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.

Consensus Statement of the Indian Academy of Pediatrics on Integrated Management of Severe Acute Malnutrition.

Justification: Severe acute malnutrition (SAM) is a major public health issue. It afflicts an estimated 8.1 million under-five children in India causing nearly 0.6 million deaths. The improved understanding of pathophysiology of SAM as well as new internationally accepted growth charts and newer modalities of integrated intervention have necessitated a relook at IAP recommendations. Process: A National Consultative Meeting on Integrated Management of Severe Acute Malnutrition was held in Mumbai on 16th and 17th October, 2010. It was attended by the invited experts in the field. Extensive discussions were held as per the program. The participants were then divided into six groups for detailed discussions. The groups deliberated on various issues pertaining to the task assigned and presented recommendations of the groups in a plenary session. The participants made a list of recommendations after extensive discussions. A Writing Committee was formed and was entrusted with the task of drawing a Consensus Statement on the basis of these Recommendations. After multiple deliberations, the following Consensus Statement was adopted. Objectives: To critically evaluate the current global evidence to formulate a consensus among stakeholders regarding diagnosis and management of SAM. Recommendations: An integrated management of malnutrition is likely to yield more dividends. Thus, management of SAM should constitute an important component of Integrated Management of Neonatal and Childhood Illnesses (IMNCI) program. Determination of SAM on the basis of Z-scores using WHO Growth charts is considered statistically more appropriate than cut-offs based on percentage weight deficit of the median. Considering the fact that many children with SAM can be successfully managed on outpatient basis and even in the community, it is no more considered necessary to advise admission of all children with SAM to a healthcare facility. Management of SAM should not be a stand-alone program. It should integrate with community management therapeutic programs and linkages with child treatment center, district hospitals and tertiary level centers offering inpatient management for SAM and include judicious use of ready-to-use-therapeutic Food (RUTF). All sections of healthcare providers need to be trained in the integrated management of SAM.

Survey of ethics committee protocol approval letters: compliance with Schedule Y / ICMR Guidelines 2006; Schedule Y requirements.

A study was carried out to determine the extent to which ECs comply with format requirements given in guidelines and regulations. ECs were sent a written communication requesting them to permit investigators to study their approval letter for compliance with the ICMR Guidelines and Schedule Y, using a predesigned proforma. Of the 60 ECs approached, only 20 agreed to participate. Legal experts and social scientists were not present at the approval meetings of most of the ECs. Only 7 ECs had a quorum according to Schedule Y. Several ECs did not state whether documents such as the clinical trial agreement and insurance policy were reviewed. Delays in sending approval letters could be shortened with efficacious operating of ECs. There is a need to train EC members and create a better awareness of regulatory requirements. There is also a need to evolve a mechanism to monitor EC functioning.

Viral ventilator-associated pneumonia: Uncovering tip of the iceberg.

Context: Hospital-acquired infections are frequently encountered by the physicians for ailments demanding prolonged hospitalization, especially in intensive care units, where patients are often mechanically ventilated. The organisms most often implicated are bacteria; viral etiology is infrequent. Aims: The study aims at reviewing lung pathology at autopsy in mechanically ventilated children admitted in pediatric intensive care unit (PICU) to assess the incidence of viral ventilator-associated pneumonias (VAP). Setting and Design: Retrospective analysis. Materials and Methods: Among the 275 children who had been autopsied, 13 who had been admitted in the PICU satisfied the criteria for VAP. These cases were analyzed on the basis of clinical data and pulmonary pathology. Depending on the overall histology, the cases were classified as being viral or bacterial in etiology. Immunohistochemistry (IHC) for detection of viral antigens was also performed. Results: Of the 13 children, nine (five males and four females) had shown the histomorphologic features, suggesting viral inflammation. The mean age was 33 months. Falling oxygen saturation and increasing respiratory distress had necessitated ventilator support. Acute lymphocytic bronchiolitis, interstitial pneumonitis, diffuse alveolar damage, and necrotizing pneumonia were the histological features. The viruses identified in five patients were adenovirus, respiratory syncytial virus and cytomegalovirus. Conclusion: This communication, though not representing the true incidence, emphasizes that a proportion of nosocomial infections is due to viral infections. This should alert the treating intensivists to actively pursue investigations to confirm viral etiology.

Healthcare-seeking behavior after seizures in children.

Background: Hardly any Indian data is available regarding practices employed by parents for preventing injuries and aspiration and controlling convulsions in children. Aims: To describe the health care-seeking behavior and practices employed by parents when a child has convulsions. Settings and Design: Prospective questionnaire-based study in a tertiary care hospital setting. Materials and Methods: Parents of children (age: 1 month -12 years) admitted with history of convulsions were enrolled and information regarding demographic characteristics, time lag, preferred health care provider and measures taken in a convulsing child was elicited using a pretested questionnaire. Statistical Analysis Used: Demographic parameters and measures employed described as percentages. Results: One hundred and forty parents were interviewed. Seventy-six children had first episode. Forty-nine of 64 children with subsequent seizures had contact with a health care provider during the previous seizure episode. The median duration of seizures was 10 minutes (Mean: 54.15+/-366.39 min); but children were brought to the hospital after a median of 2 hours (Mean: 5.22+/-10.37 h). Measures such as smelling onions, oral administration of cold water, reading religious texts and insertion of mouth gag were employed. Although 45 with previous seizure-related health care contact agreed that they were informed about measures to be taken, none of them could remember more than one measure for preventing injuries and aspiration and controlling seizures. Only four narrated "per-rectal administration of diazepam" as a measure, although only one implemented it. Only four general practitioners used per-rectal diazepam to control seizures. Conclusions: Children with seizures reach health care providers after a considerable delay putting them at higher risk for developing neurological sequel. There is a need to develop appropriate strategies for disseminating information about "first aid" measures and steps for controlling convulsions and imparting relevant skills to parents.

Reporting ethical processes in two Indian journals.

Background: In biomedical journals, authors are expected to report if the study was carried out in accordance with international and national ethical guidelines and inform readers if approval from ethics committee was obtained and if written informed consent was taken from the participant or legal guardian. Aims: To determine the proportion of research manuscripts in two pediatric journals published from India reporting on ethical clearance, obtaining of informed consent and/or assent. Settings and Design: Retrospective study for analysis of research articles published. Materials and Methods : Research articles published in the issues of Indian Pediatrics and Indian Journal of Pediatrics in 2006 were reviewed for reporting regarding ethical clearance, obtaining written informed consent from guardians or parents, and obtaining assent from research participants. Statistical Analysis Used: Descriptive statistics was used. The number of articles according to their types; the number of research designs employed according to their types; and the number of research studies mentioning ethical clearance, consent, and assent were expressed as percentages mentioning ethical clearance, consent and assent were expressed as percentages. Results: Of the 132 manuscripts reporting biomedical research, 39 (29.53%) reported having obtained approval from the ethics committee. Forty-six of the 98 (46.94%) manuscripts reporting on prospective studies indicated that informed consent was obtained from parents or lawful guardians. Neither ethical approval nor informed consent was mentioned in 45 (34.10%) published articles reporting prospective studies. A total of 54/98 (55.1%) studies enrolled children aged 7 years or more and hence were assessed for reporting of assent; eight (14.81%) reported that children's assent was obtained. Only four (7.41%) eligible studies reported ethics committee's approval, informed consent, as well as assent. Conclusions: A significant proportion of research articles published in the two pediatric journals did not provide information regarding ethical approval, written informed consent, and obtaining of assent.

Bullying in schools: prevalence and short-term impact.

OBJECTIVES: To estimate the prevalence of bullying in school children and to examine its association with common symptoms in childhood. DESIGN: Prospective survey using a pre-tested questionnaire for conducting a semi structured health interview. SETTING: Randomly selected Public and private schools in a rural area. SUBJECTS: Children aged 8-12 years studying in three schools and their parents. RESULTS: Bullying was reported by 157 (31.4%) of the 500 children interviewed. There was no significant difference in the prevalence of bullying amongst boys and girls in co-education schools. However, it was significantly low in schools enrolling girls alone. Teasing and keeping names were the commonest forms noticed. Causing physical hurt was reported bv 25 (16%) students. Only 24 (24%) parents were aware that their children were being bullied. Feeling sad, preferring to stay alone and frequent tearing of clothes were almost exclusively noted in bullied children and bullied children were more likely to report symptoms such as school phobia, vomiting and sleep disturbances. CONCLUSION: Bullying is a common phenomenon amongst school going children. Frequent bullying is associated with certain symptoms and school absenteeism. Healthcare professionals. should be aware of this phenmnenon so that they can diagnose the underlying cause when these symptoms are reported and plan for appropriate interventions.

Prediction of weight of Indian children aged upto two years based on foot-length: implications for emergency areas.

BACKGROUND: Children presenting in critical care department might receive improper drug doses, as their weight and length cannot be determined while they are being resuscitated. AIMS: To determine if there is a correlation between foot-length and weight, length and surface area and to compare the drug doses calculated as per predicted weight (determined on the basis of foot-length) with those calculated on the basis of actual weight. MATERIAL AND METHODS: Weight, length and foot-length of children aged up to 24 months were determined in the prospective study. Analysis was done using simple linear regression analysis and by determination of coefficient of determination. The dosages of emergency medications (epinephrine, atropine, Ringers lactate and diazepam) were calculated on the basis of actual weight and dosages given in standard text and were then compared with dosages likely to be administered on the basis of weight predicted by foot-length measurement. RESULTS: Five hundred subjects were enrolled in the study that demonstrated a significant linear relationship between foot-length and body weight (r2 = 0.88), total length (r2 = 0.88), and body surface area (r2 = 0.84). The weight could be predicted on the basis of the following formula Weight (kg)= [1.35 x foot-length (cm)] -5.15. The doses of drugs calculated on the basis of weight predicted from foot length were exceeded the standard dose by 2.35 to 2.40%. CONCLUSIONS: In children aged up to 2 years, foot-length can be used to predict weight and calculate doses of emergency drugs.

Clinically directed selective screening for HIV infection in hospitalized children.

BACKGROUND: As HIV infection presents with several manifestations, none of which is specific, several children are subjected to HIV testing. Very few studies have examined the issue of probability of HIV infection with a given clinical manifestation. AIM: To determine the probability of HIV infection when a child is hospitalized with at least one of the selected manifestations. MATERIAL AND METHODS: Children aged 18 mo and above, admitted to a tertiary care center in Mumbai, India with chronic diarrhea, severe malnutrition, persistent cough, generalized lymphadenopathy, oral thrush, hepatomegaly, repeated common infections, generalized dermatitis, chronic parotid swelling, recurrent bacterial infection, disseminated tuberculosis and/ or Pneumocystis carinii pneumonia were enrolled in a prospective study after obtaining informed consent. They were subjected to HIV testing using WHO-UNAIDS strategy II. The data obtained was analyzed using the Statistical Package For Social Sciences (SPSS) software program. RESULTS: Twenty-three (20 PERCENT) of the 115 children enrolled tested positive for HIV. The seropositivity rate for various features ranged from 9.1 PERCENT for chronic diarrhea to 83.3 PERCENT for chronic dermatitis. Oral thrush, generalized dermatitis and generalized lymphadenopathy were the significant independent clinical risk factors for predicting HIV seropositivity. The probability of HIV infection was higher in children who had higher number of risk factors present concomitantly CONCLUSIONS: The probability of HIV infection in a child is dependent upon the nature and number of manifestations present.

Evaluation of an Internet delivered pediatric diagnosis support system (ISABEL) in a tertiary care center in India.

BACKGROUND: Young graduates manning the emergency rooms in public hospitals often need guidance in diagnosing critically ill patients due to their limited clinical experience. Textbooks, manuals and several websites are of limited assistance, as they do not generate patient-specific advice. ISABEL diagnostic tool, an Internet-delivered pediatric diagnosis support system that provides such information has not been evaluated in developing countries. AIM: To study the sensitivity of the ISABEL diagnostic tool. MATERIAL AND METHOD: Records of patients admitted in the pediatric intensive care unit in a metropolitan hospital in India during January 2000-July 2002 were retrieved. Resident medical officers wrote key clinical and laboratory findings on the basis of admission notes and results of investigations carried out within 30 min of admission. The list of diagnoses generated by the diagnostic tool at the ISABEL site after submission of these terms was entered in a performa. The presence of final diagnosis in the list generated by the ISABEL was the outcome measure studied. RESULTS: Records of 200 subjects (boys 111, girls 89, aged 28 days-12 years) were analyzed. Congenital heart disease, respiratory tract infections, meningitis, tetanus and septicemia were the most frequently encountered diagnoses. The diagnostic tool missed 27 diagnoses (such as septicemia, tuberculosis and seizures) in 39 subjects providing a sensitivity of 80.5%. CONCLUSION: Even without any training offered to the users, ISABEL provided a reasonable sensitivity of 80.5%. The tool holds promise of being useful in the developing countries.

Recurrent acute transverse myelopathy: association with antiphospholipid antibody syndrome.

A seven-year-old boy presented with a second episode of acute transverse myelopathy. The first episode had responded dramatically to methylprednisolone. The manifestations of the second episode did not respond to methylprednisolone or IVIG. He showed persistently raised levels of antiphospholipid antibodies in the serum. Primary conditions like collagen vascular diseases, malignancy, exposure to drugs and HIV infection, which are known to be associated with the raised titers of these antibodies were ruled out clinically and by investigations. Recurrent transverse myelopathy is a rare event in childhood and reports of its association with Antiphospholipid Antibody Syndrome (APLAS) are scanty. The etiological role for these antibodies remains to be established. However, once the diagnosis is established, it may be prudent to treat the condition with agents and procedures to bring about a decrease in their titers. Long-term therapy to prevent thromboembolic complications of APLAS may also be instituted.