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Introduction: The institutional ethics committees (IECs) raise queries following protocol reviews. The quality of these queries would be a useful metric to assess how well the IEC executes its fundamental role of protecting participants., Methods: Queries received after the initial review and replies sent by a single research department were evaluated. A content analysis was done to identify the domains and categories of queries. We categorized these queries as administrative, ethics related, and scientific. The impact of each query in improving the science or safeguarding the rights and safety of research participants (ethics) was evaluated by two authors of this manuscript: one affiliated and the other nonaffiliated to the institute. Kappa statistics were used to evaluate for agreement between the two., Results: A total of 13 studies (investigator-initiated studies [IISs]: 7 and pharmaceutical industry-sponsored studies [PSSs]: 6) formed the final sample size for analysis. The total number of queries was 364 (IIS: 106 and PSS: 258; P < 0.001). With regard to the categories, we found n = 42 (11.54%) to be irrelevant at that stage of the review process; n = 51 (14.01%) were about information already available which the IEC had missed; n = 67 (18.41%) queries where the IEC needed paraphrasing; n = 50 (13.74%) were entirely relevant with the need for further clarification; and n = 154 (42.31%) had been missed by the investigator during the initial submission. The overall agreement between the affiliated and unaffiliated investigators was just 12.9% (P < 0.001)., Conclusions: We found that approximately 25% of the queries raised by the IEC were redundant. It is our opinion that this redundancy could have been channeled into greater focus on scientific and ethical aspects of the protocol. Ongoing dialog between investigators and ethics committees may help address this. Perspectives between the affiliated and the unaffiliated investigators with regard to the relevance of queries were grossly different., Competing Interests: There are no conflicts of interest., (Copyright: © 2022 Perspectives in Clinical Research.)

Dry eye syndrome (DES) is a common disorder with rising incidence due to increased use of digital devices. While multiple treatment options are available, some are not efficacious or sometimes even safe for use in DES. This is particularly true for Fixed Dose Combinations (FDCs) that may contain ingredients having no rational for their use or may actually be harmful. Various committees appointed by the Government have reviewed several FDCs marketed in India and found some of them to be irrational and recommended for their removal. This paper discusses the contents of some of these FDCs marketed for DES with an aim to ensure that prescribers are mindful of their ingredients and whether there is adequate data about their efficacy and safety and prescribe them only if they consider them necessary for managing the patient., Competing Interests: None

Predatory journals charge publication fees from authors and publish without an adequate peer review, and often do not provide editorial and/or publishing services. Our objective was to evaluate e-mail solicitations received by authors in a defined time period to identify attributes of these solicitations as a metric to identify legitimacy of the journal. All e-mails seeking article submission received between January 1 and September 30, 2019, were evaluated. Each e-mail along with its respective webpage was evaluated for the journal's and publisher's names, mention of peer review, any assurance of publication, a mention of article processing charges (APC), composite invites [in the e-mail] and mention of peer review, the presence and functionality of archives, presence of manuscript management tab, mention of APC [on the webpage]. Descriptive statistics were used for the analysis. Of the 135 e-mails screened, 100 were finally included in the analysis. We found that 72% of the journals and/ or publishers were included in Beall's list. According to our criteria, a total of 85% of the solicitations were from journals that we identified as "presumed predatory". Our study has identified assurance of publication, rapid turnaround time, ambiguous information in the email and webpage, false claims of indexing as some descriptors which may help young authors and researchers assess a journal's legitimacy.

Background and Objectives: A virtual registry study evaluating real world evidence on physicians' use of prophylactic regimens for protection against SARS-CoV-2. This paper summarizes the interim results., Methods: Asymptomatic physicians at risk of acquiring SARS-CoV-2 responded to online questions at baseline and 7 weeks post-baseline. Baseline data included demographics, prophylaxis regimen (including "no prophylaxis") and start date. Participants who provided complete week-7 data (information on type of health facility [COVID/Non-COVID], number of presumed/confirmed cases exposed to, PPE use, SARS-CoV-2 testing and symptoms, regimen adherence and intercurrent illness) comprised the Completer population. Limited data (regimen adherence, SARS-CoV-2 testing) was collected for participants who failed to provide complete week7 data. Those providing limited/complete information comprised the Evaluable population., Results: Of 369 enrolled participants, 182 (mean age 42±11.05 years) comprised the Evaluable population. They showed a male preponderance (67.6%). Practitioners from Maharashtra (59.9%) and specialties of Pediatrics, Internal Medicine, Anesthesiology and Critical Care (63.2%) accounted for the majority. ICMR's HCQ prophylaxis regimen was initiated by 125 (68.7%) participants with 31 (17%) initiating 'No prophylaxis'. The highest adherence was for the ICMRregimen (87.2%). In the Completer population comprising 150 participants, 87 were exposed to presumed (81) and/or confirmed cases (60). Most exposures to confirmed cases (49, 81.7%) were high-risk. PPE use was generally high (75-100%). Most participants (94.7%) did not report an AE. The proportions with an AE was similar with ICMR regimen (5.9%) and no prophylaxis (6.5%)., Interpretation and Conclusions: Physicians in India preferred ICMR's HCQ regimen. The regimen appears to be safe and associated with a high level of adherence., (© Journal of the Association of Physicians of India 2011.)

Objective: To determine the frequency of respiratory pathogens in infants diagnosed with acute lower respiratory tract infections., Methods: A prospective cross-sectional observational study was conducted in infants hospitalized with a diagnosis of acute lower respiratory tract infection (ALRTI), in a tertiary care hospital in a metropolitan city of Western India. Nasopharyngeal swabs were analyzed by multiplex real time polymerase chain reaction, for 18 viruses and 3 bacteria (H. influenzae type b, C. pneumoniae and M. pneumoniae). The entire data was entered in Microsoft excel sheet and frequencies were determined., Results: One hundred eligible infants were enrolled. Pathogens were detected in 82 samples, which included Respiratory syncytial viruses (RSV) A / B (35.4%), Human rhinovirus (25.6%), Adenovirus (22%), Human Parainfluenza viruses (11%), Human bocavirus (9.8), Human metapneumovirus A / B (8.5%), Influenza A (H1N1) pdm 09 (6.1%), Parechovirus (3.7%), Human coronaviruses (3.66%), Haemophilus influenzae type b (6.1%), Chlamydia pneumoniae (2.4%) and Mycoplasma pneumoniae (2.4%). Influenza A (other than H1N1), Influenza B, Human Coronavirus 229E and Enterovirus were not detected. The rate of coinfection was 34% and rhinovirus was the most common of the multiple pathogens., Conclusions: Spectrum of viral etiologies of ALRTI is highlighted. Etiological diagnosis of ALRTI would enable specific antiviral therapy, restrict antibiotic use and help in knowing burden of disease.

An observational study was carried out to determine the magnitude of dosing errors made by parents, the most-preferred drug delivery device and the association of age, gender, education of the caregiver and number of children with the proportion of accurate doses. After enrolment, parents of children aged 6-60 mo were instructed to measure 5 ml of syrup paracetamol using any of the devices (stainless steel spoon, disposable plastic syringe, dosing cup with etched markings) displayed. The quantum of measured dose was confirmed using a calibrated glass cylinder. Error was defined as over 10% variation around the prescribed dose. Of 386 participants, 72 (18.65%) committed error, with 58 (15.02%) and 14 (3.62%) committing mild and moderate errors, respectively. Measuring cup (270, 69.95%) was the commonest device chosen. Use of syringe was associated with greater accurate measurements (P < 0.05) with only 3 (3.57%) committing error compared to 18 (56.25%) and 51 (18.88%) committing error with spoon and cup, respectively. On multivariate analysis, device was the only factor significantly associated with accuracy in measurements.

A seven-months-old girl under treatment for pneumonia presented with generalized edema, decreased urinary output and was found to have hypertension, muco-cutaneous fungal infection and pulmonary hypertension. Investigations revealed that she had heavy proteinuria, hypertriglyceridemia, hypoalbuminemia and elevated levels of free T3 and T4 with suppression of TSH levels in the serum. A diagnosis of autoimmune thyroiditis (AT) in thyrotoxic phase was made on the basis of clinical presentation and presence of anti-TPO antibodies and reduced uptake in thyroid (technetium) scintigraphy. The child responded to carbimazole therapy and propranolol. The case is presented to remind pediatricians about the rare occurrence of auto-immune thyroiditis in infancy with rare complications such as nephrotic syndrome and pulmonary hypertension.

For a beginner, presenting a research paper at a conference as a podium presentation can be a daunting task. She is required to choose an appropriate conference for presentation, prepare an abstract, prepare slides and the speech that goes parallel with the slides and train oneself to answer questions posed by the audience. She has also got to overcome the fear of speaking in public and conquer the phobia of encountering a hostile audience ready to shred her paper to pieces. This communication intends to provide useful tips on how to go about preparing and presenting a research paper. Almost every conference has at least one slot reserved for oral or podium presentation of research papers. These podium presentation sessions are important for the presenters, organizers as well as for the attending delegates (Table 1). For the beginners and the recently-initiated, the challenge of organizing all the data and ideas for presentation in less than 10 minutes, might seem overwhelming. Added to that would be the anxiety of speaking in front of a crowd consisting of experts and above all, to be prepared to answer searching questions posed by the delegates. Through this communication, we intend to provide a supporting framework for the beginners about how to go about such scientific presentations, which are so vital for one's career and above all, for advancement of science. Once your research project is over, findings analyzed and report written; you should be on the lookout for conferences where presenting your research would be of relevance and interest to the delegates. But even before the conference is chosen, you could start thinking about the process of presentation., (© Journal of the Association of Physicians of India 2011.)

A scientific poster is a summary of one's research that is presented in a visually engaging manner. Posters are presented as a means of short and quick scientific communications at conferences and scientific meetings. Presenting posters has advantages for the presenters and for conference attendees and organizers. It also plays a part in dissemination of research findings and furthering science. An effective poster is the one that focuses on a single message and conveys it through a concise and artistically attractive manner. This communication intends to provide tips on creating an effective poster to young scientists., (© Journal of the Association of Physicians of India 2011.)

Background: Vaccination is considered as the most cost effective method for preventing infectious diseases. Low grade fever is a known adverse effect of vaccination. In India, it is a common clinical practice to prescribe paracetamol either prophylactically or therapeutically to manage fever. Some studies have shown that paracetamol interferes with antibody responses following immunization. This manuscript reports the outcome of a post hoc analysis of data from a clinical trial of a pentavalent vaccine in Indian infants where paracetamol was not used or was used either as prophylaxis or for treatment of fever., Methods: Pre and post vaccine antibody levels against Diphtheria, Tetanus, Pertussis, Hepatitis B, Haemophilus influenzae type B were assessed in no paracetamol and paracetamol groups. The paracetamol group was further divided into prophylactic and treatment groups., Results: Similar rates of seroprotection/seroresponse for anti-D, anti-T, anti-wP, anti-PT, anti-HBs and anti-PRP were observed in all the groups. There was no clear tendency for difference in percentage seroprotection/seroresponse and geometric mean (GM) titers in any of the groups., Conclusion: The study found no evidence that paracetamol usage either as prophylactic or for treatment impact immunological responses to DTwP-HepB-Hib combination vaccine. [Clinical trial registry of India (study registration number CTRI/2012/08/002872)]., (Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background & Objectives: The Broselow tape has been validated in both ambulatory and simulated emergency situations in the United States and is believed to reduce complications arising from inaccurate drug dosing and equipment sizing in paediatric population. This study was conducted to determine the relationship between the actual weight and weight determined by Broselow tape in the Indian children and to derive an equation for determination of weight based on height in the Indian children., Methods: This cross-sectional study was conducted at a tertiary care hospital in Mumbai, India. The participants' weights were divided into three groups <10 kg, 10-18 kg and >18 kg with a total sample size estimated to be 210 (70 in each group). Using the tape, the measured weight was compared to Broselow-predicted weight and percentage weight was calculated. Accuracy was defined as agreement on Broselow colour-coded zones, as well as agreement within 10 per cent between the measured and Broselow-predicted weights. The resulting data were compared with weights estimated by advanced paediatric life support (APLS) and updated APLS formulae using Pearson's correlation coefficient., Results: The mean percentage differences were -11.78, -17.09 and -14.27 per cent for <10, 10-18 and >18 kg weight-based groups, respectively. The Broselow colour-coded zone agreement was 33.3 per cent in children weighing <10 kg, but only 7.4 per cent in the 10-18 kg group and 33.9 per cent in the >18 kg group. Agreement within 10 per cent was 53.13 per cent for the <10 kg group, but only 21.08 per cent for the 10-18 kg group and 33.9 per cent for the >18 kg group. Application of 10 per cent weight correction factor improved the percentages to 79.2 per cent for the <10 kg category, to 55.70 per cent for the 10-18 kg group and to 61.0 per cent for the >18 kg group. The correlation coefficient between actual weight and weights estimated by Broselow tape (r=0.89) was higher than that between actual weight and weight estimated by APLS method or updated APLS formulae (r=0.68) in 12-60 months age group as well as in >60 months age group (r=0.76)., Interpretation & Conclusions: Broselow weight overestimated weight by >10 per cent in majority of Indian children. The weight overestimation was greater in children belonging to over 18 and 10-18 kg weight groups. Applying 10 per cent weight correction factor to the Broselow-predicted weight may provide a more accurate estimation of actual weight in children attending public hospital. Weights estimated using Broselow tape correlated better with actual weights than those calculated using APLS and updated APLS formulae.

Pentavalent combination vaccines are important tools to strengthen the immunization programs in numerous countries throughout the world. A large number of countries have recognized the value of combination vaccines and have introduced whole cell pentavalent vaccines into their immunization programs. A phase III, multi-center, randomized, single blinded study of a fully liquid pentavalent DTwP-HepB-Hib investigational vaccine (Shan5™) was conducted across India in 2 cohorts: 15 toddlers were evaluated for safety and immunogenicity following a single booster dose (Cohort 1) followed by 1085 infants (Cohort 2) evaluated for immunogenicity and safety following 3-dose primary immunization of the investigational vaccine or a locally licensed comparator vaccine (Pentavac SD). Immune consistency analysis among 3 lots of the investigational vaccine, and immune non-inferiority analysis of pooled (3 lots) data of investigational vaccine vs. comparator vaccine were carried out in cohort 2. The vaccines demonstrated comparable safety and immune responses in cohort 1. In cohort 2, equivalent immune consistency among 3 lots was observed for all antigens except whole cell pertussis antigens, where a marginal variation was observed which was linked to the low power of the test and concluded to not have any clinical significance. Immune non-inferiority against the comparator vaccine was demonstrated for all 5 antigens. Safety results were comparable between vaccine groups. This investigational, fully-liquid, whole-cell pertussis (wP) containing new pentavalent vaccine was found to be safe and immunologically non-inferior to the licensed comparator vaccine.

Although peer review process intends to improve the quality of published scientific literature, many authors find the process intimidating and overbearing. Responding to reviewers' comments in a hasty and inappropriate manner is self-defeating. Authors need to answer the reviewers in an objective manner providing additional description, rational arguments and relevant evidence. Peer review is an important element of the research process. It aims to maintain the quality of scientific publications by rejecting manuscripts that are trivial, weak, irrelevant or misleading and by improving the transparency, accuracy and utility of manuscripts accepted for publication.1,2 But, the process can be intimidating for some new authors. They cannot understand, let alone digest the criticism of their submitted manuscript and hence respond in a hurry and in an inappropriate manner, further jeopardizing the chances of acceptability. This article informs new authors about the way a submitted manuscript is handled in the journal office and provides suggestions on how to respond to the reviewers' and editors' comments. More importantly, it intends to provide clues on how to minimize the chances of receiving harsh criticism., (© Journal of the Association of Physicians of India 2011.)

References help readers identify and locate sources used for justifying the need for conducting the research study, verify methods employed in the study and for discussing the interpretation of results and implications of the study. It is extremely essential that references are accurate and complete. This article provides suggestions regarding choosing references and writing reference list. References are a list of sources that are selected by authors to represent the best documents concerning the research study.1 They constitute the foundation of any research paper. Although generally written towards the end of the article-writing process, they are nevertheless extremely important. They provide the context for the hypothesis and help justify the need for conducting the research study. Authors use references to inform readers about the techniques used for conducting the study and convince them about the appropriateness of methodology used. References help provide appropriate perspective in which the research findings should be seen and interpreted. This communication will discuss the purpose of citations, how to select quality sources for citing and the importance of accuracy while writing the reference list., (© Journal of the Association of Physicians of India 2011.)

Title is an important part of the article. It condenses article content in a few words and captures readers' attention. A good title for a research article is the one which, on its own, is able to introduce the research work to the fullest extent, but in a concise manner. Writing scientific titles that are informative and attractive is a challenging task. This communication describes the importance of titles and the methods of creating appropriate titles for research papers., (© Journal of the Association of Physicians of India 2011.)

Lack of awareness about isolated tubercular osteomyelitis of the sternum resulted in a delay in diagnosing the condition in an eleven-year-old girl who presented with a gradually increasing swelling over the sternum. Radiological, histological, and microbiological investigations helped diagnose the condition and the child responded well to antitubercular therapy (ATT) and surgical debridement. The report provides a brief description about the various management options available.

A forty-five-day-old female infant presented with prolonged jaundice with clinical features suggestive of congenital hypothyroidism (CHT). On investigations, the infant was noted to have indirect hyperbilirubinemia (13.8 mg/dl) with increased levels of AST (298 IU/dl) and ALT (174 IU/dl) in the serum. The child had low levels of free T 3 (<1 pg/ml) and free T 4 (0.4 ng/dl) secondary to thyroid agenesis detected on radionuclide scan and ultrasonography of the neck and raised levels of TSH (>500 microIU/ml) in the serum. The combination of indirect hyperbilirubinemia and raised levels of hepatic transaminases has not been reported in babies with CHT. Following institution of oral thyroxin therapy, the serum bilirubin levels ameliorated (2.9 mg/dl) considerably by 15 days of therapy and the serum levels of AST (40 IU/dl) and ALT (20 IU/dl) got normalized. The case demonstrates that raised levels of hepatic transaminases can occur in infants with CHT and these can resolve just with thyroxin therapy, obviating the need for extensive investigative laboratory work-up., Competing Interests: The authors declare that they have no competing interests.

is a vital part of a research paper. Besides the title, it is the most widely read section of an article. The first impressions created by the abstract on editors and reviewers can have a great influence on the fate of the article. After its publication, a reader might decide to give the article a miss, if he finds the information provided in the abstract uninteresting, irrelevant or uninspiring. An abstract should, therefore, be packed with all important relevant information about the study, so that reviewers and readers understand the rationale of the study, are assured of adequacy of the methodology employed, are informed about the important findings and appreciate the reasonable conclusions stated in the abstract. Brevity, self-sufficiency, providing complete and accurate information in an unbiased manner are some of the important characteristics of a good abstract., (© Journal of the Association of Physicians of India 2011.)

The Discussion section is an important part of the research manuscript that allows the authors to showcase the study. It is used to interpret the results for readers, describe the virtues and limitations of the study, discuss the theoretical and practical implications of the research work done and provide important “take home” message.

We present a case of disseminated Chromobacterium violaceum sepsis with multiple liver and splenic abscesses presenting with skin lesions and cardiogenic shock, and later diagnosed to have chronic granulomatous disease. The patient was treated with prolonged antimicrobial therapy, after which she recovered and remained asymptomatic on follow-up., (Copyright © 2012. Published by Elsevier B.V.)

For presenting the study results, authors need to choose from one of the three formats: text, tables and graphs. The underlying consideration of any author while making the choice is to ensure that readers find it easy to understand, to assist the author present data in a way that would catch the reader's eye, hold his interest and enhance his understanding. The choice should, therefore, be based on the advantages and limitations of each of these formats. Most of the observations are reported in textual format. Tables are useful when comparisons are to be shown. Graphs attract readers' attention better and the data they depict remains in the reader's memory. The type of graph used is dependent upon the nature of data that is to be shown. Every research paper has a lot to say through the data that has been collected and analyzed. However, this data needs to be presented in a logical, coherent and easy-to-understand manner. The way data is presented can influence the reviewers' and editors' decision. It can also make the difference between a paper being appreciated by the readers or being neglected or even trashed by them. Tables and Graphs are the two important tools that authors use to make the data more presentable and easy to read and understand., (© Journal of the Association of Physicians of India 2011.)

Results section is used to inform readers about the actual observations made in the research study. The authors should ensure that the content is appropriate, complete and objective. Using tables and graphs appropriately enhances the readers' interest and understanding., (© Journal of the Association of Physicians of India 2011.)

The Methods section of a research paper intends to inform the readers about how the research study was carried out. It allows them to judge if the methodology followed and material used were appropriate for testing the hypothesis, whether the study findings would be applicable to the patients that they treat and if the conclusions drawn and recommendations made are valid, fair and reasonable., (© Journal of the Association of Physicians of India 2011.)

The Introduction section explains the rationale for undertaking the study and clearly describes the main purpose of conducting it. It should be focused, succinct and crisp. Providing an extensive and detailed literature review, not stating the hypothesis of the objectives with clarity and not providing focused information are some of the common mistakes that the authors should steer clear of.

Authors need to take the crucial decision of choosing the journal for their prospective manuscript before even starting to write it. Although, this choice is influenced by many factors, matching the intended recipients of the main message of the manuscript with a journal's readership should override all other consideration in journal selection. That done, availability of time-bound review process,journal's visibility, indexation in databases, regularity of publication, acceptance rate and expenses involved are some other factors that will help decide the choice.

Case reports describe a patient with unusual or unexpected features. They represent the oldest type of medical publication. They are about generating a new hypothesis and not about proving a hypothesis. Hence, despite being considered as the lowest level of evidence; they continue to be relevant for clinical practice, research and medical education. This article intends to provide guidance regarding writing a case report to those wishing to make a foray in scientific writing through reporting an interesting case.

Background: There is paucity of data regarding the use of off-label (OL) and unlicensed drug (UL) use in children admitted to the Pediatric Intensive Care Units (PICUs)., Objective: To determine prevalence of OL- and UL-drug use in children admitted to PICU., Design: Prospective observational study., Setting: PICU in Mumbai (formerly Bombay), India., Participants: Consecutive patients aged 28 d-12 yr admitted over 12-mo period., Methods: Prescriptions issued to PICU patients were surveyed and demographic data, diagnosis and details of drugs used (dose, frequency, route of administration, indication, and UL use) were noted. Descriptive statistics was used for providing prevalence of OL drug (including category) and UL use. Fisher-Pearson test was used to determine the significance of age, mechanical ventilation and number of systems involved with reference to OL- and UL-drug use., Results: 482 participants received 1789 [OL: 738(41.25%) and UL: 376(21.01%)] drug prescriptions; OL-drug use was highest in infants (56.52%) with indication outside the license (32.37%) being the commonest category of OL-drug use across all age-groups. Unlicensed drug use was entirely due to extemporaneously-prepared drug (EPD) use. The OL drug- and EPD-use were significantly associated with infancy and ventilation therapy., Conclusions: The high prevalence of OL- and UL-drug use in children admitted in the PICU significantly compromises their right to safe drugs. As most of the OL drug use is related to drugs used in children for several years; legislative and regulatory initiatives are required to ensure that accumulated evidence and experience gets incorporated in the license.