1. The document provides guidance for medical record reviewers conducting retrospective case record reviews to determine the proportion of avoidable deaths in hospitals.
2. Reviewers will examine 3,400 patient deaths across 24 English hospitals to determine if higher rates of avoidable deaths identified through case review correlate with higher Hospital Standardized Mortality Ratios.
3. The review process involves systematically examining medical records to identify any problems in healthcare delivery, categorizing identified problems, and rating the avoidability of each death on a 6-point scale.
A Promulgation Of Incredulity In The Pharmaceutical IndustryStuart Silverman
It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines.
This document discusses pharmacovigilance, which is the science related to monitoring the safety of medicines. It notes that clinical trials are limited in detecting rare or long-term adverse drug reactions, so ongoing monitoring of medicines is important after approval. Pharmacovigilance systems like spontaneous reporting allow for detection of unknown adverse reactions. Underreporting of reactions is a challenge, so education to improve reporting is needed. Overall, pharmacovigilance aims to identify safety issues with medicines throughout their lifecycle to protect patients.
This case involves a research study on white blood cells that used blood samples from laboratory staff as controls without obtaining informed consent. One staff member refused to donate blood due to concerns about potentially having HIV and exposing colleagues. Key issues included the lack of informed consent, potential for coercion, and risks to confidentiality and well-being of participants. Changes such as obtaining proper informed consent, ensuring voluntary participation, and protecting confidentiality were needed to address these ethical problems.
This document analyzes the ethical considerations of conducting randomized controlled trials of the RRV-TV rotavirus vaccine in developing countries. It discusses four key ethical requirements: scientific validity, social value, favorable risk-benefit ratio, and collaborative partnership. Scientific validity requires the trials have a valid design and use reliable data. Social value means the trials must demonstrate important health benefits for developing countries. Risk-benefit ratio means the trials must ensure participants' safety and welfare. Collaborative partnership between researchers and host communities is needed to minimize exploitation and respect local contexts. The dilemma is enabling subjects to benefit from research while protecting their wellbeing and safety.
The usability of STAMP in drug development Arete-Zoe, LLC
Arete-Zoe in cooperation with Stuttgart University
Study authors: Veronika Valdova, Ronald L Sheckler, Asim Abdulkhaleq and Stefan Wagner (Jonathan M Fishbein)
Presentation of synopsis: Veronika Valdova
Presented at STAMP team meeting, PSCI, ACRES on February 26, 2016
The document discusses various methods used for causality assessment of adverse drug reactions (ADRs), including algorithms. It outlines several algorithms such as the Karch & Lasagna, Begaud, Jones, Kramer, Naranjo, WHO-UMC, Thai, CIOMS/RUCAM, and ALDEN algorithms. Each algorithm has advantages and limitations. While the Naranjo algorithm is simple and brief, its dependability and validity are not confirmed for all populations. The WHO-UMC criteria are intended as a convenient tool for individual case reports but have limitations. Specific algorithms like CIOMS/RUCAM and ALDEN are used for certain ADRs. The best algorithm depends on the type of
This document discusses different types of observational studies used in epidemiology to evaluate adverse events. It describes three major types: cross-sectional studies, case-control studies, and cohort studies. Cross-sectional studies collect data on a population at a single point in time to measure disease prevalence. Case-control studies compare subjects with a disease to controls without the disease to identify risk factors. Cohort studies follow groups over time, some exposed to potential risk factors and some not, to measure relative risk and identify causes.
Study examines hospitalist malpractice claims by Floyd Arthur (PPT)Floyd Arthur
This document summarizes a study examining hospitalist malpractice claims. The study analyzed 464 malpractice claims against hospitalists between 2007-2014. It found that 78% of claims fell into three categories: diagnostic errors (36%), treatment errors (31%), and medication errors (11%). Multiple factors contributed to these errors, including inadequate patient assessment (35%), breakdowns in provider communication (23%), and issues with therapeutic interventions (16%). Examples are provided to illustrate how failures in these areas led to patient injuries or death. The document concludes with recommendations on how hospitalists can improve patient management to help mitigate risks.
A Promulgation Of Incredulity In The Pharmaceutical IndustryStuart Silverman
It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines.
This document discusses pharmacovigilance, which is the science related to monitoring the safety of medicines. It notes that clinical trials are limited in detecting rare or long-term adverse drug reactions, so ongoing monitoring of medicines is important after approval. Pharmacovigilance systems like spontaneous reporting allow for detection of unknown adverse reactions. Underreporting of reactions is a challenge, so education to improve reporting is needed. Overall, pharmacovigilance aims to identify safety issues with medicines throughout their lifecycle to protect patients.
This case involves a research study on white blood cells that used blood samples from laboratory staff as controls without obtaining informed consent. One staff member refused to donate blood due to concerns about potentially having HIV and exposing colleagues. Key issues included the lack of informed consent, potential for coercion, and risks to confidentiality and well-being of participants. Changes such as obtaining proper informed consent, ensuring voluntary participation, and protecting confidentiality were needed to address these ethical problems.
This document analyzes the ethical considerations of conducting randomized controlled trials of the RRV-TV rotavirus vaccine in developing countries. It discusses four key ethical requirements: scientific validity, social value, favorable risk-benefit ratio, and collaborative partnership. Scientific validity requires the trials have a valid design and use reliable data. Social value means the trials must demonstrate important health benefits for developing countries. Risk-benefit ratio means the trials must ensure participants' safety and welfare. Collaborative partnership between researchers and host communities is needed to minimize exploitation and respect local contexts. The dilemma is enabling subjects to benefit from research while protecting their wellbeing and safety.
The usability of STAMP in drug development Arete-Zoe, LLC
Arete-Zoe in cooperation with Stuttgart University
Study authors: Veronika Valdova, Ronald L Sheckler, Asim Abdulkhaleq and Stefan Wagner (Jonathan M Fishbein)
Presentation of synopsis: Veronika Valdova
Presented at STAMP team meeting, PSCI, ACRES on February 26, 2016
The document discusses various methods used for causality assessment of adverse drug reactions (ADRs), including algorithms. It outlines several algorithms such as the Karch & Lasagna, Begaud, Jones, Kramer, Naranjo, WHO-UMC, Thai, CIOMS/RUCAM, and ALDEN algorithms. Each algorithm has advantages and limitations. While the Naranjo algorithm is simple and brief, its dependability and validity are not confirmed for all populations. The WHO-UMC criteria are intended as a convenient tool for individual case reports but have limitations. Specific algorithms like CIOMS/RUCAM and ALDEN are used for certain ADRs. The best algorithm depends on the type of
This document discusses different types of observational studies used in epidemiology to evaluate adverse events. It describes three major types: cross-sectional studies, case-control studies, and cohort studies. Cross-sectional studies collect data on a population at a single point in time to measure disease prevalence. Case-control studies compare subjects with a disease to controls without the disease to identify risk factors. Cohort studies follow groups over time, some exposed to potential risk factors and some not, to measure relative risk and identify causes.
Study examines hospitalist malpractice claims by Floyd Arthur (PPT)Floyd Arthur
This document summarizes a study examining hospitalist malpractice claims. The study analyzed 464 malpractice claims against hospitalists between 2007-2014. It found that 78% of claims fell into three categories: diagnostic errors (36%), treatment errors (31%), and medication errors (11%). Multiple factors contributed to these errors, including inadequate patient assessment (35%), breakdowns in provider communication (23%), and issues with therapeutic interventions (16%). Examples are provided to illustrate how failures in these areas led to patient injuries or death. The document concludes with recommendations on how hospitalists can improve patient management to help mitigate risks.
The document summarizes 5 studies on adverse drug reaction (ADR) reporting rates among healthcare professionals. A retrospective study found an ADR reporting rate of 57.14% among ICU patients. A questionnaire revealed barriers to reporting like lack of training and awareness. Healthcare professionals were then educated on ADR reporting. A prospective study post-education found an increased ADR reporting rate of 72.72%, indicating education improved reporting. The document concludes education is needed to enhance pharmacovigilance among healthcare professionals.
This document summarizes the evolution and current state of emergency medicine clinical pharmacists internationally. It describes how their role has expanded from medication distribution to active clinical roles on multidisciplinary teams. Studies show emergency medicine pharmacists can reduce medication errors, mortality, readmissions, and improve time to appropriate treatments. While initially confined to North America, their benefits are now reported internationally. More evidence is still needed on reducing adverse drug events, but existing data shows emergency medicine pharmacists improve patient outcomes and reduce costs.
- A study compared rates of preventable adverse drug events (ADEs) in intensive care units (ICUs) vs. non-ICUs at two hospitals over 6 months.
- The unadjusted ADE rate was twice as high in ICUs, but when adjusted for number of drugs, there was no difference between ICUs and non-ICUs.
- Preventable ADEs occurred due to normal systems failures like poor communication rather than overworked individuals, showing the need for systems solutions over blaming individuals.
Vaccines are an essential method for preventing infectious diseases. While vaccination programs have reduced disease rates, vaccine safety continues to be monitored. An extensive vaccine safety review found limited understanding of adverse events due to insufficient research. Improving research capacity is needed so future reviews are not handicapped. Both pre-licensure clinical trials and post-licensure surveillance systems aim to monitor vaccine safety, though assessing rare adverse events poses challenges requiring large studies and international collaboration. Standardized methods and ongoing evaluation aim to maintain public confidence in vaccination.
Pharmacist Prescription Drug Extension_Citations_edited_2015_05_07Jessica Bigger
Pharmacists and pharmacy chains have proposed expanding pharmacists' roles to allow them to prescribe certain routine medications for common illnesses. This would create a new category of "nonprescription drugs" that pharmacists could dispense without a doctor's prescription. Supporters argue this would increase access to healthcare, especially for underserved patients. However, medical associations oppose the proposal and argue that pharmacists lack sufficient medical training to safely prescribe drugs. The FDA is considering the proposal but acknowledges more evidence is needed regarding which drugs could safely be prescribed without a doctor. The future relationship between pharmacists and doctors remains unclear if pharmacists' prescribing roles expand.
SAMS EBM Online Course: Observational Study DesignsAhmad Al-Moujahed
This document discusses various observational study designs used in epidemiology, including cohort and case-control studies. It provides details on how to design, conduct, and analyze these types of studies. For cohort studies, it explains how to select the cohort population and comparison groups, and describes examples like the Framingham Heart Study and Nurses' Health Study. For case-control studies, it outlines how to select cases and controls and discusses potential biases. The document emphasizes the importance of temporal sequence between exposure and outcome and minimizing biases and confounding when using these observational study designs.
1) The WHO Solidarity Trial studied the effects of Remdesivir and other drugs on over 11,000 COVID-19 patients across 30 countries. It found no statistically significant difference in mortality between the Remdesivir and control groups.
2) However, the reviewer notes some limitations with the trial design, including a lack of standardization across sites and incomplete reporting of important baseline characteristics and co-interventions between groups.
3) Given the limitations and preliminary nature of the results, the reviewer believes it is too early to change clinical practice and recommends continuing Remdesivir use selectively until more definitive data is available.
This document summarizes the results of a survey assessing patient safety culture in 15 California hospitals. The survey was sent to over 6,000 hospital employees, including physicians, executives, and other staff, with a 47.4% overall response rate. The survey found that on average, 18% of responses suggested an absence of safety culture, while another 18% were neutral. Responses varied significantly between hospitals and job types. Clinicians, especially nurses, and frontline workers generally gave more negative responses than executives and non-clinical staff. The results provide information on how perceptions of safety culture differ within and between hospitals and employee groups. Further research is needed to understand how to improve safety culture across an organization.
1. The study analyzed factors influencing access to new direct-acting antiviral (DAA) treatments for hepatitis C using data from over 4,700 patients.
2. The analysis found that fibrosis level was the most influential factor, with substance abuse being a primary determinant of treatment for patients with F2-F4 fibrosis.
3. For patients with F2 fibrosis and no substance abuse, higher viral load and private insurance were associated with greater access, while additional comorbidities reduced access.
Controladores y estrategias para evitar la sobreutilización sanitaria en Aten...Javier González de Dios
Objectives: Identify the sources of overuse from the point of view of the Spanish primary care professionals, and
analyse the frequency of overuse due to pressure from patients in addition to the responses when professionals
face these demands.
Design: A cross-sectional study.
Setting: Primary care in Spain.
Participants: A non-randomised sample of 2201 providers (general practitioners, paediatricians and nurses) was
recruited during the survey.
Primary and secondary outcome measures: The frequency, causes and responsibility for overuse, the frequency that patients demand unnecessary tests or procedures, the profile of the most demanding patients, and arguments for dissuading the patient.
Results: In all, 936 general practitioners, 682 paediatricians and 286 nurses replied (response rate 18.6%). Patient requests (67%) and defensive medicine (40%) were the most cited causes of overuse. Five hundred and twenty-two (27%) received requests from their patients almost every day for unnecessary tests or procedures, and 132 (7%) recognised granting the requests. The lack of time in consultation, and information about new medical advances and treatments
that patients could find on printed and digital media, contributed to the professional’s inability to adequately
counter this pressure by patients. Clinical safety (49.9%) and evidence (39.4%) were the arguments that dissuaded patients from their requests the most. Cost savings was not a convincing argument (6.8%), above all for paediatricians (4.3%). General practitioners resisted more pressure from their patients (x2 =88.8, P<0.001,
percentage difference (PD)=17.0), while nurses admitted to carrying out more unnecessary procedures (x2 =175.7,
P<0.001, PD=12.3).
Conclusion: Satisfying the patient and patient uncertainty about what should be done and defensive medicine practices explains some of the frequent causes of overuse. Safety arguments are useful to dissuade patients from their requests.
A cohort study involves observing a group of individuals over time to examine exposure-outcome relationships. Key characteristics include prospectively following exposed and unexposed groups to compare disease outcomes. Major biases include loss to follow up and misclassification of exposure status. Cohort studies are well-suited for rare exposures and allow examination of multiple outcomes, but require large sample sizes and are time-consuming.
A study was conducted from July 2014 to December 2014 to detect medication errors at a hospital in India. A total of 1870 patient files were reviewed and 211 medication errors were found, representing an error rate of 11.28%. The most common errors were documentation errors (58.76%), followed by administration errors (28.90%). Nurses were responsible for most errors (88.62%), followed by doctors (10.40%). Best practices for medication safety identified included strict policies on antibiotics, narcotics, and high-alert medications, as well as improved documentation, labeling, auditing, and staff education.
Comparisonof Clinical Diagnoses versus Computerized Test Diagnoses Using the ...Nelson Hendler
The Diagnostic Paradigm from www.MarylandClinicalDiagnostics.com was able to help the former Dean of Los Angeles Chiropractic College detect medical diagnoses which he had overlooked, and he later confirmed.
Prescription event monitoring and record linkage systemRumana Hameed
PEM is a method of pharmacovigilance that studies drug safety in real-world clinical practice. It involves collecting prescription data for new drugs and surveying prescribers about patient outcomes. Advantages include a large national scale and obtaining real-world safety data. Record linkage systems combine different healthcare records to efficiently study relationships between drug exposure and health outcomes. Claims databases contain prescription and medical claims information but may lack clinical details, while medical record databases provide more clinical data but only for illnesses that were medically attended to.
Case Control Study (ANALYTICAL EPIDEMIOLOGY) Nidhi Singh
This document describes a case-control study presented by Dr. Nidhi Singh on case-control study design. It begins with an introduction to analytical study designs and when a case-control study would be warranted. The basic steps of a case-control study are then outlined, including selection of cases, selection of controls, matching cases and controls, measuring exposure, and analyzing the results. Sources of bias are discussed. Key aspects of a case-control study design such as definition of cases and controls, inclusion/exclusion criteria, and number of controls per case are also summarized.
This document provides an updated clinical practice guideline from the American Society of Clinical Oncology (ASCO) and Infectious Diseases Society of America (IDSA) on outpatient management of fever and neutropenia in adults treated for malignancy. The guideline addresses which patients may be appropriate for outpatient treatment, recommended assessments and interventions for outpatients, and antimicrobial treatment options. A systematic review was conducted and the guideline recommendations are based on the available evidence. Key recommendations include using validated tools or clinical judgment to determine which low-risk patients are candidates for outpatient management, administering initial antibiotic doses within 1 hour and monitoring patients for at least 4 hours before discharge, and considering oral fluoroquinolone plus amo
This document discusses different methods for drug safety surveillance, including passive and active surveillance. Passive surveillance involves voluntary reporting of adverse drug reactions by healthcare professionals, while active surveillance proactively collects data through methods like monitoring sentinel sites. Other discussed methods include spontaneous reporting, case series, stimulated reporting, medicine event monitoring, registries, cross-sectional studies, case-control studies, cohort studies, and targeted clinical investigations. Large databases and targeted studies can provide important safety information collected through various surveillance techniques.
Our main involvement with your clinical research recruitment program concludes with processing the responses to your mailer. As our staff members direct the respondents to your site, you can begin conducting final interviews to complete the clinical trial recruitment process.
- Cohort studies examine the association between an exposure and an outcome by following groups over time and comparing their experience.
- This document discusses what a cohort study is, how it differs from other study designs in determining temporal relationships, and provides examples of cohort designs and their analysis.
- Key aspects reviewed include prospectively following groups based on exposure status and comparing disease incidence rates and relative risks between exposed and unexposed groups over time.
This presentation has the measures to be taken for the safety of patients. It covers the 6 goals
Goal 1: Identify patients correctly
Goal 2: Improve effective communication
Goal 3: Improve the safety of high-alert medications
Goal 4: Ensure safe surgery
Goal 5: Reduce the risk of health care-associated infections
Goal 6: Reduce the risk of patient harm resulting from falls
The document discusses diagnostic error in healthcare. It begins by noting that inaccurate diagnoses, incorrect treatments, and lack of diagnoses contribute to unnecessary costs, inefficiency, and patient dissatisfaction. Improving diagnostic accuracy can help achieve quality, control costs, and increase patient satisfaction. The document then discusses:
- The high incidence of diagnostic errors, which result in tens of thousands of deaths per year and enormous financial tolls.
- Evidence that diagnostic errors commonly cause patient harm and occur across primary care, inpatient, and outpatient settings.
- An innovative solution of independent virtual second opinions to address diagnostic errors by improving accuracy and ensuring appropriate treatment.
The document summarizes 5 studies on adverse drug reaction (ADR) reporting rates among healthcare professionals. A retrospective study found an ADR reporting rate of 57.14% among ICU patients. A questionnaire revealed barriers to reporting like lack of training and awareness. Healthcare professionals were then educated on ADR reporting. A prospective study post-education found an increased ADR reporting rate of 72.72%, indicating education improved reporting. The document concludes education is needed to enhance pharmacovigilance among healthcare professionals.
This document summarizes the evolution and current state of emergency medicine clinical pharmacists internationally. It describes how their role has expanded from medication distribution to active clinical roles on multidisciplinary teams. Studies show emergency medicine pharmacists can reduce medication errors, mortality, readmissions, and improve time to appropriate treatments. While initially confined to North America, their benefits are now reported internationally. More evidence is still needed on reducing adverse drug events, but existing data shows emergency medicine pharmacists improve patient outcomes and reduce costs.
- A study compared rates of preventable adverse drug events (ADEs) in intensive care units (ICUs) vs. non-ICUs at two hospitals over 6 months.
- The unadjusted ADE rate was twice as high in ICUs, but when adjusted for number of drugs, there was no difference between ICUs and non-ICUs.
- Preventable ADEs occurred due to normal systems failures like poor communication rather than overworked individuals, showing the need for systems solutions over blaming individuals.
Vaccines are an essential method for preventing infectious diseases. While vaccination programs have reduced disease rates, vaccine safety continues to be monitored. An extensive vaccine safety review found limited understanding of adverse events due to insufficient research. Improving research capacity is needed so future reviews are not handicapped. Both pre-licensure clinical trials and post-licensure surveillance systems aim to monitor vaccine safety, though assessing rare adverse events poses challenges requiring large studies and international collaboration. Standardized methods and ongoing evaluation aim to maintain public confidence in vaccination.
Pharmacist Prescription Drug Extension_Citations_edited_2015_05_07Jessica Bigger
Pharmacists and pharmacy chains have proposed expanding pharmacists' roles to allow them to prescribe certain routine medications for common illnesses. This would create a new category of "nonprescription drugs" that pharmacists could dispense without a doctor's prescription. Supporters argue this would increase access to healthcare, especially for underserved patients. However, medical associations oppose the proposal and argue that pharmacists lack sufficient medical training to safely prescribe drugs. The FDA is considering the proposal but acknowledges more evidence is needed regarding which drugs could safely be prescribed without a doctor. The future relationship between pharmacists and doctors remains unclear if pharmacists' prescribing roles expand.
SAMS EBM Online Course: Observational Study DesignsAhmad Al-Moujahed
This document discusses various observational study designs used in epidemiology, including cohort and case-control studies. It provides details on how to design, conduct, and analyze these types of studies. For cohort studies, it explains how to select the cohort population and comparison groups, and describes examples like the Framingham Heart Study and Nurses' Health Study. For case-control studies, it outlines how to select cases and controls and discusses potential biases. The document emphasizes the importance of temporal sequence between exposure and outcome and minimizing biases and confounding when using these observational study designs.
1) The WHO Solidarity Trial studied the effects of Remdesivir and other drugs on over 11,000 COVID-19 patients across 30 countries. It found no statistically significant difference in mortality between the Remdesivir and control groups.
2) However, the reviewer notes some limitations with the trial design, including a lack of standardization across sites and incomplete reporting of important baseline characteristics and co-interventions between groups.
3) Given the limitations and preliminary nature of the results, the reviewer believes it is too early to change clinical practice and recommends continuing Remdesivir use selectively until more definitive data is available.
This document summarizes the results of a survey assessing patient safety culture in 15 California hospitals. The survey was sent to over 6,000 hospital employees, including physicians, executives, and other staff, with a 47.4% overall response rate. The survey found that on average, 18% of responses suggested an absence of safety culture, while another 18% were neutral. Responses varied significantly between hospitals and job types. Clinicians, especially nurses, and frontline workers generally gave more negative responses than executives and non-clinical staff. The results provide information on how perceptions of safety culture differ within and between hospitals and employee groups. Further research is needed to understand how to improve safety culture across an organization.
1. The study analyzed factors influencing access to new direct-acting antiviral (DAA) treatments for hepatitis C using data from over 4,700 patients.
2. The analysis found that fibrosis level was the most influential factor, with substance abuse being a primary determinant of treatment for patients with F2-F4 fibrosis.
3. For patients with F2 fibrosis and no substance abuse, higher viral load and private insurance were associated with greater access, while additional comorbidities reduced access.
Controladores y estrategias para evitar la sobreutilización sanitaria en Aten...Javier González de Dios
Objectives: Identify the sources of overuse from the point of view of the Spanish primary care professionals, and
analyse the frequency of overuse due to pressure from patients in addition to the responses when professionals
face these demands.
Design: A cross-sectional study.
Setting: Primary care in Spain.
Participants: A non-randomised sample of 2201 providers (general practitioners, paediatricians and nurses) was
recruited during the survey.
Primary and secondary outcome measures: The frequency, causes and responsibility for overuse, the frequency that patients demand unnecessary tests or procedures, the profile of the most demanding patients, and arguments for dissuading the patient.
Results: In all, 936 general practitioners, 682 paediatricians and 286 nurses replied (response rate 18.6%). Patient requests (67%) and defensive medicine (40%) were the most cited causes of overuse. Five hundred and twenty-two (27%) received requests from their patients almost every day for unnecessary tests or procedures, and 132 (7%) recognised granting the requests. The lack of time in consultation, and information about new medical advances and treatments
that patients could find on printed and digital media, contributed to the professional’s inability to adequately
counter this pressure by patients. Clinical safety (49.9%) and evidence (39.4%) were the arguments that dissuaded patients from their requests the most. Cost savings was not a convincing argument (6.8%), above all for paediatricians (4.3%). General practitioners resisted more pressure from their patients (x2 =88.8, P<0.001,
percentage difference (PD)=17.0), while nurses admitted to carrying out more unnecessary procedures (x2 =175.7,
P<0.001, PD=12.3).
Conclusion: Satisfying the patient and patient uncertainty about what should be done and defensive medicine practices explains some of the frequent causes of overuse. Safety arguments are useful to dissuade patients from their requests.
A cohort study involves observing a group of individuals over time to examine exposure-outcome relationships. Key characteristics include prospectively following exposed and unexposed groups to compare disease outcomes. Major biases include loss to follow up and misclassification of exposure status. Cohort studies are well-suited for rare exposures and allow examination of multiple outcomes, but require large sample sizes and are time-consuming.
A study was conducted from July 2014 to December 2014 to detect medication errors at a hospital in India. A total of 1870 patient files were reviewed and 211 medication errors were found, representing an error rate of 11.28%. The most common errors were documentation errors (58.76%), followed by administration errors (28.90%). Nurses were responsible for most errors (88.62%), followed by doctors (10.40%). Best practices for medication safety identified included strict policies on antibiotics, narcotics, and high-alert medications, as well as improved documentation, labeling, auditing, and staff education.
Comparisonof Clinical Diagnoses versus Computerized Test Diagnoses Using the ...Nelson Hendler
The Diagnostic Paradigm from www.MarylandClinicalDiagnostics.com was able to help the former Dean of Los Angeles Chiropractic College detect medical diagnoses which he had overlooked, and he later confirmed.
Prescription event monitoring and record linkage systemRumana Hameed
PEM is a method of pharmacovigilance that studies drug safety in real-world clinical practice. It involves collecting prescription data for new drugs and surveying prescribers about patient outcomes. Advantages include a large national scale and obtaining real-world safety data. Record linkage systems combine different healthcare records to efficiently study relationships between drug exposure and health outcomes. Claims databases contain prescription and medical claims information but may lack clinical details, while medical record databases provide more clinical data but only for illnesses that were medically attended to.
Case Control Study (ANALYTICAL EPIDEMIOLOGY) Nidhi Singh
This document describes a case-control study presented by Dr. Nidhi Singh on case-control study design. It begins with an introduction to analytical study designs and when a case-control study would be warranted. The basic steps of a case-control study are then outlined, including selection of cases, selection of controls, matching cases and controls, measuring exposure, and analyzing the results. Sources of bias are discussed. Key aspects of a case-control study design such as definition of cases and controls, inclusion/exclusion criteria, and number of controls per case are also summarized.
This document provides an updated clinical practice guideline from the American Society of Clinical Oncology (ASCO) and Infectious Diseases Society of America (IDSA) on outpatient management of fever and neutropenia in adults treated for malignancy. The guideline addresses which patients may be appropriate for outpatient treatment, recommended assessments and interventions for outpatients, and antimicrobial treatment options. A systematic review was conducted and the guideline recommendations are based on the available evidence. Key recommendations include using validated tools or clinical judgment to determine which low-risk patients are candidates for outpatient management, administering initial antibiotic doses within 1 hour and monitoring patients for at least 4 hours before discharge, and considering oral fluoroquinolone plus amo
This document discusses different methods for drug safety surveillance, including passive and active surveillance. Passive surveillance involves voluntary reporting of adverse drug reactions by healthcare professionals, while active surveillance proactively collects data through methods like monitoring sentinel sites. Other discussed methods include spontaneous reporting, case series, stimulated reporting, medicine event monitoring, registries, cross-sectional studies, case-control studies, cohort studies, and targeted clinical investigations. Large databases and targeted studies can provide important safety information collected through various surveillance techniques.
Our main involvement with your clinical research recruitment program concludes with processing the responses to your mailer. As our staff members direct the respondents to your site, you can begin conducting final interviews to complete the clinical trial recruitment process.
- Cohort studies examine the association between an exposure and an outcome by following groups over time and comparing their experience.
- This document discusses what a cohort study is, how it differs from other study designs in determining temporal relationships, and provides examples of cohort designs and their analysis.
- Key aspects reviewed include prospectively following groups based on exposure status and comparing disease incidence rates and relative risks between exposed and unexposed groups over time.
This presentation has the measures to be taken for the safety of patients. It covers the 6 goals
Goal 1: Identify patients correctly
Goal 2: Improve effective communication
Goal 3: Improve the safety of high-alert medications
Goal 4: Ensure safe surgery
Goal 5: Reduce the risk of health care-associated infections
Goal 6: Reduce the risk of patient harm resulting from falls
The document discusses diagnostic error in healthcare. It begins by noting that inaccurate diagnoses, incorrect treatments, and lack of diagnoses contribute to unnecessary costs, inefficiency, and patient dissatisfaction. Improving diagnostic accuracy can help achieve quality, control costs, and increase patient satisfaction. The document then discusses:
- The high incidence of diagnostic errors, which result in tens of thousands of deaths per year and enormous financial tolls.
- Evidence that diagnostic errors commonly cause patient harm and occur across primary care, inpatient, and outpatient settings.
- An innovative solution of independent virtual second opinions to address diagnostic errors by improving accuracy and ensuring appropriate treatment.
Patient safety has always been the industry’s focus during clinical trials. However, a recent spate of well-publicized patient safety issues have increased public scrutiny and the biotechnology, pharmaceutical and CRO industries' desire to improve study quality, resulting in larger, longer, more expensive trials. In this Q&A, James T. Gourzis, M.D., Ph.D., discusses issues affecting patient safety, including factors that have launched safety to the forefront; what to look for in evaluating CRO excellence; unique oncology considerations and the ramifications of the rare toxicity; optimizing the Data Monitoring Committee; budget decisions that affect patient safety and the evolution/future of FDA requirements.
Post marketing studies of drug effects must then generally include at least 10,000 exposed persons in a cohort study, or enroll diseased patients from a population of equivalent size for a case–control study. A study of this size would be 95% certain of observing at least one case of any adverse effect that occurs with an incidence of 3 per 10 000 or greater (see Chapter 3). However, studies this large are expensive and difficult to perform. Yet, these studies often need to be conducted quickly, to address acute and serious regulatory, commercial, and/or public health crises. For all of these reasons, the past two decades have seen a growing use of computerized databases containing medical care data, so called “automated databases,” as potential data sources for pharmacoepidemiology studies.
Whitepaper: Hospital Operations Management reduces wait states and replaces d...GE Software
No Wait States … in pursuit of the frictionless patient experience. Electronic health records have fallen short. Patients continue to wait. Costs remain high. Why focusing on operational management can help hospitals make things right … starting now.
This document discusses strategies for standardizing handoff processes throughout healthcare organizations. It explains that standardizing handoffs is challenging but important for patient safety, as ineffective handoffs can lead to medical errors and other issues. The document outlines some key steps for organizations to take, such as developing and implementing a standardized process, obtaining leadership and staff buy-in, and addressing hierarchical relationships among staff that can hinder communication. Standardizing handoffs requires significant cultural change across an entire organization.
This thesis analyzes data from the Centers for Medicare and Medicaid Services (CMS) to identify which quality measurement parameters have the greatest impact on hospitals' overall performance scores and ratings. The author sorted CMS data into categories for mortality, readmissions, safety, and patient experience. Correlation coefficients were calculated between each measurement and hospitals' total performance scores. It was found that hospital-wide readmission rates, acute myocardial infarction 30-day readmission rates, and patient experience measures of doctor communication and responsiveness of hospital staff had the strongest correlations with overall performance scores. Therefore, hospitals looking to improve their ratings may want to focus most on improving these specific factors.
Patient Safety, Culture of Safety and Just Culture by Tennessee Center for Pa...Atlantic Training, LLC.
This document discusses patient safety culture and just culture in healthcare. It defines patient safety, adverse events, and medical errors. It discusses important patient safety studies that found most errors are due to systemic issues rather than individual blame. The document introduces the concept of a just culture, which balances accountability for reckless behaviors with a non-punitive approach for errors. It also discusses measuring and improving a culture of safety through initiatives, surveys, and training to promote safety and teamwork.
This document discusses the costs of medical errors and efforts to reduce preventable hospital-acquired conditions (HACs). It notes that medical errors may cause up to 98,000 deaths per year costing up to $29 billion annually. Hospitals have little incentive to improve safety due to externalizing most error costs. In response, policies began denying Medicare/Medicaid payments for treatments from certain HACs considered preventable. This policy was expanded in 2012/2015 and may reduce payments to hospitals with the highest rates of HACs. The goal is to incentivize greater patient safety.
Johns Hopkins Hospital doctors report that 40%-80% of chronic pain patient are misdiagnosed, and that MRIs and CTs miss pathology 56%-78% of the time, Therefore, during extensive chart reviews of current medical data will produce a classic case of GIGO-garbage in giving garbage out. The need for accurate diagnoses and testing is critical for AI to work.
DB Question for Public Health in Disaster Management.docxwrite22
1) Public health surveillance involves the ongoing collection and analysis of health data to understand population health needs and influence public health. Emergency departments are well-suited for collecting this data as over 100 million Americans visit EDs annually.
2) Effective surveillance systems require collecting standardized data from multiple sources, analyzing trends, communicating findings, and applying insights to prevention and policy.
3) Syndromic surveillance focuses on pre-diagnostic identification of disease clusters through real-time monitoring of symptom patterns, allowing earlier detection and response before definitive diagnoses are made.
DB Question for Public Health in Disaster Management.docxsdfghj21
1) Public health surveillance involves the ongoing collection and analysis of health data to understand population health needs and influence public health. Emergency departments are well-suited for collecting this data as over 100 million Americans visit EDs annually.
2) Effective surveillance systems require collecting standardized data from multiple sources, analyzing trends, communicating findings, and applying insights to prevention and policy.
3) Syndromic surveillance focuses on pre-diagnostic identification of disease clusters through monitoring symptoms to enable early detection and response before definitive diagnoses are made. It uses data from healthcare visits and alternative sources.
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· Examine data collection methods in published research studies (C
Here is some more information on variables...
The dependent variable is the variable a researcher is interested in. The changes to the dependent variable are what the researcher is trying to measure with all their fancy techniques. The variable that depends on other factors that are measured.
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According to Tappen (2016), the independent variables are defined as the variables that the researcher will manipulate to see if a change occurs in the dependent variables. The independent variable is the presumed cause of change. The dependent variables are what the researcher is attempting to measure.
WEEK 4
Ethical concerns in nursing research often do not have straight forward solutions. Nursing research relies on collaboration and partnerships based on mutual trust. When that trust is breached the damage is irreversible. Honesty, openness, respect and sensitivity to others provide the cornerstones for ethical research. It is important that all nursing research is undertaken from a clear ethical stance, with ethical concerns identified at the outset and reevaluated on an ongoing basis throughout the project.
Take a look at this video about ethical issues and human subjects (9:38)
https://www.youtube.com/watch?v=-O5gsF5oyls (Links to an external site.)
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· Beneficence
· Justice
· Check out this video on Types of Sampling Methods ---
· https://www.youtube.com/watch?v=pTuj57uXWlk
Carmen,
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Preventable deaths in hospital prism 2 manual_v2_jan_14
1. 1
Dr Helen Hogan, Jan 2014
Preventable Incidents, Survival and Mortality
Study 2 (PRISM)
Medical Record Review Manual
2. 2
Introduction
Public and policy interest in hospital death rates has risen sharply, particularly following the
recent investigations into the Mid Staffordshire NHS Trust and 14 other acute Trusts around
the country. For the last decade the Department of Health (DH) has advocated the use of
hospital wide measures of mortality such as HSMR and SHMI to provide an early warning
system of quality and safety problems within hospitals and to compare performance across
hospitals. However, intense debate surrounds whether the "excess deaths" detected by
these measures are a valid indicator of the safety of a hospital. Many factors beyond patient
safety impact on HSMR/SHMI including coding standards and depth, or the local provision of
services for the dying that divert patients from hospitals. Such factors can lead to higher
scores for some hospitals which have nothing to do with quality and safety of healthcare
provision
Only four published studies, all in N America, have looked at the association between HSMR
and avoidable deaths determined by case record review. Three of the studies either found
no correlation,1, 2
or a negative correlation.3
Only one study found a significant positive
association with deaths in a single disease group (pneumonia).4
This was also the smallest
study. (Two additional unpublished studies have found no association). In 2009, we
undertook the PRISM 1 to obtain a national estimate of hospital avoidable deaths using case
note review of a 1000 deaths across 10 acute hospital sites. By extending the sample size of
our previous study from 10 hospitals (1000 deaths) to 34 hospitals (3400 deaths (2400 new
reviews across another 24 Trusts)) we will achieve sufficient statistical power to determine
the degree of correlation between avoidable death rates at hospital level and HSMR/SHMI.
The PRISM 2 correlation study will inform policy makers’ decisions on approaches to
tracking hospital quality and safety. It will also provide a national baseline for avoidable
deaths against which NHS England will compare future estimates derived from a new
national measure of avoidable deaths due to be introduced in 2014/15.
Aims and Objectives of the Study
Aim
To ascertain the relationship between hospital avoidable deaths identified by retrospective
case record review and HSMR/ SHMI
Objectives
To determine the proportion of patients dying in hospital who experience a problem in
healthcare including acts of omission (inactions) or acts of commission (affirmative actions)
and the proportion of such deaths that are avoidable
To determine the strength of correlation between the proportion of avoidable deaths at
hospital level and HSMR/ SHMI
To inform policy makers whether "excess deaths" identified by HSMR/SHMI are correlated
with avoidable deaths determined by retrospective case record review
3. 3
Study Design
The methodology for retrospective case record review (RCRR) was first developed in
California in the mid-seventies and used to identify the burden of healthcare-related harm as
part of an investigation into the costs of a no-fault insurance scheme for hospitals.5
The
method and review forms were further developed in the two largest RCRR studies of
adverse events to date: the Harvard Medical Practice Study6
and the Quality in Australian
Healthcare Study.7
The design of PRISM 2 also draws on the first British RCRR study,
conducted by Vincent et al, which examined the incidence of adverse events in 1014
admissions to two London hospitals in 1999.8
The design has also been influenced by the
methodology used by Hayward et al9
in a US study focused on preventable deaths and a
Dutch RCRR 10
which sampled 2000 deaths.
In PRISM 2, case record reviews will be conducted in 24 English acute hospital Trusts. One
hundred randomly selected admissions of adult medical and surgical patients who have died
during hospitalisation in the financial year 2012/2013 will be reviewed at each site. Obstetric,
psychiatric and paediatric patients are excluded. The exclusion of these patient populations,
which account for less than 5% of all hospital deaths in England and Wales, is in line with
previous studies and will aid comparison with death rates found in such studies.11
Admission Selection and Record Collection
The study sample will be drawn from each Trust’s Patient Administration System. The Chief
Investigator (CI) will develop a joint protocol with each site which covers sampling, location,
tracing and retrieval of medical records. The Trusts will be instructed to check that any
records which are not traceable do not vary substantially from the rest of the sample in terms
of age, sex, specialty, medico-legal investigation or coroners’ case. Each Trust will be asked
to ensure that any selected medical records subject to medico-legal issues are made
available for review.
The reviews will take place at each study hospital. Trusts will be asked to facilitate access to
case records, to provide reviewers with desk space to undertake the reviews and help
reviewers to access missing lab or imaging information via the Trust computer system. They
will also be asked to help orientate reviewers to Trust organisation including names and
types of wards and consultant lists. Reviewers will not be expected to be on site at the same
times but can coordinate their reviews with others if there is adequate space available. Ten
per cent of all records will be double reviewed.
The Review Process
For each case the reviewer will complete a Key Code document which links the patient’s
hospital number to a unique study number and indicates the date the review. This code
remains at the Trust on completion of the reviews, normally within the Clinical Governance
Department. Unique study numbers and reviewer ID numbers will be allocated before
reviews commence at a site. Reviewers should maintain oversight of the security of both
case records and the medical review forms whilst undertaking reviews.
Once reviews are complete the reviewers will contact their nominated lead reviewer to agree
a time to discuss any avoidable deaths found (usually by phone). Following these
conversations completed forms will be transported back to the London School of Hygiene
and Tropical Medicine (LSHTM) by secure courier or by hand (with prior arrangement).
Confidentiality
The PRISM 2 study is required to comply with guidance set out in the NHS Code of
Confidentiality and the GMC’s Good Research Practice Guidance. The Research Passport
4. 4
and “Letter of Access” binds each reviewer to a code of confidentiality, both for the selected
Trusts and the patients reviewed. Care should be taken to ensure that no patient identifiable
information is retained on the Review Forms. Care should also be taken that no Trust, doctor
or patient identifiable information is disclosed when using email to discuss cases with other
reviewers (as in the case of asking a speciality specific question of a colleague). In the case
of a breach of confidentiality, a reviewer will immediately be asked to leave the project and
the General Medical Council will be informed.
The Key Code document links a patient’s unique study number to their hospital number. This
code will stored in the Trusts’ Clinical Governance Department after the study finishes. The
code will only be broken if there are serious concerns of negligence in relation to the care of
a patient which need to be fed back to the Trust. If a reviewer uncovers such an issue they
should report it to the key Trust contact who will be nominated prior to the start of the
reviews. The Trust will then be expected to deal with the issue according to their own
internal policies and procedures. .
Contacts
For questions arising during the review period please contact:
Dr Helen Hogan, Clinical Lecturer in UK Public Health
Department of Health Services Research and Policy
Room 117, 15-17 Tavistock Place
London WC1H 9SH
Tel: 020 7958 8293/ 0774 067 4516
helen.hogan@lshtm.ac.uk
Operational Definitions
To identify avoidable deaths it is important to initially establish whether there were problems
in the way healthcare was delivered to the patient (the processes of care). If a patient is
harmed by healthcare but the care was delivered to an acceptable standard, this harm is
known as a complication. A death following a complication, such as intracerebral bleeding
after appropriate administration of thrombolysis would not be regarded as avoidable.
PRISM 2 defines a problem in healthcare as ‘any point where the patient’s healthcare fell
below an acceptable standard and led to harm’. Problems include:
An omission or inaction such as failure to diagnose and treat
An act of commission or affirmative actions related to the delivery of care
such as incorrect treatment or management
We have chosen to use the term “problems in healthcare” rather than the more traditional
term “adverse event” because this latter term tends to be associated with discrete incidents
and is more likely to identify acts of commission than omission. The term “problem/s in
healthcare” allows a reviewer to broaden their perspective and assess the impact of multiple
small events (usually omissions) across the patient journey.
It may be difficult to identify one clear cut problem or even identify the point at which things
went wrong. Avoidable deaths are more likely to result from a combination of problems in
healthcare, such as in the example below:
5. 5
An 82 year old female on regular warfarin developed an infected finger and was prescribed
two antibiotics (flucloxacillin and sodium fusidate) (problem 1/drugs and fluids) by her GP,
leading to an increase in the coagulant effect of warfarin. On admission the patient was
commenced on intravenous antibiotic treatment for osteomyelitis. Two days passed without
an assessment of clotting status (problem 2/clinical monitoring) whist warfarin was
continued at her standard dose. On day three the patient developed gastrointestinal
bleeding and her level of anticoagulation was found to be well above the therapeutic range.
The preferred treatment to reverse the effect of warfarin was not available on the ward
overnight (problem 3/drugs & fluids) and the patient was given a second line alternative.
Despite treatment including transfusion of blood she continued to bleed and died.
The Review Form provides space to capture these complex scenarios in Section C.
Instructions on how to undertake the review
Before the review commences reviewers should check that the record is complete, the death
occurred at some point in the financial year 2012/13 and that the patient was not admitted
for Obstetric, Psychiatric or Paediatric care. If a post mortem report is found in the medical
records this should not be read until the end of the review. The review will be primarily
focused on the admission in which the patient’s death occurred. The focus of the review will
be on those problems in healthcare that were associated or contributed to the death rather
than any that are more minor.
Ensure you review all documentation related to that admission, including GP referral letter,
ambulance summary, A&E summary, etc. and including death certification and any post
mortem reports. All healthcare records should be reviewed, not solely records completed by
medical staff.
To avoid hindsight bias i.e. judging the care provided to be deficient because the outcome is
poor (death), reviewers should follow the patient journey from the beginning, examining how
healthcare was delivered at each stage. Imagining “walking in the shoes” of the clinical team
as the story unfolds can be a helpful technique.
A systematic approach to the review would include:
1. A review of the initial presentation with special attention to the GPs referral letter,
recent outpatient care, the need for admission, timeliness of initial assessment,
diagnostic evaluation and management plan.
2. Review of the rest of the doctors’ record to determine if appropriate and timely care
was given and to evaluate the reasons for continued hospitalisation, testing and
treatment. If there are any causes for concern, these can be marked with sticky notes
during the initial read through and returned to for more detailed assessment later.
3. Review of the laboratory and radiology records to determine if important
abnormalities were reported and acted on and whether appropriate/ inappropriate
testing was performed.
4. Review of the nursing notes and monitoring charts to determine if the management
plan was adhered to and that new patient signs and symptoms were dealt with
appropriately.
5. Review of the medication record to determine if appropriate/ inappropriate medicines
were given
6. 6
6. Completion of the Review Form making sure that each one is labelled with Reviewer
ID and the patient’s unique study number.
The timing of the problem/s in healthcare
We are interested in problems in healthcare as a consequence of health care management
prior to the index hospitalisation and discovered during the index hospitalisation e.g. a
person taking a prescribed drug at home who develops side effects that cause death, and;
those that occur during the index hospitalisation and are discovered during the index
hospitalisation. We accept only a minority of problems in healthcare occurring outside
hospital will be detected in this way, and that without access to previous admission notes
from other hospitals/primary care records detail may be unclear, but want to learn from any
issues that can be identified.
Reviewers should note that if the problem in healthcare occurred prior to the index
hospitalisation there is no time limit on its inclusion in the study. The problem does however
need to be related to the patient’s death. If there have been multiple admissions as a
consequence of a problem in healthcare, the problem is counted only once.
Determination of a problem in healthcare
Some useful approaches:
a. Change analysis: Think about how care should have been for this patient and
compare it to how care was
b. Consider what would have been an acceptable standard of care for this
patient and consider how the healthcare received fell below this standard
c. Did something happen that could have been averted by different
management?
d. Would this have happened under your watch?
e. Would you be happy if a relative of yours received this standard of care?
The Review Form includes a section for a narrative account of the problems in healthcare
the patient experienced, which allows the reviewer to tell the story of the admission and what
went wrong. This is followed by a section where problems in healthcare are listed and
categorised and contributory factors (underlying reasons why the problem occurred) are
noted (if they can be determined from the records- which is not always the case) in a table.
To complete the table, the reviewer needs to refer to the separate problem category list
provided.
7. 7
Determination of avoidability
The following questions can be useful in helping to identify avoidable deaths:
Was the death expected or unexpected at the outset?
Was the death related to a healthcare intervention rather than the natural progression
of the patient’s disease?
Did any avoidable events cause harm to the patient
Was there a deviation from the accepted norms of practice?
Were there extenuating factors that reduce preventability (co-morbidity, nature of
acute illness, urgency of situation)
Were there mitigating factors which decrease preventability (appropriate use of
pressure relieving mattress in case of pressure ulcer, evidence of falls prevention
strategies)
Consider if better care had a reasonable chance of preventing the patient’s death
Is there enough evidence to justify your decision
It is important to gather enough evidence to justify the judgement of avoidability. Don’t
second guess when it comes to judging the acceptability of care. If enough detail is not
found in the record then a judgement cannot be made. This situation is more common when
determining whether there was a problem in care prior to the index admission as in the case
below:
A patient is admitted with acute myocardial infarction and dies. The history mentions that the
patient visited his GP twice in the two weeks before admission complaining of upper
gastrointestinal pain.
The reviewer has no knowledge as to whether appropriate examination and tests were
undertaken by a GP prior to the admission. If a reviewer’s judgement is hampered by lack of
evidence this should be recorded in Part E.
Avoidability Ratings
Two scales are provided for making ratings of avoidability. The 1 to 6 Likert scale is the
standard approach, but the continuous linear scale will allow for additional analysis. Each
scale should be completed independently. Outlined below are some examples of cases
rated at different levels of avoidability.
Low avoidability
40 year old with congenital hydrocephalus, cerebellar hypoplasia, epilepsy unable to walk
and requiring full time care. Admitted with fever and drowsy. Pelvic CT suggested abscess.
Taken to theatre by SpR who drained pelvic abscess and undertook salpingo-oophrectomy
plus appendicectomy. Over next few days patient became increasingly acidotic and febrile.
Second laparotomy by another SpR revealed a leak at appendicectomy site and bowel
necrosis which was dealt with. In the post op period the patient remained in a poor condition
with pancytopenia and wound sepsis. Active treatment discontinued after 2 weeks.
Mid
80 year old admitted following fall resulting in fractured neck of femur. Initially thought patient
may have had a stroke but signs changed over days. In addition there were problems
normalising electrolytes and patient developed a chest infection. Heparin commenced but
8. 8
stopped after 4 days. Operated on day 17. Sudden collapse after 24 hours, presumed
pulmonary embolus.
High avoidability
74 year old man admitted for elective fem-pop bypass. Haemoglobin immediately post op
was 9.9 g/dl. Developed acute coronary syndrome 12 hours later and haemoglobin found to
be 7.4 g/dl. Plans for angiography were never fulfilled as despite blood transfusion the team
were not able to get on top of the falling haemoglobin. No bleeding site was identified over
10 post-operative days and patient died with a haemoglobin of 3g/dl. Post mortem showed a
bleeding peptic ulcer. Patient was known to take aspirin prior to surgery and was given
heparin and clopidogrel on ward following development of cardiac problems. Record of low
haemoglobin was found in record two months before operation but this was not followed up.
Estimation of impact of avoidable death on length of life
Reviewers are asked to provide a quantitative estimate of the degree to which a patient’s life
was shortened by their avoidable death. We accept that this subjective judgement may be
difficult, but the findings from this question will be useful in helping to estimate the total
number of years of life lost as a result of avoidable deaths. Life tables and other
prognostication tools are difficult to apply in the acutely ill elderly with multiple co-morbidities
that are likely to form a large proportion of the cases reviewed. You may wish to consider
expected prognosis for a patient presenting with this condition and co-morbidities who
received an acceptable standard of healthcare, and/or average life expectancy alongside
consideration of whether the patient had better or worse general health and capacity to
recover than average
Avoiding future deaths
Suggestions for specific improvements that might avoid future deaths might come from any
of the following categories:
a. Through improved equipment or procedures e.g. via better design or ensuring correct
use.
b. Through improved organisation and management e.g. improved transfer of
knowledge or information, the quality and availability of protocols, addressing other
management issues such as staffing levels or addressing organisational cultural
issues impacting on safety.
c. Through steps to limit human error e.g. through ensuring staff who conduct a task
have suitable qualifications, training or supervision, improved task planning,
coordination or execution.
Seeking further opinions
Each review should initially be conducted independently. If, after full review, a reviewer is
uncertain as to whether a death was caused by a problem in healthcare, then a conversation
with your lead reviewer can take place. If judgement is hampered by a specialty-specific
question, contact can be made with another PRISM 2 reviewer who is a specialist in that
area. Dr Hogan will facilitate this contact.
9. 9
More space
If more space is needed to complete the free text elements of the review form, please attach
additional sheets securely to the Review Form. These sheets should be labelled with:
Patient Unique Identifier
Reviewer Identifier
Number of question
References
1. Best, W.R. and D.C. Cowper, The ratio of observed-to-expected mortality as a quality
of care indicator in non-surgical VA patients. Med Care, 1994. 32(4): p. 390-400.
2. Gibbs, J., K. Clark, S. Khuri, et al., Validating risk-adjusted surgical outcomes: chart
review of process of care. Int J Qual Health Care, 2001. 13(3): p. 187-96.
3. Guru, V., J.V. Tu, E. Etchells, et al., Relationship between preventability of death
after coronary artery bypass graft surgery and all-cause risk-adjusted mortality rates.
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