Advancing donor management research: design and implementation of a large, randomized, placebo-controlled trial

BACKGROUND:Given the persistent shortage of organs for transplantation, new donor management strategies to improve both organ utilization and quality of procured organs are needed. Current management protocols for the care of the deceased donor before organ procurement are based on physiological rationale, experiential reasoning, and retrospective studies without rigorous testing. Although many factors contribute to the lack of controlled clinical trials in donor management, a major factor is the unique challenges posed by research in the brain-dead organ donor.METHODS AND RESULTS:This article describes the study design and the challenges faced during implementation of the Beta-agonists for Oxygenation in Lung Donors (BOLD) study, a randomized, placebo-controlled clinical trial of nebulized albuterol vs. placebo in 500 organ donors. The study design and implementation are described with emphasis on aspects of the study that are unique to research in brain-dead organ donors.CONCLUSIONS:Experience gained during the design and implementation of the BOLD study should be useful for investigators planning future clinical trials in the brain-dead donor population and for intensivists who are involved in the care of the brain-dead organ donor.This item is part of the UA Faculty Publications collection. For more information this item or other items in the UA Campus Repository, contact the University of Arizona Libraries at [email protected]

Multicenter assessment of quantitative sensory testing (QST) for the detection of neuropathic-like pain responses using the topical capsaicin model

Background: The use of quantitative sensory testing (QST) in multicenter studies has been quite limited, due in part to lack of standardized procedures among centers. Aim: The aim of this study was to assess the application of the capsaicin pain model as a surrogate experimental human model of neuropathic pain in different centers and verify the variation in reports of QST measures across centers. Methods: A multicenter study conducted by the Quebec Pain Research Network in six laboratories allowed the evaluation of nine QST parameters in 60 healthy subjects treated with topical capsaicin to model unilateral pain and allodynia. The same measurements (without capsaicin) were taken in 20 patients with chronic neuropathic pain recruited from an independent pain clinic. Results: Results revealed that six parameters detected a significant difference between the capsaicin-treated and the control skin areas: (1) cold detection threshold (CDT) and (2) cold pain threshold (CPT) are lower on the capsaicin-treated side, indicating a decreased in cold sensitivity; (3) heat pain threshold (HPT) was lower on the capsaicin-treated side in healthy subjects, suggesting an increased heat pain sensitivity; (4) dynamic mechanical allodynia (DMA); (5) mechanical pain after two stimulations (MPS2); and (6) mechanical pain summation after ten stimulations (MPS10), are increased on the capsaicin-treated side, suggesting an increased in mechanical pain (P < 0.002). CDT, CPT and HPT showed comparable effects across all six centers, with CPT and HPT demonstrating the best sensitivity. Data from the patients showed significant difference between affected and unaffected body side but only with CDT. Conclusion: These results provide further support for the application of QST in multicenter studies examining normal and pathological pain responses

Quantum efficiency measurement of single photon detectors using photon pairs generated in optical fibers

Using the correlated signal and idler photon pairs generated in a dispersion shifted fiber by a pulsed pump, we measure the quantum efficiency of a InGaAs/InP avalanche photodiode-based single photon detector. Since the collection efficiency of photon pairs is a key parameter to correctly deduce the quantum efficiency, we carefully characterize the collection efficiency by studying correlation dependence of photon pairs upon the spectra of pump, signal and idler photons. This study allows us to obtain quantum efficiency of the single photon detector by using photon pairs with various kinds of bandwidths.Comment: 21pages, 6figures, 4tables, accepted for publication in J. Opt. Soc. Am.

Measuring the effect of intimate partner violence on health-related quality of life: a qualitative focus group study

Abstract Background Health related quality of life (HRQOL) can be measured by a wide range of instruments, many of which have been designed for specific conditions or uses. Preference-based measures assess the value individuals place on health, and are included in economic evaluations of treatments and interventions (such as cost effectiveness analysis). As economic evaluation becomes more common, it is important to assess the applicability of preference-based health related quality of life (HRQOL) measures to public health issues. This study investigated the usefulness of such instruments in the context of intimate partner violence (IPV), a public health concern that that can seriously affect quality of life. Methods The study consisted of focus groups with abused women to determine the aspects of life affected by IPV, and an analysis of existing HRQOL measures. Eight focus groups (n = 40) were conducted in which participants discussed the domains of health affected by IPV. Results were content analyzed and compared with the domains of health included in four commonly-used, preference-based HRQOL measures. Results The average focus group participant was 43 years old, unemployed, African American, with 3 children. Domains of health reported to be affected by IPV included physical functioning, emotional and psychological functioning, social functioning and children\u27s functioning. Psychological health was the most severely affected domain. The Short Form 36, the Health Utilities Index, the EuroQol 5D, and the Quality of Well-being Scale were found to vary in the degree to which they include domains of health important in IPV. Psychological health is included to a limited extent, and the spill-over effect of a condition on other family members, including children, is not included at all. Conclusion Emotional and psychological health plays an important role in the overall HRQOL of abused women but is relatively underemphasized in preference-based HRQOL measures. This may lead to an underestimation of the impact of partner violence on HRQOL when using these measures and in economic evaluations that rely thereon. Holistic measurement approaches or expanded measures that capture the far-reaching effects of IPV on HRQOL may be needed to accurately measure the effect of this condition on women\u27s health

Evaluation of the psychometric properties of the SF-36 health survey for use among Turkish and Moroccan ethnic minority populations in the Netherlands

Purpose: To evaluate the psychometrics of the SF-36 Health Survey among Turkish and Moroccan ethnic minority populations in the Netherlands and to compare the results to those based on the indigenous Dutch population. Methods: Data were derived from the Second Dutch National Survey of General Practice. In total, SF-36 data were available for 409 Turkish, 377 Moroccan, and 9,628 Dutch respondents. Language subgroup analyses were performed for the Turkish (n = 162) and Moroccan-Arabic (n = 52) versions of the SF-36. Psychometric properties were evaluated by descriptive statistics, factor analysis, internal consistency estimates, known-group comparisons, and differential item function (DIF) analysis. Results Low levels of missing SF-36 data were observed across all groups. Confirmatory factor analysis supported the hypothesized SF-36 scale structure for the Dutch and Turkish group, but high correlations between the MH and VT factors were observed in the Moroccan group. All Cronbach’s alpha coefficients were above 0.70, except for the Vitality scale in the Moroccan group and the Vitality and Social Functioning scales in the Moroccan-Arabic language subgroup. Known-groups validity was found across samples using age, sex, education, and comorbidity as grouping variables, but not marital status. Some evidence for DIF was found in both ethnic group samples. Conclusions: The results generally support the use of the SF-36 for general population research among Turkish and Moroccan ethnic minorities in the Netherlands. Additional studies are needed to confirm the psychometrics of the questionnaire when used among these populations in other Western European countries. (aut. ref.

The roles of herbal remedies in survival and quality of life among long-term breast cancer survivors - results of a prospective study

<p>Abstract</p> <p>Background</p> <p>Few data exist on survival or health-related quality of life (QOL) related to herbal remedy use among long-term breast cancer survivors. The objective of this report is to examine whether herbal remedy use is associated with survival or the health-related QOL of these long-term breast cancer survivors.</p> <p>Methods</p> <p>In 1999-2000, we collected the information of herbal remedy use and QOL during a telephone interview with 371 Los Angeles Non-Hispanic/Hispanic white women who had survived more than 10 years after breast cancer diagnosis. QOL was measured using the Medical Outcomes Study Short Form-36 (SF-36) questionnaire. Patients were followed for mortality from the baseline interview through 2007. 299 surviving patients completed a second telephone interview on QOL in 2002-2004. We used multivariable Cox proportional hazards methods to estimate relative risks (RR) and 95% confidence intervals (CI) for mortality and applied multivariable linear regression models to compare average SF-36 change scores (follow-up - baseline) between herbal remedy users and non-users.</p> <p>Results</p> <p>Fifty-nine percent of participants were herbal remedy users at baseline. The most commonly used herbal remedies were echinacea, herbal teas, and ginko biloba. Herbal remedy use was associated with non-statistically significant increases in the risks for all-cause (44 deaths, RR = 1.28, 95% CI = 0.62-2.64) and breast cancer (33 deaths, RR = 1.78, 95% CI = 0.72-4.40) mortality. Both herbal remedy users' and non-users' mental component summary scores on the SF-36 increased similarly from the first survey to the second survey (<it>P </it>= 0.16), but herbal remedy users' physical component summary scores decreased more than those of non-users (-5.7 vs. -3.2, <it>P </it>= 0.02).</p> <p>Conclusions</p> <p>Our data provide some evidence that herbal remedy use is associated with poorer survival and a poorer physical component score for health-related QOL among women who have survived breast cancer for at least 10 years. These conclusions are based on exploratory analyses of data from a prospective study using two-sided statistical tests with no correction for multiple testing and are limited by few deaths for mortality analysis and lack of information on when herbal remedy use was initiated or duration of or reasons for use.</p

Transitioning HIV-infected adolescents to adult care at 14 clinics across the United States: Using adolescent and adult providers’ insights to create multi-level solutions to address transition barriers

HIV-infected adolescents have disproportionately low rates of care retention and viral suppression. Approximately half disengage from care while transitioning to adult clinics, in part due to fragmented care systems and lack of streamlined protocols. We conducted 58 qualitative interviews with social service and health care providers across 14 Adolescent Trials Network clinics (n=28) and 20 adult clinics that receive transitioning adolescents (n=30) from August 2015 – June 2016. We used the constant comparative approach to examine processes, barriers, and facilitators of adult care transition. Transition barriers coalesced around three levels. Structural: insurance eligibility, transportation, and HIV-related stigma; Clinical: inter-clinic communication, differences in care cultures, and resource/personnel limitations; and Individual: adolescents’ transition readiness and developmental capacity. Staff-initiated solutions (e.g., grant-funded transportation) were often unsustainable and applied individual-level solutions to structural-level barriers. Comprehensive initiatives, which develop collaborative policies and protocols that support providers’ ability to match the solution and barrier level (i.e., structural-to-structural), are sorely needed. These initiatives should also support local systematic planning to facilitate inter-clinic structures and communication. Such approaches will help HIV-infected adolescents transition to adult care and improve long-term health outcomes

RELEASE (REdressing Long-tErm Antidepressant uSE): protocol for a 3-arm pragmatic cluster randomised controlled trial effectiveness-implementation hybrid type-1 in general practice

BACKGROUND: Many people experience withdrawal symptoms when they attempt to stop antidepressants. Withdrawal symptoms are readily misconstrued for relapse or ongoing need for medication, contributing to long-term use (> 12 months). Long-term antidepressant use is increasing internationally yet is not recommended for most people. Long-term use is associated with adverse effects including weight gain, sexual dysfunction, lethargy, emotional numbing and increased risk of falls and fractures. This study aims to determine the effectiveness of two multi-strategy interventions (RELEASE and RELEASE+) in supporting the safe cessation of long-term antidepressants, estimate cost-effectiveness, and evaluate implementation strategies. METHODS: DESIGN: 3-arm pragmatic cluster randomised controlled trial effectiveness-implementation hybrid type-1. SETTING: primary care general practices in southeast Queensland, Australia. POPULATION: adults 18 years or older taking antidepressants for longer than 1 year. Practices will be randomised on a 1.5:1:1 ratio of Usual care:RELEASE:RELEASE+. INTERVENTION: RELEASE for patients includes evidence-based information and resources and an invitation to medication review; RELEASE for GPs includes education, training and printable resources via practice management software. RELEASE+ includes additional internet support for patients and prescribing support including audit and feedback for GPs. OUTCOME MEASURES: the primary outcome is antidepressant use at 12 months self-reported by patients. Cessation is defined as 0 mg antidepressant maintained for at least 2 weeks. SECONDARY OUTCOMES: at 6 and 12 months are health-related quality of life, antidepressant side effects, well-being, withdrawal symptoms, emotional numbing, beliefs about antidepressants, depressive symptoms, and anxiety symptoms; and at 12 months 75% reduction in antidepressant dose; aggregated practice level antidepressant prescribing, and health service utilisation for costs. SAMPLE SIZE: 653 patients from 28 practices. A concurrent evaluation of implementation will be through mixed methods including interviews with up to 40 patients and primary care general practitioners, brief e-surveys, and study administrative data to assess implementation outcomes (adoption and fidelity). DISCUSSION: The RELEASE study will develop new knowledge applicable internationally on the effectiveness, cost-effectiveness, and implementation of two multi-strategy interventions in supporting the safe cessation of long-term antidepressants to improve primary health care and outcomes for patients. TRIAL REGISTRATION: ANZCTR, ACTRN12622001379707p. Registered on 27 October 2022

Health related quality of life measured by SF-36: a population-based study in Shanghai, China

<p>Abstract</p> <p>Background</p> <p>Health related quality of life (HRQL) is a research topic that has attracted increasing interests around the world over the past two decades. The 36-item Short Form (SF-36) is a commonly used instrument for measuring HRQL. However, the information on Chinese adults' quality of life is limited. This paper reports on the feasibility of using the Mandarin version of SF-36 to evaluate HRQL in the population of Shanghai, China.</p> <p>Methods</p> <p>A total of 1034 subjects were randomly sampled using a stratified multiple-stage sampling method in Shanghai. Demographic information was collected, and SF-36 was used to measure HRQL.</p> <p>Results</p> <p>Internal reliability coefficients were greater than 0.7 in six of the eight SF-36 dimensions, except social function and mental health. Intraclass correlation coefficients ranged from 0.689 to 0.972. Split-half reliability coefficients were higher than 0.9 in five SF-36 dimensions. Validity was assessed by factor analysis and correlation analysis. Our results were basically in accordance with the theoretical construction of SF-36. The average scores of most SF-36 dimensions were higher than 80. The primary influencing risk factors of HRQL included chronic diseases, age, frequency of activities, and geographical region, which were identified using multivariate stepwise regression.</p> <p>Conclusion</p> <p>Overall, HRQL in the population of Shanghai is quite good. The Mandarin version of SF-36 is a valid and reliable tool for assessing HRQL.</p