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Nevin Manimala Statistics

Improving species distribution forecasts by measuring and communicating uncertainty: An invasive species case study

Ecology. 2024 Apr 13:e4297. doi: 10.1002/ecy.4297. Online ahead of print.

ABSTRACT

Forecasting invasion risk under future climate conditions is critical for the effective management of invasive species, and species distribution models (SDMs) are key tools for doing so. However, SDM-based forecasts are uncertain, especially when correlative statistical models extrapolate to nonanalog environmental domains, such as future climate conditions. Different assumptions about the functional form of the temperature-suitability relationship can impact predicted habitat suitability under novel conditions. Hence, methods to understand the sources of uncertainty are critical when applying SDMs. Here, we use high-resolution predictions of lake water temperatures to project changes in habitat suitability under future climate conditions for an invasive macrophyte (Myriophyllym spicatum). Future suitability was predicted using five global circulation models and three statistical models that assumed different species-temperature functional responses. The suitability of lakes for M. spicatum was overall predicted to increase under future climate conditions, but the magnitude and direction of change in suitability varied greatly among lakes. Variability was most pronounced for lakes under nonanalog temperature conditions, indicating that predictions for these lakes remained highly uncertain. Integrating predictions from SDMs that differ in their species-environment response function, while explicitly quantifying uncertainty across analog and nonanalog domains, can provide a more robust and useful approach to forecasting invasive species distribution under climate change.

PMID:38613235 | DOI:10.1002/ecy.4297

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Nevin Manimala Statistics

Multivariate data analysis on multisensor measurement for inline process monitoring of adenovirus production in HEK293 cells

Biotechnol Bioeng. 2024 Apr 12. doi: 10.1002/bit.28712. Online ahead of print.

ABSTRACT

In the era of Biopharma 4.0, process digitalization fundamentally requires accurate and timely monitoring of critical process parameters (CPPs) and quality attributes. Bioreactor systems are equipped with a variety of sensors to ensure process robustness and product quality. However, during the biphasic production of viral vectors or replication-competent viruses for gene and cell therapies and vaccination, current monitoring techniques relying on a single working sensor can be affected by the physiological state change of the cells due to infection/transduction/transfection step required to initiate production. To address this limitation, a multisensor (MS) monitoring system, which includes dual-wavelength fluorescence spectroscopy, dielectric signals, and a set of CPPs, such as oxygen uptake rate and pH control outputs, was employed to monitor the upstream process of adenovirus production in HEK293 cells in bioreactor. This system successfully identified characteristic responses to infection by comparing variations in these signals, and the correlation between signals and target critical variables was analyzed mechanistically and statistically. The predictive performance of several target CPPs using different multivariate data analysis (MVDA) methods on data from a single sensor/source or fused from multiple sensors were compared. An MS regression model can accurately predict viable cell density with a relative root mean squared error (rRMSE) as low as 8.3% regardless of the changes occurring over the infection phase. This is a significant improvement over the 12% rRMSE achieved with models based on a single source. The MS models also provide the best predictions for glucose, glutamine, lactate, and ammonium. These results demonstrate the potential of using MVDA on MS systems as a real-time monitoring approach for biphasic bioproduction processes. Yet, models based solely on the multiplicity and timing of infection outperformed both single-sensor and MS models, emphasizing the need for a deeper mechanistic understanding in virus production prediction.

PMID:38613199 | DOI:10.1002/bit.28712

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Medicare Restriction of Telehealth Speech Services Negatively Impacts Patient Care

Otolaryngol Head Neck Surg. 2024 Apr 12. doi: 10.1002/ohn.779. Online ahead of print.

ABSTRACT

OBJECTIVE: Ample literature shows voice and swallowing therapy, in-person or virtual, to be essential for Otolaryngology and Speech-Language Pathology care. In March 2023, Medicare announced discontinuing teletherapy reimbursement in hospital-based outpatient departments, effective May 2023. This decision was subsequently reversed; however, the uncertain interval period provided the opportunity to study the impact of eliminating teletherapy.

STUDY DESIGN: Prospective cohort.

SETTING: Tertiary laryngology center.

METHODS: Affected Medicare patients were contacted via mailed letter, phone, and secure patient portal and offered to change appointments to in-person, teletherapy with cash self-payment ($165-282/session) or cancellation. Demographics and responses were collected. Statistical analyses conducted using Student’s t test.

RESULTS: Fifty-three patients (28 female; mean age 66.8 ± 14.2 years) were impacted. 64% (n = 34) changed to in-person appointment, 28% (n = 15) canceled, 8% (n = 4) did not respond. No patients opted to self-pay. 67% of patients that canceled telehealth care cited distance from in-person care location. The mean distance for canceled versus rescheduled patients was 92.3 ± 93.0 versus 32.8 ± 57.4 miles, P = .034. Mean age, gender, and number of sessions were not different between groups. Mean time to third next available therapy appointment was 96 ± 46 versus 46 ± 12 days before and after rule change, P = .007. Upon Medicare’s reversal, this trend rebounded to nearly baseline (mean 77 ± 12 days, P = .12).

CONCLUSION: Medicare’s discontinuation of reimbursement for teletherapy services caused nearly 30% of patients to cancel voice and swallowing therapy, primarily due to distance. These cancellations led to decreased access to care for Medicare patients with voice/swallowing diagnoses, which affect function, quality of life, and potentially even mortality risk.

PMID:38613195 | DOI:10.1002/ohn.779

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Reporting of Complications in Rhinoplasty Randomized Controlled Trials: An Analysis Using the CONSORT Extension for Harms Checklist

Otolaryngol Head Neck Surg. 2024 Apr 12. doi: 10.1002/ohn.765. Online ahead of print.

ABSTRACT

OBJECTIVE: This study aimed to assess the completeness of adverse event (AE) reporting in randomized control trials (RCTs) focused on rhinoplasty, using the Consolidated Standards for Reporting (CONSORT) Extension for Harms checklist.

STUDY DESIGN: A cross-sectional design was employed to review RCTs related to rhinoplasty published between January 1, 2005, and January 28, 2022.

SETTING: The study analyzed clinical trials on rhinoplasty retrieved from PubMed.

METHODS: We performed a comprehension search on PubMed, blind and duplicate screening, and data extraction. Adherence to the 18 recommendations of the CONSORT Extension for Harms was evaluated, with 1 point assigned for each adhered item. Percent adherence was calculated based on the 18 points, taking into account the multiple subcategories within some recommendations. Descriptive statistics were used to summarize adherence-including frequencies, percentages, and 95% confidence intervals.

RESULTS: Our search returned 240 articles, of which 56 met inclusion criteria. No RCTs adhered to all 18 CONSORT Extension for Harms items. Twenty-six (26/56, 46.4%) adhered to ≥50% of the items, and 30 (30/56, 53.6%) adhered to ≥33.3% of the items. Seven (7/56, 12.5%) RCTs adhered to no items. Across all RCTs, the average number of CONSORT-Harms items adhered to was 7.2 (7.2/18, 40.0%). The most adhered to item was item 10. Discussion balanced with regard to efficacy and AEs (80.4%, [70.0-90.8]).

CONCLUSION: This study highlights the inadequacy of AE reporting in rhinoplasty RCTs according to CONSORT-Harms guidelines. Urgent efforts are required to bridge this reporting gap and enhance transparency in surgical research, ultimately safeguarding patient well-being.

PMID:38613190 | DOI:10.1002/ohn.765

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The Health4Life e-health intervention for modifying lifestyle risk behaviours of adolescents: secondary outcomes of a cluster randomised controlled trial

Med J Aust. 2024 Apr 12. doi: 10.5694/mja2.52279. Online ahead of print.

ABSTRACT

OBJECTIVES: To investigate the effectiveness of a school-based multiple health behaviour change e-health intervention for modifying risk factors for chronic disease (secondary outcomes).

STUDY DESIGN: Cluster randomised controlled trial.

SETTING, PARTICIPANTS: Students (at baseline [2019]: year 7, 11-14 years old) at 71 Australian public, independent, and Catholic schools.

INTERVENTION: Health4Life: an e-health school-based multiple health behaviour change intervention for reducing increases in the six major behavioural risk factors for chronic disease: physical inactivity, poor diet, excessive recreational screen time, poor sleep, and use of alcohol and tobacco. It comprises six online video modules during health education class and a smartphone app.

MAIN OUTCOME MEASURES: Comparison of Health4Life and usual health education with respect to their impact on changes in twelve secondary outcomes related to the six behavioural risk factors, assessed in surveys at baseline, immediately after the intervention, and 12 and 24 months after the intervention: binge drinking, discretionary food consumption risk, inadequate fruit and vegetable intake, difficulty falling asleep, and light physical activity frequency (categorical); tobacco smoking frequency, alcohol drinking frequency, alcohol-related harm, daytime sleepiness, and time spent watching television and using electronic devices (continuous).

RESULTS: A total of 6640 year 7 students completed the baseline survey (Health4Life: 3610; control: 3030); 6454 (97.2%) completed at least one follow-up survey, 5698 (85.8%) two or more follow-up surveys. Health4Life was not statistically more effective than usual school health education for influencing changes in any of the twelve outcomes over 24 months; for example: fruit intake inadequate: odds ratio [OR], 1.08 (95% confidence interval [CI], 0.57-2.05); vegetable intake inadequate: OR, 0.97 (95% CI, 0.64-1.47); increased light physical activity: OR, 1.00 (95% CI, 0.72-1.38); tobacco use frequency: relative difference, 0.03 (95% CI, -0.58 to 0.64) days per 30 days; alcohol use frequency: relative difference, -0.34 (95% CI, -1.16 to 0.49) days per 30 days; device use time: relative difference, -0.07 (95% CI, -0.29 to 0.16) hours per day.

CONCLUSIONS: Health4Life was not more effective than usual school year 7 health education for modifying adolescent risk factors for chronic disease. Future e-health multiple health behaviour change intervention research should examine the timing and length of the intervention, as well as increasing the number of engagement strategies (eg, goal setting) during the intervention.

TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry: ACTRN12619000431123 (prospective).

PMID:38613175 | DOI:10.5694/mja2.52279

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Factors associated with development of post-operative reflux in horses with large colon volvulus and association with complications and outcomes

Equine Vet J. 2024 Apr 12. doi: 10.1111/evj.14095. Online ahead of print.

ABSTRACT

BACKGROUND: Post-operative reflux (POR) is rare following large colon volvulus (LCV) but does occur despite the absence of a small intestinal lesion. The prevalence, risk factors and association with survival of POR after LCV are currently unknown.

OBJECTIVES: To determine the prevalence of POR in horses with an LCV and its association with survival. A further objective was to assess factors which may predict POR. The hypothesis was that horses with POR following LCV surgery have a worse outcome for survival compared to those without POR.

STUDY DESIGN: A retrospective cross-sectional study.

METHODS: Clinical data of client owned horses which underwent colic surgery at a single UK referral hospital between 2008 and 2021, where LCV was the primary finding, were retrieved from hospital records. Statistical analyses included chi-squared, t-tests and odds ratios (ORs). Horses with concurrent lesions, and those that did not survive past anaesthetic recovery, were excluded from analysis. POR was defined as ≥2 L of gastric reflux on at least one occasion.

RESULTS: A total of 128 horses were included in the study, 23 of which had POR (18%). Overall survival to hospital discharge was 86%, 95% in the non-POR and 44% in the POR group. Horses with POR were less likely to survive to discharge than those without (OR = 26, 95% confidence interval [CI] [7.68-88.0], p < 0.001), and less likely to be alive 3 years after surgery (OR = 13.4, 95% CI [2.78-64.8], p < 0.001).

MAIN LIMITATIONS: Due to the retrospective study design, full data sets were not available for every case because clinical records were incomplete or, at that time, certain tests were not performed or clinical variables were not measured.

CONCLUSIONS: POR in LCV cases is a negative prognostic indicator for survival.

PMID:38613156 | DOI:10.1111/evj.14095

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Mixed histiocytic neoplasms: A multicentre series revealing diverse somatic mutations and responses to targeted therapy

Br J Haematol. 2024 Apr 12. doi: 10.1111/bjh.19462. Online ahead of print.

ABSTRACT

Histiocytic neoplasms are diverse clonal haematopoietic disorders, and clinical disease is mediated by tumorous infiltration as well as uncontrolled systemic inflammation. Individual subtypes include Langerhans cell histiocytosis (LCH), Rosai-Dorfman-Destombes disease (RDD) and Erdheim-Chester disease (ECD), and these have been characterized with respect to clinical phenotypes, driver mutations and treatment paradigms. Less is known about patients with mixed histiocytic neoplasms (MXH), that is two or more coexisting disorders. This international collaboration examined patients with biopsy-proven MXH with respect to component disease subtypes, oncogenic driver mutations and responses to conventional (chemotherapeutic or immunosuppressive) versus targeted (BRAF or MEK inhibitor) therapies. Twenty-seven patients were studied with ECD/LCH (19/27), ECD/RDD (6/27), RDD/LCH (1/27) and ECD/RDD/LCH (1/27). Mutations previously undescribed in MXH were identified, including KRAS, MAP2K2, MAPK3, non-V600-BRAF, RAF1 and a BICD2-BRAF fusion. A repeated-measure generalized estimating equation demonstrated that targeted treatment was statistically significantly (1) more likely to result in a complete response (CR), partial response (PR) or stable disease (SD) (odds ratio [OR]: 17.34, 95% CI: 2.19-137.00, p = 0.007), and (2) less likely to result in progression (OR: 0.08, 95% CI: 0.03-0.23, p < 0.0001). Histiocytic neoplasms represent an entity with underappreciated clinical and molecular diversity, poor responsiveness to conventional therapy and exquisite sensitivity to targeted therapy.

PMID:38613141 | DOI:10.1111/bjh.19462

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Relationship between number of prior lumbar spine surgeries and outcomes following spinal cord stimulator implantation: A multisite, retrospective pooled analysis

Pain Pract. 2024 Apr 12. doi: 10.1111/papr.13371. Online ahead of print.

ABSTRACT

OBJECTIVES: Lumbar spine surgery is a common procedure for treating disabling spine-related pain. In recent decades, both the number and cost of spine surgeries have increased despite technological advances and modification in surgical technique. For those patients that have continued uncontrolled back and/or lower extremity pain following lumbar spine surgery, spinal cord stimulation (SCS) has emerged as a viable treatment option. However, the impact of lumbar spine surgical history remains largely unstudied. Specifically, the current study considers the impact of number of prior lumbar spine surgeries on pain relief outcomes following SCS implantation.

MATERIALS AND METHODS: We queried the electronic medical record of five separate pain practices for all patients who have undergone a SCS implant between January 1, 2017, and March 1, 2020. Inclusion criteria consisted of any patients with an SCS implant who underwent a prior lumbar spine surgery. The primary outcome was the mean calculated percentage pain relief in patients based on number of prior lumbar spine surgeries.

RESULTS: There was a total of 1974 total SCS implant cases identified across five separate pain clinics. There was no difference in mean calculated pain relief in patients with one prior spine surgery versus those with two or more prior spine surgeries (28.2% vs. 25.8%, adjusted β-coefficient -3.1, 95% CI -8.9 to 2.7, p = 0.290). Similarly, when analyzing number of spine surgeries as a continuous variable, there was no association between number of spine surgeries and calculated pain relief (adjusted β-coefficient -1.5, 95% CI -4.0 to 1.1, p = 0.257). Additionally, after patients were stratified based on waveform, there was no association between number of prior lumbar spine surgeries (analyzed both as a categorical and continuous variable) and calculated percentage pain relief.

CONCLUSIONS: This multicentered retrospective study found that there was no significant difference in pain scores in individuals who received SCS following one or more lumbar spine surgeries. Additionally, the waveform of the SCS device had no statistically significant impact on post-operative pain scores following one or more lumbar spine surgeries.

PMID:38613136 | DOI:10.1111/papr.13371

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Vitamin D Supplementation for Patients with Dysmenorrhoea: A Meta-Analysis with Trial Sequential Analysis of Randomised Controlled Trials

Nutrients. 2024 Apr 8;16(7):1089. doi: 10.3390/nu16071089.

ABSTRACT

Vitamin D reduces prostaglandin levels and inflammation, making it a promising treatment option for dysmenorrhoea. However, its effects on pain intensity in different types of dysmenorrhoea remain unclear. We examined whether vitamin D supplementation decreases pain intensity in patients with dysmenorrhoea. The Cochrane Library, Embase, Google Scholar, Medline, and Scopus databases were searched from inception to 30 December 2023. Randomised controlled trials (RCTs) evaluating vitamin D supplementation effects on such patients were included. The primary and secondary outcomes were measured by the changes in pain intensity and rescue analgesic use, respectively. Pooled mean differences and rate ratios were calculated using a random-effect model; trial sequential analysis (TSA) was also performed. Overall, 11 studies involving 687 participants were included. Vitamin D supplementation significantly decreased pain intensity in patients with dysmenorrhoea compared with controls (pooled mean difference, -1.64; 95% confidence interval, -2.27 to -1.00; p < 0.001; CoE, moderate; I2 statistic, 79.43%) and indicated substantial heterogeneity among the included studies. TSA revealed that the current RCTs provide sufficient information. In subgroup analyses, vitamin D supplement reduced primary dysmenorrhoea pain but not secondary dysmenorrhoea pain. In conclusion, although substantial heterogeneity persists, vitamin D supplementation decreased pain intensity in patients with dysmenorrhea, especially in those with primary dysmenorrhoea.

PMID:38613122 | DOI:10.3390/nu16071089

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The Risk of Oral Cancer and the High Consumption of Thermally Processed Meat Containing Mutagenic and Carcinogenic Compounds

Nutrients. 2024 Apr 7;16(7):1084. doi: 10.3390/nu16071084.

ABSTRACT

The International Agency for Research on Cancer has classified the consumption of heat-processed meat as a direct human carcinogen and the consumption of red meat as a probable carcinogen. Mutagenic and carcinogenic compounds present in meat dishes include, among others, polycyclic aromatic hydrocarbons (PAHs) and heterocyclic aromatic amines (HAAs). These compounds can cause the development of gastrointestinal cancer. Oral cancer is one of the world’s research priorities due to the ever-increasing incidence rate. However, the effect of diet on oral cancer is still a poorly recognized issue. The aim of this study was to assess the relationship between the risk of oral cancer and dietary ingredients with a particular emphasis on red meat and thermally processed meat. This study was conducted among patients with oral cancer in 2022 and 2023. The shortened standardized Food Frequency Questionnaire (FFQ) and a multivariate regression statistical analysis were used. The high consumption of red meat in general and thermally processed meat, especially smoked, fried, roasted and boiled, increases the risk of oral cavity cancer. Limiting the consumption of meat products and modifying the methods of preparing meat dishes may reduce exposure to carcinogenic compounds from the diet and thus reduce the risk of developing oral cancer.

PMID:38613117 | DOI:10.3390/nu16071084