Satisfaction with cognitive remediation therapy: its effects on implementation and outcomes using the cognitive remediation satisfaction scale.

Cognitive Remediation (CR) improves cognition and functioning but is implemented in a variety of ways (independent, group and one-to-one). There is no information on whether service users find these implementation methods acceptable or if their satisfaction influences CR outcomes. We used mixed participatory methods, including focus groups, to co-develop a CR satisfaction scale. This was refined using three psychometric criteria (Cronbach's alpha, item discrimination, test-retest agreement) to select items. Factor analysis explored potential substructures. The refined measure was used in structural equation joint modelling to evaluate whether satisfaction with CR is affected by implementation method and treatment engagement or influences recovery outcome, using data from a randomised controlled trial. Four themes (therapy hours, therapist, treatment effects, computer use) generated a 31-item Cognitive Remediation Satisfaction scale (CRS) that reduced to 18 Likert items, 2 binary and 2 open-ended questions following psychometric assessment. CRS had good internal consistency (Alpha = 0.814), test-retest reliability (r= 0.763), and concurrent validity using the Working Alliance Inventory (r = 0.56). A 2-factor solution divided items into therapy engagement and therapy effects. Satisfaction was not related to implementation method but was significantly associated with CR engagement. Therapy hours were significantly associated with recovery, but there was no direct effect of satisfaction on outcome. Although satisfaction is important to therapy engagement, it has no direct effect on outcome. CR therapy hours directly affect outcome irrespective of which implementation model is used, so measuring satisfaction early might help to identify those who are likely to disengage. The study has mixed methods design.

Can we challenge attention and interpretation threat biases in rescued child labourers with a history of physical abuse using a computerised cognitive training task? Data on feasibility, acceptability and target engagement.

Child labourers are more likely to have experienced physical victimisation, which may increase risk for anxiety/depression, by shaping threat biases in information-processing. To target threat biases and vulnerability for anxiety/depression, we evaluated whether Cognitive Bias Modification (CBM) training could be feasibly and acceptably delivered to rescued youth labourers. Seventy-six physically abused rescued labourers aged 14-17 (40 from Nepal, 36 from India) in out-of-home care institutions received either multi-session computerised CBM or control training. Training targeted attention away from threat to positive cues and the endorsement of benign over threat interpretations. Feasibility and acceptability data were gathered along with pre and post intervention measures of attention and interpretation bias and emotional and behavioural symptoms. In terms of feasibility, uptake (proportion of those who completed the pre-intervention assessment from those who consented) and retention (proportion of those who completed the post-intervention assessment from those who completed the pre-intervention assessment) were above 75% in both countries. Average acceptability ratings were mostly 'moderate' on most indices for both countries, and none of the participants reported experiencing serious adverse events or reactions in response to or during the trial. Secondarily, CBM participants showed increased attention to positive and decreased attention to threatening stimuli, as well as increased endorsement of benign interpretation and decreased endorsement in negative interpretations of ambiguous social situations. Symptom changes were less clear. Delivering CBM to former child labourers in out-of-home care institutions has interventive potential. ClinicalTrials.gov Identifier: NCT03625206, Date of registration: August 10, 2018.

Threat biases associate with anxiety and depression in physically-abused young people with a history of child labour.

BACKGROUND AND OBJECTIVES: Young people who have experienced early-life maltreatment preferentially attend to threat and draw more threatening interpretations. In turn, these threat biases may explain elevated risk for lifelong anxiety and/or depression. We investigated whether adolescent labourers with a history of physical abuse showed threat biases relative to non-abused labourers, and whether these threat biases associated with anxiety and depression. METHODS: 100 young people (aged 13-18 years, 64% female) from Nepal rescued from illegal child work were assessed for childhood maltreatment and anxiety and/or depression disorders. Participants completed an emotional visual search task (to measure attention engagement of positive versus negative faces) and an ambiguous scenarios questionnaire (to measure the endorsement of negative versus benign interpretations). RESULTS: Seventy young people reported a history of physical (and emotional) abuse. They were more likely to meet symptom thresholds for depression, and marginally, for anxiety disorders than non-physically abused participants. Abused and non-abused participants did not differ on attention engagement/disengagement of threat or on interpretational style. Abused participants with anxiety were slower to disengage from negative faces to engage with a positive face than non-anxious abused participants. Abused participants with depression endorsed more negative interpretations of ambiguous situations than those without depression. LIMITATIONS: The cross-sectional design limits our ability to infer whether threat biases reflect risk markers of psychopathology. CONCLUSIONS: If threat biases are shown to confer risk for anxiety and depression in future studies, they could be targeted in mental health prevention programs for these vulnerable young people.

Mifepristone and misoprostol versus placebo and misoprostol for resolution of miscarriage in women diagnosed with missed miscarriage: the MifeMiso RCT.

TRIAL DESIGN: A randomised, parallel-group, double-blind, placebo-controlled multicentre study with health economic and nested qualitative studies to determine if mifepristone (Mifegyne®, Exelgyn, Paris, France) plus misoprostol is superior to misoprostol alone for the resolution of missed miscarriage. METHODS: Women diagnosed with missed miscarriage in the first 14 weeks of pregnancy were randomly assigned (1 : 1 ratio) to receive 200 mg of oral mifepristone or matched placebo, followed by 800 µg of misoprostol 2 days later. A web-based randomisation system allocated the women to the two groups, with minimisation for age, body mass index, parity, gestational age, amount of bleeding and randomising centre. The primary outcome was failure to pass the gestational sac within 7 days after randomisation. The prespecified key secondary outcome was requirement for surgery to resolve the miscarriage. A within-trial cost-effectiveness study and a nested qualitative study were also conducted. Women who completed the trial protocol were purposively approached to take part in an interview to explore their satisfaction with and the acceptability of medical management of missed miscarriage. RESULTS: A total of 711 women, from 28 hospitals in the UK, were randomised to receive either mifepristone plus misoprostol (357 women) or placebo plus misoprostol (354 women). The follow-up rate for the primary outcome was 98% (696 out of 711 women). The risk of failure to pass the gestational sac within 7 days was 17% (59 out of 348 women) in the mifepristone plus misoprostol group, compared with 24% (82 out of 348 women) in the placebo plus misoprostol group (risk ratio 0.73, 95% confidence interval 0.54 to 0.98; p = 0.04). Surgical intervention to resolve the miscarriage was needed in 17% (62 out of 355 women) in the mifepristone plus misoprostol group, compared with 25% (87 out of 353 women) in the placebo plus misoprostol group (risk ratio 0.70, 95% confidence interval 0.52 to 0.94; p = 0.02). There was no evidence of a difference in the incidence of adverse events between the two groups. A total of 42 women, 19 in the mifepristone plus misoprostol group and 23 in the placebo plus misoprostol group, took part in an interview. Women appeared to have a preference for active management of their miscarriage. Overall, when women experienced care that supported their psychological well-being throughout the care pathway, and information was delivered in a skilled and sensitive manner such that women felt informed and in control, they were more likely to express satisfaction with medical management. The use of mifepristone and misoprostol showed an absolute effect difference of 6.6% (95% confidence interval 0.7% to 12.5%). The average cost per woman was lower in the mifepristone plus misoprostol group, with a cost saving of £182 (95% confidence interval £26 to £338). Therefore, the use of mifepristone and misoprostol for the medical management of a missed miscarriage dominated the use of misoprostol alone. LIMITATIONS: The results from this trial are not generalisable to women diagnosed with incomplete miscarriage and the study does not allow for a comparison with expectant or surgical management of miscarriage. FUTURE WORK: Future work should use existing data to assess and rank the relative clinical effectiveness and safety profiles for all methods of management of miscarriage. CONCLUSIONS: Our trial showed that pre-treatment with mifepristone followed by misoprostol resulted in a higher rate of resolution of missed miscarriage than misoprostol treatment alone. Women were largely satisfied with medical management of missed miscarriage and would choose it again. The mifepristone and misoprostol intervention was shown to be cost-effective in comparison to misoprostol alone. TRIAL REGISTRATION: Current Controlled Trials ISRCTN17405024. 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. 68. See the NIHR Journals Library website for further project information.

Miscarriage is a common complication of pregnancy, affecting approximately one in four women. Sometimes, medical treatment (i.e. tablets) may be offered to start or speed up the miscarriage process in order for the womb to empty itself. A drug called misoprostol (a tablet that makes the womb contract) is currently recommended for this treatment. However, the addition of another drug called mifepristone [a tablet that reduces pregnancy hormones (Mifegyne^®, Exelgyn, Paris, France)] might help the miscarriage to resolve more quickly. Therefore, we carried out the MifeMiso trial to test if mifepristone plus misoprostol is more effective than misoprostol alone in resolving miscarriage within 7 days. Women were randomly allocated by a computer to receive either mifepristone or placebo, followed by misoprostol 2 days later. Neither the women nor their health-care professionals knew which treatment they received. Some women also talked to the researchers about their experiences of taking part in the study. In total, 711 women were randomised to receive either mifepristone plus misoprostol or placebo plus misoprostol. Overall, 83% of women who received mifepristone plus misoprostol had miscarriage resolution within 7 days, compared with 76% of the women who received a placebo plus misoprostol. Surgery was required less often in women who received mifepristone plus misoprostol: 17% of women who received it required surgery, compared with 25% of women who received the placebo. Treatment with mifepristone did not appear to have any negative effects. Treatment with mifepristone plus misoprostol was more cost-effective than misoprostol alone, with an average saving of £182 per woman. Having taken part in the study, most women would choose medical management again and would recommend it to someone they knew who was experiencing a miscarriage.

Targeting image-based autobiographical memory in childhood to prevent emotional disorders: Intervention development and a feasibility randomised controlled trial.

Maladaptive cognitive styles confer vulnerability for emotional disorders and may emerge in childhood. In three phases, we developed and evaluated a novel parent-led intervention (My Memory Forest) to target overgeneral memory and avoidance of negative memories. In phase 1, the intervention was co-designed using two focus groups (n = 30 children) and consultation with teachers and parents. The acceptability, feasibility, and clinical potential of My Memory Forest was initially evaluated in phase two (n = 12 children aged 6 to 9) and then in a feasibility randomised controlled trial in phase three, against an active control (n = 56 aged 6 to 9). Acceptability and engagement were good, and no harm was reported by parents or participants. Phase 2 identified decreases in self-reported anxiety (d = 1.08), depression (d = 0.51) and vividness of negative events (d = 0.53). There was little change in parent-reported symptoms. In phase 3, recruitment was highly feasible and participant retention excellent (100%) but parent retention poor (55%). Descriptive statistics indicated similar changes in anxiety and depression for both groups. Changes between Phases 2 and 3 (e.g. methods of recruitment) could explain the discrepancy between results. Further development is necessary before proceeding to another trial. TRIAL REGISTRATION: ISRCTN13142918.

A feasibility randomised controlled trial of a brief early intervention for adolescent depression that targets emotional mental images and memory specificity (IMAGINE).

Brief, evidence-based interventions for adolescent depression are urgently required, particularly for school-settings. Cognitive mechanisms research suggests dysfunctional mental imagery and overgeneral memory could be promising targets to improve mood. This feasibility randomised controlled trial with parallel symptomatic groups (n = 56) compared a novel imagery-based cognitive behavioural intervention (ICBI) to non-directive supportive therapy (NDST) in school settings. Blind assessments (of clinical symptoms and cognitive mechanisms) took place pre-intervention, post-intervention and follow-up three months later. The trial aimed to evaluate the feasibility and acceptability of the methodology and interventions, and estimate the likely range of effects of the intervention on self-reported depression. The pre-defined criteria for proceeding to a definitive RCT were met: full recruitment occurred within eleven months; retention was 89%; ICBI acceptability was above satisfactory; and no harm was indicated. Intention-to-treat analysis found large effects in favour of ICBI (relative to NDST) at post-intervention in reducing depressive symptoms (d = -1.34, 95% CI [-1.87, -0.80]) and improving memory specificity (d = 0.79 [0.35, 1.23]), a key cognitive target. The findings suggest that ICBI may not only improve mood but also strengthen abilities associated with imagining and planning the future, critical skills at this life stage. A fully powered evaluation of ICBI is warranted. Trial Registration: https://www.isrctn.com/; ISRCTN85369879.

Should atraumatic restorative treatment be the preferred treatment for older patients?

Design Randomised controlled trial study.Case selection Ninety-nine subjects were chosen from 219 potential subjects. The 99 who met the inclusion criteria were randomly allocated to two treatment groups: atraumatic restorative treatment (ART) and conventional treatment (CT). To be selected, patients needed to be 65 years or over, follow oral hygiene guidance and have one or more painless dentinal carious lesions. To establish suitability, a full dental examination was performed by two calibrated dentists. Prior to receiving ART or CT, all participants received standard dental care (including extractions, non-surgical treatment and oral hygiene instructions). Following ART or CT, a dental nurse collected data regarding patient treatment preferences and a calibrated independent dentist, blind to the treatment allocation, reviewed restorations six months, one year, two years and five years after treatment.Data analysis The Cox proportional-hazards (PH) model was used to assess the cumulative survival of the variables ART and CT between the intervals. Bootstrapping was employed to estimate standard errors since the multiple restorations required by many patients were not necessarily independent of each other.Results Of the 99 subjects included, only 28 (ART: 15, CT: 13) remained after five years. After five years, of the 300 restorations undertaken, 15 ART restorations and 16 CT restorations failed. The cumulative probability of restoration survival was 85% and 79% (p = 0.8095) for ART and CT, respectively, with the Cox PH model showing the treatment used had no effect on the restorations' survival.Conclusions No significant difference was noted between the treatment methods used in terms of survival of the restorations. However, it is worth noting that 64.5% of participants preferred to have dental treatment without local anaesthesia and 71.1% without the use of a dental drill. Therefore, ART was a favourable treatment option in older patients, particularly those unable to attend the dental surgery.

Effect of a multidisciplinary rehabilitation program for patients receiving weight management interventions on eating behaviours and health-related quality of life.

The rapid rise in obesity prevalence is life-style related and tackling this problem requires a pro-active multi-faceted approach to management. A private health care provider in Melbourne, Australia, developed a multidisciplinary rehabilitation program for patients who had undergone bariatric surgery or receiving pharmacological weight loss treatments. The study aim was to assess the programs' effect on patients' quality of life, mental well-being, and eating behaviours. METHODS: A prospective, observational, before and after study design was used. A total of 54 patients, 27 who had bariatric surgery and 27 receiving pharmacotherapy participated. Outcome measures were: change in weight and BMI, intuitive eating scale, impact of weight on quality of life scale and the depression, anxiety and stress scale. RESULTS: Both medical and surgical patients reported improvements in their health-related quality of life and eating behaviours. Despite this, at program completion 71.4% of patients who had bariatric surgery reported severe anxiety and 52.4% severe stress levels. CONCLUSION: Participation in a rehabilitation program that provided patients with peer support and access to expert advice supported patients to make healthy eating choices and improved their quality of life. The high prevalence of stress and anxiety related symptoms highlights the need to provide individuals who have undergone bariatric surgery with ongoing mental health support.

Mifepristone and misoprostol versus misoprostol alone for the management of missed miscarriage (MifeMiso): a randomised, double-blind, placebo-controlled trial.

BACKGROUND: The anti-progesterone drug mifepristone and the prostaglandin misoprostol can be used to treat missed miscarriage. However, it is unclear whether a combination of mifepristone and misoprostol is more effective than administering misoprostol alone. We investigated whether treatment with mifepristone plus misoprostol would result in a higher rate of completion of missed miscarriage compared with misoprostol alone. METHODS: MifeMiso was a multicentre, double-blind, placebo-controlled, randomised trial in 28 UK hospitals. Women were eligible for enrolment if they were aged 16 years and older, diagnosed with a missed miscarriage by pelvic ultrasound scan in the first 14 weeks of pregnancy, chose to have medical management of miscarriage, and were willing and able to give informed consent. Participants were randomly assigned (1:1) to a single dose of oral mifepristone 200 mg or an oral placebo tablet, both followed by a single dose of vaginal, oral, or sublingual misoprostol 800 µg 2 days later. Randomisation was managed via a secure web-based randomisation program, with minimisation to balance study group assignments according to maternal age (<30 years vs ≥30 years), body-mass index (<35 kg/m2vs ≥35 kg/m2), previous parity (nulliparous women vs parous women), gestational age (<70 days vs ≥70 days), amount of bleeding (Pictorial Blood Assessment Chart score; ≤2 vs ≥3), and randomising centre. Participants, clinicians, pharmacists, trial nurses, and midwives were masked to study group assignment throughout the trial. The primary outcome was failure to spontaneously pass the gestational sac within 7 days after random assignment. Primary analyses were done according to intention-to-treat principles. The trial is registered with the ISRCTN registry, ISRCTN17405024. FINDINGS: Between Oct 3, 2017, and July 22, 2019, 2595 women were identified as being eligible for the MifeMiso trial. 711 women were randomly assigned to receive either mifepristone and misoprostol (357 women) or placebo and misoprostol (354 women). 696 (98%) of 711 women had available data for the primary outcome. 59 (17%) of 348 women in the mifepristone plus misoprostol group did not pass the gestational sac spontaneously within 7 days versus 82 (24%) of 348 women in the placebo plus misoprostol group (risk ratio [RR] 0·73, 95% CI 0·54-0·99; p=0·043). 62 (17%) of 355 women in the mifepristone plus misoprostol group required surgical intervention to complete the miscarriage versus 87 (25%) of 353 women in the placebo plus misoprostol group (0·71, 0·53-0·95; p=0·021). We found no difference in incidence of adverse events between the study groups. INTERPRETATION: Treatment with mifepristone plus misoprostol was more effective than misoprostol alone in the management of missed miscarriage. Women with missed miscarriage should be offered mifepristone pretreatment before misoprostol to increase the chance of successful miscarriage management, while reducing the need for miscarriage surgery. FUNDING: UK National Institute for Health Research Health Technology Assessment Programme.

Diagnosis and management of miscarriage.

Miscarriage is defined as a pregnancy failure occurring before the completion of 24 weeks of gestation. Around 10 to 15% of all pregnancies end in early spontaneous first trimester miscarriage. Advancing maternal and paternal age are known to be associated with increasing chance of miscarriage. Other risk factors include being underweight or overweight, smoking and high alcohol consumption. Traditional practice classified miscarriage according to the history and findings on speculum examination but transvaginal ultrasound scan should now be considered the standard test to assess viability of the pregnancy. Assessment of the amount of vaginal bleeding experienced is best made in the context of time taken to saturate a sanitary pad. Changing a pad soaked with blood and clots more than once an hour is an indication of heavy bleeding that requires immediate referral. Following confirmation of a viable intrauterine pregnancy, symptoms may resolve. If the symptoms worsen, or persist beyond 14 days, a repeat referral should be made to the early pregnancy unit for further assessment. If a pregnancy is 12 weeks' gestation and the woman is rhesus negative, she will require anti-D prophylaxis if there are symptoms of bleeding. Expectant management is the first-line approach, and is encouraged for 7-14 days after diagnosis of miscarriage. Most women will miscarry spontaneously during this time and will need no further treatment. It is not appropriate if there are risk factors for haemorrhage, or if the woman is at increased risk from the effects of haemorrhage. Medical management of miscarriage can be offered using misoprostol. Surgical management may be chosen by a woman if she has had a previous adverse or traumatic experience associated with pregnancy.

Detecting ovarian disorders in primary care.

Ovarian cysts occur more often in premenopausal than postmenopausal women. Most of these cysts will be benign, with the risk of malignancy increasing with age. The risk of a symptomatic ovarian cyst in a premenopausal female being malignant is approximately 1:1,000 increasing to 3:1,000 at the age of 50. Ovarian cysts may be asymptomatic but presenting symptoms include pelvic pain, pressure symptoms and discomfort and menstrual disturbance. Functional cysts in particular can be linked with irregular vaginal bleeding or menorrhagia. Ovarian torsion is most common in the presence of an ovarian cyst. Dermoid cysts are most likely to tort. Torsion presents with sudden onset of severe colicky unilateral pain radiating from groin to loin. There may be nausea and vomiting. It is often confused with ureteric colic where the pain is similar but radiates loin to groin. Symptoms which may be suggestive of a malignant ovarian cyst, particularly in the over 50 age group, include: weight loss, persistent abdominal distension or bloating, early satiety, pelvic or abdominal pain and increased urinary urgency and frequency. CA125 levels should be checked in women who present with frequent bloating, feeling full quickly, loss of appetite, pelvic or abdominal pain or needing to urinate quickly or urgently. Symptomatic postmenopausal women, those with a cyst > or = 5 cm, or raised CA125 levels, should be referred to secondary care. Functional cysts, particularly when they are < 5 cm diameter, usually resolve spontaneously without the need for intervention. In premenopausal women simple cysts > or = 5 cm are less likely to resolve and need an annual ultrasound assessment as a minimum.