A Systematic Review of Quasi-Experimental Study Designs in the Fields of Infection Control and Antibiotic Resistance
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The Magic of Randomization Versus the Myth of Real-World Evidence
The new england journal of medicine Sounding Board The Magic of Randomization versus the Myth of Real-World Evidence Rory Collins, F.R.S., Louise Bowman, M.D., F.R.C.P., Martin Landray, Ph.D., F.R.C.P., and Richard Peto, F.R.S. Nonrandomized observational analyses of large safety and efficacy because the potential biases electronic patient databases are being promoted with respect to both can be appreciable. For ex- as an alternative to randomized clinical trials as ample, the treatment that is being assessed may a source of “real-world evidence” about the effi- well have been provided more or less often to cacy and safety of new and existing treatments.1-3 patients who had an increased or decreased risk For drugs or procedures that are already being of various health outcomes. Indeed, that is what used widely, such observational studies may in- would be expected in medical practice, since both volve exposure of large numbers of patients. the severity of the disease being treated and the Consequently, they have the potential to detect presence of other conditions may well affect the rare adverse effects that cannot plausibly be at- choice of treatment (often in ways that cannot be tributed to bias, generally because the relative reliably quantified). Even when associations of risk is large (e.g., Reye’s syndrome associated various health outcomes with a particular treat- with the use of aspirin, or rhabdomyolysis as- ment remain statistically significant after adjust- sociated with the use of statin therapy).4 Non- ment for all the known differences between pa- randomized clinical observation may also suf- tients who received it and those who did not fice to detect large beneficial effects when good receive it, these adjusted associations may still outcomes would not otherwise be expected (e.g., reflect residual confounding because of differ- control of diabetic ketoacidosis with insulin treat- ences in factors that were assessed only incom- ment, or the rapid shrinking of tumors with pletely or not at all (and therefore could not be chemotherapy). -
Adaptive Clinical Trials: an Introduction
Adaptive clinical trials: an introduction What are the advantages and disadvantages of adaptive clinical trial designs? How and why were Introduction adaptive clinical Adaptive clinical trial design is trials developed? becoming a hot topic in healthcare research, with some researchers In 2004, the FDA published a report arguing that adaptive trials have the on the problems faced by the potential to get new drugs to market scientific community in developing quicker. In this article, we explain new medical treatments.2 The what adaptive trials are and why they report highlighted that the pace of were developed, and we explore both innovation in biomedical science is the advantages of adaptive designs outstripping the rate of advances and the concerns being raised by in the available technologies and some in the healthcare community. tools for evaluating new treatments. Outdated tools are being used to assess new treatments and there What are adaptive is a critical need to improve the effectiveness and efficiency of clinical trials? clinical trials.2 The current process for developing Adaptive clinical trials enable new treatments is expensive, takes researchers to change an aspect a long time and in some cases, the of a trial design at an interim development process has to be assessment, while controlling stopped after significant amounts the rate of type 1 errors.1 Interim of time and resources have been assessments can help to determine invested.2 In 2006, the FDA published whether a trial design is the most a “Critical Path Opportunities -
A Case-Crossover Study of Sleep and Childhood Injury
A Case-Crossover Study of Sleep and Childhood Injury Francesca Valent, MD*; Silvio Brusaferro, MD*; and Fabio Barbone, MD, DrPH*‡ ABSTRACT. Objective. To evaluate the association n Italy (ϳ56 million inhabitants; 9 million chil- between sleep and wakefulness duration and childhood dren Ͻ15 years of age), ϳ500 children Ͻ15 years unintentional injury. of age are killed each year in unintentional inju- Study Design. Case-crossover study. I 1 ries. Homicides and suicides are much less frequent, Methods. Two hundred ninety-two injured children accounting for Ͻ10% of all fatal injuries among chil- who presented at the Children’s Emergency Center of dren.1 In Northern Italy, in 1995, injury mortality Udine, Italy, or their parents were interviewed after a rates (International Classification of Diseases, Ninth Re- structured questionnaire. Information was collected con- vision codes from 800 to 999) were 10 deaths/100 000 cerning sociodemographic variables, participant’s habits, and injury characteristics, including a brief description inhabitants under 1 year of age, 5/100 000 from 1 to of the accident dynamics. Sleep or wakefulness status of 4 years of age, and 6/100 000 from 5 to 14 years of the child was assessed retrospectively for each of the 48 age. Among infants, injury represented only 2% of hours before injury. For each child, we compared the 24 overall mortality, whereas in the 2 older age groups hours immediately before the injury (hours 1–24; case injuries accounted for 18% and 33% of all deaths, period) with hours 25 to 48 (control period). Nonparamet- respectively.2 Mortality, however, is just the tip of a ric tests were conducted to compare the difference of pyramid, where for each injury resulting in a death sleep duration between case and control periods. -
(Meta-Analyses of Observational Studies in Epidemiology) Checklist
MOOSE (Meta-analyses Of Observational Studies in Epidemiology) Checklist A reporting checklist for Authors, Editors, and Reviewers of Meta-analyses of Observational Studies. You must report the page number in your manuscript where you consider each of the items listed in this checklist. If you have not included this information, either revise your manuscript accordingly before submitting or note N/A. Reporting Criteria Reported (Yes/No) Reported on Page No. Reporting of Background Problem definition Hypothesis statement Description of Study Outcome(s) Type of exposure or intervention used Type of study design used Study population Reporting of Search Strategy Qualifications of searchers (eg, librarians and investigators) Search strategy, including time period included in the synthesis and keywords Effort to include all available studies, including contact with authors Databases and registries searched Search software used, name and version, including special features used (eg, explosion) Use of hand searching (eg, reference lists of obtained articles) List of citations located and those excluded, including justification Method for addressing articles published in languages other than English Method of handling abstracts and unpublished studies Description of any contact with authors Reporting of Methods Description of relevance or appropriateness of studies assembled for assessing the hypothesis to be tested Rationale for the selection and coding of data (eg, sound clinical principles or convenience) Documentation of how data were classified -
Quasi-Experimental Studies in the Fields of Infection Control and Antibiotic Resistance, Ten Years Later: a Systematic Review
HHS Public Access Author manuscript Author ManuscriptAuthor Manuscript Author Infect Control Manuscript Author Hosp Epidemiol Manuscript Author . Author manuscript; available in PMC 2019 November 12. Published in final edited form as: Infect Control Hosp Epidemiol. 2018 February ; 39(2): 170–176. doi:10.1017/ice.2017.296. Quasi-experimental Studies in the Fields of Infection Control and Antibiotic Resistance, Ten Years Later: A Systematic Review Rotana Alsaggaf, MS, Lyndsay M. O’Hara, PhD, MPH, Kristen A. Stafford, PhD, MPH, Surbhi Leekha, MBBS, MPH, Anthony D. Harris, MD, MPH, CDC Prevention Epicenters Program Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, Maryland. Abstract OBJECTIVE.—A systematic review of quasi-experimental studies in the field of infectious diseases was published in 2005. The aim of this study was to assess improvements in the design and reporting of quasi-experiments 10 years after the initial review. We also aimed to report the statistical methods used to analyze quasi-experimental data. DESIGN.—Systematic review of articles published from January 1, 2013, to December 31, 2014, in 4 major infectious disease journals. METHODS.—Quasi-experimental studies focused on infection control and antibiotic resistance were identified and classified based on 4 criteria: (1) type of quasi-experimental design used, (2) justification of the use of the design, (3) use of correct nomenclature to describe the design, and (4) statistical methods used. RESULTS.—Of 2,600 articles, 173 (7%) featured a quasi-experimental design, compared to 73 of 2,320 articles (3%) in the previous review (P<.01). Moreover, 21 articles (12%) utilized a study design with a control group; 6 (3.5%) justified the use of a quasi-experimental design; and 68 (39%) identified their design using the correct nomenclature. -
Epidemiology and Biostatistics (EPBI) 1
Epidemiology and Biostatistics (EPBI) 1 Epidemiology and Biostatistics (EPBI) Courses EPBI 2219. Biostatistics and Public Health. 3 Credit Hours. This course is designed to provide students with a solid background in applied biostatistics in the field of public health. Specifically, the course includes an introduction to the application of biostatistics and a discussion of key statistical tests. Appropriate techniques to measure the extent of disease, the development of disease, and comparisons between groups in terms of the extent and development of disease are discussed. Techniques for summarizing data collected in samples are presented along with limited discussion of probability theory. Procedures for estimation and hypothesis testing are presented for means, for proportions, and for comparisons of means and proportions in two or more groups. Multivariable statistical methods are introduced but not covered extensively in this undergraduate course. Public Health majors, minors or students studying in the Public Health concentration must complete this course with a C or better. Level Registration Restrictions: May not be enrolled in one of the following Levels: Graduate. Repeatability: This course may not be repeated for additional credits. EPBI 2301. Public Health without Borders. 3 Credit Hours. Public Health without Borders is a course that will introduce you to the world of disease detectives to solve public health challenges in glocal (i.e., global and local) communities. You will learn about conducting disease investigations to support public health actions relevant to affected populations. You will discover what it takes to become a field epidemiologist through hands-on activities focused on promoting health and preventing disease in diverse populations across the globe. -
A Guide to Systematic Review and Meta-Analysis of Prediction Model Performance
RESEARCH METHODS AND REPORTING A guide to systematic review and meta-analysis of prediction model performance Thomas P A Debray,1,2 Johanna A A G Damen,1,2 Kym I E Snell,3 Joie Ensor,3 Lotty Hooft,1,2 Johannes B Reitsma,1,2 Richard D Riley,3 Karel G M Moons1,2 1Cochrane Netherlands, Validation of prediction models is diagnostic test accuracy studies. Compared to therapeu- University Medical Center tic intervention and diagnostic test accuracy studies, Utrecht, PO Box 85500 Str highly recommended and increasingly there is limited guidance on the conduct of systematic 6.131, 3508 GA Utrecht, Netherlands common in the literature. A systematic reviews and meta-analysis of primary prognosis studies. 2Julius Center for Health review of validation studies is therefore A common aim of primary prognostic studies con- Sciences and Primary Care, cerns the development of so-called prognostic predic- University Medical Center helpful, with meta-analysis needed to tion models or indices. These models estimate the Utrecht, PO Box 85500 Str 6.131, 3508 GA Utrecht, summarise the predictive performance individualised probability or risk that a certain condi- Netherlands of the model being validated across tion will occur in the future by combining information 3Research Institute for Primary from multiple prognostic factors from an individual. Care and Health Sciences, Keele different settings and populations. This Unfortunately, there is often conflicting evidence about University, Staffordshire, UK article provides guidance for the predictive performance of developed prognostic Correspondence to: T P A Debray [email protected] researchers systematically reviewing prediction models. For this reason, there is a growing Additional material is published demand for evidence synthesis of (external validation) online only. -
Is It Worthwhile Including Observational Studies in Systematic Reviews of Effectiveness?
CRD_mcdaid05_Poster.qxd 13/6/05 5:12 pm Page 1 Is it worthwhile including observational studies in systematic reviews of effectiveness? The experience from a review of treatments for childhood retinoblastoma Catriona Mc Daid, Suzanne Hartley, Anne-Marie Bagnall, Gill Ritchie, Kate Light, Rob Riemsma Centre for Reviews and Dissemination, University of York, UK Background • Overall there were considerable problems with quality Figure 1: Mapping of included studies (see Table). Without randomised allocation there was a Retinoblastoma is a rare malignant tumour of the retina and high risk of selection bias in all studies. Studies were also usually occurs in children under two years old. It is an susceptible to detection and performance bias, with the aggressive tumour that can lead to loss of vision and, in retrospective studies particularly susceptible as they were extreme cases, death. The prognoses for vision and survival less likely to have a study protocol specifying the have significantly improved with the development of more intervention and outcome assessments. timely diagnosis and improved treatment methods. Important • Due to the considerable limitations of the evidence clinical factors associated with prognosis are age and stage of identified, it was not possible to make meaningful and disease at diagnosis. Patients with the hereditary form of robust conclusions about the relative effectiveness of retinoblastoma may be predisposed to significant long-term different treatment approaches for childhood complications. retinoblastoma. Historically, enucleation was the standard treatment for unilateral retinoblastoma. In bilateral retinoblastoma, the eye ■ ■ ■ with the most advanced tumour was commonly removed and EBRT Chemotherapy EBRT with Chemotherapy the contralateral eye treated with external beam radiotherapy ■ Enucleation ■ Local Treatments (EBRT). -
A Phase I, Double Blind, Three-Way Crossover Study to Assess The
A Phase I, Double Blind, Three-Way Crossover Study to Assess the Pharmacokinetic Profile of Cannabis Based Medicine Extract (CBME) Administered Sublingually in Variant Cannabinoid Ratios in Normal Healthy Male Volunteers (GWPK0215) G. W. Guy P. J. Robson SUMMARY. Primary objectives of this study were to assess the pharm- acokinetic characteristics of CBME when administered sublingually in different ratios, to determine if the pharmacokinetic profiles of THC and its metabolite 11-hydroxy-THC are different when administered sub- lingually in different formulations, and to characterise the pharmaco- kinetic profile of CBD when administered with THC in equal amounts. G. W. Guy and P. J. Robson are affiliated with GW Pharmaceuticals plc, Porton Down Science Park, Salisbury, Wiltshire, SP4 0JQ, UK. [Haworth co-indexing entry note]: “A Phase I, Double Blind, Three-Way Crossover Study to Assess the Pharmacokinetic Profile of Cannabis Based Medicine Extract (CBME) Administered Sublingually in Variant Cannabinoid Ratios in Normal Healthy Male Volunteers (GWPK0215).” Guy, G. W., and P. J. Robson. Co-published simultaneously in Journal of Cannabis Therapeutics (The Haworth Integrative Healing Press, an imprint of The Haworth Press, Inc.) Vol. 3, No. 4, 2003, pp. 121-152; and: Cannabis: From Pariah to Pre- scription (ed: Ethan Russo) The Haworth Integrative Healing Press, an imprint of The Haworth Press, Inc., 2003, pp. 121-152. Single or multiple copies of this article are available for a fee from The Haworth Document Delivery Service [1-800-HAWORTH, 9:00 a.m. - 5:00 p.m. (EST). E-mail address: docdelivery@ haworthpress.com]. http://www.haworthpress.com/store/product.asp?sku=J175 2003 by The Haworth Press, Inc. -
Randomized, Double-Blind, Placebo-Controlled, Crossover Study of the Efficacy and Safety of Lisdexamfetamine Dimesylate in Adult
UC Irvine UC Irvine Previously Published Works Title Randomized, double-blind, placebo-controlled, crossover study of the efficacy and safety of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder: novel findings using a simulated adult workplace environment design Permalink https://escholarship.org/uc/item/4kq3z3hd Journal Behavioral and Brain Functions, 6(1) ISSN 1744-9081 Authors Wigal, Timothy Brams, Matthew Gasior, Maria et al. Publication Date 2010-06-24 DOI http://dx.doi.org/10.1186/1744-9081-6-34 Peer reviewed eScholarship.org Powered by the California Digital Library University of California Wigal et al. Behavioral and Brain Functions 2010, 6:34 http://www.behavioralandbrainfunctions.com/content/6/1/34 RESEARCH Open Access Randomized,Research double-blind, placebo-controlled, crossover study of the efficacy and safety of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder: novel findings using a simulated adult workplace environment design Timothy Wigal*1, Matthew Brams2, Maria Gasior3, Joseph Gao4, Liza Squires3, John Giblin5 for 316 Study Group Abstract Background: Duration of efficacy and safety of lisdexamfetamine dimesylate (LDX) was assessed in adults (18-55 years) with attention-deficit/hyperactivity disorder (ADHD) using the simulated adult workplace environment. Methods: After open-label dose optimization (4-week) with LDX, 30-70 mg/d, subjects entered a 2-week randomized, double-blind, placebo-controlled crossover phase. Efficacy assessments included the Permanent Product Measure of Performance (PERMP) total score (attempted+correct) measured predose and from 2 to 14 hours postdose, averaged across postdose sessions (primary) and at each time point vs placebo (secondary), and ADHD Rating Scale IV (ADHD- RS-IV) with adult prompts at baseline and crossover visits. -
How to Get Started with a Systematic Review in Epidemiology: an Introductory Guide for Early Career Researchers
Denison et al. Archives of Public Health 2013, 71:21 http://www.archpublichealth.com/content/71/1/21 ARCHIVES OF PUBLIC HEALTH METHODOLOGY Open Access How to get started with a systematic review in epidemiology: an introductory guide for early career researchers Hayley J Denison1*†, Richard M Dodds1,2†, Georgia Ntani1†, Rachel Cooper3†, Cyrus Cooper1†, Avan Aihie Sayer1,2† and Janis Baird1† Abstract Background: Systematic review is a powerful research tool which aims to identify and synthesize all evidence relevant to a research question. The approach taken is much like that used in a scientific experiment, with high priority given to the transparency and reproducibility of the methods used and to handling all evidence in a consistent manner. Early career researchers may find themselves in a position where they decide to undertake a systematic review, for example it may form part or all of a PhD thesis. Those with no prior experience of systematic review may need considerable support and direction getting started with such a project. Here we set out in simple terms how to get started with a systematic review. Discussion: Advice is given on matters such as developing a review protocol, searching using databases and other methods, data extraction, risk of bias assessment and data synthesis including meta-analysis. Signposts to further information and useful resources are also given. Conclusion: A well-conducted systematic review benefits the scientific field by providing a summary of existing evidence and highlighting unanswered questions. For the individual, undertaking a systematic review is also a great opportunity to improve skills in critical appraisal and in synthesising evidence. -
Guidelines for Reporting Meta-Epidemiological Methodology Research
EBM Primer Evid Based Med: first published as 10.1136/ebmed-2017-110713 on 12 July 2017. Downloaded from Guidelines for reporting meta-epidemiological methodology research Mohammad Hassan Murad, Zhen Wang 10.1136/ebmed-2017-110713 Abstract The goal is generally broad but often focuses on exam- Published research should be reported to evidence users ining the impact of certain characteristics of clinical studies on the observed effect, describing the distribu- Evidence-Based Practice with clarity and transparency that facilitate optimal tion of research evidence in a specific setting, exam- Center, Mayo Clinic, Rochester, appraisal and use of evidence and allow replication Minnesota, USA by other researchers. Guidelines for such reporting ining heterogeneity and exploring its causes, identifying are available for several types of studies but not for and describing plausible biases and providing empirical meta-epidemiological methodology studies. Meta- evidence for hypothesised associations. Unlike classic Correspondence to: epidemiological studies adopt a systematic review epidemiology, the unit of analysis for meta-epidemio- Dr Mohammad Hassan Murad, or meta-analysis approach to examine the impact logical studies is a study, not a patient. The outcomes Evidence-based Practice Center, of certain characteristics of clinical studies on the of meta-epidemiological studies are usually not clinical Mayo Clinic, 200 First Street 6–8 observed effect and provide empirical evidence for outcomes. SW, Rochester, MN 55905, USA; hypothesised associations. The unit of analysis in meta- In this guide, we adapt the items used in the PRISMA murad. mohammad@ mayo. edu 9 epidemiological studies is a study, not a patient. The statement for reporting systematic reviews and outcomes of meta-epidemiological studies are usually meta-analysis to fit the setting of meta- epidemiological not clinical outcomes.