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1. Comparative Effectiveness of In-Hospital Use of Recombinant Factor VIIa for Off-Label Indications vs. Usual Care | Effective Health Care (EHC) Program
   effectivehealthcare-admin.ahrq.gov/products/recombinant-factor-viia/research
   March 01, 2020 - Comparative Effectiveness of In-Hospital Use of Recombinant Factor VIIa for Off-Label Indications … effectiveness and safety of using recombinant activated coagulation factor VII (rFVIIa) for clinical indications … Use of this costly biologic product has expanded beyond these hemophilia-related indications to encompass … The purpose of this report is two-fold: (1) To document the full range of clinical indications for which … provide a comparative effectiveness review of rFVIIa vs. usual care for several in-hospital clinical indications

2. QUESTIONS What are the appropriate indications for tonsillectomy Recurrent infections how many Sleep disordered breathingShould clinicians administer or prescribe perioperative antibiotics to children undergoing tonsillectomyRELEVANT… | Effective Health Care (EHC) Program
   effectivehealthcare-admin.ahrq.gov/get-involved/nominated-topics/questions-what-are-the-appropriate-indications-for-tonsillectomy-recurrent-infections-how-many-sleep-disordered-breathingshould-clinicians-administer-or-prescribe-perioperative-antibiotics-to-children-undergoing-tonsillectom
   November 01, 2017 - Evidence Reports Nominated Topics QUESTIONS What are the appropriate indications … SHARE: QUESTIONS What are the appropriate indications … QUESTIONS What are the appropriate indications for tonsillectomy Recurrent infections how many Sleep … GROUPChildren 1 to 18 years of age who may be candidates for tonsillectomyBENEFITS The 2 most common indications … created August 2014 Internet Citation: QUESTIONS What are the appropriate indications

3. Data Points #10: Proton beam radiotherapy in the U.S. Medicare population: growth in use between 2006 and 2009 | Effective Health Care (EHC) Program
   effectivehealthcare-admin.ahrq.gov/products/radiotherapy-proton-beam/research
   December 01, 2019 - CMS has yet to issue a national coverage rule for proton beam therapy or its specific indications. … Currently, LCDs vary by contractor regarding their indications for coverage of proton beam radiotherapy … A requirement (for some indications) that the patient be treated as part of a clinical trial. … Providers must contact the contractor to discuss indications and payment. … Despite the rarity of commonly accepted indications such as tumors of the eye, skull base, and spinal

4. Comparative Effectiveness, Safety and Indications of Pre-mixed Insulin Analogues for Adults with Type 2 Diabetes | Effective Health Care (EHC) Program
   effectivehealthcare-admin.ahrq.gov/products/type-2-diabetes-insulin/research
   December 01, 2019 - Home Evidence Reports Comparative Effectiveness, Safety and Indications … SHARE: Comparative Effectiveness, Safety and Indications … Project Timeline Comparative Effectiveness, Safety and Indications of Pre-mixed Insulin Analogues for … Citation: Systematic Review: Comparative Effectiveness, Safety and Indications

5. Radiotherapy-Proton-Beam Research (pdf file)
   effectivehealthcare-admin.ahrq.gov/sites/default/files/pdf/radiotherapy-proton-beam_research.pdf
   May 01, 2012 - CMS has yet to issue a national coverage rule for proton beam therapy or its specific indications. … A requirement (for some indications) that the patient be treated as part of a clinical trial. 4. … Providers must contact the contractor to discuss indications and payment. … Despite the rarity of commonly accepted indications such as tumors of the eye, skull base, and spinal … the LCDs listing specific indications. † Constitute separate categories in our analysis due to their

6. Layout 1 (pdf file)
   effectivehealthcare-admin.ahrq.gov/sites/default/files/related_files/recombinant-factor-viia_executive.pdf
   May 01, 2010 - Comparative Effectiveness of In-Hospital Use of Recombinant Factor VIIa for Off-Label Indications vs … indications that are similar to hemophilia. … Studies on other indications were included in our survey of existing research. … Studies on other indications were included in our survey of existing research. … The rate of increase may be plateauing for many indications (Figure B).

7. Evidence Report on the (pdf file)
   effectivehealthcare-admin.ahrq.gov/sites/default/files/pdf/osteoarthritis-pain_research-protocol.pdf
   August 05, 2010 - Pharmacokinetics, Indications, and Dosing of drugs to be included. … (trade names provided only for drugs under patent) Drug (any trade name): acetaminophen Labeled indications … patients (Peds): 10−15 mg/kg/dose up to 5 doses/day Drug (any trade name): aspirin Labeled indications … weighing >60 kg: extended release,1000 mg 1x/day Drug (any trade name): fenoprofen Labeled indications … renal impairment: no dose adjustment necessary Drug (any trade name): flurbiprofen Labeled indications

8. Refining Key Questions: Interactive Case Study Quiz
   effectivehealthcare-admin.ahrq.gov/sites/default/files/related_files/rfviia.pptx
   May 01, 2010 - Comparative Effectiveness of In-Hospital Use of Recombinant Factor VIIa for Off-Label Indications vs. … Comparative Effectiveness of In-Hospital Use of Recombinant Factor VIIa for Off-Label Indications vs. … Increasingly used off-label beyond hemophilia-related indications to prevent excessive bleeding for a … , and studies on the potential harms for the five indications were included. … There are no indications where potential risks are likely to greatly exceed the benefits.  

9. Refining Key Questions: Interactive Case Study Quiz
   effectivehealthcare-admin.ahrq.gov/sites/default/files/rfviia.pptx
   May 01, 2010 - Comparative Effectiveness of In-Hospital Use of Recombinant Factor VIIa for Off-Label Indications vs. … Comparative Effectiveness of In-Hospital Use of Recombinant Factor VIIa for Off-Label Indications vs. … Increasingly used off-label beyond hemophilia-related indications to prevent excessive bleeding for a … , and studies on the potential harms for the five indications were included. … There are no indications where potential risks are likely to greatly exceed the benefits.  

10. What are the indications for inserting tympanostomy tubes how many Otitis Media w Effusion or Acute Otitis Media episodes in what time frameShould clinicians obtain a hearing test prior to inserting tympanostomy tubesShould clinicians… | Effective Health Care (EHC) Program
    effectivehealthcare-admin.ahrq.gov/get-involved/nominated-topics/what-are-the-indications-for-inserting-tympanostomy-tubes-how-many-otitis-media-w-effusion-or-acute-otitis-media-episodes-in-what-time-frameshould-clinicians-obtain-a-hearing-test-prior-to-inserting-tympanostomy-tubesshould-
    November 01, 2017 - Home Evidence Reports Nominated Topics What are the indications … SHARE: What are the indications … What are the indications for inserting tympanostomy tubes how many Otitis Media w Effusion or Acute Otitis … burden and concerns over the appropriateness of surgery create a clear need for evidencebased surgical indications … Page originally created August 2014 Internet Citation: What are the indications

11. 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 - Using the data and information on labeled indications available from the FDA, prescription uses were … While similar to the algorithm of Radley, 9 we sought to explicitly consider those indications where … In using the DRUGDEX compendium, a particular challenge was matching the ICD-9 coding of indications … possible between NDTI ICD-9 codes and the DRUGDEX indications. … We assessed off-label use involving drugs used for indications not approved by the FDA.

12. Topic 0613 Tympanostomy Tubes NSD FINAL (pdf file)
    effectivehealthcare-admin.ahrq.gov/sites/default/files/pdf/TND-0765-150129.pdf
    November 03, 2014 - professional association Nomination The nominator asserts that there is clinical uncertainty regarding indications … effectiveness of obtaining a hearing test prior to inserting tympanostomy tubes to improve certainty of indications … tympanostomy tubes Intervention(s): Hearing testing Comparator(s): No test Outcome(s): Improvement in indications … What are the indications for inserting tympanostomy tubes (how many otitis media w/ effusion or acute … submit-a-suggestion-for-research/how-are-research- topics-chosen/.) § Tympanostomy tubes are used to treat different indications

13. Topic 0614 Tonsillectomy NSD FINAL CC (pdf file)
    effectivehealthcare-admin.ahrq.gov/sites/default/files/pdf/TND-0768-141211.pdf
    October 23, 2014 - s): Organization Nomination The nominator asserts that there is clinical uncertainty regarding indications … nomination notes recurrent throat infections and sleep disordered breathing (SDB) as the two most common indications … What are the appropriate indications for tonsillectomy? … The two most common indications for tonsillectomy in children are recurrent throat infections and sleep

14. Chicago-Area DEcIDE Center (pdf file)
    effectivehealthcare-admin.ahrq.gov/sites/default/files/pdf/off-label-use-research-priorities_research.pdf
    May 01, 2009 - Drug use for indications not approved by the Food and Drug Administration exceeds 20% of outpatient … Using the data and information on labeled indications available from the FDA, prescription uses were … While similar to the algorithm of Radley,9 we sought to explicitly consider those indications where … possible between NDTI ICD-9 codes and the DRUGDEX indications. … We assessed off-label use involving drugs used for indications not approved by the FDA.

15. Management of Uterine Fibroids | Effective Health Care (EHC) Program
    effectivehealthcare-admin.ahrq.gov/products/uterine-fibroids/research-protocol
    May 01, 2019 - : Ovulation induction Non-FDA labeled indications : Uterine leiomyoma Merck Serono (EMD Serono … , Inc.), Rockland, MA, USA Goserelin Acetate, Zoladex® FDA-labeled indications : Breast … : Prostate cancer, advanced Non-FDA labeled indications : Central precocious puberty; Endometrial … : emergency conception Non FDA-labeled indications: Menorrhagia, uterine leiomyoma (preoperative) … : Breast cancer, Invasive, in postmenopausal women Non-FDA labeled indications : first-line therapy

16. Efficacy and Comparative Effectiveness of Off-Label Use of Atypical Antipsychotics – Update | Effective Health Care (EHC) Program
    effectivehealthcare-admin.ahrq.gov/products/atypical-antipsychotics-off-label-update/research-protocol
    March 01, 2020 - insufficient high-quality evidence overall to reach conclusions about the efficacy of any off-label indications … treatment in October 2006) Autism (included in the original systematic review1) and all on-label indications … if they have been prescribed for other conditions; New or increased adverse effects of off-label indications … Special attention will be given to identify the effective dose and time limit for off-label indications … The evidence of risks – adverse events associated with off-label indications – will be summarized, first

17. uterine-fibroids-protocol-160301 (pdf file)
    effectivehealthcare-admin.ahrq.gov/sites/default/files/pdf/uterine-fibroids_research-protocol.pdf
    March 01, 2016 - :   Ovulation  induction     Non-­FDA  labeled  indications:   Uterine  leiomyoma   Merck  Serono   … Rockland,  MA     USA   Goserelin  Acetate     Zoladex®   FDA-­labeled  indications:  Breast  cancer … :   Prostate  cancer,  advanced     Non-­FDA  labeled  indications:   Central  precocious  puberty;; …  conception     Non  FDA-­labeled  indications:     Menorrhagia,  uterine  leiomyoma  (preoperative … :     Breast  cancer,  Invasive,  in  postmenopausal   women;;       Non-­FDA  labeled  indications:

18. Effective Health Care (pdf file)
    effectivehealthcare-admin.ahrq.gov/sites/default/files/pdf/TND_0030_06-19-2008.pdf
    January 01, 2008 - what mechanical thrombectomy devices are used in patients with acute coronary syndromes (ACSs), their indications … What are the indications for their use? 3.

19. Evidence Report on the (pdf file)
    effectivehealthcare-admin.ahrq.gov/sites/default/files/pdf/atypical-antipsychotics-off-label-update_research-protocol.pdf
    May 19, 2010 - insufficient high-quality evidence overall to reach conclusions about the efficacy of any off-label indications … treatment in October 2006) • Autism (included in the original systematic review1) and all on-label indications … they have been prescribed for other conditions; • New or increased adverse effects of off-label indications … Special attention will be given to identify the effective dose and time limit for off-label indications … The evidence of risks – adverse events associated with off-label indications – will be summarized, first

20. Stem-Cell-Children Executive (pdf file)
    effectivehealthcare-admin.ahrq.gov/sites/default/files/related_files/stem-cell-children_executive.pdf
    February 01, 2012 - A final list of indications for narrative reviews compiled by the EPC was posted for public comment … Systematic Reviews Table B shows the indications that were systematically reviewed. … 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 … Pediatric HSCT indications to be addressed with systematic review (continued) Type Disease Indication