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Background: Latino immigrants face a higher burden of colorectal cancer (CRC) and screening rates are low.Objective: To assess the effectiveness of a multilevel intervention in increasing the rate of CRC screening among Latino immigrants.Design: A randomized controlled trial, with randomization at the physician level.Participants: Pairs of 65 primary care physicians and 65 Latino immigrant patients participated, 31 in the intervention and 34 in the control group.Intervention: CRC educational video in Spanish on a portable personal digital video display device accompanied by a brochure with key information for the patient, and a patient-delivered paper-based reminder for their physician.Measurements: Completed CRC screening, physician recommendation for CRC screening, and patient adherence to physician recommended CRC screening.Results: The overall rate of completed screening for CRC was 55% for the intervention and 18% for the control group (p = 0.002). Physicians recommended CRC screening for 61% of patients in the intervention group versus 41% in the control group (p = 0.08). Of those that received a recommendation, 90% in the intervention group adhered to it versus 26% in the control group (p = 0.007).Conclusions: The intervention was successful in increasing rates of completed CRC screening primarily through increasing adherence after screening was recommended. Additional efforts should focus on developing new strategies to increase physician recommendation for CRC screening, while employing effective patient adherence interventions. [ABSTRACT FROM AUTHOR]

Background: We implemented a comprehensive intervention program targeting general practice staff, that proved successful in optimizing practice organization and clinical decision-making. In this paper, health-related quality of life (HRQL) is investigated as a clinical outcome.Objective: To evaluate the effect of the implementation of an intervention program on the HRQL in patients at high cardiovascular risk.Research Design: Randomized controlled trial. Intervention practices (n = 62) received a comprehensive intervention program (by means of outreach visitors) lasting 21 months. HRQL of patients at high cardiovascular risk was assessed by the MOS 36-Item Short-Form Health Survey (SF-36), at baseline and after intervention. Three patient categories were distinguished: diabetes mellitus, cardiovascular disease and hypertension.Results: HRQL deteriorated in all respondents, but more pronounced in the control group. In diabetes patients the differences between intervention and control group were significant for the Vitality and Mental Health scales, with mean difference in change of 3.93 (95% CI: 1.08-6.78) and 3.71 (95% CI: 0.73-6.68), respectively. Patients with cardiovascular disease had significantly different changes on three scales: physical functioning (3.57, 95% CI: 0.71-6.43), vitality (3.01, 95% CI: 0.72-5.30) and social functioning (3.96, 95% CI: 0.50-7.42). In patients with hypertension, there were no differences between the intervention and control group.Conclusion: Our comprehensive intervention program resulted in changes in HRQL on several domains, particularly in patients with diabetes and cardiovascular disease. [ABSTRACT FROM AUTHOR]

This paper investigates the effect of one dose of vitamin A on subsequent 4 month mortality in children under 6 months of age in a randomized, double-blind placebo-controlled community trial in Nepal. An earlier published intention-to-treat analysis showed no benefit, but ignored the information on actual receipt of treatment. Structural failure time models (Robins and Tsiatis, '91) use randomization based inference and incorporate compliance information which is possibly selective. The data presented here offer some new challenges for this approach: ward-based randomization induces correlation between survival outcomes; and the actual receipt of vitamin A dose is not always recorded. To tackle the problem of the clustered survival data we consider a robust version of the structural parameter vector estimator. A sensitivity analysis captures boundaries for the estimated structural parameters reflecting a range of potential values of children whose true receipt of treatment is unknown. The analysis suggests that the effect of vitamin A was beneficial in the beginning of the trial but towards the end of the trial there was a reversal of this effect. [ABSTRACT FROM AUTHOR]

Active learning combines academic content with physical activity (PA) to increase child PA and academic performance, but the impact of active learning is mixed. It may be that this is a moderated relationship in which active learning is beneficial for only some children. This paper examine the impact of baseline academic performance and gender as moderators for the effects of active learning on children's academic performance. In the ASK-study, 1129 fifth-graders from 57 Norwegian elementary schools were randomized by school to intervention or control in a physical activity intervention between November 2014 and June 2015. Academic performance in numeracy, reading, and English was measured and a composite score was calculated. Children were split into low, middle and high academic performing tertiles. 3-way-interactions for group (intervention, control)∗gender (boys, girls)∗academic performance (tertiles) were investigated using mixed model regression. There was a significant, 3-way-interaction (p=0.044). Both boys (ES=0.11) and girls (ES=0.18) in the low performing tertile had a similar beneficial trend. In contrast, middle (ES=0.03) and high performing boys (ES=0.09) responded with small beneficial trends, while middle (ES=-0.11) and high performing girls (ES=-0.06) responded with negative trends. ASK was associated with a significant increase in academic performance for low performing children. It is likely that active learning benefited children most in need of adapted education but it may have a null or negative effect for those girls who are already performing well in the sedentary classroom. Differences in gendered responses are discussed as a possible explanation for these results.Trial Registration: Clinicaltrials.gov registry, trial registration number: NCT02132494. [ABSTRACT FROM AUTHOR]

Background: Many patients undergoing anaesthesia and surgery experience postoperative complications. Our aim was to investigate whether a systematic follow-up smartphone-based assessment, using recovery assessment by phone points (RAPP) compared with standard care, had a positive effect on day surgery patients' postoperative recovery. We also investigated whether there were differences in women and men's recovery and recovery scores.Methods: The study was a single-blind, multicentre randomized controlled trial. A total of 997 patients were randomly allocated to either RAPP or standard care. The Swedish web version of a quality of recovery (SwQoR) questionnaire was used to evaluate the patients' postoperative recovery, either on paper or using an application (RAPP) on postoperative days seven and 14.Results: On postoperative day seven the RAPP group reported significantly better values in seven out of 24 items of the SwQoR: sleeping difficulties; not having a general feeling of wellbeing; having difficulty feeling relaxed/comfortable; and dizziness; headache; pain in the surgical wound; and a swollen surgical wound compared with the control group, implying a good postoperative recovery. Both men and women in the RAPP group reported significantly better values (and, hence good postoperative recovery) compared with the control group in the items sleeping difficulties; not having a general feeling of wellbeing and pain in the surgical wound.Conclusions: Measurement of patient-reported outcomes using a smartphone-based application was associated with decreased discomfort from several postoperative symptoms. Systematic e-assessment can thereby increase patients' quality of recovery and identify key areas for improvement in perioperative care.Clinical Trial Registration: NCT02492191. [ABSTRACT FROM AUTHOR]

This paper reports the 8-year results of comparing the use of two types of adjuvant chemotherapy following involved field radiotherapy for clinical stages I and II high-grade non-Hodgkin's lymphoma. Twenty-four patients received 6 weeks of VAP plus 2 years of oral maintenance chemotherapy, and 30 had six cycles of CMOPP. Four patients were not in complete remission at completion of i.v. chemotherapy (CR rate 91%). Ten patients (18.5%) have relapsed (VAP/M = 5; CMOPP = 5), with only two of these remaining alive, both of them being disease free. There have been three deaths from intercurrent causes, one from malignant melanoma and the other two from myocardial infarction. The relapse-free survivals at 2, 5 and 8 years were 80%, 76% & 76% respectively. The overall survivals at the same time points were 86%, 72% & 68%. There were no significant differences in either relapse-free or overall survival for either of the two treatment groups. The shorter period of weekly intravenous chemotherapy (VAP/M) was better tolerated than 36 weeks of CMOPP, and the former appears to produce equivalent results. [ABSTRACT FROM AUTHOR]

Copyright of Canadian Journal of Anaesthesia / Journal Canadien d'Anesthésie is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Canadian Journal of Anaesthesia / Journal Canadien d'Anesthésie is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Peripherally inserted central catheter (PICC) and umbilical venous catheter (UVC) in terms of success rate, complications, cost and time of insertion in neonatal intensive care were compared. Neonates requiring vascular access for minimum 7 days were included. Sample size of 72 per group was determined. Trial was registered at Clinical Trials Registry of India (CTRI/2015/02/005529). Success rates of the UVC and PICC were 68.1% and 65.3%, respectively (p = 0.724). Mean (SD) time needed for PICC and UVC insertion was 34.13 (34.69) and 28.31 (17.19) min, respectively (p = 0.205). Mean (SD) cost of PICC insertion vs. UVC insertion was 60.9 (8.6) vs. 11.9 (8.7) US dollars (p < 0.0001). Commonest cause for failure of UVC was displacement [6 (8.3%)] and that for PICC was blockage [9 (12.5%)].Conclusions: UVC is a cheaper alternative to PICC, with similar success rate, short-term complications and time needed for insertion. [ABSTRACT FROM AUTHOR]

Background: The PARAMEDIC cluster randomised trial evaluated the LUCAS mechanical chest compression device, and did not find evidence that use of mechanical chest compression led to an improvement in survival at 30 days. This paper reports patient outcomes from admission to hospital to 12 months after randomisation.Methods: Information about hospital length of stay and intensive care management was obtained through linkage with Hospital Episode Statistics and the Intensive Care National Audit and Research Centre. Patients surviving to hospital discharge were approached to complete questionnaires (SF-12v2, EQ-5D, MMSE, HADS and PTSD-CL) at 90days and 12 months. The study is registered with Current Controlled Trials, number ISRCTN08233942.Results: 377 patients in the LUCAS arm and 658 patients in the manual chest compression were admitted to hospital. Hospital and intensive care length of stay were similar. Long term follow-up assessments were limited by poor response rates (53.7% at 3 months and 55.6% at 12 months). Follow-up rates were lower in those with worse neurological function. Among respondents, long term health related quality of life outcomes and emotional well-being was similar between groups. Cognitive function, measured by MMSE, was marginally lower in the LUCAS arm mean 26.9 (SD 3.7) compared to control mean 28.0 (SD 2.3), adjusted mean difference -1.5 (95% CI -2.6 to -0.4).Conclusion: There were no clinically important differences identified in outcomes at long term follow-up between those allocated to the mechanical chest compression compared to those receiving manual chest compression. [ABSTRACT FROM AUTHOR]

Background: Attrition is problematic in trials, and may be exacerbated in longer studies, telehealth trials and participants with depression - three features of The Healthlines Study. Advance notification, including a photograph and using action-oriented email subject lines might increase response rates, but require further investigation. We examined the effectiveness of these interventions in three embedded Healthlines studies.Methods: Based in different trial sites, participants with depression were alternately allocated to be pre-called or not ahead of the 8-month follow-up questionnaire (Study 1), randomized to receive a research team photograph or not with their 12-month questionnaire (Study 2), and randomized to receive an action-oriented ('ACTION REQUIRED') or standard ('Questionnaire reminder') 12-month email reminder (Study 3). Participants could complete online or postal questionnaires, and received up to five questionnaire reminders. The primary outcome was completion of the Patient Health Questionnaire (PHQ-9). Secondary outcome measures were the number of reminders and time to questionnaire completion.Results: Of a total of 609 Healthlines depression participants, 190, 251 and 231 participants were included in Studies 1-3 (intervention: 95, 126 and 115), respectively. Outcome completion was ≥90 % across studies, with no differences between trial arms (Study 1: OR 0.38, 95 % CI 0.07-2.10; Study 2: OR 0.84, 95 % CI 0.26-2.66; Study 3: OR 0.53 95 % CI 0.19-1.49). Pre-called participants were less likely to require a reminder (48.4 % vs 62.1 %, OR 0.41, 95 % CI 0.21-0.78), required fewer reminders (adjusted difference in means -0.67, 95 % CI -1.13 to -0.20), and completed follow-up quicker (median 8 vs 15 days, HR 1.35, 95 % CI 1.00-1.82) than control subjects. There were no significant between-group differences in Studies 2 or 3.Conclusions: Eventual response rates in this trial were high, with no further improvement from these interventions. While the photograph and email interventions were ineffective, pre-calling participants reduced time to completion. This strategy might be helpful when the timing of study completion is important. Researchers perceived a substantial benefit from the reduction in reminders with pre-calling, despite no overall decrease in net effort after accounting for pre-notification.Trial Registration: Current Clinical Trials ISRCTN14172341. [ABSTRACT FROM AUTHOR]

Background: Alcohol, tobacco, and other drug use remains highly prevalent among US adolescents and is a threat to their well-being and to the public health. Evidence from clinical trials and meta-analyses supports the effectiveness of Screening, Brief Intervention and Referral to Treatment (SBIRT) for adolescents with substance misuse but primary care providers have been slow to adopt this evidence-based approach. The purpose of this paper is to describe the theoretically informed methodology of an on-going implementation study.Methods: This study protocol is a multi-site, cluster randomized trial (N=7) guided by Proctor's conceptual model of implementation research and comparing two principal approaches to SBIRT delivery within adolescent medicine: Generalist vs. Specialist. In the Generalist Approach, the primary care provider delivers brief intervention (BI) for substance misuse. In the Specialist Approach, BIs are delivered by behavioral health counselors. The study will also examine the effectiveness of integrating HIV risk screening within an SBIRT model. Implementation Strategies employed include: integrated team development of the service delivery model, modifications to the electronic medical record, regular performance feedback and supervision. Implementation outcomes, include: Acceptability, Appropriateness, Adoption, Feasibility, Fidelity, Costs/Cost-Effectiveness, Penetration, and Sustainability.Discussion: The study will fill a major gap in scientific knowledge regarding the best SBIRT implementation strategy at a time when SBIRT is poised to be brought to scale under health care reform. It will also provide novel data to inform the expansion of the SBIRT model to address HIV risk behaviors among adolescents. Finally, the study will generate important cost data that offer guidance to policymakers and clinic directors about the adoption of SBIRT in adolescent health care. [ABSTRACT FROM AUTHOR]

Purpose: The present study compared the antiplaque effects of two herbal mouthwashes containing Salvadora persica and Azadirachta indica, respectively, with two synthetic mouthwashes containing either chlorhexidine or cetylpyridinium.Materials and Methods: In this triple-blind, randomised controlled trial, 100 patients undergoing orthodontic treatment underwent scaling and polishing at baseline to obtain a plaque score of zero. In the first phase, they were given oral hygiene instructions and were provided with a standard toothpaste to be used twice daily for a period of three weeks. In the second phase, following scaling and polishing, they were randomly allocated to 4 groups according to 4 different types of mouthwash (A: chlorhexidine; B = cetylpyridinium; C = extracts of Salvadora persica miswak; D: extract of Azadirachta indica miswak) along with previously taught toothbrushing protocol for three more weeks. Plaque accumulation was scored three times according to the Modified Bonded Bracket Plaque Index: at the start, after the toothbrush-toothpaste trial, and at the end of mouthwash trial. The paired t-test was used to compare the pre-plaque and post-plaque indices in all groups. Analysis of mean differences of post-plaque indices between and within groups was performed using the post-hoc Tukey test. Qualitative variables were compared by Crosstab.Results: Eighty participants completed the study - 63 females and 17 males. There was a statistically significant decrease in mean plaque scores after using mouthwashes in all four groups at follow-up when compared to the baseline plaque score (p = 0.001). The greatest reduction of plaque score was found in group C (extract of Salvadora persica) when compared with group A, chlorhexidine (p = 0.016).Conclusion: Compared to other mouthwashes, Salvadora persica miswak-based mouthwash showed a maximum reduction in the plaque scores among orthodontic patients. [ABSTRACT FROM AUTHOR]

Purpose: The objective of this trial was to compare short-term patient preference for two mandibular complete denture (CD) fabrication techniques: neutral zone (NZ) and conventional (CV).Materials and Methods: A prospective, within-subject, randomized crossover trial was performed on a sample of 37 edentulous patients with complete denture experience. Two new sets of CDs were made for each patient, one set with a CV and one with a NZ mandibular denture. After consecutively wearing each set for at least 2 months after the last adjustment visit, patients indicated their preference (CV, NZ, or none). Associations and comparisons were made using the generalized linear model (GLM) and Fisher exact test between preference and sex, age, period of edentulousness, tissue quality, prosthodontic diagnostic index (PDI), and oral health-related quality of life (OHRQoL) differences of the two interventions assessed using the 20-item oral health impact profile (OHIP-20). Significance was determined at P = .05.Results: A total of 15 (40%) patients preferred NZ, 8 (22%) preferred CV dentures, and 14 (38%) had no preference. Although more women preferred NZ over CV dentures (50% versus 27%), difference in preference according to sex was not significant (P = .359). Neither was difference in preference and PDI scores significant (P = .603). Preference could not be strongly associated to period of edentulousness, age, tissue scores, and differences in OHIP-20 scores (P > .05), except for OHIP-20 scores and NZ preference (P < .001). Better fit, comfort, and eating were reasons patients preferred a type of denture. These reasons were identified for both types of denture. Appearance and speech were not identified as reasons for a particular preference.Conclusion: Based on preference expressed by patients, there is no difference between NZ and CV mandibular dentures. Denture preference could not be related to patient variables over the study's time frame. [ABSTRACT FROM AUTHOR]

Background: Uptake matters for evaluating the health impact of water, sanitation and hygiene (WASH) interventions. Many large-scale WASH interventions have been plagued by low uptake. For the WASH Benefits Bangladesh efficacy trial, high uptake was a prerequisite. We assessed the degree of technology and behavioral uptake among participants in the trial, as part of a three-paper series on WASH Benefits Intervention Delivery and Performance.Methods: This study is a cluster randomized trial comprised of geographically matched clusters among four districts in rural Bangladesh. We randomly allocated 720 clusters of 5551 pregnant women to individual or combined water, sanitation, handwashing, and nutrition interventions, or a control group. Behavioral objectives included; drinking chlorine-treated, safely stored water; use of a hygienic latrine and safe feces disposal at the compound level; handwashing with soap at key times; and age-appropriate nutrition behaviors (pregnancy to 24 months) including a lipid-based nutrition supplement (LNS). Enabling technologies and behavior change were promoted by trained local community health workers through periodic household visits. To monitor technology and behavioral uptake, we conducted surveys and spot checks in 30-35 households per intervention arm per month, over a 20-month period, and structured observations in 324 intervention and 108 control households, approximately 15 months after interventions commenced.Results: In the sanitation arms, observed adult use of a hygienic latrine was high (94-97% of events) while child sanitation practices were moderate (37-54%). In the handwashing arms, handwashing with soap was more common after toilet use (67-74%) than nonintervention arms (18-40%), and after cleaning a child's anus (61-72%), but was still low before food handling. In the water intervention arms, more than 65% of mothers and index children were observed drinking chlorine-treated water from a safe container. Reported LNS feeding was > 80% in nutrition arms. There was little difference in uptake between single and combined intervention arms.Conclusions: Rigorous implementation of interventions deployed at large scale in the context of an efficacy trial achieved high levels of technology and behavioral uptake in individual and combined WASH and nutrition intervention households. Further work should assess how to achieve similar uptake levels under programmatic conditions.Trial Registration: WASH Benefits Bangladesh: ClinicalTrials.gov, identifier: NCT01590095 . Registered on April 30, 2012. [ABSTRACT FROM AUTHOR]

Study Question: Does a policy of elective freezing of embryos, followed by frozen embryo transfer result in a higher healthy baby rate, after first embryo transfer, when compared with the current policy of transferring fresh embryos?Summary Answer: This study, although limited by sample size, provides no evidence to support the adoption of a routine policy of elective freeze in preference to fresh embryo transfer in order to improve IVF effectiveness in obtaining a healthy baby.What Is Known Already: The policy of freezing all embryos followed by frozen embryo transfer is associated with a higher live birth rate for high responders but a similar/lower live birth after first embryo transfer and cumulative live birth rate for normal responders. Frozen embryo transfer is associated with a lower risk of ovarian hyperstimulation syndrome (OHSS), preterm delivery and low birthweight babies but a higher risk of large babies and pre-eclampsia. There is also uncertainty about long-term outcomes, hence shifting to a policy of elective freezing for all remains controversial given the delay in treatment and extra costs involved in freezing all embryos.Study Design, Size, Duration: A pragmatic two-arm parallel randomized controlled trial (E-Freeze) was conducted across 18 clinics in the UK from 2016 to 2019. A total of 619 couples were randomized (309 to elective freeze/310 to fresh). The primary outcome was a healthy baby after first embryo transfer (term, singleton live birth with appropriate weight for gestation); secondary outcomes included OHSS, live birth, clinical pregnancy, pregnancy complications and cost-effectiveness.Participants/materials, Setting, Methods: Couples undergoing their first, second or third cycle of IVF/ICSI treatment, with at least three good quality embryos on Day 3 where the female partner was ≥18 and <42 years of age were eligible. Those using donor gametes, undergoing preimplantation genetic testing or planning to freeze all their embryos were excluded. IVF/ICSI treatment was carried out according to local protocols. Women were followed up for pregnancy outcome after first embryo transfer following randomization.Main Results and the Role Of Chance: Of the 619 couples randomized, 307 and 309 couples in the elective freeze and fresh transfer arms, respectively, were included in the primary analysis. There was no evidence of a statistically significant difference in outcomes in the elective freeze group compared to the fresh embryo transfer group: healthy baby rate {20.3% (62/307) versus 24.4% (75/309); risk ratio (RR), 95% CI: 0.84, 0.62 to 1.15}; OHSS (3.6% versus 8.1%; RR, 99% CI: 0.44, 0.15 to 1.30); live birth rate (28.3% versus 34.3%; RR, 99% CI 0.83, 0.65 to 1.06); and miscarriage (14.3% versus 12.9%; RR, 99% CI: 1.09, 0.72 to 1.66). Adherence to allocation was poor in the elective freeze group. The elective freeze approach was more costly and was unlikely to be cost-effective in a UK National Health Service context.Limitations, Reasons For Caution: We have only reported on first embryo transfer after randomization; data on the cumulative live birth rate requires further follow-up. Planned target sample size was not obtained and the non-adherence to allocation rate was high among couples in the elective freeze arm owing to patient preference for fresh embryo transfer, but an analysis which took non-adherence into account showed similar results.Wider Implications Of the Findings: Results from the E-Freeze trial do not lend support to the policy of electively freezing all for everyone, taking both efficacy, safety and costs considerations into account. This method should only be adopted if there is a definite clinical indication.Study Funding/competing Interest(s): NIHR Health Technology Assessment programme (13/115/82). This research was funded by the National Institute for Health Research (NIHR) (NIHR unique award identifier) using UK aid from the UK Government to support global health research. The views expressed in this publication are those of the author(s) and not necessarily those of the NIHR or the UK Department of Health and Social Care. J.L.B., C.C., E.J., P.H., J.J.K., L.L. and G.S. report receipt of funding from NIHR, during the conduct of the study. J.L.B., E.J., P.H., K.S. and L.L. report receipt of funding from NIHR, during the conduct of the study and outside the submitted work. A.M. reports grants from NIHR personal fees from Merck Serono, personal fees for lectures from Merck Serono, Ferring and Cooks outside the submitted work; travel/meeting support from Ferring and Pharmasure and participation in a Ferring advisory board. S.B. reports receipt of royalties and licenses from Cambridge University Press, a board membership role for NHS Grampian and other financial or non-financial interests related to his roles as Editor-in-Chief of Human Reproduction Open and Editor and Contributing Author of Reproductive Medicine for the MRCOG, Cambridge University Press. D.B. reports grants from NIHR, during the conduct of the study; grants from European Commission, grants from Diabetes UK, grants from NIHR, grants from ESHRE, grants from MRC, outside the submitted work. Y.C. reports speaker fees from Merck Serono, and advisory board role for Merck Serono and shares in Complete Fertility. P.H. reports membership of the HTA Commissioning Committee. E.J. reports membership of the NHS England and NIHR Partnership Programme, membership of five Data Monitoring Committees (Chair of two), membership of six Trial Steering Committees (Chair of four), membership of the Northern Ireland Clinical Trials Unit Advisory Group and Chair of the board of Oxford Brain Health Clinical Trials Unit. R.M. reports consulting fees from Gedeon Richter, honorarium from Merck, support fees for attendance at educational events and conferences for Merck, Ferring, Bessins and Gedeon Richter, payments for participation on a Merck Safety or Advisory Board, Chair of the British Fertility Society and payments for an advisory role to the Human Fertilisation and Embryology Authority. G.S. reports travel and accommodation fees for attendance at a health economic advisory board from Merck KGaA, Darmstadt, Germany. N.R.-F. reports shares in Nurture Fertility. Other authors' competing interests: none declared.Trial Registration Number: ISRCTN: 61225414.Trial Registration Date: 29 December 2015.Date Of First Patient’s Enrolment: 16 February 2016. [ABSTRACT FROM AUTHOR]

Study Question: Does acupuncture improve insulin sensitivity more effectively than metformin or sham acupuncture in women with polycystic ovary syndrome (PCOS) and insulin resistance (IR)?Summary Answer: Among women with PCOS and IR, acupuncture was not more effective than metformin or sham acupuncture in improving insulin sensitivity.What Is Known Already: Uncontrolled trials have shown that acupuncture improved insulin sensitivity with fewer side effects compared with metformin in women with PCOS and IR. However, data from randomized trials between acupuncture and metformin or sham acupuncture are lacking.Study Design, Size, Duration: This was a three-armed randomized controlled trial enrolling a total of 342 women with PCOS and IR from three hospitals between November 2015 and February 2018, with a 3-month follow-up until October 2018.Participants/materials, Setting, Methods: Women aged from 18 to 40 years with PCOS and homeostasis model assessment of insulin resistance (HOMA-IR) ≥2.14 were randomly assigned (n = 114 per group) to receive true acupuncture plus placebo (true acupuncture), metformin plus sham acupuncture (metformin, 0.5 g three times daily) or sham acupuncture plus placebo (sham acupuncture) for 4 months, with an additional 3-month follow-up. True or sham acupuncture was given three times per week, and 0.5 g metformin or placebo was given three times daily. The primary outcome was change in HOMA-IR from baseline to 4 months after baseline visit. Secondary outcomes included changes in the glucose AUC during an oral glucose tolerance test, BMI and side effects at 4 months after baseline visit.Main Results and the Role Of Chance: After 4 months of treatment, the changes of HOMA-IR were -0.5 (decreased 14.7%) in the true acupuncture group, -1.0 (decreased 25.0%) in the metformin group and -0.3 (decreased 8.6%) in the sham acupuncture group, when compared with baseline. True acupuncture is not as effective as metformin in improving HOMA-IR at 4 months after baseline visit (difference, 0.6; 95% CI, 0.1-1.1). No significant difference was found in change in HOMA-IR between true and sham acupuncture groups at 4 months after baseline visit (difference, -0.2; 95% CI, -0.7 to 0.3). During the 4 months of treatment, gastrointestinal side effects were more frequent in the metformin group, including diarrhea, nausea, loss of appetite, fatigue, vomiting and stomach discomfort (31.6%, 13.2%, 11.4%, 8.8%, 14.0% and 8.8%, respectively). Bruising was more common in the true acupuncture group (14.9%).Limitations, Reasons For Caution: This study might have underestimated the sample size in the true acupuncture group with 4 months of treatment to enable detection of statistically significant changes in HOMA-IR with fixed acupuncture (i.e. a non-personalized protocol). Participants who withdrew because of pregnancy did not have further blood tests and this can introduce bias.Wider Implications Of the Findings: True acupuncture did not improve insulin sensitivity as effectively as metformin in women with PCOS and IR, but it is better than metformin in improving glucose metabolism (which might reduce the risk of type 2 diabetes) and has less side effects. Metformin had a higher incidence of gastrointestinal adverse effects than acupuncture groups, and thus acupuncture might be a non-pharmacological treatment with low risk for women with PCOS. Further studies are needed to evaluate the effect of acupuncture combined with metformin on insulin sensitivity in these women.Study Funding/competing Interest(s): This work was supported by grants 2017A020213004 and 2014A020221060 from the Science and Technology Planning Project of Guangdong Province. The authors have no conflicts of interest.Trial Registration Number: Clinicaltrials.gov number: NCT02491333.Trial Registration Date: 8 July 2015.Date Of First Patient’s Enrollment: 11 November 2015. [ABSTRACT FROM AUTHOR]

Background: Depression treatments are typically less effective for young people than for adults. However, treatments rarely target loneliness, which is a key risk factor in the onset, maintenance and development of depression.Aims: This study evaluated the efficacy of a novel loneliness intervention, Groups 4 Health (G4H), relative to the best-practice treatment of cognitive-behavioural therapy (CBT) in reducing loneliness and depression over a 12-month period (Australian New Zealand Clinical Trial Registry: ACTRN12618000440224).Method: The study was a phase 3 randomised non-inferiority trial comparing G4H with dose-controlled group CBT. Participants were 174 people aged 15-25 years experiencing loneliness and clinically significant symptoms of depression, who were not in receipt of adjunct treatment. Participants were recruited from mental health services in Southeast Queensland, Australia. Randomisation was conducted using computer software. Follow-up assessments and statistical analyses were masked to allocation. Both interventions consisted of five 75 min group-based psychotherapy sessions. The primary outcomes were depression and loneliness, with a non-inferiority margin of 2.20 for depression.Results: The trial enrolled 174 participants between 24 April 2018 and 25 May 2019, with 84 in the G4H condition and 90 in the CBT condition. All randomised participants were included in the intention-to-treat analyses (n = 174). The pre-post effect sizes for depression were dG4H = -0.71 and dCBT = -0.91. For loneliness, they were dG4H = -1.07 and dCBT = -0.89. At 12-month follow-up, the absolute difference between groups on depression was 1.176 (95% CI -1.94 to 4.29) and on loneliness it was -0.679 (95% CI -1.43 to 0.07). No adverse effects were observed.Conclusions: G4H was non-inferior to CBT for depression and showed a slight advantage over CBT for loneliness that emerged after treatment completion. [ABSTRACT FROM AUTHOR]

Background: High intensity interval training (HIIT) has been reported to exert better effects on cardiovascular fitness in obesity, but little known about the arterial stiffness (AS) in female university students with normal weight obesity (NWO). Thus, this study aimed to investigate the effects of HIIT on the body composition, heart rate (HR), blood pressure (BP), blood lipids metabolism as well as the novel parameters of propensity for AS (arterial velocity pulse index [AVI], arterial pressure volume index [API]) for female university students with NWO.Methods: Forty female university students with NWO were randomly assigned to control group (n = 20) and HIIT group (3 bouts of 9‑min intervals at 90% of the maximal heart rate [HRmax], interspersed by 1 min rest, 5 days a week, n = 20). Tests were performed before and after 4 weeks of training. Repeated measures ANOVA and simple effect test analysis were used to analyze dependent variable changes.Results: After 4 weeks HIIT statistically significantly improved the body composition by decreasing the body mass index, body fat percent, total body fat mass (BFM), BFM of left arm, measured circumference of left arm, and obesity degree, and increasing the total body skeletal muscle mass, protein content, total body water, fat free mass, body cell mas, and InBody score. HIIT also statistically significantly decreased the HR and BP. As for the lipid profile, HIIT obviously ameliorated the blood lipids metabolism by decreasing the levels of total cholesterol (TC), triglyceride, low-density lipoprotein, and TC/HDL, and increasing the levels of high-density lipoprotein (HDL). In addition, the AVI and API were markedly decreased via HIIT intervention.Conclusions: HIIT produced significant and meaningful benefits for body composition, HR, BP, and blood lipids metabolism, and could decrease AS in female university students with NWO. This suggests that HIIT may effectively reduce the risk of arteriosclerosis and protect the cardiovascular function for female university students with NWO. Trial registration ChiCTR2100050711. Registered 3 September 2021. Retrospectively registered. [ABSTRACT FROM AUTHOR]

Rationale: The INCREASE study of inhaled treprostinil met its primary endpoint of change in 6-minute-walk distance at Week 16. In addition, there were significantly fewer clinical worsening events in patients receiving inhaled treprostinil. However, the incidence of multiple events in the same patient is unknown. Objectives: This post hoc analysis evaluated the effect of continued treatment with inhaled treprostinil on the frequency and impact of multiple disease progression events. Methods: Patients enrolled in INCREASE were analyzed for disease progression events, defined as at least 15% decline in 6-minute-walk distance, exacerbation of underlying lung disease, cardiopulmonary hospitalization, lung transplantation, at least 10% decline in forced vital capacity, or death during the duration of the 16-week study. Measurements and Main Results: In total, 147 disease progression events occurred in the inhaled treprostinil group (89/163 patients, 55%) compared with 215 events (109/163 patients, 67%) in the placebo group (P = 0.018). There was a lower incidence of each disease progression component in the inhaled treprostinil group: 6-minute-walk distance decline (45 vs. 64 events), lung disease exacerbation (48 vs. 72 events), FVC decline (19 vs. 33), cardiopulmonary hospitalization (23 vs. 33 events), and death (10 vs. 12). Fewer patients receiving inhaled treprostinil had multiple progression events compared with those receiving the placebo (35 vs. 58, 22% vs. 36%; P = 0.005). Conclusions: Patients who received inhaled treprostinil were significantly less likely to experience further disease progression events after an initial event compared with patients receiving placebo. These results support the continuation of inhaled treprostinil despite the occurrence of disease progression in clinical practice. [ABSTRACT FROM AUTHOR]

Background/objectives: Intermittent energy restriction (IER) may overcome poor long-term adherence with continuous energy restriction (CER), for weight reduction. We compared the effects of IER with CER for fasting and postprandial metabolism and appetite in metabolically healthy participants, in whom excess weight would not confound intrinsic metabolic differences.Subjects/methods: In a 2-week randomised, parallel trial, 16 young, healthy-weight participants were assigned to either CER (20% below estimated energy requirements (EER)) or 5:2 IER (70% below EER on 2 non-consecutive days; 5 days at EER, per week). Metabolic and appetite regulation markers were assessed before and for 3 h after a liquid breakfast; followed by an ad libitum lunch; pre- and post-intervention.Results: Weight loss was similar in both groups: -2.5 (95% CI, -3.4, -1.6) kg for 5:2 IER vs. -2.3 (-2.9, -1.7) kg for CER. There were no differences between groups for postprandial incremental area under the curve for serum insulin, blood glucose or subjective appetite ratings. Compared with CER, 5:2 IER led to a reduction in fasting blood glucose concentrations (treatment-by-time interaction, P = 0.018, η2p = 0.14). Similarly, compared with CER, there were beneficial changes in fasting composite appetite scores after 5:2 IER (treatment-by-time interaction, P = 0.0003, η2p = 0.35).Conclusions: There were no significant differences in postprandial insulinaemic, glycaemic or appetite responses between treatments. However, 5:2 IER resulted in greater improvements in fasting blood glucose, and beneficial changes in fasting subjective appetite ratings. [ABSTRACT FROM AUTHOR]

Background: Survivorship care plans seek to improve the transition to survivorship, but the required resources present implementation barriers. This randomized controlled trial aimed to identify the simplest, most effective approach for survivorship care planning.Methods: Stage 1-3 breast, colorectal, and prostate cancer patients aged 21 years or older completing treatment were recruited from an urban-academic and rural-community cancer center. Participants were randomly assigned, stratified by recruitment site and cancer type 1:1:1 to a mailed plan, plan delivered during a 1-time transition visit, or plan delivered during a transition visit plus 6-month follow-up visit. Health service use data were collected from participants and medical records for 18 months. The primary outcome, receipt of all plan-recommended care, was compared across intervention arms using logistic regression adjusting for cancer type and recruitment site, with P less than .05 considered statistically significant.Results: Of 378 participants randomly assigned, 159 (42.1%) were breast, 142 (37.6%) prostate, and 77 (20.4%) colorectal cancer survivors; 207 (54.8%) from the academic site and 171 (45.2%) from the community site; 316 were analyzable for the primary outcome. There was no difference across arms in the proportion of participants receiving all plan-recommended care: 45.2% mail, 50.5% 1-visit, 42.7% 2-visit (2-sided P = .60). Adherence by cancer type for mail, 1-visit, and 2-visit, respectively, was 52.2%, 53.3%, and 40.0% for breast cancer; 48.6%, 64.1%, and 57.1% for prostate cancer; and 23.8%, 19.0%, and 26.1% for colorectal cancer. There were no statistically significant interactions by recruitment site or cancer type.Conclusions: This study did not find differences in receipt of recommended follow-up care by plan delivery approach. Feasibility and other factors may determine the best approach for survivorship care planning. [ABSTRACT FROM AUTHOR]

Acupuncture using laser needles is a new totally painless stimulation method which has been described for the first time. This paper presents an experimental double-blind study in acupuncture research in healthy volunteers using a new optical stimulation method. We investigated 18 healthy volunteers (mean age +/- SD: 25.4 +/- 4.3 years; range: 21-30 years; 11 female, 7 male) in a randomized controlled cross-over trial using functional multidirectional transcranial ultrasound Doppler sonography (fTCD; n = 17) and performed functional magnetic resonance imaging (fMRI) in one volunteer. Stimulation of vision-related acupoints resulted in an increase of mean blood flow velocity in the posterior cerebral artery measured by fTCD [before stimulation (mean +/- SE): 42.2 +/- 2.5; during stimulation: 44.2 +/- 2.6; after stimulation: 42.3 +/- 2.4 cm/s, n.s.]. Mean blood flow velocity in the middle cerebral artery decreased insignificantly. Significant changes (p < 0.05) of brain activity were demonstrated in the occipital and frontal gyrus by fMRI. Optical stimulation using properly adjusted laser needles has the advantage that the stimulation cannot be felt by the patient (painless and no tactile stimulation) and the operator may also be unaware of whether the stimulation system is active. Therefore true double-blind studies in acupuncture research can be performed. [ABSTRACT FROM AUTHOR]

Buprenorphine was registered in Australia as a maintenance and detoxification agent for the management of opioid dependence in November, 2000, and became widely available in August, 2001. This paper provides an overview of key developments in the introduction of buprenorphine treatment in Australia, with an emphasis upon the delivery of services in community-based (primary care) settings. A central study in this work was the Buprenorphine Implementation Trial (BIT), a randomized, controlled trial comparing buprenorphine and methadone maintenance treatment delivered under naturalistic conditions by specialist and community-based service providers (general practitioners and community pharmacists) in 139 subjects across nineteen treatment sites. In addition to conventional patient outcome measures (treatment retention, drug use, psychosocial functioning, and cost effectiveness), the BIT study also involved the development and evaluation of clinical guidelines, training programs for clinicians, and client literature, which are described here. Integration of treatment systems (methadone with buprenorphine, specialist and primary-care programs) and factors thought to be important in the uptake of buprenorphine treatment in Australia since registration are discussed. [ABSTRACT FROM AUTHOR]

Background: Loss to follow-up (LFTU) among HIV patients remains a major obstacle to achieving treatment goals with the risk of failure to achieve viral suppression and thereby increased HIV transmission. Although use of clinical decision support systems (CDSS) has been shown to improve adherence to HIV clinical guidance, to our knowledge, this is among the first studies conducted to show its effect on LTFU in low-resource settings.Methods: We analyzed data from a cluster randomized controlled trial in adults and children (aged ≥ 18 months) who were receiving antiretroviral therapy at 20 HIV clinics in western Kenya between Sept 1, 2012 and Jan 31, 2014. Participating clinics were randomly assigned, via block randomization. Clinics in the control arm had electronic health records (EHR) only while the intervention arm had an EHR with CDSS. The study objectives were to assess the effects of a CDSS, implemented as alerts on an EHR system, on: (1) the proportion of patients that were LTFU, (2) LTFU patients traced and successfully linked back to treatment, and (3) time from enrollment on the study to documentation of LTFU.Results: Among 5901 eligible patients receiving ART, 40.6% (n = 2396) were LTFU during the study period. CDSS was associated with lower LTFU among the patients (Adjusted Odds Ratio-aOR 0.70 (95% CI 0.65-0.77)). The proportions of patients linked back to treatment were 25.8% (95% CI 21.5-25.0) and 30.6% (95% CI 27.9-33.4)) in EHR only and EHR with CDSS sites respectively. CDSS was marginally associated with reduced time from enrollment on the study to first documentation of LTFU (adjusted Hazard Ratio-aHR 0.85 (95% CI 0.78-0.92)).Conclusion: A CDSS can potentially improve quality of care through reduction and early detection of defaulting and LTFU among HIV patients and their re-engagement in care in a resource-limited country. Future research is needed on how CDSS can best be combined with other interventions to reduce LTFU. Trial registration NCT01634802. Registered at www.clinicaltrials.gov on 12-Jul-2012. Registered prospectively. [ABSTRACT FROM AUTHOR]

Context: For children with growth hormone deficiency (GHD), treatment burden with daily somatropin injections [human growth hormone (hGH)] is high, which may lead to poor adherence and suboptimal overall treatment outcomes. Lonapegsomatropin (TransCon hGH) is an investigational long-acting, once-weekly prodrug for the treatment of GHD.Objective: The objective of this study was to evaluate the efficacy and safety of once-weekly lonapegsomatropin vs daily somatropin.Design: The heiGHt trial was a randomized, open-label, active-controlled, 52-week Phase 3 trial (NCT02781727).Setting: This trial took place at 73 sites across 15 countries.Patients: This trial enrolled and dosed 161 treatment-naïve, prepubertal patients with GHD.Interventions: Patients were randomized 2:1 to receive lonapegsomatropin 0.24 mg hGH/kg/week or an equivalent weekly dose of somatropin delivered daily.Main Outcome Measure: The primary end point was annualized height velocity (AHV) at week 52. Secondary efficacy end points included change from baseline in height SD scores (SDS).Results: Least squares (LS) mean (SE) AHV at 52 weeks was 11.2 (0.2) cm/year for lonapegsomatropin vs 10.3 (0.3) cm/year for daily somatropin (P = 0.009), with lonapegsomatropin demonstrating both noninferiority and superiority over daily somatropin. LS mean (SE) height SDS increased from baseline to week 52 by 1.10 (0.04) vs 0.96 (0.05) in the weekly lonapegsomatropin vs daily somatropin groups (P = 0.01). Bone age/chronological age ratio, adverse events, tolerability, and immunogenicity were similar between groups.Conclusions: The trial met its primary objective of noninferiority in AHV and further showed superiority of lonapegsomatropin compared to daily somatropin, with similar safety, in treatment-naïve children with GHD. [ABSTRACT FROM AUTHOR]

Background: Current pharmacological and behavioral treatment options for mild cognitive impairment (MCI) are limited, motivating a search for alternative therapies that might slow the progression of cognitive decline.Objective: We investigated the effectiveness of a cognition-focused mindfulness-based intervention.Methods: An open-label, three arm randomized controlled trial was conducted at a public tertiary medical center. Older persons (ages 45-75; N = 76) diagnosed with MCI were recruited and randomized into either mindfulness-based training (MBT), cognitive rehabilitation therapy (CRT), or treatment as usual (TAU). Participants in the intervention arms received 8 weekly 2-h sessions delivered in a group setting and engaged in home practice. Primary outcomes measures included changes in index scores for attention, immediate memory, and delayed memory as measured using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). Depression was a secondary outcome.Results: Using intent-to-treat analysis, we found that participants receiving MBT showed significant improvements in global cognition (d = 0.26; [95%CI 0.03-0.56]) and delayed memory (d = 0.36; [95%CI 0.17-0.57]), with significantly greater improvements in delayed memory than CRT (ηp2 = 0.10). However, there was no benefit of MBT over TAU. No change in depression was observed in the MBT group. Reductions in depression were associated with improvements in cognitive functioning in the MBT group only.Conclusion: Our results suggest that a cognition-focused MBT did not improve cognitive functioning in MCI patients substantially more than spontaneous reversion rates, possibly as mood symptoms were not significantly alleviated in this group. [ABSTRACT FROM AUTHOR]

Physicians can play a key role in smoking cessation but often fail to advise smokers effectively, mainly because they lack counseling skills. We need effective training programs starting during residency to improve physicians' smoking cessation interventions and smokers' quit rates. To achieve this goal, we developed a curriculum using active learning methods and the stages-of-change model. A randomized trial demonstrated that this program increased the quality of physician's counseling and smokers' quit rates at 1 year. This paper describes the educational content and methods of this program. Participants learn to assess smokers' stage of change, to use counseling strategies matching the smoker's stage, and to prescribe pharmacological therapy. This 2 half-day training program includes observation of video-clips, interactive workshops, role plays, practice with standardized patients, and written material for physicians and patients. Participants reached learning objectives and appreciated the content and active methods of the program. [ABSTRACT FROM AUTHOR]

This paper reports on the evaluation of a culturally grounded prevention intervention targeting substance use among urban middle-school students. The curriculum consists of 10 lessons promoting antidrug norms and teaching resistance and other social skills, reinforced by booster activities and a media campaign. Three versions were delivered: Mexican American, combined African American and European American, and Multicultural. Thirty-five middle schools were randomly assigned to 1 of the 3 versions or the control. Students completed baseline and follow-up questionnaires over a 2-year period (total 6,035 respondents). Analyses utilizing a generalized estimating equations approach assessed the overall effectiveness of cultural grounding and the cultural matching hypothesis. Support was found for the intervention's overall effectiveness, with statistically significant effects on gateway drug use as well as norms, attitudes, and resistance strategies but with little support for the cultural matching hypothesis. Specific contrasts found the Mexican American and Multicultural versions impacted the most outcomes. [ABSTRACT FROM AUTHOR]

Vulnerability–stress models suggest that training in specific stress management techniques should yield benefits to those suffering from schizophrenia and related disorders. In this paper, we describe an evaluation of the impact of adding a stress management program to other medical and psychosocial interventions for such patients. Outcomes were compared for 121 patients randomly assigned to receive either a 12-week stress management program with follow-up sessions or participation in a social activities group. The two treatment conditions did not differ in levels of symptoms, perceived stress or life skills immediately after completion of treatment or at 1-year follow-up. Patients who received the stress management program did have fewer hospital admissions in the year following treatment. This effect of stress management was most apparent for those who showed high levels of attendance for treatment sessions. It was concluded that training in stress management may provide patients with skills for coping with acute stressors and reduce the likelihood of subsequent acute exacerbation of symptoms with need for hospitalization. [Copyright &y& Elsevier]

Background: The external validity of the randomized controlled trial (RCT) refers to the extent to which the results of the RCT apply to the relevant, non-trial population and is impacted by its eligibility criteria, its organization, and its delivery of the intervention. Here, we compared the outcomes of mortality and hospitalization between an RCT and a cohort study that concurrently enrolled HIV-exposed uninfected (HEU) newborns in Botswana.Methods: The Mpepu Study (the RCT) was a clinical trial which determined that co-trimoxazole (CTX) provided no survival benefit for HEUs, allowing both arms of the RCT to be used. The Maikaelelo study (the cohort study) was a prospective observational study that enrolled HEU newborns with telephone follow-up and no in-person visits. Rates of death and hospitalization in the pooled population, were modeled using cox-proportional hazards models for time to death or time to first hospitalization, with study setting (RCT vs. cohort study) as an independent variable. The causal effect of study setting on morbidity and mortality was obtained through a treatment effects approach.Results: In total, 4,010 infants were included; 1,306 were enrolled into the cohort study and 2,704 were enrolled into the RCT. No significant differences in mortality were observed between the two study settings (HR: 1.28, 95% CI: 0.76, 2.13), but RCT participants had a lower risk of hospitalization (HR: 0.72, 95% CI: 0.58, 0.89) that decreased with age. However, RCT participants had a higher risk of hospitalization within the first six months of life. The causal risk difference in hospitalizations attributable to the RCT setting was -0.03 (95% CI: -0.05, -0.01).Conclusions: Children in an RCT with rigorous application of national standard of care guidelines experienced a significantly lower risk of hospitalization than children participating in a cohort study that did not alter clinical care. Future research is needed to further investigate outcome disparities when real-world results fail to mirror those achieved in a clinical trial. Trial registration The Mpepu Trial was funded by the U.S. National Institutes of Health (No. NCT01229761) and the Maikaelelo Study was funded primarily by the U.S. Centers for Disease Control and Prevention (32AI007433-21). [ABSTRACT FROM AUTHOR]

Background: Identifying strategies to optimize participation in health studies is one of the major concerns for researchers. The purpose of this study was to evaluate the efficiency of different invitation strategies on participation rate in the Employees' Health Cohort Study of Iran (EHCSIR).Methods: Two cluster-randomized trials were carried out to assess the outcomes of different invitation strategies. In the first phase, 7 units with 1880 employees (3 hospitals, 3 health centers, and 1 office) were assigned to the three parallel modes of invitation: 1) invitation letter, 2) phone call and 3) Short Message Service (SMS). In the second phase, 6 hospitals with 1633 employees were allocated to two invitation methods: 1) invitation letter, 2) invitation letter plus EHCSIR project introduction video. All groups were followed up by phone calls. A logistic mixed-effects model was used to compare the effectiveness of the strategies. The cost-effectiveness of the interventions was also compared.Results: In the first phase, the participation rates in the invitation letter, phone call, and SMS groups were 27.04% (182/673), 21.55% (131/608), and 22.54% (135/599), respectively. Using an invitation letter was significantly more successful than SMS (Adjusted Odds Ratio = 1.80, 95% CI =1.14 to 2.85). Average Cost-Effectiveness Ratios (ACER) were $1.37, $1.42, and $1.55 for the invitation letter, phone call, and SMS, respectively. In the second phase, adding a project introduction video to the invitation letter did not significantly influence the participation rate (Adjusted OR = 0.58, 95% CI =0.24 to 1.36). The ACER was $1.21 for the invitation letter only and $2.01 for the invitation letter plus the introduction video.Conclusions: In comparison with the phone call and SMS, the invitation letter is the most effective invitation method for public sector employees to participate in a cohort study. Sending an introduction video did not significantly increase the participation rate compared to sending an invitation letter only. [ABSTRACT FROM AUTHOR]

The primary analysis of randomized screening trials for cancer typically adheres to the intention-to-screen principle, measuring cancer-specific mortality reductions between screening and control arms. These mortality reductions result from a combination of the screening regimen, screening technology and the effect of the early, screening-induced, treatment. This motivates addressing these different aspects separately. Here we are interested in the causal effect of early versus delayed treatments on cancer mortality among the screening-detectable subgroup, which under certain assumptions is estimable from conventional randomized screening trial using instrumental variable type methods. To define the causal effect of interest, we formulate a simplified structural multi-state model for screening trials, based on a hypothetical intervention trial where screening detected individuals would be randomized into early versus delayed treatments. The cancer-specific mortality reductions after screening detection are quantified by a cause-specific hazard ratio. For this, we propose two estimators, based on an estimating equation and a likelihood expression. The methods extend existing instrumental variable methods for time-to-event and competing risks outcomes to time-dependent intermediate variables. Using the multi-state model as the basis of a data generating mechanism, we investigate the performance of the new estimators through simulation studies. In addition, we illustrate the proposed method in the context of CT screening for lung cancer using the US National Lung Screening Trial data. [ABSTRACT FROM AUTHOR]

Background: Overconsumption of energy from food is a major contributor to the high rates of overweight and obesity in many populations. There is growing evidence that interventions that target the food environment may be effective at reducing energy intake. The current study aimed to estimate the effect of decreasing the proportion of higher energy (kcal) foods, with and without reducing portion size, on energy purchased in worksite cafeterias.Methods and Findings: This stepped-wedge randomised controlled trial (RCT) evaluated 2 interventions: (i) availability: replacing higher energy products with lower energy products; and (ii) size: reducing the portion size of higher energy products. A total of 19 cafeterias were randomised to the order in which they introduced the 2 interventions. Availability was implemented first and maintained. Size was added to the availability intervention. Intervention categories included main meals, sides, cold drinks, snacks, and desserts. The study setting was worksite cafeterias located in distribution centres for a major United Kingdom supermarket and lasted for 25 weeks (May to November 2019). These cafeterias were used by 20,327 employees, mainly (96%) in manual occupations. The primary outcome was total energy (kcal) purchased from intervention categories per day. The secondary outcomes were energy (kcal) purchased from nonintervention categories per day, total energy purchased per day, and revenue. Regression models showed an overall reduction in energy purchased from intervention categories of -4.8% (95% CI -7.0% to -2.7%), p < 0.001 during the availability intervention period and a reduction of -11.5% (95% CI -13.7% to -9.3%), p < 0.001 during the availability plus size intervention period, relative to the baseline. There was a reduction in energy purchased of -6.6% (95% CI -7.9% to -5.4%), p < 0.001 during the availability plus size period, relative to availability alone. Study limitations include using energy purchased as the primary outcome (and not energy consumed) and the availability only of transaction-level sales data per site (and not individual-level data).Conclusions: Decreasing the proportion of higher energy foods in cafeterias reduced the energy purchased. Decreasing portion sizes reduced this further. These interventions, particularly in combination, may be effective as part of broader strategies to reduce overconsumption of energy from food in out-of-home settings.Trial Registration: ISRCTN registry ISRCTN87225572. [ABSTRACT FROM AUTHOR]

Importance: Hyperoxemia may increase organ dysfunction in critically ill patients, but optimal oxygenation targets are unknown.Objective: To determine whether a low-normal Pao2 target compared with a high-normal target reduces organ dysfunction in critically ill patients with systemic inflammatory response syndrome (SIRS).Design, Setting, and Participants: Multicenter randomized clinical trial in 4 intensive care units in the Netherlands. Enrollment was from February 2015 to October 2018, with end of follow-up to January 2019, and included adult patients admitted with 2 or more SIRS criteria and expected stay of longer than 48 hours. A total of 9925 patients were screened for eligibility, of whom 574 fulfilled the enrollment criteria and were randomized.Interventions: Target Pao2 ranges were 8 to 12 kPa (low-normal, n = 205) and 14 to 18 kPa (high-normal, n = 195). An inspired oxygen fraction greater than 0.60 was applied only when clinically indicated.Main Outcomes and Measures: Primary end point was SOFARANK, a ranked outcome of nonrespiratory organ failure quantified by the nonrespiratory components of the Sequential Organ Failure Assessment (SOFA) score, summed over the first 14 study days. Participants were ranked from fastest organ failure improvement (lowest scores) to worsening organ failure or death (highest scores). Secondary end points were duration of mechanical ventilation, in-hospital mortality, and hypoxemic measurements.Results: Among the 574 patients who were randomized, 400 (70%) were enrolled within 24 hours (median age, 68 years; 140 women [35%]), all of whom completed the trial. The median Pao2 difference between the groups was -1.93 kPa (95% CI, -2.12 to -1.74; P < .001). The median SOFARANK score was -35 points in the low-normal Pao2 group vs -40 in the high-normal Pao2 group (median difference, 10 [95% CI, 0 to 21]; P = .06). There was no significant difference in median duration of mechanical ventilation (3.4 vs 3.1 days; median difference, -0.15 [95% CI, -0.88 to 0.47]; P = .59) and in-hospital mortality (32% vs 31%; odds ratio, 1.04 [95% CI, 0.67 to 1.63]; P = .91). Mild hypoxemic measurements occurred more often in the low-normal group (1.9% vs 1.2%; median difference, 0.73 [95% CI, 0.30 to 1.20]; P < .001). Acute kidney failure developed in 20 patients (10%) in the low-normal Pao2 group and 21 patients (11%) in the high-normal Pao2 group, and acute myocardial infarction in 6 patients (2.9%) in the low-normal Pao2 group and 7 patients (3.6%) in the high-normal Pao2 group.Conclusions and Relevance: Among critically ill patients with 2 or more SIRS criteria, treatment with a low-normal Pao2 target compared with a high-normal Pao2 target did not result in a statistically significant reduction in organ dysfunction. However, the study may have had limited power to detect a smaller treatment effect than was hypothesized.Trial Registration: ClinicalTrials.gov Identifier: NCT02321072. [ABSTRACT FROM AUTHOR]

AMELIORATE is a Phase III, randomized trial aiming to personalize treatment intensity in FLT3-mutated acute myeloid leukemia. The current study provides an early appraisal of chemosensitivity based on peripheral blasts clearance, as assessed by multiparameter flow cytometry, from baseline to day 4 of induction. This biomarker was previously demonstrated to predict complete remission achievement and measurable residual disease status. For patients experiencing low peripheral blast cells (i.e., ≤2.0 logs), two major adjustments of treatment as compared with current standard of care are envisioned in the experimental arm: the immediate switch to intensified induction with high-doses cytarabine (1500 mg/m2 b.i.d. on days 5-7 of induction); and the early allocation of the patient to high-risk disease category, to be further refined later based on postinduction measurable residual disease status. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the effectiveness of a multicomponent intervention (MCI) on children's dietary diversity and its impact pathway components of children's food knowledge and healthy food preferences.Design: A 6-week cluster randomised controlled trial with a MCI consisting of child nutrition education plus family engagement through parental nutrition education, meal preparation and tasting was compared with two groups: single component intervention (SCI) of child nutrition education, and control, conducted during February to July 2018. Preschool centres were randomly assigned to one of the three arms. Children's food knowledge, healthy food preferences and dietary diversity scores were collected. Intervention effects were analysed using a pre-post analysis and a difference-in-difference model.Setting: Fourteen preschool centres in an urban area of Kurunegala, Sri Lanka.Participants: Child-parent dyads of children aged 4-6 years. Final analyses included 306 (for food knowledge and preferences) and 258 (for dietary diversity) dyads.Results: MCI significantly influenced the impact pathways to children's dietary diversity by increasing children's food knowledge and healthy food preferences scores by 3·76 and 2·79 (P < 0·001), respectively, but not the dietary diversity score (P = 0·603), compared with the control arm. Relative to SCI, MCI significantly improved children's food knowledge score by 1·10 (P < 0·001), but no significant effects were noted for other outcome variables.Conclusions: Improved food knowledge and preferences require a positive food environment and time to develop into healthy eating behaviours. Research into dietary diversity should broaden to incorporate the contextual roles of the home and general food environments to more completely understand food choices of children. [ABSTRACT FROM AUTHOR]

Objective: To determine whether the prevalence of stunting differed between an intervention group and a control group and to identify factors associated with the children's linear growth.Design: This was a follow-up study of mother-child pairs who participated in a 2012-2015 cluster randomised controlled trial. Linear mixed effects models were performed to model the children's linear growth and identify the determinants of child linear growth.Setting: The study was conducted in two slums in Nairobi. The intervention group received monthly nutrition education and counselling (NEC) during pregnancy and infancy period.Participants: A birth cohort of 1004 was followed up every 3 months after delivery to the 13th month. However, as a result of dropouts, a total of 438 mother-child pairs participated during the 55-month follow-up. The loss to follow-up baseline characteristics did not differ from those included for analysis.Results: Length-for-age z-scores decreased from birth to the 13th month, mean -1·42 (sd 2·04), with the control group (33·5 %) reporting a significantly higher prevalence of stunting than the intervention group (28·6 %). Conversely, the scores increased in the 55th month, mean -0·89 (sd 1·04), with significantly more males (16·5 %) stunted in the control group than in the intervention group (8·3 %). Being in the control group, being a male child, often vomiting/regurgitating food, mother's stature of <154 cm and early weaning were negatively associated with children's linear growth.Conclusions: Home-based maternal NEC reduced stunting among under five years; however, the long-term benefits of this intervention on children's health need to be elucidated. [ABSTRACT FROM AUTHOR]

Background: During the period of hospitalization, patients can develop functional decline. The main aim of our study was to assess the natural trajectory of each activity of daily living (ADL) and to assess how in-hospital exercise could influence short-term trajectory of ADLs.Method: Acutely hospitalized patients (n = 297, 56.5% women) were randomly assigned to the intervention or control (usual care) group within the first 48 hours of admission. An exercise training program was prescribed in 2 daily sessions (morning and evening) of 20 minutes duration during 5-7 consecutive days for the intervention group. The primary endpoint was the change in every ADL (assessed with the Barthel Index) from 2 weeks before admission to hospital discharge.Results: Acute hospitalization per se led to significant in-patient's functional ability impairment in ADLs during hospitalization, whereas the exercise intervention reversed this trend (3.7 points; 95% CI: 0.5-6.8 points). After analyzing the trajectory of each one of the ADLs, patients in the control group significantly worsened all activities, but with a different degree of loss. For the between-group analysis, significant differences were obtained in many ADLs including bathing, dressing, grooming, bladder control, toilet use, transfers, mobility, and climbing stairs (p < .05). The control group had the greatest impairment in all domains analyzed (ie, feeding, bathing, dressing, grooming, bowel control, bladder control, toilet use, transfers, mobility, and climbing stairs; p < .05).Conclusions: An individualized multicomponent exercise training program in older adults is effective to reverse the loss of specific ADLs that frequently occurs during hospitalization. Each patient profile should receive an individualized prescription of exercise during hospitalizations.Clinical Trials Registration Number: NCT02300896. [ABSTRACT FROM AUTHOR]

Objective: Unintentional injuries are the leading cause of death for children under 19 years of age. For preschoolers, many injuries occur in the home. Addressing this issue, this study assessed if a storybook about home safety could be effective to increase preschoolers' safety knowledge and reduce their injury-risk behaviors.Methods: Applying a randomized controlled trial design, normally developing English speaking preschool children (3.5-5.5 years) in Southwestern Ontario Canada were randomly assigned to the control condition (a storybook about healthy eating, N = 30) or the intervention condition (a storybook about home hazards, N = 29). They read the assigned storybook with their mother for 4 weeks; time spent reading was tracked, and fidelity checks based on home visits were implemented.Results: Comparing postintervention knowledge, understanding score, and risk behaviors across groups revealed that children who received the intervention were able to identify more hazards, provide more comprehensive safety explanations, and demonstrate fewer risky behaviors compared with children in the control group (ηp2 = 0.13, 0.19, and 0.51, respectively), who showed no significant changes over time in safety knowledge, understanding, or risk behaviors. Compliance with reading the safety book and fidelity in how they did so were very good.Conclusions: A storybook can be an effective resource for educating young children about home safety and reducing their hazard-directed risk behaviors. [ABSTRACT FROM AUTHOR]

Objective: The GETSET trial found that guided graded exercise self-help (GES) improved fatigue and physical functioning more than specialist medical care (SMC) alone in adults with chronic fatigue syndrome (CFS) 12 weeks after randomisation. In this paper, we assess the longer-term clinical and health economic outcomes.Methods: GETSET was a randomised controlled trial of 211 UK secondary care patients with CFS. Primary outcomes were the Chalder fatigue questionnaire and the physical functioning subscale of the short-form-36 survey. Postal questionnaires assessed the primary outcomes and cost-effectiveness of the intervention 12 months after randomisation. Service costs and quality-adjusted life years (QALYs) were combined in a cost-effectiveness analysis.Results: Between January 2014 and March 2016, 164 (78%) participants returned questionnaires 15 months after randomisation. Results showed no main effect of intervention arm on fatigue (chi2(1) = 4.8, p = 0.03) or physical functioning (chi2(1) = 1.3, p = 0.25), adjusting for multiplicity. No other intervention arm or time*arm effect was significant. The short-term fatigue reduction was maintained at long-term follow-up for participants assigned to GES, with improved fatigue from short- to long-term follow up after SMC, such that the groups no longer differed. Healthcare costs were £85 higher for GES and produced more QALYs. The incremental cost-effectiveness ratio was £4802 per QALY.Conclusions: The short-term improvements after GES were maintained at long-term follow-up, with further improvement in the SMC group such that the groups no longer differed at long-term follow-up. The cost per QALY for GES compared to SMC alone was below the usual threshold indicating cost-effectiveness, but with uncertainty around the result. [ABSTRACT FROM AUTHOR]

Clinical practice guidelines support cognitive rehabilitation for people with a history of mild traumatic brain injury (mTBI) and cognitive impairment, but no class I randomized clinical trials have evaluated the efficacy of self-administered computerized cognitive training. The goal of this study was to evaluate the efficacy of a self-administered computerized plasticity-based cognitive training programmes in primarily military/veteran participants with a history of mTBI and cognitive impairment. A multisite randomized double-blind clinical trial of a behavioural intervention with an active control was conducted from September 2013 to February 2017 including assessments at baseline, post-training, and after a 3-month follow-up period. Participants self-administered cognitive training (experimental and active control) programmes at home, remotely supervised by a healthcare coach, with an intended training schedule of 5 days per week, 1 h per day, for 13 weeks. Participants (149 contacted, 83 intent-to-treat) were confirmed to have a history of mTBI (mean of 7.2 years post-injury) through medical history/clinician interview and persistent cognitive impairment through neuropsychological testing and/or quantitative participant reported measure. The experimental intervention was a brain plasticity-based computerized cognitive training programme targeting speed/accuracy of information processing, and the active control was composed of computer games. The primary cognitive function measure was a composite of nine standardized neuropsychological assessments, and the primary directly observed functional measure a timed instrumental activities of daily living assessment. Secondary outcome measures included participant-reported assessments of cognitive and mental health. The treatment group showed an improvement in the composite cognitive measure significantly larger than that of the active control group at both the post-training [+6.9 points, confidence interval (CI) +1.0 to +12.7, P = 0.025, d = 0.555] and the follow-up visit (+7.4 points, CI +0.6 to +14.3, P = 0.039, d = 0.591). Both large and small cognitive function improvements were seen twice as frequently in the treatment group than in the active control group. No significant between-group effects were seen on other measures, including the directly-observed functional and symptom measures. Statistically equivalent improvements in both groups were seen in depressive and cognitive symptoms. [ABSTRACT FROM AUTHOR]

Rationale: Sensitization to Fel d 1 (Felis domesticus allergen 1) contributes to persistent allergic rhinitis and asthma. Existing treatment options for cat allergy, including allergen immunotherapy, are only moderately effective, and allergen immunotherapy has limited use because of safety concerns. Objectives: To explore the relationship among the pharmacokinetic, clinical, and immunological effects of anti-Fel d 1 monoclonal antibodies (REGN1908-1909) in patients after treatment. Methods: Patients received REGN1908-1909 (n = 36) or a placebo (n = 37) in a phase 1b study. Fel d 1-induced basophil and IgE-facilitated allergen binding responses were evaluated at baseline and Days 8, 29, and 85. Cytokine and chemokine concentrations in nasal fluids were measured, and REGN1908-1909 inhibition of allergen-IgE binding in patient serum was evaluated. Measurements and Main Results: Peak serum drug concentrations were concordant with maximal observed clinical response. The anti-Fel d 1 IgE/cat dander IgE ratio in pretreatment serum correlated with Total Nasal Symptom Score improvement. The allergen-neutralizing capacity of REGN1908-1909 was observed in serum and nasal fluid and was detected in an inhibition assay. Type 2 cytokines (IL-4, IL-5, and IL-13) and chemokines (CCL17/TARC, CCL5/RANTES [regulated upon activation, normal T-cell expressed and secreted]) in nasal fluid were inhibited in REGN1908-1909-treated patients compared with placebo (P < 0.05 for all); IL-13 and IL-5 concentrations correlated with Total Nasal Symptom Score improvement. Ex vivo assays demonstrated that REGN1908 and REGN1909 combined were more potent than each alone for inhibiting FcεRI- and FcεRII (CD23)-mediated allergic responses and subsequent T-cell activation. Conclusions: A single, passive-dose administration of Fel d 1-neutralizing IgG antibodies improved nasal symptoms in cat-allergic patients and was underscored by suppression of FcεRI-, FcεRII-, and T-helper cell type 2-mediated allergic responses. Clinical trial registered with www.clinicaltrials.gov (NCT02127801). [ABSTRACT FROM AUTHOR]

This parallel group randomized controlled trial tested effectiveness of the Let's Talk About Pain training on respite workers' (RW) pain-related knowledge and feasibility-confidence-skill ratings using between-group and within-group analyses. Fourteen children's respite organizations were randomized to pain or control training. Participants (nintervention = 66; ncontrol = 92) underwent a 3-3.5 hour training and completed measures at pre-, post-, and 4-6 week follow-up. Intention-to-treat (nintervention = 65; ncontrol = 92) and per-protocol (nintervention = 26-38; ncontrol = 40-57) analyses were conducted. Pain training participants demonstrated significantly higher pain knowledge and feasibility-confidence-skill ratings post-follow-up versus control group and significant increases in knowledge from pre-post. Significant gains were maintained from post-follow-up. Results represent a promising step towards enhancing pain-related care for children with IDD. [ABSTRACT FROM AUTHOR]

Background: Norway implemented a regular cervical cancer screening program based on triennial screening in 1995, recommending participation of all women between 25 and 69 years of age. Somali and Pakistani women have the lowest participation in cervical cancer screening in Norway. This study evaluates the effect of a community-based intervention aimed at increasing participation in the screening program among women from these two groups.Methods: The intervention consisted of an oral 20-25 min presentation in Urdu and Somali on cervical cancer and screening and practical information on how to make an appointment and payment for the test. The participants were invited to pose questions related to the topic after the presentation. This study was carried out in four geographical areas surrounding the capital Oslo between February and October 2017, among women aged 25-69 years from Pakistan and Somalia. We recruited women in the intervention group directly from different community institutions, households, and religious sites. Women from Pakistan and Somalia residing in Oslo were the controls. The absolute intervention effect was measured as difference in absolute proportion of women screened and estimated as the interaction between time and group allocation in a generalized estimation equation model with binomial distribution and identity link function.Results: The percentage of women screened in the intervention group increased, from 46 to 51%. The corresponding increase in proportion in the control group was from 44 to 45.5%. After adjustment for potential confounders the intervention group showed a significant larger increase in participation in the screening program as compared to the control group with an absolute difference in change in proportion screened of 0.03 (95% CI; 0.02- 0.06).Conclusions: Our findings suggest that theory-based, culturally and linguistically sensitive educational interventions can raise awareness and motivate immigrant women to participate in cervical cancer screening program. In addition, approaching health professionals as well as immigrant women, might improve participation even more.Trial Registration: NCT03155581 . Retrospectively registered, on 16 May 2017. [ABSTRACT FROM AUTHOR]

Background: The importance of physical activity on health is clear, but changing behaviour is difficult. Successful interventions aiming to improve physical activity and reduce sedentary behaviour is therefore of importance. The aim of this study was to evaluate effects on motivation, self-efficacy and barriers to change behaviour from two different behavioural intervention focusing either on reducing sedentary behaviour or on increasing physical activity as compared to a waiting list control group.Methods: The study was designed as a cluster randomized control trial (RCT) within two private companies. Self-efficacy, motivation and perceived barriers were together with demographic variables assessed before and after a 6-month intervention. Participant cluster teams were randomly allocated to either the physical activity intervention (iPA), the sedentary behaviour intervention (iSED), or control group. The intervention was multi componential and included motivational counselling based on Cognitive behaviour therapy and Motivational interviewing, group activities and management involvement. Group differences were determined using Bayesian multilevel modelling (parameter estimate; credible interval (CI)), analysing complete cases and those who adhered to the protocol by adhering to at least 3 out of 5 intervention sessions.Results: After the intervention, the complete cases analysis showed that the iPA group had significantly higher autonomous motivation (0.33, CI: 0.05-0.61) and controlled motivation (0.27, CI: 0.04-0.51) for physical activity compared with the control group. The iSED group scored less autonomous and controlled motivation compared to the iPA group (0.38, CI: - 0.69- -0.087 respectively - 0.32, CI: - 0.57-0.07) but no significant differences compared with the control group. Among individuals that adhered to the protocol, the results showed higher scores on Exercise (3.03, CI: 0.28-6.02) and Sedentary self-efficacy (3.59, CI: 0.35-7.15) for individuals in the iPA group and on Sedentary self-efficacy (4.77, CI: 0.59-9.44) for the iSED group compared to the control group.Conclusion: These findings indicate that the interventions were successful in increasing self-efficacy in each intervention group and autonomous motivation for exercise in the iPA group, in particular when actively participating in the motivational counselling sessions. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the pharmacokinetics and pharmacodynamics of oestriol (E3) and trimegestone (TMG) in healthy women after application of three different vaginal rings over 21 days. The vaginal rings had a nominal delivery rate of 0.413/0.050 mg/day (Test 1), 0.311/0.090 mg/day (Test 2) and 0.209/0.137 mg/day (Test 3) E3/TMG.Methods: Thirty-five healthy women were randomised to receive a single application of Test 1, 2 or 3 (Clinical Trial NCT03343912). The E3 and TMG plasma concentration was determined by LC-MS/MS. Oestradiol (E2) and progesterone (PG) serum concentrations, and bleeding patern were determined as pharmacodynamic parameters. Safety was assessed by evaluation of adverse events and local tolerability.Results: The total and maximum exposure of E3 and TMG increased in a proportional ratio to dose. However, not in a magnitude which was expected from the dose differences for E3. During Test 2 and 3 treatment all E2 and PG values remained on a well suppressed level until end of treatment. E2 and PG serum levels increased distinctly earlier after ring removal with Test 1 compared to Test 2 and 3. Test 3 achieved 95.24% of "no bleeding" days under treatment followed by Test 1 (91.67%), and Test 2 (86.15%).Conclusions: The Test 3 formulation presented the best dose combination of E3/TMG for contraception. Moreover, all vaginal rings were well tolerated. [ABSTRACT FROM AUTHOR]

Background: In older people with cognitive impairment (CI), executive function (EF) has been associated with motor performance including balance and gait. The literature examining and supporting a relationship between balance performance and other cognitive domains is limited.Objective: To investigate the relationship between global cognition and cognitive domain function and balance performance in older people with CI.Methods: The iFOCIS randomized controlled trial recruited 309 community-dwelling older people with CI. Baseline assessments completed before randomization were used for analyses including the Addenbrooke's Cognitive Examination-III (ACE-III; global cognition) and its individual cognitive domains (attention; memory; verbal fluency; language; visuospatial ability) and the Frontal Assessment Battery (FAB), a measure of EF. A composite balance score was derived from postural sway and leaning balance tests.Results: In linear regression analyses adjusted for covariates, global cognition and each cognitive domain were significantly associated with balance performance. EF (verbal fluency; β= -0.254, p < 0.001, adjusted R2 = 0.387) and visuospatial ability (β= -0.258, p < 0.001, adjusted R2 = 0.391) had the strongest associations with balance performance. In a comprehensively adjusted multivariable model including all of the ACE-III cognitive domains, visuospatial ability and EF (verbal fluency) were independently and significantly associated with balance performance.Conclusion: Poorer global cognition and cognitive domain function were associated with poorer balance performance in this sample of people with CI. Visuospatial ability and EF were independently associated with balance, highlighting potential shared neural networks and the role higher-level cognitive processes and spatial perception/processing play in postural control. [ABSTRACT FROM AUTHOR]

This study aimed to investigate the chronic effects of green tea (GT) extract and resistance training (RT) on ambulatory and office blood pressure (BP), heart rate (HR), and rate-pressure product (RPP) in a sample of Iranian women with high-normal/stage 1 hypertension. Forty-four middle-aged sedentary women participated in this randomized, double-blind, placebo-controlled study. They were randomly assigned to one of four groups: GT and RT (GR, n = 11), RT (n = 10), GT (n = 10), or control (n = 13). Three weeks of GT consumption were followed by six weeks of the interaction with RT. GR and RT groups performed two circuits of RT at %50 of 1RM two days per week. RT and control groups also received placebo (maltodextrin) with the same timing. The changes of each variable from baseline to post-intervention were compared between the groups using the ANOVA test, and effect size (ES) statistic was also calculated. In comparison with the control group, significant reductions were found for office systolic BP (SBP, 8%, ES = 1.22), and 24 h-SBP (5%, ES = 1.2) in the RT group. However, GR group showed significant decreases in office SBP (10.5%, ES = 1.45), mean BP (8%, ES = 1.11), RPP (13%, ES = 1.47), 24 h-SBP (5%, ES = 1.21), and 24 h-RPP (10%, ES = 1.15). The interaction of regular RT and GT consumption seems to induce more beneficial effects on some important parameters including MBP and RPP when compared to RT or GT alone. [ABSTRACT FROM AUTHOR]

Background: Chronic inflammation may lead to frailty, however the potential for anti-inflammatory medications such as aspirin to prevent frailty is unknown. We sought to examine the association between long-term aspirin use and prevalent frailty.Methods: We included 12 101 men ≥60 years who participated in the Physicians' Health Study I, a completed aspirin randomized controlled trial (1982-1989). Annual questionnaires collected self-reported data on daily aspirin use, lifestyle, and clinical variables. Average aspirin use was summed into 2 categories: ≤60 days/year and >60 days/year. Frailty was assessed using a 33-item index 11 years after trial completion. A score of ≥0.21 was considered frail. Propensity score inverse probability of treatment weighting was used for statistical control of confounding. Logistic regression models estimated odds of frailty as a function of categories of average aspirin use.Results: Mean age was 70.5 years (range 60-101). Following an average of 11 ± 0.6 years of follow-up, aspirin use was reported as ≤60 days/year for 15%; 2413 participants (20%) were frail. Frequency of aspirin use was associated with smoking, alcohol consumption, hypertension, and cardiovascular disease, but negatively associated with bleeding and Coumadin use. The odds ratio (95% confidence intervals) for frailty was 0.85 (0.76-0.96) for average aspirin use >60 days/year versus aspirin use ≤60 days/year. Results were similar using an alternate definition of frailty.Conclusions: Long-term regular aspirin use is inversely associated with frailty among older men, even after consideration of multimorbidity and health behaviors. Work is needed to understand the role of medications with anti-inflammatory properties on aging. [ABSTRACT FROM AUTHOR]