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We aimed to compare overall survival after standard-dose versus high-dose conformal radiotherapy with concurrent chemotherapy and the addition of cetuximab to concurrent chemoradiation for patients with inoperable stage III non-small-cell lung cancer. In this open-label randomised, two-by-two factorial phase 3 study in 185 institutions in the USA and Canada, we enrolled patients (aged ≥18 years) with unresectable stage III non-small-cell lung cancer, a Zubrod performance status of 0–1, adequate pulmonary function, and no evidence of supraclavicular or contralateral hilar adenopathy. We randomly assigned (1:1:1:1) patients to receive either 60 Gy (standard dose), 74 Gy (high dose), 60 Gy plus cetuximab, or 74 Gy plus cetuximab. All patients also received concurrent chemotherapy with 45 mg/m2 paclitaxel and carboplatin once a week (AUC 2); 2 weeks after chemoradiation, two cycles of consolidation chemotherapy separated by 3 weeks were given consisting of paclitaxel (200 mg/m2) and carboplatin (AUC 6). Randomisation was done with permuted block randomisation methods, stratified by radiotherapy technique, Zubrod performance status, use of PET during staging, and histology; treatment group assignments were not masked. Radiation dose was prescribed to the planning target volume and was given in 2 Gy daily fractions with either intensity-modulated radiation therapy or three-dimensional conformal radiation therapy. The use of four-dimensional CT and image-guided radiation therapy were encouraged but not necessary. For patients assigned to receive cetuximab, 400 mg/m2 cetuximab was given on day 1 followed by weekly doses of 250 mg/m2, and was continued through consolidation therapy. The primary endpoint was overall survival. All analyses were done by modified intention-to-treat. The study is registered with ClinicalTrials.gov, number NCT00533949. Between Nov 27, 2007, and Nov 22, 2011, 166 patients were randomly assigned to receive standard-dose chemoradiotherapy, 121 to high-dose chemoradiotherapy, 147 to standard-dose chemoradiotherapy and cetuximab, and 110 to high-dose chemoradiotherapy and cetuximab. Median follow-up for the radiotherapy comparison was 22·9 months (IQR 27·5–33·3). Median overall survival was 28·7 months (95% CI 24·1–36·9) for patients who received standard-dose radiotherapy and 20·3 months (17·7–25·0) for those who received high-dose radiotherapy (hazard ratio [HR] 1·38, 95% CI 1·09–1·76; p=0·004). Median follow-up for the cetuximab comparison was 21·3 months (IQR 23·5–29·8). Median overall survival in patients who received cetuximab was 25·0 months (95% CI 20·2–30·5) compared with 24·0 months (19·8–28·6) in those who did not (HR 1·07, 95% CI 0·84–1·35; p=0·29). Both the radiation-dose and cetuximab results crossed protocol-specified futility boundaries. We recorded no statistical differences in grade 3 or worse toxic effects between radiotherapy groups. By contrast, the use of cetuximab was associated with a higher rate of grade 3 or worse toxic effects (205 [86%] of 237 vs 160 [70%] of 228 patients; p<0·0001). There were more treatment-related deaths in the high-dose chemoradiotherapy and cetuximab groups (radiotherapy comparison: eight vs three patients; cetuximab comparison: ten vs five patients). There were no differences in severe pulmonary events between treatment groups. Severe oesophagitis was more common in patients who received high-dose chemoradiotherapy than in those who received standard-dose treatment (43 [21%] of 207 patients vs 16 [7%] of 217 patients; p<0·0001). 74 Gy radiation given in 2 Gy fractions with concurrent chemotherapy was not better than 60 Gy plus concurrent chemotherapy for patients with stage III non-small-cell lung cancer, and might be potentially harmful. Addition of cetuximab to concurrent chemoradiation and consolidation treatment provided no benefit in overall survival for these patients. National Cancer Institute and Bristol-Myers Squibb.

Objective: With rapid urbanization in countries like India, understanding the nutritional status and needs of urban populations, particularly among underprivileged groups such as people living in slums, is crucial. This study investigates the prevalence, characteristics, and determinants of child malnutrition in the urban slums of the Kolkata Municipal Corporation (KMC) and Siliguri Municipal Corporation (SMC) in West Bengal, India. Methods: A cross-sectional study was conducted among 736 children aged 6–59 months. Data were collected using structured interviews to gather socioeconomic, demographic, and dietary information, alongside anthropometric measurements. The analysis employed the Composite Index of Anthropometric Failure (CIAF), and multiple linear regression (MLR) models to identify key factors influencing malnutrition. Results: The findings revealed a high prevalence of stunting (24.1%), underweight (22.3%), and wasting (15.4%) among children aged 6–59 months, with significant variations observed between the two study sites. Key predictors of anthropometric malnutrition include low household income, incidence of recent illness, low maternal nutrition, and delayed initiation of breastfeeding. Conclusions: Addressing child malnutrition in urban slums requires integrated strategies encompassing income-generation opportunities, health-sensitive urban planning, and focused maternal and child health interventions.

Background: We hypothesized that the Effective radiation Dose to the Immune Cells (EDIC) in circulating blood is a significant factor for the treatment outcome in patients with locally advanced non-small-cell lung cancer (NSCLC). Methods: This is a secondary study of a phase III trial, NRG/RTOG 0617, in patients with stage III NSCLC treated with radiation-based treatment. The EDIC was computed as equivalent uniform dose to the entire blood based on radiation doses to all blood-containing organs, with consideration of blood flow and fractionation effect. The primary endpoint was overall survival (OS), and the secondary endpoints were progression-free survival (PFS) and local progression-free survival (LPFS). The EDIC–survival relationship was analyzed with consideration of clinical significant factors. Results: A total of 456 patients were eligible. The median EDIC values were 5.6 Gy (range, 2.1–12.2 Gy) and 6.3 Gy (2.1–11.6 Gy) for the low- and high-dose groups, respectively. The EDIC was significantly associated with OS (hazard ratio [HR] = 1.12, p = 0.005) and LPFS (HR = 1.09, p = 0.02) but PFS (HR = 1.05, p = 0.17) after adjustment for tumor dose, gross tumor volume and other factors. OS decreased with an increasing EDIC in a non-linear pattern: the two-year OS decreased first with a slope of 8%/Gy when the EDIC < 6 Gy, remained relatively unchanged when the EDIC was 6–8 Gy, and followed by a further reduction with a slope of 12%/Gy when the EDIC > 8 Gy. Conclusions: The EDIC is a significant independent risk factor for poor OS and LPFS in RTOG 0617 patients with stage III NSCLC, suggesting that radiation dose to circulating immune cells is critical for tumor control. Organ at risk for the immune system should be considered during RT plan.

The importance of positive N2 lymph node staging for prognosis and treatment decisions is now recognized for patients with Pancoast tumors. The authors of this review assert that a multi-disciplinary management strategy is needed for these patients, and that survival advantages have been observed using combined and multimodality regimens. The role of surgery in the context of viable treatment options and the use of imaging for assessing treatment response is critically discussed. The management of Pancoast tumors has challenged surgeons and radiation and medical oncologists over several decades. Retrospective studies have raised a greater awareness of the importance of positive N2 lymph nodes in terms of prognosis and treatment decision making. While patients with positive N2 lymph nodes have generally been excluded from trials of preoperative chemoradiation for superior sulcus tumors, the potential of surgery for these patients is still being evaluated. The role of PET for initial staging as well as for assessment of disease response to induction therapy continues to evolve. The use of combined treatment modalities has enhanced the progress in successfully treating Pancoast tumors. The historical data showing improved results with a combination of surgery and radiation compared with surgery alone for patients with positive N2 nodes provides the basis for several important clinical trials that integrate the use of chemotherapy into the treatment paradigm. The Southwest Oncology Group and Japanese Clinical Oncology Group have shown dramatic improvements in complete resection rates following a neoadjuvant course of combined chemotherapy and radiation therapy compared with historical series. We discuss relevant ongoing clinical trials that include consolidative taxane-based chemotherapy and the role of prophylactic cranial irradiation in complete responders. Future potential areas of investigation, including the role of surgery for patients with N2-positive disease and the use of imaging to assess response after induction therapy, are discussed. Key Points Determining the status of the N2 nodes has important prognostic and treatment decision-making implications Single modality treatments (surgery, radiation therapy, or chemotherapy) for Pancoast tumors have been associated with poor survival Southwestern Oncology Group (SWOG) 9416 was a landmark trial that demonstrated a 5-year overall survival with preoperative chemoradiation A multimodality approach requires close coordination between the radiation and medical oncologists and the thoracic surgeon Additional studies are required to develop better predictors of response to treatments and to design treatment strategies to control distant sites of failure

Background A national Publicly Funded Health Insurance (PFHI) scheme called Pradhan Mantri Jan Arogaya Yojana (PMJAY) was launched by government of India in 2018. PMJAY seeks to cover 500 million persons with an annual cover of around 7000 USD per household. PMJAY claims to be the largest government funded health scheme globally and has attracted an international debate as a policy for Universal Health Coverage. India’s decade-long experience of the earlier national and state-specific PFHI schemes had shown poor effectiveness in financial protection. Most states in India have completed a year of implementation of PMJAY but no evaluations are available of this important scheme. Methods The study was designed to find out the effect of enrolment under PMJAY in improving utilisation of hospital services and financial protection in Chhattisgarh which has been a leading state in implementing PFHI in terms of enrolment and claims. The study analyses three repeated cross-sections. Two of the cross-sections are from National Sample Survey (NSS) health rounds – year 2004 when there was no PFHI and 2014 when the older PFHI scheme was in operation. Primary data was collected in 2019-end to cover the first year of PMJAY implementation and it formed the third cross-section. Multivariate analysis was carried out. In addition, Propensity Score Matching and Instrumental Variable method were applied to address the selection problem in insurance. Results Enrollment under PMJAY or other PFHI schemes did not increase utilisation of hospital-care in Chhattisgarh. Out of Pocket Expenditure (OOPE) and incidence of Catastrophic Health Expenditure did not decrease with enrollment under PMJAY or other PFHI schemes. The size of OOPE was significantly greater for utilisation in private sector, irrespective of enrollment under PMJAY. Conclusion PMJAY provided substantially larger vertical cover than earlier PFHI schemes in India but it has not been able to improve access or financial protection so far in the state. Though PMJAY is a relatively new scheme, the persistent failure of PFHI schemes over a decade raises doubts about suitability of publicly funded purchasing from private providers in the Indian context. Further research is recommended on such policies in LMIC contexts.

Background India launched a national health insurance scheme named Ayushman Bharat Pradhan Mantri Jan Arogya Yojana (AB-PMJAY) in 2018 as a key policy for universal health coverage. The ambitious scheme covers 100 million poor households. None of the studies have examined its impact on the quality of care. The existing studies on the impact of AB-PMJAY on financial protection have been limited to early experiences of its implementation. Since then, the government has improved the scheme’s design. The current study was aimed at evaluating the impact of AB-PMJAY on improving utilisation, quality, and financial protection for inpatient care after four years of its implementation. Methods Two annual waves of household surveys were conducted for years 2021 and 2022 in Chhattisgarh state. The surveys had a sample representative of the state’s population, covering around 15,000 individuals. Quality was measured in terms of patient satisfaction and length of stay. Financial protection was measured through indicators of catastrophic health expenditure at different thresholds. Multivariate adjusted models and propensity score matching were applied to examine the impacts of AB-PMJAY. In addition, the instrumental variable method was used to address the selection problem. Results Enrollment under AB-PMJAY was not associated with increased utilisation of inpatient care. Among individuals enrolled under AB-PMJAY who utilised private hospitals, the proportion incurring catastrophic health expenditure at the threshold of 10% of annual consumption expenditure was 78.1% and 70.9% in 2021 and 2022, respectively. The utilisation of private hospitals was associated with greater catastrophic expenditure irrespective of AB-PMJAY coverage. Enrollment under AB-PMJAY was not associated with reduced out-of-pocket expenditure or catastrophic health expenditure. Conclusions AB-PMJAY has achieved a large coverage of the population but after four years of implementation and an evidence-based increase in reimbursement prices for hospitals, it has not made an impact on improving utilisation, quality, or financial protection. The private hospitals contracted under the scheme continued to overcharge patients, and purchasing was ineffective in regulating provider behaviour. Further research is recommended to assess the impact of publicly funded health insurance schemes on financial protection in other low- and middle-income countries.

Introduction Understanding the cost of care associated with different kinds of healthcare providers is necessary for informing the policy debates in mixed health-systems like India’s. Existing studies reporting Out of Pocket Expenditure (OOPE) per episode of outpatient care in public and private providers in India do not provide a fair comparison because they have not taken into account the government subsidies received by public facilities. Public and private health insurance in India do not cover outpatient care and for-profit providers have to meet all their costs out of the payments they take from patients. Methods The average direct cost per acute episode of outpatient care was compared for public providers, for-profit formal providers and informal private providers in Chhattisgarh state of India. For public facilities, government subsidies for various inputs were taken into account. Resources used were apportioned using Activity Based Costing. Land provided free to public facilities was counted at market prices. The study used two datasets: a) household survey on outpatient utilisation and OOPE b) facility survey of public providers to find the input costs borne by government per outpatient-episode. Results The average cost per episode of outpatient care was Indian Rupees (INR) 400 for public providers, INR 586 for informal private providers and INR 2643 for formal for-profit providers and they managed 39.3, 37.9 and 22.9% of episodes respectively. The average cost for government and households put together was greater for using formal for-profit providers than the public providers. The disease profile of care handled by different types of providers was similar. Volume of patients and human-resources were key cost drivers in public facilities. Close to community providers involved less cost than others. Conclusions and recommendations The findings have implications for the desired mix of public and private providers in India’s health-system. Poor regulation of for-profit providers was an important structural cost driver. Purchasing outpatient care from private providers may not reduce average cost. Policies to strengthen public provisioning of curative primary care close to communities can help in reducing cost.

Background The elderly face a greater burden of illnesses than other age groups and have a more frequent need of healthcare, including in-patient hospitalisations. Catastrophic expenditure on hospitalisation of the elderly poses a significant challenge to India’s aim of achieving Universal Health Coverage (UHC). India has implemented a policy of Publicly Funded Health Insurance (PFHI) to provide free inpatient care by empanelling private and public hospitals. The existing studies have examined the performance of PFHI in financial protection of the elderly. Methods This study utilised the Longitudinal Ageing Study in India (LASI) Wave 1, conducted in 2017–18. LASI is a large-scale nationally representative survey collecting data on elderly health including illness burden, healthcare use and out of pocket expenditure (OOPE). It covered a sample 72,250 individuals aged 45 or above. Financial Protection was measured in terms of Catastrophic Health Expenditure (CHE). Multivariate analysis was conducted to find effect of PFHI on OOPE—quantile and logistic models were applied for OOPE and CHE respectively. For robustness, Propensity Score Matching (PSM) model was applied. Results Of the hospitalisations, 35% had taken place in public hospitals. The mean OOPE for a hospitalisation in public sector was Indian Rupees (INR) 8276, whereas it was INR 49,700 in private facilities. Incidence of CHE was several times greater for using private hospitals as compared to public hospitals. Multi-variate analyses showed that enrolment under PFHI was not associated with lower OOPE or CHE. PSM model also confirmed that PFHI-enrolment had no effect on OOPE or CHE. Use of private facilities was a key determinant of OOPE, irrespective of enrolment under PFHI. Conclusions This was the first study in India to examine the performance of PFHI in the context of catastrophic hospitalisation expenditure faced by the elderly. It found that PFHI was not effective in financial protection of the elderly. The ongoing reliance on a poorly regulated private sector seems to be a key limitation of PFHI policy. Governments need to find more effective ways of protecting the elderly from catastrophic health expenditure if the goal of UHC has to be realized.

Objective Institutional deliveries have been promoted in India to reduce maternal and neonatal mortality. While the institutional deliveries have increased, they tend to involve large out of pocket expenditure (OOPE) and distress financing for households. In order to protect the families from financial hardship, publicly funded health insurance (PFHI) schemes have been implemented in India. An expanded national health insurance scheme called the Ayushman Bharat Pradhan Mantri Jan Arogya Yojana (PMJAY) was launched in 2018. The current study was aimed at evaluating the performance of PFHI in reducing the OOPE and distress financing for the caesarean and non-caesarean institutional deliveries after the launch of PMJAY. This study analysed the nationally representative dataset of the National Family Health Survey (NFHS-5) conducted in 2019-21. Results Enrollment under PMJAY or other PFHI was not associated with any reduction in out of pocket expenditure or distress financing for caesarean or non-caesarean institutional deliveries across India. Irrespective of the PFHI coverage, the average OOPE in private hospitals was five times larger than public hospitals. Private hospitals showed an excessive rate of using caesarean-section. Utilization of private hospitals was significantly associated with incurring larger OOPE and occurrence of distress financing.

Objective The COVID-19 pandemic has caused widespread illness and a significant proportion of the infected required hospitalisation for treatment. People in developing countries like India were vulnerable to high hospitalisation costs. Despite its crucial importance, few primary studies are available on this aspect of the pandemic. This study was aimed at finding out the out of pocket expenditure (OOPE) and incidence of catastrophic expenditure on hospitalisation of persons infected with COVID-19. A primary survey of 492 randomly selected hospitalisations of individuals tested positive for COVID-19 in high-burden districts during August to November 2020 was carried out telephonically in Chhattisgarh state of India. Results Public hospitals accounted for 69% of the hospitalisations for COVID-19 treatment. Mean OOPE per hospitalisation was Indian Rupees (INR) 4871 in public hospitals and INR 169,504 in private hospitals. Around 3% of hospitalisations in public hospitals and 59% in private hospitals resulted in catastrophic expenditure, at a threshold of 40% of non-food annual household expenditure. Enrolment under publicly or privately funded health insurance was not effective in curtailing OOPE. Multivariate analysis showed that utilisation of private hospitals was a key determinant of incurring catastrophic expenditure.