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Aims: To present opportunities and a model to redress the under‐representation of rural communities and people in Australian clinical trials. Context: Clinical trials are essential for building and understanding the health evidence base. The lack of representation of rural people in clinical trials is evident in other countries. Examining the Australian New Zealand Clinical Trial Registry (ANZCTR) suggests this is also the case in Australia. Approach: We propose an approach that empowers rurally based academics and clinicians to co‐design clinical trials and increase rural Australians' participation in clinical trials to address this inequality of access. A case study of a decentralised, co‐designed clinical trial is presented to support this approach. Conclusion: Decentralising clinical trials could improve access to clinical trials, strengthen the social capital of rural communities and help address the health inequalities that exist between rural and metropolitan communities. [ABSTRACT FROM AUTHOR]

(1) Background: Continuous growth in pharmaceutical expenditure indicates the need for more advanced pharmacoeconomics evaluations to optimize healthcare outcomes and resource allocation. This study assesses the extent to which accredited pharmacy colleges in the United States cover pharmacoeconomics content within the didactic curriculum of their Doctor of Pharmacy (PharmD) programs. (2) Methods: We conducted a systematic search of the websites of accredited professional-degree programs in pharmacy schools located in the United States to identify pertinent content related to pharmacoeconomics. (3) Results: Out of 141 pharmacy programs, a total of 111 programs of varying sizes were found to have publicly accessible information regarding the content of their pharmacoeconomic curricula on their websites. All these programs required the inclusion of pharmacoeconomics content in their curricula. An examination of course syllabi revealed that the goals and descriptions were broad, aiming to provide students with an introductory understanding of the principles of pharmacoeconomics. The number of credit hours allocated to pharmacoeconomics education ranged from one to seven across the programs. The approach to delivering pharmacoeconomics content varied among the programs. (4) Conclusions: Advanced knowledge of the principles of pharmacoeconomics must be an integral component of all PharmD curricula to prepare pharmacists to assess the rational use of pharmacy products and services, improve clinical outcomes, and mitigate healthcare expenditures. [ABSTRACT FROM AUTHOR]

Background: Anticoagulation significantly reduces the risk of ischaemic stroke in patients with atrial fibrillation (AF). There are a proportion of patients with known AF who remain off anticoagulation. Aims This study aims to retrospectively compare the baseline characteristics, treatments and functional outcomes between patients with ischaemic stroke and known AF based on their anticoagulation status. Methods: A single‐centre, retrospective review of consecutive patients with an ischaemic stroke and a known history of AF was conducted. Results: Two hundred four patients with an ischaemic stroke had documented AF prior to the index admission, of which 126 were anticoagulated. Median admission National Institutes of Health Stroke Scale score was lower for anticoagulated patients, though not statistically significant (5.1 vs 7.0, P = 0.09). Median baseline modified Rankin score (mRS) did not significantly differ. Nonanticoagulated patients were more likely to have large vessel occlusions (37.2% vs 23.8%, P = 0.04) and more likely to receive intravenous thrombolysis (15.4% vs 1.6%, P < 0.01). There was no difference in rates of endovascular clot retrieval between groups (P > 0.05). Unfavourable functional outcome at 90 days (mRS ≥ 3) did not significantly differ between groups (P = 0.51). A total of 38.5% of nonanticoagulated patients had no documented reason for this. Of the patients who survived the index admission, 81.5% of patients who were not anticoagulated on admission received anticoagulation. Conclusions: Baseline anticoagulation was associated with milder stroke severity in ischaemic stroke patients with known AF. There was no significant difference in functional outcomes at 90 days between groups. Larger observational studies are required to further assess this cohort. [ABSTRACT FROM AUTHOR]

• -We described the evolution of use and cost of antiseizure medications (ASMs) in USA privately-insured patients between 2006 and 2021. • -The proportion of generic ASM use increased 3.6-fold: from 23 % of prescription days in 2006 to 83 % of prescription days in 2021. • -The median inflation-adjusted average wholesale price (AWP) per person-year increased by 102 % from $2684 in 2006 to $5417 in 2021. • -The increased use of generic ASMs helped buffer the growing costs of brand-name ASMs. • -The current proportion of generics (83 %) leaves little room to further contain costs by just increasing the proportion of generic use. To describe the evolution in use and cost of antiseizure medications (ASM) in the United States of America (USA). Retrospective descriptive study using the IBM MarketScan Commercial Database (data of privately-insured patients) for the years 2006 to 2021. We identified patients with epilepsy who were on ASM. We adjusted cost for inflation with the Gross Domestic Product Implicit Price Deflator. We evaluated 347,158 patients (46.9 % males; median (p 25 -p 75) age: 33 (17–49) years; 28 % with pediatric-onset epilepsy and 72 % with adult-onset epilepsy) with a total of 1,385,382 person-years and 588,285,065 ASM prescription days. The most commonly prescribed (as percentage of prescription days) ASMs in 2006 were valproate (18 %) and lamotrigine (17 %) in pediatric-onset epilepsy and phenytoin (21 %) and carbamazepine (17 %) in adult-onset epilepsy, but starting in the 2010s, levetiracetam and lamotrigine became the most commonly prescribed ASMs in both pediatric-onset (in 2021, levetiracetam 25 %, lamotrigine 16 %) and adult-onset (in 2021, levetiracetam 27 %, lamotrigine 20 %) epilepsy. The proportion of generic ASM use increased 3.6-fold: from 23 % of prescription days in 2006 to 83 % of prescription days in 2021. The median (p 25 -p 75) average wholesale price (AWP) per person-year increased by 102 % from $2,684 ($990-$5,509) in 2006 to $5,417 ($2,858-$12,310) in 2021. The increases were greater in absolute terms for brand-name ASMs by 419 %: $3,109 ($1,564-$5,068 in 2006 and $16,149 ($12,950-$23,377) in 2021 than for generic ASMs by 462 %: $699 ($457-$1,678) in 2006 and $3,931 ($2,618-$6,081) in 2021. The costs directly borne by the patient (copay, coinsurance, deductibles, and pharmacy processing fees) increased by 69 % for brand-name ASMs from $393 ($246-$570) in 2006 to $665 ($335-$1,308) in 2021, but decreased by 37 % for generic ASMs from $147 ($98-$213) in 2006 to $92 ($51-$141) in 2021. The median cost of ASMs per person-year approximately doubled from 2006 to 2021. The increase in use of generic ASMs probably helped buffer the growing costs of ASMs. However, generic ASMs already represent 83 % of prescription days in 2021, with limited room to further contain costs by just increasing the proportion of generics. [ABSTRACT FROM AUTHOR]

Lesbian, gay, bisexual, transgender, queer, intersex, asexual, aromantic, and other sexual and/or gender minority (LGBTQIA+) communities are underrepresented in health research and subject to documented health disparities. In addition, LGBTQIA+ communities have experienced mistreatment, discrimination, and stigma in health care and health research settings. Effectively engaging LGBTQIA+ communities and individuals in health research is critical to developing representative data sets, improving health care provision and policy, and reducing disparities. However, little is known about what engagement approaches work well with LGBTQIA+ people. This paper describes the development of PRIDEnet (pridenet.org), a national network dedicated to catalyzing LGBTQIA+ community involvement in health research and built upon well-established community-engaged research (CEnR) principles. PRIDEnet’s relationship building and digital communications activities engage thousands of LGBTQIA+-identified people across the country and offer multiple low-threshold ways to participate in specific studies and shape research. These activities comprise a CEnR infrastructure that engages LGBTQIA+ people on behalf of other projects, primarily The PRIDE Study (pridestudy.org) and the National Institutes of Health’s All of Us Research Program (joinallofus.org/lgbtqia). Our impact, results, and lessons learned apply to those engaging communities underserved in biomedical research and include: the importance of building adaptable infrastructure that sustains transformational relationships long-term; implementing high-touch activities to establish trust and broad-reach activities to build large data sets; nurturing a team of diverse professionals with lived experiences that reflect those of the communities to be engaged; and maintaining CEnR mechanisms that exceed advice-giving and result in substantive research contributions from beginning to end.

Genetic disorders are a leading contributor to mortality in neonatal and pediatric intensive care units (ICUs). Rapid whole-genome sequencing (rWGS)-based rapid precision medicine (RPM) is an intervention that has demonstrated improved clinical outcomes and reduced costs of care. However, the feasibility of broad clinical deployment has not been established. The objective of this study was to implement RPM based on rWGS and evaluate the clinical and economic impact of this implementation as a first line diagnostic test in the California Medicaid (Medi-Cal) program. Project Baby Bear was a payor funded, prospective, real-world quality improvement project in the regional ICUs of five tertiary care children's hospitals. Participation was limited to acutely ill Medi-Cal beneficiaries who were admitted November 2018 to May 2020, were

Objective: The primary aim is to explore rural clinicians' self‐reported knowledge, skills and attitudes in the decision‐making process for requesting aeromedical retrieval of patients with suspected appendicitis. A secondary aim is to understand the supports and barriers of rural clinicians experience in this clinical scenario. Setting: Clinician interviews conducted face‐to‐face in three rural hospitals in Central Queensland. Participants: Rural doctors and nurses. Design: A five‐part qualitative content analysis. Results: The majority of 44 participants identified the strong and effective teamwork. The decision to request aeromedical retrieval was a shared, joint process and identified a supportive collegial culture which supported the asking of questions and not expecting to have all the answers. Perceived barriers were lack of receiving clinicians understanding of transfer agreements, and data connectivity. Clinician pessimism was identified for perceived patient outcomes. Discussion Effective teamwork can nurture trust and collaboration across multiple health service roles. High job satisfaction may counter the physical isolation in some rural environments. Fragmentation of care is the unintended consequence of interhospital transfer and may impact rural clinicians' perception of patients' outcomes and hinder receiving clinicians' understanding of rural service limitations. Conclusion: Future work in the area of linked electronic medical records could remove a barrier for rural clinicians and improve their reflective practice by challenging their perception of definitive patient outcomes. Increased awareness by receiving clinicians of the limitation of rural services, may minimize communication barriers and thereby, improve timely patient care transfers. [ABSTRACT FROM AUTHOR]

Purpose of Review: Following cardiac transplantation, patients have an increased risk of developing cardiac allograft vasculopathy and atherosclerotic cardiovascular disease. Therefore, aggressive lipid management is indicated. Some patients do not achieve optimal lipid profiles with statin monotherapy, however, or discontinue statins due to intolerance. In this review, we investigated the use of PCSK9 inhibitors as an alternative treatment for hyperlipidemia following cardiac transplantation. Recent Findings: Nine published articles were identified that included 110 patients treated with alirocumab or evolocumab after cardiac transplantation. PCSK9 inhibitors were tolerated by all patients, and each study demonstrated an effective reduction of low-density lipoprotein ranging from 40 to 87% decrease from baseline. Summary: In our study, the 110 patients from literature review were added to a cohort of 7 similar patients from our institution for combined analysis. This report supports that PCSK9 inhibitors should be considered following cardiac transplantation when conventional medial therapy is not tolerated or ineffective. [ABSTRACT FROM AUTHOR]

(1) Background: Continuous growth in pharmaceutical expenditure indicates the need for more advanced pharmacoeconomics evaluations to optimize healthcare outcomes and resource allocation. This study assesses the extent to which accredited pharmacy colleges in the United States cover pharmacoeconomics content within the didactic curriculum of their Doctor of Pharmacy (PharmD) programs. (2) Methods: We conducted a systematic search of the websites of accredited professional-degree programs in pharmacy schools located in the United States to identify pertinent content related to pharmacoeconomics. (3) Results: Out of 141 pharmacy programs, a total of 111 programs of varying sizes were found to have publicly accessible information regarding the content of their pharmacoeconomic curricula on their websites. All these programs required the inclusion of pharmacoeconomics content in their curricula. An examination of course syllabi revealed that the goals and descriptions were broad, aiming to provide students with an introductory understanding of the principles of pharmacoeconomics. The number of credit hours allocated to pharmacoeconomics education ranged from one to seven across the programs. The approach to delivering pharmacoeconomics content varied among the programs. (4) Conclusions: Advanced knowledge of the principles of pharmacoeconomics must be an integral component of all PharmD curricula to prepare pharmacists to assess the rational use of pharmacy products and services, improve clinical outcomes, and mitigate healthcare expenditures.

Little is known about the general public's perceptions regarding community pharmacist-delivered naloxone services at the national level. Accordingly, the purpose of this study was to describe the US general public's awareness, knowledge, beliefs, comfort, perceived barriers, abilities, and communication preferences related to community pharmacy-based naloxone services. A national, online cross-sectional survey was conducted in September 2021 among US adults ≥18 years recruited via Amazon Mechanical Turk (MTurk). Primary outcome measures were assessed via 5-point Likert-type scales, including: (1) naloxone awareness and knowledge; (2) naloxone beliefs; (3) comfort with pharmacist-provided naloxone; (4) perceived barriers to pharmacy-based naloxone; (5) opioid overdose competencies, concerns, and readiness; and (6) preferred pharmacist-patient naloxone communication strategy. Analyses included descriptive statistics and logistic regression models to assess predictors of preferred communication strategies. Of 301 respondents, 82.1% were White, 48.8% female, and mean 43 years. Eighty-five percent were unaware of pharmacy-provided naloxone and mean [SD] knowledge score was low (29.3% [16.8]). Mean [SD] beliefs (3.78 [0.61]) and comfort (3.70 [0.54]) were positive, while perceived barriers were low/neutral (2.93 [0.78]). For communication, 54% preferred general advertisement, 32.9% universal offer, and 13.3% targeted offer. The odds of preferring a general advertisement or universal offer over a targeted offer increased with greater awareness (AOR:4.52; p = 0.003) and comfort (AOR:3.79; p = 0.003), and decreased with greater competence (AOR:0.35; p = 0.001). Although awareness and knowledge regarding community pharmacy-based naloxone services was low, beliefs and comfort were positive and perceived barriers were low/neutral. General or universal offers of naloxone were preferred over targeted approaches. Future studies should test the impact of communication strategies on naloxone uptake. [ABSTRACT FROM AUTHOR]

Introduction: Little is known about racial differences in inpatient outcomes following hospitalizations for myasthenia gravis (MG). In this study, we used a claims-based database to assess racial differences in outcomes in hospitalized myasthenics. Methods: The 2006–2014 National Inpatient Sample database was queried using the International Classification of Diseases 9th Edition diagnosis code (358.01) to identify adult patients (age >17 years) undergoing hospitalization for MG. Race was categorized into – white, black/African American (AA), Asian or Pacific Islander, Hispanic, Native American, and other. Complications assessed included urinary tract infections, acute renal failure, cardiac complications, systemic infection, deep venous thrombosis, and pulmonary embolism. Multivariate logistic regression analyses were used to assess whether race was associated with a difference in outcomes, after controlling for baseline demographics, hospital characteristics, and treatment factors. Results: A total of 56,189 patient admissions, using a weighted sample, underwent hospitalization for MG between 2006 and 2014. Black/AA patients had significantly higher odds of experiencing systemic infections (odds ratio [OR] 1.35 [95% confidence intervals [CI] 1.16–1.58]; p < 0.001), deep venous thrombosis (OR 2.11 [95% CI 1.36–3.27]; p = 0.001), and renal failure (OR 1.19 [95% CI 1.05–1.35]; p = 0.005). Black/AA patients were more likely to be intubated (OR 1.09 [95% CI 1.01–1.19]; p = 0.028) and receive noninvasive mechanical ventilation (OR 1.62 [95% CI 1.46–1.79]; p < 0.001), however, were less likely to receive intravenous immunoglobulin (OR 0.77 [95% CI 0.73–0.82]; p < 0.001) and plasmapheresis (OR 0.77 [95% CI 0.72–0.82]; p < 0.001). Black/AA and Hispanic patients had lower mortality (OR 0.74 [95% CI 0.59–0.94; p = 0.012]. Conclusions: Significant racial differences exist in both treatment utilization and inpatient outcomes for patients hospitalized for MG. [ABSTRACT FROM AUTHOR]

Purpose: Hemophilia A is a rare bleeding disorder that leads to recurrent hemarthrosis, which can ultimately result in reduced mobility and poor quality of life. Qualitative exit interviews provide insights into patient perspectives and support the interpretation of quantitative trial data, such as patient-reported outcome measures. In the Phase 3 XTEND-1 study (NCT04161495) of efanesoctocog alfa in participants with severe hemophilia A, exit interviews were conducted to understand pre- and post-study experiences with pain and physical functioning and to evaluate participants' treatment experiences., Methods: In XTEND-1, participants (≥12 years old) received once-weekly efanesoctocog alfa prophylaxis 50 IU/kg for 52 weeks (Arm A) or on-demand efanesoctocog alfa 50 IU/kg for 26 weeks followed by 26 weeks once-weekly prophylaxis (50 IU/kg; Arm B). Optional qualitative exit interviews were conducted using a semi-structured guide in a subset of participants following study completion. Interviews included open-ended questions about participants' pre- and post-study experiences with hemophilia A and targeted questions relating to improvements in patient-reported outcomes assessed during XTEND-1, including the Haemophilia Quality of Life Questionnaire for Adults Physical Health subscale (Haem-A-QoL PH). Content validity of the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity 3a measure was also assessed, particularly the worst pain item., Findings: Exit interviews were conducted with 29 of 159 patients enrolled in XTEND-1 (mean [range] age 40 [16-73] years). Of 17 participants enrolled in Arm A, 13 (76.5%) reported a "wearing off" feeling with pre-study treatment, including more aches/pain, breakthrough bleeds, and limited physical activities. Joint pain was the most reported pre-study symptom (96.6%; n = 28/29), followed by a reduced ability to move without pain (89.7%, n = 26/29). Improvements following efanesoctocog alfa prophylaxis in ≥1 Haem-A-QoL PH domain were reported by 89.7% (n = 26/29) of participants, with improvements in joint pain, the ability to move without pain, and painful swellings reported by at least 21 (84%) participants. Participants reported that the PROMIS Pain Intensity 3a items were relevant, clear, and easy to answer. Most participants (96.6%) were "quite satisfied" or "very satisfied" with efanesoctocog alfa prophylaxis. All participants preferred efanesoctocog alfa over pre-study treatment., Implications: The exit interviews demonstrated that once-weekly efanesoctocog alfa prophylaxis resulted in patient-relevant and meaningful improvements in pain and physical functioning, consistent with the quantitative findings from XTEND-1. These results support the validity of the Haem-A-QoL PH and PROMIS Pain Intensity 3a assessed during XTEND-1, demonstrating the potential for change with efficacious treatment., Trial Registry: ClinicalTrials.gov TRIAL REGISTRATION NUMBER: NCT04161495 REGISTRY URL: https://clinicaltrials.gov/study/NCT04161495., Competing Interests: Declaration of competing interest Dana DiBenedetti is a full-time employee of RTI Health Solutions, an independent non-profit research organization, which was retained by Sanofi to conduct the research which is the subject of this manuscript. Her compensation is unconnected to the studies on which she works. Daniela Neme has received personal or institutional honoraria from Biomarin, CSL Behring, Novo Nordisk, Pfizer, Roche, Sanofi, and Takeda. Brigitte Pan-Petesch has no conflicts of interest to declare. Annemieke Willemze is an employee of Sanofi and may hold stock or stock options in Sanofi. Tung Wynn has participated as a study PI for Sanofi, Takeda, Spark, and Sobi. Spouse was an employee of Takeda from October 2022 until June 2023. Nana Kragh is an employee of Sobi and may have stock or stock options. Amanda Wilson was an employee of Sanofi at the time the study was conducted and may hold stock or stock options in Sanofi., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Objective: To evaluate the possible effect of reldesemtiv, a fast skeletal muscle troponin activator, on prescription and acceptance of durable medical equipment (DME) in the FORTITUDE-ALS trial. Methods: Health economic outcome information was collected in FORTITUDE-ALS (NCT03160898); sites recorded if and when DME, specifically manual or power wheelchairs, gastrostomy tubes, noninvasive ventilators, or augmentative language devices, was prescribed by a physician and accepted by the patient (DME-PAP) during the trial. Acceptance was defined as the patient agreeing the item was needed. Cox regression analysis compared time to DME-PAP for each reldesemtiv dose with placebo. Post hoc analyses evaluated all reldesemtiv doses compared with placebo. Results: At least one DME item was prescribed and accepted by 33/114 (28.9%) of placebo patients, 19/112 (17.0%) of patients receiving reldesemtiv 150 mg bid, 24/113 (21.2%) receiving 300 mg bid, and 29/117 (24.8%) receiving 450 mg bid. The proportion of new DME-PAP was significantly lower in patients receiving reldesemtiv 150 mg bid vs placebo (17.0% vs 28.9%, p = 0.032). The hazard ratio versus placebo for accepting at least one DME item for all reldesemtiv doses combined was 0.61 (confidence interval: 0.39, 0.96, p = 0.032). 25% of placebo patients were prescribed and agreed to obtain a DME item by 84 days; this threshold was met for reldesemtiv-treated patients at 120 days. Conclusions: Results suggest ALS patients receiving reldesemtiv may have lower risk of and delayed need for DME related to impaired mobility, breathing, swallowing, or speaking; this delay is consistent with other measures indicating delay in disease progression. [ABSTRACT FROM AUTHOR]

Abstract Background It is not well-known if diagnosing and treating sleep breathing disorders among individuals with idiopathic pulmonary fibrosis (IPF) improves health outcomes. We evaluated the association between receipt of laboratory-based polysomnography (which is the first step in the diagnosis and treatment of sleep breathing disorders in Ontario, Canada) and respiratory-related hospitalization and all-cause mortality among individuals with IPF. Methods We used a retrospective, population-based, cohort study design, analyzing health administrative data from Ontario, Canada, from 2007 to 2019. Individuals with IPF were identified using an algorithm based on health administrative codes previously developed by IPF experts. Propensity score matching was used to account for potential differences in 41 relevant covariates between individuals that underwent polysomnography (exposed) and individuals that did not undergo polysomnography (controls), in order minimize potential confounding. Respiratory-related hospitalization and all-cause mortality were evaluated up to 12 months after the index date. Results Out of 5044 individuals with IPF identified, 201 (4.0%) received polysomnography, and 189 (94.0%) were matched to an equal number of controls. Compared to controls, exposed individuals had significantly reduced rates of respiratory-related hospitalization (hazard ratio [HR] 0.43, 95% confidence interval [CI] 0.24–0.75), p = 0.003) and all-cause mortality (HR 0.49, 95% CI 0.30–0.80), p = 0.004). Significantly reduced rate of respiratory-related hospitalization (but not all-cause mortality) was also observed among those with > = 1 respiratory-related hospitalization (HR 0.38, 95% CI 0.15–0.99) and systemic corticosteroid receipt (HR 0.37, 95% CI 0.19–0.94) in the year prior to the index date, which reflect sicker subgroups of persons. Conclusions Undergoing polysomnography was associated with significantly improved clinically-important health outcomes among individuals with IPF, highlighting the potential importance of incorporating this testing in IPF disease management.

Background: In model-based economic evaluations, the effectiveness parameter is often informed by studies with a limited duration of follow-up, requiring extrapolation of the treatment effect over a longer time horizon. Extrapolation from short-term data alone may not adequately capture uncertainty in that extrapolation. This study aimed to use structured expert elicitation to quantify uncertainty associated with extrapolation of the treatment effect observed in a clinical trial. Methods: A structured expert elicitation exercise was conducted for an applied study of a podiatry intervention designed to reduce the rate of falls and fractures in the elderly. A bespoke web application was used to elicit experts' beliefs about two outcomes (rate of falls and odds of fracture) as probability distributions (priors), for two treatment options (intervention and treatment as usual) at multiple time points. These priors were used to derive the temporal change in the treatment effect of the intervention, to extrapolate outcomes observed in a trial. The results were compared with extrapolation without experts' priors. Results: The study recruited thirty-eight experts (geriatricians, general practitioners, physiotherapists, nurses, and academics) from England and Wales. The majority of experts (32/38) believed that the treatment effect would depreciate over time and expressed greater uncertainty than that extrapolated from a trial-based outcome alone. The between-expert variation in predicted outcomes was relatively small. Conclusions: This study suggests that uncertainty in extrapolation can be informed using structured expert elicitation methods. Using structured elicitation to attach values to complex parameters requires key assumptions and simplifications to be considered. [ABSTRACT FROM AUTHOR]

Background: In model-based economic evaluations, the effectiveness parameter is often informed by studies with a limited duration of follow-up, requiring extrapolation of the treatment effect over a longer time horizon. Extrapolation from short-term data alone may not adequately capture uncertainty in that extrapolation. This study aimed to use structured expert elicitation to quantify uncertainty associated with extrapolation of the treatment effect observed in a clinical trial. Methods: A structured expert elicitation exercise was conducted for an applied study of a podiatry intervention designed to reduce the rate of falls and fractures in the elderly. A bespoke web application was used to elicit experts' beliefs about two outcomes (rate of falls and odds of fracture) as probability distributions (priors), for two treatment options (intervention and treatment as usual) at multiple time points. These priors were used to derive the temporal change in the treatment effect of the intervention, to extrapolate outcomes observed in a trial. The results were compared with extrapolation without experts' priors. Results: The study recruited thirty-eight experts (geriatricians, general practitioners, physiotherapists, nurses, and academics) from England and Wales. The majority of experts (32/38) believed that the treatment effect would depreciate over time and expressed greater uncertainty than that extrapolated from a trial-based outcome alone. The between-expert variation in predicted outcomes was relatively small. Conclusions: This study suggests that uncertainty in extrapolation can be informed using structured expert elicitation methods. Using structured elicitation to attach values to complex parameters requires key assumptions and simplifications to be considered. [ABSTRACT FROM AUTHOR]

Krista M Schroeder,1 Steve Gelwicks,1 April N Naegeli,1 Pamela C Heaton2 1Global Patient Outcomes – Real World Evidence, Eli Lilly and Company, Indianapolis, IN, USA; 2James L. Winkle College of Pharmacy, University of Cincinnati Academic Health Center, Cincinnati, OH, USACorrespondence: Krista M SchroederEli Lilly and Company, Indianapolis, IN 46285, USATel +1 317 276 3039Email schroeder_krista_marie@lilly.comBackground: Establishing disease-related cost and/or healthcare resource utilization (HCRU) is an important aspect of health outcomes research, particularly when considering the cost offset of novel treatments. However, few studies have compared methodologies used to assess disease-related cost/HCRU.Methods: Data from the United States IBM® MarketScan® Research Databases were used to compare four different methods of calculating disease-related cost and HCRU in patients with rheumatoid arthritis (RA). The analysis was repeated, in part, for patients with ulcerative colitis (UC) to explore the generalizability of findings to a second autoimmune disease. Four methods of disease-related cost/HCRU attribution were selected following a literature search for potential methods: Method 1, claim-wide cost/HCRU attribution based on claim-listed diagnosis codes and a predetermined disease-related medication list (pharmacy claims only); Method 2, line-item cost/HCRU attribution based on procedures/medications more likely to occur in disease cases than in matched controls at two likelihood ratio cutoffs (1.5× and 3.5×); Method 3, disease-related cost/HCRU calculated as the difference in total average cost/HCRU between cases and matched controls; Method 4, line-item cost/HCRU attribution based on clinician manual determination of procedures/medications related to the disease.Results and conclusion: Overall, 24,373 patients with RA and 9665 with UC were included. Average total cost during 2015 was $US28,750 per patient with RA and $US20,480 per patient with UC. Disease-related cost and HCRU for RA calculated using Method 4 were most closely approximated by Methods 1 and 2 (3.5×), with Method 2 (3.5×) the closest approximation. However, in certain research scenarios, the simplest method compared in this analysis, Method 1, may provide an adequate approximation of disease-related cost and HCRU. Although Method 4 was not executed in the UC analysis because of its labor-intensive nature, similar patterns of disease-related cost and HCRU were observed for Methods 1–3 in patients with UC and RA.Keywords: health outcomes research, methods, disease-related cost, administrative claims databases, autoimmune diseases

Background: The positive predictive value (PPV) of the International Classification of Diseases, Ninth Revision-Clinical Modification (ICD-9-CM) code for "essential and other specified forms of tremor" in identifying essential tremor (ET) cases was found to be less than 50%. The ability of the ICD-10-CM G25.0 code for "essential tremor" to identify ET has not been determined. The study objective was to determine the PPV of the G25.0 code., Methods: Patients in a tertiary health system with a primary care encounter associated with ICD-10-CM code G25.0 in 2022 underwent medical record review to determine if the consensus criteria from the International Parkinson and Movement Disorder Society for an ET diagnosis were met., Results: 442 patients were included. The PPV of G25.0 in identifying probable ET cases was 74.7% (95% confidence interval (CI) 70.4-78.5%). Among patients prescribed propranolol, the PPV improved to 87.8% (95% CI 78.0-93.6%)., Discussion: Compared to the ICD-9-CM code 333.1, G25.0 is superior for identifying ET cases. A potential limitation of this study is that the consensus criteria applied relies on nonspecific physical exam findings which may lead to an overestimation of the PPV of G25.0., Highlights: The ICD-10-CM diagnosis code for essential tremor has not been previously validated. The objective of this study was to determine the PPV of the G25.0 code. The PPV in identifying essential tremor cases was 74.7%. The PPV improved among patients prescribed propranolol., Competing Interests: The authors have no competing interests to declare., (Copyright: © 2024 The Author(s).)

Background: It is not well-known if diagnosing and treating sleep breathing disorders among individuals with idiopathic pulmonary fibrosis (IPF) improves health outcomes. We evaluated the association between receipt of laboratory-based polysomnography (which is the first step in the diagnosis and treatment of sleep breathing disorders in Ontario, Canada) and respiratory-related hospitalization and all-cause mortality among individuals with IPF.Methods: We used a retrospective, population-based, cohort study design, analyzing health administrative data from Ontario, Canada, from 2007 to 2019. Individuals with IPF were identified using an algorithm based on health administrative codes previously developed by IPF experts. Propensity score matching was used to account for potential differences in 41 relevant covariates between individuals that underwent polysomnography (exposed) and individuals that did not undergo polysomnography (controls), in order minimize potential confounding. Respiratory-related hospitalization and all-cause mortality were evaluated up to 12 months after the index date.Results: Out of 5044 individuals with IPF identified, 201 (4.0%) received polysomnography, and 189 (94.0%) were matched to an equal number of controls. Compared to controls, exposed individuals had significantly reduced rates of respiratory-related hospitalization (hazard ratio [HR] 0.43, 95% confidence interval [CI] 0.24-0.75), p = 0.003) and all-cause mortality (HR 0.49, 95% CI 0.30-0.80), p = 0.004). Significantly reduced rate of respiratory-related hospitalization (but not all-cause mortality) was also observed among those with >  = 1 respiratory-related hospitalization (HR 0.38, 95% CI 0.15-0.99) and systemic corticosteroid receipt (HR 0.37, 95% CI 0.19-0.94) in the year prior to the index date, which reflect sicker subgroups of persons.Conclusions: Undergoing polysomnography was associated with significantly improved clinically-important health outcomes among individuals with IPF, highlighting the potential importance of incorporating this testing in IPF disease management. [ABSTRACT FROM AUTHOR]

Objective: To describe the epidemiology and health resource utilization for convulsive status epilepticus (SE) in the emergency department (ED).Methods: Retrospective descriptive study in the Nationwide Emergency Department Sample (NEDS). Primary SE and secondary SE (SE in a case who visited the ED for other primary reason) were compared with non-SE seizures. Secondary SE is expected to have worse outcomes and higher costs because of another primary cause for ED visit.Results: In the period 2010-2014, there were 149,750 ED visits with primary SE; 83,459 ED with secondary SE; and 5,359,103 ED visits with non-SE seizures. On multivariable analysis adjusting for potential confounders, the odds of hospital admission were 7 times higher for primary SE than for non-SE seizures, and 5 times higher for secondary SE than for non-SE seizures; the odds of transfer to another hospital were 9 times higher for primary SE than for non-SE seizures, and 3 times higher for secondary SE than for non-SE seizures; the odds of death were 2.5 times higher for primary SE than for non-SE seizures, and 12 times higher for secondary SE than for non-SE seizures; and the charges (in January 2020 USA dollars) were $9000 higher in primary SE than in non-SE seizures, and $35,000 higher in secondary SE than in non-SE seizures.Conclusion: Among all reasons for ED visits, SE, and in particular, secondary SE, are among the most resource-consuming conditions, being much more expensive than non-SE seizures in the ED. [ABSTRACT FROM AUTHOR]

Introduction: The impact of the COVID-19 pandemic on hospitalizations for alcohol-associated hepatitis (AH) is poorly understood. Here we explore AH trends from 2016-2020 and evaluate demographic disparities including sex and race., Methods: A retrospective analysis of the 2016-2020 Healthcare Cost and Utilization Project National Inpatient Sample was performed to assess temporal trends in hospitalizations for AH. The 2020 dataset was evaluated to compare AH hospitalizations between those with and without an additional diagnosis of COVID-19., Results: Included were 607,140 weighted inpatient AH discharges per 145,055,152 all-cause discharges from 2016-2020. AH hospitalizations increased at a rate of 23.4 hospitalizations per 100,000 all-cause discharges per year between 2016-2019 and increased to 113 hospitalizations per 100,000 all-cause discharges in 2020. Mortality was higher in females despite lower rates of hospitalization than males. The adjusted odds of hospitalization for AH in 2020 were higher than in 2016-2019 (aOR= 1.28, p < 0.001). The Hispanic population had greater odds of hospitalization with AH and COVID-19 compared to other races (aOR= 2.71, p <0.001)., Discussion: Increased efforts toward primary prevention of excessive alcohol use and greater social support for those with alcohol used disorder are needed. More research is required to elucidate the racial disparities among the Hispanic population with AH and COVID-19., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background and Aim: The incidence and overall mortality of hepatocellular carcinoma (HCC) in the US have been increasing over the past decade. Venous thromboembolism (VTE) is a leading cause of morbidity and mortality in cancer patients. This study aims at examining the epidemiology, risk factors, and short-term outcomes of VTE in hospitalized patients with HCC. Methods: We utilized the National Inpatient Sample for the years 2008–2013. Using the International Classification of Diseases codes, ninth edition, we identified hospitalized adult patients with a prior diagnosis of HCC who were diagnosed with VTE. Weighted multivariate logistic regression models were used to examine the effect of patients' sociodemographic and clinical characteristics on the occurrence of VTE, and to evaluate the impact of VTE on in-hospital mortality and length of hospital stay. Results: We identified a total of 54,275 hospitalized patients with a prior diagnosis of HCC. The prevalence of VTE in the study cohort was 2.8% (2.5% in 2008 to 3.0% in 2013, a statistically significant increase). Older age, African American ethnicity, history of metastasis, and higher Elixhauser comorbidity index were associated with higher odds of VTE. However, having a prior diagnosis of cirrhosis, hepatitis C, or diabetes mellitus were associated with lower odds of VTE in HCC patients. Furthermore, development of VTE was associated with longer hospital stay and increased in-hospital mortality. Conclusion: Our work highlights significant age, racial, and comorbid factors in the development of VTE in hospitalized patients with HCC in the US. These findings can help in stratification of HCC patients according to their VTE risk. Patients at higher risk of VTE may benefit from more aggressive pharmacologic prophylaxis, an area for future investigation. [ABSTRACT FROM AUTHOR]

Great gains were achieved with the introduction of the United Nations' Millennium Development Goals, including improved child survival. Transition to the Sustainable Development Goals (SDGs) focused on surviving, thriving, and transforming, representing an important shift to a broader public health goal, the achievement of which holds the promise of longer-term individual and societal benefits. A similar shift is needed with respect to outcomes for infants born to women living with HIV (WLHIV). Programming to prevent vertical HIV transmission has been successful in increasingly achieving a goal of HIV-free survival for infants born to WLHIV. Unfortunately, HIV-exposed uninfected (HEU) children are not achieving comparable health and developmental outcomes compared with children born to HIV-uninfected women under similar socioeconomic circumstances. The 3rd HEU Child Workshop, held as a satellite session of the International AIDS Society's 9th IAS Conference in Paris in July 2017, provided a venue to discuss HEU child health and development disparities. A summary of the Workshop proceedings follows, providing current scientific findings, emphasizing the gap in systems for long-term monitoring, and highlighting the public health need to establish a strategic plan to better quantify the short and longer-term health and developmental outcomes of HEU children.

Abstract: Objective: To examine tobacco knowledge, attitudes and behaviours of community members in Central Australia and to compare these by participant's location (town or remote community). Design: Community‐based survey of 165 smokers and recent ex‐smokers. Outcome measures: Knowledge was assessed using responses to questions on the health risk of smoking (e.g. lung cancer) and knowledge of quit support services. Attitudes towards smoking were assessed using statements that asked participant whether they agreed or disagreed. Smoking behaviours were assessed by asking participants about quit attempts, cigarettes per day and time to first cigarette (used to calculate the heaviness of smoking index). Results: There were high levels of knowledge about most common diseases associated with smoking, including cancer (93%) and heart disease (89%). There was less knowledge about quit support services that are available through telephone (69%), online (27%) and apps (32%). Responses to attitude statements were suggestive of the normalised practices towards smoking in town and remote participants, with remote participants more likely to disagree that ‘ok to smoke close to a building’ and to disagree ‘if I had my time over again I would not have started’. Over 75% of the participants had attempted to quit smoking and 55% had a sustained quit attempt (>1 month). Conclusion: There are greater challenges to reduce smoking in remote areas due to the social and communal practices of smoking and in providing service needs that encourage quit attempts. This supports the need for continued and increased investment for targeted tobacco control by remote health services. [ABSTRACT FROM AUTHOR]

Abstract: Objective: To determine the percentage of research projects funded by the National Health and Medical Research Council in the period 2000–2014 that aimed specifically to deliver health benefits to Australians living in rural and remote areas and to estimate the proportion of total funding this represented in 2005–2014. Design: This is a retrospective analysis of publicly available datasets. Setting: National Health and Medical Research Council Rural and Remote Health Research 2000–2014. Outcome measures: ‘Australian Rural Health Research’ was defined as: research that focussed on rural or remote Australia; that related to the National Health and Medical Research Council's research categories other than Basic Science; and aimed specifically to improve the health of Australians living in rural and remote areas. Grants meeting the inclusion criteria were grouped according to the National Health and Medical Research Council's categories and potential benefit. Funding totals were aggregated and compared to the total funding and Indigenous funding for the period 2005–2014. Results: Of the 16 651 National Health and Medical Research Council‐funded projects, 185 (1.1%) that commenced funding during the period 2000–2014 were defined as ‘Australian Rural Health Research’. The funding for Australian Rural Health Research increased from 1.0% of the total in 2005 to 2.4% in 2014. A summary of the funding according to the National Health and Medical Research Council's research categories and potential benefit is presented. Conclusion: Addressing the health inequality experienced by rural and remote Australians is a stated aim of the Australian Government. While National Health and Medical Research Council funding for rural health research has increased over the past decade, at 2.4% by value, it appears very low given the extent of the health status and health service deficits faced by the 30% who live in rural Australia. [ABSTRACT FROM AUTHOR]

AIMS Diuretic drugs may theoretically improve respiratory health outcomes in chronic obstructive pulmonary disease (COPD) through several possible mechanisms, but they might also lead to respiratory harm. We evaluated the association of incident oral diuretic drug use with respiratory-related morbidity and mortality among older adults with COPD. METHODS This was a population-based, retrospective cohort study using health administrative data from Ontario, Canada, for the period 2008–2013. We identified adults aged 66 years and older with nonpalliative COPD using a validated algorithm. Respiratoryrelated morbidity and mortality were evaluated within 30 days of incident oral diuretic drug use compared to nonuse using Cox proportional hazard regression and applying inverse probability of treatment weighting using the propensity score to minimize confounding. RESULTS Out of 99 766 individuals aged 66 years and older with COPD identified, incident diuretic receipt occurred in 51.7%. Relative to controls, incident diuretic users had significantly increased rates for hospitalization for COPD or pneumonia [hazard ratio (HR) 1.22, 95% confidence interval (CI) 1.07–1.40], as well as more emergency room visits for COPD or pneumonia (HR 1.35, 95% CI 1.18–1.56), COPD or pneumonia-related mortality (HR 1.41; 95% CI 1.04–1.92) and all-cause mortality (HR 1.20, 95% CI 1.06–1.35). The increased respiratory-related morbidity and mortality observed were specifically as a result of loop diuretic use. CONCLUSIONS Incident diuretic drugs, and more specifically loop diuretics, were associated with increased rates of respiratory-related morbidity andmortality among older adults with nonpalliative COPD. Further studies are needed to determine if this association is causative or due to unresolved confounding. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the validity of the Gleason score after neoadjuvant hormonal treatment as predictor of diseasespecific mortality after radical prostatectomy. Patients and Methods: A total of 2,880 patients with a complete data set and a mean follow-up of 10.3 years were studied; 425 of them (15%) had a history of hormonal treatment prior to surgery. The cumulative incidence of deaths from prostate cancer was determined by univariate and multivariate competing risk analysis. Cox proportional hazard models for competing risks were used to study combined effects of the variables on prostate cancer-specific mortality. Results: A higher portion of specimens with a history of neoadjuvant hormonal treatment were assigned Gleason scores of 8-10 (28 vs. 17%, p < 0.0001). The mortality curves in the Gleason score strata <8 vs. 8-10 were at large congruent in patients with and without neoadjuvant hormonal treatment. In patients with neoadjuvant hormonal treatment, a Gleason score of 8-10 was an independent predictor of prostate cancer- specific mortality; the hazard ratio was, however, somewhat lower than in patients without neoadjuvant hormonal treatment. Conclusion: This study suggests that the prognostic value of the post-radical prostatectomy Gleason score is not meaningfully jeopardized by heterogeneous neoadjuvant hormonal treatment in a routine clinical setting. [ABSTRACT FROM AUTHOR]

Objective Little is known about rural-urban cancer disparities, particularly in South Korea, and this study is to identify cancer-specific mortality inequalities between the rural and urban areas of the country. Design, setting, and participants For 11 specific cancer sites, age-standardised mortality rates were analysed for the rural and urban administrative districts of South Korea during 2006-2011. Main outcome measures The Poisson log linear regression models were employed to estimate cancer-specific mortality rates, and Bonferroni comparison method was used to identify rural-urban disparities. Results There were significant rural-urban disparities observed for all cancer sites except prostate, pancreas and leukaemia. The mortality rates of lung, liver and stomach cancers, the three most common cancers in the country, were observed to be significantly higher in rural areas than in metropolitan areas. In contrast, the reverse relationship was observed for the reproductive system (breast and uterus) and colon cancers. Central nervous system cancer mortality was observed to be significantly higher in rural areas than in non-metro urban areas. Conclusions For the first time ever, significant rural-urban disparity patterns in cancer mortality rates in South Korea have been identified in this paper. Future investigations on cancer risk factors for the country should address these disparity patterns. [ABSTRACT FROM AUTHOR]

Background: The aim of screening for colorectal cancer is to improve prognosis by the detection of cancer at its early stages. In order to inform the decision on the specific test to be used in the population-based programme in the Basque Autonomous Region (Spain), we compared two immunochemical faecal occult blood quantitative tests (I-FOBT). Methods: Residents of selected study areas, aged 50-69 years, were invited to participate in the screening. Two tests based on latex agglutination (OC-Sensor and FOB Gold) were randomly assigned to different study areas. A colonoscopy was offered to patients with a positive test result. The cut-off point used to classify a result as positive, according to manufacturer’s recommendations, was 100 ng/ml for both tests. Results: The invited population included 37,999 individuals. Participation rates were 61.8% (n=11,162) for OC-Sensor and 59.1% (n=11,786) for FOB Gold, (p=0.008). Positive rate for OC-Sensor was 6.6% (n=737) and 8.5% (n=1,002) for FOB Gold, (p< 0.0001). Error rates were higher for FOB gold (2.3%) than for OC-Sensor (0.2%), (p< 0.0001). Predictive Positive Value (PPV) for total malignant and premalignant lesions was 62.4% for OC-Sensor and 58.9% for FOB Gold, (p=0.137), respectively. Conclusions: OC-Sensor test appears to be superior for I-FOBT based CRC screening, given its acceptance, ease of use, associated small number of errors and its screening accuracy. FOB-Gold on the other hand, has higher rate of positive values, with more colonoscopies performed, it shows higher detection incidence rates, but involves more false positives.

Background: Consensus guidelines support non-operative preventives for dental caries management; yet, their use in practice is far from universal. The purpose of this study was to evaluate the effectiveness of non-operative anti-caries agents in caries prevention among high caries risk adults at a university clinic where risk-based caries management is emphasized. Methods: This retrospective observational study drew data from the electronic patient records of non-edentulous adult patients deemed to be at high risk for dental caries during baseline oral evaluations that were completed between July 1, 2007 and December 31, 2012 at a dental university in the United States. We calculated and compared adjusted mean estimates for the number of new decayed or restored teeth (DFT increment) from baseline to the next completed oral evaluation (N = 2,724 patients with follow-up) across three categories of delivery of non-operative anti-caries agents (e.g., high-concentration fluoride toothpaste, chlorhexidine rinse, xylitol products): never, at a single appointment, or at ≥2 appointments ≥4 weeks apart. Estimates were adjusted for patient and provider characteristics, baseline dental status, losses-to-follow-up, and follow-up time. Results: Approximately half the patients did not receive any form of non-operative anti-caries agent. Most that received anti-caries agents were given more than one type of product in combination. One-time delivery of anti-caries agents was associated with a similar DFT increment as receiving no such therapy (difference in increment: -0.04; 95 % CI: -0.28, 0.21). However, repeated, spaced delivery of anti-caries agents was associated with approximately one decayed or restored tooth prevented over 18 months for every three patients treated (difference in increment: -0.35; 95 % CI: -0.65, -0.08). Conclusions: These results lend evidence that repeatedly receiving anti-caries agents can reduce tooth decay among high-risk patients engaged in regular dental care. [ABSTRACT FROM AUTHOR]

Background: To evaluate the longitudinal value of a chronic disease management program, My Health Guardian (MHG), in reducing hospital utilization and costs over 4 years. Methods: The MHG program provides individualized support via telephonic nurse outreach and online tools for self-management, behavior change and well-being. In follow up to an initial 18-month analysis of MHG, the current study evaluated program impact over 4 years. A matched-cohort analysis retrospectively compared MHG participants with heart disease or diabetes (treatment, N = 4,948) to non-participants (comparison, N = 28,520) on utilization rates (hospital admission, readmission, total bed days) and hospital claims cost savings. Outcomes were evaluated using regression analyses, controlling for remaining demographic, disease, and pre-program admissions or cost differences between the study groups. Results: Over the 4 year period, program participation resulted in significant reductions in hospital admissions (-11.4%, P < 0.0001), readmissions (-36.7%, P < 0.0001), and bed days (-17.2%, P < 0.0001). The effect size increased over time for admissions and bed days. The relative odds of any admission and readmission over the 4 years were 27% and 45% lower, respectively, in the treatment group. Cumulative program savings from reduced hospital claims was $3,549 over 4-years; savings values for each program year were significant and increased with time (P = 0.003 to P < 0.0001). Savings calculations did not adjust for pooled costs (and savings) in Australia's risk equalization system for private insurers. Conclusions: Results confirm and extend prior program outcomes and support the longitudinal value of the MHG program in reducing hospital utilization and costs for individuals with heart disease or diabetes and demonstrate the increasing program effect with continued participation over time. [ABSTRACT FROM AUTHOR]

Background The aim of this study was to confirm whether the level of lifetime fluoridation exposure is associated with lower dental caries experience in younger adults (15-46 years). Methods Data of the cohort born between 1960 and 1990 residing outside Australia's capital cities from the 2004−2006 Australian National Survey of Adult Oral Health were analysed. Residential history questionnaires were used to determine the percentage of each person's lifetime exposure to fluoridated water (<50%/50+%). Examiners recorded decayed, missing and filled permanent teeth ( DMFT). Socio-demographic variables, periodontal risk factors, and access to dental care were included in multivariable least-squares regression models. Results In bivariate analysis, the higher level of fluoridation category had significantly lower DMFT (mean 6.01 [ SE = 0.62]) than the lower level of fluoridation group (9.14 [ SE = 0.73] p < 0.01) and lower numbers of filled teeth (4.08 [ SE = 0.43], 7.06 [ SE = 0.62], p < 0.01). In multivariate analysis, the higher number of full-time equivalent dentists per 100 000 people was associated with a lower mean number of missing teeth (regression coefficient estimate = -1.75, p = 0.03), and the higher level of water fluoridation with a lower mean DMFT (-2.45, p < 0.01) and mean number of filled teeth (-2.52, p < 0.01). Conclusions The higher level of lifetime fluoridation exposure was associated with substantially lower caries experience in younger rural adults, largely due to a lower number of filled teeth. [ABSTRACT FROM AUTHOR]

Objective To examine the association between children's clinical oral health status and their residential location using the latest available data (2009) and to ascertain whether poor oral health among rural children is related to being Indigenous, having less access to fluoridated water or being of lower socioeconomic status ( SES), than children from urban areas. Design Cross-sectional survey. Setting and participant Data were collected on 74 467 children aged 5-12 years attending school dental services in Australia (data were not available for Victoria or New South Wales). Main outcome measures Clinical oral health was determined by the mean number of permanent teeth with untreated caries, missing and filled permanent teeth, and the mean decayed, missing and filled permanent teeth index ( DMFT) of 8 to 12-year-old-children and the mean number deciduous teeth with untreated caries, missing and filled deciduous teeth, and the mean decayed, missing and filled deciduous teeth index (dmft) of 5-10-year-olds. Results The multivariable models that included coefficients on whether the child was Indigenous, from an area with fluoridated water and SES, were controlled for age and sex. The mean DMFT of 8-12-year-old children and the mean dmft of 5-10-year-old-children were significantly higher in rural areas compared with urban centres after accounting for Indigenous status, fluoridated water and SES. Conclusion Children's oral health was poorer in rural areas than in major city areas. [ABSTRACT FROM AUTHOR]

An instrument or instrumental variable is often used in an effort to avoid selection bias in inference about the effects of treatments when treatment choice is based on thoughtful deliberation. Instruments are increasingly used in health outcomes research. An instrument is a haphazard push to accept one treatment or another, where the push can affect outcomes only to the extent that it alters the treatment received. There are two key assumptions here: (R) the push is haphazard or essentially random once adjustments have been made for observed covariates, (E) the push affects outcomes only by altering the treatment, the so-called “exclusion restriction.” These assumptions are often said to be untestable; however, that is untrue if testable means checking the compatibility of assumptions with other things we think we know. A test of this sort may result in a collection of claims that are individually plausible but mutually inconsistent, without clear indication as to which claim is culpable for the inconsistency. We discuss this subject in the context of our on-going study of the effects of delivery by cesarean section on the survival of extremely premature infants of 23–24 weeks gestational age. Supplementary materials for this article are available online. [ABSTRACT FROM AUTHOR]

Abstract: Objectives: In this pilot study we evaluated the feasibility of and methods for assessing the quality of life of long term survivors of European Organisation for Research and Treatment of Cancer (EORTC) phase III clinical trials. Here we report the results pertaining to the feasibility of conducting such research. Methods: In this cross-sectional study, we recruited long-term, disease-free survivors from two mature EORTC clinical trials in testicular and prostate cancer from centres in Northern and Southern Europe, and the United Kingdom (UK). Results: A number of challenges were encountered in recruiting participating centres, obtaining medical ethical approval and in recruiting survivors and collecting the health-related quality of life (HRQoL) data in a timely manner. The efficiency with which the study could be conducted varied widely across centres and countries. Time to obtain medical ethical approval for the study ranged from 1.5 to 25months. We encountered most problems with ethical approval in the UK, Italy and Belgium. In most cases, data collection was completed within 3months (range 10weeks–1year). Completed questionnaires were obtained from 68% and 56%, respectively, of the testicular and prostate cancer survivors who were approached. Conclusions: HRQoL research among long-term survivors of EORTC phase III clinical trials is possible, but the process of ethical approval and data collection is a lengthy one. To minimise many of the logistical problems, long-term follow-up of patients should be an integral part of future clinical trials. Moreover, regulations governing medical ethical approval for clinical research within the EU should be carefully evaluated to facilitate long-term follow-up of cancer survivors in Europe. [Copyright &y& Elsevier]

Objective To determine if clinical oral health outcomes differ between people who reside in major city, inner regional and outer regional areas of Australia. Design Data from the National Survey of Adult Oral Health 2004-06 that used a clustered stratified random sampling design with telephone interviews, standardised oral epidemiological examinations and self-complete questionnaires were used to compare the clinical oral health. Main outcome measures Decayed, missing and filled permanent teeth. Participants Australians aged 15 years or more. Data were weighted by age, sex and regional location to the Estimated Resident Population, bivariate analysis undertaken to determine confounders and multivariate analysis completed with dental caries clinical measures as dependent variables. Results Inner regional people had a significantly higher decayed, missing and filled teeth than people from major cities ( Estimate = 1.15, P < 0.01), but there was no difference between inner and regional areas. Older people had higher outcomes for decayed, missing and filled teeth (15.42, P < 0.01) and missing teeth (9.66, P < 0.01), but less decayed teeth (−0.37, P < 0.01), and people with the highest incomes had lower dental caries experience (−1.34, P < 0.01) and missing teeth (−1.42, P < 0.01). Conclusion Dental caries experience was greater in inner regional areas than in major city areas, but not outer regional areas. Dental caries experience was similar in outer regional and major city areas. [ABSTRACT FROM AUTHOR]

Objective Recent efforts to redress the deficit of rural medical practitioners have considered the problem of recruitment and retention of rural doctors as one of influencing individuals' career choices. Exposure to rural medical environments during basic medical training is one long-standing example of an initiative aimed in this direction and there is some evidence that it is effective. This study sought to determine whether or not various domains of personality are related to medical students' attitude to practising as rural doctors after graduation. Design The sample comprised 914 students commencing medical studies in Australian universities. They were recruited as part of the Medical Schools Outcomes Database project and indicated intended location of future medical practice. Setting Seven Australian basic medical training programs. Main outcome measures All students completed the NEO five-factor index ( NEO-FFI) and Adjective Checklist ( ACL) personality instruments. Results A preference for a rural practice location was associated with a combination of six domains of personality. The probability of rural preference was greater with higher scores on openness to experience, agreeableness and self-confidence but lower with higher scores on extraversion, autonomy and intraception. Taken together these six domains of personality provide useful although imperfect discrimination between students with a rural versus urban location preference. After controlling for student age the associations with extraversion and agreeableness failed to reach statistical significance. Conclusions While personality does not fully explain medical students' attitude towards practicing as a rural doctor, the data suggest it is an important factor and that some individuals may be better suited to a rural medical career than others. Considering personality along with other characteristics of the individual might allow targeted 'marketing' of rural practice. [ABSTRACT FROM AUTHOR]

Background Clinical trials demonstrate improved survival for patients with completely resected non-small-cell lung cancer (NSCLC) who receive adjuvant chemotherapy. Concerns have been raised about the implementation of those data. The present study measured rates of referral for adjuvant chemotherapy and barriers to referral, and it also evaluated a knowledge translation strategy to change practice. Methods An audit and feedback approach was used. Using a retrospective cohort of patients undergoing thoracotomy at St. Joseph's Hospital in Hamilton, Ontario, during January-December 2008, anonymized data were presented to a group of thoracic surgeons for evaluation and feedback. Results Among 150 thoracotomies performed, 55 patients with NSCLC were potentially eligible for adjuvant chemotherapy, but only 27 (49%) were referred for it. Significant variability in referral between surgeons (19%-100%) was observed. Reasons for non-referral were poorly documented in the medical record, but appeared to be primarily the surgeon's decision. The feedback session with surgeons produced a number of constructive suggestions to implement change in practice. Conclusions Our findings suggest that surgeon choice was the most significant barrier to implementation of adjuvant chemotherapy for NSCLC. Audit and feedback was a useful knowledge translation strategy. However, longer follow-up is needed to document change in practice. [ABSTRACT FROM AUTHOR]

This study examines the distribution of health outcomes research (HOR) studies in the clinical literature by clinical areas and journal impact factor. The authors reviewed 535 journals and divided the sample into higher and lower impact journals across four clinical area. Mann-Whitney and Kruskal-Wallis tests were used to examine differences across four categories of outcomes research articles published, specifically the incidence of articles in higher versus lower impact journals and differences across clinical areas. All high-impact journals published more safety and quality articles than process assessment, quality of life, or cost analysis studies. The number of each type of outcomes research study published was highly variable across all clinical areas. Only arthritis and outcomes research journals showed statistically significant differences between higher versus lower impact journals. Authors may benefit from considering these differences in their clinical specialty area when deciding where to submit HOR studies. [ABSTRACT FROM AUTHOR]

The objective of this study was to assess the validity and observed effect size of a new instrument, the Optimality Index–United States (OI-US), for use in perinatal clinical research. Using a large, hospital-based, midwifery service clinical database that included complete obstetric data for 3425 women, we examined discriminant validity and the effects of two different scoring methods used with the OI-US. Discriminant validity was confirmed by comparing OI scores for women who remained low risk and did not require physician involvement in their care (OI score mean = 84%; standard deviation [SD] = 8%) compared to those whose condition changed to require physician involvement in their care (mean = 71%; SD = 10%; P < .001). Two methods of scoring the OI-US were compared, finding no significant difference and suggesting that the types of data available and the research question can drive this decision. Finally, effect size was calculated by two methods: Cohen''s d (−1.4) and the effect size correlation (r = −0.548), the latter of which corresponds to a d of −1.3, both resulting in a similarly large effect size estimation. The OI-US is a new instrument that shows promise for use in perinatal clinical research, particularly when assessing more subtle clinical differences in outcomes between study groups. [Copyright &y& Elsevier]