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Effectiveness and safety of an interactive internet-based intervention to improve insomnia: Results from a randomised controlled trial.

Many adults suffer from insomnia. Cognitive-behavioural therapy for insomnia is the recommended treatment option, but access to it is not readily available. Digital interventions have the potential to close the treatment gap by offering scalable and cost-efficient options. The present randomised controlled trial aimed at investigating the effectiveness and safety of somnovia, an interactive internet-based intervention for patients with insomnia. A total of 290 participants with chronic insomnia were randomised to intervention (n = 149) or the control (n = 141) condition. Participants of the intervention group received access to somnovia for 6 months in addition to treatment as usual, whereas participants in the control group only had access to treatment as usual for the time of the study. Online questionnaires were filled in before randomisation and after 3 and 6 months. The primary endpoint was the Insomnia Severity Index, with the Patient Health Questionnaire-9, the Generalised Anxiety Disorder Assessment-7, and the Work and Social Adjustment Scale as secondary endpoints. After 3 months, the intervention group showed lower insomnia (Cohen's d = 0.71, CI = [0.44, 0.98]), depressive (Cohen's d = 0.66, CI = [0.41, 0.90]), and anxiety (Cohen's d = 0.56, CI = [0.32, 0.81]) symptoms, as well as improved overall functioning (Cohen's d = 0.50, CI = [0.24, 0.76]) compared with participants in the control group. The effects stayed stable after 6 months. The results indicate that next to a therapeutic effect on insomnia symptoms, somnovia might potentially help to prevent the onset of other psychiatric disorders such as depression and anxiety.

Journal of sleep research · randomised controlled trial · 7 citationsread the source →

Health behaviour outcomes of a family based intervention for paediatric obesity in primary care: A randomized type II hybrid effectiveness-implementation trial.

Background: Paediatric obesity is a multifaceted public health problem. Family based behavioural interventions are the recommended approach for the prevention of excess weight gain in children and adolescents, yet few have been tested under "real-world" conditions. Objectives: To evaluate the effectiveness of a family based intervention, delivered in coordination with paediatric primary care, on child and family health outcomes. Methods: A sample of 240 families with racially and ethnically diverse (86% non-White) and predominantly low-income children (49% female) ages 6 to 12 years (M = 9.5 years) with body mass index (BMI) ≥85th percentile for age and gender were identified in paediatric primary care. Participants were randomized to either the Family Check-Up 4 Health (FCU4Health) program (N = 141) or usual care plus information (N = 99). FCU4Health, an assessment-driven individually tailored intervention designed to preempt excess weight gain by improving parenting skills was delivered for 6 months in clinic, at home and in the community. Child BMI and body fat were assessed using a bioelectrical impedance scale and caregiver-reported health behaviours (eg, diet, physical activity and family health routines) were obtained at baseline, 3, 6 and 12 months. Results: Change in child BMI and percent body fat did not differ by group assignment. Path analysis indicated significant group differences in child health behaviours at 12 months, mediated by improved family health routines at 6 months. Conclusion: The FCU4Health, delivered in coordination with paediatric primary care, significantly impacted child and family health behaviours that are associated with the development and maintenance of paediatric obesity. BMI did not significantly differ.

Pediatric obesity · randomised controlled trial · 23 citationsread the source →

Is Self-Help Dangerous? Examination of Adverse Effects of a Psychological Internet-Based Self-Help Intervention for Body-Focused Repetitive Behavior (Free From BFRB).

Despite the proven effectiveness of psychotherapy for psychiatric disorders, adverse events or unwanted effects may occur. Unwanted effects, however, are rarely assessed. In self-help interventions, which usually are not supported by a therapist, such effects have received even less attention even though special caution is needed regarding unwanted effects such as those related to misapplication. For the present study, we present the newly developed Positive and Negative Effects of Psychotherapy Scale for Internet-Based Intervention (PANEPS-I) and examine possible unwanted effects of an internet-based self-help intervention in individuals with body-focused repetitive behaviors (BFRBs), aggregating three different techniques: habit reversal training (HRT), decoupling (DC), and decoupling in sensu (DC-is). Some HRT users have expressed concern that the suppression of the problematic behavior could lead to rebound effects, but this has not been examined rigorously. Following baseline assessment, 141 participants with at least one BFRB were randomly assigned to two intervention groups that differed only with respect to the delivery mode (video, manual); the content was the same. After 6 weeks, a post-assessment was conducted. Unwanted effects were assessed using the PANEPS-I. A total of 70% of the participants (both treatment groups combined) reported at least one positive effect of the intervention. Negative effects were reported by 14-92% of participants, depending on the effect. The highest agreement rates were found for "no positive goal orientation" (52.5%), "did not address personal problems" (48.8%), "time/performance pressure" (20.9%), shame (16.3%), and concerns about data privacy (14.3%). Participants in the manual intervention group reported unethical procedures (e.g., data privacy concerns) more often (Cohen's d = .44) than those in the video intervention group. Responders reported more positive effects and nonresponders more malpractice (|d| = .80, .54, respectively). HRT users (self-report) showed no significant differences compared to nonusers regarding negative effects. Stepwise hierarchical regression analyses indicated a dose-response relationship for reported positive effects and malpractice. Side effects may occur in any kind of intervention. Usage of HRT did not lead to more reported negative effects compared to nonusage. To improve the quality and effectiveness and ensure the safety of the user, especially those using digital self-help interventions, it is important to regularly assess unintended effects since there is no supervision of the patient in unguided self-help interventions.

Behavior therapy · randomised controlled trial · 5 citationsread the source →

Comparison of behavioural activation with guided self-help for treatment of depression in adults with intellectual disabilities: a randomised controlled trial.

Background: Psychological therapies are first-line interventions for depression, but existing provision is not accessible for many adults with intellectual disabilities. We investigated the clinical and cost-effectiveness of a behavioural activation intervention (BeatIt) for people with intellectual disabilities and depression. BeatIt was compared with a guided self-help intervention (StepUp). Methods: We did a multicentre, single-blind, randomised, controlled trial with follow-up at 4 months and 12 months after randomisation. Participants aged 18 years or older, with mild to moderate intellectual disabilities and clinically significant depression were recruited from health and social care services in the UK. The primary outcome was the Glasgow Depression Scale for people with a Learning Disability (GDS-LD) score at 12 months. Analyses were done on an intention-to-treat basis. This trial is registered with ISCRTN, number ISRCTN09753005. Findings: Between Aug 8, 2013, and Sept 1, 2015, 161 participants were randomly assigned (84 to BeatIt; 77 to StepUp); 141 (88%) participants completed the trial. No group differences were found in the effects of BeatIt and StepUp based on GDS-LD scores at 12 months (12·03 [SD 7·99] GDS-LD points for BeatIt vs 12·43 [SD 7·64] GDS-LD points for StepUp; mean difference 0·26 GDS-LD points [95% CI -2·18 to 2·70]; p=0·833). Within-group improvements in GDS-LD scores occurred in both groups at 12 months (BeatIt, mean change -4·2 GDS-LD points [95% CI -6·0 to -2·4], p<0·0001; StepUp, mean change -4·5 GDS-LD points [-6·2 to -2·7], p<0·0001), with large effect sizes (BeatIt, 0·590 [95% CI 0·337-0·844]; StepUp, 0·627 [0·380-0·873]). BeatIt was not cost-effective when compared with StepUp, although the economic analyses indicated substantial uncertainty. Treatment costs were only approximately 3·6-6·8% of participants' total support costs. No treatment-related or trial-related adverse events were reported. Interpretation: This study is, to our knowledge, the first large randomised controlled trial assessing individual psychological interventions for people with intellectual disabilities and mental health problems. These findings show that there is no evidence that BeatIt is more effective than StepUp; both are active and potentially effective interventions. Funding: National Institute for Health Research.

The lancet. Psychiatry · randomised controlled trial · 49 citationsread the source →

Cognitive behavioural therapy in addition to antispasmodic therapy for irritable bowel syndrome in primary care: randomised controlled trial.

Objectives: To determine whether cognitive behavioural therapy (CBT) in addition to antispasmodic treatment offers a cost-effective benefit to primary care patients with irritable bowel syndrome (IBS) and to identify predictors of outcome. Design: This was a randomised controlled trial in primary care of the addition of CBT to standard general practice management of IBS, using the antispasmodic agent mebeverine hydrochloride. The study set out to compare the addition of a standardised package of IBS-specific CBT to treatment with mebeverine hydrochloride. Setting: Ten general practices, serving a population of around 45,000 patients, located principally in south London, with some patients resident in north London. Participants: Patients identified as having IBS by their GPs, aged between 17 and 54 (mean 34) years and predominantly white; 82% were female and half had had IBS for more than 5 years. Interventions: Practice nurses delivered CBT in a randomised trial of the addition of CBT to mebeverine in patients who had IBS of moderate or greater severity after 2 weeks of GP care and 4 weeks of mebeverine. The Symptom Severity Scale (SSS) was used to identify patients with moderate or severe IBS. Patients who continued to report moderate or severe IBS after 4 weeks of mebeverine at a dose of 270 mg three times a day were randomised to receive six sessions of CBT in addition to mebeverine (72 patients) or mebeverine alone (77 patients). These patients were followed at 3, 6 and 12 months after treatment. As part of the baseline evaluation, blood tests for antiendomysial and antigliadin antibodies were carried out on 141 patients to determine the prevalence of coeliac disease in this population. Main outcome measures: The principal outcome measure was the SSS. Others included the Hospital Anxiety and Depression Scale, psychopathology, the Work and Social Adjustment Scale (WASA, disability), a modified version of the Illness Perception Questionnaire (illness perceptions), the Beliefs about Medicine Questionnaire (attitudes to medication), the Reported Adherence to Medication Scale (adherence to prescribed medication), the Client Service Receipt Inventory (economic analysis), the Cognitive Scale for Functional Bowel Disorders (illness cognitions) and the Behaviour Scale for IBS (IBS coping behaviour). Results: The addition of CBT produced a significant benefit compared with the mebeverine-only group at 3 months after treatment on all outcome measures, except for the adherence to medication scales. The difference between the groups was 107.8 points on the SSS, 24.5 points on question 4 of the SSS and 6.3 points on the WASA, representing therapeutic gains of approximately 20%, 28% and 40%, respectively. However, there was also evidence that these improvements began to wane, so that at 6 and 12 months follow-up significant therapeutic benefit of the addition of CBT could only be detected on question 4 of the SSS and on the WASA. The behaviour scale for IBS detected significant, positive changes in coping behaviours at up to 6 months after treatment. Three factors predicting a poor outcome were identified: male gender, believing that IBS had serious consequences and belief in an external aetiology, all of which were associated with greater than average disability at follow-up. The addition of CBT to mebeverine did not reduce overall treatment or social costs. The nested study on testing for coeliac disease provides cautious support for the inclusion of antiendomysial and antigliadin antibody testing in the investigation of patients thought to have IBS. Conclusions: Specially trained practice nurses can provide effective CBT to primary care patients with a clinical diagnosis of IBS, which although effective does not reduce service or social costs. Using a variety of measures the beneficial therapeutic effects of the addition of CBT to antispasmodic therapy persist for up to 6 months. Future research might include studies of the long-term follow-up of IBS patients treated with CBT, cost-benefit analyses comparing CBT with other therapeutic approaches to IBS, and evaluating means of training both non-specialist health professionals and GPs to deliver CBT.

Health technology assessment (Winchester, England) · randomised controlled trial · 48 citationsread the source →

Internet treatment for depression: a randomized controlled trial comparing clinician vs. technician assistance.

Background: Internet-based cognitive behavioural therapy (iCBT) for depression is effective when guided by a clinician, less so if unguided. Question: Would guidance from a technician be as effective as guidance from a clinician? Method: Randomized controlled non-inferiority trial comparing three groups: Clinician-assisted vs. technician-assisted vs. delayed treatment. Community-based volunteers applied to the VirtualClinic (www.virtualclinic.org.au) research program, and 141 participants with major depressive disorder were randomized. Participants in the clinician- and technician-assisted groups received access to an iCBT program for depression comprising 6 online lessons, weekly homework assignments, and weekly supportive contact over a treatment period of 8 weeks. Participants in the clinician-assisted group also received access to a moderated online discussion forum. The main outcome measures were the Beck Depression Inventory (BDI-II) and the Patient Health QUESTIONnaire-9 Item (PHQ-9). Completion rates were high, and at post-treatment, both treatment groups reduced scores on the BDI-II (p<0.001) and PHQ-9 (p<0.001) compared to the delayed treatment group but did not differ from each other. Within group effect sizes on the BDI-II were 1.27 and 1.20 for the clinician- and technician-assisted groups respectively, and on the PHQ-9, were 1.54 and 1.60 respectively. At 4-month follow-up participants in the technician group had made further improvements and had significantly lower scores on the PHQ-9 than those in the clinician group. A total of approximately 60 minutes of clinician or technician time was required per participant during the 8-week treatment program. Conclusions: Both clinician- and technician-assisted treatment resulted in large effect sizes and clinically significant improvements comparable to those associated with face-to-face treatment, while a delayed treatment control group did not improve. These results provide support for large scale trials to determine the clinical effectiveness and acceptability of technician-assisted iCBT programs for depression. This form of treatment has potential to increase the capacity of existing mental health services. Trial registration: Australian New Zealand Clinical Trials Registry ACTRN12609000559213.

PloS one · randomised controlled trial · 268 citationsread the source →

An online self-help CBT intervention for chronic lower back pain.

Objectives: Research has shown that cognitive and behavioral therapies can effectively improve quality of life in chronic pain patients. Unfortunately, many patients lack access to cognitive and behavioral therapy treatments. We developed a pilot version of an interactive online intervention to teach self-management skills for chronic lower back pain, a leading cause of disability and work absenteeism. The objective of this randomized, controlled trial was to evaluate its efficacy. Methods: Individuals with chronic lower back pain were recruited over the Internet, screened by phone, and randomly assigned to receive access to the intervention (Wellness Workbook; WW) either immediately (intervention group) or after a 3-week delay (wait-list control). Participants (n=141, 83% female, 23% minority) were asked to complete the WW over 3 weeks. Self-report measures of pain, disability, disabling attitudes and beliefs, self-efficacy for pain control, and mood regulation were completed at baseline, week 3, and week 6. Results: Controlling for baseline individual differences in the outcome measures, multivariate analysis of covariance revealed that, at week 3, the intervention group scored better than the wait-list control group on all outcomes, including pain severity ratings. At week 6, after both groups had been exposed to the WW, there were no differences between groups. Discussion: Use of this pilot intervention seems to have had positive effects on a number of pain-related outcomes, including disability. Future research will evaluate the effectiveness of the completed intervention, with particular attention to quality of life and disability.

The Clinical journal of pain · randomised controlled trial · 113 citationsread the source →

Effects of tadalafil treatment on erectile function recovery following bilateral nerve-sparing radical prostatectomy: a randomised placebo-controlled study (REACTT).

Background: The potential rehabilitative and protective effect of phosphodiesterase type 5 inhibitors (PDE5-Is) on penile function after nerve-sparing radical prostatectomy (NSRP) remains unclear. Objective: The primary objective was to compare the efficacy of tadalafil 5mg once daily and tadalafil 20mg on demand versus placebo taken over 9 mo in improving unassisted erectile function (EF) following NSRP, as measured by the proportion of patients achieving an International Index of Erectile Function-Erectile Function domain (IIEF-EF) score ≥ 22 after 6-wk drug-free washout (DFW). Secondary measures included IIEF-EF, Sexual Encounter Profile question 3 (SEP-3), and penile length. Design, setting, and participants: Randomised, double-blind, double-dummy, placebo-controlled trial in men ≤ 68 yr of age with adenocarcinoma of the prostate (Gleason ≤ 7) and normal preoperative EF who underwent NSRP at 50 centres from nine European countries and Canada. Interventions: 1:1:1 randomisation to 9 mo of treatment with tadalafil 5mg once daily, tadalafil 20mg on demand, or placebo followed by a 6-wk DFW and 3-mo open-label tadalafil once daily (all patients). Outcome measurements and statistical analysis: Logistic regression, mixed-effects model for repeated measures, and analysis of covariance, adjusting for treatment, age, and country, were applied to IIEF-EF scores ≥ 22, SEP-3, and penile length. Results and limitations: Four hundred twenty-three patients were randomised to tadalafil once daily (n=139), on demand (n=143), and placebo (n=141). The mean age was 57.9 yr of age (standard deviation: 5.58 yr); 20.9%, 16.9%, and 19.1% of patients in the tadalafil once daily, on demand, and placebo groups, respectively, achieved IIEF EF scores ≥ 22 after DFW; odds ratios for tadalafil once daily and on demand versus placebo were 1.1 (95% confidence interval [CI], 0.6-2.1; p=0.675) and 0.9 (95% CI, 0.5-1.7; p=0.704). At the end of double-blind treatment (EDT), least squares (LS) mean IIEF-EF score improvement significantly exceeded the minimally clinically important difference (MCID: ΔIIEF-EF ≥ 4) in both tadalafil groups; for SEP-3 (MCID ≥ 23%), this was the case for tadalafil once daily only. Treatment effects versus placebo were significant for tadalafil once daily only (IIEF-EF: p=0.016; SEP-3: p=0.019). In all groups, IIEF-EF and SEP-3 decreased during DFW but continued to improve during open-label treatment. At month 9 (EDT), penile length loss was significantly reduced versus placebo in the tadalafil once daily group only (LS mean difference 4.1mm; 95% CI, 0.4-7.8; p=0.032). Conclusions: Tadalafil once daily was most effective on drug-assisted EF in men with erectile dysfunction following NSRP, and data suggest a potential role for tadalafil once daily provided early after surgery in contributing to the recovery of EF after prostatectomy and possibly protecting from penile structural changes. Unassisted EF was not improved after cessation of active therapy for 9 mo. Trial registration: ClinicalTrials.gov identifier NCT01026818.

European urology · randomised controlled trial · 179 citationsread the source →

Stereotactic laser ablation as treatment for brain metastases that recur after stereotactic radiosurgery: a multiinstitutional experience.

OBJECTIVE Therapeutic options for brain metastases (BMs) that recur after stereotactic radiosurgery (SRS) remain limited. METHODS The authors provide the collective experience of 4 institutions where treatment of BMs that recurred after SRS was performed with stereotactic laser ablation (SLA). RESULTS Twenty-six BMs (in 23 patients) that recurred after SRS were treated with SLA (2 patients each underwent 2 SLAs for separate lesions, and a third underwent 2 serial SLAs for discrete BMs). Histological findings in the BMs treated included the following: breast (n = 6); lung (n = 6); melanoma (n = 5); colon (n = 2); ovarian (n = 1); bladder (n = 1); esophageal (n = 1); and sarcoma (n = 1). With a median follow-up duration of 141 days (range 64-794 days), 9 of the SLA-treated BMs progressed despite treatment (35%). All cases of progression occurred in BMs in which < 80% ablation was achieved, whereas no disease progression was observed in BMs in which ≥ 80% ablation was achieved. Five BMs were treated with SLA, followed 1 month later by adjuvant SRS (5 Gy daily × 5 days). No disease progression was observed in these patients despite ablation efficiency of < 80%, suggesting that adjuvant hypofractionated SRS enhances the efficacy of SLA. Of the 23 SLA-treated patients, 3 suffered transient hemiparesis (13%), 1 developed hydrocephalus requiring temporary ventricular drainage (4%), and 1 patient who underwent SLA of a 28.9-cm3 lesion suffered a neurological deficit requiring an emergency hemicraniectomy (4%). Although there is significant heterogeneity in corticosteroid treatment post-SLA, most patients underwent a 2-week taper. CONCLUSIONS Stereotactic laser ablation is an effective treatment option for BMs in which SRS fails. Ablation of ≥ 80% of BMs is associated with decreased risk of disease progression. The efficacy of SLA in this setting may be augmented by adjuvant hypofractionated SRS.

Neurosurgical focus · cohort or longitudinal · 52 citationsread the source →

Robotic radical prostatectomy in the community setting--the learning curve and beyond: initial 200 cases.

Purpose: The introduction of robotic assistance has the potential to improve surgical outcomes and reduce the steep learning curve associated with conventional laparoscopic radical prostatectomy. We report on our experience with robotic radical prostatectomy in the community setting. Materials and methods: A total of 200 patients underwent robotic radical prostatectomy during 18 months. Prospective data collection included a quality of life (Expanded Prostate Cancer Index Composite) questionnaire, basic demographics, prostate specific antigen (PSA), clinical stage and Gleason grade. Operative outcome measures included operative time, estimated blood loss and complications. Postoperative outcome measures included hospital stay, catheter time, pathology, PSA and return of continence. Results: Average operative time was 141 minutes with an estimated blood loss of 75 cc. The intraoperative complication rate was 1% with no mortality, reexploration or transfusion. Of the patients 95% were discharged home on postoperative day 1 (1 to 3) with hematocrit averaging 34.5 (range 25 to 45). The average difference in preoperative and postoperative hematocrit was 3 points (range -2 to 15). Average catheter time was 7.2 days (range 5 to 15). The positive margin rate was 10.5% for the entire series, 5.7% for T2 tumors, 28.5% (T3a), 20% (T3b) and 33% (T4a). Of the patients 95% had undetectable PSA (less than 0.1 ng/ml) at average followup of 9.7 months. Continence at 1, 3, 6, 9 and 12 months was 47%, 78%, 89%, 92% and 98%, respectively. Conclusions: Our initial experience with robotic radical prostatectomy is promising. The learning curve was approximately 20 to 25 cases. With a structured methodical approach we were able to implement robotics safely and effectively into our community practice with minimal patient morbidity, and good oncological and functional outcomes.

The Journal of urology · clinical trial · 270 citationsread the source →

Intergenerational programming of impaired nephrogenesis and hypertension in rats following maternal protein restriction during pregnancy.

Associations between birth weight and CVD in adult life are supported by experiments showing that undernutrition in fetal life programmes blood pressure. In rats, the feeding of a maternal low-protein (MLP) diet during gestation programmes hypertension. The present study aimed to assess the potential for a nutritional insult to impact across several generations. Pregnant female Wistar (F0) rats were fed a control (CON; n 10) or MLP (n 10) diet throughout gestation. At delivery all animals were fed a standard laboratory chow diet. At 10 weeks of age, F1 generation offspring were mated to produce a second generation (F2) without any further dietary change. The same procedure produced an F3 generation. Blood pressure in all generations was determined at 4, 6 and 8 weeks of age and nephron number was determined at 10 weeks of age. F1 generation MLP-exposed offspring exhibited raised (P < 0.001) systolic blood pressure (male 143 (sem 4) mmHg; female 141 (sem 4) mmHg) compared with CON animals (male 132 (sem 3) mmHg; female 134 (sem 4) mmHg). Raised blood pressure and reduced nephron number was also noted in the F2 generation (P < 0.001) and this intergenerational transmission occurred via both the maternal and paternal lines, as all three possible offspring crosses (MLP x CON, CON x MLP and MLP x MLP) were hypertensive (132 (sem 3) mmHg) compared with CON animals (CON x CON; 123 (sem 2) mmHg). No effect was noted in the F3 generation. It is concluded that fetal protein restriction may play a critical role in determining blood pressure and overall disease risk in a subsequent generation.

The British journal of nutrition · cohort or longitudinal · 99 citationsread the source →

Digital Health Technologies for Maternal and Child Health in Africa and Other Low- and Middle-Income Countries: Cross-disciplinary Scoping Review With Stakeholder Consultation.

Background: Maternal and child health (MCH) is a global health concern, especially impacting low- and middle-income countries (LMIC). Digital health technologies are creating opportunities to address the social determinants of MCH by facilitating access to information and providing other forms of support throughout the maternity journey. Previous reviews in different disciplines have synthesized digital health intervention outcomes in LMIC. However, contributions in this space are scattered across publications in different disciplines and lack coherence in what digital MCH means across fields. Objective: This cross-disciplinary scoping review synthesized the existing published literature in 3 major disciplines on the use of digital health interventions for MCH in LMIC, with a particular focus on sub-Saharan Africa. Methods: We conducted a scoping review using the 6-stage framework by Arksey and O'Malley across 3 disciplines, including public health, social sciences applied to health, and human-computer interaction research in health care. We searched the following databases: Scopus, PubMed, Google Scholar, ACM Digital Library, IEEE Xplore, Web of Science, and PLOS. A stakeholder consultation was undertaken to inform and validate the review. Results: During the search, 284 peer-reviewed articles were identified. After removing 41 duplicates, 141 articles met our inclusion criteria: 34 from social sciences applied to health, 58 from public health, and 49 from human-computer interaction research in health care. These articles were then tagged (labeled) by 3 researchers using a custom data extraction framework to obtain the findings. First, the scope of digital MCH was found to target health education (eg, breastfeeding and child nutrition), care and follow-up of health service use (to support community health workers), maternal mental health, and nutritional and health outcomes. These interventions included mobile apps, SMS text messaging, voice messaging, web-based applications, social media, movies and videos, and wearable or sensor-based devices. Second, we highlight key challenges: little attention has been given to understanding the lived experiences of the communities; key role players (eg, fathers, grandparents, and other family members) are often excluded; and many studies are designed considering nuclear families that do not represent the family structures of the local cultures. Conclusions: Digital MCH has shown steady growth in Africa and other LMIC settings. Unfortunately, the role of the community was negligible, as these interventions often do not include communities early and inclusively enough in the design process. We highlight key opportunities and sociotechnical challenges for digital MCH in LMIC, such as more affordable mobile data; better access to smartphones and wearable technologies; and the rise of custom-developed, culturally appropriate apps that are more suited to low-literacy users. We also focus on barriers such as an overreliance on text-based communications and the difficulty of MCH research and design to inform and translate into policy.

Journal of medical Internet research · review · 40 citationsread the source →

Neurodevelopmental Outcomes after Multiple General Anesthetic Exposures before 5 Years of Age: A Cohort Study.

Background: The general anaesthesia or awake-regional anaesthesia in infancy (GAS) trial demonstrated evidence that most neurodevelopmental outcomes at 2 and 5 yr of age in infants who received a single general anesthetic for elective inguinal herniorrhaphy were clinically equivalent when compared to infants who did not receive general anesthesia. More than 20% of the children in the trial had at least one subsequent anesthetic exposure after their initial surgery. Using the GAS database, this study aimed to address whether multiple (two or more) general anesthetic exposures compared to one or no general anesthetic exposure in early childhood were associated with worse neurodevelopmental outcomes at 5 yr. Methods: Children with multiple general anesthetic exposures and children with one or no general anesthetic exposure were identified from the GAS database. The primary outcome was the full-scale intelligence quotient on the Wechsler Preschool and Primary Scale of Intelligence (third edition) at 5 yr of age. Secondary outcomes included neurocognitive tests addressing all major developmental domains and caregiver-reported questionnaires assessing emotional and behavioral problems. Results: Complete assessment was available from a total of 90 children in the multiple general anesthetic group and 141 children in the no or one general anesthetic group. Compared with children with a single or no general anesthetic exposure, multiply exposed children scored on average almost 6 points lower (mean, -5.8; 95% CI, -10.2 to -1.4; P = 0.011) in the Wechsler Preschool and Primary Scale of Intelligence full-scale intelligence quotient. They also demonstrated lower verbal and performance IQ scores and more emotional, behavioral, and executive function difficulties. However, significant residual confounding cannot be excluded from the results due to the observational nature of this study. Conclusions: Multiple general anesthetic exposures before 5 yr of age were associated with reduced performance in general intelligence score and some domains of neurodevelopmental assessments. The clinical significance of this study's results must be cautiously interpreted in light of several sources of limitations including small sample size and unadjusted residual confounding. This study illustrates the limitations of trial data sets that may not be fit for the purpose for the secondary analysis.

Anesthesiology · 19 citationsread the source →

Acceptability and Outcomes of Transdiagnostic Guided Self-help Bibliotherapy for Internalizing Disorder Symptoms in Adults: A Fully Remote Nationwide Open Trial.

Introduction: Doing What Matters in Times of Stress (DWM) is a five-module transdiagnostic guided self-help (GSH) intervention developed by the World Health Organization, originally in a group-based format. In a sample of individuals recruited from across the United States, we conducted an open trial to study the feasibility and acceptability of an adaptation of DWM in which guidance was provided individually and remotely via phone and videoconferencing. Methods: We assessed internalizing symptoms, psychological well-being, work and social functioning, usability of the intervention, and emotion regulation over the course of 6 weeks. Results: A total of 263 individuals completed our screening. Of those, 75.29% (n = 198) qualified for the intervention. We reached most participants who qualified (71.21%, n = 141) via phone to schedule a GSH session. Most of those scheduled attended a study session (84.4%, n = 119), and most of those who attended a session completed more than half the treatment (84.03%, n = 100). Retention rates were comparable to meta-analytic estimates of dropout rates in GSH. Participants showed improvement on internalizing symptoms, psychological well-being, work and social functioning, usability of the intervention, and emotion regulation. Conclusion: DWM is a freely available, seemingly efficacious transdiagnostic intervention for internalizing disorder symptoms. Supplementary information: The online version contains supplementary material available at 10.1007/s10608-022-10338-5.

Cognitive therapy and research · 7 citationsread the source →

Burnout among workers in emergency Departments in Palestinian hospitals: prevalence and associated factors.

Background: Working in Emergency Departments (EDs) entails high work pressure and stress due to witnessing human suffering and the unpredictable nature of the work. This environment puts personnel at risk of burnout. This analysis aims to assess burnout levels and associated risk factors among health workers in EDs in Palestinian hospitals. Also, it examines the association between burnout and workplace violence, as well as with job turnover. Methods: Cross-sectional design utilising a self-administered questionnaire was used to collect data from all workers at 14 EDs; 8 from the West Bank and 6 from the Gaza Strip. Burnout was measured using Maslach Burnout Inventory-Human Services Survey. Results: A total of 444 workers (response rate 74.5%) participated: 161(36.3%) nurses, 142(32.0%) physicians and 141(31.7%) administrative personnel. Results showed high levels of burnout among EDs workers; 64.0% suffered from high emotional exhaustion, 38.1% from high depersonalization and 34.6% from low personal accomplishment. In addition, high levels of emotional exhaustion (72.3%) was significantly prevalent among physicians compared to nurses (69.8%) and administrative workers (51.4%) (p < 0.05). In comparison, high levels of depersonalization was significantly prevalent among nurses (48.8%) compared to physicians (32.1%) and administrative workers (31.9%) (p < 0.05). However, there were no significant differences in the levels of personal accomplishment burnout among the three groups (p > 0.05). Moreover, high degree of burnout was more prevalent among EDs workers in the West Bank than among those working in the Gaza Strip (OR 2.02, 95% CI = 1.11-3.69, p = 0.019), and higher among younger workers (aged ≤30 years old) than their older counterparts (OR 2.4, 95% CI = 1.302-4.458, p = 0.005). Exposure to physical violence was significantly associated with having a high degree of burnout (OR 2.017 95% CI = 1.121-3.631, p = 0.019), but no association was observed with regards to exposure to verbal violence (p > 0.05). Finally, burnout was significantly associated with workers' intention to leave work at EDs (p < 0.05). Conclusions: Burnout is considerably prevalent among EDs' workers, especially nurses and physicians. Burnout is positively associated with job turnover intention and also with exposure to workplace violence. Therefore, there is a need for prevention and management strategies to address occupational burnout and reduce negative consequences on workers, patients and organisations.

BMC health services research · 73 citationsread the source →

Burden of 375 diseases and injuries, risk-attributable burden of 88 risk factors, and healthy life expectancy in 204 countries and territories, including 660 subnational locations, 1990-2023: a systematic analysis for the Global Burden of Disease Study 2023.

Background: For more than three decades, the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) has provided a framework to quantify health loss due to diseases, injuries, and associated risk factors. This paper presents GBD 2023 findings on disease and injury burden and risk-attributable health loss, offering a global audit of the state of world health to inform public health priorities. This work captures the evolving landscape of health metrics across age groups, sexes, and locations, while reflecting on the remaining post-COVID-19 challenges to achieving our collective global health ambitions. Methods: The GBD 2023 combined analysis estimated years lived with disability (YLDs), years of life lost (YLLs), and disability-adjusted life-years (DALYs) for 375 diseases and injuries, and risk-attributable burden associated with 88 modifiable risk factors. Of the more than 310 000 total data sources used for all GBD 2023 (about 30% of which were new to this estimation round), more than 120 000 sources were used for estimation of disease and injury burden and 59 000 for risk factor estimation, and included vital registration systems, surveys, disease registries, and published scientific literature. Data were analysed using previously established modelling approaches, such as disease modelling meta-regression version 2.1 (DisMod-MR 2.1) and comparative risk assessment methods. Diseases and injuries were categorised into four levels on the basis of the established GBD cause hierarchy, as were risk factors using the GBD risk hierarchy. Estimates stratified by age, sex, location, and year from 1990 to 2023 were focused on disease-specific time trends over the 2010-23 period and presented as counts (to three significant figures) and age-standardised rates per 100 000 person-years (to one decimal place). For each measure, 95% uncertainty intervals [UIs] were calculated with the 2·5th and 97·5th percentile ordered values from a 250-draw distribution. Findings: Total numbers of global DALYs grew 6·1% (95% UI 4·0-8·1), from 2·64 billion (2·46-2·86) in 2010 to 2·80 billion (2·57-3·08) in 2023, but age-standardised DALY rates, which account for population growth and ageing, decreased by 12·6% (11·0-14·1), revealing large long-term health improvements. Non-communicable diseases (NCDs) contributed 1·45 billion (1·31-1·61) global DALYs in 2010, increasing to 1·80 billion (1·63-2·03) in 2023, alongside a concurrent 4·1% (1·9-6·3) reduction in age-standardised rates. Based on DALY counts, the leading level 3 NCDs in 2023 were ischaemic heart disease (193 million [176-209] DALYs), stroke (157 million [141-172]), and diabetes (90·2 million [75·2-107]), with the largest increases in age-standardised rates since 2010 occurring for anxiety disorders (62·8% [34·0-107·5]), depressive disorders (26·3% [11·6-42·9]), and diabetes (14·9% [7·5-25·6]). Remarkable health gains were made for communicable, maternal, neonatal, and nutritional (CMNN) diseases, with DALYs falling from 874 million (837-917) in 2010 to 681 million (642-736) in 2023, and a 25·8% (22·6-28·7) reduction in age-standardised DALY rates. During the COVID-19 pandemic, DALYs due to CMNN diseases rose but returned to pre-pandemic levels by 2023. From 2010 to 2023, decreases in age-standardised rates for CMNN diseases were led by rate decreases of 49·1% (32·7-61·0) for diarrhoeal diseases, 42·9% (38·0-48·0) for HIV/AIDS, and 42·2% (23·6-56·6) for tuberculosis. Neonatal disorders and lower respiratory infections remained the leading level 3 CMNN causes globally in 2023, although both showed notable rate decreases from 2010, declining by 16·5% (10·6-22·0) and 24·8% (7·4-36·7), respectively. Injury-related age-standardised DALY rates decreased by 15·6% (10·7-19·8) over the same period. Differences in burden due to NCDs, CMNN diseases, and injuries persisted across age, sex, time, and location. Based on our risk analysis, nearly 50% (1·27 billion [1·18-1·38]) of the roughly 2·80 billion total global DALYs in 2023 were attributable to the 88 risk factors analysed in GBD. Globally, the five level 3 risk factors contributing the highest proportion of risk-attributable DALYs were high systolic blood pressure (SBP), particulate matter pollution, high fasting plasma glucose (FPG), smoking, and low birthweight and short gestation-with high SBP accounting for 8·4% (6·9-10·0) of total DALYs. Of the three overarching level 1 GBD risk factor categories-behavioural, metabolic, and environmental and occupational-risk-attributable DALYs rose between 2010 and 2023 only for metabolic risks, increasing by 30·7% (24·8-37·3); however, age-standardised DALY rates attributable to metabolic risks decreased by 6·7% (2·0-11·0) over the same period. For all but three of the 25 leading level 3 risk factors, age-standardised rates dropped between 2010 and 2023-eg, declining by 54·4% (38·7-65·3) for unsafe sanitation, 50·5% (33·3-63·1) for unsafe water source, and 45·2% (25·6-72·0) for no access to handwashing facility, and by 44·9% (37·3-53·5) for child growth failure. The three leading level 3 risk factors for which age-standardised attributable DALY rates rose were high BMI (10·5% [0·1 to 20·9]), drug use (8·4% [2·6 to 15·3]), and high FPG (6·2% [-2·7 to 15·6]; non-significant). Interpretation: Our findings underscore the complex and dynamic nature of global health challenges. Since 2010, there have been large decreases in burden due to CMNN diseases and many environmental and behavioural risk factors, juxtaposed with sizeable increases in DALYs attributable to metabolic risk factors and NCDs in growing and ageing populations. This long-observed consequence of the global epidemiological transition was only temporarily interrupted by the COVID-19 pandemic. The substantially decreasing CMNN disease burden, despite the 2008 global financial crisis and pandemic-related disruptions, is one of the greatest collective public health successes known. However, these achievements are at risk of being reversed due to major cuts to development assistance for health globally, the effects of which will hit low-income countries with high burden the hardest. Without sustained investment in evidence-based interventions and policies, progress could stall or reverse, leading to widespread human costs and geopolitical instability. Moreover, the rising NCD burden necessitates intensified efforts to mitigate exposure to leading risk factors-eg, air pollution, smoking, and metabolic risks, such as high SBP, BMI, and FPG-including policies that promote food security, healthier diets, physical activity, and equitable and expanded access to potential treatments, such as GLP-1 receptor agonists. Decisive, coordinated action is needed to address long-standing yet growing health challenges, including depressive and anxiety disorders. Yet this can be only part of the solution. Our response to the NCD syndemic-the complex interaction of multiple health risks, social determinants, and systemic challenges-will define the future landscape of global health. To ensure human wellbeing, economic stability, and social equity, global action to sustain and advance health gains must prioritise reducing disparities by addressing socioeconomic and demographic determinants, ensuring equitable health-care access, tackling malnutrition, strengthening health systems, and improving vaccination coverage. We live in times of great opportunity. Funding: Gates Foundation and Bloomberg Philanthropies.

Lancet (London, England) · 257 citationsread the source →

Vagus nerve stimulation for children with treatment-resistant epilepsy: a consecutive series of 141 cases.

Object: The authors undertook this study to analyze the efficacy of vagus nerve stimulation (VNS) in a large consecutive series of children 18 years of age and younger with treatment-resistant epilepsy and compare the safety and efficacy in children under 12 years of age with the outcomes in older children. Methods: The authors retrospectively reviewed 141 consecutive cases involving children (75 girls and 66 boys) with treatment-resistant epilepsy in whom primary VNS implantation was performed by the senior author between November 1997 and April 2008 and who had at least 1 year of follow-up since implantation. The patients' mean age at vagus nerve stimulator insertion was 11.1 years (range 1-18 years). Eighty-six children (61.0%) were younger than 12 years at time of VNS insertion (which constitutes off-label usage of this device). Results: Follow-up was complete for 91.8% of patients and the mean duration of VNS therapy in these patients was 5.2 years (range 25 days-11.4 years). Seizure frequency significantly improved with VNS therapy (mean reduction 58.9%, p < 0.0001) without a significant reduction in antiepileptic medication burden (median number of antiepileptic drugs taken 3, unchanged). Reduction in seizure frequency of at least 50% occurred in 64.8% of patients and 41.4% of patients experienced at least a 75% reduction. Major (3) and minor (6) complications occurred in 9 patients (6.4%) and included 1 deep infection requiring device removal, 1 pneumothorax, 2 superficial infections treated with antibiotics, 1 seroma/hematoma treated with aspiration, persistent cough in 1 patient, severe but transient neck pain in 1 patient, and hoarseness in 2 patients. There was no difference in efficacy or complications between children 12 years of age and older (FDA-approved indication) and those younger than 12 years of age (off-label usage). Linear regression analyses did not identify any demographic and clinical variables that predicted response to VNS. Conclusions: Vagus nerve stimulation is a safe and effective treatment for treatment-resistant epilepsy in young adults and children. Over 50% of patients experienced at least 50% reduction in seizure burden. Children younger than 12 years had a response similar to that of older children with no increase in complications. Given the efficacy of this device and the devastating effects of persistent epilepsy during critical developmental epochs, randomized trials are needed to potentially expand the indications for VNS to include younger children.

Journal of neurosurgery. Pediatrics · 111 citationsread the source →

The Important People Drug and Alcohol interview: psychometric properties, predictive validity, and implications for treatment.

Research with the Important People instrument has shown that social support for abstinence is related to alcohol treatment outcomes, but less work has been done on the role of network support in drug treatment outcomes. A drug and alcohol version of the Important People instrument (IPDA) was developed and administered to 141 patients in residential treatment for cocaine dependence. Three components were found, all with acceptable internal consistency: (a) substance involvement of the network, (b) general/treatment support, and (c) support for abstinence. These components and three fundamental network characteristics (size of daily network, size of network, and importance of the most important people) were investigated as correlates of pretreatment and posttreatment alcohol and drug use. The general/treatment support component and network size were inversely related to pretreatment days using drugs, whereas network substance involvement positively correlated with pretreatment drinking frequency. Size of the daily network predicted less drinking, less drug use, and less problem severity during the 6 months after treatment, whereas general/treatment support and support for abstinence did not predict outcome. Network substance involvement decreased for patients who stayed abstinent but not for those who later relapsed. Results suggest that increasing the number of people the patient sees daily while replacing substance-involved with abstinent-supportive people may improve treatment outcomes. Treatment programs may use the IPDA to identify clients most likely to benefit from changes in their social networks.

Journal of substance abuse treatment · 79 citationsread the source →