ISPOR Good Research Practices for Retrospective Database Analysis Task Force
|
|
- James Moore
- 6 years ago
- Views:
Transcription
1 ISPOR Good Research Practices for Retrospective Database Analysis Task Force II. GOOD RESEARCH PRACTICES FOR COMPARATIVE EFFECTIVENESS RESEARCH: APPROACHES TO MITIGATE BIAS AND CONFOUNDING IN THE DESIGN OF NON-RANDOMIZED STUDIES OF TREATMENT EFFECTS USING SECONDARY DATA SOURCES - Report of the ISPOR Retrospective Database Analysis Task Force Part II Comments received from Reviewer/Leadership/ISPOR Membership : Respondent #1 Thank you for the opportunity to review and comment on the documents pertaining to good research practices for nonrandomized studies of treatment effects using secondary databases. This is very important work and the authors have put together very thoughtful and useful information. I will comment on the documents generally and then each document separately. Overall comments It would benefit the audience if the authors could first define their key terms such as effectiveness research comparative effectiveness research as secondary data sources. observational data epidemiologic studies and to use these terms and definitions consistently across the three documents. Providing common definitions would also be extremely helpful to the field. It s not clear whether these series is limited to comparative effectiveness or effectiveness. The authors seem to use observational research and epidemiologic research interchangeably. In discussing the relative merits of observational studies versus RTCs, the authors should acknowledge that most evidence hierarchies consider RTCs the gold standard of evidence and rank case control and cohort studies further done on the evidence later. The main reason for this is that unmeasured or unobservable confounding brings into question the validity of observational studies. This does not mean that observational studies are not useful, it just acknowledges how they are currently being viewed and why. The role of unobservable confounding and the limited clinical information to control for confounding should be acknowledged early on in the documents. II.Comments Specific to Good Research Practices for Designing Non-Randomized Studies of Treatment Effects Using Secondary Databases. The definition of comparative effectiveness provided in the abstract sounds more like effectiveness than comparative effectiveness, for example, see the IOM definition of comparative effectiveness clinical information on the relative merits or outcomes of one intervention in comparison to one or more others; benefits or harms (Institute of Medicine. 2007), Additionally, in some places of the manuscript the definition of secondary data seems limited to insurance claims data, in other places it seems to include medical records. Are hospital discharge abstracts such as HCUP and registries included in the definition? The document by Berger and colleague seems to include these types of data in the definition of secondary data. The paper covers a lot of ground but could benefit from an overall organizing viewpoint that is laid out in the introduction so that the reader can anticipate what will be presented and how it all fits together. 1
2 Much of the discussion focused on measurement error in claims data. The presumption is that there is less error in primary data collection studies, which seems to be a simplification. Some items, for example, expenditures and utilization, will be much more accurately measured in claims than through primary data collection. An important limitation in secondary data, perhaps more important than the discussion of measurement error, is the lack of clinically data on secondary data. These may include laboratory tests, pathology results, radiology reports, symptoms scales, measures of functioning, etc. Although EMR data sets have more clinically rich data, many of these data elements will be missing in various systems. Thus a key limitation of secondary data analysis, that could be discussed, is the fact that you are working of the data that you have rather than the data that you would ideally want to control for confounding or measure outcomes. A key problem with claims and EMR data that may deserve more discussion is censoring bias. Secondary data is both subject to left and right censoring. For example, incident users are only defined as incident to the extent that patients can be followed retrospectively and most studies do not include more than a 3 or 6 month clean period. On the other hand, outcomes are often measured only over continuously enrolled patients which may lead to the exclusion of patients who dropped out because of serious illness or death. Respondent #3 Overall- it would be nice to have a short commentary/executive summary talking about all of the papers together and outlining the recommendations from them. Paper2 Focused on administrative claim and EMR data- I think much of the information would pertain to registry data as well as secondary analyses of a completed prospective study- maybe worth mentioning. In the abstract it mentions that compared to RCT, observational studies have issues with validity. May want to specify internal validity. On page 4, when talking about prescription claim data, it may be worth mentioning that although it is a wealth of informationit still doesn t tell us whether or not they actually took the medicine. Casual graphs are discussed but colliders or effect modifiers are not mentioned. I understand that the focus is on confounding but I think it should at least be mentioned. Box highlighting the overall recommendations Respondent #6 Thank you for providing me the chance to read these documents. All the topics are interesting and provide careful insight to the respective subject matter. However in the attachment: Comments on II. GOOD RESEARCH PRACTICES FOR DESIGNING NON-RANDOMIZED STUDIES OF TREATMENT EFFECTS USING SECONDARY DATABASES: Report of the ISPOR Retrospective Database Analysis Task Force Part II This report has good points. It seems that the recommendations should be numbered and listed in a table. There is some overlap between this report and the first one by Berger et al. Recommend that the domains for each be established and points managed in a single document. 2
3 Line 441 Patients with the Same Treatment Indication: Alternative Drug Users. The authors could perhaps include a mention that some studies may want to identify different indications in order to compare outcomes and remove the impact of the underlying disease. For example, some side effects may be due to the drug or to the disease or to both (interaction). Using a group exposed to the drug but not having the disease is a distinct advantage here. Respondent #8 Thanks for this important work! It is very helpful for evaluating routine data. I plan to use it as a sort of checklist so I won t forget important questions. You should take into account that a lot of work with this type of data is never published because it is used for decision making or negotiations in settings which are not very transparent. There it is of high priority to answer questions in time and fitting the system you are working in. Scientific accuracy in most cases is not so important because results are not published. Publication only occurs in transparent settings or if some people think it supporting for their career. So it would be helpful to have these reports published so they can be referred to. Respondent #11 II. Good Research Practices for Designing Non-randomized Studies of Treatment Effects Using Secondary Databases Need some practical explanantions. Respondent #12 3. To check reliability of the study, grading on the scale of 10 should be done. 4. Unpublished and published case series can be helpful for the preparation of the databases. Pulling data from different case series (may be from same region) can form a bigger sample size. 5. Stratification of case series, for a particular disease can be performed to target a research question. 6. Addition of the drug utilization studies into the task can be helpful to make a database to find out cost effective treatment for a disease. Respondent #13 I appreciated the opportunity to review the three working papers from the ISPOR Good Research Practices - Retrospective Database Analysis Task Force. I found all three well written and informative. My one comment would be to encourage this ISPOR task force to consider cross trial comparisons as part of your mandate to recommend good research practices for non-randomized studies of treatment effects using secondary databases. As you know, cross trial comparisons are routinely conducted by Industry and HTA agencies such as NICE and DERP to explore both issues of comparative and cost -effectiveness. Whilst the original clinical trial may have met the definition of a RCT, when they are aggregated for these cross trial comparisons the database (a collection of clinical trials) is no longer a randomized trial and face many of the same methodological challenges you discuss in your task force papers as a simple example, the publication may not contain sufficient information to determine that patients are comparable at baseline. Using placebo controlled trials to make head-to-head comparisons certainly qualifies the analysis as secondary. A white paper that offers guidance on designing and conducting scientifically robust cross trial comparisons would greatly benefit the field. Respondent #14 The drafts look very good. I just have a few comments. 3
4 2. Report II (1) the table below line 145, is it worth mentioning negative binomial as an error distribution for count data? Negative binomial regression can be used when there are signs of overdispersion in Poisson regression. Respondent #15 Thank you very much for the opportunity to briefly comment on these excellent reports. As more and more transnational research is performed, and in the light of increasingly limited resources, a comment on prespecified country-specific secondary analyses of such studies - if performed in a multinational setting - may be of help for country-specific decision making, however: - Justification for such secondary country-specific analyses needs to be provided a priori - Meaningful, pre-defined minimum patient numbers from these countries need to be reached (conditio sine qua non) and CID should be determined - Country-specific results need to be put into perspective, i.e., discussed in the light of the results of the entire cohort Respondent #17 Comments for Report II Authors did a great job in describing main challenges of using data from non-randomized studies for epidemiological or effectiveness analysis. This review identifies principal possible sources of biases in misclassification and confounding, as well as possible problems in measurement of exposure and outcome. The review has valuable recommendations for researchers on how to deal with these possible challenges to provide valid and evidence based conclusions. Below are comments on some of the parts of the review. They provide additional perspectives to the issues described in the review. First a few typos: Line 73.It is measure Line 74.It is inaccuracies Line 81.Tables need to be numbered. Line 86. Largely because it is designed for billing purposes, prescription claim data has important information on payments, including payment by insurers, co-payments and deductibles. This economic data can affect the exposure and the outcome of the drug therapy. The claims data often has information on pharmacies where the drug was sold and this information on pharmacies can be used to deal with potential confounding factors such as: accessibility, accessibility within health insurance coverage and competitiveness of the prices in the local pharmacy market. ECONOMIC DATA AS A PART OF CLAIM INFORMATION CAN BE IMPORTANT SOURCE TO IDENTIFY CLASSIFICATION BIAS AND POSSIBLE CONFOUNDING FACTORS. Line 119. In Table X, it is important that the fact of use or being exposed to the drug based on medication claims can be biased. The claim provides evidence of the fact that the drug was purchased but some of these drugs may not be used or may be used for other purposes. For example, a patient can purchase antibiotics, but take it for shorter period of time than it was 4
5 prescribed. FILLING PRESCRIPTION AT THE PHARMCY (AS IT IS EVIDENCED BY THE CLAIM) DOESN T NECESSARULY IMPLY THAT THE PATIENT IS EXPOSED TO THE MEDICATION AND IT CAN BE THE SOURCE OF POTENTIAL BIASE. Line 170 and 192.It is important to adjust not only for eligibility but also for the benefit plan design because having different benefit plan designs or changing it can affect compliance and therefore contribute to the classification bias. For example, a switch to the less expensive health plan but with higher out-of-pocket payments for medications can cause the patient to stop taking medication (especially, when it is not life-threatening condition). SO NOT ONLY ELIGIBILITY MUST BE CONTROLLED BUT ALSO BENFIT PLAN DESIGN OF HEALTH CARE PLANS. Line 215. A follow-up period should be long enough to obtain important outcomes measures and at the same time short enough to have sufficient sample size of continuously enrolled patients with characteristics of interest. Line 237. Whenever possible one should exclude from the study individuals enrolled in capitated health plans. Line 241. Misclassification of diagnosis and procedures are not rare in the claims data. As authors correctly pointed out for some diseases the source lies in clinical misclassification. For example, asthma, COPD and some other respiratory conditions are often misdiagnosed, especially when not all available tools for diagnosis are used, like spirometry. Most importantly, researchers must make clear from the beginning what case definition for the condition they use and underscore possible limitations in generalizability of the results. Line 407. Adherence can cause classification bias of exposure and can be a confounding factor in the analysis. Adherence is affected among other factors by the level of the risk aversion of the individual, in other words by the degree of how risky the person is. Another factor to access the adherence to the certain medication is whether there is a substitute for this drug. For example, when the study is about the effect of controller medication to prevent asthma patients from exacerbations, asthma patient may have low adherence to the controller medications because of willingness to take this risk and reliance on reliever medications. Respondent #19 On document 2, designing: There seems to be no appropriate introductory section describing the overall need to create operational definitions of exposures and outcomes that will keep the limitations of each dataset in mind -- this section is critical, along with illustrative examples. There are bits and pieces throughout, but it's really a central theme that should be displayed up front. The authors should be careful NOT to describe confounding as a bias, because it is not one -- it is not a systemic design or data collection issue, it is a reality that must be addressed and mitigated. I am not sure of the rationale for describing anything but a "new user" design as the basis for treatment-effect studies. This seems like the best document for describing demographic and/or propensity matching as well as IV designs. Why was this not included? On document 3, analyzing: Stratification's benefits extend beyond epidemiology; would suggest replacing the term with "observational study". Missing from the regression section is the notion of "common support". It is not enough to include covariates that may or may not differ on average between two treatment groups. Scatter-plotting must also be done to make sure the distribution of each variable has enough overlap between groups -- if these distributions occupy very different areas of the covariate space, a bias will be imparted to any regression model (Dehejia R, J Economics 2005; Heckman JJ, Rev Econ Stud 1997) Respondent #23 5
6 I am afraid that I could not reply to this request in time. ISPOR Good Research Practices for Retrospective Database Analysis Task Force Comments If I may add a few comments for these great papers, I would like to point out to add a section how to integrate patient reports. I think patients' self-reported dataset which will fill in the bias of secondary datasets, mostly likely to be claims based information. Respondent #24 Thank you for considering me to make comments on these documents. In general, I think that they are well written and understandable. I just make few comments and I hope they can be useful. Comments to the following documents: Good research practices for designing non-randomized studies of treatments effects using secondary data bases In the section that talks about eligibility, it may be worth to deep on how the lack of eligibility can be controlled or corrected in the study? In the paragraph that talks about the questions that we need to consider to address the issue of confounding. It may be appropriate to specify another question before to ask about the way to control confounding. It may be worth to know to what extent confounding can affect the outcomes of the study. If we describe the magnitude of the effect of confounding in the study, it may be easy to describe the more appropriate approach to tackle this issue. Therefore the comprehension of this point may be follow easily when reading about this issue. This is because, I think that confounding is not an easy topic to follow, especially if you are beginning to know about it. It may lead to several confusions; therefore it should be clear for the reader the origin, its importance and the potential harmful for the study, as well as the consequences of not addressing this point adequately. Respondent #25 II. GOOD RESEARCH PRACTICES FOR DESIGNING NON-RANDOMIZED STUDIES OF TREATMENT EFFECTS USING SECONDARY DATABASES: Report of the ISPOR Retrospective Database Analysis Task Force Part II Line 301 The assertion that traditional textbook techniques are inadequate in controlling for simultaneity might be inaccurate. Indeed, 2SLS or instrumental variables techniques and dynamic panel data models can be used in analyzing/addressing the issue of simultaneity. Line 336 A brief commentary on whether the confounding being described in the report is individualspecific and how to handle such a situation may be helpful. Line 357 Since restrictions tends to be based on observables, I believe confounding attributable to unobservables may still plague the analysis. Overall, the report could benefit from some proofing (grammar, punctuation,etc.) III. GOOD RESEARCH PRACTICES FOR THE ANALYSIS OF NON-RANDOMIZED STUDIES OF TREATMENT EFFECTS USING SECONDARY DATABASES: Report of the ISPOR Retrospective Respondent #26 Please find comments as requested below: II. Good Research Practices for Designing Non-randomized Studies of Treatment Effects Using Secondary Databases 6
7 This paper gives very clear information up until the section of causal graphs (line 312). At this point issues are addressed with the guidance of the causal graph. I found myself having to re-read these sections a couple of times to grasp this idea. I have read these three papers as a consumer looking for guidance and have found them very useful. I hope these comments will in some way be help. Respondent #27 Comments for report 2: Results and conclusion derived from this study are more helpful to understand the different aspects about drug exposure and medication. Points discussed under the heading of "classification" and "new user design" are very impressive. Lot of efforts have been taken by authors to propose this valuable and very useful study. Respondent #31 Overall- it would be nice to have a short commentary/executive summary talking about all of the papers together and outlining the recommendations from them. Paper2 Focused on administrative claim and EMR data- I think much of the information would pertain to registry data as well as secondary analyses of a completed prospective study- maybe worth mentioning. In the abstract it mentions that compared to RCT, observational studies have issues with validity. May want to specify internal validity. On page 4, when talking about prescription claim data, it may be worth mentioning that although it is a wealth of information- it still doesn t tell us whether or not they actually took the medicine. Casual graphs are discussed but colliders or effect modifiers are not mentioned. I understand that the focus is on confounding but I think it should at least be mentioned. Box highlighting the overall recommendations Respondent #32 II. Good Research Practices for Designing Non-randomized Studies of Treatment Effects Using Secondary Databases Line 74: "in accuracies" should be replaced by "inaccuracies" Line 81: Table x - I hope the x would be replaced by an actual number later? Line 96-97: "...NDCs codes is used" should be replaced by "...NDC codes are used". Line 152: "...someone as drug exposed" be replaced by "...subjects as being exposed to drug" Line 179: The requirement of continuous health plan enrollment often reduce the study sample significantly - may talk about the trade-off between the sample size and longer period of continuous health plan enrollment. Line : I am not sure how readily the information like prior authorization be available in administrative claims databases. Line : I think measuring exposure to OTC medication using administrative claims data is not a good idea to begin with. Line : "...that considered clinical..." should be replaced by "...what is considered as clinically..." Line 286: I could not find where unmeasured (residual) confounding factors discussed in this report. 7
8 Line 407: Please note that socio-economic variables such as "educational status" will not be available in a typical claims database. One can, of course, link the claims database to other databases to capture SES data. Line 415: I will include the following sentence after the full stop: Therefore, it is recommended that for comparisons involving a new drug, the study should ideally include only new patients. Line 438: I would drop "unmeasured" or qualify its use in some other way as it is impossible to determine the unmeasured risk factors between the treated and the comparison cohorts. 8
Manuscript ID BMJ entitled "Benzodiazepines and the Risk of Allcause Mortality in Adults: A Cohort Study"
12-Jan-2017 Dear Dr. Patorno Manuscript ID BMJ.2016.036319 entitled "Benzodiazepines and the Risk of Allcause Mortality in Adults: A Cohort Study" Thank you for sending us your paper. We sent it for external
More informationextraction can take place. Another problem is that the treatment for chronic diseases is sequential based upon the progression of the disease.
ix Preface The purpose of this text is to show how the investigation of healthcare databases can be used to examine physician decisions to develop evidence-based treatment guidelines that optimize patient
More informationRecent developments for combining evidence within evidence streams: bias-adjusted meta-analysis
EFSA/EBTC Colloquium, 25 October 2017 Recent developments for combining evidence within evidence streams: bias-adjusted meta-analysis Julian Higgins University of Bristol 1 Introduction to concepts Standard
More informationOnline Supplementary Material
Section 1. Adapted Newcastle-Ottawa Scale The adaptation consisted of allowing case-control studies to earn a star when the case definition is based on record linkage, to liken the evaluation of case-control
More informationCost-Motivated Treatment Changes in Commercial Claims:
Cost-Motivated Treatment Changes in Commercial Claims: Implications for Non- Medical Switching August 2017 THE MORAN COMPANY 1 Cost-Motivated Treatment Changes in Commercial Claims: Implications for Non-Medical
More informationPropensity Score Methods to Adjust for Bias in Observational Data SAS HEALTH USERS GROUP APRIL 6, 2018
Propensity Score Methods to Adjust for Bias in Observational Data SAS HEALTH USERS GROUP APRIL 6, 2018 Institute Institute for Clinical for Clinical Evaluative Evaluative Sciences Sciences Overview 1.
More informationAuthor's response to reviews
Author's response to reviews Title: Gender differences in Greek centenarians. A cross-sectional nation-wide study, examining multiple socio-demographic and personality factors and health locus of control.
More informationLecture 2. Key Concepts in Clinical Research
Lecture 2 Key Concepts in Clinical Research Outline Key Statistical Concepts Bias and Variability Type I Error and Power Confounding and Interaction Statistical Difference vs Clinical Difference One-sided
More informationThe Pretest! Pretest! Pretest! Assignment (Example 2)
The Pretest! Pretest! Pretest! Assignment (Example 2) May 19, 2003 1 Statement of Purpose and Description of Pretest Procedure When one designs a Math 10 exam one hopes to measure whether a student s ability
More informationPropensity Score Matching with Limited Overlap. Abstract
Propensity Score Matching with Limited Overlap Onur Baser Thomson-Medstat Abstract In this article, we have demostrated the application of two newly proposed estimators which accounts for lack of overlap
More informationSystematic reviews and meta-analyses of observational studies (MOOSE): Checklist.
Systematic reviews and meta-analyses of observational studies (MOOSE): Checklist. MOOSE Checklist Infliximab reduces hospitalizations and surgery interventions in patients with inflammatory bowel disease:
More informationPropensity Score Methods for Estimating Causality in the Absence of Random Assignment: Applications for Child Care Policy Research
2012 CCPRC Meeting Methodology Presession Workshop October 23, 2012, 2:00-5:00 p.m. Propensity Score Methods for Estimating Causality in the Absence of Random Assignment: Applications for Child Care Policy
More informationDRAFT (Final) Concept Paper On choosing appropriate estimands and defining sensitivity analyses in confirmatory clinical trials
DRAFT (Final) Concept Paper On choosing appropriate estimands and defining sensitivity analyses in confirmatory clinical trials EFSPI Comments Page General Priority (H/M/L) Comment The concept to develop
More informationAuthor's response to reviews
Author's response to reviews Title:Mental health problems in the 10th grade and non-completion of upper secondary school: the mediating role of grades in a population-based longitudinal study Authors:
More informationCASE STUDY 2: VOCATIONAL TRAINING FOR DISADVANTAGED YOUTH
CASE STUDY 2: VOCATIONAL TRAINING FOR DISADVANTAGED YOUTH Why Randomize? This case study is based on Training Disadvantaged Youth in Latin America: Evidence from a Randomized Trial by Orazio Attanasio,
More informationImproved Transparency in Key Operational Decisions in Real World Evidence
PharmaSUG 2018 - Paper RW-06 Improved Transparency in Key Operational Decisions in Real World Evidence Rebecca Levin, Irene Cosmatos, Jamie Reifsnyder United BioSource Corp. ABSTRACT The joint International
More informationJae Jin An, Ph.D. Michael B. Nichol, Ph.D.
IMPACT OF MULTIPLE MEDICATION COMPLIANCE ON CARDIOVASCULAR OUTCOMES IN PATIENTS WITH TYPE II DIABETES AND COMORBID HYPERTENSION CONTROLLING FOR ENDOGENEITY BIAS Jae Jin An, Ph.D. Michael B. Nichol, Ph.D.
More informationEPF s response to the European Commission s public consultation on the "Summary of Clinical Trial Results for Laypersons"
EPF s response to the European Commission s public consultation on the "Summary of Clinical Trial Results for Laypersons" August 2016 This document received funding under an operating grant from the European
More informationInterpreting Prospective Studies
Comparative Effectiveness Research Collaborative Initiative (CER CI) PART 1: INTERPRETING OUTCOMES RESEARCH STUDIES FOR HEALTH CARE DECISION MAKERS ASSESSING PROSPECTIVE DATABASE STUDIES: A PROPOSED MEASUREMENT
More informationWILLIAMS, WYCKOFF & OSTRANDER, PLLC Attorneys at Law
WILLIAMS, WYCKOFF & OSTRANDER, PLLC Attorneys at Law Wayne L. Williams Douglas P. Wyckoff Dane D. Ostrander 2958 Limited Lane N.W. P O Box 316 Olympia, WA 98507 Telephone (360) 528-4800 Telefax (360) 943-2430
More informationTitle: The effect of Breast Cancer Awareness Month on Internet search activity - a comparison with awareness campaigns for lung and prostate cancer
Author's response to reviews Title: The effect of Breast Cancer Awareness Month on Internet search activity - a comparison with awareness campaigns for lung and prostate cancer Authors: Ronan W Glynn (ronanglynn@doctors.net.uk)
More informationJuly 7, Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm Rockville, MD 20852
July 7, 2012 Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Re: Docket No. FDA 2012-N-0408: Risk Evaluation and Mitigation Strategy Assessments:
More informationPresenter Disclosure Information
Presenter Disclosure Information Soko Setoguchi, MD DrPH Prescription Drug Data: Advantages, Availability, and Access FINANCIAL DISCLOSURE: Grants/Research Support: NIH, AHRQ UNLABELED/UNAPPROVED USES
More informationReduce Tension by Making the Desired Choice Easier
Daniel Kahneman Talk at Social and Behavioral Sciences Meeting at OEOB Reduce Tension by Making the Desired Choice Easier Here is one of the best theoretical ideas that psychology has to offer developed
More informationPEER REVIEW HISTORY ARTICLE DETAILS VERSION 1 - REVIEW. Ball State University
PEER REVIEW HISTORY BMJ Open publishes all reviews undertaken for accepted manuscripts. Reviewers are asked to complete a checklist review form (see an example) and are provided with free text boxes to
More informationStatistical Analysis Plans
Statistical Analysis Plans PROFESSOR CARROL GAMBLE UNIVERSITY OF LIVERPOOL Clinical Trials Lots of different types of clinical trials Various interventions Pharmaceutical/drugs regulated Regulated environment
More informationConducting Strong Quasi-experiments
Analytic Technical Assistance and Development Conducting Strong Quasi-experiments Version 1 May 2015 This report was prepared for the Institute of Education Sciences (IES) by Decision Information Resources,
More informationStakeholder Comments and Responses for
Stakeholder Comments and Responses for Comprehensive Research Plan: Treatment of ADHD in Adults Consolidated Report April 29 th, 2015 30 Bond Street, Toronto ON, M5B 1W8 www.odprn.ca info@odprn.ca 2 OVERALL
More informationObservational Study Designs. Review. Today. Measures of disease occurrence. Cohort Studies
Observational Study Designs Denise Boudreau, PhD Center for Health Studies Group Health Cooperative Today Review cohort studies Case-control studies Design Identifying cases and controls Measuring exposure
More informationISA 540, Auditing Accounting Estimates, Including Fair Value Accounting Estimates, and Related Disclosures Issues and Task Force Recommendations
Agenda Item 1-A ISA 540, Auditing Accounting Estimates, Including Fair Value Accounting Estimates, and Related Disclosures Issues and Task Force Recommendations Introduction 1. Since the September 2016
More informationChallenges of Observational and Retrospective Studies
Challenges of Observational and Retrospective Studies Kyoungmi Kim, Ph.D. March 8, 2017 This seminar is jointly supported by the following NIH-funded centers: Background There are several methods in which
More informationConfounding by indication developments in matching, and instrumental variable methods. Richard Grieve London School of Hygiene and Tropical Medicine
Confounding by indication developments in matching, and instrumental variable methods Richard Grieve London School of Hygiene and Tropical Medicine 1 Outline 1. Causal inference and confounding 2. Genetic
More informationInvestigator Initiated Study Proposal Form
Please submit completed form to IISReview@KCI1.com Date Submitted Name & Title Institution Address Phone Number Email Address Principal Investigator / Institution YES NO Multi Center Study Acelity Product(s)
More informationCHECK-LISTS AND Tools DR F. R E Z A E I DR E. G H A D E R I K U R D I S TA N U N I V E R S I T Y O F M E D I C A L S C I E N C E S
CHECK-LISTS AND Tools DR F. R E Z A E I DR E. G H A D E R I K U R D I S TA N U N I V E R S I T Y O F M E D I C A L S C I E N C E S What is critical appraisal? Critical appraisal is the assessment of evidence
More informationEc331: Research in Applied Economics Spring term, Panel Data: brief outlines
Ec331: Research in Applied Economics Spring term, 2014 Panel Data: brief outlines Remaining structure Final Presentations (5%) Fridays, 9-10 in H3.45. 15 mins, 8 slides maximum Wk.6 Labour Supply - Wilfred
More informationAuthor s response to reviews
Author s response to reviews Title: The epidemiologic characteristics of healthcare provider-diagnosed eczema, asthma, allergic rhinitis, and food allergy in children: a retrospective cohort study Authors:
More informationAn Update on BioMarin Clinical Research and Studies in the PKU Community
An Update on BioMarin Clinical Research and Studies in the PKU Community Barbara Burton, MD, Professor of Pediatrics, Northwestern University Feinberg School of Medicine, Director of PKU Clinic, Children
More informationGuidelines for Writing and Reviewing an Informed Consent Manuscript From the Editors of Clinical Research in Practice: The Journal of Team Hippocrates
Guidelines for Writing and Reviewing an Informed Consent Manuscript From the Editors of Clinical Research in Practice: The Journal of Team Hippocrates 1. Title a. Emphasize the clinical utility of the
More informationVERDIN MANUSCRIPT REVIEW HISTORY REVISION NOTES FROM AUTHORS (ROUND 2)
1 VERDIN MANUSCRIPT REVIEW HISTORY REVISION NOTES FROM AUTHORS (ROUND 2) Thank you for providing us with the opportunity to revise our paper. We have revised the manuscript according to the editors and
More informationGetting ready for propensity score methods: Designing non-experimental studies and selecting comparison groups
Getting ready for propensity score methods: Designing non-experimental studies and selecting comparison groups Elizabeth A. Stuart Johns Hopkins Bloomberg School of Public Health Departments of Mental
More informationThe Impact of Relative Standards on the Propensity to Disclose. Alessandro Acquisti, Leslie K. John, George Loewenstein WEB APPENDIX
The Impact of Relative Standards on the Propensity to Disclose Alessandro Acquisti, Leslie K. John, George Loewenstein WEB APPENDIX 2 Web Appendix A: Panel data estimation approach As noted in the main
More informationIn this second module, we will focus on features that distinguish quantitative and qualitative research projects.
Welcome to the second module in the Overview of Qualitative Research Methods series. My name is Julie Stoner and I am a Professor at the University of Oklahoma Health Sciences Center. This introductory
More informationLecture II: Difference in Difference. Causality is difficult to Show from cross
Review Lecture II: Regression Discontinuity and Difference in Difference From Lecture I Causality is difficult to Show from cross sectional observational studies What caused what? X caused Y, Y caused
More informationAuthor's response to reviews
Author's response to reviews Title: Pneumococcal vaccination and otitis media in Australian Aboriginal infants: comparison of two birth cohorts before and after introduction of vaccination Authors: Grant
More informationGRADE. Grading of Recommendations Assessment, Development and Evaluation. British Association of Dermatologists April 2018
GRADE Grading of Recommendations Assessment, Development and Evaluation British Association of Dermatologists April 2018 Previous grading system Level of evidence Strength of recommendation Level of evidence
More informationStructural Approach to Bias in Meta-analyses
Original Article Received 26 July 2011, Revised 22 November 2011, Accepted 12 December 2011 Published online 2 February 2012 in Wiley Online Library (wileyonlinelibrary.com) DOI: 10.1002/jrsm.52 Structural
More informationHealth authorities are asking for PRO assessment in dossiers From rejection to recognition of PRO
UNDERSTANDING AND ADDRESSING POTENTIAL BIAS IN PATIENT-REPORTED OUTCOMES FROM CLINICAL TRIALS ISPOR Barcelona Workshop Tuesday 13 November 14:00-15:00 Prof. Olivier Chassany EA 7334, Patient-Centered Outcomes
More informationPurpose. Study Designs. Objectives. Observational Studies. Analytic Studies
Purpose Study Designs H.S. Teitelbaum, DO, PhD, MPH, FAOCOPM AOCOPM Annual Meeting Introduce notions of study design Clarify common terminology used with description and interpretation of information collected
More informationA Practical Guide to Getting Started with Propensity Scores
Paper 689-2017 A Practical Guide to Getting Started with Propensity Scores Thomas Gant, Keith Crowland Data & Information Management Enhancement (DIME) Kaiser Permanente ABSTRACT This paper gives tools
More informationGRADE. Grading of Recommendations Assessment, Development and Evaluation. British Association of Dermatologists April 2014
GRADE Grading of Recommendations Assessment, Development and Evaluation British Association of Dermatologists April 2014 Previous grading system Level of evidence Strength of recommendation Level of evidence
More informationPros and Cons of Clinical Trials vs. Observational Studies. Beth Devine PCORP Summer Institute July 14, 2015
Pros and Cons of Clinical Trials vs. Observational Studies Beth Devine PCORP Summer Institute July 14, 2015 Outline Randomized Trials Definitions: Pragmatic-explanatory continuum indicator summary (PRECIS)
More informationWhat is a Special Interest Group (SIG)?
PATIENT REPORTED OUTCOMES RESEARCH SPECIAL INTEREST GROUP Open Meeting 20 th Annual European Congress November 6, 2017 Glasgow, Scotland What is a Special Interest Group (SIG)? Member-driven group interested
More informationDates to which data relate The effectiveness data were gathered from 1 July 1996 to 20 June No price year was reported.
Impact of first-line vs second-line antibiotics for the treatment of acute uncomplicated sinusitis Piccirillo J F, Mager D E, Frisse M E, Bophy R H, Goggin A Record Status This is a critical abstract of
More informationTitle:Continuity of GP care is associated with lower use of complementary and alternative medical providers A population-based cross-sectional survey
Author's response to reviews Title:Continuity of GP care is associated with lower use of complementary and alternative medical providers A population-based cross-sectional survey Authors: Anne Helen Hansen
More informationSurveillance report Published: 6 April 2016 nice.org.uk. NICE All rights reserved.
Surveillance report 2016 Chronic obstructive pulmonary disease in over 16s: diagnosis and management (2010) NICE guideline CG101 Surveillance report Published: 6 April 2016 nice.org.uk NICE 2016. All rights
More informationPractitioner s Guide To Stratified Random Sampling: Part 1
Practitioner s Guide To Stratified Random Sampling: Part 1 By Brian Kriegler November 30, 2018, 3:53 PM EST This is the first of two articles on stratified random sampling. In the first article, I discuss
More informationPEER REVIEW HISTORY ARTICLE DETAILS TITLE (PROVISIONAL)
PEER REVIEW HISTORY BMJ Open publishes all reviews undertaken for accepted manuscripts. Reviewers are asked to complete a checklist review form (http://bmjopen.bmj.com/site/about/resources/checklist.pdf)
More informationISPOR Task Force Report: ITC & NMA Study Questionnaire
INDIRECT TREATMENT COMPARISON / NETWORK META-ANALYSIS STUDY QUESTIONNAIRE TO ASSESS RELEVANCE AND CREDIBILITY TO INFORM HEALTHCARE DECISION-MAKING: AN ISPOR-AMCP-NPC GOOD PRACTICE TASK FORCE REPORT DRAFT
More informationAuthor's response to reviews
Author's response to reviews Title: Physiotherapy interventions in scientific physiotherapy publications focusing on interventions for children with cerebral palsy: A qualitative phenomenographic approach.
More informationSUPPLEMENTARY DATA. Supplementary Figure S1. Search terms*
Supplementary Figure S1. Search terms* *mh = exploded MeSH: Medical subject heading (Medline medical index term); tw = text word; pt = publication type; the asterisk (*) stands for any character(s) #1:
More informationLecture 5 Conducting Interviews and Focus Groups
Lecture 5 Conducting Interviews and Focus Groups Talking to participants enables in-depth information about the experiences of health and illness; and of factors that influence health and illness behaviour
More informationReview of Veterinary Epidemiologic Research by Dohoo, Martin, and Stryhn
The Stata Journal (2004) 4, Number 1, pp. 89 92 Review of Veterinary Epidemiologic Research by Dohoo, Martin, and Stryhn Laurent Audigé AO Foundation laurent.audige@aofoundation.org Abstract. The new book
More informationHow Clinical Trials Work
A Guide to: How Clinical Trials Work Clinical trials are rigorously controlled tests designed to examine the safety and / or effectiveness of medicines, devices, treatments, or preventive measures in humans.
More information1. Draft checklist for judging on quality of animal studies (Van der Worp et al., 2010)
Appendix C Quality appraisal tools (QATs) 1. Draft checklist for judging on quality of animal studies (Van der Worp et al., 2010) 2. NICE Checklist for qualitative studies (2012) 3. The Critical Appraisal
More informationSetting The setting was the community. The economic study was carried out in New Jersey, USA.
Asthma rescue and allergy medication use among asthmatic children with prior allergy prescriptions who initiated asthma controller therapy Luskin A, Bukstein D, Kocevar V S, Yin D D Record Status This
More informationPatrick Breheny. January 28
Confidence intervals Patrick Breheny January 28 Patrick Breheny Introduction to Biostatistics (171:161) 1/19 Recap Introduction In our last lecture, we discussed at some length the Public Health Service
More informationMeasuring and Assessing Study Quality
Measuring and Assessing Study Quality Jeff Valentine, PhD Co-Chair, Campbell Collaboration Training Group & Associate Professor, College of Education and Human Development, University of Louisville Why
More informationCONSORT 2010 checklist of information to include when reporting a randomised trial*
CONSORT 2010 checklist of information to include when reporting a randomised trial* Section/Topic Title and abstract Introduction Background and objectives Item No Checklist item 1a Identification as a
More informationIn this chapter we discuss validity issues for quantitative research and for qualitative research.
Chapter 8 Validity of Research Results (Reminder: Don t forget to utilize the concept maps and study questions as you study this and the other chapters.) In this chapter we discuss validity issues for
More informationTranscript of Interview with WHO Director of Public Health and Environment, Dr Maria Neira, 5 th November 2013
Transcript of Interview with WHO Director of Public Health and Environment, Dr Maria Neira, 5 th November 2013 Time Text / Audio 00 00 An interview with Dr. Maria Neira Director, Public Health and Environment
More informationInstrumental Variables Estimation: An Introduction
Instrumental Variables Estimation: An Introduction Susan L. Ettner, Ph.D. Professor Division of General Internal Medicine and Health Services Research, UCLA The Problem The Problem Suppose you wish to
More informationSpecial guidelines for preparation and quality approval of reviews in the form of reference documents in the field of occupational diseases
Special guidelines for preparation and quality approval of reviews in the form of reference documents in the field of occupational diseases November 2010 (1 st July 2016: The National Board of Industrial
More informationWhy do Psychologists Perform Research?
PSY 102 1 PSY 102 Understanding and Thinking Critically About Psychological Research Thinking critically about research means knowing the right questions to ask to assess the validity or accuracy of a
More information58. Translarna drug Policy for use. The Hon. Member for Douglas South (Mrs Beecroft) to ask the Minister for Health and Social Care:
58. Translarna drug Policy for use The Hon. Member for Douglas South (Mrs Beecroft) to ask the Minister for Health and Social Care: What his policy is regarding the use of the drug Translarna? The President:
More informationAuthor s response to reviews
Author s response to reviews Title: The validity of a professional competence tool for physiotherapy students in simulationbased clinical education: a Rasch analysis Authors: Belinda Judd (belinda.judd@sydney.edu.au)
More informationPEER REVIEW HISTORY ARTICLE DETAILS
PEER REVIEW HISTORY BMJ Open publishes all reviews undertaken for accepted manuscripts. Reviewers are asked to complete a checklist review form (http://bmjopen.bmj.com/site/about/resources/checklist.pdf)
More informationChapter 7: Descriptive Statistics
Chapter Overview Chapter 7 provides an introduction to basic strategies for describing groups statistically. Statistical concepts around normal distributions are discussed. The statistical procedures of
More informationTRENDS IN LEGAL ADVOCACY: INTERVIEWS WITH LEADING PROSECUTORS AND DEFENCE LAWYERS ACROSS THE GLOBE
TRENDS IN LEGAL ADVOCACY: INTERVIEWS WITH LEADING PROSECUTORS AND DEFENCE LAWYERS ACROSS THE GLOBE Instructions to Interviewers Each interview with a prosecutor or defence lawyer will comprise a book chapter
More informationDavid O. Meltzer* Opportunities in the Economics of Personalized Health Care and Prevention
DOI 10.1515/fhep-2013-0012 Forum for Health Economics and Policy 2013; 16(2): S13 S22 David O. Meltzer* Opportunities in the Economics of Personalized Health Care and Prevention Abstract: Personalized
More informationMRS Advanced Certificate in Market & Social Research Practice. Preparing for the Exam: Section 2 Q5- Answer Guide & Sample Answers
MRS Advanced Certificate in Market & Social Research Practice Preparing for the Exam: Section 2 Q5- Answer Guide & Sample Answers This answer guide was developed to provide support for examiners in marking
More informationClinical research in AKI Timing of initiation of dialysis in AKI
Clinical research in AKI Timing of initiation of dialysis in AKI Josée Bouchard, MD Krescent Workshop December 10 th, 2011 1 Acute kidney injury in ICU 15 25% of critically ill patients experience AKI
More informationDrug Surveillance and Effectiveness Epidemiology Research - Questions to Ask your Epidemiologist
Drug Surveillance and Effectiveness Epidemiology Research - Questions to Ask your Epidemiologist Roberta Glass, OptumInsight Life Sciences, Waltham, Massachusetts ABSTRACT As a SAS analyst starting work
More information11/12/2015 THE LATEST ON THE 340B FRONT AGENDA MEGA GUIDANCE RELEASED. Mega Guidance released. Audit update from HRSA. Maintaining compliance
November 19, 2015 Connie Ouellette, Principal Carole Barker, Senior Consultant THE LATEST ON THE 340B FRONT berrydunn.com AGENDA Mega Guidance released Audit update from HRSA Maintaining compliance Areas
More informationTHE LATEST ON THE 340B FRONT
September 1, 2015 Connie Ouellette, Principal Carole Barker, Senior Consultant THE LATEST ON THE 340B FRONT berrydunn.com AGENDA Mega Guidance released! Audit update from HRSA Maintaining compliance Areas
More informationDON M. PALLAIS, CPA 14 Dahlgren Road Richmond, Virginia Telephone: (804) Fax: (804)
DON M. PALLAIS, CPA 14 Dahlgren Road Richmond, Virginia 23233 Telephone: (804) 784-0884 Fax: (804) 784-0885 Office of the Secretary PCAOB 1666 K Street, NW Washington, DC 20006-2083 Gentlemen: November
More informationComplications of Proton Pump Inhibitor Therapy. Gastroenterology 2017; 153:35-48 발표자 ; F1 김선화
Complications of Proton Pump Inhibitor Therapy Gastroenterology 2017; 153:35-48 발표자 ; F1 김선화 Background Proton pump inhibitors (PPIs) are among the most commonly prescribed medicines for gastroesophageal
More informationGLOSSARY OF GENERAL TERMS
GLOSSARY OF GENERAL TERMS Absolute risk reduction Absolute risk reduction (ARR) is the difference between the event rate in the control group (CER) and the event rate in the treated group (EER). ARR =
More informationAOTA S EVIDENCE EXCHANGE CRITICALLY APPRAISED PAPER (CAP) GUIDELINES Annual AOTA Conference Poster Submissions Critically Appraised Papers (CAPs) are
AOTA S EVIDENCE EXCHANGE CRITICALLY APPRAISED PAPER (CAP) GUIDELINES Annual AOTA Conference Poster Submissions Critically Appraised Papers (CAPs) are at-a-glance summaries of the methods, findings and
More informationJose Merino (Chair), Georg Roeggla, Tiago Villaneuva, John Fletcher. Amy Price, Elisabeth Loder. Jamie Kirhham (statisticians), Rubin Minhas
BMJ.2017.037871 "Efficacy of drugs used in preventive chemotherapy against soil-transmitted helminths: systematic review and network meta-analysis" *********************************************************************************************************
More informationChecklist for Case Control Studies. The Joanna Briggs Institute Critical Appraisal tools for use in JBI Systematic Reviews
The Joanna Briggs Institute Critical Appraisal tools for use in JBI Systematic Reviews Checklist for http://joannabriggs.org/research/critical-appraisal-tools.html www.joannabriggs.org The Joanna Briggs
More informationWhat Constitutes a Good Contribution to the Literature (Body of Knowledge)?
What Constitutes a Good Contribution to the Literature (Body of Knowledge)? Read things that make good contributions to the body of knowledge. The purpose of scientific research is to add to the body of
More informationConfusion in Hospital Patients. Dr Nicola Lovett, Geratology Consultant OUH
Confusion in Hospital Patients Dr Nicola Lovett, Geratology Consultant OUH I'm one of the geratology consultants working here at the John Radcliffe. This is a really wonderful opportunity for us to tell
More informationThe Immediate Post-Launch Phase and Confounding by Indication or Channeling Bias: How does it affect our ability to conduct CER?
The Immediate Post-Launch Phase and Confounding by Indication or Channeling Bias: How does it affect our ability to conduct CER? Cynthia J Girman Executive Director and Head of Data Analytics & Observational
More informationOUTPATIENT SERVICES PSYCHOLOGICAL SERVICES CONTRACT
OUTPATIENT SERVICES PSYCHOLOGICAL SERVICES CONTRACT (This is a detailed document. Please feel free to read at your leisure and discuss with Dr. Gard in subsequent sessions. It is a document to review over
More information7 Statistical Issues that Researchers Shouldn t Worry (So Much) About
7 Statistical Issues that Researchers Shouldn t Worry (So Much) About By Karen Grace-Martin Founder & President About the Author Karen Grace-Martin is the founder and president of The Analysis Factor.
More information9699 SOCIOLOGY. Mark schemes should be read in conjunction with the question paper and the Principal Examiner Report for Teachers.
CAMBRIDGE INTERNATIONAL EXAMINATIONS GCE Advanced Subsidiary Level and GCE Advanced Level MARK SCHEME for the May/June 2014 series 9699 SOCIOLOGY 9699/23 Paper 2 (Theory and Methods), maximum raw mark
More informationTitle:The role of BRCA1 and BRCA2 mutations in prostate, pancreatic and stomach cancers.
Author's response to reviews Title:The role of BRCA1 and BRCA2 mutations in prostate, pancreatic and stomach cancers. Authors: Helen Cavanagh (helen21987@hotmail.com) Katherine MA Rogers (k.rogers@qub.ac.uk)
More informationDeclaration of interests. Register-based research on safety and effectiveness opportunities and challenges 08/04/2018
Register-based research on safety and effectiveness opportunities and challenges Morten Andersen Department of Drug Design And Pharmacology Declaration of interests Participate(d) in research projects
More informationYou must answer question 1.
Research Methods and Statistics Specialty Area Exam October 28, 2015 Part I: Statistics Committee: Richard Williams (Chair), Elizabeth McClintock, Sarah Mustillo You must answer question 1. 1. Suppose
More informationCONSULTANT PHYSICIAN v SANOFI
CASE AUTH/2477/2/12 CONSULTANT PHYSICIAN v SANOFI Conduct of representative A consultant physician alleged that at a hospital diabetes meeting a Sanofi representative had been unprofessional in that she
More information