Constitution of evidence

Study Designs for

“Accuracy of Diagnostic and screening test ”
i

Dr MARINA SOOMRO
LECTURER
SULEMAN ROSHAN COLLEGE OF PHYSIOTHERAPY AND REHABILITATION SCIENCES TANDOADAM
Objectives of lecture
To learn about:

• Study designs for “accuracy of diagnostic and screening tests”

• Definition of “diagnostic and screening tests”.
• Brief description of cross sectional studies with examples.
Recall from last lecture
Questions can be categorized:
Harm or etiology.
Effects of intervention. Discussed in previous lectures.
Patients experience. Discussed in previous lecture.
The course of condition (prognosis). Discussed in last lecture.
The accuracy of diagnostic tests. Will be discussed in this lecture.
All of these questions are important and each is answered with
different kind of evidence (study designs)
A 45 years old man presents with low back pain for 2 weeks which is
radiating to his right leg with no apparent neurological deficits.
The pain start with heavy lifting at work and progressively worsens.
His GP prescribed analgesics and bed rest for 5 days but no improvement.
Referred to you for pain relieving and restoration of physical function.

Question Requires evidence about:

o Is heavy lifting cause? etiology

o Could this problem be prevented? Effects of intervention

o Should I advise for bed rest or stay active?
o How to relieve pain?
o How to speed the recovery?
o How he feels about bed rest or staying active? Patient experiences
o What is his main concern?

o How to exclude nerve root involvement? Diagnosis

o Which test to exclude underlying serious condition
like malignancy?
o What is the probability of self resolving ? prognosis
o What are the chances of success / recurrence?
Types of study designs for “Accuracy of
Diagnostic and screening test”
1. Clinical observation:
is based on day-to-day clinical practice of physicians with time.

2. Clinical research:
a) Cross sectional studies.
b) Randomized trials.
c) Screening.
3. Systemic reviews.
1. Clinical observation

In routine clinical practice, the accuracy of a

diagnostic test can be observed by simply
using the test to many people and than see
how well the test's findings corresponds with
the correct diagnosis.
2. CLINICAL RESEARCH:
High quality clinical research provides better estimates of
accuracy of diagnostic tests.

a) CROSS-SECTIONAL STUDIES:
• is a type of observational study that analyses data from a
population, or a representative subset, at a specific point in time.
• involves applying the test to many people and then determining how
well the test's findings corresponds with correct diagnosis.
• are concerned with how accurately a test can determine whether a
disease or condition is present at the time the test is conducted.
Difference between cross-sectional and
longitudinal study.
Cross-sectional studies of Diagnostic tests
• A group of people is subjected to a clinical test of interest
• The same people are also tested with gold standard test or reference
standard test and the findings are compared.
• Vroomen et al compared the findings of simple clinical tests for
lumbosacral nerve root compression in people with sciatica with the
finding of MRI. The simple clinical tests were based on history and
clinical examination
Diagnostic value of history and physical examination in patients
suspected of lumbosacral nerve root compression
PCAJ Vroomen, M C T F M de Krom, J T Wilmink,ADM Kester, J A Knottnerus
• Objective: To evaluate patient characteristics, symptoms, and examination findings in the clinical diagnosis of
lumbosacral nerve root compression causing sciatica.
• Methods: The study involved 274 patients with pain radiating into the leg. All had a standardised clinical
assessment and magnetic resonance (MR) imaging. The associations between patient characteristics, clinical
findings, and lumbosacral nerve root compression on MR imaging were analysed.
• Results: Nerve root compression was associated with three patient characteristics, three symptoms, and four
physical examination findings (paresis, absence of tendon reflexes, a positive straight leg raising test, and
increased finger-floor distance). Multivariate analysis, analysing the independent diagnostic value of the
tests, showed that nerve root compression was predicted by two patient characteristics, four symptoms, and
two signs (increased finger-floor distance and paresis). The straight leg raise test was not predictive. The area
under the curve of the receiver-operating characteristic was 0.80 for the history items. It increased to 0.83
when the physical examination items were added.
• Conclusions: Various clinical findings were found to be associated with nerve root compression on MR
imaging. While this set of findings agrees well with those commonly used in daily practice, the tests tended
to have lower sensitivity and specificity than previously reported. Stepwise multivariate analysis showed that
most of the diagnostic information revealed by physical examination findings had already been revealed by
the history items.
 :
2. Clinical research continued

b) RANDOMIZED TRIALS:
 are clinical trails that compare the effects of drugs, surgical
techniques, medical devices, diagnostic tests or
procedures or other medical treatments.
Clinical trial randomization is the process of assigning
patients by chance to groups that receive different
treatments.
2. Clinical research: continued
Randomized trials for accuracy of diagnostic tests:
Subjects are randomly allocated to groups that either receive or do
not receive the diagnostic tests of interest and the outcome of two
groups are compared.
Severe randomized trials have been conducted to determine the
value of routine X-rays in primary care with law back pain. Patients
presented to general medical practitioners with low back pain were
either routinely referred for X-rays or not and the outcome of two
groups were compared. Outcomes include disability, subsequent
medical consultations and health care costs
Radiography for low back pain: a randomised controlled
trial and observational study in primary care
Sally Kerry 1, Sean Hilton, Derek Dundas, Elizabeth Rink, Pippa Oakeshott
• Background: Lumbar spine radiography has limited use in diagnosing the cause of acute low back pain. Consensus-based
guidelines recommend that lumbar spine x-rays are not used routinely. However there have been no studies of the effect of
referral for radiography at first presentation with low back pain in primary care.
• Aim: To compare short and long-term physical, social, and psychiatric outcomes for patients with low back pain who are referred
or not referred for lumbar spine x-ray at first presentation in general practice.
• Design of study: A randomised unblinded controlled trial with an observational arm to enable comparisons to be made with
patients not recruited to the trial.
• Setting: Ninety-four general practices in south London and the South Thames region.
• Method: Patients consulting their general practitioner (GP) with low back pain at first presentation were recruited to a randomised
controlled trial (RCT) or to an observational group. Patients in the trial were randomly allocated to immediate referral for x-ray or
to no referral. All patients were asked to complete questionnaires initially, and then at six weeks and one year after recruitment.
• Results: Six hundred and fifty-nine patients were recruited over 26 months: 153 to the randomised trial and 506 to the
observational arm. In the RCT referral for x-ray had no effect on physical functioning, pain or disability, but was associated with a
small improvement in psychological wellbeing at six weeks and one year. These findings were supported by the observational
study in which there were no differences between the groups in physical outcomes after adjusting for length of episode at
presentation; however, those referred for x-ray had lower depression scores.
• Conclusions: Referral for lumbar spine radiography for first presentation of low back pain in primary care is not associated with
improved physical functioning, pain or disability. The possibility of minor psychological improvement should be balanced against
the high radiation dose involved.
Clinical research ……………. continued
c) Screening
What is Screening ??
• A screening test is done to detect potential health disorders or
diseases in people who do not have any symptoms of disease. The
goal is early detection and lifestyle changes or surveillance, to reduce
the risk of disease, or to detect it early enough to treat it most
effectively.
• Screening programmes are best evaluated with randomized trials. e.g.
RCT for pap smear for cervical cancer.
RCT of the effects of mammogram for breast cancer
Study design of randomized controlled clinical trials of breast cancer screening
Paci E, Alexander FE. Study design of randomized controlled clinical trials of breast cancer
screening. J Natl Cancer Inst Monogr. 1997;(22):21-5. doi: 10.1093/jncimono/1997.22.21. PMID:
9709270.

• Abstract
• Evaluation of population screening must be based on a randomized clinical
trial (RCT) with the study population randomized into two arms: an
intervention group invited to screening and a control group not invited to
screening. Reduced mortality in the intervention group is evidence of a
benefit from screening. Individual randomization is the ideal, but cluster
randomization is often used for logistical and ethical reasons. The use of
volunteer subjects is methodologically acceptable, but results cannot be
generalized.
• Seven RCTs of breast cancer screening by mammography have been
carried out in the United States, Canada, Sweden, and Scotland. All the
studies, except the Canadian, were designed to assess the effect of screening
across a wide range of ages at entry. The question of the efficacy of breast
cancer screening at younger ages (< 50 years) arose early, after the first
results were reported. To address this question, basic elements of the
screening protocol must be considered when interpreting the results; these
are screening modality (e.g., mammography with or without physical
Systemic reviews
3. SYSTEMIC REVIEWS:

All possible studies related to given topic, design and reviews are
collected and their results are analyzed.

Cochrane library and Pedro are the important sources of systemic

reviews
Systemic reviews of the studies of accuracy
of diagnostic tests
Examples:

• Anterior cruciate ligament injury (Scolten et al 2003)

• Ottawa Ankle Rules ( pro-ortho.com.au )

Accuracy of Ottawa ankle rules to exclude fractures of the ankle and mid-foot: systematic
review
LM Bachmann, E Kolb, MT Koller, J Steurer, and G ter Riet.
http://bmj.bmjjournals.com/cgi/content/full/326/7386/417
Thank you

"People who are crazy enough to think

they can change the world are the ones who do.“ -
(Siltanen)

"Do the best you can, until you know better.

Then when you know better, do better." – (Maya Angelou)