Publications by authors named "Edward Leung"

87 Publications

Development and Validation of a Liquid Chromatography Mass Spectrometry Method for Simultaneous Measurement of 25(OH)D3, epi-25(OH)D3, 25(OH)D2, Vitamin A, α-Tocopherol, and γ-Tocopherol.

Am J Clin Pathol 2021 Aug 31. Epub 2021 Aug 31.

Department of Pathology and Laboratory Medicine, Children's Hospital of Los Angeles, Los Angeles, CA, USA.

Objectives: Fat-soluble vitamins are measured to identify deficiencies that may lead to rickets, osteomalacia, night blindness, and reversible motor and sensory neuropathies. We present a rapid liquid chromatography-mass spectrometry (LC-MS/MS) method that simultaneously measures 25-hydroxyvitamin D3 (25[OH]D3), epi-25(OH)D3, 25(OH)D2, vitamin A, α-tocopherol, and γ-tocopherol.

Methods: We mixed 100 µL serum with internal standard and extracted it by using supported liquid extraction plates. Reconstituted specimens were analyzed by LC-MS/MS with a 10-minute gradient.

Results: The method was linear, covering physiological levels with r2 > 0.99, and the total precision was less than 15% at all quality control levels. The lower limit of the measuring intervals for 25(OH)D3, epi-25(OH)D3, 25(OH)D2, vitamin A, α-tocopherol, and γ-tocopherol were 4 ng/mL, 4 ng/mL, 4 ng/mL, 1 µg/dL, 0.2 µg/mL, and 0.2 µg/mL, respectively, with coefficient of variation of 20% or less. Recoveries were between 92% and 111% for National Institute of Standards and Technology reference materials and 81% and 122% for spike-recovery studies. Comparison studies for vitamin D total, vitamin A, and α-tocopherol demonstrated slopes between 1.04 and 1.11 and r2 between 0.94 and 0.96. Minimal matrix effect was observed for all analytes.

Conclusions: We developed and validated a rapid LC-MS/MS method for the simultaneous measurement of 25(OH)D3, epi-25(OH)D3, 25(OH)D2, vitamin A, α-tocopherol, and γ-tocopherol.
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http://dx.doi.org/10.1093/ajcp/aqab088DOI Listing
August 2021

Parathyroid hormone.

Adv Clin Chem 2021 20;101:41-93. Epub 2020 Jul 20.

Department of Pathology and Laboratory Medicine, Children's Hospital Los Angeles, Los Angeles, CA, United States; Department of Pathology, Keck School of Medicine of University of Southern California, Los Angeles, CA, United States. Electronic address:

Parathyroid hormone is an essential regulator of extracellular calcium and phosphate. PTH enhances calcium reabsorption while inhibiting phosphate reabsorption in the kidneys, increases the synthesis of 1,25-dihydroxyvitamin D, which then increases gastrointestinal absorption of calcium, and increases bone resorption to increase calcium and phosphate. Parathyroid disease can be an isolated endocrine disorder or part of a complex syndrome. Genetic mutations can account for diseases of parathyroid gland formulation, dysregulation of parathyroid hormone synthesis or secretion, and destruction of the parathyroid glands. Over the years, a number of different options are available for the treatment of different types of parathyroid disease. Therapeutic options include surgical removal of hypersecreting parathyroid tissue, administration of parathyroid hormone, vitamin D, activated vitamin D, calcium, phosphate binders, calcium-sensing receptor, and vitamin D receptor activators to name a few. The accurate assessment of parathyroid hormone also provides essential biochemical information to properly diagnose parathyroid disease. Currently available immunoassays may overestimate or underestimate bioactive parathyroid hormone because of interferences from truncated parathyroid hormone fragments, phosphorylation of parathyroid hormone, and oxidation of amino acids of parathyroid hormone.
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http://dx.doi.org/10.1016/bs.acc.2020.06.005DOI Listing
July 2021

The adjuvanted recombinant zoster vaccine is efficacious and safe in Asian adults ≥ 50 years of age: a sub-cohort analysis of the ZOE-50 and ZOE-70 randomized trials.

Hum Vaccin Immunother 2021 07 19;17(7):2050-2057. Epub 2021 Feb 19.

GSK, Rockville, MD, USA.

In two large clinical trials (ZOE-50 [NCT01165177] and ZOE-70 [NCT01165229]), two doses of the adjuvanted recombinant zoster vaccine (RZV) demonstrated >90% efficacy (VE) against herpes zoster (HZ) in adults ≥50 years of age (YOA). This post-hoc analysis assessed the VE against HZ and postherpetic neuralgia (PHN), in participants from Asian study sites enrolled in ZOE-50/70. Reactogenicity and safety were also assessed. Participants ≥50 YOA were randomized 1:1 to receive 2 doses of either RZV or placebo, 2 months apart. VE was evaluated for a median follow-up of 4 years post-vaccination overall and by age in the ZOE-50 Asian population ≥50 YOA and in the pooled ZOE-50/70 Asian population ≥70 YOA. Of the 2,729 participants included in the ZOE-50 Asian population ≥50 YOA, 3 RZV and 66 placebo recipients reported a confirmed HZ episode. Overall VE was 95.6% (95% confidence interval [CI]: 86.4-99.1) against HZ and 100% (95% CI: 35.44-100) against PHN. In the pooled ZOE-50/70 Asian population ≥70 YOA, 4 RZV and 75 placebo recipients out of the 2,723 participants reported a confirmed HZ episode. Overall VE was 94.7% (95% CI: 85.9-98.6) against HZ and 89.8% (95% CI: 28.39-99.77) against PHN. Pain and myalgia were the most frequent solicited local and general adverse events, respectively, in both populations. No safety concern was identified during the study periods. RZV is highly efficacious against HZ and PHN and has an acceptable safety profile in Asian populations ≥50 YOA, similar to what was observed in the general ZOE-50/70 populations.: is a trademark owned by or licensed to the GSK group of companies.
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http://dx.doi.org/10.1080/21645515.2020.1859321DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8189096PMC
July 2021

Longitudinal changes in emotional functioning following pediatric resective epilepsy surgery: 2-Year follow-up.

Epilepsy Behav 2021 01 1;114(Pt A):107585. Epub 2020 Dec 1.

Neurosciences and Mental Health Program, The Hospital for Sick Children, Toronto, ON, Canada; Department of Psychology, The Hospital for Sick Children, Toronto, ON, Canada; Department of Psychology, University of Toronto Mississauga, Mississauga, ON, Canada. Electronic address:

Objective: To examine longitudinal changes and predictors of depression and anxiety 2 years following resective epilepsy surgery, compared to no surgery, in children with drug-resistant epilepsy (DRE).

Method: This multicenter cohort study involved 128 children and adolescents with DRE (48 surgical, 80 nonsurgical; 8-18 years) who completed self-report measures of depression and anxiety at baseline and follow-up (6-month, 1-year, 2-year). Child demographic (age, sex, IQ) and seizure (age at onset, duration, frequency, site and side) variables were collected.

Results: Linear mixed-effects models controlling for age at enrolment found a time by treatment by seizure outcome interaction for depression. A negative linear trend across time (reduction in symptoms) was found for surgical patients, irrespective of seizure outcome. In contrast, the linear trend differed depending on seizure outcome in nonsurgical patients; a negative trend was found for those with continued seizures, whereas a positive trend (increase in symptoms) was found for those who achieved seizure freedom. Only a main effect of time was found for anxiety indicating a reduction in symptoms across patient groups. Multivariate regressions failed to find baseline predictors of depression or anxiety at 2-year follow-up in surgical patients. Older age, not baseline anxiety or depression, predicted greater symptoms of anxiety and depression at 2-year follow-up in nonsurgical patients.

Conclusion: Children with DRE reported improvement in anxiety and depression, irrespective of whether they achieve seizure control, across the 2 years following surgery. In contrast, children with DRE who did not undergo surgery, but achieved seizure freedom, reported worsening of depressive symptoms, which may indicate difficulty adjusting to life without seizures and highlight the potential need for ongoing medical and psychosocial follow-up and support.
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http://dx.doi.org/10.1016/j.yebeh.2020.107585DOI Listing
January 2021

Typology of pain coping and associations with physical health, mental health, and pain profiles in Hong Kong Chinese older adults.

Aging Ment Health 2021 Nov 5;25(11):2169-2177. Epub 2020 Oct 5.

Department of Psychiatry, North District Hospital, Hong Kong.

Objectives: To identify typology of pain coping in older adults and to see whether the coping types or patterns were associated with pain, physical health, and mental health outcomes.

Methods: Six hundred and fifty six Chinese older adults were recruited on a convenience basis from social centers in Hong Kong. A 14-item Brief Pain Coping Scale (BPCS) was constructed on the basis of the Chronic Pain Coping Inventory. Outcome measures included pain intensity, pain disability, pain-related cognitions, depressive symptoms, health-related quality of life, and health and physical functioning (in terms of chronic illnesses, basic and instrumental activities of daily living, and self-rated health). Coping typology was identified using latent class analysis.

Results: A 3-class solution based on BPCS provided the best fit to data. Class 1 used almost all coping strategies on a daily basis, Class 2 used the strategies less frequently, whereas Class 3 adopted few strategies. Yet, Class 3 was basically indistinguishable from Class 1 across the outcome variables, even though the participants had more chronic illnesses and poorer instrumental activities of daily living than those in Class 1. Class 2, however, had the poorest outcome profiles, reporting more pain, disability, depression, and health-related quality of life than the other two classes. The differences in coping could not be explained by the differential effectiveness of coping strategies across groups.

Conclusion: The way coping was used, and the way it was related to pain, mood, health and functioning outcomes, varied substantially across individuals. Implications for coping skills interventions are discussed.
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http://dx.doi.org/10.1080/13607863.2020.1821171DOI Listing
November 2021

Evaluation of the Order SMARTT: An Initiative to Reduce Phlebotomy and Improve Sleep-Friendly Labs on General Medicine Services.

J Hosp Med 2020 08;15(8):479-482

Department of Medicine, University of Chicago, Chicago, Illinois.

We assessed the effectiveness of a quality improvement project to reduce routine labs in clinically stable patients, while also promoting sleep-friendly lab timing. The electronic health record was modified with an "Order Sleep" shortcut to facilitate sleep-friendly lab draws. A "4 AM Labs" column was added to electronic patient lists to signal which patients had early morning labs ordered. Among 7,045 patients over 50,951 total patient-days, on average we observed 26.3% fewer routine lab draws per patient-day per week postintervention (4.68 before vs 3.45 after; difference, 1.23; 95% CI, 0.82-1.63; P < .05). In interrupted time series analysis, the "Order Sleep" tool was associated with a significant increase in sleep-friendly lab orders per encounter per week on resident medicine services (intercept, 1.03; standard error (SE), 0.29; P < .001). The "4 AM Labs" column was associated with a significant increase in sleep-friendly lab orders per patient encounter per week on the hospitalist medical service (intercept, 1.17; SE, 0.50; P = .02). We demonstrate the success of an initiative to simultaneously reduce daily labs and improve sleep-friendly ordering.
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http://dx.doi.org/10.12788/jhm.3423DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7518135PMC
August 2020

Is routine colonoscopy necessary for patients who have an unequivocal computerised tomography diagnosis of acute diverticulitis?

Scott Med J 2021 Feb 11;66(1):11-15. Epub 2020 Aug 11.

Consultant general surgeon, General Surgery Department, University Hospital Crosshouse, UK.

Aims: To assess the incidence of underlying colorectal malignancy in patients admitted as an emergency with a CT diagnosis of acute diverticulitis and determine the need for routine follow up colonoscopy.

Methods: A retrospective study was performed on all patients who had been admitted to our surgical unit with CT diagnosed diverticulitis from September 2016 to September 2018 (n = 125).

Results: 11 patients (8.8%) required emergency resection with no underlying malignancy found. 76 patients (61%) had a follow up colonoscopy after being discharged. 4 patients were found to have an underlying colorectal malignancy, one of them suspected on CT and another an incidentally detected caecal polyp cancer. Therefore 3/87(3.4%) had an unexpected cancer diagnosis and all those in the diseased segment were within complicated diverticulitis.

Conclusion: Nowadays, multi-slice CT scanners are so good at giving an accurate assessment of colonic pathology. In our study, 96.6% of the patients with a CT diagnosis of acute diverticulitis had no underlying malignancy in the diseased segment with all the cancers within complicated diverticulitis. With such a low yield of underlying malignancy in uncomplicated diverticulitis, we question the need for routine follow up colonoscopy when there is no CT suspicion of malignancy in these patients.
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http://dx.doi.org/10.1177/0036933020949228DOI Listing
February 2021

A National Spinal Muscular Atrophy Registry for Real-World Evidence.

Can J Neurol Sci 2020 11 4;47(6):810-815. Epub 2020 Jun 4.

Department of Pediatrics, Children's Hospital of Eastern Ontario, University of Ottawa, Ottawa, ON, Canada.

Background: Spinal muscular atrophy (SMA) is a devastating rare disease that affects individuals regardless of ethnicity, gender, and age. The first-approved disease-modifying therapy for SMA, nusinursen, was approved by Health Canada, as well as by American and European regulatory agencies following positive clinical trial outcomes. The trials were conducted in a narrow pediatric population defined by age, severity, and genotype. Broad approval of therapy necessitates close follow-up of potential rare adverse events and effectiveness in the larger real-world population.

Methods: The Canadian Neuromuscular Disease Registry (CNDR) undertook an iterative multi-stakeholder process to expand the existing SMA dataset to capture items relevant to patient outcomes in a post-marketing environment. The CNDR SMA expanded registry is a longitudinal, prospective, observational study of patients with SMA in Canada designed to evaluate the safety and effectiveness of novel therapies and provide practical information unattainable in trials.

Results: The consensus expanded dataset includes items that address therapy effectiveness and safety and is collected in a multicenter, prospective, observational study, including SMA patients regardless of therapeutic status. The expanded dataset is aligned with global datasets to facilitate collaboration. Additionally, consensus dataset development aimed to standardize appropriate outcome measures across the network and broader Canadian community. Prospective outcome studies, data use, and analyses are independent of the funding partner.

Conclusion: Prospective outcome data collected will provide results on safety and effectiveness in a post-therapy approval era. These data are essential to inform improvements in care and access to therapy for all SMA patients.
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http://dx.doi.org/10.1017/cjn.2020.111DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7656664PMC
November 2020

Orally consumed cannabinoids provide long-lasting relief of allodynia in a mouse model of chronic neuropathic pain.

Neuropsychopharmacology 2020 06 7;45(7):1105-1114. Epub 2019 Dec 7.

Department of Pharmacology, University of Washington, 1959 NE Pacific St., Seattle, WA, 98195, USA.

Chronic pain affects a significant percentage of the United States population, and available pain medications like opioids have drawbacks that make long-term use untenable. Cannabinoids show promise in the management of pain, but long-term treatment of pain with cannabinoids has been challenging to implement in preclinical models. We developed a voluntary, gelatin oral self-administration paradigm that allowed male and female mice to consume ∆-tetrahydrocannabinol, cannabidiol, or morphine ad libitum. Mice stably consumed these gelatins over 3 weeks, with detectable serum levels. Using a real-time gelatin measurement system, we observed that mice consumed gelatin throughout the light and dark cycles, with animals consuming less THC-gelatin than the other gelatin groups. Consumption of all three gelatins reduced measures of allodynia in a chronic, neuropathic sciatic nerve injury model, but tolerance to morphine developed after 1 week while THC or CBD reduced allodynia over three weeks. Hyperalgesia gradually developed after sciatic nerve injury, and by the last day of testing, THC significantly reduced hyperalgesia, with a trend effect of CBD, and no effect of morphine. Mouse vocalizations were recorded throughout the experiment, and mice showed a large increase in ultrasonic, broadband clicks after sciatic nerve injury, which was reversed by THC, CBD, and morphine. This study demonstrates that mice voluntarily consume both cannabinoids and opioids via gelatin, and that cannabinoids provide long-term relief of chronic pain states. In addition, ultrasonic clicks may objectively represent mouse pain status and could be integrated into future pain models.
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http://dx.doi.org/10.1038/s41386-019-0585-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7235274PMC
June 2020

Analytical Differences in Intraoperative Parathyroid Hormone Assays.

J Appl Lab Med 2019 03 1;3(5):788-798. Epub 2019 Feb 1.

Department of Pathology, Pritzker School of Medicine, The University of Chicago, Chicago, IL.

Background: We compared the rates of intraoperative parathyroid hormone (PTH) decline using the Siemens Immulite Turbo PTH and Roche Elecsys short turnaround time PTH assays in 95 consecutive surgical patients to investigate analytical and turnaround time (TAT) differences between the tests performed in the operating room (OR) vs the central clinical chemistry laboratory (CCL).

Methods: Serial blood samples from 95 patients undergoing parathyroidectomy were collected and measured using the 2 immunoassays. Specimens from the first 15 patients were measured simultaneously in the OR and CCL and used for the TAT study. In addition to 2 baseline samples, specimens were collected at 5, 10, and 15 min (for some patients, >15 min) after parathyroidectomy.

Results: In the TAT study, a significant difference was observed (OR median 20 min vs CCL median 27 min; < 0.05). Of the 95 patient series, slower rates of parathyroid hormone decrease were observed in approximately 20% of the patients when comparing the Roche with the Immulite immunoassay.

Conclusions: There was a slightly longer TAT in the CCL compared with running the assay directly within the OR (median difference of approximately 7 min). For a majority of the patients, both methods showed equivalent rates of PTH decline; however, for approximately 20% of the patients, there was a slower rate of PTH decline using the Roche assay.
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http://dx.doi.org/10.1373/jalm.2018.026815DOI Listing
March 2019

Evaluation of a New Generation Automated Assay for 25-Hydroxy Vitamin D Based on Competitive Protein Binding.

J Appl Lab Med 2019 09 26;4(2):247-253. Epub 2019 Jun 26.

Department of Pathology, Pritzker School of Medicine, The University of Chicago, Chicago, IL;

Background: The interest for vitamin D has exponentially increased testing demand for 25-hydroxy vitamin D [25(OH)D]. Consequently, many laboratories are switching from LC-MS/MS methods to automated, high-throughput immunoassays. One of the major potential issues with these assays has been the lack of cross-reactivity with 25(OH)D2.

Methods: We have evaluated the Roche Elecsys vitamin D total II assay for accuracy by comparing 79 patient samples with LC-MS/MS. The cross-reactivity for 25(OH)D2 was evaluated by analyzing samples with high 25(OH)D2 separately and estimating 25(OH)D2 recovery, as well as by spiking of 25(OH)D2. The assay was further evaluated for precision, linearity, sample type, and common interferences.

Results: There was mostly good agreement between the Elecsys and LC-MS/MS assays (Deming regression: = 0.95 + 0.70), with an overall bias of 2.3% (-0.84 ng/mL). However, there were 6 out of 79 (7.6%) discordant samples. The Deming regression for samples with high 25(OH)D2 compared to LC-MS/MS showed similar slope and intercept ( = 0.97 - 1.1). The average recovery of 25(OH)D2 for these samples was 90%. The initial precision studies were in general agreement with the package insert, but long-term clinical use showed higher-than-claimed imprecision (11.7%-14.4% at 12 ng/mL and 6.9%-7.6% at 27 ng/mL; claimed: 7.2% and 5.0%, respectively). We observed 1 falsely high result in plasma, an issue previously addressed by Roche in a medical device correction.

Conclusions: The analytical performance of the Roche Vitamin D assay was acceptable, and the assay had a good cross-reactivity for 25(OH)D2.
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http://dx.doi.org/10.1373/jalm.2018.028415DOI Listing
September 2019

Pharmacogenomic genotypes define genetic ancestry in patients and enable population-specific genomic implementation.

Pharmacogenomics J 2020 02 11;20(1):126-135. Epub 2019 Sep 11.

University of Chicago, Center for Personalized Therapeutics, Chicago, IL, USA.

The importance of genetic ancestry characterization is increasing in genomic implementation efforts, and clinical pharmacogenomic guidelines are being published that include population-specific recommendations. Our aim was to test the ability of focused clinical pharmacogenomic SNP panels to estimate individual genetic ancestry (IGA) and implement population-specific pharmacogenomic clinical decision-support (CDS) tools. Principle components and STRUCTURE were utilized to assess differences in genetic composition and estimate IGA among 1572 individuals from 1000 Genomes, two independent cohorts of Caucasians and African Americans (AAs), plus a real-world validation population of patients undergoing pharmacogenomic genotyping. We found that clinical pharmacogenomic SNP panels accurately estimate IGA compared to genome-wide genotyping and identify AAs with ≥70 African ancestry (sensitivity >82%, specificity >80%, PPV >95%, NPV >47%). We also validated a new AA-specific warfarin dosing algorithm for patients with ≥70% African ancestry and implemented it at our institution as a novel CDS tool. Consideration of IGA to develop an institutional CDS tool was accomplished to enable population-specific pharmacogenomic guidance at the point-of-care. These capabilities were immediately applied for guidance of warfarin dosing in AAs versus Caucasians, but also provide a real-world model that can be extended to other populations and drugs as actionable genomic evidence accumulates.
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http://dx.doi.org/10.1038/s41397-019-0095-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7184888PMC
February 2020

Development of a Nonradioactive Platelet Serotonin Uptake and Release Assay by Micro-Liquid Chromatography Tandem Mass Spectrometry Using Minimal Blood Volume.

Am J Clin Pathol 2019 11;152(6):718-724

Department of Pathology, University of Chicago, Chicago, IL.

Objectives: Analysis of platelet functional responses to stimuli is presently quite limited with respect to measurement of dense granule secretion. We sought to develop a nonradioactive assay of stimulated serotonin release using liquid chromatography tandem mass spectrometry (LC-MS/MS).

Methods: Citrated whole blood (200 μL) was incubated with deuterated serotonin (d45-HT). Following uptake by platelets, blood was diluted 10-fold and aliquots were incubated with platelet stimuli. Following stimulation, blood was further diluted, centrifuged, and supernatant was assayed for released d45-HT by micro-LC-MS/MS.

Results: This study demonstrated a broad linear range of 50 to 2,000 pg/mL d45-HT, with a total precision of less than 15.0% coefficient of variation at all quality control levels and a limit of quantitation of 50 pg/mL.

Conclusions: Quantification of d45-HT by micro-LC-MS/MS assay offers a highly sensitive, nonradioactive methodology for quantitating platelet serotonin uptake and dense granule secretion, requiring only small volumes of patient blood.
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http://dx.doi.org/10.1093/ajcp/aqz094DOI Listing
November 2019

Dosage Related Efficacy and Tolerability of Cannabidiol in Children With Treatment-Resistant Epileptic Encephalopathy: Preliminary Results of the CARE-E Study.

Front Neurol 2019 3;10:716. Epub 2019 Jul 3.

Service de Neurologie Pédiatrique, Département de Neurosciences, Centre Hospitalier Universitaire Sainte-Justine, Université de Montréal, Montreal, QC, Canada.

There is uncertainty regarding the appropriate dose of Cannabidiol (CBD) for childhood epilepsy. We present the preliminary data of seven participants from the Cannabidiol in Children with Refractory Epileptic Encephalopathy (CARE-E) study. The study is an open-label, prospective, dose-escalation trial. Participants received escalating doses of a Herbal Extract (CHE) preparation of 1:20 Δ-tetrahydrocannabinol (THC): CBD up to 10-12 mg CBD/kg/day. Seizure frequency was monitored in daily logs, participants underwent regular electroencephalograms, and parents filled out modified Quality of Life in Childhood Epilepsy (QOLCE) and Side Effect rating scale questionnaires. Steady-state trough levels (C) of selected cannabinoids were quantified. All seven participants tolerated the CHE up to 10-12 mg CBD/kg/day and had improvements in seizure frequency and QOLCE scores. C plasma levels for CBD, THC, and cannabichromene (CBC) showed dose-independent pharmacokinetics in all but one participant. C CBD levels associated with a >50% reduction in seizures and seizure freedom were lower than those reported previously with purified CBD. In most patients, C levels of THC remained lower than what would be expected to cause intoxication. The preliminary data suggest an initial CBD target dose of 5-6 mg/kg/day when a 1:20 THC:CBD CHE is used. Possible non-linear pharmacokinetics of CBD and CBC needs investigation. The reduction in seizure frequency seen suggests improved seizure control when a whole plant CHE is used. Plasma THC levels suggest a low risk of THC intoxication when a 1:20 THC:CBD CHE is used in doses up to 12 mg/kg CBD/kg/day.
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http://dx.doi.org/10.3389/fneur.2019.00716DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6616248PMC
July 2019

Smartphone EEG and remote online interpretation for children with epilepsy in the Republic of Guinea: Quality, characteristics, and practice implications.

Seizure 2019 Oct 31;71:93-99. Epub 2019 May 31.

Department of Neurology, Massachusetts General Hospital, Boston, MA, USA; Neurological Clinical Research Institute, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA. Electronic address:

Purpose: Children with epilepsy in low-income countries often go undiagnosed and untreated. We examine a portable, low-cost smartphone-based EEG technology in a heterogeneous pediatric epilepsy cohort in the West African Republic of Guinea.

Methods: Children with epilepsy were recruited at the Ignace Deen Hospital in Conakry, 2017. Participants underwent sequential EEG recordings with an app-based EEG, the Smartphone Brain Scanner-2 (SBS2) and a standard Xltek EEG. Raw EEG data were transmitted via Bluetooth connection to an Android tablet and uploaded for remote EEG specialist review and reporting via a new, secure web-based reading platform, crowdEEG. The results were compared to same-visit Xltek 10-20 EEG recordings for identification of epileptiform and non-epileptiform abnormalities.

Results: 97 children meeting the International League Against Epilepsy's definition of epilepsy (49 male; mean age 10.3 years, 29 untreated with an antiepileptic drug; 0 with a prior EEG) were enrolled. Epileptiform discharges were detected on 21 (25.3%) SBS2 and 31 (37.3%) standard EEG recordings. The SBS2 had a sensitivity of 51.6% (95%CI 32.4%, 70.8%) and a specificity of 90.4% (95%CI 81.4%, 94.4%) for all types of epileptiform discharges, with positive and negative predictive values of 76.2% and 75.8% respectively. For generalized discharges, the SBS2 had a sensitivity of 43.5% with a specificity of 96.2%.

Conclusions: The SBS2 has a moderate sensitivity and high specificity for the detection of epileptiform abnormalities in children with epilepsy in this low-income setting. Use of the SBS2+crowdEEG platform permits specialist input for patients with previously poor access to clinical neurophysiology expertise.
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http://dx.doi.org/10.1016/j.seizure.2019.05.025DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6783351PMC
October 2019

Developing a Short Multidimensional Measure of Pain Self-efficacy: The Chronic Pain Self-efficacy Scale-Short Form.

Gerontologist 2020 04;60(3):e127-e136

Department of Psychiatry, North District Hospital, Hong Kong.

Background And Objectives: The 22-item Chronic Pain Self-efficacy Scale (CPSS) measures three domains of pain self-efficacy: pain management, physical functioning, and coping with symptoms. This study aims to develop a short form (CPSS-SF) that retains the multidimensional structure of the instrument.

Research Design And Methods: Six hundred sixty-four community-dwelling Chinese older adults aged 60-95 years with chronic pain completed a survey. Confirmatory factor analysis (CFA) was conducted on the 22-item CPSS. Regression analyses were performed to examine the items' correlations with criterion variables. After CPSS-SF items were selected, the performance of CPSS-SF subscales in terms of accounting for pain-related outcomes was compared with the full version.

Results: CFA supported a modified 3-factor model of the CPSS. On the basis of factor loadings on the 3 dimensions and the items' correlations with pain intensity and pain disability, 11 items were selected for the CPSS-SF, which correlated at .97 with the full version. Regression analyses showed that the associations of the CPSS-SF subscales with pain intensity, pain disability, depressive symptoms, instrumental activities of daily living, and physical and mental health-related quality of life, were indistinguishable from their full-version counterparts.

Discussion And Implications: The CPSS-SF is a valid instrument that can be used in lieu of the full scale. Its availability will facilitate the assessment of pain self-efficacy in research and clinical settings due to its brevity but strong psychometric properties. However, the current evidence is limited to Chinese older adults; more research is needed to ascertain its validity in other age and cultural groups.
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http://dx.doi.org/10.1093/geront/gnz041DOI Listing
April 2020

Natural History of Perinatal and Infantile Hypophosphatasia: A Retrospective Study.

J Pediatr 2019 06 9;209:116-124.e4. Epub 2019 Apr 9.

University Children's Hospital, University of Würzburg, Würzburg, Germany.

Objective: To report clinical characteristics and medical history data obtained retrospectively for a large cohort of pediatric patients with perinatal and infantile hypophosphatasia.

Study Design: Medical records from academic medical centers known to diagnose and/or treat hypophosphatasia were reviewed. Patients born between 1970 and 2011 with hypophosphatasia and any of the following signs/symptoms at age <6 months were eligible: vitamin B6-dependent seizures, respiratory compromise, or rachitic chest deformity (NCT01419028). Patient demographics and characteristics, respiratory support requirements, invasive ventilator-free survival, and further complications of hypophosphatasia were followed for up to the first 5 years of life.

Results: Forty-eight patients represented 12 study sites in 7 countries; 13 patients were alive, and 35 were dead (including 1 stillborn). Chest deformity, respiratory distress, respiratory failure (as conditioned by the eligibility criteria), failure to thrive, and elevated calcium levels were present in >70% of patients between birth and age 5 years. Vitamin B6-dependent seizures and respiratory distress and failure were associated significantly (P < .05) with the risk of early death. Serum alkaline phosphatase activity in all 41 patients tested (mean [SD]: 18.1 [15.4] U/L) was below the mean lower limit of normal of the reference ranges of the various laboratories (88.2 U/L). Among the 45 patients with relevant data, 29 had received respiratory support, of whom 26 had died at the time of data collection. The likelihood of invasive ventilator-free survival for this cohort decreased to 63% at 3 months, 54% at 6 months, 31% at 12 months, and 25% at 5 years.

Conclusions: Patients with perinatal or infantile hypophosphatasia and vitamin B6-dependent seizures, with or without significant respiratory distress or chest deformities, have high morbidity and mortality in the first 5 years of life.

Trial Registration: ClinicalTrials.gov: NCT01419028.
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http://dx.doi.org/10.1016/j.jpeds.2019.01.049DOI Listing
June 2019

The Pain Catastrophizing Scale-short form: psychometric properties and threshold for identifying high-risk individuals.

Int Psychogeriatr 2019 11 20;31(11):1665-1674. Epub 2019 Feb 20.

Department of Psychiatry, North District Hospital, Hong Kong.

Objective: The Pain Catastrophizing Scale (PCS) measures three aspects of catastrophic cognitions about pain-rumination, magnification, and helplessness. To facilitate assessment and clinical application, we aimed to (a) develop a short version on the basis of its factorial structure and the items' correlations with key pain-related outcomes, and (b) identify the threshold on the short form indicative of risk for depression.

Design: Cross-sectional survey.

Setting: Social centers for older people.

Participants: 664 Chinese older adults with chronic pain.

Measurements: Besides the PCS, pain intensity, pain disability, and depressive symptoms were assessed.

Results: For the full scale, confirmatory factor analysis showed that the hypothesized 3-factor model fit the data moderately well. On the basis of the factor loadings, two items were selected from each of the three dimensions. An additional item significantly associated with pain disability and depressive symptoms, over and above these six items, was identified through regression analyses. A short-PCS composed of seven items was formed, which correlated at r=0.97 with the full scale. Subsequently, receiver operating characteristic (ROC) curves were plotted against clinically significant depressive symptoms, defined as a score of ≥12 on a 10-item version of the Center for Epidemiologic Studies-Depression Scale. This analysis showed a score of ≥7 to be the optimal cutoff for the short-PCS, with sensitivity = 81.6% and specificity = 78.3% when predicting clinically significant depressive symptoms.

Conclusions: The short-PCS may be used in lieu of the full scale and as a brief screen to identify individuals with serious catastrophizing.
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http://dx.doi.org/10.1017/S1041610219000024DOI Listing
November 2019

Effectiveness of SIESTA on Objective and Subjective Metrics of Nighttime Hospital Sleep Disruptors.

J Hosp Med 2019 01;14(1):38-41

University of Chicago Medicine, Chicago, Illinois, USA.

We created Sleep for Inpatients: Empowering Staff to Act (SIESTA), which combines electronic "nudges" to forgo nocturnal vitals and medications with interprofessional education on improving patient sleep. In one "SIESTAenhanced unit," nurses received coaching and integrated SIESTA into daily huddles; a standard unit did not. Six months pre- and post-SIESTA, sleep-friendly orders rose in both units (foregoing vital signs: SIESTA unit, 4% to 34%; standard, 3% to 22%, P < .001 both; sleeppromoting VTE prophylaxis: SIESTA, 15% to 42%; standard, 12% to 28%, P < .001 both). In the SIESTAenhanced unit, nighttime room entries dropped by 44% (-6.3 disruptions/room, P < .001), and patients were more likely to report no disruptions for nighttime vital signs (70% vs 41%, P = .05) or medications (84% vs 57%, P = .031) than those in the standard unit. The standard unit was not changed. Although sleep-friendly orders were adopted in both units, a unit-based nursing empowerment approach was associated with fewer nighttime room entries and improved patient experience.
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http://dx.doi.org/10.12788/jhm.3091DOI Listing
January 2019

The relationship of self-efficacy to catastrophizing and depressive symptoms in community-dwelling older adults with chronic pain: A moderated mediation model.

PLoS One 2018 18;13(9):e0203964. Epub 2018 Sep 18.

Department of Psychiatry, North District Hospital, Hong Kong SAR, China.

Self-efficacy has been consistently found to be a protective factor against psychological distress and disorders in the literature. However, little research is done on the moderating effect of self-efficacy on depressive symptoms in the context of chronic pain. This cross-sectional study aimed to examine if pain self-efficacy attenuated the direct relationship between pain intensity and depressive symptoms, as well as their indirect relationship through reducing the extent of catastrophizing when feeling pain (moderated mediation). 664 community-dwelling Chinese older adults aged 60-95 years who reported chronic pain for at least three months were recruited from social centers. They completed a battery of questionnaires on chronic pain, pain self-efficacy, catastrophizing, and depressive symptoms in individual face-to-face interviews. Controlling for age, gender, education, self-rated health, number of chronic diseases, pain disability, and pain self-efficacy, pain catastrophizing was found to partially mediate the connection between pain intensity and depressive symptoms. Furthermore, the relationship between pain intensity and depressive symptoms was moderated by pain self-efficacy. Self-efficacy was also found to moderate the relationship between pain intensity and catastrophizing and the moderated mediation effect was confirmed using bootstrap analysis. The results suggested that with increasing levels of self-efficacy, pain intensity's direct effect on depressive symptoms and its indirect effect on depressive symptoms via catastrophizing were both reduced in a dose-dependent manner. Our findings suggest that pain self-efficacy is a significant protective factor that contributes to psychological resilience in chronic pain patients by attenuating the relationship of pain intensity to both catastrophizing and depressive symptoms.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0203964PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6143242PMC
February 2019

Reengineering Critical Laboratory Testing for Timely Chemotherapeutic Management.

J Appl Lab Med 2018 Sep;3(2):240-249

Department of Pathology, The University of Chicago, Chicago, IL.

Background: Delivery of cytotoxic therapy is a complex multifaceted process that involves harmonized collaboration between all systems involved. Optimizing laboratory turnaround time (TAT) ensures timely delivery of chemotherapy, which potentially translates into improved patient outcomes and satisfaction. In this study, we aimed to reduce the laboratory TAT for key laboratory tests to optimize the timely administration of chemotherapy.

Methods: TAT data for complete blood count (CBC) and comprehensive metabolic panel (CMP) included specimen collection to receipt (Col-Rcv), specimen receipt to result release (Rcv-Res), and the overall TAT from specimen collection to result release (Col-Res). Work flows were reconfigured to transport CBC specimens directly to the hematology laboratory after collection and to treat all CMP samples from chemotherapy clinics as urgent [i.e., shortest turnaround time (STAT)]. From the CMP, total bilirubin and creatinine-the 2 key analytes for liver and renal toxicity assessment before chemotherapy drug administration-were analyzed on ABL 800 whole blood analyzers to further improve the laboratory TAT.

Results: CBC showed a significant reduction in the median (Col-Res) TAT to 16 min (P < 0.0001). For CMP, by processing all specimens as STAT samples, the median (Col-Res) TAT was reduced from 74 min to 54 min (P < 0.0001), and it was further reduced to 9 min (P < 0.0001) for total bilirubin and creatinine.

Conclusion: Careful work flow analysis and reengineering of preanalytical and analytical process for key laboratory tests significantly reduced median overall TAT to <20 min, which helped facilitate more timely delivery of chemotherapy, without necessitating the construction of a satellite laboratory.
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http://dx.doi.org/10.1373/jalm.2017.025973DOI Listing
September 2018

The protocol for the Cannabidiol in children with refractory epileptic encephalopathy (CARE-E) study: a phase 1 dosage escalation study.

BMC Pediatr 2018 07 7;18(1):221. Epub 2018 Jul 7.

Cannabinoid Research Initiative of Saskatchewan (CRIS), University of Saskatchewan, Saskatoon, Saskatchewan, Canada.

Background: Initial studies suggest pharmaceutical grade cannabidiol (CBD) can reduce the frequency of convulsive seizures and lead to improvements in quality of life in children affected by epileptic encephalopathies. With limited access to pharmaceutical CBD, Cannabis extracts in oil are becoming increasingly available. Physicians show reluctance to recommend Cannabis extracts given the lack of high quality safety data especially regarding the potential for harm caused by other cannabinoids, such as Δ-tetrahydrocannabinol (Δ-THC). The primary aims of the study presented in this protocol are (i) To determine whether CBD enriched Cannabis extract is safe and well-tolerated for pediatric patients with refractory epilepsy, (ii) To monitor the effects of CBD-enriched Cannabis extract on the frequency and duration of seizure types and on quality of life.

Methods: Twenty-eight children with treatment resistant epileptic encephalopathy ranging in age from 1 to 10 years will be recruited in four Canadian cities into an open-label, dose-escalation phase 1 trial. The primary objectives for the study are (i) To determine if the CBD-enriched Cannabis herbal extract is safe and well-tolerated for pediatric patients with treatment resistant epileptic encephalopathy and (ii) To determine the effect of CBD-enriched Cannabis herbal extract on the frequency and duration of seizures. Secondary objectives include (i) To determine if CBD-enriched Cannabis herbal extracts alter steady-state levels of co-administered anticonvulsant medications. (ii) To assess the relation between dose escalation and quality of life measures, (iii) To determine the relation between dose escalation and steady state trough levels of bioactive cannabinoids. (iv) To determine the relation between dose escalation and incidence of adverse effects.

Discussion: This paper describes the study design of a phase 1 trial of CBD-enriched Cannabis herbal extract in children with treatment-resistant epileptic encephalopathy. This study will provide the first high quality analysis of safety of CBD-enriched Cannabis herbal extract in pediatric patients in relation to dosage and pharmacokinetics of the active cannabinoids.

Trial Registration: http://clinicaltrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2016 Dec 16. Identifier NCT03024827, Cannabidiol in Children with Refractory Epileptic Encephalopathy: CARE-E; 2017 Jan 19 [cited 2017 Oct]; Available from: http://clinicaltrials.gov/ct2/show/NCT03024827.
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http://dx.doi.org/10.1186/s12887-018-1191-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6035794PMC
July 2018

Quality of Life Impact of an Adjuvanted Recombinant Zoster Vaccine in Adults Aged 50 Years and Older.

J Gerontol A Biol Sci Med Sci 2019 07;74(8):1231-1238

University of Bristol, UK.

Background: To determine the efficacy of an adjuvanted recombinant zoster vaccine in reducing the herpes zoster (HZ) burden of illness, HZ burden of interference with activities of daily living, and HZ impact on quality of life.

Methods: The assessments were integrated in two Phase III trials, ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229). HZ burden of illness and HZ burden of interference with activities of daily living were assessed by the Zoster Brief Pain Inventory (ZBPI) instrument and quality of life by the EuroQol-5 Dimension (EQ-5D) utility index and the SF-36 health survey. We report the ZOE-50 results and a pooled analysis of patients aged 70 years and older from the trials combined.

Results: The estimated vaccine efficacy in reducing HZ burden of illness and HZ burden of interference was greater than 90% in both the ZOE-50 and the pooled ZOE-70 analysis. In confirmed HZ cases, adjuvanted recombinant zoster vaccine reduced the maximal ZBPI worst-pain score in the pooled ZOE-70 analysis (p = .032) and the maximal ZBPI average-pain scores in both the ZOE-50 (p = .049) and the pooled ZOE-70 analysis (p = .043). In breakthrough HZ cases, trends for diminished loss of quality of life compared with placebo-recipient HZ cases were observed, with differences up to 0.14 on the EQ-5D index at time points during the 4 weeks following HZ onset.

Conclusions: Adjuvanted recombinant zoster vaccine reduced the HZ burden of illness significantly, particularly due to its very high vaccine efficacy in preventing HZ. For breakthrough HZ cases, the results suggest that the adjuvanted recombinant zoster vaccine mitigated severity of HZ-related pain, burden of interference with activities of daily living, and recipients' utility loss.
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http://dx.doi.org/10.1093/gerona/gly150DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6625590PMC
July 2019

Development and validation of a targeted affinity-enrichment and LC-MS/MS proteomics approach for the therapeutic monitoring of adalimumab.

Clin Chim Acta 2018 Aug 9;483:308-314. Epub 2018 May 9.

Department of Pathology, Pritzker School of Medicine, The University of Chicago, Chicago, IL, United States.

Background: The anti-tumor necrosis factor alpha (TNFα) therapeutic monoclonal antibodies (mAbs), such as adalimumab, are widely used in the treatment of rheumatoid arthritis, inflammatory bowel diseases, and other auto-immune diseases. The administration of adalimumab can elicit the immune responses from some patients, resulting in the formation of anti-drug antibodies (ADAbs). The ADAbs can diminish the therapeutic effects of adalimumab by neutralizing the TNFα binding site or increasing its clearance from circulation.

Methods: To effectively monitor the therapeutic concentrations of adalimumab, we developed and validated a targeted quantitative proteomic assay to determine the circulating concentrations of adalimumab. Since drug effects can be attenuated by ADAbs, the method adopted an affinity-enrichment step to selectively quantify the bioavailable forms of adalimumab in patient serum samples.

Results: The performance of the LC-MS/MS based assay provides the analytical measuring range and precisions applicable for the therapeutic monitoring of adalimumab. It also provides comparable results to a cell-based activity assay when evaluating patient samples with different concentrations of adalimumab.

Conclusion: Our assay can quantify both sub-therapeutic and therapeutic concentrations of bioavailable adalimumab in patient serum samples. This assay design provides an alternative to isotope-labeled peptides approach currently adopted in targeted proteomics methods.
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http://dx.doi.org/10.1016/j.cca.2018.05.015DOI Listing
August 2018

Smith-Lemli-Opitz Syndrome in a newborn infant with developmental abnormalities and low endogenous cholesterol.

Clin Chim Acta 2018 Apr 31;479:208-211. Epub 2018 Jan 31.

Department of Pathology, Pritzker School of Medicine, The University of Chicago, United States.

Background: Patients with Smith-Lemli-Opitz Syndrome (SLOS) have defective endogenous cholesterol synthesis, and present with decreased cholesterol levels and multiple developmental dysmorphologies.

Case Description: A newborn infant with normal XY karyotype and normal microarray was born with multiple developmental defects and ambiguous genitalia. The patient was diagnosed with SLOS, following biochemical genetic analysis of serum 7-DHC concentrations. The clinical course of the patient was further complicated by the comorbidities associated with SLOS and the bacterial infections.

Conclusion: We provide a detailed biochemical profile of the SLOS patient. The report can help us further understand the pathological impacts of cholesterol synthesis deficiency and provide relevant clinical management with outcome of this rare genetic disorder.
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http://dx.doi.org/10.1016/j.cca.2018.01.027DOI Listing
April 2018

Staff preparedness for providing palliative and end-of-life care in long-term care homes: Instrument development and validation.

Geriatr Gerontol Int 2018 May 16;18(5):745-749. Epub 2018 Jan 16.

Hong Kong Association of Gerontology, Hong Kong, China.

Aim: Although much attention has been on integrating the palliative care approach into services of long-term care homes for older people living with frailty and progressive diseases, little is known about the staff preparedness for these new initiatives. The present study aimed to develop and test the psychometric properties of an instrument for measuring care home staff preparedness in providing palliative and end-of-life care.

Methods: A 16-item instrument, covering perceived knowledge, skill and psychological readiness, was developed. A total of 247 staff members of different ranks from four care homes participated in the study. Exploratory factor analysis using the principal component analysis extraction method with varimax rotation was carried out for initial validation. Known group comparison was carried out to examine its discriminant validity. Reliability of the instrument was assessed based on test-retest reliability of a subsample of 20 participants and the Cronbach's alpha of the items.

Results: Exploratory factor analysis showed that the instrument yielded a three-factor solution, which cumulatively accounted for 68.5% of the total variance. Three subscales, namely, willingness, capability and resilience, showed high internal consistency and test-retest reliability. It also showed good discriminant validity between staff members of professional and non-professional groups.

Conclusions: This is a brief, valid and reliable scale for measuring care home staff preparedness for providing palliative and end-of-life care. It can be used to identify their concerns and training needs in providing palliative and end-of-life care, and as an outcome measure to evaluate the effects of interventional studies for capacity building in this regard. Geriatr Gerontol Int 2018; 18: 745-749.
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http://dx.doi.org/10.1111/ggi.13244DOI Listing
May 2018

A multicomponent intervention for the management of chronic pain in older adults: study protocol for a randomized controlled trial.

Trials 2017 Nov 9;18(1):528. Epub 2017 Nov 9.

Department of Psychiatry, North District Hospital, 9 Po Kin Road, Sheung Shui, New Territories, Hong Kong.

Background: Studies have shown that physical interventions and psychological methods based on the cognitive behavioral approach are efficacious in alleviating pain and that combining both tends to yield more benefits than either intervention alone. In view of the aging population with chronic pain and the lack of evidence-based pain management programs locally, we developed a multicomponent intervention incorporating physical exercise and cognitive behavioral techniques and examined its long-term effects against treatment as usual (i.e., pain education) in older adults with chronic musculoskeletal pain in Hong Kong.

Methods/design: We are conducting a double-blind, cluster-randomized controlled trial. A sample of 160 participants aged ≥ 60 years will be recruited from social centers or outpatient clinics and will be randomized on the basis of center/clinic to either the multicomponent intervention or the pain education program. Both interventions consist of ten weekly sessions of 90 minutes each. The primary outcome is pain intensity, and the secondary outcomes include pain interference, pain persistence, pain self-efficacy, pain coping, pain catastrophizing cognitions, health-related quality of life, depressive symptoms, and hip and knee muscle strength. All outcome measures will be collected at baseline, postintervention, and at 3 and 6 months follow-up. Intention-to-treat analysis will be performed using mixed-effects regression to see whether the multicomponent intervention alleviates pain intensity and associated outcomes over and above the effects of pain education (i.e., a treatment × time intervention effect).

Discussion: Because the activities included in the multicomponent intervention were carefully selected for ready implementation by allied health professionals in general, the results of this study, if positive, will make available an efficacious, nonpharmacological pain management program that can be widely adopted in clinical and social service settings and will hence improve older people's access to pain management services.

Trial Registration: Chinese Clinical Trial Registry, ChiCTR-IIR-16008387. Registered on 28 April 2016.
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http://dx.doi.org/10.1186/s13063-017-2270-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5680817PMC
November 2017

The Asia-Pacific Clinical Practice Guidelines for the Management of Frailty.

J Am Med Dir Assoc 2017 Jul;18(7):564-575

Western Australia Center for Health and Aging, University of Western Australia, Perth, Australia.

Objective: To develop Clinical Practice Guidelines for the screening, assessment and management of the geriatric condition of frailty.

Methods: An adapted Grading of Recommendations, Assessment, Development, and Evaluation approach was used to develop the guidelines. This process involved detailed evaluation of the current scientific evidence paired with expert panel interpretation. Three categories of Clinical Practice Guidelines recommendations were developed: strong, conditional, and no recommendation.

Recommendations: Strong recommendations were (1) use a validated measurement tool to identify frailty; (2) prescribe physical activity with a resistance training component; and (3) address polypharmacy by reducing or deprescribing any inappropriate/superfluous medications. Conditional recommendations were (1) screen for, and address modifiable causes of fatigue; (2) for persons exhibiting unintentional weight loss, screen for reversible causes and consider food fortification and protein/caloric supplementation; and (3) prescribe vitamin D for individuals deficient in vitamin D. No recommendation was given regarding the provision of a patient support and education plan.

Conclusions: The recommendations provided herein are intended for use by healthcare providers in their management of older adults with frailty in the Asia Pacific region. It is proposed that regional guideline support committees be formed to help provide regular updates to these evidence-based guidelines.
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http://dx.doi.org/10.1016/j.jamda.2017.04.018DOI Listing
July 2017

A Multisite Retrospective Study Evaluating the Implementation of the Pasero Opioid-Induced Sedation Scale (POSS) and Its Effect on Patient Safety Outcomes.

Pain Manag Nurs 2017 08 9;18(4):193-201. Epub 2017 Jun 9.

Eskenazi Health, Indianapolis, Indiana.

The Joint Commission recommended the Pasero Opioid-induced Sedation Scale (POSS) to minimize opioid-induced respiratory depression. However, there is a paucity of data describing its impact on patient safety. This study assessed the impact of POSS implementation or reeducation on naloxone use in patients receiving hydromorphone. This retrospective, Institutional Review Board-approved study performed with the Indianapolis Coalition for Patient Safety was conducted in two phases, 3 months before and after intervention. The intervention was POSS implementation or reeducation at six sites in a variety of practice settings. A total of 212 patients were evaluated. For the primary endpoint, naloxone use occurred in 1.9% of patients in each group and occurred in 3.1 versus 3.5 patients per 1,000 patient days pre- versus postintervention (p = .902). For secondary endpoints, POSS documentation increased post- versus preintervention, 78.1% versus 26.4% (p < .001). More patients experienced unintended sedation based on the Richmond Agitation and Sedation Scale or POSS post- versus preintervention, 12.2% versus 3.8% (p = .04). When the POSS was used, unintended sedation was likely detected before respiratory depression occurred and before naloxone was required. The lack of change in naloxone use and increased sedation postintervention may reflect that a POSS score 3 or 4 is a better marker of unintended sedation and should be considered as an endpoint instead of naloxone in future studies. The implementation or reeducation of the POSS at six area health-systems resulted in increased documentation of POSS and opioid-induced unintended sedation detection with no change in naloxone use.
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http://dx.doi.org/10.1016/j.pmn.2017.03.006DOI Listing
August 2017
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