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]

Intradialytic versus home based exercise training in hemodialysis patients: a randomised controlled trial

Background: Exercise training in hemodialysis patients improves fitness, physical function, quality of life and markers of cardiovascular disease such as arterial stiffness. The majority of trials investigating this area have used supervised exercise training during dialysis (intradialytic), which may not be feasible for some renal units. The aim of this trial is to compare the effects of supervised intradialytic with unsupervised home-based exercise training on physical function and arterial stiffness

Psychometric properties of the Chinese quality of life instrument (HK version) in Chinese and Western medicine primary care settings

Background: The Chinese Quality of Life Measure (ChQOL) had only been validated on a small number of selected subjects in Hong Kong and had never been tested in the Western medicine (WM) primary care setting. Aims: and objectives To test the psychometrics properties of ChQOL(HK version) in both TCM and WM general outpatient clinics. Methods: Three samples of Chinese adult patients [(1) 569 consulting TCM clinics for episodic illnesses; (2) 524 consulting WM clinics for episodic illnesses; (3) 205 consulting WM clinics for chronic disease follow-up] in Hong Kong were invited to complete the ChQOL(HK version) and the SF-36 Health Survey during their consultations and 2 weeks after consultations. The scaling assumptions, factor structure, convergent construct validity, reliability, responsiveness, and discriminatory power of the ChQOL were evaluated. Results: Majority of items satisfied the scaling assumptions. A two instead of 3-factor structure was found with physical form and emotion facets loading on one factor. Convergent construct validity was confirmed with moderate correlations with SF-36 scores. Internal consistency and test-retest reliability were satisfactory. The ChQOL(HK version) was able to detect significant improvements 2 weeks after consultations, and it was able to discriminate between groups with different illness severity, age, and sex. Conclusion The ChQOL(HK version) was shown to have satisfactory validity, reliability, discriminatory power, and responsiveness in both TCM and Western medicine primary care settings. The validity of the 3-domain scaling structure needs further evaluation. © The Author(s) 2011.published_or_final_versionSpringer Open Choice, 21 Feb 201

Cross-sectional and longitudinal construct validity of two rotator cuff disease-specific outcome measures

BACKGROUND: Disease-specific Quality Of Life (QOL) measures are devised to assess the impact of a specific disease across a spectrum of important domains of life. The purpose of this study was to examine the cross-sectional and longitudinal construct validity (sensitivity to change) of two rotator cuff disease-specific measures, the Rotator Cuff-Quality Of Life (RC-QOL) and the Western Ontario Rotator Cuff (WORC) index, in relation to one another and to other joint and limb specific measures in the same population of the patients suffering from rotator cuff pathology. METHODS: Participants enrolled were consecutive patients who received physical therapy for management of impingement syndrome or received treatment following rotator cuff repair, acromioplasty or decompression surgeries. All subjects received physical therapy treatment and completed four outcome measures at 3 single points (initial, interim, and final). Cross-sectional convergent validity was assessed at each of the 3 time-points by correlating the WORC and RC-QOL's scores to each other and to two alternative scales; a joint-specific scale, the American Shoulder and Elbow Surgeons (ASES) standardized shoulder assessment form and a limb-specific measure, the Upper Extremity Functional Index (UEFI). Non-parametric statistics (Spearman's rho and Wilcoxon-Mann-Whitney tests) examined the construct validity. The standardized response mean (SRM) was used to examine sensitivity to change. RESULTS: Forty-one participants entered the study and their scores were compared at 3 cross sectional single points. The correlation coefficients among the 4 measures varied from 0.60 to 0.91. Correlation between corresponding domains of the WORC and RC-QOL varied from 0.45 to 0.85. The known group validity was not significantly different among individual sub-scores and total scores. The final SRMs were (1.42), (1.43), (1.44), and (1.54) for the ASES, RCQOL, WORC, and UEFI respectively. CONCLUSION: The WORC and RC-QOL exhibit similar cross-sectional convergent validity in patients suffering from rotator cuff pathology. The sensitivity to change was very close among all scores, with the UEFI having the highest sensitivity. Further research is needed to examine the extent to which each physical or emotional domain contributes to prognostic or therapeutic decision-making

An interdisciplinary intervention for older Taiwanese patients after surgery for hip fracture improves health-related quality of life

Abstract Background The effects of intervention programs on health-related quality of life (HRQOL) of patients with hip fracture have not been well studied. We hypothesized that older patients with hip fracture who received our interdisciplinary intervention program would have better HRQOL than those who did not. Methods A randomized experimental design was used. Older patients with hip fracture (N = 162), 60 to 98 years old, from a medical center in northern Taiwan were randomly assigned to an experimental (n = 80) or control (n = 82) group. HRQOL was measured by the SF-36 Taiwan version at 1, 3, 6, and 12 months after discharge. Results The experimental group had significantly better overall outcomes in bodily pain (β = 9.38, p = 0.002), vitality (β = 9.40, p < 0.001), mental health (β = 8.16, p = 0.004), physical function (β = 16.01, p < 0.001), and role physical (β = 22.66, p < 0.001) than the control group at any time point during the first year after discharge. Physical-related health outcomes (physical functioning, role physical, and vitality) had larger treatment effects than emotional/mental- and social functioning-related health outcomes. Conclusions This interdisciplinary intervention program may improve health outcomes of elders with hip fracture. Our results may provide a reference for health care providers in countries using similar programs with Chinese/Taiwanese immigrant populations. Trial registration NCT01052636http://deepblue.lib.umich.edu/bitstream/2027.42/78259/1/1471-2474-11-225.xmlhttp://deepblue.lib.umich.edu/bitstream/2027.42/78259/2/1471-2474-11-225.pdfPeer Reviewe

Laminin γ2 fragments are increased in the circulation of patients with early phase acute lung injury

Katayama, M., Ishizaka, A., Sakamoto, M. et al. Intensive Care Med (2010) 36: 479. https://doi.org/10.1007/s00134-009-1719-

Measuring health-related quality of life in population-based studies of coronary heart disease: comparing six generic indexes and a disease-specific proxy score

To compare HRQoL differences with CHD in generic indexes and a proxy CVD-specific score in a nationally representative sample of U.S. adults. The National Health Measurement Study, a cross-sectional random-digit-dialed telephone survey of adults aged 35–89, administered the EQ-5D, QWB-SA, HUI2, HUI3, SF-36v2™ (yielding PCS, MCS, and SF-6D), and HALex. Analyses compared 3,350 without CHD (group 1), 265 with CHD not taking chest pain medication (group 2), and 218 with CHD currently taking chest pain medication (group 3), with and without adjustment for demographic variables and comorbidities. Data on 154 patients from heart failure clinics were used to construct a proxy score utilizing generic items probing CVD symptoms. Mean scores differed between CHD groups for all indexes with and without adjustment (P < 0.0001 for all except MCS P = 0.018). Unadjusted group 3 versus 1 differences were about three times larger than for group 2 versus 1. Standardized differences for the proxy score were similar to those for generic indexes, and were about 1.0 for all except MCS for group 3 versus 1. Generic indexes capture differences in HRQoL in population-based studies of CHD similarly to a score constructed from questions probing CVD-specific symptoms

The relationship between risk factors for falling and the quality of life in older adults

BACKGROUND: Falls are one of the major health problems that effect the quality of life among older adults. The aim of this study was to explore the relationship between quality of life (Short Form-12) and the risk factors of falls (balance, functional mobility, proprioception, muscle strength, flexibility and fear of falling) in older adults. METHODS: One hundred sixteen people aged 65 or older and living in the T.C. Emekli Sandigi Narlidere nursing home participated in the study. Balance (Berg Balance test), functional mobility (Timed Up and Go), proprioception (joint position sense), muscle strength (back/leg dynamometer), flexibility (sit and reach) and fear of falling (Visual Analogue Scale) were assessed as risk factors for falls. The quality of life was measured by Short Form-12 (SF-12). RESULTS: A strong positive correlation was observed between Physical Health Component Summary of SF-12, General Health Perception and balance, muscle strength. Proprioception and flexibility did not correlated with SF-12 (p > 0.05). There was negative correlation between Physical Health Component Summary of SF-12, General Health Perception and fear of falling, functional mobility (p < 0.05). CONCLUSION: We concluded that the risk factors for falls (balance, functional mobility, muscle strength, fear of falling) in older adults are associated with quality of life while flexibility and proprioception are not