Guidelines Index for Outcomes Research Logo
Guideline Index for Outcomes Research and Use in Health Care Decision Making

The objective of the Outcomes Research Guideline Index is to improve state-of-the-art methods in outcomes research and gain acceptance of their use in research and decision-making. The ‘GENERATING HEALTH CARE EVIDENCE » SYNTHESIZING EVIDENCE » USING EVIDENCE IN HEALTH CARE DECISIONS: OUTCOMES RESEARCH GUIDELINE INDEX was developed to: 1) identify current health care evidence methodology guidelines* (see guideline definition below) as well as  useful textbooks and review papers; 2) identify health care evidence methodology guideline  gaps; and 3) to provide a useful tool to prioritize and develop contentious evidence generation, synthesis and use methods. The ‘Outcomes Research Guideline Index’ is a web-based compendium of methods guidelines (as well as key textbooks and review papers) used in generating health care research evidence, synthesizing evidence, and using evidence in health care decision making. These methods are applicable to all diseases and health disorders and health care interventions. This compendium is organized as follows:

Generating Health Care Evidence
  1. Quantitative Clinical Outcomes Assessment & Reporting Methods
  2. Qualitative Clinical Outcomes Assessment Methods
  3. Patient Preference Methods
  4. Health Economic Evaluation Methods
  5. Health Care Research Statistical Methods
  6. Social and Ethical Aspects of Health Technologies Research Methods
Synthesizing Health Care Evidence
  1. Evidence Synthesis Research Methods
  2. Modeling/Decision Analysis Methods
  3. Health Economic Evaluation Framework and Methods
  4. Social and Ethical Aspects of Health Technologies Research Methods
Using Evidence in Health Care Decisions
  1. Payer (population-based) Health Care Decision
  2. Individual Health Care Decisions by Clinicians & Patients

Outcomes Research Guidelines Task Force

*Health Care Evidence Methodology Guideline Definition

Comments:
Your assistance is needed in updating this ‘Outcomes Research Guideline Index’, please email your comments, suggested guidelines, key textbooks or review articles (full citation and website link) to: guidelines@ispor.org. Indicate the method for which these documents are provided.

ArrowGenerating Health Care Evidence

Methods GUIDELINES TEXTBOOKS REVIEWS/KEYPAPERS
I. Quantitative Clinical Outcomes Assessment & Reporting Methods
  1. Randomized Clinical Research & Reporting Methods
Title: CONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomized Trials
Source: CONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomized Trials
Comments:
Title: Principles and Practice of Clinical Research by Gallin, J.I.,
Source: San Diego, CA: Academic Press, ed. 2002
Comments:
 
  1. Adaptive clinical trials
Title: Standards for Patient-Centered Outcomes Research
Source: http://pcori.org/assets/Methodology-Report-072312.pdf
   
  Title: PCORI Methodology Standards
Source: http://pcori.org/assets/PCORI-Methodology-Standards1.pdf
   
  1. Pragmatic clinical trial/large simple clinical trials
Title: Guidelines for reporting experimental studies
Source: Guidelines for reporting experimental studies
Comments:
   
  Title: Improving the reporting of pragmatic trials: an extension of the CONSORT statement.
Source: Improving the reporting of pragmatic trials: an extension of the CONSORT statement.
Comments:
   
  1. Generalizability of clinical trial information-RCT vs. adaptive/pragmatic trial; geographic generalization
     
  1. Validation of surrogate and intermediate endpoints
     
  1. Prospective Observational Research & Reporting Methods
Title: Guidelines for reporting observational studies
Source: Guidelines for reporting observational studies
Comments:
Title: Risk Adjustment for Measuring Healthcare Outcomes by Iezzoni, L.I.
Source: 3rd ed. Chicago, IL: Health Administration Press, ed. 2003
Comments:
 
  1. Safety/Pharmacovigilance methods
Title: Assessing Harms when Comparing Medical Interventions
Source: Assessing Harms when Comparing Medical Interventions
Comments:
   
  Title: International Ethical Guidelines for Biomedical Research Involving Human Subjects
Source: Council for International Organizations of Medical Sciences (CIOMS)
Comments:
   
  1. Pharmacoepidemiology methods
Title: European Network of Centes for Pharmcoepidemiology and Pharmacovigilance (ENCePP) ENCePP Guide on Methodological Standards in Pharmacoepdiemiolgy
Source: Standards and Guidances
Comments:
Title: Clinical Epidemiology: How to Do Clinical Practice Research by Haynes, R.B.
Source: 3rd ed. Philadelphia, PA: Lippincott Williams & Wilkins, 2006
Comments:
 
  Title: Guidelines for Good Pharmacoepidemiology Practices (GPP)
Source: Guidelines for Good Pharmacoepidemiology Practices (GPP)
Comments:
Title: Clinical Trials: a Methodologic Perspective by Piantadosi, S.
Source: 2nd ed. New York, NY: John Wiley and Sons, Inc, 2005
Comments:
 
    Title: Epidemiology by Gordis, L.
Source: 3rd ed. Philadelphia, PA: W.B. Saunders, 2004
Comments:
 
    Title: Modern Epidemiology by Rothman J.K., Greenland S.
Source: 2nd edition. Philadelphia, PA: Lippincott Williams & Wilkins., 1998
Comments:
 
    Title: Population Health: Concepts and Methods by Young T.K.
Source: Second edition. New York: Oxford University Press 2005
Comments:
 
  1. Disease prevalence / incidence methods
Title: Strobe-Statement
Source: Strobe-Statement
Comments:
   
  1. Patient registry methods
Title: Registries for Evaluating Patient Outcomes: A User’s Guide: 2nd Edition
Source: Registries for Evaluating Patient Outcomes: A User’s Guide: 2nd Edition
Comments:
   
  1. Surveys
  Title: Designing and Conducting Health Surveys: A Comprehensive Guide by Aday, L.A., Cornelius, L.J.
Source: 3rd ed. San Francisco, CA: Jossey-Bass Publishers, 2006
Comments:
 
    Title: Doing Survey Research: a Guide to Quantitative Methods by Nardi, P.M.
Source: 2nd ed. Boston, MA: Pearson/Allyn & Bacon, 2006
Comments:
 
    Title: Focus Groups: A Practical Guide for Applied Research by Krueger, R.A., Kasey, M.A.
Source: 3rd ed. Thousand Oaks, CA: Sage Publications, 2000
Comments:
 
    Title: Mail and Internet Surveys - The Tailored Design Method by Dillman, D. A.
Source: 2nd edition. New York: John Wiley & Sons, Inc., 2007
Comments:
 
    Title: Survey Methodology by Groves, R.M.
Source: New York, NY: John Wiley and Sons, Inc, et al. 2004
Comments:
 
  1. Reporting of observational research
Title: STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies.
Source: The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies
Comments:
Title: Community Based Participatory Research for Health by Minkler, M., Wallerstein, N.
Source: San Francisco, CA: Jossey-Bass Publishers, eds. 2002
Comments:
 
  Title: Observational Studies in Epidemiology (STROBE):explanation and elaboration.
Source: Strengthening the Reporting of Observational Studies in Epidemiology (STROBE):explanation and elaboration; Strobe-Statement
Comments:
Title: Cross-cultural Survey Methods by Harkness, J.A., van de Vijver, F.J.R., Mohler, P.P.
Source: Hoboken, NJ: John Wiley and Sons, Inc, eds. 2003
Comments:
 
    Title: Experimental and Quasi-experimental Designs for Research by Campbell, D.T., Stanley, J.C.
Source: Chicago, IL: Rand McNally, 1969
Comments:
 
    Title: Handbook of Health Research Methods, Investigation Measurement and Analysis by Bowling, A., Ebrahim, S.
Source: Washington, DC: National Academies Press, 2005
Comments:
 
    Title: Methods in Community-based Participatory Research for Health by Israel, B.A., Eng, E., Schulz, A.J., Parker, E.A.
Source: San Francisco, CA: Jossey-Bass Publishers, eds. 2005
Comments:
 
    Title: Social Science Approaches to Health Services Research by Choi, T., Greenberg, J.N.
Source: Ann Arbor, MI: Health Administration Press, eds. 1983
Comments:
 
  1. Observational - Secondary Database Research Methods
     
  1. Health care data – assessment of types, database design, and management
     
  1. Health care data - medical record extraction and abstracting methods
     
  1. Health care claims data analysis
Title: Guidelines for Good Database Selection and use in Pharmacoepidemiology Research
Source: Guidelines for Good Database Selection and use in Pharmacoepidemiology Research
Comments:
   
  1. Retrospective (secondary) database analysis
Title: Observational Study Methods-Database Methods/A Checklist For Retrospective Database Studies
Source: Observational Study Methods-Database Methods/A Checklist For Retrospective Database Studies
Comments:
   
  1. Retrospective (secondary) database analysis-confounding, bias, causal inference
Title: Retrospective Database Analysis – Bias & Confounding in the Design
Source: Retrospective Database Analysis – Bias & Confounding in the Design
Comments:
   
  Title: Retrospective Database Analysis – Causal Inference
Source: Retrospective Database Analysis – Causal Inference
Comments:
   
  1. Retrospective (secondary) database analysis-reporting
Title: Retrospective Database Analysis – Defining, Reporting & Interpreting
Source: Retrospective Database Analysis – Defining, Reporting & Interpreting
Comments:
   
  Title: The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies
Source: The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies
Comments:
   
  1. Generalizability of secondary database research methods and/or results
     
  1. Observational comparative effectiveness research
Title: Developing a Protocol for Observational Comparative Effectiveness Research: A User's Guide
Source:
http://effectivehealthcare.ahrq.gov/ehc/products
/440/1166/User-Guide-Observational-CER-130113.pdf

Comments:
   
  1. Medication adherence / compliance / persistence
Title: A Checklist for Medication Compliance and Persistence Studies Using Retrospective Databases
Source: A Checklist for Medication Compliance and Persistence Studies Using Retrospective Databases
Comments:
   
  Title: Medication Compliance and Persistence: Terminology and Definitions
Source: A Checklist for Medication Compliance and Persistence Studies Using Retrospective Databases
Comments:
   
  Title: Methods for Integrating Medication Compliance and Persistence in Pharmacoeconomic Evaluations
Source: Methods for Integrating Medication Compliance and Persistence in Pharmacoeconomic Evaluations
Comments:
   
  1. Real time analyses (rapid learning healthcare system)
     
  1. Dealing with heterogeneity of treatment effect
     
  1. Classical subgroup analysis
     
  1. Personalized medicine methods – biomarkers; stratification of patients methods for clinical studies
     
  1. Patient-Centered Outcomes Research
Title: Standards for Patient-Centered Outcomes Research
Source: http://pcori.org/assets/Methodology-Report-072312.pdf
   
Title: PCORI Methodology Standards
Source: http://pcori.org/assets/PCORI-Methodology-Standards1.pdf
   
II. Qualitative Clinical Outcomes Assessment Methods
  1. Qualitative research methods
  Title: Basics of Qualitative Research: Techniques and Procedures for Developing Grounded Theory by Strauss, A., Corbin, J. M.
Source: Thousand Oaks, CA: Sage Publications, 1998
Comments:
 
    Title: Measuring Health: a Guide to Rating Scales and Questionnaires by McDowell, I., Newell, C.
Source: 3rd ed. New York, NY: Oxford University Press, 2006
Comments:
 
    Title: Qualitative Data Analysis: An Expanded Sourcebook by Miles, M. B., Huberman, A. M.
Source: 2nd ed. Thousand Oaks, CA: Sage Publications, 1994
Comments:
 
    Title: Qualitative Research and Evaluation Methods by Patton, M.Q.
Source: 3rd ed. Thousand Oaks, CA: Sage Publications, 2002
Comments:
 
    Title: The Sage Handbook of Qualitative Research by Denzin, N.K., Lincoln, Y.S.
Source: Thousand Oaks, CA: Sage Publications, eds. 2005
Comments:
 
  1. Patient reported outcomes assessment
Title: Incorporating the Patient's Perspective into Drug Development and Communication
Source: Incorporating the Patient's Perspective into Drug Development and Communication
Comments:
Title: Fundamentals of Item Response Theory by Hambleton, R. K., Swaminathan, H., Rogers, J.
Source: Newbury Park, CA: Sage Publications, 1991
Comments:
 
  1. Health related quality of life-translation
Title: Multinational Trials—Recommendations on the Translations Required,Approaches to Using the Same Language in Different Countries, and the Approaches to Support Pooling the Data:The ISPOR Patient-Reported Outcomes Translation and Linguistic Validation Good R
Source: Multinational Trials—Recommendations on the Translations Required,Approaches to Using the Same Language in Different Countries, and the Approaches to Support Pooling the Data:The ISPOR Patient-Reported Outcomes Translation and Linguistic Validation Good R
Comments:
   
  Title: Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures: Report of the ISPOR Task Force for Translation and Cultural Adaptation
Source: Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures: Report of the ISPOR Task Force for Translation and Cultural Adaptation
Comments:
   
  1. Patient Reported Outcomes Assessment-content validity, new and existing instruments
Title: Good Research Practices on New PRO Instruments – Assessing Respondent Understanding
Source: Good Research Practices on New PRO Instruments – Assessing Respondent Understanding
Comments:
   
  Title: Good Research Practices on New PRO Instruments – Eliciting Concepts
Source: Good Research Practices on New PRO Instruments – Eliciting Concepts
Comments:
   
  Title: Use of Existing Patient-Reported Outcome (PRO) Instruments and Their Modification: The ISPOR Good Research Practices for Evaluating and Documenting Content Validity for the Use of Existing Instruments and Their Modification PROTask Force Report
Source: Use of Existing Patient-Reported Outcome (PRO) Instruments and Their Modification:The ISPOR Good Research Practices for Evaluating and Documenting Content Validity for the Use of Existing Instruments and Their Modification PROTask Force Report
Comments:
   
  1. PRO in children and adolescents methods
Title: Pediatric Patient-Reported Outcome Instruments for Research to Support Medical Product Labeling: Report of the ISPOR Good Research Practices for the Assessment of Patient-Reported Outcomes in Children and Adolescents Task Force
Source: http://www.ispor.org/workpaper/PROchildrenadolescents
/Matza_et_al_2013_ISPOR_Task_Force_PROs_in_Children.pdf

Comments:
   
  1. ePRO systems validation methods
Title: Validation of Electronic Systems to Collect Patient-Reported Outcome (PRO) Data - Recommendations for Clinical Trial Teams: Report of the ISPOR ePRO Systems Validation Good Research Practices Task Force
Source: https://www.ispor.org/ValueInHealth/
ShowValueInHealth.aspx?
issue=F0949C6B-A38B-45F6-A90B-6433DD97F05C

Comments:
   
  1. Mixed modes to collecting PRO data methods
Title: PRO Task Force: Good Research Practices for Mixed Modes to Collect PRO Data in Clinical Trials
Source: PRO Task Force: GOOD RESEARCH PRACTICES FOR Mixed Modes to Collect PRO Data in Clinical Trials
Comments:
   
  1. Patient and treatment Satisfaction
     
  1. Work performance
     
  1. Clinician- reported outcomes
     
  1. Observer-reported outcomes
     
III. Patient Preference Methods
  1. Stated preferences
     
  1. Contingent valuation
  Title: Contingent Valuation: A Comprehensive Bibliography and History by Carson R.
Source: Cheltenham, UK: Edward Elgar, 2011
Comments:
 
    Title: Economic Valuation with States Preferences Techniques: A Maual by Bateman I, et al.
Source: Cheltenham, UK: Edward Elgar, 2002
Comments:
 
  1. i. Willingness to Pay
  Title: Methods for the Economic Evaluation of Health Care Programmes (3rd edition, chapter 7) by Drummond, MF et al.
Source: Oxford, UK: Oxford University Press, 2005

Comments:
Title: Willingness to pay: a valid and reliable measure of health state preference? By O'Brien B, Viramontes JL.
Source: Medical Decision Making 1994;14:289-97
Comments:
      Title: Theory versus practice: A review of “willingness-to-pay” in health and health care, by Olsen JA, Smith RD.
Source: Health Economics 2001;10:39-52.

Comments:
  1. ii. Probability threshold techniques
    Title: Using a trade-off technique to assess patients' treatment preferences for benign prostatic hyperplasia by Llewellyn-Thomas H et al.
Source: Medical Decision Making 1995;16:262-272.

Comments:  
  1. Conjoint Analysis
Title: ISPOR conjoint analysis good research practices checklist TF report
Source: Conjoint Analysis Applications in Health—a Checklist: A Report of the ISPOR Good Research Practices for Conjoint Analysis Task Force
Comments:
Title: Applied Choice Analysis: A Primer by Hensher DA, Rose JM, Greene WH.
Source: New York: Cambridge University Press 2005
Comments:
Title: Discrete-choice experiments in health economics: a review of the literature by de Bekker-Grob E, et al.
Source: Health Economics 2012;21:145-72
Comments:
  Title: Constructing Experimental Designs for Discrete-Choice Experiments: Report of the ISPOR Conjoint Analysis Experimental Design Task Force
Source: https://www.ispor.org/ValueInHealth/
ShowValueInHealth.aspx?issue=3551E3F3-83A8-4895-9415-5272AF29A9DF

Comments:
Title: Stated Choice Methods by Louviere JJ, Hensher DA, Swait JD.
Source: New York: Cambridge University Press 2000

Comments:
Title: Conjoint analysis applications in health – how are studies being designed and reported? An update on current practice in the published literature between 2005 and 2008 by Marshall DA et al.
Source: Patient  2010;3:249-56.
Comments:
  Title: ISPOR conjoint analysis statistical methods TF report (in development)
Source:
Comments:
 

Title: Things are looking up since we started listening to patients: trends in the application of conjoint analysis in health 1982-2007 by Bridges JFR, et al.
Source: Patient 2008;1: 273-82

  1. Health-state utility measurement
  Title: Utility Assessment by Mauskopf JA
Source: Methods and Designs for Outcomes Research, American Society of Health-System Pharmacists, 2006
Comments:
 
  1. i. Direct elicitation (time tradeoff, standard gamble)
    Title: Standard gamble, time tradeoff, and rating scale – experimental results on the ranking properties of QALYs by Bleichrodt H, Johanneson M.
Source: Journal of Health Economics; 1997:155-75.
  1. ii. Multi- attribute utility
    Title: Multi-attribute and single-attribute utility functions for the Health Utilities Index Mark 3 system by Feeny D et al.
Source: Medical Care 2002;40:113-28
  1. Revealed preferences (patient decision-making behavior measurement)
     
IV. Health Economic Evaluation Methods
  1. Costing Method
     
  1. Health care resource use (measuring costs)
Title: Good Research Practices for Measuring Drug Costs in Cost Effectiveness Analyses: Issues and Recommendations: The ISPOR Drug Cost Task Force Report—Part I
Source: Good Research Practices for Measuring Drug Costs in Cost Effectiveness Analyses: Issues and Recommendations:The ISPOR Drug Cost Task Force Report—Part I
Comments:
   
  Title: Good Research Practices for Measuring Drug Costs in Cost Effectiveness Analyses:An Industry Perspective: The ISPOR Drug Cost Task Force Report—Part V
Source: Good Research Practices for Measuring Drug Costs in Cost Effectiveness Analyses:An Industry Perspective: The ISPOR Drug Cost Task Force Report—Part V
Comments:
   
  Title: Good Research Practices for Measuring Drug Costs in Cost-Effectiveness Analyses: Medicare, Medicaid and Other US Government Payers Perspectives: The ISPOR Drug Cost Task Force Report—Part IV
Source: Good Research Practices for Measuring Drug Costs in Cost-Effectiveness Analyses: Medicare, Medicaid and Other US Government Payers Perspectives: The ISPOR Drug Cost Task Force Report—Part IV
Comments:
   
  Title: Good Research Practices for Measuring Drug Costs in Cost-Effectiveness Analyses:A Managed Care Perspective: The ISPOR Drug Cost Task Force Report—Part III
Source: Good Research Practices for Measuring Drug Costs in Cost-Effectiveness Analyses:A Managed Care Perspective: The ISPOR Drug Cost Task Force Report—Part III
Comments:
   
  Title: Good Research Practices for Measuring Drug Costs in Cost-Effectiveness Analyses:A Societal Perspective: The ISPOR Drug Cost Task Force Report—Part II
Source: Good Research Practices for Measuring Drug Costs in Cost-Effectiveness Analyses:A Societal Perspective: The ISPOR Drug Cost Task Force Report—Part II
Comments:
   
  Title: Good Research Practices for Measuring Drug Costs in Cost-Effectiveness Analyses:An International Perspective:The ISPOR Drug Cost Task Force Report—Part VI
Source: Good Research Practices for Measuring Drug Costs in Cost-Effectiveness Analyses:An International Perspective:The ISPOR Drug Cost Task Force Report—Part VI
Comments:
   
  1. Cost of illness/burden of disease
     
  1. Budget impact
Title: Principles of Good Practice for Budget Impact Analysis: Report of the ISPOR Task Force on Good Research Practices—Budget Impact Analysis
Source: Principles of Good Practice for Budget Impact Analysis: Report of the ISPOR Task Force on Good Research Practices—Budget Impact Analysis
Comments:
   
  1. Practicalities of estimating productivity costs
     
  1. Transferability of economic information
Title: Economic Evaluation Methods/Transferability of Economic Evaluations Across Jurisdictions
Source: Economic Evaluation Methods/Transferability of Economic Evaluations Across Jurisdictions
Comments:
  1. Health Economic Evaluation Reporting
Title:  Consolidated Health Economic Evaluation Reporting Standards (CHEERS)—Explanation and Elaboration: A Report of the ISPOR Health Economic Evaluation Publication Guidelines Good Reporting Practices Task Force
Source:  https://www.ispor.org/ValueInHealth/ShowValueInHealth.aspx?issue=3D35FDBC-D569-431D-8C27-378B8F99EC67
   
V. Health Care Research Statistical Methods
  1. Frequentist Methods
  Title: Biostatistics: a Methodology for the Health Sciences by Van Belle, G., Fisher, L.D., Heagerty, P., Lumley, T.
Source: 2nd ed. New York, NY: John Wiley and Sons, Inc., 2004
Comments:
 
    Title: Data Analysis Using Stata by Kohler, U., Kreuter, F.
Source: College Station, TX: Stata Press, 2005
Comments:
 
    Title: Fundamentals of Biostatistics by Rosner, B.
Source: 6th ed. Pacific Grove, CA: Duxbury Press, 2006
Comments:
 
    Title: Nonparametric Statistics by Hollander, M., Wolfe D.
Source: 2nd ed. New York, NY: Wiley-InterScience, 1999
Comments:
 
    Title: Statistical Methods for Health Care Research by Munro, B.H.
Source: Philadelphia, PA: Lippincott Williams & Wilkins, 2005
Comments:
 
    Title: Statistical Methods in Medical Research by Armitage, P., Berry, G., Matthews, J.N.S.
Source: 4th ed. Boston, MA, Oxford: Blackwell Scientific Publications, 2001
Comments:
 
  1. Bayesian Analytical Methods
  Title: A Primer on Bayesian Statistics in Health Economics and Outcomes Research by O'Hagan A, Luce B.
Source: Bethesda, Maryland: Medtap International, 2003
Comments:
 
  1. Specific estimation methods
     
  1. Multivariable regression
  Title: Applied Linear Regression Models by Netter J., Wasserman W., Kutner M.H.
Source: 2nd ed. Boston, MA:Irwin, 1989
Comments:
 
    Title: Applied Logistic Regression by Hosmer D.L., Lemeshow S.
Source: 2nd edition. New York, NY: John Wiley and Sons, 2001
Comments:
 
    Title: Applied Regression Analysis and Other Multivariable Methods by Kleinbaum, L.
Source: 3rd Edition. Pacific Grove: Duxbury Press, et al. 1998
Comments:
 
    Title: Regression Models for Categorical and Limited Dependent Variables by Long, J.S.
Source: Thousand Oaks, CA: Sage Publications, 1997
Comments:
 
    Title: Regression Models for Categorical Data Using Stata by Long, J.S., Freese, J.
Source: 2nd ed. College Station, TX: Stata Press, 2006
Comments:
 
  1. Parametric and semi-parametric survival modeling
  Title: Modeling Survival Data in Medical Research by Collett D
Source: London: Chapman and Hall/CRC, 1994
Comments:
 
  1. Longitudinal data analysis
     
  1. Propensity score methods
     
  1. Stratification methods
     
  1. Mixture modeling methods
     
  1. Instrumental variables methods
     
  1. Structural equation modeling methods
     
  1. Marginal structural modeling methods
     
  1. Health econometric methods
  Title: Econometric Analysis by Greene, L.
Source: 5th ed. Upper Saddle River, NJ: Prentice Hall, 2003
Comments:
 
    Title: Guide to Econometrics by Kennedy, P.
Source: 5th ed. Cambridge, MA: MIT Press, 2003
Comments:
 
  1. Econometric analysis of cost data
     
  1. Econometric analysis of quality of life data
     
  1. Econometric analysis for health care program evaluation (including selection modeling and cost-benefit analysis)
     
  1. Econometric analysis of health care supply & demand
     
VI. Social and Ethical Aspects of Health Technologies Research Methods
  1. Analysis of the delivery models of technology, and of resources, management and cultural issues within a variety of stakeholders in- and outside the organization including the health care system level
     
  1. Analysis of social aspects (patients' and significant others' considerations, worries and experiences with the health technology
     
  1. Ethical analysis of social and moral norms and values relevant for the technology in question
     

ArrowSYNTHESIZING Health Care EVIDENCE

Methods GUIDELINES TEXTBOOKS REVIEWS/KEYPAPERS
I. Evidence Synthesis Research Methods
  1. Systematic review
Title: Guidelines for reporting systematic reviews and meta-analysis
Source: Stroup DF, Berlin JA, Morton SC, Olkin I, Williamson GD, Rennie D, Moher D, Becker BJ, Sipe TA, Thacker SB. Meta-analysis of observational studies in epidemiology: a proposal for reporting. Meta-analysis Of Observational Studies in Epidemiology (MOOSE) group. JAMA 2000; 283(15):2008-2012.
Guidelines for reporting systematic reviews and meta-analysis
Comments:
Title: Meta-Analysis in Medicine and Health Policy by Stangl, D. and Berry, D.
Source: New York, eds. 2000
Comments:
 
  Title: Standards for reporting literature searches
Source:
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1629442/
pdf/i1536-5050-094-04-0421.pdf
   
      Title: Center for Reviews and Dissemination (CRD): Systematic Reviews
Source: http://www.york.ac.uk/inst
/crd/index_guidance.htm
    Title: Cochrane Handbook for Systematic Reviews of Interventions
Source: http://handbook.cochrane.org/
Comments:
 
  1. Meta-analysis
Title: Guidelines for reporting systematic reviews and meta-analysis
Source: Stroup DF, Berlin JA, Morton SC, Olkin I, Williamson GD, Rennie D, Moher D, Becker BJ, Sipe TA, Thacker SB. Meta-analysis of observational studies in epidemiology: a proposal for reporting. Meta-analysis Of Observational Studies in Epidemiology (MOOSE) group. JAMA 2000; 283(15):2008-2012.
Guidelines for reporting systematic reviews and meta-analysis
Comments:
Title: Meta-Analysis in Medicine and Health Policy by Stangl, D. and Berry, D.
Source: New York, eds. 2000
Comments:
 
      Title: Meta-analysis of individual participant data: rationale, conduct, and reporting by Riley RD, Lambert PC, bo-Zaid G.
Source: BMJ 2010; 340:c221.
    Title: Methods for meta-analysis in medical research by Sutton AJ, Abrams KR, Jones DR, Sheldon TA, Song F.
Source: London: Wiley, 2000
 
    Title: Systematic Reviews in Health Care: Meta-Analysis in Context, Second Edition by(editors): Matthias Egger, George Davey Smith, Douglas G Altman
Source: BMJ Publishing Group 2001
Comment:
 
  1. Indirect treatment & network meta-analysis comparisons
Title: Conducting Indirect-Treatment-Comparison and Network-Meta-Analysis Studies: Report of the ISPOR Task Force on Indirect Treatment Comparisons Good Research Practices—Part 2
Source: Conducting Indirect-Treatment-Comparison
and Network-Meta-Analysis Studies: Report of the ISPOR
Task Force on Indirect Treatment Comparisons
Good Research Practices—Part 2

Comments:
Title: Evidence Synthesis for Decision Making in Health Care by  NJ Welton, A.J Sutton, NJ Cooper, K.R. Abrams, AE Ades.
Source: Wiley-Blackwell, 2012
 
  Title: EUnetHTA guideline “Comparators and comparisons – Direct and Indirect Comparisons”
Source: http://www.eunethta.eu/sites/5026.fedimbo.belgium.be
/files/Direct%20and%20indirect%20comparisons.pdf
   
  1. Handling bias in evidence synthesis studies
     
  1. Publication bias
     
  1. Observational study confounding and selection bias
     
  1. Generalizability of RCTs and observational studies
     
  1. Assessing the quality of evidence
  Title: Medical Technologies Evaluation Programme
Source: Medical Technologies Evaluation Programme
Comments:
 
  1. Individual patient data synthesis
     
  1. Heterogeneity: measurement, meta regression, sub-group analysis
  Title: Systematic Reviews in Health Care: Meta-Analysis in Context, Second Edition
Editor(s): Matthias Egger, George Davey Smith, Douglas G Altman
Source: 2001 BMJ Publishing Group
 
  1. Methods for integrating stakeholders (e.g., patients, clinicians) aspects into HTA
  Title: Health Technology Assessment Handbook
Source: Chapter 7 in Health Technology Assessment Handbook
Comments:
 
II. Modeling/Decision Analysis Methods
  1. Conceptualizing a model
Title: Conceptualizing a Model: A Report of the ISPOR-SMDM Modeling Good Research Practices Task Force-2
Source: Conceptual Modeling Working Group
Comments:
   
  1. Model parameter estimation and uncertainty
Title: Model Parameter Estimation and Uncertainty Analysis: A Report of the ISPOR-SMDM Modeling Good Research Practices Task Force-6
Source: Model Parameter Estimation and Uncertainty Working Group
Comments:
Title: Decision Modeling for Health Economic Evaluation by Briggs A, Claxton K, Sculpher M.
Source: Oxford: Oxford University Press, 2006.
Comments:
 
  1. Model transparency and validation
Title: Model Transparency and Validation: A Report of the ISPOR-SMDM Modeling Good Research Practices Task Force-7
Source: Model Transparency and Validation Working Group
Comments:
   
  1. State transition modeling
Title: State-Transition Modeling: A Report of the ISPOR-SMDM Modeling Good Research Practices Task Force-3
Source: State-Transition Modeling Working Group
Comments:
   
  1. Modeling using discrete event simulation
Title: Modeling using Discrete Event Simulation: A Report of the ISPOR-SMDM Modeling Good Research Practices Task Force-4
Source: Discrete Event Simulation Working Group
Comments:
   
  1. Dynamic Transition Modeling
Title: Dynamic Transmission Modeling: A Report of the ISPOR-SMDM Modeling Good Research Practices Task Force-5
Source: Dynamic Transmission Modeling Working Group
Comments:
   
  1. Health Systems Modeling Methods
     
  1. Methods to assess new technologies during product development
     
  1. Multi-criteria decision analysis
     
  1. Multi criteria decision analysis vs. deliberative methods for economic analysis - incorporating preferences and uncertainty
    Title: Multi-criteria clinical decision support: A primer on the use of multiple criteria decision making methods to promote evidence-based, patient-centered healthcare by Dolan JG
Source: Patient 2010; 3(4): 229-248
Comments: Provides a general introduction multi-criteria decision methods; methods include balance sheet, even swap method, ordinal ranking methods, direct weighting methods, multi-attribute decision analysis, and AHP; includes examples and glossary of terms
    Title: Trends in multiple criteria decision analysis by Greco S, Ehrgott M, Figueira JR (Eds).
Source: Springer, 2010 edition
Comment:
Title: Multiple criteria decision analysis for health technology assessment: Report by the Decision Support Unit by Thokala P and Durenas A
Source: Value in Health 2012; 15(8): 1172-1181.
Comments: Includes introduction to most common types of MCDA models and critical review of state-of-the-art methods for incorporating multiple criteria in health technology assessment
    Title: Multiple criteria decision analysis: State of the art surveys by Greco S (Ed)
Source: Springer, 2004
Comment:
 
  1. Incorporating preferences and uncertainty in health care decisions - analytical hierarchy process
     
  1. Fuzzy logic decision support systems
Title: Fuzzy multi-criteria decision making: theory and applications with recent developments by Kahraman C (Ed)
Source: Springer, 2008
Comment:
 
  1. Clinical decision analysis
  Title: Decision Making in Health and Medicine: Integrating Evidence and Values.
Source: Cambridge University Press, 2001
 
    Title: Medical Tests-White Paper Series
Source: Agency for Healthcare Research and Quality (US); Rockville (MD): 2009-
 
III. Health Economic Evaluation Framework and Methods
  1. General methods
Title: General Methods for the Assessment of the Relation of Benefits to Costs
Source: General Methods for the Assessment of the Relation of Benefits to Costs
Comments:
Title: Methods for the Economic Evaluation of Health Care Programmes. 3rd ed. by Drummond MF, Sculpher MJ, Torrance GW, O'Brien B, Stoddart GL.
Source: Oxford: Oxford University Press, 2005.
Comments:
 
    Title: Cost-Effectiveness in Health Care by Gold, M.R., Siegel, J.E., Russell, L.B., Weinstein, W.C.
Source: New York, NY: Oxford University Press., eds. 1996
Comments:
 
  Title: Guide to the Methods of Technology Appraisal (reference N0515)
Source: Guide to the Methods of Technology Appraisal (reference N0515)
Comments:
   
  Title: Guidelines for the Economic Evaluation of Health Technologies: Canada
Source: Guidelines for the Economic Evaluation of Health Technologies: Canada
Comments:
   
  Title: The AMCP Format for Formulary Submissions
Source: The AMCP Format for Formulary Submissions
Comments:
   
      Title: When should decision analytic modeling be used in the economic evaluation of health care?
Source: Eur J Health Econ. 2003;4:143–150.
  1. General Methods - Outcomes
Title: EUnetHTA guideline “Endpoints used for relative effectiveness assessment of pharmaceuticals
Health-Related Quality Of Life And Utility Measures
Source: https://5026.fedimbo.belgium.be/sites/
5026.fedimbo.belgium.be/files/
Health-related%20quality%20of%20life.pdf
  Title: A Different Approach to Health State Valuation
Source: A Different Approach to Health State Valuation
Comments:
      Title: Editorial: Moving the QALY Forward or Just Stuck in Traffic?
Source: Editorial: Moving the QALY Forward or Just Stuck in Traffic?
Comments:
      Title: Editorial: On the Benefits of Modeling Using QALYs for Societal Resource Allocation: The Model Is the Message
Source: Editorial: On the Benefits of Modeling Using QALYs for Societal Resource Allocation: The Model Is the Message
Comments:
      Title: Moving the QALY Forward: Rationale for Change
Source: Moving the QALY Forward: Rationale for Change
Comments:
      Title: QALYs: Some Challenges
Source: QALYs: Some Challenges
Comments:
      Title: QALYs: The Basics
Source: QALYs: The Basics
Comments:
      Title: Retaining, and Enhancing, the QALY
Source: Retaining, and Enhancing, the QALY
Comments:
      Title: The Use of QALYs in Clinical and Patient Decision-Making:Issues and Prospects
Source: The Use of QALYs in Clinical and Patient Decision-Making:Issues and Prospects
Comments:
      Title: Toward a Consensus on the QALY
Source: Toward a Consensus on the QALY
  1. General Methods - Costs
     
  1. Cost-benefit/net benefit analysis
  Title: Applied Methods of Cost-Benefit Analysis in Health Care (Handbooks in Health Economic Evaluation by McIntosh E, Clarke P, Frew E, Louviere J.
Source: Oxford University Press, 2010
Comments:
 
  1. Cost-effectiveness (efficacy) analysis
Title: Good Research Practices for Cost-Effectiveness Analysis Alongside Clinical Trials: The ISPOR RCT-CEA Task Force Report
Source: Good Research Practices for Cost-Effectiveness Analysis Alongside Clinical Trials: The ISPOR RCT-CEA Task Force Report
Comments:
   
  1. Economic study reporting
Title: Health Economic Evaluation Publication Guidelines Good Reporting Practices
Source: Health Economic Evaluation Publication Guidelnes – CHEERS*: Good Reporting Practices Task Force
Comments:
   
  1. Economic analysis: the role of clinical trials and models
Title: Economic evaluation alongside randomized controlled trials: design, conduct, analysis, and reporting
Source: Economic evaluation alongside randomized controlled trials: design, conduct, analysis, and reporting
Comments:
   
  Title: Economic evaluation using decision analytical modeling: design, conduct, analysis, and reporting
Source: Economic evaluation using decision analytical modeling: design, conduct, analysis, and reporting
Comments:
  Title: Whither trial-based economic evaluation for health care decision making? by Sculpher MJ, Claxton KP, Drummond MF, McCabe C.
Source: Health Economics 2006;15:677-87.
      Title: When should decision analytic modeling be used in the economic evaluation of health care?
Source: Eur J Health Econ. 2003;4:143–150.
  1. Determining cost effectiveness thresholds
    Title: The NICE cost-effectiveness threshold: what it is and what that means by McCabe C, Claxton K, Culyer AJ .
Source: Pharmacoeconomics 2008;26:733-44
Comments:
      Title: What Does the Value of Modern Medicine Say About the $50,000 per Quality-Adjusted Life-Year Decision Rule?
Source: What Does the Value of Modern Medicine Say About the $50,000 per Quality-Adjusted Life-Year Decision Rule?
Comments:
  1. How to deal with equity issues in economic evaluations
     
  1. Methods for research prioritization including value of information analysis
  Title: Decision Modeling for Health Economic Evaluation by Briggs A, Claxton K, Sculpher M.
Source: Oxford: Oxford University Press, 2006.
Comments:
 
      Title: Calculating partial expected value of perfect information via Monte Carlo sampling algorithms by Brennan A, Kharroubi S, O'Hagan A, Chilcott J Medical
Source: Medical Decision Making 2007;27:448-70
Comments:
  1. Incorporating heterogeneity (personalization / individualization) in economic evaluations
    Title: Subgroups and heterogeneity in cost-effectiveness analysis by Sculpher MJ.
Source: Pharmacoeconomics 2008;26:799-806
Comments:
      Title: Value of information on preference heterogeneity and individualized care by Basu A, Meltzer D.
Source: Medical Decision Making 2007;27:112-27
Comments:
      Title: Challenges in the development and reimbursement of personalized medicine-payer and manufacturer perspectives and implications for health economics and outcomes research: a report of the ISPOR personalized medicine special interest group.
Source: Value Health. 2012 Dec;15(8):1162-71.
    Title: Pharmacogenomics Bias - Systematic distortion of study results by genetic heterogeneity (DIMDI HTA Methods Report).
Source:
GMS Health Technol Assess. 2008
Comment:
 
  1. HTA Agency Guidelines
    Title: Key principles for the improved conduct of health technology assessments for resource allocation decisions.
Source: Int J Technol Assess Health Care. 2008
IV. Social and Ethical Aspects of Health Technologies Research Methods
  1. Review of studies of delivery models of technology, and of resources, management and cultural issues within a variety of stakeholders in- and outside the organization including the health care system level
  Title: HTA Core Model®
Source: http://fio.stakes.fi/htacore/ViewHandbook.aspx
#domainguidance7

Comment:
 
    Title: Health Technology Assessment Handbook
Source: Chapter 8 in Health Technology Assessment
Comments:
 
  1. Review of studies of social aspects (patients' and significant others' considerations, worries and experiences with the health technology
  Title: HTA Core Model®
Source: http://fio.stakes.fi/htacore/ViewHandbook.aspx
#domainguidance8

Comment:
 
    Title: Health Technology Assessment Handbook
Source: Chapter 7 in Health Technology Assessment
Comment:
 
  1. Review of ethical analyses of social and moral norms and values relevant for the technology in question
  Title: HTA Core Model®
Source:
http://fio.stakes.fi/htacore/ViewHandbook.aspx
#domainguidance6

Comment:
 
    Title: Health Technology Assessment Handbook
Source: Chapter 2 in Health Technology Assessment
Comments
 

ArrowUSING EVIDENCE IN HEALTH CARE DECISIONS

Methods GUIDELINES TEXTBOOKS REVIEWS/KEYPAPERS
I. Payer (population-based) Health Care Decision
  1. HTA terminology
Title: HTA Glossary –
Source: http://htaglossary.net/HomePage
Title: ISPOR Book of Terms –
Source: http://www.ispor.org/
publications/lexicon_index.asp
Title: What is Health Care Technology Assessment
Source: http://www.medicine.ox.ac.uk/
bandolier/painres/download/whatis/
What_is_health_tech.pdf
    Title: Health Technology Assessment: Konzepte, Methoden, Praxis fur Wissenschaft und Entscheidungsfindung.
Source: http://books.google.ca/books/
about/Health_technology_Assessment.html
?id=hWQCkhGnkogC&redir_esc=y
 
    Title: Evaluating Investments in Health Care Systems: Health Technology Assessment
Source: http://www.amazon.ca/
Evaluating-Investments-Health-Care-Systems/dp/3319025430
 
  1. Framework/principles for HTA and benchmarking HTA organizations
Title: AHRQ Series Paper 2: Principles for developing guidance: AHRQ and the Effective Health-Care Program   Title: Key principles for the improved conduct of health technology assessments for resource allocation decisions.
Source: http://www.ncbi.nlm.nih.gov/
pubmed/18601792
  Title: Understanding Health Technology Assessment (HTA)
Source: http://img.eurordis.org/newsletter/
pdf/nov-2010/58-1%20HEE
%20Guide%20To%20HTA%20
for%20Patients%20English.pdf
  Title: Developing Health Technology Assessment to address health care system needs.
Source: http://www.ncbi.nlm.nih.gov
/pubmed/19889471
  Title: The HTA Core Model 2.0 – www.corehta.info [Internet]. EUnetHTA Work Package 8; 2013.
Source: http://www.corehta.info/model
/HTACoreModel2.0.pdf
  Title Health Technology Assessments by the National Institute for Health and Clinical Excellence A Qualitative Study
Source: http://www.springer.com/public+health/
book/978-0-387-71995-5
  Title: Danish Centre for Health Technology Assessment, Health technology assessment handbook
Source: http://www.dacehta.dk
   
  1. Structure / governance / organizational aspects of HTA
    Title: Health technology assessment agencies: an international overview of organizational aspects.
Source: http://www.ncbi.nlm.nih.gov/
pubmed/17937828
  1. Organization readiness
Title: An Approach to Organizational Self Assessment Developed for the IUCN M&E Team by Universalia
Source(s): http://cmsdata.iucn.org/
downloads/oa_overview_00.pdf


https://www.anzsog.edu.au/media/
upload/publication/131_Flynn-and-Ugyel- Diagnostic-Tool-ANZAM-2013.pdf
   
  1. Priority setting for HTA
Title: Priority Setting for Health Technology Assessment: Theoretical Considerations and Practical Approaches: A paper produced by the Priority Setting Subgroup of the EUR-ASSESS Project
Source: http://www.ncbi.nlm.nih.gov/
pubmed/9194351
Title: Setting Priorities for Health Technologies Assessment: A Model Process
Source: http://www.nap.edu/catalog/2011.html
Title: Priority setting for health technology assessments: a systematic review of current practical approaches.
Source: http://www.ncbi.nlm.nih.gov/
pubmed/17579932
  Title: NICE Technology appraisal topic selection
Source: http://www.nice.org.uk/proxy/?
sourceUrl=http%3a%2f%2fwww.nice.org.uk
%2fgetinvolved%2ftopicselection
%2fTechnologyAppraisalTopicSelection.jsp
   
  Title: Washinton State Health Care Authority, Health Technology Assesment - HTA, Prioritization Criteria
Source: http://www.hca.wa.gov/hta/
documents/prioritization_criteria.pdf

   
  1. Determining evidence requirements / framing questions
Title: SUPPORT Tools for evidence-informed health Policymaking (STP) 4: Using research evidence to clarify a problem
Source: Health Research Policy and Systems 2009, 7(Suppl 1):S4 doi:10.1186/1478-4505-7-S1-S4
Title: A model for evidence-informed decision making in public health.
Source: http://www.nccmt.ca/pubs/
FactSheet_EIDM_EN_WEB.pdf
Title: Best practice in undertaking and reporting health technology assessments. Working group 4 report.
Source: http://www.ncbi.nlm.nih.gov/
pubmed/12053427
  Title: NICE, Guide to the methods of technology appraisal 2013; Evidence
Source: http://www.nice.org.uk/article/
PMG9/chapter/3-Evidence
  Title: Observational studies in systemic reviews of comparative effectiveness: AHRQ and the Effective Health Care Program
Source: http://www.sciencedirect.com/
science/ article/pii/S0895435611000618
  Title: Danish Centre for Health Technology Assessment, Health technology assessment handbook
Source: http://www.dacehta.dk
   
  1. Scope of HTA - determining feasibility, availability of evidence or potential duplication
Title: The HTA Core Model 2.0 – www.corehta.info [Internet]. EUnetHTA Work Package 8; 2013.
Source: http://www.corehta.info/model/
HTACoreModel2.0.pdf
   
  Title: Danish Centre for Health Technology Assessment, Health technology assessment handbook
Source: http://www.dacehta.dk
   
  1. Evidence appraisal
Title: NICE, Guide to the methods of technology appraisal 2013
Source: http://www.nice.org.uk/article/
pmg9/chapter/1-introduction
Title: A Framework for Science Advice on Health: Principles and Guidelines.
Source: http://www.eusanh.eu/
wp/wp-content/uploads/2011/
12/EuSANH_principlesandguidelines.pdf
 
  Title: NICE, Guide to the methods of technology appraisal 2013; The appraisal of the evidence and structured decision-making
Source: http://www.nice.org.uk/article/PMG9/
chapter/6-The-appraisal-of-the-evidence-and-structured-decision-making
   
  Title: The HTA Core Model 2.0 – www.corehta.info [Internet]. EUnetHTA Work Package 8; 2013.
Source: http://www.corehta.info/model/
HTACoreModel2.0.pdf
   
  1. Outcomes research studies for decision-making
     
  1. Observational studies - prospective and retrospective
Title: Assessing Retrospective Observational Studies for Health Care Decisions Task Force
Source: Assessing Retrospective Observational Studies for Health Care Decisions Task Force
Title: Users' Guides to the Medical Literature: a Manual for Evidence-based Clinical Practice by Guyatt, G., Rennie, D.
Source: Chicago, IL: American Medical Association, eds. 2002
 
  Title: Assessing Prospective Observational Studies for Health Care Decisions Task Force
Source: Assessing Prospective Observational Studies for Health Care Decisions Task Force
Title: Interpreting the Medical Literature by Gehlbach, S.H.
Source: 5th ed. New York, NY: McGraw-Hill, Professions Division, 2006
Comments:
 
  1. Modeling studies
Title: Assessing Modeling Studies for Health Care Decisions Task Force
Source: Assessing Modeling Studies for Health Care Decisions Task Force
  Title: Reporting guidelines for modelling studies                      
Source:
http://www.biomedcentral.com/
1471-2288/12/168
  1. Feasibility / health services delivery / studies
    Title: How do new technologies impact on workforce organisation? A rapid review of international evidence 2011. 
Source: http://www.skillsforhealth.org.uk/
component/docman/doc_view/
1834-how-do-new-technologies-impact-on-workforce-organiastion-082011.html
  1. Systematic reviews, meta-analyses, decision analysis, and qualitative synthesis studies
Title: Guide to the Methods of Technology Appraisal (reference N0515)
Source: Guide to the Methods of Technology Appraisal (reference N0515)
Title: Finding what works in health care: standards for systematic reviews. Eden J, editor. Washington, D.C: National Academies Press; 2011. 317 p.
Source: http://www.iom.edu/Reports/2011/Finding-What-Works-in-Health-Care-Standards-for-Systematic-Reviews.aspx
Title: Deciding how much confidence to place in a systematic review.
Source: http://www.health-policy-systems.com/content/pdf/
1478-4505-7-S1-s8.pdf
      Title: Towards systematic reviews that inform health care management and policy-making
Source: http://www.ncbi.nlm.nih.gov/pubmed/
16053582?dopt=Abstract

  1. Indirect treatment comparison studies
Title: Interpreting Indirect Treatment Comparisons and Network Meta-Analysis for Health-Care Decision Making: Report of the ISPOR Task Force on Indirect Treatment Comparisons Good Research Practices: Part 1
Source: Interpreting Indirect Treatment Comparisons and Network Meta-Analysis for Health-Care Decision Making: Report of the ISPOR Task Force on Indirect Treatment Comparisons Good Research Practices: Part 1
   
  Title: Assessing Indirect Treatment Comparison Studies
Source: Assessing Indirect Treatment Comparison Studies
   
  Title: A GRADE Working Group approach for rating the quality of treatment effect estimates from network meta-analysis
Source: http://www.bmj.com/content/349/bmj.g5630
   
  1. Cost-effectiveness
Title: IQWIG General Methods
Source: General Methods
Title: Methods for the economic evaluation of health care programmes by Drummond MF, Sculpher MJ, Torrance GW, O’Brien BJ, Stoddart GL
Source: Oxford University Press, USA; 3rd edition, 2005.
Title: Health Economic Assessment: Cost-Effectiveness Thresholds and Other Decision Criteria
Source: Int J Environ Res Public Health
http://www.ncbi.nlm.nih.gov/pmc/
articles/PMC2872336/
  1. Budget Impact Analysis
     
  1. Equity issues
    Title: Taking equity into consideration when assessing the findings of a systematic review.
Source: http://www.health-policy-systems.com/content/pdf/1478-4505-7-S1-s10.pdf
  1. Methods for integrating stakeholders (e.g., patients, clinicians) values / perspectives
  Title: Health Technology Assessment Handbook
Source: Chapter 7 in Health Technology Assessment Handbook
Title: Public engagement in health technology assessment and coverage decisions: a study of experiences in France, Germany, and the United Kingdom.
Source: http://www.ncbi.nlm.nih.gov/
pubmed/23052686
  1. Deliberative processes
Title: Evaluating Deliberative Processes
Source: http://www.ncchpp.ca/docs/
DeliberativeFS3_evaluation_EN.pdf
  Title: Deliberative processes in decisions about health care technologies: combining different types of evidence, values, algorithms and people.
Source: http://www.ohe.org/publications/
article/deliberative-processes-in-decisions
-about-health-care-technologies-30.cfm
  Title: What is a deliberative process?
Source: http://www.ncchpp.ca/docs/
DeliberativeDoc1_EN_pdf.pdf
 

Title: Deliberations about deliberative methods: issues in the design and evaluation of public participation processes
Source: http://www.cprn.org/download.cfm
?doc=353&file=20819_en.pdf&
format=pdf&l=en

  Title: Deliberative Processes - Inventory of Resources
Source: http://www.ncchpp.ca/docs/
DeliberativeInventory_EN_pdf.pdf
   
  1. Multi-criteria decision analysis
Title: Multiple criteria decision analysis for HTA
Source: http://www.nicedsu.org.uk/
MCDA%20for%20HTA%20DSU.pdf
  Title: Multi-criteria Analysis Manual for
Making Government Policy
Source: https://www.gov.uk/government/
publications/ multi-criteria-analysis-
manual-for-making-government-policy
      Title: Comparative Weight Elicitation Methods
Source: https://www.evidem.org/docs/2012/
Weight-Elicitation-Techniques.pdf
      Title: International Study on Decision Criteria
Source: https://www.evidem.org/
international-study.php
  1. Patient engagement - patient advisory groups
  Title: Understanding Health Technology
Assessment (HTA)
Source: http://img.eurordis.org/newsletter
/pdf/nov-2010/58-1%20HEE%20Guide%20
To%20HTA %20for%20Patients%20English.pdf
Title: New Era Of Patient Engagement
Source: Special Issues of Health Affairs,February 2013; Volume 32, Issue 2
  1. Implementation of HTA
     
  1. Managed entry agreements: risk-sharing/ performance-based, coverage with evidence development agreements
Title: Performance-Based Risk-Sharing Arrangements - Good Practices for Design, Implementation and Evaluation: A Report of the ISPOR Good Practices for Performance-Based Risk-Sharing Arrangements Task Force
Source: http://www.ispor.org/TaskForces/
documents/Performance-based-Risk-Sharing-Guidelines.pdf
  Title: Managed entry agreements for pharmaceuticals:
The European experience
Source: http://ec.europa.eu/enterprise/
sectors/healthcare/files/docs/
mea_report_en.pdf
      Title: What principles should govern the use of managed entry agreements?>
Source: http://www.ncbi.nlm.nih.gov/
pubmed/?term=21262072
      Title: Principles of design of access with evidence development approaches: a consensus statement from the Banff Summit.
Source: http://www.ncbi.nlm.nih.gov/
pubmed/20085388
      Title: Current status and trends in performance-based risk-sharing arrangements between healthcare payers and medical product manufacturers.
Source: http://www.ncbi.nlm.nih.gov/
pubmed/24664994
  1. Supporting disinvestment decisions
Title: Identification, prioritization and assessment of obsolete health technologies. A methodological guideline.
Source: Identification, prioritization and assessment of obsolete health technologies. A methodological guideline.
   
      Title: Reducing the use of ineffective health care interventions
Source: Reducing the use of ineffective health care interventions
  1. Pricing and value-based pricing
  Title: Pricing. Prices of reimbursed drugs, negotiations, and risk sharing
PDF file - 3.5 MB
Scientific editing: Krzysztof Łanda
Source: http://www.ceestahc.org/en/
activity,publishing.html?i7
Title: Reimbursement of pharmaceuticals: reference pricing versus health technology assessment.
Source: http://www.ncbi.nlm.
nih.gov/pmc/articles/
PMC3078322/
  1. Evidence-based / strategic procurement
    Title: Concept of evidence-based public procurement
Source: http://www.unpcdc.org/media/4476/
global%20evidence%20based%20pp.pdf
  1. Impact of HTA
     
  1. Measuring impact
Title: Planning monitoring and evaluation of policies.
Source: http://www.health-policy-systems.com/content/pdf/1478-4505-7-S1-s18.pdf
  Title: Bridging the gap: The role of monitoring and evaluation in evidence-based policy making. UNICEF, the World Bank and the International Develop- ment Evaluation Association.
Source: http://www.unicef.org/ ceecis/evidence_based_policy_making.pdf
  Title: HTA agencies and. decision makers. an INAHTA guidance document.
Source:   http://www.inahta.org/wp-content/themes/inahta/img/
HTA%20%20Decision%20Makers.pdf
  Title: How can the impact of HTA be enhanced?
Source: http://www.euro.who.int/__data/
assets/pdf_file/0019/73225/E93420.pdf
II. Individual Health Care Decisions by Clinicians & Patients
  1. Risk-benefit – efficacy vs. safety
    Title: A framework for organizing and selecting quantitative approaches for benefit-harm assessment by Puhan MA, Singh S, Weiss CO, Varadhan R, Boyd CM.
Source: BMC Medical Research Methodology 2012; 12:173 http://www.biomedcentral.com/1471-2288/12/173
      Title: Benefit-risk evaluation: A tiered approach to an enhanced scope for safety, efficacy, and quality evidence2007.
Source: Health Canada.   http://www.hc-sc.gc.ca/dhp-mps/homologation-licensing/model/evaluation-eng.php. Accessed February 24, 2011.
      Title: Benefit-Risk methodology project - Description of the current practice of benefit-risk assessment for centralised procedure products in the EU regulatory network.
Source: European Medicines Agency. London UK: 2010.
      Title: A United States Regulator's Perspective on Risk-Benefit Considerations by Jenking J.
Source: Center for Drug Evaluation and ResearchFood and Drug Administration; 2010.
      Title: Draft Guidance for Industry and Food and Drug Administration Staff. Factors to Consider when Making Benefit-Risk Determinations in Medical Device Premarket Review
Source: Department of Health and Human Services Food and Drug Administration, Center for Devices and Radiological Health, Center for Biologics Evaluation and Research; August 15, 2011.
      Title:  Benefit-Risk methodology project work package 2 report: Applicability of current tools and processes for regulatory benefit-risk assessment.
Source: European Medicines Agency, London UK:2010
  1. Patient engagement in treatment decisions
     
  1. Shared decision making instruments
     
  1. Using behavioral methods to help clinicians and patients fulfill decisions made
  Title: Decision making in health and medicine: Integrating evidence and values by Myriam Hunink MG, Glasziou PP, Siegel JE, Weeks JC, Pliskin JS, Elstein AS, Weinstein MC
Source: Cambridge University Press, 2001
 
  1. Evidence-based decision making for clinicians
  Title: Evidence-based Medicine: How to Practice and Teach EBM by Sackett, D.L., Strauss, S.E., Richardson, W.S., Rosenberg, W., Haynes, R.B.
Source: Scotland: Elsevier, 2005
 
    Title: Decision Making in Health and Medicine: Integrating Evidence and Values
Source: Cambridge University Press, 2001
 
    Title: Medical Tests-White Paper Series
Source: Agency for Healthcare Research and Quality (US); Rockville (MD): 2009 -
 
    Title: Users' Guide to the Medical Literature.  A manual for Evidence -Based Clinical Practice.  2nd edition 2008 by Gordon Guyatt, MD, Drummond Rennie, MD, Maureen O Meade, MD and Deborah J Cook, MD.