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Statistical Reporting in Indian Pediatrics

Authors:
Jaykaran Charan at All India Institute of Medical Sciences Jodhpur
Jaykaran Charan
Jagdish Prasad Goyal at All India Institute of Medical Sciences Jodhpur
Jagdish Prasad Goyal
Pankaj Bhardwaj at All India Institute of Medical Sciences Jodhpur
Pankaj Bhardwaj
Preeti Yadav at Government Medical College, Surat
Preeti Yadav
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Abstract

We analyzed 45 original articles from Indian Pediatrics for appropriateness of the statistical methods. Appropriate statistical tests (93%), no use of obscure test and use of exact P value were the positive findings observed. Sample size was calculated in 24% and confidence interval in 13%. There is a need to generate awareness regarding confidence interval and sample size calculations.
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INDIAN PEDIATRICS 811 VOLUME 46__SEPTEMBER 17, 2009
RESEARCH LETTERS
from immunoglobulin administration. In Group I,
only one patient (8%) expired as compared to 6/13
(46%) in Group II (P=0.04). Recovery of left
ventricular function was not significantly different
between two groups (49% vs. 46%) (P=0.13).
Our reports showed that IVIG group had
significant higher survival rate (92%) than other
group who did not receive IVIG (54%). The
therapeutic efficacy of high-dose IVIG in Kawasaki
disease has been already established(2). Other
experimental animal and human studies in acute
myocarditis have also reported better outcome with
IVIG(3-6).
Our study had few limitations. The diagnosis was
based on clinical features, CXR, ECG, and
echocardiography. Small sample size and
retrospective nature of the study were the other
hinderances. However, this study provides support
for aggressive supportive care and early use of IVIG
in acute myocarditis in children.
Anwarul Haque, Samreen Bhatti
and Fahad J Siddiqui
Department of Pediatrics and Child Health,
Aga Khan University Hospital,
Stadium Road, P O Box 3500,
Karachi 74800, Pakistan.
anwar.haq@aku.edu
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AS, Chung KJ, Duffy CE, et al. The treatment of
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TABLE I PATIENT CHARACTERISTICS OF TWO GROUPS
Variables IVIG- IVIG+ P
(controls) (cases) value
n = 13 n =12
Age (mo), mean(SD) 12.0 (4.9) 7.3 (5.8) 0.04
Gender (M/F) 6/7 6/6 0.6
Hepatomegaly 12 9 0.3
Cardiomegaly 12 12 0.5
ECG: Low-voltage 12 9 0.3
Initial EF (%), mean(SD) 22.5 (11.1) 17.5 (5.0) 0.17
Inotropes 1.5 (0.9) 3.0 (1.1) 0.001
EF: ejection fraction
Statistical Reporting in Indian Pediatrics
We analyzed 45 original articles from Indian Pediatrics for
appropriateness of the statistical methods. Appropriate
statistical tests (93%), no use of obscure test and use of
exact P value were the positive findings observed. Sample
size was calculated in 24% and confidence interval in
13%. There is a need to generate awareness regarding
confidence interval and sample size calculations.
Key words: India,Journal, Statistics.
Statistical errors are common in scientific
literature(1-3). We conducted this study to evaluate
the appropriateness of statistical techniques used and
types of statistical errors present in original papers
INDIAN PEDIATRICS 812 VOLUME 46__SEPTEMBER 17, 2009
RESEARCH LETTERS
published in Indian Pediatrics. The journal has
separate advisors for biostatistics(4).
All the authors independently surveyed 45 Lead
Articles and Research Papers published in Indian
Pediatrics in 2007 and 2008 on the basis of a
modified checklist(5). The results are summarized in
Table I.
Appropriate statistical tests were used in 42
(93%) articles. In few studies parametric test were
used in place of nonparametric tests. Mainly these
data were dealing with rank and scores. The
incidence of inappropriate tests is less as compared
to other studies published in this area(2,3,6).
Sample size was calculated in only 11 studies;
among the clinical trials it was calculated in 46% of
studies. Data were checked for normal distribution
in only 21% studies. Multiple hypothesis testing was
done in most of the articles. Separate test was used
for each variable. Another neglected aspect was
confidence interval, calculated in only 13% articles.
Confidence interval gives us range of the value
around the effect size of sample where population
mean actually lies. Other encouraging point is
mentioning of exact P value in most of the articles.
We observed that as compared to previous
studies in other journals, the statistical reporting of
Indian Pediatrics is better(6,7). Editors should
generate more awareness regarding confidence
interval, distribution of data, nonparametric statistics
and calculation of sample size.
Jay Karan, JP Goyal, *P Bhardwaj and
Preeti Yadav
Government Medical College, Surat; and
*Era’s Medical College, Lucknow, India.
drjayakaran@yahoo.co.in
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TABLE I REPORTING OF STATISTICAL METHODS IN INDIAN
PEDIATRICS
Checklist points Frequency(%)n=45
Sample size calculation 11 (24.4)
Baseline comparison 43 (95.5)
Ratio + nominal data 22 (48)
Nominal data 11 (24)
Ratio data 9 (20)
Ordinal 2 (4)
Ratio + ordinal 1 (2)
Appropriate statistical test 42 (93)
Parametric test 38 (84)
Nonparametric test 7 (15)
Normal distribution analyzed 7 (15)
Obscure test 0
Post hoc subgroup analysis 0
Two tailed test 45 (100)
Outliers 0
Correlation 9 (20)
r value 7 (15)
P value <0.05 45 (100)
Confidence interval 6 (13)
Relative risk reduction 0
Absolute risk reduction 0
Number needed to treat 0
Use of software 31 (29)
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... One of the fallacies during clinical trials is use of inappropriate or wrong statistical tests. [1][2][3][4][5] Number of reasons cited for considering a test to be inappropriate. As mentioned earlier before using the particular statistical tests, all the assumptions for that statistical test should be fulfilled. ...
... In many of the clinical trials published in Indian medical journals it is observed that distribution of data was not checked which is an important prerequisite before applying parametric statistical tests. [1,2] Biological variables are usually more prone to fall in skewed distribution, hence checking of distribution become very important. Variable measured from small samples are also more prone to fall under skewed distribution. ...
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... We believe that this work is important as very few studies are done regarding reporting of statistics in Indian medical journals. [18,19] Each author surveyed these negative clinical trials for reporting of sample size calculation and power on predesigned proforma. We looked for reporting of the sample size and various components of sample size calculation (reporting of power, comment on power, reporting of delta, reason for delta, assumption of the control group, reason for the control group, confidence interval, and reporting of one tailed or two tailed). ...
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... Use of wrong or inappropriate statistical test is a common phenomenon observed in articles published in biomedical journals. [1][2][3][4] Wrong statistical tests can be seen in many conditions like use of paired test for unpaired data or use of parametric statistical tests for the data which does not follow the normal distribution or incompatibility of statistical tests with the type of data, etc. [5] Because of the availability of different types of statistical software, performing the statistical tests become easy, but selection of appropriate statistical test is still a problem. ...
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Full-text available
  • Apr 2012
  • J POSTGRAD MED
Use of multivariable logistic regression (MLR) modeling has steeply increased in the medical literature over the past few years. Testing of model assumptions and adequate reporting of MLR allow the reader to interpret results more accurately. To review the fulfillment of assumptions and reporting quality of MLR in selected Indian medical journals using established criteria. Analysis of published literature. Medknow.com publishes 68 Indian medical journals with open access. Eight of these journals had at least five articles using MLR between the years 1994 to 2008. Articles from each of these journals were evaluated according to the previously established 10-point quality criteria for reporting and to test the MLR model assumptions. SPSS 17 software and non-parametric test (Kruskal-Wallis H, Mann Whitney U, Spearman Correlation). One hundred and nine articles were finally found using MLR for analyzing the data in the selected eight journals. The number of such articles gradually increased after year 2003, but quality score remained almost similar over time. P value, odds ratio, and 95% confidence interval for coefficients in MLR was reported in 75.2% and sufficient cases (>10) per covariate of limiting sample size were reported in the 58.7% of the articles. No article reported the test for conformity of linear gradient for continuous covariates. Total score was not significantly different across the journals. However, involvement of statistician or epidemiologist as a co-author improved the average quality score significantly (P=0.014). Reporting of MLR in many Indian journals is incomplete. Only one article managed to score 8 out of 10 among 109 articles under review. All others scored less. Appropriate guidelines in instructions to authors, and pre-publication review of articles using MLR by a qualified statistician may improve quality of reporting.
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... Hanif and Ajmal [16] also reported a comparable rate of inappropriate statistical tests (28.8%), Allam et al. [4] and Šimundić and Nikolac [17] reported higher rates (53.2% and 61.8%, respectively), while Karan et al. [18] reported a lower rate (7.0%). ...
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  • Oct 2020
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... The most widely used approaches to multivariable models in clinical studies are multivariable linear regression, multivariable logistic regression (MLR), and proportional hazards regression [1] . The independent variables in MLR model can be continuous, categorical, or ordinal. ...
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Fundamental concepts in statistics form the cornerstone of scientific inquiry. If we fail to understand fully these fundamental concepts, then the scientific conclusions we reach are more likely to be wrong. This is more than supposition: for 60 years, statisticians have warned that the scientific literature harbors misunderstandings about basic statistical concepts. Original articles published in 1996 by the American Physiological Society's journals fared no better in their handling of basic statistical concepts. In this review, we summarize the two main scientific uses of statistics: hypothesis testing and estimation. Most scientists use statistics solely for hypothesis testing; often, however, estimation is more useful. We also illustrate the concepts of variability and uncertainty, and we demonstrate the essential distinction between statistical significance and scientific importance. An understanding of concepts such as variability, uncertainty, and significance is necessary, but it is not sufficient; we show also that the numerical results of statistical analyses have limitations.
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Full-text available
  • Jul 2006
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Article
  • Sep 1986
We compared the efficacy of intravenous gamma globulin plus aspirin with that of aspirin alone in reducing the frequency of coronary-artery abnormalities in children with acute Kawasaki syndrome in a multicenter, randomized trial. Children randomly assigned to the gamma globulin group received intravenous gamma globulin, 400 mg per kilogram of body weight per day, for four consecutive days; both treatment groups received aspirin, 100 mg per kilogram per day, through the 14th day of illness, then 3 to 5 mg per kilogram per day. Two-dimensional echocardiograms were interpreted blindly and independently by two or more readers. Two weeks after enrollment, coronary-artery abnormalities were present in 18 of 78 children (23 percent) in the aspirin group, as compared with 6 of 75 (8 percent) in the gamma globulin group (P = 0.01). Seven weeks after enrollment, abnormalities were present in 14 of 79 children (18 percent) in the aspirin group and in 3 of 79 (4 percent) in the gamma globulin group (P = 0.005). No child had serious adverse effects from receiving gamma globulin. We conclude that high-dose intravenous gamma globulin is safe and effective in reducing the prevalence of coronary-artery abnormalities when administered early in the course of Kawasaki syndrome.
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Statistical problems in the reporting of clinical trials. A survey of three medical journals
Article
  • Sep 1987
Reports of clinical trials often contain a wealth of data comparing treatments. This can lead to problems in interpretation, particularly when significance testing is used extensively. We examined 45 reports of comparative trials published in the British Medical Journal, the Lancet, or the New England Journal of Medicine to illustrate these statistical problems. The issues we considered included the analysis of multiple end points, the analysis of repeated measurements over time, subgroup analyses, trials of multiple treatments, and the overall number of significance tests in a trial report. Interpretation of large amounts of data is complicated by the common failure to specify in advance the intended size of a trial or statistical stopping rules for interim analyses. In addition, summaries or abstracts of trials tend to emphasize the more statistically significant end points. Overall, the reporting of clinical trials appears to be biased toward an exaggeration of treatment differences. Trials should have a clearer predefined policy for data analysis and reporting. In particular, a limited number of primary treatment comparisons should be specified in advance. The overuse of arbitrary significance levels (for example, P less than 0.05) is detrimental to good scientific reporting, and more emphasis should be given to the magnitude of treatment differences and to estimation methods such as confidence intervals.
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Globulin treatment of acute myocarditis in the pediatric population
Article
  • Feb 1994
Myocardial damage in myocarditis is mediated, in part, by immunological mechanisms. High-dose intravenous gamma-globulin (IVIG) is an immunomodulatory agent that is beneficial in myocarditis secondary to Kawasaki disease, as well as in murine myocarditis. Since 1990, the routine management of presumed acute myocarditis at Children's Hospital, Boston, and Children's Hospital, Los Angeles, has included administration of high-dose IVIG. We treated 21 consecutive children presenting with presumed acute myocarditis with IVIG, 2 g/kg, over 24 hours, in addition to anticongestive therapies. A comparison group comprised 25 recent historical control patients meeting identical eligibility criteria but not receiving IVIG therapy. Left ventricular function was assessed during five time intervals: 0 to 7 days, 1 to 3 weeks, 3 weeks to 3 months, 3 to 6 months, and 6 to 12 months. At presentation, the IVIG and non-IVIG groups had comparable left ventricular enlargement and poor fractional shortening. Compared with the non-IVIG group, those treated with IVIG had a smaller mean adjusted left ventricular end-diastolic dimension and higher fractional shortening in the periods from 3 to 6 months (P = .008 and P = .033, respectively) and 6 to 12 months (P = .072 and P = .029, respectively). When adjusting for age, biopsy status, intravenous inotropic agents, and angiotensin-converting enzyme inhibitors, patients treated with IVIG were more likely to achieve normal left ventricular function during the first year after presentation (P = .03). By 1 year after presentation, the probability of survival tended to be higher among IVIG-treated patients (.84 versus .60, P = .069). We observed no adverse effects of IVIG administration. These data suggest that use of high-dose IVIG for treatment of acute myocarditis is associated with improved recovery of left ventricular function and with a tendency to better survival during the first year after presentation.
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Intravenous Immune Globulin in the Therapy of Myocarditis and Acute Cardiomyopathy
Article
  • Jul 1997
Although an autoimmune pathogenesis has been postulated for dilated cardiomyopathy, immunosuppressive therapy has not been shown to be effective in clinical trials. Immune modulatory therapy with immune globulin is an effective therapy for Kawasaki disease in children, and recent data suggest that it improves ventricular function in children with new-onset dilated cardiomyopathies. The role of immune globulin therapy in adults with this disorder has not previously been evaluated. Ten patients were treated with high-dose intravenous immune globulin infusions (2 g/kg). All were hospitalized with NYHA class III to IV heart failure, left ventricular ejection fraction (LVEF) < 0.40, and symptoms for < 6 months at the time of presentation. One patient died before the completion of therapy. The remaining 9 were discharged, and LVEF was reassessed 12 months after therapy. LVEF improved from 0.24 +/- 0.02 (mean +/- SEM) at baseline to 0.41 +/- 0.04 at follow-up (P = .003). All 9 patients improved functionally to NYHA class I to II, and there have been no subsequent hospitalizations for heart failure during the course of follow-up. In this series of patients with new-onset dilated cardiomyopathy treated with high-dose immune globulin, LVEF improved 17 EF units. The effectiveness of intravenous immune globulin therapy in this disorder should be evaluated in a randomized, multicenter trial.
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Statistics in medical journals: Some recent trends
Article
  • Dec 2000
I review some areas of medical statistics that have gained prominence over the last 5-10 years: meta-analysis, evidence-based medicine, and cluster randomized trials. I then consider several issues relating to data analysis and interpretation, many relating to the use and misuse of hypothesis testing, drawing on recent reviews of the use of statistics in medical journals. I also consider developments in the reporting of research in medical journals.
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Diagnosis and treatment of pediatric viral myocarditis
Article
  • Apr 2001
Acute myocarditis is characterized by the rapid development of life-threatening congestive heart failure and arrhythmias. Although the initial stages of this disorder apparently result from direct cytopathic effects on the atrial and ventricular myocardium, later stages of progressive decompensation may result from immune-mediated myocyte destruction. There has been recent improvement in understanding the role of this immunologic cascade. As a result, treatment now begins earlier in the course of the disease and can target both the virus and the immune response. Our ability to implement mechanical support in children as a bridge to transplant or recovery, even in children presenting in the final stages of their disease, has led to an improved outcome regarding morbidity and mortality.
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