The document summarizes research conducted by the Patient-Centered Outcomes Research Institute (PCORI) on engaging patients. It discusses how PCORI aims to produce high-quality, evidence-based research guided by patients to help people make informed healthcare decisions. It also outlines some draft methodology standards developed by PCORI's Methodology Committee related to patient-centeredness and engagement in medical research.
PCORI held a special webinar on Friday, August 3, 2012, from 1:00 p.m.− 2:00 p.m. ET, to brief stakeholders on PCORI’s draft Methodology Report and encourage public comment.
The draft report, released July 23, 2012, offers standards to guide health care stakeholders towards the best and most appropriate methods for conducting patient-centered outcomes research.
The document summarizes a webinar presented by the Patient-Centered Outcomes Research Institute's (PCORI) Methodology Committee on their report setting standards for patient-centeredness and research prioritization. The webinar agenda included introductions, a focus on patient engagement, an overview of the Methodology Committee's mission and report, and a discussion of patient-centeredness and research prioritization. The report proposed standards in key domains to guide high-quality, patient-centered outcomes research.
The document summarizes a webinar presented by the Patient-Centered Outcomes Research Institute (PCORI) Methodology Committee regarding their draft report on setting standards for patient-centeredness and research prioritization. The webinar covered PCORI's focus on patient engagement, the Methodology Committee's mission and draft report, standards for patient-centeredness and engagement, and a framework for research prioritization. Attendees were invited to submit questions and comments on the draft report.
This document discusses the categorization and review of quality improvement (QI) projects by Institutional Review Boards (IRBs). It defines key terms like research and QI. It describes how QI projects fall on a continuum between clinical practice and clinical research. The document outlines the different levels of IRB review including exempt, expedited and full board review based on the level of risk. It discusses current controversies around the appropriate role and scope of IRB review for QI projects. A case study of a QI project that was initially deemed exempt but later required further IRB review is also summarized.
Knowledge transfer, and evidence informed health policy-minster's meetingDr Ghaiath Hussein
This document discusses knowledge transfer between researchers and policymakers. It begins with an overview of the knowledge cycle and evidence-based healthcare. It notes that while researchers seek truth and policymakers seek compromise, their common goal is improving public health. The document recommends establishing units to facilitate knowledge transfer and decision support. It also suggests training policymakers to identify how research can help and accessing evidence to inform decisions. The overall message is that researchers and policymakers must understand each other and work together toward their shared goal of improving health outcomes.
The document discusses the principles and issues of ICMR guidelines for biomedical research involving human subjects. It provides an overview of ICMR's history of developing ethical guidelines since 1980 to protect participants. The document then outlines 12 general ethical principles that research should adhere to, including principles of essentiality, voluntariness, non-exploitation, and minimizing risks and maximizing benefits. It also discusses issues like informed consent processes, assessing risks and benefits, maintaining privacy and confidentiality, and ensuring distributive justice.
Evidence based dentistry, public health , Prosthodontics and EBD,
history of ebd steps, evidence based medicine,evidence based practise. steps in ebd. advantages ,disadvantages, limitations.
prosthodontic considerations.
This document provides an overview of precision medicine and pharmacogenomics. It discusses barriers to implementing pharmacogenomic testing, key medical settings and patient populations to target, and considerations for integrating test results into clinical workflows. Evidence is presented showing pharmacogenomic testing can reduce adverse drug reactions and alter prescribing. The document emphasizes engaging patients and generating more evidence of the clinical value and economic benefits of pharmacogenomic testing.
PCORI held a special webinar on Friday, August 3, 2012, from 1:00 p.m.− 2:00 p.m. ET, to brief stakeholders on PCORI’s draft Methodology Report and encourage public comment.
The draft report, released July 23, 2012, offers standards to guide health care stakeholders towards the best and most appropriate methods for conducting patient-centered outcomes research.
The document summarizes a webinar presented by the Patient-Centered Outcomes Research Institute's (PCORI) Methodology Committee on their report setting standards for patient-centeredness and research prioritization. The webinar agenda included introductions, a focus on patient engagement, an overview of the Methodology Committee's mission and report, and a discussion of patient-centeredness and research prioritization. The report proposed standards in key domains to guide high-quality, patient-centered outcomes research.
The document summarizes a webinar presented by the Patient-Centered Outcomes Research Institute (PCORI) Methodology Committee regarding their draft report on setting standards for patient-centeredness and research prioritization. The webinar covered PCORI's focus on patient engagement, the Methodology Committee's mission and draft report, standards for patient-centeredness and engagement, and a framework for research prioritization. Attendees were invited to submit questions and comments on the draft report.
This document discusses the categorization and review of quality improvement (QI) projects by Institutional Review Boards (IRBs). It defines key terms like research and QI. It describes how QI projects fall on a continuum between clinical practice and clinical research. The document outlines the different levels of IRB review including exempt, expedited and full board review based on the level of risk. It discusses current controversies around the appropriate role and scope of IRB review for QI projects. A case study of a QI project that was initially deemed exempt but later required further IRB review is also summarized.
Knowledge transfer, and evidence informed health policy-minster's meetingDr Ghaiath Hussein
This document discusses knowledge transfer between researchers and policymakers. It begins with an overview of the knowledge cycle and evidence-based healthcare. It notes that while researchers seek truth and policymakers seek compromise, their common goal is improving public health. The document recommends establishing units to facilitate knowledge transfer and decision support. It also suggests training policymakers to identify how research can help and accessing evidence to inform decisions. The overall message is that researchers and policymakers must understand each other and work together toward their shared goal of improving health outcomes.
The document discusses the principles and issues of ICMR guidelines for biomedical research involving human subjects. It provides an overview of ICMR's history of developing ethical guidelines since 1980 to protect participants. The document then outlines 12 general ethical principles that research should adhere to, including principles of essentiality, voluntariness, non-exploitation, and minimizing risks and maximizing benefits. It also discusses issues like informed consent processes, assessing risks and benefits, maintaining privacy and confidentiality, and ensuring distributive justice.
Evidence based dentistry, public health , Prosthodontics and EBD,
history of ebd steps, evidence based medicine,evidence based practise. steps in ebd. advantages ,disadvantages, limitations.
prosthodontic considerations.
This document provides an overview of precision medicine and pharmacogenomics. It discusses barriers to implementing pharmacogenomic testing, key medical settings and patient populations to target, and considerations for integrating test results into clinical workflows. Evidence is presented showing pharmacogenomic testing can reduce adverse drug reactions and alter prescribing. The document emphasizes engaging patients and generating more evidence of the clinical value and economic benefits of pharmacogenomic testing.
This document summarizes a presentation about the Patient Centered Outcomes Research Institute (PCORI) and its methods. It discusses how PCORI funds research to help patients make informed healthcare decisions by producing high-quality evidence. Key points include that PCORI research must be patient-centered, compare at least two alternatives, and use outcomes that matter to patients. It also outlines PCORI's research portfolio, methodology standards, and application review process.
Here are the key points from the contributors' comments:
- The manual provides a wealth of information about clinical trials in an accessible way to allow non-experts like ethics committee members to become confident in their roles.
- It complements other readings in the field of research ethics and good clinical practice.
- As a guide, it is widely applicable to ethics committee review across countries and is not specific to any one regulatory system.
- At around one afternoon's reading, it is comprehensive yet concise.
- Ethics committee members should have an overview of product development and study designs to better assess risks and identify ethics issues - this manual provides that context.
- Compared to other books, it covers the
Patient safety has always been the industry’s focus during clinical trials. However, a recent spate of well-publicized patient safety issues have increased public scrutiny and the biotechnology, pharmaceutical and CRO industries' desire to improve study quality, resulting in larger, longer, more expensive trials. In this Q&A, James T. Gourzis, M.D., Ph.D., discusses issues affecting patient safety, including factors that have launched safety to the forefront; what to look for in evaluating CRO excellence; unique oncology considerations and the ramifications of the rare toxicity; optimizing the Data Monitoring Committee; budget decisions that affect patient safety and the evolution/future of FDA requirements.
The document discusses ethical issues in clinical trials conducted in emerging regions. It summarizes that over 40% of US-regulated trials are now conducted overseas, driven by increasing trial numbers, large sample size demands, and availability of lower-cost patient recruitment abroad. However, ethical challenges arise from cultural differences, vulnerability of populations, and crisis opportunism in places with limited healthcare. Informed consent can be difficult given literacy and comprehension issues. Placebo controls remain controversial, though active controls are preferred from scientific, ethical and regulatory perspectives when proven treatments exist.
1) The study aims to understand barriers to obtaining oral cancer treatment and the impact on patient experience by assessing financial toxicity, psychosocial burden, and factors associated with treatment satisfaction.
2) Preliminary findings show that while wait times and costs cause distress, receiving treatment reduces worry. Higher costs were not significantly associated with more distress. Patients waited an average of 8-9 days for medications.
3) Increased costs and wait times may be linked to greater psychosocial stress, though receiving treatment lessened worry. Further analysis of factors like memory, mood, and finances could provide more insights into adherence.
This document discusses evidence-based medicine (EBM) and its key steps. EBM involves integrating the best available research evidence with clinical expertise and patient values. The rise of EBM was driven by various factors. The five steps of EBM are: 1) formulating a question, 2) finding evidence, 3) critically appraising the evidence, 4) applying findings to practice, and 5) evaluating performance. A case study example of a patient with acute pulmonary edema is provided to demonstrate applying EBM in practice.
Guideline on patient safety and well being in clinical trialsTrialJoin
Patient safety is and should be the number one priority in clinical research. Human participants in a clinical trial are necessary in order to improve and develop new therapies for certain conditions and advance the understanding of how a condition can be treated. Such medical advancements wouldn’t be possible without human subjects as participants. However, even though we all know the importance of clinical trials in the advancement of medicine, most people still have some misconceptions regarding this topic.
The feeling of being treated as a ‘’guinea pig’’ and fear of potential risks and side effects are still common among patients who suffer from a certain condition. Such misinformation and misconceptions regarding clinical trials can unnecessarily prevent patients from finding a potential cure or relief, and can also decrease the number of enrolled patients in studies.
In order to clarify these misunderstandings, we’ve decided to tell you everything there is to know about patient safety in clinical trials. We hope that with this information we can help you to better understand patient safety in clinical trials so that you gain more insight and start considering clinical trials as valid options that can help you improve any condition.
The characteristics of the Ideal Source for practicing Evidence-Based Medicine are:-
Located in the clinical setting
Easy to use
Fast, reliable connection
Comprehensive /Full Text
Provides primary data
A presentation by Niklas Nielsen at the 2017 meeting of the Scandinavian Society of Anaestesiology and Intensive Care Medicine.
All available content from SSAI2017: https://scanfoam.org/ssai2017/
Delivered in collaboration between scanFOAM, SSAI & SFAI.
National OncoVenture (NOV) was launched as a now government R&D program for cancer drug development in 2011 to bridge the gap between discovery and development in drug development in Korea. NOV is carrying out high standard preclinical and early stage clinical trials of novel anti-cancer drug candidates from industry, academia and research institutes in Korea.
History ethical guide lines to clinical trialAnju Thejkumar
The document summarizes the history of ethical guidelines for clinical trials. It discusses several key documents and events that shaped modern research ethics, including the Nuremberg Code established after World War 2 Nazi experiments, the Declaration of Helsinki, Belmont Report, ICH GCP guidelines, and India's Ethical Guidelines for Biomedical Research in Human Subjects. Overall it provides an overview of the evolution of clinical trial ethics from the 1940s to 2000 to protect human subjects and ensure scientific integrity.
National OncoVenture (NOV) was launched as a now government R&D program for cancer drug development in 2011 to bridge the gap between discovery and development in drug development in Korea. NOV is carrying out high standard preclinical and early stage clinical trials of novel anti-cancer drug candidates from industry, academia and research institutes in Korea
An introduction to evidence based medicine, Prof. Usama M.Foudaumfrfouda
This document provides an introduction to evidence-based medicine (EBM). It defines EBM as a systematic approach to clinical problem solving that integrates the best available research evidence, clinical expertise, and patient values and preferences. The key steps of EBM are outlined as asking a focused clinical question, acquiring the best evidence to answer that question, appraising the validity and importance of the evidence, and applying the evidence to individual patients. Levels of evidence are also discussed, with the highest levels being systematic reviews and randomized controlled trials. Overall, the document provides a high-level overview of the basic principles and process of evidence-based medicine.
From the event "Specimen Science: Ethics and Policy Implications," held at Harvard Law School on November 16, 2015.
This event was a collaboration between The Center for Child Health and Policy at Case Western Reserve University and University Hospitals Rainbow Babies & Children’s Hospital; the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School; the Multi-Regional Clinical Trials Center of Harvard and Brigham and Women's Hospital; and Harvard Catalyst | The Harvard Clinical and Translational Science Center. It was supported by funding from the National Human Genome Research Institute and the Oswald DeN. Cammann Fund at Harvard University.
For more information, visit our website at http://petrieflom.law.harvard.edu/events/details/specimen-science-ethics-and-policy
MedicalResearch.com: Exclusive Interviews with Medical Research and Health Care Researchers from Major and Specialty Medical Research Journals and Meetings
INFORMED CONSENT: Pledge, Promise, Contract or Platitude? Key Aspects of Inf...Michael Swit
A discussion of the various theories of how informed consent operates under the law, who is bound by it, who is liable for a breach, and key cases relating to access to drugs.
Clinical trial protocol, ammendments, Protocol deviations and violationsAmol Patil
This document provides guidelines for developing a clinical trial protocol including general information, background, aims and objectives, inclusion/exclusion criteria, study design, methodology, statistics, ethics, quality control, and protocol amendments. Key elements that must be addressed in the protocol are enumerated such as the research question, treatment characteristics, data collection and analysis, and legal responsibilities. Protocol deviations and violations that occur during the study are also discussed along with examples and regulatory requirements for reporting them. Adherence to good clinical practice and obtaining necessary approvals are emphasized.
The National Cancer Center Korea(NCC) launched a new government R&D program, called "National OncoVenture" for cancer drug development in 2011 to bridge the gap between discovery and development in drug development in Korea. The National OncoVenture, formerly known as the Bridging and Development ("B&D") Program for Cancer Therapeutics with System Integration, is to facilitate the drug development process by letting a group of drug development experts in and out of the NCC carry out preclinical, clinical trials of the new anti-cancer drug candidates they have licensed in from the original inventors in industry, academia and government-funded institutes. The National Oncoventure aims to develop 4 Global Drug Candidates that have completed phase 2a human clinical trials by 2016.
Jean Slutsky, the director of the Center for Outcomes and Evidence at the Agency for Healthcare Research and Quality, asks how the Center for Understanding in Evidence can contribute to AHRQ's Effective Healthcare Program. She leads the center, which provides evidence to help improve healthcare.
The document describes a panel discussion on engaging customers in research. It discusses strengths and challenges of customer engagement based on a Q&A with Lori Frank, Kate Ryan, and C. Daniel Mullins. However, it does not provide any details on the answers given or topics discussed.
This document summarizes a presentation about the Patient Centered Outcomes Research Institute (PCORI) and its methods. It discusses how PCORI funds research to help patients make informed healthcare decisions by producing high-quality evidence. Key points include that PCORI research must be patient-centered, compare at least two alternatives, and use outcomes that matter to patients. It also outlines PCORI's research portfolio, methodology standards, and application review process.
Here are the key points from the contributors' comments:
- The manual provides a wealth of information about clinical trials in an accessible way to allow non-experts like ethics committee members to become confident in their roles.
- It complements other readings in the field of research ethics and good clinical practice.
- As a guide, it is widely applicable to ethics committee review across countries and is not specific to any one regulatory system.
- At around one afternoon's reading, it is comprehensive yet concise.
- Ethics committee members should have an overview of product development and study designs to better assess risks and identify ethics issues - this manual provides that context.
- Compared to other books, it covers the
Patient safety has always been the industry’s focus during clinical trials. However, a recent spate of well-publicized patient safety issues have increased public scrutiny and the biotechnology, pharmaceutical and CRO industries' desire to improve study quality, resulting in larger, longer, more expensive trials. In this Q&A, James T. Gourzis, M.D., Ph.D., discusses issues affecting patient safety, including factors that have launched safety to the forefront; what to look for in evaluating CRO excellence; unique oncology considerations and the ramifications of the rare toxicity; optimizing the Data Monitoring Committee; budget decisions that affect patient safety and the evolution/future of FDA requirements.
The document discusses ethical issues in clinical trials conducted in emerging regions. It summarizes that over 40% of US-regulated trials are now conducted overseas, driven by increasing trial numbers, large sample size demands, and availability of lower-cost patient recruitment abroad. However, ethical challenges arise from cultural differences, vulnerability of populations, and crisis opportunism in places with limited healthcare. Informed consent can be difficult given literacy and comprehension issues. Placebo controls remain controversial, though active controls are preferred from scientific, ethical and regulatory perspectives when proven treatments exist.
1) The study aims to understand barriers to obtaining oral cancer treatment and the impact on patient experience by assessing financial toxicity, psychosocial burden, and factors associated with treatment satisfaction.
2) Preliminary findings show that while wait times and costs cause distress, receiving treatment reduces worry. Higher costs were not significantly associated with more distress. Patients waited an average of 8-9 days for medications.
3) Increased costs and wait times may be linked to greater psychosocial stress, though receiving treatment lessened worry. Further analysis of factors like memory, mood, and finances could provide more insights into adherence.
This document discusses evidence-based medicine (EBM) and its key steps. EBM involves integrating the best available research evidence with clinical expertise and patient values. The rise of EBM was driven by various factors. The five steps of EBM are: 1) formulating a question, 2) finding evidence, 3) critically appraising the evidence, 4) applying findings to practice, and 5) evaluating performance. A case study example of a patient with acute pulmonary edema is provided to demonstrate applying EBM in practice.
Guideline on patient safety and well being in clinical trialsTrialJoin
Patient safety is and should be the number one priority in clinical research. Human participants in a clinical trial are necessary in order to improve and develop new therapies for certain conditions and advance the understanding of how a condition can be treated. Such medical advancements wouldn’t be possible without human subjects as participants. However, even though we all know the importance of clinical trials in the advancement of medicine, most people still have some misconceptions regarding this topic.
The feeling of being treated as a ‘’guinea pig’’ and fear of potential risks and side effects are still common among patients who suffer from a certain condition. Such misinformation and misconceptions regarding clinical trials can unnecessarily prevent patients from finding a potential cure or relief, and can also decrease the number of enrolled patients in studies.
In order to clarify these misunderstandings, we’ve decided to tell you everything there is to know about patient safety in clinical trials. We hope that with this information we can help you to better understand patient safety in clinical trials so that you gain more insight and start considering clinical trials as valid options that can help you improve any condition.
The characteristics of the Ideal Source for practicing Evidence-Based Medicine are:-
Located in the clinical setting
Easy to use
Fast, reliable connection
Comprehensive /Full Text
Provides primary data
A presentation by Niklas Nielsen at the 2017 meeting of the Scandinavian Society of Anaestesiology and Intensive Care Medicine.
All available content from SSAI2017: https://scanfoam.org/ssai2017/
Delivered in collaboration between scanFOAM, SSAI & SFAI.
National OncoVenture (NOV) was launched as a now government R&D program for cancer drug development in 2011 to bridge the gap between discovery and development in drug development in Korea. NOV is carrying out high standard preclinical and early stage clinical trials of novel anti-cancer drug candidates from industry, academia and research institutes in Korea.
History ethical guide lines to clinical trialAnju Thejkumar
The document summarizes the history of ethical guidelines for clinical trials. It discusses several key documents and events that shaped modern research ethics, including the Nuremberg Code established after World War 2 Nazi experiments, the Declaration of Helsinki, Belmont Report, ICH GCP guidelines, and India's Ethical Guidelines for Biomedical Research in Human Subjects. Overall it provides an overview of the evolution of clinical trial ethics from the 1940s to 2000 to protect human subjects and ensure scientific integrity.
National OncoVenture (NOV) was launched as a now government R&D program for cancer drug development in 2011 to bridge the gap between discovery and development in drug development in Korea. NOV is carrying out high standard preclinical and early stage clinical trials of novel anti-cancer drug candidates from industry, academia and research institutes in Korea
An introduction to evidence based medicine, Prof. Usama M.Foudaumfrfouda
This document provides an introduction to evidence-based medicine (EBM). It defines EBM as a systematic approach to clinical problem solving that integrates the best available research evidence, clinical expertise, and patient values and preferences. The key steps of EBM are outlined as asking a focused clinical question, acquiring the best evidence to answer that question, appraising the validity and importance of the evidence, and applying the evidence to individual patients. Levels of evidence are also discussed, with the highest levels being systematic reviews and randomized controlled trials. Overall, the document provides a high-level overview of the basic principles and process of evidence-based medicine.
From the event "Specimen Science: Ethics and Policy Implications," held at Harvard Law School on November 16, 2015.
This event was a collaboration between The Center for Child Health and Policy at Case Western Reserve University and University Hospitals Rainbow Babies & Children’s Hospital; the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School; the Multi-Regional Clinical Trials Center of Harvard and Brigham and Women's Hospital; and Harvard Catalyst | The Harvard Clinical and Translational Science Center. It was supported by funding from the National Human Genome Research Institute and the Oswald DeN. Cammann Fund at Harvard University.
For more information, visit our website at http://petrieflom.law.harvard.edu/events/details/specimen-science-ethics-and-policy
MedicalResearch.com: Exclusive Interviews with Medical Research and Health Care Researchers from Major and Specialty Medical Research Journals and Meetings
INFORMED CONSENT: Pledge, Promise, Contract or Platitude? Key Aspects of Inf...Michael Swit
A discussion of the various theories of how informed consent operates under the law, who is bound by it, who is liable for a breach, and key cases relating to access to drugs.
Clinical trial protocol, ammendments, Protocol deviations and violationsAmol Patil
This document provides guidelines for developing a clinical trial protocol including general information, background, aims and objectives, inclusion/exclusion criteria, study design, methodology, statistics, ethics, quality control, and protocol amendments. Key elements that must be addressed in the protocol are enumerated such as the research question, treatment characteristics, data collection and analysis, and legal responsibilities. Protocol deviations and violations that occur during the study are also discussed along with examples and regulatory requirements for reporting them. Adherence to good clinical practice and obtaining necessary approvals are emphasized.
The National Cancer Center Korea(NCC) launched a new government R&D program, called "National OncoVenture" for cancer drug development in 2011 to bridge the gap between discovery and development in drug development in Korea. The National OncoVenture, formerly known as the Bridging and Development ("B&D") Program for Cancer Therapeutics with System Integration, is to facilitate the drug development process by letting a group of drug development experts in and out of the NCC carry out preclinical, clinical trials of the new anti-cancer drug candidates they have licensed in from the original inventors in industry, academia and government-funded institutes. The National Oncoventure aims to develop 4 Global Drug Candidates that have completed phase 2a human clinical trials by 2016.
Jean Slutsky, the director of the Center for Outcomes and Evidence at the Agency for Healthcare Research and Quality, asks how the Center for Understanding in Evidence can contribute to AHRQ's Effective Healthcare Program. She leads the center, which provides evidence to help improve healthcare.
The document describes a panel discussion on engaging customers in research. It discusses strengths and challenges of customer engagement based on a Q&A with Lori Frank, Kate Ryan, and C. Daniel Mullins. However, it does not provide any details on the answers given or topics discussed.
This document discusses issues with the FDA approval process for medical devices. It notes that over 95% of new medical devices enter the market through the 510(k) premarket notification process, which does not require clinical trials, inspections, or post-market studies to demonstrate safety and efficacy. It cites reports that half a billion 510(k) devices were recalled in 2010-2011 as high risk and that about 15% of regulated devices are ultimately recalled as high or moderate risk. The document argues that clinical trials and other evidence are needed to properly evaluate medical devices and ensure patient safety.
Lorraine Johnson discusses her journey from representing individual patient interests to taking on a broader role advocating for patients collectively. She describes moving from focusing solely on her own Lyme disease experience to serving on the steering committee of Consumers United for Evidence-Based Healthcare to help empower patient voices industry-wide. Johnson emphasizes that patient perspectives are shaped by experiences and true partnership requires representatives having a seat at the table to provide balanced input into healthcare decisions that affect patients.
This document discusses who counts as a consumer in healthcare. It outlines that patients are consumers of healthcare and should have representation at decision making tables. Consumer representatives bring a unique perspective as laypeople without medical training, but who understand complex medical issues. They must balance individual views with representing whole communities, and should not have conflicts of interest with the healthcare industry so they can advocate independently for consumers. The key criteria for consumer representatives are that they actively engage with the healthcare system, prioritize consumer protection, have connections to consumer advocacy groups, and have no financial stakes in the healthcare system.
The document discusses engaging hard-to-reach consumers in research. It defines hard-to-reach consumers as those underrepresented in research, like minorities, low-income groups, elderly patients, non-English speakers, and those with disabilities. It emphasizes meeting these consumers where they are, building trust over time through community outreach and pre-engagement. It also provides a 10-step process for continuous patient engagement in research from topic selection to dissemination of results.
The document is titled "HOW WE KNOW CONSUMERS ARE MAKING A DIFFERENCE" and is authored by Anton Gunn, Director of External Affairs of the U.S. Department of Health and Human Services. However, the document only lists the title and author, and does not contain any other text, so it is not possible to summarize the content in 3 sentences or less.
The document summarizes a panel discussion on effecting change through consumer advocacy. It features a Q&A with Jennifer Sweeney and Judy Norsigian on their work advocating for consumers and how individuals can create change through civic engagement.
The document discusses a panel on the role of Citizens United for Evidence-Based Drug Policy (CUE) members with the FDA. It includes a Q&A with Diana Zuckerman who discusses CUE's role in advocating for evidence-based drug policy and ensuring FDA decisions are informed by independent experts rather than influenced by industry.
Judy Norsigian, Executive Director of Our Bodies, Ourselves, discusses how consumer input has changed things. She explains that consumer advocacy and feedback has led to improvements in how healthcare providers communicate with patients and in the information and services provided to consumers. Consumer voices have helped shape healthcare to better meet individual needs and preferences.
The document summarizes a webinar presented by the Patient-Centered Outcomes Research Institute's (PCORI) Methodology Committee on setting standards for research methods. The webinar covered the committee's mission to define methodological standards, discussed key topics in the committee's draft report including selecting research methods and developing standards, and took questions from webinar participants.
This document discusses accountable care and evidence-based decision making in health care. It provides background on rising health care costs in the US and efforts to promote comparative effectiveness research (CER) and patient-centered outcomes research (PCOR) to address this. It describes the 2009 $1.1 billion ARRA investment in CER and subsequent funding opportunities for PCOR through the Patient-Centered Outcomes Research Trust Fund and the Patient-Centered Outcomes Research Institute (PCORI). The document also discusses challenges of using CER/PCOR findings and the need to incorporate clinical decision-maker perspectives. It analyzes how different payment models like fee-for-service, pay-for-quality programs, episode-based
This document introduces key concepts in systematic reviews and meta-analysis from a health care perspective. It discusses terminology, standards from the Institute of Medicine for conducting rigorous systematic reviews, and challenges in synthesizing the large volume of existing research evidence. Key steps in conducting a systematic review are outlined, including assessing the quality and risk of bias of individual studies and addressing heterogeneity. Standards for evaluating the overall strength of evidence from the body of literature are also presented.
13-Jan-12
1
AHCP 5330
Introduction to Informatics
Research Methods and
Evidence-Based Medicine
Research Methods
Quantitative
Qualitative
Quantitative
Most common, most familiar
Numbers, Statistics
Sensitivity, Specificity
TP, TN, FP, FN
Accuracy, Precision
Positive Predictive Value
Negative Predictive Value
Null hypothesis
Bayes’ theorem
13-Jan-12
2
Examples of good, quantitative
research studies can be found in
almost any peer reviewed journal
Qualitative
Less common, less familiar
Some research doesn’t lend itself to
numerical and statistical analysis
Observations, interviews, biographies,
historical accounts
No numbers (OK, maybe a few)
? “fuzzy” research – NOT
Good qualitative research is
reproducible
Some examples of good qualitative
research studies:
13-Jan-12
3
The Stanford Prison Experiment
Philip Zimbardo
The Perils of Obedience
Stanley Milgram
A Consensus Statement on
Considerations for a Successful
CPOE Implementation
Joan S. Ash, PhD, MLS, P. Zoë Stavri, PhD,
MLS, and Gilad J. Kuperman, MD, PhD
13-Jan-12
4
Evidence-Based Medicine
Definition:
Evidence-based medicine is the use
of information derived from
research for making well-informed
clinical decisions
Principles of evidence-based medicine:
1. Evidence alone is never
sufficient to make a clinical decision
2. There is a hierarchy of evidence
13-Jan-12
5
Hierarchy of evidence:
a) N-of-1 randomized controlled trial
b) Systematic review of randomized trials
c) Single randomized trial
d) Systematic review of observational
studies addressing patient-important outcomes
e) Single observational study addressing
patient-important outcomes
f) Physiologic study
g) Unsystematic clinical observation
Critical thinking –
Are the results valid?
How large was the therapeutic effect?
Are the results statistically meaningful?
Are they worthwhile?
Can I use the information?
References
Resources for finding EBM studies:
Chochrane Collaboration
http://www.cochrane.org
PubMed, http://www.pubmed.gov
emedicine, http://www.emedicine.com
Medscape, http://www.medscape.com
13-Jan-12
6
References:
Resources for finding EBM studies:
Chochrane Collaboration
http://www.cochrane.org
PubMed
http://www.pubmed.gov
emedicine
http://www.emedicine.com
Medscape
http://www.medscape.com
Reference – The Stanford Prison
Experiment
http://www.prisonexp.org/links.htm
Click on “Selected Articles by Dr. Zimbardo”, then
click on “Interpersonal Dynamics in a Simulated
Prison (IJCP, 1973)”
References – “Perils of Obedience”
• Description of the experiment:
– http://www.nmmi.edu/academics/leadership/documents/Milgram-
Obedience2.pdf
• Clips of a three part series showing a recreation of the experiment:
– http://www.youtube.com/watch?v=BcvSNg0HZwk
– http://www.youtube.com/watch?v=IzTuz0mNlwU&NR=1
– http://www.youtube.com/watch?v=CmFCoo-cU3Y&feature=related
13-Jan-12
7
Reference – CPOE
A Consensus Statement on Considerations for a
Su.
The executive director provided an update on the activities and achievements of the Patient-Centered Outcomes Research Institute (PCORI) over the past few months. Key points included funding 50 pilot projects totaling $30.8 million to engage patients and stakeholders in research, finalizing the national research agenda, and relocating to a new office in Washington, D.C. The methodology committee delivered its first report on methodological standards for patient-centered outcomes research and plans to seek public comment on the report over the next few months before presenting it for board approval.
EVIDENCE –BASED PRACTICES 1
Evidence-Based Practices
Stephanie Petit-homme
Miami Regional University
Professor: Garcia Mercedes
07/05/2021
Evidence-Based Practices to Guide Clinical Practices
In other terms recognized as evidence-based medication, evidence-based scientific practice is elucidated as the careful, obvious, and judicious use of the best indication in creating results for the outstanding care of separate patients. It helps those who brand the choices to device best healthcare practices while drawing the roadmaps for the health system. In clinical trials, the integration of the EBCP entails clinical respiratory medicine considers two fundamental principles. For example, the principle is the hierarchy of the evidence and the art of clinical decision-making.
The interrelationship between the theory, research, and EBP
The relationship between the theory, research, and the EBP supports the three recognition programs. They still relate in terms of the magnet model component of modern knowledge, innovation, and advancement. They describe in a way in which they lead to the promotion of quality in a setting that makes supports professional practices. Second, there is the identification of excellence in giving nursing services to sick people or the people who stay around. For instance, the model, which is other terms the magnet theory, has got five components ( Reddy, 2018).
The first constituent includes transformational management; the additional is structural authorization. The third one is archetypal specialized practices, new information, invention, and upgrading. Lastly, in the model, there are the empirical quality outcomes. For the achievement of the aims of the goals that have been set, there is a need to make sure that the theory, current knowledge innovation, and the improvements and the components that are found in view all the nurses who are located in the levels of the healthcare company need to get involved.
The research has its primary purpose for the help of coming up with knowledge or the validation done for the knowledge that has always been there from before based on the theory. There is systematic, scientific questioning in the research to give the answers to some of the specific questions. It can use the test hypotheses and the rigorous method, the primary purpose of the study being for investigation knowing of the new things and the exploration. There is a need to understand the philosophy of science.
Second, on the EBP, there is no development of the new knowledge or even the learning being validated. The primary purpose of the EBP is to translate the evidence and then apply it to medical executive. It uses the indication available to brand patient-care choices. The EBP goes yonder the exploration as fine as the persevering penchants and ideals. The EBP retains into deliberation that the best indication is for the opinion leaders and the experts. Even though there is the existence of definitiv ...
The webinar provided an overview of the PCORI Methodology Standards and the process used to develop them. It discussed how the standards aim to improve the quality, transparency, and rigor of patient-centered outcomes research by reflecting best practices. The webinar faculty described how some standards apply broadly to most projects while others are specific to certain study designs or data sources. They emphasized applying the standards to formulating important research questions, using patient-centered approaches, and fully documenting methods and results. Looking ahead, PCORI plans to provide more guidance on implementing the standards while continuing to refine them based on experience.
EVB-Evidence Based Practice- principles,purposes,valuechristenashantaram
This brief out the principles,purposes,value involved in EVB-Evidence Based Practice and helps health, scoial care practisioner to know more about the EVB-Evidence Based Practicein health and scocial care international base.
Icmr ethical guidelines for biomedical research on human subjectSuraj Pamadi
This document outlines ethical guidelines for biomedical research involving human subjects presented by Suraj P.S. It discusses the ICMR Code established in 1949 and covers several topics including general principles of biomedical research, informed consent, composition and responsibilities of ethics committees, training requirements, and the review process. The key principles are that research must be directed to increasing knowledge, conducted in a way that respects human dignity, and subjected to evaluation at all stages.
This document discusses evidence-based periodontology. It begins by defining evidence-based practice as integrating clinical expertise with the best available research evidence from systematic research. It then discusses the key components of evidence-based periodontology, including systematic reviews, meta-analyses, and critically appraising studies for bias and confounding. The document contrasts evidence-based and traditional approaches to periodontology, noting evidence-based periodontology is more objective and transparent. It emphasizes the importance of evidence-based practice in providing the best patient care.
Significance and formalities of ethics committees for Clinical ResearchRaktimavaDasSarkar
Clinical research plays a pivotal role in advancing medical knowledge, developing
new treatments, and improving patient care. However, with these advancements
come ethical responsibilities to ensure the safety, dignity, and rights of research
participants are protected.
. Evidence-based dentistry (EBD) is the integration and interpretation of the available current research evidence, combined with personal experience. It allows dentists, as well as academics researchers, to keep update of the new developments and to make decisions that should improve their clinical practice.
Efforts to place the patient at the center of medical research, spurred by the Affordable Care Act’s founding of the Patient Centered Outcomes Research Institute, have begun to change the way clinical research is conceptualized and conducted. Such efforts hold great promise, but also raise potential challenges for ethical oversight. How should oversight bodies approach the presence of patients in potentially unfamiliar research roles, such as investigator? What forms of patient involvement in research, if any, warrant increased scrutiny from oversight bodies? How do we keep the patient voice from being ‘captured’ by special interest groups? This symposium brought together a diverse group of patients and community members, policymakers, bioethicists, and regulatory officials to address these and other issues.
Evidence based practice in prosthetics and orthotics YashikaBhatt1
This document discusses the importance and process of evidence-based practice in the field of prosthetics and orthotics. It defines evidence-based practice as making clinical decisions based on the best available scientific evidence combined with clinical expertise and patient values. The process involves formulating a clinical question, locating relevant evidence, critically appraising the evidence, and applying it to patient care. Barriers to evidence-based practice in prosthetics and orthotics include lack of time, knowledge and administrative support. Overcoming these barriers requires educating practitioners, prioritizing evidence-based practice, and encouraging research in the field.
This document provides an introduction to evidence-based practice (EBP) in athletic training. It defines evidence-based medicine (EBM) and EBP, explaining that EBP integrates the best research evidence with clinical expertise and patient values. The history of EBM in athletic training is discussed, noting it began gaining momentum in the early 2000s and is now mandated in athletic training education and clinical practice. The 5-step EBP process is outlined as asking questions, acquiring evidence, appraising evidence, applying to practice, and assessing outcomes. Various EBP resources are also introduced.
This document discusses a program called SCOSI that aims to reduce opioid misuse and optimize safe opioid use through physician education. SCOSI blends academic detailing visits from clinical pharmacists with data from South Carolina's prescription drug monitoring program (SCRIPTS). The academic detailing visits will provide evidence-based education on pain management and opioid prescribing. SCOSI seeks to increase physician awareness and use of the SCRIPTS database to inform treatment decisions and conduct prescribing self-audits. By combining these two strategies, SCOSI intends to serve as a national model for optimizing pain management and increasing safe opioid prescribing.
This document provides information about a training for scientific reviewers for the Patient-Centered Outcomes Research Institute (PCORI). It discusses the agenda for the training, which covers the application and review process, phases of merit review including scientific review and impact review, and use of the online system. It also provides background on PCORI's mission to fund patient-centered research and national priorities, which focus on improving healthcare outcomes and decisions through research guided by patients. A unique aspect of PCORI is its requirement that stakeholders be included in the research process.
This document provides an overview of evidence-based practice (EBP) in healthcare. It defines EBP as integrating the best research evidence, clinical expertise, and patient values and preferences. The key elements of EBP are outlined, including formulating answerable clinical questions using the PICOT format, searching for and appraising evidence, applying evidence to individual patients, and evaluating outcomes. The steps of the EBP process and strategies to bridge the research-practice gap are also summarized. Overall, the document emphasizes that EBP aims to improve clinical decision-making and patient outcomes by basing practices on rigorous research evidence rather than tradition alone.
Recommendations on Evidence Needed to Support Measurement Equivalence between...CRF Health
Patient-reported outcomes (PROs) are the consequences of disease and/or its treatment
as reported by the patient. The importance of PRO measures in clinical trials for new drugs, biologic
agents, and devices was underscored by the release of the US Food and Drug Administration’s draft
guidance for industry titled "Patient-Reported Outcome Measures: Use in Medical Product Development
to Support Labeling Claims." The intent of the guidance was to describe how the FDA will evaluate the
appropriateness and adequacy of PRO measures used as effectiveness endpoints in clinical trials. In
response to the expressed need of ISPOR members for further clarification of several aspects of the draft
guidance, ISPOR’s Health Science Policy Council created three task forces, one of which was charged
with addressing the implications of the draft guidance for the collection of PRO data using electronic data
capture modes of administration (ePRO). The objective of this report is to present recommendations from
ISPOR’s ePRO Good Research Practices Task Force regarding the evidence necessary to support the
comparability, or measurement equivalence, of ePROs to the paper-based PRO measures from which
they were adapted.
The document discusses a panel featuring Sally Okun and Carol Sakala answering questions on the topic of "Where Do We Get Our Information?". The panelists likely answered questions about the various sources people use to get informed, such as traditional media, social media, word-of-mouth, and their reliability. However, no other context or direct quotes from the panelists are provided in the document.
The 11th Annual CUE Membership Meeting celebrates CUE's 10th anniversary and looks ahead to its next 10 years. Nancy Fitton provides an update on CUE's accomplishments including new membership representatives from organizations like Centering Healthcare Institute and work done in collaboration with groups like the Kaiser Family Foundation. The summary highlights CUE's focus on consumer engagement and empowerment as shown through projects like the Consumer Engagement Task Force and Cochrane Colloquium workshop.
The document discusses the Guidelines International Network (G-I-N) and G-I-N North America. It summarizes that G-I-N is a global network of guideline organizations that aims to reduce duplication of effort and promote best practices in guideline development. It also discusses G-I-N's consumer involvement activities through G-I-N PUBLIC and the toolkit it has created on patient and public involvement in guidelines. Finally, it promotes partnership opportunities between G-I-N North America and CUE to further consumer engagement in guideline development.
Lorraine Johnson, co-chair of CUE and CEO of Lymedisease.org, welcomed attendees and provided a steering committee report. As co-chair, she discussed the committee's work to organize the conference and their goals to facilitate discussion and information sharing.
Kate Ryan, a senior program coordinator at the National Women's Health Network, discusses the TEST Act, a proposed federal legislation. The TEST Act would require medical tests to be evaluated for their effectiveness, safety, and clinical validity before being marketed directly to consumers. It aims to establish oversight of direct-to-consumer genetic testing and protect consumers from potentially misleading or ambiguous results without appropriate medical guidance.
The document discusses the benefits of exercise for mental health. Regular physical activity can help reduce anxiety and depression and improve mood and cognitive function. Exercise causes chemical changes in the brain that may help protect against mental illness and improve symptoms.
The document discusses a panel on open access to research data featuring Peter Doshi, Kate Ryan, and Steven Salzberg. The panel addressed questions about making research data openly available and addressed barriers to open data as well as ways to increase access.
The document is a Q&A session with Ann Fonfa, Jim Hulbert, Sue Sheridan, and Claire Snyder from the Patient-Centered Outcomes Research Institute (PCORI) panel. The panelists answered questions about their work at PCORI.
This document summarizes a presentation given at the Consumers United for Evidence-based Healthcare 2013 Annual Membership Meeting. The presentation discussed how social networking sites like PatientsLikeMe can provide important information to patients and advance research. PatientsLikeMe allows patients to connect with others, track their health over time, and participate in research. Analysis of patient-reported data on the site has provided insights that illuminate gaps in evidence-based care and treatment impacts. The presenter argues that engaging patients through sites like PatientsLikeMe can advance research and improve patient outcomes.
The document summarizes the history of HIV/AIDS treatment activism from the early days of ACT UP to modern times. It discusses how ACT UP accelerated drug approval and access to treatment, yet deaths still rose due to a lack of national strategy. It then covers how treatment activism matured and focused on reforming research, improving clinical trials, and holding companies accountable. It describes key campaigns around treatment guidelines and addressing issues like coinfections, aging, and engagement in care. It stresses the importance of education, collaboration, and using influence wisely.
This document summarizes global initiatives to increase open access to clinical trial data. It discusses several key events and studies from 2000-2013 that highlighted issues of incomplete or suppressed trial results. Regulatory agencies like the EMA and FDA have since taken steps to increase reactive and proactive publication of trial data. However, pharmaceutical companies have argued against full data sharing due to concerns about misleading analyses, commercial confidentiality, and costs. Patient and advocacy groups are campaigning for all trial results to be reported. Regulators are now seeking public comments on policies to improve access to clinical trial data.
The document summarizes key findings from three national surveys on mothers' experiences with pregnancy and childbirth. It finds that while many mothers use online sources for information, they rate their healthcare providers as the most trustworthy sources. However, many mothers report not receiving sufficient information and guidance from providers about options for procedures like cesareans and inductions. The surveys also identify gaps in mothers' knowledge about issues like breastfeeding recommendations and complications of different birthing methods. Overall, the surveys provide insights into how to better support informed decision-making and improve the quality of maternity care in the US.
CUE celebrated its 10th anniversary at its annual membership meeting on July 26, 2013. Over the past decade, CUE has accomplished much in advocating for evidence-based healthcare and anticipates continued progress in the next 10 years. CUE thanked its funders, steering committee members, and staff for their contributions over the past 10 years. The first CUE meeting was held in 2003 with representatives from various consumer advocacy organizations discussing their shared goals of promoting evidence-based healthcare and influencing healthcare reform. Looking ahead, CUE aims to make learning about evidence-based healthcare more accessible and establish itself as a leading consumer partnership network recognized for its knowledgeable, unbiased representation of patients.
The document provides advice from John Santa of the Consumer Reports Health Ratings Center on partnerships for the next decade. It suggests focusing partnerships on improving health outcomes, lowering costs, and increasing patient satisfaction by sharing data and coordinating care across organizations for better results.
Rebecca Burkholder, co-chair of CUE and Vice President of Health Policy at the National Consumers League, welcomed attendees and provided a steering committee report. The report discussed the committee's work over the past year to advance consumer priorities in healthcare and their goals for the coming year.
Ann Fonfa, President of the Annie Appleseed Project, discusses the role of CUE members serving as peer reviewers. She notes that CUE members can provide valuable feedback and perspectives to other organizations applying for grants. Their experience and knowledge of what works can help strengthen applications. CUE members reviewing applications brings transparency and credibility to the process.
This document summarizes a project to standardize the presentation of patient-reported outcomes (PRO) data to improve understanding and use by patients and clinicians. The project will engage stakeholders including patients, caregivers, clinicians, and PRO researchers to determine how PRO data is currently presented, identify barriers to interpretation, and develop standardized presentation methods. An investigative team led by Drs. Claire Snyder and Michael Brundage was funded by PCORI to conduct the research with guidance from a stakeholder advisory board representing key perspectives. The goal is to actively involve stakeholders throughout the research process from designing the study to disseminating the results to ultimately increase understanding and use of PRO data.
The document outlines a proposed mentorship program for reviewers to provide peer-to-peer guidance and hands-on support to build a community of reviewers and help them grow. Mentors would assist with training, provide ongoing support and feedback to help reviewers strengthen their written critiques, and identify strong reviewers who could mentor others. The goal is for reviewers to feel confident, develop lasting relationships, and clearly articulate their viewpoints and ideas through knowledge transfer between experienced and new reviewers.
The document outlines the Patient-Centered Outcomes Research Institute's (PCORI) vision for patient engagement in research. PCORI aims to establish a large, diverse community of patients and caregivers that are actively involved in all aspects of the research process. This includes having patients help determine research topics, evaluate funding proposals, monitor study conduct, and disseminate findings. The goal is for research to be done differently through meaningful patient partnership.
Marguerite Koster, John Santa and Lisa Simpson participated in a panel discussion about CUE in Partnership. The panelists discussed CUE's partnership approach and how they work with other organizations. They took questions from the audience about specific partnerships and how CUE collaborates with different partners to advance shared goals.
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Dr. Tan's Balance Method.pdf (From Academy of Oriental Medicine at Austin)GeorgeKieling1
Home
Organization
Academy of Oriental Medicine at Austin
Academy of Oriental Medicine at Austin
Academy of Oriental Medicine at Austin
About AOMA: The Academy of Oriental Medicine at Austin offers a masters-level graduate program in acupuncture and Oriental medicine, preparing its students for careers as skilled, professional practitioners. AOMA is known for its internationally recognized faculty, award-winning student clinical internship program, and herbal medicine program. Since its founding in 1993, AOMA has grown rapidly in size and reputation, drawing students from around the nation and faculty from around the world. AOMA also conducts more than 20,000 patient visits annually in its student and professional clinics. AOMA collaborates with Western healthcare institutions including the Seton Family of Hospitals, and gives back to the community through partnerships with nonprofit organizations and by providing free and reduced price treatments to people who cannot afford them. The Academy of Oriental Medicine at Austin is located at 2700 West Anderson Lane. AOMA also serves patients and retail customers at its south Austin location, 4701 West Gate Blvd. For more information see www.aoma.edu or call 512-492-303434.
Giloy in Ayurveda - Classical Categorization and SynonymsPlanet Ayurveda
Giloy, also known as Guduchi or Amrita in classical Ayurvedic texts, is a revered herb renowned for its myriad health benefits. It is categorized as a Rasayana, meaning it has rejuvenating properties that enhance vitality and longevity. Giloy is celebrated for its ability to boost the immune system, detoxify the body, and promote overall wellness. Its anti-inflammatory, antipyretic, and antioxidant properties make it a staple in managing conditions like fever, diabetes, and stress. The versatility and efficacy of Giloy in supporting health naturally highlight its importance in Ayurveda. At Planet Ayurveda, we provide a comprehensive range of health services and 100% herbal supplements that harness the power of natural ingredients like Giloy. Our products are globally available and affordable, ensuring that everyone can benefit from the ancient wisdom of Ayurveda. If you or your loved ones are dealing with health issues, contact Planet Ayurveda at 01725214040 to book an online video consultation with our professional doctors. Let us help you achieve optimal health and wellness naturally.
- Video recording of this lecture in English language: https://youtu.be/Pt1nA32sdHQ
- Video recording of this lecture in Arabic language: https://youtu.be/uFdc9F0rlP0
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Nano-gold for Cancer Therapy chemistry investigatory projectSIVAVINAYAKPK
chemistry investigatory project
The development of nanogold-based cancer therapy could revolutionize oncology by providing a more targeted, less invasive treatment option. This project contributes to the growing body of research aimed at harnessing nanotechnology for medical applications, paving the way for future clinical trials and potential commercial applications.
Cancer remains one of the leading causes of death worldwide, prompting the need for innovative treatment methods. Nanotechnology offers promising new approaches, including the use of gold nanoparticles (nanogold) for targeted cancer therapy. Nanogold particles possess unique physical and chemical properties that make them suitable for drug delivery, imaging, and photothermal therapy.
5-hydroxytryptamine or 5-HT or Serotonin is a neurotransmitter that serves a range of roles in the human body. It is sometimes referred to as the happy chemical since it promotes overall well-being and happiness.
It is mostly found in the brain, intestines, and blood platelets.
5-HT is utilised to transport messages between nerve cells, is known to be involved in smooth muscle contraction, and adds to overall well-being and pleasure, among other benefits. 5-HT regulates the body's sleep-wake cycles and internal clock by acting as a precursor to melatonin.
It is hypothesised to regulate hunger, emotions, motor, cognitive, and autonomic processes.
Travel Clinic Cardiff: Health Advice for International TravelersNX Healthcare
Travel Clinic Cardiff offers comprehensive travel health services, including vaccinations, travel advice, and preventive care for international travelers. Our expert team ensures you are well-prepared and protected for your journey, providing personalized consultations tailored to your destination. Conveniently located in Cardiff, we help you travel with confidence and peace of mind. Visit us: www.nxhealthcare.co.uk
Discover the benefits of homeopathic medicine for irregular periods with our guide on 5 common remedies. Learn how these natural treatments can help regulate menstrual cycles and improve overall menstrual health.
Visit Us: https://drdeepikashomeopathy.com/service/irregular-periods-treatment/
2. Patient-Centered Outcomes Research
P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE
Patient-Centered Outcomes Research (PCOR)
Helps people and their caregivers communicate and make informed
health care decisions, allowing their voices to be heard in assessing the
value of health care options. This research answers patient-centered
questions such as:
Expectations Options Outcomes Decisions
• “Given my • “What are my • “What can I do • “How can
personal options and what to improve the clinicians and the
characteristics, are the potential outcomes that care delivery
conditions and benefits and are most systems they
preferences, harms of those important to work in help me
what should I options?” me?” make the best
expect will decisions about
happen to me?” my health and
healthcare?”
2
3. The Mission
P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE
To help people make informed health care decisions and
improve health care delivery and outcomes by:
PCORI ‒ Producing and promoting high integrity, evidence-
based information that comes from research
guided by patients, caregivers and the broader
health care community
To define methodological best practices
To identify gaps in methods knowledge
Methodology
Committee To prioritize methodological areas of focus so that
PCORI can accomplish its PCOR agenda.
3
4. Methodology Report
P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE
The Methodology Committee,
in accordance with PCORI’s
establishing legislation,
submitted to the Board of
Governors on May 10, 2012,
the first draft PCORI
Methodology Report
The draft report was accepted
by the PCORI Board of
Governors on May 21, 2012
A public comment period on
the draft report will begin in
July
4 Source: http://www.pcori.org/what-we-do/methodology/
5. Methodology Committee Awarded Contracts
Awarded RFP Topic/TypeOM ES R ES EA R CH IN S T ITUTE
P A T IENT -CENTERED O U T C
Contractor
Methods for Topic Generation 1. Hayes Inc.
Setting Value of Information Analysis 2. NORC at The University of Chicago
Priorities in Value of Information Analysis 3. Duke University, Evidence-Based Practice Center
Research
Peer Review 4. University of Wisconsin, Medical College
(White Paper)
Evidence for 5. Oregon Health & Science University, The Center for
Stakeholder Interview
Eliciting the Evidence-Based Policy
Patient’s Literature Review 6. Mayo Clinic, Knowledge and Evaluation Research Unit
Perspective in 7. University of Maryland School of Pharmacy,
Supplement to Stakeholder Interviews
PCOR Pharmaceutical Health Services Research Department
Standards in the Prevention and Handling of Missing Data in
Observational and Experimental Patient Centered Outcomes 8. Johns Hopkins Bloomberg School of Public Health
Research.
Standards in the Design and Selection of Patient-Reported 9. Northwestern University/UNC Chapel Hill
Outcomes Measures (PROMs) for Use in Patient Centered
10. Oxford Outcomes
Outcomes Research.
Review of
Standards in the Design, Conduct, and Evaluation of Adaptive
Guidance 11. Berry Consultants
Randomized Clinical Trials.
Documents for
Standards in the Design, Conduct, and Evaluation of Research
Selected
Evaluating Diagnostic Testing Strategies for Patient Centered 12. Brown University
Methods in
Outcomes Research.
PCOR
Standards for Causal Inference Methods in Analyses of Data from 13. Division of Pharmacoepidemiology and
Observational and Experimental Studies in Patient Centered Pharmacoeconomics, Department of Medicine, Brigham
Outcomes Research. and Women's Hospital and Harvard Medical School
Standards in the Conduct of Registry Studies for Patient Centered
14. Outcome Sciences, Inc. (A Quintiles Company)
Outcomes Research.
Networks or Distributed Data Networks in Patient Centered
15. University of California and San Diego
Outcomes Research.
5
6. Standards for Patient-Centeredness and Engagement
P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE
3.1.2 Identify Specific Populations and Health Decision(s) Affected by the Research
3.1.5 Measure Outcomes that People in the Population of Interest Notice and Care About
4.1.1 Engage Patient Informants, Persons Representative of the Population of Interest, in
All Phases of Patient-centered Outcomes Research (PCOR)
4.1.2 Identify, Select, Recruit, and Retain Study Participants Representative of the
Spectrum of the Population of Interest Facing the Health Decision of Interest and Ensure
that Data Are Collected Thoroughly and Systematically from All Study Participants
4.1.3 Use Patient-Reported Outcomes When Patients or People at Risk of a Condition Are
the Best Source of Information
4.1.4 Develop and Implement a Dissemination Assessment to Achieve Broad Awareness of
Study Results
6
7. PCORI Research: Eliciting the Patient Perspective in PCOR
A Meta Narrative Systematic Review
P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE
09 Potentially relevant references 5551 Potentially relevant
Environmental Scan identified by manual search / references identified by
Expert contact electronic search
Abstract
screening
09 Studies included at this level 199 Studies at this level
Full text
screening
Data extraction
Duplicate
elimination
194 Studies included in the
53 Included Documents
Systematic review
11 Systematic 7 Randomized 49 Non Systematic
103 Qualitative 8 Single Cohort 7 Case report 9 Cross Sectional Review
Review Controlled Trials
7 Source: Hassan Murad et al. (2012). Eliciting Patient Perspective in Patient-Centered Outcomes Research: A Meta Narrative Systematic Review. Rochester, MN:
Mayo Clinic.
8. In Which Therapeutic and Topic Areas Was Engagement
Studied?
P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE
Study settings
Physical disabilities
HIV
Mental and neurological health
Neoplastic diseases
Social topics
Chronic diseases (i.e. TB, DM, etc.)
General health research
0 5 10 15 20 25 30 35 40 45
N
8 Source: Hassan Murad et al. (2012). Eliciting Patient Perspective in Patient-Centered Outcomes Research: A Meta Narrative Systematic Review. Rochester, MN:
Mayo Clinic.
9. What Study Designs Were Used to Study Engagement?
P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE
Included Study Design
N 30
25
20
15
10
5
0
Agenda Setting Study Design & Study Recruitment Data Collection Data Analysis Dissemination Implementation Evaluation
Procedures
Preparation Execution Translation
Systematic Review Randomized Controlled Trail Qualitative Cross Sectional Case Report Literature Review Commentary
9 Source: Hassan Murad et al. (2012). Eliciting Patient Perspective in Patient-Centered Outcomes Research: A Meta Narrative Systematic Review. Rochester, MN:
Mayo Clinic.
10. How Was Engagement Achieved?
P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE
Used Methods to obtain informant's voice
N
18
16
14
12
10
8
6
4
2
0
Agenda Setting Study Design & Study Data Collection Data Analysis Dissemination Implementation Evaluation
Procedures Recruitment
Preparation Execution Translation
Focus Group Interview Survey Deliberation/Organizational participation
10 Source: Hassan Murad et al. (2012). Eliciting Patient Perspective in Patient-Centered Outcomes Research: A Meta Narrative Systematic Review. Rochester, MN:
Mayo Clinic.
11. Conclusions From Reviewing the Literature
P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE
Methods not well described in most studies
Environmental scan:
‒ Disease specific social networks
‒ Networks designated for patient engagement (Europe/Canada)
We did not find comparative studies to determine the relative efficacy of
a particular method of identifying patient representatives
11 Source: Hassan Murad et al. (2012). Eliciting Patient Perspective in Patient-Centered Outcomes Research: A Meta Narrative Systematic Review. Rochester, MN:
Mayo Clinic.
12. Next Step: Speaking to People About Engagement PCORI
Expert Interviews Project
P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE
299 experts identified
‒ Existing professional
networks
‒ Environmental scan
‒ Snowball technique
128 contacted
87 interviews completed
‒ Phone
‒ 30-60 minutes
‒ December 12, 2011 –
February 15, 2012
12 Source: Curtis, P, Slaughter-Mason, S, Thielke, A, Gordon, C, Pettinari, C, Ryan, K, Church, B, King, V(2012). PCORI Expert Interviews Project: Final report.
Portland, OR: Center for Evidence-based Policy, Oregon Health & Science University.
13. PCORI Expert Interviews Project: Facilitated Discussions
P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE
13 Source: Curtis, P, Slaughter-Mason, S, Thielke, A, Gordon, C, Pettinari, C, Ryan, K, Church, B, King, V(2012). PCORI Expert Interviews Project: Final report.
Portland, OR: Center for Evidence-based Policy, Oregon Health & Science University.
14. PCORI Expert Interviews Project: Key Themes
P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE
Respect
Communication
Dedicated Resources
14 Source: Curtis, P, Slaughter-Mason, S, Thielke, A, Gordon, C, Pettinari, C, Ryan, K, Church, B, King, V(2012). PCORI Expert Interviews Project: Final report.
Portland, OR: Center for Evidence-based Policy, Oregon Health & Science University.
15. Using Patient-Reported Outcomes
P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE
Develop “Ideal” or “Best
Practices” standards...
‒ from conceptualization
‒ to development
‒ through evaluating
psychometric properties
‒ in multiple diverse
populations.
Differentiate research use vs.
healthcare use of PROs
15 Source: Butt, Z and Reeve, B (2012). Enhancing the Patient’s Voice: Standards in the Design and Selection of Patient-Reported Outcomes Measures (PROMs)
for Use in Patient-Centered Outcomes Research: Methodology Committee Report. Evanston, IL: Northwestern University.
16. Emerging Models of Engagement
P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE
Informant Selection
Re-Assessment & Building Reciprocal
Feedback Partnerships
Co-learning
Researchers Informants
Source: 1Curtis, P, Slaughter-Mason, S, Thielke, A, Gordon, C, Pettinari, C, Ryan, K, Church, B, King, V(2012). PCORI Expert Interviews Project: Final report.
Portland, OR: Center for Evidence-based Policy, Oregon Health & Science University. 2Hassan Murad et al. (2012). Eliciting Patient Perspective in Patient-
16 Centered Outcomes Research: A Meta Narrative Systematic Review. Rochester, MN: Mayo Clinic.
17. Engagement Principles: From Thought to Action
P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE
Ideal Practice: Engage “Early and Often”
Trust Pre-
Training:
Engagement
Patient and
with Target
Transparency Participant
Population
Co-learning Require
Longitudinal Elements for
Relationship Proper
Reciprocal Building/ Indexing –
Maintenance Permit
Evaluation
relationships
Evaluation of
Partnerships Comprehension
over Time
Honesty
17 Source: Hassan Murad et al. (2012). Eliciting Patient Perspective in Patient-Centered Outcomes Research: A Meta Narrative Systematic Review. Rochester, MN:
Mayo Clinic.
18. Patient-Centered Research Objectives
P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE
Outcomes Stakeholder Input
Outcomes are meaningful and Study design, outcomes and
important to patients comparators have been informed by
patients
• And others: family, clinicians,
policymakers, - ?
Engagement What Works for Whom…?
Engage patients iteratively Assess disease course and treatment
effect based on biomarker and
• From topic generation to research
“psychomarker” data
prioritization through dissemination
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19. Patient-Centered Perspective
P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE
• Who determined?
– The research questions
– For database studies, the database to use
– The variables to examine: outcomes, comparators, covariates
– The analytic methods?
• Who is on the research team?
– Patients or patient advocates?
– Other stakeholders?
• What will the research team do with the information?
– How will results apply to health decisions?
• Is there a plan for interaction between researchers and the
community?
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20. Connect with PCORI
P A T IENT -CENTERED O U T C OM ES R ES EA R CH IN S T ITUTE
Visit us at www.pcori.org
Subscribe to PCORI updates at
www.pcori.org/subscribe
Follow @PCORI on Twitter
Watch our YouTube channel –
PCORINews
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