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Shana B Traina,1 Susan D Mathias,2 Hilary H Colwell,2 Ross D Crosby,2–4 Charles Abraham5 1Patient-Reported Outcomes, Janssen Global Services, LLC, Raritan, NJ, USA; 2Health Outcomes Solutions, Winter Park, FL, USA; 3Biomedical Statistics & Methodology, Neuropsychiatric Research Institute, Fargo, ND, USA; 4Department of Clinical Neuroscience, University of North Dakota School of Medicine and Health Sciences, Grand Forks, ND, USA; 5Psychology Applied to Health, University of Exeter Medical School, Exeter, UK Background: This study assessed measurement properties of the 17-item Diabetes Intention, Attitude, and Behavior Questionnaire (DIAB-Q), which measures intention to engage in self-care behaviors, including following a diabetes diet and engaging in appropriate physical activity. Methods: The DIAB-Q includes questions based on the Theory of Planned Behavior. Items were developed using published literature, input from health care professionals, and qualitative research findings in patients with and without type 2 diabetes mellitus (T2DM). In Stage I of the study, 23 adults with T2DM were interviewed to evaluate the content and clarity of the DIAB-Q. In Stage II 1,015 individuals with T2DM completed the DIAB-Q and supplemental questionnaires, including the Short Form-36 acute (SF-36), section III of the Multidimensional Diabetes Questionnaire, the Summary of Diabetes Self-Care Activities questionnaire, and self-administered items relevant to the treatment and management of T2DM (eg, blood pressure and glycated hemoglobin [HbA1c]) at baseline and 3–7 days later. Once the DIAB-Q scale structure was determined, its test–retest reliability, construct validity, and known-groups validity were evaluated, and minimal clinically important change was estimated. Results: In Stage I, the 23 respondents surveyed generally reported that the DIAB-Q was clear and comprehensive and endorsed questions as relevant to their intentions to engage in diabetes-related self-care activities. Most subjects in Stage II were male, Caucasian, and married. Mean age was 63 years. Factor analysis revealed six psychological constructs (Behavior, Planning, Intention, Perceived Behavioral Control, Attitude, and Subjective Norm). Test–retest reliability was acceptable (≥0.70) for all scales, except Perceived Behavioral Control. Construct validity was demonstrated based on correlations with diabetes-specific items/scales and the SF-36. Known-groups validity was confirmed for Behavior, Planning, and Intention when respondents were categorized into groups that differed based on body mass index, disease severity, and HbA1c. Item scores were transformed to a 100-point scale, and minimal clinically important change estimates ranged from 6–11 points, representing the change that would be considered important to a respondent. Conclusion: The DIAB-Q is a brief, psychometrically sound, patient-reported outcome that can be used among individuals with T2DM to evaluate intention to engage in self-care behaviors. Keywords: diabetes, Theory of Planned Behavior, DIAB-Q, attitude, intention, behavior, patient-reported outcome, questionnaire

Shana B Traina,1 Hilary H Colwell,2 Ross D Crosby,2,3 Susan D Mathias2 1Janssen Global Services, LLC, Raritan, NJ, 2Health Outcomes Solutions, Winter Park, FL, 3Neuropsychiatric Research Institute and University of North Dakota School of Medicine and Health Sciences, Fargo, ND, USA Background: The concept of diabetes-related health satisfaction encompasses issues specifically related to living with diabetes (eg, blood glucose, blood pressure levels, body weight). Health satisfaction is more specific than overall health-related quality of life because it considers disease-related factors, and is different from diabetes treatment satisfaction because it addresses issues not specifically related to treatment. Low levels of health satisfaction in people with type 2 diabetes mellitus (T2DM) may negatively affect self-care behaviors and treatment outcomes; however, there are currently no instruments available to assess health satisfaction in this population. This study assessed the measurement properties of a newly constructed, 14-item Current Health Satisfaction Questionnaire (CHES-Q) designed to assess diabetes-related health satisfaction and knowledge of the disease and important laboratory results. Methods: In-depth interviews were conducted in 23 adults with T2DM to confirm the content and clarity of the CHES-Q. The revised instrument was administered to 1,015 individuals with T2DM, along with supplemental questionnaires, including the Short Form-36. All subjects completed the questionnaires again 3 to 7 days later. CHES-Q test-retest reliability, construct validity, and known-groups validity were evaluated. Results: In general, respondents found the CHES-Q to be clear and comprehensive. Test-retest reliability was generally acceptable for all items (≥0.70), except for three that fell just below the widely accepted cut-point of 0.70 (range 0.63–0.69). Convergent and divergent validity was demonstrated based on hypothesized correlations with the Short Form-36. Known-groups validity was confirmed for most CHES-Q items when respondents were split into groups known to differ clinically by body mass index, disease severity, or glycated hemoglobin. Conclusion: Health satisfaction is a unique and important concept to consider when developing individualized strategies for managing T2DM because health satisfaction is a key element of patient-centered care. The CHES-Q allows for the pragmatic assessment of many aspects of diabetes-related health satisfaction in a single questionnaire. Keywords: diabetes, health satisfaction, reliability, validity, Current Health Satisfaction Questionnaire, patient-reported outcomes

Many low-threshold experiments observe sharply rising event rates of yet unknown origins below a few hundred eV, and larger than expected from known backgrounds. Due to the significant impact of this excess on the dark matter or neutrino sensitivity of these experiments, a collective effort has been started to share the knowledge about the individual observations. For this, the EXCESS Workshop was initiated. In its first iteration in June 2021, ten rare event search collaborations contributed to this initiative via talks and discussions. The contributing collaborations were CONNIE, CRESST, DAMIC, EDELWEISS, MINER, NEWS-G, NUCLEUS, RICOCHET, SENSEI and SuperCDMS. They presented data about their observed energy spectra and known backgrounds together with details about the respective measurements. In this paper, we summarize the presented information and give a comprehensive overview of the similarities and differences between the distinct measurements. The provided data is furthermore publicly available on the workshop’s data repository together with a plotting tool for visualization.

Aims: The study aimed to adapt the original English-language oral health values scale (OHVS) to the Arabic culture and to test its psychometric properties., Methods: The original OHVS was translated into Arabic language and pre-tested using cognitive interviewing. The psychometric properties of Arabic OHVS were examined in a sample comprising 416 Libyan adults aged 18-70 years, recruited from the main public and private dental clinics in Benghazi. The participants' demographic information, oral health behaviour, perceived oral health, the Arabic version of the OHVS (A-OHVS), dental neglect scale, oral health-related quality of life, oral health literacy, simplified oral hygiene index (OHI-S), and decayed, missing, and filled teeth index (DMFT) were collected. Psychometric properties were tested using content validity, construct validity, discriminating validity, internal consistency, test-retest reliability, and floor as well as ceiling effects were examined., Results: The Arabic OHVS was successfully and smoothly developed. It showed an acceptable level of equivalence to the original version, The A-OHVS presented an overall Cronbach's Alpha of 0.74 and the average score was 40.02, ranging between 26 and 54. All hypotheses predefined to test construct validity were confirmed. The bivariate correlation between A-OHVS and other health indicators shows a significant positive correlation between A-OHVS and oral health literacy (p = 0.000). On the other hand, statistically significant negative correlations were observed between A-OHVS and dental neglect and quality of life (p ≤ 0.001) as well as DMFT and OHI-S (p ≤ 0.001). Floor or ceiling effects were not observed., Conclusions: The A-OHVS was shown to be a valid and reliable tool for assessing oral health values in the Arabic-speaking population.

Background: Cervical cancer is a major health problem in Latin America. In 2019, the Italian Agency for Development Cooperation (La Paz regional site) conducted a pilot study to estimate the prevalence of high-risk human papillomavirus (HPV) and the feasibility of HPV screening in Bolivia through self-sampling and portable and transportable laboratory instruments for HPV testing in urban and rural areas., Methods: Women aged 20-65 years from La Paz (urban area), Toro Toro (rural area), and Acasio (rural area) were enrolled in local public health centers between Dec 1, 2019, and June 30, 2021. Self-sampling was carried out with the Viba-Brush system (Rovers, Oss, Netherlands) and samples were preserved in ThinPrep containers (Hologic Corporation, San Diego, CA, USA). The GeneXpert system (Cepheid, Sunnyvale, CA, USA) for high-risk HPV testing detects HPV E6 and E7 DNA via real-time PCR in a mobile system of easy execution requiring minimal manual intervention. The system provides results in about 1 h. The hr- HPV prevalence data, overall and partial genotyping, were analyzed considering the following age groups: 20-34, 35-44, and 45-65 years old., Findings: 2168 women were enrolled: 614 (28.3%) in La Paz, 743 (34.3%) in Toro Toro, and 811 (37.4%) in Acasio. Only one sample was collected from each participant. 2043 (94.2%) of 2168 samples were adequate for HPV testing. 255 (12.5%) samples were positive for high-risk HPV. Comparing the urban area (La Paz) versus rural combined areas (Acasio+Toro Toro), using a logistic model, the HPV total rate was statistically significantly higher in the city of La Paz (15.0% vs 11.4%; OR:1.37;95% CI: 1.04-1.80). Furthermore, the HPV prevalence was declining by age, and the urban/rural odds ratio was 1.50; (95% IC 1.13-19). The overall HPV 16 positivity was 2.7% (55/2043) and for HPV 18/45 was 1.8% (37/2043) without any statistically significant differences between the three BHU enrolling centers. Only the prevalence of HPV group '39/56/66/68' was significantly higher in La Paz (p<0,001) in comparison to Acasio and Toro Toro., Interpretation: The total and age-adjusted prevalence of high-risk HPV infection in rural and urban areas in Bolivia, as measured with a validated test for screening, is similar to that observed in Europe and the USA. Our study shows that a screening protocol for HPV testing with self-sampling would be feasible in urban and rural areas in Bolivia, and that the reported high occurrence of cervical cancer in Bolivia is not related to a higher rate of high-risk HPV infections. Carrying out HPV tests locally avoids the issues associated with transportation and storage of the collected material and allows the participant to wait in the clinic for the test result, overcoming the very long response time for screening test in Bolivia., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Carozzi et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Medication adherence represents a complex and multifaceted process. Standardized terminology is essential to enable a reproducible process in various languages. The study's aim was to translate and adapt the original Ascertaining Barriers for Compliance (ABC) Taxonomy on medication adherence, first proposed in 2012, into Italian language. The study was carried out according to the Preferred Methods for Translation of the ABC Taxonomy for Medication Adherence adopted by the ESPACOMP. Key steps included: (1) a systematic literature review using PubMed and Embase according to the PRISMA Guidelines to identify published Italian terms and definitions, and Italian adherence experts; (2) a forward translation of terms and definitions; (3) panelists' selection; (4) a three-round Delphi survey. From the systematic review, 19 studies allowed detection of 4 terms, 4 definitions and 767 Italian experts. To these, Italian ESPACOMP members and experts though snowball sampling were added. The identified Italian adherence experts received the Delphi questionnaire. The Italian ABC Taxonomy was achieved after three rounds of Delphi survey by reaching at least a moderate consensus on unambiguous naming and definition of medication adherence-related terms. The Taxonomy is intended to be used in research, academic, and professional fields in order to harmonize adherence terminology and avoid confusion in comparing research findings., Competing Interests: The authors declare no conflict of interest. The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript; or in the decision to publish the results.

In a Drug Prescription Network (DPN), each drug is represented as a node and two drugs co-prescribed to the same patient are represented as an edge linking the nodes. The use of DPNs is a novel approach that has been proposed as a means to study the complexity of drug prescription. The aim of this study is to demonstrate the analytical power of the DPN-based approach when it is applied to the analysis of administrative data. Drug prescription data that were collected at a local health unit (ASL TO4, Regione Piemonte, Italy), over a 12-month period (July 2018-June 2019), were used to create several DPNs that correspond to the five levels of the Anatomical Therapeutic Chemical classification system. A total of 5,431,335 drugs prescribed to 361,574 patients (age 0-100 years; 54.7% females) were analysed. As indicated by our results, the DPNs were dense networks, with giant components that contain all nodes. The disassortative mixing of node degrees was observed, which implies that non-random connectivity exists in the networks. Network-based methods have proven to be a flexible and efficient approach to the analysis of administrative data on drug prescription.

Introduction: On the basis of reductions in diabetic kidney disease (DKD) progression and major adverse cardiovascular events observed in the landmark CREDENCE trial, canagliflozin 100 mg received an extension to its EU marketing authorisation in July 2020 to include the treatment of DKD in people with type 2 diabetes mellitus (T2DM) making it the first pharmacological therapy to receive regulatory authorisation for treatment of DKD since the RENAAL and IDNT trials in nearly 20 years. Efficient allocation of limited healthcare resources requires evaluation not only of clinical safety and efficacy but also economic consequences. The study aim was to estimate the cost-effectiveness of canagliflozin when added to current standard of care (SoC) versus SoC alone from the perspective of the NHS in England., Methods: A microsimulation model was developed using patient-level data from CREDENCE, including risk equations for the key clinical outcomes of start of dialysis, hospitalisation for heart failure, nonfatal myocardial infarction, nonfatal stroke, and all-cause mortality. DKD progression was modelled using estimated glomerular filtration rate and urinary albumin-to-creatinine ratio evolution equations. Risk for kidney transplant was sourced from UK-specific sources given the near absence of events in CREDENCE. Patient characteristics and treatment effects were sourced from CREDENCE. Unit costs (£2019) and disutility weights were sourced from the literature and discounted at 3.5% annually. The time horizon was 10 years in the base case, and sensitivity analysis was performed., Results: Canagliflozin was associated with sizable gains in life-years and quality-adjusted life-year (QALYs) over 10 years, with gains increasing with simulation duration. Cost offsets associated with reductions in cardiovascular and renal complications were sufficient to achieve overall net cost savings. The findings were generally confirmed in the sensitivity analyses., Conclusion: Model results suggest that adding canagliflozin 100 mg to SoC can improve patient outcomes while reducing overall net costs from the NHS perspective in England., Trial Registration: ClinicalTrials.gov identifier, NCT02065791.

Objectives: Prescription of proton pump inhibitors (PPIs) may be a source of potentially clinically relevant drug-drug interactions (DDIs) and related complications for elderly patients with complex polytherapy at discharge from hospital. The aim of the study was to identify, through the analysis of hospital discharge records, the co-administrations (PPIs + one or more drugs potentially generating DDIs) hypothetically leading to severe consequences according to the literature and online databases. Subsequently, alternatives to PPIs were evaluated for the treatment of gastric acidity and ulcers., Methods: The medical records of 1288 patients, discharged from a geriatric ward at the Città della Salute e della Scienza Hospital in Turin from January 2012 to December 2013, were collected in an Excel database for analysis of DDIs using the literature and online sources such as Micromedex. RESULTS : Six hundred and sixty-three of the 1288 clinical folders had a PPI prescription. A list of 18 drugs considered potentially hazardous and able to trigger a DDI when co-administrated with PPIs was drafted; the frequencies of the co-prescriptions of each PPI with one of the listed drugs were esomeprazole 65.38%, lansoprazole 52.87%, omeprazole 48.19% and pantoprazole 37.11%. An analysis of these co-prescriptions, according to Micromedex classification, gave a percentage of major interactions of 11.01% over 663 clinical folders including a PPI., Conclusions: This study provides a collection of potentially hazardous drug associations and helpful suggestions to improve the quality of prescriptions for elderly patients and strengthens the case for synergic work between doctors and pharmacists in the wards., Competing Interests: Competing interests: None declared., (© European Association of Hospital Pharmacists 2020. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: The medication process in the Neonatal Intensive Care Unit (NICU), can be challenging in terms of costs, time, and the risk of errors. Newborns, especially if born preterm, are more vulnerable to medication errors than adults. Recently, robotic medication compounding has reportedly improved the safety and efficiency of the therapeutic process. In this study, we analyze the advantages of using the I.V. Station ® system in our NICU, compared to the manual preparation of injectable drugs in terms of accuracy, cost, and time. Method: An in vitro experimental controlled study was conducted to analyze 10 injectable powdered or liquid drugs. Accuracy was calculated within a 5% difference of the bottle weight during different stages of preparation (reconstitution, dilution, and final product). The overall cost of manual and automated preparations were calculated and compared. Descriptive statistics for each step of the process are presented as mean ± standard deviation or median (range). Results: The median error observed during reconstitution, dilution, and final therapy of the drugs prepared by the I.V. Station ® ranged within ±5% accuracy, with narrower ranges of error compared to those prepared manually. With increasing preparations, the I.V. Station ® consumed less materials, reduced costs, decreased preparation time, and optimized the medication process, unlike the manual method. In the 10 drugs analyzed, the time saved from using the I.V. Station ® ranged from 16 s for acyclovir to 2 h 57 min for teicoplanin, and cost savings varied from 8% for ampicillin to 66% for teicoplanin. These advantages are also capable of continually improving as the total amount of final product increases. Conclusions: The I.V. Station ® improved the therapeutic process in our NICU. The benefits included increased precision in drug preparation, improved safety, lowered cost, and saved time. These advantages are particularly important in areas such as the NICU, where the I.V. Station ® could improve the delivery of the high complexity of care and a large amount of intravenous therapy typically required. In addition, these benefits may lead to the reduction in medication errors and improve patient and family care; however, additional studies will be required to confirm this hypothesis., (Copyright © 2019 Amodeo, Pesenti, Raffaeli, Sorrentino, Zorz, Traina, Magnani, Russo, Muscolo, Plevani, Mosca and Cavallaro.)

Background: Evidence from patient-reported outcomes in clinical trials may explain health-related behaviors observed in the real world., Objective: The purpose of this analysis was to evaluate the effect of treatment with canagliflozin, a sodium glucose co-transporter 2 inhibitor, compared with placebo or sitagliptin on health-related quality-of-life outcomes in participants with type 2 diabetes mellitus from the clinical development program., Methods: Patient-reported outcomes data from four randomized controlled trials of canagliflozin (n = 2536) were pooled and analyzed to evaluate participants' interest in continuing study medication; satisfaction with weight; and physical, mental, and emotional health after 26-52 weeks of treatment with canagliflozin vs. placebo or sitagliptin., Results: Upon trial completion, participants treated with canagliflozin were more likely to express interest in continuing study medication than participants treated with placebo or sitagliptin [odds ratio (95% confidence interval) of 1.54 (1.19-1.99); p = 0.001]. Those treated with canagliflozin were also more likely to be satisfied with their weight and report favorable outcomes (score improvement or maintenance of good scores) related to physical and emotional health., Conclusions: The results of this pooled analysis suggest that people with type 2 diabetes mellitus treated with canagliflozin generally had positive experiences with treatment and improvements in health-related quality of life. Future research is needed to determine if these improvements result in improved type 2 diabetes mellitus management and treatment adherence. CLINICALTRIALS., Gov Identifiers: NCT01106625, NCT01106677, NCT01137812, NCT02025907.

Wildland fire is an important ecological process in the California Sierra Nevada. Personal accounts from pre-20th century describe a much smokier environment than present day. The policy of suppression beginning in the early 20th century and climate change are contributing to increased megafires. We use a single particulate monitoring site at the wildland urban interface to explore impacts from prescribed, managed, and full suppression wildland fires from 2006 to 2015 producing a contextual assessment of smoke impacts over time at the landscape level. Prescribed fire had little effect on local fine particulate matter (PM 2.5 ) air quality with readings typical of similar non-fire times; hourly and daily good to moderate Air Quality Index (AQI) for PM 2.5 , maximum hourly concentrations 21-103 μg m -3 , and mean concentrations between 7.7 and 13.2 μg m -3 . Hourly and daily AQI was typically good or moderate during managed fires with 3 h and one day reaching unhealthy while the site remained below National Ambient Air Quality Standards (NAAQS), with maximum hourly concentrations 27-244 μg m -3 , and mean concentrations 6.7-11.7 μg m -3 . The large high intensity fire in this area created the highest short term impacts (AQI unhealthy for 4 h and very unhealthy for 1 h), 11 unhealthy for sensitive days, and produced the only annual value (43.9 μg m -3 ) over the NAAQS 98th percentile for PM 2.5 (35 μg m -3 ). Pinehurst remained below the federal standards for PM 2.5 when wildland fire in the local area was managed to 7800 ha (8-22% of the historic burn area). Considering air quality impacts from smoke using the NAAQS at a landscape level over time can give land and air managers a metric for broader evaluation of smoke impacts particularly when assessing ecologically beneficial fire. Allowing managers to control the amount and timing of individual wildland fire emissions can help lessen large smoke impacts to public health from a megafire., (Published by Elsevier Ltd.)

In past years, external dacryocystorhinostomy has been considered the gold standard in terms of functional outcome for treatment for nasolacrimal duct obstruction. In comparison, interest in the use of the recently developed endonasal dacyocystorhinostomy procedure has been rekindled because of advances in instrumentation. For the past 10 years, differences in the outcomes between the two techniques have been reduced; thus, currently, the choice of the type of surgery is associated with the experience of the surgeon, resources available in the healthcare system and patient preferences.

Two-week average concentrations of ozone (O3), nitric acid vapor (HNO3) and ammonia (NH3) were measured with passive samplers during the 2002 summer season across the central Sierra Nevada Mountains, California, along the San Joaquin River drainage. Elevated concentrations of the pollutants were determined with seasonal means for individual sites ranging between 62 and 88 ppb for O3, 1.0-3.8 microg m(-3) for HNO3, and 2.6-5.2 microg m(-3) for NH3. Calculated O3 exposure indices were very high, reaching SUM00-191 ppm h, SUM60-151 ppm h, and W126-124 ppm h. Calculated nitrogen (N) dry deposition ranged from 1.4 to 15 kg N ha(-1) for maximum values, and 0.4-8 kg N ha(-1) for minimum values; potentially exceeding Critical Loads (CL) for nutritional N. The U.S., California, and European 8 h O3 human health standards were exceeded during 104, 108, and 114 days respectively, indicating high risk to humans from ambient O3.

Pro has been shown to play an important role in ameliorating environmental stress in plants and microorganisms, including heavy metal stress. Here, we describe the effects of the expression of a mothbean delta(1)-pyrroline-5-carboxylate synthetase (P5CS) gene in the green microalga Chlamydomonas reinhardtii. We show that transgenic algae expressing the mothbean P5CS gene have 80% higher free-Pro levels than wild-type cells, grow more rapidly in toxic Cd concentrations (100 microM), and bind fourfold more Cd than wild-type cells. In addition, Cd-K edge extended x-ray absorption fine structure studies indicated that Cd does not bind to free Pro in transgenic algae with increased Pro levels but is coordinated tetrahedrally by sulfur of phytochelatin. In contrast to P5CS-expressing cells, Cd is coordinated tetrahedrally by two oxygen and two sulfur atoms in wild-type cells. Measurements of reduced/oxidized GSH ratios and analyses of levels of malondialdehyde, a product of the free radical damage of lipids, indicate that free Pro levels are correlated with the GSH redox state and malondialdehyde levels in heavy metal-treated algae. These results suggest that the free Pro likely acts as an antioxidant in Cd-stressed cells. The resulting increased GSH levels facilitate increased phytochelatin synthesis and sequestration of Cd, because GSH-heavy metal adducts are the substrates for phytochelatin synthase.

The distribution of aqueous Pb(II) sorbed at the interface between Burkholderia cepacia biofilms and hematite (alpha-Fe(2)O(3)) or corundum (alpha-Al(2)O(3)) surfaces has been probed by using an application of the long-period x-ray standing wave technique. Attached bacteria and adsorbed organic matter may interfere with sorption processes on metal oxide surfaces by changing the characteristics of the electrical double layer at the solid-solution interface, blocking surface sites, or providing a variety of new sites for metal binding. In this work, Pb L(alpha) fluorescence yield profiles for samples equilibrated with 10(-7) to 10(-3.8) M Pb(II) were measured and modeled to determine quantitatively the partitioning of Pb(II) at the biofilm-metal oxide interface. Our data show that the reactive sites on the metal oxide surfaces were not passivated by the formation of a monolayer biofilm. Instead, high-energy surface sites on the metal oxides form the dominant sink for Pb(II) at submicromolar concentrations, following the trend alpha-Fe(2)O(3) (0001) > alpha-Al(2)O(3) (1102) > alpha-Al(2)O(3) (0001), despite the greater site density within the overlying biofilms. At [Pb] > 10(-6) M, significant Pb uptake by the biofilms was observed.