Effect of Door-to-Door Screening and Awareness Generation Activities in the Catchment Areas of Vision Centers on Service Use: Protocol for a Randomized Experimental Study.

BACKGROUND: A vision center (VC) is a significant eye care service model to strengthen primary eye care services. VCs have been set up at the block level, covering a population of 150,000-250,000 in rural areas in North India. Inadequate use by rural communities is a major challenge to sustainability of these VCs. This not only reduces the community's vision improvement potential but also impacts self-sustainability and limits expansion of services in rural areas. The current literature reports a lack of awareness regarding eye diseases and the need for care, social stigmas, low priority being given to eye problems, prevailing gender discrimination, cost, and dependence on caregivers as factors preventing the use of primary eye care. OBJECTIVE: Our organization is planning an awareness-cum-engagement intervention-door-to-door basic eye checkup and visual acuity screening in VCs coverage areas-to connect with the community and improve the rational use of VCs. METHODS: In this randomized, parallel-group experimental study, we will select 2 VCs each for the intervention arm and the control arm from among poor, low-performing VCs (ie, walk-in of ≤10 patients/day) in our 2 operational regions (Vrindavan, Mathura District, and Mohammadi, Kheri District) of Uttar Pradesh. Intervention will include door-to-door screening and awareness generation in 8-12 villages surrounding the VCs, and control VCs will follow existing practices of awareness generation through community activities and health talks. Data will be collected from each VC for 4 months of intervention. Primary outcomes will be an increase in the number of walk-in patients, spectacle advise and uptake, referral and uptake for cataract and specialty surgery, and operational expenses. Secondary outcomes will be uptake of refraction correction and referrals for cataract and other eye conditions. Differences in the number of walk-in patients, referrals, uptake of services, and cost involved will be analyzed. RESULTS: Background work involved planning of interventions and selection of VCs has been completed. Participant recruitment has begun and is currently in progress. CONCLUSIONS: Through this study, we will analyze whether our door-to-door intervention is effective in increasing the number of visits to a VC and, thus, overall sustainability. We will also study the cost-effectiveness of this intervention to recommend its scalability. TRIAL REGISTRATION: ClinicalTrials.gov NCT04800718; https://clinicaltrials.gov/ct2/show/NCT04800718. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/31951

Correction: Effect of Door-to-Door Screening and Awareness Generation Activities in the Catchment Areas of Vision Centers on Service Use: Protocol for a Randomized Experimental Study

[This corrects the article DOI: 10.2196/31951.]. The corrections will appear in the online version of the paper on the JMIR Publications website on January 18, 2022, with the publication of this correction notice. Because this was made after submission to PubMed, PubMed Central, and other full-text repositories, the corrected article has also been resubmitted to those repositories

Evaluating the Effectiveness of Interventions to Improve the Follow-up Rate for Children With Visual Disabilities in an Eye Hospital in Nepal: Nonrandomized Study

Background: Monitoring ocular morbidity among pediatric patients requires regular follow-up visits. We found that the follow-up rate was poor among children in our setting. Therefore, we intended to assess the effectiveness of 2 interventions—(1) counseling and (2) SMS text messaging and phone calls—to improve the follow-up rates. Objective: This study aimed to evaluate the effectiveness of 2 interventions, counseling and SMS and phone calls group, as well as a routine standard care for improving the follow-up rate of pediatric patients. Methods: A Nonrandomized, quasiexperimental design was used. Children (aged 0-16 years) with ocular conditions requiring at least 3 follow-up visits during the study period were included. A total of 264 participants were equally allocated to the 3 intervention groups of (1) counseling, (2) SMS and phone calls, and (3) routine standard care group. A 20-minute counseling session by a trained counselor with the provision of disease-specific leaflets were given to those in the counseling group. For the second intervention group, parents of children received an SMS text 3 days before and a phone call 1 day before their scheduled follow-up visits. Participants allocated for the routine standard care group were provided with the existing services with no additional counseling and reminders. Participants attending 3 follow-ups within 2 days of the scheduled visit date were considered compliant. The difference in and among the proportion of participants completing all 3 follow-up visits in each group was assessed. Results: The demographic characteristics of the participants were similar across the study groups. Only 3% (8/264) of participants completed all 3 follow-up visits, but overall compliance with the follow-up, as defined by the investigators, was found to be only 0.76% (2/264). There was no statistically significant difference in the proportion of follow-up between the intervention groups. However, the proportion of participants attending the first and second follow-ups, as well as the overall total number of follow-ups, was more in the SMS and phone-call group followed by the counseling group. Conclusions: We did not find any evidence on the effectiveness of our interventions to improve the follow-up rate. The primary reason could be that this study was conducted during the COVID-19 pandemic. It could also be possible that the intensity of the interventions may have influenced the outcomes. A rigorously designed study during the absence of any lockdown restrictions is warranted to evaluate intervention effectiveness. The study also provides useful insights and highlights the importance of designing and systematically developing interventions for improving the follow-up rate and ensuring a continuum of care to children with visual disabilities in Nepal and similar contexts. Trial Registration: ClinicalTrials.gov NCT04837534; https://clinicaltrials.gov/ct2/show/NCT04837534 International Registered Report Identifier (IRRID): RR2-10.2196/3157

Clinical presentation, disease course, and outcome of COVID-19 in hospitalized patients with and without pre-existing cardiac disease: a cohort study across 18 countries.

Patients with cardiac disease are considered high risk for poor outcomes following hospitalization with COVID-19. The primary aim of this study was to evaluate heterogeneity in associations between various heart disease subtypes and in-hospital mortality. We used data from the CAPACITY-COVID registry and LEOSS study. Multivariable Poisson regression models were fitted to assess the association between different types of pre-existing heart disease and in-hospital mortality. A total of 16 511 patients with COVID-19 were included (21.1% aged 66-75 years; 40.2% female) and 31.5% had a history of heart disease. Patients with heart disease were older, predominantly male, and often had other comorbid conditions when compared with those without. Mortality was higher in patients with cardiac disease (29.7%; n = 1545 vs. 15.9%; n = 1797). However, following multivariable adjustment, this difference was not significant [adjusted risk ratio (aRR) 1.08, 95% confidence interval (CI) 1.02-1.15; P = 0.12 (corrected for multiple testing)]. Associations with in-hospital mortality by heart disease subtypes differed considerably, with the strongest association for heart failure (aRR 1.19, 95% CI 1.10-1.30; P  Considerable heterogeneity exists in the strength of association between heart disease subtypes and in-hospital mortality. Of all patients with heart disease, those with heart failure are at greatest risk of death when hospitalized with COVID-19. Serious cardiac complications are rare during hospitalization

Clinical presentation, disease course, and outcome of COVID-19 in hospitalized patients with and without pre-existing cardiac disease: a cohort study across 18 countries

Patients with cardiac disease are considered high risk for poor outcomes following hospitalization with COVID-19. The primary aim of this study was to evaluate heterogeneity in associations between various heart disease subtypes and in-hospital mortality. We used data from the CAPACITY-COVID registry and LEOSS study. Multivariable Poisson regression models were fitted to assess the association between different types of pre-existing heart disease and in-hospital mortality. A total of 16 511 patients with COVID-19 were included (21.1% aged 66-75 years; 40.2% female) and 31.5% had a history of heart disease. Patients with heart disease were older, predominantly male, and often had other comorbid conditions when compared with those without. Mortality was higher in patients with cardiac disease (29.7%; n = 1545 vs. 15.9%; n = 1797). However, following multivariable adjustment, this difference was not significant [adjusted risk ratio (aRR) 1.08, 95% confidence interval (CI) 1.02-1.15; P = 0.12 (corrected for multiple testing)]. Associations with in-hospital mortality by heart disease subtypes differed considerably, with the strongest association for heart failure (aRR 1.19, 95% CI 1.10-1.30; P < 0.018) particularly for severe (New York Heart Association class III/IV) heart failure (aRR 1.41, 95% CI 1.20-1.64; P < 0.018). None of the other heart disease subtypes, including ischaemic heart disease, remained significant after multivariable adjustment. Serious cardiac complications were diagnosed in <1% of patients. Considerable heterogeneity exists in the strength of association between heart disease subtypes and in-hospital mortality. Of all patients with heart disease, those with heart failure are at greatest risk of death when hospitalized with COVID-19. Serious cardiac complications are rare during hospitalization

Clinical presentation, disease course, and outcome of COVID-19 in hospitalized patients with and without pre-existing cardiac disease: a cohort study across 18 countries

AIMS: Patients with cardiac disease are considered high risk for poor outcomes following hospitalization with COVID-19. The primary aim of this study was to evaluate heterogeneity in associations between various heart disease subtypes and in-hospital mortality. METHODS AND RESULTS: We used data from the CAPACITY-COVID registry and LEOSS study. Multivariable Poisson regression models were fitted to assess the association between different types of pre-existing heart disease and in-hospital mortality. A total of 16 511 patients with COVID-19 were included (21.1% aged 66-75 years; 40.2% female) and 31.5% had a history of heart disease. Patients with heart disease were older, predominantly male, and often had other comorbid conditions when compared with those without. Mortality was higher in patients with cardiac disease (29.7%; n = 1545 vs. 15.9%; n = 1797). However, following multivariable adjustment, this difference was not significant [adjusted risk ratio (aRR) 1.08, 95% confidence interval (CI) 1.02-1.15; P = 0.12 (corrected for multiple testing)]. Associations with in-hospital mortality by heart disease subtypes differed considerably, with the strongest association for heart failure (aRR 1.19, 95% CI 1.10-1.30; P < 0.018) particularly for severe (New York Heart Association class III/IV) heart failure (aRR 1.41, 95% CI 1.20-1.64; P < 0.018). None of the other heart disease subtypes, including ischaemic heart disease, remained significant after multivariable adjustment. Serious cardiac complications were diagnosed in <1% of patients. CONCLUSION: Considerable heterogeneity exists in the strength of association between heart disease subtypes and in-hospital mortality. Of all patients with heart disease, those with heart failure are at greatest risk of death when hospitalized with COVID-19. Serious cardiac complications are rare during hospitalization

Clinical presentation, disease course and outcome of COVID-19 in hospitalized patients with and without pre-existing cardiac disease – a cohort study across eighteen countries

AimsPatients with cardiac disease are considered high risk for poor outcomes following hospitalization with COVID-19. The primary aim of this study was to evaluate heterogeneity in associations between various heart disease subtypes and in-hospital mortality.Methods and resultsWe used data from the CAPACITY-COVID registry and LEOSS study. Multivariable Poisson regression models were fitted to assess the association between different types of pre-existing heart disease and in-hospital mortality. A total of 16 511 patients with COVID-19 were included (21.1% aged 66–75 years; 40.2% female) and 31.5% had a history of heart disease. Patients with heart disease were older, predominantly male, and often had other comorbid conditions when compared with those without. Mortality was higher in patients with cardiac disease (29.7%; n = 1545 vs. 15.9%; n = 1797). However, following multivariable adjustment, this difference was not significant [adjusted risk ratio (aRR) 1.08, 95% confidence interval (CI) 1.02–1.15; P = 0.12 (corrected for multiple testing)]. Associations with in-hospital mortality by heart disease subtypes differed considerably, with the strongest association for heart failure (aRR 1.19, 95% CI 1.10–1.30; P ConclusionConsiderable heterogeneity exists in the strength of association between heart disease subtypes and in-hospital mortality. Of all patients with heart disease, those with heart failure are at greatest risk of death when hospitalized with COVID-19. Serious cardiac complications are rare during hospitalization.</div

Pirfenidone in patients with idiopathic pulmonary fibrosis (CAPACITY): two randomised trials

Background Idiopathic pulmonary fibrosis is a progressive and fatal lung disease with inevitable loss of lung function. The CAPACITY programme (studies 004 and 006) was designed to confirm the results of a phase 2 study that suggested that pirfenidone, a novel antifibrotic and anti-inflammatory drug, reduces deterioration in lung function in patients with idiopathic pulmonary fibrosis. Methods In two concurrent trials (004 and 006), patients (aged 40–80 years) with idiopathic pulmonary fibrosis were randomly assigned to oral pirfenidone or placebo for a minimum of 72 weeks in 110 centres in Australia, Europe, and North America. In study 004, patients were assigned in a 2:1:2 ratio to pirfenidone 2403 mg/day, pirfenidone 1197 mg/day, or placebo; in study 006, patients were assigned in a 1:1 ratio to pirfenidone 2403 mg/day or placebo. The randomisation code (permuted block design) was computer generated and stratified by region. All study personnel were masked to treatment group assignment until after final database lock. Treatments were administered orally, 801 mg or 399 mg three times a day. The primary endpoint was change in percentage predicted forced vital capacity (FVC) at week 72. Analysis was by intention to treat. The studies are registered with ClinicalTrials.gov, numbers NCT00287729 and NCT00287716. Findings In study 004, 174 of 435 patients were assigned to pirfenidone 2403 mg/day, 87 to pirfenidone 1197 mg/day, and 174 to placebo. In study 006, 171 of 344 patients were assigned to pirfenidone 2403 mg/day, and 173 to placebo. All patients in both studies were analysed. In study 004, pirfenidone reduced decline in FVC (p=0·001). Mean FVC change at week 72 was −8·0% (SD 16·5) in the pirfenidone 2403 mg/day group and −12·4% (18·5) in the placebo group (difference 4·4%, 95% CI 0·7 to 9·1); 35 (20%) of 174 versus 60 (35%) of 174 patients, respectively, had a decline of at least 10%. A significant treatment effect was noted at all timepoints from week 24 and in an analysis over all study timepoints (p=0·0007). Mean change in percentage FVC in the pirfenidone 1197 mg/day group was intermediate to that in the pirfenidone 2403 mg/day and placebo groups. In study 006, the difference between groups in FVC change at week 72 was not significant (p=0·501). Mean change in FVC at week 72 was −9·0% (SD 19·6) in the pirfenidone group and −9·6% (19·1) in the placebo group, and the difference between groups in predicted FVC change at week 72 was not significant (0·6%, −3·5 to 4·7); however, a consistent pirfenidone effect was apparent until week 48 (p=0·005) and in an analysis of all study timepoints (p=0·007). Patients in the pirfenidone 2403 mg/day group had higher incidences of nausea (125 [36%] of 345 vs 60 [17%] of 347), dyspepsia (66 [19%] vs 26 [7%]), vomiting (47 [14%] vs 15 [4%]), anorexia (37 [11%] vs 13 [4%]), photosensitivity (42 [12%] vs 6 [2%]), rash (111 [32%] vs 40 [12%]), and dizziness (63 [18%] vs 35 [10%]) than did those in the placebo group. Fewer overall deaths (19 [6%] vs 29 [8%]) and fewer deaths related to idiopathic pulmonary fibrosis (12 [3%] vs 25 [7%]) occurred in the pirfenidone 2403 mg/day groups than in the placebo groups. Interpretation The data show pirfenidone has a favourable benefit risk profile and represents an appropriate treatment option for patients with idiopathic pulmonary fibrosis