ArticlePDF Available

"Sorting out lemons and oranges:" Towards better quality of reporting clinical trials in Journal of Physical Therapy - the CONSORT 2010 statement


Abstract and Figures

The editorial aims to welcome the JPT readers to its first issue on a historical note of clinical trials in the field of Medicine and the Consolidated Standards Of Reporting Trials (CONSORT) statement’s reporting guidelines. History of research and randomized controlled trials (RCTs) in physiotherapy and the continuous growth in number of RCTs in physiotherapy evidence database (PEDro) necessitates better quality in reporting clinical trials by use of CONSORT checklist and flow diagram for clinical trials. Recently, the CONSORT statement was revised in 2010 and JPT became a journal endorser of the statement in its new version. The last section of the editorial envisions the aims of Journal of Physical Therapy in improving quality of reporting trials published by mandating the use of the statement.
Content may be subject to copyright.
J Phys Ther.
Di stributed i n Open Access Policy under Creative Commons
Attribution License 3. 0
“Sorting out Lemons and Oranges:”
Towards Better Quality of Reporting
Clinical Trials in
Journal of Physical Therapy - The
CONSORT 2010 Statement.
Senthil P Kumar MPT, (PhD)
The editorial aims to welcome the JPT readers to its first
issue on a historical note of clinical trials in the field of Medicine
and the Consolidated Standards Of Reporting Trials
(CONSORT) statement’s reporting guidelines. History of
research and randomized controlled trials (RCTs) in
physiotherapy and the continuous growth in number of RCTs in
physiotherapy evidence database (PEDro) necessitates better
quality in reporting clinical trials by use of CONSORT checklist
and flow diagram for clinical trials. Recently, the CONSORT
statement was revised in 2010 and JPT became a journal
endorser of the statement in its new version. The last section of
the editorial envisions the aims of Journal of Physical Therapy
in improving quality of reporting trials published by mandating
the use of the statement.
Key words:
clinical trial reporting, CONSORT 2010 statement,
guidelines for reporting, randomized controlled trials.
Author’s information:
*- Corresponding author. Associate professor, Dept of Physiotherapy,
Kasturba Medical College (Manipal University), Mangalore- 575001,
The editorial in this
first issue of Journal of
Physical Therapy welcomes its
readers with a historical note
of clinical trials and in Physical
Therapy and the need for a
change as a part of paradigm
shift in research, not only in
the conduct of clinical trials but
also in their reporting, as
recommended by
CONsolidated Standards Of
Reporting Trials (CONSORT)
statement- 2010.
History of clinical trial:
According to The Old
Testament, King
Nebuchadnezzar ruled
Babylon for almost 60 years,
his reign ending in 562 BC.
During his reign, according to
the “Book of Daniel” in The
Bible, Nebuchadnezzar
ordered his people to eat only
meat and drink only wine, a
diet he believed would keep
them in perpetual health.
Herbivorous youth who
refused were ordered to eat
only legumes and drink water.
The comparison lasted 10
days after which he again
ordered assessment of their
When Nebuchadnezzar’s
experiment ended, the bean-
loving men appeared better
nourished than the mandated
meat-eaters, the king then
allowed them to continue their
Clinical trials often
involve studies performed on
patients on effectiveness of
interventions and/or their
comparisons. Historically, the
first “published” clinical trial
was performed in 1747, on
board the ship- Salisbury by
then Scottish Physician, Dr
James Lind (1716-1794),
Key points and pre-publication history of this article is available at the end of the paper.
J Phys Ther.
CONSORT 2010 statement
Kumar SP
J Phys Ther. 2010;1:1-10.
Figure-2. An artist’s work of depiction of the historical
clinical trial by Dr James Lind.
which he performed on his
shipmen with Scurvy. In his own
book, A Treatise on the
(figure-1) he described
as follows, his first ever clinical
experiment on the ship (figure-
Figure- 1. Coverpage of the
book, “A Treatise on the
Scurvy” by Dr James Lind.
……Of the Prevention of the
I shall conclude the precepts
relating to the preservation of
seamen with showing the best
means of obviating many
inconveniences which attend
long voyages and of removing
the several causes productive
of this mischief. The following
are the experiments…
…..On the 20
May 1747, I took
twelve patients in the scurvy, on
board the Salisbury at sea.
Their cases were as similar I
could have them. They all in
general had putrid gums, the
spots and lassitude, with
weakness of their knees. They
lay together in one place, being
a proper apartment for the
sick in the fore-hold; and had
one diet common to all, viz.
water-gruel sweetened with
sugar in the morning; fresh
mutton broth often times for
dinner; at other times
puddings, boiled biscuit with
sugar etc. And for supper,
barley and raisins, rice and
currants, sago and wine, or
the like. Two of these were
ordered each a quart of cider
a day, upon an empty
stomach; using a gargle
strongly acidulated with it for
their mouths. Two others took
two spoonfuls of vinegar three
times a day, upon an empty
stomach: having their gruels
and their food well acidulated
with it, as also the gargle for
their mouths. Two of the
worst patients, with the
tendons in the hamrigid (a
symptom none of the rest
had) were put under a course
sea-water. Of this they drank
half a pint every day, and
sometimes more or less as it
operated, by way of a gentle
physic. Two others had each
two oranges and one lemon
given them every day. These
they eat with greediness, at
different times, upon an
empty stomach. They
continued but six days under
this course, having consumed
the quantity that could be
spared. The two remaining
patients, took the bigness of a
nutmeg three times a day of
an electuary recommended
by a hospital-surgeon, made
of garlic, mustard-feed, rad.
Raphan, balsam of Peru, and
gum myrr; using for common
drink barley water well
acidulated with tamarinds; by
a decoction of which, with the
addition of cremor tartar, they
were greatly purged three or
four times during the course.
The consequence was, that
the most sudden and visible
good effects were perceived
from the use of the oranges
and lemons; one of those who
had taken them, being at the
end of six days fit for duty.
The spots were not indeed at
that time quite off his body,
nor his gums sound; but
without any other medicine,
than a gargle of vitriol, he
J Phys Ther.
CONSORT 2010 statement
Kumar SP
J Phys Ther. 2010;1:1-10.
functioned by replacing a
missing dietary component did
not emerge until formulated by
George Budd (1808-1882)
over half a century later.
It took two centuries
afterwards to implement this
into routine clinical practice. It
took less than a century for the
scientists to find out that
vitamin C was involved in the
disease and another to find
out that oranges and lemons
had in them, greater content of
vitamin C. It was finally in
1930s, that it was found the
anti-scorbutic factor was
became quite healthy before
we came into Plymouth, which
was on the 16
June. The
other was the best recovered
of any in his condition; and
being now deemed pretty well,
was appointed nurse to the
rest of the sick.”
The above “story”
clearly depicted the
importance of use of oranges
and lemons for treating scurvy.
The following six important
queries arise on reading the
above information;
How many Scurvy patients
participated in “his” study?
How many treatment groups
were there in “his” study?
What treatments were given
for each of the groups?
How many patients were there
in each of the treatment
How many of “his” patients
completed the study?
How can we conclude
“oranges and lemons” are the
only effective remedy for
I hope our JPT readers
would be able to answer these
at the end of reading this
paper. Historically however,
Medical scientists were very
skeptical in “his” findings.
There was a growing
controversy in the
interpretation of “his” findings
into either as rationally-derived
experimentation or controlled
It took nearly
forty-two years for the relevant
authorities and The Navy Sick
and Hurt Board to address the
issue based on Dr. Lind’s
study results.
It should be
recalled, however, that even
Lind probably did not think of
scurvy as primarily a
nutritional disorder and the
theory that antiscorbutics
Table-1: Types of clinical trials
Purpose of
clinical trial
Clinical trial methodology
Tests new drugs, therapies, devices or
Tests new means to prevent disease:
medicines, vaccines, lifestyle changes.
Tests new ways of diagnosing diseases
or conditions.
Tests new ways of detecting diseases
or conditions.
Quality of life
Tests new ways of improving quality of
life for people with chronic illnesses.
Source: U.S National Institutes of Health
Table-2: Phases of clinical trials
Phase of clinical
Initial testing of a new method
(treatment) on a small group of human
subjects to evaluate safety, as a certain
dosage range and identify side effects.
The therapy (method) is tested on a
larger group to determine its efficacy
(i.e., whether it works under ideal
Randomized controlled multicenter trials
on even larger patient groups to confirm
effectiveness, (whether the treatment or
method does more good than harm
under usual care conditions).
Post-market studies gathering data on
whether the new method affects
population groups differently or whether
there are side effects associated with its
long-term use.
Source: U.S National Library of Medicine.
J Phys Ther.
CONSORT 2010 statement
Kumar SP
J Phys Ther. 2010;1:1-10.
What is a clinical trial?
Meinert and Tonascia
in their text- Clinical Trials:
Design, Conduct, and Analysis
explain the term “clinical trials”
as follows;
Trial is from the Anglo–
French trier, meaning to try.
Broadly, it refers to the action
or process of putting
something to a test or proof.
Clinical is from clinic, from the
French cliniqu´e and from the
Greek klinike, and refers to the
practice of caring for the sick
at the bedside. Hence,
narrowly, a clinical trial is the
action or process of putting
something to a test or proof at
the bedside of the sick.”
Clinical trials are
classified into five categories
(table-1) depending upon their
purpose; treatment,
prevention, diagnostic,
screening and quality of life.
The interventional studies or
treatment trials can further be
divided into four phases
(table-2) for conduct of the
study at various levels to
answer a research question
valid enough to imply for a
target population.
The objective of a
clinical trial is to study the
effects of a relatively less
scientifically established
intervention. The intervention
to be studied is the
experimental intervention and
the patients in the group are
termed as experimental group.
The comparison group may be
another intervention or a group
either without any intervention
(control), or a deceivably
similar but no-effect
intervention (sham) or a
psycho-motivating intervention
(placebo). Randomized
controlled trials are for
studying comparison between
a control group and one or
more experimental groups
while randomized clinical trials
are for comparison between
two or more experimental
groups. However, many
authors use these terms
interchangeably thus
misleading the reading clinical
community. This is explainable
by the known fact that
studying a group truly without
administering any treatment
for its effects, is deemed to be
unethical in a clinical situation
where the patient-centered
treatment-decisions and
payer’s policies influence on
bio-ethical grounds.
Lind’s experiment in
1747 was a “controlled” clinical
trial; the first use of sham
procedure for comparison was
done by Haygarth in 1799 and
of placebo treatment as a
comparison group was done
by Gull in 1863.
sham procedure was used
much earlier than placebo
treatments in randomized
Sham-controlled trials
are often used in studying
treatment techniques which
involve non-physiological
effects like Manual Physical
Therapy where it is widely
believed that hands-on- touch
of the therapist will eventually
lead to subjective relief of
symptoms more than actual
biomechanical effects of the
technique. Placebo-controlled
trials are often used in
studying interventions with
probable psychological/
perceptual effects. For
example, comparing
ultrasound with laser therapy
is a randomized clinical trial;
comparing ultrasound with no
treatment is a randomized
controlled trial; comparing
ultrasound with detuned
(switched-off) ultrasound is a
sham-controlled trial; and,
comparing ultrasound with
verbally positively-reinforced
supine-lying is a placebo-
controlled trial.
Clinical trials are done
on patients and hence clinical
decision-making was
supposed to be “informed”
rather than being “driven” by
evidence from such trial’s
findings. Randomized
controlled/ clinical trials
(RCTs) are the single-most
individual level of evidence for
evidence-based practice
(EBP) in applying study results
for interventions. The rigorous
methodology adopted in RCTs
is sometimes argued to be
impractical and does not
mimic real-life clinical practice
situations. The term
“randomized” in RCT implies
either random sampling of
patients for recruitment into
the study or random allocation
of patients to receive either of
the interventions studied.
History of Clinical trials in
Physical Therapy:
Journals are
acknowledged as crucial
sources of evidence-based
information relevant to
physiotherapy practice.
first research about physical
therapy in the United States
was published in March 1921
in The PT Review.
J Phys Ther.
CONSORT 2010 statement
Kumar SP
J Phys Ther. 2010;1:1-10.
Figure-3. Cover page of the first
RCT in physical therapy in
Medical Research Council
Special Report Series in 1929.
On a historical note,
the first ever randomized
controlled trial in Physical
Therapy evaluated Ultra-Violet
radiation therapy and was
published in 1929 by Dora
Colebrook (figure-3) in Medical
Research Council Special
Report Series.
Initially the
RCTs were published in
medical journals and not until
1967, for the first time an RCT
evaluating physical therapy
intervention was published in a
physical therapy journal. This
unique credit goes to author-
Landen B whose study
evaluated superficial heat vs.
cold in LBP and was published
in Physical Therapy journal.
Presently as was on March
2010, there were 15,920
records in Physiotherapy
Evidence Database (PEDro)
which includes 13,096
randomized controlled trials in
physiotherapy alone. In
April2010, there are 13,189
RCTs (Figure-4). The last
month thus witnessed an
increase of 93 RCTs in a
month- an average of 3 RCTs
added to PEDro every day.
This is the number for trials
added to PEDro database
alone. This number is the best
example of “tip of an iceberg”
The actual number of
trials in Physical Therapy will
be a lot different considering
Figure-4: Showing the steady increase in the number of randomized controlled trials in
PEDro- Physiotherapy Evidence Database in the previous one year (April 2009 to May
2010). Source: PEDro (
J Phys Ther.
CONSORT 201 0 statement
Kumar SP
J Phys Ther. 2010;1:1-10.
Figure 4. CONSORT Flow diagram of the progress through
the phases of a parallel randomised trial of two groups
(that is, enrolment, intervention allocation, follow-up, and
data analysis).
(For a downloadable version of this
diagram see the CONSORT website- www.consort-
the actual number of trials
performed and stay as
unpublished trials or trials
published but are not yet
added to PEDro.
As true it is to interpret
evidence from RCT, also is
true that certain guidelines be
followed for standardized
reporting of trial findings for
better accurate dissemination
of trial findings and thus
effective translation into
clinical practice thus facilitating
evidence-based healthcare.
Thus the EBP paradigm
demands reporting of
evidence to be a single-most
significant factor which
influences evidence-informed
clinical decision-making.
The need for trial reporting
guidelines- history of
CONSORT statement:
The work towards
formation of reporting
guidelines was begun in mid
1990s which then noticed The
CONsolidated Standards Of
Reporting Trials CONSORT
group first publishing its
original version in 1996
later revising it in 2001.
2004, the CONSORT
statement was extended to
include reporting of harms.
2008, the statement was
extended with explanation and
elaboration with excellent
examples of reporting for use
in non-pharmacological
The updating and
publication of latest revision of
the statement was done this
year 2010.
The use of
reporting guidelines for various
levels in a RCT (CONSORT-
2010) are schematically
shown as CONSORT flow
diagram in figure-4.
The use of the
CONSORT statement was
associated with improvements
in the quality of reporting
RCTs when the authors
compared journals which
required CONSORT as
mandatory versus the ones
which did not.
Hywel Williams
added, “The benefits of
CONSORT are manifest right
from trial conception to the
application of evidence to
patients in the clinic. A trial
that is “CONSORTED” gives a
signal to the reader that they
can find what they want to
find. CONSORT 2010 is not a
tool to catch out well
intentioned researchers with a
straightjacket of prescriptive
reporting formats it is simply
an aid to ensure that a trial
report contains key
information. Whether you are
buying a car or a trial report,
you need essential information
to help you decide whether it
is a good one. CONSORT
2010 helps you to do that. Use
CONSORT 2010 if you are a
generator of research. Insist
on it if you are a user of
CONSORT 2010 and history
The historical
“controlled” clinical trial by
James Lind is depicted in the
new CONSORT 2010
flowchart in figure- 5. It is now
evident how a different style of
reporting (description in text
versus CONSORT flowchart)
makes interpretation clearer
for our readers.
The lack of standards of
reporting (illustrated below)
often undermines the value of
the scientific findings which
always is true. Atleast half-a-
J Phys Ther.
CONSORT 2010 statement
Kumar SP
J Phys Ther. 2010;1:1-10.
Figure-5. CONSORT 2010 Flowchart of the historical Dr James Lind’s “first controlled
clinical trial” in 1753. (U*- unexplained or unreported by the author).
century before Dr Lind’s report
of his findings on “oranges and
lemons” for Scurvy, an
European traveler, John Flyer
(1650-1733) noticed the
“proven” value of citrus fruits
(oranges and fresh limes) for
Scurvy in sailors at a place
less well developed when
compared to Western
countries, India, during his
travel from 1672 to 1681,
which he wrote;
“. . . when half the fleet were
disabled by distempers
acquired by salt meats, and a
long voyage without
refreshments. . . . The first
care then was to send the sick
men ashore, which it is
incredible to relate how
strangely they revivifed in so
short a time by feeding on
oranges and fresh limes. . . .
Dominik Wujastik
described the importance of
John Flyer’s observations in
India in his paper, as follows;
“Amongst the many
narrative and descriptive
accounts of India written by
European travelers in the
seventeenth century… that of
John Fryer (1650–1733)
stands out for its attention to
daily life and the Indian
environment, and especially
for its many comments on the
medical situation in India.
Among scientifically important
observations made on arrival
in India, Fryer noted the value
of citrus fruits in curing sailors
of scurvy, predating Lind’s
famous observations by half a
century. Fryer travelled in
India for nine years, between
1672 and 1681.”
Past is past indeed.
Presently, the 20
May 2010
marks in the pages of History,
another event of highly
relevant importance, The
International Clinical Trials
Day, at Stockholm, Sweden,
organized by European
Clinical Research
Infrastructures Network
(ECRIN) to mark the 264
anniversary of James Lind's
first controlled clinical trial in
J Phys Ther.
CONSORT 2010 statement
Kumar SP
J Phys Ther. 2010;1:1-10.
We, the global
editorial board of Journal of
Physical Therapy assure you,
our reader just that, of being
responsive to change. We
welcome articles that would
bring a change, to move
Physical Therapy forward, in
lines of World Physical
Therapy 2011 (WCPT).
Every article in JPT will have a
key points tab where past-
information what already exist
on the topic; present-
information provided by this
article; future- what implication
the article has towards
“moving Physical Therapy
forward”. JPT editorial policy
makes it mandatory for all
submitted clinical trials to
follow CONSORT 2010
statement- the CONSORT
checklist for abstract and
report, and flow diagram for
trial procedure. JPT will also
ensure unbiased publication of
well-reported trials irrespective
of their findings and direction
of treatment-effect.
Article pre-publication
Date of submission- 17
April 2010.
Reviewer- Prof Maureen Simmonds
Date of acceptance- 10
May 2010.
Reviewer- R. Selvam
Date of publication- 16
May 2010.
WFIN: JPT-2010-ERN-107-1(1)-1-10.
Role of Journal of Physical
It is a mutual
responsibility on reporting
authors and endorsing
journals alike, in not only
including the CONSORT for
reporting clinical trials but to
mandate such standards both
in conduct of research and in
instructions to authors
respectively. JPT promises to
ensure quality in reporting
standards as recommended
by CONSORT 2010, and this
was evident when JPT
became the fourth
the physiotherapy journals to
endorse the new statement
and the JPT instructions to
authors (Altman, 2005)
provide the prospective
authors with link to
CONSORT website and direct
download citation link for the
published reference.
“It is not the strongest of the
species that survives, nor the
most intelligent, but the one
most responsive to change.”
- Charles Darwin.
According to National
Library of Medicine,
are four broad categories of
journals- research,
clinical/practice, review and
general. Whilst research
journals publish scholarly
articles, practice journals
publish practice-oriented
discussions and case reports.
JPT aims to strike a balance
between the two in an effort to
bridge the gap between
academicians, clinicians and
researchers for the betterment
of Physical Therapy globally.
1. Collier R. Legumes, lemons and
streptomycin- a short history of the
clinical trial. CMAJ. 2009;180:23-24.
2. Lind J: A Treatise of the Scurvy in
Three Parts. Containing an inquiry
into the Nature, Causes and Cure of
that Disease, together with a Critical
and Chronological View of what has
been published on the subject. A.
Millar, London, 1753. Available at:
Accessed: May 1
, 2010.
3. Hughes RE. James Lind and the
cure of Scurvy: an experimental
approach. Med Hist. 1975;19:342-351.
4. Trohler U. Lind and Scurvy: 1747 to
1795. J Royal Soc Med. 2005;98:519-
5. Hughes RE. George Budd (1808-
1882) and nutritional deficiency
diseases. Med Hist. 1973;17:127-135.
6. Meinert CL, Tonascia S. Clinical
Trials: Design, Conduct, and Analysis.
Oxford University Press, New York,
7. National Institutes of Health. Clinical
Trials. Available at:
Accessed: May 16
, 2010.
8. Turner P. Evidence-based practice
and Physiotherapy in the 1990s.
Physiother Theory Pract. 2001;17:107-
9. CSP- The Chartered Society of
Physiotherapy. History. London, UK.
Available at:
Accessed: May 1st, 2010.
10. Maher CG, Moseley AM,
Sherrington C, Elkins MR, Herbert RD.
A description of the trials, reviews and
practice guidelines indexed in the
PEDro database. Phys Ther.
11. PEDro. Physiotherapy Evidence
Database. Faculty of Health Sciences,
University of Sydney, Australia.
Available at:
Accessed: May 1
, 2010.
12. Freemantle N, Mason JM, Haines
A, Eccles MP. CONSORT: an
important step toward evidence-based
health care. Ann Intern Med.
13. Begg C, ChoM, Eastwood S,
Horton R, Moher D, Olkin I, et al.
Improving the quality of reporting of
randomized controlled trials. The
CONSORT statement. J Am Med
Assoc. 1996;276:637-9.
14. Moher D, Schulz KF, Altman DG.
The CONSORT statement: revised
recommendations for improving the
quality of reports of parallel-group
randomized trials. J Am Med Assoc.
J Phys Ther.
CONSORT 2010 statement
Kumar SP
J Phys Ther. 2010;1:1-10.
15. Ioannidis JPA, Evans SJW,
Gotzsche PC, O-Neill RT, Altman DG,
Schulz K, Moher D, the CONSORT
group. Better reporting of harms in
randomized trials: an extension of the
CONSORT statement. Ann Intern
Med. 2004;141:781-788.
16. Boutron I, Moher D, Altman DG,
Schulz KF, Ravaud P, the CONSORT
group. Extending the CONSORT
statement to randomized trials of
nonpharmacologic treatment:
explanation and elaboration. Ann
Intern Med. 2008;148:295-309.
17. Boutron I, Moher D, Altman DG,
Schulz KF, Ravaud P, the CONSORT
group. Methods and processes of the
CONSORT group: example of an
Extension for Trials Assessing
nonpharmacologic treatments. Ann
Intern Med. 2008;148:W60-W66.
18. Schulz KF, Altman DG, Moher D,
2010 Statement: updated guidelines
for reporting parallel group
randomised trials Trials 2010;11:32.
19. Moher D, Jones A, Lepage L, the
CONSORT group. Use of the
CONSORT statement and quality of
reports of randomized trials- a
comparative before-and-after
evaluation. J Am Med Assoc.
20. Williams HC. Cars, CONSORT
2010 and clinical practice. Trials
2010;11:33. Available at:
Accessed: May 16
, 2010.
21. Wujastik D. Change and creativity
in early modern Indian medical
thought. J Indian Philos. 2005;33:95-
22. ECRIN- European Clinical
Research Infrastructures Network.
Available at:
Accessed: April 29
, 2010.
23. CONSORT website. List of
Journal endorsers for CONSORT
2010. Available at:
Accessed: April 7
, 2010.
24. Altman DG. Endorsement of the
CONSORT statement by high impact
medical journals: survey of
instructions for authors. BMJ.
25. World Physical Therapy 2011.
World Confederation for Physical
Therapy, Geneva, 2010.
Available at:
Accessed: May 16
, 2010.
26. Tharyan P, Premkumar TS,
Matthew V, Barnabas JP, ManuelRaj.
Editorial policy and the reporting of
randomized controlled trials: A survey
of instructions for authors and
assessment of trial reports in Indian
medical journals (2004–05). Natl Med
J India. 2008;21:62–68.
Key points:
The first clinical trial was performed by Dr James Lind on
sailors with Scurvy and he found lemons and oranges were
effective in curing the disorder. The CONsolidated Standards
Of Reporting Trials (CONSORT) statement was formed in
1996, and was revised in 2001 and then extended to non-
pharmacologic interventions.
The CONSORT statement is revised this year 2010
with updated reporting guidelines. The randomized controlled
trials (RCTs) in physical therapy are increasing at the rate of 3
studies getting added to physiotherapy evidence database
(PEDro) everyday.
To improve evidence-based healthcare and evidence-
informed decision-making in physical therapy, the Journal of
Physical Therapy (JPT) endorsed the CONSORT 2010
statement and mandated the statement and its flow diagram for
future intervention studies submitted to JPT.
J Phys Ther.
CONSORT 2010 statement
Kumar SP
J Phys Ther. 2010;1:1-10.
Appendix 1- CONSORT 2010 Checklist for randomized trials.
... [105] With newer measurement methods being developed and reported to estimate treatment effects in randomized trials such as "years-needed-to-treat," [106] palliative care would evidently benefit from the evidence-base provided by high-quality RCTs, which are more of multi-centric, pragmatic following robust reporting guidelines such as the CONSORT statement. [107][108][109] It would be interesting to analyze the quality of reporting RCTs before and after the CONSORT 2010 statement, [110] as it was found earlier for the earlier version of CONSORT statement by Moher et al. [111] The generalizability of findings from RCTs is questionable since RCT patients and treatments are not typical of those in clinical practice, and most patients in clinical practice are receiving treatments that do not have direct empirical support. [112] One of the acceptable limitations of this study was that it included journals from MEDLINE through PubMed, since it was the most common and most widely searched database and is freely accessible. ...
... Disseminar os resultados de pesquisas científicas pode refletir na melhora da qualidade do serviço prestado, além projetar cenários futuros (25). A necessidade de operar a crítica interna da produção tem sido apontada como condição para que o conhecimento produzido possa ser incorporado pela comunidade e cumprir o seu papel transformador (1,26). ...
Full-text available
INTRODUÇÃO: Avaliar a produção do conhecimento de uma área pode facilitar a compreensão de sua identidade, bem como apontar quais rumos está percorrendo. OBJETIVO: Verificar qual a área de estudos e os descritores de maior ocorrência em artigos publicados em revistas de circulação nacional voltadas à fisioterapia. MÉTODO: Trata-se de uma pesquisa documental com abordagem qualitativa e quantitativa dos dados por meio da análise de conteúdo e da contagem das aparições dos descritores. Foram incluídos resumos de periódicos de fisioterapia brasileiros, com classificação maior ou igual a B2 no WebQualis e acesso livre em sítio da internet. Com esses critérios foram selecionadas a Revista Brasileira de Fisioterapia e a Fisioterapia em Movimento, de 1996 a 2009. Os itens analisados foram: palavras-chave e área de estudo. Utilizou-se o programa TextStat para a contagem das palavras. RESULTADOS: Foram analisados 726 artigos. As áreas de estudo de maior ocorrência foram ortopedia, neurologia, pneumologia e pediatria, que somadas englobam 65% da produção em fisioterapia, sendo a ortopedia, isoladamente, responsável por 36% dos estudos. Em relação à palavra-chave, a prevalência foi maior do descritor "fisioterapia", seguido de "idoso" e "atividade física". DISCUSSÃO: Quanto à área de estudos, o destaque para a ortopedia reflete a atuação do fisioterapeuta, que historicamente concentrou-se em hospitais e clínicas de reabilitação sob a tutela dos médicos ortopedistas, buscando sua independência num segundo momento. Em relação aos descritores, a maior frequência da palavra "fisioterapia" deve ser reavaliada pelos pesquisadores, pois não reflete o conteúdo dos estudos. CONCLUSÃO: A produção científica em ortopedia teve maior ocorrência, refletindo a maior área de atuação profissional.
... As clinicians, we should avoid using the terms interchangeably when we communicate with clients and stakeholders and understand the implications of applying the evidence on one or more of the four terms for a particular therapy. As the Journal of Physical Therapy (JPT) steps over third consecutive step (third published volume), the editorial board assures the reader of the accuracy in reporting 52 these terms in future published studies of JPT. "A technique is studied for its effects; A treatment is studied for its efficacy; A therapy is studied for its efficiency; and, A professional approach is studied for its effectiveness?" ...
Full-text available
The Journal of Physical Therapy (JPT) is stepping over its third volume of successful dissemination of research findings with information shared across the globe in the field of physical therapy. The aim of this editorial in this issue of Journal of Physical Therapy (JPT) is to explore into the understanding behind the use of four common terms-effects, efficacy, efficiency and effectiveness as four inter-related yet different terms in the field of Physical therapy (PT) with a historical perspective and implications for the future.
Full-text available
The present work was aimed to isolate the mucilage using microwave assisted extraction technique and to evaluate its excipient properties. The yield was found to be 22.56g/kg. The drugs and the isolated mucilage powder were found to be compatible as confirmed by the IR spectral studies. The sedimentation rates of the prepared suspensions using a model drug metronidazole were similar to that of the marketed sample and they were easily redispersible and do not form a hard cake. The drug content of all the prepared suspension formulations was found to be in the range of 94.2-96.1%. The isolated mucilage was also studied for its binding nature using ibuprofen as a model drug. The prepared granules were free flowing and the compressed tablets showed good hardness and friability as compared with the starch and marketed product, thereby confirming the mechanical resistance of the tablets. The drug content of all the prepared tablet formulations was found to be between 93.0-99.45%. The rate of drug release from tablet formulations using mucilage as binder was fast when compared to formulations containing starch and marketed product. Formulation F4 (1:2 ratio) of the prepared ibuprofen tablets showed similar release profile in comparison with the marketed product. The drug release mechanism for the formulation F4 was predicted as first order model with the r 2 value of 0.9632.
Full-text available
The structural and spectroscopic characterization of Schiff base ligand, (Z)-N′-(3-(hidroksiimino)butan-2-ylidene)-4metilbenzensulfonohidrazide (HL) are presented in this paper. The optimized geometry and vibrational frequencies of the ligand have been calculated by using DFT/B3LYP method with 6-311G(d,p) and 6-311G+(d,p) basis sets. The calculated wave numbers are used to assign vibrational bands obtained in IR spectroscopy and find out to the manifestations of hydrogen bonding in the νstr(N–H) and νstr(O–H) vibrations. The UV-Vis absorption peaks of the ligand predicted by the time-dependent DFT method matched quite well with experimentally observed UV-Vis bands. The molecular electrostatic potential and the energy profile with respect to rotations about the selected torsion angle τ(C5-S1-N3-N2) is also calculated.
Full-text available
Physical therapy as a profession has its roots to earliest of time, when the techniques were used for treatment much earlier than that of origin of the very term “physiotherapy” itself. This professional discussion paper is a review of the past, present and future of physical therapy as a profession in its three roles- educator, clinician and researcher. The ensuing paradigm shift in favor of advanced teaching methodologies and pedagogues evolved the present situation of physical therapy education. The shift from evidence-based practice to an evidence-informed one witnessed clinical therapists to pursue continuing educational programmes and professional development. The growing evidence in terms of increasing randomized controlled trials in physical therapy indicated development of quality clinical practice guidelines to translate evidence into practice. Professionalization in physical therapy needs a shift towards professionalism to move physical therapy forward in all three core areas of the profession.
Full-text available
This perspective provides an overview of the randomized controlled trials, systematic reviews, and evidence-based clinical practice guidelines in physical therapy. Data from the Physiotherapy Evidence Database (PEDro) are used to describe key events in the history of physical therapy research and the growth of evidence of effects of interventions used in the various subdisciplines of physical therapy. The 11,494 records that were identified reveal a rich history of physical therapy research dating back to the first trial in 1929. Most of the randomized controlled trials, systematic reviews, and evidence-based clinical practice guidelines in physical therapy have been published since the year 2000. This rapid growth presents a challenge for physical therapists who want to keep up to date in clinical practice.
Full-text available
Just like you would not buy a car without key information such as service history, you would not "buy" a clinical trial report without key information such as concealment of allocation. Implementation of the updated CONSORT 2010 statement enables the reader to see exactly what was done in a trial, to whom and when. A fully "CONSORTed" trial report does not necessarily mean the trial is a good one, but at least the reader can make a judgement. Clear reporting is a pre-requisite for judgement of study quality. The CONSORT statement evolves as empirical research moves on. CONSORT 2010 is even clearer than before and includes some new items with a particular emphasis on selective reporting of outcomes. The challenge is for everyone to use it.
Full-text available
The CONSORT statement is used worldwide to improve the reporting of randomised controlled trials. Kenneth Schulz and colleagues describe the latest version, CONSORT 2010, which updates the reporting guideline based on new methodological evidence and accumulating experience. To encourage dissemination of the CONSORT 2010 Statement, this article is freely accessible on and will also be published in the Lancet, Obstetrics and Gynecology, PLoS Medicine, Annals of Internal Medicine, Open Medicine, Journal of Clinical Epidemiology, BMC Medicine, and Trials.
This book starts with a general discussion of clinical trials. It goes on to describe the activities of a typical study, comparing single center and multicenter trials, reviewing cost factors and assessing the usefulness of clinical trials for the practice of medicine. The book then considers design principles and practices such as sample size estimates and the mechanics of treatment masking, and provides a detailed consideration of a variety of issues involved in implementation and analysis, including execution, follow-up, and quality assurance. The book also includes a three-chapter section on management and an in-depth treatment of reporting procedures.
To comprehend the results of a randomized, controlled trial (RCT), readers must understand its design, conduct, analysis, and interpretation. That goal can be achieved only through complete transparency from authors. Despite several decades of educational efforts, the reporting of RCTs needs improvement. Investigators and editors developed the original CONSORT (Consolidated Standards of Reporting Trials) statement to help authors improve reporting by using a checklist and flow diagram. The revised CONSORT statement presented in this paper incorporates new evidence and addresses some criticisms of the original statement. The checklist items pertain to the content of the Title, Abstract, Introduction, Methods, Results, and Discussion. The revised checklist includes 22 items selected because empirical evidence indicates that not reporting the information is associated with biased estimates of treatment effect or because the information is essential to judge the reliability or relevance of the findings. We intended the flow diagram to depict the passage of participants through an RCT. The revised flow diagram depicts information from four stages of a trial (enrollment, intervention allocation, follow-up, and analysis). The diagram explicitly includes the number of participants, for each intervention group, that are included in the primary data analysis. Inclusion of these numbers allows the reader to judge whether the authors have performed an intention-to-treat analysis. In sum, the CONSORT statement is intended to improve the reporting of an RCT, enabling readers to understand a trial's conduct and to assess the validity of its results.
This summary corresponds to the translation into Spanish of the Special Communication published in the Journal of the American Medical Association in August 1996, along with the editorial published in the same issue "How to report Randomized Controlled Trials. The Consort Statement". It describes the Consolidated Standars for Preparation of Controlled Clinical Trials, prepared by a work group made up of members of the SORT Group and of the Asilomar Work Group, along with the editor of a magazine and the author of the report on a clinical trial. The work was carried out by means of a Delphy process and the result was a check list and a process diagram. The check list is made up of 21 items that mainly refer to methods, results and discussions on the report of a controlled clinical trial, identifying the necessary information in order to be able to evaluate the internal and external value of the report, judging the improvement to be positive for the patient, the editors and the reviewers of the magazines.
Physiotherapy emerged as a profession only a century ago and has a fragile, but evolving research evidence base. Physiotherapy has been subject to decades of criticism for its lack of research utilisation, and is often perceived as a profession whose treatment techniques lack scientific support. Numerous editorials and scholarly addresses have urged physiotherapists to become research consumers. The 1990s saw evidence-based practice emerge as a new paradigm within health care and health education, and also the emergence of initiatives like the Cochrane Collaboration, and the UK Department of Health Research and Development initiative, which aim to promote evidence use within the health professions. To determine the extent to which physiotherapy has responded to these criticisms and initiatives this paper presents studies that have explored the fundamental questions of whether physiotherapists read journal literature, implement research findings into practice, and employ scientific documentation and measures. The results of the various studies consistently indicate that despite the numerous initiatives to promote evidence use, many physiotherapy clinicians remain unaware of the extent and nature of published research evidence. The assimilation and utilisation of research literature among physiotherapy clinicians is limited, with the exception of those with higher-degree experience. Journal provision and access to journal clubs within physiotherapy hospital departments is poor. The major factors infl uencing practice were education, prior experience, and peer opinion, rather than research and evidence. Deficiencies in quality and type of documentation also emerged in addition to an apparent unwillingness to employ evidence-based outcome measures. Methods for maximising the positive findings and addressing the deficiencies that emerged are proposed.