Although lung cancer remains the leading cause of cancer deaths in the US, recent advances in early detection and treatment have led to improvements in survival. However, there is a considerable risk of recurrence or second primary lung cancer (SPLC) following curative-intent treatment in patients with early-stage non-small cell lung cancer (NSCLC). Professional societies recommend routine surveillance with CT to optimise the detection of potential recurrence and SPLC at a localised stage. However, no definitive evidence demonstrates the effect of imaging surveillance on survival in patients with NSCLC. To close these research gaps, the Advancing Precision Lung Cancer Surveillance and Outcomes in Diverse Populations (PLuS2) study will leverage real-world electronic health records (EHRs) data to evaluate surveillance outcomes among patients with and without guideline-adherent surveillance. The overarching goal of the PLuS2 study is to assess the long-term effectiveness of surveillance strategies in real-world settings.
PLuS2 is an observational study designed to assemble a cohort of patients with incident pathologically confirmed stage I/II/IIIA NSCLC who have completed curative-intent therapy. Patients undergoing imaging surveillance will be followed from 2012 to 2026 by linking EHRs with tumour registry data in the OneFlorida+ Clinical Research Consortium. Data will be consolidated into a unified repository to achieve three primary aims: (1) Examine the utilisation and determinants of CT imaging surveillance by race/ethnicity and socioeconomic status, (2) Compare clinical endpoints, including recurrence, SPLCs and survival of patients who undergo semiannual versus annual CT imaging and (3) Use the observational data in conjunction with validated microsimulation models to simulate imaging surveillance outcomes within the US population. To our knowledge, this study represents the first attempt to integrate real-world data and microsimulation models to assess the long-term impact and effectiveness of imaging surveillance strategies.
This study involves human participants and was approved by the University of Florida Institutional Review Board (IRB), University of Florida IRB 01, under approval number IRB202300782. The results will be disseminated through publications and presentations at national and international conferences. Safety considerations encompass ensuring the confidentiality of patient information. All disseminated data will be de-identified and summarised.
To assess factors associated with the adoption of the WHO Package of Essential Non-Communicable Diseases (PEN) Protocol 1 at primary healthcare (PHC) facilities in Nepal after healthcare workers received training.
Cross-sectional study.
PHC facilities across various provinces in Nepal.
A total of 180 healthcare workers trained in PEN, recruited from a random selection of 105 basic healthcare facilities.
The adoption of PEN Protocol 1 components: blood pressure measurement, blood glucose screening, 10-year cardiovascular disease (CVD) risk assessment using WHO/International Society of Hypertension risk charts and body mass index (BMI) assessment. Factors associated with protocol adoption were assessed using generalised estimating equations for ORs.
Among participants, 100% reported measuring blood pressure, while 56% measured blood sugar, 28% assessed CVD risk and 27% assessed BMI. The adoption of the CVD risk prediction chart was positively associated with the availability of amlodipine (adjusted OR (aOR) 3.00; 95% CI 1.09 to 8.27). The adoption of BMI assessment was positively associated with access to a stadiometer (aOR 3.23; 95% CI 1.26 to 8.30) and a glucometer (aOR 3.07; 95% CI 1.12 to 8.40), and negatively associated with lack of motivation/inertia of previous practice (aOR 0.60; 95% CI 0.42 to 0.87) and environmental factors such as lack of time and resources (aOR 0.57; 95% CI 0.37 to 0.89). Blood glucose level measurements were positively associated with being at a PHC centre (aOR 7.34; 95% CI 2.79 to 19.3) and the availability of metformin (OR 2.40; 95% CI 1.08 to 5.29).
Adoption of PEN Protocol 1 varied by component and was influenced by resource availability, provider motivation and system barriers. Addressing these factors is key to optimising implementation in low-resource settings.
Drug–drug interactions (DDIs) are a significant concern for patients on complex therapeutic regimens, especially involving cardiovascular medications, which are frequently implicated in these interactions.
This study used a standardised interaction database to determine the frequency, severity and risk factors associated with potential DDIs (pDDIs) among cardiovascular disease (CVD) in-patients.
The prospective cross-sectional study was conducted at a tertiary care hospital in Nepal from April 2024 to October 2024. A total of 106 eligible CVD in-patients were evaluated for pDDIs using the Lexicomp DDI checker database, and the interactions were categorised based on severity and risk rating. Binary logistic regression identified factors associated with pDDIs.
The study identified 621 pDDIs using the Lexicomp database, with median values of 8 pDDIs per patient. Patients with at least one pDDI comprised 64.2% of the sample. Most pDDIs were of moderate severity (77.3%) with risk ratings of C (65.7%). The most common cardiovascular medications involved in the detected DDI pairs were diuretics (31.2%), antiplatelets and anticoagulants (23.8%) and calcium channel blockers (12.2%). Multivariate binary logistic regression revealed that patients who stayed longer (adjusted OR (AOR) 9.08, 95% CI 1.027 to 80.216, p=0.047), those receiving more medications (AOR 18.85, 95% CI 2.975 to 119.370, p=0.002) and those who were admitted to the intensive cardiac care unit (AOR 16.31, 95% CI 2.728 to 97.461, p=0.002) were significantly more likely to experience pDDIs.
This study found a higher prevalence of pDDIs. It is advisable to incorporate medication reviews into routine cardiac care and use a drug interaction checker to identify pDDIs.
Knee osteoarthritis often starts in the patellofemoral compartment of the knee and is diagnosed in about 39% of people with knee pain aged above 30 years. Patellofemoral osteoarthritis plays a crucial role in the reduction of quality of life and in the rise of healthcare costs. There is still no consensus for treatment recommendation for isolated patella-femoral osteoarthritis in clinical guidelines. Current therapeutic approaches are limited to pain management, alleviation of symptoms or total knee replacement. Nasal chondrocyte tissue-engineered cartilage (N-TEC) has already been successfully introduced in clinical studies phase I and II for the treatment of focal cartilage lesions and in pilot studies in osteoarthritis patients.
A randomised controlled trial involving 75 patients with patellofemoral osteoarthritis from nine different clinical centres in Switzerland, Germany and Croatia is being conducted to evaluate the effectiveness of N-TEC implantation compared with standard treatment with platelet-rich plasma (PRP). In the intervention group, an autologous nasal cartilage cell-derived graft is implanted into the cartilage defects of the patella and/or trochlea during an open surgical procedure. The control group receives three PRP injections at weekly intervals. The primary outcome is the mean Knee Injury and Osteoarthritis Outcome Score Pain Change from baseline to 24 months between groups. Secondary outcomes, including patients’ self-assessed questionnaires, X-ray and MRI scans, physiotherapeutic assessments and safety, will be assessed and compared between the intervention and control group. In addition, the study is complemented with a health-economic evaluation to establish the intervention’s value for money and impact on productivity in working-age individuals. The planned duration of the study is 4 years including baseline and follow-up measurements at 6, 12 and 24 months.
All centres involved in the implementation of the intervention have obtained approval from their respective competent ethics committees. This includes approval from the following ethics committees: Ethics Committees of North-Western and Central Switzerland (EKNZ): 2024–00075 (associated ethical committees: Cantonal Ethics Committee Bern, Cantonal Research Ethics Commission Geneva (CCER), Cantonal Ethics Committee Ticino, Cantonal Ethics Committee Zurich). The EKNZ covers several cantons in Switzerland, including Basel. The site in Lugano falls under the Cantonal Ethics Committee Ticino. Ethics Germany according to CTIS: 2023-508640-21-00 (Medicinal Ethical Commission of the Julius-Maximilians-University Wuerzburg, Ethical Commission of the Albert-Ludwigs-University Freiburg) and Central Ethical Committee Croatia, Republic of Croatia Ministry of Health: 2023-508640-21-00. The Swissmedic reference number is 701788.
Prior to participation, all participants must have signed informed consent. Study information will be disseminated via hospital websites, newsletters and an open-access publication of the protocol. Results will be published in peer-reviewed journals, presented at national and international conferences and shared with the public.
ClinicalTrials.gov Registration No.: NCT06163573; Registration number CTIS: 2023-508640-21-00.
This study aimed to assess the coronavirus disease 2019 (COVID-19) hospitalisation costs and its associated factors on Nepalese households during the second wave of the pandemic, within the context of Nepal’s COVID-19 response.
A cost-descriptive cross-sectional study.
Kathmandu Metropolitan City, Nepal.
We enrolled 306 hospitalised patients.
Telephonic interviews were conducted with COVID-19 patients between May and July 2022. Cost was assessed from a patient’s perspective. We assessed factors associated with the medical cost of COVID-19 treatment services using a generalised linear model with gamma distribution and log link in both bivariable and multivariable models for estimating coefficients and confidence intervals. Data were analysed using STATA version 13, adjusting for the potential confounders: socio-demographic characteristics, type of hospital, intensive care unit (ICU) requirement, lead time to hospital admission and number of days at hospital stay.
The total median cost for hospitalisation was US$ 754.9. The median direct medical, direct non-medical and indirect costs were US$ 624.4, US$ 49.3 and US$ 493.02, respectively. After adjusting for potential confounders, the cost of COVID-19 treatment was 6.9 times higher among those admitted to private hospital (95% CI 5.72 to 8.32, p
The cost of the COVID-19 treatment was beyond the average monthly income of Nepalese, indicating adverse consequences from the financial burden of a household. The direct medical cost was associated with the type of hospital, requirement of ICU, lead time to hospital admission, and length of hospital stay. Therefore, it is urgent to address the issue of high medical expenses, particularly to strengthen the health system’s resilience against unforeseen crises and pandemics.