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Peer-reviewed works with DOI and abstract, discovered from MEDLINE-indexed literature. Candidates: no tier, no stated finding, not yet read.
The global burden of perinatal common mental health disorders and substance use among migrant women: a systematic review and meta-analysis.
Background: There are one billion migrants globally, of whom 82 million are forced migrants. Pregnant migrants face pre-migration stressors such as conflict, transit stressors including poverty, and post-migration stressors including navigating the immigration system; these stressors can make them vulnerable to mental illness. We aimed to assess the global prevalence of and risk factors for perinatal mental health disorders or substance use among women who are migrants.
Methods: In this systematic review and meta-analysis, we searched OVID MEDLINE, Embase, PsycINFO, CENTRAL, Global Health, Scopus, and Web of Science for studies published from database inception until July 8, 2022. Cohort, cross-sectional, and interventional studies with prevalence data for any mental illness in pregnancy or the postnatal period (ie, up to a year after delivery) or substance use in pregnancy were included. The primary outcome was the prevalence of perinatal common mental health disorders among women who are migrants, globally. Data for study quality and risk factors were also extracted. A random-effects meta-analysis was used to calculate pooled prevalence estimates, when appropriate. Sensitivity analyses were conducted according to study quality, sample representativeness, and method of outcome assessment. Risk factor data were synthesised narratively. This study is registered with PROSPERO, CRD42021226291.
Findings: 18 650 studies were retrieved, of which 135 studies comprising data from 621 995 participants met the inclusion criteria. 123 (91%) of 135 studies were conducted in high-income host countries. Five (4%) of 135 studies were interventional, 40 (30%) were cohort, and 90 (66%) were cross-sectional. The most common regions of origin of participants were South America, the Middle East, and north Africa. Only 26 studies presented disaggregated data for forced migrants or economic migrants. The pooled prevalence of perinatal depressive disorders was 24·2% (range 0·5-95·5%; I2 98·8%; τ2 0·01) among all women who are migrants, 32·5% (1·5-81·6; 98·7%; 0·01) among forced migrants, and 13·7% (4·7-35·1; 91·5%; 0·01) among economic migrants (p<0·001). The pooled prevalence of perinatal anxiety disorders was 19·6% (range 1·2-53·1; I2 96·8%; τ2 0·01) among all migrants. The pooled prevalence of perinatal post-traumatic stress disorder (PTSD) among all migrant women was 8·9% (range 3·2-33·3; I2 97·4%; τ2 0·18). The pooled prevalence of perinatal PTSD among forced migrants was 17·1% (range 6·5-44·3; I2 96·6%; τ2 0·32). Key risk factors for perinatal depression were being a recently arrived immigrant (ie, approximately within the past year), having poor social support, and having a poor relationship with one's partner.
Interpretation: One in four women who are migrants and who are pregnant or post partum experience perinatal depression, one in five perinatal anxiety, and one in 11 perinatal PTSD. The burden of perinatal mental illness appears higher among women who are forced migrants compared with women who are economic migrants. To our knowledge, we have provided the first pooled estimate of perinatal depression and PTSD among women who are forced migrants. Interpreting the prevalence estimate should be observed with caution due to the very wide range found within the included studies. Additionally, 66% of studies were cross-sectional representing low quality evidence. These findings highlight the need for community-based routine perinatal mental health screening for migrant communities, and access to interventions that are culturally sensitive, particularly for forced migrants who might experience a higher burden of disease than economic migrants.
Funding: UK National Institute for Health Research (NIHR); March of Dimes European Preterm Birth Research Centre, Imperial College; Imperial College NIHR Biomedical Research Centre; and Nuffield Department of Population Health, University of Oxford.
The Lancet. Public health · meta-analysis · 63 citationsread the source →
Bilateral versus unilateral cochlear implants in children: a study of spoken language outcomes.
Objectives: Although it has been established that bilateral cochlear implants (CIs) offer additional speech perception and localization benefits to many children with severe to profound hearing loss, whether these improved perceptual abilities facilitate significantly better language development has not yet been clearly established. The aims of this study were to compare language abilities of children having unilateral and bilateral CIs to quantify the rate of any improvement in language attributable to bilateral CIs and to document other predictors of language development in children with CIs.
Design: The receptive vocabulary and language development of 91 children was assessed when they were aged either 5 or 8 years old by using the Peabody Picture Vocabulary Test (fourth edition), and either the Preschool Language Scales (fourth edition) or the Clinical Evaluation of Language Fundamentals (fourth edition), respectively. Cognitive ability, parent involvement in children's intervention or education programs, and family reading habits were also evaluated. Language outcomes were examined by using linear regression analyses. The influence of elements of parenting style, child characteristics, and family background as predictors of outcomes were examined.
Results: Children using bilateral CIs achieved significantly better vocabulary outcomes and significantly higher scores on the Core and Expressive Language subscales of the Clinical Evaluation of Language Fundamentals (fourth edition) than did comparable children with unilateral CIs. Scores on the Preschool Language Scales (fourth edition) did not differ significantly between children with unilateral and bilateral CIs. Bilateral CI use was found to predict significantly faster rates of vocabulary and language development than unilateral CI use; the magnitude of this effect was moderated by child age at activation of the bilateral CI. In terms of parenting style, high levels of parental involvement, low amounts of screen time, and more time spent by adults reading to children facilitated significantly better vocabulary and language outcomes. In terms of child characteristics, higher cognitive ability and female sex were predictive of significantly better language outcomes. When family background factors were examined, having tertiary-educated primary caregivers and a family history of hearing loss were significantly predictive of better outcomes. Birth order was also found to have a significant negative effect on both vocabulary and language outcomes, with each older sibling predicting a 5 to 10% decrease in scores.
Conclusions: Children with bilateral CIs achieved significantly better vocabulary outcomes, and 8-year-old children with bilateral CIs had significantly better language outcomes than did children with unilateral CIs. These improvements were moderated by children's ages at both first and second CIs. The outcomes were also significantly predicted by a number of factors related to parenting, child characteristics, and family background. Fifty-one percent of the variance in vocabulary outcomes and between 59 to 69% of the variance in language outcomes was predicted by the regression models.
Ear and hearing · cohort or longitudinal · 81 citationsread the source →
Psychosocial interventions for post-traumatic stress disorder in refugees and asylum seekers resettled in high-income countries: Systematic review and meta-analysis.
Treatment of post-traumatic stress disorder (PTSD) in refugees and asylum seekers resettled in high-income countries presents specific challenges. This systematic review examined the effectiveness of psychosocial interventions for this group. We searched the Cochrane Central Register of randomised trials, CINAHL, EMBASE, PILOTS, PsycINFO, PubMed and Web of Science up to July 2016. Studies included randomised and controlled clinical trials comparing psychosocial interventions with waiting list or treatment as usual in adult refugees and asylum seekers with PTSD resettled in high-income countries. PTSD symptoms post-intervention was the primary outcome. We computed standardized mean differences (SMD) with 95% confidence intervals (CI). This study is registered with PROSPERO: CRD42015027843. Twelve studies were included in the meta-analysis. Psychosocial interventions were effective in decreasing PTSD symptoms relative to control groups (SMD -1·03, 95% CI -1·55 to -0·51; number needed to treat 4·4; I2 86%; 95% CI 77 to 91). Narrative exposure therapy, a manualized short-term variant of cognitive behavioural therapy with a trauma focus, was the best-supported intervention (5 RCTs, 187 participants, SMD -0·78, 95% CI -1·18 to -0·38, I2 37%; 95% CI 0 to 77). Methodological quality of the included studies was limited. Overall, psychosocial interventions for asylum seekers and refugees with PTSD resettled in high-income countries were found to provide significant benefits in reducing PTSD symptoms. Yet, the number of studies is small and their methodological quality limited, so that more rigorous trials should be conducted in the future.
PloS one · meta-analysis · 119 citationsread the source →
Alcoholics Anonymous and other 12-step programs for alcohol use disorder.
Background: Alcohol use disorder (AUD) confers a prodigious burden of disease, disability, premature mortality, and high economic costs from lost productivity, accidents, violence, incarceration, and increased healthcare utilization. For over 80 years, Alcoholics Anonymous (AA) has been a widespread AUD recovery organization, with millions of members and treatment free at the point of access, but it is only recently that rigorous research on its effectiveness has been conducted.
Objectives: To evaluate whether peer-led AA and professionally-delivered treatments that facilitate AA involvement (Twelve-Step Facilitation (TSF) interventions) achieve important outcomes, specifically: abstinence, reduced drinking intensity, reduced alcohol-related consequences, alcohol addiction severity, and healthcare cost offsets.
Search methods: We searched the Cochrane Drugs and Alcohol Group Specialized Register, Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, Embase, CINAHL and PsycINFO from inception to 2 August 2019. We searched for ongoing and unpublished studies via ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) on 15 November 2018. All searches included non-English language literature. We handsearched references of topic-related systematic reviews and bibliographies of included studies.
Selection criteria: We included randomized controlled trials (RCTs), quasi-RCTs and non-randomized studies that compared AA or TSF (AA/TSF) with other interventions, such as motivational enhancement therapy (MET) or cognitive behavioral therapy (CBT), TSF treatment variants, or no treatment. We also included healthcare cost offset studies. Participants were non-coerced adults with AUD.
Data collection and analysis: We categorized studies by: study design (RCT/quasi-RCT; non-randomized; economic); degree of standardized manualization (all interventions manualized versus some/none); and comparison intervention type (i.e. whether AA/TSF was compared to an intervention with a different theoretical orientation or an AA/TSF intervention that varied in style or intensity). For analyses, we followed Cochrane methodology calculating the standard mean difference (SMD) for continuous variables (e.g. percent days abstinent (PDA)) or the relative risk (risk ratios (RRs)) for dichotomous variables. We conducted random-effects meta-analyses to pool effects wherever possible.
Main results: We included 27 studies containing 10,565 participants (21 RCTs/quasi-RCTs, 5 non-randomized, and 1 purely economic study). The average age of participants within studies ranged from 34.2 to 51.0 years. AA/TSF was compared with psychological clinical interventions, such as MET and CBT, and other 12-step program variants. We rated selection bias as being at high risk in 11 of the 27 included studies, unclear in three, and as low risk in 13. We rated risk of attrition bias as high risk in nine studies, unclear in 14, and low in four, due to moderate (> 20%) attrition rates in the study overall (8 studies), or in study treatment group (1 study). Risk of bias due to inadequate researcher blinding was high in one study, unclear in 22, and low in four. Risks of bias arising from the remaining domains were predominantly low or unclear. AA/TSF (manualized) compared to treatments with a different theoretical orientation (e.g. CBT) (randomized/quasi-randomized evidence) RCTs comparing manualized AA/TSF to other clinical interventions (e.g. CBT), showed AA/TSF improves rates of continuous abstinence at 12 months (risk ratio (RR) 1.21, 95% confidence interval (CI) 1.03 to 1.42; 2 studies, 1936 participants; high-certainty evidence). This effect remained consistent at both 24 and 36 months. For percentage days abstinent (PDA), AA/TSF appears to perform as well as other clinical interventions at 12 months (mean difference (MD) 3.03, 95% CI -4.36 to 10.43; 4 studies, 1999 participants; very low-certainty evidence), and better at 24 months (MD 12.91, 95% CI 7.55 to 18.29; 2 studies, 302 participants; low-certainty evidence) and 36 months (MD 6.64, 95% CI 1.54 to 11.75; 1 study, 806 participants; low-certainty evidence). For longest period of abstinence (LPA), AA/TSF may perform as well as comparison interventions at six months (MD 0.60, 95% CI -0.30 to 1.50; 2 studies, 136 participants; low-certainty evidence). For drinking intensity, AA/TSF may perform as well as other clinical interventions at 12 months, as measured by drinks per drinking day (DDD) (MD -0.17, 95% CI -1.11 to 0.77; 1 study, 1516 participants; moderate-certainty evidence) and percentage days heavy drinking (PDHD) (MD -5.51, 95% CI -14.15 to 3.13; 1 study, 91 participants; low-certainty evidence). For alcohol-related consequences, AA/TSF probably performs as well as other clinical interventions at 12 months (MD -2.88, 95% CI -6.81 to 1.04; 3 studies, 1762 participants; moderate-certainty evidence). For alcohol addiction severity, one study found evidence of a difference in favor of AA/TSF at 12 months (P < 0.05; low-certainty evidence). AA/TSF (non-manualized) compared to treatments with a different theoretical orientation (e.g. CBT) (randomized/quasi-randomized evidence) For the proportion of participants completely abstinent, non-manualized AA/TSF may perform as well as other clinical interventions at three to nine months follow-up (RR 1.71, 95% CI 0.70 to 4.18; 1 study, 93 participants; low-certainty evidence). Non-manualized AA/TSF may also perform slightly better than other clinical interventions for PDA (MD 3.00, 95% CI 0.31 to 5.69; 1 study, 93 participants; low-certainty evidence). For drinking intensity, AA/TSF may perform as well as other clinical interventions at nine months, as measured by DDD (MD -1.76, 95% CI -2.23 to -1.29; 1 study, 93 participants; very low-certainty evidence) and PDHD (MD 2.09, 95% CI -1.24 to 5.42; 1 study, 286 participants; low-certainty evidence). None of the RCTs comparing non-manualized AA/TSF to other clinical interventions assessed LPA, alcohol-related consequences, or alcohol addiction severity. Cost-effectiveness studies In three studies, AA/TSF had higher healthcare cost savings than outpatient treatment, CBT, and no AA/TSF treatment. The fourth study found that total medical care costs decreased for participants attending CBT, MET, and AA/TSF treatment, but that among participants with worse prognostic characteristics AA/TSF had higher potential cost savings than MET (moderate-certainty evidence).
Authors' conclusions: There is high quality evidence that manualized AA/TSF interventions are more effective than other established treatments, such as CBT, for increasing abstinence. Non-manualized AA/TSF may perform as well as these other established treatments. AA/TSF interventions, both manualized and non-manualized, may be at least as effective as other treatments for other alcohol-related outcomes. AA/TSF probably produces substantial healthcare cost savings among people with alcohol use disorder.
The Cochrane database of systematic reviews · meta-analysis · 192 citationsread the source →
Effects of Balance Training on Balance Performance in Healthy Older Adults: A Systematic Review and Meta-analysis.
Background: The effects of balance training (BT) in older adults on proxies of postural control and mobility are well documented in the literature. However, evidence-based dose-response relationships in BT modalities (i.e., training period, training frequency, training volume) have not yet been established in healthy older adults.
Objectives: The objectives of this systematic literature review and meta-analysis are to quantify BT intervention effects and to additionally characterize dose-response relationships of BT modalities (e.g., training period, training frequency) through the analysis of randomized controlled trials (RCTs) that could maximize improvements in balance performance in healthy community-dwelling older adults.
Data sources: A computerized systematic literature search was performed in the electronic databases PubMed and Web of Science from January 1985 up to January 2015 to capture all articles related to BT in healthy old community-dwelling adults.
Study eligibility criteria: A systematic approach was used to evaluate the 345 articles identified for initial review. Only RCTs were included if they investigated BT in healthy community-dwelling adults aged ≥65 years and tested at least one behavioral balance performance outcome (e.g., center of pressure displacements during single-leg stance). In total, 23 studies met the inclusionary criteria for review.
Study appraisal and synthesis methods: Weighted mean standardized mean differences between subjects (SMDbs) of the intervention-induced adaptations in balance performance were calculated using a random-effects model and tested for an overall intervention effect relative to passive controls. The included studies were coded for the following criteria: training modalities (i.e., training period, training frequency, training volume) and balance outcomes [static/dynamic steady-state (i.e., maintaining a steady position during standing and walking), proactive balance (i.e., anticipation of a predicted perturbation), reactive balance (i.e., compensation of an unpredicted perturbation) as well as balance test batteries (i.e., combined testing of different balance components as for example the Berg Balance Scale)]. Heterogeneity between studies was assessed using I2 and Chi2-statistics. The methodological quality of each study was tested by means of the Physiotherapy Evidence Database (PEDro) Scale.
Results: Weighted mean SMDbs showed that BT is an effective means to improve static steady-state (mean SMDbs = 0.51), dynamic steady-state (mean SMDbs = 0.44), proactive (mean SMDbs = 1.73), and reactive balance (mean SMDbs = 1.01) as well as the performance in balance test batteries (mean SMDbs = 1.52) in healthy older adults. Our analyses regarding dose-response relationships in BT revealed that a training period of 11-12 weeks (mean SMDbs= 1.26), a frequency of three training sessions per week (mean SMDbs= 1.20), a total number of 36-40 training sessions (mean SMDbs = 1.39), a duration of a single training session of 31-45 min (mean SMDbs = 1.19), and a total duration of 91-120 min of BT per week (mean SMDbs = 1.93) of the applied training modalities is most effective in improving overall balance performance. However, it has to be noted that effect sizes for the respective training modalities were computed independently (i.e., modality specific). Because of the small number of studies that reported detailed information on training volume (i.e., number of exercises per training session, number of sets and/or repetitions per exercise, duration of single-balance exercises) dose-response relationships were not computed for these parameters.
Limitations: The present findings have to be interpreted with caution because we indirectly compared dose-response relationships across studies using SMDbs and not in a single controlled study as it is difficult to separate the impact of a single training modality (e.g., training frequency) from that of the others. Moreover, the quality of the included studies was rather limited with a mean PEDro score of 5 and the heterogeneity between studies was considerable (i.e., I2 = 76-92 %).
Conclusions: Our detailed analyses revealed that BT is an effective means to improve proxies of static/dynamic steady-state, proactive, and reactive balance as well as performance in balance test batteries in healthy older adults. Furthermore, we were able to establish effective BT modalities to improve balance performance in healthy older adults. Thus, practitioners and therapists are advised to consult the identified dose-response relationships of this systematic literature review and meta-analysis. However, further research of high methodologic quality is needed to determine (1) dose-response relationships of BT in terms of detailed information on training volume (e.g., number of exercises per training session) and (2) a feasible and effective method to regulate training intensity in BT.
Sports medicine (Auckland, N.Z.) · meta-analysis · 265 citationsread the source →
The treatment of premenstrual syndrome with preparations of Vitex agnus castus: a systematic review and meta-analysis.
Background: Premenstrual syndrome is characterized by the cyclic occurrence of physical, behavioral and psychological symptoms during the luteal phase of the menstrual cycle disappearing within a few days of the onset of menstruation. Generally symptoms are mild, but 5-8% of women suffer from severe PMS. Apart from conventional drugs, like serotonin reuptake inhibitors and oral contraceptives, complementary and alternative medicines such as Vitex agnus castus are used by many women experiencing PMS.
Objective: Our objective was to determine the efficacy, tolerability, and acceptability of Vitex agnus castus preparations for treatment of premenstrual syndrome.
Study design: All journals in the Ovid software from inception through January 2016 were searched, including the Cochrane Central Register of Controlled Trials, MEDLINE, Embase, and PsycINFO. Gray literature was searched by Google Scholar and manufacturers of Vitex agnus castus preparations were contacted for information about unpublished trials. We included randomized controlled trials with Vitex agnus castus in women with premenstrual syndrome and/or premenstrual dysphoric disorder with a minimal duration of 2 menstrual cycles. The eligibility of the manuscripts was assessed by 2 reviewers independently. The data abstracted included characteristics of the study design, characteristics of the patient population, intervention details, type of comparator, method of diagnosis, and outcome measures. We adhered to the PRISMA guidelines.
Results: We found 17 randomized controlled trials of Vitex agnus castus in the treatment of premenstrual syndrome. Fourteen of these could be included in the quantitative analysis. Thirteen of 14 studies with placebo, dietary supplements, or herbal preparations as controls reported positive effects of Vitex agnus castus on total premenstrual syndrome symptoms. Unfortunately most of the trials are associated with a high risk of bias. The pooled effect of Vitex agnus castus in placebo-controlled trials was large (Hedges g, -1.21; 95% confidence interval, -1.53 to -0.88), but heterogeneity was extremely high (I2, 91%). We were unable to single out factors that could explain this heterogeneity satisfactorily. The funnel plot and Egger tests suggest the presence of publication bias.
Conclusion: Although meta-analysis shows a large pooled effect of Vitex agnus castus in placebo-controlled trials, the high risk of bias, high heterogeneity, and risk of publication bias of the included studies preclude a definitive conclusion. The pooled treatment effects should be viewed as merely explorative and, at best, overestimating the real treatment effect of Vitex agnus castus for premenstrual syndrome symptoms. There is a clear need for high-quality trials of appropriate size examining the effect of standardized extracts of Vitex agnus castus in comparison to placebo, selective serotonin reuptake inhibitors, and oral contraceptives to establish relative efficacy.
American journal of obstetrics and gynecology · meta-analysis · 35 citationsread the source →
Zalsman G, Hawton K, Wasserman D, van Heeringen K, Arensman E, Sarchiapone M, Carli V, Höschl C, Barzilay R, Balazs J, Purebl G, Kahn JP, Sáiz PA, Lipsicas CB, Bobes J, Cozman D, Hegerl U, Zohar J. (2016)MEDLINE-indexed journal, not yet read by usThe lancet. Psychiatry · systematic review Suicide prevention strategies revisited: 10-year systematic review.
Background: Many countries are developing suicide prevention strategies for which up-to-date, high-quality evidence is required. We present updated evidence for the effectiveness of suicide prevention interventions since 2005.
Methods: We searched PubMed and the Cochrane Library using multiple terms related to suicide prevention for studies published between Jan 1, 2005, and Dec 31, 2014. We assessed seven interventions: public and physician education, media strategies, screening, restricting access to suicide means, treatments, and internet or hotline support. Data were extracted on primary outcomes of interest, namely suicidal behaviour (suicide, attempt, or ideation), and intermediate or secondary outcomes (treatment-seeking, identification of at-risk individuals, antidepressant prescription or use rates, or referrals). 18 suicide prevention experts from 13 European countries reviewed all articles and rated the strength of evidence using the Oxford criteria. Because the heterogeneity of populations and methodology did not permit formal meta-analysis, we present a narrative analysis.
Findings: We identified 1797 studies, including 23 systematic reviews, 12 meta-analyses, 40 randomised controlled trials (RCTs), 67 cohort trials, and 22 ecological or population-based investigations. Evidence for restricting access to lethal means in prevention of suicide has strengthened since 2005, especially with regard to control of analgesics (overall decrease of 43% since 2005) and hot-spots for suicide by jumping (reduction of 86% since 2005, 79% to 91%). School-based awareness programmes have been shown to reduce suicide attempts (odds ratio [OR] 0·45, 95% CI 0·24-0·85; p=0·014) and suicidal ideation (0·5, 0·27-0·92; p=0·025). The anti-suicidal effects of clozapine and lithium have been substantiated, but might be less specific than previously thought. Effective pharmacological and psychological treatments of depression are important in prevention. Insufficient evidence exists to assess the possible benefits for suicide prevention of screening in primary care, in general public education and media guidelines. Other approaches that need further investigation include gatekeeper training, education of physicians, and internet and helpline support. The paucity of RCTs is a major limitation in the evaluation of preventive interventions.
Interpretation: In the quest for effective suicide prevention initiatives, no single strategy clearly stands above the others. Combinations of evidence-based strategies at the individual level and the population level should be assessed with robust research designs.
Funding: The Expert Platform on Mental Health, Focus on Depression, and the European College of Neuropsychopharmacology.
The lancet. Psychiatry · systematic review · 1070 citationsread the source →
Co-occurrence of conduct disorder and depression in a clinic-based sample of boys with ADHD.
Background: Children with attention-deficit/hyperactivity disorder (ADHD) are at risk for the development of comorbid conduct disorder (CD) and depression. The current study examined potential psychosocial risk factors for CD and depression in a clinic-based sample of 203 boys (aged 6-10 years) with ADHD.
Methods: The boys and their mothers participated in an evaluation that involved assessments of cognitive, behavioral, academic, and family functioning. Potential predictors of CD and depression involved four domains: parenting behaviors, family environment, academic/cognitive functioning, and peer relations. ADHD groups were defined using mother- and teacher-report of DSM-IV symptoms. Mother-ratings of DSM-IV symptoms were obtained for a subsample of 91 boys approximately 5 years after the initial assessment.
Results: For both mother- and teacher-defined ADHD groups, social problems were related to depression symptoms; hostile, inconsistent, and detached parenting behaviors were related to CD symptoms; and family environment characterized by low cohesion, high conflict, and low marital satisfaction was related to CD and depression symptoms. For the teacher-defined ADHD group, parenting variables also predicted depression symptoms. Academic and cognitive variables did not predict CD or depression symptoms when parenting, family, and peer relationship variables were taken into account. Depression prospectively predicted CD, but not the reverse, and parental hostile control and familial conflict prospectively predicted CD for the teacher-defined ADHD group only.
Conclusions: Source-specificity is a useful consideration when describing the relation of parenting and home environment with CD and depression symptoms in boys with ADHD. Intervention efforts that address these parenting, family, and peer relationship variables may aid in preventing the development of comorbid conditions.
Journal of child psychology and psychiatry, and allied disciplines · 52 citationsread the source →
Spirituality, religiosity, and spiritual pain among caregivers of patients with advanced cancer.
Background: Caregivers of patients with advanced cancer often face physical, social, and emotional distress as well as spiritual pain. Limited research has focused on the spiritual aspects of caregivers' suffering in the palliative care setting.
Methods: We interviewed 43 caregivers of patients with advanced cancer in our palliative care outpatient clinic. We determined demographic characteristics, religious affiliation, and relationship to the patient. Levels of spirituality, religiosity, and spiritual pain were self-reported using numeric rating scales (0 = lowest; 10 = highest). The participants completed various validated questionnaires to assess sleep disturbances, psychosocial distress, coping skills, and quality of life (QOL).
Results: The median age was 52 years (range, 21-83); 29 (67%) were women, 34 (78%) were white, 7 (17%) were African American, and 2 (5%) were Hispanic; 39 (91%) were Christian, 1 (2%) was Jewish, and 1 (2%) was agnostic; 37 (86%) were married; 18 (42%) were working full time; and 25 (58%) were spouses. All considered themselves spiritual, and 98% considered themselves religious, with median scores of 8 (interquartile range, 6-10) and 8 (interquartile range, 4-9), respectively. All the caregivers reported that spirituality and religiosity helped them cope with their loved one's illness, and many reported that spirituality and religiosity had a positive impact on their loved one's physical (58%) and emotional (76%) symptoms. Spiritual pain was reported by 23 (58%), with a median score of 5 (interquartile range, 2-8). Caregivers with spiritual pain had higher levels of anxiety (median 10 vs 4; P = .002), depression (6 vs 2; P = .006), and denial (3 vs 2; P = .01); more behavioral disengagement (3 vs 2; P = 0.011) more dysfunctional coping strategies (19 vs 16; P < .001) and worse QOL (70 vs 51; P < .001) than those who did not have spiritual pain.
Conclusions: The majority of caregivers of patients with advanced cancer considered themselves spiritual and religious. Despite this, there is high prevalence of spiritual pain in this population. Caregivers with spiritual pain experienced worse psychological distress and worse QOL. These findings support the importance of spiritual assessment of and spiritual support for caregivers in this setting.
The American journal of hospice & palliative care · 65 citationsread the source →
Little P, Stuart B, Hobbs FR, Kelly J, Smith ER, Bradbury KJ, Hughes S, Smith PW, Moore MV, Lean ME, Margetts BM, Byrne CD, Griffin S, Davoudianfar M, Hooper J, Yao G, Zhu S, Raftery J, Yardley L. (2016)MEDLINE-indexed journal, not yet read by usThe lancet. Diabetes & endocrinology · randomised controlled trial An internet-based intervention with brief nurse support to manage obesity in primary care (POWeR+): a pragmatic, parallel-group, randomised controlled trial.
Background: The obesity epidemic has major public health consequences. Expert dietetic and behavioural counselling with intensive follow-up is effective, but resource requirements severely restrict widespread implementation in primary care, where most patients are managed. We aimed to estimate the effectiveness and cost-effectiveness of an internet-based behavioural intervention (POWeR+) combined with brief practice nurse support in primary care.
Methods: We did this pragmatic, parallel-group, randomised controlled trial at 56 primary care practices in central and south England. Eligible adults aged 18 years or older with a BMI of 30 kg/m(2) or more (or ≥28 kg/m(2) with hypertension, hypercholesterolaemia, or diabetes) registered online with POWeR+-a 24 session, web-based, weight management intervention lasting 6 months. After registration, the website automatically randomly assigned patients (1:1:1), via computer-generated random numbers, to receive evidence-based dietetic advice to swap foods for similar, but healthier, choices and increase fruit and vegetable intake, in addition to 6 monthly nurse follow-up (control group); web-based intervention and face-to-face nurse support (POWeR+Face-to-face [POWeR+F]; up to seven nurse contacts over 6 months); or web-based intervention and remote nurse support (POWeR+Remote [POWeR+R]; up to five emails or brief phone calls over 6 months). Participants and investigators were masked to group allocation at the point of randomisation; masking of participants was not possible after randomisation. The primary outcome was weight loss averaged over 12 months. We did a secondary analysis of weight to measure maintenance of 5% weight loss at months 6 and 12. We modelled the cost-effectiveness of each intervention. We did analysis by intention to treat, with multiple imputation for missing data. This trial is registered as an International Standard Randomised Controlled Trial, number ISRCTN21244703.
Findings: Between Jan 30, 2013, and March 20, 2014, 818 participants were randomly assigned to the control group (n=279), the POWeR+F group (n=269), or the POWeR+R group (n=270). Weight loss averaged over 12 months was recorded in 666 (81%) participants. The control group lost almost 3 kg over 12 months (crude mean weight: baseline 104·38 kg [SD 21·11; n=279], 6 months 101·91 kg [19·35; n=136], 12 months 101·74 kg [19·57; n=227]). The primary imputed analysis showed that compared with the control group, patients in the POWeR+F group achieved an additional weight reduction of 1·5 kg (95% CI 0·6-2·4; p=0·001) averaged over 12 months, and patients in the POWeR+R group achieved an additional 1·3 kg (0·34-2·2; p=0·007). 21% of patients in the control group had maintained a clinically important 5% weight reduction at month 12, compared with 29% of patients in the POWeR+F group (risk ratio 1·56, 0·96-2·51; p=0·070) and 32% of patients in the POWeR+R group (1·82, 1·31-2·74; p=0·004). The incremental overall cost to the health service per kg weight lost with the POWeR+ interventions versus the control strategy was £18 (95% CI -129 to 195) for POWeR+F and -£25 (-268 to 157) for POWeR+R; the probability of being cost-effective at a threshold of £100 per kg lost was 88% and 98%, respectively. No adverse events were reported.
Interpretation: Weight loss can be maintained in some individuals by use of novel written material with occasional brief nurse follow-up. However, more people can maintain clinically important weight reductions with a web-based behavioural program and brief remote follow-up, with no increase in health service costs. Future research should assess the extent to which clinically important weight loss can be maintained beyond 1 year.
Funding: Health Technology Assessment Programme of the National Institute for Health Research.
The lancet. Diabetes & endocrinology · randomised controlled trial · 85 citationsread the source →
Barlow DH, Farchione TJ, Bullis JR, Gallagher MW, Murray-Latin H, Sauer-Zavala S, Bentley KH, Thompson-Hollands J, Conklin LR, Boswell JF, Ametaj A, Carl JR, Boettcher HT, Cassiello-Robbins C. (2017)MEDLINE-indexed journal, not yet read by usJAMA psychiatry · randomised controlled trial The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders Compared With Diagnosis-Specific Protocols for Anxiety Disorders: A Randomized Clinical Trial.
Importance: Transdiagnostic interventions have been developed to address barriers to the dissemination of evidence-based psychological treatments, but only a few preliminary studies have compared these approaches with existing evidence-based psychological treatments.
Objective: To determine whether the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) is at least as efficacious as single-disorder protocols (SDPs) in the treatment of anxiety disorders.
Design, setting, and participants: From June 23, 2011, to March 5, 2015, a total of 223 patients at an outpatient treatment center with a principal diagnosis of panic disorder with or without agoraphobia, generalized anxiety disorder, obsessive-compulsive disorder, or social anxiety disorder were randomly assigned by principal diagnosis to the UP, an SDP, or a waitlist control condition. Patients received up to 16 sessions of the UP or an SDP for 16 to 21 weeks. Outcomes were assessed at baseline, after treatment, and at 6-month follow-up. Analysis in this equivalence trial was based on intention to treat.
Interventions: The UP or SDPs.
Main outcomes and measures: Blinded evaluations of principal diagnosis clinical severity rating were used to evaluate an a priori hypothesis of equivalence between the UP and SDPs.
Results: Among the 223 patients (124 women and 99 men; mean [SD] age, 31.1 [11.0] years), 88 were randomized to receive the UP, 91 to receive an SDP, and 44 to the waitlist control condition. Patients were more likely to complete treatment with the UP than with SDPs (odds ratio, 3.11; 95% CI, 1.44-6.74). Both the UP (Cohen d, -0.93; 95% CI, -1.29 to -0.57) and SDPs (Cohen d, -1.08; 95% CI, -1.43 to -0.73) were superior to the waitlist control condition at acute outcome. Reductions in clinical severity rating from baseline to the end of treatment (β, 0.25; 95% CI, -0.26 to 0.75) and from baseline to the 6-month follow-up (β, 0.16; 95% CI, -0.39 to 0.70) indicated statistical equivalence between the UP and SDPs.
Conclusions and relevance: The UP produces symptom reduction equivalent to criterion standard evidence-based psychological treatments for anxiety disorders with less attrition. Thus, it may be possible to use 1 protocol instead of multiple SDPs to more efficiently treat the most commonly occurring anxiety and depressive disorders.
Trial registration: clinicaltrials.gov Identifier: NCT01243606.
JAMA psychiatry · randomised controlled trial · 458 citationsread the source →
Bennell KL, Nelligan RK, Rini C, Keefe FJ, Kasza J, French S, Forbes A, Dobson F, Abbott JH, Dalwood A, Harris A, Vicenzino B, Hodges PW, Hinman RS. (2018)MEDLINE-indexed journal, not yet read by usPain · randomised controlled trial Effects of internet-based pain coping skills training before home exercise for individuals with hip osteoarthritis (HOPE trial): a randomised controlled trial.
This assessor-, therapist-, and participant-blinded randomised controlled trial evaluated the effects of an automated internet-based pain coping skills training (PCST) program before home exercise for people with clinically diagnosed hip osteoarthritis. One hundred forty-four people were randomised to either the PCST group or the comparator group. In the first 8 weeks, the PCST group received online education and PCST, whereas the comparison group received online education only. From weeks 8 to 24, both groups visited a physiotherapist 5 times for home exercise prescription. Assessments were performed at baseline, 8, 24, and 52 weeks. Primary outcomes were hip pain on walking (11-point numerical rating scale) and physical function (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC]) at 24 weeks. Secondary outcomes were other measures of pain, quality-of-life, global change, self-efficacy, pain coping, pain catastrophizing, depression, anxiety, stress, physical activity, and adverse events. Primary outcomes were completed by 137 (95%), 131 (91%), and 127 (88%) participants at 8, 24, and 52 weeks, respectively. There were no significant between-group differences in primary outcomes at week 24 (change in: walking pain [mean difference 0.5 units; 95% confidence interval, -0.3 to 1.3] and function [-0.9 units; 95% confidence interval, -4.8 to 2.9]), with both groups showing clinically relevant improvements. At week 8, the PCST group had greater improvements in function, pain coping, and global improvement than comparison. Greater pain coping improvements persisted at 24 and 52 weeks. In summary, online PCST immediately improved pain coping and function but did not confer additional benefits to a subsequent exercise program, despite sustained pain coping improvements.
Pain · randomised controlled trial · 54 citationsread the source →
Khunti K, Griffin S, Brennan A, Dallosso H, Davies M, Eborall H, Edwardson C, Gray L, Hardeman W, Heathcote L, Henson J, Morton K, Pollard D, Sharp S, Sutton S, Troughton J, Yates T. (2021)MEDLINE-indexed journal, not yet read by usHealth technology assessment (Winchester, England) · randomised controlled trial Behavioural interventions to promote physical activity in a multiethnic population at high risk of diabetes: PROPELS three-arm RCT.
Background: Type 2 diabetes is a leading cause of mortality globally and accounts for significant health resource expenditure. Increased physical activity can reduce the risk of diabetes. However, the longer-term clinical effectiveness and cost-effectiveness of physical activity interventions in those at high risk of type 2 diabetes is unknown.
Objectives: To investigate whether or not Walking Away from Diabetes (Walking Away) - a low-resource, 3-hour group-based behavioural intervention designed to promote physical activity through pedometer use in those with prediabetes - leads to sustained increases in physical activity when delivered with and without an integrated mobile health intervention compared with control.
Design: Three-arm, parallel-group, pragmatic, superiority randomised controlled trial with follow-up conducted at 12 and 48 months.
Setting: Primary care and the community.
Participants: Adults whose primary care record included a prediabetic blood glucose measurement recorded within the past 5 years [HbA1c ≥ 42 mmol/mol (6.0%), < 48 mmol/mol (6.5%) mmol/mol; fasting glucose ≥ 5.5 mmol/l, < 7.0 mmol/l; or 2-hour post-challenge glucose ≥ 7.8 mmol/l, < 11.1 mmol/l] were recruited between December 2013 and February 2015. Data collection was completed in July 2019.
Interventions: Participants were randomised (1 : 1 : 1) using a web-based tool to (1) control (information leaflet), (2) Walking Away with annual group-based support or (3) Walking Away Plus (comprising Walking Away, annual group-based support and a mobile health intervention that provided automated, individually tailored text messages to prompt pedometer use and goal-setting and provide feedback, in addition to biannual telephone calls). Participants and data collectors were not blinded; however, the staff who processed the accelerometer data were blinded to allocation.
Main outcome measures: The primary outcome was accelerometer-measured ambulatory activity (steps per day) at 48 months. Other objective and self-reported measures of physical activity were also assessed.
Results: A total of 1366 individuals were randomised (median age 61 years, median body mass index 28.4 kg/m2, median ambulatory activity 6638 steps per day, women 49%, black and minority ethnicity 28%). Accelerometer data were available for 1017 (74%) and 993 (73%) individuals at 12 and 48 months, respectively. The primary outcome assessment at 48 months found no differences in ambulatory activity compared with control in either group (Walking Away Plus: 121 steps per day, 97.5% confidence interval -290 to 532 steps per day; Walking Away: 91 steps per day, 97.5% confidence interval -282 to 463). This was consistent across ethnic groups. At the intermediate 12-month assessment, the Walking Away Plus group had increased their ambulatory activity by 547 (97.5% confidence interval 211 to 882) steps per day compared with control and were 1.61 (97.5% confidence interval 1.05 to 2.45) times more likely to achieve 150 minutes per week of objectively assessed unbouted moderate to vigorous physical activity. In the Walking Away group, there were no differences compared with control at 12 months. Secondary anthropometric, biomechanical and mental health outcomes were unaltered in either intervention study arm compared with control at 12 or 48 months, with the exception of small, but sustained, reductions in body weight in the Walking Away study arm (≈ 1 kg) at the 12- and 48-month follow-ups. Lifetime cost-effectiveness modelling suggested that usual care had the highest probability of being cost-effective at a threshold of £20,000 per quality-adjusted life-year. Of 50 serious adverse events, only one (myocardial infarction) was deemed possibly related to the intervention and led to the withdrawal of the participant from the study.
Limitations: Loss to follow-up, although the results were unaltered when missing data were replaced using multiple imputation.
Conclusions: Combining a physical activity intervention with text messaging and telephone support resulted in modest, but clinically meaningful, changes in physical activity at 12 months, but the changes were not sustained at 48 months.
Future work: Future research is needed to investigate which intervention types, components and features can help to maintain physical activity behaviour change over the longer term.
Trial registration: Current Controlled Trials ISRCTN83465245.
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. 25, No. 77. See the NIHR Journals Library website for further project information.
Health technology assessment (Winchester, England) · randomised controlled trial · 17 citationsread the source →
Ahern AL, Wheeler GM, Aveyard P, Boyland EJ, Halford JCG, Mander AP, Woolston J, Thomson AM, Tsiountsioura M, Cole D, Mead BR, Irvine L, Turner D, Turner D, Suhrcke M, Pimpin L, Retat L, Jaccard A, Webber L, Cohn SR, Jebb SA. (2017)MEDLINE-indexed journal, not yet read by usLancet (London, England) · randomised controlled trial Extended and standard duration weight-loss programme referrals for adults in primary care (WRAP): a randomised controlled trial.
Background: Evidence exist that primary care referral to an open-group behavioural programme is an effective strategy for management of obesity, but little evidence on optimal intervention duration is available. We aimed to establish whether 52-week referral to an open-group weight-management programme would achieve greater weight loss and improvements in a range of health outcomes and be more cost-effective than the current practice of 12-week referrals.
Methods: In this non-blinded, parallel-group, randomised controlled trial, we recruited participants who were aged 18 years or older and had body-mass index (BMI) of 28 kg/m2 or higher from 23 primary care practices in England. Participants were randomly assigned (2:5:5) to brief advice and self-help materials, a weight-management programme (Weight Watchers) for 12 weeks, or the same weight-management programme for 52 weeks. We followed-up participants over 2 years. The primary outcome was weight at 1 year of follow-up, analysed with mixed-effects models according to intention-to-treat principles and adjusted for centre and baseline weight. In a hierarchical closed-testing procedure, we compared combined behavioural programme arms with brief intervention, then compared the 12-week programme and 52-week programme. We did a within-trial cost-effectiveness analysis using person-level data and modelled outcomes over a 25-year time horizon using microsimulation. This study is registered with Current Controlled Trials, number ISRCTN82857232.
Findings: Between Oct 18, 2012, and Feb 10, 2014, we enrolled 1269 participants. 1267 eligible participants were randomly assigned to the brief intervention (n=211), the 12-week programme (n=528), and the 52-week programme (n=528). Two participants in the 12-week programme had been found to be ineligible shortly after randomisation and were excluded from the analysis. 823 (65%) of 1267 participants completed an assessment at 1 year and 856 (68%) participants at 2 years. All eligible participants were included in the analyses. At 1 year, mean weight changes in the groups were -3·26 kg (brief intervention), -4·75 kg (12-week programme), and -6·76 kg (52-week programme). Participants in the behavioural programme lost more weight than those in the brief intervention (adjusted difference -2·71 kg, 95% CI -3·86 to -1·55; p<0·0001). The 52-week programme was more effective than the 12-week programme (-2·14 kg, -3·05 to -1·22; p<0·0001). Differences between groups were still significant at 2 years. No adverse events related to the intervention were reported. Over 2 years, the incremental cost-effectiveness ratio (ICER; compared with brief intervention) was £159 per kg lost for the 52-week programme and £91 per kg for the 12-week programme. Modelled over 25 years after baseline, the ICER for the 12-week programme was dominant compared with the brief intervention. The ICER for the 52-week programme was cost-effective compared with the brief intervention (£2394 per quality-adjusted life-year [QALY]) and the 12-week programme (£3804 per QALY).
Interpretation: For adults with overweight or obesity, referral to this open-group behavioural weight-loss programme for at least 12 weeks is more effective than brief advice and self-help materials. A 52-week programme produces greater weight loss and other clinical benefits than a 12-week programme and, although it costs more, modelling suggests that the 52-week programme is cost-effective in the longer term.
Funding: National Prevention Research Initiative, Weight Watchers International (as part of an UK Medical Research Council Industrial Collaboration Award).
Lancet (London, England) · randomised controlled trial · 156 citationsread the source →
Bennell KL, Lawford BJ, Keating C, Brown C, Kasza J, Mackenzie D, Metcalf B, Kimp AJ, Egerton T, Spiers L, Proietto J, Sumithran P, Harris A, Quicke JG, Hinman RS. (2022)MEDLINE-indexed journal, not yet read by usAnnals of internal medicine · randomised controlled trial Comparing Video-Based, Telehealth-Delivered Exercise and Weight Loss Programs With Online Education on Outcomes of Knee Osteoarthritis : A Randomized Trial.
Background: Scalable knee osteoarthritis programs are needed to deliver recommended education, exercise, and weight loss interventions.
Objective: To evaluate two 6-month, telehealth-delivered exercise programs, 1 with and 1 without dietary intervention.
Design: 3-group, parallel randomized (5:5:2) trial. (Australian New Zealand Clinical Trials Registry: ACTRN12618000930280).
Setting: Australian private health insurance members.
Participants: 415 persons with symptomatic knee osteoarthritis and a body mass index between 28 and 40 kg/m2 who were aged 45 to 80 years.
Intervention: All groups received access to electronic osteoarthritis information (control). The exercise program comprised 6 physiotherapist consultations via videoconference for exercise, self-management advice, and behavioral counseling, plus exercise equipment and resources. The diet and exercise program included an additional 6 dietitian consultations for a ketogenic very-low-calorie diet (2 formulated meal replacements and a low-carbohydrate meal daily) followed by a transition to healthy eating, as well as nutrition and behavioral resources.
Measurements: Primary outcomes were changes in knee pain (numerical rating scale [NRS] of 0 to 10, higher indicating worse) and physical function (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC]; scale, 0 to 68, higher indicating worse) at 6 months (primary time point) and 12 months. Secondary outcomes were weight, physical activity, quality of life, mental health, global change, satisfaction, willingness to have surgery, orthopedic appointments, and knee surgery.
Results: A total of 379 participants (91%) provided 6-month primary outcomes, and 372 (90%) provided 12-month primary outcomes. At 6 months, both programs were superior to control for pain (between-group mean difference in change on NRS: diet and exercise, -1.5 [95% CI, -2.1 to -0.8]; exercise, -0.8 [CI, -1.5 to -0.2]) and function (between-group mean difference in change on WOMAC: diet and exercise, -9.8 [CI, -12.5 to -7.0]; exercise, -7.0 [CI, -9.7 to -4.2]). The diet and exercise program was superior to exercise (pain, -0.6 [CI, -1.1 to -0.2]; function, -2.8 [CI, -4.7 to -0.8]). Findings were similar at 12 months.
Limitation: Participants and clinicians were unblinded.
Conclusion: Telehealth-delivered exercise and diet programs improved pain and function in people with knee osteoarthritis and overweight or obesity. A dietary intervention conferred modest additional pain and function benefits over exercise.
Primary funding source: Medibank, the Medibank Better Health Foundation Research Fund, and a National Health and Medical Research Council Centre of Research Excellence.
Annals of internal medicine · randomised controlled trial · 76 citationsread the source →
Freeman D, Loe BS, Yu LM, Freeman J, Chadwick A, Vaccari C, Shanyinde M, Harris V, Waite F, Rosebrock L, Petit A, Vanderslott S, Lewandowsky S, Larkin M, Innocenti S, Pollard AJ, McShane H, Lambe S. (2021)MEDLINE-indexed journal, not yet read by usThe Lancet. Public health · randomised controlled trial Effects of different types of written vaccination information on COVID-19 vaccine hesitancy in the UK (OCEANS-III): a single-blind, parallel-group, randomised controlled trial.
Background: The effectiveness of the COVID-19 vaccination programme depends on mass participation: the greater the number of people vaccinated, the less risk to the population. Concise, persuasive messaging is crucial, particularly given substantial levels of vaccine hesitancy in the UK. Our aim was to test which types of written information about COVID-19 vaccination, in addition to a statement of efficacy and safety, might increase vaccine acceptance.
Methods: For this single-blind, parallel-group, randomised controlled trial, we aimed to recruit 15 000 adults in the UK, who were quota sampled to be representative. Participants were randomly assigned equally across ten information conditions stratified by level of vaccine acceptance (willing, doubtful, or strongly hesitant). The control information condition comprised the safety and effectiveness statement taken from the UK National Health Service website; the remaining conditions addressed collective benefit, personal benefit, seriousness of the pandemic, and safety concerns. After online provision of vaccination information, participants completed the Oxford COVID-19 Vaccine Hesitancy Scale (outcome measure; score range 7-35) and the Oxford Vaccine Confidence and Complacency Scale (mediation measure). The primary outcome was willingness to be vaccinated. Participants were analysed in the groups they were allocated. p values were adjusted for multiple comparisons. The study was registered with ISRCTN, ISRCTN37254291.
Findings: From Jan 19 to Feb 5, 2021, 15 014 adults were recruited. Vaccine hesitancy had reduced from 26·9% the previous year to 16·9%, so recruitment was extended to Feb 18 to recruit 3841 additional vaccine-hesitant adults. 12 463 (66·1%) participants were classified as willing, 2932 (15·6%) as doubtful, and 3460 (18·4%) as strongly hesitant (ie, report that they will avoid being vaccinated for as long as possible or will never get vaccinated). Information conditions did not alter COVID-19 vaccine hesitancy in those willing or doubtful (adjusted p values >0·70). In those strongly hesitant, COVID-19 vaccine hesitancy was reduced, in comparison to the control condition, by personal benefit information (mean difference -1·49, 95% CI -2·16 to -0·82; adjusted p=0·0015), directly addressing safety concerns about speed of development (-0·91, -1·58 to -0·23; adjusted p=0·0261), and a combination of all information (-0·86, -1·53 to -0·18; adjusted p=0·0313). In those strongly hesitant, provision of personal benefit information reduced hesitancy to a greater extent than provision of information on the collective benefit of not personally getting ill (-0·97, 95% CI -1·64 to -0·30; adjusted p=0·0165) or the collective benefit of not transmitting the virus (-1·01, -1·68 to -0·35; adjusted p=0·0150). Ethnicity and gender were found to moderate information condition outcomes.
Interpretation: In the approximately 10% of the population who are strongly hesitant about COVID-19 vaccines, provision of information on personal benefit reduces hesitancy to a greater extent than information on collective benefits. Where perception of risk from vaccines is most salient, decision making becomes centred on the personal. As such, messaging that stresses the counterbalancing personal benefits is likely to prove most effective. The messaging from this study could be used in public health communications. Going forwards, the study highlights the need for future health campaigns to engage with the public on the terrain that is most salient to them.
Funding: National Institute for Health Research (NIHR) Oxford Biomedical Research Centre and NIHR Oxford Health Biomedical Research Centre.
The Lancet. Public health · randomised controlled trial · 196 citationsread the source →
Dikshit R, Gupta PC, Ramasundarahettige C, Gajalakshmi V, Aleksandrowicz L, Badwe R, Kumar R, Roy S, Suraweera W, Bray F, Mallath M, Singh PK, Sinha DN, Shet AS, Shet AS, Gelband H, Jha P, Million Death Study Collaborators. (2012)MEDLINE-indexed journal, not yet read by usLancet (London, England) Cancer mortality in India: a nationally representative survey.
Background: The age-specific mortality rates and total deaths from specific cancers have not been documented for the various regions and subpopulations of India. We therefore assessed the cause of death in 2001-03 in homes in small areas that were chosen to be representative of all the parts of India.
Methods: At least 130 trained physicians independently assigned causes to 122,429 deaths, which occurred in 1·1 million homes in 6671 small areas that were randomly selected to be representative of all of India, based on a structured non-medical surveyor's field report.
Findings: 7137 of 122,429 study deaths were due to cancer, corresponding to 556,400 national cancer deaths in India in 2010. 395,400 (71%) cancer deaths occurred in people aged 30-69 years (200,100 men and 195,300 women). At 30-69 years, the three most common fatal cancers were oral (including lip and pharynx, 45,800 [22·9%]), stomach (25,200 [12·6%]), and lung (including trachea and larynx, 22,900 [11·4%]) in men, and cervical (33,400 [17·1%]), stomach (27,500 [14·1%]), and breast (19,900 [10·2%]) in women. Tobacco-related cancers represented 42·0% (84,000) of male and 18·3% (35,700) of female cancer deaths and there were twice as many deaths from oral cancers as lung cancers. Age-standardised cancer mortality rates per 100,000 were similar in rural (men 95·6 [99% CI 89·6-101·7] and women 96·6 [90·7-102·6]) and urban areas (men 102·4 [92·7-112·1] and women 91·2 [81·9-100·5]), but varied greatly between the states, and were two times higher in the least educated than in the most educated adults (men, illiterate 106·6 [97·4-115·7] vs most educated 45·7 [37·8-53·6]; women, illiterate 106·7 [99·9-113·6] vs most educated 43·4 [30·7-56·1]). Cervical cancer was far less common in Muslim than in Hindu women (study deaths 24, age-standardised mortality ratio 0·68 [0·64-0·71] vs 340, 1·06 [1·05-1·08]).
Interpretation: Prevention of tobacco-related and cervical cancers and earlier detection of treatable cancers would reduce cancer deaths in India, particularly in the rural areas that are underserved by cancer services. The substantial variation in cancer rates in India suggests other risk factors or causative agents that remain to be discovered.
Funding: Bill & Melinda Gates Foundation and US National Institutes of Health.
Lancet (London, England) · 296 citationsread the source →
Sleep quality, depression state, and health status of older adults after silver yoga exercises: cluster randomized trial.
Background: Sleep disturbances, depression, and low perception of health status are commonly seen in elderly population; however, clinicians tend to underestimate or overlook the presence of these symptoms and assume them to be a part of normal aging. Non-pharmacological methods that promote a mind-body interaction should be tested to enhance the mental health of older adults.
Objective: To test the effects of 6 months of silver yoga exercises in promoting the mental health of older adults in senior activity centers, especially their sleep quality, depression, and self-perception of health status.
Design: Cluster randomized trial.
Settings: Eight senior activity centers, southern Taiwan.
Participants: A sample of 139 participants was recruited, and 128 of them completed the study.
Inclusion criteria: (1) community-dwelling older adults ages 60 and over, (2) no previous training in yoga, (3) able to walk without assistance, (4) cognitively alert based on the Short Portable Mental Status Questionnaire (SPMSQ) score of eight or higher, and (5) independent or mildly dependent in self-care based on a Barthel Index (BI) score of 91 or higher. The mean age of the participants was 69.20 +/- 6.23 years, and the average number of chronic illness was 0.83 +/- 0.90. The average BI score of the participants was 99.92 +/- 0.62, and the mean SPMSQ score was 9.90 +/- 0.30.
Methods: Participants were randomly assigned into either the experimental (n=62) or the control (n=66) group based on attendance at selected senior activity centers. A 70-min silver yoga exercise program was implemented three times per week for 6 months as the intervention for the participants in the experimental group.
Results: Most of the mental health indicators of the participants in the experimental group had significantly improved after the silver yoga interventions, and many of the indicators improved after 3 months of intervention and were maintained throughout the 6 months study. The mental health indicators of the participants in the experimental group were all better than the participants in the control group (all p<.05).
Conclusions: After 6 months of silver yoga exercises, the sleep quality, depression, and health status of older adults were all improved.
International journal of nursing studies · randomised controlled trial · 116 citationsread the source →
Ruffin MT, Nease DE, Sen A, Pace WD, Wang C, Acheson LS, Rubinstein WS, O'Neill S, Gramling R, Family History Impact Trial (FHITr) Group. (2011)MEDLINE-indexed journal, not yet read by usAnnals of family medicine · randomised controlled trial Effect of preventive messages tailored to family history on health behaviors: the Family Healthware Impact Trial.
Purpose: We wanted to determine the impact of automated family history assessment and tailored messages for coronary heart disease, stroke, diabetes, colorectal, breast, and ovarian cancer on preventive behaviors compared with a standard preventive message.
Methods: The study was a cluster-randomized clinical trial that included 41 primary care practices, the majority in the Midwest, using Family Healthware, a self-administered, Web-based tool that assesses familial risk for the diseases and provides personalized risk-tailored messages. Patients in the control group received an age- and sex-specific health message related to lifestyle and screening. Smoking cessation, fruit and vegetable intake, physical activity, aspirin use, blood pressure, and cholesterol and blood glucose screening were assessed at baseline and 6 months after the intervention.
Results: Of 4,248 participants, 3,344 (78%) completed the study. Participants were white (91%), female (70%), and insured (97%), and had a mean age of 50.6 years (range 35-65 years). Intervention participants were more likely to increase daily fruit and vegetable consumption from 5 or fewer servings a day to 5 or more servings a day (OR = 1.29; 95% confidence interval [CI], 1.05-1.58) and to increase physical activity (OR = 1.47; 95% CI, 1.08-1.98) to 5 to 6 times a week for 30 minutes or more a week. The absolute differences in proportion were 3% and 4%, respectively. Intervention participants were less likely to move from not having cholesterol screening in the last 5 years to having their cholesterol measured within 5 years (OR = 0.34; 95% CI, 0.17-0.67), with an absolute difference of 15%.
Conclusions: Messages tailored to an individual's familial risk for 6 common diseases modestly increased self-reported physical activity and fruit and vegetable intake but reduced the likelihood of receiving cholesterol screening.
Annals of family medicine · randomised controlled trial · 105 citationsread the source →
Cognitive behavioural treatment for women who have menopausal symptoms after breast cancer treatment (MENOS 1): a randomised controlled trial.
Background: Hot flushes and night sweats (HFNS) affect 65-85% of women after breast cancer treatment; they are distressing, causing sleep problems and decreased quality of life. Hormone replacement therapy is often either undesirable or contraindicated. Safe, effective non-hormonal treatments are needed. We investigated whether cognitive behavioural therapy (CBT) can help breast cancer survivors to effectively manage HFNS.
Methods: In this randomised controlled trial, we recruited women from breast clinics in London, UK, who had problematic HFNS (minimum ten problematic episodes a week) after breast-cancer treatment. Participants were randomly allocated to receive either usual care or usual care plus group CBT (1:1). Randomisation was done in blocks of 12-20 participants, stratifying by age (younger than 50 years, 50 years or older), and was done with a computer-generated sequence. The trial statistician and researchers collecting outcome measures were masked to group allocation. Group CBT comprised one 90 min session a week for 6 weeks, and included psycho-education, paced breathing, and cognitive and behavioural strategies to manage HFNS. Assessments were done at baseline, 9 weeks, and 26 weeks after randomisation. The primary outcome was the adjusted mean difference in HFNS problem rating (1-10) between CBT and usual care groups at 9 weeks after randomisation. Analysis of the primary endpoint was done by modified intention to treat. The trial is registered, ISRCTN13771934, and was closed March 15, 2011.
Findings: Between May 5, 2009, and Aug 27, 2010, 96 women were randomly allocated to group CBT (n=47) or usual care (n=49). Group CBT significantly reduced HFNS problem rating at 9 weeks after randomisation compared with usual care (mean difference -1·67, 95% CI -2·43 to -0·91; p<0·0001) and improvements were maintained at 26 weeks (mean difference -1·76, -2·54 to -0·99; p<0·0001). We recorded no CBT-related adverse events.
Interpretation: Group CBT seems to be a safe and effective treatment for women who have problematic HFNS after breast cancer treatment with additional benefits to mood, sleep, and quality of life. The treatment could be incorporated into breast cancer survivorship programmes and delivered by trained breast cancer nurses.
Funding: Cancer Research UK.
The Lancet. Oncology · randomised controlled trial · 190 citationsread the source →
Effect of a cash transfer programme for schooling on prevalence of HIV and herpes simplex type 2 in Malawi: a cluster randomised trial.
Background: Lack of education and an economic dependence on men are often suggested as important risk factors for HIV infection in women. We assessed the efficacy of a cash transfer programme to reduce the risk of sexually transmitted infections in young women.
Methods: In this cluster randomised trial, never-married women aged 13-22 years were recruited from 176 enumeration areas in the Zomba district of Malawi and randomly assigned with computer-generated random numbers by enumeration area (1:1) to receive cash payments (intervention group) or nothing (control group). Intervention enumeration areas were further randomly assigned with computer-generated random numbers to conditional (school attendance required to receive payment) and unconditional (no requirements to receive payment) groups. Participants in both intervention groups were randomly assigned by a lottery to receive monthly payments ranging from US$1 to $5, while their parents were independently assigned with computer-generated random numbers to receive $4-10. Behavioural risk assessments were done at baseline and 12 months; serology was tested at 18 months. Participants were not masked to treatment status but counsellors doing the serologic testing were. The primary outcomes were prevalence of HIV and herpes simplex virus 2 (HSV-2) at 18 months and were assessed by intention-to-treat analyses. The trial is registered, number NCT01333826.
Findings: 88 enumeration areas were assigned to receive the intervention and 88 as controls. For the 1289 individuals enrolled in school at baseline with complete interview and biomarker data, weighted HIV prevalence at 18 month follow-up was 1·2% (seven of 490 participants) in the combined intervention group versus 3·0% (17 of 799 participants) in the control group (adjusted odds ratio [OR] 0·36, 95% CI 0·14-0·91); weighted HSV-2 prevalence was 0·7% (five of 488 participants) versus 3·0% (27 of 796 participants; adjusted OR 0·24, 0·09-0·65). In the intervention group, we noted no difference between conditional versus unconditional intervention groups for weighted HIV prevalence (3/235 [1%] vs 4/255 [2%]) or weighted HSV-2 prevalence (4/233 [1%] vs 1/255 [<1%]). For individuals who had already dropped out of school at baseline, we detected no significant difference between intervention and control groups for weighted HIV prevalence (23/210 [10%] vs 17/207 [8%]) or weighted HSV-2 prevalence (17/211 [8%] vs 17/208 [8%]).
Interpretation: Cash transfer programmes can reduce HIV and HSV-2 infections in adolescent schoolgirls in low-income settings. Structural interventions that do not directly target sexual behaviour change can be important components of HIV prevention strategies.
Funding: Global Development Network, Bill & Melinda Gates Foundation, National Bureau of Economic Research Africa Project, World Bank's Research Support Budget, and several World Bank trust funds (Gender Action Plan, Knowledge for Change Program, and Spanish Impact Evaluation fund).
Lancet (London, England) · randomised controlled trial · 389 citationsread the source →
Manchikanti L, Kaye AM, Knezevic NN, McAnally H, Slavin K, Trescot AM, Blank S, Pampati V, Abdi S, Grider JS, Kaye AD, Manchikanti KN, Cordner H, Gharibo CG, Harned ME, Albers SL, Atluri S, Aydin SM, Bakshi S, Barkin RL, Benyamin RM, Boswell MV, Buenaventura RM, Calodney AK, Cedeno DL, Datta S, Deer TR, Fellows B, Galan V, Grami V, Hansen H, Helm Ii S, Justiz R, Koyyalagunta D, Malla Y, Navani A, Nouri KH, Pasupuleti R, Sehgal N, Silverman SM, Simopoulos TT, Singh V, Solanki DR, Staats PS, Vallejo R, Wargo BW, Watanabe A, Hirsch JA. (2017)MEDLINE-indexed journal, not yet read by usPain physician · guideline Responsible, Safe, and Effective Prescription of Opioids for Chronic Non-Cancer Pain: American Society of Interventional Pain Physicians (ASIPP) Guidelines.
Background: Opioid use, abuse, and adverse consequences, including death, have escalated at an alarming rate since the 1990s. In an attempt to control opioid abuse, numerous regulations and guidelines for responsible opioid prescribing have been developed by various organizations. However, the US opioid epidemic is continuing and drug dose deaths tripled during 1999 to 2015. Recent data show a continuing increase in deaths due to natural and semisynthetic opioids, a decline in methadone deaths, and an explosive increase in the rates of deaths involving other opioids, specifically heroin and illicit synthetic fentanyl. Contrary to scientific evidence of efficacy and negative recommendations, a significant proportion of physicians and patients (92%) believe that opioids reduce pain and a smaller proportion (57%) report better quality of life. In preparation of the current guidelines, we have focused on the means to reduce the abuse and diversion of opioids without jeopardizing access for those patients suffering from non-cancer pain who have an appropriate medical indication for opioid use.
Objectives: To provide guidance for the prescription of opioids for the management of chronic non-cancer pain, to develop a consistent philosophy among the many diverse groups with an interest in opioid use as to how appropriately prescribe opioids, to improve the treatment of chronic non-cancer pain and to reduce the likelihood of drug abuse and diversion. These guidelines are intended to provide a systematic and standardized approach to this complex and difficult arena of practice, while recognizing that every clinical situation is unique.
Methods: The methodology utilized included the development of objectives and key questions. The methodology also utilized trustworthy standards, appropriate disclosures of conflicts of interest, as well as a panel of experts from various specialties and groups. The literature pertaining to opioid use, abuse, effectiveness, and adverse consequences was reviewed, with a best evidence synthesis of the available literature, and utilized grading for recommendation as described by the Agency for Healthcare Research and Quality (AHRQ).Summary of Recommendations:i. Initial Steps of Opioid Therapy 1. Comprehensive assessment and documentation. (Evidence: Level I; Strength of Recommendation: Strong) 2. Screening for opioid abuse to identify opioid abusers. (Evidence: Level II-III; Strength of Recommendation: Moderate) 3. Utilization of prescription drug monitoring programs (PDMPs). (Evidence: Level I-II; Strength of Recommendation: Moderate to strong) 4. Utilization of urine drug testing (UDT). (Evidence: Level II; Strength of Recommendation: Moderate) 5. Establish appropriate physical diagnosis and psychological diagnosis if available. (Evidence: Level I; Strength of Recommendation: Strong) 6. Consider appropriate imaging, physical diagnosis, and psychological status to collaborate with subjective complaints. (Evidence: Level III; Strength of Recommendation: Moderate) 7. Establish medical necessity based on average moderate to severe (≥ 4 on a scale of 0 - 10) pain and/or disability. (Evidence: Level II; Strength of Recommendation: Moderate) 8. Stratify patients based on risk. (Evidence: Level I-II; Strength of Recommendation: Moderate) 9. Establish treatment goals of opioid therapy with regard to pain relief and improvement in function. (Evidence: Level I-II; Strength of Recommendation: Moderate) 10. Obtain a robust opioid agreement, which is followed by all parties. (Evidence: Level III; Strength of Recommendation: Moderate)ii. Assessment of Effectiveness of Long-Term Opioid Therapy 11. Initiate opioid therapy with low dose, short-acting drugs, with appropriate monitoring. (Evidence: Level II; Strength of Recommendation: Moderate) 12. Consider up to 40 morphine milligram equivalent (MME) as low dose, 41 to 90 MME as a moderate dose, and greater than 91 MME as high dose. (Evidence: Level II; Strength of Recommendation: Moderate) 13. Avoid long-acting opioids for the initiation of opioid therapy. (Evidence: Level I; Strength of Recommendation: Strong) 14. Recommend methadone only for use after failure of other opioid therapy and only by clinicians with specific training in its risks and uses, within FDA recommended doses. (Evidence: Level I; Strength of Recommendation: Strong) 15. Understand and educate the patients of the effectiveness and adverse consequences. (Evidence: Level I; Strength of Recommendation: Strong) 16. Similar effectiveness for long-acting and short-acting opioids with increased adverse consequences of long-acting opioids. (Evidence: Level I-II; Strength of recommendation: Moderate to strong) 17. Periodically assess pain relief and/or functional status improvement of ≥ 30% without adverse consequences. (Evidence: Level II; Strength of recommendation: Moderate) 18. Recommend long-acting or high dose opioids only in specific circumstances with severe intractable pain. (Evidence: Level I; Strength of Recommendation: Strong)iii. Monitoring for Adherence and Side Effects 19. Monitor for adherence, abuse, and noncompliance by UDT and PDMPs. (Evidence: Level I-II; Strength of Recommendation: Moderate to strong) 20. Monitor patients on methadone with an electrocardiogram periodically. (Evidence: Level I; Strength of Recommendation: Strong). 21. Monitor for side effects including constipation and manage them appropriately, including discontinuation of opioids when indicated. (Evidence: Level I; Strength of Recommendation: Strong)iv. Final Phase 22. May continue with monitoring with continued medical necessity, with appropriate outcomes. (Evidence: Level I-II; Strength of Recommendation: Moderate) 23. Discontinue opioid therapy for lack of response, adverse consequences, and abuse with rehabilitation. (Evidence: Level III; Strength of Recommendation: Moderate) CONCLUSIONS: These guidelines were developed based on comprehensive review of the literature, consensus among the panelists, in consonance with patient preferences, shared decision-making, and practice patterns with limited evidence, based on randomized controlled trials (RCTs) to improve pain and function in chronic non-cancer pain on a long-term basis. Consequently, chronic opioid therapy should be provided only to patients with proven medical necessity and stability with improvement in pain and function, independently or in conjunction with other modalities of treatments in low doses with appropriate adherence monitoring and understanding of adverse events. Key words: Chronic pain, persistent pain, non-cancer pain, controlled substances, substance abuse, prescription drug abuse, dependency, opioids, prescription monitoring, drug testing, adherence monitoring, diversionDisclaimer: The guidelines are based on the best available evidence and do not constitute inflexible treatment recommendations. Due to the changing body of evidence, this document is not intended to be a "standard of care."
Pain physician · guideline · 225 citationsread the source →
Botulinum toxin type A in the treatment of lower limb spasticity in children with cerebral palsy.
Background: Cerebral palsy (CP) is the most common cause of physical disabilities in children in high-income countries. Spasticity is the most common motor disturbance in CP. Botulinum toxin type A (BoNT-A) is considered the first-line treatment for focal spasticity in people with CP.
Objectives: To evaluate the effectiveness and safety of BoNT-A compared to other treatments used in the management of lower limb spasticity in children with CP.
Search methods: We searched CENTRAL, PubMed, four other databases, and two trial registers in October 2018. We also searched the reference lists of relevant studies and reviews and contacted experts in the field. We did not apply any date or language restrictions.
Selection criteria: Randomised controlled trials of children with CP, aged between birth and 19 years, treated with BoNT-A injections in the lower limb muscles compared to other interventions. The primary outcomes were gait analysis and function. The secondary outcomes were joint range of motion, quality of life, satisfaction, spasticity, and adverse events.
Data collection and analysis: Two review authors independently selected studies, extracted data, assessed risk of bias, and rated the quality of the evidence using GRADE. A third review author arbitrated in case of disagreements. We conducted meta-analyses of available data whenever possible, analysing dichotomous data with risk ratios (RR), and continuous data with mean differences (MD) or standardised mean differences (SMD), with 95% confidence intervals (CI). We considered a 5% significance level for all analyses. Whenever possible, we analysed outcomes at the time points at which they were assessed: short term (2 to 8 weeks); medium term (12 to 16 weeks); and long term (> 24 weeks).
Main results: We included 31 randomised controlled trials assessing 1508 participants. Most studies included ambulatory patients with more than one motor type of CP, and with a mean age of between three and seven years. There was a slight predominance of males. Studies compared BoNT-A in the lower limb muscles to usual care or physiotherapy (14 studies), placebo or sham (12 studies), serial casting (4 studies), or orthoses (1 study).We rated studies as at high or unclear risk of bias mainly due to random sequence generation, allocation concealment, blinding of participants and personnel, and blinding of outcome assessment. BoNT-A versus usual care or physiotherapyBoNT-A might improve overall gait scores at medium-term follow-up (MD 2.80, 95% CI 1.55 to 4.05; 1 study, 40 children; very low-quality evidence) and is moderately effective at improving function at short-term (SMD 0.59, 95% CI 0.23 to 0.95; 2 studies, 123 children) and medium-term (SMD 1.04, 95% CI 0.16 to 1.91; 4 studies, 191 children) follow-up (all very low-quality evidence).BoNT-A improves ankle range of motion, satisfaction, and ankle plantarflexors spasticity at one or more time points (very low-quality evidence).The proportion of adverse events in the BoNT-A group was 0.37 (95% CI 0.08 to 0.66; I2 = 95%; very low-quality evidence). No adverse events were reported in the control group. BoNT-A versus placebo or shamBoNT-A improves overall gait scores at short-term (RR 1.66, 95% CI 1.16 to 2.37, P = 0.006; 4 studies, 261 assessments) and medium-term (RR 1.90, 95% CI 1.32 to 2.74, P < 0.001; 3 studies, 248 assessments) follow-up, and may improve peak ankle dorsiflexion in stance (MD 15.90 degrees, 95% CI 4.87 to 26.93, P = 0.005; 1 study, 19 children) and in swing (MD 10.20 degrees, 95% CI 4.01 to 16.39, P = 0.001; 1 study, 19 children) at short-term follow-up (all moderate-quality evidence).BoNT-A is not more effective than placebo or sham at improving function at short-term (SMD 0.24, 95% CI -0.35 to 0.83, P = 0.42; 4 studies, 305 children) or long-term (SMD -0.07, 95% CI -0.48 to 0.35, P = 0.76; 2 studies, 91 children) follow-up, but has a small positive effect at medium-term follow-up (SMD 0.28, 95% CI 0.06 to 0.49, P = 0.01; 5 studies, 327 children) (all moderate-quality evidence).BoNT-A improves passive ankle range of motion, satisfaction, and ankle plantarflexors spasticity at one or more time points (moderate-quality evidence).There was no difference between groups in the rate of adverse events at short-term follow-up (RR 1.29, 95% CI 0.87 to 1.93, P = 0.21; 12 studies, 918 children; moderate-quality evidence).BoNT-A versus serial castingThere was no difference between groups for overall gait scores at short-term (MD 0.00, 95% CI -1.66 to 1.66); medium-term (MD 0.65, 95% CI -1.21 to 2.51); or long-term (MD 0.46, 95% CI -1.33 to 2.25) follow-up in one study with 18 children (moderate-quality evidence).BoNT-A improved instrumented gait analysis only in terms of ankle dorsiflexion at initial contact (MD 6.59 degrees, 95% CI 1.39 to 11.78, P = 0.01; 2 studies, 47 children). There was no difference between groups for peak ankle dorsiflexion in stance and swing, and gait speed at any time point (moderate- and low-quality evidence).BoNT-A is not more effective than serial casting at improving function, ankle range of motion, and spasticity at any time point (moderate- and low-quality evidence).BoNT-A is not associated with a higher risk of adverse events than serial casting (RR 0.59, 95% CI 0.03 to 11.03; 3 studies, 64 children; low-quality evidence).BoNT-A versus orthosesThere was no difference between groups for function at medium-term follow-up (MD 11.14, 95% CI -0.05 to 22.33; 1 study, 43 children), but BoNT-A is more effective than orthoses at improving hip range of motion and hip adductors spasticity (all very low-quality evidence).
Authors' conclusions: The quality of the evidence was low or very low for most of the outcomes analysed. We found limited evidence that BoNT-A is more effective than placebo or a non-placebo control at improving gait, joint range of motion, satisfaction, and lower limb spasticity in children with CP, whereas the results for function were contradictory. The rate of adverse events with BoNT-A is similar to placebo. BoNT-A is not more effective than ankle serial casting to treat ankle contractures for any of the assessed outcomes, but is more effective than orthotics at improving range of motion and spasticity.
The Cochrane database of systematic reviews · review · 38 citationsread the source →
Autism Spectrum Disorder: A Review.
Importance: Autism spectrum disorder (ASD), characterized by deficits in social communication and the presence of restricted, repetitive behaviors or interests, is a neurodevelopmental disorder affecting approximately 2.3% children aged 8 years in the US and approximately 2.2% of adults. This review summarizes evidence on the diagnosis and treatment of ASD.
Observations: The estimated prevalence of ASD has been increasing in the US, from 1.1% in 2008 to 2.3% in 2018, which is likely associated with changes in diagnostic criteria, improved performance of screening and diagnostic tools, and increased public awareness. No biomarkers specific to the diagnosis of ASD have been identified. Common early signs and symptoms of ASD in a child's first 2 years of life include no response to name when called, no or limited use of gestures in communication, and lack of imaginative play. The criterion standard for the diagnosis of ASD is a comprehensive evaluation with a multidisciplinary team of clinicians and is based on semistructured direct observation of the child's behavior and semistructured caregiver interview focused on the individual's development and behaviors using standardized measures, such as the Autism Diagnostic Observation Schedule-Second Edition and the Autism Diagnostic Interview. These diagnostic measures have sensitivity of 91% and 80% and specificity of 76% and 72%, respectively. Compared with people without ASD, individuals with ASD have higher rates of depression (20% vs 7%), anxiety (11% vs 5%), sleep difficulties (13% vs 5%), and epilepsy (21% with co-occurring intellectual disability vs 0.8%). Intensive behavioral interventions, such as the Early Start Denver Model, are beneficial in children 5 years or younger for improvement in language, play, and social communication (small to medium effect size based on standardized mean difference). Pharmacotherapy is indicated for co-occurring psychiatric conditions, such as emotion dysregulation or attention-deficit/hyperactivity disorder. Risperidone and aripiprazole can improve irritability and aggression (standardized mean difference of 1.1, consistent with a large effect size) compared with placebo. Psychostimulants are effective for attention-deficit/hyperactivity disorder (standardized mean difference of 0.6, consistent with a moderate effect size) compared with placebo. These medications are associated with adverse effects including, most commonly, changes in appetite, weight, and sleep.
Conclusions and relevance: ASD affects approximately 2.3% of children aged 8 years and approximately 2.2% of adults in the US. First-line therapy consists of behavioral interventions, while co-occurring psychiatric conditions, such as anxiety or aggression, may be treated with specific behavioral therapy or medication.
JAMA · review · 467 citationsread the source →
Gamification and Oral Health in Children and Adolescents: Scoping Review
BACKGROUND: Oral health is a determinant of overall well-being and quality of life. Individual behaviors, such as oral hygiene and dietary habits, play a central role in oral health. Motivation is a crucial factor in promoting behavior change, and gamification offers a means to boost health-related knowledge and encourage positive health behaviors. OBJECTIVE: This study aims to evaluate the impact of gamification and its mechanisms on oral health care of children and adolescents. METHODS: A systematic search covered multiple databases: PubMed/MEDLINE, PsycINFO, the Cochrane Library, ScienceDirect, and LILACS. Gray literature, conference proceedings, and WHOQOL internet resources were considered. Studies from January 2013 to December 2022 were included, except for PubMed/MEDLINE, which was searched until January 2023. A total of 15 studies were selected following PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. The eligibility criteria were peer-reviewed, full-text, and empirical research related to gamification in oral health care, reports of impact, and oral health care outcomes. The exclusion criteria encompassed duplicate articles; unavailable full texts; nonoriginal articles; and non-digital game-related, non-oral health-related, and protocol studies. Selected studies were scrutinized for gamification mechanisms and outcomes. Two main questions were raised: "Does gamification in oral health care impact oral health?" and "Does oral health care gamification enhance health promotion and literacy?" The PICO (Patient, Intervention, Comparison, Outcome) framework guided the scoping review. RESULTS: Initially, 617 records were obtained from 5 databases and gray literature sources. After applying exclusion criteria, 15 records were selected. Sample size in the selected studies ranged from 34 to 190 children and adolescents. A substantial portion (11/15, 73%) of the studies discussed oral self-care apps supported by evidence-based oral health. The most clearly defined data in the apps were "brushing time" (11/11, 100%) and "daily amount brushing" (10/11, 91%). Most studies (11/15, 73%) mentioned oral health care behavior change techniques and included "prompt intention formation" (11/26, 42%), "providing instructions" (11/26, 42%), "providing information on the behavior-health link" (10/26, 38%), "providing information on consequences" (9/26, 35%), "modeling or demonstrating behavior" (9/26, 35%), "providing feedback on performance" (8/26, 31%), and "providing contingent rewards" (8/26, 31%). Furthermore, 80% (12/15) of the studies identified game design elements incorporating gamification features in oral hygiene applications. The most prevalent gamification features were "ideological incentives" (10/12, 83%) and "goals" (9/16, 56%), which were found in user-specific and challenge categories, respectively. CONCLUSIONS: Gamification in oral health care shows potential as an innovative approach to promote positive health behaviors. Most studies reported evidence-based oral health and incorporated oral health care behavior change techniques.
Interactive Journal of Medical Research · review · 23 citationsread the source →
Preferences of Young Adults With First-Episode Psychosis for Receiving Specialized Mental Health Services Using Technology: A Survey Study.
Background: Despite the potential and interest of using technology for delivering specialized psychiatric services to young adults, surprisingly limited attention has been paid to systematically assess their perspectives in this regard. For example, limited knowledge exists on the extent to which young people receiving specialized services for a first-episode psychosis (FEP) are receptive to using new technologies as part of mental health care, and to which types of technology-enabled mental health interventions they are amenable to.
Objective: The purpose of this study is to assess the interest of young adults with FEP in using technology to receive mental health information, services, and supports.
Methods: This study uses a cross-sectional, descriptive survey design. A convenience sample of 67 participants between the ages of 18 and 35 were recruited from two specialized early intervention programs for psychosis. Interviewer-administered surveys were conducted between December 2013 and October 2014. Descriptive statistics are reported.
Results: Among the 67 respondents who completed the survey, the majority (85%, 57/67) agreed or strongly agreed with YouTube as a platform for mental health-related services and supports. The top five technology-enabled services that participants were amenable to were (1) information on medication (96%, 64/67); (2) information on education, career, and employment (93%, 62/67); (3) decision-making tools pertaining to treatment and recovery (93%, 62/67); (4) reminders for appointments via text messaging (93%, 62/67); and (5) information about mental health, psychosis, and recovery in general (91%, 61/67). The top self-reported barriers to seeking mental health information online were lack of knowledge on how to perform an Internet search (31%, 21/67) and the way information is presented online (27%, 18/67). Two thirds (67%; 45/67) reported being comfortable in online settings, and almost half (48%; 32/67) reported a preference for mixed formats when viewing mental health information online (eg, text, video, visual graphics).
Conclusions: Young people diagnosed with FEP express interest in using the Internet, social media, and mobile technologies for receiving mental health-related services. Increasing the awareness of young people in relation to various forms of technology-enabled mental health care warrants further attention. A consideration for future research is to obtain more in-depth knowledge on young people's perspectives, which can help improve the design, development, and implementation of integrated technological health innovations within the delivery of specialized mental health care.
JMIR mental health · 77 citationsread the source →
Functional neuroanatomy and the rationale for using EEG biofeedback for clients with Asperger's syndrome.
This paper reviews the symptoms of Asperger's Syndrome (AS), a disorder along the autism continuum, and highlights research findings with an emphasis on brain differences. Existing theories concerning AS are described, including theory of mind (Hill and Frith in Phil Trans Royal Soc Lond, Bull 358:281-289, 2003), mirror neuron system (Ramachandran and Oberman in Sci Am 295(5):62-69, 2006), and Porges' (Ann N Y Acad Sci 1008:31-47, 2003, The neurobiology of autism, Johns Hopkins University Press, Baltimore, 2004) polyvagal theory. (A second paper, Outcomes using EEG Biofeedback Training in Clients with Asperger's Syndrome, summarizes clinical outcomes obtained with more than 150 clients.) Patterns seen with QEEG assessment are then presented. Single channel assessment at the vertex (CZ) reveals patterns similar to those found in Attention-Deficit/Hyperactivity Disorder. Using 19-channel data, significant differences (z-scores > 2) were found in the amplitude of both slow waves (excess theta and/or alpha) and fast waves (beta) at various locations. Differences from the norm were most often found in mirror neuron areas (frontal, temporal and temporal-parietal). There were also differences in coherence patterns, as compared to a normative database (Neuroguide). Low Resolution Electromagnetic Tomography Analysis (Pascual-Marqui et al. in Methods Find Exp Clin Pharmacol 24C:91-95, 2002) suggested the source of the abnormal activity was most often the anterior cingulate. Other areas involved included the amygdala, uncus, insula, hippocampal gyrus, parahippocampal gyrus, fusiform gyrus, and the orbito-frontal and/or ventromedial areas of the prefrontal cortex. Correspondence between symptoms and the functions of the areas found to have abnormalities is evident and those observations are used to develop a rationale for using EEG biofeedback, called neurofeedback (NFB), intervention. NFB training is targeted to improve symptoms that include difficulty reading and mirroring emotions, poor attention to the outside world, poor self-regulation skills, and anxiety. Porges' polyvagal theory is used to emphasize the need to integrate NFB with biofeedback (BFB), particularly heart rate variability training. We term this emerging understanding the Systems Theory of Neural Synergy. The name underscores the fact that NFB and BFB influence dynamic circuits and emphasizes that, no matter where we enter the nervous system with an intervention, it will seek its own new balance and equilibrium.
Applied psychophysiology and biofeedback · review · 20 citationsread the source →
A Novel System for Supporting Autism Diagnosis Using Home Videos: Iterative Development and Evaluation of System Design.
Background: Observing behavior in the natural environment is valuable to obtain an accurate and comprehensive assessment of a child's behavior, but in practice it is limited to in-clinic observation. Research shows significant time lag between when parents first become concerned and when the child is finally diagnosed with autism. This lag can delay early interventions that have been shown to improve developmental outcomes.
Objective: To develop and evaluate the design of an asynchronous system that allows parents to easily collect clinically valid in-home videos of their child's behavior and supports diagnosticians in completing diagnostic assessment of autism.
Methods: First, interviews were conducted with 11 clinicians and 6 families to solicit feedback from stakeholders about the system concept. Next, the system was iteratively designed, informed by experiences of families using it in a controlled home-like experimental setting and a participatory design process involving domain experts. Finally, in-field evaluation of the system design was conducted with 5 families of children (4 with previous autism diagnosis and 1 child typically developing) and 3 diagnosticians. For each family, 2 diagnosticians, blind to the child's previous diagnostic status, independently completed an autism diagnosis via our system. We compared the outcome of the assessment between the 2 diagnosticians, and between each diagnostician and the child's previous diagnostic status.
Results: The system that resulted through the iterative design process includes (1) NODA smartCapture, a mobile phone-based application for parents to record prescribed video evidence at home; and (2) NODA Connect, a Web portal for diagnosticians to direct in-home video collection, access developmental history, and conduct an assessment by linking evidence of behaviors tagged in the videos to the Diagnostic and Statistical Manual of Mental Disorders criteria. Applying clinical judgment, the diagnostician concludes a diagnostic outcome. During field evaluation, without prior training, parents easily (average rating of 4 on a 5-point scale) used the system to record video evidence. Across all in-home video evidence recorded during field evaluation, 96% (26/27) were judged as clinically useful, for performing an autism diagnosis. For 4 children (3 with autism and 1 typically developing), both diagnosticians independently arrived at the correct diagnostic status (autism versus typical). Overall, in 91% of assessments (10/11) via NODA Connect, diagnosticians confidently (average rating 4.5 on a 5-point scale) concluded a diagnostic outcome that matched with the child's previous diagnostic status.
Conclusions: The in-field evaluation demonstrated that the system's design enabled parents to easily record clinically valid evidence of their child's behavior, and diagnosticians to complete a diagnostic assessment. These results shed light on the potential for appropriately designed telehealth technology to support clinical assessments using in-home video captured by families. This assessment model can be readily generalized to other conditions where direct observation of behavior plays a central role in the assessment process.
JMIR mHealth and uHealth · 37 citationsread the source →
Screening for Adverse Childhood Experiences in a Family Medicine Setting: A Feasibility Study.
Introduction: The role of adverse childhood experiences (ACEs) in predicting later adverse adult health outcomes is being widely recognized by makers of public policy. ACE questionnaires have the potential to identify in clinical practice unaddressed key social issues that can influence current health risks, morbidity, and early mortality. This study seeks to explore the feasibility of implementing the ACE screening of adults during routine family medicine office visits.
Methods: At 3 rural clinical practices, the 10-question ACE screen was used before visits with 111 consecutive patients of 7 clinicians. Clinician surveys about the use of the results and the effect on the visits were completed immediately after the visits. The presence of any ACE risk and "high-risk" ACE scores (≥4) were compared with clinician survey responses.
Results: A risk of ACEs was present in 62% of patients; 22% had scores ≥4. Clinicians were more likely to have discussed ACE issues for high-risk patients (score 0-3, 36.8%; score ≥4, 83.3%; P =. 00). Clinicians also perceived that they gained new information (score 0-3, 35.6%; score ≥4, 83.3%; P = .00). Clinical care changed for a small proportion of high-risk patients, with no change in immediate referrals or plan for follow-up. In 91% of visits where a risk of ACEs was present, visit length increased by ≤5 minutes.
Conclusions: Incorporation of ACE screening during routine care is feasible and merits further study. ACE screening offers clinicians a more complete picture of important social determinants of health. Primary care-specific interventions that incorporate treatment of early life trauma are needed.
Journal of the American Board of Family Medicine : JABFM · 72 citationsread the source →
Global, regional, and national levels of maternal mortality, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015.
Background: In transitioning from the Millennium Development Goal to the Sustainable Development Goal era, it is imperative to comprehensively assess progress toward reducing maternal mortality to identify areas of success, remaining challenges, and frame policy discussions. We aimed to quantify maternal mortality throughout the world by underlying cause and age from 1990 to 2015.
Methods: We estimated maternal mortality at the global, regional, and national levels from 1990 to 2015 for ages 10-54 years by systematically compiling and processing all available data sources from 186 of 195 countries and territories, 11 of which were analysed at the subnational level. We quantified eight underlying causes of maternal death and four timing categories, improving estimation methods since GBD 2013 for adult all-cause mortality, HIV-related maternal mortality, and late maternal death. Secondary analyses then allowed systematic examination of drivers of trends, including the relation between maternal mortality and coverage of specific reproductive health-care services as well as assessment of observed versus expected maternal mortality as a function of Socio-demographic Index (SDI), a summary indicator derived from measures of income per capita, educational attainment, and fertility.
Findings: Only ten countries achieved MDG 5, but 122 of 195 countries have already met SDG 3.1. Geographical disparities widened between 1990 and 2015 and, in 2015, 24 countries still had a maternal mortality ratio greater than 400. The proportion of all maternal deaths occurring in the bottom two SDI quintiles, where haemorrhage is the dominant cause of maternal death, increased from roughly 68% in 1990 to more than 80% in 2015. The middle SDI quintile improved the most from 1990 to 2015, but also has the most complicated causal profile. Maternal mortality in the highest SDI quintile is mostly due to other direct maternal disorders, indirect maternal disorders, and abortion, ectopic pregnancy, and/or miscarriage. Historical patterns suggest achievement of SDG 3.1 will require 91% coverage of one antenatal care visit, 78% of four antenatal care visits, 81% of in-facility delivery, and 87% of skilled birth attendance.
Interpretation: Several challenges to improving reproductive health lie ahead in the SDG era. Countries should establish or renew systems for collection and timely dissemination of health data; expand coverage and improve quality of family planning services, including access to contraception and safe abortion to address high adolescent fertility; invest in improving health system capacity, including coverage of routine reproductive health care and of more advanced obstetric care-including EmOC; adapt health systems and data collection systems to monitor and reverse the increase in indirect, other direct, and late maternal deaths, especially in high SDI locations; and examine their own performance with respect to their SDI level, using that information to formulate strategies to improve performance and ensure optimum reproductive health of their population.
Funding: Bill & Melinda Gates Foundation.
Lancet (London, England) · editorial or comment · 831 citationsread the source →
Preferences for dietary oils and fats in cooking and food preparation methods: a cross-sectional analysis of Australian adults.
Dietary oils and fats contain different fatty acid compositions that are associated with cardiometabolic disease risk. Despite their influence on disease outcomes, the types of dietary oils and fats predominately used in Australian households remain unknown. The aim of this study was to investigate the use of dietary oils and fats in cooking and food preparation in Australia. Adults living in Australia completed a cross-sectional online survey outlining their current household oil and fat use from July to December 2021. The survey was disseminated via social media platforms and included questions about the types of dietary oils and fats used for different cooking methods and the perceived motivators for choosing the main household oil. A total of 1248 participants responded to the survey. Participants were mostly female (91·6 %) aged between 25 and 44 years (56·7 %). The majority of participants (84·5 %) reported using some form of olive oil as their main source of oil for cooking and food preparation. Almost two-thirds of the sample (65·4 %) reported using extra virgin olive oil (EVOO), mainly in raw food preparation (71·5 %) or savoury baking and roasting (58 %). Fewer households reported using rice bran oil (4·6 %), canola oil (4·3 %) and vegetable oil (1·8 %). Almost half of all participants (49·6 %) identified perceived health benefits as the primary motivating factor for their main choice of oil, followed by sensory preference (46·7 %), versatility (10·2 %) and convenience (8·8 %). Australian adults frequently use olive oil, specifically EVOO, as the main oil for cooking and food preparation in the household.
The British journal of nutrition · 4 citationsread the source →
Spirituality, religiosity, and spiritual pain in advanced cancer patients.
Context: Spirituality, religiosity, and spiritual pain may affect advanced cancer patients' symptom expression, coping strategies, and quality of life.
Objectives: To examine the prevalence and intensity of spirituality, religiosity, and spiritual pain, and how spiritual pain was associated with symptom expression, coping, and spiritual quality of life.
Methods: We interviewed 100 advanced cancer patients at the M.D. Anderson palliative care outpatient clinic in Houston, TX. Self-rated spirituality, religiosity, and spiritual pain were assessed using numeric rating scales (0=lowest, 10=highest). Patients also completed validated questionnaires assessing symptoms (Edmonton Symptom Assessment Scale [ESAS] and Hospital Anxiety and Depression Scale), coping (Brief COPE and Brief R-COPE), the value attributed by the patient to spirituality/religiosity in coping with cancer (Systems of Belief Inventory-15R), and spiritual quality of life (Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being-Expanded [FACIT-Sp-Ex]).
Results: The median age was 53 years (range 21-85) and 88% were Christians. Almost all patients considered themselves spiritual (98%) and religious (98%), with a median intensity of 9 (interquartile range 7-10) of 10 and 9 (range 5-10) of 10, respectively. Spiritual pain was reported in 40 (44%) of 91 patients, with a median score of 3 (1-6) among those with spiritual pain. Spiritual pain was significantly associated with lower self-perceived religiosity (7 vs. 10, P=0.002) and spiritual quality of life (FACIT-Sp-Ex 68 vs. 81, P=0.001). Patients with spiritual pain reported that it contributed adversely to their physical/emotional symptoms (P<0.001). There was a trend toward increased depression, anxiety, anorexia, and drowsiness, as measured by the ESAS, among patients with spiritual pain (P<0.05), although this was not significant after Bonferroni correction.
Conclusion: A vast majority of advanced cancer patients receiving palliative care considered themselves spiritual and religious. Spiritual pain was common and was associated with lower self-perceived religiosity and spiritual quality of life.
Journal of pain and symptom management · 171 citationsread the source →
An 8-year longitudinal study of the natural history of threshold, subthreshold, and partial eating disorders from a community sample of adolescents.
The authors examined the natural history of threshold, subthreshold, and partial eating disorders in a community sample of 496 adolescent girls who completed annual diagnostic interviews over an 8-year period. Lifetime prevalence by age 20 years was 0.6% and 0.6% for threshold and subthreshold anorexia nervosa (AN), 1.6% and 6.1% for threshold and subthreshold bulimia nervosa (BN), 1.0% and 4.6% for threshold and subthreshold binge-eating disorder (BED), and 4.4% for purging disorder (PD). Overall, 12% of adolescents experienced some form of eating disorder. Subthreshold BN and BED and threshold PD were associated with elevated treatment, impairment, and distress. Peak age of onset was 17-18 years for BN and BED and 18-20 years for PD. Average episode duration in months was 3.9 for BN and BED and 5.1 for PD. One-year recovery rates ranged from 91% to 96%. Relapse rates were 41% for BN, 33% for BED, and 5% for PD. For BN and BED, subthreshold cases often progressed to threshold cases and diagnostic crossover was most likely for these disorders. Results suggest that subthreshold eating disorders are more prevalent than threshold eating disorders and are associated with marked impairment.
Journal of abnormal psychology · 232 citationsread the source →
The effects of an expressive writing intervention on pregnancy rates, alexithymia and psychophysical health during an assisted reproductive treatment.
Objective: World Health Organization reported that in developed countries one in four couples experience infertility with serious implications for the psychophysical well-being. Aim of this study was to evaluate the effects of Pennebaker's writing technique on pregnancy rates, alexithymia and psychophysical health during an assisted reproductive treatment (ART).Method: 91 women admitted for an ART were randomly divided into two groups: an experimental one (n = 46), where women wrote about their thoughts and emotions concerning the infertility experience, and a control group (n = 45) where women did not write. All subjects completed a socio-demographic questionnaire, the 20-item Toronto Alexithymia Scale and the Symptoms Checklist-90-R before and after the writing sessions. Results: A significant difference in pregnancy rates between the experimental group (n = 13) and the control group (n = 5) was found (χ2 = 4.216; p < .04). A significant difference was also found between women who participated in the study (experimental + control= 91) and women who declined to participate, in the direction of more ART successes (n = 18 vs. n = 0) in the group of women who participated (χ2 = 10.17; p < .01).Conclusions: The findings support the usefulness of the writing technique during ART in promoting treatment success.
Psychology & health · 19 citationsread the source →
An Adjunctive Internet-Based Intervention to Enhance Treatment for Depression in Adults: Randomized Controlled Trial.
Background: Internet-based interventions promise to enhance the accessibility of mental health care for a greater number of people and in more remote places. Their effectiveness has been shown for the prevention and treatment of various mental disorders. However, their potential when delivered as add-on to conventional treatment (ie, blended care) is less clear.
Objective: The aim of this study is to study the effectiveness of an internet intervention (ASCENSO) implemented in addition to face-to-face treatment as usual (TAU) for depression.
Methods: A 2-arm, parallel-group, randomized controlled trial was conducted in an outpatient private mental health care center in Chile. In all, 167 adults, diagnosed with major depressive disorder, without severe comorbidities, and with internet access, were included. Eighty-four participants were assigned to the intervention group and received medical and psychological TAU from the mental health center plus access to the ASCENSO online platform. The control group (n=83) received only TAU. The ASCENSO platform includes psycho-educational information, depressive symptom monitoring and feedback, and managing emergencies based on the principles of cognitive behavioral therapy. Emergency management was mental health provider-assisted. TAU includes access to primary care physicians and psychiatrists, to a brief individual psychotherapy, and to medication when needed. The baseline questionnaires were administered in person, and 6- and 9-months assessments were conducted online. Depression symptoms and quality of life were measured by self-administered questionnaires, and treatment adherence was determined via the Mental Health Center's internal records. The usage of ASCENSO was assessed by server logs. Reduction on depressive symptomatology was considered as the primary outcome of the intervention and quality of life as a secondary outcome.
Results: Of the 84 participants in the intervention group, 5 participants (6%) never accessed the online platform. Of the remaining 79 participants who accessed ASCENSO, 1 (1%, 1/79) did not answer any of the symptom questionnaire, and most participants (72/79, 91%) answered the monitoring questionnaires irregularly. The ASCENSO intervention implemented in addition to face-to-face care did not improve the outcome of the usual care delivered at the mental health center, either in terms of reduction of depressive symptoms (F2,6087= 0.48; P=.62) or in the improvement of quality of life (EQ-5D-3L: F2,7678=0.24; P=.79 and EQ-VAS: F2,6670= 0.13; P=.88). In contrast, for the primary (F2,850=78.25; P<.001) and secondary outcomes (EQ-5D-3L: F2,1067=37.87; EQ-VAS: F2,4390= 51.69; P<.001) in both groups, there was an improvement from baseline to 6 months (P<.001), but there was no change at 9 months. In addition, no effects on adherence to or use of TAU were found. Finally, the dropout rate for the face-to-face treatment component was 54% (45/84) for the intervention group versus 39% (32/83) for the control group (P=.07).
Conclusions: The fact that the adjunctive access to ASCENSO did not improve outcome could be due to both the rather high effectiveness of TAU and to patients' limited use of the online platform.
Trial registration: ClinicalTrials.gov NCT03093467; https://clinicaltrials.gov/ct2/show/NCT03093467.
JMIR mental health · 14 citationsread the source →
Global, regional, and national burden of stroke and its risk factors, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019.
Background: Regularly updated data on stroke and its pathological types, including data on their incidence, prevalence, mortality, disability, risk factors, and epidemiological trends, are important for evidence-based stroke care planning and resource allocation. The Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) aims to provide a standardised and comprehensive measurement of these metrics at global, regional, and national levels.
Methods: We applied GBD 2019 analytical tools to calculate stroke incidence, prevalence, mortality, disability-adjusted life-years (DALYs), and the population attributable fraction (PAF) of DALYs (with corresponding 95% uncertainty intervals [UIs]) associated with 19 risk factors, for 204 countries and territories from 1990 to 2019. These estimates were provided for ischaemic stroke, intracerebral haemorrhage, subarachnoid haemorrhage, and all strokes combined, and stratified by sex, age group, and World Bank country income level.
Findings: In 2019, there were 12·2 million (95% UI 11·0-13·6) incident cases of stroke, 101 million (93·2-111) prevalent cases of stroke, 143 million (133-153) DALYs due to stroke, and 6·55 million (6·00-7·02) deaths from stroke. Globally, stroke remained the second-leading cause of death (11·6% [10·8-12·2] of total deaths) and the third-leading cause of death and disability combined (5·7% [5·1-6·2] of total DALYs) in 2019. From 1990 to 2019, the absolute number of incident strokes increased by 70·0% (67·0-73·0), prevalent strokes increased by 85·0% (83·0-88·0), deaths from stroke increased by 43·0% (31·0-55·0), and DALYs due to stroke increased by 32·0% (22·0-42·0). During the same period, age-standardised rates of stroke incidence decreased by 17·0% (15·0-18·0), mortality decreased by 36·0% (31·0-42·0), prevalence decreased by 6·0% (5·0-7·0), and DALYs decreased by 36·0% (31·0-42·0). However, among people younger than 70 years, prevalence rates increased by 22·0% (21·0-24·0) and incidence rates increased by 15·0% (12·0-18·0). In 2019, the age-standardised stroke-related mortality rate was 3·6 (3·5-3·8) times higher in the World Bank low-income group than in the World Bank high-income group, and the age-standardised stroke-related DALY rate was 3·7 (3·5-3·9) times higher in the low-income group than the high-income group. Ischaemic stroke constituted 62·4% of all incident strokes in 2019 (7·63 million [6·57-8·96]), while intracerebral haemorrhage constituted 27·9% (3·41 million [2·97-3·91]) and subarachnoid haemorrhage constituted 9·7% (1·18 million [1·01-1·39]). In 2019, the five leading risk factors for stroke were high systolic blood pressure (contributing to 79·6 million [67·7-90·8] DALYs or 55·5% [48·2-62·0] of total stroke DALYs), high body-mass index (34·9 million [22·3-48·6] DALYs or 24·3% [15·7-33·2]), high fasting plasma glucose (28·9 million [19·8-41·5] DALYs or 20·2% [13·8-29·1]), ambient particulate matter pollution (28·7 million [23·4-33·4] DALYs or 20·1% [16·6-23·0]), and smoking (25·3 million [22·6-28·2] DALYs or 17·6% [16·4-19·0]).
Interpretation: The annual number of strokes and deaths due to stroke increased substantially from 1990 to 2019, despite substantial reductions in age-standardised rates, particularly among people older than 70 years. The highest age-standardised stroke-related mortality and DALY rates were in the World Bank low-income group. The fastest-growing risk factor for stroke between 1990 and 2019 was high body-mass index. Without urgent implementation of effective primary prevention strategies, the stroke burden will probably continue to grow across the world, particularly in low-income countries.
Funding: Bill & Melinda Gates Foundation.
The Lancet. Neurology · 5441 citationsread the source →
An online acceptance, commitment, and self-compassion based treatment to decrease psychological distress in people with type 2 diabetes: A feasibility randomised-controlled trial.
Background and purpose: This study explored the feasibility and acceptability of conducting a larger trial of a self-guided, online self-compassion and acceptance and commitment therapy (ACT) focused treatment among people with type 2 diabetes (T2D) to decrease psychological distress.
Materials and methods: This study was a two-arm, parallel, feasibility randomised controlled trial with nested qualitative methods. UK adults with T2D were randomly (1:1) allocated to a five-week online self-compassion and ACT treatment or waitlist control. Information regarding recruitment, trial retention, and treatment completion was collected, and post-treatment semi-structured interviews were conducted to assess feasibility and acceptability. Self-report measures of psychological distress (depression, anxiety, diabetes distress) and potential treatment processes (self-compassion and psychological flexibility) were completed as secondary feasibility outcomes.
Results: Fifty-five (60.44 %) out of 91 people who accessed the study link were eligible to participate. Of these, 33 eligible participants (60 %) were randomly assigned to treatment (n = 19) or control arms (waitlist; n = 14). While treatment completion was 47.37 %, trial retention rates were 39.39 % (5-week follow-up) and 21.2 % (9-week follow-up). Secondary feasibility outcomes of treatment effect estimates are difficult to interpret in light of low treatment completion and trial retention rates.
Conclusion: A larger trial of the self-guided, online self-compassion treatment to decrease psychological distress in people with T2D may be beneficial, but it has limited feasibility in its current form. Further efforts are needed to improve treatment acceptability of online self-compassion and ACT focused treatment and trial procedures.
Internet interventions · 2 citationsread the source →
Factors associated with low utilisation of cervical cancer screening among urban women in Lilongwe, Malawi: a cross sectional study.
Background: In 2012, more than half a million women (528,000) were diagnosed with cervical cancer around the world. More than 80% of cervical cancer occurs in developing nations, such as Malawi, where estimates of the disease's burden show an incidence of 75.9 per 100,000 women and a mortality rate of 49.8 per 100,000 women (both age-adjusted). Despite its case fatality rate, cervical cancer can be avoided through immunization, early detection and screening. Malawi however, has low immunization and screening rates with coverage as low as 9% and 15%, respectively. Here our aim is to uncover factors that contribute to low utilization of cervical cancer screening services among women in Lilongwe, a large urban center.
Methods: This was a qualitative cross-sectional study. Participants were chosen at random from a big metropolitan health center. In-depth interviews and two observations were undertaken by the researchers. Interviews were taped, transcribed verbatim, and content assessed.
Results: A total of 24 women and 5 health workers, with an average age of 34.8 years, were questioned. 50% of women had completed secondary school, 33.3% had completed primary school, and 4% had completed no formal education. The majority of the women were housewives and entrepreneurs. 62.5% of the respondents had fewer than four children, 25% had four to six children, and 8.3% had more than six children. 91 - 6% of those surveyed were married, with 78% of Christians and 20% of Muslims. The majority of women were unaware of the importance of cervical cancer screening. Some people were concerned about marital troubles, pain during the process, "laziness," and the amount of time necessary. The majority of people would come for a test as a result of signs and symptoms. Male health personnel would be unable to screen Muslim women. All of the medical personnel had at least two years of experience. Women's low involvement in cervical cancer screening has been linked by health workers to a lack of resources and a lack of community awareness.
Conclusion: Cervical cancer can be prevented by early detection and treatment. Women, on the other hand, are uninformed about cervical cancer. Myths, misconceptions, cultural and religious beliefs, as well as service restrictions and community sensitization, influence the use of cervical cancer screening services. Addressing these issues has the potential to boost cervical cancer screening rates.
BMC women's health · 16 citationsread the source →
Effect of a Nurse-Led, Patient-Centered, Gratitude Intervention on Patient Hospitalization Experience.
Objective: Objectives were to evaluate patient perceptions of a nurse-led, patient-centered gratitude intervention and if nurses identified actionable items to improve patient's hospitalization experience.
Background: Research demonstrates positive effects of gratitude and caring interventions on patient health and well-being. Evidence is sparse regarding nurse-led gratitude interventions improving hospitalized patient's experiences.
Methods: In this pilot study, 91 adult medical patients completed gratitude forms twice daily for up to 6 shifts and a study discharge form documenting intervention perceptions. In response to the patients' gratitude-related feedback, RNs recorded patient experience-related actions they and interprofessional teams could implement.
Results: On average, patients perceived the nurse-led gratitude intervention as helpful (4.2) (1 = very unhelpful, 5 = very helpful) and improved hospitalization experiences (4.3) (1 = seldom, 5 = never). Most of the time actions were required or to be taken, based on patient gratitude intervention responses.
Conclusions: Patient perceptions of nurse-led gratitude intervention demonstrated helpfulness and improved hospitalization experience.
The Journal of nursing administration · 4 citationsread the source →
Prevalence and identification of anxiety disorders in pregnancy: the diagnostic accuracy of the two-item Generalised Anxiety Disorder scale (GAD-2).
Objective: To estimate the population prevalence of anxiety disorders during pregnancy and investigate the diagnostic accuracy of the two-item Generalised Anxiety Disorder scale (GAD-2) for a) GAD and b) any anxiety disorder.
Design: Cross-sectional survey using a stratified sampling design. Sampling weights were used in the analysis to adjust for the bias introduced by the stratified sampling.
Setting: Inner-city maternity service, South London.
Participants: 545 pregnant women were interviewed after their first antenatal appointment; 528 provided answers on the GAD-2 questions.
Main outcome measures: Diagnosis generated by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, 4th edition (SCID).
Results: Population prevalence of anxiety disorders was 17% (95% CI 12% to 21%): 5% (95% CI 3% to 6%) for GAD, 4% (95% CI 2% to 6%) for social phobia, 8% (95% CI 5% to 11%) for specific phobia and 2% (95% CI 1% to 4%) for obsessive-compulsive disorder. Post-traumatic stress disorder (PTSD) prevalence was unclear due to higher levels of reluctance to respond to PTSD interview questions but sensitivity analyses suggest population prevalence maybe up to 4% (95% CI 2% to 6%). Weighted sensitivity of GAD-2 for GAD (cut-off ≥3) was 69%, specificity 91%, positive predictive value 26%, negative predictive value 98% and likelihood ratio 7.35. For any anxiety disorder the weighted sensitivity was 26%, specificity 91%, positive predictive value 36%, negative predictive value 87% and likelihood ratio 2.92.
Conclusions: Anxiety disorders are common but GAD-2 generates many false positives and may therefore be unhelpful in maternity services.
BMJ open · 50 citationsread the source →
24-Hour Movement Behaviors and Internalizing and Externalizing Behaviors Among Youth.
Purpose: The Canadian 24-Hour Movement Guidelines for Children and Youth (≥60 minutes of moderate-to-vigorous physical activity per day, ≤2 hours of recreational screen time per day, and 9-11 hours of sleep per night for 5-13 years old) are associated with better physical health, but less is known about how these behaviors are related to mental health. This study examined the association of meeting these guideline recommendations with internalizing and externalizing behaviors among youth.
Methods: A large and broadly representative cross-sectional sample of 9- to 11-year-old U.S. youth (N = 11,875) from the Adolescent Brain and Cognitive Development study was analyzed. Internalizing and externalizing behaviors were measured using the Child Behaviour Checklist. Associations were examined using negative binomial regression adjusted for several confounders.
Results: Compared to meeting none of the recommendations, meeting recommendations for screen time and sleep but not physical activity was associated with a lower prevalence ratio of total, internalizing, and externalizing behaviors. Meeting two or all three recommendations was more strongly associated with these outcomes than meeting one recommendation or none. The prevalence ratio of the group meeting all three recommendations was .77 (95% confidence interval [CI]: .68-.86) for total problem scores, .78 (95% CI: .68-.89) for internalizing problem scores, and .79 (95% CI: .68-.91) for externalizing problem scores.
Conclusions: Meeting the 24-hour movement guidelines was associated with a lower risk of internalizing and externalizing behaviors in youth. These associations were mainly explained by meeting the screen time and sleep duration recommendations.
The Journal of adolescent health : official publication of the Society for Adolescent Medicine · 41 citationsread the source →
Use of rumination and activity monitoring for the identification of dairy cows with health disorders: Part I. Metabolic and digestive disorders.
The objectives of this study were to evaluate (1) the performance of an automated health-monitoring system (AHMS) to identify cows with metabolic and digestive disorders-including displaced abomasum, ketosis, and indigestion-based on an alert system (health index score, HIS) that combines rumination time and physical activity; (2) the number of days between the first HIS alert and clinical diagnosis (CD) of the disorders by farm personnel; and (3) the daily rumination time, physical activity, and HIS patterns around CD. Holstein cattle (n=1,121; 451 nulliparous and 670 multiparous) were fitted with a neck-mounted electronic rumination and activity monitoring tag (HR Tags, SCR Dairy, Netanya, Israel) from at least -21 to 80 d in milk (DIM). Raw data collected in 2-h periods were summarized per 24 h as daily rumination and activity. A HIS (0 to 100 arbitrary units) was calculated daily for individual cows with an algorithm that used rumination and activity. A positive HIS outcome was defined as a HIS of <86 during at least 1 d from -5 to 2 d after CD. Blood concentrations of nonesterified fatty acids, β-hydroxybutyrate, total calcium, and haptoglobin were determined in a subgroup of cows (n=459) at -11±3, -4±3, 0, 3±1, 7±1, 14±1, and 28±1 DIM. The sensitivity of the HIS was 98% [95% confidence interval (CI): 93, 100] for displaced abomasum (n=41); 91% (95% CI: 83, 99) for ketosis (n=54); 89% (95% CI: 68, 100) for indigestion (n=9); and 93% (95% CI: 89, 98) for all metabolic and digestive disorders combined (n=104). Days (mean and 95% CI) from the first positive HIS <86 and CD were -3 (-3.7, -2.3), -1.6 (-2.3, -1.0), -0.5 (-1.5, 0.5), and -2.1 (-2.5, -1.6) for displaced abomasum, ketosis, indigestion, and all metabolic and digestive disorders, respectively. The patterns of rumination, activity, and HIS for cows flagged by the AHMS were characterized by lower levels than for cows without a health disorder and cows not flagged by the AHMS from -5 to 5 d after CD, depending on the disorder and parameter. Differences between cows without health disorders and those flagged by the AHMS for blood markers of metabolic and health status confirmed the observations of the CD and AHMS alerts. The overall sensitivity and timing of the AHMS alerts for cows with metabolic and digestive disorders indicated that AHMS that combine rumination and activity could be a useful tool for identifying cows with metabolic and digestive disorders.
Journal of dairy science · 106 citationsread the source →
Wu NL, Chen Y, Dieffenbach BV, Ehrhardt MJ, Hingorani S, Howell RM, Jefferies JL, Mulrooney DA, Oeffinger KC, Robison LL, Weil BR, Yuan Y, Yasui Y, Hudson MM, Leisenring WM, Armstrong GT, Chow EJ. (2023)MEDLINE-indexed journal, not yet read by usJournal of clinical oncology : official journal of the American Society of Clinical Oncology Development and Validation of a Prediction Model for Kidney Failure in Long-Term Survivors of Childhood Cancer.
Purpose: Kidney failure is a rare but serious late effect following treatment for childhood cancer. We developed a model using demographic and treatment characteristics to predict individual risk of kidney failure among 5-year survivors of childhood cancer.
Methods: Five-year survivors from the Childhood Cancer Survivor Study (CCSS) without history of kidney failure (n = 25,483) were assessed for subsequent kidney failure (ie, dialysis, kidney transplantation, or kidney-related death) by age 40 years. Outcomes were identified by self-report and linkage with the Organ Procurement and Transplantation Network and the National Death Index. A sibling cohort (n = 5,045) served as a comparator. Piecewise exponential models accounting for race/ethnicity, age at diagnosis, nephrectomy, chemotherapy, radiotherapy, congenital genitourinary anomalies, and early-onset hypertension estimated the relationships between potential predictors and kidney failure, using area under the curve (AUC) and concordance (C) statistic to evaluate predictive power. Regression coefficient estimates were converted to integer risk scores. The St Jude Lifetime Cohort Study and the National Wilms Tumor Study served as validation cohorts.
Results: Among CCSS survivors, 204 developed late kidney failure. Prediction models achieved an AUC of 0.65-0.67 and a C-statistic of 0.68-0.69 for kidney failure by age 40 years. Validation cohort AUC and C-statistics were 0.88/0.88 for the St Jude Lifetime Cohort Study (n = 8) and 0.67/0.64 for the National Wilms Tumor Study (n = 91). Risk scores were collapsed to form statistically distinct low- (n = 17,762), moderate- (n = 3,784), and high-risk (n = 716) groups, corresponding to cumulative incidences in CCSS of kidney failure by age 40 years of 0.6% (95% CI, 0.4 to 0.7), 2.1% (95% CI, 1.5 to 2.9), and 7.5% (95% CI, 4.3 to 11.6), respectively, compared with 0.2% (95% CI, 0.1 to 0.5) among siblings.
Conclusion: Prediction models accurately identify childhood cancer survivors at low, moderate, and high risk for late kidney failure and may inform screening and interventional strategies.
Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 15 citationsread the source →
Conrad N, Judge A, Tran J, Mohseni H, Hedgecott D, Crespillo AP, Allison M, Hemingway H, Cleland JG, McMurray JJV, Rahimi K. (2018)MEDLINE-indexed journal, not yet read by usLancet (London, England) Temporal trends and patterns in heart failure incidence: a population-based study of 4 million individuals.
Background: Large-scale and contemporary population-based studies of heart failure incidence are needed to inform resource planning and research prioritisation but current evidence is scarce. We aimed to assess temporal trends in incidence and prevalence of heart failure in a large general population cohort from the UK, between 2002 and 2014.
Methods: For this population-based study, we used linked primary and secondary electronic health records of 4 million individuals from the Clinical Practice Research Datalink (CPRD), a cohort that is representative of the UK population in terms of age and sex. Eligible patients were aged 16 years and older, had contributed data between Jan 1, 2002, and Dec 31, 2014, had an acceptable record according to CPRD quality control, were approved for CPRD and Hospital Episodes Statistics linkage, and were registered with their general practice for at least 12 months. For patients with incident heart failure, we extracted the most recent measurement of baseline characteristics (within 2 years of diagnosis) from electronic health records, as well as information about comorbidities, socioeconomic status, ethnicity, and region. We calculated standardised rates by applying direct age and sex standardisation to the 2013 European Standard Population, and we inferred crude rates by applying year-specific, age-specific, and sex-specific incidence to UK census mid-year population estimates. We assumed no heart failure for patients aged 15 years or younger and report total incidence and prevalence for all ages (>0 years).
Findings: From 2002 to 2014, heart failure incidence (standardised by age and sex) decreased, similarly for men and women, by 7% (from 358 to 332 per 100 000 person-years; adjusted incidence ratio 0·93, 95% CI 0·91-0·94). However, the estimated absolute number of individuals with newly diagnosed heart failure in the UK increased by 12% (from 170 727 in 2002 to 190 798 in 2014), largely due to an increase in population size and age. The estimated absolute number of prevalent heart failure cases in the UK increased even more, by 23% (from 750 127 to 920 616). Over the study period, patient age and multi-morbidity at first presentation of heart failure increased (mean age 76·5 years [SD 12·0] to 77·0 years [12·9], adjusted difference 0·79 years, 95% CI 0·37-1·20; mean number of comorbidities 3·4 [SD 1·9] vs 5·4 [2·5]; adjusted difference 2·0, 95% CI 1·9-2·1). Socioeconomically deprived individuals were more likely to develop heart failure than were affluent individuals (incidence rate ratio 1·61, 95% CI 1·58-1·64), and did so earlier in life than those from the most affluent group (adjusted difference -3·51 years, 95% CI -3·77 to -3·25). From 2002 to 2014, the socioeconomic gradient in age at first presentation with heart failure widened. Socioeconomically deprived individuals also had more comorbidities, despite their younger age.
Interpretation: Despite a moderate decline in standardised incidence of heart failure, the burden of heart failure in the UK is increasing, and is now similar to the four most common causes of cancer combined. The observed socioeconomic disparities in disease incidence and age at onset within the same nation point to a potentially preventable nature of heart failure that still needs to be tackled.
Funding: British Heart Foundation and National Institute for Health Research.
Lancet (London, England) · 925 citationsread the source →
Peer-to-peer support model to improve quality of life among highly vulnerable, low-income older adults in Cape Town, South Africa.
Background: Developing countries are experiencing rapid population ageing. Many do not have the resources or formal structures available to support the health and wellbeing of people as they age. In other contexts, the use of peer support programmes have shown favourable outcomes in terms of reducing loneliness, increasing physical activity and managing chronic disease. Such programmes have not been previously developed or tested in African countries. We piloted a peer-to-peer support model among vulnerable community-dwelling adults in a developing country (South Africa) to examine the program's effect on wellbeing and social engagement.
Methods: A pre-post, pilot design was used to evaluate targeted outcomes, including wellbeing, social support, social interaction, mood, loneliness and physical activity. A total of 212 persons, aged 60+ years and living independently in a low-income area in Cape Town were recruited and screened for eligibility by trained assessors. Participants were assessed using the interRAI CheckUp, WHO-5 Wellbeing index, and the MOS-SS 8 instruments before and after the 5-month intervention, during which they received regular visits and phone calls from trained peer volunteers. During visits volunteers administered a wellness screening, made referrals to health and social services; built friendships with clients; encouraged social engagement; promoted healthy living; and provided emotional and informational support.
Results: Volunteer visits with clients significantly increased levels of self-reported wellbeing by 58%; improved emotional and informational support by 50%; decreased reports of reduced social interaction by 91%; reduced loneliness by 70%; improved mood scores represented as anxiety, depression, lack of interest or pleasure in activities, and withdrawal from activities of interest; and increased levels of physical activity from 49 to 66%.
Discussion: The intervention led to demonstrable improvement in client wellbeing. Policymakers should consider integrating peer-support models into existing health programs to better address the needs of the elderly population and promote healthy ageing in resource-poor community settings. Longer-term and more rigorous studies with a control group are needed to support these findings and to investigate the potential impact of such interventions on health outcomes longitudinally.
BMC geriatrics · 37 citationsread the source →
What makes a difference: Early Head Start evaluation findings in a developmental context.
The federal Early Head Start (EHS) program began in 1995, and a randomized trial was conducted to evaluate the efficacy of 17 EHS programs. In all, 3,001 low-income families (35% African American, 24% Hispanic, and 37% White) with a pregnant women or an infant under the age of 12 months were randomly assigned to a treatment or control group (with 91% of the treatment group receiving some services). Data were collected when the children were about 1, 2, and 3 years of age, and at age 5 (2 years after leaving EHS). Research questions examined (1) impacts of EHS at ages 2 and 3 (when services were being offered) and at age 5, and (2) contributions of early education experiences across children's first 5 years of life. Child outcomes included cognition, language, attention, behavior problems, and health; maternal outcomes included parenting, mental health, and employment. Overall impact analyses at ages 2 and 3 indicated that EHS benefited children and families: impacts were seen in all domains, with effect sizes of significant impacts ranging from .10 to .20. At age 5, EHS children had better attention and approaches toward learning as well as fewer behavior problems than the control group, although they did not differ on early school achievement. Subgroup analyses indicated that cognitive impacts were sustained 2 years after the program ended for African American children and language impacts for Hispanic children who spoke Spanish. Some significant family benefits were seen at age 5. Mediated analyses identified which child and family impacts at ages 2 and 3 contributed to the child impacts at age 5 (most relevant were earlier treatment effects on child cognition and on engagement with the parent). Growth curve analyses were also conducted. Although fewer than half the children enrolled in center-based preschool programs between ages 3 and 4, almost 90% participated in the year preceding kindergarten. A higher percentage of EHS than control children were enrolled. Nonexperimental analyses suggested that formal program participation enhanced children's readiness for school while also increasing parent-reported aggression. At age 5, those children and families who experienced EHS followed by formal programs fared best overall. However, the benefits of the two experiences were associated with outcomes in different ways. Benefits in language, behavior, and parenting were associated primarily with EHS; benefits in early school achievement were associated primarily with preschool attendance.
Monographs of the Society for Research in Child Development · 41 citationsread the source →
Prediction of functional outcome in individuals at clinical high risk for psychosis.
Importance: A major public health concern associated with schizophrenia and psychotic disorders is the long-term disability that involves impaired cognition, lack of social support, and an inability to function independently in the community. A critical goal of early detection and intervention studies in psychosis is therefore to understand the factors leading to this often profound impairment.
Objective: To develop a predictive model of functional (social and role) outcome in a clinical high-risk sample for psychosis.
Design: Prospective, naturalistic, longitudinal 3- to 5-year follow-up study.
Setting: The Recognition and Prevention Program in New York, a research clinic located in the Zucker Hillside Hospital in New York.
Participants: One hundred one treatment-seeking patients at clinical high risk for psychosis. Ninety-two (91%) were followed up prospectively for a mean (SD) of 3 (1.6) years.
Intervention: Neurocognitive and clinical assessment.
Main outcomes and measures: The primary outcome variables were social and role functioning at the last follow-up visit.
Results: Poor social outcome was predicted by reduced processing speed (odds ratio [OR], 1.38; 95% CI, 1.050-1.823; P = .02), impaired social functioning at baseline (OR, 1.85; 95% CI, 1.258-2.732; P = .002), and total disorganized symptoms (OR, 5.06; 95% CI, 1.548-16.527; P = .007). Reduced performance on tests for verbal memory (OR, 1.74; 95% CI, 1.169-2.594; P = .006), role functioning at baseline (OR, 1.34; 95% CI, 1.053-1.711; P = .02), and motor disturbances (OR, 1.77; 95% CI, 1.060-2.969; P = .03) predicted role outcome. The areas under the curve for the social and role prediction models were 0.824 (95% CI, 0.736-0.913; P < .001) and 0.77 (95% CI, 0.68-0.87; P < .001), respectively, demonstrating a high discriminative ability. In addition, poor functional outcomes were not entirely dependent on the development of psychosis, because 40.3% and 45.5% of nonconverters at clinical high risk had poor social and role outcomes, respectively.
Conclusions and relevance: Results from this study support the increasing emphasis on functional decline as a critically important outcome that parallels conversion to psychosis and suggest that both psychosis and long-term functional disability are equally important targets for prevention. Reduced neurocognitive performance, functional impairments, and nonpositive attenuated symptoms at baseline were associated with an increased risk of poor functional outcomes in our sample. Poor functional outcomes were not entirely dependent on positive symptoms and the development of psychosis, further highlighting the need for intervention at this early stage of development for those who do and do not convert to a full-blown psychotic disorder.
JAMA psychiatry · 211 citationsread the source →
Breastfeeding duration and postpartum psychological adjustment: role of maternal attachment styles.
Aim: Depressive and anxiety symptoms are common in new mothers. The aim of this study is to explore the link between postpartum psychological adjustment and feeding preferences of the mothers.
Methods: Sixty mothers and newborns were enrolled in this prospective, longitudinal study. Maternal depressive symptoms were screened by the Edinburgh Postpartum Depression Scale (EPDS), and maternal anxiety level was assessed by the State-Trait Anxiety Inventory at 1 month postpartum. The Multidimensional Scale of Perceived Social Support was used for the assessment of maternal social support. The Adult Attachment Scale was used to determine the attachment style of the mother. Infants were examined and evaluated at 1 and 4 months of life.
Results: All mothers started breastfeeding their infants postpartum; 91% and 68.1% continued exclusive breastfeeding at 1 and 4 months, respectively. The first-month median EPDS score of mothers who breastfeed at the fourth month was statistically significantly lower than those who were not breastfeeding (6 and 12, respectively) (P = 0001). The first-month median EPDS score of mothers with secure attachment was lower than the median score of mothers with insecure attachment (5 and 9, respectively) (P < 0001). Exclusive breastfeeding rate was not statistically different among mothers with secure and insecure attachment styles. The median state and trait anxiety scores and social support scores of mothers were not different between groups according to breastfeeding status.
Conclusions: This study has shown an association between higher EPDS scores and breastfeeding cessation by 4 months after delivery.
Journal of paediatrics and child health · 61 citationsread the source →
Lawrence E, Barry RA, Brock RL, Bunde M, Langer A, Ro E, Fazio E, Mulryan L, Hunt S, Madsen L, Dzankovic S. (2011)MEDLINE-indexed journal, not yet read by usPsychological assessment The Relationship Quality Interview: evidence of reliability, convergent and divergent validity, and incremental utility.
Relationship satisfaction and adjustment have been the target outcome variables for almost all couple research and therapies. In contrast, far less attention has been paid to the assessment of relationship quality. The present study introduces the Relationship Quality Interview (RQI), a semistructured, behaviorally anchored individual interview. The RQI was designed to provide a more objective assessment of relationship quality as a dynamic, dyadic construct across 5 dimensions: (a) quality of emotional intimacy in the relationship, (b) quality of the couple's sexual relationship, (c) quality of support transactions in the relationship, (d) quality of the couple's ability to share power in the relationship, and (e) quality of conflict/problem-solving interactions in the relationship. Psychometric properties of RQI ratings were examined through scores obtained from self-report questionnaires and behavioral observation data collected cross-sectionally from a sample of 91 dating participants and longitudinally from a sample of 101 married couples. RQI ratings demonstrated strong reliability (internal consistency, interrater agreement, interpartner agreement, and correlations among scales), convergent validity (correlations between RQI scale ratings and questionnaire scores assessing similar domains of relationship quality), and divergent validity (correlations between RQI scale ratings and (a) behavioral observation codes assessing related constructs, (b) global relationship satisfaction scores, and (c) scores on individual difference measures of related constructs). Clinical implications of the RQI for improving couple assessment and interventions are discussed.
Psychological assessment · 24 citationsread the source →
McGillicuddy JW, Gregoski MJ, Weiland AK, Rock RA, Brunner-Jackson BM, Patel SK, Thomas BS, Taber DJ, Chavin KD, Baliga PK, Treiber FA. (2013)MEDLINE-indexed journal, not yet read by usJMIR research protocols Mobile Health Medication Adherence and Blood Pressure Control in Renal Transplant Recipients: A Proof-of-Concept Randomized Controlled Trial.
Background: Mobile phone based programs for kidney transplant recipients are promising tools for improving long-term graft outcomes and better managing comorbidities (eg, hypertension, diabetes). These tools provide an easy to use self-management framework allowing optimal medication adherence that is guided by the patients' physiological data. This technology is also relatively inexpensive, has an intuitive interface, and provides the capability for real-time personalized feedback to help motivate patient self-efficacy. Automated summary reports of patients' adherence and blood pressure can easily be uploaded to providers' networks helping reduce clinical inertia by reducing regimen alteration time.
Objective: The aim of this study was to assess the feasibility, acceptability, and preliminary outcomes of a prototype mobile health (mHealth) medication and blood pressure (BP) self-management system for kidney transplant patients with uncontrolled hypertension.
Methods: A smartphone enabled medication adherence and BP self-management system was developed using a patient and provider centered design. The development framework utilized self-determination theory with iterative stages that were guided and refined based on patient/provider feedback. A 3-month proof-of-concept randomized controlled trial was conducted in 20 hypertensive kidney transplant patients identified as non-adherent to their current medication regimen based on a month long screening using an electronic medication tray. Participants randomized to the mHealth intervention had the reminder functions of their electronic medication tray enabled and received a bluetooth capable BP monitor and a smartphone that received and transmitted encrypted physiological data and delivered reminders to measure BP using text messaging. Controls received standard of care and their adherence continued to be monitored with the medication tray reminders turned off. Providers received weekly summary reports of patient medication adherence and BP readings.
Results: Participation and retention rates were 41/55 (75%) and 31/34 (91%), respectively. The prototype system appears to be safe, highly acceptable, and useful to patients and providers. Compared to the standard care control group (SC), the mHealth intervention group exhibited significant improvements in medication adherence and significant reductions in clinic-measured systolic blood pressures across the monthly evaluations. Physicians made more anti-hypertensive medication adjustments in the mHealth group versus the standard care group (7 adjustments in 5 patients versus 3 adjustments in 3 patients) during the 3-month trial based on the information provided in the weekly reports.
Conclusions: These data support the acceptability and feasibility of the prototype mHealth system. Further trials with larger sample sizes and additional biomarkers (eg, whole blood medication levels) are needed to examine efficacy and effectiveness of the system for improving medication adherence and blood pressure control after kidney transplantation over longer time periods.
Trial registration: Clinicaltrials.gov NCT01859273; http://clinicaltrials.gov/ct2/show/NCT01859273 (Archived by WebCite at http://www.webcitation.org/6IqfCa3A3).
JMIR research protocols · 144 citationsread the source →
A national profile of childhood epilepsy and seizure disorder.
Objective: To determine sociodemographics, patterns of comorbidity, and function of US children with reported epilepsy/seizure disorder.
Methods: Bivariate and multivariable cross-sectional analysis of data from the National Survey of Children's Health (2007) on 91 605 children ages birth to 17 years, including 977 children reported by their parents to have been diagnosed with epilepsy/seizure disorder.
Results: Estimated lifetime prevalence of epilepsy/seizure disorder was 10.2/1000 (95% confidence interval [CI]: 8.7-11.8) or 1%, and of current reported epilepsy/seizure disorder was 6.3/1000 (95% CI: 4.9-7.8). Epilepsy/seizure disorder prevalence was higher in lower-income families and in older, male children. Children with current reported epilepsy/seizure disorder were significantly more likely than those never diagnosed to experience depression (8% vs 2%), anxiety (17% vs 3%), attention-deficit/hyperactivity disorder (23% vs 6%), conduct problems (16% vs 3%), developmental delay (51% vs 3%), autism/autism spectrum disorder (16% vs 1%), and headaches (14% vs 5%) (all P < .05). They had greater risk of limitation in ability to do things (relative risk: 9.22; 95% CI: 7.56-11.24), repeating a school grade (relative risk: 2.59; CI: 1.52-4.40), poorer social competence and greater parent aggravation, and were at increased risk of having unmet medical and mental health needs. Children with prior but not current seizures largely had intermediate risk.
Conclusions: In a nationally representative sample, children with seizures were at increased risk for mental health, developmental, and physical comorbidities, increasing needs for care coordination and specialized services. Children with reported prior but not current seizures need further study to establish reasons for their higher than expected levels of reported functional limitations.
Pediatrics · 386 citationsread the source →
Not all coping strategies are created equal: a mixed methods study exploring physicians' self reported coping strategies.
Background: Physicians experience workplace stress and draw on different coping strategies. The primary goal of this paper is to use interview data to explore physicians' self reported coping strategies. In addition, questionnaire data is utilized to explore the degree to which the coping strategies are used and are associated with feelings of emotional exhaustion, a key symptom of burnout.
Methods: This mixed methods study explores factors related to physician wellness within a large health region in Western Canada. This paper focuses on the coping strategies that physicians use in response to work-related stress. The qualitative component explores physicians' self reported coping strategies through open ended interviews of 42 physicians representing diverse medical specialties and settings (91% response rate). The major themes extracted from the qualitative interviews were used to construct 12 survey items that were included in the comprehensive quantitative questionnaire. Questionnaires were sent to all eligible physicians in the health region with 1178 completed surveys (40% response rate.) Questionnaire items were used to measure how often physicians draw on the various coping strategies. Feelings of burnout were also measured in the survey by 5 items from the Emotional Exhaustion subscale of the revised Maslach Burnout Inventory.
Results: Major themes identified from the interviews include coping strategies used at work (e.g., working through stress, talking with co-workers, taking a time out, using humor) and after work (e.g., exercise, quiet time, spending time with family). Analysis of the questionnaire data showed three often used workplace coping strategies were positively correlated with feeling emotionally exhausted (i.e., keeping stress to oneself (r = .23), concentrating on what to do next (r = .16), and going on as if nothing happened (r = .07)). Some less often used workplace coping strategies (e.g., taking a time out) and all those used after work were negatively correlated with frequency of emotional exhaustion.
Conclusions: Physicians' self reported coping strategies are not all created equal in terms of frequency of use and correlation with feeling emotionally exhausted from one's work. This knowledge may be integrated into practical physician stress reduction interventions.
BMC health services research · 68 citationsread the source →