Abstract:
BACKGROUND:In this era of evidence-based medicine, clinicians require a comprehensive range of well-designed studies to support prescribing decisions and patient management. In recent years, data from observational studies have become an increasingly important source of evidence because of improvements in observational-study methods and advances in statistical analysis. OBJECTIVE:This article reviews the current literature and reports some of the key studies indicating that observational studies can both complement and build on the evidence base established by randomized controlled trials (RCTs). METHODS:A literature search using the MEDLINE/PubMed database (years: 1966-present) was carried out using the search terms observational or observational study(ies), historical control, nonrandomized, and postmarketing surveillance. All references comparing observational studies with randomized controlled trials were obtained and reviewed and were also hand-checked for studies not identified in the database searches. RESULTS:Observational studies play an important role in investigating treatment outcomes. Data from large observational studies can clarify the tolerability profile of marketed medicines. In particular, observational studies can be of benefit in the study of large, heterogeneous patient populations with complex, chronic diseases such as diabetes mellitus. Observational studies have played a key role in supporting the results of Phase III studies of insulin analogues for the treatment of patients with type 1 and type 2 diabetes. Future observational studies in the field of diabetes such as PREDICTIVE (Predictable Results and Experience in Diabetes through Intensification and Control to Target: an International Variability Evaluation) and IMPROVE will further our understanding of this global pandemic. CONCLUSIONS:Well-designed observational studies can play a key role in supporting the evidence base for drugs and therapies. Current evidence suggests that observational studies can be conducted using the same exacting and rigorous standards as are used for RCTs. The observational study design should be considered as a complementary rather than a rival analytic technique.
journal_name
Clin Therjournal_title
Clinical therapeuticsauthors
Ligthelm RJ,Borzì V,Gumprecht J,Kawamori R,Wenying Y,Valensi Pdoi
10.1016/j.clinthera.2007.07.004subject
Has Abstractpub_date
2007-06-01 00:00:00pages
1284-92issue
6 Pt 1eissn
0149-2918issn
1879-114Xpii
S0149-2918(07)00184-1journal_volume
29pub_type
杂志文章,评审abstract::In its clinical assessment of the respiratory syncytial virus (RSV)-specific monoclonal antibody palivizumab, the IMpact-RSV Study Group demonstrated a reduction in hospitalizations for RSV-related lower respiratory tract infection in infants who received prophylaxis compared with infants who did not receive prophylax...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/S0149-2918(00)88326-5
更新日期:1999-04-01 00:00:00
abstract:BACKGROUND:Endotracheal intubation and mechanical ventilation are major components of routine intensive care for very low birth weight newborns and sick full-term newborns. These procedures are associated with physiologic, biochemical, and clinical responses indicating pain and stress in the newborn. Most neonates rece...
journal_title:Clinical therapeutics
pub_type: 杂志文章,meta分析,评审
doi:10.1016/j.clinthera.2005.06.019
更新日期:2005-06-01 00:00:00
abstract::Twenty-five patients with typhoid fever, who were resistant to amoxicillin and chloramphenicol, were successfully treated with ofloxacin. Ofloxacin was administered at a dosage of 200 mg three times daily for 7 to 10 days. In a few seriously ill patients, a dosage of 400 mg three times daily for 3 days, followed by 20...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章
doi:
更新日期:1994-09-01 00:00:00
abstract:BACKGROUND:The Clinical Brain Disorders Branch Sibling Study data set was initiated in 1996 to examine genetic associations and to identify biological traits associated with susceptibility gene effects. Characterizing genes--and translating their effects on brain development and function--has potential implications for...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/j.clinthera.2005.07.016
更新日期:2005-01-01 00:00:00
abstract:BACKGROUND:Olanzapine is a psychotropic agent that belongs to the thienobenzodiazepine class. OBJECTIVE:The aim of this study was to assess the bioequivalence of 2 commercial 10-mg tablet formulations of olanzapine by statistical analysis of the pharmacokinetic parameters C(max), AUC from 0 to 72 hours after dosing (A...
journal_title:Clinical therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.clinthera.2009.03.008
更新日期:2009-03-01 00:00:00
abstract::The effects of long-term aprindine administration on cardiac function were clinically investigated in seven patients with supraventricular or ventricular arrhythmias associated with organic heart disease. Three patients had normal cardiac function and four had various degrees of cardiac dysfunction before treatment wi...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:
更新日期:1984-01-01 00:00:00
abstract:PURPOSE:The goal of this study was to assess the effect of glucagon-like peptide-1 receptor agonists (GLP-1 RAs) on lipid profiles in patients with type 2 diabetes. METHODS:The MEDLINE, Embase, Cochrane Library, and ClinicalTrials.gov databases were searched from inception through October 31, 2013. Randomized controll...
journal_title:Clinical therapeutics
pub_type: 杂志文章,meta分析,评审
doi:10.1016/j.clinthera.2014.11.008
更新日期:2015-01-01 00:00:00
abstract::The objective of this 12-week, double-masked, randomized, multicenter study was to compare the elastoviscous properties of a high-molecular-weight viscosupplement, hylan G-F 20 (polymer concentration, 0.8%), with those of a lower-molecular-weight hyaluronan (LMW HA) product (polymer concentration, 1%) and to determine...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:10.1016/s0149-2918(00)80010-7
更新日期:1999-09-01 00:00:00
abstract::The field of rheumatology has made major contributions to medicine through the identification of cellular and molecular targets and with the development of therapies for the treatment of an impressive range of immune-mediated rheumatic diseases. In recent years new milestones have been achieved. These include the reco...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2019.04.014
更新日期:2019-07-01 00:00:00
abstract::We investigated the usefulness of the C64 quantitative tuning fork in assessing vibratory sensation in patients with diabetic neuropathy. The vibratory sensation scores determined by using the C64 quantitative tuning fork were significantly correlated with severity of subjective symptoms of numbness, cold, desensitiza...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:
更新日期:1994-11-01 00:00:00
abstract:BACKGROUND:Due to the emergence of community-associated strains, the prevalence of invasive methicillin-resistant Staphylococcus aureus (MRSA) infections has increased substantially in pediatric patients. A vancomycin AUC(0-24)/MIC index >400 best predicts treatment outcomes for invasive MRSA infection in adults. Data ...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2010.03.005
更新日期:2010-03-01 00:00:00
abstract:BACKGROUND:Since the recognition that asthma is characterized by extensive inflammation of the airways, the use of inhaled corticosteroids (ICSs) as controller therapy has become central to successful disease management. As the prevalence of asthma increases worldwide, there is concern about increasing numbers of patie...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/s0149-2918(03)80302-8
更新日期:2003-01-01 00:00:00
abstract:BACKGROUND:Therapeutic proteins have revolutionized the treatment of many diseases. In the near future, many more therapeutic proteins are likely to become available for an increasingly wide range of indications. OBJECTIVES:This article reviews the incidence, causes, and consequences of formation of antibodies to ther...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/s0149-2918(02)80075-3
更新日期:2002-11-01 00:00:00
abstract:PURPOSE:This Phase 1 pharmacokinetic (PK) comparability study in healthy subjects was performed to compare the PK properties and tolerability of single-dose golimumab 100 mg delivered subcutaneously by an autoinjector device or by a standard needle and syringe that had been used for the subcutaneous (SC) delivery of go...
journal_title:Clinical therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.clinthera.2014.09.012
更新日期:2015-02-01 00:00:00
abstract:PURPOSE:The recommended first-line treatment for young children infected with HIV includes the liquid formulation of the co-formulated protease inhibitors lopinavir/ritonavir (Kaletra® [Abbott Laboratories, Chicago, Illinois]). Clinical reports indicate that some children readily accept the taste of Kaletra, whereas ot...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2017.08.012
更新日期:2017-10-01 00:00:00
abstract::After a brief analysis of the financial and health care motives that have led to the current boom in disease management (DM) programs, this paper discusses the pragmatic realities of a particular DM program for treating asthma. A model of the institutional structures necessary for DM to work is presented, emphasizing ...
journal_title:Clinical therapeutics
pub_type:
doi:10.1016/s0149-2918(96)80089-0
更新日期:1996-11-01 00:00:00
abstract:BACKGROUND:Previous evaluations of the Southwestern Ontario (SSWO) cohort have reported that hypertension (HTN) and dyslipidemia (DYS) are undertreated illnesses; however, concomitant treatment is unknown. OBJECTIVES:The objectives of this study were to assess the prevalence and associated treatment of HTN and DYS in ...
journal_title:Clinical therapeutics
pub_type: 杂志文章,多中心研究
doi:10.1016/j.clinthera.2008.06.004
更新日期:2008-06-01 00:00:00
abstract:PURPOSE:To evaluate the safety and efficacy of glycoprotein IIb/IIIa inhibitors (GPIs) in patients with acute myocardial infarction (AMI) in the presence of intracoronary thrombus undergoing percutaneous coronary interventions. METHODS:This study, performed from January 1, 2004, to November 31, 2014, at 55 centers in ...
journal_title:Clinical therapeutics
pub_type: 信件,多中心研究
doi:10.1016/j.clinthera.2020.02.022
更新日期:2020-05-01 00:00:00
abstract:BACKGROUND:Clarithromycin is a semisynthetic macrolide that exhibits broad-spectrum activity against gram-positive, gram-negative, and atypical respiratory tract and skin/skin structure pathogens, Mycobacterium species, and Helicobacter pylori. It is indicated for the treatment of a wide variety of respiratory and derm...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1016/s0149-2918(01)80060-6
更新日期:2001-04-01 00:00:00
abstract:BACKGROUND:Diabetes mellitus (DM) is a powerful independent risk factor for multivessel, diffuse coronary artery disease (CAD). The optimal coronary revascularization strategy in DM is not clearly defined, but past trials have suggested an advantage for coronary artery bypass grafting (CABG). Recently, the Future Revas...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/j.clinthera.2013.07.427
更新日期:2013-08-01 00:00:00
abstract::In the past decade surgeons and sex therapists have given an enormous amount of attention to and assistance for men's sexual problems. Now pharmacological help, although controversial, is also available, both informally and from physicians. Sexual disorders afflict men in all walks of life, be they executives or windo...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:
更新日期:1987-01-01 00:00:00
abstract:BACKGROUND:Valproic acid has been associated with a highly variable intersubject absorptive phase; therefore, magnesium salt (magnesium valproate [MgV]) was developed to diminish variation during enteric absorption. OBJECTIVES:The aims of this study were to assess the pharmacokinetics of single oral doses of MgV 500-m...
journal_title:Clinical therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.clinthera.2009.09.016
更新日期:2009-09-01 00:00:00
abstract:OBJECTIVE:The aim of this study was to determine the time to onset of pain relief from a single dose of a tablet formulation of paracetamol (acetaminophen) containing sodium bicarbonate (PSC). METHODS:A single oral dose of PSC or placebo was randomly administered to patients with acute sore throat under double-blind c...
journal_title:Clinical therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.clinthera.2006.09.009
更新日期:2006-09-01 00:00:00
abstract:BACKGROUND:The off-label use of beta-blockers might be prevalent, but no studies have provided empiric data on the off-label use based on utilization data. OBJECTIVE:This secondary data analysis was conducted to describe the trends of off-label use of beta-blockers among ambulatory visits made to office-based physicia...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2006.10.015
更新日期:2006-10-01 00:00:00
abstract:BACKGROUND:Numerous reviews and meta-analyses of the antidepressant literature in major depressive disorders (MDD), both acute and maintenance, have been published, some claiming that antidepressants are mostly ineffective and others that they are mostly effective, in either acute or maintenance treatment. OBJECTIVE:T...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/j.clinthera.2011.11.019
更新日期:2011-12-01 00:00:00
abstract:BACKGROUND:Pitavastatin, a fully synthetic β-hydroxy-β-methylglutaryl-coenzyme A reductase inhibitor, is potent for the treatment of primary hyperlipidemia and mixed dyslipidemia. Recently, the original product and some generic products of pitavastatin calcium have become available in China. However, the intrasubject v...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2014.06.021
更新日期:2014-09-01 00:00:00
abstract:PURPOSE:Megestrol acetate oral suspension is an appetite stimulant indicated for cachexia. It is available in a conventional formulation and as a nanocrystal dispersion. The aim of this study was to compare the tolerability and pharmacokinetics of these formulations under fed conditions in healthy Korean volunteers. M...
journal_title:Clinical therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.clinthera.2014.09.022
更新日期:2015-02-01 00:00:00
abstract:BACKGROUND:Glucagon-like peptide (GLP-1) is a neuroendocrine hormone that increases blood glucose and is a drug target for treatment of type 2 diabetes. Liraglutide, a subcutaneous, once-daily GLP-1 agonist, is approved for the treatment of type 2 diabetes in the United States and Europe. It also has been studied for w...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/j.clinthera.2011.06.004
更新日期:2011-07-01 00:00:00
abstract:BACKGROUND:Ezetimibe (EZE) is a cholesterol-lowering drug that inhibits absorption of dietary and biliary cholesterol across the intestinal wall without affecting absorption of bile acids, fatty acids, fat-soluble vitamins, or triglycerides. It has a complementary mechanism of action to the statins, which inhibit chole...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:10.1016/j.clinthera.2005.02.011
更新日期:2005-02-01 00:00:00
abstract::Exposure of the eye to airborne particles in patients predisposed to allergy often results in the signs and symptoms of allergic conjunctivitis such as red, itchy eyes and ocular discharge. The mediators of these allergic symptoms include histamine, inflammatory substances such as prostaglandins, and other products of...
journal_title:Clinical therapeutics
pub_type: 杂志文章,多中心研究
doi:10.1016/0149-2918(95)80066-2
更新日期:1995-09-01 00:00:00