Critical Appraisal
Validity
01
Validity
● Results of a study are valid when the observed or estimated
parameter is the same as the true/actual value.
● The term bias refers to a systematic error in the study relating
to its design, data collection methods, or data analysis.
● Biases in epidemiological/patient-based studies fall into 3
categories: selection bias, information bias, and confounding
bias
● Criteria that are helpful for evaluating data include the study
design and the type of question being addressed (diagnosis,
treatment, prognosis, or harm).
Validity
● we will focus on appraisal of the literature based on the
primary clinical activities with which we are engaged in
clinical practice:
○ 1) choosing and interpreting diagnostic tests;
○ 2) selecting treatments/interventions; and,
○ 3) making prognoses.
Validity
Apakah uji diagnostic ini valid?
● Apakah uji diagnostik dibandingkan dengan baku emas yang
benar?
● Apakah pemeriksaan uji dan baku emas dilakukan secara
independen?
● Apakah uji diagnostik dilakukan terhadap spektrum pasien
seperti dalam praktik sehari hari ?
● Apakah pemeriksaan baku emas dilakukan kepada seluruh
subyek tanpa melihat hasil uji diagnostik?
How to read
an article?
TYPES OF SCHOLARLY ARTICLES
● Not every article in a scholarly, peer-reviewed journal is a
research article. There are several other types you may
encounter:
○ News, book reviews, opinion/editorials, letters to the
editor
○ Theoretical articles, relating to abstract principles – do not
contain original research
○ Review articles – summaries of the current research in a
field, but not considered to be research articles
themselves
WHAT IS A RESEARCH ARTICLE?
● A research article reports on the results of a study or
experiment. It is written by the person or people who did the
research. It is new, original work that has not been done
before.
● Look for these words in the title and abstract:
• Study
• Research
• Measure
• Subjects
• Data Effects
• Survey
• Statistical
THE ABSTRACT
● The abstract is a summary of the article.
● The abstract will give you enough information to determine
whether you want to use this article as a source.
THE LITERATURE REVIEW
● It gives the reader a summary of other research findings and
the current state of understanding of the topic, including areas
of incomplete data and questions that remain.
THE RESEARCH QUESTION
● The authors explain their hypothesis – the question they were
trying to answer with the study they have done.
● They should be doing something new, not simply copying what
someone else has already done.
● The authors may predict what they think they will find, and will
test their hypothesis to see if it is true.
MATERIALS AND METHODS I
● This section gives the details of the experiment:
○ How it was conducted
○ What techniques were used
○ What subjects were studied
○ How many people, animals or cells were included in the
study
○ The type of study
RESULTS
● This section presents the study’s findings, often using graphs
and statistical tables to illustrate.
● You will see statistical terms such as:
○ Mean – the average value of the responses
○ Standard deviation – how the variables are distributed
around the mean. A larger number means the responses
are more spread out: they deviate more from the mean.
○ P-value – a measure of how trustworthy the results are. A
pvalue will tell you whether the results are considered
statistically significant. When p < .05, it means there is a
95% chance that the differences in the study groups were
due to the manipulations of the study, and not due to
chance.
Diagnostic
02
Overview
Diagnose is a verb that means to:
● Identify
● Determine
● Distinguish
● Pinpoint
● Recognize characteristic that are individual peculiar and
proper
Characteristic of diagnostic test
● It must provide series of scores, each representing
performance in specific skill
● The respective skill must be carried to the over all
performance being evaluated such as reading achievement or
arithmetic achievement
● The sub test used to access each of these skills must
represent a valid measure
● Each subset must have high reliability
● The correlation among subset must be low
Preperation
DIAGNOSIS WORKSHEET
Apakah uji diagnostic ini valid ?
● Apakah uji diagnostik dibandingkan dengan baku emas yang
benar?
● Apakah pemeriksaan uji dan baku emas dilakukan secara
independen?
● Apakah uji diagnostik dilakukan terhadap spektrum pasien
seperti dalam praktik sehari hari ?
● Apakah pemeriksaan baku emas dilakukan kepada seluruh
subyek tanpa melihat hasil uji diagnostik?
DIAGNOSIS WORKSHEET
Apakah uji diagnostik ini penting ? Ya
● Sensitivitas : ?
● Spesifisitas :?
● NPV :?
● PPV :?
SAMPLE CALCULATIONS
DIAGNOSIS WORKSHEET
● Sensitivity = a/(a+c) = 731/809 = 90%
● Specificity = d/(b+d) = 1500/1770 = 85%
● Likelihood ratio for a positive test result = LR+ = sens/(1-spec)
= 90%/15% = 6
● Likelihood ratio for a negative test result = LR - = (1-sens)/spec
= 10%/85% = 0.12
● Positive Predictive Value = a/(a+b) = 731/1001 = 73%
● Negative Predictive Value = d/(c+d) = 1500/1578 = 95%
● Pre-test probability (prevalence) = (a+c)/(a+b+c+d) = 809/2579
= 32%
● Pre-test odds = prevalence/(1-prevalence) = 31%/69% = 0.45
DIAGNOSIS WORKSHEET
Dapatkah kita menerapkan hasil study pada pasien kita?
The Role of Diagnostic Tests
Diagnostic tests are used routinely in clinical practice. They can
be non-specific (complete blood count) and specific (Anti-CCP for
rheumatoid arthritis). Diagnostic tests are utilised for three key
reasons:
● Identification
Upon evaluating a patient, including a physical exam and
reviewal of symptoms, a clinician will order diagnostic tests to
confirm a suspected condition or to exclude conditions.
● Monitoring
Following a diagnosis, further diagnostic tests can be
requested to determine if the treatment is working effectively
The Role of Diagnostic Tests
● Prognosis
Diagnostic testing can aid a doctor in reviewing the
progression of disease and predict how long one will live.
RESEARCH
03
Why to do research
● Add to scientific knowledge.
● Improve the medical and health practice.
● Benefit the patients and community.
● Study new phenomenon for establishing the facts.
● Help in planning the medical and health programs.
● Support managerial aspects of health development.
● Improve diagnostic techniques by newer, cheaper and
accurate tests.
● Help in effective patient care management.
Type of research
INTRODUCTION
● Population is a large group of study subjects (human, animals,
tissues, blood specimens, medical records, etc) with defined
characteristics [“Population is a group of study subjects defined
by the researcher as population”]
● Sample is a subset of population which will be directly
investigated. Sample should be (or assumed to be)
representative to the population; otherwise all statistical
analyses will be invalid
● All investigations are always performed in the sample, and the
results will be applied to the population
Avoid using ambiguous terms
● Sample population
● Sampled population
● Populasi sampel
● Study population ~ sample
Sample is assumed to be representative to the population.
In research: measurements are always done in the sample,
the results will be applied to population
P P
P S
Investigation
S P
S
Sampling
Inference
Results
Target population Accessible
population
Intended
Sample
Actual
study subjects
● Target population = domain = population in which the results
of the study will be applied. In clinical research it is usually
characterized by demographic & clinical characteristics; e.g.
normal infants, teens with epilepsy, post-menopausal women
with osteoporosis.
● Accessible population = subset of target population which can
be accessed by the investigator. Frame: time & place. Example:
teens with epilepsy in RSCM, 2000-2005; women with
osteoporosis, 2002 RSGS
● Intended sample = subjects who meet eligibility criteria and
selected to be included in the study
● Actual study subjects = subjects who actually completed the
participation in the study
Accessible
population
(+ time,
place)
Usually based on practical
purposes
Appropriate
sampling
technique
[Non-response, drop outs,
withdrawals, loss to follow-up]
Target population
(demographic, clinical)
Intended
Sample
[Subjects selected
for study]
Actual
study
subjects
Subjects
completed
the study
Dikutip dari slide Prof Dr.dr. Sudidgo Sastroasmoro, SpA(K) ; s_sudigdo@yahoo.com/2014
SAMPLING PROCESS
STEP
SAMPLING TECHNIQUES
PROBABILITY
SAMPLING
01
PROBABILITY SAMPLING
● Probability sampling means that every item in the population
has an equal chance of being included in sample.
● Salah satu cara untuk melakukan pengambilan sampel secara
acak adalah jika peneliti membuat kerangka pengambilan
sampel terlebih dahulu dan kemudian menggunakan program
komputer penghasil angka acak untuk mengambil sampel dari
kerangka pengambilan sampel. (Zikmund, 2002).
● Probabilitas atau pengambilan sampel acak mempunyai
kebebasan paling besar dari bias namun mungkin mewakili
sampel yang paling mahal dalam hal waktu dan energi untuk
tingkat kesalahan pengambilan sampel tertentu.
PROBABILITY SAMPLING
• every case of the population has an equal probability of inclusion in
sample.
• Disadvantages :
• A complete frame ( a list of all units in the whole population) is
needed
• In some studies, such as surveys by personal interviews, the costs of
obtaining the sample can be high if the units are geographically
widely scattered;
Simple random sampling
PROBABILITY SAMPLING
• Systematic sampling is where every case after a random start is selected.
• The advantage : its simplicity
• How to do it :
• Sampling frame is needed*
• Calculate sample size
• Divide number of population with number of sample size > you got nth
(kelipatan)
• Start with the number randomized, than pick based on the nth you got
Systematic sampling
PROBABILITY SAMPLING
• This method is a modification of the simple random sampling
• Sampling frame is needed
• the whole population is divided into homogeneous strata or subgroups
according a demographic factor (e.g. gender, age, religion, socio-economic
level, education, or diagnosis etc.).
• Then, the researchers select draw a random sample from the different
strata
• Used when population is heterogen
Stratified random sampling
PROBABILITY SAMPLING
• How to do it
• Simple Stratified Random Sampling :
• Divide sample size with the strata
• Proportional Stratified Random Sampling
• Divide sample size based on the proportion of population in each
strata
Stratified random sampling
Example :
Simple Stratified Random Sampling
Example :
Proportional Stratified Random
Sampling
PROBABILITY SAMPLING
• It is used when creating a sampling frame is nearly impossible due to the
large size of the population.
• Cluster sampling is where the whole population is divided into clusters or
groups
• Subsequently, a random sample is taken from these clusters, all of which
are used in the final sample (Wilson, 2010)
• In this method, the population is divided by geographic location into
clusters
CLUSTER SAMPLING
PROBABILITY SAMPLING
How to do it :
• Choose cluster grouping for sampling frame, such as type of company or
geographical region
• Number each of the clusters
• Select sample using random sampling
CLUSTER SAMPLING
Simple one stage Cluster Sampling
SINGLE CLUSTER
RW RW RW
JAKARTA
Kelayakan
04
▪ Selection and critical appraisal of
research literature
▪ 10 QUESTIONSTO ASK WHEN
CRITICALLY APPRAISING A
RESEARCH ARTICLE:
1 Is the study question relevant?
2 Does the study add anything new?
3What type of research question is
being asked?
4Was the study design appropriate
for the research question?
Introduction
You can give a brief description of the topic you want to talk about
here. For example, if you want to talk about Mercury, you can say that
it’s the smallest planet in the entire Solar System
TEN QUESTIONS TO ASK WHEN CRITICALLY
APPRAISING A RESEARCH ARTICLE: Cont.
5. Did the study methods address the most important sources of
bias?
6. Was the study performed according to the original protocol?
7. Does the study test a stated hypothesis?
8. Were the statistical analyses performed correctly?
9. Do the data justify the conclusions?
10. Are there any conflicts of interest?
Daftar Pustaka
1. Taherdoost, H. Sampling Methods in Research Methodology; How to
Choose a Sampling Technique for Research. International Journal of
Academic Research in Management (IJARM) Vol. 5, No. 2, 2016, Page:
18-27, ISSN: 2296-1747
2. © Helvetic Editions LTD, Switzerland
3. Elfil, M. Negida, A. Sampling methods in Clinical Research; an
Educational Review . Emergency. 2017; 5 (1): e52
4. Guest Editorials. Sampling Methods in Research Design. Headache.
American Headache Society.2019. Wiley Periodicals, Inc Publishers.
5. Sastroasmoro, S. Ismael,S. Dasar Dasar Metodologi Penelitian
Klinis.ed.4.Sagung Seto.2011

Critical Appraisal

  • 1.
  • 2.
  • 3.
    Validity ● Results ofa study are valid when the observed or estimated parameter is the same as the true/actual value. ● The term bias refers to a systematic error in the study relating to its design, data collection methods, or data analysis. ● Biases in epidemiological/patient-based studies fall into 3 categories: selection bias, information bias, and confounding bias ● Criteria that are helpful for evaluating data include the study design and the type of question being addressed (diagnosis, treatment, prognosis, or harm).
  • 4.
    Validity ● we willfocus on appraisal of the literature based on the primary clinical activities with which we are engaged in clinical practice: ○ 1) choosing and interpreting diagnostic tests; ○ 2) selecting treatments/interventions; and, ○ 3) making prognoses.
  • 5.
    Validity Apakah uji diagnosticini valid? ● Apakah uji diagnostik dibandingkan dengan baku emas yang benar? ● Apakah pemeriksaan uji dan baku emas dilakukan secara independen? ● Apakah uji diagnostik dilakukan terhadap spektrum pasien seperti dalam praktik sehari hari ? ● Apakah pemeriksaan baku emas dilakukan kepada seluruh subyek tanpa melihat hasil uji diagnostik?
  • 6.
  • 7.
    TYPES OF SCHOLARLYARTICLES ● Not every article in a scholarly, peer-reviewed journal is a research article. There are several other types you may encounter: ○ News, book reviews, opinion/editorials, letters to the editor ○ Theoretical articles, relating to abstract principles – do not contain original research ○ Review articles – summaries of the current research in a field, but not considered to be research articles themselves
  • 8.
    WHAT IS ARESEARCH ARTICLE? ● A research article reports on the results of a study or experiment. It is written by the person or people who did the research. It is new, original work that has not been done before. ● Look for these words in the title and abstract: • Study • Research • Measure • Subjects • Data Effects • Survey • Statistical
  • 9.
    THE ABSTRACT ● Theabstract is a summary of the article. ● The abstract will give you enough information to determine whether you want to use this article as a source.
  • 10.
    THE LITERATURE REVIEW ●It gives the reader a summary of other research findings and the current state of understanding of the topic, including areas of incomplete data and questions that remain.
  • 11.
    THE RESEARCH QUESTION ●The authors explain their hypothesis – the question they were trying to answer with the study they have done. ● They should be doing something new, not simply copying what someone else has already done. ● The authors may predict what they think they will find, and will test their hypothesis to see if it is true.
  • 12.
    MATERIALS AND METHODSI ● This section gives the details of the experiment: ○ How it was conducted ○ What techniques were used ○ What subjects were studied ○ How many people, animals or cells were included in the study ○ The type of study
  • 13.
    RESULTS ● This sectionpresents the study’s findings, often using graphs and statistical tables to illustrate. ● You will see statistical terms such as: ○ Mean – the average value of the responses ○ Standard deviation – how the variables are distributed around the mean. A larger number means the responses are more spread out: they deviate more from the mean. ○ P-value – a measure of how trustworthy the results are. A pvalue will tell you whether the results are considered statistically significant. When p < .05, it means there is a 95% chance that the differences in the study groups were due to the manipulations of the study, and not due to chance.
  • 14.
  • 15.
    Overview Diagnose is averb that means to: ● Identify ● Determine ● Distinguish ● Pinpoint ● Recognize characteristic that are individual peculiar and proper
  • 16.
    Characteristic of diagnostictest ● It must provide series of scores, each representing performance in specific skill ● The respective skill must be carried to the over all performance being evaluated such as reading achievement or arithmetic achievement ● The sub test used to access each of these skills must represent a valid measure ● Each subset must have high reliability ● The correlation among subset must be low
  • 17.
  • 18.
    DIAGNOSIS WORKSHEET Apakah ujidiagnostic ini valid ? ● Apakah uji diagnostik dibandingkan dengan baku emas yang benar? ● Apakah pemeriksaan uji dan baku emas dilakukan secara independen? ● Apakah uji diagnostik dilakukan terhadap spektrum pasien seperti dalam praktik sehari hari ? ● Apakah pemeriksaan baku emas dilakukan kepada seluruh subyek tanpa melihat hasil uji diagnostik?
  • 19.
    DIAGNOSIS WORKSHEET Apakah ujidiagnostik ini penting ? Ya ● Sensitivitas : ? ● Spesifisitas :? ● NPV :? ● PPV :?
  • 20.
  • 21.
    DIAGNOSIS WORKSHEET ● Sensitivity= a/(a+c) = 731/809 = 90% ● Specificity = d/(b+d) = 1500/1770 = 85% ● Likelihood ratio for a positive test result = LR+ = sens/(1-spec) = 90%/15% = 6 ● Likelihood ratio for a negative test result = LR - = (1-sens)/spec = 10%/85% = 0.12 ● Positive Predictive Value = a/(a+b) = 731/1001 = 73% ● Negative Predictive Value = d/(c+d) = 1500/1578 = 95% ● Pre-test probability (prevalence) = (a+c)/(a+b+c+d) = 809/2579 = 32% ● Pre-test odds = prevalence/(1-prevalence) = 31%/69% = 0.45
  • 22.
    DIAGNOSIS WORKSHEET Dapatkah kitamenerapkan hasil study pada pasien kita?
  • 23.
    The Role ofDiagnostic Tests Diagnostic tests are used routinely in clinical practice. They can be non-specific (complete blood count) and specific (Anti-CCP for rheumatoid arthritis). Diagnostic tests are utilised for three key reasons: ● Identification Upon evaluating a patient, including a physical exam and reviewal of symptoms, a clinician will order diagnostic tests to confirm a suspected condition or to exclude conditions. ● Monitoring Following a diagnosis, further diagnostic tests can be requested to determine if the treatment is working effectively
  • 24.
    The Role ofDiagnostic Tests ● Prognosis Diagnostic testing can aid a doctor in reviewing the progression of disease and predict how long one will live.
  • 25.
  • 26.
    Why to doresearch ● Add to scientific knowledge. ● Improve the medical and health practice. ● Benefit the patients and community. ● Study new phenomenon for establishing the facts. ● Help in planning the medical and health programs. ● Support managerial aspects of health development. ● Improve diagnostic techniques by newer, cheaper and accurate tests. ● Help in effective patient care management.
  • 27.
  • 28.
    INTRODUCTION ● Population isa large group of study subjects (human, animals, tissues, blood specimens, medical records, etc) with defined characteristics [“Population is a group of study subjects defined by the researcher as population”] ● Sample is a subset of population which will be directly investigated. Sample should be (or assumed to be) representative to the population; otherwise all statistical analyses will be invalid ● All investigations are always performed in the sample, and the results will be applied to the population
  • 29.
    Avoid using ambiguousterms ● Sample population ● Sampled population ● Populasi sampel ● Study population ~ sample
  • 30.
    Sample is assumedto be representative to the population. In research: measurements are always done in the sample, the results will be applied to population P P
  • 31.
  • 32.
  • 33.
    ● Target population= domain = population in which the results of the study will be applied. In clinical research it is usually characterized by demographic & clinical characteristics; e.g. normal infants, teens with epilepsy, post-menopausal women with osteoporosis. ● Accessible population = subset of target population which can be accessed by the investigator. Frame: time & place. Example: teens with epilepsy in RSCM, 2000-2005; women with osteoporosis, 2002 RSGS ● Intended sample = subjects who meet eligibility criteria and selected to be included in the study ● Actual study subjects = subjects who actually completed the participation in the study
  • 34.
    Accessible population (+ time, place) Usually basedon practical purposes Appropriate sampling technique [Non-response, drop outs, withdrawals, loss to follow-up] Target population (demographic, clinical) Intended Sample [Subjects selected for study] Actual study subjects Subjects completed the study Dikutip dari slide Prof Dr.dr. Sudidgo Sastroasmoro, SpA(K) ; s_sudigdo@yahoo.com/2014
  • 35.
  • 36.
  • 37.
  • 38.
    PROBABILITY SAMPLING ● Probabilitysampling means that every item in the population has an equal chance of being included in sample. ● Salah satu cara untuk melakukan pengambilan sampel secara acak adalah jika peneliti membuat kerangka pengambilan sampel terlebih dahulu dan kemudian menggunakan program komputer penghasil angka acak untuk mengambil sampel dari kerangka pengambilan sampel. (Zikmund, 2002). ● Probabilitas atau pengambilan sampel acak mempunyai kebebasan paling besar dari bias namun mungkin mewakili sampel yang paling mahal dalam hal waktu dan energi untuk tingkat kesalahan pengambilan sampel tertentu.
  • 39.
    PROBABILITY SAMPLING • everycase of the population has an equal probability of inclusion in sample. • Disadvantages : • A complete frame ( a list of all units in the whole population) is needed • In some studies, such as surveys by personal interviews, the costs of obtaining the sample can be high if the units are geographically widely scattered; Simple random sampling
  • 40.
    PROBABILITY SAMPLING • Systematicsampling is where every case after a random start is selected. • The advantage : its simplicity • How to do it : • Sampling frame is needed* • Calculate sample size • Divide number of population with number of sample size > you got nth (kelipatan) • Start with the number randomized, than pick based on the nth you got Systematic sampling
  • 41.
    PROBABILITY SAMPLING • Thismethod is a modification of the simple random sampling • Sampling frame is needed • the whole population is divided into homogeneous strata or subgroups according a demographic factor (e.g. gender, age, religion, socio-economic level, education, or diagnosis etc.). • Then, the researchers select draw a random sample from the different strata • Used when population is heterogen Stratified random sampling
  • 42.
    PROBABILITY SAMPLING • Howto do it • Simple Stratified Random Sampling : • Divide sample size with the strata • Proportional Stratified Random Sampling • Divide sample size based on the proportion of population in each strata Stratified random sampling
  • 43.
  • 44.
  • 45.
    PROBABILITY SAMPLING • Itis used when creating a sampling frame is nearly impossible due to the large size of the population. • Cluster sampling is where the whole population is divided into clusters or groups • Subsequently, a random sample is taken from these clusters, all of which are used in the final sample (Wilson, 2010) • In this method, the population is divided by geographic location into clusters CLUSTER SAMPLING
  • 46.
    PROBABILITY SAMPLING How todo it : • Choose cluster grouping for sampling frame, such as type of company or geographical region • Number each of the clusters • Select sample using random sampling CLUSTER SAMPLING
  • 47.
    Simple one stageCluster Sampling SINGLE CLUSTER RW RW RW JAKARTA
  • 48.
  • 49.
    ▪ Selection andcritical appraisal of research literature ▪ 10 QUESTIONSTO ASK WHEN CRITICALLY APPRAISING A RESEARCH ARTICLE: 1 Is the study question relevant? 2 Does the study add anything new? 3What type of research question is being asked? 4Was the study design appropriate for the research question?
  • 50.
    Introduction You can givea brief description of the topic you want to talk about here. For example, if you want to talk about Mercury, you can say that it’s the smallest planet in the entire Solar System
  • 51.
    TEN QUESTIONS TOASK WHEN CRITICALLY APPRAISING A RESEARCH ARTICLE: Cont. 5. Did the study methods address the most important sources of bias? 6. Was the study performed according to the original protocol? 7. Does the study test a stated hypothesis? 8. Were the statistical analyses performed correctly? 9. Do the data justify the conclusions? 10. Are there any conflicts of interest?
  • 52.
    Daftar Pustaka 1. Taherdoost,H. Sampling Methods in Research Methodology; How to Choose a Sampling Technique for Research. International Journal of Academic Research in Management (IJARM) Vol. 5, No. 2, 2016, Page: 18-27, ISSN: 2296-1747 2. © Helvetic Editions LTD, Switzerland 3. Elfil, M. Negida, A. Sampling methods in Clinical Research; an Educational Review . Emergency. 2017; 5 (1): e52 4. Guest Editorials. Sampling Methods in Research Design. Headache. American Headache Society.2019. Wiley Periodicals, Inc Publishers. 5. Sastroasmoro, S. Ismael,S. Dasar Dasar Metodologi Penelitian Klinis.ed.4.Sagung Seto.2011

Editor's Notes

  • #41 In some situations, it is not necessary to have the sampling frame if there is a specifific hospital or center which the patients are visiting regularly. In this case, the researcher can start randomly and then systemically chooses next patients using a fixed interval