Nevin Manimala

J Foot Ankle Res. 2024 Dec;17(4):e70021. doi: 10.1002/jfa2.70021.

ABSTRACT

BACKGROUND: The visual analogue scale (VAS) and the Foot Health Status Questionnaire (FHSQ) are patient-reported outcome measures that are frequently used to evaluate the management of plantar heel pain. This study aimed to re-calculate (i.e. revise) the minimal important differences (MIDs) of the VAS and the FHSQ when used for plantar heel pain to enhance the validity and precision of previous estimates.

METHODS: This study used an anchor-based method to calculate MIDs and incorporated best-practice analyses to ensure credibility of the estimates. Data from 369 participants previously recruited from the community into four randomised controlled trials that evaluated interventions for plantar heel pain were used. VAS and FHSQ data from these participants at baseline and follow-up were pooled to calculate the MIDs (95% confidence intervals). A 15-point global rating of change Likert scale was used at follow-up as the transition scale, which was anchored to baseline. For the VAS, MIDs for two distinct types of pain were calculated: average pain and first-step pain. For the FHSQ, MIDs for two domains were calculated: foot pain and foot function.

RESULTS: The revised MIDs for the 100 mm VAS were -8.5 mm (95% CI: -12.2 to -4.7) for average pain and -19.2 mm (95% CI: -24.7 to -13.8) for first-step pain, which represent improvements in pain. The MIDs for the FHSQ were 12.4 points (95% CI: 6.9 to 18.0) for foot pain and 6.4 points (95% CI: 0.9 to 11.9) for foot function, which represent improvements in foot health status.

CONCLUSIONS: The revised MIDs from this study for the VAS and the FHSQ when used for plantar heel pain have enhanced validity and precision compared to previous estimates. This is important for clinicians and researchers as it provides a better understanding of how much improvement is required by an individual before an important change is experienced. The revised MIDs will also assist researchers with prospective sample size calculations, so future clinical trials are appropriately powered from a statistical standpoint.

PMID:39682003 | DOI:10.1002/jfa2.70021

Head Neck. 2024 Dec 16. doi: 10.1002/hed.28006. Online ahead of print.

ABSTRACT

BACKGROUND: Lymph node count (LNC) from neck dissection has been associated with undernutrition and survival in head and neck squamous cell carcinoma (HNSCC). As local components of the immune system, cervical lymph nodes may reflect anti-tumor immune status. This study investigates the relationship between decreased LNC, formation of tertiary lymphoid structures (TLS), and primary tumor infiltration by lymphocytes in undernourished patients.

METHODS: A matched-cohort study was conducted in a tertiary medical center, where neck dissection quality was standardized for a total of 384 subjects that were evaluated. Six head and neck cancer patients that underwent primary surgery including neck dissection with low LNC and BMI (low BMI < 23, low LNC ≤ 5.6 per neck level) were matched by stage, p16 status, and subsite to 16 patients with normal BMI and high LNC. Multiplexed immunohistochemistry was used to evaluate the tumor-infiltrating lymphocytes and the number and quality of TLS within primary tumors. Whole primary cancers underwent automated analysis and counting of leukocytes after multiplexed immunohistochemistry staining of tumor slides. A head and neck pathologist blindly scored the number and maturity of TLS. Descriptive statistics were used to analyze outcomes.

RESULTS: The patients with low BMI and low LNC had significantly fewer CD3 (p = 0.0136), CD8 (p = 0.0003), and CD20 (p = 0.0334) cells in their primary tumors compared to patients with normal BMI and LNC. The low BMI low LNC patients also had fewer mature TLS (0.83/tumor) in their primary cancers compared to patients with normal BMI and high LNC (5.4/tumor) and also had greater than fourfold lower mature TLS density (TLS per μm² mean) (6.34 × 10^-9 vs. 2.82 × 10^-8), with significantly worsened survival relative to patients with low BMI and normal LNC and patients with normal BMI.

CONCLUSION: Low LNC predicts worsened survival only in low BMI HNSCC patients with non-HPV related tumors and in these patients is associated with markers of immunosuppression such as fewer tumor-infiltrating CD8+ T-cells, CD20+ cells, and fewer TLS in primary cancers compared to matched normal BMI patients with high LNC.

PMID:39681999 | DOI:10.1002/hed.28006

Mol Pharm. 2024 Dec 16. doi: 10.1021/acs.molpharmaceut.4c00829. Online ahead of print.

ABSTRACT

A framework for the rational selection of a minimal suite of nondegenerate developability assays (DAs) that maximize insight into candidate developability or storage stability is lacking. To address this, we subjected nine formulation:mAbs to 12 mechanistically distinct DAs together with measurement of their accelerated and long-term storage stability. We show that it is possible to identify a reduced set of key variables from this suite of DAs by using orthogonal statistical methods. We exemplify our approach by predicting the rank formulation:mAb degradation rate at 25 °C (determined over 6 months) using just five DAs that can be measured in less than 1 day, spanning a range of physicochemical features. Implementing such approaches focuses on resources, thus increasing sustainability and decreasing development costs.

PMID:39681988 | DOI:10.1021/acs.molpharmaceut.4c00829

Psychooncology. 2024 Dec;33(12):e70045. doi: 10.1002/pon.70045.

ABSTRACT

OBJECTIVE: To identify the feasibility, acceptability, and effectiveness of web-based acceptance and commitment therapy (ACT) on health-related outcomes in patients with lung cancer.

METHODS: A feasibility, prospective, parallel, individual-based, assessor-blinded randomized controlled trial was designed. This study was conducted at a third-level hospital in Sichuan Province, China. A total of 101 participants were enrolled and randomly assigned to usual care group or 7-weekly web-based acceptance and commitment therapy group. The primary outcome was feasibility and acceptability of the intervention, and the secondary outcomes including quality of life, psychological flexibility, anxiety, depression, fatigue, and sleep disturbance. Generalized estimating equations were used to evaluate the group differences. All analyses followed the principle of intention-to-treat.

RESULTS: Web-based ACT presented good feasibility and acceptability in this study, with an attrition rate of 13.86%, a median compliance rate of 71.43%, and a satisfaction rate of 65.9%. Compared with control group, participants in intervention group reported statistically significant increases in quality of life (MD = 15.10, 95% CI: [10.09, 20.11], d = 0.37), psychological flexibility (MD = -8.42, 95% CI: [-10.81, -6.03], d = -1.47), anxiety (MD = -1.27, 95% CI: [-2.50, -0.05], d = -0.44), depression (MD = -2.11, 95% CI: [-3.28, -0.95], d = -0.76), and sleep disturbance (MD = -1.85, 95% CI: [-3.10, -0.59], d = 0.13) at postintervention, however, the improvement in fatigue was not statistically significant (MD = -2.02, 95% CI: [-9.02, 4.98], d = -0.12).

CONCLUSIONS: Web-based ACT was an approach with good feasibility and acceptability, and it could effectively improve quality of life, psychological flexibility, anxiety, depression, and sleep disturbance in patients with lung cancer. In order to achieve better results, there is a need to design a more tailored intervention plan and a more operational platform.

PMID:39681977 | DOI:10.1002/pon.70045

BMC Glob Public Health. 2024 Dec 10;2(1):83. doi: 10.1186/s44263-024-00105-x.

ABSTRACT

BACKGROUND: Despite a wealth of data from high-income countries, there is limited information on the distinct epidemiological patterns observed in diverse, densely populated regions within Latin America. This retrospective analysis of COVID-19’s four major waves in Bogotá, Colombia, evaluates 1.77 million cases in detail.

METHODS: A comprehensive suite of statistical methods was employed. Transmission dynamics were assessed by estimating the instantaneous reproduction number $R\left(t\right)$ , while variant-specific transmission advantages were estimated using multinomial logistic regression models. Disease severity was assessed through a suite of indicators: Hospitalisation Case Ratio (HCR), intensive care unit case ratio (ICU-CR), case fatality ratio (CFR), hospitalisation fatality ratio (HFR), and ICU fatality ratio (ICU-FR). Additionally, we analysed the distribution of hospitalisations, ICU admissions, and fatalities by age group and wave. We employed a Bayesian hierarchical model to capture epidemiological delays-such as onset-to-death, hospitalisation, and ICU admission durations to estimate hospital and ICU stay durations.

RESULTS: Our findings reveal substantial variation in $R\left(t\right)$ , with peaks exceeding 2.5 during the ancestral and Omicron waves. Over the course of the pandemic, we observed a 78% reduction in CFR, underscoring shifts in clinical severity. The third wave, associated with the Mu variant, recorded the highest case and death counts, alongside a decreased CFR, an elevated HFR, and a shift in the most affected age group towards younger populations. In contrast, the fourth wave, driven by the Omicron variant, exhibited the highest reproduction number and the lowest overall severity. This wave was characterised by a significant increase in pediatric hospitalisations. The study reveals a continued decline in the mean durations of hospital and ICU stays across the four waves, with hospital stays decreasing from 10.84 to 7.85 days and ICU stays dropping from 16.2 to 12.4 days.

CONCLUSIONS: This study reveals significant shifts in transmission and severity metrics-including mortality, hospitalisation, and ICU rates and stays-across age groups during Bogotá’s four COVID-19 waves. These insights underscore the value of retrospective analyses to understand the pandemic’s varied impact and inform public health strategies in diverse urban settings.

PMID:39681974 | DOI:10.1186/s44263-024-00105-x

BMC Glob Public Health. 2024 Sep 3;2(1):58. doi: 10.1186/s44263-024-00087-w.

ABSTRACT

New, first-in-class oral antibiotics like zoliflodacin, developed in a public-private partnership, require an optimal introduction strategy while ensuring antibiotic stewardship. Zoliflodacin, given as a single dose for uncomplicated urogenital gonorrhoea, recently demonstrated non-inferiority to ceftriaxone plus azithromycin and safety in a phase 3 randomised controlled trial. Following regulatory approval, zoliflodacin could improve sexually transmitted infection (STI) management and help address the threat of untreatable gonorrhoea, as levels of resistance to current first-line treatments increase. The Global Antibiotic Research & Development Partnership (GARDP) convened an expert meeting during the 2023 STI and HIV World Congress to discuss key questions about the introduction of zoliflodacin in low- and middle-income countries (LMICs). The questions included: which patients to treat in which situations, the timing of introduction, and what additional evidence is needed to change policy for the use of new antibiotics for gonorrhoea. Recommendations from the expert group included: the generation of evidence for the role of a drug like zoliflodacin in clinical treatment failures; the need for additional antimicrobial resistance surveillance; investigation of the role of novel diagnostic approaches, such as point-of-care tests, to improve stewardship; study of preferences and values among the population in need; and modelling of the emergence of N. gonorrhoeae resistance and transmission in different scenarios. Forthcoming World Health Organization (WHO) global guidelines could outline recommendations for a new oral antibiotic like zoliflodacin based on existing evidence, and rational approaches for certain populations or use cases, while the evidence base is further strengthened.

PMID:39681965 | DOI:10.1186/s44263-024-00087-w

Health Serv Res. 2024 Dec 16:e14420. doi: 10.1111/1475-6773.14420. Online ahead of print.

ABSTRACT

OBJECTIVE: To evaluate the impact of the Massachusetts Medicaid program’s reimbursement policy change for perinatal depression screening on utilization rates.

STUDY SETTING AND DESIGN: This study employed a difference-in-differences design to compare insurance-paid prenatal and postpartum depression screening rates as well as postpartum antidepressant receipt rates between Medicaid and privately insured individuals before and after policy implementation in May 2016.

DATA SOURCES AND ANALYTIC SAMPLE: Data are from the 2014-2020 Massachusetts All-Payer Claims Database. The study included individuals with a live birth from October 10, 2014, to December 31, 2019, who were continuously insured either by Medicaid or private insurance.

PRINCIPAL FINDINGS: Among 141,085 births, 42.6% were covered by Medicaid. Among those with Medicaid, 1.9% had a paid postpartum depression screening prior to the policy and 16.9% after (1.5% vs. 12.3% for prenatal screening); among privately insured, 3.8% had a paid postpartum screening prior to the policy and 10.6% after (0.9% vs. 6.7% for prenatal screening). Antidepressant receipt rose from 6.9% to 8.3% among Medicaid enrollees and from 3.3% to 4.9% among privately insured individuals after the policy. After regression adjustment, implementation of the Massachusetts Medicaid reimbursement policy was positively associated with perinatal depression screening rates with a differential increase of 10.0 percentage points (p < 0.001) for postpartum screening and 3.5 percentage points (p < 0.001) for prenatal screening among Medicaid enrollees versus privately insured. Despite increased depression screening, the policy was not associated with a statistically significant change in antidepressant receipt among Medicaid enrollees compared to privately insured individuals.

CONCLUSIONS: Separate payment for perinatal depression screening significantly improved screening rates among Medicaid beneficiaries, highlighting Medicaid’s critical role in identifying mental health needs for vulnerable populations. However, the persistence of sub-optimal screening rates among perinatal individuals underscores the need for a comprehensive approach to ensure universal screening and effective treatment for perinatal depression.

PMID:39681957 | DOI:10.1111/1475-6773.14420

BMC Glob Public Health. 2024 Apr 17;2(1):25. doi: 10.1186/s44263-024-00056-3.

ABSTRACT

BACKGROUND: Intimate partner violence (IPV) against women has harmful effects on their psychological and physical health. However, help-seeking for IPV is significantly low among women in the Indian context. This study examines the different factors that influence help-seeking behaviour among women in India. It also studies associations of the type of IPV with the source of help.

METHODS: The study analyses data from the fifth round of the National Family Health Survey that was conducted in India (2019-2021). Independent variables were categorized at individual, relationship-household and community levels. The Stata 14.2 software was used to calculate the prevalence ratios and their corresponding 95% confidence intervals. Variables with p-values less than 0.05 were considered statistically significant. Poisson regression helped identify factors associated with help-seeking.

RESULTS: Results indicate that among 72,320 women aged 18-49 years, 17,765 women ever-faced IPV. Of them, 14.2% of women who faced either physical and/or sexual IPV sought any help. Husband’s consumption of alcohol almost doubled the likelihood of help-seeking among women (19.91%), compared to women whose husbands did not drink alcohol (10.19%). Witnessing parental IPV also increased the odds (17.26%) of help-seeking. Women who were not empowered were more likely to seek help (14.11%) compared to women who were empowered (12.56%). The police were the predominant source where women went for formal help (6.94 to 8.43%), followed by doctors (1.84 to 2.71%). Close to 1 in 4 women (22.5%) sought help for sexual IPV, while 14.4% of women sought help for physical IPV. Around 95% of all women who faced IPV sought informal help, with 3 in 5 of them approaching their own families, and 3 in 10 approaching their in-laws or marital families.

CONCLUSIONS: Two significant factors that associate positively with help-seeking by women facing IPV are husbands’ alcohol consumption and witnessing parental IPV. Most women preferred informal help from the natal family, while among formal providers, the police were the foremost choice. Programmes and initiatives to build capacities of communities, and of police to respond to women seeking help for IPV, would enable more women to reach out for help.

PMID:39681945 | DOI:10.1186/s44263-024-00056-3

BMC Glob Public Health. 2024 May 6;2(1):28. doi: 10.1186/s44263-024-00061-6.

ABSTRACT

BACKGROUND: Colorectal cancer (CRC) poses a significant public health challenge in Canada, with the Atlantic provinces bearing a particularly high burden. The implementation of population-based colon screening programs is aimed to address this concern. However, limited research exists on the effect of these programs especially in Canada. This study aimed to examine the impact of the first few years of the CRC screening programs in the Atlantic provinces of Canada by assessing changes in screening uptake, barriers, and predictors of screening among eligible populations.

METHODS: Employing a repeated cross-sectional design, this study analyzed data from a representative sample of 7614 respondents in 2010 and 6850 in 2017 from the Atlantic provinces aged 50-74 years, extracted from the Canadian Community Health Survey (CCHS). The outcomes measured were CRC screening rates, changes in predictors of screening uptake, and barriers to participation. Potential predictors examined included age, sex, income, education, smoking, and health status.

RESULTS: The proportion of adults aged 50-74 years who meet CRC screening requirements increased from 42% in 2010 to 54% in 2017 yet below the national target of 60%. New Brunswick reported the most significant increase in screening prevalence (18%, p < 0.05). Participation in fecal tests increased from 19.6 to 32.4%. Despite these improvements, disparities in screening participation remained, with lower uptake observed among individuals with lower income and education levels. Age (> 60 years, OR = 2.09, p < 0.01), the presence of multiple chronic health conditions (OR = 2.11, p < 0. 01), being female (OR = 1.21, p < 0.01), married status (OR = 1.21, p < 0.05), access to regular healthcare (OR = 1.91, p < 0.01), and nonsmoking status (OR = 2.55, p < 0.01) were identified as significant predictors of CRC screening uptake.

CONCLUSIONS: This study shows that while CRC screening uptake increased across the Atlantic provinces between 2010 and 2017, barriers to and disparities in screening participation persist. This highlights the need for targeted interventions to improve awareness, access, and screening uptake, particularly among disadvantaged groups, to promote equitable healthcare outcomes. Continued efforts should focus on reducing barriers to screening and leveraging available evidence to inform interventions aimed at mitigating the CRC burden in the region.

PMID:39681936 | DOI:10.1186/s44263-024-00061-6

BMC Glob Public Health. 2024 May 3;2(1):27. doi: 10.1186/s44263-024-00057-2.

ABSTRACT

BACKGROUND: Travel restrictions and border controls were used extensively during the COVID-19 pandemic. However, the processes for making robust evidence-based risk assessments of source countries to inform border control policies was in many cases very limited.

METHODS: Between April 2020 and February 2022, all international arrivals to New Zealand were required to spend 14 days in government-managed quarantine facilities and were tested at least twice. The infection rates among arrivals in the years 2020, 2021 and 2022 were respectively 6.3, 9.4 and 90.0 cases per thousand arrivals (487, 1064 and 1496 cases). Test results for all arrivals were linked with travel history, providing a large and comprehensive dataset on the number of SARS-CoV-2-positive and negative travellers from different countries over time. We developed a statistical model to predict the country-level infection risk based on infection rates among recent arrivals and reported cases in the country of origin. The model incorporates a country-level random effect to allow for the differences between the infection risk of the population of each country and that of travellers to New Zealand. A time dependent auto-regressive component of the model allows for short term correlation in infection rates.

RESULTS: A model selection and checking exercise found that the model was robust and reliable for forecasting arrival risk for 2 weeks ahead. We used the model to forecast the number of infected arrivals in future weeks and categorised countries according to their risk level. The model was implemented in R and was used by the New Zealand Ministry of Health to help inform border control policy during 2021.

CONCLUSIONS: A robust and practical forecasting tool was developed for forecasting infection risk among arriving passengers during a period of controlled borders during the COVID-19 pandemic. The model uses historical infection rates among arrivals and current infection rates in the source country to make separate risk predictions for arrivals from each country.

PMID:39681931 | DOI:10.1186/s44263-024-00057-2