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Health-Research-Methods-HRM-1.pptx
1. M U H A M M A D S A L M A N
L E C T U R E R
P U N J A B U N I V E R S I T Y C O L L E G E O F
P H A R M A C Y
Health System Research (HSR)
2. Research?
Research simply seeks the answer of certain
questions which have not been answered so far and
the answers depend upon human efforts
3. Example of the moon
Some years ago man did not know what exactly the
moon is?
Was this problem which had no solution?
Man could only make some assumptions about it but
the man know this time by his efforts, he went to the
moon brought the soil of the moon and studied it
The man is now able to give concrete answer of the
problem what is the moon?
4. Now the question arises
“Is the answer of the question in examination also
research”?
The answer is ‘no’, because the answers of these
questions are available (text-books, class-notes etc)
Research answers only those questions of which the
answers are not available in literature i.e., in human
knowledge
5. Therefore, we can say research seeks the answer only of those
questions of which the answers can be given on the basis of
available facilities
Research is simply the process of arriving as dependable
solution to a problem through the planned and systematic
collection, analysis and interpretation of data
It is the most important process for advancing knowledge for
promoting progress
Also enables man to relate more effectively to his environment
to accomplish his purpose and to resolve his conflicts
7. “Research is a systematized effort to gain new
knowledge.” (V. Redman and A.V.H. Mory)
“Research is an honest exhaustive, intelligent
searching for facts and their meanings or
implications with reference to a given problem. The
product or findings of a given piece of research
should be an authentic, verifiable and contribution
to knowledge in the field studied.” (P.M. Cook)
8. He emphasized the following characteristics of
research in his definition:
It is an honest and exhaustive process.
The facts are studied with understanding.
The facts are discovered in the light of problem. Research is
problem-centred.
The findings are valid and verifiable.
Research work should contribute new knowledge in that field
9. Objectives of research
Theoretical objective
Formulate the new theories, principles or laws.
Such type of research is explanatory because it explains the
relationship of certain variables.
These researches contribute some basic knowledge to the
human knowledge.
The researches in different disciplines such ads physics,
chemistry, mathematics etc. have theoretical objective.
10. Factual objective
Researches whose objective is factual find out new facts
This objective is by nature descriptive
Application objective
Research having application objective does not contribute a
new knowledge in the fund of human knowledge but suggests
new applications. By application we mean improvement and
modification in practice.
For example if anyone gives a new application of electricity
then such type of research has application objective
11. General characteristics of research
Gathers new knowledge or data from primary or first –hand sources
Places emphasis upon the discovery of general principles
An exact systematic and accurate investigation
Uses certain valid data gathering devices
Logical and objective
Researcher resists the temptation to seek only the data that support
his/her hypotheses
Researcher eliminates personal feelings and preferences
Endeavors to organize data in quantitative terms
Patient and unhurried activity
Researcher is willing to follow his/her procedures to the conclusions
that may be unpopular and bring social disapproval
Research is carefully recorded and reported conclusions and
generalizations are arrived at carefully and cautiously
12. Health research → A systematic collection, analysis and
interpretation of health and health-related data to answer a
certain question or to solve a problem
Health systems research also known as health services
research or health policy and systems research
Health systems research → "The people, institutions, and
activities whose primary purpose is to generate high quality
knowledge that can be used to promote, restore, and or
maintain the health status of populations. It can include the
mechanisms adopted to encourage the utilization of research.“
(HRSA, WHO)
13. Classification of Research
Basic level
It is designed to add an organized body of scientific knowledge
and does not necessarily produce results of immediate
practical value
Applied level
Applied research is undertaken to solve an immediate practical
problem and the goal of adding to scientific knowledge is
secondary
14. Kinds of research
There are various bases to classify the research
On the basis of objective of the research
Fundamental research
Action research
On the basis of approach of the research
Longitudinal research
Cross sectional research
On the basis of precision in research findings
Experimental research
Non experimental research
15. On the basis of nature of findings
Explanatory research
Descriptive research
According to national science foundation
Basic research: Those researches which embrace origin or
unique investigation for the advancement of knowledge
Applied research: which may be characterized as utilization in
practice
Developmental research: use of scientific knowledge for the
production of useful materials, devices, systems, methods for
processes excluding design and production engineering.
16. Health research triangle
three operational interlinked categories of biomedical, health services and behavioral
research, the so-called health research triangle
Bio-medical Behavioral
Health services
17. Research process
Selection of Research problem
Formulation of hypothesis
Research plan
Data collection
Analysis of data
Formulation of result and conclusions
19. Hypothesis
Carefully constructed statements about a
phenomenon in the population
Generated by deductive reasoning, or based on
inductive reasoning from prior observations
One of the most useful tools of health research is the
generation of hypotheses which, when tested, will
lead to the identification of the most likely causes of
disease or changes in the condition being observed
20. Mill’s canons of inductive reasoning are frequently
utilized in the forming of hypotheses which relate
association and causation.
Method of difference - when the frequency of a
disease is markedly dissimilar under two
circumstances, and a factor can be identified in one
circumstance and not the other, this factor, or its
absence, may be the cause of the disease
for example → the difference in frequency of lung
cancer in smokers and nonsmokers
21. Method of agreement - if a factor, or its absence is
common to a number of different circumstances that
are found to be associated with the presence of a
disease, that factor, or its absence may be causally
associated with the disease
The occurrence of hepatitis A is associated with
patient contact, poor sanitation and hygiene, each
conducive to the transmission of the hepatitis virus
22. Method of concomitant variation, or the dose response
effect
The increasing expression of endemic goiter with
decreasing levels of iodine in the diet
The increasing frequency of leukemia with increasing
radiation exposure
The increase in prevalence of elephantiasis in areas of
increasing filarial endemicity
23. Method of analogy – the distribution and frequency
of a disease or effect may be similar enough to that of
some other disease to suggest commonality in cause
e.g. hepatitis B virus infection and cancer of the liver
24. Research plan/design
Defining the population, characteristics of interest
and probability distributions
Type of study
observational or experimental
25. method of data collection, management and analysis:
sample selection
measuring instruments (reliability and validity of instruments)
training of interviewers
quality control of measurements
computerization, checking and validating measurements
the issue of missing observations
statistical summarization of information
testing of hypothesis
ethical considerations
Conclusions
26. Deductive Reasoning
Thinking precedes from general assumption to specific
application
GENERAL → SPECIFIC
Inductive reasoning
Conclusions about events are based on information generated
through many individual and direct observations
SPECIFIC → GENERAL
27. Inductive reasoning Deductive reasoning
SPECIFIC → GENERAL GENERAL → SPECIFIC
Every rabbit has been observed has
lungs. Therefore, every rabbit has lungs
Every mammal has lungs. All rabbits
are mammals. Therefore, every rabbit
has lungs.
30. Classification
Non-international
AKA observational studies
Researchers do not manipulate situations/objects
Only describes or analyses situations/objects
Interventional
Participants are assigned to receive one or more interventions
(or no intervention) so that researchers can evaluate the effects
of the interventions on biomedical or health-related outcomes.
31. Non-interventional studies
Descriptive studies
Case series
Community diagnosis or need assessment
Epidemiological description of disease occurrence
Descriptive cross-sectional studies
Ecological descriptive studies
Analytical studies
Case-control studies
Cohort studies
Prospective cohort studies
Retrospective cohort studies
Analytical cross-sectional studies
32. Descriptive studies
When an epidemiological study is not structured
formally as an analytical or experimental study i.e.
when it is not aimed specifically to test a hypothesis,
it is called a descriptive study
The wealth of material obtained in most descriptive
studies allows the generation of hypotheses, which
can then be tested by analytical or experimental
designs
33. Case series
based on reports of a series of cases of a specific condition, or a
series of treated cases, with no specifically allocated control
group
These represent the numerator of disease occurrence, and
should not be used to estimate risks
34. Community diagnosis or needs assessment
This kind of study entails collection of data on
existing health problems
Programs
Achievements
Constraints
social stratification
leadership patterns
focal points of resistance or high prevalence, or groups at highest
risk.
Its purpose is to identify existing needs and to provide baseline
data for the design of further studies or action
35. Epidemiological description of the disease occurrence
This common use of the descriptive approach involves the collection of
data on the occurrence and distribution of disease in populations
according to
specific characteristics of individuals
Age
Sex
Education
Smoking habits
Religion
Occupation
social class
Marital status
Health status
Personality
Place (rural/urban, local, national, international)
Time (epidemic, seasonal, cyclic, secular)
36. Descriptive cross-sectional studies
AKA population/community surveys
Entail the collection of data on, as the term implies, a cross-section
of the population, which may comprise the whole population or a
proportion (sample) of it
Many cross-sectional studies do not aim at testing a hypothesis about
an association
Provide a prevalence rate at a particular point in time → point
prevalence
Or over a period of time → period prevalence
37. Ecological descriptive studies
When the unit of observation is an aggregate (e.g. family, clan
or school)
Or an ecological unit (a village, town or country) the study
becomes an ecological descriptive study
38. Analytical strategies of epidemiological studies
Observational studies, where establishing a relationship
between a ‘risk factor’ (etiological agent) and an outcome
(disease) is the primary goal, are termed analytical
hypothesis testing is the primary tool of inference
39. Case-control studies
Simplest and most commonly used analytical strategy in
epidemiology
Designed primarily to establish the causes of diseases by
investigating associations between exposure to a risk factor
and the occurrence of disease
Design is relatively simple, except that it is backward-looking
(retrospective) based on the exposure histories of cases and
controls
40. one investigates an association by contrasting the exposure of
a series of cases of the specified disease with the exposure
pattern of carefully selected control groups free from that
particular disease
41. Advantages Disadvantages
Relatively quick and inexpensive great risk of bias in the selection of
cases and
Controls
feasible for rare disease Prone to recall bias (it may be very
difficult or impossible to obtain
information on exposure if the recall
period is long)
Requires a smaller sample size than
cohort study
Cannot measure incidence, only relative
risk is measured
Little problem with attrition, as when
follow-up requires periodic
investigations and some subjects refuse
to continue to cooperate
42. Cohort studies
Prospective cohort study
The common strategy of cohort studies is to start with a reference
population (or a representative sample thereof)
Some of whom have certain characteristics or attributes relevant to
the study (exposed group), with others who do not have those
characteristics (unexposed group)
Both groups should, at the outset of the study, be free from the
condition or conditions under consideration
Both groups are then observed over a specified period to find out the
risk each group has of developing the condition(s) of interest
45. Design features
Selection of cohort
a community cohort of specific age and sex
an exposure cohort, e.g. radiologists, smokers, users of oral
contraceptives
a birth cohort, e.g. school entrants
an occupational cohort, e.g. miners, military personnel
a diagnosed or treated cohort, e.g. cases treated with radiotherapy,
surgery, hormonal treatment
The usual procedure is to locate or identify the cohort, which
may be a total population in an area or sample thereof
46. Data to be collected
data on the exposure of interest to the study hypotheses
data on the outcome of interest to the study hypotheses
characteristics of the cohort that might confound the association
under study
Methods of data collection
Several methods are used to obtain the above data, which should
be on a longitudinal basis.
These methods include
Interview surveys with follow-up procedures
Medical records monitored over time
Medical examinations and laboratory testing
47. Measures of frequency
Cumulative incidence
Incidence density (Person-year approach)
48. In September 2009, 3000 Birmingham university freshman enrolled in a study
of health behaviors that aimed to track them over 4 years of college. Data from
September 2012 are shown below
What is the cumulative incidence of obesity over 4 years?
No. of
new
cases
No of
students
“at risk”
at the
begining
Admitted to the emergency room for an alcohol-related
injury
400 3500
Unintended pregnancy? 252 2000
Diagnosed with depression? 310 3000
Obese? 543 2100
49. Person-time approach/incidence density
This approach is an improvement over the conventional
measure of incidence, because it takes into consideration both
the number observed and the duration of observation for each
individual
If 30 individuals were observed as follows: 10 for two years, 5
for three years, and 15 for four years, they would contribute
(10x2)+(5x3)+(15x4) = 95 person-years of observation, which
would become the denominator. The numerator is the number
of new cases observed in these groups over the specified period
of time………
50. Advantages Disadvantages
Allow calculation of incidence rates,
relative risk , attributable risk etc.
Expensive
If a probability sample is taken from the
reference population, it is possible to
generalize from the sample to the
reference population with a known
degree of Precision
long-term and sometimes are not
always feasible
capable of identifying other diseases
that may be related to the same risk
factor
Sample sizes required for cohort studies
are extremely large
The most serious problem is that of
attrition
52. Analytical cross-sectional study
Investigator measures exposure and disease simultaneously in
a representative sample of the population
By taking a representative sample, it is possible to generalize
the results obtained in the sample for the population as a
whole
Cross-sectional studies measure the association between the
exposure variable and existing disease (prevalence)
Unlike cohort studies, which measure the rate of developing
disease (incidence)
54. Experimental study designs
An experiment is the best epidemiological study
design to prove causation
Viewed as a final or definitive step in the research
process
A mechanism for confirming or rejecting the validity
of ideas, assumptions, postulates and hypotheses
about the behavior of objects, or effects upon them
which result from interventions under defined sets of
conditions
55. Investigator has control of the subjects, the
intervention, outcome measurements, and sets the
conditions under which the experiment is conducted
In particular, the experimenter determines who will
be exposed to the intervention and who will not
This selection is done in such a way that the
comparison of outcome measure between the
exposed and unexposed groups is as free of bias as
possible
57. The most commonly encountered experiment in
health science research, and the research strategy by
which evidence of effectiveness is measured, is the
randomized, controlled, double-blind clinical trial,
commonly known as an RCT
58.
59. Clinical trials may be done for various purposes
Some of the common types of clinical trial (according
to purpose) are:
prophylactic trials, e.g. immunization, contraception
therapeutic trials, e.g. drug treatment, surgical procedure
safety trials, e.g. side-effects of oral contraceptives and
injectable
Risk-factor trials, e.g. withdrawing the agent (e.g. smoking)
through cessation
60. Therapeutic trials may be conducted to test efficacy
does a therapeutic agent work in an ideal, controlled
situation?
or to test effectiveness (e.g. after having established
efficacy, if the therapy is introduced to the
population at large, will it be effective when having
to deal with other co-interventions, confounding,
contamination, etc.?
61. The intervention in a clinical trial may include
drugs for prevention, treatment or palliation
clinical devices, such as intrauterine devices
surgical procedures, rehabilitation procedures
medical counselling
diet, exercise, change of other lifestyle habits
risk factors
communication approaches, e.g. face-to-face communication versus
pamphlets
different categories of health personnel, e.g. doctors versus nurses
treatment regimens, e.g. once-a-day dispensation versus three times
a day
62. Usually, clinical trials of new therapies or devices
pass through four phases
Phase I
Phase II
Phase III
Phase IV
63. Phase I clinical trial
This first phase in humans is preceded by
considerable research
Including pharmacological and toxicological studies
in experimental animals
To establish that the new agent is effective and may
be suitable for human use,
And to estimate roughly the dose to be used in man
64. Phase I trials include studies of volunteers who
receive, initially, a fraction of what the anticipated
dose is likely to be
And are monitored for effects on body functions,
such as
Hepatic
Cardiovascular
Renal
Gastroinstestinal
Endocrinal functions
65. The metabolism of the drug may also be investigated
at this stage
These studies are normally done on volunteers, who
are usually institutionalized, and occupy what are
called ‘research beds’
Require close supervision
short duration
66. Phase II clinical trial
Also carried out on volunteers selected according to
strict criteria
Purpose of Phase II is
to assess the effectiveness of the drug or device
to determine the appropriate dosage
to investigate its safety
Further information on the pharmacology, especially
the dose-response relationship of the drug, is
collected
67. Phase III clinical trials
This is the classical phase
The one usually referred to as a ‘clinical trial’ and
reported in health research journals
Performed on patients, who should consent to being
in a clinical trial
Strict criteria for inclusion in and exclusion
purpose of this phase is
to assess the effectiveness
to assess safety in continue use of the drug or device in a larger
and more heterogeneous population than in Phase II
68. It includes more detailed studies and monitoring
than those given in a normal service situation
Usually carried out on hospital inpatients, but may
be performed on outpatients with intense monitoring
follow-up
It requires superior clinical and epidemiological
skills, in addition to the required laboratory
technology
69. Results from these trials are used by regulatory
agencies to evaluate whether a new product or device
should be licensed for general public use
70. Phase IV
To identify and evaluate the long-term effects of new
drugs and treatments over a lengthy period for a
greater number of patients.
Phase IV research takes place after the FDA approves
the marketing of a new drug
Through Phase IV clinical studies, new drugs can be
tested continuously to uncover more information
about efficacy, safety and side effects after being
approved for marketing
71. Factors that affect the design of and analysis of
trial (phase III)
The agent, treatment or experimental factor
Conditions to be treated
The target population
Ethical issues
Outcomes to be measured
Side-effects
Study instruments
Blinding
Stopping rule
Plans for the analysis
Selective attrition
Methods for ensuring the integrity of the data
The choice of design
Time required
72. Community intervention trials
CITs are usually carried out in hospitals or clinics,
and are usually directed at a patient group with
specific health conditions
a test of whether the introduction of iron-fortified
salt in the community would reduce the incidence of
anemia in the community
The major difference from the RCT is that the
randomization is done on communities rather than
individuals
Notas del editor
Research has moved during this century from the periphery to the centre of our social and economic life. What is the nature of this force? Why it is getting momentum? Most of us recognize that the progress which has been made in our society has been largely the result of research, we do not have an exact definition of the term. Most of us have a vague idea of what is involved but our concept of research generally is too much oriented toward experimentation as conducted in the social sciences
Although it is not the only way, it is one of the more effective ways of solving scientific problems.
P.M. Cook has given a very comprehensive and functional definition of the term research
Researches whose objectives are theoretical formulate the new theories, principles or laws
Trevers has defined basic level as basic research
Explanatory research-Such researches explain more concerned theories. laws and principles. DR-more concerned with facts
Another way of classify health research, be it empirical or theoretical, basic or applied, is to describe it under three operational interlinked categories Biomedical: deals primarily with basic research involving processes at the cellular level; behavioral: deals with the interaction of man and the environment in a manner reflecting the beliefs, attitudes and practices of the individual in society; health services: Deals with issues in the environment surrounding man, which promote changes at the cellular level
Stephen M. Corey
Although we cannot draw definite conclusions, or claim proof using the inductive method, we can come ever closer to the truth by knocking down existing hypotheses and replacing them with ones of greater plausibility
In health research, hypotheses are often constructed and tested to identify causes of disease and to explain the distribution of disease in populations
Elephantiasis refers to a parasitic infection that causes extreme swelling in the arms and legs. The disease is caused by the filarial worm, which is transmitted form human to human via the female mosquito when it takes a blood meal
The critical requirement in the design of research, the one that ensures validity, is the evaluation of probability from beginning to end. The most salient elements of design, which are meant to ensure the integrity of probability and the prevention of bias, are: representative sampling, randomization in the selection of study groups, maintenance of comparison groups as controls, blinding of experiments and subjects, and the use of probability (statistical)
methods in the analysis and interpretation of outcome. Probability is a measure of the uncertainty or variability of the characteristic among individuals in the population.
Many ways but major types are interventional and non-interventional
Secular is a descriptive term used to refer to market activities occurring over a long-term time frame.
The basic approach in analytical studies is to develop a specific, testable hypothesis, and to design the study to control any extraneous variables that could potentially confound the observed relationship between the studied factor and the disease
Cumulative incidence: This incidence measure provides an estimate of the probability or risk of developing disease among all members of the group who were included in the study at its initiation, and were at risk
of disease.
Person-years do not represent the number of persons: 400 person-years of observation could represent 400 persons each observed for one year, or 40 persons each observed for 10 years
In health research, we are often interested in comparative experiment, where one or more groups with specific interventions is compared with a group unexposed to interventions (placebo in clinical trials) or exposed to the best treatment currently available.
This phase, which is of short duration (usually one or two months), requires high technology in biochemistry, pharmacology and endocrinology, and varied medical expertise. It also requires access to highly
developed laboratory facilities
(one could argue that it is still only an efficacy trial, because of the strict conditions under which the study is conducted)
Knowledge that is as complete as possible about the treatment should be available to the researchers. This knowledge usually comes from Phase I and Phase II trials, as well as from many ancillary sources. For example, one should know the pharmacological action, toxicity, dose, safety and method of
administration of the drug.
Stopping rule: Criteria for terminating the trial should be clearly specified. In most cases, a fixed sample size has to be reached before the trial is stopped. A variation on his is the sequential clinical trial, where the results are analysed frequently, and the trial stopped as soon as statistically significant differences are observed.