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Laparoscopic ileocaecal resection versus infliximab for terminal ileitis in Crohn's disease: a randomised controlled, open-label, multicentre trial.

Background: Treatment of patients with ileocaecal Crohn's disease who have not responded to conventional therapy is commonly scaled up to biological agents, but surgery can also offer excellent short-term and long-term results. We compared laparoscopic ileocaecal resection with infliximab to assess how they affect health-related quality of life. Methods: In this randomised controlled, open-label trial, in 29 teaching hospitals and tertiary care centres in the Netherlands and the UK, adults with non-stricturing, ileocaecal Crohn's disease, in whom conventional therapy has failed were randomly allocated (1:1) by an internet randomisation module with biased-coin minimisation for participating centres and perianal fistula to receive laparoscopic ileocaecal resection or infliximab. Eligible patients were aged 18-80 years, had active Crohn's disease of the terminal ileum, and had not responded to at least 3 months of conventional therapy with glucocorticosteroids, thiopurines, or methotrexate. Patients with diseased terminal ileum longer than 40 cm or abdominal abscesses were excluded. The primary outcome was quality of life on the Inflammatory Bowel Disease Questionnaire (IBDQ) at 12 months. Secondary outcomes were general quality of life, measured by the Short Form-36 (SF-36) health survey and its physical and mental component subscales, days unable to participate in social life, days on sick leave, morbidity (additional procedures and hospital admissions), and body image and cosmesis. Analyses of the primary outcome were done in the intention-to-treat population, and safety analyses were done in the per-protocol population. This trial is registered at the Dutch Trial Registry (NTR1150). Findings: Between May 2, 2008, and October 14, 2015, 73 patients were allocated to have resection and 70 to receive infliximab. Corrected for baseline differences, the mean IBDQ score at 12 months was 178·1 (95% CI 171·1-185·0) in the resection group versus 172·0 (164·3-179·6) in the infliximab group (mean difference 6·1 points, 95% CI -4·2 to 16·4; p=0·25). At 12 months, the mean SF-36 total score was 112·1 (95% CI 108·0-116·2) in the resection group versus 106·5 (102·1-110·9) in the infliximab group (mean difference 5·6, 95% CI -0·4 to 11·6), the mean physical component score was 47·7 (45·7-49·7) versus 44·6 (42·5-46·8; mean difference 3·1, 4·2 to 6·0), and the mean mental component score was 49·5 (47·0-52·1) versus 46·1 (43·3-48·9; mean difference 3·5, -0·3 to 7·3). Mean numbers of days of sick leave were 3·4 days (SD 7·1) in the resection group versus 1·4 days (4·7) in the infliximab group (p<0·0001), days not able to take part in social life were 1·8 days (6·3) versus 1·1 days (4·5; p=0·20), days of scheduled hospital admission were 6·5 days (3·8) versus 6·8 days (3·2; p=0·84), and the number of patients who had unscheduled hospital admissions were 13 (18%) of 73 versus 15 (21%) of 70 (p=0·68). Body-image scale mean scores in the patients who had resection were 16·0 (95% CI 15·2-16·8) at baseline versus 17·8 (17·1-18·4) at 12 months, and cosmetic scale mean scores were 17·6 (16·6-18·6) versus 18·6 (17·6-19·6). Surgical intervention-related complications classified as IIIa or worse on the Clavien-Dindo scale occurred in four patients in the resection group. Treatment-related serious adverse events occurred in two patients in the infliximab group. During a median follow-up of 4 years (IQR 2-6), 26 (37%) of 70 patients in the infliximab group had resection, and 19 (26%) of 73 patients in the resection group received anti-TNF. Interpretation: Laparoscopic resection in patients with limited (diseased terminal ileum <40 cm), non-stricturing, ileocaecal Crohn's disease in whom conventional therapy has failed could be considered a reasonable alternative to infliximab therapy. Funding: Netherlands Organisation for Health Research and Development.

The lancet. Gastroenterology & hepatology · randomised controlled trial · 228 citationsread the source →

Association between autism symptoms and family functioning in children with attention-deficit/hyperactivity disorder: a community-based study.

Autism spectrum disorder (ASD) symptoms are elevated in populations of children with attention-deficit/hyperactivity disorder (ADHD). This study examined cross-sectional associations between ASD symptoms and family functioning in children with and without ADHD. Participants were recruited to a longitudinal cohort study, aged 6-10 years (164 ADHD; 198 controls). ADHD cases were ascertained using community-based screening and diagnostic confirmation from a diagnostic interview. ASD symptoms were measured using the Social Communication Questionnaire. Outcome variables were parent mental health, family quality of life (FQoL), couple conflict and support, and parenting behaviours. After adjustment for a range of child and family factors (including other mental health comorbidities), higher ASD symptoms were associated with poorer FQoL across all three domains; emotional impact (p = 0.008), family impact (p = 0.001) and time impact (p = 0.003). In adjusted analyses by subgroup, parents of children with ADHD+ASD had poorer parent self-efficacy (p = 0.01), poorer FQoL (p ≤ 0.05), with weak evidence of an association for less couple support (p = 0.06), compared to parents of children with ADHD only. Inspection of covariates in the adjusted analyses indicated that the association between ASD symptoms and most family functioning measures was accounted forby child internalising and externalising disorders, ADHD severity, and socioeconomic status; however, ASD symptoms appear to be independently associated with poorer FQoL in children with ADHD. The presence of ASD symptoms in children with ADHD may signal the need for enhanced family support.

European child & adolescent psychiatry · 8 citationsread the source →

Trial for Reducing Weight Retention in New Mums: a randomised controlled trial evaluating a low intensity, postpartum weight management programme.

Background: Failure to return to pregnancy weight by 6 months postpartum is associated with long-term obesity, as well as adverse health outcomes. This research evaluated a postpartum weight management programme for women with a body mass index (BMI) > 25 kg m(-2) that combined behaviour change principles and a low-intensity delivery format with postpartum nutrition information. Methods: Women were randomised at 24-28 weeks to control (supported care; SC) or intervention (enhanced care; EC) groups, stratified by BMI cohort. At 36 weeks of gestation, SC women received a 'nutrition for breastfeeding' resource and EC women received a nutrition assessment and goal-setting session about post-natal nutrition, plus a 6-month correspondence intervention requiring return of self-monitoring sheets. Weight change, anthropometry, diet, physical activity, breastfeeding, fasting glucose and insulin measures were assessed at 6 weeks and 6 months postpartum. Results: Seventy-seven percent (40 EC and 41 SC) of the 105 women approached were recruited; 36 EC and 35 SC women received a programme and 66.7% and 48.6% completed the study, respectively. No significant differences were observed between any outcomes. Median [interquartile range (IQR)] weight change was EC: -1.1 (9.5) kg versus SC: -1.1 (7.5) kg (6 weeks to 6 months) and EC: +1.0 (8.7) kg versus SC: +2.3 (9) kg (prepregnancy to 6 months). Intervention women breastfed for half a month longer than control women (180 versus 164 days; P = 0.10). An average of 2.3 out of six activity sheets per participant was returned. Conclusions: Despite low intervention engagement, the high retention rate suggests this remains an area of interest to women. Future strategies must facilitate women's engagement, be individually tailored, and include features that support behaviour change to decrease women's risk of chronic health issues.

Journal of human nutrition and dietetics : the official journal of the British Dietetic Association · randomised controlled trial · 30 citationsread the source →

Prophylactic vaccination against human papillomaviruses to prevent cervical cancer and its precursors.

Background: Persistent infection with high-risk human papillomaviruses (hrHPV) types is causally linked with the development of cervical precancer and cancer. HPV types 16 and 18 cause approximately 70% of cervical cancers worldwide. Objectives: To evaluate the harms and protection of prophylactic human papillomaviruses (HPV) vaccines against cervical precancer and HPV16/18 infection in adolescent girls and women. Search methods: We searched MEDLINE, Cochrane Central Register of Controlled Trials (CENTRAL) and Embase (June 2017) for reports on effects from trials. We searched trial registries and company results' registers to identify unpublished data for mortality and serious adverse events. Selection criteria: Randomised controlled trials comparing efficacy and safety in females offered HPV vaccines with placebo (vaccine adjuvants or another control vaccine). Data collection and analysis: We used Cochrane methodology and GRADE to rate the certainty of evidence for protection against cervical precancer (cervical intraepithelial neoplasia grade 2 and above [CIN2+], CIN grade 3 and above [CIN3+], and adenocarcinoma-in-situ [AIS]), and for harms. We distinguished between the effects of vaccines by participants' baseline HPV DNA status. The outcomes were precancer associated with vaccine HPV types and precancer irrespective of HPV type. Results are presented as risks in control and vaccination groups and risk ratios (RR) with 95% confidence intervals in brackets. Main results: We included 26 trials (73,428 participants). Ten trials, with follow-up of 1.3 to 8 years, addressed protection against CIN/AIS. Vaccine safety was evaluated over a period of 6 months to 7 years in 23 studies. Studies were not large enough or of sufficient duration to evaluate cervical cancer outcomes. All but one of the trials was funded by the vaccine manufacturers. We judged most included trials to be at low risk of bias. Studies involved monovalent (N = 1), bivalent (N = 18), and quadrivalent vaccines (N = 7). Most women were under 26 years of age. Three trials recruited women aged 25 and over. We summarize the effects of vaccines in participants who had at least one immunisation. Efficacy endpoints by initial HPV DNA statushrHPV negativeHPV vaccines reduce CIN2+, CIN3+, AIS associated with HPV16/18 compared with placebo in adolescent girls and women aged 15 to 26. There is high-certainty evidence that vaccines lower CIN2+ from 164 to 2/10,000 (RR 0.01 (0 to 0.05)) and CIN3+ from 70 to 0/10,000 (RR 0.01 (0.00 to 0.10). There is moderate-certainty evidence that vaccines reduce the risk of AIS from 9 to 0/10,000 (RR 0.10 (0.01 to 0.82).HPV vaccines reduce the risk of any CIN2+ from 287 to 106/10,000 (RR 0.37 (0.25 to 0.55), high certainty) and probably reduce any AIS lesions from 10 to 0/10,000 (RR 0.1 (0.01 to 0.76), moderate certainty). The size of reduction in CIN3+ with vaccines differed between bivalent and quadrivalent vaccines (bivalent: RR 0.08 (0.03 to 0.23), high certainty; quadrivalent: RR 0.54 (0.36 to 0.82), moderate certainty). Data in older women were not available for this comparison.HPV16/18 negativeIn those aged 15 to 26 years, vaccines reduce CIN2+ associated with HPV16/18 from 113 to 6 /10,000 (RR 0.05 (0.03 to 0.10). In women 24 years or older the absolute and relative reduction in the risk of these lesions is smaller (from 45 to 14/10,000, (RR 0.30 (0.11 to 0.81), moderate certainty). HPV vaccines reduce the risk of CIN3+ and AIS associated with HPV16/18 in younger women (RR 0.05 (0.02 to 0.14), high certainty and RR 0.09 (0.01 to 0.72), moderate certainty, respectively). No trials in older women have measured these outcomes. Vaccines reduce any CIN2+ from 231 to 95/10,000, (RR 0.41 (0.32 to 0.52)) in younger women. No data are reported for more severe lesions. Regardless of HPV DNA statusIn younger women HPV vaccines reduce the risk of CIN2+ associated with HPV16/18 from 341 to 157/10,000 (RR 0.46 (0.37 to 0.57), high certainty). Similar reductions in risk were observed for CIN3+ associated with HPV16/18 (high certainty). The number of women with AIS associated with HPV16/18 is reduced from 14 to 5/10,000 with HPV vaccines (high certainty).HPV vaccines reduce any CIN2+ from 559 to 391/10,000 (RR 0.70 (0.58 to 0.85, high certainty) and any AIS from 17 to 5/10,000 (RR 0.32 (0.15 to 0.67), high certainty). The reduction in any CIN3+ differed by vaccine type (bivalent vaccine: RR 0.55 (0.43 to 0.71) and quadrivalent vaccine: RR 0.81 (0.69 to 0.96)).In women vaccinated at 24 to 45 years of age, there is moderate-certainty evidence that the risks of CIN2+ associated with HPV16/18 and any CIN2+ are similar between vaccinated and unvaccinated women (RR 0.74 (0.52 to 1.05) and RR 1.04 (0.83 to 1.30) respectively). No data are reported in this age group for CIN3+ or AIS.Adverse effectsThe risk of serious adverse events is similar between control and HPV vaccines in women of all ages (669 versus 656/10,000, RR 0.98 (0.92 to 1.05), high certainty). Mortality was 11/10,000 in control groups compared with 14/10,000 (9 to 22) with HPV vaccine (RR 1.29 [0.85 to 1.98]; low certainty). The number of deaths was low overall but there is a higher number of deaths in older women. No pattern in the cause or timing of death has been established. Pregnancy outcomesAmong those who became pregnant during the studies, we did not find an increased risk of miscarriage (1618 versus 1424/10,000, RR 0.88 (0.68 to 1.14), high certainty) or termination (931 versus 838/10,000 RR 0.90 (0.80 to 1.02), high certainty). The effects on congenital abnormalities and stillbirths are uncertain (RR 1.22 (0.88 to 1.69), moderate certainty and (RR 1.12 (0.68 to 1.83), moderate certainty, respectively). Authors' conclusions: There is high-certainty evidence that HPV vaccines protect against cervical precancer in adolescent girls and young women aged 15 to 26. The effect is higher for lesions associated with HPV16/18 than for lesions irrespective of HPV type. The effect is greater in those who are negative for hrHPV or HPV16/18 DNA at enrolment than those unselected for HPV DNA status. There is moderate-certainty evidence that HPV vaccines reduce CIN2+ in older women who are HPV16/18 negative, but not when they are unselected by HPV DNA status. We did not find an increased risk of serious adverse effects. Although the number of deaths is low overall, there were more deaths among women older than 25 years who received the vaccine. The deaths reported in the studies have been judged not to be related to the vaccine. Increased risk of adverse pregnancy outcomes after HPV vaccination cannot be excluded, although the risk of miscarriage and termination are similar between trial arms. Long-term of follow-up is needed to monitor the impact on cervical cancer, occurrence of rare harms and pregnancy outcomes.

The Cochrane database of systematic reviews · systematic review · 290 citationsread the source →

Pharmacological and electronic cigarette interventions for smoking cessation in adults: component network meta-analyses.

Background: Tobacco smoking is the leading preventable cause of death and disease worldwide. Stopping smoking can reduce this harm and many people would like to stop. There are a number of medicines licenced to help people quit globally, and e-cigarettes are used for this purpose in many countries. Typically treatments work by reducing cravings to smoke, thus aiding initial abstinence and preventing relapse. More information on comparative effects of these treatments is needed to inform treatment decisions and policies. Objectives: To investigate the comparative benefits, harms and tolerability of different smoking cessation pharmacotherapies and e-cigarettes, when used to help people stop smoking tobacco. Search methods: We identified studies from recent updates of Cochrane Reviews investigating our interventions of interest. We updated the searches for each review using the Cochrane Tobacco Addiction Group (TAG) specialised register to 29 April 2022. Selection criteria: We included randomised controlled trials (RCTs), cluster-RCTs and factorial RCTs, which measured smoking cessation at six months or longer, recruited adults who smoked combustible cigarettes at enrolment (excluding pregnant people) and randomised them to approved pharmacotherapies and technologies used for smoking cessation worldwide (varenicline, cytisine, nortriptyline, bupropion, nicotine replacement therapy (NRT) and e-cigarettes) versus no pharmacological intervention, placebo (control) or another approved pharmacotherapy. Studies providing co-interventions (e.g. behavioural support) were eligible if the co-intervention was provided equally to study arms. Data collection and analysis: We followed standard Cochrane methods for screening, data extraction and risk of bias (RoB) assessment (using the RoB 1 tool). Primary outcome measures were smoking cessation at six months or longer, and the number of people reporting serious adverse events (SAEs). We also measured withdrawals due to treatment. We used Bayesian component network meta-analyses (cNMA) to examine intervention type, delivery mode, dose, duration, timing in relation to quit day and tapering of nicotine dose, using odds ratios (OR) and 95% credibility intervals (CrIs). We calculated an effect estimate for combination NRT using an additive model. We evaluated the influence of population and study characteristics, provision of behavioural support and control arm rates using meta-regression. We evaluated certainty using GRADE. Main results: Of our 332 eligible RCTs, 319 (835 study arms, 157,179 participants) provided sufficient data to be included in our cNMA. Of these, we judged 51 to be at low risk of bias overall, 104 at high risk and 164 at unclear risk, and 118 reported pharmaceutical or e-cigarette/tobacco industry funding. Removing studies at high risk of bias did not change our interpretation of the results. Benefits We found high-certainty evidence that nicotine e-cigarettes (OR 2.37, 95% CrI 1.73 to 3.24; 16 RCTs, 3828 participants), varenicline (OR 2.33, 95% CrI 2.02 to 2.68; 67 RCTs, 16,430 participants) and cytisine (OR 2.21, 95% CrI 1.66 to 2.97; 7 RCTs, 3848 participants) were associated with higher quit rates than control. In absolute terms, this might lead to an additional eight (95% CrI 4 to 13), eight (95% CrI 6 to 10) and seven additional quitters per 100 (95% CrI 4 to 12), respectively. These interventions appeared to be more effective than the other interventions apart from combination NRT (patch and a fast-acting form of NRT), which had a lower point estimate (calculated additive effect) but overlapping 95% CrIs (OR 1.93, 95% CrI 1.61 to 2.34). There was also high-certainty evidence that nicotine patch alone (OR 1.37, 95% CrI 1.20 to 1.56; 105 RCTs, 37,319 participants), fast-acting NRT alone (OR 1.41, 95% CrI 1.29 to 1.55; 120 RCTs, 31,756 participants) and bupropion (OR 1.43, 95% CrI 1.26 to 1.62; 71 RCTs, 14,759 participants) were more effective than control, resulting in two (95% CrI 1 to 3), three (95% CrI 2 to 3) and three (95% CrI 2 to 4) additional quitters per 100 respectively. Nortriptyline is probably associated with higher quit rates than control (OR 1.35, 95% CrI 1.02 to 1.81; 10 RCTs, 1290 participants; moderate-certainty evidence), resulting in two (CrI 0 to 5) additional quitters per 100. Non-nicotine/placebo e-cigarettes (OR 1.16, 95% CrI 0.74 to 1.80; 8 RCTs, 1094 participants; low-certainty evidence), equating to one additional quitter (95% CrI -2 to 5), had point estimates favouring the intervention over control, but CrIs encompassed the potential for no difference and harm. There was low-certainty evidence that tapering the dose of NRT prior to stopping treatment may improve effectiveness; however, 95% CrIs also incorporated the null (OR 1.14, 95% CrI 1.00 to 1.29; 111 RCTs, 33,156 participants). This might lead to an additional one quitter per 100 (95% CrI 0 to 2). Harms There were insufficient data to include nortriptyline and non-nicotine EC in the final SAE model. Overall rates of SAEs for the remaining treatments were low (average 3%). Low-certainty evidence did not show a clear difference in the number of people reporting SAEs for nicotine e-cigarettes, varenicline, cytisine or NRT when compared to no pharmacotherapy/e-cigarettes or placebo. Bupropion may slightly increase rates of SAEs, although the CrI also incorporated no difference (moderate certainty). In absolute terms bupropion may cause one more person in 100 to experience an SAE (95% CrI 0 to 2). Authors' conclusions: The most effective interventions were nicotine e-cigarettes, varenicline and cytisine (all high certainty), as well as combination NRT (additive effect, certainty not rated). There was also high-certainty evidence for the effectiveness of nicotine patch, fast-acting NRT and bupropion. Less certain evidence of benefit was present for nortriptyline (moderate certainty), non-nicotine e-cigarettes and tapering of nicotine dose (both low certainty). There was moderate-certainty evidence that bupropion may slightly increase the frequency of SAEs, although there was also the possibility of no increased risk. There was no clear evidence that any other tested interventions increased SAEs. Overall, SAE data were sparse with very low numbers of SAEs, and so further evidence may change our interpretation and certainty. Future studies should report SAEs to strengthen certainty in this outcome. More head-to-head comparisons of the most effective interventions are needed, as are tests of combinations of these. Future work should unify data from behavioural and pharmacological interventions to inform approaches to combined support for smoking cessation.

The Cochrane database of systematic reviews · systematic review · 114 citationsread the source →

A Randomized Trial of Collaborative Care for Perinatal Depression in Socioeconomically Disadvantaged Women: The Impact of Comorbid Posttraumatic Stress Disorder.

Objective: The comorbidity of posttraumatic stress disorder (PTSD) with antenatal depression poses increased risks for postpartum depression and may delay or diminish response to evidence-based depression care. In a secondary analysis of an 18-month study of collaborative care for perinatal depression, the authors hypothesized that pregnant, depressed, socioeconomically disadvantaged women with comorbid PTSD would show more improvement in the MOMCare intervention providing Brief Interpersonal Psychotherapy and/or antidepressants, compared to intensive public health Maternity Support Services (MSS-Plus). Methods: A multisite randomized controlled trial with blinded outcome assessment was conducted in the Seattle-King County Public Health System, July 2009-January 2014. Pregnant women were recruited who met criteria for a probable diagnosis of major depressive disorder (MDD) on the Patient Health Questionnaire-9 and/or dysthymia on the MINI-International Neuropsychiatric Interview (5.0.0). The primary outcome was depression severity at 3-, 6-, 12-and 18-month follow-ups; secondary outcomes included functional improvement, PTSD severity, depression response and remission, and quality of depression care. Results: Sixty-five percent of the sample of 164 met criteria for probable comorbid PTSD. The treatment effect was significantly associated with PTSD status in a group-by-PTSD severity interaction, controlling for baseline depression severity (Wald χ²₁ = 4.52, P = .03). Over the 18-month follow-up, those with comorbid PTSD in MOMCare (n = 48), versus MSS-Plus (n = 58), showed greater improvement in depression severity (Wald χ²₁ = 8.51, P < .004), PTSD severity (Wald χ²₁ = 5.55, P < .02), and functioning (Wald χ²₁ = 4.40, P < .04); higher rates of depression response (Wald χ²₁ = 4.13, P < .04) and remission (Wald χ²₁ = 5.17, P < .02); and increased use of mental health services (Wald χ²₁ = 39.87, P < .0001) and antidepressant medication (Wald χ²₁ = 8.07, P < .005). Participants without comorbid PTSD in MOMCare (n = 33) and MSS-Plus (n = 25) showed equivalent improvement on these outcomes. Conclusions: Collaborative depression care had a greater impact on perinatal depressive outcomes for socioeconomically disadvantaged women with comorbid PTSD than for those without PTSD. Findings suggest that a stepped care treatment model for high-risk pregnant women with both MDD and PTSD could be integrated into public health systems in the United States. Trial registration: ClinicalTrials.gov identifier: NCT01045655.

The Journal of clinical psychiatry · randomised controlled trial · 29 citationsread the source →

Clinical and economic outcomes of remotely delivered cognitive behaviour therapy versus treatment as usual for repeat unscheduled care users with severe health anxiety: a multicentre randomised controlled trial.

Background: It is challenging to engage repeat users of unscheduled healthcare with severe health anxiety in psychological help and high service costs are incurred. We investigated whether clinical and economic outcomes were improved by offering remote cognitive behaviour therapy (RCBT) using videoconferencing or telephone compared to treatment as usual (TAU). Methods: A single-blind, parallel group, multicentre randomised controlled trial was undertaken in primary and general hospital care. Participants were aged ≥18 years with ≥2 unscheduled healthcare contacts within 12 months and scored >18 on the Health Anxiety Inventory. Randomisation to RCBT or TAU was stratified by site, with allocation conveyed to a trial administrator, research assessors masked to outcome. Data were collected at baseline, 3, 6, 9 and 12 months. The primary outcome was change in HAI score from baseline to six months on an intention-to-treat basis. Secondary outcomes were generalised anxiety, depression, physical symptoms, function and overall health. Health economics analysis was conducted from a health service and societal perspective. Results: Of the 524 patients who were referred and assessed for trial eligibility, 470 were eligible and 156 (33%) were recruited; 78 were randomised to TAU and 78 to RCBT. Compared to TAU, RCBT significantly reduced health anxiety at six months, maintained to 9 and 12 months (mean change difference HAI -2.81; 95% CI -5.11 to -0.50; P = 0.017). Generalised anxiety, depression and overall health was significantly improved at 12 months, but there was no significant change in physical symptoms or function. RCBT was strictly dominant with a net monetary benefit of £3,164 per participant at a willingness to pay threshold of £30,000. No treatment-related adverse events were reported in either group. Conclusions: RCBT may reduce health anxiety, general anxiety and depression and improve overall health, with considerable reductions in health and informal care costs in repeat users of unscheduled care with severe health anxiety who have previously been difficult to engage in psychological treatment. RCBT may be an easy-to-implement intervention to improve clinical outcome and save costs in one group of repeat users of unscheduled care. Trial registration: The trial was registered at ClinicalTrials.gov on 19 Nov 2014 with reference number NCT02298036.

BMC medicine · randomised controlled trial · 41 citationsread the source →

Comparison of 2 family therapies for adolescent anorexia nervosa: a randomized parallel trial.

Importance: Anorexia nervosa (AN) is a serious disorder with high rates of morbidity and mortality. Family-based treatment (FBT) is an evidence-based therapy for adolescent AN, but less than half of those who receive this approach recover. Hence, it is important to identify other approaches to prevent the development of the chronic form of AN for which there is no known evidence-based treatment. Objective: To compare FBT with systemic family therapy (SyFT) for the treatment of adolescent-onset AN. Design, setting, and participants: Research in Anorexia Nervosa (RIAN) is a 2-group (FBT and SyFT) randomized trial conducted between September 2005 and April 2012. Interviewers were blinded to the treatment condition. A total of 564 adolescents receiving care at 6 outpatient clinics experienced in the treatment of AN were screened. Of these, 262 adolescents did not meet the inclusion criteria and 138 declined to participate; hence, 164 adolescents (aged 12-18 years) of both sexes meeting the criteria for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, AN (except for amenorrhea) were enrolled. Three participants were withdrawn from FBT and 7 were withdrawn from SyFT after serious adverse events occurred. Interventions: Two manualized family therapies with 16 one-hour sessions during 9 months. Family-based therapy focuses on the facilitation of weight gain, whereas SyFT addresses general family processes. Main outcomes and measures: The primary outcomes were percentage of ideal body weight (IBW) and remission (≥95% of IBW). The a priori hypothesis was that FBT would result in faster weight gain early in treatment and at the end of treatment (EOT). Results: There were no statistically significant differences between treatment groups for the primary outcome, for eating disorder symptoms or comorbid psychiatric disorders at the EOT or follow-up. Remission rates included FBT, 33.1% at the EOT and 40.7% at follow-up and SyFT, 25.3% and 39.0%, respectively. Family-based therapy led to significantly faster weight gain early in treatment, significantly fewer days in the hospital, and lower treatment costs per patient in remission at the EOT (FBT, $8963; SyFT, $18 005). An exploratory moderator analysis found that SyFT led to greater weight gain than did FBT for participants with more severe obsessive-compulsive symptoms. Conclusions and relevance: The findings of this study suggest that FBT is the preferred treatment for adolescent AN because it is not significantly different from SyFT and leads to similar outcomes at a lower cost than SyFT. Adolescents with more severe obsessive-compulsive symptoms may receive more benefits with SyFT. Trial registration: clinicaltrials.gov Identifier NCT00610753.

JAMA psychiatry · randomised controlled trial · 170 citationsread the source →

Integrated motivational interviewing and cognitive behavioural therapy for people with psychosis and comorbid substance misuse: randomised controlled trial.

Objectives: To evaluate the effectiveness of integrated motivational interviewing and cognitive behavioural therapy in addition to standard care for patients with psychosis and a comorbid substance use problem. Design: Two centre, open, rater blind randomised controlled trial. Setting: Secondary care in the United Kingdom. Participants: 327 patients with a clinical diagnosis of schizophrenia, schizophreniform disorder, or schizoaffective disorder and a diagnosis of dependence on or misuse of drugs, alcohol, or both according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition. Intervention: The intervention was integrated motivational interviewing and cognitive behavioural therapy plus standard care, which was compared with standard care alone. Phase one of therapy-"motivation building"-concerns engaging the patient, then exploring and resolving ambivalence for change in substance use. Phase two-"action"-supports and facilitates change using cognitive behavioural approaches. Up to 26 therapy sessions were delivered over one year. Main outcome measures: The primary outcome was death from any cause or admission to hospital in the 12 months after completion of therapy. Secondary outcomes were frequency and amount of substance use (assessed using the timeline followback method), readiness to change, perceived negative consequences of use, psychotic symptom ratings, number and duration of relapses, and global assessment of functioning and deliberate self harm at 12 and 24 months, with additional timeline followback assessments at 6 and 18 months. Analysis was by intention to treat and robust treatment effect estimates were produced. Results: 327 participants were randomly allocated to either the intervention (n=164) or treatment as usual (n=163). At 24 months, 326 (99.7%) were assessed on the primary outcome and 246 (75.2%) on the main secondary outcomes. Treatment had no beneficial effect on hospital admissions or death during follow-up, with 23.3% (38/163) of the therapy group and 20.2% (33/163) of controls deceased or admitted (adjusted odds ratio 1.16, 95% confidence interval 0.68 to 1.99; P=0.579). Therapy had no effect on the frequency of substance use or the perceived negative consequences of misuse, but did have a statistically significant effect on amount used per substance using day (adjusted ORs for main substance 1.50, 95% CI 1.08 to 2.09; P=0.016; and all substances 1.48, 95% CI 1.07 to 2.05; P=0.017). Treatment had a statistically significant effect on readiness to change use at 12 months (adjusted OR 2.05, 95% CI 1.26 to 3.31; P=0.004) that was not maintained at 24 months (0.78, 95% CI 0.48 to 1.28; P=0.320). There were no effects of treatment on clinical outcomes such as relapses, psychotic symptoms, functioning, and self harm. Conclusions: Integrated motivational interviewing and cognitive behavioural therapy for people with psychosis and substance misuse do not improve outcome in terms of hospitalisation, symptom outcomes, or functioning. This approach does reduce the amount of substance used for at least one year after completion of therapy. Trial registration: Current Controlled Trials: ISRCTN14404480.

BMJ (Clinical research ed.) · randomised controlled trial · 124 citationsread the source →

The association of patient relationship style and outcomes in collaborative care treatment for depression in patients with diabetes.

Purpose: We sought to determine whether relationship style in patients with diabetes receiving depression treatment is associated with differential quality of care and depression outcomes. Methods: From 9 health maintenance organization clinics, 324 primary care patients with diabetes and comorbid major depression and/or dysthymia participated in the Pathways randomized controlled trial of collaborative care for depression (n = 160) versus usual care (n = 164). The intervention provided outreach, enhanced support of antidepressant medication use, and problem-solving treatment delivered by nurse case managers. Using attachment theory principles, we categorized patients as having an independent (n = 190) or interactive (n = 134) relationship style. We assessed whether patient relationship style moderated treatment group differences in quality of care and depression outcomes. Results: Among independent relationship style patients, the intervention resulted in significantly greater satisfaction with depression care in the first 6 months and 47 more depression-free days (P < 0.0003) based on the Hopkins Symptom Checklist at 12 months, compared with usual care. There were no significant treatment group differences in satisfaction with care or depression outcomes among patients with interactive relationship style. Among patients receiving the intervention, those with an independent relationship style received significantly more problem-solving treatment sessions as compared with patients with an interactive relationship style. Conclusion: Among depressed patients with diabetes, the Pathways collaborative care intervention improved quality of care for depression compared with usual care in both relationship style groups but was associated with significantly better depressive outcomes and greater satisfaction with care compared with usual care in patients with independent but not interactive relationship style.

Medical care · randomised controlled trial · 47 citationsread the source →

Developmental Coordination Disorder

For the last 100 years, poor motor coordination in children has been recognized as a developmental problem.1 As early as 1937, these children were classified as “clumsy.”1 Since then, other terms such as “motorically awkward,” “motor impaired,” and “physically awkward” have been used to describe these children, and the terms “developmental apraxia” and “perceptual motor difficulties” have been used to characterize this developmental problem.2,3 Since the 1994 International Consensus Conference on Children and Clumsiness, the term “developmental coordination disorder” (DCD) has been used to describe the condition of children with motor incoordination.1,4 The purpose of this article is to provide the following information about DCD: (1) definition, (2) prevalence, (3) etiology, (4) discussion regarding the difficulties in classifying these children, (5) common characteristics, (6) long-term prognosis, and (7) brief review of treatment approaches. Developmental coordination disorder, a chronic and usually permanent condition found in children, is characterized by motor impairment that interferes with the child's activities of daily living and academic achievement.3,5 In order for a child to be diagnosed with DCD, these motor impairments must negatively affect some other aspect of his or her life.6 Impairment alone, however, does not qualify a child for the diagnosis of DCD; the motor impairment must not be caused by or have the symptoms of an identifiable neurological problem.2,5 That is, the child must not have any disturbances of muscle tone (ataxia or spasticity), sensory loss, or involuntary movements. If mental retardation is present, the testable IQ of the child must be greater than 70 and the motor impairments must be greater than what would normally be expected for children with mental retardation.5 Finally, a child diagnosed with DCD must not meet the criteria for a diagnosis of pervasive developmental disorder.6 Developmental coordination disorder appears to be a fairly common disorder of childhood and is usually identified in children between 6 and 12 years of age. Ten years ago, researchers7,8 estimated that DCD occurred in 10% to 19% of school-aged children. With a more precise definition of DCD, the current prevalence is estimated to be between 5% and 8% of all school-aged children,5,9–11 with more boys than girls (2:1) being diagnosed with DCD.12 This difference may reflect higher referral rates for boys, because the behavior of boys with motor incoordination may be more difficult to manage at home and in the classroom.8 In addition, a higher incidence of DCD may be found among children with a history of prenatal or perinatal difficulties.3 Due to the heterogeneity of DCD, finding its cause has been difficult.3 Several theories speculate that the etiology of DCD is part of the continuum of cerebral palsy5,13; is secondary to prenatal, perinatal, or neonatal insult3; or is secondary to neuronal damage at the cellular level in the neurotransmitter or receptor systems.14 Hadders-Algra14 based her view that DCD is a result of damage at the cellular level on evidence that cerebral palsy is often caused by prenatal damage that cannot be identified by current diagnostic techniques. Developmental coordination disorder, a chronic and usually permanent condition found in children, is characterized by motor impairment that interferes with the child’s activities of daily living. Although both standard and nonstandard functional tests are available to identify the specific disabilities experienced by a child with DCD, relating the observed disabilities to the primary impairment(s) or any possible neuropathology is not easily accomplished. The problems experienced by children with DCD are believed to emanate from abnormalities in neurotransmitter or receptor systems rather than from damage to specific groups of neurons or brain regions.15 Children's difficulties with coordination can result from a combination of one or more impairments in proprioception, motor programming, timing, or sequencing of muscle activity. A number of theories have evolved in an attempt to shed light on the specific neuronal processing deficits that contribute to DCD. Current models used to explain the neural regulation of posture and movement during development can serve as a basis for the examination and management of individuals with DCD. Using these models, many of the deficits of motor control observed in these children can be described. A variety of theoretical models exist to explain the role of the nervous system in motor development. Forty years ago, the primitive reflex model was a generally accepted theory used to explain how the brain regulates early motor behavior.16 As development proceeded, the higher centers exerted increasing control over the lower reflexes.16 These earlier models were based on a hierarchy of motor control in which higher centers were capable of planning and executing a motor plan without external or internal feedback from lower centers of the central nervous system (CNS). The more recently proposed systems model suggests a more complex interaction among various levels of the CNS. In the systems model, sensory feedback is interpreted by the CNS, and the appropriate movement strategy is selected based on current experience, the state of the internal and external environment, and memory of similar movements. Edelman's neuronal group selection theory includes aspects of both of these models and proposes that functional groups of neurons exist at all levels of the CNS.17 These neuronal groups are determined by evolution, but their functional integrity is dependent on afferent information produced by movement and experience.17 In this regard, these genetically determined collections of interconnected neurons (neuronal groups) in both cortical and subcortical structures serve as an early repertoire for motor behavior or receipt of specific sensory information.14,17,18 According to neuronal group selection theory, motor development proceeds in 2 phases.15 The first, the phase of primary variability, is characterized by crude and erratic motor activity that does not require sensory information for its initiation or guidance. These self-generated movements give rise to afferent (visual, kinesthetic) inputs that reinforce more specific synaptic connections within each group. An intermediate period in which effective patterns are selected is followed by the secondary variability phase. In this phase, sensory and motor factors interact to establish the intercellular connections that produce the specific and complex muscle contraction patterns that characterize coordinated, goal-directed movement. Reciprocal connections between groups subserving movements in various body parts and representing different parts of visual space are reinforced with each repetition of a particular function. As the more efficient movement patterns are practiced, the appropriate synaptic circuits are reinforced and subsequently established.14,17,19,20 The literature includes a wide variation in terminology and criteria to describe DCD. This variation has made studying the causes of DCD and developing treatment approaches for the child with DCD difficult. In their analysis of clinical trial data, Macnab et al21 identified 5 different subtype profiles of DCD. The first subtype included children with better gross motor than fine motor skills, although both were still below normal while standing balance and visual-perceptual skills were both within normal ranges. Compared with children of the same age with DCD, children in the second subtype scored high on measures of upper-limb speed and dexterity, visuomotor integration, and visual-perception skills, but they demonstrated poor performance on measures of kinesthetic ability (accuracy in discriminating movement and position of the upper limbs) and balance. Children in subtype 3 demonstrated the greatest overall motor involvement and were the only subtype to have difficulty with both kinesthetic and visual skills. Compared with their peers with DCD, children in subtype 4 performed well on kinesthetic tasks but demonstrated poor performance on tasks requiring visual and dexterity skills. Children in subtype 5 demonstrated poor performance on measurements of running speed and agility compared with their peers with DCD; however, they performed well relative to their peers with DCD in the tasks involving visual-perception skills. The development of different classification systems for DCD may have been influenced by the design of motor tests.21 For example, items testing one motor skill may be influenced by a related motor skill (eg, ball-throwing skills cannot be separated from visuomotor skills). In addition, a test may have an over-representation of one skill that could unduly influence the child's performance on the test. For example, having a greater number of items testing gross motor rather than fine motor skills could either positively or negatively influence a child's score, depending on the child's specific strengths and weaknesses. Another difficulty in interpreting the literature on DCD is the lack of inclusion criteria. Geuze et al22 reviewed 164 publications on the study of DCD and found that only 60% of the studies had objective inclusion criteria. Because of this lack of inclusion criteria, Geuze et al recommended that a child scoring below the 15th percentile on standardized tests of motor skills and having an IQ score above 69 would qualify for a diagnosis of DCD. The inconsistency among standardized motor tests used to identify children with DCD is another problem. In one study,5 the Bruininks-Oseretsky Test of Motor Proficiency (BOTMP) and the Movement Assessment Battery for Children (M-ABC) were administered to 157 children with DCD and 155 children with no motor difficulties; the test results were in agreement 82% (kappa=.62) of the time in distinguishing children who had DCD from children who did not have DCD. This is considered a substantial level of agreement.23 In a study of 202 children (101 with DCD and 101 without DCD), the BOTMP and M-ABC agreed only 67% of the time (kappa=.41), which was considered a moderate level of agreement.24 Because the BOTMP and the M-ABC are 2 of the most commonly used tests for identifying children with DCD, the potential lack of agreement by these tests in identifying children who have DCD is a concern. Two primary factors may explain the difference in outcomes between the BOTMP and M-ABC when used to identify children with DCD.24 First, the BOTMP allows the tester to verbally prompt and correct the child during the testing procedure, allowing the child who is dependent on more external controls to do better on the BOTMP. The BOTMP tends to under-identify children with DCD. Second, the M-ABC requires more careful instruction on the part of the examiner and allows more opportunities for the examinee to practice, but does not allow any verbal or physical prompting by the examiner. Children with attention problems may have more difficulty with the careful instructions for the M-ABC. Another difficulty in classifying children with DCD is the overlap with other disorders. Approximately 41% of children with attention-deficit/hyperactivity disorder (ADHD) and 56% of children with learning disabilities also have DCD.5,21 Further confusing the classification scheme is that the terms “developmental coordination disorder,” for which no identifiable organic brain damage is present, and “apraxia,” which is caused by identifiable brain damage, have been used interchangeably.3 Children with DCD may have a wide range of dysfunctions. These dysfunctions can be grouped into 3 areas: gross motor, fine motor, and psychosocial. Many children with DCD have neurological soft signs such as hypotonia, persistence of primitive reflexes, and immature balance reactions that interfere with gross motor development.5,25 These children also may demonstrate an awkward running pattern, fall frequently, drop items, and have difficulty imitating body positions and following 2- to 3-step motor commands.8 Because of their gross motor problems, children with DCD also perform poorly in sporting events,2 possibly due, in part, to their slow reaction and movement times.7 Their decreased participation in sports may result in decreased muscle force.8 Difficulty with handwriting or drawing often is the first identifiable sign of a fine motor problem and is the most frequently mentioned motor problem experienced by children with DCD. Children with DCD frequently have difficulty planning and executing other fine motor skills such as gripping and dressing.26–29 Unfortunately, children with DCD may experience problems not limited to fine or gross motor areas. These children also may experience psychosocial problems at school. Children with DCD may have learning disabilities or reading problems and may be at increased risk for lower intelligence.5,8 They may act out in class more than other children,13 may be the class clown, and may exhibit less socially desirable means of gaining recognition and friends.8 Adolescents with DCD have been found to have fewer friends, and they have more feelings of low self-worth and more anxiety than peers without DCD and younger children with DCD.30 Historically, parents have been told not to worry about their child's clumsiness because the child will outgrow the problem.31 However, current researchers in the area of DCD report that the children do not outgrow clumsiness and that, without intervention, they will not improve.1,8,12,27,31 Losse et al31 tested 17 children aged 6 years and retested them at age 16 years. The children with motor difficulties at 6 years of age continued to exhibit problems at 16 years of age. In another study,32 818 children with DCD were tested for reading comprehension at age 7 years and then again at age 10 years. A positive correlation in poor reading comprehension existed for children with DCD at 7 and 10 years of age. A follow-up study was conducted on 22-year-old individuals (N=55) who at age 7 years had either DCD or attention-deficit/hyperactivity disorder (ADHD), or both.33 The children with DCD and those with both DCD and ADHD had poorer outcomes than their similarly aged peers without DCD and children with ADHD only. The children with DCD and those with both DCD and ADHD were found to have had more criminal offenses, more incidences of substance abuse and other psychiatric disorders, and lower levels of schooling. Treatment approaches used by occupational therapists and physical therapists can be broadly categorized into either bottom-up or top-down approaches (Tab. 1).10,12,34–36 Bottom-up approaches are based on hierarchical theories of motor control. These theories tend to explain the remediation of motor dysfunction through activation of higher levels of neuronal functioning in a child. The bottom-up approaches frequently used in managing children with DCD are sensory integration, the process-oriented treatment approach, and perceptual motor training.34 Summary of Bottom-Up Versus Top-Down Approaches Summary of Bottom-Up Versus Top-Down Approaches In sensory integration therapy, the child is provided sensory stimulation designed to promote motor development and higher cortical learning. A child undergoing sensory integration therapy may show some gains in motor development, but these gains often do not generalize to functional skills.34 Kinesthesia (the perception of one's own body parts, weight, and movement) is integral to the acquisition of motor skills in process-oriented treatment approaches. Therapeutic intervention with process-oriented treatment is based on specifically designed kinesthetic training activities. As described by Laszlo and Bairstow,37 this approach has an inherent reward system built into it through its use of positive reinforcement, presentation of desirable activities within the capabilities of the child, and judicious progression of the level of difficulty. The usefulness of the process-oriented treatment approach has been the subject of considerable study.9,10,37,38 Sims and colleagues35 suggested that much of the success of this approach can be attributed to a strong motivation effect, fostered by positive feedback and a sense of self-competence. Perceptual motor training, an eclectic approach, offers the child with DCD a wide range of motor experiences along with ample opportunities to practice these skills. Often, in outcome studies, children who receive perceptual motor training are compared with children who receive either sensory integration therapy or process-oriented treatment. Children perceptual motor training have been found to demonstrate motor to or greater than those of children either sensory integration therapy or process-oriented perceptual motor training, process-oriented may promote learning through positive feedback and reinforcement, these do not and to the that top-down approaches approaches use a approach to motor skill development and have been influenced by the systems approach to motor learning and control. This approach suggests that motor skills from an interaction of many both internal and external to the approaches also the in which motor behavior intervention and approaches or are the 2 most commonly intervention on of a The theoretical for intervention in a child's motor performance is the result of learning on a specific Motor tasks are into with each and then to the Children with this approach have demonstrated gains in motor skills.34 approaches to motor development problem The approach strategy the to to the and perform the well did plan The child verbal to the to motor learning. In this approach, the as a by the child out how to his or her motor performance on various motor intervention, the results of studies of approaches are In one 10 children with DCD who were with a approach to motor development were compared with 10 children who were with a bottom-up The children were for and groups on various standardized motor tests 10 treatment However, children in the approach group motor skill and to better than children who were the bottom-up and the approach both provide repetition and practice of specific motor skills, and the approach has the of problem The greater success of top-down when compared with bottom-up be a result of the top-down inclusion of both and motor learning with for attention to and memory as the child in activities. The results of these studies, in to outcome measures of the different approaches in children with DCD, would that approaches that systems theory on sensory information being only part of the and motor learning theory be most effective for these 2 a brief of clinical the of various treatment approaches used with children with of Treatment Approaches for Children With Developmental approach to daily occupational performance treatment approach treatment group integration, perceptual motor, gross and fine motor integration Assessment Battery for Test of Motor Test of for of Motor and of of Treatment Approaches for Children With Developmental approach to daily occupational performance treatment approach treatment group integration, perceptual motor, gross and fine motor integration Assessment Battery for Test of Motor Test of for of Motor and of The neuronal group selection theory can provide a for interpreting the in outcomes among the various approaches. children with moderate to cerebral palsy have a limited repertoire of primary neuronal which children with DCD are believed to experience difficulty at the level of secondary variability, that is, in and the most efficient and effective for a normal development, experience a primary role in the neuronal group selection that the for and According to the neuronal group selection theory, this of motor skill during the of secondary variability as a result of of neuronal selection of specific neurons within each repetition of synaptic within and among neuronal and sensory synaptic which act in and cortical and subcortical and following to a variety of motor of these connections is dependent on sensory Bottom-up approaches such as sensory integration, process-oriented and perceptual motor training sensory experience, with less on processing and motor Although an intervention based on information processing may provide the experience to the most effective neuronal bottom-up approaches may not provide for motor practice of and goal-directed tasks in order to reinforce and establish these approaches less on the specific impairments to decreased coordination and more on the of that is, the among a number of structures and systems and the within which the is Treatment based on a top-down approach that provide the child the to in problem while afferent subcortical structures the feedback and to identify and the most efficient movement for the Because integration, internal of motor and appropriate motor at the level of secondary the on sensory rather than factors by the bottom-up approaches in part, be for the observed in outcomes following treatment. A number of motor learning theories have been proposed in an attempt to explain the through which are into more complex According to the motor control and learning theory proposed by and motor circuits that the and following long-term these and functioning neuronal circuits through practice, the child is to motor into more complex movements. and proposed 2 to such the first of which on sensory to neuronal is during the second that the to the specific motor tasks through the and involving the and in the first of learning requires attention and The motor then in the of learning through repetition and top-down approaches meet both of these bottom-up approaches information processing only. the and of the neural in children with DCD is a not Motor control are complex and on functioning of and motor only are children with DCD a group in terms of functional disabilities the specific of the problems observed can from one child to the Because of these an approach to the management of children with DCD is Developmental coordination disorder is a complex disorder 5% to of school-aged children. intervention, these children will to exhibit poor motor skills and show deficits in other as for may (1) the most appropriate level of intervention (2) which produce results that generalize to the and provide long-term in motor (3) what have on the child's motor and (4) motor skills to the that to the

Physical Therapy · review · 472 citationsread the source →

Spiritual intimacy, spiritual one-upmanship, and marital conflict across the transition to parenthood.

Dyadic discussions that directly tap into spouses' views on spirituality and religiousness (S/R) represent an understudied but important facet of marital functioning that may be tied, for better or worse, to marital conflict and resolution processes. This study used longitudinal data gathered from 164 married couples across the transition to parenthood (TtP) to address this possibility. Specifically, during late pregnancy and when their infant was 3, 6, and 12 months old, husbands and wives completed measures about both spouses' spiritual intimacy (i.e., self-disclosure and support of partner's disclosures about spirituality) and spiritual one-upmanship (i.e., relying on spiritual and religious [dis]beliefs and opinions to assert superiority in conflicts). Criterion variables were the frequency of marital conflict and both partners' use of collaborative, hostile, and stalemating communication strategies during marital conflicts. Using fixed-effects regression models with both predictors entered, we found that greater spiritual intimacy by wives and husbands predicted less frequent conflict (p < .01), more collaborative communication by husbands (p < .01) and less stalemating (p < .01) by both spouses. Wives' spiritual intimacy also predicted more collaboration and less verbal hostility by wives (p < .01). By contrast, greater spiritual one-upmanship by both spouses predicted greater stalemating by both spouses (p < .05) and verbal hostility by husbands (p < .05). The findings indicate that 2 contrasting types of S/R dialogues are differentially linked to disagreements and conflict-resolution skills after accounting for stable aspects of the couples across the TtP (e.g., personality traits). (PsycInfo Database Record (c) 2021 APA, all rights reserved).

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

Effect of delaying treatment of first-episode psychosis on symptoms and social outcomes: a longitudinal analysis and modelling study.

Background: Delayed treatment for first episodes of psychosis predicts worse outcomes. We hypothesised that delaying treatment makes all symptoms more refractory, with harm worsening first quickly, then more slowly. We also hypothesised that although delay impairs treatment response, worse symptoms hasten treatment, which at presentation mitigates the detrimental effect of treatment delay on symptoms. Methods: In this longitudinal analysis and modelling study, we included two longitudinal cohorts of patients with first-episode psychosis presenting to English early intervention services from defined catchments: NEDEN (recruiting 1003 patients aged 14-35 years from 14 services between Aug 1, 2005, and April 1, 2009) and Outlook (recruiting 399 patients aged 16-35 years from 11 services between April 1, 2006, and Feb 28, 2009). Patients were assessed at baseline, 6 months, and 12 months with the Positive and Negative Symptom Scale (PANSS), Calgary Depression Scale for Schizophrenia, Mania Rating Scale, Insight Scale, and Social and Occupational Functioning Assessment Scale. Regression was used to compare different models of the relationship between duration of untreated psychosis (DUP) and total symptoms at 6 months. Growth curve models of symptom subscales tested predictions arising from our hypotheses. Findings: We included 948 patients from the NEDEN study and 332 patients from the Outlook study who completed baseline assessments and were prescribed dopamine antagonist antipsychotics. For both cohorts, the best-fitting models were logarithmic, describing a curvilinear relationship of DUP to symptom severity: longer DUP predicted reduced treatment response, but response worsened more slowly as DUP lengthened. Increasing DUP by ten times predicted reduced improvement in total symptoms (ie, PANSS total) by 7·339 (95% CI 5·762 to 8·916; p<0·0001) in NEDEN data and 3·846 (1·689 to 6·003; p=0·0005) in Outlook data. This was true of treatment response for all symptom types. Nevertheless, longer DUP was not associated with worse presentation for any symptoms except depression in NEDEN (coefficients 0·099 [95% CI 0·033 to 0·164]; p=0·0028 in NEDEN and 0·007 [-0·081 to 0·095]; p=0·88 in Outlook). Interpretation: Long DUP was associated with reduced treatment response across subscales, consistent with a harmful process upstream of individual symptoms' mechanisms; response appeared to worsen quickly at first, then more slowly. These associations underscore the importance of rapid access to a comprehensive range of treatments, especially in the first weeks after psychosis onset. Funding: UK Department of Health, National Institute of Health Research, and Medical Research Council.

The lancet. Psychiatry · 116 citationsread the source →

SOGC Guideline Retirement Notice No. 2.

These documents have been archived because they contain outdated information. They should not be consulted for clinical use, but for historical research only. Please visit the journal website for the most recent guidelines. The Use of Magnetic Resonance Imaging in the Obstetric Patient [J Obstet Gynaecol Can 36 (2014) 349-355] AUTHORS Yves Patenaude, MD, Sherbrooke, QC Denise Pugash, MD, Vancouver, BC Kenneth Lim, MD, Vancouver, BC Lucie Morin, MD, Montreal, QC The Role of Surgery in Endometrial Cancer [J Obstet Gynaecol Can 35 (2013) 370-371] AUTHORS Christopher Giede, MD, Saskatoon, SK Tien Le, MD, Ottawa, ON Patti Power, MD, St John's, NL Female Genital Cutting [J Obstet Gynaecol Can 35 (2013) 1028-1045] AUTHORS Liette Perron, MSW, Ottawa, ON Vyta Senikas, MD, Ottawa, ON Margaret Burnett, MD, Winnipeg, ON Victoria Davis, MD, Scarborough, ON Technical Update on Pessary Use [J Obstet Gynaecol Can 35 (2013) 664-674] AUTHORS Magali Robert, MD, Calgary, AB Jane A. 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Allen, MD, MSc, Halifax, NS R. Douglas Wilson, MD, MSc, Philadelphia, PA Canadian Contraception Consensus-Update on Depot Medroxyprogesterone Acetate (DMPA) [J Obstet Gynaecol Can 28 (2006) 305-308] AUTHOR Amanda Black, MD, Ottawa, ON Guidelines for Training Requirements in Colposcopy and its Related Treatment Modalities [J Obstet Gynaecol Can 28 (2006) 314-316] AUTHOR Susan M. McFaul, MD, Ottawa, ON Pelvic Examinations by Medical Trainees [J Obstet Gynaecol Can 28 (2006) 320-321] AUTHORS Kimberly E. Liu, MD, Edmonton, AB Deborah Robertson, MD, Montréal, QC Glenn Posner, MDCM, Ottawa, ON Sukhbir S. Singh, MD, London, ON Lawrence Oppenheimer, MD, Ottawa, ON Stillbirth and Bereavement: Guidelines for Stillbirth Investigation [J Obstet Gynaecol Can 28 (2006) 540-545] AUTHOR Line Leduc, MD, Montréal, QC Progesterone-Only and Non-Hormonal Contraception in the Breast Cancer Survivor: Joint Review and Committee Opinion of the Society of Obstetricians and Gynaecologists of Canada and the Society of Gynecologic Oncologists of Canada [J Obstet Gynaecol Can 28 (2006) 616-626] AUTHORS Jenna McNaught, MD, Winnipeg, MB Robert L. Reid, MD, Kingston, ON Breast Self-Examination [J Obstet Gynaecol Can 28 (2006) 728-730] AUTHOR Vera Rosolowich, RN, SCM, IBCLC, Winnipeg, MB The Physician Expert in Legal Proceedings [J Obstet Gynaecol Can 28 (2006) 913-915] AUTHORS Titus Owolabi, MD, Toronto, ON George Vilos, MD, Toronto, ON Induced Abortion Guidelines [J Obstet Gynaecol Can 28 (2006) 1014-1027] AUTHOR Victoria Jane Davis, MD Health Professionals Working With First Nations, Inuit, and Métis Consensus Guideline [J Obstet Gynaecol Can 35 (2013) S1-S4] AUTHORS Don Wilson, MD, FRCSC (Co-chair), Hellisuk Nation, Comox, BC Sandra de la Ronde, MD, FRCSC (Co-chair), Ottawa, ON Simon Brascoupé, Kitigan Zibi Anishinabeg, Ottawa, ON Alisha Nicole Apale, MSc, Ottawa, ON Lucy Barney, RN, MSN, Lillooet Nation, Vancouver, BC Bing Guthrie, MD, FRCSC, Yellowknife, NT Elizabeth Harrold, RN, Vancouver, BC Ojistoh Horn, MD, CCFP, Mohawk, Kahnawake, QC Robin Johnson, MD, FRCSC, Esdilagh, First Nation, Williams Lake, BC Darrien Rattray, MD, Tahltan, Halifax, NS Nicole Robinson, MA, Ottawa, ON Introduction [J Obstet Gynaecol Can 35 (2013) S5-S6] Chapter 1 Definitions [J Obstet Gynaecol Can 35 (2013) S7-S8] Chapter 2 Demographics [J Obstet Gynaecol Can 35 (2013) S9-S12] Chapter 3 Social Determinants of Health Among First Nations, Inuit, and Métis [J Obstet Gynaecol Can 35 (2013) S13-S23] Chapter 4 Health Systems, Policies, and Services for First Nations, Inuit, and Métis [J Obstet Gynaecol Can 35 (2013) S24-S27] Chapter 5 First Nations, Inuit, and Métis Women's Sexual and Reproductive Health [J Obstet Gynaecol Can 35 (2013) S28-S32] Chapter 6 First Nations, Inuit, and Métis Maternal Health [J Obstet Gynaecol Can 35 (2013) S33-S36] Chapter 7 Mature Women's Health [J Obstet Gynaecol Can 35 (2013) S37] Chapter 8 Changing Outcomes Through Culturally Competent Care [J Obstet Gynaecol Can 35 (2013) S38-S41] Chapter 9 Conclusion [J Obstet Gynaecol Can 35 (2013) S42-S43] Chapter 10 Case Studies [J Obstet Gynaecol Can 35 (2013) S44-S47] Appendix 1. Apology for the Forced Relocation of Inukjuak and Pond Inlet Families [J Obstet Gynaecol Can 35 (2013) S48] Appendix 2. Apology for the Residential School System [J Obstet Gynaecol Can 35 (2013) S49] Appendix 3. Avoiding Re-Traumatization of Sexual Abuse/Assault Victims During the Birthing Process [J Obstet Gynaecol Can 35 (2013) S50].

Journal of obstetrics and gynaecology Canada : JOGC = Journal d'obstetrique et gynecologie du Canada : JOGC · 3 citationsread the source →

Medical education in times of COVID-19: German students' expectations - A cross-sectional study.

Background: Since the COVID-19 pandemic has affected the education of medical students, medical faculties have faced the challenge of adapting instruction to digital platforms. Although medical students are willing to support pandemic response efforts, how the crisis will affect their medical training remains uncertain. Thus, in this study, we investigated the teaching- and learning-related stressors and expectations of medical students in Germany during the COVID-19 pandemic. Methods: A cross-sectional survey was distributed online to undergraduate medical students at medical faculties in Germany. Students answered questions about COVID-19 and teaching (on a 7-point Likert scale from 0 ("not at all") to 6 ("completely")) and completed mental well-being measurements, including the State-Trait Anxiety Inventory (STAI), the Generalised Anxiety Disorder scale (GAD-7) and the Perceived Health Questionnaire (PHQ-9). Descriptive data analysis, a t-test and Pearson correlations were performed to process the data. Results: Medical students felt well-informed about COVID-19 in general (M = 5.64, SD = 1.28) and in the medical context (M = 5.14, SD = 1.34) but significantly less informed about the pandemic in the academic context, M = 2.47, SD = 1.49, t(371) = 31.98, p < .001. Their distress levels were high (STAI: M = 45.12, SD = 4.73) and significantly correlated with the academic context (rp = .164, p < .01) but not their private lives. Concerning how they were taught, they most often expected online lectures (91.7%) and live broadcasts (67.2%) and less often expected innovative digital teaching strategies, including serious games (17.3%) and virtual-reality exercises (16.7%). Discussion: Medical students seem to be aware of the COVID-19 pandemic and its consequences for academic and healthcare contexts. They also seem to think that their teachers will enhance their digital competencies during the pandemic. Therefore, faculties of medicine need to rapidly and adequately digitalise their approaches to teaching.

PloS one · 69 citationsread the source →

COVID-19 Racism and Mental Health in Chinese American Families.

Objectives: The coronavirus disease 2019 (COVID-19) pandemic has fueled xenophobia against Chinese Americans. We examined the rates of 6 types of COVID-19 racism and racial discrimination experienced by Chinese American parents and youth and the associations with their mental health. Methods: We recruited a population-based sample of Chinese American families to participate in this self-reported survey study conducted from March 14, 2020, to May 31, 2020. Eligible parent participants identified as ethnically/racially Chinese, lived in the United States, and had a 4- to 18-year-old child; their eligible children were 10 to 18 years old. Results: The sample included 543 Chinese American parents (mean [SD] age, 43.44 [6.47] years; 425 mothers [78.3%]), and their children (N = 230; mean [SD] age, 13.83 [2.53] years; 111 girls [48.3%]). Nearly half of parents and youth reported being directly targeted by COVID-19 racial discrimination online (parents: 172 [31.7%]; youth: 105 [45.7%]) and/or in person (parents: 276 [50.9%]; youth: 115 [50.2%]). A total of 417 (76.8%) parents and 176 (76.5%) youth reported at least 1 incident of COVID-19 vicarious racial discrimination online and/or in person (parents: 481 [88.5%]; youth: 211 [91.9%]). A total of 267 (49.1%) parents and 164 (71.1%) youth perceived health-related Sinophobia in America, and 274 (50.4%) parents and 129 (56.0%) youth perceived media-perpetuated Sinophobia. Higher levels of parent- and youth-perceived racism and racial discrimination were associated with their poorer mental health. Conclusions: Health care professionals must attend to the racism-related experiences and mental health needs of Chinese Americans parents and their children throughout the COVID-19 pandemic via education and making appropriate mental health referrals.

Pediatrics · 199 citationsread the source →

Impact of a Mindfulness-Based Stress Reduction Program on Psychological Well-Being, Cortisol, and Inflammation in Women Veterans.

Background: Women veterans experience higher levels of stress-related symptoms than their civilian counterparts. Psychological stress is associated with greater inflammation and may increase risk for cardiovascular disease (CVD). Mindfulness-based stress reduction (MBSR) has been found to improve psychological well-being in other populations but no randomized controlled trials (RCT) have been conducted examining the impact of MBSR on well-being and inflammation in women veterans at risk for CVD. Objective: Determine the effectiveness of MBSR in improving psychological well-being, cortisol, and inflammation associated with CVD in women veterans. Design: The design is a RCT comparing MBSR to an active control condition (ACC) consisting of a health education program. Participants: Women veterans (N=164) with risk factors for CVD from the Chicagoland area participated in the study. Intervention: An 8-week MBSR program with weekly 2.5-h classes was compared to an ACC consisting of an 8-week health promotion education program with weekly 2.5-h classes. Main measures: The outcomes were psychological well-being [perceived stress, depressive symptoms, loneliness, and post-traumatic stress disorder (PTSD)] symptoms and stress-related markers, including diurnal salivary cortisol and cytokines interleukin-6 (IL-6) and interferon gamma (IFN-γ). Data were collected at baseline, 4 weeks (mid-point of intervention), 8 weeks (completion of intervention), and 6 months after completion of MBSR or ACC. Key results: Compared to the ACC, women who participated in MBSR reported less perceived stress, loneliness, and symptoms of PTSD. Although there were no significant differences between groups or changes over time in IL-6 or IFN-γ, participants in the MBSR program demonstrated a more rapid decline in diurnal salivary cortisol as compared to those in the ACC. Conclusions: MBSR was found to improve psychological well-being and decrease diurnal salivary cortisol in women veterans at risk for CVD. Health care providers may consider MBSR for women veterans as a means by which to improve their psychological well-being.

Journal of general internal medicine · 21 citationsread the source →

Antiepileptic Drug Exposure in Infants of Breastfeeding Mothers With Epilepsy.

Importance: There is limited information on infant drug exposure via breastfeeding by mothers who are receiving antiepileptic drug therapy. Objective: To provide direct, objective information on antiepileptic drug exposure through breast milk. Design, setting, and participants: This prospective cohort study was conducted between December 2012 to October 2016, with follow-up in children until 6 years of age at 20 sites across the United States. Data were collected via an observational multicenter investigation (Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs [MONEAD]) of outcomes in pregnant mothers with epilepsy and their children. Pregnant women with epilepsy who were aged 14 to 45 years, had pregnancies that had progressed to less than 20 weeks' gestational age, and had measured IQ scores of more than 70 points were enrolled and followed up through pregnancy and 9 postpartum months. Their infants were enrolled at birth. Data were analyzed from May 2014 to August 2019. Exposures: Antiepileptic drug exposure in infants who were breastfed. Main outcomes and measures: The percentage of infant-to-mother concentration of antiepileptic drugs. Antiepileptic drug concentrations were quantified from blood samples collected from infants and mothers at the same visit, 5 to 20 weeks after birth. Concentrations of antiepileptic drugs in infants at less than the lower limit of quantification were assessed as half of the lower limit. Additional measures collected were the total duration of all daily breastfeeding sessions and/or the volume of pumped breast milk ingested from a bottle. Results: A total of 351 women (of 865 screened and 503 eligible individuals) were enrolled, along with their 345 infants (179 female children [51.9%]; median [range] age, 13 [5-20] weeks). Of the 345 infants, 222 (64.3%) were breastfed; the data collection yielded 164 matching infant-mother concentration pairs from 138 infants. Approximately 49% of all antiepileptic drug concentrations in nursing infants were less than the lower limit of quantification. The median percentage of infant-to-mother concentration for all 7 antiepileptic drugs and 1 metabolite (carbamazepine, carbamazepine-10,11-epoxide, levetiracetam, lamotrigine, oxcarbazepine, topiramate, valproate, and zonisamide) ranged from 0.3% (range, 0.2%-0.9%) to 44.2% (range, 35.2%-125.3%). In multiple linear regression models, maternal concentration was a significant factor associated with lamotrigine concentration in infants (Pearson correlation coefficient, 0.58; P < .001) but not levetiracetam concentration in infants. Conclusions and relevance: Overall, antiepileptic drug concentrations in blood samples of infants who were breastfed were substantially lower than maternal blood concentrations. Given the well-known benefits of breastfeeding and the prior studies demonstrating no ill effects when the mother was receiving antiepileptic drugs, these findings support the breastfeeding of infants by mothers with epilepsy who are taking antiepileptic drug therapy.

JAMA neurology · 90 citationsread the source →

Sanctification of marriage and spiritual intimacy predicting observed marital interactions across the transition to parenthood.

We examined whether 164 heterosexual, married couples' reports of the sanctification of their marriage and their spiritual intimacy predicted their observed behavior across the transition to parenthood, using highly conservative statistical strategies to control for time-invariant factors and time-varying factors (marital love, collaborative communication skills) that could explain away these links. Spouses provided self-reports of marital sanctification and love, and joint reports of spiritual intimacy and collaboration by each partner. Criterion variables were positive and negative behaviors that spouses exhibited during dyadic discussions of marital conflicts, videotaped during pregnancy and when the couple's first infant was 3, 6, and 12 months old. Using bivariate fixed-effects regression models to control unmeasured time-invariant predictors (e.g., stable traits), his and her sanctification of marriage predicted more observed positivity by 1 or both spouses, and his and her spiritual intimacy predicted more positivity and less negativity by both spouses. Using multivariate regression analyses that controlled for demographic factors, the interdependency of spouses' responses, and salient time-varying marital (spouses' love and collaborative skills), her spiritual intimacy predicted more positivity by both spouses and less negativity by him, and his sanctification marginally predicted more positivity and less negativity by him. Findings offer rigorous causal modeling that spousal reports about marital spirituality influence observed spousal behavior by using longitudinal data to rule out unmeasured and measured third-variable confounds, multiple reporters (husbands, wives), multiple methods (self and joint reports, direct observation), and cross-informant data (spousal reports about him predicting her behavior, and vice versa).

Journal of Family Psychology · 87 citationsread the source →