aby boli v\u0161etky d\u00f4kazy hodnoten\u00e9 s primeranou opatrnos\u0165ou. Ke\u010f\u017ee mno\u017estvo zdravotn\u00fdch d\u00e1t neust\u00e1le rastie, klinick\u00ed lek\u00e1ri by mali by\u0165 pripraven\u00ed kriticky posudzova\u0165 ich kvalitu. Pri posudzovan\u00ed \u0161t\u00fadi\u00ed zalo\u017een\u00fdch na RWE by sa mali zv\u00e1\u017ei\u0165 nasleduj\u00face faktory:<\/p>\n\n\n\n V\u0161etci zainteresovan\u00ed v zdravotnej starostlivosti maj\u00fa d\u00f4le\u017eit\u00fa \u00falohu pri zabezpe\u010den\u00ed efekt\u00edvneho vyu\u017e\u00edvania RWE. Transparentnos\u0165 v oblasti relevantnosti d\u00e1t a ich kvality pom\u00e1ha vytv\u00e1ra\u0165 u\u017eito\u010dn\u00e9 inform\u00e1cie, ktor\u00e9 lek\u00e1ri m\u00f4\u017eu pou\u017ei\u0165 na podporu rozhodovania v zdravotnej starostlivosti. Hoci RCT zost\u00e1vaj\u00fa hlavn\u00fdm n\u00e1strojom na hodnotenie \u00fa\u010dinnosti a bezpe\u010dnosti liekov, spr\u00e1vne analyzovan\u00e9 a vyu\u017e\u00edvan\u00e9 RWD a RWE pon\u00fakaj\u00fa doplnkov\u00e9 inform\u00e1cie na lep\u0161\u00ed individualizovan\u00fd pr\u00edstup k lie\u010dbe pacientov.<\/p>\n","protected":false},"excerpt":{"rendered":" Tieto inform\u00e1cie, ozna\u010dovan\u00e9 ako re\u00e1lne svetov\u00e9 d\u00f4kazy (real-world evidence, RWE), predstavuj\u00fa zdravotn\u00e9 \u00fadaje zhroma\u017eden\u00e9 v re\u00e1lnych podmienkach, mimo tradi\u010dn\u00fdch randomizovan\u00fdch kontrolovan\u00fdch \u0161t\u00fadi\u00ed (RCT). RWE m\u00f4\u017ee dop\u013a\u0148a\u0165 zlat\u00fd \u0161tandard RCT a pom\u00e1ha\u0165 lek\u00e1rom pri personalizovanej starostlivosti o pacientov, \u010do potenci\u00e1lne vedie k lep\u0161\u00edm v\u00fdsledkom. Na individu\u00e1lnej \u00farovni sa RWD vyskytuje vo forme osobn\u00fdch zdravotn\u00fdch meran\u00ed, napr\u00edklad […]<\/p>\n","protected":false},"author":2,"featured_media":20,"comment_status":"closed","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-13","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-inovacie"],"_links":{"self":[{"href":"https:\/\/digitalpharma.sk\/sk\/wp-json\/wp\/v2\/posts\/13","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/digitalpharma.sk\/sk\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/digitalpharma.sk\/sk\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/digitalpharma.sk\/sk\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/digitalpharma.sk\/sk\/wp-json\/wp\/v2\/comments?post=13"}],"version-history":[{"count":6,"href":"https:\/\/digitalpharma.sk\/sk\/wp-json\/wp\/v2\/posts\/13\/revisions"}],"predecessor-version":[{"id":49,"href":"https:\/\/digitalpharma.sk\/sk\/wp-json\/wp\/v2\/posts\/13\/revisions\/49"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/digitalpharma.sk\/sk\/wp-json\/wp\/v2\/media\/20"}],"wp:attachment":[{"href":"https:\/\/digitalpharma.sk\/sk\/wp-json\/wp\/v2\/media?parent=13"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/digitalpharma.sk\/sk\/wp-json\/wp\/v2\/categories?post=13"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/digitalpharma.sk\/sk\/wp-json\/wp\/v2\/tags?post=13"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}![\"\"](\"https:\/\/digitalpharma.sk\/sk\/cms\/wp-content\/uploads\/2025\/03\/automatic-pharmaceutical-production-line-modern-factory-workshop-conveyor-belt-with-medicine-bottles-scaled.jpg\")
<\/figure>\n\n\n\nObmedzenia a v\u00fdzvy spojen\u00e9 s RWD\/RWE<\/h1>\n\n\n\n
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Ako efekt\u00edvne vyu\u017e\u00edva\u0165 RWE v klinickom rozhodovan\u00ed?<\/h1>\n\n\n\n
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