An audit of institutional ethics committee queries raised after initial project submission by a single research department at a tertiary referral center in India.

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.

Irrational ophthalmic fixed-dose combinations for dry eye syndrome.

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.

An analysis of invitations for article submission received via emails.

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.

Liquid Drug Dosage Measurement Errors with Different Dosing Devices.

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.

Respiratory Pathogens in Infants Diagnosed with Acute Lower Respiratory Tract Infection in a Tertiary Care Hospital of Western India Using Multiplex Real Time PCR.

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.

Auto-immune Thyroiditis in an Infant Masquerading as Congenital Nephrotic Syndrome.

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.

Creating Posters for Effective Scientific Communication.

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.

Validity of Broselow tape for estimating weight of Indian children.

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.

Effect of prophylactic or therapeutic administration of paracetamol on immune response to DTwP-HepB-Hib combination vaccine in Indian infants.

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)].

Presenting Research Paper: Learning the steps.

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.

A Swelling over Sternum in a Child: Reminder of an Uncommon Diagnosis.

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.

Satisfying Doubters and Critics: Dealing with the Peer Review.

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.