Related references
Note: Only part of the references are listed.Patients With Irritable Bowel Syndrome Are Willing to Take Substantial Medication Risks for Symptom Relief
Shawn L. Shah et al.
CLINICAL GASTROENTEROLOGY AND HEPATOLOGY (2021)
FDA's Benefit-Risk Framework for Human Drugs and Biologics: Role in Benefit-Risk Assessment and Analysis of Use for Drug Approvals
Leila Lackey et al.
THERAPEUTIC INNOVATION & REGULATORY SCIENCE (2021)
Composite outcomes for pain clinical trials: considerations for design and interpretation
Jennifer S. Gewandter et al.
PAIN (2021)
Essential statistical principles of clinical trials of pain treatments
Robert H. Dworkin et al.
PAIN REPORTS (2021)
Estimands in a Chronic Pain Trial: Challenges and Opportunities
Francesca Callegari et al.
STATISTICS IN BIOPHARMACEUTICAL RESEARCH (2020)
Presenting Risks and Benefits: Helping the Data Monitoring Committee Do Its Job
Scott R. Evans et al.
ANNALS OF INTERNAL MEDICINE (2020)
Priorities of patients with multimorbidity and of clinicians regarding treatment and health outcomes: a systematic mixed studies review
Harini Sathanapally et al.
BMJ OPEN (2020)
2019 American College of Rheumatology/Arthritis Foundation Guideline for the Management of Osteoarthritis of the Hand, Hip, and Knee
Sharon L. Kolasinski et al.
ARTHRITIS & RHEUMATOLOGY (2020)
Estimands and missing data in clinical trials of chronic pain treatments: advances in design and analysis
Xueya Cai et al.
PAIN (2020)
Patient preferences for osteoarthritis pain and chronic low back pain treatments in the United States: a discrete-choice experiment
D. Turk et al.
OSTEOARTHRITIS AND CARTILAGE (2020)
Interpretation of chronic pain clinical trial outcomes: IMMPACT recommended considerations
Shannon M. Smith et al.
PAIN (2020)
Patient Centricity in Patient Preference Studies: The Patient Perspective
Eline van Overbeeke et al.
FRONTIERS IN MEDICINE (2020)
A Novel Method to Combine Assessment of Benefit and Harm: Outcome Measures in Rheumatology 3x3 Methodology Applied to Two Active Comparator Trials
Maarten Boers et al.
ARTHRITIS CARE & RESEARCH (2019)
Patient Perspectives on DMARD Safety Concerns in Rheumatology Trials: Results from Inflammatory Arthritis Patient Focus Groups and OMERACT Attendees Discussion
Kathleen M. Andersen et al.
JOURNAL OF RHEUMATOLOGY (2019)
Challenges with Implementing the Centers for Disease Control and Prevention Opioid Guideline: A Consensus Panel Report
Kurt Kroenke et al.
PAIN MEDICINE (2019)
Recommendations for the Reporting of Harms in Manuscripts on Clinical Trials Assessing Osteoarthritis Drugs: A Consensus Statement from the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO)
Germain Honvo et al.
DRUGS & AGING (2019)
The evolving role of patient preference studies in health-care decision-making, from clinical drug development to clinical care management
Yanina Jackson et al.
EXPERT REVIEW OF PHARMACOECONOMICS & OUTCOMES RESEARCH (2019)
The silent epidemic of chronic pain in older adults
Anthony F. Domenichiello et al.
PROGRESS IN NEURO-PSYCHOPHARMACOLOGY & BIOLOGICAL PSYCHIATRY (2019)
Prevalence of Chronic Pain and High-Impact Chronic Pain in Cancer Survivors in the United States
Changchuan Jiang et al.
JAMA ONCOLOGY (2019)
Opportunities and challenges for the inclusion of patient preferences in the medical product life cycle: a systematic review
Rosanne Janssens et al.
BMC MEDICAL INFORMATICS AND DECISION MAKING (2019)
Evaluating treatment modalities in chronic pain treatment by the multi-criteria decision making procedure
Ender Sir et al.
BMC MEDICAL INFORMATICS AND DECISION MAKING (2019)
Effectiveness of physical and cognitive-behavioural intervention programmes for chronic musculoskeletal pain in adults: A systematic review and meta-analysis of randomised controlled trials
Joyce Oi Suet Cheng et al.
PLOS ONE (2019)
Craniosacral therapy for chronic pain: a systematic review and meta-analysis of randomized controlled trials
Heidemarie Haller et al.
BMC MUSCULOSKELETAL DISORDERS (2019)
Improving Benefit-harm Assessment of Therapies from the Patient Perspective: OMERACT Premeeting Toward Consensus on Core Sets for Randomized Controlled Trials
Kathleen M. Andersen et al.
JOURNAL OF RHEUMATOLOGY (2019)
The double opioid crisis: A call for balance
Marjolein J. M. Vranken et al.
PHARMACOEPIDEMIOLOGY AND DRUG SAFETY (2019)
The Potential Role of Individual-Level Benefit-Risk Assessment in Treatment Decision Making: A DIA Study Endpoints Community Workstream
Matthew Reaney et al.
THERAPEUTIC INNOVATION & REGULATORY SCIENCE (2019)
Opioid Epidemic or Pain Crisis? Using the Virginia All Payer Claims Database to Describe Opioid Medication Prescribing Patterns and Potential Harms for Patients With Cancer
Virginia T. LeBaron et al.
JOURNAL OF ONCOLOGY PRACTICE (2019)
Benefit-risk evaluation: the past, present and future
Juhaeri Juhaeri
THERAPEUTIC ADVANCES IN DRUG SAFETY (2019)
Prospective clinical trial registration: not sufficient, but always necessary
S. M. Smith et al.
ANAESTHESIA (2018)
Treatment of Chronic Pain With Various Buprenorphine Formulations: A Systematic Review of Clinical Studies
Rohit Aiyer et al.
ANESTHESIA AND ANALGESIA (2018)
Use of composite outcomes to assess risk-benefit in clinical trials
Pamela A. Shaw
CLINICAL TRIALS (2018)
Retrospective harm benefit analysis of pre-clinical animal research for six treatment interventions
Pandora Pound et al.
PLOS ONE (2018)
Prevalence of Chronic Pain and High-Impact Chronic Pain Among Adults - United States, 2016
James Dahlhamer et al.
MMWR-MORBIDITY AND MORTALITY WEEKLY REPORT (2018)
Opioids for Chronic Noncancer Pain A Systematic Review and Meta-analysis
Jason W. Busse et al.
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION (2018)
Benefit-Risk Assessments at the US Food and Drug Administration Finding the Balance
Robert M. Califf
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION (2017)
Marshaling FDA Benefit-Risk Expertise to Address the Current Opioid Abuse Epidemic
Scott Gottlieb et al.
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION (2017)
Do patients and health care providers have discordant preferences about which aspects of treatments matter most? Evidence from a systematic review of discrete choice experiments
Mark Harrison et al.
BMJ OPEN (2017)
Structured Benefit-risk assessment: a review of key publications and initiatives on frameworks and methodologies
Shahrul Mt-Isa et al.
PHARMACEUTICAL STATISTICS (2016)
Adverse Event Reporting in Clinical Trials of Intravenous and Invasive Pain Treatments: An ACTTION Systematic Review
Mark R. Williams et al.
JOURNAL OF PAIN (2016)
Current concepts of Harm-Benefit Analysis of Animal Experiments - Report from the AALAS-FELASA Working Group on Harm-Benefit Analysis - Part 1
Aurora Bronstad et al.
LABORATORY ANIMALS (2016)
Recommendations for benefit-risk assessment methodologies and visual representations
Diana Hughes et al.
PHARMACOEPIDEMIOLOGY AND DRUG SAFETY (2016)
A Framework for Incorporating Patient Preferences Regarding Benefits and Risks into Regulatory Assessment of Medical Technologies
Martin Ho et al.
VALUE IN HEALTH (2016)
Using Outcomes to Analyze Patients Rather than Patients to Analyze Outcomes: A Step Toward Pragmatism in Benefit:Risk Evaluation
Scott R. Evans et al.
STATISTICS IN BIOPHARMACEUTICAL RESEARCH (2016)
Quality of Regulatory Decision-Making Practices: Issues Facing Companies and Agencies
Magdalena Bujar et al.
THERAPEUTIC INNOVATION & REGULATORY SCIENCE (2016)
Desirability of Outcome Ranking (DOOR) and Response Adjusted for Duration of Antibiotic Risk (RADAR)
Scott R. Evans et al.
CLINICAL INFECTIOUS DISEASES (2015)
A holistic approach to chronic pain management that involves all stakeholders: change is needed
Hans-Georg Kress et al.
CURRENT MEDICAL RESEARCH AND OPINION (2015)
Pharmacotherapy for neuropathic pain in adults: a systematic review and meta-analysis
Nanna B. Finnerup et al.
LANCET NEUROLOGY (2015)
Development and preliminary validation of an integrated efficacy-tolerability composite measure for the evaluation of analgesics
Nathaniel P. Katz et al.
PAIN (2015)
A Universal Framework for the Benefit-Risk Assessment of Medicines: Is This the Way Forward?
Stuart Walker et al.
THERAPEUTIC INNOVATION & REGULATORY SCIENCE (2015)
OARSI guidelines for the non-surgical management of knee osteoarthritis
T. E. McAlindon et al.
OSTEOARTHRITIS AND CARTILAGE (2014)
Adverse event reporting in nonpharmacologic, noninterventional pain clinical trials: ACTTION systematic review
Matthew Hunsinger et al.
PAIN (2014)
Balancing benefit and risk of medicines: a systematic review and classification of available methodologies
Shahrul Mt-Isa et al.
PHARMACOEPIDEMIOLOGY AND DRUG SAFETY (2014)
Two Approaches to Incorporate Clinical Data Uncertainty into Multiple Criteria Decision Analysis for Benefit-Risk Assessment of Medicinal Products
Shihua Wen et al.
VALUE IN HEALTH (2014)
Cognitive-Behavioral Therapy for Individuals With Chronic Pain Efficacy, Innovations, and Directions for Research
Dawn M. Ehde et al.
AMERICAN PSYCHOLOGIST (2014)
A discrete-choice experiment of United Kingdom patients′ willingness to risk adverse events for improved function and pain control in osteoarthritis
A. B. Hauber et al.
OSTEOARTHRITIS AND CARTILAGE (2013)
Adverse event assessment, analysis, and reporting in recent published analgesic clinical trials: ACTTION systematic review and recommendations
Shannon M. Smith et al.
PAIN (2013)
Prevalence and impact of pain among older adults in the United States: Findings from the 2011 National Health and Aging Trends Study
Kushang V. Patel et al.
PAIN (2013)
Expect analgesic failure; pursue analgesic success
Andrew Moore et al.
BMJ-BRITISH MEDICAL JOURNAL (2013)
Patient Preferences Versus Physicians' Judgement: Does it Make a Difference in Healthcare Decision Making?
Axel C. Muehlbacher et al.
APPLIED HEALTH ECONOMICS AND HEALTH POLICY (2013)
Adherence to CONSORT harms-reporting recommendations in publications of recent analgesic clinical trials: An ACTTION systematic review
Shannon M. Smith et al.
PAIN (2012)
Simultaneous evaluation of the harms and benefits of treatments in randomized clinical trials: demonstration of a new approach
E. Frank et al.
PSYCHOLOGICAL MEDICINE (2012)
Reliability of adverse symptom event reporting by clinicians
Thomas M. Atkinson et al.
QUALITY OF LIFE RESEARCH (2012)
Stated Preferences of Physicians and Chronic Pain Sufferers in the Use of Classic Strong Opioids
Jeremy Chancellor et al.
VALUE IN HEALTH (2012)
Communicating Data About the Benefits and Harms of Treatment A Randomized Trial
Steven Woloshin et al.
ANNALS OF INTERNAL MEDICINE (2011)
Application of the BRAT Framework to Case Studies: Observations and Insights
B. S. Levitan et al.
CLINICAL PHARMACOLOGY & THERAPEUTICS (2011)
Development of a Framework for Enhancing the Transparency, Reproducibility and Communication of the Benefit-Risk Balance of Medicines
P. M. Coplan et al.
CLINICAL PHARMACOLOGY & THERAPEUTICS (2011)
Can Modeling of Health Outcomes Facilitate Regulatory Decision Making?: The Benefit-Risk Tradeoff for Rosiglitazone in 1999 vs. 2007
J. T. Cross et al.
CLINICAL PHARMACOLOGY & THERAPEUTICS (2011)
How to assess the clinical impact of treatments on patients, rather than the statistical impact of treatments on measures
Helena Chmura Kraemer et al.
INTERNATIONAL JOURNAL OF METHODS IN PSYCHIATRIC RESEARCH (2011)
A first step to assess harm and benefit in clinical trials in one scale
Maarten Boers et al.
JOURNAL OF CLINICAL EPIDEMIOLOGY (2010)
Importance of Side Effects in Opioid Treatment A Trade-Off Analysis With Patients and Physicians
Razmic S. Gregorian et al.
JOURNAL OF PAIN (2010)
The Missing Voice of Patients in Drug-Safety Reporting
Ethan Basch
NEW ENGLAND JOURNAL OF MEDICINE (2010)
Regulatory Benefit-Risk Assessment and Comparative Effectiveness Research Strangers, Bedfellows or Strange Bedfellows?
Louis P. Garrison
PHARMACOECONOMICS (2010)
A quantitative evaluation of the regulatory assessment of the benefits and risks of rofecoxib relative to naproxen: an application of the incremental net-benefit framework
Larry D. Lynd et al.
PHARMACOEPIDEMIOLOGY AND DRUG SAFETY (2010)
Quantifying Women's Stated Benefit-Risk Trade-Off Preferences for IBS Treatment Outcomes
F. Reed Johnson et al.
VALUE IN HEALTH (2010)
A Review of Quantitative Risk-Benefit Methodologies for Assessing Drug Safety and Efficacy-Report of the ISPOR Risk-Benefit Management Working Group
Jeff J. Guo et al.
VALUE IN HEALTH (2010)
The Evaluation of Genomic Applications in Practice and Prevention (EGAPP) initiative: methods of the EGAPP Working Group
Steven M. Teutsch et al.
GENETICS IN MEDICINE (2009)
How to Ascertain Drug Safety in the Context of Benefit. Controversies and Concerns
Lee S. Simon et al.
JOURNAL OF RHEUMATOLOGY (2009)
Heterogeneous but standard coding systems for adverse events: Issues in achieving interoperability between apples and oranges
Rachel L. Richesson et al.
CONTEMPORARY CLINICAL TRIALS (2008)
Measures for conducting comparative benefit: Risk assessment
Christy Chuang-Stein et al.
DRUG INFORMATION JOURNAL (2008)
Crohn's disease patients' risk-benefit preferences:: Serious adverse event risks versus treatment efficacy
F. Reed Johnson et al.
GASTROENTEROLOGY (2007)
Assessing a structured, quantitative health outcomes approach to drug risk-benefit analysis
Louis P. Garrison et al.
HEALTH AFFAIRS (2007)
The FDA and drug safety - A proposal for sweeping changes
Curt D. Furberg et al.
ARCHIVES OF INTERNAL MEDICINE (2006)
Core outcome measures for chronic pain clinical trials: IMMPACT recommendations
RH Dworkin et al.
PAIN (2005)
CIOMS and ICH initiatives in pharmacovigilance and risk management - Overview and implications
P Tsintis et al.
DRUG SAFETY (2004)
Better reporting of harms in randomized trials: An extension of the CONSORT statement
JPA Ioannidis et al.
ANNALS OF INTERNAL MEDICINE (2004)
Treatment options in knee osteoarthritis - The patient's perspective
L Fraenkel et al.
ARCHIVES OF INTERNAL MEDICINE (2004)
Core outcome domains for chronic pain clinical trials: IMMPACT recommendations
DC Turk et al.
PAIN (2003)
Completeness of safety reporting in randomized trials - An evaluation of 7 medical areas
JPA Ioannidis et al.
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION (2001)
Share Paper
