Drug Information and Literature Evaluation, Second Edition — bibliography

  1. AGREE. The Appraisal of Guidelines for Research and Evaluation (AGREE). https://www.agreetrust.org/
  2. Althunian TA et al. (2017). Defining the noninferiority margin and analysing noninferiority: An overview. Br J Clin Pharmacol 83(8):1636-42. doi: 10.1111/bcp.13280
  3. Balistreri WF (2007). Landmark, landmine, or landfill? The role of peer review in assessing manuscripts. J Pediatr 151:107-8. doi: 10.1016/j.jpeds.2007.05.049
  4. Blommel MJ, Abate MA (2007). A rubric to assess critical literature evaluation skills. Am J Pharm Educ 71(4):Article 63. doi: 10.5688/aj710463
  5. BMC.Discussion and conclusions. BioMed Central Ltd. https://www.biomedcentral.com/ getpublished/writing-resources/discussion-and-conclusions
  6. Bruce N, Pope D, Stanistreet D (2018). Quantitative methods for health research, 2nd ed. West Sussex: John Wiley & Sons Ltd.
  7. Cheng C et al. (2017). Chemical leukoderma associated with methylphenidate transdermal system: data from the US Food and Drug Administration Adverse Event Reporting System. J Pediatr 180:241-6. doi: 10.1016/j.jpeds.2016.09.008
  8. Chinchilli VM (2007). General principles for systematic reviews and meta-analyses and a critique of a recent systematic review of long-acting beta-agonists. J Allergy Clin Immunol 119:303-6. doi: 10.1016/j.jaci.2006.11.632
  9. Creswell JW, Creswell JD (2018). Research Design: Qualitative, Quantitative, and Mixed Methods Approaches, 5th ed. Thousand Oaks, CA: Sage Publishing.
  10. Duan N, Kravitz RL, Schmid CH (2013). Single-patient (n-of-1) trials: a pragmatic clinical decision methodology for patient-centered comparative effectiveness research. J Clin Epidemiol 66(8):S21-8. doi: 10.1016/j.jclinepi.2013.04.006
  11. Duerden M (2009). What are hazard ratios? What is…? series. Hayward Group Ltd. https://www. researchgate.net/publication/242181989_What_are_hazard_ratios
  12. Edwards IR, Aronson JK (2000). Adverse drug reactions: definitions, diagnosis, and management. Lancet 356(9237):1255-9. doi: 10.1016/S0140-6736(00)02799-9
  13. Egger M, Smith GD (1998). Bias in location and selection of studies. BMJ 316(7124): 61-6. doi: 10.1136/bmj.316.7124.61
  14. Flynn R (2012). Survival analysis. J Clin Nurs 21(19-20): 2789-97. doi: 10.1111/j.13652702.2011.04023.x
  15. Food and Drug Administration (1998). A Guide to Informed Consent. https://www.fda.gov/ regulatory-information/search-fda-guidance-documents/guide-informed-consent#general
  16. FDA .MedWatch: The FDA Safety Information and Adverse Event Reporting Program. https:// www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program
  17. Friedman LM, Furberg CD, DeMets DL (2015).  Fundamentals of Clinical Trials. 5th ed. New York, NY: Springer.
  18. Galt KA, Calis KA, Turcasso NM (1995). Clinical Skills Program: Module 3 Drug Information.
  19. Bethesda, MD: American Society of Health-System Pharmacists Inc.
  20. Gopalakrishnan S, Ganeshkumar P (2013). Systematic reviews and meta-analysis: understanding the best evidence in primary healthcare. J Family Med Prim Care 2(1): 9-14. doi: 10.4103/22494863.109934
  21. Ghosh R, Alajbegovic A, Gomes AV (2015). NSAIDs and cardiovascular diseases: role of reactive oxygen species. Oxid Med Cell Longev 2015:536962. doi: 10.1155/2015/536962
  22. Grasselli G et al. (2020). Risk Factors Associated With Mortality Among Patients With COVID-19 in Intensive Care Units in Lombardy, Italy. JAMA Intern Med 180: 1345-55. doi: 10.1001/ jamainternmed.2020.3539. Erratum in: JAMA Intern Med 2021,18:1021. doi: 10.1001/ jamainternmed.2021.1229
  23. Green J, Thorogood N (2018). Qualitative Methods for Health Research. 4th ed. Thousand Oaks, CA: Sage Publishing.
  24. Gregory AT, Denniss AR (2019). Everything you need to know about peer review – the good, the bad and the ugly. Heart Lung Circ 28(8): 1148-53. doi: 10.1016/j.hlc.2019.05.171
  25. Guyatt G et al. eds. (2015). Users’ guides to the medical literature. Essentials of evidence-based clinical practice, 3rd ed. New York, NY: The McGraw-Hill Education.
  26. Hess DR (2004). How to write an effective discussion. Respir Care 49(10): 1238-41. PMID: 15447810
  27. Institute of Medicine (2011). Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press. doi.org/10.17226/13058
  28. Institute for Safe Medication Practices (ISMP) (2022). ISMP Targeted Medication Safety Best Practices for Hospitals. https://www.ismp.org/guidelines/best-practices-hospitals
  29. Janosky JE (2005). Use of the single subject design for practice based primary care research. Postgrad Med J  81(959):549–51. doi: 10.1136/pgmj.2004.031005
  30. Kaul S (2021). Understanding the merits and drawbacks of noninferiority trials in cardiovascular medicine. Can J Cardiol Sep;37(9):1378-93. doi: 10.1016/j.cjca.2021.05.017
  31. Koletsi D, Pandis N (2017). Survival analysis, part 1: Introduction. Am J Orthod Dentofacial Orthop 152(3):428-30. doi: 10.1016/j.ajodo.2017.07.007
  32. Koren G, Nachmani A (2019). Drugs that can kill a toddler with one tablet or teaspoonful: a 2018 updated list. Clin Drug Investig 39:217-20. doi: 10.1007/s40261-018-0726-1
  33. Lang TA, Secic M. (2006). How to Report Statistics in Medicine. Philadelphia, PA: American College of Physicians.
  34. Leon AC (2011). Comparative effectiveness clinical trials in psychiatry: superiority, noninferiority, and the role of active comparators. J Clin Psychiatry 72:1344-9. doi: 10.4088/JCP.10m06089whi
  35. Leung JT et al. (2020). Non-inferiority trials in cardiology: what clinicians need to know. Heart 106(2): 99-104. doi: 10.1136/heartjnl-2019-315772
  36. Mahase E (2021). US taskforce advises against low dose aspirin for primary prevention of cardiovascular disease. BMJ 2021, 375:n2521. doi: 10.1136/bmj.n2521
  37. Margolis A, Giuliano C (2019). Making the switch: from case studies to N-of-1 trials. Epilepsy Behav Rep 12:100336. doi: 10.1016/j.ebr.2019.100336
  38. Motulsky H (2018). Intuitive Biostatistics. 4th ed. New York, NY: Oxford University Press.
  39. Murad MH et al. (2014). How to read a systematic review and meta-analysis and apply the results to patient care: users’ guides to the medical literature. JAMA 312(2):171-9. doi: 10.1001/ jama.2014.5559
  40. Naranjo CA et al. (1981). A method for estimating the probability of adverse drug reactions. Clin
  41. Pharmacol Ther 30:239-45. doi: 10.1038/clpt.1981.154
  42. National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance Project (NEISS-CADES). https://www.cpsc.gov/Research–Statistics/NEISS-Injury-Data
  43. Oczkowski SJ (2014). A clinician’s guide to the assessment and interpretation of noninferiority trials for novel therapies .Open Med 8(2): e67-72. PMICD: PMC4085087
  44. Phillips MR et al. (2022). The clinician’s guide to p values, confidence intervals, and magnitude of effects. Eye  36:341–2. doi: 10.1038/s41433-021-01863-w. Erratum in: Eye 2022 Jan 19. doi: 10.1038/s41433-021-01914-2
  45. Pierre-Victor D, Pinsky PF (2019). Association of nonadherence to cancer screening examinations with mortality from unrelated causes: a secondary analysis of the PLCO cancer screening trial. JAMA Intern Med 179(2): 196-203. doi: 10.1001/jamainternmed.2018.5982
  46. Pintor-Marmol A et.al. (2012). Terms used in patient safety related to medication: a literature review. Pharmacoepidemiol Drug Saf  21:799-809. doi: 10.1002/pds.3296
  47. Pope C, Mays N (2020). Qualitative Research in Health Care. 4th ed. West Sussex: John Wiley & Sons Ltd.
  48. Portney LG (2020). Foundations of Clinical Research. 4th ed. Philadephia, PA: F.A. Davis Company.
  49. Piaggio G et al. (2012). Reporting of noninferiority and equivalence randomized trials: extension of the CONSORT 2010 statement. JAMA 308(24):2594-604. doi: 10.1001/jama.2012.87802 Schulz KF, Grimes DA (2002). Blinding in randomised trials: hiding who got what. Lancet 359:696–700. doi: 10.1016/S0140-6736(02)07816-9
  50. Shea BJ et al. (2017). AMSTAR 2: a critical appraisal tool for systematic reviews that include randomised or non-randomised studies of healthcare interventions, or both. BMJ  358:j4008. doi: 10.1136/bmj.j4008
  51. Schünemann HJ et al. (2022), Chapter 15: Interpreting results and drawing conclusions. In: Higgins JPT et al. (editors). Cochrane Handbook for Systematic Reviews of Interventions version 6.3 (updated February 2022). Cochrane, 2022. https://training.cochrane.org/handbook/current/chapter-15.
  52. Siemieniuk R, Guyatt G (2022). What is GRADE? 2022. BMJ Best Practice. https://bestpractice.bmj.com/info/toolkit/learn-ebm/what-is-grade/
  53. Singh S (2017). How to Conduct and Interpret Systematic Reviews and Meta-Analyses. Clin Transl Gastroenterol 8(5): e93. doi: 10.1038/ctg.2017.20
  54. Sterne JAC et al. (2019). RoB 2: a revised tool for assessing risk of bias in randomised trials. BMJ  366: l4898. doi: 10.1136/bmj.l4898
  55. Taylor H. The growing influence and use of health care information online. The Harris Poll #98, September 15, 2011.
  56. Tripepi G et al. (2020). Intention to treat and per protocol analysis in clinical trials. Nephrology (7): 513-17. doi: 10.1111/nep.13709
  57. Urdan TC (2017). Statistics in plain English. New York, NY: Routledge.
  58. U.S. Department of Health and Human Services, Office for Human Research Protections (2018).
  59. Institutional Review Board Written Procedures: Guidance for Institutions and IRBs (2018). https://www.hhs.gov/ohrp/regulations-and-policy/guidance/institutional-issues/institutionalreview-board-written-procedures/index.html
  60. Vavken P (2011). Rationale for and methods of superiority, noninferiority, or equivalence designs in orthopaedic, controlled trials. Clin Orthop Relat Res 469(9):2645-53. doi: 10.1007/s11999-0111773-6
  61. Vickers A (2010). What is a p-value anyway? Boston, MA: Addison-Wesley.
  62. Watanabe AS, Conner CS (1978). Principles of Drug Information Services. Hamilton, IL: Drug Intelligence Publications Inc.
  63. Uppsala Monitoring Centre. The use of the WHO-UMC system for standardised case causality assessment. https://www.who.int/medicines/areas/quality_safety/safety_efficacy/WHOcausality_assessment.pdf
  64. Yeh JS, Sarpatwari A, Kesselheim AS (2016). Ethical and practical considerations in removing black box warnings from drug labels. Drug Saf  39(8):709-14. doi: 10.1007/s40264-016-0419-8