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1. Chicago-Area DEcIDE Center (pdf file)
   effectivehealthcare-admin.ahrq.gov/sites/default/files/pdf/off-label-use-research-priorities_research.pdf
   May 01, 2009 - ICD-9 code did not match with an FDA approved indication for the drug. … to support common use for the other indication. … Off- label Indication Third Most Common Off-label Indication 1 quetiapine Schizophrenia Bipolar … c The number of uses for this off-label drug indication exceeded that for its most common on-label indication … and diagnosis where a non-specific diagnosis was used and the indication was quite specific.

2. Supplemental Evidence and Data Guidelines | Effective Health Care (EHC) Program
   effectivehealthcare-admin.ahrq.gov/get-involved/submit-sead/guidelines
   November 01, 2022 - it includes the following: A list of all completed studies your company has sponsored for this indication … ClinicalTrials.gov that includes the following elements: study number study period design methodology indication … effectiveness/efficacy and safety results A list of ongoing studies your company has sponsored for this indication … registered, the protocol for the study including a study number, the study period, design, methodology, indication … submitted information on ALL Phase II and above clinical trials sponsored by your company for this indication

3. Developing Evidence-Based Research Priorities for Off-Label Drug Use | Effective Health Care (EHC) Program
   effectivehealthcare-admin.ahrq.gov/products/off-label-use-research-priorities/research
   June 01, 2020 - Once approval for an indication is given, however, the FDA has a minimal role in determining whether … ICD-9 code did not match with an FDA approved indication for the drug. … to support common use for the other indication. … Off-label Indication Third Most Common Off-label Indication Footnotes: Diagnoses that … The number of uses for this off-label drug indication exceeded that for its most common on-label indication

4. Comparative Effectiveness Review No. 234 Evidence Summary: Management of Primary Headaches in Pregnancy (pdf file)
   effectivehealthcare-admin.ahrq.gov/sites/default/files/related_files/cer-234-headaches-pregnancy-summary.pdf
   November 01, 2020 -  Systematic reviews of harms (regardless of indication) report that acetaminophen, prednisolone, indomethacin … , we also searched for relevant SRs of interventions in women in the same phase, regardless of the indication … We identified indirect evidence (i.e., systematic reviews regardless of indication) that the following … We also identified indirect evidence (i.e., systematic reviews regardless of indication) that antihistamines … We identified indirect evidence (i.e., systematic reviews regardless of indication) that use of the

5. Quantitative Synthesis II: Interactive Quiz (ppt file)
   effectivehealthcare-admin.ahrq.gov/sites/default/files/related_files/selecting-evidence-quiz.ppt
   September 02, 2013 - What is confounding by indication? … Assessing Bias in Observational Studies Assessing Bias in Observational Studies What is confounding by indication … Confounding by indication is a type of selection bias that occurs when study groups differ because they … It is often difficult to adjust for confounding by indication in analyses; therefore, studies with a … Studies with a high risk of bias due to confounding by indication are usually not suitable for inclusion

6. Quantitative Synthesis II: Interactive Quiz (ppt file)
   effectivehealthcare-admin.ahrq.gov/sites/default/files/selecting-evidence-quiz.ppt
   September 02, 2013 - What is confounding by indication? … Assessing Bias in Observational Studies Assessing Bias in Observational Studies What is confounding by indication … Confounding by indication is a type of selection bias that occurs when study groups differ because they … It is often difficult to adjust for confounding by indication in analyses; therefore, studies with a … Studies with a high risk of bias due to confounding by indication are usually not suitable for inclusion

7. S13 (pdf file)
   effectivehealthcare-admin.ahrq.gov/sites/default/files/s13.pdf
   October 01, 2007 - vulnerable to random error, or confounding by a variable such as another drug, a disease, or the drug indication … stud- ies of the effectiveness of pharmaceuticals, present unique challenges involving confounding by indication … .12 People who receive a drug are different from people who do not, in that they have an indication for … This indication is commonly associated with the outcome under study, so unless the indication can be … Complete measurement of confound- ing by indication in this situation, on a longitudinal basis, is extraordinarily

8. Stem-Cell-Children Executive (pdf file)
   effectivehealthcare-admin.ahrq.gov/sites/default/files/related_files/stem-cell-children_executive.pdf
   February 01, 2012 - They are distinguished in each by the specific indication and the type of transplant procedure, as … They are distinguished in each by the specific indication and the type of transplant procedure, as … Pediatric HSCT indications to be addressed with narrative review (continued) Type Disease Indication … Pediatric HSCT indications to be addressed with narrative review (continued) Type Disease Indication … The strength of the body of evidence for each indication was assessed.

9. Disposition of Comments for Progestogens for Prevention of Preterm Birth (pdf file)
   effectivehealthcare-admin.ahrq.gov/sites/default/files/related_files/progestogens-preterm-birth-disposition-121205.pdf
   September 07, 2012 - The review now includes a meta-analysis by indication. … The review now includes a meta-analysis by indication. … Across other forms, the studies lack similarity in indication and use. … Indication appears to have more weight than formulation as all formulation. … None of the tables make this indication either.

10. Biologic and Nonbiologic Systemic Agents and Phototherapy for Treatment of Chronic Plaque Psoriasis | Effective Health Care (EHC) Program
    effectivehealthcare-admin.ahrq.gov/products/psoriasis-chronic/research-protocol
    December 01, 2019 - 500 mg/dL) hypertriglyceridemia Currently available; not currently being developed for this indication … † FDA indication as listed on the 510K preapproval documentation. … Only studies that evaluate interventions and comparators with a current indication approved by the U.S … For agents with an FDA-approved indication for the treatment of psoriasis, a search for completed trials … For agents with an FDA-approved indication for the treatment of psoriasis, a search for completed trials

11. White Paper: Enhancing Systematic Review Methods by Incorporating Unpublished Drug Trials (pdf file)
    effectivehealthcare-admin.ahrq.gov/sites/default/files/related_files/unpublished-drug-trials-white-paper.pdf
    December 01, 2024 - After going through this process for the three drug-indication combinations, we conducted analyses only … FDA-Approved Indications Versus Off-Label Uses: FDA reviews only cover drug- indication combinations … Indication approval FDA-approved indications Off-label uses FDA reviews available only for approved … Approval timing First approved indication Subsequently approved indications As explained above … We searched for additional drug-indication pairs but did not find one suitable for analysis; for example

12. Evidence-based Practice Center Systematic Review Protocol (pdf file)
    effectivehealthcare-admin.ahrq.gov/sites/default/files/pdf/psoriasis-chronic_research-protocol.pdf
    January 10, 2012 - † FDA indication as listed on the 510K preapproval documentation. … Only studies that evaluate interventions and comparators with a current indication approved by thus … For agents with an FDA-approved indication for the treatment of psoriasis, a search for completed trials … For agents with an FDA-approved indication for the treatment of psoriasis, a search for completed … approved indication for the treatment of psoriasis, a search for completed trials with posted results

13. Effectiveness of Medical Therapy, Endovascular Therapy, and Surgery for Peripheral Arterial Disease | Effective Health Care (EHC) Program
    effectivehealthcare-admin.ahrq.gov/products/peripheral-artery-disease-effectiveness/abstract
    December 01, 2019 - endovascular approaches will focus on the chart review sample where critical factors such as procedure indication … Adjusting for confounding will include stratification by key variables (i.e. procedure indication) as

14. S131 (pdf file)
    effectivehealthcare-admin.ahrq.gov/sites/default/files/s131.pdf
    October 01, 2007 - Restricting study cohorts to patients who are homogeneous regarding their indication for the study drug … confounding by selecting patients with the same indication (eg, indication for using celecoxib vs. rofecoxib … by the initiation of a treatment specific to the indication. … Obviously, patients on therapy most likely have a medical indication; by contrast a large proportion … of nonusers have no medical indication.

15. Disclosure Policy and Form (pdf file)
    effectivehealthcare-admin.ahrq.gov/sites/default/files/wysiwyg/pdf/epc-ki-tep-confidentiality-form.pdf
    August 01, 2020 - If they agree to provide comments, comments will be de-identified such that there will be no indication … If they agree to provide comments, comments will be de-identified such that there will be no indication

16. Evidence-based Practice Center Systematic Review Protocol (pdf file)
    effectivehealthcare-admin.ahrq.gov/sites/default/files/related_files/recombinant-factor-viia_disposition-comments.pdf
    June 01, 2010 - Introduction Indication/trial specific issues in analysis methodology The report acknowledges … In addition, we describe the criteria for combining certain studies on a given indication when the … behind decisions to pool, or not pool, studies (see specific sections for each indication entitled … As described above, for each indication, the report includes a section discussing heterogeneity and … needed so that the reporting of each key indication can stand on its own.

17. Data Points #20: Echocardiography Trends | Effective Health Care (EHC) Program
    effectivehealthcare-admin.ahrq.gov/products/echocardiography/research
    December 01, 2019 - The criteria vary by previous service and clinical indication, but in general echocardiography testing … is viewed as appropriate to assess conditions that have an indication of being cardiac in nature or

18. Topic 0613 Tympanostomy Tubes NSD FINAL (pdf file)
    effectivehealthcare-admin.ahrq.gov/sites/default/files/pdf/TND-0765-150129.pdf
    November 03, 2014 - children with chronic otitis media with effusion (OME) at different thresholds of frequency of clinical indication … children with recurrent acute otitis media (AOM) at different thresholds of frequency of clinical indication

19. #05 DEPRESSION (pdf file)
    effectivehealthcare-admin.ahrq.gov/sites/default/files/depression-horizon-scan-high-impact-1406.pdf
    June 01, 2014 - However, in May 2014, Corcept halted development of mifepristone for this indication, citing a failure … (Minneapolis, MN); Medtronic has since abandoned clinical trials for this indication but has stated … Lisdexamfetamine’s manufacturer, Shire, plc (Dublin, Ireland), is pursuing an expanded indication for …  Key Expert Comments: Experts commenting on ketamine for this indication were optimistic about its … FDA has granted fast-track status to esketamine for this indication, and Janssen has indicated plans

20. AHRQ Slide Template 2009 (ppt file)
    effectivehealthcare-admin.ahrq.gov/sites/default/files/related_files/selecting-evidence.ppt
    January 01, 2010 - Confounding by Indication Confounding by indication is a type of selection bias that occurs when groups … It is often difficult to adjust for confounding by indication; therefore, studies with a high degree … of potential bias because of confounding by indication are usually not suitable for inclusion in a comparative … Bias from confounding by indication can sometimes be mitigated by using propensity scores. … Confounding by indication is not much of an issue for unexpected or unpredictable harms, so observational