The impact of consultant led weekend ward rounds in a UK district general hos...NHS Improving Quality
The impact of consultant led weekend ward rounds in a UK district general hospital
Royal Wolverhampton NHS Trust
Poster from the 'Delivering NHS services, seven days a week' event held in Birmingham on 16 November 2013
More information about this event can be found at
http://www.nhsiq.nhs.uk/news-events/events/nhs-services-seven-days-a-week.aspx
The final protocol (v5.3). Notable changes include:
1) Confirmation of audit standard (Page 6).
2) Refinement of inclusion and exclusion criteria (Page 7)
3) Confirmation of audit status (Appendix C)
4) Refinement of required data fields (Page 19) including definitions (Pages 20-25)
Ben Bridgewater: Measuring outcomes for surgeryThe King's Fund
Ben Bridgewater, Director of Clinical Audit, University Hospital of South Manchester NHS Foundation Trust, discusses how to measure outcomes for surgery, including the patient's perspective.
STARSurg - student audit and research collaboration presentationDr Edward Fitzgerald
STARSurg is a student-led collaborative that empowers medical students to participate in national research studies related to surgery. It facilitates annual research projects involving over 1000 collaborators across multiple medical schools. Participating students gain transferable skills in research, audit, and evidence-based practice while making meaningful contributions through studies published in top journals. STARSurg aims to promote a culture of student engagement in research through training, online resources, and recognition of student work.
The document provides an overview of the career path and training required to become a Clinical Scientist in Molecular Genetics in the UK. It details the educational requirements, two training routes, certification process, and typical daily responsibilities in the laboratory. The document also compares roles in Molecular Genetics versus Microbiology and provides tips and resources for those interested in pursuing this career path.
This document discusses strategies to reduce hospital wait times and avoidable hospitalizations in Saudi Arabia, the UAE, and the United States. It identifies that increased healthcare costs and patient dissatisfaction with long wait times are issues. It proposes identifying high-risk patients for unnecessary admissions and applying alternative modeling techniques. Implementing policies to address problems leading to wait times and incorporating patient preferences could help reduce costs for patients and hospitals from long waits and hospitalizations.
This document contains Stacey James' resume, including her contact information, work history from 2016 to 2007 at various medical facilities in Boston, MA as a medical assistant and phlebotomist, and education and skills. Her work history details responsibilities like greeting patients, taking vitals, performing phlebotomy, EKGs, assisting physicians with exams and procedures, processing lab orders and samples, and maintaining medical records. She has a certificate as a clinical medical assistant from 2004. Her skills include venipuncture, medical procedures, laboratory procedures, compliance with medical standards, terminology, billing, referrals, insurance knowledge, and office support.
STARSurg, Tripartite Colorectal Conference, July 2014STARSurg
Tripartite is an international colorectal meeting of surgeons from across Europe, Australasia and the Americas.
Here we presented the colorectal-specific findings of STARSurg's first national collaborative cohort study, assesing the safety profile of NSAIDs in colorectal resection.
The impact of consultant led weekend ward rounds in a UK district general hos...NHS Improving Quality
The impact of consultant led weekend ward rounds in a UK district general hospital
Royal Wolverhampton NHS Trust
Poster from the 'Delivering NHS services, seven days a week' event held in Birmingham on 16 November 2013
More information about this event can be found at
http://www.nhsiq.nhs.uk/news-events/events/nhs-services-seven-days-a-week.aspx
The final protocol (v5.3). Notable changes include:
1) Confirmation of audit standard (Page 6).
2) Refinement of inclusion and exclusion criteria (Page 7)
3) Confirmation of audit status (Appendix C)
4) Refinement of required data fields (Page 19) including definitions (Pages 20-25)
Ben Bridgewater: Measuring outcomes for surgeryThe King's Fund
Ben Bridgewater, Director of Clinical Audit, University Hospital of South Manchester NHS Foundation Trust, discusses how to measure outcomes for surgery, including the patient's perspective.
STARSurg - student audit and research collaboration presentationDr Edward Fitzgerald
STARSurg is a student-led collaborative that empowers medical students to participate in national research studies related to surgery. It facilitates annual research projects involving over 1000 collaborators across multiple medical schools. Participating students gain transferable skills in research, audit, and evidence-based practice while making meaningful contributions through studies published in top journals. STARSurg aims to promote a culture of student engagement in research through training, online resources, and recognition of student work.
The document provides an overview of the career path and training required to become a Clinical Scientist in Molecular Genetics in the UK. It details the educational requirements, two training routes, certification process, and typical daily responsibilities in the laboratory. The document also compares roles in Molecular Genetics versus Microbiology and provides tips and resources for those interested in pursuing this career path.
This document discusses strategies to reduce hospital wait times and avoidable hospitalizations in Saudi Arabia, the UAE, and the United States. It identifies that increased healthcare costs and patient dissatisfaction with long wait times are issues. It proposes identifying high-risk patients for unnecessary admissions and applying alternative modeling techniques. Implementing policies to address problems leading to wait times and incorporating patient preferences could help reduce costs for patients and hospitals from long waits and hospitalizations.
This document contains Stacey James' resume, including her contact information, work history from 2016 to 2007 at various medical facilities in Boston, MA as a medical assistant and phlebotomist, and education and skills. Her work history details responsibilities like greeting patients, taking vitals, performing phlebotomy, EKGs, assisting physicians with exams and procedures, processing lab orders and samples, and maintaining medical records. She has a certificate as a clinical medical assistant from 2004. Her skills include venipuncture, medical procedures, laboratory procedures, compliance with medical standards, terminology, billing, referrals, insurance knowledge, and office support.
STARSurg, Tripartite Colorectal Conference, July 2014STARSurg
Tripartite is an international colorectal meeting of surgeons from across Europe, Australasia and the Americas.
Here we presented the colorectal-specific findings of STARSurg's first national collaborative cohort study, assesing the safety profile of NSAIDs in colorectal resection.
The document discusses standard of care (SOC) costs in oncology clinical trials. It notes that SOC considerations can help avoid double payments and ensure fair market value, and that incorporating SOC into trial design and budgets can result in significant cost savings of up to 34%. SOC works well for oncology trials because national guidelines for cancer treatment (NCCN guidelines) are widely accepted and followed in the US and influence third-party payer reimbursement and protocol design.
This document discusses telemedicine and reducing healthcare costs through innovative programs. It provides data on the breakdown of healthcare costs by category for a pilot population, showing that hospital care accounts for the largest share. The document also summarizes results from several telemedicine programs that led to reductions in ICU and hospital days, readmission rates, and overall healthcare costs compared to national averages. It concludes that preliminary data suggests healthcare costs were reduced by around 50% through telemedicine interventions but that more investigation is still needed.
HEALTH_PROC_8_Waiting times for selected elective surgeries.pdfKhalilSemlali
This document provides definitions and methodology for measuring waiting times for elective surgeries in OECD countries. It describes 6 common metrics for measuring waiting times from specialist assessment to treatment, including mean and median wait times in days and percentage waiting over 3 months. It then provides country-specific sources, procedures measured, and notes for Australia, Canada, and Chile.
For evidence based decision making. helpfull for public health officials in planning in advance & reach desired goals . In era of health insurance acceptable levels of unit costing by bottom up approach . In addition comparing private to public also identifies the gaps that can be adddressed.
Developing a budget for a migraine study by xiomara arias fernandez (2)Xiomara Arias Fernandez
This document provides a detailed budget for a proposed migraine study. It includes costs for each study procedure and visit, investigator and coordinator time, screening failures, and other study-level costs such as start-up, IRB review, pharmacy set-up, and advertising. Justification is provided for each cost based on comparing to historical data, accounting for inflation, considering indirect costs like overhead, and including potential additional expenses such as amendments, legal issues, and delayed starts. The total proposed budget across all costs is $29,400.
Technology Assessment, Outcomes Research and Economic Analysesevadew1
This document discusses technology assessment, outcomes research, and economic analyses in healthcare. It provides background on rising healthcare costs in the US and outlines a hierarchy for assessing new medical technologies from technical efficacy to patient and societal outcomes. Randomized controlled trials are described as the gold standard but limitations are noted. Alternative study designs like modeling and assessing intermediate outcomes are proposed when RCTs are not feasible. The document uses CT for appendicitis as an example to work through initial steps in outcomes research. It also discusses limitations and alternative outcomes like assessing the therapeutic value of diagnostic tests.
This document discusses technology assessment, outcomes research, and economic analyses in healthcare. It provides background on rising healthcare costs in the US without clear improvements in health outcomes compared to other countries. The rationale for assessing new technologies and their impact is described. Key aspects of technology assessment are outlined, including technical efficacy, diagnostic accuracy, diagnostic impact, therapeutic impact, patient outcomes, and societal outcomes. Challenges with randomized controlled trials in assessing technologies are reviewed. The National Lung Screening Trial is presented as an example. Finally, computed tomography for appendicitis is analyzed as a hypothetical example of how modeling could be used to assess a technology when a randomized trial may not be feasible.
This document discusses methods for controlling rising health care costs in the United States. It explores how increased use of health information technology, evidence-based medicine, and new models of primary care such as the patient-centered medical home can improve efficiency and reduce expenditures. Alternative delivery methods like urgent care clinics and greater use of nurse practitioners and physician assistants may also lower costs. While concierge medicine provides enhanced services, there is no data showing it contains overall spending. Tort reform aims to curb defensive medicine practices that drive up healthcare costs.
Cytori Therapeutics is developing adipose-derived regenerative cell therapies using a point-of-care device platform. The platform allows for autologous cell therapies to be prepared at the bedside from a patient's own fat tissue. Clinical trials show the cells are safe and may provide benefits in cardiac and soft tissue applications. Near-term value drivers include government contract milestones and cardiovascular trial data. The business model involves selling single-use consumables for each procedure at price points around $2,000-$12,000, depending on the indication.
This document summarizes a study that used hospital discharge data to estimate the average daily cost of hospitalization by diagnosis and level of care (ICU/CCU or regular care). The study found that:
1) The average daily cost across all conditions was $2,401 in the ICU/CCU and $1,122 in regular care.
2) Daily costs varied significantly by diagnosis, ranging from $1,241 to $3,315 in the ICU/CCU and $1,176 to $3,081 in regular care.
3) Estimating daily costs by diagnosis and care level can provide useful information for cost-effectiveness analyses of healthcare interventions.
This document discusses cost-effectiveness analysis for evaluating health interventions. It defines efficacy versus effectiveness, and cost-effectiveness as assessing whether health improvements are worth the additional costs. The document outlines methods for cost-effectiveness analysis including identifying alternatives, measuring outcomes and costs, and using decision rules. Key points covered include measuring outcomes directly, considering both short and long term costs and benefits, and discounting future values.
Cost utility analysis of interventions to return employees to work following ...ScHARR HEDS
The document describes the Health Economics and Decision Science (HEDS) section within the School of Health and Related Research (ScHARR) at the University of Sheffield. HEDS conducts research to promote excellence in healthcare resource allocation and supports the implementation of research results through education and training. Its research portfolio includes areas like evidence synthesis, health economics modeling, and more. HEDS also offers post-graduate programs and short courses. It focuses on a wide range of disease areas and provides consultancy services including modeling for clinical trials and health economics analyses. The decision modeling team at HEDS specializes in cost-effectiveness analyses to support healthcare decision making.
Intensive therapy for type 1 diabetes was found to be more costly than conventional therapy due to increased use of medical resources. However, it provided significant health benefits by reducing the risk of microvascular complications like blindness, kidney failure, and amputations. While intensive therapy costs $4 billion more over a lifetime for 120,000 patients, it yields 5.1 additional years of life per patient and improves quality of life. The cost per year of life gained and per quality-adjusted life year gained was found to be comparable to other accepted medical interventions. Therefore, intensive diabetes therapy represents good value for money from a health economic perspective.
Writer’s Surname 1[Name of the Writer][Name of Ins.docxannetnash8266
Writer’s Surname 1
[Name of the Writer]
[Name of Instructor]
[Subject]
[Date]
Professional Coder Practicum Documentation
Medical coding is the conversion of medical diagnosis, equipment, procedures, and medical services into universal medical alphanumeric codes. The procedure and diagnoses codes are taken from medical record documentation such as laboratory, radiologic results, and transcription of doctor’s notes. Professional coder practicum make sure the codes are applied correctly during the medical billing process. In this paper four cases has been reviewed to see if there is any missing data in documentation that can be needed by coder. The first case is of a patient suffering from invasive ductal carcinoma (Nie, Liqiang, et al. 2015).
410057
The patient is suffering from invasive ductal carcinoma of the right breast. the patient is 57 years old female with an extensive surgical history involving her bilateral breasts including prior mastopexies as well as breast augmentation. The patient was brought to the preoperative area and was marked for an inferior pedicle wise pattern reduction. According to the coding summary provided by supervisor all the information such as reason for visit, primary diagnosis, secondary diagnosis, procedural details, cancer follow up information, pertinent laboratory tests, medical history, current medication list, and symptoms of disease is present for this case. All the information is present for coder and there is no missing data for this patient.
The second case is of a patient suffering from benign neoplasm of ascending colon.
410092
The patient had colonoscopy at 4/11/2014. Multiple resected polyps diagnosed as tubulovillous adenomas and tubular adenomas. Patient states that not all areas were resected and he is presenting for colonoscopy with endoscopy mucosal resection. The medical notes contain information about his evaluation and detailed medical history which include allergies, anesthetic complications, and cardiovascular history. The case also provide information about patient’s vitals, physical exam details, lab tests details, anesthesia assessment plan, home medications, current hospital medications, pathology consultation report, and procedural details. There is no missing information in this case. The doctor clearly diagnosed the disease and coding is always done on definitive diagnosis. There is information related to gene analysis which has not been assigned any code as per clinic policies.
The third case is of a patient suffering from epidermal cyst.
410198
The patient had the cyst at the site many years ago and recently she has noticed the scar has enlarged, become itchy and at times drains foul smelling material. The female patient is 49 years old and has no other medical condition. The medical notes contain the diagnosis, past medical history, past surgical history, medication details, family history, social history, anesthesia complication, physical exam details, assessm.
EVIDENCE-BASED CPGs FOR HEMATOLOGY - ONCOLOGY UNIT, KING SAUD UNIVERSITY HOPSITALS
Saudi Arabia, Riyadh
King Saud University Hospitals
CPGs Committee
Quality Management Dept
CPGs Program
By YASSER SAMI AMER
Presentation from the 3rd Joint Meeting of the Antimicrobial Resistance and Healthcare-Associated Infections (ARHAI) Networks, organised by the European Centre of Disease Prevention and Control - Stockholm, 11-13 February 2015
This document outlines a presentation on clinical research and development challenges and opportunities. It discusses the low productivity and increasing costs of R&D, potential loss of revenue from expiring patents, and reasons for low productivity such as target and trial design issues. It also covers trends like globalization of clinical trials to reduce costs and access large patient populations. Finally, it discusses the need for quality and qualified investigators to address the supply and demand imbalance.
Observational Studies: Strategic, Operational and Budgetary ConsiderationsTTC, llc
Observational studies provide important real-world data on drug safety, effectiveness, and value that complement randomized controlled trials. However, conducting observational studies presents unique operational challenges and requires specialized skills different from traditional clinical trials. If properly designed and managed, observational studies can fulfill post-approval regulatory obligations in a cost-effective manner by generating real-world evidence on safety, clinical outcomes, economics, and patient experiences.
The document discusses standard of care (SOC) costs in oncology clinical trials. It notes that SOC considerations can help avoid double payments and ensure fair market value, and that incorporating SOC into trial design and budgets can result in significant cost savings of up to 34%. SOC works well for oncology trials because national guidelines for cancer treatment (NCCN guidelines) are widely accepted and followed in the US and influence third-party payer reimbursement and protocol design.
This document discusses telemedicine and reducing healthcare costs through innovative programs. It provides data on the breakdown of healthcare costs by category for a pilot population, showing that hospital care accounts for the largest share. The document also summarizes results from several telemedicine programs that led to reductions in ICU and hospital days, readmission rates, and overall healthcare costs compared to national averages. It concludes that preliminary data suggests healthcare costs were reduced by around 50% through telemedicine interventions but that more investigation is still needed.
HEALTH_PROC_8_Waiting times for selected elective surgeries.pdfKhalilSemlali
This document provides definitions and methodology for measuring waiting times for elective surgeries in OECD countries. It describes 6 common metrics for measuring waiting times from specialist assessment to treatment, including mean and median wait times in days and percentage waiting over 3 months. It then provides country-specific sources, procedures measured, and notes for Australia, Canada, and Chile.
For evidence based decision making. helpfull for public health officials in planning in advance & reach desired goals . In era of health insurance acceptable levels of unit costing by bottom up approach . In addition comparing private to public also identifies the gaps that can be adddressed.
Developing a budget for a migraine study by xiomara arias fernandez (2)Xiomara Arias Fernandez
This document provides a detailed budget for a proposed migraine study. It includes costs for each study procedure and visit, investigator and coordinator time, screening failures, and other study-level costs such as start-up, IRB review, pharmacy set-up, and advertising. Justification is provided for each cost based on comparing to historical data, accounting for inflation, considering indirect costs like overhead, and including potential additional expenses such as amendments, legal issues, and delayed starts. The total proposed budget across all costs is $29,400.
Technology Assessment, Outcomes Research and Economic Analysesevadew1
This document discusses technology assessment, outcomes research, and economic analyses in healthcare. It provides background on rising healthcare costs in the US and outlines a hierarchy for assessing new medical technologies from technical efficacy to patient and societal outcomes. Randomized controlled trials are described as the gold standard but limitations are noted. Alternative study designs like modeling and assessing intermediate outcomes are proposed when RCTs are not feasible. The document uses CT for appendicitis as an example to work through initial steps in outcomes research. It also discusses limitations and alternative outcomes like assessing the therapeutic value of diagnostic tests.
This document discusses technology assessment, outcomes research, and economic analyses in healthcare. It provides background on rising healthcare costs in the US without clear improvements in health outcomes compared to other countries. The rationale for assessing new technologies and their impact is described. Key aspects of technology assessment are outlined, including technical efficacy, diagnostic accuracy, diagnostic impact, therapeutic impact, patient outcomes, and societal outcomes. Challenges with randomized controlled trials in assessing technologies are reviewed. The National Lung Screening Trial is presented as an example. Finally, computed tomography for appendicitis is analyzed as a hypothetical example of how modeling could be used to assess a technology when a randomized trial may not be feasible.
This document discusses methods for controlling rising health care costs in the United States. It explores how increased use of health information technology, evidence-based medicine, and new models of primary care such as the patient-centered medical home can improve efficiency and reduce expenditures. Alternative delivery methods like urgent care clinics and greater use of nurse practitioners and physician assistants may also lower costs. While concierge medicine provides enhanced services, there is no data showing it contains overall spending. Tort reform aims to curb defensive medicine practices that drive up healthcare costs.
Cytori Therapeutics is developing adipose-derived regenerative cell therapies using a point-of-care device platform. The platform allows for autologous cell therapies to be prepared at the bedside from a patient's own fat tissue. Clinical trials show the cells are safe and may provide benefits in cardiac and soft tissue applications. Near-term value drivers include government contract milestones and cardiovascular trial data. The business model involves selling single-use consumables for each procedure at price points around $2,000-$12,000, depending on the indication.
This document summarizes a study that used hospital discharge data to estimate the average daily cost of hospitalization by diagnosis and level of care (ICU/CCU or regular care). The study found that:
1) The average daily cost across all conditions was $2,401 in the ICU/CCU and $1,122 in regular care.
2) Daily costs varied significantly by diagnosis, ranging from $1,241 to $3,315 in the ICU/CCU and $1,176 to $3,081 in regular care.
3) Estimating daily costs by diagnosis and care level can provide useful information for cost-effectiveness analyses of healthcare interventions.
This document discusses cost-effectiveness analysis for evaluating health interventions. It defines efficacy versus effectiveness, and cost-effectiveness as assessing whether health improvements are worth the additional costs. The document outlines methods for cost-effectiveness analysis including identifying alternatives, measuring outcomes and costs, and using decision rules. Key points covered include measuring outcomes directly, considering both short and long term costs and benefits, and discounting future values.
Cost utility analysis of interventions to return employees to work following ...ScHARR HEDS
The document describes the Health Economics and Decision Science (HEDS) section within the School of Health and Related Research (ScHARR) at the University of Sheffield. HEDS conducts research to promote excellence in healthcare resource allocation and supports the implementation of research results through education and training. Its research portfolio includes areas like evidence synthesis, health economics modeling, and more. HEDS also offers post-graduate programs and short courses. It focuses on a wide range of disease areas and provides consultancy services including modeling for clinical trials and health economics analyses. The decision modeling team at HEDS specializes in cost-effectiveness analyses to support healthcare decision making.
Intensive therapy for type 1 diabetes was found to be more costly than conventional therapy due to increased use of medical resources. However, it provided significant health benefits by reducing the risk of microvascular complications like blindness, kidney failure, and amputations. While intensive therapy costs $4 billion more over a lifetime for 120,000 patients, it yields 5.1 additional years of life per patient and improves quality of life. The cost per year of life gained and per quality-adjusted life year gained was found to be comparable to other accepted medical interventions. Therefore, intensive diabetes therapy represents good value for money from a health economic perspective.
Writer’s Surname 1[Name of the Writer][Name of Ins.docxannetnash8266
Writer’s Surname 1
[Name of the Writer]
[Name of Instructor]
[Subject]
[Date]
Professional Coder Practicum Documentation
Medical coding is the conversion of medical diagnosis, equipment, procedures, and medical services into universal medical alphanumeric codes. The procedure and diagnoses codes are taken from medical record documentation such as laboratory, radiologic results, and transcription of doctor’s notes. Professional coder practicum make sure the codes are applied correctly during the medical billing process. In this paper four cases has been reviewed to see if there is any missing data in documentation that can be needed by coder. The first case is of a patient suffering from invasive ductal carcinoma (Nie, Liqiang, et al. 2015).
410057
The patient is suffering from invasive ductal carcinoma of the right breast. the patient is 57 years old female with an extensive surgical history involving her bilateral breasts including prior mastopexies as well as breast augmentation. The patient was brought to the preoperative area and was marked for an inferior pedicle wise pattern reduction. According to the coding summary provided by supervisor all the information such as reason for visit, primary diagnosis, secondary diagnosis, procedural details, cancer follow up information, pertinent laboratory tests, medical history, current medication list, and symptoms of disease is present for this case. All the information is present for coder and there is no missing data for this patient.
The second case is of a patient suffering from benign neoplasm of ascending colon.
410092
The patient had colonoscopy at 4/11/2014. Multiple resected polyps diagnosed as tubulovillous adenomas and tubular adenomas. Patient states that not all areas were resected and he is presenting for colonoscopy with endoscopy mucosal resection. The medical notes contain information about his evaluation and detailed medical history which include allergies, anesthetic complications, and cardiovascular history. The case also provide information about patient’s vitals, physical exam details, lab tests details, anesthesia assessment plan, home medications, current hospital medications, pathology consultation report, and procedural details. There is no missing information in this case. The doctor clearly diagnosed the disease and coding is always done on definitive diagnosis. There is information related to gene analysis which has not been assigned any code as per clinic policies.
The third case is of a patient suffering from epidermal cyst.
410198
The patient had the cyst at the site many years ago and recently she has noticed the scar has enlarged, become itchy and at times drains foul smelling material. The female patient is 49 years old and has no other medical condition. The medical notes contain the diagnosis, past medical history, past surgical history, medication details, family history, social history, anesthesia complication, physical exam details, assessm.
EVIDENCE-BASED CPGs FOR HEMATOLOGY - ONCOLOGY UNIT, KING SAUD UNIVERSITY HOPSITALS
Saudi Arabia, Riyadh
King Saud University Hospitals
CPGs Committee
Quality Management Dept
CPGs Program
By YASSER SAMI AMER
Presentation from the 3rd Joint Meeting of the Antimicrobial Resistance and Healthcare-Associated Infections (ARHAI) Networks, organised by the European Centre of Disease Prevention and Control - Stockholm, 11-13 February 2015
This document outlines a presentation on clinical research and development challenges and opportunities. It discusses the low productivity and increasing costs of R&D, potential loss of revenue from expiring patents, and reasons for low productivity such as target and trial design issues. It also covers trends like globalization of clinical trials to reduce costs and access large patient populations. Finally, it discusses the need for quality and qualified investigators to address the supply and demand imbalance.
Observational Studies: Strategic, Operational and Budgetary ConsiderationsTTC, llc
Observational studies provide important real-world data on drug safety, effectiveness, and value that complement randomized controlled trials. However, conducting observational studies presents unique operational challenges and requires specialized skills different from traditional clinical trials. If properly designed and managed, observational studies can fulfill post-approval regulatory obligations in a cost-effective manner by generating real-world evidence on safety, clinical outcomes, economics, and patient experiences.
Dr. Tom Schaible discussed late phase clinical trial planning and budgeting at Johnson & Johnson. Late stage studies include Phase II, III, IIIb, and post-marketing trials. Factors driving investment in post-marketing trials include worldwide regulatory commitments to study clinical outcomes and comparative effectiveness as well as evolving healthcare economics and reimbursement environments. Post-approval regulatory commitments under laws like FDAAA provide enforcement for meeting study commitments through both interventional and observational trials.
Annual State of Clinical Development CostsTTC, llc
The document summarizes key findings from a survey and presentation on annual clinical development costs. It discusses how:
1) Drug development costs are increasing while productivity is declining, putting pressure on the traditional development model.
2) Cost management strategies being used by companies include greater use of CROs, new geographic sites, and standard of care payments to reduce sponsor costs while increasing site payments.
3) Survey findings show CRO costs have risen significantly in recent years and continue to increase, while costs are lower in new geographic sites like Eastern Europe, Asia, and Latin America.
The pharmaceutical industry faces significant challenges in developing new drugs including rising costs, decreased returns on investment, and a more complex regulatory environment. Development times and costs have increased dramatically, while success rates have declined. Return on investment for R&D has turned negative as development costs have risen much faster than sales. Additionally, regulatory requirements have increased, requiring more extensive safety data and outcomes evidence prior to approval. These challenges are driving the need for changes across the industry.
This document discusses standard of care and research billing compliance. It defines standard of care and identifies the importance of distinguishing between customary clinical care that can be billed to insurers versus care only done for research purposes. It outlines five common billing errors called "the deadly five" and stresses the importance of a thorough coverage analysis to determine what is billable versus research-related. It also discusses how sponsors use the term "standard of care" and the need for sites to understand billing compliance to receive accurate budgets and avoid improper billing.
This document discusses challenges in budgeting and negotiating investigator grants for global clinical trials in countries that are difficult to work with. It asks questions about central budgeting, outsourcing negotiations, gathering market intelligence, ensuring fair market value, dealing with differing regulatory timelines, and whether lower costs outweigh longer start-up times. The document is from a meeting in Philadelphia on January 10, 2012 discussing investigator grants in countries like Poland, Brazil, Russia, Argentina, China, India, and Japan.
Working with Countries that are Difficult to Negotiate withTTC, llc
This document discusses considerations for working with countries that are difficult to negotiate with for clinical trials. The potential benefits include rapid enrollment of treatment naïve patients and willing investigators. However, there are also risks such as language barriers, intellectual property and data rights issues, subject privacy concerns, complex regulatory processes, insurance requirements, and unstable political environments that require careful management. Budgeting must also account for costs of importing study drugs, comparators, equipment, and dealing with variable regulatory start-up times.
The State of Clinical Development - GlobalizationTTC, llc
The document discusses the increasing globalization of clinical trials. It notes that in 2010, ACRO member companies managed nearly 2 million participants in over 11,500 clinical trials across 114 countries. The companies employ over 72,000 people worldwide and were involved in developing many top-selling drugs. While globalization provides benefits like increased availability of patients and investigators, it also presents challenges regarding infrastructure, regulations, ethics, and data quality across regions. The document outlines recent and ongoing research by ACRO examining data quality and other factors across mature and emerging market regions.
Investigator-Initiated Studies: Two Stories from the NIHTTC, llc
The document discusses two investigator-initiated studies funded by the National Heart, Lung, and Blood Institute (NHLBI). The first story describes a study that found reopening occluded arteries in patients who had a heart attack over 24 hours prior did not reduce risk of death or heart attack and was difficult to conduct due to physician bias in favor of the procedure and slow funding and recruitment. The second story discusses a study that found certain blood thinning drugs can prevent heart attacks and strokes, despite initial resistance from the medical community. The document advocates for continued government funding of investigator-initiated clinical trials to evaluate new treatments while managing conflicts of interest.
Phase IIIB & IV Studies Reflect the Evolution of Industry Needs & Market Real...TTC, llc
Phase IIIb & IV studies are evolving to better meet industry needs and market realities. Historically, these studies were commercially driven with low clinical and scientific value, but they are now focusing more on proactive safety to maintain benefits while reducing risks. Studies are also taking a more continuous development approach without clear boundaries between phases. This reflects the new global healthcare landscape where economics will play a central role and understanding of personalized medicine will increase. Future studies will need to generate and test hypotheses using large amounts of data to gain regulatory approval in this new environment of constrained resources.
Future Challenges of Clinical Development; a View from the CRO - Hani ZakiTTC, llc
The document discusses current challenges and future trends in clinical development from the perspective of a CRO. It notes that the global CRO market is large but fragmented, and outlines pressures on the pharmaceutical industry like high R&D costs, patent expirations, and regulatory demands. The text also examines trends towards more global, efficient trials using new technologies and less traditional geographies to address these challenges. It argues that collaboration between industry, regulators and CROs will be key to transforming clinical research processes to increase competitiveness and innovation.
This document discusses the impact of corporate integrity agreements (CIAs) on clinical research and development operations. Specifically:
- Recent CIAs with AstraZeneca, Allergan, and Elan have imposed civil penalties and new compliance requirements that directly impact R&D activities, such as annual certification of clinical trial plans and audits.
- Future CIAs are expected to further influence R&D as these functions become more aligned with commercial operations. Areas like research fraud will also face increased scrutiny.
- Applying fair market value principles to clinical services makes good business sense and ensures compliance with various federal laws regarding transparency of financial relationships with healthcare professionals and institutions.
The document discusses transparency requirements for reporting payments and transfers of value from applicable manufacturers to covered recipients such as physicians. It provides an overview of the federal "Sunshine" provisions and state transparency laws. Key points include who must report, what must be reported, reporting deadlines, and preemption of similar state laws.
Poor patient enrollment is a major problem for clinical trials. 85% of trials are behind schedule, mainly due to slow enrollment, and only 6% finish on time. Enrollment delays are often due to poor feasibility assessments that overlook complex medical, clinical, and logistical factors, as well as mismanaged projects with unrealistic optimism and poor communication. Thorough feasibility studies conducted by specialized experts and maximum logistical support for sites can help trials better estimate enrollment needs and avoid delays.
Clinical Trial Costs in Emerging Geographies - Stephen PorterTTC, llc
1. VDDI Pharmaceuticals utilizes a virtual business model to outsource drug development functions like preclinical and clinical trials to reduce costs.
2. Xemilofiban is a drug product that has already undergone Phase II and III trials and has proven safety and efficacy advantages over existing products.
3. Conducting multi-center Phase II and III trials in China provides an opportunity to secure Chinese regulatory approval and save 2-4 years bringing the drug to market in China compared to other regions.
Effective Global Site Budgeting and Cost Management - Natalie GosciminskiTTC, llc
The document discusses Johnson & Johnson's current process for global site budgeting and cost management for clinical trials. The current process aims to provide consistency in approach, fair reimbursement, transparency, and appropriate support for negotiators. It involves developing a global reimbursement range based on fair market value assumptions, collecting county-level cost data, and negotiating site budgets while documenting any exceptions. Challenges include accounting for complex trial procedures, making efficient yet globally comparable budget comparisons, and balancing timelines.
Effective Global Site Budgeting and Cost Management - Forrest SwopeTTC, llc
Effective global site budgeting and cost management requires balancing sponsor expectations with site needs while navigating internal constraints. The document discusses opportunities to improve budgeting at both the sponsor and site level. For sponsors, it recommends providing high-level cost estimates pre-award and more detailed estimates post-award, while leveraging experience and consistency across countries. For sites, it suggests negotiating at a high level to avoid haggling over line items, and ensuring agreed budgets can be tracked and paid.
Future Challenges of Clinical Development; a View from the CRO - Hani ZakiTTC, llc
The document discusses current challenges and future trends in clinical development from the perspective of a CRO. It notes that the global CRO market is large but fragmented, and outlines pressures on the pharmaceutical industry like high R&D costs, patent expirations, and regulatory demands. The text also examines trends towards more global, efficient trials using new technologies and less traditional geographies to address these challenges. It argues that collaboration between industry, regulators and CROs will be key to transforming clinical research methods.
Payment Practices, FMV, and Study Performance - Harold GlassTTC, llc
The document discusses several topics related to clinical drug trials including:
1) Payment levels do not improve study performance but may raise questions for regulators, and certain CROs and sites get paid more for reasons other than performance.
2) A study is examining factors associated with faster completion times in clinical trials such as the nature of the organization running the study, study design, and site selection.
3) There is no difference in completion times between studies run by sponsor companies or CROs, but larger companies tend to be slower and pay more except in Latin America.
Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
share - Lions, tigers, AI and health misinformation, oh my!.pptxTina Purnat
• Pitfalls and pivots needed to use AI effectively in public health
• Evidence-based strategies to address health misinformation effectively
• Building trust with communities online and offline
• Equipping health professionals to address questions, concerns and health misinformation
• Assessing risk and mitigating harm from adverse health narratives in communities, health workforce and health system
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.
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
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...Oleg Kshivets
Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
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.
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
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.
3. SOC Analysis – Embolism and Deep Vein Thrombosis Study Study Duration 42 Days Number of Visits 13 Number of Patients 500 Number of Procedures 15 Number of SOC Procedures 7 Number of Expensive Procedures 0 Total Cost for Procedures Per Patient before SOC (w/ overhead) $4,808 USD Total Cost for Procedures Per Patient after SOC (w/ overhead) $3,515 USD Total SOC Savings Per Patient $1,293 USD Total SOC Savings for All Patients $646,365 USD Total % of SOC Savings 27%
4. SOC Analysis – Allergic and Asthmatic Bronchitis Study Study Duration 6 Months Number of Visits 10 Number of Patients 200 Number of Procedures 20 Number of SOC Procedures 9 Number of Expensive Procedures 0 Total Cost for Procedures Per Patient before SOC (w/ overhead) $3,499 USD Total Cost for Procedures Per Patient after SOC (w/ overhead) $2,669 USD Total SOC Savings Per Patient $830 USD Total SOC Savings for All Patients $166,050 USD Total % of SOC Savings 24%
5. SOC Analysis – Psoriatic Arthritis Study Study Duration 109 Weeks Number of Visits 16 Number of Patients 300 Number of Procedures 34 Number of SOC Procedures 12 Number of Expensive Procedures 0 Total Cost for Procedures Per Patient before SOC (w/ overhead) $13,625 USD Total Cost for Procedures Per Patient after SOC (w/ overhead) $10,430 USD Total SOC Savings Per Patient $3,195 USD Total SOC Savings for All Patients $958,500 USD Total % of SOC Savings 23%
6. SOC Analysis – Type 2 Diabetes Mellitus Study Study Duration 28 Weeks Number of Visits 29 Number of Patients 500 Number of Procedures 15 Number of SOC Procedures 8 Number of Expensive Procedures 0 Total Cost for Procedures Per Patient before SOC (w/ overhead) $4,210 USD Total Cost for Procedures Per Patient after SOC (w/ overhead) $3,257 USD Total SOC Savings Per Patient $953 USD Total SOC Savings for All Patients $476,625 USD Total % of SOC Savings 23%