Reporting statistics in clinical trials published in Indian journals: a survey

Objectives

Clinical trials are having very important place in the hierarchy of evidence based medicine. It has been observed that current methods of use and reporting of statistics of clinical trials are responsible for errors in the interpretation of results. So we decided to evaluate clinical trials published in three Indian journals of 2007 and 2008 to analyse statistical issues which may affect the interpretation of results.

Settings and Design

Retrospective observational study

Materials and Methods

We analyzed all the clinical trials (46) published in Indian pediatrics, Indian journal of pharmacology, journal of postgraduate medicine and of 2007–2008.

Results

We found that median number of end points reported in clinical trials was 4 and median number of end points which were used for testing of significance was also 4. (21) 45% of trials reported repeated measurement. 18 (39%) trials had three or more than three treatment groups. median number of test of significance was 15. post hoc subgroup analysis was done in 19% (9) of trials. P value was the sole criteria for interpretation of results in most of the trials, confidence interval was calculated in 11 (23%) trials. Baseline comparison between the study groups was done in 41 (89%) trials. in all cases comparison was done by statistical tests. Exact sample size was calculated in 18 (39%) trials.

Conclusion

There are great chances of having error during the interpretation of results of these trials was because of multiple treatment groups, repeated measurements of endpoints, multiple tests of significance, over reliability on P value and less use of confidence interval. Statistical methods available for reducing chances of errors should be used and result should be interpreted accordingly.     

Reporting of demographics, methodology, and ethical procedures in journals in pediatric and child psychology.

OBJECTIVE: To identify potential problems in methodology reporting that may limit research interpretations and generalization. METHODS: We examined the rates at which articles in four major journals publishing research in pediatric, clinical child, and child psychology report 18 important demographic, methodological, and ethical information variables, such as participants' gender, socioeconomic status, ethnicity, inclusion/exclusion criteria, and consent and assent procedures. RESULTS: Overall, participants' ages, genders, and ethnicity were reported at moderate to high rates, whereas socioeconomic status was reported less often. Reports of research methodology frequently did not include information on how and where participants were recruited, the participation/consent rates, or attrition rates. Consent and assent procedures were not frequently described. CONCLUSIONS: There is wide variability in articles reporting key demographic, methodological, and ethical procedure information. Necessary information about characteristics of participation samples, important for drawing conclusions, is lacking in the flagship journals serving the child psychology field.     

Reporting an abrupt-onset persistent hypotensive transfusion reaction in an Indian female patient

Blood transfusion [BT] may sometimes result in a rare type of adverse event causing an isolated fall in blood pressure, commonly referred to as a hypotensive transfusion reaction [HyTR]. It is mediated by the biological response mediators, in particular cytokines such as bradykinin characterized by a sudden and unforeseen onset of hypotension as the predominant clinical manifestation during BT. In this case, the authors wish to highlight two consecutive episodes of abrupt-onset HyTR following blood administration in an Indian female patient, which, however, characteristically subsided on stopping the BT. She received appropriate management for the same. In fact, on discharge, we advised the patient to receive washed blood components, if needed, to prevent the recurrence of HyTR in future.     

Reporting on health-related research in two prestigious Brazilian newspapers

OBJECTIVES:

The dissemination of health-related news through newspapers can influence the behavior of patients and of health care providers. We conducted a study to analyze the characteristics of health-related research published by two leading Brazilian newspapers.

METHOD:

We retrospectively evaluated health-related news published in the electronic versions of the newspapers Folha de São Paulo and O Estado de São Paulo over a period of three months (July through September, 2009). Only articles mentioning medical research were included. The articles were categorized according to topic, source, study location and the nature of the headline. We also analyzed the presence of background information on the topic, citations of medical periodicals, national contextualization and references to products or companies.

RESULTS:

Scientific research articles corresponded to 57% and 20% of health-related articles published by Folha de São Paulo and O Estado de São Paulo, respectively. Folha de São Paulo published significantly more articles about national studies, and most articles were written by its own staff. In contrast, most articles in O Estado de São Paulo came from news agencies. Folha de São Paulo also better contextualized its reports for Brazilian society. O Estado de São Paulo tended to cite the name of the periodical in which the study was published more frequently, but their articles lacked national contextualization.

CONCLUSION:

The results showed a significant difference in the way in which the studied newspapers report on health-related research. Folha de São Paulo tends to write its own articles and more frequently publishes the results of national research, whereas O Estado de São Paulo publishes articles that originate in news agencies, most of which have little national contextualization.     

Multiple authorship in two English-language journals in radiation oncology.

Multiple authorship is the listing of more than one person as author of an article in the scholarly literature. Editors, researchers, and others in science publishing have raised concerns about the increasing number of authors being listed per article, the practice of "honorary authorship" (listing as an author someone who made little or no contribution to the work being reported), and the danger of the dilution of responsibility when many authors are involved. The authors studied multiauthorship in the two most popular English-language journals on radiation oncology, examining 1,908 papers and letters published in the International Journal of Radiation Oncology, Biology, and Physics (IJROBP) and Radiotherapy and Oncology (RO) from 1983 through 1987. There was no increase in the number of authors per article during this period, when the median number for IJROBP was four and that for RO was three. The number of authors varied by type of article, by country (France had the largest median number, six for IJROBP and five for RO), and by the authors' institution. The first author's gender was unrelated to the number of subsequent authors for an article. The proportion of men first authors varied widely between countries and institutions. Possible explanations for these variations include the multidisciplinary nature and complexity of some forms of research, institutional policies concerning the use of authorship as a commodity of exchange, and social-cultural factors.     

Frequency and citations of published authors in two community psychology journals

The current study examined the development of community psychology through publications in the main journals of the field, the American Journal of Community Psychology (AJCP) and Journal of Community Psychology (JCP). The investigation assessed which individuals played a major role in shaping the field through their publications by recording information from every citation in AJCP and JCP since the journals started in 1973 through 2004. Each author and the year of publication were documented. In addition, the number of times each article was cited by other researchers was also documented as an approximation of the impact of the article. To document trends over time, three periods (1973–1983; 1984–1994; 1995–2004) were assessed. The relative contribution of authors to the field's literature is presented by rank orders of productivity and influence. Historical trends are discussed. © 2009 Wiley Periodicals, Inc.     

A survey of variable selection methods in two Chinese epidemiology journals

Background  

Although much has been written on developing better procedures for variable selection, there is little research on how it is practiced in actual studies. This review surveys the variable selection methods reported in two high-ranking Chinese epidemiology journals.     

Histocompatibility Antigens in two American Indian Tribes of French Guiana

Two South American Indian populations were typed for HLA antigens. In each, the individuals typed were related and their genealogies were known. Determination of their genotypes was done; there seemed to be neither excess nor deficiency in homozygotes. The antigens observed, A2, A9, Aw19.2 (Aw30-Aw31), A28 for the first locus and B5, Bw15, Bw35, Bw40 for the second locus are in accordance with those previously described for other South American Indians. The two populations belong to the same primary linguistic family Tupi-Guarani and they live in the same geographic area, but there was no intertribal marriage until recently. Genetic drift can explain the differences observed.     

Reporting characteristics of cancer pain: a systematic review and quantitative analysis of research publications in palliative care journals

Objective:

A common disorder requiring symptom palliation in palliative and end-of-life care is cancer. Cancer pain is recognized as a global health burden. This paper sought to systematically examine the extent to which there is an adequate scientific research base on cancer pain and its reporting characteristics in the palliative care journal literature.

Materials and Methods:

Search conducted in MEDLINE and CINAHL sought to locate all studies published in 19 palliative/ hospice/ supportive/ end-of-life care journals from 2009 to 2010. The journals included were: American Journal of Hospice and Palliative Care, BMC Palliative Care, Current Opinion in Supportive and Palliative Care, End of Life Care Journal, European Journal of Palliative Care, Hospice Management Advisor, Indian Journal of Palliative Care, International Journal of Palliative Nursing, Internet Journal of Pain Symptom Control and Palliative Care, Journal of Pain and Palliative Care Pharmacotherapy, Journal of Palliative Care, Journal of Palliative Medicine, Journal of Social Work in End-of-life and Palliative Care, Journal of Supportive Oncology, Palliative Medicine, Palliative and Supportive Care, and Supportive Care in Cancer. Journal contents were searched to identify studies that included cancer pain in abstract.

Results:

During the years 2009 and 2010, of the selected 1,569 articles published in the journals reviewed, only 5.86% (92 articles) were on cancer pain.

Conclusion:

While researchers in the field of palliative care have studied cancer pain, the total percentage for studies is still a low 5.86%. To move the field of palliative care forward so that appropriate guidelines for cancer pain management can be developed, it is critical that more research be reported upon which to base cancer pain therapy in an evidence-based palliative care model.     

Bombay phenotype in two North Indian brothers: a case report

Bombay phenotype is unique in the aspect that the red cells are not agglutinated by antisera A, B and H. However the serum of such individuals contains anti A, B and strongly reactive anti H which agglutinates red cells of 'O' group individuals through a wide thermal range. The blood specimen of a 35 year old male donor who donated blood for the first time was subjected to detailed cell and serum grouping. There was a discrepancy between the results. The possibility of Bombay phenotype was considered and the sample was tested with anti H lectin. Further confirmation of blood group and secretor status was done from a reference laboratory. Family studies showed the same blood group in the elder sibling of the propositus. The present case highlights the significance of correlating cell and serum grouping results. Moreover, this blood group is very rare in North India. Family studies revealed the propositus to possess the B gene which was suppressed in the donor but expressed in the offsprings. The use of anti H in discrepant blood grouping results is recommended.