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Evaluation of the efficacy and safety of once-a-day dosing of tadalafil 5mg and 10mg in the treatment of erectile dysfunction: results of a multicenter, randomized, double-blind, placebo-controlled trial.

Background: Erectile dysfunction (ED) is a chronic disease; however, therapy is currently administered as needed with oral phosphodiesterase 5 (PDE5) inhibitors like tadalafil. Because the 17.5-h half-life of tadalafil enables therapeutic plasma levels to be sustained with daily administration, tadalafil is a good candidate for once daily dosing therapy. Methods: This multicenter, randomized, double-blind, placebo-controlled, parallel-group, 12-week study enrolled 268 men 1:2:2 to placebo, tadalafil 5mg, and tadalafil 10mg taken once daily. Primary efficacy measures included changes in the International Index of Erectile Function Erectile Function domain (IIEF EF), Sexual Encounter Profile diary Questions 2 (SEP2: successful penetration), and 3 (SEP3: successful completion of intercourse), and tolerability. Secondary measures included percentage of patients at endpoint who reported improved erectile function (EF), and percentage who reported "no ED" (IIEF EF score 26-30). Results: For patients who took placebo, tadalafil 5mg, and tadalafil 10mg, changes from baseline to endpoint were, respectively, 0.9, 9.7, and 9.4 for IIEF EF; 11.2, 36.5, and 39.4 for SEP2; and 13.2, 45.5, and 50.1 for SEP3. At endpoint, 28.3%, 84.5%, and 84.6% reported improved erections, and 8.3%, 51.5%, and 50.5% reported "no ED," respectively. All comparisons between tadalafil and placebo were significant (p<0.001). Adverse events that occurred in at least 5% of patients were dyspepsia, headache, back pain, upper abdominal pain, and myalgia; nine patients (3.4%) discontinued because of adverse events. Conclusions: Once-a-day tadalafil 5mg or 10mg was well tolerated and significantly improved EF in men with ED.

European urology · randomised controlled trial · 120 citationsread the source →

Smoking cessation support delivered via mobile phone text messaging (txt2stop): a single-blind, randomised trial.

Background: Smoking cessation programmes delivered via mobile phone text messaging show increases in self-reported quitting in the short term. We assessed the effect of an automated smoking cessation programme delivered via mobile phone text messaging on continuous abstinence, which was biochemically verified at 6 months. Methods: In this single-blind, randomised trial, undertaken in the UK, smokers willing to make a quit attempt were randomly allocated, using an independent telephone randomisation system, to a mobile phone text messaging smoking cessation programme (txt2stop), comprising motivational messages and behavioural-change support, or to a control group that received text messages unrelated to quitting. The system automatically generated intervention or control group texts according to the allocation. Outcome assessors were masked to treatment allocation. The primary outcome was self-reported continuous smoking abstinence, biochemically verified at 6 months. All analyses were by intention to treat. This study is registered, number ISRCTN 80978588. Findings: We assessed 11,914 participants for eligibility. 5800 participants were randomised, of whom 2915 smokers were allocated to the txt2stop intervention and 2885 were allocated to the control group; eight were excluded because they were randomised more than once. Primary outcome data were available for 5524 (95%) participants. Biochemically verified continuous abstinence at 6 months was significantly increased in the txt2stop group (10·7% txt2stop vs 4·9% control, relative risk [RR] 2·20, 95% CI 1·80-2·68; p<0·0001). Similar results were obtained when participants that were lost to follow-up were treated as smokers (268 [9%] of 2911 txt2stop vs 124 [4%] of 2881 control [RR 2·14, 95% CI 1·74-2·63; p<0·0001]), and when they were excluded (268 [10%] of 2735 txt2stop vs 124 [4%] of 2789 control [2·20, 1·79-2·71; p<0·0001]). No significant heterogeneity was shown in any of the prespecified subgroups. Interpretation: The txt2stop smoking cessation programme significantly improved smoking cessation rates at 6 months and should be considered for inclusion in smoking cessation services. Funding: UK Medical Research Council, Primary Care Research Networks.

Lancet (London, England) · randomised controlled trial · 520 citationsread the source →

A systematic review of prehabilitation programs in abdominal cancer surgery.

Introduction: Prehabilitation programs aim to optimise patients in order to enhance post-operative recovery. This study aims to review the composition of prehabilitation programs for patients undergoing major abdominal cancer surgery and define the outcome measures that are used to evaluate this intervention. Methods: A systematic literature review of all comparative studies on prehabilitation versus standard care in patients undergoing abdominal cancer surgery was performed in accordance with PRISMA guidelines. Literature search was performed using Medline, OVID, EMBASE, Google Scholar, and Cochrane databases. Outcomes of interest included prehabilitation program composition (exercise, nutritional, and psychological interventions), duration, mode of delivery, and outcome measures used to determine impact of prehabilitation versus standard care. Results: 9 studies (7 randomised controlled and 2 prospective non-randomised trials) comprising of 549 patients (281 prehabilitation versus 268 standard care) were included in this review. 5 studies reported patients undergoing surgery for colorectal cancer, 2 for bladder tumours, 1 for liver resections, and 1 involving unspecified abdominal oncological operations. The 6 min walk test (6MWT) was used in 4 studies to measure functional capacity with a threshold of >20 m improvement at 4-8 weeks post-operatively deemed significant (distance range from 278 to 560 m). Changes in anaerobic threshold and VO2max with prehabilitation were evaluated in 5 studies (ml/kg/min). Health-related quality of life was evaluated using SF-36 system, anxiety assessed using hospital anxiety and depression score (HADS). Post-operative complications were classified according to the Clavien-Dindo classification with no significant difference between prehabilitation and standard care groups. Conclusion: Prehabilitation programs in patients undergoing abdominal cancer surgery remain heterogeneous in their composition, mode of administration, outcome measures of functional capacity that are used to evaluate their impact. All these aspects require standardisation prior to the evaluation of prehabilitation on a larger scale.

International journal of surgery (London, England) · systematic review · 198 citationsread the source →

Music interventions for acquired brain injury.

Background: Acquired brain injury (ABI) can result in impairments in motor function, language, cognition, and sensory processing, and in emotional disturbances, which can severely reduce a survivor's quality of life. Music interventions have been used in rehabilitation to stimulate brain functions involved in movement, cognition, speech, emotions, and sensory perceptions. An update of the systematic review published in 2010 was needed to gauge the efficacy of music interventions in rehabilitation for people with ABI. Objectives: To assess the effects of music interventions for functional outcomes in people with ABI. We expanded the criteria of our existing review to: 1) examine the efficacy of music interventions in addressing recovery in people with ABI including gait, upper extremity function, communication, mood and emotions, cognitive functioning, social skills, pain, behavioural outcomes, activities of daily living, and adverse events; 2) compare the efficacy of music interventions and standard care with a) standard care alone, b) standard care and placebo treatments, or c) standard care and other therapies; 3) compare the efficacy of different types of music interventions (music therapy delivered by trained music therapists versus music interventions delivered by other professionals). Search methods: We searched the Cochrane Stroke Group Trials Register (January 2016), the Cochrane Central Register of Controlled Trials (CENTRAL) (2015, Issue 6), MEDLINE (1946 to June 2015), Embase (1980 to June 2015), CINAHL (1982 to June 2015), PsycINFO (1806 to June 2015), LILACS (1982 to January 2016), and AMED (1985 to June 2015). We handsearched music therapy journals and conference proceedings, searched dissertation and specialist music databases, trials and research registers, reference lists, and contacted relevant experts and music therapy associations to identify unpublished research. We imposed no language restriction. We performed the original search in 2009. Selection criteria: We included all randomised controlled trials and controlled clinical trials that compared music interventions and standard care with standard care alone or combined with other therapies. We examined studies that included people older than 16 years of age who had ABI of a non-degenerative nature and were participating in treatment programmes offered in hospital, outpatient, or community settings. We included studies in any language, published and unpublished. Data collection and analysis: Two review authors independently extracted data and assessed the risk of bias of the included studies. We contacted trial researchers to obtain missing data or for additional information when necessary. Where possible, we presented results for continuous outcomes in meta-analyses using mean differences (MDs) and standardised mean differences (SMDs). We used post-test scores. In cases of significant baseline difference, we used change scores. We conducted a sensitivity analysis to assess the impact of the randomisation method. Main results: We identified 22 new studies for this update. The evidence for this update is based on 29 trials involving 775 participants. A music intervention known as rhythmic auditory stimulation may be beneficial for improving the following gait parameters after stroke. We found a reported increase in gait velocity of 11.34 metres per minute (95% confidence interval (CI) 8.40 to 14.28; 9 trials; 268 participants; P < 0.00001; moderate-quality evidence). Stride length of the affected side may also benefit, with a reported average of 0.12 metres more (95% CI 0.04 to 0.20; 5 trials; 129 participants; P = 0.003; moderate-quality evidence). We found a reported average improvement for general gait of 7.67 units on the Dynamic Gait Index (95% CI 5.67 to 9.67; 2 trials; 48 participants; P < 0.00001). There may also be an improvement in gait cadence, with a reported average increase of 10.77 steps per minute (95% CI 4.36 to 17.18; 7 trials; 223 participants; P = 0.001; low-quality evidence).Music interventions may be beneficial for improving the timing of upper extremity function after stroke as scored by a reduction of 1.08 seconds on the Wolf Motor Function Test (95% CI -1.69 to -0.47; 2 trials; 122 participants; very low-quality evidence).Music interventions may be beneficial for communication outcomes in people with aphasia following stroke. Overall, communication improved by 0.75 standard deviations in the intervention group, a moderate effect (95% CI 0.11 to 1.39; 3 trials; 67 participants; P = 0.02; very low-quality evidence). Naming was reported as improving by 9.79 units on the Aachen Aphasia Test (95% CI 1.37 to 18.21; 2 trials; 35 participants; P = 0.02). Music interventions may have a beneficial effect on speech repetition, reported as an average increase of 8.90 score on the Aachen Aphasia Test (95% CI 3.25 to 14.55; 2 trials; 35 participants; P = 0.002).There may be an improvement in quality of life following stroke using rhythmic auditory stimulation, reported at 0.89 standard deviations improvement on the Stroke Specific Quality of Life Scale, which is considered to be a large effect (95% CI 0.32 to 1.46; 2 trials; 53 participants; P = 0.002; low-quality evidence). We found no strong evidence for effects on memory and attention. Data were insufficient to examine the effect of music interventions on other outcomes. The majority of studies included in this review update presented a high risk of bias, therefore the quality of the evidence is low. Authors' conclusions: Music interventions may be beneficial for gait, the timing of upper extremity function, communication outcomes, and quality of life after stroke. These results are encouraging, but more high-quality randomised controlled trials are needed on all outcomes before recommendations can be made for clinical practice.

The Cochrane database of systematic reviews · meta-analysis · 116 citationsread the source →

Internet-Delivered Health Interventions That Work: Systematic Review of Meta-Analyses and Evaluation of Website Availability.

Background: Due to easy access and low cost, Internet-delivered therapies offer an attractive alternative to improving health. Although numerous websites contain health-related information, finding evidence-based programs (as demonstrated through randomized controlled trials, RCTs) can be challenging. We sought to bridge the divide between the knowledge gained from RCTs and communication of the results by conducting a global systematic review and analyzing the availability of evidence-based Internet health programs. Objectives: The study aimed to (1) discover the range of health-related topics that are addressed through Internet-delivered interventions, (2) generate a list of current websites used in the trials which demonstrate a health benefit, and (3) identify gaps in the research that may have hindered dissemination. Our focus was on Internet-delivered self-guided health interventions that did not require real-time clinical support. Methods: A systematic review of meta-analyses was conducted using Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines (PROSPERO Registration Number CRD42016041258). MEDLINE via Ovid, PsycINFO, Embase, Cochrane Database of Systematic Reviews, and the Cumulative Index to Nursing and Allied Health Literature (CINAHL) were searched. Inclusion criteria included (1) meta-analyses of RCTs, (2) at least one Internet-delivered intervention that measured a health-related outcome, and (3) use of at least one self-guided intervention. We excluded group-based therapies. There were no language restrictions. Results: Of the 363 records identified through the search, 71 meta-analyses met inclusion criteria. Within the 71 meta-analyses, there were 1733 studies that contained 268 unique RCTs which tested self-help interventions. On review of the 268 studies, 21.3% (57/268) had functional websites. These included evidence-based Web programs on substance abuse (alcohol, tobacco, cannabis), mental health (depression, anxiety, post-traumatic stress disorder [PTSD], phobias, panic disorders, obsessive compulsive disorder [OCD]), and on diet and physical activity. There were also evidence-based programs on insomnia, chronic pain, cardiovascular risk, and childhood health problems. These programs tended to be intensive, requiring weeks to months of engagement by the user, often including interaction, personalized and normative feedback, and self-monitoring. English was the most common language, although some were available in Spanish, French, Portuguese, Dutch, German, Norwegian, Finnish, Swedish, and Mandarin. There were several interventions with numbers needed to treat of <5; these included painACTION, Mental Health Online for panic disorders, Deprexis, Triple P Online (TPOL), and U Can POOP Too. Hyperlinks of the sites have been listed. Conclusions: A wide range of evidence-based Internet programs are currently available for health-related behaviors, as well as disease prevention and treatment. However, the majority of Internet-delivered health interventions found to be efficacious in RCTs do not have websites for general use. Increased efforts to provide mechanisms to host "interventions that work" on the Web and to assist the public in locating these sites are necessary.

Journal of medical Internet research · systematic review · 166 citationsread the source →

Effect of Shamiri Layperson-Provided Intervention vs Study Skills Control Intervention for Depression and Anxiety Symptoms in Adolescents in Kenya: A Randomized Clinical Trial.

Importance: Low-cost interventions for adolescent depression and anxiety are needed in low-resource countries such as those in Sub-Saharan Africa. Objective: To assess whether Shamiri, a 4-week layperson-delivered group intervention that teaches growth mindset, gratitude, and value affirmation, can alleviate depression and anxiety symptoms in symptomatic Kenyan adolescents. Design, setting, and participants: This school-based randomized clinical trial included outcomes assessed at baseline, posttreatment, and 2-week and 7-month follow-up from 4 secondary schools in Nairobi and Kiambu County, Kenya. Adolescents aged 13 to 18 years with elevated symptoms on standardized depression or anxiety measures were eligible. Intent-to-treat analyses were used to analyze effects. Recruitment took place in June 2019; follow-up data were collected in August 2019 and February 2020. Intervention: Adolescents were randomized to the Shamiri intervention or to a study skills control. All adolescents in both conditions met in groups (mean group size, 9) for 60 minutes per week for 4 weeks. Main outcomes and measures: Primary outcomes were depression (Patient Health Questionnaire-8 item) and anxiety (Generalized Anxiety Disorder-7 item) symptoms. Analyses of imputed data were hypothesized to reveal significant reductions in depression and anxiety symptoms for adolescents assigned to Shamiri compared with those in the study skills group. Results: Of 413 adolescents, 205 (49.6%) were randomized to Shamiri and 208 (50.4%) to study skills. The mean (SD) age was 15.5 (1.2) years, and 268 (65.21%) were female. A total of 307 youths completed the 4-week intervention. Both Shamiri and study skills were rated highly useful (4.8/5.0) and reduced symptoms of depression and anxiety, but analyses with imputed data revealed that youths receiving Shamiri showed greater reductions in depressive symptoms at posttreatment (Cohen d = 0.35 [95% CI, 0.09-0.60]), 2-week follow-up (Cohen d = 0.28 [95% CI, 0.04-0.54]), and 7-month follow-up (Cohen d = 0.45 [95% CI, 0.19-0.71]) and greater reductions in anxiety symptoms at posttreatment (Cohen d = 0.37 [95% CI, 0.11-0.63]), 2-week follow-up (Cohen d = 0.26 [95% CI, -0.01 to 0.53]), and 7-month follow-up (Cohen d = 0.44 [95% CI, 0.18-0.71]). Conclusions and relevance: Both the Shamiri intervention and a study skills control group reduced depression and anxiety symptoms; the low-cost Shamiri intervention had a greater effect, with effects lasting at least 7 months. If attrition is reduced and the clinical significance of outcome differences is established, this kind of intervention may prove useful in other global settings where there are limited resources, mental illness stigma, or a shortage of professionals and limited access to mental health care. Trial registration: Pan-African Clinical Trials Registry Identifier: PACTR201906525818462.

JAMA psychiatry · randomised controlled trial · 49 citationsread the source →

Integrated Hepatitis C-Opioid Use Disorder Care Through Facilitated Telemedicine: A Randomized Trial.

Importance: Facilitated telemedicine may promote hepatitis C virus elimination by mitigating geographic and temporal barriers. Objective: To compare sustained virologic responses for hepatitis C virus among persons with opioid use disorder treated through facilitated telemedicine integrated into opioid treatment programs compared with off-site hepatitis specialist referral. Design, setting, and participants: Prospective, cluster randomized clinical trial using a stepped wedge design. Twelve programs throughout New York State included hepatitis C-infected participants (n = 602) enrolled between March 1, 2017, and February 29, 2020. Data were analyzed from December 1, 2022, through September 1, 2023. Intervention: Hepatitis C treatment with direct-acting antivirals through comanagement with a hepatitis specialist either through facilitated telemedicine integrated into opioid treatment programs (n = 290) or standard-of-care off-site referral (n = 312). Main outcomes and measures: The primary outcome was hepatitis C virus cure. Twelve programs began with off-site referral, and every 9 months, 4 randomly selected sites transitioned to facilitated telemedicine during 3 steps without participant crossover. Participants completed 2-year follow-up for reinfection assessment. Inclusion criteria required 6-month enrollment in opioid treatment and insurance coverage of hepatitis C medications. Generalized linear mixed-effects models were used to test for the intervention effect, adjusted for time, clustering, and effect modification in individual-based intention-to-treat analysis. Results: Among 602 participants, 369 were male (61.3%); 296 (49.2%) were American Indian or Alaska Native, Asian, Black or African American, multiracial, or other (ie, no race category was selected, with race data collected according to the 5 standard National Institutes of Health categories); and 306 (50.8%) were White. The mean (SD) age of the enrolled participants in the telemedicine group was 47.1 (13.1) years; that of the referral group was 48.9 (12.8) years. In telemedicine, 268 of 290 participants (92.4%) initiated treatment compared with 126 of 312 participants (40.4%) in referral. Intention-to-treat cure percentages were 90.3% (262 of 290) in telemedicine and 39.4% (123 of 312) in referral, with an estimated logarithmic odds ratio of the study group effect of 2.9 (95% CI, 2.0-3.5; P < .001) with no effect modification. Observed cure percentages were 246 of 290 participants (84.8%) in telemedicine vs 106 of 312 participants (34.0%) in referral. Subgroup effects were not significant, including fibrosis stage, urban or rural participant residence location, or mental health (anxiety or depression) comorbid conditions. Illicit drug use decreased significantly (referral: 95% CI, 1.2-4.8; P = .001; telemedicine: 95% CI, 0.3-1.0; P < .001) among cured participants. Minimal reinfections (n = 13) occurred, with hepatitis C virus reinfection incidence of 2.5 per 100 person-years. Participants in both groups rated health care delivery satisfaction as high or very high. Conclusions and relevance: Opioid treatment program-integrated facilitated telemedicine resulted in significantly higher hepatitis C virus cure rates compared with off-site referral, with high participant satisfaction. Illicit drug use declined significantly among cured participants with minimal reinfections. Trial registration: ClinicalTrials.gov Identifier: NCT02933970.

JAMA · randomised controlled trial · 49 citationsread the source →

Randomised controlled trial and economic analysis of an internet-based weight management programme: POWeR+ (Positive Online Weight Reduction).

Background: Behavioural counselling with intensive follow-up for obesity is effective, but in resource-constrained primary care settings briefer approaches are needed. Objectives: To estimate the clinical effectiveness and cost-effectiveness of an internet-based behavioural intervention with regular face-to-face or remote support in primary care, compared with brief advice. Design: Individually randomised three-arm parallel trial with health economic evaluation and nested qualitative interviews. Setting: Primary care general practices in the UK. Participants: Patients with a body mass index of ≥ 30 kg/m2 (or ≥ 28 kg/m2 with risk factors) identified from general practice records, recruited by postal invitation. Interventions: Positive Online Weight Reduction (POWeR+) is a 24-session, web-based weight management intervention completed over 6 months. Following online registration, the website randomly allocated participants using computer-generated random numbers to (1) the control intervention (n = 279), which had previously been demonstrated to be clinically effective (brief web-based information that minimised pressure to cut down foods, instead encouraging swaps to healthier choices and increasing fruit and vegetables, plus 6-monthly nurse weighing); (2) POWeR+F (n = 269), POWeR+ supplemented by face-to-face nurse support (up to seven contacts); or (3) POWeR+R (n = 270), POWeR+ supplemented by remote nurse support (up to five e-mails or brief telephone calls). Main outcome measures: The primary outcome was a modelled estimate of average weight reduction over 12 months, assessed blind to group where possible, using multiple imputation for missing data. The secondary outcome was the number of participants maintaining a 5% weight reduction at 12 months. Results: A total of 818 eligible individuals were randomised using computer-generated random numbers. Weight change, averaged over 12 months, was documented in 666 out of 818 participants (81%; control, n = 227; POWeR+F, n = 221; POWeR+R, n = 218). The control group maintained nearly 3 kg of weight loss per person (mean weight per person: baseline, 104.4 kg; 6 months, 101.9 kg; 12 months, 101.7 kg). Compared with the control group, the estimated additional weight reduction with POWeR+F was 1.5 kg [95% confidence interval (CI) 0.6 to 2.4 kg; p = 0.001] and with POWeR+R was 1.3 kg (95% CI 0.34 to 2.2 kg; p = 0.007). By 12 months the mean weight loss was not statistically significantly different between groups, but 20.8% of control participants, 29.2% of POWeR+F participants (risk ratio 1.56, 95% CI 0.96 to 2.51; p = 0.070) and 32.4% of POWeR+R participants (risk ratio 1.82, 95% CI 1.31 to 2.74; p = 0.004) maintained a clinically significant 5% weight reduction. The POWeR+R group had fewer individuals who reported doing another activity to help lose weight [control, 47.1% (64/136); POWeR+F, 37.2% (51/137); POWeR+R, 26.7% (40/150)]. The incremental cost to the health service per kilogram weight lost, compared with the control group, was £18 (95% CI -£129 to £195) for POWeR+F and -£25 (95% CI -£268 to £157) for POWeR+R. The probability of being cost-effective at a threshold of £100 per kilogram was 88% and 98% for POWeR+F and POWeR+R, respectively. POWeR+R was dominant compared with the control group. No harms were reported and participants using POWeR+ felt more enabled in managing their weight. The qualitative studies documented that POWeR+ was viewed positively by patients and that health-care professionals generally enjoyed supporting patients using POWeR+. Study limitations: Maintenance of weight loss after 1 year is unknown. Future work: Identifying strategies for longer-term engagement, impact in community settings and increasing physical activity. Conclusion: Clinically valuable weight loss (> 5%) is maintained in 20% of individuals using novel written materials with brief follow-up. A web-based behavioural programme and brief support results in greater mean weight loss and 10% more participants maintain valuable weight loss; it achieves greater enablement and fewer participants undertaking other weight-loss activities; and it is likely to be cost-effective. Trial registration: Current Controlled Trials ISRCTN21244703. Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 4. See the NIHR Journals Library website for further project information.

Health technology assessment (Winchester, England) · randomised controlled trial · 34 citationsread the source →

Olive Oil Polyphenols Improve HDL Cholesterol and Promote Maintenance of Lipid Metabolism: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

In 2011, the European Food Safety Authority (EFSA) accorded a health claim to olive oil polyphenols in that they protected LDL particles from oxidative damage. However, limited scientific evidence has so far failed to confer any claim of function on the maintenance of normal lipid metabolism. We performed a systematic review and meta-analysis of human RCTs, evaluating the effect of olive oil polyphenol administration on lipid profiles. Previous literature was acquired from six electronic databases until June 2023. A total of 75 articles were retrieved and screened for inclusion criteria, which resulted in the selection of 10 RCTs that evaluated the effect of daily exposure to olive oil polyphenols on serum lipids in adults. Meta-analyses were built by tertiles of outcomes, as follows: low (0-68 mg/kg), medium (68-320 mg/kg), and high (320-600 mg/kg) polyphenols for HDL and LDL cholesterol (HDL-C and LDL-C, respectively), and low (0-59.3 mg/kg), medium (59.3-268 mg/kg), and high (268-600 mg/kg) polyphenols for total cholesterol (TC). The study protocol was registered on PROSPERO (registration code: CRD42023403383). The study design was predominantly cross-over (n = 8 of 10) but also included parallel (n = 2 of 10). The study population was predominantly European and healthy. Daily consumption of olive oil polyphenols did not affect TC levels and only slightly significantly reduced LDL-C, with WMD statistically significant only for high daily consumption of olive oil polyphenols (WMD -4.28, 95%CI -5.78 to -2.77). Instead, our data found a statistically significant HDL-C enhancing effect (WMD pooled effect model: 1.13, 95%CI 0.45; 1.80, heterogeneity 38%, p = 0.04) with WMD by daily exposure level showing a statistically significant improvement effect for low (WMD 0.66, 95%CI 0.10-1.23), medium (WMD 1.36, 95%CI 0.76-1.95), and high (WMD 1.13, 95%CI 0.45-1.80) olive oil polyphenol consumptions. Olive oil polyphenols contribute toward maintaining lipid metabolism. Thus, food labeling regulations should stress this health feature of olive oil, whereby a declaration of the olive oil polyphenol content should be added to products on the market. Consumers need to be aware of the quality and possible health effects of any products they consume, and enforcement of nutrition labels offers the best way of providing this information.

Metabolites · review · 16 citationsread the source →

Validation of the Spanish versions of the long (26 items) and short (12 items) forms of the Self-Compassion Scale (SCS)

BACKGROUND: Self-compassion is a key psychological construct for assessing clinical outcomes in mindfulness-based interventions. The aim of this study was to validate the Spanish versions of the long (26 item) and short (12 item) forms of the Self-Compassion Scale (SCS). METHODS: The translated Spanish versions of both subscales were administered to two independent samples: Sample 1 was comprised of university students (n = 268) who were recruited to validate the long form, and Sample 2 was comprised of Aragon Health Service workers (n = 271) who were recruited to validate the short form. In addition to SCS, the Mindful Attention Awareness Scale (MAAS), the State-Trait Anxiety Inventory-Trait (STAI-T), the Beck Depression Inventory (BDI) and the Perceived Stress Questionnaire (PSQ) were administered. Construct validity, internal consistency, test-retest reliability and convergent validity were tested. RESULTS: The Confirmatory Factor Analysis (CFA) of the long and short forms of the SCS confirmed the original six-factor model in both scales, showing goodness of fit. Cronbach's α for the 26 item SCS was 0.87 (95% CI = 0.85-0.90) and ranged between 0.72 and 0.79 for the 6 subscales. Cronbach's α for the 12-item SCS was 0.85 (95% CI = 0.81-0.88) and ranged between 0.71 and 0.77 for the 6 subscales. The long (26-item) form of the SCS showed a test-retest coefficient of 0.92 (95% CI = 0.89-0.94). The Intraclass Correlation (ICC) for the 6 subscales ranged from 0.84 to 0.93. The short (12-item) form of the SCS showed a test-retest coefficient of 0.89 (95% CI: 0.87-0.93). The ICC for the 6 subscales ranged from 0.79 to 0.91. The long and short forms of the SCS exhibited a significant negative correlation with the BDI, the STAI and the PSQ, and a significant positive correlation with the MAAS. The correlation between the total score of the long and short SCS form was r = 0.92. CONCLUSION: The Spanish versions of the long (26-item) and short (12-item) forms of the SCS are valid and reliable instruments for the evaluation of self-compassion among the general population. These results substantiate the use of this scale in research and clinical practice.

Health and Quality of Life Outcomes · 307 citationsread the source →

Diabetes Distress Among Persons With Type 1 Diabetes.

Purpose The purpose of this study is to evaluate associations between diabetes distress and a range of psychological health behaviors and concerns among persons with type 1 diabetes for the benefit of enhancing early identification and intervention of at-risk individuals. Methods Persons with type 1 diabetes (n = 268; 57.1% female, 91.0% white, 76.8% <18 years of age, average A1C 8.4%) completed the 2-item Diabetes Distress Screening Scale (DDS2) and a battery of psychometrically sound instruments measuring satisfaction with life, self-esteem, self-efficacy, depression, perfectionism, body image satisfaction, dietary restraint and eating, and shape and weight concerns. Each subscale score was compared within age groups (<18 years vs ≥18 years) between groups (diabetes distress level [low, moderate, high]) using analysis of variance (with Bonferroni correction or the Kruskal-Wallis test if the variables were not normally distributed). Results For both age groups, high diabetes distress was independently associated with greater A1C values, higher depression scores and eating, and shape and weight concerns than those with low or moderate distress. For patients <18 years of age, those with high diabetes distress scored lower on measures of satisfaction with life, self-esteem, and self-efficacy and higher on dietary restraint and several areas of perfectionism than those with low or moderate distress. Conclusions Individuals with type 1 diabetes who have high diabetes distress also report higher A1C values and poorer psychological health concerns. A brief diabetes distress questionnaire can help to identify those who need additional screening, education and support, and treatment for overall health and well-being.

The Diabetes educator · 45 citationsread the source →

Parental phubbing accelerates depression in late childhood and adolescence:A two-path model.

Introduction: Phubbing is a social exclusion behavior related to mobile phone use. It undermines interpersonal relationships and mental health. This study aimed to test the connections between parental phubbing and depression in late childhood and adolescence, as well as the mediating roles of parental warmth, parental rejection, and relatedness need satisfaction. Methods: We conducted two studies. Study 1 was a cross-sectional study of 530 Chinese students (268 boys and 262 girls, Mage = 13.15 ± 0.64 years) who completed self-report questionnaires. We conducted structural modeling to test the relationship between parental phubbing and depression. Study 2 used a short longitudinal design to validate the results of Study 1 and test the mediating roles of parental warmth, parental rejection, and relatedness need satisfaction. In Study 2, we recruited 293 Chinese students (151 boys, 141 girls, and one participant with no reported gender information, Mage = 12.87 ± 0.74 years) to complete the questionnaires and applied structural equation modeling to analyze the data. Results: Two sequential mediation effects were found. The first was parental phubbing → parental warmth → relatedness need satisfaction → depression (protection-reduced effect). The second was parental phubbing → parental rejection → relatedness need satisfaction → depression (risk-increased effect). Gender differences were non-significant. Conclusions: The study revealed that parental phubbing was associated with students' depression in late childhood and adolescence through two paths. The present study highlights the need to establish family norms regulating mobile phone use to reduce phubbing.

Journal of adolescence · 59 citationsread the source →

Daily communication, conflict resolution, and marital quality in Chinese marriage: A three-wave, cross-lagged analysis.

Based on three annual waves of data obtained from 268 Chinese couples in the early years of marriage and using a three-wave, cross-lagged approach, the present study examined the associations among daily marital communication, marital conflict resolution, and marital quality. Results indicated unidirectional associations linking daily marital communication or marital conflict resolution to marital quality (instead of reciprocal associations); and when considered simultaneously in a single model, daily marital communication and marital conflict resolution explained variance in marital quality above and beyond each other. Furthermore, the authors also found a significant longitudinal, indirect association linking husbands' daily marital communication at Wave 1 to husbands' marital quality at Wave 3 via husbands' marital conflict resolution at Wave 2. Taken altogether, the current study adds to an emerging body of research aimed at clarifying: (a) the directionality of the associations between couple interactive processes and marital well-being; (b) the unique roles of daily marital communication and marital conflict resolution in predicting marital outcomes; and (c) how daily marital communication and marital conflict resolution may operate in conjunction with each other to shape the development of couple relationship well-being. (PsycINFO Database Record

Journal of family psychology : JFP : journal of the Division of Family Psychology of the American Psychological Association (Division 43) · 8 citationsread the source →

Prevalence and management of chronic insomnia in Swiss primary care: Cross-sectional data from the "Sentinella" practice-based research network.

We investigated the prevalence and treatment of patients with chronic insomnia presenting to Swiss primary care physicians (PCPs) part of "Sentinella", a nationwide practice-based research network. Each PCP consecutively asked 40 patients if they had sleep complaints, documented frequency, duration, comorbidities, and reported ongoing treatment. We analysed data of 63% (83/132) of the PCPs invited. The PCPs asked 76% (2,432/3,216) of included patients about their sleep (51% female); 31% (761/2,432) of these had had insomnia symptoms; 36% (875/2,432) had current insomnia symptoms; 11% (269/2,432) met the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for chronic insomnia (61% female). In all, 75% (201/269) of patients with chronic insomnia had comorbidities, with 49% (99/201) reporting depression. Chronic insomnia was treated in 78% (209/269); 70% (188/268) took medication, 38% (102/268) benzodiazepines or benzodiazepine receptor agonists, 32% (86/268) took antidepressants. Only 1% (three of 268) had been treated with cognitive behavioural therapy for insomnia (CBT-I). A third of patients presenting for a non-urgent visit in Swiss primary care reported insomnia symptoms and 11% met the DSM-5 criteria for chronic insomnia. Hypnotics were the most common treatment, but almost no patients received first-line CBT-I. Reducing the burden of insomnia depends on disseminating knowledge about and access to CBT-I, and encouraging PCPs to discuss it with and offer it as a first-line treatment to patients with chronic insomnia.

Journal of sleep research · 30 citationsread the source →

Attitudes toward strategies to increase organ donation: views of the general public and health professionals.

Background and objective: The acceptability of financial incentives for organ donation is contentious. This study sought to determine (1) the acceptability of expense reimbursement or financial incentives by the general public, health professionals involved with organ donation and transplantation, and those with or affected by kidney disease and (2) for the public, whether financial incentives would alter their willingness to consider donation. Design, setting, participants, & measurements: Web-based survey administered to members of the Canadian public, health professionals, and people with or affected by kidney disease asking questions regarding acceptability of strategies to increase living and deceased kidney donation and willingness to donate a kidney under various financial incentives. Results: Responses were collected from 2004 members of the Canadian public October 11-18, 2011; responses from health professionals (n=339) and people with or affected by kidney disease (n=268) were collected during a 4-week period commencing October 11, 2011. Acceptability of one or more financial incentives to increase deceased and living donation was noted in >70% and 40% of all groups, respectively. Support for monetary payment for living donors was 45%, 14%, and 27% for the public, health professionals, and people with or affected by kidney disease, respectively. Overall, reimbursement of funeral expenses for deceased donors and a tax break for living donors were the most acceptable. Conclusion: The general public views regulated financial incentives for living and deceased donation to be acceptable. Future research needs to examine the impact of financial incentives on rates of deceased and living donors.

Clinical journal of the American Society of Nephrology : CJASN · 29 citationsread the source →