The document discusses recommendations from experts on treating rheumatoid arthritis (RA) to target specific treatment goals. It presents the results of a systematic literature review and consensus process to develop overarching principles and 10 recommendations for treating RA to target remission or low disease activity. The recommendations are based on evidence that abrogation of inflammation and regular measurement of disease activity to adjust treatment can optimize long-term outcomes for patients with RA.
Personalized Therapies for OA: Can Biomarkers Get Us There?OARSI
This document discusses the potential for using biomarkers to enable personalized therapies for osteoarthritis (OA). It defines key terms like personalized therapies, biomarkers, phenotypes, and endotypes. The presenter argues that biomarkers could help identify the right treatment for individual OA patients by enabling prognostic and predictive enrichment in clinical trials. However, moving biomarkers from discovery to clinical validation and use involves a long process including assay development, testing biological links and hypotheses, and conducting randomized controlled trials. Several studies are highlighted that have discovered potential new biomarkers and are beginning to test biological links and hypotheses regarding how biomarkers may reflect disease processes and response to treatments.
The document provides guidelines for the management of thyrotoxicosis from the American Thyroid Association and American Association of Clinical Endocrinologists task force. It includes 100 evidence-based recommendations on topics such as the initial evaluation and diagnosis of thyrotoxicosis, management of Graves' hyperthyroidism using radioactive iodine, antithyroid drugs, or surgery, and management of toxic multinodular goiter or toxic adenoma. The task force developed the recommendations based on a systematic review of the literature and expert consensus using a standardized grading system for strength of recommendations and quality of evidence.
This randomized controlled trial compared the effectiveness of corticosteroid injections (CSI) and manual physical therapy (MPT) for treating unilateral shoulder impingement syndrome over one year. 104 patients were randomly assigned to receive either a subacromial CSI or 6 sessions of MPT. Both groups experienced approximately 50% improvement in shoulder pain and disability scores that was maintained at one year, with no significant differences between groups. Both groups also improved on global rating of change and pain scales, again with no significant between-group differences. However, the CSI group used more shoulder-related healthcare resources and received additional steroid injections more frequently over the year than the MPT group. The study found that CSI and MPT produced similar
Clinical prediction rule in spinal painNityal Kumar
This lecture is on spinal pain and the clinical methods used in treating the pain. Clinical prediction rules is a research method done systematically describing when to use which method of treatment approach
Clinical trials have a long history dating back to Avicenna in the 11th century who established principles for testing drug effectiveness. Modern clinical trials involve extensive pre-clinical testing followed by 4 phases of human trials. Phase I trials in healthy volunteers establish safety. Phase II trials in patients provide preliminary efficacy and safety data. Phase III trials involve thousands of patients to confirm efficacy and monitor side effects. Phase IV occurs after approval to further monitor long-term safety. Randomization, blinding, and use of control groups aim to reduce bias in trial design and interpretation of results.
This systematic review examined 67 studies on strategies to reduce or discontinue long-term opioid therapy (LTOT) for chronic pain and the effect of dose reduction on patient outcomes. The key findings were:
1) Interdisciplinary pain programs had the highest completion and opioid discontinuation rates, ranging from 76-100% and 29-100% respectively across 31 studies of varying quality.
2) Buprenorphine-assisted dose reduction resulted in opioid discontinuation rates ranging from 33-100% in 10 poor quality studies.
3) Among 40 studies of varying quality examining patient outcomes after dose reduction, improvement was reported in pain severity, function, and quality of life, though the overall evidence quality was very
This document discusses clinical prediction rules (CPRs), which are decision tools used by clinicians to predict outcomes. It covers the development, validation, and functions of CPRs. Specifically, it outlines 8 standards for developing a CPR, including clearly defining outcomes and predictors, ensuring reliability of predictors, having an adequate sample size, and accurately measuring a CPR's performance. An example CPR for ankle fractures is used to illustrate the development process. The document emphasizes the importance of prospectively validating CPRs in new populations before implementation, to assess their accuracy outside the initial study.
Personalized Therapies for OA: Can Biomarkers Get Us There?OARSI
This document discusses the potential for using biomarkers to enable personalized therapies for osteoarthritis (OA). It defines key terms like personalized therapies, biomarkers, phenotypes, and endotypes. The presenter argues that biomarkers could help identify the right treatment for individual OA patients by enabling prognostic and predictive enrichment in clinical trials. However, moving biomarkers from discovery to clinical validation and use involves a long process including assay development, testing biological links and hypotheses, and conducting randomized controlled trials. Several studies are highlighted that have discovered potential new biomarkers and are beginning to test biological links and hypotheses regarding how biomarkers may reflect disease processes and response to treatments.
The document provides guidelines for the management of thyrotoxicosis from the American Thyroid Association and American Association of Clinical Endocrinologists task force. It includes 100 evidence-based recommendations on topics such as the initial evaluation and diagnosis of thyrotoxicosis, management of Graves' hyperthyroidism using radioactive iodine, antithyroid drugs, or surgery, and management of toxic multinodular goiter or toxic adenoma. The task force developed the recommendations based on a systematic review of the literature and expert consensus using a standardized grading system for strength of recommendations and quality of evidence.
This randomized controlled trial compared the effectiveness of corticosteroid injections (CSI) and manual physical therapy (MPT) for treating unilateral shoulder impingement syndrome over one year. 104 patients were randomly assigned to receive either a subacromial CSI or 6 sessions of MPT. Both groups experienced approximately 50% improvement in shoulder pain and disability scores that was maintained at one year, with no significant differences between groups. Both groups also improved on global rating of change and pain scales, again with no significant between-group differences. However, the CSI group used more shoulder-related healthcare resources and received additional steroid injections more frequently over the year than the MPT group. The study found that CSI and MPT produced similar
Clinical prediction rule in spinal painNityal Kumar
This lecture is on spinal pain and the clinical methods used in treating the pain. Clinical prediction rules is a research method done systematically describing when to use which method of treatment approach
Clinical trials have a long history dating back to Avicenna in the 11th century who established principles for testing drug effectiveness. Modern clinical trials involve extensive pre-clinical testing followed by 4 phases of human trials. Phase I trials in healthy volunteers establish safety. Phase II trials in patients provide preliminary efficacy and safety data. Phase III trials involve thousands of patients to confirm efficacy and monitor side effects. Phase IV occurs after approval to further monitor long-term safety. Randomization, blinding, and use of control groups aim to reduce bias in trial design and interpretation of results.
This systematic review examined 67 studies on strategies to reduce or discontinue long-term opioid therapy (LTOT) for chronic pain and the effect of dose reduction on patient outcomes. The key findings were:
1) Interdisciplinary pain programs had the highest completion and opioid discontinuation rates, ranging from 76-100% and 29-100% respectively across 31 studies of varying quality.
2) Buprenorphine-assisted dose reduction resulted in opioid discontinuation rates ranging from 33-100% in 10 poor quality studies.
3) Among 40 studies of varying quality examining patient outcomes after dose reduction, improvement was reported in pain severity, function, and quality of life, though the overall evidence quality was very
This document discusses clinical prediction rules (CPRs), which are decision tools used by clinicians to predict outcomes. It covers the development, validation, and functions of CPRs. Specifically, it outlines 8 standards for developing a CPR, including clearly defining outcomes and predictors, ensuring reliability of predictors, having an adequate sample size, and accurately measuring a CPR's performance. An example CPR for ankle fractures is used to illustrate the development process. The document emphasizes the importance of prospectively validating CPRs in new populations before implementation, to assess their accuracy outside the initial study.
This journal club discussion summarizes a randomized controlled trial that compared the glucose-lowering drug rosiglitazone to metformin and glyburide in patients with recently diagnosed type 2 diabetes. The study was well-designed, experimental in nature, and included over 4,000 patients followed for a median of 4 years. The primary outcome was time to monotherapy failure based on fasting glucose levels. The results showed that rosiglitazone delayed monotherapy failure better than the other drugs and had a lower incidence of progression to higher fasting glucose levels. However, the study also reported some safety concerns with rosiglitazone like increased risk of heart failure. Overall, the discussant found the study to be valid and that the
This document summarizes the results of a study that evaluated the health care resource utilization and costs of patients with symptomatic multiple myeloma in the United Kingdom. The study found that the average total cost per treatment line was £34,296, with most costs attributed to anti-tumor drugs. The average cost per month of active treatment was £5,168. For patients receiving best supportive care after discontinuing active treatment, the average total cost was £1,444 if they progressed or £2,480 if they did not progress before death.
This study aims to evaluate the effectiveness of somatosensory rehabilitation for treating allodynia in patients with CRPS or peripheral nerve injury. It will involve 120 participants split between 4 groups: those with CRPS, peripheral nerve injury, a hand fracture, or healthy volunteers. Participants will complete various assessments at baseline and 3-month follow-up to evaluate outcomes of somatosensory rehabilitation compared to usual treatment. Additional objectives are to develop measurement properties of assessment tools for CRPS/nerve injury and evaluate the diagnostic accuracy of skin temperature asymmetry.
This document provides an overview of oncology and cancer clinical trials from a data standards and programming perspective. It begins with basic cancer definitions and epidemiology. Key aspects of clinical trials in oncology are then discussed, including complex efficacy endpoints, safety evaluations, and exposure assessments. Standardization efforts through CDISC are summarized, including SDTM and ADaM domains for oncology. Regulatory guidelines from the FDA and EMA are also covered. Throughout, challenges specific to oncology trials from a data and programming standpoint are highlighted. The aim of the PhUSE oncology wiki is also introduced as a resource for further information.
This study surveyed 560 Indian medical students over 5 years to assess tobacco use and attitudes. The study found that 33% of students used tobacco, with 45.4% chewing tobacco, 32.2% smoking cigarettes, and 22.4% doing both. Most students felt tobacco should be restricted and doctors should advise quitting, but specific training was still needed to develop cessation skills. The high tobacco use rates among future doctors underscores the need for comprehensive intervention strategies in medical curricula to address this issue.
The document discusses the topic of evidence-based practice in music therapy. It provides examples of different types of studies that have been conducted, including randomized controlled trials, case studies, qualitative research, and meta-analyses. It also addresses some of the challenges music therapists face in meeting demands for evidence-based support and the need for more research training.
1) The study compared real-world outcomes of pomalidomide plus low-dose dexamethasone (POM+LoDEX) to other active treatments for relapsed and refractory multiple myeloma using individual patient data from clinical trials and retrospective analyses.
2) After adjusting for baseline characteristics, POM+LoDEX showed significantly better survival outcomes compared to other active treatments, with a median overall survival of 14.4 months versus 4.6 months for other treatments.
3) There was no significant difference in survival between bendamustine-containing regimens and other standard treatments used in this patient population.
This document summarizes several research studies that have investigated the physiological effects and potential therapeutic applications of wet cupping therapy. Specifically, the studies found that wet cupping therapy can reduce oxidative stress biomarkers, restore autonomic nervous system balance, reduce pain and improve function for neck pain patients, and may have benefits for over 120 medical conditions according to traditional Persian medicine texts. However, the document also notes that many cupping studies to date have been of low methodological quality.
Clinical prediction rules use combinations of clinical findings to predict the probability of a specific condition or outcome. This document summarizes several clinical prediction rules for orthopedic conditions seen in outpatient settings, including rules for ankle injuries, knee injuries, patellofemoral pain, hip osteoarthritis, and low back pain. It provides details on the clinical findings and validation levels for each rule. The document concludes by describing where to find more information on clinical prediction rules and validation studies.
Chapter 25 assessment of clincal responsesNilesh Kucha
The document discusses guidelines for assessing clinical response in cancer patients based on tumor size changes. The RECIST (Response Evaluation Criteria in Solid Tumors) criteria provide a standardized approach for measuring lesions and determining objective tumor responses. Key points include defining measurable vs. non-measurable lesions, methods for measurement and assessment, and criteria for complete response, partial response, stable disease and progressive disease based on tumor burden changes. The guidelines aim to improve consistency in evaluating clinical trial outcomes.
Referral For Invasive Procedures For Cancer Pain Dr Alison Mitchellepicyclops
Lecture given to the North British Pain Association on 16th May 2008 by Dr Alison Mitchell. In this talk, Dr Mitchell discusses the indications for referral of patients with cancer pain for invasive procedures. She describes the new interventional cancer pain service being set up in Glasgow. www.nbpa.org.uk
The document outlines five overarching principles and ten recommendations for managing hand osteoarthritis based on a systematic review and expert consensus. The principles focus on individualized treatment, education, and a multidisciplinary approach. The recommendations address non-pharmacological therapies, analgesics, injections, surgery, and follow-up based on levels of evidence and expert agreement.
1. The document discusses the roles of biomedical scientists in disease detection and management through various tests and investigations. It covers topics like whole population screening, disease diagnosis, monitoring, and discusses tests in pathology disciplines like immunopathology and hematology.
2. It also discusses non-biomedical investigations like blood pressure measurement, electromyography, and magnetic resonance imaging.
3. Specifically, it discusses myocardial infarction - the signs and symptoms are analyzed using electrocardiograms, blood tests to detect cardiac troponin, and other biomarkers to confirm the diagnosis.
This document discusses various types of endpoints used in clinical research trials. It defines endpoints as the final outcomes measured to assess a drug's efficacy or safety. Endpoints are classified as primary or secondary. Primary endpoints directly answer the main trial questions, while secondary endpoints are analyzed post-hoc. Endpoints can also be hard or soft, composite, surrogate, clinical, or related to mortality, morbidity, quality of life, or patient-reported outcomes. The document provides examples of endpoints used in oncology trials like overall survival and progression-free survival.
CDISC journey in solid tumor using recist 1.1 (Paper)Kevin Lee
This document summarizes the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 guidelines for evaluating tumor response in clinical trials. It introduces the three types of oncology studies, defines target and non-target lesions, and describes how lesion measurements are used to determine complete response, partial response, stable disease, progression disease, and not evaluable responses. It also discusses how RECIST 1.1 data are organized in CDISC SDTM and ADaM domains, and provides an example of how these domains can be used to evaluate tumor response and analyze outcomes like objective response rate, progression-free survival, and time to progression.
Part of the MaRS BioEntrepreneurship series session: Clinical Trials Strategy
Speaker: Miklos Schulz
This is available as an audio presentation:
http://www.marsdd.com/bioent/feb12
Also view the event blog and summary:
http://blog.marsdd.com/2007/02/14/bioentrepreneurship-clinical-trial-strategies-its-never-too-soon/
Declaration of helsinki powerpoint presentationPoojaGupta767
The document summarizes the history and key principles of the Declaration of Helsinki, which establishes ethical guidelines for medical research involving human subjects. It originated in 1964 and has undergone several revisions. The Declaration's goals are to protect research participants and ensure research is justified. Some key principles are that research must have scientific merit and potential benefits outweigh risks, participants must provide informed consent, and special protections apply to biomedical research combined with patient care.
Presented at PhUSE 2013
The evaluation of efficacy in oncology studies, in particular for solid tumors, is pretty standard and well defined by several regulatory guidance (e.g. EMA and FDA), including some specific cancer type guidance (e.g. NSCLC from FDA).
Although some references will be also given for non-solid tumors, the paper will mainly focus on solid tumors efficacy
endpoints.
Overall Survival, Best Overall Response as per RECIST criteria, Progression Free Survival (PFS), Time to Progression (TTP), Best Overall Response Rate are some of the key efficacy indicators that will be discussed.
Epidemiology is defined as the study of the distribution and determinants of health-related states or events in populations and the application of this study to control health problems. It involves descriptive studies that ask questions about disease occurrence, magnitude, location, time period, and affected individuals. Analytical studies like case-control and cohort studies are used to test hypotheses about disease causes. Randomized controlled trials experimentally study interventions by applying or withdrawing suspected causes between study groups.
This journal club discussion summarizes a randomized controlled trial that compared the glucose-lowering drug rosiglitazone to metformin and glyburide in patients with recently diagnosed type 2 diabetes. The study was well-designed, experimental in nature, and included over 4,000 patients followed for a median of 4 years. The primary outcome was time to monotherapy failure based on fasting glucose levels. The results showed that rosiglitazone delayed monotherapy failure better than the other drugs and had a lower incidence of progression to higher fasting glucose levels. However, the study also reported some safety concerns with rosiglitazone like increased risk of heart failure. Overall, the discussant found the study to be valid and that the
This document summarizes the results of a study that evaluated the health care resource utilization and costs of patients with symptomatic multiple myeloma in the United Kingdom. The study found that the average total cost per treatment line was £34,296, with most costs attributed to anti-tumor drugs. The average cost per month of active treatment was £5,168. For patients receiving best supportive care after discontinuing active treatment, the average total cost was £1,444 if they progressed or £2,480 if they did not progress before death.
This study aims to evaluate the effectiveness of somatosensory rehabilitation for treating allodynia in patients with CRPS or peripheral nerve injury. It will involve 120 participants split between 4 groups: those with CRPS, peripheral nerve injury, a hand fracture, or healthy volunteers. Participants will complete various assessments at baseline and 3-month follow-up to evaluate outcomes of somatosensory rehabilitation compared to usual treatment. Additional objectives are to develop measurement properties of assessment tools for CRPS/nerve injury and evaluate the diagnostic accuracy of skin temperature asymmetry.
This document provides an overview of oncology and cancer clinical trials from a data standards and programming perspective. It begins with basic cancer definitions and epidemiology. Key aspects of clinical trials in oncology are then discussed, including complex efficacy endpoints, safety evaluations, and exposure assessments. Standardization efforts through CDISC are summarized, including SDTM and ADaM domains for oncology. Regulatory guidelines from the FDA and EMA are also covered. Throughout, challenges specific to oncology trials from a data and programming standpoint are highlighted. The aim of the PhUSE oncology wiki is also introduced as a resource for further information.
This study surveyed 560 Indian medical students over 5 years to assess tobacco use and attitudes. The study found that 33% of students used tobacco, with 45.4% chewing tobacco, 32.2% smoking cigarettes, and 22.4% doing both. Most students felt tobacco should be restricted and doctors should advise quitting, but specific training was still needed to develop cessation skills. The high tobacco use rates among future doctors underscores the need for comprehensive intervention strategies in medical curricula to address this issue.
The document discusses the topic of evidence-based practice in music therapy. It provides examples of different types of studies that have been conducted, including randomized controlled trials, case studies, qualitative research, and meta-analyses. It also addresses some of the challenges music therapists face in meeting demands for evidence-based support and the need for more research training.
1) The study compared real-world outcomes of pomalidomide plus low-dose dexamethasone (POM+LoDEX) to other active treatments for relapsed and refractory multiple myeloma using individual patient data from clinical trials and retrospective analyses.
2) After adjusting for baseline characteristics, POM+LoDEX showed significantly better survival outcomes compared to other active treatments, with a median overall survival of 14.4 months versus 4.6 months for other treatments.
3) There was no significant difference in survival between bendamustine-containing regimens and other standard treatments used in this patient population.
This document summarizes several research studies that have investigated the physiological effects and potential therapeutic applications of wet cupping therapy. Specifically, the studies found that wet cupping therapy can reduce oxidative stress biomarkers, restore autonomic nervous system balance, reduce pain and improve function for neck pain patients, and may have benefits for over 120 medical conditions according to traditional Persian medicine texts. However, the document also notes that many cupping studies to date have been of low methodological quality.
Clinical prediction rules use combinations of clinical findings to predict the probability of a specific condition or outcome. This document summarizes several clinical prediction rules for orthopedic conditions seen in outpatient settings, including rules for ankle injuries, knee injuries, patellofemoral pain, hip osteoarthritis, and low back pain. It provides details on the clinical findings and validation levels for each rule. The document concludes by describing where to find more information on clinical prediction rules and validation studies.
Chapter 25 assessment of clincal responsesNilesh Kucha
The document discusses guidelines for assessing clinical response in cancer patients based on tumor size changes. The RECIST (Response Evaluation Criteria in Solid Tumors) criteria provide a standardized approach for measuring lesions and determining objective tumor responses. Key points include defining measurable vs. non-measurable lesions, methods for measurement and assessment, and criteria for complete response, partial response, stable disease and progressive disease based on tumor burden changes. The guidelines aim to improve consistency in evaluating clinical trial outcomes.
Referral For Invasive Procedures For Cancer Pain Dr Alison Mitchellepicyclops
Lecture given to the North British Pain Association on 16th May 2008 by Dr Alison Mitchell. In this talk, Dr Mitchell discusses the indications for referral of patients with cancer pain for invasive procedures. She describes the new interventional cancer pain service being set up in Glasgow. www.nbpa.org.uk
The document outlines five overarching principles and ten recommendations for managing hand osteoarthritis based on a systematic review and expert consensus. The principles focus on individualized treatment, education, and a multidisciplinary approach. The recommendations address non-pharmacological therapies, analgesics, injections, surgery, and follow-up based on levels of evidence and expert agreement.
1. The document discusses the roles of biomedical scientists in disease detection and management through various tests and investigations. It covers topics like whole population screening, disease diagnosis, monitoring, and discusses tests in pathology disciplines like immunopathology and hematology.
2. It also discusses non-biomedical investigations like blood pressure measurement, electromyography, and magnetic resonance imaging.
3. Specifically, it discusses myocardial infarction - the signs and symptoms are analyzed using electrocardiograms, blood tests to detect cardiac troponin, and other biomarkers to confirm the diagnosis.
This document discusses various types of endpoints used in clinical research trials. It defines endpoints as the final outcomes measured to assess a drug's efficacy or safety. Endpoints are classified as primary or secondary. Primary endpoints directly answer the main trial questions, while secondary endpoints are analyzed post-hoc. Endpoints can also be hard or soft, composite, surrogate, clinical, or related to mortality, morbidity, quality of life, or patient-reported outcomes. The document provides examples of endpoints used in oncology trials like overall survival and progression-free survival.
CDISC journey in solid tumor using recist 1.1 (Paper)Kevin Lee
This document summarizes the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 guidelines for evaluating tumor response in clinical trials. It introduces the three types of oncology studies, defines target and non-target lesions, and describes how lesion measurements are used to determine complete response, partial response, stable disease, progression disease, and not evaluable responses. It also discusses how RECIST 1.1 data are organized in CDISC SDTM and ADaM domains, and provides an example of how these domains can be used to evaluate tumor response and analyze outcomes like objective response rate, progression-free survival, and time to progression.
Part of the MaRS BioEntrepreneurship series session: Clinical Trials Strategy
Speaker: Miklos Schulz
This is available as an audio presentation:
http://www.marsdd.com/bioent/feb12
Also view the event blog and summary:
http://blog.marsdd.com/2007/02/14/bioentrepreneurship-clinical-trial-strategies-its-never-too-soon/
Declaration of helsinki powerpoint presentationPoojaGupta767
The document summarizes the history and key principles of the Declaration of Helsinki, which establishes ethical guidelines for medical research involving human subjects. It originated in 1964 and has undergone several revisions. The Declaration's goals are to protect research participants and ensure research is justified. Some key principles are that research must have scientific merit and potential benefits outweigh risks, participants must provide informed consent, and special protections apply to biomedical research combined with patient care.
Presented at PhUSE 2013
The evaluation of efficacy in oncology studies, in particular for solid tumors, is pretty standard and well defined by several regulatory guidance (e.g. EMA and FDA), including some specific cancer type guidance (e.g. NSCLC from FDA).
Although some references will be also given for non-solid tumors, the paper will mainly focus on solid tumors efficacy
endpoints.
Overall Survival, Best Overall Response as per RECIST criteria, Progression Free Survival (PFS), Time to Progression (TTP), Best Overall Response Rate are some of the key efficacy indicators that will be discussed.
Epidemiology is defined as the study of the distribution and determinants of health-related states or events in populations and the application of this study to control health problems. It involves descriptive studies that ask questions about disease occurrence, magnitude, location, time period, and affected individuals. Analytical studies like case-control and cohort studies are used to test hypotheses about disease causes. Randomized controlled trials experimentally study interventions by applying or withdrawing suspected causes between study groups.
Know most amazing facts about Indian Railways. One should know and feel proud of being Indian. To know more you can explore information from website https://www.classicrailjourneys.com
Este documento proporciona instrucciones sobre cómo insertar y formatear elementos en una presentación de PowerPoint. Explica cómo agregar diapositivas, cambiar el diseño y fondo, insertar texto, tablas, imágenes, hipervínculos, botones de acción, sonido, videos y configurar la presentación con transiciones y animaciones.
El documento es una carta que envía sonrisas y buenos deseos a la persona, expresando que son importantes para el remitente. Incluye varios tipos de sonrisas y finaliza diciendo que no hay sonrisa más bonita que la de la persona y deseando que tengan una semana maravillosa.
El documento define los conceptos de población, muestra y variable en el contexto de estudios estadísticos. Explica que la población es el conjunto total de elementos a estudiar, la muestra es un subconjunto de la población que permite extraer conclusiones sobre esta, y la variable es una característica o propiedad de lo que se estudia. Además, provee dos ejemplos ilustrativos de cómo aplicar estos conceptos en encuestas concretas.
Las tablas son una forma efectiva de organizar y presentar información en Word. Puedes insertar tablas vacías y luego agregar filas y columnas para organizar texto, números, imágenes y otros objetos. Las tablas te permiten alinear y formato el contenido de una manera fácil de leer y comprender.
Galileo fue un astrónomo y físico italiano considerado uno de los padres de la ciencia moderna. Realizó importantes descubrimientos sobre la caída de los cuerpos y construyó un potente telescopio que le permitió hacer numerosas observaciones astronómicas. Descubrió las leyes de la caída de los cuerpos y de la trayectoria parabólica de los proyectiles.
Este documento presenta descripciones breves de varias ensaladas en un restaurante, incluyendo Ensalada Noel preparada por un joven chef con ingredientes como lechuga, tomate y pollo; Ensalada de pato del Penedés con lechuga, tomate, nueces, mozzarella y jamón de pato; y La Cabra para amantes del queso servido en tostada con queso gratinado.
1) The document discusses a lecture on evidence-based medicine (EBM) and critical appraisal.
2) EBM involves integrating the best available research evidence with clinical expertise and patient values. It includes formulating clinical questions, searching for evidence, appraising research, and applying the evidence to patient care.
3) The lecture reviews the principles of EBM and critical appraisal, including how to formulate answerable clinical questions using the PICO framework, search for evidence, and appraise different types of research studies.
This document summarizes a lecture on medical literature, including the basic purpose of research, common study designs, tools for reviewing studies, and principles of writing research manuscripts. The lecture covers estimating the truth, variability in perceptions of research findings, evolving nature of research, basic study designs like randomized trials and observational studies, analytical aspects like measures of association and issues with numerical approaches, standards for assessing research quality like CONSORT and STROBE, and considerations for writing manuscripts like clinical relevance and brevity. An example randomized controlled trial on spironolactone is presented and discussed.
Guidelines - what difference do they make? A Dutch perspectiveepicyclops
This lecture was given by Dr Raymond Ostelo of the EMGO Institute, VU University Medical Center, Amsterdam, to the North British Pain Association Spring Scientific Meeting in Edinburgh on Friday 18th May, 2007. His lecture forms part of a conference "Blurring the Boundaries - Managing Pain in Primary Care and Secondary Care".
This document discusses randomised controlled trials (RCTs) and their use in evaluating health care interventions. It provides background on James Lind, who in 1747 conducted one of the earliest known clinical trials to test treatments for scurvy. The document outlines key aspects of RCTs such as defining the research question, population, interventions, and outcomes, as well as the importance of randomization and blinding to reduce bias. It distinguishes between explanatory and pragmatic trials and notes RCTs are generally considered the gold standard for evaluating health care technologies.
DASH - does arthritis self-management help?epicyclops
This lecture was given by Dr Marta Buszewicz, General Practitioner from North London and Senior Lecturer in Community Based Teaching & Research at UCL, to the North British Pain Association Spring Scientific Meeting in Edinburgh on Friday 18th May, 2007. Her lecture forms part of a conference "Blurring the Boundaries - Managing Pain in Primary Care and Secondary Care".
Prof. Todor (Ted) A. Popov - 6th Clinical Research ConferenceStarttech Ventures
Ομιλία - Παρουσίαση: Prof. Todor (Ted) A. Popov, Professor of Medicine, Medical University in Sofia, Chairman of the Bulgarian Ethics Committee for Multicenter Studies
Τίτλος Παρουσίασης: «Do databases around the world speak the same language?»
This clinical trial protocol summarizes a phase 2 double-blind randomized placebo-controlled trial to evaluate the safety and efficacy of TJ301 for the treatment of active ulcerative colitis. The trial will enroll 90 patients to receive either 600mg of TJ301 biweekly, 300mg of TJ301 biweekly, or placebo biweekly for 12 weeks. The primary endpoint is clinical and endoscopic remission at week 12. Secondary endpoints include safety assessments, pharmacokinetic measures, and changes in disease activity scores from baseline to week 12. The protocol outlines the study design, patient selection criteria, treatments, assessments, data management, and statistical analysis plan.
Ana Marusic - MedicReS World Congress 2011MedicReS
Four clinical trials (Trials A-D) tested active treatments against placebo for about 5 years. Trial A reported survival rates, Trial B reported risk reduction, Trial C reported mortality reduction, and Trial D reported number needed to treat. Clinicians considered Trials B and D most useful for practice based on how the results were reported. Reporting guidelines recommend presenting numbers of events, absolute risk reductions, relative risks with confidence intervals, and number needed to treat to improve interpretation and clinical applicability of trial results. Adopting reporting standards can enhance transparency and reliability of research literature.
This document outlines a 4-phase rehabilitation protocol for patellofemoral dysfunction. Phase I focuses on reducing acute symptoms such as pain and swelling. Goals include restoring range of motion and gait, and increasing strength specifically of the VMO muscle. Treatments include bracing, cardiovascular exercise, isometric strengthening, and flexibility exercises. Progress is evaluated through range of motion, proprioception, strength, and stability tests. Phase II adds intermediate strengthening and aims to further increase range of motion, strength, and proprioception while decreasing pain with daily activities.
IPF & Progressive Pulmonary Fibrosis in Adult ATS ERS JRS Clinical Practive G...ChicyWidyaMorfi
This guideline from the American Thoracic Society, European Respiratory Society, Japanese Respiratory Society, and Asociacion Latinoamericana de Torax updates recommendations for diagnosing and treating idiopathic pulmonary fibrosis (IPF) and addresses progressive pulmonary fibrosis (PPF) in other interstitial lung diseases. Key points include:
1. Radiological and histopathological criteria for IPF were updated, and transbronchial lung cryobiopsy and genomic testing were evaluated.
2. PPF was defined as worsening symptoms, radiological progression, and physiological progression within a year in a patient with an interstitial lung disease other than IPF.
3.
The document discusses challenges in survivorship care and improving support for cancer patients after initial treatment. It notes the growing population of cancer survivors and issues around long-term health, quality of life, and unmet needs. Additionally, it examines evidence for interventions like physical activity programs, smoking cessation, and cognitive behavioral therapy in managing late and long-term effects of cancer treatment.
This document discusses evidence-based practice in emergency medical services (EMS). It begins with background on EMS developing globally with variations in practice and the need for standardization. It discusses how EMS personnel should base practice on protocols informed by the best available evidence. The document then covers knowledge translation from research to practice and evaluating different types of medical studies. It provides guidance on applying evidence-based practice in EMS through formulating focused clinical questions, acquiring and evaluating relevant evidence, applying results to patients, and assessing impact on EMS protocols, guidelines, algorithms and practice.
Dr. Julie Li-Yu presented updated recommendations on how to screen and treat tuberculosis in patients with rheumatic diseases. Dr. Li-Yu and Dr Juan Javier Lichauco were representatives of the Philippine Rheumatology Association to the Task Force developing guidelines for TB management in the country. The slides posted were presented during the Joint Rheumatoid Arthritis - Osteoarthritis Special Interest Symposium held at the F1 Hotel in Taguig City last 28 November 2014.
This document summarizes evidence from a systematic review on effective interventions to improve antibiotic prescribing in primary care. The review found that interventions involving multiple components, including educational materials and meetings for physicians, were most effective at reducing total antibiotic prescribing. Delayed prescribing strategies that provide clear instructions on use were also effective. Communication skills training for physicians, with or without decision aids, reduced prescribing for respiratory tract infections. The use of near-patient tests also reduced prescribing when combined with clinical training.
Corticosteroids for sore throat sr ma bmj 2018Mayra Serrano
This systematic review and meta-analysis found that a single low dose of corticosteroids, such as oral dexamethasone up to 10 mg, provides moderate to high quality evidence of pain relief for patients with sore throat. Patients who received corticosteroids were twice as likely to experience pain relief after 24 hours and 1.5 times more likely to have no pain at 48 hours, with no increase in serious adverse effects. The mean time to complete pain resolution was about 11 hours shorter with corticosteroids. Included trials enrolled over 1400 individuals and assessed outcomes up to 48 hours, but did not evaluate risks of repeated corticosteroid use for recurrent sore throats.
Assessing and reporting outcomes that are important to patients in trials and...cmaverga
The document discusses the importance of including patient-reported outcomes (PROs) in clinical trials and Cochrane reviews. PROs are any reports coming directly from patients about how they function or feel in relation to their health condition or treatment, without interpretation by clinicians. It is important to include PROs because they capture effects only known to patients, like symptoms, function, and feelings. The document provides examples of PROs being incorporated into Cochrane reviews and identifies some of the methodological challenges in doing so.
This document provides information about conducting and appraising a meta-analysis on the use of prophylactic antibiotics for pancreatic necrosis. It outlines the steps of formulating the clinical question using PICO, acquiring relevant studies through database searches and hand searches, appraising study quality, collecting and recording study data, analyzing results using both individual and pooled treatment effects, and reporting findings in a forest plot. Key aspects of meta-analysis methodology are discussed including biases that can affect results.
This clinical protocol provides guidelines for rehabilitation of shoulder dysfunction across 4 phases. Phase I focuses on reducing acute symptoms such as pain and inflammation through techniques like PRICE, ROM exercises, and strengthening. The goals are to regain full pain-free ROM and decrease strength deficits. Clinical evaluation includes assessment of ROM, strength, and special tests. Treatment options include manual therapy, passive ROM, proprioception, and cardiovascular exercise. Progress is evaluated through reports comparing strength and ROM to progression to Phase II.
Síndrome de piernas inquietas RiesgodeFractura.comriesgodefractura
El documento presenta información sobre el Síndrome de Piernas Inquietas (SPI). Define el SPI como un trastorno del movimiento caracterizado por sensaciones desagradables e impulso para mover las piernas que empeoran con el reposo y afectan el sueño. Explica su asociación con deficiencia de hierro y disfunción del sistema dopaminérgico, y que su tratamiento incluye suplementos de hierro, agonistas dopaminérgicos y otros fármacos.
El documento define el insomnio y provee criterios para su diagnóstico. Explica que puede ser primario o secundario a otras condiciones y clasifica el insomnio por duración, severidad, perfil temporal y etiología. También describe la evaluación del paciente con insomnio, incluyendo historia clínica, escalas, actigrafía y polisomnografía. Finalmente, discute objetivos y opciones de tratamiento.
El documento discute la perspectiva de la humanización en el sistema de salud. Explica que la humanización significa tratar a las personas de manera cordial y empática, centrándose en el bienestar físico, mental y social. También describe los enfoques psicológico, biológico y neurofisiológico de la naturaleza humana, y cómo la comunicación, el cuidado detallado y la empatía pueden humanizar la atención médica. Finalmente, señala que la humanización puede mejorar la eficiencia
El tratamiento en la fibromialgia RiesgodeFractura.comriesgodefractura
El documento describe el tratamiento farmacológico de la fibromialgia, incluyendo fármacos neuromoduladores que disminuyen los mecanismos excitatorios como la pregabalina y gabapentina, e incrementan los mecanismos inhibitorios como los antidepresivos tricíclicos y duales. También discute otros tratamientos como la estimulación magnética transcraneal, terapias cognitivo-conductuales y físicas. Concluye que se requiere un enfoque multidisciplinario para el tratamiento de la fibrom
El diagnostico en fibromialgia RiesgodeFractura.comriesgodefractura
1) El documento resume la investigación actual sobre el diagnóstico y características de la fibromialgia, incluyendo su prevalencia, síntomas, factores de riesgo, y hallazgos en estudios de neuroimagen y neurofisiología. 2) Los estudios muestran alteraciones en el procesamiento del dolor en áreas del cerebro como la corteza cingular anterior, la ínsula y la amígdala en pacientes con fibromialgia. 3) También se han encontrado niveles elevados de sustancias pronociceptivas como la sustancia P
Este documento resume las consideraciones clínicas y los hallazgos de ultrasonido para la evaluación de nódulos tiroideos. Describe los patrones ecográficos benignos, indeterminados y sospechosos de malignidad, así como el uso del Doppler y la biopsia con aguja fina para el diagnóstico. Resalta que el ultrasonido no debe usarse para tamizaje en ausencia de factores de riesgo y que la biopsia no es necesaria para nódulos menores a 1 cm sin hallazgos sospechosos.
Este documento describe el uso de la tomografía axial computarizada (TAC) en enfermedades reumatológicas. La TAC se utiliza para evaluar fracturas, tumores óseos, masas de tejidos blandos, evaluaciones postquirúrgicas, artrosis, gota, espondilitis anquilosante y artritis reumatoide. Proporciona detalles anatómicos precisos y puede detectar cambios óseos y de tejidos blandos con mayor sensibilidad que las radiografías convencionales. Sin embargo, la reson
Ronquido: diagnóstico y tratamiento RiesgodeFractura.comriesgodefractura
The document discusses snoring, focusing on diagnostic and therapeutic approaches. It mentions evaluating snoring using a multilevel approach, and assessing factors like sleep time and causes like nasal obstruction. Treatment may include CPAP or other therapies depending on the underlying issue. The presentation was given by Dr. Mariana Saltos Cristiano on snoring for a risk of fracture symposium.
Este documento presenta una guía para el uso de la resonancia magnética para la sospecha clínica de diferentes patologías, incluyendo tumores, isquemia, procesos inflamatorios, esclerosis múltiple, epilepsia y neurootología. Proporciona detalles sobre los síntomas clínicos, antecedentes y secuencias de resonancia magnética apropiadas para cada condición.
Radiogradía simple en enfermedades reumatológicas RiesgodeFractura.comriesgodefractura
Este documento describe la historia y utilidad del ultrasonido en reumatología. Resume las ventajas del ultrasonido como su accesibilidad, bajo costo y capacidad de mostrar imágenes en tiempo real. Explica cómo el ultrasonido puede detectar condiciones como la sinovitis, erosiones óseas y entesitis con mayor sensibilidad que las radiografías. También describe cómo el Doppler puede visualizar el flujo sanguíneo y así identificar la inflamación. El documento concluye resaltando el valor del ultrasonido para realizar diagnósticos tempranos y mejorar los
Indicaciones y utilidad de ultrasonido en AR RiesgodeFractura.comriesgodefractura
Este documento describe la historia y utilidad del ultrasonido en reumatología. El ultrasonido ofrece ventajas como accesibilidad, bajo costo y capacidad de realizar evaluaciones en tiempo real. Permite detectar condiciones como sinovitis, erosiones óseas y entesitis con mayor sensibilidad que las radiografías. El Doppler color ayuda a identificar la actividad inflamatoria al visualizar el flujo sanguíneo. El ultrasonido mejora el diagnóstico y monitoreo de enfermedades reumáticas como la artritis reumatoide y las es
El documento habla sobre los parasomnias más comunes como el terror nocturno, el sonambulismo, el trastorno del comportamiento del sueño REM, las pesadillas y la jactatio capitis nocturna. Explica sus características como la frecuencia, síntomas, edades de aparición y tratamientos. También compara los parasomnias con la epilepsia y analiza la arquitectura normal del sueño.
El documento habla sobre la gamagrafía ósea, una exploración de medicina nuclear que proporciona imágenes funcionales del metabolismo óseo. Explica las indicaciones, técnicas y fases de la gamagrafía, incluyendo su uso para detectar enfermedades óseas malignas y benignas, artritis reumatoide, y sacroilitis. También discute nuevas técnicas como SPECT y PET que pueden proporcionar mayor especificidad.
Este documento presenta un modelo de gestión aplicado al dolor neuropático. Explica las definiciones de dolor crónico y persistente, y describe la epidemiología, caracterización y factores que alteran el umbral del dolor neuropático. Además, analiza consideraciones sobre el manejo farmacológico y no farmacológico del dolor neuropático, incluyendo bloqueos nerviosos y neurolisis. Finalmente, propone la creación de centros de excelencia para el manejo de enfermedades crónicas.
Este documento resume los principales aspectos de la densitometría ósea, incluyendo cómo cambia la densidad mineral ósea con la edad, las indicaciones para solicitar una densitometría, los diferentes métodos de medición como DXA y sus principios, y la interpretación de los resultados para diagnosticar osteopenia u osteoporosis.
Este documento resume las definiciones y aplicaciones clínicas de CPAP, BiPAP y APAP en el tratamiento de la apnea obstructiva del sueño. Describe los mecanismos, indicaciones y modalidades de estas terapias de presión positiva de la vía aérea, así como sus beneficios y limitaciones. Resalta que la CPAP es el tratamiento de primera línea para la mayoría de pacientes, mientras que la BiPAP se reserva para casos específicos. El APAP puede usarse para titulación asistida o tratamiento, pero requiere segu
Este documento discute el síndrome de apnea-hipopnea del sueño (SAHS), incluyendo sus mecanismos, riesgos cardiovasculares asociados, tratamientos como la presión positiva continua (PPC) y oxígeno suplementario, y sus efectos en condiciones como la hipertensión arterial, la insuficiencia cardíaca, los accidentes cerebrovasculares y la diabetes. El SAHS es una enfermedad sistémica que causa estrés oxidativo, inflamación y otros cambios que aumentan el riesgo cardiovascular. La P
Este documento resume las definiciones, prevalencia y tratamiento del síndrome metabólico. Define el síndrome metabólico como la presencia de al menos 3 de los siguientes factores: obesidad abdominal, hipertrigliceridemia, bajos niveles de HDL, hipertensión y elevación de glucosa en ayunas. Explica que la prevalencia es alta y que está asociado con un mayor riesgo de enfermedades cardiovasculares y diabetes. Finalmente, recomienda el tratamiento a través de cambios en el estilo de vida como
Este documento describe un programa de evaluación de pacientes con enfermedades reumáticas y autoinmunes llamado "Evaluación de Día". El programa ofrece una evaluación multidisciplinaria cada 4 meses para monitorear la eficacia, seguridad y calidad de vida de pacientes que reciben terapias biológicas. El objetivo es mejorar el cumplimiento del tratamiento y brindar atención alternativa a la del sistema de salud actual. El programa se lleva a cabo en un centro que cuenta con equipos multidisciplinarios, salas para procedimientos
El documento proporciona información sobre la obesidad y su tratamiento. Resume las definiciones de obesidad y sobrepeso, los factores que contribuyen, y los objetivos y métodos de tratamiento, incluidos cambios en el estilo de vida, medicamentos como la sibutramina y la metformina, y cirugía como último recurso.
Rasamanikya is a excellent preparation in the field of Rasashastra, it is used in various Kushtha Roga, Shwasa, Vicharchika, Bhagandara, Vatarakta, and Phiranga Roga. In this article Preparation& Comparative analytical profile for both Formulationon i.e Rasamanikya prepared by Kushmanda swarasa & Churnodhaka Shodita Haratala. The study aims to provide insights into the comparative efficacy and analytical aspects of these formulations for enhanced therapeutic outcomes.
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The UK is currently facing a Adhd Medication Shortage Uk, which has left many patients and their families grappling with uncertainty and frustration. ADHD, or Attention Deficit Hyperactivity Disorder, is a chronic condition that requires consistent medication to manage effectively. This shortage has highlighted the critical role these medications play in the daily lives of those affected by ADHD. Contact : +1 (747) 209 – 3649 E-mail : sales@trinexpharmacy.com
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Cell Therapy Expansion and Challenges in Autoimmune DiseaseHealth Advances
There is increasing confidence that cell therapies will soon play a role in the treatment of autoimmune disorders, but the extent of this impact remains to be seen. Early readouts on autologous CAR-Ts in lupus are encouraging, but manufacturing and cost limitations are likely to restrict access to highly refractory patients. Allogeneic CAR-Ts have the potential to broaden access to earlier lines of treatment due to their inherent cost benefits, however they will need to demonstrate comparable or improved efficacy to established modalities.
In addition to infrastructure and capacity constraints, CAR-Ts face a very different risk-benefit dynamic in autoimmune compared to oncology, highlighting the need for tolerable therapies with low adverse event risk. CAR-NK and Treg-based therapies are also being developed in certain autoimmune disorders and may demonstrate favorable safety profiles. Several novel non-cell therapies such as bispecific antibodies, nanobodies, and RNAi drugs, may also offer future alternative competitive solutions with variable value propositions.
Widespread adoption of cell therapies will not only require strong efficacy and safety data, but also adapted pricing and access strategies. At oncology-based price points, CAR-Ts are unlikely to achieve broad market access in autoimmune disorders, with eligible patient populations that are potentially orders of magnitude greater than the number of currently addressable cancer patients. Developers have made strides towards reducing cell therapy COGS while improving manufacturing efficiency, but payors will inevitably restrict access until more sustainable pricing is achieved.
Despite these headwinds, industry leaders and investors remain confident that cell therapies are poised to address significant unmet need in patients suffering from autoimmune disorders. However, the extent of this impact on the treatment landscape remains to be seen, as the industry rapidly approaches an inflection point.
8 Surprising Reasons To Meditate 40 Minutes A Day That Can Change Your Life.pptxHolistified Wellness
We’re talking about Vedic Meditation, a form of meditation that has been around for at least 5,000 years. Back then, the people who lived in the Indus Valley, now known as India and Pakistan, practised meditation as a fundamental part of daily life. This knowledge that has given us yoga and Ayurveda, was known as Veda, hence the name Vedic. And though there are some written records, the practice has been passed down verbally from generation to generation.
Basavarajeeyam is a Sreshta Sangraha grantha (Compiled book ), written by Neelkanta kotturu Basavaraja Virachita. It contains 25 Prakaranas, First 24 Chapters related to Rogas& 25th to Rasadravyas.
8. Conclusion: Intensive therapy was successfully carried out in the present trial by an expert team of diabetologists, nurses, dietitians, and behavioral specialists, and the time, effort, and cost required were considerable. Because the resources needed are not widely available, new strategies are needed to adapt methods of intensive treatment for use in the general community at less cost and effort. Meanwhile, the health care system should provide the support necessary to make intensive therapy available to those patients who will benefit. NEJM 1993;329:977-86
13. T2T : Pasos principales Les experts Objetivos Metodologia Selección de las preguntas principales EULAR estudio Revisión sistemática de la literatura: tratamiento guiado por objetivos Recomendaciones provisionales Steering Committee
14. T2T : Steering group Coordinador general J. Smolen (Austria) Comite asistente D. Aletaha (Austria), B. Haraoui (Canada), E. Keystone (Canada), B. Combe (France), M. Dougados (France), G. Burmester (Germany), J. Kalden (Germany), D. Boumpas (Greece), M. Cutolo (Italy), C. Montecucco (Italy), T. Kvien (Norway), J. Gomez-Reino (Spain), E. Martin-Mola (Spain), J.W.J. Bijlsma (The Netherlands), F. Breedveld (The Netherlands), M. de Wit (The Netherlands), D. Van der Heijde (The Netherlands), P. Emery (UK), I. MacInnes (UK), A. Gibofsky (USA) Fellow M. Schoels (Austria)
15. Recomendaciones T2T : Proceso de consenso Presentación/discusión: - Resultados del SLR - Recomendaciones provisionales Discusión Reformulación Nuevas formulaciones Técnica Delfi Recomendaciones finales Nivel de consenso Invitación a 46 expertos adicionales :Europa, Norte y Latinoamérica, Japon y Australia, incluyendo 5 pacientes
16. T2T: Grupo de consenso Argentina: Guillermo Tate Australia: Peter Nash, Evangelos Romas Austria: Daniel Aletaha, Winfried Graninger, Monika Schoels, Josef Smolen Belgium: Patrick Durez Brazil: Ieda Maria Laurindo Canada: Vivian Bykerk, Hani El Gabalawy, Boulos Haraoui, Jamie Henderson, Edward Keystone Cyprus: Marios Kouloumas (patient) Czech Republic: Karel Pavelka Denmark: Kim Hørslev-Peterson, Mikkel Østergaard Finland: Pekka Hannonen, Marjatta Leirisalo-Repo, Tuulikki Sokka France: Bernard Combe, Maxime Dougados, Bruno Fautrel, Laure Gossec Germany: Harald Burkhardt, Gerd Burmester, Jochen Kalden Greece: Dimitrios Boumpas, Alexandros Drosos, Athanasios Tzioufas Italy: Maurizio Cutolo, Gianfranco Ferracioli, Carlomaurizio Montecucco, Luigi Sinigaglia Japan: Tsutomu Takeuchi Mexico: Mario Humberto Cardiel Rios Norway: Clara Gjesdal, Espen Haavardsholm, Sesilie Halland (patient), Wenche Koldingsnes, Tore Kvien Poland: Ewa Stanislawska-Biernat Portugal: Joao-Eurico Fonseca, José Peirera da Silva Romania: Minisoara Codruta-Zabalan (patient) Spain: Jose-Luis Andreu, Hector Corominas, Jesus Gomez-Reino, Emilio Martin-Mola Switzerland: Cem Gabay, Peter Villiger The Netherlands: Johannes Bijlsma, Ferry Breedveld, Maarten de Wit, Marieke Scholte (patient), Désirée Van der Heijde UK: Paul Emery, Cristina Estrach, Andrew Ostor, Duncan Porter, Enid Quest (patient) USA: Martin Bergman, Roy Fleischmann , Alan Gibofsky, Jonhatan Kay, Iain MacInnes
24. Categorization of evidence and strengths of T2T recommendations Shekelle, et al. BMJ 1999; 318:593-6 Category of evidence I a Evidence from meta-analyses of randomized controlled trials I b Evidence from at least one randomized controlled trial II a Evidence from at least one controlled study without randomization II b Evidence from at least one type of quasi-experimental study III Evidence from descriptive studies, such as comparative, correlation, or case–control IV Evidence from expert committee reports or opinions or clinical experience of respected authorities, or both Strength of Recommendation A Directly based on category I evidence B Directly based on category II evidence or extrapolated recommendations from category I evidence C Directly based on category III evidence or extrapolated recommendation from category I or II evidence D Directly based on category IV evidence or extrapolated recommendation from category II or III evidence
25.
26. The Overarching Principles Smolen et al (submitted) A. The treatment of rheumatoid arthritis must be based on a shared decision between patient and rheumatologist. B. The primary goal of treating the patient with rheumatoid arthritis is to maximize long term health-related quality of life through control of symptoms, prevention of structural damage, normalization of function and social participation. C. Abrogation of inflammation is the most important way to achieve these goals. D. Treatment to target by measuring disease activity and adjusting therapy accordingly optimizes outcomes in rheumatoid arthritis.
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31. Final set of 10 recommendations on treating rheumatoid arthritis to target based on both evidence and expert opinion Smolen et al (submitted) 1. The primary target for treatment of rheumatoid arthritis should be a state of clinical remission. 2. Clinical remission is defined as the absence of signs and symptoms of significant inflammatory disease activity. 3. While remission should be a clear target, based on available evidence low disease activity may be an acceptable alternative therapeutic goal, particularly in established, long-standing disease. 4. Until the desired treatment target is reached, drug therapy should be adjusted at least every 3 months.. 5. Measures of disease activity must be obtained and documented regularly, as frequently as monthly for patients with high/moderate disease activity or less frequently (such as every 3 to 6 months) for patients in sustained low disease activity or remission. 6. The use of validated composite measures of disease activity, which include joint assessmen ts , is needed in routine clinical practice to guide treatment decisions.
32. Final set of 10 recommendations on treating rheumatoid arthritis to target based on both evidence and expert opinion Smolen et al (submitted) 7. Structural changes and functional impairment should be considered when making clinical decisions, in addition to assessing composite measures of disease activity. 8. The desired treatment target should be maintained throughout the remaining course of the disease. 9. The choice of the (composite) measure of disease activity and the level of the target value may be influenced by considerations of co-morbidities, patient factors and drug related risks. 10. The patient has to be appropriately informed about the treatment target and the strategy planned to reach this target under the supervision of the rheumatologist.
33. Algorithm to treat RA to Target Active RA Main target Alternative target Remission Sustained Remission Low disease activity Sustained low disease activity Adapt therapy according to disease activity Adapt therapy according to disease activity Adapt therapy if state is lost Use a composite measure of disease activity every 1-3 months Assess disease activity about every 3-6 months Adapt therapy If state is lost Smolen et al (submitted)
48. As a reminder… DAS (Disease Activity Score based on 28-joint evaluation) DAS28 with 4 variables: DAS28 = 0.56 √ (TJC28) + 0.28 √ (SJC28) + 0.70 Ln (ESR) + 0.014 (GH) DAS28 with 3 variables: DAS28 = [ 0.56 √ (TJC28) + 0.28 √ (SJC28) + 0.70 Ln (ESR) ]1.08 + 0.16 Cut-points • High disease activity > 5.1 • Low disease activity < 3.2 • Remission < 2.6 TJC28: 28 joint count for tenderness SJC28: 28 joint count for swelling Ln (ESR): natural logarithm of Westergren's Erythrocyte Sedimentation Rate GH: General Health or Patient's Global Assessment of disease activity on a Visual Analogue Scale of 100mm Van der Heijde et al, J Rheumatol 1993;20:579-581. Prevoo et al, Arthritis Rheum 1995;38:44-48.
49. As a reminder… SDAI (Simplified Disease Activity Index) SDAI=TJC + SJC + PGA + EGA + CRP Cut-points • High disease activity > 26 • Moderate disease activity > 11 - 26 • Low disease activity > 3.3 - 11 • Remission < 3.3 TJC: tender joint count based on a 28-joint assessment SJC: swollen joint count based on a 28-joint assessment PGA: patient global assessment of disease activity [ PGA visual analogue scale (VAS) 0–10 cm] EGA: evaluator (physician) global assessment of disease activity (MDGA VAS 0–10 cm) C-reactive protein (CRP in mg/dl) Smolen, et al. Rheumatology 2003; 42: 244-257.
50. As a reminder… CDAI (Clinical Disease Activity Index) CDAI=TJC + SJC + PGA + EGA Cut-points • High disease activity > 22 • Moderate disease activity > 10 - 22 • Low disease activity > 2.8 - 10 • Remission < 2.8 TJC: tender joint count based on a 28-joint assessment SJC: swollen joint count based on a 28-joint assessment PGA: patient global assessment of disease activity [ PGA visual analogue scale (VAS) 0–10 cm] EGA: evaluator (physician) global assessment of disease activity (MDGA VAS 0–10 cm) Smolen, et al. Rheumatology 2003; 42: 244-257. Aletaha D Arthritis Rheum 2005; 52: 2625-36
51. For information… New ACR/EULAR remission criteria: in preparation Aletaha et al (submitted)
Editor's Notes
We have today unprecedented outcomes, that can be achieved for our patients. Over the last decade or two, we’ve had major advances in therapies, totally novel therapies, targeted therapies have emerged and being used by all of us. We had significant advances in the way we measure all the various characteristics of the disease. In part by radiographics and functional assessment, but also, and that’s where many of the advancements have occurred, by using composite measures of disease activity that have been validated. And especially over the last few years, there has been an enhanced understanding of ‘how to approach the therapy of rheumatoid arthritis strategically’, to achieve an optimal outcome. However, these insights have not yet been clearly formulated in a set of recommendations. Consequently, many of these changes have not been brought into effect in most of the countries in Europe and other parts of the world
So, it is important that these treatment targets are adopted, but also that we can demonstrate that not only short term, but especially in long term, that we indeed can make a difference with the patients.
And then, these are the first results. If you look to the achieved level of HbA1c then you see in the conventional treatment, it remained very high over time, around 9, and in the intensive treatment there was fast reduction and then it remained a bit around 7, so they did not really reach their targets, 6.05, but they could maintain it around a level of 7.
And what are the consequences of that? So if you look to the retinopathy, you see that in the primary prevention, you can see already after two years that there is a distinction, between the two groups. And not only in the primary intervention, but also in the secondary prevention, you can see that there is a significant reduction in retinopathy in those groups of patients over a long period of time.
In rheumatology we also have a number of publications indicating that targeted therapy, employing tighter disease control improves patients’ outcome. But the challenge is still to define the target that will be acceptable in daily practice, will be acceptable for all of us, and will also be implementable in daily practice. Because many things we accept, but bringing them into reality in our everyday patient care is sometimes not so easy.
Steering Committee: 20 rheumatologists and a patient with RA, identified on the basis of their expertise in treating RA, participation in clinical trials, development of consensus statements and regional distribution across Europe and North America;
Consensus group: steering committee and 40 additional experts from Europe, North and Latin America, Japan and Australia, including 5 patient representatives.
When we started the literature search, we had to make a few definitions. We had to define what is studied that investigates the effectiveness of treating to target. The first thing is we defined treat to target trials as trials that investigate the value of using a pre-defined target for a therapeutic intervention. So some numerical thresholds that need to be reached within that trial, and if they’ve not been reached, there’s some consequence to it. That’s actually a second bullet point. And within the trial, and that was an important additional requirement, the “steered” therapy would need to be compared to some arm in the trial that was not using this steered approach, so you can assess, not the efficacy of the drug intervention, but assess the efficacy of the intervention to treat to target.
This is the flow of the search. As you can see here, the initial retrieval was about 6,000 hits. When you excluded those that were non-human, non-English and non full-text, you got to about 3,500 hits. But Monika had to look at the title and abstracts of these three and a half thousand articles to identify whether they are useful or not, and below, in the boxes here, you can see the reasons why she would exclude some or many of the studies within each of the searches. So the next boxes here are really the ones that we retrieved for more detailed reviews. So those were the articles that we really had to read in detail and extract data and summarize data. That was 76 articles, and from those, obviously, after you read the article, you find out that there’s some reasons why this is not what you needed, and you can see the reasons for exclusion after the thorough assessment. They are listed in these boxes, and really this line, you can see down here, it’s 21 studies that really came out of the process.
And from these, really six studies are what we called core treat to target studies that for RCTs compared a really T2T approach versus some routine approach: there was one randomized control trial testing two targeted treatment approaches, in two arms there was one study that compared targeted treatment approach to an historical routine control in an observational manner the rest of the studies were providing some circumstantial evidence And I will briefly touch on the difficulty of interpreting these results in terms of looking at the effectiveness of looking at Treat To Target.
I’m really going to focus on the core trials. There are the 6 trials. As you can see, you are probably going to be familiar with all of them, there is: the TICORA study comparing a targeted approach to routine the CAMERA study the study by Fransen the study by Symmons I will go into some more detail of these studies in a moment And there’s a study by van Tuyl, which is the one that compares two different targeted approaches and the observational study by Stenger.
To sum up … - Most of the core trials used the state of the target. - Mostly the state was low disease activity. - The timeframe for assessment of the target was one to four months, at most - Most of the studies were actually in early RA - And all studies showed, at least those studies comparing the T2T with the routine approach, showed that clinical outcomes were significantly improved. Future Research Question -The effect of T2T on functional and radiographic outcomes needs further investigation -More studies are needed in established/late RA
Shekelle, et al. BMJ 1999; 318:593-6
The 10 statements 1. The primary target for treatment of rheumatoid arthritis should be a state of clinical remission. 2. Clinical remission is defined as the absence of signs and symptoms of significant inflammatory disease activity. 3. While remission should be a clear target, based on available evidence low disease activity may be an acceptable alternative therapeutic goal, particularly in established, long-standing disease. 4. Until the desired treatment target is reached, drug therapy should be adjusted at least every 3 months.. 5. Measures of disease activity must be obtained and documented regularly, as frequently as monthly for patients with high/moderate disease activity or less frequently (such as every 3 to 6 months) for patients in sustained low disease activity or remission. 6. The use of validated composite measures of disease activity, which include joint assessments, is needed in routine clinical practice to guide treatment decisions. 7. Structural changes and functional impairment should be considered when making clinical decisions, in addition to assessing composite measures of disease activity. 8. The desired treatment target should be maintained throughout the remaining course of the disease. 9. The choice of the (composite) measure of disease activity and the level of the target value may be influenced by considerations of co-morbidities, patient factors and drug related risks. 10. The patient has to be appropriately informed about the treatment target and the strategy planned to reach this target under the supervision of the rheumatologist.
The 10 statements 1. The primary target for treatment of rheumatoid arthritis should be a state of clinical remission. 2. Clinical remission is defined as the absence of signs and symptoms of significant inflammatory disease activity. 3. While remission should be a clear target, based on available evidence low disease activity may be an acceptable alternative therapeutic goal, particularly in established, long-standing disease. 4. Until the desired treatment target is reached, drug therapy should be adjusted at least every 3 months.. 5. Measures of disease activity must be obtained and documented regularly, as frequently as monthly for patients with high/moderate disease activity or less frequently (such as every 3 to 6 months) for patients in sustained low disease activity or remission. 6. The use of validated composite measures of disease activity, which include joint assessments, is needed in routine clinical practice to guide treatment decisions. 7. Structural changes and functional impairment should be considered when making clinical decisions, in addition to assessing composite measures of disease activity. 8. The desired treatment target should be maintained throughout the remaining course of the disease. 9. The choice of the (composite) measure of disease activity and the level of the target value may be influenced by considerations of co-morbidities, patient factors and drug related risks. 10. The patient has to be appropriately informed about the treatment target and the strategy planned to reach this target under the supervision of the rheumatologist.