The document discusses the need for more consistency in outcomes reported across clinical trials. It introduces the Core Outcome Measures in Effectiveness Trials (COMET) Initiative, which aims to develop standardized "core outcome sets" that define the minimum outcomes that should be reported in all trials for specific clinical areas. The COMET Initiative website provides resources for developing outcome sets and identifying existing related work to avoid duplication. Stakeholders like funders and journal editors are encouraged to support the use of core outcomes in order to make trial results more useful for patients and healthcare decision-making.
Randomized Control Trials
Enigma of Blinding Unraveled
Introduction
RCT
Steps in a RCT
Allocation Concealment
Bias in RCT
Phases in RCT
Types of RCT
Study Designs of RCT
Blinding
Methods of Blinding in different trials
Assessment of Blinding
Un-blinding
Current Scenario of Blinding
CONSORT
Conclusion
References
• The PRISMA 2020 Statement was published in 2021.
• It consists of a checklist and a flow diagram, and is intended
to be accompanied by the PRISMA 2020 Explanation and
Elaboration document.
Basics of Systematic Review and Meta-analysis: Part 3Rizwan S A
A 4 part lecture series on the basics of Systematic Review and Meta-analysis, Part 3 discusses the software needed and analytical techniques used for this purpose.
his is the first in a series of interactive webinars designed to build capacity in the basic principles of knowledge translation and implementation science.
WATCH-ON DEMAND: https://goo.gl/hnp8gi
Randomized Control Trials
Enigma of Blinding Unraveled
Introduction
RCT
Steps in a RCT
Allocation Concealment
Bias in RCT
Phases in RCT
Types of RCT
Study Designs of RCT
Blinding
Methods of Blinding in different trials
Assessment of Blinding
Un-blinding
Current Scenario of Blinding
CONSORT
Conclusion
References
• The PRISMA 2020 Statement was published in 2021.
• It consists of a checklist and a flow diagram, and is intended
to be accompanied by the PRISMA 2020 Explanation and
Elaboration document.
Basics of Systematic Review and Meta-analysis: Part 3Rizwan S A
A 4 part lecture series on the basics of Systematic Review and Meta-analysis, Part 3 discusses the software needed and analytical techniques used for this purpose.
his is the first in a series of interactive webinars designed to build capacity in the basic principles of knowledge translation and implementation science.
WATCH-ON DEMAND: https://goo.gl/hnp8gi
The scientific study of methods to promote the systematic uptake of research findings and other evidence-based practices into routine practice and hence improve the quality and effectiveness of health services
Overview of the Patient-Centered Outcomes Research Institute (PCORI), how PCORI views Patient-Centered Outcomes Research and how this is related to PCORI’s major funding mechanisms.
Policy and Funding for CER: Making Sense of a Confusing Landscape CTSI at UCSF
UCSF researcher, Michael Steinman, MD, Director of CTSI's Comparative Effectiveness Research initiative presents. View more related presentations and resources at http://accelerate.ucsf.edu/research/cer
'Demystifying Knowledge Transfer- an introduction to Implementation Science M...NEQOS
Powerpoint presentation from 'Demystifying Knowledge Transfer: an introduction to Implementation Science' - 28th May 2014.
Facilitated by Professor Jeremy Grimshaw and Dr Justin Presseau
How Community Engagement Fits Into The Mission Of The National Center for Adv...SC CTSI at USC and CHLA
Christopher Austin, MD, Director of the National Center for Advancing Translational Sciences (NCATS) shared his thoughts on how community engagement fits into the mission of NCATS at the recent CTSA Community Engagement Key Function Committee (KFC) conference. He proposed a revision of NCATS' mission: "To catalyze the generation of innovative methods and technologies that will enhance the development, testing and implementation of interventions that tangibly improve human health across a wide range of human diseases and conditions." Learn more about NCATS http://www.ncats.nih.gov/
A presentation to the Health Psychology in Public Health Network annual on practical, policy and research challenges in applying research to public health practice
Paying for performance to improve the delivery of health interventions in LMICsReBUILD for Resilience
This presentation from Sophie Witter & Karin Diaconu of Queen Margaret University, UK outlines the findings from a Cochrane review undertaken by the team on paying for performance to improve the delivery of health interventions in low and middle-income countries.
Transitional Care for Pediatric Patients with Neuromuscular Diseases: A Healt...HTAi Bilbao 2012
Transitional Care for Pediatric Patients with Neuromuscular Diseases: A Health Technology Assessment
Jackie Tran, MD
University of Medicine and Dentistry of New Jersey, USA
HTAi 9th Annual Meeting, Bilbao
Integrated Care for a Patient Centered System
25 June, 2012
Health Technology Assessment (HTA) Report: Interventions to increase particip...HTAi Bilbao 2012
Health Technology Assessment (HTA) Report: Interventions to increase participation to organised cancer screening programs
Ministry of Health Grant for Applied Research
Giorgi Rossi P, Camilloni L, Ferroni E, Jimenez B, Furnari G, Guasticchi G, Borgia P.
Laziosanità – Agenzia di Sanità Pubblica della Regione Lazio
Social values international programme: integrating research and policy to ens...HTAi Bilbao 2012
Social values international programme: integrating research and policy to ensure fair allocation of health care resources .
HTAi Conference 2012 Panel Session
Joint chairs
Professor Peter Littlejohns and Professor Albert Weale
Challenges in commissioning research on what works in integrated careHTAi Bilbao 2012
Challenges in commissioning research on what works in integrated care.
Tara Lamont, Scientific Adviser
NIHR Evaluation, Trials and Studies Coordinating Centre (NETSCC)
www.netscc.ac.uk
EVALUATION OF PSYCHOSOCIAL FACTORS INFLUENCING HEALTHCARE PROFESSIONAL ACCEPT...HTAi Bilbao 2012
EVALUATION OF PSYCHOSOCIAL FACTORS INFLUENCING HEALTHCARE PROFESSIONAL ACCEPTANCE OF TELEMONITORING FOR CHRONIC PATIENTS
Estibalitz Orruño1, Marie-Pierre Gagnon2-3, José Asua4, Eva Reviriego1
1 Basque Office for Health Technology Assessment (Osteba), Department of Health and Consumer Affairs, Basque Government, Vitoria-Gasteiz, Spain.
2 Faculty of Nursing Sciences, Université Laval, Québec, Canada.
3 Research Centre of the Centre Hospitalier Universitaire de Québec, Québec, Canada.
4 Direction of Knowledge Management and Evaluation, Department of Health and Consumer Affairs, Basque Government, Vitoria-Gasteiz, Spain.
METHODS, MATHEMATICAL MODELS, DATA QUALITY ASSESSMENT AND RESULT INTERPRETATI...HTAi Bilbao 2012
METHODS, MATHEMATICAL MODELS, DATA QUALITY ASSESSMENT AND RESULT INTERPRETATION: SOLUTIONS DEVELOPED IN THE IFEDH FRAMEWORK
G. Zauner
dwh Simulation Services
Vienna , Austria
How to promote the prescription of evidence-based non-pharmacological treatme...HTAi Bilbao 2012
How to promote the prescription of evidence-based non-pharmacological treatments in France?
HTAi 2012, Bilbao
Clémence Thébaut, Olivier Scemama, Françoise Hamers, Catherine Rumeau-Pichon
Department of economic and public health evaluation
Integrating Ayurveda into Parkinson’s Management: A Holistic ApproachAyurveda ForAll
Explore the benefits of combining Ayurveda with conventional Parkinson's treatments. Learn how a holistic approach can manage symptoms, enhance well-being, and balance body energies. Discover the steps to safely integrate Ayurvedic practices into your Parkinson’s care plan, including expert guidance on diet, herbal remedies, and lifestyle modifications.
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
ABDOMINAL TRAUMA in pediatrics part one.drhasanrajab
Abdominal trauma in pediatrics refers to injuries or damage to the abdominal organs in children. It can occur due to various causes such as falls, motor vehicle accidents, sports-related injuries, and physical abuse. Children are more vulnerable to abdominal trauma due to their unique anatomical and physiological characteristics. Signs and symptoms include abdominal pain, tenderness, distension, vomiting, and signs of shock. Diagnosis involves physical examination, imaging studies, and laboratory tests. Management depends on the severity and may involve conservative treatment or surgical intervention. Prevention is crucial in reducing the incidence of abdominal trauma in children.
DISSERTATION on NEW DRUG DISCOVERY AND DEVELOPMENT STAGES OF DRUG DISCOVERYNEHA GUPTA
The process of drug discovery and development is a complex and multi-step endeavor aimed at bringing new pharmaceutical drugs to market. It begins with identifying and validating a biological target, such as a protein, gene, or RNA, that is associated with a disease. This step involves understanding the target's role in the disease and confirming that modulating it can have therapeutic effects. The next stage, hit identification, employs high-throughput screening (HTS) and other methods to find compounds that interact with the target. Computational techniques may also be used to identify potential hits from large compound libraries.
Following hit identification, the hits are optimized to improve their efficacy, selectivity, and pharmacokinetic properties, resulting in lead compounds. These leads undergo further refinement to enhance their potency, reduce toxicity, and improve drug-like characteristics, creating drug candidates suitable for preclinical testing. In the preclinical development phase, drug candidates are tested in vitro (in cell cultures) and in vivo (in animal models) to evaluate their safety, efficacy, pharmacokinetics, and pharmacodynamics. Toxicology studies are conducted to assess potential risks.
Before clinical trials can begin, an Investigational New Drug (IND) application must be submitted to regulatory authorities. This application includes data from preclinical studies and plans for clinical trials. Clinical development involves human trials in three phases: Phase I tests the drug's safety and dosage in a small group of healthy volunteers, Phase II assesses the drug's efficacy and side effects in a larger group of patients with the target disease, and Phase III confirms the drug's efficacy and monitors adverse reactions in a large population, often compared to existing treatments.
After successful clinical trials, a New Drug Application (NDA) is submitted to regulatory authorities for approval, including all data from preclinical and clinical studies, as well as proposed labeling and manufacturing information. Regulatory authorities then review the NDA to ensure the drug is safe, effective, and of high quality, potentially requiring additional studies. Finally, after a drug is approved and marketed, it undergoes post-marketing surveillance, which includes continuous monitoring for long-term safety and effectiveness, pharmacovigilance, and reporting of any adverse effects.
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
Adv. biopharm. APPLICATION OF PHARMACOKINETICS : TARGETED DRUG DELIVERY SYSTEMSAkankshaAshtankar
MIP 201T & MPH 202T
ADVANCED BIOPHARMACEUTICS & PHARMACOKINETICS : UNIT 5
APPLICATION OF PHARMACOKINETICS : TARGETED DRUG DELIVERY SYSTEMS By - AKANKSHA ASHTANKAR
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
Novas diretrizes da OMS para os cuidados perinatais de mais qualidade
Core Outcome Measures in Effectiveness Trials
1. Core Outcome Measures in Effectiveness Trials
www.comet-initiative.org
Dr Aoife Waters
MRC North West Hub for Trials Methodology Research
University of Liverpool, UK
2. Outline
• Background
– What is the problem?
– Why do we need a more scientific approach to
outcomes?
• Core Outcome Sets (COS)
• The COMET Initiative
3. Why are outcomes important?
• Interventions are compared in RCTs by measuring
differences in patient outcomes between the groups
• Selection of appropriate outcomes is therefore crucial in
order to assess the effectiveness of an intervention
• “Clinical trials are only as credible as their outcomes”
(Tugwell 1993)
4. What is the problem?
• Several tens of thousands of research studies are underway and 500+ are
published every week
• Identifying effectiveness of interventions can be challenging because studies in
the same clinical area or of comparable interventions describing findings in
different ways
• It’s also difficult for trials to affect policy and healthcare decision making unless
they are designed in ways that reveal meaningful answers for patients
• Measurement and reporting of outcomes needs to be tidied up if research is to
achieve its aim of helping practitioners and patients to improve health care and
health
5. Cosmetic Outcomes Systematic Review
Aspects of cosmesis assessed
Potter et al. Assessment of Cosmesis After Breast Reconstruction Surgery: a Systematic Review. Ann Surg Oncol (2011) 18:813–823
6. Problems with outcomes in six
important Cochrane reviews
5 most accessed in 2009*:
• Preventing childhood obesity
• Treating childhood obesity
• Promoting activity in children
• Preventing falls in the elderly
• Preventing Type 2 DM
Most cited in 2009*:
• Nicotine replacement therapy
*Tovey D. Impact of Cochrane Reviews [editorial]. The Cochrane Library 2010 (7 July)
7. “The studies … varied greatly in intervention design, outcome
measurements and methodological quality.” (Preventing childhood obesity)
“Appropriate short- and long-term outcomes need to be defined for
children and youth at various weight levels, rather than using conventional
or adult-oriented outcomes.” (Treating childhood obesity)
“The studies were heterogeneous in terms of study design, quality, target
population, theoretical underpinning, and outcome measures, making it
impossible to combine study findings using statistical methods..”
(Promoting activity in children)
“No study reported relevant data on diabetes and cardiovascular related
morbidity, mortality and quality of life..” (Preventing Type 2 DM)
“We sought data for rate of falls, number of people falling, and number of
people sustaining a fracture. However, few studies provided fracture data.”
(Preventing falls in the elderly)
“Definitions of abstinence varied considerably ... In five studies it was unclear
exactly how abstinence was defined.” (Nicotine
replacement therapy)
8. Outcome reporting bias
-the selection of a subset of the original recorded outcomes in a study,
selected on the basis of the results, for inclusion in publication
• ORB suspected in at least one trial in 34% of 283 reviews (Kirkham et al,
BMJ 2010)
•42 significant meta-analyses
– 8 (19%) would not have remained significant
– 11 (26%) would have overestimated the treatment effect by > 20%
• Outcomes that are statistically significant are more likely to be fully
reported
OR 2.2 to 4.7 (Dwan et al, PLoS ONE 2008)
9. Core outcome sets
– an agreed standardised set of outcomes that should be
measured and reported, as a minimum, in all clinical
trials in specific areas of health or health care
•Disease/condition specific
•All treatment types or a particular intervention
•Should consider both benefits and harms
•The minimum – expect others to be collected
•Focus of effectiveness trials
•Involve stakeholders in their development
•Relevant within routine clinical practice
10. Advantages of COS
•Increases consistency across trials
• Maximise potential for trials to contribute to meta-
analyses of these key outcomes
•Reduction in selective reporting
• Much more likely to measure appropriate outcomes due
to early involvement of stakeholders
•More likely to reach a conclusion about an interventions
effectiveness more quickly
11. The COMET (Core Outcome Measures
in Effectiveness Trials) Initiative
• Brings together people interested in the development of COS
• Facilitate and promote development and application of COS
• Liverpool, 2010; Bristol, 2011
- Trialists, systematic reviewers, health service users, clinical
teams, journal editors, trial funders, policy makers, regulators
12. The COMET (Core Outcome Measures
in Effectiveness Trials) Initiative
• ‘What’ to measure
– Guidance on methods for developing core outcome sets,
including patient involvement and funding applications
– Providing a reporting standard for COS
• ‘How’ to measure (validity, reliability, feasibility)
– PROMIS
– COSMIN
– TREAT-NMD
13. COMET website and database
• COMET website makes it easier to find existing research,
helping
• funders who may wish to fund work in this area avoid
duplication
• researchers who want to know what developments
are underway
www.comet-
initiative.org/studies/search
14. COMET website and database
• Work is ongoing to identify, collate and maintain
relevant resources in an online searchable database
• 130 completed projects in various areas of health
• COS development is planned or ongoing in 25 clinical
areas, with a further 32 in discussion
www.comet-
initiative.org/studies/search
16. Impact
• In the months since the launch of the COMET website and
database (August 2011)
– 1335 searches have been undertaken
– 3874 individuals visited (6679 visits, 27791 page views)
– 91 countries visiting the site
17. Development of core outcome sets:
issues to consider (submitted)
• Scope
• Identifying existing knowledge
• Stakeholder involvement
• Consensus methods
• Achieving global consensus
• Implementation
• Regular review, feedback, updating
18. What next?
• SR and survey
– Identify COS (and other relevant work)
– Describe methods used for COS development
– Survey COS developers
• Cochrane CRG survey
• Funding applications
• COMET III
• PPI meeting
19. Stakeholder buy-in: NIHR HTA
‘Where established Core Outcomes exist they should be
included amongst the list of outcomes unless there is
good reason to do otherwise. Please see The COMET
Initiative website at www.comet-initiative.org to
identify whether Core Outcomes have been
established.'
20. Professor Hywel Williams, Chair of the NIHR HTA
Commissioning Board: ‘Patients and professionals making
decisions about health care need access to reliable
evidence. The new COMET database will help researchers
across the NIHR family and beyond when choosing the
outcomes to include in the studies that will establish this
evidence base'.
21. In conclusion
• Currently little consistency
– Unacceptable waste of data
– Need to make things better
• It is vital to collect important outcomes in all trials
– Especially outcomes important to patients
– There should be a more scientific approach to outcomes
• Growing activity in development of core outcomes and
support for COMET
• Improving the quality of evidence to support informed
healthcare decision and inform policy
22. www.comet-initiative.org
Elizabeth Gargon
e.gargon@liv.ac.uk
Twitter: @COMETinitiative
Acknowledgments
COMET Management Group: Doug Altman, Jane Blazeby, Elizabeth
Gargon, Mike Clarke, Paula Williamson
Funding: MRC HTMR Network, now MRC
Collaborators: Peter Tugwell, Maarten Boers, Caroline Terwee, Holger
Schunemann, Michael Rose, Sunita Vohra, Roberto D’Amico, Lorenzo
Moja
Editor's Notes
However, not only is there variation in which outcomes are measured, there is also a big variation in how these are measured and this was well demonstrated by a SR conducted by Shelley Potter in Bristol in which she looked at studies reporting on cosmetic outcome in women who have had reconstructive surgery following mastectomy for breast cancer. She identified 194 studies, and found that cosmetic outcome was measured in 16 different ways and that the most frequently measured outcome wasn’t even reported in half of the total studies. There is a clear lack of consistency but one way of addressing this is through the development of COS.
In six very important Cochrane reviews, the authors clearly describe problems with outcome, selection, measurement and reporting. problems with outcomes were explicitly identified in these reviews.
For those of you who may not be entirely familiar with the concept of outcome reporting bias, it has been defined as the selection of a subset of the original recorded outcomes in a study, selected on the basis of the results, for inclusion in publication. There is strong evidence of an association between significant results and publication; studies that report positive or significant results are more likely to be published and outcomes that are statistically significant have higher odds of being fully reported.
COS can apply to a specific disease/condition Not ‘one size fits all’
Remit is ‘what’ not HOW Ultimately we want to work towards providing a reporting standard for COS development e.g. If use delphi- how many stakeholders, rounds etc. Links to these on web-site Established a more formal link with these groups in work going forward, work packages
Mention how many of the 130 are consensus COS – 42 consensus 14/25 ongoing are consensus Currently resource rather than a guideline Issues with backing ‘COS’ needs updated
Projects looking at core outcome sets and their development Linked research indicated i.e. SR-DELPHI for same project
Scope of the core outcome set- in my example of head and neck cancer we wondered about disease sub-site, stage, treatment modality, stratifying by HPV status. Identifying existing knowledge- systematic review Consensus methods- many methods employed by COS developers- Delphi, nominal group technique Should be developed scientifically guidance Uptake should be monitored and feedback sought to assess impact (OMERACT evaluation ongoing) to inform possible future update
Identify COS work will enable us to describe methods Together should help to inform guidance around developing COS negotiation stage with EU FP7 grant (but don't say 'awarded')
FUNDING APPLICATION FORM FOR RCTs
The National Institute of Health Research, the largest funder of healthcare research in the UK, highlighted the importance of core outcome sets, the work of COMET and the COMET database on its home page in late 2011.
Little consistency in outcome measurement and reporting