By L. Ramon. University of Kentucky. 2018.

Colhoun purchase chloramphenicol 250mg, 2004 Yes Yes Yes Yes Yes Yes (CARDS) CARE Yes Yes Yes Yes Yes Yes 1996 Den Hartog Yes Not reported Some differences Yes Yes Not reported (Pilot Study) Statins Page 317 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 6 generic 250 mg chloramphenicol with visa. Internal validity of controlled clinical trials Patient Different or overall high Study or Author unaware of Intention-to-treat Maintained Reported attrition discount 250 mg chloramphenicol, crossovers, loss to follow- Year treatment? Arntz et al, 2000 Yes Yes- able to calculate Yes Attrition yes, others no Yes: 9 patients in control (L-CAD) group withdrew consent after learning treatment assignment. ASCOT Yes Yes NR Attrition unclear; others NR No Cannon et al, 2004 Yes Not clear Yes Attrition yes, others no No. No (CARDS) able to calculate CARE Yes Yes Yes Attrition: yes, crossovers-no, adherence-no, No 1996 and contamination-yes Den Hartog Yes Yes No Attrition yes, others no No, 2 placebo vs 0 prava (Pilot Study) lost to followup. High discontinuation rate (22%) and more placebo patients discontinued overall (26. Internal validity of controlled clinical trials Study or Author Score Year (good/ fair/ poor) Arntz et al, 2000 Fair (L-CAD) ASCOT Fair-Good Cannon et al, 2004 Fair (PROVE-IT) Colhoun, 2004 Good (CARDS) CARE Good 1996 Den Hartog Poor (Pilot Study) Statins Page 319 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 6. Internal validity of controlled clinical trials Study or Author Randomization Allocation Eligibility criteria Outcome assessors Care provider Year adequate? Heljic B, 2009 Method not reported Not reported Yes Yes NR NR Hogue J, 2008 Method not reported Not reported Yes Yes NR NR Holdaas NR Adequate; serially- Yes Yes Yes Yes numbered identical medication packs HPS NR Adequate; Unclear; "good balance" Yes Yes Yes centralized indicated; data NR Pederson, 2005 NR NR Yes Yes Yes No- open label, (IDEAL) blinded endpoint classification Statins Page 320 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 6. Internal validity of controlled clinical trials Patient Different or overall high Study or Author unaware of Intention-to-treat Maintained Reported attrition, crossovers, loss to follow- Year treatment? Heljic B, 2009 NR Unclear--not reported Unclear NR NR NR NR NR Hogue J, 2008 NR Unclear--not reported (5% Unclear Yes No in atorva arm vs 1. No (IDEAL) endpoint classification Statins Page 321 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 6. Internal validity of controlled clinical trials Study or Author Score Year (good/ fair/ poor) Heljic B, 2009 Poor Hogue J, 2008 Fair-Poor Holdaas Good HPS Good Pederson, 2005 Fair (IDEAL) Statins Page 322 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 6. Internal validity of controlled clinical trials Study or Author Randomization Allocation Eligibility criteria Outcome assessors Care provider Year adequate? Ridker P, 2008 Yes Yes Yes Yes Stated "double-blind" Stated "double-blind" JUPITER but no details but no details Liem et al, 2002 Method not reported Not reported Yes Yes States "double blind," Not reported (FLORIDA) but no details. LIPID Yes Not reported Yes Yes Yes Yes 1998 Nakamura et al, 2006 Yes, computer- Not reported Yes Yes Yes, endpoint Open-label MEGA generated list assessors were blinded and were reviewed by the endpoint committee. Schwartz et al, Method not reported Not reported Yes Yes Yes Yes 2001 (MIRACL) Thompson, 2004 Method not reported Not reported Higher total cholesterol in Yes Yes Yes (PACT) placebo group, more placebo patients on HRT, and more prava patients on anticoagulants. Asselbergs, 2004 Yes Not reported Appear similar Yes Yes No details given (PREVEND IT) Statins Page 323 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 6. Internal validity of controlled clinical trials Patient Different or overall high Study or Author unaware of Intention-to-treat Maintained Reported attrition, crossovers, loss to follow- Year treatment? Ridker P, 2008 Yes Yes Yes Attrition-yes, others-no No JUPITER Liem et al, 2002 States "double blind," Yes Yes Attrition and adherence yes, crossover and No (FLORIDA) but no details. Asselbergs, 2004 Yes Yes Yes Yes No (PREVEND IT) Statins Page 324 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 6. Internal validity of controlled clinical trials Study or Author Score Year (good/ fair/ poor) Ridker P, 2008 Good JUPITER Liem et al, 2002 Fair (FLORIDA) LIPID Good 1998 Nakamura et al, 2006 Fair MEGA Schwartz et al, Fair 2001 (MIRACL) Thompson, 2004 Fair-Poor (PACT) Asselbergs, 2004 Fair (PREVEND IT) Statins Page 325 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 6. Internal validity of controlled clinical trials Study or Author Randomization Allocation Eligibility criteria Outcome assessors Care provider Year adequate? Stone et al, 2005 NR NR atorva group higher weight Yes Yes Not specified (198 lbs vs 188 lbs control), otherwise similar. Wanner et al, 2005 Yes NR Yes Yes Yes Not specified (but described as double- blind) Statins Page 326 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 6. Internal validity of controlled clinical trials Patient Different or overall high Study or Author unaware of Intention-to-treat Maintained Reported attrition, crossovers, loss to follow- Year treatment? No numbers and reasons for numbers withdrawing withdrawal are given. Wanner et al, 2005 Not specified (but Yes Yes Attrition and adherence reported. No described as double- blind) Statins Page 327 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 6. Internal validity of controlled clinical trials Study or Author Score Year (good/ fair/ poor) PROSPER Good Sakamoto T, 2006 Fair-Poor Stone et al, 2005 Fair Wanner et al, 2005 Fair Statins Page 328 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 6. Internal validity of controlled clinical trials Study or Author Randomization Allocation Eligibility criteria Outcome assessors Care provider Year adequate? WOSCOPS, 1995 Yes Yes Yes Yes Yes Yes Xu K, 2007 NR NR Yes Yes NR NR Studies from Evidence Table 4: Post-revascularization LIPS NR Adequate; serially- No, more fluva patients with Yes Yes Yes numbered identical diabetes mellitus (14. Internal validity of controlled clinical trials Patient Different or overall high Study or Author unaware of Intention-to-treat Maintained Reported attrition, crossovers, loss to follow- Year treatment?

Direct analysis: The practice of using data from head-to-head trials to draw conclusions about the comparative effectiveness of drugs within a class or group discount chloramphenicol 250 mg mastercard. Results of direct analysis are the preferred source of data in Drug Effectiveness Review Project reports generic chloramphenicol 250 mg fast delivery. Dosage form: The physical form of a dose of medication buy chloramphenicol 250 mg without prescription, such as a capsule, injection, or liquid. The route of administration is dependent on the dosage form of a given drug. Various dosage forms may exist for the same compound, since different medical conditions may warrant different routes of administration. Dose-response relationship: The relationship between the quantity of treatment given and its effect on outcome. In meta-analysis, dose-response relationships can be investigated using meta- regression. Double-blind: The process of preventing those involved in a trial from knowing to which comparison group a particular participant belongs. While double-blind is a frequently used term Newer antiplatelet agents 65 of 98 Final Update 2 Report Drug Effectiveness Review Project in trials, its meaning can vary to include blinding of patients, caregivers, investigators, or other study staff. Double-dummy: The use of two placebos in a trial that match the active interventions when they vary in appearance or method of administrations (for example, when an oral agent is compared with an injectable agent). Effectiveness: The extent to which a specific intervention used under ordinary circumstances does what it is intended to do. Effectiveness outcomes: Outcomes that are generally important to patients and caregivers, such as quality of life, responder rates, number and length of hospitalizations, and ability to work. Data on effectiveness outcomes usually comes from longer-term studies of a “real-world” population. Effect size/estimate of effect: The amount of change in a condition or symptom because of a treatment (compared to not receiving the treatment). It is commonly expressed as a risk ratio (relative risk), odds ratio, or difference in risk. Efficacy: The extent to which an intervention produces a beneficial result under ideal conditions in a selected and controlled population. Equivalence level: The amount which an outcome from two treatments can differ but still be considered equivalent, as in an equivalence trial, or the amount which an outcome from treatment A can be worse than that of treatment B but still be considered noninferior, as in a noninferiority trial. Equivalence trial: A trial designed to determine whether the response to two or more treatments differs by an amount that is clinically unimportant. This lack of clinical importance is usually demonstrated by showing that the true treatment difference is likely to lie between a lower and an upper equivalence level of clinically acceptable differences. Exclusion criteria: The criteria, or standards, set out before a study or review. Exclusion criteria are used to determine whether a person should participate in a research study or whether an individual study should be excluded in a systematic review. Exclusion criteria may include age, previous treatments, and other medical conditions. External validity: The extent to which results provide a correct basis for generalizations to other circumstances. For instance, a meta-analysis of trials of elderly patients may not be generalizable to children. Studies are assumed to be measuring the same overall effect. Fixed-dose combination product: A formulation of two or more active ingredients combined in a single dosage form available in certain fixed doses. Forest plot: A graphical representation of the individual results of each study included in a meta- analysis and the combined result of the meta-analysis. The plot allows viewers to see the heterogeneity among the results of the studies. The results of individual studies are shown as squares centered on each study’s point estimate. A horizontal line runs through each square to show each study’s confidence interval—usually, but not always, a 95% confidence interval. The overall estimate from the meta-analysis and its confidence interval are represented as a diamond. The center of the diamond is at the pooled point estimate, and its horizontal tips show the confidence interval. Newer antiplatelet agents 66 of 98 Final Update 2 Report Drug Effectiveness Review Project Funnel plot: A graphical display of some measure of study precision plotted against effect size that can be used to investigate whether there is a link between study size and treatment effect. Half- life: The time it takes for the plasma concentration or the amount of drug in the body to be reduced by 50%.

Quick-relief medications for asthma Page 78 of 113 Final Report Update 1 Drug Effectiveness Review Project Appendix D purchase chloramphenicol 250 mg mastercard. Excluded studies Reasons for exclusion: 1 = Foreign language 2 = Outcome not included 3 = Drug not included 4 = Population not included a 5 = Wrong publication type b 6 = Wrong study design a Wrong publication type (letter with insufficient information purchase 250 mg chloramphenicol with mastercard, editorial purchase chloramphenicol 500mg mastercard, non-systematic review, case report, case series < 10 patients) b Wrong study design (placebo-controlled trial, active-controlled trial, sample size < 10 patients, focus on delivery method, dosing range study, LABA vs. SABA) Citation Exclusion Code A levalbuterol metered-dose inhaler (Xopenex HFA) for asthma. Bronchodilators in acute bronchial 3 asthma : a comparative study. Double blind controlled and randomized clinical trial. Treatment of asthma in pre- 6-DELIVERY school children with inhalation of terbutaline in Turbuhaler compared with Nebuhaler. Efficacy of salmeterol 5 versus alternative treatments in non-controlled asthmatic children. A systematic review of 5 risk factors associated with near-fatal and fatal asthma. Adverse effects of short-acting beta-agonists: potential 5 impact when anti-inflammatory therapy is inadequate: comment. American Lung Association Asthma Clinical Research, C. Regional lung function in asthmatics in 6-DESIGN remission, before and after fenoterol. Bronchodilator treatment and 6 deaths from asthma: case-control study. Inhaled and oral 6 bronchodilator therapy in exercise induced asthma. Quick-relief medications for asthma Page 79 of 113 Final Report Update 1 Drug Effectiveness Review Project Citation Exclusion Code Angelici E, Delfino M, Carlone S, Serra P, Fineberg NS, Farber MO. SHORT bronchodilating effects of formoterol and albuterol delivered by hydrofluoroalkane pressurized metered-dose inhaler. Anticholinergic 5 bronchodilators versus beta -adrenoceptor agonists for stable chronic2 obstructive pulmonary disease. Appleton S, Poole P, Smith B, Cates C, Veale A, Bara A. Long-acting 6 beta -agonists for chronic obstructive pulmonary disease patients with2 poorly reversible airflow limitation. Protective effect of Duovent 6 versus salbutamol in long-term treatment. Variations of individual susceptibility to beta- 1 adrenergic and anticholinergic bronchodilator drugs. SHORT bronchodilation over 12 hours after inhaled formoterol: individual responses. Arvidsson P, Larsson S, Lofdahl CG, Melander B, Svedmyr N, 6-LONG VS. Inhaled formoterol during one year in asthma: a comparison with salbutamol. Arvidsson P, Larsson S, Lofdahl CG, Melander B, Wahlander L, 6-LONG VS. Formoterol, a new long-acting bronchodilator for inhalation. Routine nebulized ipratropium 6 and albuterol together are better than either alone in COPD. Avila-Castanon L, Casas-Becerra B, Del Rio-Navarro BE, Velazquez- 6-LONG VS. Quick-relief medications for asthma Page 80 of 113 Final Report Update 1 Drug Effectiveness Review Project Citation Exclusion Code Ayers ML, Mejia R, Ward J, Lentine T, Mahler DA. Effectiveness of 6 salmeterol versus ipratropium bromide on exertional dyspnoea in COPD. Experience with the inhalation of Berotec powder in 6 the treatment of asthma in children. Ventilatory capacity after bronchodilatation 6-DESIGN with a new beta-sympathomimetic substance. Nebulised salbutamol in treatment of acute asthma in 5 children. The effectiveness of nebulised salbutamol in the 6 management of acute asthma in children. Fenoterol inhalation powder in long-term 6-DESIGN therapy of bronchial asthma.

Risperidone in children with autism: randomized cheap 500mg chloramphenicol visa, placebo- controlled cheap chloramphenicol 500 mg online, double-blind study buy chloramphenicol 250mg fast delivery. Long-term effects of risperidone in children with autism spectrum disorders: a placebo discontinuation study. A placebo-controlled, fixed-dose study of aripiprazole in children and adolescents with irritability associated with autistic disorder. Aripiprazole in the treatment of irritability in children and adolescents with autistic disorder. A double-blind placebo-controlled pilot study of olanzapine in childhood/adolescent pervasive developmental disorder. Malone RP, Cater J, Sheikh RM, Choudhury MS, Delaney MA. Olanzapine versus haloperidol in children with autistic disorder: an open pilot study. Effect of aripiprazole on quality of life and caregiver strain in the treatment of irritability associated with autistic disorder (CN139- 178/179) [poster]. Paper presented at: 162nd American Psychiatric Association (APA) Annual Meeting; May 16-21, 2009; San Francisco, CA. Safety and tolerability of aripiprazole in the treatment of irritability associated with autistic disorder. Paper presented at: 162nd American Psychiatric Association (APA) Annual Meeting, 2009; San Francisco, CA. Miral S, Gencer O, Inal-Emiroglu FN, Baykara B, Baykara A, Dirik E. Risperidone versus haloperidol in children and adolescents with AD : a randomized, controlled, double-blind trial. Gencer O, Emiroglu FNI, Miral S, Baykara B, Baykara A, Dirik E. Comparison of long- term efficacy and safety of risperidone and haloperidol in children and adolescents with autistic disorder. Risperidone in the treatment of childhood autistic disorder: an open pilot study. Corson AH, Barkenbus JE, Posey DJ, Stigler KA, McDougle CJ. A Retrospective Analysis of Quetiapine in the Treatment of Pervasive Developmental Disorders. An open clinical trial of risperidone monotherapy in young children with autistic disorder. Risperidone treatment of children with autistic disorder: effectiveness, tolerability, and pharmacokinetic implications. Risperidone monotherapy in preschool children with pervasive developmental disorders. Atypical antipsychotic drugs Page 192 of 230 Final Report Update 3 Drug Effectiveness Review Project 526. An open trial of risperidone in young autistic children. An open-label trial of risperidone in children with autism. Open-label risperidone treatment of 6 children and adolescents with autism. NR163: Quetiapine open-label trial in children and adolescents with developmental disorders. Paper presented at: 156th Annual Meeting of the American Psychiatric Association May 17-22, 2003; San Francisco, California. Snyder R, Turgay A, Aman M, Binder C, Fisman S, Carroll A. Effects of risperidone on conduct and disruptive behavior disorders in children with subaverage IQs. Findling RI, McNamara NK, Branicky LA, Schluchter MD, Lemon E, Blumer JL. A double-blind pilot study of risperidone in the treatment of conduct disorder. Aman MG, De Smedt G, Derivan A, Lyons B, Findling RL. Double-blind, placebo- controlled study of risperidone for the treatment of disruptive behaviors in children with subaverage intelligence. Buitelaar JK, van der Gaag RJ, Cohen-Kettenis P, Melman CT. A randomized controlled trial of risperidone in the treatment of aggression in hospitalized adolescents with subaverage cognitive abilities. Reyes M, Buitelaar J, Toren P, Augustyns I, Eerdekens M. A randomized, double-blind, placebo-controlled study of risperidone maintenance treatment in children and adolescents with disruptive behavior disorders.