Search

• To be relevant clinical trials must report outcomes that are critically important to patients and clinicians including patient reported outcomes. • Patient reported outcomes must be supported by valid and reliable measures. • Validity and reliability requires the application of research methods that include quantitative and qualitative techniques. • Patient reported outcome measures are critical to providing evidence to support clinical guidelines and patient centred care. Randomised controlled clinical trials provide the gold standard for evidence underpinning clinical guidelines and patient centred care. However, this is only true when they are robustly designed, conducted and reported and then only if they include outcomes that are important to patients and clinicians. Important outcomes include those that measure impact on patient experience, quality of life, overall well-being, and physical, social, cognitive and emotional functioning, all of which require patient reported outcome measures (PROMs). Patient centred care must be underpinned by objective evidence of the effect of interventions on outcomes that are important to patients. Evidence for patient reported outcomes must be supported by valid and reliable PROMs. Importantly the PROM must reflect patient experience of the impact of the intervention on the outcome and enable quantitative evaluation of that impact. The purpose of this paper is to highlight the critical role of mixed methods research in developing PROMs that are valid (measure what they purport to measure), acceptable to those reporting the outcome and able to reliably detect meaningful differences between individuals with different conditions or severity and with time. This can only be achieved through a structured mixed methods program combining qualitative and quantitative research techniques. [ABSTRACT FROM AUTHOR]

Systemic lupus erythematosus (SLE) is an autoimmune disease with the characterized presence of autoantibodies and resulting in multiple organ damage, which is incurable and can be lethal. The current treatments are limited and less progress has been made in drug discovery for the last few decades. Researches imply that gut dysbiosis exists in both patients and murine models with SLE, taking part in the pathogenesis of SLE through multiple mechanisms such as microbiota translocation and molecular mimicry. Intestinal interventions on the gut microbiome by fecal transplantations to reconstitute the gut-immunity homeostasis serve as a novel therapeutic option for SLE patients. Fecal microbiota transplantation (FMT), which is usually used in intestinal diseases, has been firstly demonstrated to be safe and efficient in recovering gut microbiota structure of SLE patients and reducing lupus activity in our recent clinical trial, which is the first trial testing FMT therapy in SLE treatment. In this paper, we reviewed the results of the single-arm clinical trial and made recommendations on FMT practice in SLE treatment including therapeutic indications, screening items and dosage regimen, trying to provide references for future study and clinical practice. We also came up with the unanswered questions that need to be solved by the ongoing randomized controlled trial as well as the future expectations for the intestinal intervention strategies of SLE patients. • Patients with active lupus presenting by albuminuria and high anti-dsDNA antibody titers are indicated to accept FMT treatment. • SLE patients with high abundance of Anaerobutyricum hallii and low activity of IFN-pathways in lymphocytes are more likely to respond to FMT. • Administration of weekly FMT for 3 weeks is recommended as a course, and the second should be added 6 weeks after the first course if needed. [ABSTRACT FROM AUTHOR]

Abstract: Objective: The aim of this study was to evaluate the effectiveness of school-based nutrition education interventions in reducing or preventing overweight and obesity among children and adolescents. Methods: We conducted a systematic search of 14 databases until May 2010 and cross-reference check in 8 systematic reviews (SRs) for studies published that described randomized controlled trials conducted in schools to reduce or prevent overweight in children and adolescents. An additional search was carried out using PubMed for papers published through May 2012, and no further papers were identified. Body mass index (BMI) was the primary outcome. The title and abstract review and the quality assessment were performed independently by two researchers. The software EPPI-Reviewer3 was used to store, manage and analyze all data. This SR is registered at ClinicalTrials.gov (NCT00985972). Results: From the 4888 references initially retrieved, only 8 met the eligibility criteria for a random-effects meta-analysis. The total population consisted of 8722 children and adolescents. Across the studies, there was an average treatment effect of −0.33kg/m2 (−0.55, −0.11 95% CI) on BMI, with 84% of this effect explained by the highest quality studies. Conclusion: This systematic review provides evidence that school-based nutrition education interventions are effective in reducing the BMI of children and adolescents. [Copyright &y& Elsevier]

In this paper, we propose a new data-driven method to explore complex regression dependence structures in a multi-dimensional contingency table with an ordinal response variable and categorical (ordinal or nominal) explanatory variables. The proposed method is based on a sequential decomposition of the overall regression dependence for the data quantified by the checkerboard copula regression association measure (Wei and Kim, 2021) in an informative and interpretable fashion. It can measure the marginal and conditional contributions of any subset of all available explanatory variables to the overall regression association in a hierarchical manner taking into account the order of the explanatory variables. Thus, the proposed method enables a holistic description of various aspects of regression association in a multivariate contingency table, including marginal and conditional associations between an ordinal response variable and a subset of explanatory variables of interest. We investigate theoretical properties of the proposed decomposition method, and we further illustrate its performance through simulation and two real data examples, one from a randomized controlled trial and the other from a longitudinal epidemiological study. [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]

A causal effect can be defined as a comparison of outcomes that result from two or more alternative actions, with only one of the action-outcome pairs actually being observed. In healthcare, the gold standard for causal effect measurements is randomized controlled trials (RCTs), in which a target population is explicitly defined and each study sample is randomly assigned to either the treatment or control cohorts. The great potential to derive actionable insights from causal relationships has led to a growing body of machine-learning research applying causal effect estimators to observational data in the fields of healthcare, education, and economics. The primary difference between causal effect studies utilizing observational data and RCTs is that for observational data, the study occurs after the treatment, and therefore we do not have control over the treatment assignment mechanism. This can lead to massive differences in covariate distributions between control and treatment samples, making a comparison of causal effects confounded and unreliable. Classical approaches have sought to solve this problem piecemeal, first by predicting treatment assignment and then treatment effect separately. Recent work extended part of these approaches to a new family of representation-learning algorithms, showing that the upper bound of the expected treatment effect estimation error is determined by two factors: the outcome generalization-error of the representation and the distance between the treated and control distributions induced by the representation. To achieve minimal dissimilarity in learning such distributions, in this work we propose a specific auto-balancing, self-supervised objective. Experiments on real and benchmark datasets revealed that our approach consistently produced less biased estimates than previously published state-of-the-art methods. We demonstrate that the reduction in error can be directly attributed to the ability to learn representations that explicitly reduce such dissimilarity; further, in case of violations of the positivity assumption (frequent in observational data), we show our approach performs significantly better than the previous state of the art. Thus, by learning representations that induce similar distributions of the treated and control cohorts, we present evidence to support the error bound dissimilarity hypothesis as well as providing a new state-of-the-art model for causal effect estimation. [Display omitted] • Problem : Causal treatment effect estimations in observational data are confounded and unreliable. • What is already known : with deep learning, the treatment effect estimation error is determined by the outcome generalization-error of the learned representation and the distance between the treated and control distributions induced by the representation itself • What this paper adds : a multi-task deep neural network designed to learn minimally dissimilar treated and untreated distributions enabling, hence, less biased treatment effect estimates than previously published methods [ABSTRACT FROM AUTHOR]

Lunch breaks constitute the longest within-workday rest period, but it is unclear how they affect recovery from job stress. We conducted two randomized controlled trials with 153 Finnish knowledge workers who engaged for 15 min daily in prescribed lunch break activities for ten consecutive working days. Participants were randomly assigned to a: 1) park walking group ( N = 51), 2) relaxation exercises group ( N = 46) and 3) control group ( N = 56). The study was divided into two parts scheduled in spring ( N = 83) and fall ( N = 70). Recovery experiences (detachment, relaxation, enjoyment) and recovery outcomes (restoration, fatigue, job satisfaction) were assessed with SMS and paper-and-pencil questionnaires several times per day before, during and after the intervention period. A manipulation check revealed that both intervention groups reported less tension after lunch breaks during the intervention than before. In spring, the interventions did hardly affect recovery experiences and outcomes. In fall, restoration increased and fatigue decreased markedly immediately after lunch breaks and in the afternoon in both intervention groups ( d = 0.22–0.58) and most consistent positive effects across the day were reported by the park walking group. Park walks and relaxation exercises during lunch breaks can enhance knowledge workers' recovery from work, but effects seem weak, short-lived and dependent on the season. [ABSTRACT FROM AUTHOR]

The current state of child nutrition is critical. About 5.9 million children under the age of five still died worldwide with nearly half are attributable to undernutrition. One explanation is inequality in children's food consumption. One strategy to address inequality among the poor is conditional cash transfers (CCTs). Taking advantage of the two large clustered-randomized trials in Indonesia from 2007 to 2009, this paper provides evidence on the impact of household cash transfer (PKH) and community cash transfer (Generasi) on child's food consumption. The sample sizes are 14,000 households for PKH and 12,000 households for Generasi. After two years of implementation, difference-in-differences (DID) analyses show that both cash transfers lead to significant increases in food consumption particularly for protein-rich items. The programs significantly increase the consumption of milk and fish by up to 19% and 14% for PKH and Generasi, respectively. Both programs significantly reduce some measures of severe malnutrition. PKH significantly reduces the probability of wasting and severe wasting by 33% and 41% and Generasi significantly reduces the probability of being severely underweight by 47%. This underscores the potential of household and community cash transfers to fight undernutrition among the poor. [ABSTRACT FROM AUTHOR]

Objective: The benefit of male circumcision is greatest among men who are most at risk of HIV infection. Encouraging this population of men to get circumcised maximizes the benefit that can be achieved through the scale-up of circumcision programs. This paper examines how the price of circumcision affects the risk profile of men who receive a voluntary medical circumcision.Methods: In 2010, 1649 uncircumcised adult men in urban Malawi were interviewed and provided a voucher for a subsidized voluntary medical male circumcision, at randomly assigned prices. Clinical data were collected indicating whether the men in the study received a circumcision.Results: Men who took-up circumcision with a zero-priced voucher were 25 percentage points less likely than those who took-up with a positive-price voucher, to be from a tribe that traditionally circumcises (p=0.101). Zero-priced vouchers also brought in men with more sexual partners in the past year (p=0.075) and past month (p=0.003). None of the men who were most at risk of HIV at baseline (those with multiple partners and who did not use a condom the last time they had sex) received a circumcision if they were offered a positive-priced voucher. Lowering the price to zero increased circumcision take-up to 25% for men of this risk group. The effect of price on take-up was largest among those at highest risk (p=0.096).Conclusions: Reducing the price of circumcision surgery to zero can increase take-up among those who are most at risk of HIV infection. [ABSTRACT FROM AUTHOR]

The link between intentions and action in weight control is weaker than previously thought, so recent research has called for further investigation of ways to improve weight control that bypass conscious intentions. Priming has been shown to have effects on individual behavior in a variety of contexts by influencing subconscious cognition. This paper investigates the effects of semantic priming using healthy body image, goal-oriented words on food consumption. The moderating role of both restrained eating and gender is investigated. 161 participants were involved in an experiment using a novel version of a scrambled sentence priming game. The outcome measure was the number of kilocalories consumed, examined using a between subjects ANCOVA with priming, gender, restrained eating index, self-reported BMI, and two interaction terms (primingxgender, and primingxrestrained eating index). There was no main effect of priming but there was an interaction of priming with gender. Females consumed significantly fewer kilocalories after being exposed to priming words related to a healthy body image (i.e. "slim", "fit,") compared to females receiving the neutral prime, with a medium effect size (d = 0.58). The body image prime did not significantly affect food intake for males, nor did it have a differential effect on restrained eaters. This study shows that priming can be an effective method for influencing females to reduce food intake, regardless of whether they are restrained or unrestrained eaters. Future studies could investigate whether different priming words related to a male's healthy body image goal (i.e. "buff," "muscles," etc.) would similarly reduce food intake for males. [ABSTRACT FROM AUTHOR]

Because body weight is largely seen as controllable, weight stigma-the social devaluation of those who are overweight-is not subject to the social norms that condemn open expression of racism and sexism. Indeed, rejection of peers based on perceptions of excess weight is normative. Since weight stigma is internalized, popular views (and often the views of physicians) have suggested that increasing the salience of weight stigma might produce a reduction in overeating and/or an increase in physical activity. However, that perspective is not rooted in scientific evidence. Recent randomized controlled designs demonstrate that stigma may promote overeating. Correlational evidence suggests that self-reported stigma experience is associated with risk for binge eating and decreased interest in physical exercise and dieting, for children and adults. In addition to reviewing these research studies, this paper examines the potential for intersectionality of stigma across multiple social identities and considers alternatives to stigmatizing weight loss interventions. [ABSTRACT FROM AUTHOR]

Psychiatric disorders represent a frequent comorbidity in patients with epilepsy affecting quality of life, morbidity and mortality. Evidence-based data on the management of these conditions are limited but a number of recommendations are now available to guide clinical practice. The present paper reviews the pharmacological treatment of psychiatric problems in epilepsy with special attention to data coming from randomised controlled trials (RCTs), pharmacological interactions with AEDs and the issue of seizure worsening during treatment with psychotropic drugs. Epidemiologically or clinically relevant psychiatric conditions are discussed namely mood and anxiety disorders, psychoses and attention deficit hyperactivity disorder. [ABSTRACT FROM AUTHOR]

This paper proposes a general framework for probabilistic certification of cancer therapies. The certification is defined in terms of two key issues which are the tumor contraction and the lower admissible bound on the circulating lymphocytes which is viewed as indicator of the patient health. The certification is viewed as the ability to guarantee with a predefined high probability the success of the therapy over a finite horizon despite of the unavoidable high uncertainties affecting the dynamic model that is used to compute the optimal scheduling of drugs injection. The certification paradigm can be viewed as a tool for tuning the treatment parameters and protocols as well as for getting a rational use of limited or expensive drugs. The proposed framework is illustrated using the specific problem of combined immunotherapy/chemotherapy of cancer. [ABSTRACT FROM AUTHOR]

Human papillomavirus (HPV) infection is in the vast majority of patients accountable for the development of vulvar, cervical and vaginal intraepithelial neoplasia (VIN, CIN, VAIN); precursors of vulvar, cervical and vaginal cancers. The currently preferred treatment modality for high grade VIN, CIN and VAIN is surgical excision. Nevertheless surgical treatment is associated with adverse pregnancy outcomes and recurrence is not uncommon. The aim of this review is to present evidence on the efficacy, safety and tolerability of imiquimod (an immune response modifier) in HPV-related VIN, CIN and VAIN. A search for papers on the use of imiquimod in VIN, CIN and VAIN was performed in the MEDLINE, EMBASE and Cochrane library databases. Data was extracted and reviewed. Twenty-one articles met the inclusion criteria and were analyzed; 16 on VIN, 3 on CIN and 2 on VAIN. Complete response rates in VIN ranged from 5 to 88%. Although minor adverse effects were frequently reported, treatment with imiquimod was well tolerated in most patients. Studies on imiquimod treatment of CIN and VAIN are limited and lack uniformly defined endpoints. The available evidence however, shows encouraging effect. Complete response rates for CIN 2–3 and VAIN 1–3 ranged from 67 to 75% and 57 to 86% respectively. More randomized controlled trials on the use of imiquimod in CIN, VAIN and VIN with extended follow-up are necessary to determine the attributive therapeutic value in these patients. [ABSTRACT FROM AUTHOR]

Abstract: Objective: To evaluate the effect of school-based physical activity (PA) and nutritional education (NE) interventions on children's and adolescents' body mass index. Methods: We conducted a systematic search in fourteen databases until September 2012 for randomised controlled trials on PA and NE, conducted in the school setting, and delivered to children and adolescents. Additionally, we performed a cross-reference check in related papers. The title and abstract review and the quality assessment were performed by two independent researchers. The software EPPI-Reviewer3 was used to store, manage and analyse all data. The meta-analysis was conducted using the random-effects model, and the outcomes were reported as standardised mean difference (SMD). As a secondary analysis, we pooled together the interventions that considered PA or NE alone. Results: Thirty-eight studies met the eligibility criteria. The main analysis showed a SMD between intervention and control groups of −0.03 (95% CI: −0.09, 0.04; n=28,870; I2 =83%). When we considered all 57 trials, there was no difference between the results of the primary analysis. Conclusion: The synthesis of school-based PA and NE interventions showed no statistically significant mean reduction on children's and adolescents' body mass index. The high heterogeneity among studies requires caution in the generalisation of the results. [Copyright &y& Elsevier]

Abstract: Objective: The mainstay of treatment for most vulvar malignancies is surgery to the vulva with lymphadenectomy to the inguino-femoral areas, plus radiotherapy or/and chemotherapy for locally advanced, or recurrent disease. Treatment is associated with significant physical, sexual, and psychological morbidity. The high morbidity rate has resulted in a continuing shift in treatment paradigms that focus on treatments that reduce morbidity without compromising cure rates. This paper reviews the complications associated with contemporary surgical treatment for vulva cancer and discusses preventative strategies. Methods: A review of the English literature was undertaken for articles published between 1965 and August 31, 2012 to identify articles that assessed complications resulting from surgery to the vulva or groins in patients with vulva cancer. Two independent researchers selected and qualitatively analyzed the articles using a predetermined protocol. Results: The heterogeneity of articles and differences in definitions and outcomes made this unsuitable for meta-analysis. Most studies advocated for change in surgical technique to reduce complications associated with inguino-femoral lymphadenectomy and surgery to the vulva, with varying success. The most effective means of preventing complications is by omitting systematic lymph node dissection. This can be achieved safely through sentinel lymph node biopsy. Saphenous vein sparing, VTE prophylaxis, the use of flaps and grafts, and preoperative counseling are additional ways to decrease morbidity. Conclusion: Despite technical advances, complications following surgical treatment for vulva cancer remain high. More research, particularly multi centered randomized controlled trials to improve the quality of evidence and studies that focus on complications as an outcome measure and analyze individual surgeon complication rates, are needed. Measures also need to be standardized throughout the gynecologic oncology community to allow for better comparison between studies. [Copyright &y& Elsevier]

Abstract: Recent changes in nutrition standards for the National School Lunch and School Breakfast Programs assume that modification of the nutritional serving practices of school cafeterias will result in improved childhood nutrition in the school environment. The primary aim of this paper is to summarize the findings from two recent cluster randomized controlled trials (Wise Mind and LA Health) that tested the hypothesis that modification of school cafeteria environments, including changes in nutrition standards, would yield beneficial changes in childhood nutrition and healthy eating in the school lunch environment. A secondary aim was to investigate the association of participant characteristics and changes in nutrition and healthy eating. A third aim was to investigate the relationships between the food intake of children and: (1) foods selected by the children and (2) food that was uneaten during the lunch meal (plate waste). The studies used similar approaches for modifying the school cafeteria environment and both studies used the digital photography method to measure changes in food intake, food selection, and plate waste. Both studies reported significant improvements in childhood nutrition, and the LA Health study reported improved healthy eating, following introduction of the cafeteria modification program in comparison to baseline and/or control arms. These studies confirm the hypothesis that interventions that modify the school cafeteria environment can beneficially impact childhood nutrition. [Copyright &y& Elsevier]

Abstract: Objective: This community randomized trial evaluated effects of the Ozioma News Service on the amount and quality of cancer coverage in Black weekly newspapers in 24 U.S. cities. Method: We created and operated Ozioma, the first cancer information news service specifically for Black newspapers. Over 21months, Ozioma developed community- and race-specific cancer news releases for each of 12 Black weekly newspapers in intervention communities. Cancer coverage in these papers was tracked before and during the intervention and compared to 12 Black newspapers in control communities. Results: From 2004 to 2007, we coded 9257 health and cancer stories from 3178 newspaper issues. Intervention newspapers published approximately 4 times the expected number of cancer stories compared to control newspapers (p 12,21mo <.01), and also saw an increase in graphics (p 12,21mo <.01), local relevance (p 12mo =.01), and personal mobilization (p 12mo <.10). However, this increased coverage supplanted other health topics and had smaller graphics (NS), had less community mobilization (p 21mo =.01), and is less likely to be from a local source (NS). Conclusion: Providing news releases with localized and race-specific features to minority-serving media outlets can increase the quantity of cancer coverage. Results are mixed for the journalistic and public health quality of this increased cancer coverage in Black newspapers. [Copyright &y& Elsevier]

• A social robot can deliver a psychotherapeutic treatment. • The robot received positive evaluations on its interactive nature and sociable persona. • Detailed recommendations are provided for designing robot interactions for healthcare. • Greater personalization in future will allow closer simulations of client-centred counselling. This paper reports the design and qualitative evaluation of a social robot programmed to deliver a talk-based treatment program to improve health behaviour change for food intake and weight loss. A qualitative study was conducted to investigate factors that influenced human-robot interaction and its relationship to health treatment outcomes. Semi-structured interviews were undertaken on completion of a randomised controlled trial that used an autonomous robot to deliver a 4-week behavioral intervention to help coach people to decrease the consumption of high calorie foods. Questions focused on individuals' preferences, learnings and outcomes from their participation in the trial. Twenty participants completed the treatment, and 18 conducted an interview. Content analysis found that a social robot to deliver a psychotherapeutic treatment was effective and feasible. Participants did make changes to their health behaviour change with a >50% reduction in high calorie intake and average reduction of 4.4 kilograms in weight loss. The robot received positive evaluations on its interactive nature and sociable persona. Most participants made improvements that were aligned with their chosen health goal after completing the robot-delivered sessions, and reported that the robot sessions helped them to achieve their behaviour change goals, such as consuming fewer high calorie foods. Detailed recommendations are provided for the future design of healthcare interventions by robots, including key considerations for robot behaviour, treatment content, and presentation of the program. Future recommendations are presented for the development of robot personalization to more closely resemble techniques and skills from client-centred counselling. [ABSTRACT FROM AUTHOR]

This paper deploys a framed field experiment and uses high-frequency data to evaluate the short- and long-run effects of three behavioral interventions on residential water use during extreme drought. Our study of the effects of Home Water Reports (HWRs) on hourly water use yields three main results. First, even when layered on top of a 25% drought conservation mandate, HWRs led to conservation effects of 4 to 5%. Second, across three variants of HWRs, the profile of water conservation is similar, suggesting that households did not respond to the messaging or recommendations contained in the HWRs. Third, the water conservation effect of all interventions dissipated five months after the intervention ended. In our setting, these behavioral interventions align with utility incentives to achieve immediate but temporary water conservation in response to drought. [ABSTRACT FROM AUTHOR]

Abstract: Objective: High blood pressure is an important and modifiable cardiovascular disease risk factor that remains under-detected and under-treated. Community-level interventions that address high blood pressure and other modifiable risk factors are a promising strategy to improve cardiovascular health in populations. The present study is a community cluster-randomised trial testing the effectiveness of CHAP (Cardiovascular Health Awareness Program) on the cardiovascular health of older adults. Methods: Thirty-nine mid-sized communities in Ontario, Canada were stratified by geographic location and size of the population aged ≥65 years and randomly allocated to receive CHAP or no intervention. In CHAP communities, residents aged ≥65 years were invited to attend cardiovascular risk assessment sessions held in pharmacies over 10 weeks in Fall, 2006. Sessions included blood pressure measurement and feedback to family physicians. Trained volunteers delivered the program with support from pharmacists, community nurses and local organisations. Results: The primary outcome measure is the relative change in the mean annual rate of hospital admission for acute myocardial infarction, congestive heart failure and stroke (composite end-point) among residents aged ≥65 years in intervention and control communities, using routinely collected, population-based administrative health data. Conclusion: This paper highlights considerations in design, implementation and evaluation of a large-scale, community-wide cardiovascular health promotion initiative. [Copyright &y& Elsevier]

Abstract: Background: The empirical evidence of effectiveness of many school-based programs against substance abuse is rather weak. The EU-Dap study is a multicenter cluster randomized community trial (CRCT) designed to evaluate such a program. This paper presents study design and baseline characteristics of the study population. Methods: 170 schools from 9 centers from seven countries (Austria, Belgium, Germany, Greece, Italy, Spain, Sweden), stratified according to average social status in the catchment area, were randomized to either three variants of the active intervention (basic curriculum, basic with peer involvement, and basic with parent involvement) or to a control group. The program under evaluation is based on a comprehensive social influence approach, and was delivered during the scholar year 2004–2005 to a population of 12- to 14-year-old students attending junior high school. An anonymous questionnaire administered before and after the intervention was used to track behavioral and attitudinal changes. Results: All in all, we included in the study 143 schools and 7079 students, of which 3547 in the intervention groups and 3532 in the control group. At baseline, 34.9% of students had smoked cigarettes, 24.7% had been drunk, and 8.9% had used cannabis at least once in life. Discussion: EU-Dap is the first European multicenter randomized study to evaluate the effectiveness of a school program targeting tobacco, alcohol and drug use. The baseline assessment showed high prevalence and wide geographical variations of substance use. [Copyright &y& Elsevier]

The heart rate signal contains valuable information about cardiac health, which cannot be extracted without the use of appropriate computerized methods. This paper presents an analysis of various electrocardiograms, the aim of which is to categorize them into two distinct groups. Group A represents young male subjects with no prior occurrence of coronary disease events and Group B represents middle-aged male subjects who have symptomatic coronary artery disease without myocardial infarction and whose 12-lead ECGs do not contain any abnormalities, thus wrongly indicating a normal subject. Electrocardiographic recordings are approximately 2 h in length and acquired under conditions that favor the stationarity of collected data. Linear and nonlinear characteristics are studied by applying several techniques including Fourier analysis, Correlation Dimension Estimation, Approximate Entropy, and the Discrete Wavelet Transform. The small variations of the diagnostic information given by each one of the methods as well as the slightly different conclusions among similar studies indicate the necessity of further investigation, combined use, and complementary application of different approaches. [Copyright &y& Elsevier]

Inconsistencies exist with regard to influence of tibolone treatment on the lipid profile. The reasons for these inconsistencies might derive from several factors, i.e., differences in baseline variables, intervention duration, participants' health status or baseline body mass index (BMI). To address these inconsistencies, based on a systematic search in Scopus, PubMed/Medline, Web of Science, and Embase for papers published until 21 December 2020, we conducted the current dose-response meta-analysis of randomized controlled trials (RCTs) to determine the impact of tibolone treatment on the lipid profile. The overall findings were derived from 26 RCTs. Tibolone administration decreased total cholesterol (TC) (weighted mean difference, WMD: −18.55 mg/dL, CI: −25.95 to −11.16, P < 0.001), high-density lipoprotein-cholesterol (HDL-C) (WMD: −9.42 mg/dL, CI: −11.83 to −7.01, P < 0.001) and triglyceride (TG) (WMD: −21.43 mg/dL, CI: −27.15 to −15.70, P < 0.001) levels. A significant reduction in LDL-C occurred when tibolone was prescribed for ≤ 26 weeks (WMD: −7.64 mg/dL, 95% CI: −14.58 to −0.70, P = 0.031) versus > 26 weeks (WMD: −8.84 mg/dL, 95% CI: −29.98, 12.29, P = 0.412). The decrease in TG (WMD: −22.64 mg/dL) and TC (−18.55 mg/dL) concentrations was more pronounced in patients with BMI ≥ 25 kg/m2 versus BMI < 25 kg/m2. This systematic review and meta-analysis discovered that tibolone decreases TC, HDL-C and TG levels. LDL-C concentrations are significantly reduced when tibolone administration lasts for ≤ 26 weeks. [Display omitted] [ABSTRACT FROM AUTHOR]

The American Academy of Paediatrics (AAP) divides adolescence into early (12-14 years), middle (15-17 years), and late (18-21 years) stages. School-based HPV educational interventions are largely directed at parents of early adolescents at the time of vaccination. As the average age of first sexual intercourse in high income countries is 15-17 years old, a second educational intervention for middle adolescents could have a strong impact on HPV prevention, providing an opportunity for self-consenting to HPV vaccination in many countries. This paper appraises literature exploring the impact of school-based educational interventions in 15-17 year olds, on HPV vaccination uptake and/or perceptions/knowledge of HPV and its associated cancers. Randomised controlled trials (RCTs) and quasi-experimental designs (QEDs) (2007-2019) were included if they delivered a school-based educational intervention for 15-17 year olds, and the outcome measures included HPV vaccination uptake, knowledge of HPV and associated cancers or perception/attitude regarding self-protection against HPV. Fifteen studies met the inclusion criteria and were assessed for quality using the Quality Assessment Tool for Quantitative Studies. All studies demonstrated a statistically significant improvement in at least one major outcome measure post-intervention, despite the wide range in design of interventions, though only three studies actually measured changes to HPV vaccination uptake. Stakeholder engagement was absent in most intervention designs and many were not grounded in evidenced theory. Content was largely focused on female cervical cancer, rarely discussing oropharyngeal cancer, the most pre-dominant HPV-associated cancer in men. An optimal mixed gender intervention remains to be established for middle adolescents. [ABSTRACT FROM AUTHOR]

Objective: This paper reports on factors associated with colorectal cancer (CRC) screening decision stage (SDS) in screening-eligible primary care patients. Methods: Baseline telephone survey data (i.e., sociodemographic background, CRC screening perceptions, and SDS) were obtained for 1515 patients in a randomized behavioral intervention trial. Respondents reported SDS, a measure of proximity to actual screening, after listening to descriptions of screening stool blood testing and flexible sigmoidoscopy as had never heard of (NHO), were not considering or were undecided (NCU), or decided to do (DTD) each test. Polychotomous regression analyses were performed to differentiate participants by SDS. Results: At baseline, SDS was distributed as follows: NHO (8%), NCU (41%), and DTD (51%). We found that individuals who had DTD compared to those who were NCU about screening were older (OR=0.64), had prior cancer screening (OR=1.43), believed screening is important (OR=3.44), and had high social support (OR=2.49). Persons who were NCU compared to NHO participants were female (OR=2.18), were white (OR=2.35), had prior cancer screening (OR=2.81), and believed screening is important (OR=2.44). Conclusions: Prior screening and belief in screening importance were found to be consistently associated with SDS across comparisons, while older age, gender, race, and social support were not. [Copyright &y& Elsevier]

Child maltreatment has long-lasting negative impacts, and interventions are needed to improve caregiver's parenting skills to prevent maltreatment. This paper reports on a randomized trial comparing the SafeCare© model to services as usual (SAU) for child-welfare referred caregivers. SafeCare is an 18-session behavioral parenting program that teaches skills in positive parent-child interactions, home safety, and child health. SAU is generally unstructured and includes support, crisis management, referrals for need, and parenting education. Teams of providers at nine sites were randomized to implement SafeCare (19 teams; 119 providers) or continue SAU (17 teams; 118 providers). Two-hundred eighty eight caregivers (193 SafeCare; 95 SAU) with children aged 0-5 who were receiving services agreed to complete a baseline and 6-month assessment. Assessments measured positive parenting behaviors, parenting stress, protective factors, and neglectful behaviors using validated scales. Participants were primarily white (74.6%), female (87.0%), and low-income (68.6%), and had a mean age of 29. Latent change score models (LCSM) using a sandwich estimator consistent with the trial design were used to examine changes in 13 outcomes. Results indicated that SafeCare had small to medium effects for improving several parenting outcomes including supporting positive child behaviors (d = 0.46), proactive parenting (d = 0.25), and two aspects of parenting stress (d = 0.28 and .30). No differential change between groups was found for other indicators, including all indicators of neglect. Parenting programs such as SafeCare offer a promising mode of intervention for child welfare systems. Scale-up of parenting programs can improve parenting, improve child outcomes, and potentially reduce maltreatment. CLINICALTRIAL.GOV REGISTRATION NUMBER: NCT02549287. [ABSTRACT FROM AUTHOR]

The seminal studies by Allcott and Mullainathan (2010), Allcott (2011), and Allcott and Rogers (2014) show that social comparison-based home energy reports (HER) are a cost-effective climate policy intervention in the US. Our paper demonstrates the context-dependency of this result. In most industrialized countries, average electricity consumption and carbon intensity are well below US levels. Consequently, HER interventions can only become cost-effective if treatment effect sizes are substantially higher. For Germany, we provide evidence from a large-scale randomized controlled trial that effect sizes are in fact considerably lower than in the US. We conclude by illustrating that targeting highly responsive subgroups is crucial to reach cost-effectiveness and by identifying the few countries in which HER are promising policy instruments. [ABSTRACT FROM AUTHOR]

Tuberculosis (TB) is currently a clinical and public health problem. There is a concern about the emergence and development of multidrug-resistant (MDR-TB) and extensively drug-resistant (XDR-TB) species. Additionally, the lack of effective vaccines is another limitation to control the related infections. To overcome these problems various approaches have been pursued such as finding novel drug candidates with a new mechanism of action or repurposing conventional antibiotics. However, these strategies are still far from clinical application. Hence, the use of adjunctive therapy has been suggested for TB. In this paper, we review non-antibiotic adjunctive treatment options for TB. Natural products, vitamins, micronutrients, and trace elementals, as well as non-antibiotic drugs, are examples of agents which have been used as adjunctive therapies. The use of these adjunctive therapies has been shown to improve disease outcomes and reduce the adverse effects of antibiotic drugs. Employing these agents, either alone or in combination with antibiotics, might be considered as a promising approach to control TB infections and achieve better clinical outcomes. However, supportive evidence from randomized controlled trials is still scant and merits further investigations. [ABSTRACT FROM AUTHOR]