A Real-World Observational Study to Evaluate the Safety and Effectiveness of Fluticasone Furoate-Oxymetazoline Fixed Dose Combination Nasal Spray in Patients with Allergic Rhinitis.

BACKGROUND: Allergic rhinitis (AR) has shown an increasing prevalence leading to a considerable medical and social burden. Nasal congestion is the cardinal symptom of AR, and the upper respiratory tract is most affected by this long-lasting ailment. Intranasal corticosteroids alleviate nasal congestion, along with other symptoms of AR, but their effect is not evident immediately. Oxymetazoline has a rapid onset of action, but its use should be limited to 3-5 days. OBJECTIVE: The study aimed to evaluate the safety and effectiveness of the fixed-dose combination nasal spray containing fluticasone furoate and oxymetazoline hydrochloride (FF + OXY) 27.5/50 mcg once daily in patients with AR in a real-world clinical setting. METHODS: The study was a prospective, open-label, single-arm, multicenter, real-world observational study conducted in patients with AR for a period of 28 days. Patients (n = 388) with a diagnosis of AR were treated with a combination of FF + OXY nasal spray. Total nasal symptom score (TNSS), total ocular symptom score (TOSS) and total symptom score (TSS) were documented at baseline and at the end of study period. The overall effectiveness of treatment with FF + OXY was rated by the investigators as very good/good/satisfactory/poor (4-point Likert scale) for each patient. RESULTS: Treatment with FF + OXY resulted in significant reduction in the TNSS, TOSS and TSS, from 7.18 ± 3.38 at baseline to 0.20 ± 0.84 (p < 0.001), from 2.34 ± 2.29 at baseline to 0.09 ± 0.53 (p < 0.001), from 9.51 ± 4.94 at baseline to 0.29 ± 1.32 (p < 0.001) at 28 days respectively. With respect to effectiveness, the investigators reported very good effectiveness in 52.12% of patients. No serious adverse events were reported. CONCLUSION: The fixed-dose combination of once-daily fluticasone furoate and oxymetazoline hydrochloride nasal spray 27.5/50 mcg was effective in relieving the nasal congestion and reduction of TNSS, TOSS and TSS in patients suffering from AR. The combination was safe and well tolerated with no rebound congestion throughout the treatment period.

Monitoring the Family Health Centres in Kerala, India: Findings from a facility survey.

Introduction: Kerala, a south Indian state, has often been cited globally as a model for better health outcomes at low cost but faces unique challenges in achieving Universal Health Coverage (UHC). To propel the efforts in achieving UHC, the Government of Kerala announced the "Aardram" health reform initiative, emphasising improving the quality of primary care service delivery. The reforms started in 2017, and in the first stage, 170 of 848 Primary Health Centres (PHCs) were upgraded to Family Health Centres (FHCs). The facilities were provided with additional doctors, nurses, and paramedical staff; the working hours were extended, and the range of services offered increased. In support of these processes, we carried out a facility assessment to assess differences between upgraded FHCs and existing PHCs. Materials and Methods: We conducted a facility-based cross-sectional assessment in eight primary care facilities of Kerala, FHC (N=4) and PHCs (N=4) from June to October 2019. A structured questionnaire covering utilisation and coverage of selected priority services for various populations and health outcome data was filled out by health staff to report data for the financial year 2018-19. Data were analysed in Microsoft Excel spreadsheets for easy analysis and replication by state stakeholders. Results: Coverage indicators such as full antenatal care and full immunization coverage were not appreciably different in FHCs as compared to PHCs. However, key reform-related differences were observed. On average, FHCs had 0.8 medical officers and one staff nurse per 10,000 population, whereas PHCs had 0.7 medical officers and less than 0.4 staff nurses per 10,000 population, even as the size of populations served by these human resources varied greatly across both types of facilities. The number of outpatient department visits per 10,000 population annually was 11,343 persons in FHCs and 9,580 persons in PHCs. FHCs also provided additional services such as screening for depression and chronic obstructive pulmonary disorders. Conclusion: Aardram primary healthcare reforms are still in their early days and appear to be associated with improved service coverage at the institutional level. However, some patterns are uneven: reforms should be carefully documented, and population-level impacts monitored over time.

Intersecting sex-related inequalities in self-reported testing for and prevalence of Non-Communicable Disease (NCD) risk factors in Kerala.

BACKGROUND: Non-Communicable Diseases (NCDs) are among India's top burdens, particularly in states like Kerala, which is at an advanced stage of the epidemiological transition. Evidence in India points towards intersectional inequalities in risk factors of NCDs and testing, both of which are understudied in Kerala. We estimated the self-reported testing and prevalence of key NCD risk factors-blood pressure (BP) and blood glucose (BG) comparing Kerala men and women across educational, wealth, religion, as well as caste and tribal status subgroups. METHOD: A multistage random sample survey of 3398 women and 2982 men aged 30 years and over was administered in 4 districts of Kerala from July to October 2019. Descriptive analysis for men and women was undertaken using survey weights. Slope index of Inequality and Relative Concentration Index for wealth and education related inequalities, and, Weighted Mean Difference from Mean and Index of Disparity for caste and tribal status, as well as religion related inequalities were calculated using World Health Organisation's Health Equity Assessment Toolkit Plus and Stata 12. RESULTS: A significantly higher proportion of women reported BP and BG testing by medical personnel in the previous year than men (BP Testing among Women (BPTw): 90.3% vs BP Testing among Men (BPTM):80.8%, BG Testing among Women (BGTw): 86.2% vs BG Testing among Women (BGTM):78.3%). Among those tested, more women (11.2%) than men (7.9%) reported High Blood Pressure (HBP) but not High Blood Glucose (HBG). Testing for BP was concentrated among less-educated women while BG testing was concentrated among both less educated women and men. HBP and HBG were concentrated among less educated and wealthier groups. Although sex differences were insignificant across caste and tribal status and religion subgroups, magnitude of inequalities was high for HBP and HBG. CONCLUSION: Distinct patterns of sex inequalities were present in self-reported testing and prevalence of NCD risk factors in Kerala. Education and wealth seem to be associated with testing while prevalence appeared to vary by religious groups. Given the low rates of illiteracy, it is encouraging but maybe a data artefact that a small population of less-educated persons was getting tested; however, exclusion of poor groups and inequalities by other dimensions raise concerns. Further exploration is needed to understand underlying mechanisms of these inequalities to ensure we leave no one behind.

Epidemic Landscape and Forecasting of SARS-CoV-2 in India.

BACKGROUND: India was one of the countries to institute strict measures for Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) control in the early phase. Since, then, the epidemic growth trajectory was slow before registering an explosion of cases due to local cluster transmissions. METHODS: We estimated the growth rate and doubling time of SARS-CoV-2 for India and high burden states using crowdsourced time series data. Further, we also estimated the Basic Reproductive Number (R0) and Time-dependent Reproductive number (Rt) using serial intervals from the data. We compared the R0 estimated from five different methods and R0 from SB was further used in the analysis. We modified standard Susceptible-Infectious-Recovered (SIR) models to SIR/Death (SIRD) model to accommodate deaths using R0 with the sequential Bayesian method for simulation in SIRD models. RESULTS: On average, 2.8 individuals were infected by an index case. The mean serial interval was 3.9 days. The R0 estimated from different methods ranged from 1.43 to 1.85. The mean time to recovery was 14 ± 5.3 days. The daily epidemic growth rate of India was 0.16 [95% CI; 0.14, 0.17] with a doubling time of 4.30 days [95% CI; 3.96, 4.70]. From the SIRD model, it can be deduced that the peak of SARS-CoV-2 in India will be around mid-July to early August 2020 with around 12.5% of the population likely to be infected at the peak time. CONCLUSION: The pattern of spread of SARS-CoV-2 in India is suggestive of community transmission. There is a need to increase funds for infectious disease research and epidemiologic studies. All the current gains may be reversed if air travel and social mixing resume rapidly. For the time being, these must be resumed only in a phased manner and should be back to normal levels only after we are prepared to deal with the disease with efficient tools like vaccines or medicine. KEY POINTS: . QUESTION: What are the estimates of infectious disease parameters of early phase of novel SARS-CoV-2 epidemic in India? FINDINGS: Incidence pattern SARS-CoV-2 shows possible evidence of community transmission. However, the estimated Basic Reproductive Number (R0) is relatively lower than those observed in high burden regions (range 1.43-1.85). Our simulation using susceptible-infectious-recovered/death model shows that peak of SARS-CoV-2 in India is farther than currently projected and is likely to affect around 12.5% of population. MEANING: The lower estimated R0 is indicative of the effectiveness of early social distancing measures and lockdown. Premature relaxation of the current control measures may result in large numbers of cases in India.

Correlation Between Retropalatal Collapse as Observed During Muller's Maneuver to Severity of OSA.

Objective of the study was to evaluate the reliability of Muller's maneuver (MM) with the severity of obstructive sleep apnea (OSA) at the retropalatal level. Case series of 58 adult patients diagnosed to have OSA. Sleep apnoea clinic in a tertiary referral center in south India. Fifty-eight adult OSA patients underwent outpatient based MM under local anaesthesia. Collapse of hypopharynx and the retroglossal regions were assessed during a maximal inspiratory effort against the closed mouth and sealed nose (reverse valsalva). Correlation co efficient was used to compare MM grade with apnea-hypopnea index (AHI) scores. Severity of OSA based on AHI scores were compared with the results of Muller's maneuver at the retropalatal level. The correlation coefficient was 0.213, hence no correlation was found, p value was 0.019, which was not statistically significant. MM is an useful tool for evaluation of upper airway collapse. The advantages include simplicity, cost-effectiveness, relatively easy to perform, thorough evaluation of upper airway. The pitfalls of the procedure includes the subjectiveness of the procedure and the fact that it is performed on awake patients and therefore remains an indirect estimation of obstruction that occurs during sleep. In our study, we did not find correlation between the severity of OSA based on the AHI scores and the collapse at the retropalate level assessed by the Muller's maneuver.

Metallic foreign body penetrating the carotid sheath: a case report.

Foreign bodies are a common problem seen in otolaryngological practice. Of the reported foreign bodies, metallic foreign bodies are a rare entity. One of the least common complications of foreign body ingestion is penetration and migration. We describe a case of a migrating metallic foreign body in a 50-year-old woman with a history of accidental ingestion causing odynophagia. In the present case, the foreign body migrated extraluminally into the carotid sheath. Our review of literature revealed that few such cases have been reported.

A case of isolated laryngeal candidiasis mimicking laryngeal carcinoma in an immunocompetent individual.

Respiratory fungal infections are usually found in immunocompromised individuals who have received either long-term steroid therapy or broad-spectrum anti-microbial therapy or have a non-resolving underlying chronic disease. These infections are seen as a part of bronchopulmonary fungal infections, and their isolated and primary occurrence as laryngeal diseases is highly uncommon. Laryngeal fungal infections can also mimic various diseases, such as gastroesophageal reflux disease, granulomatous diseases, leukoplakia, and carcinoma, thereby misleading the treating team from correct diagnosis and management. It is therefore important to identify the lesion at the earliest point possible to avoid morbid or life-threatening consequences. We report a case of isolated laryngeal candidiasis in an immunocompetent Indian male with an unusual presentation mimicking laryngeal carcinoma. The clinical and histological features are highlighted with a review of relevant literature to demonstrate the possibility of such an isolated fungal lesion, even in an immunocompetent individual.

Isolated sphenoid sinus disease - a retrospective analysis.

OBJECTIVE: To evaluate the etiology, symptoms, signs, imaging, surgical findings and outcomes of isolated sphenoid sinus disease (ISSD). DESIGN: Retrospective study. SETTINGS: Tertiary university based referral center. MATERIALS AND METHODS: All 8 patients aged 17-63, managed surgically in the department of ENT and Head and Neck Surgery at St. John's Medical College and Hospital, Bangalore from 2006 to 2008 for ISSD. Demographic data, presenting signs and symptoms endoscopic and imaging findings, surgical management, surgical pathology and clinical outcomes were investigated in the above patients. RESULTS: Of the 8 cases of ISSD, 5 were male; 3 were female, with an age range of 17-63 years. The most common presenting symptom was headache (7 patients [87.5%]), followed by nasal obstruction and recurrent URTI (5 cases [62.5%]). Imaging included CT and/or MRI studies in all cases. Sphenoid sinus pathology was varied and included 5 (62.5%) inflammatory cases, 1 (11.1%) cerebrospinal fluid fistula and 2 (22.2%) cases of sphenoid sinus neop;asms. Of the inflammatory cases 2 (40%) had isolated polyps in the sphenoid sinus [sphenochoanal polyps] and 3 (60%) had fungal sinusitis. Treatment was surgical, endoscopic transnasal sphenoidotomy under general anesthesia in all 5 patients with inflammatory ISSD Two patients with sphenoid sinus tumors underwent endoscopic biopsy. CONCLUSION: ISSD is rare. A high index of suspicion is required for diagnosis, which should be an active process and not one of exclusion. Both diagnostic nasal endoscopy and CT imaging are essential for diagnosis. The direct approach to the sphenoid sinus, transnasal endoscopic sphenoidotomy without ethmoidectomy is safe and effective. With early and adequate surgery we were able to avoid the morbidity associated with ISSD.

Intramuscular haemangioma of mylohyoid muscle: A case report.

OBJECTIVE: To report a case of intramuscular haemangioma (IMH) with a rare presentation in the mylohyoid, with emphasis on the clinical appearance, and histologic characteristics of the lesion. METHOD: Case report and review of the literature. CONCLUSION: Neck swellings can often present a diagnostic dilemma, with a wide preoperative differential diagnosis. IMH are rare benign haemangiomas occurring within the skeletal muscle. They account for approximately 1% of all haemangiomas. These are uncommon in the head and neck region and occur most frequently in the trunk and extremities. In the head and neck, masseter and trapezius are the most common sites involved. Intramuscular haemangioma is seldom diagnosed preoperatively, perhaps due to unfamiliarity with this uncommon lesion and nonspecific clinical findings.