The document describes the development and validation of a new multidimensional tool called CLEO for assessing the potential impact of pharmacist interventions (PIs). It involved:
1. Conducting a systematic review of existing models and tools which identified limitations and informed the development of the optimal SP(ECH)O-P model.
2. Developing the CLEO tool based on the model, with 3 dimensions (clinical, economic, organizational) and defined scoring criteria.
3. Validating the CLEO tool by testing inter-rater and intra-rater reliability on samples of PIs, which showed moderate to substantial agreement, demonstrating the tool is reliable for assessing impacts of PIs
Pharmacovigilance and Materiovigilance, Drugs and Cosmetics Actshashi sinha
Due to side effects of Medicines and Medical Devices increasing day by day it is important to monitor the Adverse Events arising out of use of Medicines and Medical Devices. The Pharmacovigilance and Materiovigilance monitors adverse events arising our of usage of Drugs and Medical Devices respectively. This chapter also deals with Drugs and Cosmetics Act 1940 and their important provisions.
Patient safety goals effective january 1, 2016Hisham Aldabagh
Includes the patient safety goals which must be achieved during the year 2016, focusing on patient identification, proper patient medication, protection patient against infection, and strict per operative patient safety procedures
Pharmacovigilance and Materiovigilance, Drugs and Cosmetics Actshashi sinha
Due to side effects of Medicines and Medical Devices increasing day by day it is important to monitor the Adverse Events arising out of use of Medicines and Medical Devices. The Pharmacovigilance and Materiovigilance monitors adverse events arising our of usage of Drugs and Medical Devices respectively. This chapter also deals with Drugs and Cosmetics Act 1940 and their important provisions.
Patient safety goals effective january 1, 2016Hisham Aldabagh
Includes the patient safety goals which must be achieved during the year 2016, focusing on patient identification, proper patient medication, protection patient against infection, and strict per operative patient safety procedures
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
5 Ways Healthcare Organizations Can Promote Patient SafetyAKW Medical
Patients and healthcare professionals can work together to improve patient safety to ensure a higher quality of care, reduce medical errors, and refocus on supporting good health and well-being.
Joint Commission International 6th Edition standards interpretation FAQ'sJoven Botin Bilbao
Joint Commission International (JCI) works to improve patient safety and quality of health care in the international community by offering education, publications, advisory services, and international accreditation and certification.
MEDICAL AUDIT
Evaluation of data, documents, and resources to check performance of systems meets specified standards
PRESCRIPTION MONITORING, ADR, DRUG RELATED PROBLEMS, staff safety, data,defining standards,
collecting data,
identifying areas for improvement,
making necessary changes
back round to defining new standards.
Pharmacoeconomics is a branch of health economics which compares the value of one drug or a drug therapy to another.
By understanding the principles, methods, and application of pharmacoeconomics, healthcare professionals will be prepared to make better decisions regarding the use of pharmaceutical products and services.
Patient recruitment & retention is highlighted as the key factor in ensuring study success, the area of patient retention in clinical trials is often overlooked. Retention of patients throughout the life of a clinical trial is however extremely vital from scientific as well as economic point of view. Poor recruitment & retention negatively impacts on the overall evaluable data for regulatory submissions. Dropped participants must be replaced which incurs further expenditures and time delays. Subject dropout rates are estimated to range from 15-40% of enrolled participants in clinical trials.
Dr Brent James: quality improvement techniques at the frontlineNuffield Trust
Dr Brent James, Intermountain Institute for Healthcare Delivery Research, presents to the Health Policy Summit 2015 on delivering quality improvement techniques at the frontline.
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
5 Ways Healthcare Organizations Can Promote Patient SafetyAKW Medical
Patients and healthcare professionals can work together to improve patient safety to ensure a higher quality of care, reduce medical errors, and refocus on supporting good health and well-being.
Joint Commission International 6th Edition standards interpretation FAQ'sJoven Botin Bilbao
Joint Commission International (JCI) works to improve patient safety and quality of health care in the international community by offering education, publications, advisory services, and international accreditation and certification.
MEDICAL AUDIT
Evaluation of data, documents, and resources to check performance of systems meets specified standards
PRESCRIPTION MONITORING, ADR, DRUG RELATED PROBLEMS, staff safety, data,defining standards,
collecting data,
identifying areas for improvement,
making necessary changes
back round to defining new standards.
Pharmacoeconomics is a branch of health economics which compares the value of one drug or a drug therapy to another.
By understanding the principles, methods, and application of pharmacoeconomics, healthcare professionals will be prepared to make better decisions regarding the use of pharmaceutical products and services.
Patient recruitment & retention is highlighted as the key factor in ensuring study success, the area of patient retention in clinical trials is often overlooked. Retention of patients throughout the life of a clinical trial is however extremely vital from scientific as well as economic point of view. Poor recruitment & retention negatively impacts on the overall evaluable data for regulatory submissions. Dropped participants must be replaced which incurs further expenditures and time delays. Subject dropout rates are estimated to range from 15-40% of enrolled participants in clinical trials.
Dr Brent James: quality improvement techniques at the frontlineNuffield Trust
Dr Brent James, Intermountain Institute for Healthcare Delivery Research, presents to the Health Policy Summit 2015 on delivering quality improvement techniques at the frontline.
Most clinicians neither have enough time nor are trained to pick the best information from the enormous literature available. By practicing Evidence Based Medicine, they can give better patient care. EBM is the integration of the best research evidence with clinical expertise and patient values to make clinical decisions
Paying for performance to improve the delivery of health interventions in LMICsReBUILD for Resilience
This presentation from Sophie Witter & Karin Diaconu of Queen Margaret University, UK outlines the findings from a Cochrane review undertaken by the team on paying for performance to improve the delivery of health interventions in low and middle-income countries.
Development and validation of the Vi-Med ® tool for medication reviewHA VO THI
linical pharmacy practice in Vietnam is unregulated by standard procedures, thus motivating this study, which developed and validated a tool called Vi-Med ® for use in supporting medication review (MR) in Vietnamese hospitals. Six clinical pharmacists from six hospitals used the tool, which comprises three forms: Form 1 for the collection of patient information, Form 2 for the implementation of MR, and Form 3 for the documentation of pharmacist interventions (PIs). The tool also comes with eight pre-identified drug-related problems (DRPs) and seven PIs. The pharmacists were asked to categorize 30 PI-associated scenarios under appropriate DRPs and corresponding interventions. Concordance among the pharmacists was assessed on the basis of agreement level (%) and Cohen's kappa (κ). We also evaluated the user-friendliness of the tool using a four-point Likert scale. Concordance in the panel with respect to DRPs and PIs was substantial (κ = 0.76 and 80.4% agreement) and almost perfect (κ = 0.83 and 87.6% agreement), respectively. All the experts were satisfied with the structure and content of Vi-Med ®. Five of them evaluated the tool as very suitable, very useful, and definitely fitting for everyday use. Vi-Med ® satisfactorily achieved consistency and user-friendliness, enabling its use in daily clinical pharmacy practice.
This presentation explains the main features of medicines which will be developed and authorised via the adaptive pathways. It provides a definition of real world evidence and the caveats associated with the use and analysis of real world evidence in drug development.
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
Adv. biopharm. APPLICATION OF PHARMACOKINETICS : TARGETED DRUG DELIVERY SYSTEMSAkankshaAshtankar
MIP 201T & MPH 202T
ADVANCED BIOPHARMACEUTICS & PHARMACOKINETICS : UNIT 5
APPLICATION OF PHARMACOKINETICS : TARGETED DRUG DELIVERY SYSTEMS By - AKANKSHA ASHTANKAR
These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
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.
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
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.
Presentation_Thesis defense _Thi Ha VO. 16.12.2015
1. Assessment of the potential impact of
pharmacist interventions: development and
validation of the CLEO multidimensional tool
Thi Ha VO
Pharmacist, PhD Student
Director: Assoc.Prof. Pierrick Bedouch
Codirecteur: Prof. Benoit Allenet
Laboratory TIMC-IMAG UMR CNRS 5525
PhD Defense - 16 December 2015
2. 1. Introduction
2. Development of a new tool
2.1. Review of models and tools
2.2. Development of the CLEO tool
3. Validation of the CLEO tool
3.1. Test in a general practice
3.2. Test in a specific clinical service
4. Discussion & Perspectives
5. Conclusion
Plan
3. Drug-related problems (DRP) 2-27%2 of hospital admission
50%1 DRPs are
preventable
Solution = team working
with clinical pharmacists
Introduction – What’s clinical pharmacists’ rolesIntroduction – What’s role of clinical pharmacists?
1. McKenney JM et al. Drug-related hospital admission. Am J Hosp Pharm. 1976;33(8):792-5
2. Kohn LT et al. To Error is Human. 1999
4. Collect patient
information
Identify DRPs
Suggest Pharmacist
interventions (PIs)
Medication Review
Pharmacist intervention (PI): «any action by a clinical pharmacist that
directly results in a change in patient management or therapy»1. (Dooley at al.
BJCP 2004)
Introduction – What’s pharmacist interventions ?Introduction – What’s a pharmacist intervention?
5. Introduction – How to evaluate impacts of PIs ?
Impacts
of the
PI
When ?
Potential or
actual impacts
Where ?
Hospital,
community
pharmacy
How ?
Models, tools,
process of
evaluation… What ?
Clinical,
economic,
humanistic…
For whom ?
Patient,
physician, nurse,
pharmacist,
hospital, society
Evaluation of impacts of PIs is essential for demonstrating the added value
of pharmacists, continuing quality improvement, research and education…
Introduction – How to evaluate PIs?
Reponses to these questions are important to develop a new tool for
assessing impacts of PIs
6. Overhage and Lakes, USA,1999
5 distinct tools found in 10 studies from a review of articles from 1966 to 1997
Overhage and Lakes. Practical, reliable, comprehensive method for characterizing pharmacists’ clinical activities. Am J Health-Syst Pharm. 1999; 56:2444-50
Introduction – Tools to evaluate PIs?
7. Conduct an updated systematic review of tools for assessing
potential impacts of PIs
Review models of evaluations and develop an optimal model for
evaluation of PIs
Objectives
Develop and validate a multidimensional tool
for assessing potential impact of PIs
8. 1. Introduction
2. Development of a new tool
2.1. Review of models and tools
2.2. Development of the CLEO tool
3. Validation of the CLEO tool
3.1. Test in a general practice
3.2. Test in a specific clinical service
4. Discussion & Perspectives
5. Conclusion
Plan
10. 873 Abstracts
scanned
Exclusion criteria:
• Specific type of DRPs/PIs only
• Actual impacts only
• Economic impact only
• Non-accessible and review
articles
82 tools in 133
studies: models &
content, structure,
validity
A systematic review – Method
Keywords: DRP* AND PI*
Inclusion criteria :
• Langue: English, French
• Abstract available
• Peer review journals
• Pharmacists involved
• Explicit description of tools
Databases
- Pubmed (1986-2013)
- PsycINFO (1999-2013)
- PASCAL (1997-2013)
- CINAHL (1993-2013)
Review of tools for assessing potential impacts of PIs
Hand searchs
- References of
(review) articles
- Thesis of Quélennec
11. • Model of Donabedian
• Model of Kozma et al.
• Pharmacoeconomic model
• Risk assessment matrix
SP(ECH)O-P model
Models of evaluations
A systematic review – Results & Discussion
Indicators of content of tools
• Structure
• Process
• Outcome
- Clinical
- Humanistic
- Economic
• Probability
A. Models & content of tools
12. A systematic review – Results & Discussion
STRUCTURE
Settings
Staffs: trained pharmacists
Equipments
Information resources
Financal stability
….NOT FOUND IN TOOLS
PROCESS
Technical
Consistency to standards
Informational intervention
Acceptance by HCPs…
Interpersonal
Satisfaction of HCPs
Collaboration between HCPs
Continuation of care…
OUTCOME
Clinical
Humanistic
Economic
…
1. Model of Donabedian 1966 Quality of a pharmacist intervention
Donabedian et al (1966). Evaluating the quality of medical care. Milbank Mem Fund Q.
13. A systematic review – Results & Discussion
STRUCTURE
Settings
Staffs: trained pharmacists
Equipments
Information resources
Financal stability
….
PROCESS
Technical
N° DRPs/PIs
Consistency to standards
Agreement between HCPs
Acceptance
Interpersonal
Satisfaction of HCPs
Collaboration btw HCPs
OUTCOME
CLINICAL
• Severity of DRPs: harm,
ADR…
• Significance of PIs:
Health care resources
avoided (emergency visit,
hospitalization…)
ECONOMIC
• Direct costs: cost of
implementation of the PI
cost saving, cost
avoidance
• Indirect costs: missing
working
• Intangible costs: pain,
suffering…
HUMANISTIC
• Patient’s satisfaction
• Knowledge
• Medication compliance
• Quality of life…
2. Model of Kozma et al. 1993 Outcomes of a pharmacist intervention
Kozma et al (1993). Economic, clinical, and humanistic outcomes: a planning model for pharmacoeconomic research. Clin Ther.
14. STRUCTURE
Settings
Staffs: trained pharmacists
Equipments
Information resources
Financal stability
….
PROCESS
Technical
N° DRPs/PIs
Consistency to standards
Agreement between HCPs
Acceptance
Interpersonal
Satisfaction of HCPs
Collaboration between HCPs
CLINICAL
• Severity of DRPs: harm,
ADR, therapeutic failure
• Significance of PIs:
Health care resources
avoided (eg., emergency
visit, hospitalization…)
ECONOMIC
• Direct costs: cost of
implementation of the PI
cost saving, cost
avoidance
• Indirect costs: missing
working
• Intangible costs: pain,
suffering…
• HUMANISTIC
• Patient’s satisfaction
• Knowledge
• Medication compliance
• Quality of life
• …
3. Pharmacoeconomic model Value of a PI
Value = Differences between the scenarios without and with the PI
A systematic review – Results & Discussion
Schumock GT et al. (2000). Method to assess the economic outcomes of clinical pharmacy services. Pharmacotherapy.
15. 15
STRUCTURE
Settings
Staffs: trained pharmacists
Equipments
Information resources
Financal stability
….
PROCESS
Technical
N° DRPs/PIs
Consistency to standards
Agreement between HCPs
Acceptance
Interpersonal
Satisfaction of HCPs
Collaboration between HCPs
CLINICAL
• Severity of DRPs: harm,
ADR, therapeutic failure
• Significance of PIs:
Health care resources
avoided(eg., emergency
visit, hospitalization…)
ECONOMIC
• Direct costs: cost of
implementation of the PI
cost saving, cost
avoidance
• Indirect costs: missing
working
• Intangible costs: pain,
suffering…
HUMANISTIC
• Patient’s satisfaction
• Knowledge
• Medication compliance
• Quality of life
• …
Severity X Probability = Risk Matrix
4. Risk assessment matrix
A systematic review – Results & Discussion
National patient safety agency (2008). A risk matrix for risk managers.
16. STRUCTURE
Settings
Staffs: trained pharmacists
Equipments
Information resources
Financal stability
….
PROCESS
Technical
N° DRPs/PIs
Consistency to standards
Agreement between HCPs
Acceptance
Interpersonal
Satisfaction of HCPs
Collaboration between HCPs
OUTCOME
Clinical
Humanistic
Economic
…
CLINICAL
• Severity of DRPs: harm,
ADR, therapeutic failure
• Significance of PIs:
Health care resources
avoided (eg., emergency
visit, hospitalization…)
ECONOMIC
• Direct costs: cost of
implementation of the PI
cost saving, cost
avoidance
• Indirect costs: missing
working
• Intangible costs: pain,
suffering…
HUMANISTIC
• Patient’s satisfaction
• Knowledge
• Medication compliance
• Quality of life
• …
Value = Differences between the scenarios without and with the PI
Severity X Probability = Risk Matrix
An optimal model of evaluation of impacts of PIs: SP(ECH)O-P
17. Multi- or mono-dimensional
Independent/Integrated
Ordinal/Nominal
Numeric/Non-numeric
Explicit/Implicit
Opened/closed
B. Properties of structure of tools
A systematic review – Results & Discussion
Few tools have these optimal properties of structure
A. Models & content of tools
18. C. Properties of validation of tools
A systematic review – Results & Discussion
Inter-rater
reliability
• Agreement
between
raters
• 48/133
studies
Intra-rater
reliability
• Agreement of
same raters
between
times
• 2/133 studies
Validity
• Agreement
between
raters’ and
gold
standard
ratings
• 8/133 studies
A. Models & content of tools
B. Properties of structure of tools
Need of test inter-rater, intra-rater reliability and validity of a new tool
19. 1. Introduction
2. Development of a new tool
2.1. Review of models and tools
2.2. Development of the CLEO tool
3. Validation of the CLEO tool
3.1. Test in a general practice
3.2. Test in a specific clinical service
4. Discussion & Perspectives
5. Conclusion
Plan
20. 20
Development of the CLEO tool
PROCESS OF DEVELOPMENT
• GROUP: 7 pharmacists of the working
group of SFPC (French Society of Clinical
Pharmacy)
• WHY ? A simple, comprehensive, reliable
tool
• WHERE ? Hospital
• WHAT ? clinical, humanistic, economic,
process-related. No probability.
• WHEN? Potential impact
• FOR WHOM ? For the patient, hospital,
HCPs
• HOW ? 3 dimensions, 4-7 categories,
opened
• RESULTS: 6 direct meetings, 5 versions of
the CLEO tool
SCORE IMPACTS
CLINICAL (CL)
-1C Negative
0C Null
1C Positive – Humanistic
2C Favorable – Minor
3C Favorable – Major
4C Favorable – Vital
ND Non-determined
ECONOMIC (E)
-1E Negative
0E Null
1E Positive
ND Non-determined
ORGANIZATIONAL (O)
-1O Negative
0O Null
1O Positive
ND Non-determined
Score (CL, E, O)
21. Score Impact
The clinical impact is evaluated according to the most likely case expected,
not the worst/best case
-1C Nuisible The PI can lead to adverse outcomes on clinical status, knowledge, satisfaction,
patient adherence and/or quality of life of the patient.
0C Null The PI can have no influence on the patient regarding the clinical status,
knowledge, satisfaction, patient adherence and or quality of life of the patient.
1C Minor The PI can improve knowledge, satisfaction, medication adherence and/or
quality of life of the patient OR the IP can prevent damage that does not require
monitoring/treatment.
2C Moderate The PI can prevent harm that requires further monitoring/treatment, but does not
lead or dose extend a hospital stay of the patient.
3C Major The PI can prevent harm which causes or lengthens a hospital stay OR causes
permanent disability or handicap.
4C Lethal The PI can prevent an accident that causes a potentially intensive care or death of
the patient.
ND Non-
determined
The available information does not determine the clinical impact.
21
1. CLINICAL IMPACT6 levels of Hatoum’s tool
Severity categories from the
NCC MERP Index
Humanistic indicators = low
levels from the Williams et al.’s tool
Development of the CLEO tool
The « Clinical impact » focuses on clinical and humanistic impacts of the
PI for the patient.
22. 22
2. ECONOMIC IMPACT
Score Impact Definition
-1E Increase of cost The PI increases the cost of the drug treatment of the patient.
0E No change The PI does not change the cost of drug treatment of the patient.
1E Decrease of cost The PI saves the cost of drug treatment of the patient.
ND Non-determined The available information does not allow determining the economic
impact.
The cost of drug therapy contains two main elements:
• The cost of drugs
• The cost of monitoring of drug therapy (e.g., clinical, kinetic, biological monitoring ...).
The cost of drug therapy is based on the financial cost of a hospital.
Development of the CLEO tool
The « Economic impact » dimension focuses on cost savings of PIs
based on the financial cost for a hospital
23. 23
3. ORGANIZATIONAL IMPACT
Score Impact Definition
-1O Negative The PI reduces the quality of care process.
0O Null The PI does not change the quality of the care process.
1O Positive The PI increases the quality of the care process.
ND Non-determined The available information does not identify the organizational impact.
The organizational impact is coded regarding the overall impact on the quality of the care
process from the perspective of health care providers (eg, time savings, improved security,
knowledge, job satisfaction of nursing staff; facilitating professional tasks or teamwork,
continuity of care, etc.)
Development of the CLEO tool
The « Organizational impact » dimension focuses on benefits of PIs on
process of care for HCPs
24. 24
Development of the CLEO tool
A CASE STUDY
• Description: Woman 85 years old was
treated by AUGMENTIN (amoxicillin +
clavulanic acid) IV for sinusitis.
• PM: the patient was known to be
allergic to beta-lactams
(angioedema).
• IP: change to PYOSTACINE
(pristinamycin) 500mg tablet.
SCORE IMPACTS
CLINICAL (CL)
-1C Negative
0C Null
1C Positive – Humanistic
2C Favorable – Minor
3C Favorable – Major
4C Favorable – Vital
ND Non-determined
ECONOMIC (E)
-1E Negative – Increase of cost
0E Null – No change
1E Positive – Decrease of costs
ND Non-determined
ORGANIZATIONAL (O)
-1O Negative
0O Null
1O Positive
ND Non-determined
Score (3C, -1E, 1O)
25. 1. Introduction
2. Development of a new tool
2.1. Review of models and tools
2.2. Development of the CLEO tool
3. Validation of the CLEO tool
3.1. Test in a general practice
3.2. Test in a specific clinical service
4. Discussions & Perspectives
5. Conclusions
Plan
26. Test in a general practice - Method
1st
rating
2nd
rating
3rd
rating
50 PIs from the Act-IP®
database
30 PIs from the 6 pharmacists’
hospital practice
10 PIs from the same 30 PIs
The CLEO v1
The CLEO v2
The CLEO v2
Raters TestScenarios Tool
InTER-rater
reliability
InTER-rater
reliability
InTRA-rater
reliability
7 pharmacists of the
group of SFPC
The SP(ECH)O-P model The CLEO
27. Test in a specific practice - Method
Kappa value – Agreement
< 0 : poor
0.00-0.20: slight
0.21-0.40: fair
0.41-0.60: moderate
0.61-0.80: substantial
0.81-1.00: almost perfect
Agreement: %
Validity/Reliability: Weighted kappa (kw)
Statistical test
Gisev et al (2013). Interrater agreement and interrater reliability: key concepts, approaches, and applications. Res Social Adm Pharm.
Expected weighted kappa: kw ≥ 0.41 (moderate agreement)
Interpretation of kappa value by Landais & Koch:
28. Test in a general practice - Results
1st
rating
2nd
rating
3rd
rating
The CLEO v1
The CLEO v2
The CLEO v2
Raters TestTool
InTER-rater reliability
CL: 36%, kw = 0.34 X
E: 65%, kw = 0.53
O: 57%, kw = 0.26 X
InTER-rater reliability
CL: 39%, kw = 0.41
E: 90%, kw = 0.93
O: 62%, kw = 0.39 !
InTRA-rater reliability
CL: 33%, kw = 0.38 !
E: 80%, kw = 0.70
The CLEO v2
CL nearly validated
E validated
O nearly validated
Expected weighted kappa: kw ≥ 0.41 (moderate agreement)
29. 1. Introduction
2. Development of a new tool
2.1. Review of models and tools
2.2. Development of the CLEO tool
3. Validation of the CLEO tool
3.1. Test in a general practice
3.2. Test in a specific clinical service
4. Discussion & Perspectives
5. Conclusions
Plan
30. Test in a specific practice - Method
Objective: To assess validity and reliabilty of the CLEO tool used in
daily practice in a Centralized Preparation Unit of Anticancer Drugs
(CPU) at the Grenoble University Hospital
Type of study: mono-center, prospective
Services included :
• Complete Hospitalisation in hematology and oncology
• One-day Hospital in hematology, oncology, pneumology, hepato-
gastroenterology and radiotherapy
Period of study : 10 weeks (July 2014 to September 2014)
Sample: 214 PIs related to 167 patients.
31. 1st
rating
2nd
rating
3rd
rating
Ward-based pharmacist (P2)
Hematology
43 PI
Oncology
radiotherapy
146 PI
Pneumology
33 PI
Hepatogastro
enterology
15 PI
1 panel for each speciality 4 panels
Pharmacist at the CPU (P1)
Expert panel (EP)
Composition of each panel : 4 members (a specialist – physician, a clinical pharmacist,
a pharmacist at the CPU and a pharmacist at a pharmacovigilance center)
The CLEO v2
The CLEO v2
The CLEO v2
InTER-rater reliability (P1-P2)
Validity (P1-EP)
Validity (P2-EP)
Raters TestTool
Test in a specific practice - Method
Process of ratings
32. Test in a specific practice - Method
1st
rating
2nd
rating
3rd
rating
Ward-bassed pharmacist (P2)
Pharmacist at the CPU (P1)
Expert panel (EP)
The CLEO v2
The CLEO v2
The CLEO v2
Inter-rater reliability (P1-P2)
CL: 51%, kw = 0.48
E: 71%, kw = 0.61
O: 60%, 0.27 X
Validity (P1-EP)
CL: 41%, kw = 0.32 !
E: 68%, kw = 0.53
O: 57%, kw = 0.17 X
Validity (P2-EP)
CL: 54%, kw = 0.56
E: 81%, kw = 0.75
O: 49%, kw = 0.11 X
Raters TestThe tool
The CLEO v2
CL nearly validated
E validated
O NOT validated
Expected weighted kappa: kw ≥ 0.41 (moderate agreement)
33. 1. Introduction
2. Development of a new tool
2.1. Review of models and tools
2.2. Development of the CLEO tool
3. Validation of the CLEO tool
3.1. Test in a general practice
3.2. Test in a specific clinical service
4. Discussion & Perspectives
5. Conclusion
Plan
34. A updated systematic review of tools of assessing
potential impacts of PIs was conducted with:
• 82 distinct tools found in 133 studies: rich resources for
development of new tools
• 6 models of evaluations
• 12 recommendations of methods of assessment of
potential impacts of PIs: theoretical, psychometric and
pragmatic properties
Discussion & Perspectives
1. Principal findings
35. The SP(ECH)O-P model:
• The first specific model in literature for evaluation of PIs
• A comprehensive model including 6 main types of
indicators
• Relationships between types of indicators
Discussion & Perspectives
1. Principal findings
36. ▷Content & Structure: humanistic indicators
included, health care resouces included, structure
inspired the Hatoum’s tool, content inspired from
NCC MERP, 7 categories
▷Validation properties
33-54%, Kw = 0.32-0.56 VALIDATED
▷
▷Content & Structure: cost savings (drug,
monitoring), 4 categories
▷Validation properties
68-90% , Kw = 0.53-0.93 VALIDATED
▷Content & Structure: integration of many
organizational indicators and persepctives of HCPs, 4
categories
▷Validation properties
49-63% , Kw = 0.11-0.39 NOT VALIDATED
Economic impact
Test of the CLEO in 2 studies - Results
Clinical impact
Organizational impact
Content, Structure & Validity of the CLEO tool
1. Principal findings
37. Discussion & Perspectives
Improvement of validation properties: training, examples
Establisment relationship between potential and actual clinical
impact
Development of separate tools for measuring humanistic impacts
Specific study for improvement of organizational impact: eg., qualitative
studies on perceptions of HCPs of organizational impacts
Estimation of direct costs (cost savings, cost avoidance and cost of
implementation of a PI)
Adding estimation of probability
2. Validity of findings – Quality of the CLEO tool
Develop of assessment matrix (a global score)
38. Discussion – The CLEO tool
2. Validity of findings – Validity of research method
Internal validity
- Confounding: perceptions
of raters
- Maturation of raters:
familiarity with the tool
- Testing bias: awareness of
ratings
- Selection bias of PIs
- Statistical test: %, kw
External validity
- Raters: 7 raters involved to
develop another tool 10
years ago
- Ratings: requirement of
confirmations of ratings in
some cases
- Settings: a specific
practice (CPU)
- Tool: the French-written
CLEO tool for hospital
40. 1. Introduction
2. Development of a new tool
2.1. Review of models and tools
2.2. Development of the CLEO tool
3. Validation of the CLEO tool
3.1. Test in a general practice
3.2. Test in a specific clinical service
4. Discussion & Perspectives
5. Conclusion
Plan
41. The updated systematic review of tools for assessing of potential
impacts of PIs synthesized models, content, structure and
validation properties of tools.
The specific and comprehensive model for evaluations of PIs,
named SP(ECH)O-P was developed.
The CLEO tool of assessing potential impacts of PIs (including 3
dimensions: Clinical Impact, Economic Impact, and Organizational
impact) was constructed and tested in 2 studies. However, only
« Clinical impact » and « Economic impact » dimensions were
validated.
Conclusion
42. 42
Discussion, conclusion
Working group “Standardizing and
demonstrating the value of clinical
pharmacy activities” of the SFPC
(the French Society of Clinical
Pharmacy)
Group of clinical
practitioners (pharmacists,
physicians) at the Grenoble
University Hospital
Acknowledgements
43. 43
It is not hard to make decisions once you know
what your values are. Roy E. Disney
Editor's Notes
Hello every body
My name’s Thi Ha Vo, a pharmacist – and a lecturer at Hue Unversity of Medicine and Pharmacy in Vietnam. I’m a PhD student in Grenoble since 4 years. Today, I’m pleasure to present the results of my thesis study: « Assessment of the potential impact of PIs: development and validation of the CLEO multidimensional tool ».
The plan of my presentation consists of five parts.
Firstly, I introduce the context and why I conduct this study.
Then, process of development of a new tool, named CLEO are presented.
Next, I present the process of validation of the CLEO in 2 studies.
Finally, I finish my presentation by some discussions and perspectives
- As you may know, DRPs are ones of major problems of health care systems. Some examples of DRPs are: adverse drug reactions, overdose, drug interactions, drug contra-indications…
DRPs are causes of 2-27% of hospital admissions. About 50% of DRPs are potentially preventable.
And Clinical pharmacists play a key role to work with other HCPs such as physicians, nurses to optimize drug use for patients.
There are a variety of clinical pharmacy services that pharmacists can do. Of which, MR is one of major contribution of pharmacists. MR means that pharmacists collect all relevant patient information and review updated knowledge of treatment in literature in order to identify DRPs and then suggest changes, named PIs. .
PI is defined as any action by a clinical pharmacist that directly results in a change in patient management or therapy. For example, change the drug, route of admistration, change of dosage..
Evaluation of impacts of PIs is essential for demonstrating the added value of clinical pharmacists, continuing quality improvement, research and education…That is reasons why we want to develop a tool for evaluation of impacts of PIs.
However, at the begining of the study, we raised many questions concerning evaluation of PIs:
+ When should we evaluate them, whether should we evaluate potential or actual impacts ?
+ Where should our tool target to be used ? Only in hospitals or both hospital and community pharmacies
+ How about models or tools of evaluations, and process of evaluation known in literature ?
+ Which impacts do we need to evaluate ? Clinical, economic impacts and anything else ?
+ For whom do the PIs provide impacts ?
In 1999, Overhage and Lakes in USA conducted a review of tool for assessing impacts PIs from 1966 to 1997. They found 5 distinct tools in 10 studies.
Only the tool of Folli et al was widely used. The tool of Folli assessed severity of error.
The tool of Hatoum et al evaluated clinical impact of PIs
The tool of Brandt et al. and used by Walters et al. focussed on only drug administration errors.
The classification of Neville and coll focussed on potential effects and inconvenience of prescription errors to the patients.
In a study of community pharmacies, Rupp and coll categorized severity of error into health resources avoided
Based on results obtained,Overhage and Lakes developped a new tool including 2 dimensiosn: severity of error inspired from Folli, significance of PIs inspired from the tool of Hatoum.
High reliability was demonstrated for this new tool.
This validated tool has been widely used and adopted in other studies. However, results of reliability were low in many studies.
And this tool has some other limitations: although the tool of Overhage et al consists of 2 dimensions, it only focused on clinical impact and doesn’t evaluate other impacst, such as economic, humanistic impacst
Therefore, the our study aimed to
conduct an updated systematic review of tool for assessing potential impacts of PIs.
(2) Review models of evaluations and develop an optimal model for evaluation of PIs
In order to reach the objective:
(3) Develop and validate a multidimensional tool for assessing potential impacts of PIs
Firstly, I present the review of models and tools of evaluation in literature
The results of this systematic review was published in the journal Drug Safety a week ago.
Concerning the method of the review, we followed the guidlines of Cochrance and PRISMA for systematic review.
2 pharmacists conducted the review independently.
We used combination of different keywords of DRPs and PIs and searched in 4 databases: Pubmed, PsyINFO, PASCAL, CINAHL for the period 1986-2013.
As final results, we scanned 873 abstracts and found 82 distinct tools in 133 studies.
Few studies described how they constructed their tools, which models of evaluations inspired them to develop their tools.
I will present 4 main models which were applicable to construct tools in literature and then introduced a new model we constructed for assessing impacts of PIs.
These models consists of 6 types of indicators of content of tools: related to structure, process, clinical, humanistic and economic outcomes, and probability of impacts.
According to the model of Donabedian, the author stated that quality of any heath care interventions depends on 3 types of indicators: related to structure of care, process of care, and outcomes of health care interventions.
Application of this model to evaluation of quality of PIs, we need to evaluate also properties of structure in which pharmacists conducted interventions such as: staffs, equipments, drug information resources…
However, these structure-related indicators were not found in tools because PIs aimed to influence on the individual patient and process of care rather than influence on structural settings.
Some process-related indicators were found in different tools such as consistency of practice to standards, acceptance of PIs by physicians, satisfaction or collaboration btw HCPs
Concerning outcomes of PIs, according to the model of Kozma et al applicable to PIs, the outcomes of pharmaceutical products or services consists of clinical, economic and humanistic outcomes.
Clinical outcomes are defined as medical event that occur due to disease or medical interventions.
In tools indentified, clinical impacts was estimated in two ways. The first (and most common) way was to assess the severity of harm to the patient avoided by the PI. The second way was to estimate the resources that would have been required to manage the patient as a result of the DRP such as hospitalization, emergency visit…
humanistic outcomes are defined as the consequences of disease or treatment on patient functional status or quality of life. In tools, some humanistic indicators found in some tools were patient’s satisfaction, knowledge of patients, medication compliance and quality of life of patient
Concerning economic outcomes, economic outcomes as defined as direct cost, indirect cost and intangible costs.
According to the pharmacoeconomic model applicable to the PI, the value of a PI depends on difference of inputs and outputs between the scenario without and with the PI.
Inputs means resources consumed related to structure and process of care in order to conduct the PI.
Inputs includes 2 types of costs: costs of implementation of the PIs such as salary to pay pharmacists, telephone, fax; or costs savings such as cost of drug change, monitoring.
Outputs means outcomes of the PI, including clinical, humanistic and economic outcomes.
Clinical and humanistic outcomes can be converted to economic value. For example, importance of clinical outcomes of the PI were determined by health care resources avoided by the PIs which can be converted to cost avoidance of the PI.
Or humanistic outcomes can be converted to intangible costs.
However, value of a PIs found in all studies using tools were calculated from only 3 types of direct costs: cost savings plus cost avoidance less cost of implementation.
Indirect and intangible costs were ignored because it was so difficult to estimate.
According the risk assessment matrix, combination of severity and probability of each consequences contributes to overal priority risk. However, a few tools combined severity and probability of only clincal impact.
- By combining the above general models to the case of evaluation of a PI and using results obtained from the systematic review, we developed an intergrated model, named SP(ECH)O-P.
According to this model, the value of a PI depends on 6 types of indicators: related to structure and process and clinical, economic and humanistic outcomes, and probability.
The value of the PI is calculated from the differences of these indicators between the scenarios without and with a PI.
Concerning to structure of tools, we found some prefered properties of structure of tools, including:
The structure was multidimensional, meaning the tool can answer many different questions related to impacts of PIs
Different types of indicators were evaluated independently
Each dimension consists of ordered and numeric levels
Each levels was defined clearly
Structure of tools was opened, meaning each dimension has a category like non-determined or others for cases when available information did not allow to determine the impacts.
- We found in the review, few tools had these optimal properties.
Concerning to properties of validation of tools, about a third of tools was tested for inter-rater reliability (that means agreement of ratings between different raters), intra-rater raliability (that means agreement of ratings by the same rater between different times) and validity (that means agreement between ratings of raters and gold standard ratings such as an expert panel)
Of that, many tools tested had low agreement.
- In short, a new tool need to be tested for 3 variables: inter and intra rater reliability and validity.
Now, I will present how the CLEO tool was constructed
- The group of 7 clinical pharmacists who worked in 6 French hospital, belonging to the French Society of CP was involved in developted the new tool.
Based on results of review and inputs of the experts, we discussed a lot to find answers to questions raised. Aftter 6 direct meetings, 5 versions of the CLEO were suggested.
Finally, we wanted to develop a simple, comprehensive and reliable tool for each pharmacist who can rated indepedently in their hospital.
This is the final version of the CLEO. The CLEO tool consists of 3 dimensions: clinical, economic and organizational impacts. By assessing impacts of PI with the CLEO, each PI can have a score of 3 value.
To develop the « Clinical impact », we inspired the structure of 6 levels of Hatoum’s tool.
For integration of humanistic indicators into the « clinical impacts », we inspired the tool of Williams et al. In the tool of Williams et al., they included patient’s knowledge and patient compliance into low and mild levels of clinical impact. In our tool, we included 4 major humanistic indicators: patient’s knowledge, satisfaction, compliance and quality of life into the level 1 – minor positive impact.
The definitions of levels 2, 3, 4 were inspired from the severity categories of the NCC MERP – a popular severity classification of actual harm of medication error.
In short, the clinical impact focuses on clinical and humanistic impacts of the PI for the patient
The economic impact consists of 4 categories: increase of cost, no change, decrease of cost and non-determined.
The economic impact evaluates cost savings related to drug or monitoring of drug therapy.
In bref, the economic impact dimension focuses on cost savings of PIs based on the financial cost of the hospital
- Concerning the organizational impact, the organization impact is rated the impact of the PI on process of care from perspective of HCPs into 4 categories: negative, null, positive and non-determined.
We included many process-related indicators found in the review, meaning benefits of PIs for HCP such as time savings, improved security, knowledge, job satisfaction of nursing staffs, facilitating professional tasks…
In bref, the organization impact dimensiosn focuses in benefits of PIs in process of care for HCPs
- For example, in one case study: …
Because the PI can prevent allergic reaction (such as angioedema) for the patient which requires hospitalization, therefore the clinical impact accoding to the CLEO was the level 3C.
Because we had to change to more expensive drug for the patient, so the level of the eco impact was -1E.
With this PI, the patient was changed from IV to orall administration, which was more simple and less time-consuming for nurses. Therefore, the PI had a positive orga impact.
At final, this PI has a score: 3C, -1E, and 1O.
Now, I will present process of validation of the CLEO tool. The first one tested the CLEO tool in a general practice
- Objective of this study was to test reliability of different verions of the CLEO when assessing impacts of variety of types of PIs sellected from different context.
- After the we developped a model of evaluation and six versions of the CLEO tools. Two versions of the CLEO were tested, named CLEO v1, v2.
For the first ratings, 7 pharmacists of the group rated impacts of 50 PIs sellected from the French database of PIs, named Act-IP in order to calculate the inter-rater reliability. We questioned also satisfactions of the pharmacists and suggestions for modifications of the CLEO. Based on these suggestion, we modified and obtained the CLEO v2.
For the second ratings, we asked 7 pharmacists who worked in 6 hospitals to collect 10 PIs for each one in their hospital. Then, we choosed 30 PIs with complete informations and assured to balanced types of DRPs and PIs.
And required 7 pharmacists to rate impacts using the CLEO v2 in order to calculate inter-rater reliability
For the third ratings, we sellected randomly 10 PIs from the same 30 PIs and asked the pharmacists to rate the second time 2 month lahers in order to calculate the intra-rater reliability
Regaring statistical test, we used 2 variables for evaluating reliability or validity. Those were « percentage of agreement » and « weighted kappa »
Percentage of agreement: is defined as the percentage of possible cases scores/ratings are identical
Kappa score relates to the extent of variability and error inherent in a measurement. The kappa provides a chance-corrected index and are based on the ratio of the proportion of times agreement is observed, to the maximum proportion of times that the raters could agree (both corrected for chance agreement).
Therefore, the kappa score is more exact to demonstrate true agreement.
We used the weighted kappa instead kappa. Whereas kappa considers only total (“all-or-none”) agreement or disagreement, weighted kappa allows for the assignment of weights to different categories such that similar categories can be in partial agreement.
We used the interpretation of kappa score proposed by Landis and Koch.
Based on results of low kappa score obtained in many studies in the review, we targeted a weighted kappa equal or more than 0.41 (moderate agreement)
The results obtained were that
Kappa Scores of the CLEO v2 were higher than ones of the CLEO v1.
For the inTER-rater reliability of the CLEO v2, kw scores were equal to 0.41 for clinical impact, much higher than 0.41 for the economic impact, and slightly lower 0.41 for the organizational impact, however percentage of agreement of « organizational impact » was quite high 62%.
Concerning to the inTRA-rater reliability of the CLEO v2, the results were slightly lower than 0.41 for clincial impact and much higher 0.41 for economic impact. We did not tested intra-rater reliability for organizational impact.
In conclusion, the CL impact was nearly validated, the E impact was validated and the O impact was nearly validated.
Therefore, the CLEO v2 was then used for test in the next study.
The version 2 of the CLEO was then tested for validity and inter-reliability in daily practice at a centralized preparation unit of anticancer drugs (CPU) at the Grenoble Univeristy hospital
This was a mono-center, prospective study which lasted for 10 weeks, including
Complete Hospitalisation in hematology and oncology
One-day Hospital in hematology, oncology, pneumology, hepato-gastroenterology and radiotherapy
Finally, we collected 214 PIs related to 167 patients
The process of ratings as follows:
For the first ratings, a pharmacist at the CPU who suggested a PIs during the study period evaluated impacts of their PI immediately
For the second ratings, a second pharmacist who worked in services with physicians and patients collected all informations related to PIs several days later and coded.
For the third ratings, all PIs were evaluated in consensus by expert panels. There were 4 expert panels for 4 specific therapeutic domains
And each expert panel consisted of 4 members: a specialist – physician, a clinical pharmacist, a pharmacist at the CPU and a pharmacist at a pharmacovigilance center
We compared results of ratinsg btw 2 pharmacists in order to calculate inter-rater reliability
We compared results of ratings btw each pharmacist and expert panels to calculate validity of the CLEO tool.
the validity between the second pharmacist and EPs were higher levels of agreement than one bewteen the first pharmacist and Eps for the clinical and economic impact, but the same low level of agreement for the organizational impact
In general,
- The results of inter-rater reliability and validity obtained were:
Regarding the clinical impact, kappa was higher than 0.41 except kappa of validity between the first pharmacist and EP was slightly lower than 0.41.
Redarding the economic impact, kappa were much higher than 0.41.
Regarding the organizational impact, kappa were much lower than 0.41
In conclusion, the « CL » impact was nearly validated, the E impact was validated, and the O impact was not validated.
From results obtained, we had some discussions and perspectives
Secondly, our systematic review of tools of assessing potential impacts of PIs contributed to update the knowledge on this topic. .
82 distinct tools found in 133 studies provided rich resources for other researchers or practitioner to develop new tools. A great numbers of tools found in our review showed that after the first step to implementation of clinical pharmacy services for many decades, nowadays, pharmacists focuses more and more on demonstration of benefits of their services
Futhermore, currently, there are no formal guidelines concerning methods of assessing potential impacts of PIs, taking into account the results of this review, we suggested 12 recommendations about theoretical, psychometrics and pragmatic properties of methods of assessment.
Concerning to principal findings of the study, the first major finding was we constructed a new model, SP(ECH)O-P model for evaluation of PIs
The advantages of this model are:
+ Firstly, it is a specific model of evaluation of PIs
+ Secondly, the model is comprehensive, including 6 major types of indicators
+ Thirdly, the model described also the relationships between types of indicators
The third principal findings were related to the CLEO tool.
The CLEO tool evaluates the « clinical and humanistic impact » for the patient, the cost savings for the hospital and the organizational impact – benefits for HCPs.
The CLEO tool was tested in 2 studies for inter, intra reliability and validity.
And the kappa score for the « CL » impact was from 0.32 to 0.56. When comparing to other tools having 5-7 categories in literature, our results were better than many tools and just worse than the tool of Overhage and Lakes, and the tool of Struck et collegues. Therefore, we considered the CL impact as validated.
The kappa score for E impact was high enough with the value from 0.53-0.93. Then, the E impact was valiated.
The kappa score the O impact was lower than 0.41 in two studies, then the it is not validated.
Regarding validity of findings of the work, we discuss firtly quality of CLEO tool and how to improve it
Concerning to the clinical impact,
+ Improvement of validation properties by training pharmacists, providing examples and guide of ratings should be conducted.
+ there is a need of study who that will establishrelationship between potential and actual clinical impact
Concerning to humanistic impacts, we need developement of separate tools for measuirng humanistic impacts
Concerning to economic impact, we need further economic studies which will estimate 3 types of direct costs (including..) and even indirect and intangible costs.
Concerning to the organizational impact, we need to conduct qualitative studies on perceptions of HCPs to defined clearly organizational impacts and we can try to modify the « organizational impact » by seperation of organizational indicators and types of HCPs.
We need also to add estimation of probability and develop an assessment matrix which combined all important impacts into a global score
- Concerning to the validity of research method:
There were some main threats to internal validitity in the study
+ Confounding factors: results of agreement btw raters in two studies may be affected by perceptions of raters themselves rather than functionality of the tool. To minimize this bias, we choose a great mumber of raters (7 for the first one and 10 for the second one)
+ Maturation of raters: raters rate more consistently overtime because they becom be more familiar to the tool, espectically in the first study, the pharmaacist of the Group SFPC who was involved in development of the tool. To deal this bias, we conduct the second study in which raters were all new to the tool.
+ Testing bias: evaluators are aware of that their ratings will be compared to others, than, thay are likely to rate based on what researchers expect rather than based on their true perception. To minimize this threat, we informed clearly objectives of studies was to test the functionality of the tool.
We minimized bias of selections of samples of PIs by applyng different method of sellection in 2 studies
We used weighted kappa to test reliability/validity, then weighted kappa values tend to be higher than unweighted kappa values. Therefore, comprarison to ther studies need to consider this point.
Concerning to the external validity of findings in this work, the studies may have included unique characteristics that make the results unique to the study, and cannot be transfered to others.
+ Fistly, the group of SFPC was involved in development another tool 10 ys ago, which can influence the ratings in these studies. However, this is minor threat because of long times ago.
+ Secondly, in the second rating of the first study, we required confirmations of rating in some cases when the investigators found one valuator rated so differently compared to majority of raters. The objective was to prevent cognitive or unintentional errors. However, only few PIs were needed to do so. Therefore, this bias was minor.
+ We tested in daily practice in one specific setting (CPU), and other largem, multi center studies are needed.
+ Finally, the CLEO tool was written in French and tested by French hospital pharmacists. Other studies are needed for translation and tool adoption for use in other languages/countries.
Results of this work can open some perspectives
At the present, some colleages in different French hospitals from Lyon, Annecy, Epernay…contacted us for testing the CLEO in their hospitals
We are going to add the « Clinical impact » and « Economic impact » into the French database of PI, named Act-IP. This databased is constructed by the SIG from 2006. At the present, there are over 276.00 documented PIs.
We need also to modify the CLEO for use in community pharmacies
Finally, after finishing the study in France, I will return back to Vietnam, and I will conduct another study for tool translation and adoption in Vietnam.
From results obtained, we had some discussions and perspectives
I would like to thanks the working group of SFPC and the group pf physicians and pharmacists at the Grenoble University Hospital who were involved in this study.
I thank also to laboratory TIMC-IMAG, Unversity Grenoble Alpes.