Real world study （RWS） has become a hotspot for clinical research. Data quality plays a vital role in research achievement and other clinical research fields. In this paper, the common quality problems in the RWS of...Real world study （RWS） has become a hotspot for clinical research. Data quality plays a vital role in research achievement and other clinical research fields. In this paper, the common quality problems in the RWS of traditional Chinese medicine are discussed, and a countermeasure is proposed.展开更多
Prospective real-world data from large patient samples,which re-port on the long-term effectiveness of the employed different drug therapies,are rare in Parkinson's disease(PD).The non interven-tional"Transde...Prospective real-world data from large patient samples,which re-port on the long-term effectiveness of the employed different drug therapies,are rare in Parkinson's disease(PD).The non interven-tional"Transdermal Rotigotine User Surveillance Study"(TRUST)trial represents such a real-world study.It investigated long-term treatment with different dopamine substituting treatment regimens in 2195 PD patients(Mfiller et al.,2018).Participation in TRUST meant that the treating neurologists were only asked to document and modify the dopaminergic drug regimen without any prior PD patient selection criteria.Thus this unique trial design reflects the real world of patient maintenance.展开更多
Background Recombinant human GH(rhGH)was first approved to treat children with growth hormone deficiency(GHD)by Food and Drug Administration(FDA)in the United States in 1985.The indications subsequently expanded to gr...Background Recombinant human GH(rhGH)was first approved to treat children with growth hormone deficiency(GHD)by Food and Drug Administration(FDA)in the United States in 1985.The indications subsequently expanded to growth failure secondary to chronic renal failure,Turner syndrome,Prader‒Willi syndrome,small for gestational age(SGA)without catch-up growth,idiopathic short stature(ISS),SHOX deficiency,Noonan syndrome and so on[1].The efficacy and the safety of rhGH have been proven in randomized controlled trials(RCTs),which are considered the highest level of evidences in clinical practice.However,due to the strict criteria and short observational time,RCTs could not fully reflect the reality of rhGH,especially in terms of safety[2].展开更多
Coronary heart disease(CHD)is a chronic,systemic disease and the primary global cause of death,affecting more than 100 million individuals worldwide.[1]It is associated with various symptoms,a deterioration in clinica...Coronary heart disease(CHD)is a chronic,systemic disease and the primary global cause of death,affecting more than 100 million individuals worldwide.[1]It is associated with various symptoms,a deterioration in clinical outcomes,and increasing healthcare expenditures.[2]Patients with CHD are at elevated long-term risk of major adverse cardiovascular events(MACEs),which typically include new-onset or recurrent myocardial infarction,stroke,and cardiovascular mortality.展开更多
文摘Real world study （RWS） has become a hotspot for clinical research. Data quality plays a vital role in research achievement and other clinical research fields. In this paper, the common quality problems in the RWS of traditional Chinese medicine are discussed, and a countermeasure is proposed.
文摘Prospective real-world data from large patient samples,which re-port on the long-term effectiveness of the employed different drug therapies,are rare in Parkinson's disease(PD).The non interven-tional"Transdermal Rotigotine User Surveillance Study"(TRUST)trial represents such a real-world study.It investigated long-term treatment with different dopamine substituting treatment regimens in 2195 PD patients(Mfiller et al.,2018).Participation in TRUST meant that the treating neurologists were only asked to document and modify the dopaminergic drug regimen without any prior PD patient selection criteria.Thus this unique trial design reflects the real world of patient maintenance.
文摘Background Recombinant human GH(rhGH)was first approved to treat children with growth hormone deficiency(GHD)by Food and Drug Administration(FDA)in the United States in 1985.The indications subsequently expanded to growth failure secondary to chronic renal failure,Turner syndrome,Prader‒Willi syndrome,small for gestational age(SGA)without catch-up growth,idiopathic short stature(ISS),SHOX deficiency,Noonan syndrome and so on[1].The efficacy and the safety of rhGH have been proven in randomized controlled trials(RCTs),which are considered the highest level of evidences in clinical practice.However,due to the strict criteria and short observational time,RCTs could not fully reflect the reality of rhGH,especially in terms of safety[2].
文摘Coronary heart disease(CHD)is a chronic,systemic disease and the primary global cause of death,affecting more than 100 million individuals worldwide.[1]It is associated with various symptoms,a deterioration in clinical outcomes,and increasing healthcare expenditures.[2]Patients with CHD are at elevated long-term risk of major adverse cardiovascular events(MACEs),which typically include new-onset or recurrent myocardial infarction,stroke,and cardiovascular mortality.
