Atul Juneja

Cervical cancer screening in India: Strategies revisited

With the change in the life styles and demographic profiles of developing countries, noncommunicable diseases are emerging to be important health problems that demand appropriate control program before they assume epidemic proportion. One of these is the problem of cancer. In India, cervical cancer is a significant problem in terms of incidence, mortality and morbidity. Cervical cancer is a disease that can be prevented through both primary prevention and early detection using screening techniques. Several screening modalities are now available for early detection of cervical cancer and its precursor lesions. They all differ with regard to their test characteristics, feasibility and economic considerations. This communication reviews different aspects of these screening modalities and provides different options considering mass application.

Clinical Trials Registry - India: Redefining the conduct of clinical trials

Recently, there has been growing concern about the selective publication of clinical trial results[1,2] and its consequences on the practice of “evidence-based medicine.” Selective reporting of clinical trials results leads to bias in published clinical trial literature in favor of positive or promising results. This contention has been convincingly demonstrated by Simes as early as 1986.[3] He reported that a pooled analysis of published clinical trials demonstrates a significant survival advantage for advanced ovarian cancer given combination chemotherapy (versus initial alkylating agent, P = 0.02). However, no significant difference in survival is demonstrated based on a pooled analysis of registered trials (P = 0.25). Similarly, for multiple myeloma patients, whereas pooled analysis of registered trials also shows a survival benefit for patients receiving combination chemotherapy, the estimated magnitude of the benefit is reduced. These data underscore the propensity for misleading information being generated from data analysis of only published clinical trial literature. The most effective antidote to this problem may be through registration of all clinical trials and making their results available publicly. Registration of clinical trials offers other benefits as well, such as safeguarding of patient interests and ensuring greater transparency, accountability and accessibility of clinical trials whereas at the same time also helping to raise the standard of research.

Challenges in Administering a Clinical Trials Registry: Lessons from the Clinical Trials Registry-India

The Clinical Trials Registry - India (CTRI), an online system (www.ctri.nic.in) for the registration of clinical trials being conducted in India, has its secretariat at the National Institute of Medical Statistics of the Indian Council of Medical Research in New Delhi. The primary objective of the CTRI is to ensure that all clinical trials conducted in India are registered in order to bring transparency, accountability and access to clinical trials. Since its launch on 20 July 2007, the CTRI has gone from strength to strength and, as of January 2013, more than 3,300 trials had been registered. Although initiated as a voluntary exercise, registration of trials requiring approval by the drug regulatory authority in India has been made mandatory. Editors from 11 major biomedical journals in India require submission of the clinical trial registration number as a prerequisite for publication. In addition, several ethics committees also insist upon trial registration. The CTRI is a primary registry of the WHO’s International Clinical Trials Registry Platform. This article discusses the challenges encountered during the setting up of the CTRI and the strategies adopted, and also explains the steps to trial registration in the CTRI.

Testing of Hypothesis in Equivalence and Non Inferiority Trials-A Concept.

Establishing the appropriate hypothesis is one of the important steps for carrying out the statistical tests/analysis. Its understanding is important for interpreting the results of statistical analysis. The current communication attempts to provide the concept of testing of hypothesis in non inferiority and equivalence trials, where the null hypothesis is just reverse of what is set up for conventional superiority trials. It is similarly looked for rejection for establishing the fact the researcher is intending to prove. It is important to mention that equivalence or non inferiority cannot be proved by accepting the null hypothesis of no difference. Hence, establishing the appropriate statistical hypothesis is extremely important to arrive at meaningful conclusion for the set objectives in research.

Evaluation of the American Heart Association 2015 revised Jones criteria versus existing guidelines

Objectives To compare the diagnostic yield of acute rheumatic fever (ARF) by the American Heart Association/ American College of Cardiology (AHA/ACC) 2015 revised Jones criteria with the WHO 2004 and Australian guidelines 2012. Methods Retrospective observational study in 93 cases of suspected ARF admitted to the Division of Paediatric Cardiology between January 2012 and December 2014. WHO 2004, Australian guidelines and AHA/ACC 2015 Jones criteria were applied to assess definite and probable ARF. Results Of the 93 cases, 50 were diagnosed as the first episode of ARF and 43 as a recurrence of the condition. Subclinical carditis was a predominant presentation (38%) in the first episode group (p<0.01) whereas in the recurrence group carditis (88%) was the main presentation (p<0.01). Among the joint manifestations, the majority of patients in both the first episode group and the recurrence group presented with arthralgia. Of all the patients with suspected ARF (50), 34% of cases did not fulfil the standard Jones criteria 2004; however, 86% qualified as having ARF on applying the Australian and AHA/ACC 2015 criteria. Surprisingly in the recurrence group only 67% of the patients fulfilled AHA/ACC 2015 despite the modifications incorporated beyond WHO 2004; however, all the patients fulfilled the Australian guidelines either as definite (88.4%) or probable (11.6%). Inclusion of subclinical carditis, polyarthralgia and monoarthritis as major criteria influenced the diagnosis to definite ARF in 20%, 10% and 4% of patients, respectively. Conclusions The clinical manifestations of ARF, comprising subclinical carditis and arthralgia, are possibly milder in the Indian population; hence, inclusion of subclinical carditis, polyarthralgia and monoarthritis as major criteria in the newer guidelines has improved the diagnostic yield of ARF. In the absence of a gold standard for the diagnosis of ARF, it is not possible to comment on sensitivity and specificity.

Share of tobacco related cancers: gender and time gaps-Indian scenario.

INTRODUCTION Cancer is one of the leading causes of mortality in Indian population with control approach of varied kind which the health system of the country needs to prioritize. The tobacco related cancer which account for major share of all the cancers could be largely controlled through primary prevention a strategy effective in terms of resources hence take priority in terms of cancer control activities. It would be worthwhile to study the cancer of sites and relative magnitude of the cancers which are tobacco related and are amenable for prevention. MATERIALS AND METHODS The age specific cancer incidence rates of cancer as available from the consolidated reports of the National Cancer Registry Program of Indian Council of Medical Research for the years 1990-96 an 2001-04 were utilized for computing proportion of tobacco related cancers which included population based cancer registries at Bangalore, Bhopal, Barshi a rural registry in Maharashtra, Chennai, Delhi and Mumbai. As defined cancer of the sites oral cavity, lip, tongue, oropharynx, hypopharnx, pharynx, oesophagus, larynx, lung, urinary bladder were considered as tobacco related cancers. The statistical evaluation of proportion of tobacco related cancers between two time periods under consideration was carried out by proportion test. RESULTS There was a significant decline of proportion of tobacco related cancers from 1990-96 to 2003 for all the registries except Bhopal where around 50% of the total cancers attributed to tobacco habits for the two time periods under consideration. The Barshi also reported a decline but was not statistically significant. In females the proportion of tobacco related cancers ranged between 17% in Bangalore 10% in Delhi for the two time periods under review. All the registries showed significant decline in proportion of tobacco related cancers for the periods under consideration, except Delhi and Bhopal, while rural registry at Barshi revealed an increase of 3.3 %. The gender difference of the proportion of tobacco related cancers ranges between 19.8% to 34% during the period 1990-96, while it was 18.5% to 35% for the period 2001-03. While examining the difference between gender gap between the two time periods, the results from Mumbai registry revealed significant decline.

Issues of sample size in sensitivity and specificity analysis with special reference to oncology

Sample size is one of the basics issues, which medical researcher including oncologist faces with any research program. The current communication attempts to discuss the computation of sample size when sensitivity and specificity are being evaluated. The article intends to present the situation that the researcher could easily visualize for appropriate use of sample size techniques for sensitivity and specificity when any screening method for early detection of cancer is in question. Moreover, the researcher would be in a position to efficiently communicate with a statistician for sample size computation and most importantly applicability of the results under the conditions of the negotiated precision.