A systematic review of patient-reported and economic outcomes: value to stakeholders in the decision-making process in patients with type 2 diabetes mellitus.

Abstract:

BACKGROUND:The need for an approach to measuring health results that incorporates patients' and payers' perspectives has generated a wide range of health care outcomes (HCOs), but it is yet unknown whether these HCOs are appropriate or valid for the health care decision-making process. OBJECTIVE:The goal of this study was to assess HCOs, patient-reported outcomes (PROs), and economic outcomes in terms of validity and appropriateness to health care decision making in type 2 diabetes mellitus (T2DM). METHODS:This systematic review of studies published between January 1, 1996, and November 1, 2010, comprised an electronic literature search of MEDLINE and Centre for Reviews and Dissemination databases. Studies included were clinical trials, observational studies, economic analyses, and studies on the development and validation of HCOs in T2DM in the adult population. HCOs were assessed and classified according to their relevance for decision makers in terms of feasibility for routine use, validity, sensitivity, reliability, understanding, and scope. RESULTS:Two independent reviewers screened 4497 citations. Of these, 281 potentially eligible full articles were retrieved, and 185 met the inclusion criteria. A total of 121 HCOs in T2DM were identified: 80 (66.1%) PROs and 41 (33.9%) economic outcomes. Only 44.6% of the outcomes assessed were appropriate and valid for health care decision making. Greater deficiencies in evidence were found for PROs (61.3%), followed by economic outcomes (43.9%). CONCLUSIONS:A large number of HCOs are being used in the health care decision-making process, but a significant proportion of these new outcomes have not been properly validated. Despite the fact that appropriate measures will depend on the specific needs of the decision makers, researchers need to use HCOs for which evidence of quality and appropriateness is available.

journal_name

Clin Ther

journal_title

Clinical therapeutics

authors

Vieta A,Badia X,Sacristán JA

doi

10.1016/j.clinthera.2011.07.013

subject

Has Abstract

pub_date

2011-09-01 00:00:00

pages

1225-45

issue

9

eissn

0149-2918

issn

1879-114X

pii

S0149-2918(11)00505-4

journal_volume

33

pub_type

杂志文章,评审
  • Utilization patterns of antihypertensive drugs among the chronic kidney disease population in the United States: a cross-sectional analysis of the national health and nutrition examination survey.

    abstract:PURPOSE:Antihypertensive drugs are prescribed to patients with chronic kidney disease (CKD) for their cardioprotective and renoprotective effects. Nationally representative information on the use of antihypertensive drugs among CKD patients is limited. The purpose of this study was to assess the utilization patterns of...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章

    doi:10.1016/j.clinthera.2014.11.011

    authors: Sonawane KB,Qian J,Hansen RA

    更新日期:2015-01-01 00:00:00

  • Radiotherapy during pregnancy: effects on fetuses and neonates.

    abstract::To optimize the efficacy of radiotherapy for cancer patients who are pregnant, the following factors must be considered: the potential effects of the therapy on fetuses and neonates, the stage and prognosis of the mother's disease, and the possible risks to the patient of restricting cancer treatment. Malformations an...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章

    doi:10.1016/s0149-2918(97)80101-4

    authors: Nakagawa K,Aoki Y,Kusama T,Ban N,Nakagawa S,Sasaki Y

    更新日期:1997-07-01 00:00:00

  • Electrical Muscle Stimulation Induces an Increase of VEGFR2 on Circulating Hematopoietic Stem Cells in Patients With Diabetes.

    abstract:PURPOSE:External electric muscle stimulation (EMS) of the thigh muscles was found to reduce pain resulting from diabetic neuropathy (DN), a vascular complication of diabetes. This study investigated circulating hematopoietic stem cells (HSCs) after EMS treatment. Impaired function of HSCs and the subpopulation endothel...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章

    doi:10.1016/j.clinthera.2017.05.340

    authors: Hidmark A,Spanidis I,Fleming TH,Volk N,Eckstein V,Groener JB,Kopf S,Nawroth PP,Oikonomou D

    更新日期:2017-06-01 00:00:00

  • Secondary immunodeficiencies and stem cell transplantation: issues of administration and safety of intravenous immunoglobulin.

    abstract::This article reviews the administration, efficacy, and safety of prophylactic intravenous immunoglobulin in patients with secondary immunodeficiency and those undergoing allogeneic bone marrow transplantation. Associated infections in these immunosuppressed patients are examined as they relate to transfusion-associate...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章

    doi:10.1016/s0149-2918(96)80204-9

    authors: Sullivan KM

    更新日期:1996-01-01 00:00:00

  • Use of direct thrombin inhibitors in acute coronary syndrome.

    abstract:OBJECTIVE:This paper examines the rationale for using direct thrombin inhibitors in the management of acute coronary syndrome (ACS). BACKGROUND:With traditional management of ACS using aspirin and unfractionated heparin (UH), refractory angina and new myocardial infarction (MI) continue to develop. Growing understandi...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章,meta分析

    doi:10.1016/S0149-2918(00)80065-X

    authors: Nemergut C,Cheng JW

    更新日期:2000-08-01 00:00:00

  • Progression to insulin for patients with diabetes mellitus using the Texas Medicaid database.

    abstract:BACKGROUND:Patients newly diagnosed with type 2 diabetes mellitus generally initiate therapy with either metformin [Met] or a sulfonylurea [SU] drug, followed by the addition of a second agent (Met, an SU drug, or a thiazolidinedione [TZD] drug) if the diabetes is not well controlled. If necessary, the usual third line...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章

    doi:10.1016/j.clinthera.2011.10.018

    authors: Rascati KL,Richards KM,Lopez D,Cheng LI,Wilson JP

    更新日期:2011-12-01 00:00:00

  • Management of refractory essential thrombocythemia with anagrelide in a patient undergoing hemodialysis.

    abstract:BACKGROUND:Management of essential thrombocythemia (ET) in high-risk patients is difficult because high platelet numbers can lead to vascular occlusive events and bleeding. Therapeutic interventions in ET are limited to hydroxyurea and anagrelide; however, in Europe, anagrelide is contraindicated in patients with chron...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章

    doi:10.1016/j.clinthera.2009.11.006

    authors: Mesquita Mdo C,Sol EB,Malarme M,Noubouossie D,Demulder AC

    更新日期:2009-11-01 00:00:00

  • Granisetron versus granisetron/dexamethasone combination for the treatment of nausea, retching, and vomiting after major gynecologic surgery: a randomized, double-blind study.

    abstract:BACKGROUND:Granisetron, a selective 5-hydroxytryptamine3 antagonist, is effective for the treatment of patients with postoperative nausea and vomiting. Dexamethasone decreases chemotherapy-induced emesis when added to an antiemetic regimen. OBJECTIVE:This study compared the efficacy of granisetron alone with granisetr...

    journal_title:Clinical therapeutics

    pub_type: 临床试验,杂志文章,随机对照试验,收录出版

    doi:10.1016/s0149-2918(03)80092-9

    authors: Fujii Y,Tanaka H

    更新日期:2003-02-01 00:00:00

  • Pharmacokinetic properties of single-dose loratadine and ambroxol alone and combined in tablet formulations in healthy men.

    abstract:BACKGROUND:Due to Mexico's complicated socioeconomic environment, causing a high occurrence of >1 person sharing a single room, respiratory conditions are spread easily. Respiratory conditions are the main reason for consultation with a physician. The most frequent symptoms are throat soreness and cough; therefore, a n...

    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(03)80215-1

    authors: Villacampa J,Alcántar F,Rodríguez JM,Morales JM,Herrera J,Rosete R

    更新日期:2003-08-01 00:00:00

  • Application of concentration ratios to analyze the phenomenon of "next-door" pharmacy in Taiwan.

    abstract:BACKGROUND:In Taiwan, a policy of separation of prescribing and dispensing practices of practitioners at Western medical and dental clinics was implemented on an incremental basis in 1997. The purpose of this policy was to promote pharmacists' autonomy and increase the transparency and safety of prescribing medications...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章

    doi:10.1016/j.clinthera.2006.08.005

    authors: Ji Chen T,Chou LF,Hwang SJ

    更新日期:2006-08-01 00:00:00

  • Pharmacokinetic bridging approach for developing biologics-delivery devices: a case study with a golimumab autoinjector.

    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

    authors: Xu Z,Marciniak SJ Jr,Frederick B,Kim L,Zhuang Y,Davis HM,Zhou H

    更新日期:2015-02-01 00:00:00

  • Cost-minimization analysis of simvastatin versus atorvastatin for maintenance therapy in patients with coronary or peripheral vascular disease.

    abstract:BACKGROUND:Previous health economic studies have demonstrated the cost-effectiveness of simvastatin in the treatment of coronary heart disease (CHD) based on clinical results of the Scandinavian Simvastatin Survival Study. A prior analysis evaluated the "cost of getting to goal," but ignored all costs after titration. ...

    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)80010-2

    authors: Attanasio E,Russo P,Allen SE

    更新日期:2001-02-01 00:00:00

  • Bioavailability of three rufinamide oral suspensions compared with the marketed 400-mg tablet formulation: results from a randomized-sequence, open-label, four-period, four-sequence crossover study in healthy subjects.

    abstract:BACKGROUND:Rufinamide is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in patients aged ≥4 years. OBJECTIVES:The primary purpose of this study was to compare the relative bioavailability and other pharmacokinetics of rufinamide administered as a 400-mg tablet formulation (r...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.clinthera.2011.01.016

    authors: Critchley DJ,Aluri J,Boyd P,Whayman M,Narurkar M,Delargy H,Bibbiani F

    更新日期:2011-01-01 00:00:00

  • The effects of intramuscular interferon beta-Ia in patients at high risk for development of multiple sclerosis: a post hoc analysis of data from CHAMPS.

    abstract:BACKGROUND:In the Controlled High Risk Subjects Avonex Multiple Sclerosis Prevention Study (CHAMPS), intramuscular (IM) interferon beta-1a (IFNbeta-1a) delayed the development of clinically definite multiple sclerosis (CDMS) in patients with a single demyelinating event who had magnetic resonance imaging (MRI) evidence...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章

    doi:10.1016/s0149-2918(03)80339-9

    authors: O'Connor P,CHAMPS.

    更新日期:2003-11-01 00:00:00

  • Medicare Part D research highlights and policy updates, 2013: impact and insights.

    abstract:BACKGROUND:Since its implementation in 2006, Medicare Part D has evolved from a program that offered basic access to covered drugs for beneficiaries to one that has the potential to affect patient outcomes. OBJECTIVES:The purpose of this article was to highlight key research findings on Medicare Part D published in 20...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章

    doi:10.1016/j.clinthera.2013.02.024

    authors: Stubbings J,Lau DT

    更新日期:2013-04-01 00:00:00

  • New insights and treatments: opiate withdrawal and cocaine addiction.

    abstract::Basic research in the neurosciences has led to a theory of opiate withdrawal involving endogenous opioid peptides and hyperactive norepinephrine neurons. This theory predicts the efficacy of clonidine, a nonopiate agent, in the management of opiate withdrawal. Clonidine, which offers numerous advantages over methadone...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章,评审

    doi:

    authors: Gold MS,Dackis CA

    更新日期:1984-01-01 00:00:00

  • The role of losartan in the management of patients with heart failure.

    abstract:BACKGROUND:Heart failure places a burden on patients and health care systems worldwide. Although the advent of angiotensin-converting enzyme (ACE) inhibitors markedly improved management of this chronic disorder, treatment is still not optimal, and morbidity and mortality remain high. OBJECTIVE:This review summarizes ...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章,meta分析,评审

    doi:10.1016/s0149-2918(01)80120-x

    authors: Dickstein K

    更新日期:2001-09-01 00:00:00

  • Antibiotic prescribing in ambulatory care settings for adults with colds, upper respiratory tract infections, and bronchitis.

    abstract:BACKGROUND:Imprudent prescribing of antibiotics for patients with colds, upper respiratory tract infections (URIs), and bronchitis may contribute to antibiotic resistance and waste economic resources. OBJECTIVE:The purpose of this study was to determine the antibiotic prescribing rate for adults diagnosed with colds, ...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章

    doi:10.1016/s0149-2918(02)85013-5

    authors: Cantrell R,Young AF,Martin BC

    更新日期:2002-01-01 00:00:00

  • Efficacy of GLP-1 receptor agonists and DPP-4 inhibitors: meta-analysis and systematic review.

    abstract:BACKGROUND:Considerable clinical data on the treatment of type 2 diabetes with incretin-based therapies (glucagon-like peptide 1 receptor agonists [GLP-1RAs] and dipeptidyl-peptidase IV [DPP-4] inhibitors) are available. OBJECTIVE:This meta-analysis was performed to support the understanding of the overall evidence by...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章,meta分析,评审

    doi:10.1016/j.clinthera.2012.04.013

    authors: Aroda VR,Henry RR,Han J,Huang W,DeYoung MB,Darsow T,Hoogwerf BJ

    更新日期:2012-06-01 00:00:00

  • Cost-effectiveness of escitalopram in major depressive disorder in the Dutch health care setting.

    abstract:OBJECTIVE:This study assessed the cost-effectiveness of escitalopram for the treatment of depression in the Netherlands from a societal perspective. METHODS:A decision tree model was constructed using decision analytical techniques. Data sources included published literature, clinical trials, official price/tariff lis...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章

    doi:10.1016/j.clinthera.2012.04.006

    authors: Nuijten MJ,Brignone M,Marteau F,den Boer JA,Hoencamp E

    更新日期:2012-06-01 00:00:00

  • Type 2 Diabetes, Hypoglycemia, and Basal Insulins: Ongoing Challenges.

    abstract::Hypoglycemia in people with insulin-treated type 2 diabetes can be a limiting factor for management and a barrier to optimizing glycemic control. Even mild episodes of hypoglycemia can affect an individual's quality of life, and fear of hypoglycemia can lead to underinsulinization. This article explores the prevalence...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章,评审

    doi:10.1016/j.clinthera.2016.09.020

    authors: Blumer I,Clement M

    更新日期:2017-08-01 00:00:00

  • Nonadherence to oral linezolid after hospitalization: a retrospective claims analysis of the incidence and consequence of claim reversals.

    abstract:BACKGROUND:Linezolid is available in an oral as well as an intravenous formulation. It is an oxazolidinone antibiotic and is effective in treating resistant gram-positive organisms such as methicillin-resistant Staphylococcus aureus and multidrug-resistant Streptococcus pneumoniae. OBJECTIVES:The goals of this study w...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章

    doi:10.1016/S0149-2918(10)80027-X

    authors: Ball AT,Xu Y,Sanchez RJ,Shelbaya A,Deminski MC,Nau DP

    更新日期:2010-12-01 00:00:00

  • Effects of losartan and candesartan monotherapy and losartan/hydrochlorothiazide combination therapy in patients with mild to moderate hypertension. Losartan Trial Investigators.

    abstract:OBJECTIVE:The goal of this multicenter, double-blind, randomized, parallel-group study was to compare the effects of losartan potassium (hereafter referred to as losartan), candesartan cilexitil (hereafter referred to as candesartan), and losartan/hydrochlorothiazide (HCTZ) in patients with mild to moderate hypertensio...

    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)83062-3

    authors: Manolis AJ,Grossman E,Jelakovic B,Jacovides A,Bernhardi DC,Cabrera WJ,Watanabe LA,Barragan J,Matadamas N,Mendiola A,Woo KS,Zhu JR,Mejia AD,Bunt T,Dumortier T,Smith RD

    更新日期:2000-10-01 00:00:00

  • New methods for the detection of Chlamydia trachomatis.

    abstract::The increasing worldwide recognition of the deleterious sequelae of Chlamydia trachomatis urogenital tract infections makes rapid, inexpensive diagnostic tests a high priority. Cell culture, still the standard for all other methods, is only 90% sensitive. Direct fluorescent antibody (FA) tests use highly specific mono...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章

    doi:

    authors: Thompson SE

    更新日期:1986-01-01 00:00:00

  • Effects of simvastatin on the lipid profile and attainment of low-density lipoprotein cholesterol goals when added to thiazolidinedione therapy in patients with type 2 diabetes mellitus: A multicenter, randomized, double-blind, placebo-controlled trial.

    abstract:BACKGROUND:Coronary heart disease is the major cause of mortality in individuals with diabetes mellitus (DM). Given the increasingly aggressive low-density lipoprotein cholesterol (LDL-C) goals for patients with DM set by the National Cholesterol Education Program Adult Treatment Panel III and the American Diabetes Ass...

    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(04)90033-1

    authors: Lewin AJ,Kipnes MS,Meneghini LF,Plotkin DJ,Perevozskaya IT,Shah S,Maccubbin DL,Mitchel YB,Tobert JA,Simvastatin\/Thiazolidinedione Study Group.

    更新日期:2004-03-01 00:00:00

  • Adverse effects of benzalkonium chloride on the nasal mucosa: allergic rhinitis and rhinitis medicamentosa.

    abstract::Prolonged, repeated use of nasal decongestants for symptomatic relief of allergic rhinitis often results in rhinitis medicamentosa (RM), a condition involving "rebound swelling" and additional congestion. Most decongestant sprays contain the preservative benzalkonium chloride (BKC), which causes toxic reactions in the...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章,评审

    doi:10.1016/S0149-2918(99)80053-8

    authors: Graf P

    更新日期:1999-10-01 00:00:00

  • Effectiveness and tolerability of zafirlukast for the treatment of asthma in children.

    abstract:OBJECTIVE:This study was undertaken to examine the dose-response relationship of zafirlukast (5 to 40 mg BID) and to assess the efficacy and tolerability of the 10-mg BID dose in school-aged children with mild to moderate asthma. BACKGROUND:The efficacy and tolerability of zafirlukast, an oral leukotriene-receptor ant...

    journal_title:Clinical therapeutics

    pub_type: 临床试验,杂志文章,多中心研究

    doi:10.1016/S0149-2918(00)90007-9

    authors: Pearlman DS,Lampl KL,Dowling PJ Jr,Miller CJ,Bonuccelli CM

    更新日期:2000-06-01 00:00:00

  • Economic evaluation of zuclopenthixol acetate compared with injectable haloperidol in schizophrenic patients with acute psychosis.

    abstract::Zuclopenthixol acetate is a rapid-acting, injectable neuroleptic drug with a duration of action that allows for administration once every 2 to 3 days, in contrast to injectable haloperidol, which may require administration more than once daily. To assess the place of zuclopenthixol acetate in the treatment of acute ep...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章

    doi:10.1016/s0149-2918(97)80120-8

    authors: Laurier C,Kennedy W,Lachaine J,Gariepy L,Tessier G

    更新日期:1997-03-01 00:00:00

  • Alendronate and raloxifene use related to cardiovascular diseases: differentiation by different dosing regimens of alendronate.

    abstract:BACKGROUND:Bisphosphonates are the class of medication used most widely to treat osteoporosis. Since an article reported that patients who used zoledronic acid, a bisphosphonate, had a higher proportion of atrial fibrillation (AF) in 2007, the issue of bisphosphonates and AF has become a growing concern. Due to the wid...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章

    doi:10.1016/j.clinthera.2011.07.012

    authors: Lu PY,Hsieh CF,Tsai YW,Huang WF

    更新日期:2011-09-01 00:00:00

  • Clinical and Economic Outcomes Associated With the Timing of Initiation of Basal Insulin in Patients With Type 2 Diabetes Mellitus Previously Treated With Oral Antidiabetes Drugs.

    abstract:PURPOSE:In patients with type 2 diabetes mellitus (T2DM) not achieving glycemic targets using oral antidiabetes drugs (OADs), studies suggest that timely insulin initiation has clinical benefits. Insulin initiation at the early versus late stage of disease progression has not been explored in detail. This retrospective...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章

    doi:10.1016/j.clinthera.2015.11.011

    authors: Levin P,Zhou S,Durden E,Farr AM,Gill J,Wei W

    更新日期:2016-01-01 00:00:00