This document provides guidance on how to write an effective study protocol. It explains that a study protocol should describe each step of the study to check that the objectives can be achieved and the study is feasible. It also ensures all relevant information is collected and rules are established for partners. The document recommends following a checklist of key items and obtaining examples from similar studies. It then outlines the typical sections of a study protocol, including background, objectives, methods, ethics, management, timetable and resources. It emphasizes important considerations for each section like study design, population, analysis plan and limitations.
An overview on priorities in health research was a part of a course for research methodology delivered in King Saud University College of Medicine August 2015
The Medical Affairs team at GVK Biosciences (GVK BIO) comprises of well trained medical professionals with cumulative Clinical Research experience of about 28 years.
The NIHR Research Design Service provides support to NHS staff and academics preparing research proposals for submission to peer-reviewed funding competitions for applied health or social care research.
Knowledge transfer, and evidence informed health policy-minster's meetingDr Ghaiath Hussein
A presentation given to the highest executive body in the Federal Ministry of Health in Sudan, which led to the adoption of a new evidence-based policy.
Implementing a mixed-methods protocol in impact evaluation: challenges and op...valéry ridde
Presentation realised for an organised session on Application and challenges to the use of mixed methods in health systems research, held at HSR 2016, the Fourth Global Symposium on Health Systems Research, Vancouver, 14-18 november 2016.
Author: Manuela De Allegri
The fifth webinar continues the momentum of the series as it focuses on providing concrete approaches for identifying barriers and enablers, emphasising behaviour change approaches.
READ MORE: http://bit.ly/2LOwbj0
An overview on priorities in health research was a part of a course for research methodology delivered in King Saud University College of Medicine August 2015
The Medical Affairs team at GVK Biosciences (GVK BIO) comprises of well trained medical professionals with cumulative Clinical Research experience of about 28 years.
The NIHR Research Design Service provides support to NHS staff and academics preparing research proposals for submission to peer-reviewed funding competitions for applied health or social care research.
Knowledge transfer, and evidence informed health policy-minster's meetingDr Ghaiath Hussein
A presentation given to the highest executive body in the Federal Ministry of Health in Sudan, which led to the adoption of a new evidence-based policy.
Implementing a mixed-methods protocol in impact evaluation: challenges and op...valéry ridde
Presentation realised for an organised session on Application and challenges to the use of mixed methods in health systems research, held at HSR 2016, the Fourth Global Symposium on Health Systems Research, Vancouver, 14-18 november 2016.
Author: Manuela De Allegri
The fifth webinar continues the momentum of the series as it focuses on providing concrete approaches for identifying barriers and enablers, emphasising behaviour change approaches.
READ MORE: http://bit.ly/2LOwbj0
لعبة البيرة تعتبر من أحسن الألعاب الجديدة الموجودة علي الساحة وأيضا اللعبة تعتمد علي سرعتك في التقاط زجاجات العاب بيرة المتساقطة من أعلي اللعبة باستخدام الماوس فقط كل ما عليك هو أنك توجه الماوس نحو زجاجات البيرة المتساقطه داخل الصندوق وكلما أيضا جمعت عدد اكبر كلما انتقلت الي مرحلة أعلي وتكون فيها تساقط الزجاجات أسرع من الاول بكتير ولكن احذر فانت لديك ثلاثة محاولات تفلت منك فيها الزجاجات بعد ذلك تخسر لعبة البيرة والنسوان وتظهر لك جملة جيم أوفر .
http://www.download-al3ab.com/2013/08/beera-game-online-2014.html
Data collection process for survey reseach.pptxSunita Poudel
A survey is a systematic method of collecting data from a population of interest.
Information is gathered by asking individuals questions, using structured and standardized questionnaire.
Surveys are mainly quantitative in nature.
Surveys aim to collect information from a sample population that is representative of the overall population, within a certain degree of error.
Survey Research is defined as the process of conducting research using surveys that researchers send to survey respondents and statistically analyzing collected data to draw meaningful research conclusions.
Survey research has developed with scientifically tested strategies detailing who to include (representative sample), what and how to distribute (survey method), and when to initiate the survey(time) and follow up with non-responders (reducing non-response error), in order to ensure a high-quality research process and outcome.
Advantages: Allow for relatively straightforward recruitment and consenting procedures.
Gather accurate data about an individual’s subjective memories or personal accounts, knowledge, attitudes, appraisals, interpretations, and perceptions about experiences.
Integrate effectively with other research methods as supplemental or complementary approaches to ensure data quality and validity(Data triangulation).
key approaches: Qualitative and Quantitative Data Collection Approaches
Data collection process: Make logistical arrangements
Prepare and pretest the questionnaire
Select appropriate field workers
Train the field workers
Choose and prepare the equipment
Carry out the pilot study
Set up computers and hire data processing staff
Make arrangements for returning questionnaires to central authority/ headquarters
Prepare for collecting supplementary information
Address ethical considerations
Integrity of data collection: The primary rationale for preserving data integrity is to support the detection of errors in the data collection process, whether they are made intentionally (deliberate falsifications) or not (systematic or random errors).
The two approaches that can preserve data integrity and ensure the scientific validity of study results which are implemented at different points in the research timeline are:
Quality assurance
Quality control
Foundations of Agricultural Research by Prof Jayne MugweJayne Mugwe
This PPT presentation gives overview of Agricultural Research. Explains meaning of scientifc research, Characteristics of research, research process at a glance, Importance of research and research development continnum
Prof Jayne Mugwe
Kenyatta University
An overview of the GPC initiative that resulted in the release of best practices for ensuring validity when oncology clinical trial patients switch treatments.
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.
Engage and Retain Patients in Long-term Observational StudiesJohn Reites
Traditionally, real-world and late phase studies require sites to enroll, engage and retain patients and collect and record patient reported outcomes (PRO), which can be burdensome to both sites and patients. Overtime, sites and patients may lose motivation to participate, contributing to high patient dropout rates, increased study costs and site dissatisfaction. This session will focus on innovative approaches for effectively engaging and retaining patients in long-term studies, such as: identifying design and operational considerations with conducting long-term observational research, understanding site and patient retention challenges, and examining engagement strategies and opportunities for improving retention and compliance.
A community needs assessment identifies the strengths and resources available in the community to meet the needs of children, youth, and families. The assessment focuses on the capabilities of the community, including its citizens, agencies, and organizations.
HOT NEW PRODUCT! BIG SALES FAST SHIPPING NOW FROM CHINA!! EU KU DB BK substit...GL Anaacs
Contact us if you are interested:
Email / Skype : kefaya1771@gmail.com
Threema: PXHY5PDH
New BATCH Ku !!! MUCH IN DEMAND FAST SALE EVERY BATCH HAPPY GOOD EFFECT BIG BATCH !
Contact me on Threema or skype to start big business!!
Hot-sale products:
NEW HOT EUTYLONE WHITE CRYSTAL!!
5cl-adba precursor (semi finished )
5cl-adba raw materials
ADBB precursor (semi finished )
ADBB raw materials
APVP powder
5fadb/4f-adb
Jwh018 / Jwh210
Eutylone crystal
Protonitazene (hydrochloride) CAS: 119276-01-6
Flubrotizolam CAS: 57801-95-3
Metonitazene CAS: 14680-51-4
Payment terms: Western Union,MoneyGram,Bitcoin or USDT.
Deliver Time: Usually 7-15days
Shipping method: FedEx, TNT, DHL,UPS etc.Our deliveries are 100% safe, fast, reliable and discreet.
Samples will be sent for your evaluation!If you are interested in, please contact me, let's talk details.
We specializes in exporting high quality Research chemical, medical intermediate, Pharmaceutical chemicals and so on. Products are exported to USA, Canada, France, Korea, Japan,Russia, Southeast Asia and other countries.
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
These lecture slides, by Dr Sidra Arshad, offer a quick overview of 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 leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
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. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
Follow us on: Pinterest
Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
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!
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
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
Factory Supply Best Quality Pmk Oil CAS 28578–16–7 PMK Powder in Stockrebeccabio
Factory Supply Best Quality Pmk Oil CAS 28578–16–7 PMK Powder in Stock
Telegram: bmksupplier
signal: +85264872720
threema: TUD4A6YC
You can contact me on Telegram or Threema
Communicate promptly and reply
Free of customs clearance, Double Clearance 100% pass delivery to USA, Canada, Spain, Germany, Netherland, Poland, Italy, Sweden, UK, Czech Republic, Australia, Mexico, Russia, Ukraine, Kazakhstan.Door to door service
Hot Selling Organic intermediates
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
1. How to write a study protocol
EPIET, Lazareto, Menorca
September 2005
2. Study protocol
What is it?
• Describes every step of a study
• Answer relevant questions
- public health problem important?
- study question relevant to problem?
- objectives consistent with study
question?
- study design achieves objectives?
- sufficient power?
- public health impact of the findings?
3. Study protocol:
Why do it?
• Check
- can objectives be achieved?
- is study feasible?
• Ensure collect crucial information
• Lay down rules for all partners (quality)
• Obtain approval of ethical committee(s)
• Apply for funds
4. Study protocol
How to start ?
• Get
– good examples
– ideas from similar published studies
– ideas from colleagues
• Use a checklist of items to include
• Obtain requested format
(grant application)
6. 1. Presentation
• Title
– short, accurate, concise
• Investigators
• Main centres
• Steering committee
• Summary of the protocol
7. 2. Background and justification
• Statement of problem, study justification
− importance of subject area
• magnitude, frequency
− gaps in existing knowledge
− principal question(s) to be addressed
− contribution of results to existing knowledge
− public health use of results
• Review relevant literature
8. 3. Objectives
• Should answer the study question
• S.M.A.R.T.
Principal objective
• Must be achieved
• Dictates design and methods
Secondary objectives
• Of interest, but not essential
9. Principal objective
• To determine if sharing a haemodialysis
machine with an HCV infected patient
is a risk factor for HCV infection.
Secondary objective:
• To identify failures in procedures
designed to prevent cross-infection
via haemodialysis machines
3. Objectives
example 1
10. 3. Objectives
example 2
• To estimate the current mortality,
among the Internally Displaced
Population present in the
settlements at the time of the
survey, in each of the
three states of Greater Darfur region
12. Hypotheses
• Translation of the objectives
in terms that allow statistical testing
“The incidence of HCV infection
in haemodialysis patients
is higher
in patients sharing machines
with HCV infected patients
than
in patients not sharing machines
with HCV infected patients”
13. Hypothesis
• The current crude mortality rate
in IDPs in Darfur
is above 1 death per
10,000 per day
CMR > 1/10,000/day
15. 4. Methods
• Procedures to achieve objectives
– what will be done?
– how?
• Information used to judge validity
16. 4. Methods
• Study design
− cohort, case-control, cross-sectional…
− brief justification
• Study population
− definition
− criteria for inclusion and exclusion
− mechanisms of recruitment
− accessibility, follow up, representativeness
17. 4. Methods
• Sampling design
− frame: district, household, persons,…
− method: random, cluster, stratified,…
− randomisation procedures
− replacement procedures (in case of refusal)
• Sample size
− sample size, power calculations based on
principal objective
− feasibility
18. 4. Methods
• Selection and definition
− exposures:
risk factors, protective factors, confounding factors
− outcomes:
definition of case and the control group
• Items to be measured
– scales used
• e.g: smoking ? lung cancer
- smoking: definition, quantification, categories
- lung cancer: case definition, control group definition
19. CC study of sporadic cases
of Salmonella Enteritidis infection
• Exposure
– consumption of custard slices
• Case
– a person living in South-West Wales with
a laboratory confirmed infection due to S.Enteritidis
in June and July 1991
• Case finding
– through Public Health Laboratory; weekly notifications
• Control
– persons living in SW Wales in same neighborhood as
cases
• Control finding
– random selection of people using telephone’s directory
20. Methods
Data analysis plan
• Structured in terms of objectives
• Hypotheses tested, dummy tables
• Statistical tests used, adjustment,
standardisation
21. Methods
Data analysis plan
• Define
– indicators you will need to reach objectives
– data you will need to collect
• Better estimates of sample size
for analysis of sub groups
22. Methods
Data analysis
Dummy table:
Food specific attack rates of Salmonella infection
in a day care centre, Paris, May 1999
ill
n
total
n
AR
%
RR 95%CI
ice-cream yes
ice-cream no
fruit cake yes
fruit cake no
pudding yes
pudding no
23. Methods
Data analysis
Case-control study, risk factors for brucellosis in France
Cases Controls OR
Exposed Unexp Exposed Unexp
Age group
< 15
15 – 25
26 - 60
> 60
Sex
M
F
Occupation
Travel
Cheese
24. 4. Methods
Data collection
• How
− interview, observation, record review
• By whom
− interviewers: selection, training
− level of supervision
• Tools
− questionnaires, recording materials
− questionnaires: self or interviewer administered,
face to face or telephone interview
• Procedures for taking samples
25. 4. Methods
Data handling
• Coding
− during data collection, afterwards?
− by whom?
• Processing
− software, hardware
− entry
• during the study, afterwards?
• single entry, double entry?
• Validation and data cleaning
26. 4. Methods
Pilot studies, pre-testing
• No study without test
− Feasibility of sampling
− Data collection, measurement methods
− Questionnaire
• Describe how to test
27. 4. Methods
Limitations
• Identification of potential sources of biases
− selection bias
− information bias
• How to deal with them
− possibilities for correcting
− how they will affect the results
29. 5. Ethical considerations
• Informed consent
• Confidentiality, record anonymity
• Data storage and protection
• Ethical committee
30. 6. Project management
• Participating institutes and persons
• Responsibilities and tasks of each partner
• Data ownership
31. 7. Timetable
Planning/organisation of the study
• questionnaire design, recruitment, purchases
• permission
• obtain funding
“Pilot study”
Final study
• data collection
• analysis
• presentation of results and write up
32. 8. Resources
• Extent of this section depends on target
audience
• Specify
− available sources
− requested sources
• Keep budget
− reasonable
− detailed
− well justified
33. 9. References
• Limit number of references to key
articles
• Follow recommended style
• Vancouver
www.library.soton.ac.uk/infoskills/vancouver.shtm
l
34. 10. Appendices
• Methodological appendices
• List of definitions
• Questionnaires
• Introductory letters to study participants
• Forms for informed consent
…..
35. Common problems
• Too ambitious: too many questions
• Insufficient attention to literature
• Poor justification
− why is it important to answer this question?
− what impact does it have on public health?
• Poorly formulated objectives
• Inappropriate analysis
• Inadequate description
• Absence of pilot
Next week
One of the key EPIET objectives
Cover all the ingredients that should go into the recipe
Temptation to be veryAmbitious
Opportunity to identify gaps – ensure collect crucial information
Key investigators
Main centres involved in study
SC responsible for overseeing the conduct of the study
Summary of main elements of the protocol
Statement of the problem, why are you undertaking the study?
What is the PH importance of the disease or the condition that you want to study. Is it very common? Is it very serious? Is there a lot of public concern?
Are there any gaps in existing knowledge that could aid the development of intervention measures? This could be in terms of risk factors for infection or identifying or effective control measures
What is the principle question that you want to address? Important the study is focused. Not too many questions that you are trying to address.
How will the results of your study contribute to the what we already know.
How can the results be used in public health terms.
An important part of the background – is a short focused review of the literature, identifying they key, most recent articles.
Next section is the OBJECTIVES.
These should ANSWER the study question.
Your objectives should be SMART:
Specific = focused
Measurable =
Action Oriented = measure/describe something IN ORDER TO
Realistic =
Time oriented =
Divided into primary and secondary objectives.
PRIMARY - have to be achieved. THIS objective is the one the dictates how you undertake the study – in terms of study design and the methods used.
SECONDARY – are of interest, but not so critical if not able to achieve.
Example 1: Principle and secondary objectives.
Are these SMART?
Specific = …Study population. Clear question. Non-specific would be “to identify risk factors for HCV infection”…no primary question
Measurable = …could think of potential study designs to address this objective for example case-control design…
Action oriented = why undertaking study? In order to inform HD prevention measures.
Realistic = HCV prevalence pretty high in this population….probably realistic to undertake a study such as this.
Time oriented =
Is this SMART?
Specific = study population (IPD in Darfur), outcome = mortality
Measurable = using survey
Action-oriented = ? Lacking. Why are we looking at this objective.
Realistic = seems quite ambitious…..
Time-oriented = when is the study period?
Once you’ve defined your SMART objectives….you then need to turn your objectives into terms that allow you to undertake statistically test…..
So how do we do that practically?
When we hypthothsis test, we usullay start with a null hypthosis – that there is not a significant effect – with our alternative hypothsis, we define the effect or the difference that we wish to detect.
If we look at the objectives that we have already defined, our alternative hypothsis is:
Analytical study:
Outcome (incidence of HCV)
Exposures (patients sharing machine and NOT sharing a machine)
Descriptive survey:
Outcome of interest – crude mortality rate.
Is the CMR above a certain critical threshold level….1/10 000….which
Is indicative of a public health emergency…..highlights need to PH action.
What should the methods include?
Describe what needs to be done to achieve your objectives – i.e. details of your study design.
Need to include enough information on your methods to be able to judge whether or not they are actually valid…will they be able to answer the question you set out at the beginning.
Study design
Type of study design cross sectional, longitudinal retrospective prospective , case-control, For example to answer your question regarding HCV amongst haemodialysis patients.
Brief justification for the design chosen – why have you chosen a cohort study, rather than a case-control design to answer your question??
Study population
What will be the study population? For your study on HCV in haemodialysis patients. Will it be all patients attending a particular clinic, or a series of clinics? The criteria that you will use to select and define the study population needs to be carefully defined.
This needs to be linked to your original study objectives. You need to take into account various factors including the accessibility, co-operation and stability of your study population – which has important implications for follow up. Also the representativeness of your study sample – which will allow you to generalise your results. So you need to think carefully about which population you would like your results to be applied to.
For example: nurses studies, physician cohort – have different issues regarding accessibility, co-operation, stability and implications for follow up.
What will be your criteria for inclusion and exclusion. Time, place and person issues can help here. For example only including persons who were resident in a certain place in a certain period of time, can be used to define your study cohort.
What will be your sampling design?
What will be the sampling frame? We heard earlier that the frame is the list of all the sampling units that you will sample from. It could be all the households in a certain town, or all the persons in a school etc….
What will be the method of sampling? Will it be simple, random sampling, cluster sampling, stratified sampling. We heard earlier about the indications for each…and their strengths and weaknesses.
For any randomisation procedures – how will these be undertaken? Using software such as Epi-Info or random number tables or…..
If you are not able to recruit a particular sampling unit – if it is not accessible (e.g. in certain parts of Darfur) or if a person refuses to take part in the study. What do you do then? Do you recruit a replacement – and if so how selected? ….
It is also critical that you include sample size or power calculations. This should be based upon your primary objective. If there are important sub-group analyses – then these should be included too. The results of this will also give a clear indication of the feasibility of your study…particularly in terms of the resources that might be avilable – in terms time, persons and money…….
You need to include in very clear terms in the methods:
Definitions of both the EXPOSURES and the OUTCOMES need to be clearly made.
EXPOSURES can be of three types – risk factors e.g. particular food item, protective factors e.g. vaccination and (potential) confounding factors e.g. age, gender.
You also need to define your OUTCOMES – i.e. clear case definition….and for a case-control study defining the control population….and how each will be selected.
For each of these items – you need to define carefully the scale you will be using.
E.g. for a case-control study on whether smoking causes lung cancer – you need to carefully define your exposure – which in this case is SMOKING. Are we only interested in active, current smoking? How will we quantify – cigarettes/day? What categories will we use?
We also need to define our outcomes. What will be a case of lung cancer? How will we define our control population – who should provide an estimate of the exposure in the source population which gave rise to the cases.
Here, we have a practical example. A case-control study of looking for risk factors for infection amongst sporadic cases of Salmonella enteritidis.
In this study, we have carefully defined our:
Exposure:
Who is a case: in terms of time, place, person and clinical features.
How we will find our cases.
Who will be in our control series: and thus provide an estimate of exposure in the source population which gave rise to the cases.
Finally – how we will find our controls: using random selection.
Your methods also need to include a data analysis plan.
This should be structured according to your principle and secondary objectives.
You need to make sure that you test each of your hypotheses – and present the dummy (or pretend tables) to show how you will do this.
State what statistical tests you will use – will you estimate the relative risk – with 95% ci. Or the OR. Matched or unmatched? Will this just be the crude or adjusted – what variables will potentially be included in your adjustment.
So your data analysis plan will define the indicators that you will need to present to reach your objectives.
And also indicate the data that you will need to collect to meet those objectives.
Once you have seen your data analysis plan – you may then realise the key importance of some sub-group analyses – and you can then refine your sample size estimates accordingly.
This is a dummy table for a retrospective cohort study of an otbreak of Salmonella in a day-care centre in Paris.
You can clearly see the different exposures that will be examined. The number of ill cases and totals in the exposed and unexposed cohorts, the AR and finally the RR for each food item together with its associated 95% confidence interval.
Contrarily, this is a dummy table for a case-control study to look at risk factors for brucellosis infection in France. Here we can see our cases and controls and the numbers of each that will have been exposed and unexposed for a series of different exposures. From this can be derived the odds ratio of various exposures amongsts cases compared to controls.
Then in the methods, you need to describe how the data will be collected.
HOW, BY WHOM, WITH WHAT.
The HOW – could be by interview, observation of the study participant or review of medical records.
The BY WHOM – will
Another important methods section is how will the data be handled?
This should include:
CODING of the data that you have collected. E.g. male = 0, female = 1 etc.
When will this happen – during data collection, or after?
Who will do it?
2. DATA PROCESSING – what software and hardware will be used? To create the data-base.
When will the data be entered – during or after the study. Will there be single or double entry.
3. WHAT VALIDATION CHECKS and CLEANING will be undertaken. This could be e.g. range checks, outlying values etc etc.
One of the key messages is NO STUDY WITHOUT A TEST or PILOT……
This allows the team to look at the feasibility of the proposed sampling method, to test the data collection tool…in particular the questionnaire
Try to outline how it will be tested….on whom? Where? When?
It is usually good practice to also give some thought already to the possible limitations of your study…this allows you to already think in the design phase how you might deal with these issues.
In particular, you should think of potential biases in your study…you will hear in the next lecture by MARTA, what the various different biases are…these might be selection or information biases etc etc.
There might be possibilities to correct them..either in your design – or possibly in your analysis. If not, you need to state how they might distort your results
The final part of your protocol outline, should include these key elements……
You need to give careful thought to the ethical dimensions of your study.
Usually planned research studies should be submitted for review by an ethical committee…
In this you will need to give thought to issues such will there be informed consent to take part in a study. How will this operate for children etc….
How will you ensure confidentiality? Will you anonymise records?
How will data be stored? For how long? Which could be patient identifiable and potentially of a sensitive nature be protected.
There should be a section devoted to how the project will be managed.
This should include all the participating institutes and persons.
What each of their roles and responsiblites will be?
Who will analyse the data, who will write it up?
Who will own the data?
Publication of report and articles – including issues such as authorship – which can often be contentious.
Another important part of the protocol is the study time-table.
You can make one of these summaries in a GANTT chart (microsoft project), but also Excel.
This should include the timing of all the elements from beginning to end – from planning the study, the pilot and the main study – data collection, analysis and presentation.
Resources….can be critical. It depends on the audience. At a minimum, it should include information on what possible sources of funding might be approached, or perhaps have been approached and the total sum involved.
If this is an application to a funding agency – it will need to reasonable, quite detailed and justified – broken down into the various sections – person time consummables, overheads etc.
Key references should be included.
Not an exhaustive list – just the key ones.
Follow the recommended style….the default is Vancouver.
More details available at….
In the appendix – you can include various other sections for reference for those who might be interested…..
What are the most common problems in a study protocol?
One of the most common…is being overly ambitious…too many questions. It is really critical that you focus on a key question…the rest of the protocol should follow from that.
Another is not enough attention being paid to the literature…what is already known and has been done before. You need to identify the gaps in knowledge that your study will address…..
You need to give a strong justification for your study – why is your question of particular importance, what impact will your study have on public health. Remember – you will usually be competing for limited resources
Your objectives need to be very clearly stated (SMART!!)
Ensure your analysis is appropriate e.g. matched design = matched analysis.
Give adequate description to each stage…particularly the methods
And finally ensure you have a pilot.