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1.
Qian Xiao Andriy Derkach Steven C. Moore Wei Zheng Xiao-Ou Shu Fangyi Gu Neil E. Caporaso Joshua N. Sampson Charles E. Matthews 《Metabolomics : Official journal of the Metabolomic Society》2017,13(5):63
Introduction
Sleep plays an important role in cardiometabolic health. The sleep-wake cycle is partially driven by the endogenous circadian clock, which governs a range of metabolic pathways. The association between sleep and cardiometabolic health may be mediated by alterations of the human metabolome.Objectives
To better understand the biological mechanism underlying the association between sleep and health, we examined human plasma metabolites in relation to sleep duration and sleep timing.Methods
Using an untargeted approach, 329 fasting plasma metabolites were measured in 277 Chinese participants. We measured sleep timing (midpoint between bedtime and wake up time) using repeated time-use surveys (4 weeks during 1 year) and previous night sleep duration from questionnaires completed before sample donation.Results
We found 64 metabolites that were associated with sleep timing with a false discovery rate of 0.2 or lower, after adjusting for potential confounders. Notably, we found that later sleep timing was associated with higher levels of multiple metabolites in amino acid metabolism, including branched chain amino acids and their gamma-glutamyl dipeptides. We also found widespread associations between sleep timing and numerous metabolites in lipid metabolism, including bile acids, carnitines and fatty acids. In contrast, previous night sleep duration was not associated with plasma metabolites in our study.Conclusion
Sleep timing was associated with a large number of metabolites across a variety of biochemical pathways. Some metabolite associations are consistent with a relationship between late chronotype and adverse effects on cardiometabolic health.2.
Background
Software applications (apps) could potentially promote exercise adherence. However, it is unclear whether adolescents with painful hyperkyphosis will use an app designed for a home exercise program. The purpose of this study is to assess factors regarding adherence to an app-based home exercise program in adolescents with hyperkyphosis and back pain who were provided a one-time exercise treatment.Methods
Twenty-one participants were instructed in a one-time exercise treatment and asked to complete a home exercise program 3 times a week for 6 months using an app called PT PAL. At a 6-month follow-up, 14 participants completed a survey assessing factors related to their experiences using the app and their treatment engagement.Results
Although most participants did not use the app, they reported performing their exercises a few times per week. The adolescent participants considered the app to be more of a barrier than a supportive measure for promoting exercise adherence. Most participants still reported bothersome back pain.Conclusions
Although adherence to the 6-month app-based home exercise program was not successful, adolescents still viewed technology support such as text reminders as a potential solution.Trial registration
ClinicalTrials.gov Identifier: NCT03212664. Registered 11 July 2017. Retrospectively registered.3.
Lia Bally Cédric Bovet Christos T. Nakas Thomas Zueger Jean-Christophe Prost Jean-Marc Nuoffer Alexander B. Leichtle Georg Martin Fiedler Christoph Stettler 《Metabolomics : Official journal of the Metabolomic Society》2017,13(7):78
Introduction
Exercise-associated metabolism in type 1 diabetes (T1D) remains under-studied due to the complex interplay between exogenous insulin, counter-regulatory hormones and insulin-sensitivity.Objective
To identify the metabolic differences induced by two exercise modalities in T1D using ultra high-performance liquid chromatography coupled to high-resolution mass spectrometry (UHPLC–HRMS) based metabolomics.Methods
Twelve T1D adults performed intermittent high-intensity (IHE) and continuous-moderate-intensity (CONT) exercise. Serum samples were analysed by UHPLC–HRMS.Results
Metabolic profiling of IHE and CONT highlighted exercise-induced changes in purine and acylcarnitine metabolism.Conclusion
IHE may increase beta-oxidation through higher ATP-turnover. UHPLC–HRMS based metabolomics as a data-driven approach without an a priori hypothesis may help uncover distinctive metabolic effects during exercise in T1D.Clinical trial registration number is www.clinicaltrials.gov: NCT02068638.4.
Ted A. Skolarus Sarah T. Hawley Daniela A. Wittmann Jane Forman Tabitha Metreger Jordan B. Sparks Kevin Zhu Megan E. V. Caram Brent K. Hollenbeck Danil V. Makarov John T. Leppert Jeremy B. Shelton Vahakn Shahinian Sriram Srinivasaraghavan Anne E. Sales 《Implementation science : IS》2018,13(1):144
Background
Men with prostate cancer are often castrated with long-acting injectable drugs termed androgen deprivation therapy (ADT). Although many benefit, ADT is also used in patients with little or nothing to gain. The best ways to stop this practice are unknown, and range from blunt pharmacy restrictions to informed decision-making. This study will refine and pilot two different de-implementation strategies for reducing ADT use among those unlikely to benefit in preparation for a comparative effectiveness trial.Methods/design
This innovative mixed methods research program has three aims. Aim 1: To assess preferences and barriers for de-implementation of chemical castration in prostate cancer. Guided by the theoretical domains framework (TDF), urologists and patients from facilities with the highest and lowest castration rates across the VA will be interviewed to identify key preferences and de-implementation barriers for reducing castration as prostate cancer treatment. This qualitative work will inform Aim 2 while gathering rich information for two proposed pilot intervention strategies. Aim 2: To use a discrete choice experiment (DCE), a novel barrier prioritization approach, for de-implementation strategy tailoring. The investigators will conduct national surveys of urologists to prioritize key barriers identified in Aim 1 for stopping incident castration as localized prostate cancer treatment using a DCE experiment design. These quantitative results will identify the most important barriers to be addressed through tailoring of two pilot de-implementation strategies in preparation for Aim 3 piloting. Aim 3: To pilot two tailored de-implementation strategies to reduce castration as localized prostate cancer treatment. Building on findings from Aims 1 and 2, two de-implementation strategies will be piloted. One strategy will focus on formulary restriction at the organizational level and the other on physician/patient informed decision-making at different facilities. Outcomes will include acceptability, feasibility, and scalability in preparation for an effectiveness trial comparing these two widely varying de-implementation strategies.Discussion
Our innovative approach to de-implementation strategy development is directly aligned with state-of-the-art complex implementation intervention development and implementation science. This work will broadly advance de-implementation science for low value cancer care, and foster participation in our de-implementation evaluation trial by addressing barriers, facilitators, and concerns through pilot tailoring.Trial registration
ClinicalTrials.gov Identifier: NCT03579680, First Posted July 6, 2018.5.
Jonas Eriksson Ström Jamshid Pourazar Robert Linder Anders Blomberg Anne Lindberg Anders Bucht Annelie F. Behndig 《Respiratory research》2018,19(1):244
Background
Cytotoxic lymphocytes are increased in the airways of COPD patients. Whether this increase is driven primarily by the disease or by smoking is not clear, nor whether it correlates with the rate of decline in lung function.Methods
Bronchoscopy with BAL was performed in 52 subjects recruited from the longitudinal OLIN COPD study according to pre-determined criteria; 12 with COPD and a rapid decline in lung function (loss of FEV1?≥?60?ml/year), 10 with COPD and a non-rapid decline in lung function (loss of FEV1?≤?30?ml/year), 15 current and ex-smokers and 15 non-smokers with normal lung function. BAL lymphocyte subsets were determined using flow cytometry.Results
In BAL fluid, the proportions of NK, iNKT and NKT-like cells all increased with pack-years. Within the COPD group, NK cells – but not iNKT or NKT-like cells – were significantly elevated also in subjects that had quit smoking. In contrast, current smoking was associated with a marked increase in iNKT and NKT-like cells but not in NK cells. Rate of lung function decline did not significantly affect any of the results.Conclusions
In summary, increased proportions of NK cells in BAL fluid were associated with COPD; iNKT and NKT-like cells with current smoking but not with COPD. Interestingly, NK cell percentages did not normalize in COPD subjects that had quit smoking, indicating that these cells might play a role in the continued disease progression seen in COPD even after smoking cessation.Trial registration
Clinicaltrials.gov identifier NCT02729220.6.
7.
J Steinbuch AC van Dijk FHBM Schreuder MTB Truijman J Hendrikse PJ Nederkoorn A van der Lugt E Hermeling APG Hoeks WH Mess 《Cardiovascular ultrasound》2017,15(1):9
Background
Mean or maximal intima-media thickness (IMT) is commonly used as surrogate endpoint in intervention studies. However, the effect of normalization by surrounding or median IMT or by diameter is unknown. In addition, it is unclear whether IMT inhomogeneity is a useful predictor beyond common wall parameters like maximal wall thickness, either absolute or normalized to IMT or lumen size. We investigated the interrelationship of common carotid artery (CCA) thickness parameters and their association with the ipsilateral internal carotid artery (ICA) stenosis degree.Methods
CCA thickness parameters were extracted by edge detection applied to ultrasound B-mode recordings of 240 patients. Degree of ICA stenosis was determined from CT angiography.Results
Normalization of maximal CCA wall thickness to median IMT leads to large variations. Higher CCA thickness parameter values are associated with a higher degree of ipsilateral ICA stenosis (p?<?0.001), though IMT inhomogeneity does not provide extra information. When the ratio of wall thickness and diameter instead of absolute maximal wall thickness is used as risk marker for having moderate ipsilateral ICA stenosis (>50%), 55 arteries (15%) are reclassified to another risk category.Conclusions
It is more reasonable to normalize maximal wall thickness to end-diastolic diameter rather than to IMT, affecting risk classification and suggesting modification of the Mannheim criteria.Trial registration
Clinical trials.gov NCT01208025.8.
Background
The prevalence of atrial fibrillation (AF) is growing as the population ages, and at least 15% of ischemic strokes are attributed to AF. However, many high-risk AF patients are not offered guideline-recommended stroke prevention therapy due to a variety of system, provider, and patient-level barriers.Methods
We will conduct a pragmatic, cluster-randomized controlled trial randomizing primary care clinics to test a “toolkit” of quality improvement interventions in primary care. In keeping with the recommendations of the chronic care model to simultaneously activate patients and facilitate proactive care by providers, the toolkit includes provider-focused strategies (education, audit and feedback, electronic decision support, and reminders) plus patient-directed strategies (educational letters and reminders). The trial will include two feedback cycles at baseline and approximately 6 months and a final data collection at approximately 12 months. The study will be powered to show a difference of 10% in the primary outcome of proportion of patients receiving guideline-recommended stroke prevention therapy. Analysis will follow the intention-to-treat principle and will be blind to treatment allocation. Unit of analysis will be the patient; models will use generalized estimating equations to account for clustering at the clinical level.Discussion
Stroke prevention therapy using anticoagulation in patients with AF is known to reduce strokes by two thirds or more in clinical trials, but most studies indicate under-use of this treatment in real-world practice. If the toolkit successfully improves care for patients with AF, stakeholders will be engaged to facilitate broader application to maximize the potential to improve patient outcomes. The intervention toolkit tested in this project could also provide a model to improve quality of care for other chronic cardiovascular conditions managed in primary care.Trial registration
ClinicalTrials.gov (NCT01927445). Registered August 14, 2014 at https://clinicaltrials.gov/.9.
Amir Abdoli 《生物学前沿》2017,12(6):387-391
Background
Inflammatory conditions are involved in the pathophysiology of cancer. Recent findings have revealed that excessive salt and fat intake is involved in the development of severe inflammatory reactions.Methods
literature search was performed on various online databases (PubMed, Scopus, and Google Scholar) regarding the roles of high salt and fat intake in the induction of inflammatory reactions and their roles in the etiopathogenesis of cancer.Results
The results indicate that high salt and fat intake can induce severe inflammatory conditions. However, various inflammatory conditions have been strongly linked to the development of cancer. Hence, high salt and fat intake might be involved in the pathogenesis of cancer progression via putative mechanisms related to inflammatory reactions.Conclusion
Reducing salt and fat intake may decrease the risk of cancer.10.
Guillaume Foldes-Busque Stéphanie Hamel Geneviève Belleville Richard Fleet Julien Poitras Jean-Marc Chauny Alain Vadeboncoeur Kim L. Lavoie André Marchand 《BioPsychoSocial medicine》2016,10(1):30
Background
Panic disorder (PD) is highly prevalent in patients with non-cardiac chest pain (NCCP). This study aims to explore the role of psychological factors (PD intensity, anxiety sensitivity, heart-related fear, attention and avoidance) common to NCCP and PD in predicting chest pain levels in patients with both conditions.Methods
This association was investigated in emergency department patients with NCCP and PD receiving either evidence-based treatment of PD or treatment as usual. Patients were assessed at baseline and 14 weeks later for post-treatment.Results
Only heart-focused fear and attention for cardiac sensations independently explained a significant portion of the variance in baseline pain (n?=?66). At 3 months follow-up (n?=?53), changes in heart-related fear was the only factor independently associated with changes in chest pain intensity. Even in patients with PD, fear specific to cardiac sensations seems to play a central role in determining NCCP intensity.Conclusion
These results suggest that the efficacy of intervention for patients with PD and comorbid NCCP could be improved by targeting heart-related fear and attention.Trial registration
NCT0073634611.
Background
Numerous studies suggest that exercise may be an effective adjunct treatment for substance use disorders. It has been suggested that exercise-induced improvements in inhibitory control may reduce craving for the substance of abuse. However, this potential mechanism has seldom been researched.Objectives
The aim of the ExAlCo Study is to examine how acute bouts of exercise, at varying intensities, impact on craving for cocaine or alcohol. Cerebral haemodynamic responses during cognitive tests of inhibitory control, and exposure to substance-related cue imagery, will also be assessed using functional near-infrared spectroscopy.Design
The study is a crossover randomised controlled trial. Participants will be recruited from inpatient and outpatient psychiatric treatment centres, on the approval of their treating physician. A healthy control group will be recruited using online advertising. All participants will undergo each of three conditions in randomised order: 20?min of cycle ergometry at 50–60% of maximum heart rate; 20?min of exercise at 70–80% of maximum heart rate; and 20?min of quiet reading. Immediately before and after each condition, participants will be asked to complete a computerised Stroop test, watch a film containing substance-related images and self-report craving levels. During the Stroop test and film viewing, participants’ neural activity will be measured via functional near-infrared spectroscopy.Outcomes
The primary outcome measures are self-reported craving, inhibitory control and cerebral haemodynamic response to the Stroop test and a substance-related film. It is hoped that the findings from this study will shed more light on the role of exercise in the treatment of substance use disorders, particularly its scope in preventing relapse through reduced craving severity.Trial registration
ClinicalTrials.gov, NCT03502486. Registered retrospectively on 5 April 2018.12.
Bo?Cai Mei?Guo Yao?Wang Yajing?Zhang Jun?Yang Yelei?Guo Hanren?Dai Changlin?Yu Qiyun?Sun Jianhui?Qiao Kaixun?Hu Hongli?Zuo Zheng?Dong Zechuan?Zhang Mingxing?Feng Bingxia?Li Yujing?Sun Tieqiang?Liu Zhiqing?Liu Yi?Wang Yajing?Huang Bo?Yao Weidong?Han Huisheng?Ai
Background
Elderly patients with relapsed and refractory acute lymphoblastic leukemia (ALL) have poor prognosis. Autologous CD19 chimeric antigen receptor-modified T (CAR-T) cells have potentials to cure patients with B cell ALL; however, safety and efficacy of allogeneic CD19 CAR-T cells are still undetermined.Case presentation
We treated a 71-year-old female with relapsed and refractory ALL who received co-infusion of haplo-identical donor-derived CD19-directed CAR-T cells and mobilized peripheral blood stem cells (PBSC) following induction chemotherapy. Undetectable minimal residual disease by flow cytometry was achieved, and full donor cell engraftment was established. The transient release of cytokines and mild fever were detected. Significantly elevated serum lactate dehydrogenase, alanine transaminase, bilirubin and glutamic-oxalacetic transaminase were observed from days 14 to 18, all of which were reversible after immunosuppressive therapy.Conclusions
Our preliminary results suggest that co-infusion of haplo-identical donor-derived CAR-T cells and mobilized PBSCs may induce full donor engraftment in relapsed and refractory ALL including elderly patients, but complications related to donor cell infusions should still be cautioned.Trial registration
Allogeneic CART-19 for Elderly Relapsed/Refractory CD19+ ALL. NCT0279955013.
Background
Fabry disease (FD) is a genetic disorder resulting from deficiency of the lysosomal enzyme α-galactosidase A (α-Gal A), which leads to globotriaosylceramide (GL-3) accumulation in multiple tissues. We report on the safety and pharmacodynamics of migalastat hydrochloride, an investigational pharmacological chaperone given orally at 150 mg every-other-day.Methods
Two open-label uncontrolled phase 2 studies of 12 and 24 weeks (NCT00283959 and NCT00283933) in 9 males with FD were combined. At multiple time points, α-Gal A activity and GL-3 levels were quantified in blood cells, kidney and skin. GL-3 levels were also evaluated through skin and renal histology.Results
Compared to baseline, increased α-Gal A activity of at least 50% was demonstrated in blood, skin and kidney in 6 of 9 patients. Patients’ increased α-Gal A activities paralleled the α-Gal A increases observed in vitro in HEK-293 cells transfected with the corresponding mutant form of the enzyme. The same 6 patients who demonstrated increases of α-Gal A activity also had GL-3 reduction in skin, urine and/or kidney, and had α-Gal A mutations that responded in transfected cells incubated with the drug. The 3 patients who did not show a consistent response in vivo had α-Gal A mutations that did not respond to migalastat HCl in transfected cells. Migalastat HCl was well tolerated.Conclusions
Migalastat HCl is a candidate pharmacological chaperone that provides a novel genotype-specific treatment for FD. It enhanced α-Gal A activity and resulted in GL-3 substrate decrease in patients with responsive GLA mutations. Phase 3 studies are ongoing.Trial registration
Clinicaltrial.gov: NCT00283959 and NCT0028393314.
Background
Melatonin is a hormone which is produced from pineal gland in human and is said to have various impacts in human body like controlling sleep wake cycle, regulating the immune and cardiovascular system and regulating the peripheral organ functioning to name a few. Researchers have reported that the melatonin levels correlates with cancer risks.Objective
In this review article, focus has been given to the therapeutic applications and impact of melatonin hormone in human behavior and physiologic activities. Through this article we aim in compiling the scattered information regarding melatonin and its various aspects of importance in human system.Methods
We made an analysis of existing hypothesis and studies published on melatonin and circadian rhythm, factors effecting Melatonin secretions in body, sleep disturbances and cancer risks and melatonin therapy in cancer patients.Results
Melatonin’s role as an endogenous synchronizer, growing evidence suggests its anti-oxidative activity as well as its having a role in modulating immune responses. Fluctuating melatonin levels can be boosted by ingesting products containing melatonin. A large portion of the examinations detailed by the researchers clearly conclude that keeping up an impeccable sleep-wake cycle and having a healthy diet is extremely important to keep up the regular melatonin levels and in order to stay fit.Conclusions
Melatonin is considered as a critical hormone that controls and regulates many functions in our body. Melatonin production is emphatically related to the night time duration. Its most absolute biological role is to convey information to the body about day length for a variety of physiologic functions. In addition to melatonin’s role as an endogenous synchronizer, growing evidence suggests its anti-oxidative activity as well as its having a role in modulating immune responses. At present, a growing interest is focused on the validity of the anti-tumor mechanisms of melatonin.15.
N. Cesbron A.-L. Royer Y. Guitton A. Sydor B. Le Bizec G. Dervilly-Pinel 《Metabolomics : Official journal of the Metabolomic Society》2017,13(8):99
Introduction
Collecting feces is easy. It offers direct outcome to endogenous and microbial metabolites.Objectives
In a context of lack of consensus about fecal sample preparation, especially in animal species, we developed a robust protocol allowing untargeted LC-HRMS fingerprinting.Methods
The conditions of extraction (quantity, preparation, solvents, dilutions) were investigated in bovine feces.Results
A rapid and simple protocol involving feces extraction with methanol (1/3, M/V) followed by centrifugation and a step filtration (10 kDa) was developed.Conclusion
The workflow generated repeatable and informative fingerprints for robust metabolome characterization.16.
Surya P. Bhatt Hrudaya P. Nath Young-il Kim Rekha Ramachandran Jubal R. Watts Nina L. J. Terry Sushil Sonavane Swati P. Deshmane Prescott G. Woodruff Elizabeth C. Oelsner Sandeep Bodduluri MeiLan K. Han Wassim W. Labaki J. Michael Wells Fernando J. Martinez R. Graham Barr Mark T. Dransfield for the SPIROMICS investigators 《Respiratory research》2018,19(1):257
Background
Chronic obstructive pulmonary disease (COPD) is associated with a two-to-five fold increase in the risk of coronary artery disease independent of shared risk factors. This association is hypothesized to be mediated by systemic inflammation but this link has not been established.Methods
We included 300 participants enrolled in the SPIROMICS cohort, 75 each of lifetime non-smokers, smokers without airflow obstruction, mild-moderate COPD, and severe-very severe COPD. We quantified emphysema and airway disease on computed tomography, characterized visual emphysema subtypes (centrilobular and paraseptal) and airway disease, and used the Weston visual score to quantify coronary artery calcification (CAC). We used the Sobel test to determine whether markers of systemic inflammation mediated a link between spirometric and radiographic features of COPD and CAC.Results
FEV1/FVC but not quantitative emphysema or airway wall thickening was associated with CAC (p?=?0.036), after adjustment for demographics, diabetes mellitus, hypertension, statin use, and CT scanner type. To explain this discordance, we examined visual subtypes of emphysema and airway disease, and found that centrilobular emphysema but not paraseptal emphysema or bronchial thickening was independently associated with CAC (p?=?0.019). MMP3, VCAM1, CXCL5 and CXCL9 mediated 8, 8, 7 and 16% of the association between FEV1/FVC and CAC, respectively. Similar biomarkers partially mediated the association between centrilobular emphysema and CAC.Conclusions
The association between airflow obstruction and coronary calcification is driven primarily by the centrilobular subtype of emphysema, and is linked through bioactive molecules implicated in the pathogenesis of atherosclerosis.Trial Registration
ClinicalTrials.gov: Identifier: NCT01969344.17.
Gail M Gauvreau Louis-Philippe Boulet Christine Schmid-Wirlitsch Johanne Côté MyLinh Duong Kieran J Killian Joanne Milot Francine Deschesnes Tara Strinich Richard M Watson Dirk Bredenbröker Paul M O'Byrne 《Respiratory research》2011,12(1):140
Background
Phosphodiesterase 4 (PDE4) inhibitors increase intracellular cyclic adenosine monophosphate (cAMP), leading to regulation of inflammatory cell functions. Roflumilast is a potent and targeted PDE4 inhibitor. The objective of this study was to evaluate the effects of roflumilast on bronchoconstriction, airway hyperresponsiveness (AHR), and airway inflammation in mild asthmatic patients undergoing allergen inhalation challenge.Methods
25 subjects with mild allergic asthma were randomized to oral roflumilast 500 mcg or placebo, once daily for 14 days in a double-blind, placebo-controlled, crossover study. Allergen challenge was performed on Day 14, and FEV1 was measured until 7 h post challenge. Methacholine challenge was performed on Days 1 (pre-dose), 13 (24 h pre-allergen), and 15 (24 h post-allergen), and sputum induction was performed on Days 1, 13, 14 (7 h post-allergen), and 15.Results
Roflumilast inhibited the allergen-induced late phase response compared to placebo; maximum % fall in FEV1 (p = 0.02) and the area under the curve (p = 0.01). Roflumilast had a more impressive effect inhibiting allergen-induced sputum eosinophils, neutrophils, and eosinophil cationic protein (ECP) at 7 h post-allergen (all p = 0.02), and sputum neutrophils (p = 0.04), ECP (p = 0.02), neutrophil elastase (p = 0.0001) and AHR (p = 0.004) at 24 h post-allergen.Conclusions
This study demonstrates a protective effect of roflumilast on allergen-induced airway inflammation. The observed attenuation of sputum eosinophils and neutrophils demonstrates the anti-inflammatory properties of PDE4 inhibition and supports the roles of both cell types in the development of late phase bronchoconstriction and AHR.Trial Registration
ClinicalTrials.gov: NCT0136553318.
19.
Jeff Kirk Svane Shu-Ti Chiou Oliver Groene Milena Kalvachova Mirna Zagrajski Brkić Isao Fukuba Tiiu Härm Jerneja Farkas Yen Ang Mikkel Østerheden Andersen Hanne Tønnesen 《Implementation science : IS》2018,13(1):153
Background
Implementation of clinical health promotion (CHP) aiming at better health gain is slow despite its effect. CHP focuses on potentially modifiable lifestyle risks such as smoking, alcohol, diet, and physical inactivity. An operational program was created to improve implementation. It included patients, staff, and the organization, and it combined existing standards, indicators, documentation models, a performance recognition process, and a fast-track implementation model.The aim of this study was to evaluate if the operational program improved implementation of CHP in clinical hospital departments, as measured by health status of patients and staff, frequency of CHP service delivery, and standards compliance.Methods
Forty-eight hospital departments were recruited via open call and stratified by country. Departments were assigned to the operational program (intervention) or usual routine (control group). Data for analyses included 36 of these departments and their 5285 patients (median 147 per department; range 29–201), 2529 staff members (70; 10–393), 1750 medical records (50; 50–50), and standards compliance assessments.Follow-up was measured after 1 year. The outcomes were health status, service delivery, and standards compliance.Results
No health differences between groups were found, but the intervention group had higher identification of lifestyle risk (81% versus 60%, p?<?0.01), related information/short intervention and intensive intervention (54% versus 39%, p?<?0.01 and 43% versus 25%, p?<?0.01, respectively), and standards compliance (95% versus 80%, p?=?0.02).Conclusions
The operational program improved implementation by way of lifestyle risk identification, CHP service delivery, and standards compliance. The unknown health effects, the bias, and the limitations should be considered in implementation efforts and further studies.Trial registration
ClinicalTrials.gov: NCT01563575. Registered 27 March 2012. https://clinicaltrials.gov/ct2/show/NCT0156357520.
Joseph G. Wasser Daniel C. Herman MaryBeth Horodyski Jason L. Zaremski Brady Tripp Phillip Page Kevin R. Vincent Heather K. Vincent 《Trials》2017,18(1):630