Organ donation after circulatory death in Denmark.

Donation after circulatory death (DCD) is practiced in several countries to increase the number of organs for transplantation. This review summarises the key points in a new protocol which will introduce controlled DCD in Denmark as an option in seriously ill patients, in whom death is inevitable and the criteria for brain death is not met. It includes a no touch period of five minutes following circulatory arrest. Rapid procurement or normothermic regional perfusion may be applied depending on the organs to be transplanted. The introduction of DCD requires thorough training of involved health personnel.

Hip precautions after posterior-approach total hip arthroplasty among patients with primary hip osteoarthritis do not influence early recovery: a systematic review and meta-analysis of randomized and non-randomized studies with 8,835 patients.

BACKGROUND AND PURPOSE: Hip precautions are routinely prescribed to patients with osteoarthritis to decrease dislocation rates after total hip arthroplasty (THA) using a posterior approach. However, recommendations have been based on very low certainty of evidence. We updated the evidence on the influence of hip precautions on early recovery following THA by this systematic review. MATERIALS AND METHODS: We performed systematic searches for randomized controlled trials (RCT) and non-randomized (NRS) studies in MEDLINE, Embase, PEDro, and CINAHL published from 2016 to July 2022. 2 reviewers independently included studies comparing postoperative precautions with minimal or no precautions, extracted data, and assessed the risk of bias. Random effects meta-analyses were used to synthesize the results. The certainty of the evidence was rated by the Grading of Recommendations Assessment and Evaluation approach. The critical outcome was the risk of hip dislocations within 3 months of surgery. Other outcomes were long-term risk of dislocation and reoperation, self-reported and performance-based assessment of function, quality of life, pain, and time to return to work. RESULTS: 4 RCTs and 5 NRSs, including 8,835 participants, were included. There may be no or negligible difference in early hip dislocations (RCTs: risk ratio [RR] 1.8, 95% confidence interval [CI] 0.6-5.2; NRS: RR 0.9, CI 0.3-2.5). Certainty in the evidence was low for RCTs and very low for NRSs. Finally, precautions may reduce the performance-based assessment of function slightly, but the evidence was very uncertain. For all other outcomes, no differences were found (moderate to very low certainty evidence). CONCLUSION: The current evidence does not support routinely prescribing hip precautions post-surgically for patients undergoing THA to prevent hip dislocations. However, the results might change with high-quality studies.

Substituting sedentary time with sleep or physical activity and subsequent weight-loss maintenance.

OBJECTIVE: In this study, the associations between the substitution of sedentary time with sleep or physical activity at different intensities and subsequent weight-loss maintenance were examined. METHODS: This prospective study included 1152 adults from the NoHoW trial who had achieved a successful weight loss of ≥5% during the 12 months prior to baseline and had BMI ≥25 kg/m2 before losing weight. Physical activity and sleep were objectively measured during a 14-day period at baseline. Change in body weight was included as the primary outcome. Secondary outcomes were changes in body fat percentage and waist circumference. Cardiometabolic variables were included as exploratory outcomes. RESULTS: Using isotemporal substitution models, no associations were found between activity substitutions and changes in body weight or waist circumference. However, the substitution of sedentary behavior with moderate-to-vigorous physical activity was associated with a decrease in body fat percentage during the first 6 months of the trial (-0.33% per 30 minutes higher moderate-to-vigorous physical activity [95% CI: -0.60% to -0.07%], p = 0.013). CONCLUSIONS: Sedentary behavior had little or no influence on subsequent weight-loss maintenance, but during the early stages of a weight-loss maintenance program, substituting sedentary behavior with moderate-to-vigorous physical activity may prevent a gain in body fat percentage.

Usefulness of Cochrane Reviews in Clinical Guideline Development-A Survey of 585 Recommendations.

The Danish Health Authority develops clinical practice guidelines to support clinical decision-making based on the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system and prioritizes using Cochrane reviews. The objective of this study was to explore the usefulness of Cochrane reviews as a source of evidence in the development of clinical recommendations. Evidence-based recommendations in guidelines published by the Danish Health Authority between 2014 and 2021 were reviewed. For each recommendation, it was noted if and how Cochrane reviews were utilized. In total, 374 evidence-based recommendations and 211 expert consensus recommendations were published between 2014 and 2021. Of the 374 evidence-based recommendations, 106 included evidence from Cochrane reviews. In 28 recommendations, all critical and important outcomes included evidence from Cochrane reviews. In 36 recommendations, a minimum of all critical outcomes included evidence from Cochrane reviews, but not all important outcomes. In 33 recommendations, some but not all critical outcomes included evidence from Cochrane reviews. Finally, in nine recommendations, some of the important outcomes included evidence from Cochrane reviews. In almost one-third of the evidence-based recommendations, Cochrane reviews were used to inform clinical recommendations. This evaluation should inform future evaluations of Cochrane review uptake in clinical practice guidelines concerning outcomes important for clinical decision-making.

Supervised exercise therapy compared with no exercise therapy to reverse debilitating effects of androgen deprivation therapy in patients with prostate cancer: a systematic review and meta-analysis.

BACKGROUND: Androgen deprivation therapy (ADT) in patients with prostate cancer can have several debilitating side effects. Supervised exercise is recommended to ameliorate these negative effects. OBJECTIVE: To systematically evaluate the effect of supervised exercise therapy compared to no exercise therapy in patients with prostate cancer undergoing ADT, primarily according to the patient critical outcomes, 'disease-specific quality of life' and 'walking performance' measured at end of treatment. METHODS: We searched PubMed/Medline, Embase, Cochrane Library, Cinahl and Pedro, to identify randomised controlled trials (RCTs), which investigated the effect of supervised exercise therapy compared to no exercise therapy in patients with prostate cancer receiving ADT, last search: June 2021. Two independent reviewers extracted data, and assessed risk of bias using Cochrane Risk of Bias Tool and evaluated the certainty of evidence using the GRADE-method. RESULTS: Eigthteen RCTs (n = 1477) comprised patients with prostate cancer stages T1-T4 were included in the meta-analyses. Compared to no exercise therapy, supervised exercise therapy showed clinically relevant improvements in 'disease-specific quality of life' and 'walking performance'. The standardised mean differences were 0.43 (95% confidence interval (CI): 0.29, 0.58) and -0.41 (95% CI: -0.60, -0.22), respectively. The overall certainty of evidence was moderate due to serious risk of bias. CONCLUSIONS: Evidence of moderate quality shows that supervised exercise therapy probably is superior to no exercise therapy in improving 'disease-specific quality of life' and 'walking performance' in patients with prostate cancer undergoing ADT. The results apply to all patients receiving androgen deprivation therapy regardless of cancer stage. The results support a strong recommendation for supervised exercise therapy for managing side effects in this population. PROTOCOL REGISTRATION: NKR-38-Focused-questions-PICOs-for-updating1.ashx (sst.dk).

Hair Cortisol Concentration, Weight Loss Maintenance and Body Weight Variability: A Prospective Study Based on Data From the European NoHoW Trial.

Several cross-sectional studies have shown hair cortisol concentration to be associated with adiposity, but the relationship between hair cortisol concentration and longitudinal changes in measures of adiposity are largely unknown. We included 786 adults from the NoHoW trial, who had achieved a successful weight loss of ≥5% and had a body mass index of ≥25 kg/m2 prior to losing weight. Hair cortisol concentration (pg/mg hair) was measured at baseline and after 12 months. Body weight and body fat percentage were measured at baseline, 6-month, 12-month and 18-month visits. Participants weighed themselves at home ≥2 weekly using a Wi-Fi scale for the 18-month study duration, from which body weight variability was estimated using linear and non-linear approaches. Regression models were conducted to examine log hair cortisol concentration and change in log hair cortisol concentration as predictors of changes in body weight, change in body fat percentage and body weight variability. After adjustment for lifestyle and demographic factors, no associations between baseline log hair cortisol concentration and outcome measures were observed. Similar results were seen when analysing the association between 12-month concurrent development in log hair cortisol concentration and outcomes. However, an initial 12-month increase in log hair cortisol concentration was associated with a higher subsequent body weight variability between month 12 and 18, based on deviations from a nonlinear trend (ß: 0.02% per unit increase in log hair cortisol concentration [95% CI: 0.00, 0.04]; P=0.016). Our data suggest that an association between hair cortisol concentration and subsequent change in body weight or body fat percentage is absent or marginal, but that an increase in hair cortisol concentration during a 12-month weight loss maintenance effort may predict a slightly higher subsequent 6-months body weight variability. Clinical Trial Registration: ISRCTN registry, identifier ISRCTN88405328.

Evidence-Based Digital Tools for Weight Loss Maintenance: The NoHoW Project.

BACKGROUND: Effective interventions and commercial programmes for weight loss (WL) are widely available, but most people regain weight. Few effective WL maintenance (WLM) solutions exist. The most promising evidence-based behaviour change techniques for WLM are self-monitoring, goal setting, action planning and control, building self-efficacy, and techniques that promote autonomous motivation (e.g., provide choice). Stress management and emotion regulation techniques show potential for prevention of relapse and weight regain. Digital technologies (including networked-wireless tracking technologies, online tools and smartphone apps, multimedia resources, and internet-based support) offer attractive tools for teaching and supporting long-term behaviour change techniques. However, many digital offerings for weight management tend not to include evidence-based content and the evidence base is still limited. The Project: First, the project examined why, when, and how many European citizens make WL and WLM attempts and how successful they are. Second, the project employed the most up-to-date behavioural science research to develop a digital toolkit for WLM based on 2 key conditions, i.e., self-management (self-regulation and motivation) of behaviour and self-management of emotional responses for WLM. Then, the NoHoW trial tested the efficacy of this digital toolkit in adults who achieved clinically significant (≥5%) WL in the previous 12 months (initial BMI ≥25). The primary outcome was change in weight (kg) at 12 months from baseline. Secondary outcomes included biological, psychological, and behavioural moderators and mediators of long-term energy balance (EB) behaviours, and user experience, acceptability, and cost-effectiveness. IMPACT: The project will directly feed results from studies on European consumer behaviour, design and evaluation of digital toolkits self-management of EB behaviours into development of new products and services for WLM and digital health. The project has developed a framework and digital architecture for interventions in the context of EB tracking and will generate results that will help inform the next generation of personalised interventions for effective self-management of weight and health.

Consistent sleep onset and maintenance of body weight after weight loss: An analysis of data from the NoHoW trial.

BACKGROUND: Several studies have suggested that reduced sleep duration and quality are associated with an increased risk of obesity and related metabolic disorders, but the role of sleep in long-term weight loss maintenance (WLM) has not been thoroughly explored using prospective data. METHODS AND FINDINGS: The present study is an ancillary study based on data collected on participants from the Navigating to a Healthy Weight (NoHoW) trial, for which the aim was to test the efficacy of an evidence-based digital toolkit, targeting self-regulation, motivation, and emotion regulation, on WLM among 1,627 British, Danish, and Portuguese adults. Before enrolment, participants had achieved a weight loss of ≥5% and had a BMI of ≥25 kg/m2 prior to losing weight. Participants were enrolled between March 2017 and March 2018 and followed during the subsequent 12-month period for change in weight (primary trial outcome), body composition, metabolic markers, diet, physical activity, sleep, and psychological mediators/moderators of WLM (secondary trial outcomes). For the present study, a total of 967 NoHoW participants were included, of which 69.6% were women, the mean age was 45.8 years (SD 11.5), the mean baseline BMI was 29.5 kg/m2 (SD 5.1), and the mean weight loss prior to baseline assessments was 11.4 kg (SD 6.4). Objectively measured sleep was collected using the Fitbit Charge 2 (FC2), from which sleep duration, sleep duration variability, sleep onset, and sleep onset variability were assessed across 14 days close to baseline examinations. The primary outcomes were 12-month changes in body weight (BW) and body fat percentage (BF%). The secondary outcomes were 12-month changes in obesity-related metabolic markers (blood pressure, low- and high-density lipoproteins [LDL and HDL], triglycerides [TGs], and glycated haemoglobin [HbA1c]). Analysis of covariance and multivariate linear regressions were conducted with sleep-related variables as explanatory and subsequent changes in BW, BF%, and metabolic markers as response variables. We found no evidence that sleep duration, sleep duration variability, or sleep onset were associated with 12-month weight regain or change in BF%. A higher between-day variability in sleep onset, assessed using the standard deviation across all nights recorded, was associated with weight regain (0.55 kg per hour [95% CI 0.10 to 0.99]; P = 0.016) and an increase in BF% (0.41% per hour [95% CI 0.04 to 0.78]; P = 0.031). Analyses of the secondary outcomes showed that a higher between-day variability in sleep duration was associated with an increase in HbA1c (0.02% per hour [95% CI 0.00 to 0.05]; P = 0.045). Participants with a sleep onset between 19:00 and 22:00 had the greatest reduction in diastolic blood pressure (DBP) (P = 0.02) but also the most pronounced increase in TGs (P = 0.03). The main limitation of this study is the observational design. Hence, the observed associations do not necessarily reflect causal effects. CONCLUSION: Our results suggest that maintaining a consistent sleep onset is associated with improved WLM and body composition. Sleep onset and variability in sleep duration may be associated with subsequent change in different obesity-related metabolic markers, but due to multiple-testing, the secondary exploratory outcomes should be interpreted cautiously. TRIAL REGISTRATION: The trial was registered with the ISRCTN registry (ISRCTN88405328).

Estimating physical activity and sedentary behaviour in a free-living environment: A comparative study between Fitbit Charge 2 and Actigraph GT3X.

BACKGROUND: Activity trackers such as the Fitbit Charge 2 enable users and researchers to monitor physical activity in daily life, which could be beneficial for changing behaviour. However, the accuracy of the Fitbit Charge 2 in a free-living environment is largely unknown. OBJECTIVE: To investigate the agreement between Fitbit Charge 2 and ActiGraph GT3X for the estimation of steps, energy expenditure, time in sedentary behaviour, and light and moderate-to-vigorous physical activity under free-living conditions, and further examine to what extent placing the ActiGraph on the wrist as opposed to the hip would affect the findings. METHODS: 41 adults (n = 10 males, n = 31 females) were asked to wear a Fitbit Charge 2 device and two ActiGraph GT3X devices (one on the hip and one on the wrist) for seven consecutive days and fill out a log of wear times. Agreement was assessed through Bland-Altman plots combined with multilevel analysis. RESULTS: The Fitbit measured 1,492 steps/day more than the hip-worn ActiGraph (limits of agreement [LoA] = -2,250; 5,234), while for sedentary time, it measured 25 min/day less (LoA = -137; 87). Both Bland-Altman plots showed fixed bias. For time in light physical activity, the Fitbit measured 59 min/day more (LoA = -52;169). For time in moderate-to-vigorous physical activity, the Fitbit measured 31 min/day less (LoA = -132; 71) and for activity energy expenditure it measured 408 kcal/day more than the hip-worn ActiGraph (LoA = -385; 1,200). For the two latter outputs, the plots indicated proportional bias. Similar or more pronounced discrepancies, mostly in opposite direction, appeared when comparing to the wrist-worn ActiGraph. CONCLUSION: Moderate to substantial differences between devices were found for most outputs, which could be due to differences in algorithms. Caution should be taken if replacing one device with another and when comparing results.

Association between objectively measured sleep duration, adiposity and weight loss history.

BACKGROUND: An association between sleep and obesity has been suggested in several studies, but many previous studies relied on self-reported sleep and on BMI as the only adiposity measure. Moreover, a relationship between weight loss history and attained sleep duration has not been thoroughly explored. DESIGN: The study comprised of 1202 participants of the European NoHoW trial who had achieved a weight loss of ≥5% and had a BMI of ≥25 kg/m2 prior to losing weight. Information was available on objectively measured sleep duration (collected during 14 days), adiposity measures, weight loss history and covariates. Regression models were conducted with sleep duration as the explanatory variable and BMI, fat mass index (FMI), fat-free mass index (FFMI) and waist-hip ratio (WHR) as response variables. Analyses were conducted with 12-month weight loss, frequency of prior weight loss attempts or average duration of weight maintenance after prior weight loss attempts as predictors of measured sleep duration. RESULTS: After adjusting for physical activity, perceived stress, smoking, alcohol consumption, education, sex and age, sleep duration was associated to BMI (P < 0.001), with the highest BMI observed in the group of participants sleeping <6 h a day [34.0 kg/m2 (95% CI: 31.8-36.1)]. Less difference in BMI was detected between the remaining groups, with the lowest BMI observed among participants sleeping 8-<9 h a day [29.4 kg/m2 (95% CI: 28.8-29.9)]. Similar results were found for FMI (P = 0.008) and FFMI (P < 0.001). We found no association between sleep duration and WHR. Likewise, we found no associations between weight loss history and attained sleep duration. CONCLUSION: In an overweight population who had achieved a clinically significant weight loss, short sleep duration was associated with higher BMI, with similar associations for fat and lean mass. We found no evidence of association between weight loss history and attained sleep duration.

The NoHoW protocol: a multicentre 2×2 factorial randomised controlled trial investigating an evidence-based digital toolkit for weight loss maintenance in European adults.

INTRODUCTION: Obesity and associated diseases place a severe burden on healthcare systems. Behavioural interventions for weight loss (WL) are successful in the short term but often result in weight regain over time. Self-regulation of eating and activity behaviours may significantly enhance weight loss maintenance (WLM) and may be effectively augmented by contextual behavioural approaches to emotion regulation. The NoHoW trial tests the efficacy of a theoretically informed, evidence-based digital toolkit using a mobile-enabled website, activity trackers and Wi-Fi scales for WLM aiming to target (1) self-regulation and motivation, and (2) emotion regulation in adults who achieved clinically significant (≥5%) WL in the previous 12 months (initial body mass index (BMI) ≥25 kg/m2). METHODS AND ANALYSIS: The study is an 18-month, 3-centre, 2×2 factorial single-blind, randomised controlled trial, which recruited 1627 participants achieving ≥5% WL between March 2017 and March 2018. Participants are randomly allocated to one of four arms: (1) self-monitoring only (self-weighing and activity tracker), (2) self-regulation and motivation, (3) emotion regulation or (4) combined self-regulation, motivation and emotion regulation. Participants attend four clinical investigation days at 0, 6, 12 and 18 months and are instructed to use the digital toolkit for 18 weeks during the first 6 months and at their discretion for the remaining 12 months. The primary outcome is change in weight (kg) at 12 months from baseline. Secondary outcomes are body composition (eg, bioimpedance analysis), health biomarkers (glycated haemoglobin, lipids, blood pressure, hair cortisol), dietary intake, physical activity, sleep, motivational, self-regulatory, emotion regulatory moderators/mediators of WLM, engagement, user experience, acceptability and cost-effectiveness of the interventions. ETHICS AND DISSEMINATION: Ethical approval was granted by Institutional Ethics Committees at the Universities of Leeds (17-0082; 27 February 2017), Lisbon (17/2016; 20 February 2017) and Capital Region of Denmark (H-16030495, 8 March 2017). Results will be published in scientific journals. TRIAL REGISTRATION NUMBER: ISRCTN88405328.