Sexual abuse prevalence and association with adverse labour and birth outcomes

In the past decade there has been growing recognition that a sexual abuse history may manifest during health care examinations. More recently, awareness has been raised about a possible link between a history of sexual abuse and traumatic labour and birth. It is theoretically likely that the intimacy of labour and birth for women with a history of sexual abuse may trigger post-traumatic stress symptomatology. In this cross sectional study, a survey method was used to establish prevalence of sexual abuse and to measure obstetric outcomes, birth experience and birth trauma in a cohort of women who have recently given birth and to test whether there are associations between sexual abuse and birth outcomes. Eighty-five women whose 3½ to 5 year old children attend kindergarten participated. Lifetime sexual abuse was found to be a common experience for study participants. One out of every three women disclosed an experience of sexual abuse in her lifetime. A history of sexual abuse was not associated with adverse labour and birth outcomes; however women with a positive sexual abuse history were more likely to report postnatal depression. A quarter of the women had PTSD symptoms but overall, women had positive birth experiences and felt well supported. Many women are able to overcome traumatic abuse experiences and successfully cope with birth, an event that may potentially replicate the dynamics of sexual abuse. Further research is needed to identify women who may be at high risk for traumatic birth experiences. Undertaking screening for sexual abuse in the antenatal period in a safe environment may provide reassurance for women and enable identification of those women at high risk for abuse related traumatic birth experiences

A cross-sectional examination of the prevalence of psychotropic medications for people living with dementia in Australian long-term care facilities: issues of concern

Background: Behavioral and psychological symptoms of dementia (BPSD) are a common problem in long-term care facilities (LTC). Clinical guidelines dictate that first-line treatments for BPSD are psychosocial and behavioral interventions; if these are unsuccessful, psychotropic medications may be trialed at low doses and their effects can be monitored.Methods: There have previously been no studies with nationally representative samples to investigate psychotropic administration in LTCs in Australia. This study determines the prevalence of psychotropic administration in a representative stratified random sample of 446 residents living with dementia from 53 Australian LTCs. Questionnaire and medical chart data in this study is drawn from a larger cross-sectional, mixed methods study on quality of life in Australian LTCs.Results: It was found that 257 (58%) residents were prescribed psychotropic medications including: antipsychotics (n = 160, 36%), benzodiazepines (n = 136, 31%), antidepressants (n = 117, 26%), and anti-dementia medications (n = 9, 2%). BPSD were found to be very common in the sample, with 82% (n = 364) of participants experiencing at least one BPSD. The most prevalent BPSD were depression (n = 286, 70%) and agitation (n = 299, 67%).Conclusions: Although detailed background information was not collected on individual cases, the prevalence found is indicative of systematic industry-wide, over-prescription of psychotropic medications as a first-line treatment for BPSD. This study highlights a clear need for further research and interventions in this area

Safety and efficacy of eculizumab in anti-acetylcholine receptor antibody-positive refractory generalised myasthenia gravis (REGAIN): a phase 3, randomised, double-blind, placebo-controlled, multicentre study

Background Complement is likely to have a role in refractory generalised myasthenia gravis, but no approved therapies specifically target this system. Results from a phase 2 study suggested that eculizumab, a terminal complement inhibitor, produced clinically meaningful improvements in patients with anti-acetylcholine receptor antibody-positive refractory generalised myasthenia gravis. We further assessed the efficacy and safety of eculizumab in this patient population in a phase 3 trial. Methods We did a phase 3, randomised, double-blind, placebo-controlled, multicentre study (REGAIN) in 76 hospitals and specialised clinics in 17 countries across North America, Latin America, Europe, and Asia. Eligible patients were aged at least 18 years, with a Myasthenia Gravis-Activities of Daily Living (MG-ADL) score of 6 or more, Myasthenia Gravis Foundation of America (MGFA) class II\ue2\u80\u93IV disease, vaccination against Neisseria meningitides, and previous treatment with at least two immunosuppressive therapies or one immunosuppressive therapy and chronic intravenous immunoglobulin or plasma exchange for 12 months without symptom control. Patients with a history of thymoma or thymic neoplasms, thymectomy within 12 months before screening, or use of intravenous immunoglobulin or plasma exchange within 4 weeks before randomisation, or rituximab within 6 months before screening, were excluded. We randomly assigned participants (1:1) to either intravenous eculizumab or intravenous matched placebo for 26 weeks. Dosing for eculizumab was 900 mg on day 1 and at weeks 1, 2, and 3; 1200 mg at week 4; and 1200 mg given every second week thereafter as maintenance dosing. Randomisation was done centrally with an interactive voice or web-response system with patients stratified to one of four groups based on MGFA disease classification. Where possible, patients were maintained on existing myasthenia gravis therapies and rescue medication was allowed at the study physician's discretion. Patients, investigators, staff, and outcome assessors were masked to treatment assignment. The primary efficacy endpoint was the change from baseline to week 26 in MG-ADL total score measured by worst-rank ANCOVA. The efficacy population set was defined as all patients randomly assigned to treatment groups who received at least one dose of study drug, had a valid baseline MG-ADL assessment, and at least one post-baseline MG-ADL assessment. The safety analyses included all randomly assigned patients who received eculizumab or placebo. This trial is registered with ClinicalTrials.gov, number NCT01997229. Findings Between April 30, 2014, and Feb 19, 2016, we randomly assigned and treated 125 patients, 62 with eculizumab and 63 with placebo. The primary analysis showed no significant difference between eculizumab and placebo (least-squares mean rank 56\uc2\ub76 [SEM 4\uc2\ub75] vs 68\uc2\ub73 [4\uc2\ub75]; rank-based treatment difference \ue2\u88\u9211\uc2\ub77, 95% CI \ue2\u88\u9224\uc2\ub73 to 0\uc2\ub796; p=0\uc2\ub70698). No deaths or cases of meningococcal infection occurred during the study. The most common adverse events in both groups were headache and upper respiratory tract infection (ten [16%] for both events in the eculizumab group and 12 [19%] for both in the placebo group). Myasthenia gravis exacerbations were reported by six (10%) patients in the eculizumab group and 15 (24%) in the placebo group. Six (10%) patients in the eculizumab group and 12 (19%) in the placebo group required rescue therapy. Interpretation The change in the MG-ADL score was not statistically significant between eculizumab and placebo, as measured by the worst-rank analysis. Eculizumab was well tolerated. The use of a worst-rank analytical approach proved to be an important limitation of this study since the secondary and sensitivity analyses results were inconsistent with the primary endpoint result; further research into the role of complement is needed. Funding Alexion Pharmaceuticals