Nevin Manimala

Appetite. 2023 Jan 8:106450. doi: 10.1016/j.appet.2023.106450. Online ahead of print.

ABSTRACT

Genetically modified (GM) foods have been assumed to be seen through intuitive and affective routes (i.e., affect heuristics) rather than analytical and deliberative routes. We examined the impact of the graphical presentation of benefits derived from GM or conventionally bred foods on the acceptance of these varieties. In the two experiments (n = 266 for study 1 and n = 402 for study 2), no differences emerged in the estimation of farmers’ benefits resulting from the introduction of improved varieties by the type of improvement. However, there was a statistically significant difference in the magnitude of risk and the degree of acceptance of the improved varieties. Therefore, despite presenting identical benefits as a graphical figure, GM foods were consistently evaluated as providing higher risk and were less frequently accepted than conventionally bred foods. These results suggest that while the graphical presentation of benefits may promote comprehension of some advantages of the introduction of GM varieties, this may not lead to acceptance from the consumer’s point of view. Based on the current findings, as well as previous studies on trust in risk managers, we discuss the specific factors that might promote acceptance of GM products.

PMID:36632936 | DOI:10.1016/j.appet.2023.106450

Contemp Clin Trials. 2023 Jan 9:107082. doi: 10.1016/j.cct.2023.107082. Online ahead of print.

ABSTRACT

BACKGROUND: Early in the pandemic, there were no evidence-based treatments for SARS-CoV-2, creating an urgent need to identify effective therapeutics. However, public participation in medical research is low; trial enrollment in the US is typically 10-20%. Thus, the aim of this study was to identify common themes underpinning patient reasons to decline participation and evaluate the impact of specific contextual factors.

METHODS: This sub-study was conducted in five VISN-1 Clinical Trials Network participating facilities from 4/10/2020-2/3/2021. The trial evaluated the addition of the IL-6-inhibitor, Sarilumab, to the current standard of care for inpatients with moderate-to-severe SARS-CoV-2. Consent procedures varied by site and included fully in-person and fully remote processes. Reasons for declining enrollment were collected among eligible patients who declined to participate but agreed to answer a short follow-up question. Qualitative data were analyzed using directed content analysis. Enrollment rates were assessed using simple, descriptive statistics.

RESULTS: N = 417 COVID-19 positive inpatients were screened and 53/162 eligible patients enrolled. Enrollment varied across study sites and by study period. Prior to identification of effective treatment, the enrollment rate was 10/11 (91%) versus 43/144 (30%) during the later period of the study. N = 85/102 patients who did not enroll answered the follow-up question. The most commonly reported responses were: concerns about the study drug and participation in clinical research in general, comorbidity concerns, competing priorities, external factors, and external advice and influence from family members and clinicians.

CONCLUSIONS: Identifying reasons behind declining to enroll may help investigators develop strategies to increase research participation.

PMID:36632925 | DOI:10.1016/j.cct.2023.107082

J Pharm Sci. 2023 Jan 9:S0022-3549(23)00003-5. doi: 10.1016/j.xphs.2023.01.001. Online ahead of print.

ABSTRACT

For systemically administered monoclonal antibodies (mAbs) with pharmacological targets in the epithelial lining fluid (ELF), information on the partitioning of mAb between plasma and ELF is instrumental for dose predictions. Bronchoalveolar lavage (BAL) combined with measurements of urea as indicator of sample dilution is often used to estimate ELF concentrations of a drug. However, unbalanced extraction of mAb and urea could potentially lead to a systematic bias in the back-calculated ELF concentration. In the present study 0.5, 1, or 4 mL phosphate-buffered saline was instilled to lungs of rats to obtain lavage samples after systemic dosing of mAb and tool small molecule (n≥4/group). Furthermore, extraction of urea, mAb and the small molecule was assessed by repeatedly lavaging the lung (n=4). There was no statistically significant difference in the calculated partitioning into ELF between the evaluated instillation volumes. Repeated BAL demonstrated that urea and the small molecule were extracted from other sources than the ELF. In contrast, there was limited to none in-flow of mAb into the lavage fluid. The unbalanced extraction of urea and mAb could theoretically result in underestimated ELF concentrations and the calculated partitioning of 0.17±0.062 might therefore constitute a lower boundary for the true partitioning.

PMID:36632919 | DOI:10.1016/j.xphs.2023.01.001

Int J Infect Dis. 2023 Jan 9:S1201-9712(22)00683-X. doi: 10.1016/j.ijid.2022.12.044. Online ahead of print.

ABSTRACT

BACKGROUND: The COVID-19 pandemic had a disruptive impact on tuberculosis (TB) and HIV services. We assessed the in-hospital TB diagnostic care among people with HIV (PWH) overall, before and during the pandemic.

METHODS: In this prospective study, adult PWH admitted at three hospitals in Ghana were recruited if they had a positive World Health Organization four-symptom screen (W4SS), or one or more WHO danger signs or advanced HIV. We collected data on patient characteristics, TB assessment and clinical outcomes after 8 weeks and used descriptive statistics and survival analysis.

RESULTS: We enrolled 248 PWH with a median CD4 count of 80.5 cells/mm³ (IQR 24-193). Of those, 246 (99.2%) patients had a positive W4SS. Overall, 112 (45.2%) patients obtained a sputum Xpert result, 66 (46.5%) in the pre-pandemic and 46 (43.4%) in the pandemic period, p=0.629. The TB prevalence of 46/246 (18.7%) was similar in the pre-pandemic 28/140 (20.0%) and pandemic 18/106 (17.0%) population, p=0.548. The 8 weeks all-cause mortality was 62/246 (25.2%) with no difference in cumulative survival when stratifying for pandemic period, log-rank p=0.412.

CONCLUSIONS: The study highlighted a large gap in access to TB investigation and high early mortality among hospitalized PWH, irrespective of the COVID-19 pandemic.

PMID:36632893 | DOI:10.1016/j.ijid.2022.12.044

Photodiagnosis Photodyn Ther. 2023 Jan 8:103275. doi: 10.1016/j.pdpdt.2023.103275. Online ahead of print.

ABSTRACT

PURPOSE: to detect the effect of various types of COVID-19 vaccine on macular and optic disc microvasculature.

METHOD: one hundred subjects receiving various types of COVID-19 vaccine (AstraZeneca, Sinopharm, Sinovac, Pfizer, and Moderna) were included in this study. A complete ophthalmic examination was done which included best-corrected visual acuity measurement, slit-lamp biomicroscopy, intraocular pressure measurement with Goldmann applanation tonometry, and fundus examination. Optical coherence tomography angiography (OCT-A) was done before and 1 week after receiving the vaccine. Superficial and deep macular capillary densities were measured in the form of the whole image, fovea, parafoveal, and perifoveal capillary density. Optic disc vessel density in the form of the whole disc, inside disc, and peripapillary were also measured.

RESULTS: The superficial macular vessel densities, (whole image, fovea, parafoveal, and perifoveal) showed statistically non-significant changes with P-values (0.269, 0.167, 0.346, and 0.476) respectively. Also, the deep macular vessel densities showed statistically non-significant changes with P-values (0.491, 0.096, 0.724, and 0.386) for the whole image, fovea, parafoveal, and perifoveal respectively. Moreover, RPC (radial peripapillary capillary) density showed no significant changes either (the whole disc, inside disc, or peripapillary) with P-values (0.807, 0.141, 0.883) respectively.

CONCLUSION: various types of COVID-19 vaccines had no statistically significant effects on macular or optic disc microvasculature.

PMID:36632871 | DOI:10.1016/j.pdpdt.2023.103275

Am J Epidemiol. 2023 Jan 11:kwad010. doi: 10.1093/aje/kwad010. Online ahead of print.

ABSTRACT

Ensuring that patients with opioid use disorder (OUD) have access to optimal medication therapies is a critical challenge in substance use epidemiology. The paper by Rudolph et al. (Am J Epidemiol. 2022; XXX(X):XXXX-XXXX) demonstrated that sophisticated data-adaptive statistical techniques can be used to learn optimal, individualized treatment rules which can aid providers in choosing a medication for opioid use disorder (MOUD) treatment modality for a particular patient. This important work also highlights the effects of the mathematization of epidemiologic research. Here, we define mathematization and demonstrate how it operates in the context of MOUD effectiveness research using the paper by Rudolph et al. as a springboard. In particular, we address the normative dimension of mathematization, and how it tends to resolve a fundamental tension in epidemiologic practice between technical sophistication and public health considerations in favor of more technical solutions. The process of mathematization is a fundamental part of epidemiology; we argue not for eliminating it but for balancing mathematization and technical demands equally with practical and community-centric public health needs.

PMID:36632844 | DOI:10.1093/aje/kwad010

Ren Fail. 2023 Dec;45(1):2158103. doi: 10.1080/0886022X.2022.2158103.

ABSTRACT

BACKGROUND: Immune-inflammatory biomarkers (IIBs) have been shown to be correlated with prognosis in patients undergoing peritoneal dialysis (PD). In this study, we aimed to evaluate the relationship between a novel comprehensive biomarker, the pan-immune-inflammation value (PIV), and the prognosis of patients undergoing PD.

METHODS: We retrospectively analyzed data from a multicenter, large-sample PD database. PIV was calculated as (neutrophil count × platelet count × monocyte count)/lymphocyte count. The prognostic endpoints in this study were all-cause death all-cause, cardiovascular disease (CVD) and infection-related death. The Kaplan-Meier method, a Cox proportional hazards regression, Fine-Gray competing risk model, smooth curve, and subgroup analysis were used to analyze the independent relationship between PIV and the prognosis of patients undergoing PD.

RESULTS: A total of 2796 cases of PD were included, and the study population was divided into Tertiles 1, 2, and 3, according to the tertiles of baseline PIVs. After adjusting for multiple model factors, patients in the Tertile 3 group had a significantly higher risk of all-cause death, CVD death and infection-related death compared with patients with PIV in the Tertile 1 group. Interaction tests showed no positive correlations for subgroup parameters. Regarding all-cause death, compared with the lowest tertile, the multivariable-adjusted hazard ratios (95% confidence intervals) of the highest and middle tertiles were 1.55 (1.25-1.94) and 1.77 (1.43-2.19), respectively; PIV (log2 processing) was associated with 17% excess of mortality in the continuous model.

CONCLUSIONS: A high PIV at baseline was significantly associated with an increased risk of deaths due to all-causes, CVD and infection in patients undergoing PD.

PMID:36632816 | DOI:10.1080/0886022X.2022.2158103

Radiat Prot Dosimetry. 2023 Jan 11:ncac297. doi: 10.1093/rpd/ncac297. Online ahead of print.

ABSTRACT

With an objective to establish adult diagnostic reference levels in the practice of nuclear medicine (NM) in the state of Tamil Nadu (TN), data on the predominant NM procedures carried out in the state are analyzed. In this study, data on total NM diagnostic procedures during the years 2015-19 along with patient-specific diagnostic NM procedure data for the period April-June 2021 from all centers in Tamil Nadu are collected and analyzed using SPSS statistical software. Nine predominant types of NM scans are analyzed. Collective effective dose from NM scans and per capita dose for the TN population are estimated. The 75th percentile of the distribution and average administered activity (AAA) has been derived and local reference levels are reported. Based on the statistical analysis, it is observed that the whole-body positron emission tomography (PET), renal diethylenetriamine pentaacetate (DTPA) scan, bone methylene diphosphonate (MDP) scan, iodine-131 whole body scan, thyroid studies using Technetium per technetate, renal dimercaptosuccinic acid (DMSA), myocardial perfusion methoxyisobutyl isonitrile sestamibi (MIBI), mebrofenin, Galium-68 prostate-specific membrane antigen (PSMA) are the most common procedure covering >90% of the practices carried out. The collective effective dose is 410 man-Sv in the year 2019, leading to a mean effective dose of 0.006 mSv per capita of the TN state population. The 75th percentile of the distribution of AA is slightly higher than diagnostic reference level (DRL) as compared with Australian DRL (310 MBq). It is also observed that F-18 PET procedures are primarily responsible for most of the collective effective dose, local DRL is 316 MBq and it is important to establish national DRLs for NM diagnostic scans to optimize the NM examinations.

PMID:36632802 | DOI:10.1093/rpd/ncac297

Vet Med Sci. 2023 Jan 12. doi: 10.1002/vms3.1045. Online ahead of print.

ABSTRACT

BACKGROUND: Gastrointestinal foreign bodies are a common indication for abdominal exploratory surgery.

OBJECTIVES: The objective of this study was to evaluate the relationship of pre-operative abdominal discomfort and duration of clinical signs with surgical resolution of canine small intestinal foreign body obstructions (SIFBO).

METHODS: We performed a retrospective study of 181 canine abdominal exploratory surgeries for confirmed SIFBO at two referral hospitals. Animals were categorized into five surgical groups (gastrotomy after manipulation into the stomach, enterotomy, resection-and-anastomosis [R&A], manipulated into colon, already in colon) and further grouped by whether entry into the gastrointestinal tract (GIT) was required.

RESULTS: Abdominal discomfort was noted in 107/181 cases (59.1%), but no significant differences in abdominal discomfort rates were present among the surgical groups or between GIT entry and no entry groups. Clinical sign duration was associated with surgical procedure; median durations were R&A = 3 days (range, 1-9), enterotomy = 2 days (range, 1-14), gastrotomy = 2 days (range, 1-6), already in colon = 1.5 days (range, 1-2), and manipulated into colon = 1 day (range, 1-7). In a pairwise comparison, differences in the duration of clinical signs were found for obstructions manipulated into the colon versus R&A, gastrotomy versus R&A, and in colon versus R&A. When patients were grouped according to GIT entry, cases with entry had a longer duration of clinical signs (median = 2 days [range, 1-14] versus 1 day [range, 1-7], respectively).

CONCLUSIONS: Abdominal discomfort was not associated with surgical complexity; however, the duration of clinical signs was associated with surgical complexity, with longer duration being associated with entry into the GIT and R&A. Despite statistical significance, the maximum difference of 2 days between surgical groups is unlikely to be clinically relevant.

PMID:36632768 | DOI:10.1002/vms3.1045

Curr Med Res Opin. 2023 Jan 12:1-25. doi: 10.1080/03007995.2023.2165814. Online ahead of print.

ABSTRACT

BACKGROUND: The pharmaceutical industry requires a highly qualified workforce with diverse skillsets. Medical affairs pharmaceutical physicians (MAPPs) have unique qualifications among pharmaceutical company employees, but the exact contribution of their education and training is unknown. This study aimed to identify the medical education and training competencies MAPPs use in the pharmaceutical industry in relation to the four external stakeholders, regulators, payors, prescribers, and patients.

METHOD: Ten MAPPs were recruited using convenience sampling via professional networks. A systematic literature review and the Jandhyala method, a two-stage qualitative online consensus method, identified which of MAPPs’ medical education and training competencies they used in their work with each external stakeholder. Statistical analyses determined heterogeneity in the relevance of competencies and competency categories to each stakeholder.

RESULTS: Nine MAPPs completed the study. Of the 59 competencies identified, 54 were relevant to all external stakeholders. Relevance of competencies varied significantly between external stakeholders (p = 0.0434). Binary competency scores varied significantly for three pairs of stakeholders, ‘patient vs payor’ (p = 0.025), ‘prescriber vs regulator’ (p = 0.013) and ‘prescriber vs payor’ (p = 0.008). Between-stakeholder overall frequency count varied significantly for two of the nine competency categories.

CONCLUSION: MAPPs develop a highly specialized set of competencies during medical education and training from which they use distinct subsets to meet the needs of external stakeholders in the pharmaceutical industry. Undergraduate and postgraduate competency-based medical education appears to prepare MAPPs for cognitive and technical work. Further exploration may aid understanding of how they develop soft skills.

PMID:36632732 | DOI:10.1080/03007995.2023.2165814