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1.
Transl Behav Med ; 2020 May 02.
Article in English | MEDLINE | ID: mdl-32359068

ABSTRACT

One in three college students have overweight or obesity and are in need of brief, simple weight loss interventions. Implementation intentions, a strategy that connects a goal-aligned behavior to a cue, facilitate goal attainment of health behaviors but have not been applied as a standalone treatment for weight loss. The purpose of this study was to examine the efficacy of an implementation intention weight loss intervention in college students. In this three-arm, proof-of-concept, randomized controlled trial, college students with overweight/obesity (N = 95) were randomized to one of three conditions: an implementation intention group (IMP), an enhanced implementation intention group (IMP+) that included text message reminders and fluency training (i.e., training for speed and accuracy), and a control goal intention group (GOL) for 4 weeks. Participants completed anthropometric and self-report assessments pretreatment and posttreatment and experience-sampling assessments during the study to assess how implementation intentions contribute to behavior change. Across the sample, IMP and IMP+ groups reported significantly more goal-congruent behaviors than the GOL group. However, no between-condition differences emerged for weight and diet outcomes. Across conditions, students lost a statistically significant amount of weight, improved diet quality, and reduced caloric intake (ps < .05). Setting implementation intentions was associated with increased behaviors consistent with weight loss goals. Moreover, participants in all groups lost a statistically significant amount of weight. Incorporating implementation intentions into weight loss interventions, and testing the efficacy of this approach on weight loss over a longer duration, may be beneficial for college students with overweight/obesity.

2.
Clin Nutr ESPEN ; 37: 178-186, 2020 Jun.
Article in English | MEDLINE | ID: mdl-32359741

ABSTRACT

BACKGROUND AND AIMS: Curcuminoids and vitamin D have been shown to improve blood pressure and body weight in diabetic animals; however, consistent findings in type 2 diabetes mellitus (T2DM) patients are limited. This study was performed to evaluate the effects of curcuminoids and vitamin D, simultaneously or singly on anthropometric measurements and blood pressure in T2DM patients with insufficient vitamin D level. METHODS: In this randomized, placebo-controlled clinical trial, eighty T2DM patients were randomly assigned into 4 groups receiving (1) 500 mg/day curcuminoids; (2) 50,000 IU/week vitamin D3; (3) 50,000 IU/week vitamin D3 plus 500 mg/d curcuminoids; or (4) placebos for 12 weeks. Blood pressure and anthropometric measurements were evaluated before and after intervention. RESULTS: Intergroup comparisons showed that Vitamin D (main effect) significantly reduced systolic blood pressure (SBP) and diastolic blood pressure (DBP) (P = 0/000). Curcuminoids (main effect) significantly reduced DBP (P = 0/001). Interaction effects showed that curcuminoids significantly prevented the effect of vitamin D on the reduction of SBP (P = 0.006). Whereas, vitamin D and curcuminoids had a synergistic effect on DBP reduction (P = 0.006). The comparison of changes in anthropometric measurements between the four groups showed no significant differences in the raw and adjusted models. In-group comparisons showed that SBP, DBP, waist to hip circumference (WHR), body fat mass (BFM), percent body fat (PBF) and visceral fat area (VFA) values were significantly reduced in all groups except the placebo group compared to baseline values. Only in the CR-D group, there was a significant reduction in body weight (P = 0/047). CONCLUSIONS: Curcuminoids and vitamin D may have beneficial effects on blood pressure and anthropometric measurements in T2DM patients. CLINICAL REGISTRATION: http://www.IRCT.ir:IRCT2017041213678N22.

3.
Photodiagnosis Photodyn Ther ; : 101800, 2020 Apr 29.
Article in English | MEDLINE | ID: mdl-32360852

ABSTRACT

BACKGROUND: Although studies have been done that evaluated the effect of photodynamic therapy (PDT) in cigarette smokers and vapers, however, literature on the impact of these types of smoking on peri-implant parameters lack. The present clinical trial assessed the effectiveness of PDT as an adjunctive therapeutic modality in the treatment of peri-implant mucositis (p-iM) in individuals vaping e-cigs and cigarette smokers. METHODS: Individuals with p-iM were divided into three groups. (a) Group 1: Cigarette smokers with p-iM (b) Group 2: Vapers (e-cigarette smokers) with p-iM, (c) Group 3: Non-smokers with p-iM. Plaque index (PI), bleeding on probing (BOP) and probing depth (PD) were calculated. Pro-inflammatory biomarkers including matrix metalloproteinase (MMP)-8 and tumor necrosis factor-alpha (TNF-α) were quantified using enzyme linked immunosorbent assay. All assessments were performed at baseline (before treatment) and 12 weeks post treatment. Full mouth disinfection (FMD) was done with the ultrasonic scaler and copious irrigation. The photodynamic therapy (PDT) was done with a diode laser (wavelength: 670 nm, power: 150 mW, density: 1.1 W/cm2). Methylene blue photosensitizer (0.005% concentration) was incorporated inside the periimplant pockets (10 seconds at a depth of 3 mm), and the pockets were irradiated a flexible tip for one minute on the buccal and lingual surfaces. The session of PDT was performed only once at baseline. RESULTS: Twenty-five cigarette-smokers (Group 1), 21 electronic cigarette smokers (Group 2) and 25 never-smokers (Group 3) participated in the study. The mean age of the selected participants in groups 1, 2 and 3 was 29.5, 27.8, and 30.2 years, respectively. Statistically significant reduction in PI and PD parameters was observed on baseline and at 12 weeks in all groups. BOP significantly increased in group 1 and 2 at 12 weeks. A statistically significant reduction from baseline to 12 weeks was reported in the biomarker levels for all the study groups. CONCLUSION: PDT with adjunctive mechanical debridement reduced the plaque index and probing depth, while increased bleeding on probing, in addition to reducing pro-inflammatory biomarkers in tobacco smokers.

4.
Contemp Clin Trials ; : 106023, 2020 Apr 29.
Article in English | MEDLINE | ID: mdl-32360887

ABSTRACT

BACKGROUND: Self-management support (SMS) for patients with COPD can improve health-related quality of life (HRQOL). However, it remains unclear what SMS strategies are most effective. Using peer support to advance self-management is promising, as peer supporters possess credibility and can serve as role models. METHODS: We conducted a single-blinded RCT comparing the effectiveness of two strategies to support patients with COPD. The strategies were 'Health Care Professional (HCP)' and 'HCP Plus Peer' support. Peer support was provided by patients with COPD who have stopped smoking, completed an acute pulmonary rehabilitation program, and met the requirements for becoming a peer supporter. We enrolled patients receiving treatment at inpatient and outpatient settings. Patients were encouraged to invite one family-caregiver to enroll with them. The primary outcome measure was the change in HRQOL at 6 months post enrollment. Secondary outcomes included COPD-related and all-cause hospitalizations and ED visits. Caregiver outcomes included preparedness for caregiving, caregiver stress, and coping. RESULTS: A total of 292 patients and into this study as well as 50 family-caregivers were enrolled. The average patient age was 67.3 yrs. (SD 9.4), 61% were female and 26% were African-Americans. The majority of caregivers were females (68%) and were a spouse/partner (58%). DISCUSSION: This study tested a dual strategy for providing support to patients with COPD that incorporates peer and health care professional support. The study had minimal exclusion criteria. If shown effective, the study offers a program of peer support that can be readily implemented in health care settings.

5.
Metab Brain Dis ; 2020 May 04.
Article in English | MEDLINE | ID: mdl-32363472

ABSTRACT

Lately, focus on the relation between Parkinson's disease (PD) and Diabetes has risen greatly, as neuroprotective properties have been attributed to insulin use. Several studies have assessed the effect of glitazones, an insulin-sensitizing agent, in diabetic population on PD future risk. However, reports on the effect of their use have been heterogeneous. We aimed to synthesize the available scientific evidence which assesses the effect of glitazone use in type 2 diabetes patients on PD incidence. A systematic review was performed on multiple electronic databases. Considered for inclusion were studies that assessed the incidence of PD in type 2 diabetes glitazone users. Two reviewers worked independently and in duplicate to assess all studies, extract information and assess the methodological quality in each included study. Four high quality retrospective cohorts fulfilled inclusion criteria. Comparison groups varied across studies. In each study, incidence of PD was lower in glitazone-exposed patients compared to their respective comparison group. Pooled analysis showed lesser risk of PD in ever versus never glitazone users (RR 0.75 [95% C.I. 0.67-0.85; p < .0001; I2 = 0]). Our pooled analysis showed lesser risk of PD in glitazone versus non glitazone users, however, we advise to take results with caution since results are non-adjusted to possible confounding variables, furthermore, different glitazone-exposure time, follow up and comparison groups are aspects that also need to be pointed out. More clinical research focused on glitazone use and its relation with PD is needed, as this could result in new potential treatment modalities.

6.
Dig Dis Sci ; 2020 May 04.
Article in English | MEDLINE | ID: mdl-32363529

ABSTRACT

BACKGROUND: Early diagnosis of gastric cancer is difficult in China due to the lack of a valid method for endoscopic screening. Early gastric cancer, especially flat gastric cancer, lacks specific endoscopic features. Many cases appear to be similar to ordinary gastritis cases under normal white light endoscopy, which can lead to misdiagnosis. AIMS: In order to find a new method to improve detection rate of early gastric cancer in China, we designed a trial to validate linked color imaging (LCI) for screening of early gastric cancer in a high-risk population, as compared to white light imaging (WLI). METHOD: Subjects were randomly allocated to either the LCI + WLI or WLI group and then subjected to gastroscopy and all endoscopies were made after special preparation. All endoscopists had knowledge of this experiment. The main indicator was the rate of detection of gastric neoplastic lesions. The difference in the detection rate between the two groups is reported. RESULTS: The detection rate was 4.31% in the WLI group and 8.01% in the LCI + WLI group. This is a difference of 3.70% with a P value < 0.001 and an OR (95% CI) of 1.934 (1.362, 2.746). The lower limit of the 95% CI was greater than 0, and the superiority margin was 1%. CONCLUSION: The detection rate of gastric neoplastic lesions was higher in the LCI + WLI group than in the WLI group, LCI might be an effective method for screening early gastric cancer.

7.
Clin Nurs Res ; : 1054773820920487, 2020 May 04.
Article in English | MEDLINE | ID: mdl-32363944

ABSTRACT

This study aims to determine the effects of transtheoretical model-based walking exercise training and follow-up on improving exercise behavior and metabolic control in patients with type 2 diabetes. This randomized controlled trial was conducted as a pre-test and post-test experimental model with 76 intervention and 76 control individuals. The intervention group received the transtheoretical model-based exercise training. Data were collected using patient identification form, transtheoretical model scales, pedometer and metabolic outcomes. Data were analyzed by Chi square, two-way ANOVA, Mauchly's, Greenhouse-Geisser, Friedman, and McNamer test. The overall score means for the exercise change processes, decision-making balance and self-efficacy scales increased compared to the pre-test (p < .001). The mean HDL increased from 41.39 ± 10.35 to 49.18 ± 11.58, and average number of steps per day increased from 3264.31 ± 1933.03 to 5639.37 ± 2317.01. Consequently, this difference between the groups was significant (p < .05).

8.
BMC Endocr Disord ; 20(1): 56, 2020 Apr 29.
Article in English | MEDLINE | ID: mdl-32349748

ABSTRACT

BACKGROUND: Satisfactory tools to preclude low-risk patients from intensive diagnostic testing for primary aldosteronism (PA) are lacking. Therefore, we aimed to develop a decision tool to determine which patients with difficult-to-control hypertension have a low probability of PA, thereby limiting the exposure to invasive testing while at the same time increasing the efficiency of testing in the remaining patients. METHODS: Data from consecutive patients with difficult-to-control hypertension, analysed through a standardized diagnostic protocol between January 2010 and October 2017 (n = 824), were included in this cross-sectional study. PA was diagnosed by a combined approach: 1) elevated aldosterone-to-renin ratio (> 5.0 pmol/fmol/s), confirmed with 2) non-suppressible aldosterone after standardized saline infusion (≥280 pmol/L). Multivariable logistic regression analyses including seven pre-specified clinical variables (age, systolic blood pressure, serum potassium, potassium supplementation, serum sodium, eGFR and HbA1c) was performed. After correction for optimism, test reliability, discriminative performance and test characteristics were determined. RESULTS: PA was diagnosed in 40 (4.9%) of 824 patients. Predicted probabilities of PA agreed well with observed frequencies and the c-statistic was 0.77 (95% confidence interval (95%CI) 0.70-0.83). Predicted probability cut-off values of 1.0-2.5% prevented unnecessary testing in 8-32% of the patients with difficult-to-control hypertension, carrying sensitivities of 0.98 (95%CI 0.96-0.99) and 0.92 (0.83-0.97), and negative predictive values of 0.99 (0.98-1.00) and 0.99 (0.97-0.99). CONCLUSIONS: With a decision tool, based on seven easy-to-measure clinical variables, patients with a low probability of PA can be reliably selected and a considerable proportion of patients with difficult-to-control hypertension can be spared intensive diagnostic testing.

9.
Viruses ; 12(5)2020 04 28.
Article in English | MEDLINE | ID: mdl-32354022

ABSTRACT

Recently, the SARS-CoV-2 induced disease COVID-19 has spread all over the world. Nearly 20% of the patients have severe or critical conditions. SARS-CoV-2 exploits ACE2 for host cell entry. ACE2 plays an essential role in the renin-angiotensin-aldosterone system (RAAS), which regulates blood pressure and fluid balance. ACE2 also protects organs from inflammatory injuries and regulates intestinal functions. ACE2 can be shed by two proteases, ADAM17 and TMPRSS2. TMPRSS2-cleaved ACE2 allows SARS-CoV-2 cell entry, whereas ADAM17-cleaved ACE2 offers protection to organs. SARS-CoV-2 infection-caused ACE2 dysfunction worsens COVID-19 and could initiate multi-organ failure. Here, we will explain the role of ACE2 in the pathogenesis of severe and critical conditions of COVID-19 and discuss auspicious strategies for controlling the disease.


Subject(s)
Coronavirus Infections/physiopathology , Peptidyl-Dipeptidase A/metabolism , Pneumonia, Viral/physiopathology , Virus Internalization , ADAM17 Protein/metabolism , Coronavirus Infections/enzymology , Coronavirus Infections/prevention & control , Critical Illness , Humans , Pandemics/prevention & control , Pneumonia, Viral/enzymology , Pneumonia, Viral/prevention & control , Serine Endopeptidases/metabolism
10.
Diabetes Technol Ther ; 22(5): 374-382, 2020 May.
Article in English | MEDLINE | ID: mdl-32357109

ABSTRACT

Aims: Teens with type 1 diabetes (T1D) often struggle with diabetes self-management, which may lead to suboptimal self-care and worsening hemoglobin A1c (HbA1c). Innovative strategies are needed to improve self-care and protect against glycemic decline, especially during adolescence. We aimed to assess the impact on HbA1c of two interventions, problem-solving and text messaging, in teens with T1D. Methods: In a two-site randomized controlled trial, teens (N = 301) 13-17 years of age with T1D were randomized to one of the four groups using a 2 × 2 factorial design: Teenwork (TW), Text Messaging (Text), TW+Text, or Usual Care. TW intervention included problem-solving aimed at improving T1D self-care for blood glucose (BG) monitoring and insulin bolus dosing. Text intervention involved text reminders to check BG. The primary outcome was change in HbA1c from baseline to 12 months. Results: At baseline, teens (51% female, 78% white, 59% pump-treated) were (mean ± SD) 15.0 ± 1.3 years, had diabetes duration of 6.5 ± 3.7 years, and HbA1c 8.5% ± 1.1%. There was no significant difference in HbA1c over time by study group. Responsiveness to text reminders by teens in the TEXT and TW+TEXT predicted glycemic benefit; TW did not. Conclusions: Despite no HbA1c difference by study group, greater response to text message reminders to check BG led to better glycemic control and no deterioration in HbA1c; the problem-solving intervention did not. Given the high penetration of mobile phones and the wide acceptance of text messaging among teens in general, it is encouraging that a text messaging intervention can preserve HbA1c, thus preventing the expected deterioration in glycemic control often seen in teens with T1D.

11.
Int J Biometeorol ; 2020 May 02.
Article in English | MEDLINE | ID: mdl-32361959

ABSTRACT

Low back pain (LBP) is one of the most costly diseases in the developed world. This study aimed to investigate the effects of underwater traction therapy on chronic low back pain. The primary objective was to prove that underwater traction therapy has favorable effects on LBP. Our secondary objective was to evaluate whether it also leads to improvement in the quality of life. This is a prospective, multicenter, follow-up study. A total of 176 patients with more than 3 months of low back pain enrolled from outpatient clinics were randomized into three groups: underwater weight bath traction therapy and non-steroidal anti-inflammatory drugs (NSAIDs); weight bath; and only NSAIDs. The following parameters were measured before, right after, and 9 weeks after the 3-week therapy: levels of low back pain in rest and during activity were tested using the visual analogue scale (VAS), the Oswestry Low Back Disability Questionnaire, and the EuroQol-5D-5L Questionnaire.The VAS levels improved significantly (p < 0.05) in both underwater weight bath traction therapy groups by the end of the treatment, whereas the improvement in the third group was not statistically significant. Furthermore, the improvements measured in the groups receiving traction therapy were persistent during the follow-up period. There were no significant changes in the Oswestry Index or the EuroQol-5D-5L without VAS parameters in any of the groups.Based on our results, for patients suffering from LBP pain who underwent underwater weight bath traction therapy, there were favorable impacts on the pain levels at rest or during activity. Clinical trial registration ID: NCT03488498, April 5, 2018.

12.
J Hum Hypertens ; 2020 May 04.
Article in English | MEDLINE | ID: mdl-32366927

ABSTRACT

This randomized crossover and placebo-controlled trial evaluated the effects of daily use of sildenafil citrate (SIL, 1-month 50 mg twice daily) on penile and systemic endothelial microvascular function in hypertensive patients presenting with erectile dysfunction. The effects of SIL on arterial pressure were evaluated using ambulatory blood pressure monitoring (ABPM). Fifty patients diagnosed with primary arterial hypertension and erectile dysfunction (aged 57.4 ± 5.6 years), recruited in a tertiary public hospital, were treated with SIL (50 mg twice daily) or placebo (PLA) for two 30-day periods with a 30-day washout between them. Laser speckle contrast imaging coupled with acetylcholine skin iontophoresis was used to evaluate penile and systemic (forearm) cutaneous microvascular reactivity. SIL treatment increased penile basal microvascular flow (P = 0.002) and maximal endothelial-dependent peak response to skin iontophoresis of acetylcholine (ACh, P = 0.006). The area under the curve of microvascular vasodilation induced by ACh was also significantly increased (P = 0.02). Lastly, SIL treatment did not modify systemic microvascular reactivity. Twenty-four-hour ABPM (P = 0.0002) and daytime (P = 0.002) and nighttime (P = 0.001) mean diastolic blood pressure values were significantly reduced after SIL treatment. The scores of the Simplified International Index of Erectile Function (P < 0.0001) and the number of patients with positive responses to Sexual Encounter Profile question 3 (P < 0.0001) also increased after SIL treatment. Penile endothelium-dependent microvascular reactivity improved after continuous use of sildenafil in hypertensive patients with erectile dysfunction; the treatment also reduced blood pressure, suggesting that, in addition to improving erectile function, daily use of sildenafil could improve blood pressure control.

13.
Article in English | MEDLINE | ID: mdl-32367194

ABSTRACT

This controlled trial evaluated the effectiveness of a mental health literacy intervention for parents delivered through community sport clubs. In total, 540 parents (321 females, 219 males) of adolescent athletes participated in a brief educational workshop on youth mental health (n = 352) or a community-matched control group (n = 188). Generalised linear mixed models revealed no significant improvements in the intervention group compared to control in the primary mental health literacy outcomes, at 1 month follow-up. However, parents in the intervention group were more likely to seek formal help for themselves, had increased confidence and knowledge to help someone experiencing a mental health disorder, experienced reduced psychological distress, and perceived more support from other parents in their sport club, relative to the control group. Overall, the findings suggest that a brief educational intervention delivered through community sports clubs can positively affect some components of parents' mental health literacy.

14.
Clin Trials ; : 1740774520914609, 2020 May 05.
Article in English | MEDLINE | ID: mdl-32367737

ABSTRACT

BACKGROUND: Effective recruitment of patients by health professionals is challenging but pivotal to the success of clinical trials. Many trials fail to include the required number of participants, which affects the power of the study, generalizability of results, and timely dissemination of positive outcomes. Existing research is inconclusive regarding factors influencing recruitment results, and most research does not focus on perceptions of recruiting health professionals themselves. Therefore, thorough evaluations of recruitment facilitators and barriers in trials are needed in order to optimize future patient recruitment in trials. We observed divergent recruitment results among nurses who recruited diabetes patients to our trial, which examined the effectiveness of an eHealth programme. Therefore, we aimed to describe nurses' recruitment results and related shifts over time, and to qualitatively explore factors influencing nurses' recruitment results. METHODS: Nurses' recruitment results and related temporal shifts were derived from trial data (NTR6840). Based on their recruitment results, nurses were categorized as non-, low-, medium-, or high-recruiters. Subsequently, a subset of nurses per group participated in an individual semi-structured telephone interview. Interviews were analysed using NVivo software, applying an inductive coding approach. RESULTS: Ninety-six nurses participated in our trial and recruited on average seven patients (range: 0-32). Fifteen nurses did not recruit any patients. Most patients were recruited close to recruitment onset. Nurses who did not recruit patients close to recruitment onset generally ended up recruiting no patients. Data show a relatively high number of early recruited patients that progressively declined over time. High-recruiters were generally successful throughout the entire recruitment period. Recruitment facilitators and barriers comprised organizational, study, patient, and especially recruiter characteristics. Contrary to non- and low-recruiters, medium- and high-recruiters reported more in-depth knowledge about the study and trial requirements, expressed more personal participation-related benefits and fewer barriers, and incorporated more recruitment activities, reminders, and barrier-focused coping strategies. CONCLUSION AND IMPLICATIONS: To optimize patient recruitment to clinical trials, suggested intervention targets include the continued inclusion of recruiters after initial recruitment onset and the encouragement of early recruitment success. A personalized approach may aid recruiters to become and remain successful. Primarily, it is important to provide recruiters with sufficient information on trial requirements and to address salient benefits for participation in the trial, both for themselves and for their patients. Finally, teaching recruiters skills on how to overcome barriers may further enhance motivation and recruitment capacities.

15.
Plast Reconstr Surg ; 2020 Apr 28.
Article in English | MEDLINE | ID: mdl-32355086

ABSTRACT

BACKGROUND: Occult breast carcinoma is occasionally found in breast reduction specimens. Although its incidence varies widely there is a trend toward an increased incidence for women with prior history of breast cancer. We performed a systematic review and meta-analysis of occult carcinoma incidence in breast reduction specimens. METHODS: The Medline and EMBASE databases were searched for peer-reviewed studies with no language restrictions for studies that recorded incidence of occult carcinoma in breast reduction specimens. Cancer incidence per specimen was pooled for women with and without a history of breast cancer. RESULTS: Forty-two studies were eligible for inclusion, of which 29 were quantitatively analysed. Pooled incidence of carcinoma was higher within specimens from women with breast cancer (3.4%; 95% CI 2.2-5.3) than without (0.6%; 95% CI 0.4-0.8) and this increased likelihood was significant when populations were directly compared (OR 6.02; 95% CI 3.06-11.86; p<0.0001). CONCLUSION: Women with a prior history of breast cancer have an increased incidence of occult breast carcinoma within their breast reduction specimens compared to women with no breast cancer history. There is a need for pre-operative radiology screening, counselling and histopathology guidelines to ensure adequate diagnosis and management of these women.

16.
Article in English | MEDLINE | ID: mdl-32356107

ABSTRACT

Inflammation as a cardiovascular risk factor has attracted increasing attention . The current standard of care for decreasing the occurrence of cardiovascular events includes controlling risk factors such as hypertension and maximizing the lowering of low-density lipoprotein cholesterol (LDL-C). However, a recent study demonstrated decreased cardiovascular risk with the anti-inflammatory agent canakinumab and created more interest in decreasing cardiovascular risk by decreasing inflammation. Canakinumab is not yet approved and will undoubtedly be very expensive, so interest in an established medication such as colchicine, which is inexpensive to produce, is appropriate if evidence-based benefit is adequately confirmed. Colchicine has existing indications for gout and familial Mediterranean fever and for decreasing the incidence of postpericardiotomy syndrome. If an evidence-based benefit in decreasing cardiovascular risk can be demonstrated for colchicine, it will be of significant importance. Meta-analyses and observational studies have provided evidence to suggest that colchicine decreases cardiovascular risk because of its anti-inflammatory effects. However, randomized controlled trials (RCTs) are needed, and the recently published COLCOT (Colchicine Cardiovascular Outcomes Trial) showed definite benefit on cardiovascular outcomes in adults who had experienced a myocardial infarction within the previous 30 days. Sufficient evidence now supports the use of colchicine for secondary prevention in patients at the highest cardiovascular risk who continue to have cardiovascular events despite good blood pressure control and maximum LDL-C reduction. Nevertheless, more RCTs will be necessary before widespread general use of colchicine in cardiovascular disease prevention can be recommended. The current acquisition cost issues with colchicine also need to be resolved.

17.
BMJ Open ; 10(5): e034804, 2020 May 07.
Article in English | MEDLINE | ID: mdl-32385061

ABSTRACT

INTRODUCTION: Acute exacerbation (AE) is a major cause of disease progression and death in patients with chronic obstructive pulmonary disease (COPD), accounting for majority of medical expenditures. Correct inhalation therapy is effective in preventing AE attacks. However, inappropriate usage of dry powder inhaler, partially due to the unrecovered peak inhalation flow rate (PIFR) after acute exacerbation of COPD (AECOPD), results in increased risk of early treatment failure. Therefore, we designed a multicentre, randomised clinical trial to determine whether PIFR-based optimised inhalation therapy and training on inhaler usage at discharge could effectively reduce early treatment failure events. METHODS AND ANALYSIS: A total of 416 hospitalised patients just recovering from AECOPD will be recruited and equally randomised into the PIFR group and the control group at a 1:1 ratio. The PIFR group will receive additive support before discharge, including choice of PIFR-guided inhaler and education on its usage. PIFR is measured by InCheck DIAL. In comparison, the control group will receive inhalers based on judgement of the respiratory physician. The primary outcome of the study is 30-day treatment failure rate. Other endpoints include PIFR, error rate of inhalation device use, satisfaction with inhalation devices, 30-day mortality, 90-day mortality, symptoms and quality of life of patients, and COPD-related treatment costs. ETHICS AND DISSEMINATION: The trial has been approved by the Ethics Committee of Zhongshan Hospital of Fudan University (B2019-142). Participants will be screened and enrolled from hospitalised patients with AECOPD by clinicians, with no public advertisement for recruitment. After the trial has completed, the results will be reported to the public through conference presentations and peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT04000958.

18.
BMJ Open ; 10(5): e035241, 2020 May 07.
Article in English | MEDLINE | ID: mdl-32385063

ABSTRACT

INTRODUCTION: Cow's milk is a dietary staple for children in North America. Though clinical guidelines suggest children transition from whole (3.25% fat) milk to reduced (1% or 2%) fat milk at age 2 years, recent epidemiological evidence supports a link between whole milk consumption and lower adiposity in children. The purpose of this trial is to determine which milk fat recommendation minimises excess adiposity and optimises child nutrition and growth. METHODS AND ANALYSIS: Cow's Milk Fat Obesity pRevention Trial will be a pragmatic, superiority, parallel group randomised controlled trial involving children receiving routine healthcare aged 2 to 4-5 years who are participating in the TARGet Kids! practice-based research network in Toronto, Canada. Children (n=534) will be randomised to receive one of two interventions: (1) a recommendation to consume whole milk or (2) a recommendation to consume reduced (1%) fat milk. The primary outcome is adiposity measured by body mass index z-score and waist circumference z-score; secondary outcomes will be cognitive development (using the Ages and Stages Questionnaire), vitamin D stores, cardiometabolic health (glucose, high-sensitivity C-reactive protein, non-high density lipoprotein (non-HDL), low density lipoprotein (LDL), triglyceride, HDL and total cholesterol, insulin and diastolic and systolic blood pressure), sugary beverage and total energy intake (measured by 24 hours dietary recall) and cost effectiveness. Outcomes will be measured 24 months postrandomisation and compared using analysis of covariance (ANCOVA), adjusting for baseline measures. ETHICS AND DISSEMINATION: Ethics approval has been obtained from Unity Health Toronto and The Hospital for Sick Children. Results will be presented locally, nationally and internationally and published in a peer-reviewed journal. The findings may be helpful to nutrition guidelines for children in effort to reduce childhood obesity using a simple, inexpensive and scalable cow's milk fat intervention. TRIAL REGISTRATION NUMBER: NCT03914807; pre-results.

19.
BMC Health Serv Res ; 20(1): 405, 2020 May 11.
Article in English | MEDLINE | ID: mdl-32393307

ABSTRACT

BACKGROUND: Clinical practice guidelines and policies direct community mental health services to provide preventive care to address chronic disease risks, however, such care is infrequently provided in routine consultations. An alternative model of care is to appoint a clinician to the dedicated role of offering and providing preventive care in an additional consultation: the 'specialist clinician' model. Economic evaluations of models of care are needed to determine the cost of adhering to guidelines and policies, and to inform pragmatic service delivery decisions. This study is an economic evaluation of the specialist clinician model; designed to achieve policy concordant preventive care delivery. METHODS: A retrospective analysis of the incremental costs, cost-effectiveness, and budget impact of a 'specialist preventive care clinician' (an occupational therapist) was conducted in a randomised controlled trial, where participants were randomised to receive usual care; or usual care plus the offer of an additional preventive care consultation with the specialist clinician. The study outcome was client acceptance of referrals to two free telephone-based chronic disease prevention services. This is a key care delivery outcome mandated by the local health district policy of the service. The base case analysis assumed the mental health service cost perspective. A budget impact analysis determined the annual budget required to implement the model of care for all clients of the community mental health service over 5 years. RESULTS: There was a significantly greater increase from baseline to follow-up in the proportion of intervention participants accepting referrals to both telephone services, compared to usual care. The incremental cost-effectiveness ratio was $347 per additional acceptance of a referral (CI: $263-$494). The annual budget required to implement the model of care for all prospective clients was projected to be $711,446 over 5-years; resulting in 2616 accepted referrals. CONCLUSIONS: The evaluation provides key information regarding the costs for the mental health service to adhere to policy targets, indicating the model of care involved a low per client cost whilst increasing key preventive care delivery outcomes. Additional modelling is required to further explore its economic benefits. TRIAL REGISTRATION: ACTRN12616001519448. Registered 3 November 2016, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371709.

20.
Int J Behav Nutr Phys Act ; 17(1): 57, 2020 May 11.
Article in English | MEDLINE | ID: mdl-32393357

ABSTRACT

BACKGROUND: To date, it is unclear if consumer wearable activity trackers (CWATs), with or without behaviour multi-component strategies, effectively improve adherence to physical activity and health outcomes under free living conditions in populations with chronic diseases. Therefore, we systematically evaluated the efficacy of CWAT-based interventions to promote physical activity levels and cardiometabolic health in populations with chronic diseases. METHODS: Randomised controlled trials were collected from five bibliographic databases (PubMed, Embase, Web of Science, The Cochrane Central Register of Controlled Trials and CINAHL). Studies were eligible for inclusion if they evaluated a CWAT-based counselling intervention versus control intervention among patients with chronic respiratory diseases, type 2 diabetes mellitus, cardiovascular diseases, overweight/obesity, cognitive disorders, or sedentary older adults. Data were pooled using a random-effects model. RESULTS: After deduplication 8147 were identified of which 35 studies met inclusion criteria (chronic respiratory diseases: 7, type 2 diabetes mellitus: 12, cardiovascular diseases: 6, overweight/obesity: 3, cognitive disorders: 1, sedentary older adults: 6). Compared to control groups, CWAT-based interventions significantly increased physical activity by 2123 steps per day (95% confidence interval [CI], [1605-2641]; p < 0.001). In addition, CWAT-based interventions in these populations significantly decreased systolic blood pressure (- 3.79 mm Hg; 95% CI: [- 4.53, - 3.04] mm Hg; p < 0.001), waist circumference (- 0.99 cm; 95% CI: [- 1.48, - 0.50] cm; p < 0.001) and low-density lipoprotein cholesterol concentration (- 5.70 mg/dl; 95% CI: [- 9.24, - 2.15] mg/dl; p = 0.002). CONCLUSION: CWAT-based interventions increase physical activity and have beneficial effects on important health-related outcomes such as systolic blood pressure, waist circumference and LDL cholesterol concentration in patients with chronic diseases.

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