Sensitivity and specificity of Aboriginal-developed items to supplement the adapted PHQ-9 screening measure for depression: results from the Getting it Right study.

OBJECTIVE: To determine the psychometric properties of an Aboriginal and Torres Strait Islander-developed depressive symptom screening scale. DESIGN: Prospective diagnostic accuracy study. SETTING: Ten primary health care services or residential alcohol and other drug rehabilitation services in Australia that predominantly serve Aboriginal and Torres Strait Islander peoples. PARTICIPANTS: 500 adults (18 years or older) who identified as Aboriginal and/or Torres Strait Islander and were able to communicate sufficiently to respond to questionnaire and interview questions. Recruitment occurred between 25 March 2015 and 2 November 2016. MAIN OUTCOME MEASURE: Criterion validity of seven Aboriginal and Torres Strait Islander-developed items, using the adapted Patient Health Questionnaire 9 (aPHQ-9) and depression module of the Mini International Neuropsychiatric Interview (MINI) 6.0.0 as the criterion standards. RESULTS: The seven-item scale had good internal consistency (α = 0.83) and correlated highly with the aPHQ-9 (ρ = 0.76). All items were significantly associated with diagnosis of a current major depressive episode. Discriminant function and decision tree analysis identified three items forming a summed scale that classified 85% of participants correctly. These three items showed equivalent sensitivity and specificity to the aPHQ-9 when compared with the MINI-identified diagnosis of a current major depressive episode. CONCLUSION: Three items developed by and for Aboriginal and Torres Strait Islander people may provide effective, efficient and culturally appropriate screening for depression in Aboriginal and Torres Strait Islander health care contexts.

Prevalence of depression and anxiety symptoms after stroke in young adults: A systematic review and meta-analysis.

BACKGROUND: Young adults with stroke have distinct professional and social roles making them vulnerable to symptoms of post-stroke depression (PSD) and post-stroke anxiety (PSA). Prior reviews have examined the prevalence of anxiety and depression in stroke populations. However, there are a lack of studies that have focused on these conditions in young adults. OBJECTIVE: We performed a systematic review and meta-analysis of observational studies that reported on symptoms of PSD, PSA and comorbid PSD/PSA in young adults aged 18 to 55 years of age. METHODS: MEDLINE, EMBASE, SCOPUS and PsycINFO were searched for studies reporting the prevalence of symptoms of PSD and/or PSA in young adults with stroke from inception until June 23, 2023. We included studies that evaluated depression and/or anxiety symptoms with screening tools or interviews following ischemic or hemorrhagic stroke. Validated methods were employed to evaluate risk of bias. RESULTS: 4748 patients from twenty eligible studies were included. Among them, 2420 were also evaluated for symptoms of PSA while 847 participants were evaluated for both PSD and PSA symptoms. Sixteen studies were included in the random effects meta-analysis for PSD symptoms, with a pooled prevalence of 31 % (95 % CI 24-38 %). Pooled PSA symptom prevalence was 39 % (95 % CI 30-48 %) and comorbid PSD with PSA symptom prevalence was 25 % (95 % CI 12-39 %). Varying definitions of 'young adult', combinations of stroke subtypes, and methods to assess PSD and PSA contributed to high heterogeneity amongst studies. CONCLUSIONS: We identified high heterogeneity in studies investigating the prevalence of symptoms of PSD and PSA in young adults, emphasizing the importance of standardized approaches in future research to gain insight into the outcomes and prognosis of PSD and PSA symptoms following stroke in young adults. Larger longitudinal epidemiological studies as well as studies on tailored interventions are required to address the mental health needs of this important population. FUNDING: None.

Efficacy and safety of a 4-week course of repeated subcutaneous ketamine injections for treatment-resistant depression (KADS study): randomised double-blind active-controlled trial.

BACKGROUND: Prior trials suggest that intravenous racemic ketamine is a highly effective for treatment-resistant depression (TRD), but phase 3 trials of racemic ketamine are needed. AIMS: To assess the acute efficacy and safety of a 4-week course of subcutaneous racemic ketamine in participants with TRD. Trial registration: ACTRN12616001096448 at www.anzctr.org.au. METHOD: This phase 3, double-blind, randomised, active-controlled multicentre trial was conducted at seven mood disorders centres in Australia and New Zealand. Participants received twice-weekly subcutaneous racemic ketamine or midazolam for 4 weeks. Initially, the trial tested fixed-dose ketamine 0.5 mg/kg versus midazolam 0.025 mg/kg (cohort 1). Dosing was revised, after a Data Safety Monitoring Board recommendation, to flexible-dose ketamine 0.5-0.9 mg/kg or midazolam 0.025-0.045 mg/kg, with response-guided dosing increments (cohort 2). The primary outcome was remission (Montgomery-Åsberg Rating Scale for Depression score ≤10) at the end of week 4. RESULTS: The final analysis (those who received at least one treatment) comprised 68 in cohort 1 (fixed-dose), 106 in cohort 2 (flexible-dose). Ketamine was more efficacious than midazolam in cohort 2 (remission rate 19.6% v. 2.0%; OR = 12.1, 95% CI 2.1-69.2, P = 0.005), but not different in cohort 1 (remission rate 6.3% v. 8.8%; OR = 1.3, 95% CI 0.2-8.2, P = 0.76). Ketamine was well tolerated. Acute adverse effects (psychotomimetic, blood pressure increases) resolved within 2 h. CONCLUSIONS: Adequately dosed subcutaneous racemic ketamine was efficacious and safe in treating TRD over a 4-week treatment period. The subcutaneous route is practical and feasible.

A practical guide to living evidence: Reducing the knowledge-to-practice gap.

Living evidence involves continuous evidence surveillance to incorporate new relevant evidence into systematic reviews and clinical practice guideline recommendations as soon as it becomes available. Thus, living evidence may improve the timeliness of recommendation updates and reduce the knowledge-to-practice gap. When considering a living evidence model, several processes and practical aspects need to be explored. Some of these include identifying the need for a living evidence model, funding, governance structure, time, team skills and capabilities, frequency of updates, approval and endorsement and publication and dissemination.

Mental health in the two years following hypertensive and normotensive pregnancy: The Postpartum, Physiology, Psychology and Paediatric follow-up (P4) cohort study.

BACKGROUND: Postpartum mental illnesses and hypertensive disorders of pregnancy (HDP) are both common, and both associated with adverse maternal and child health outcomes. However, the relationship between them is unclear. This study aimed to investigate prevalence and symptom severity of depression, anxiety, and post-traumatic stress disorder (PTSD) 2-years postpartum in women with normal blood pressure (NBP) during pregnancy versus preeclampsia or gestational hypertension (GH). METHODS: Two-years follow-up of the prospective Postpartum, Physiology, Psychology and Paediatric (P4) Cohort Study was conducted in metropolitan Australia. Prevalence and symptom severity of depression (Edinburgh Postnatal Depression Scale, EPDS > 12), anxiety (7-item Generalized Anxiety Disorder scale, GAD-7 ≥ 10) and PTSD (Posttraumatic stress Diagnostic Scale, PDS/PDS-5) were measured and calculated for women with NBP, preeclampsia and GH. RESULTS: Among 365 participants (NBP: n = 271, preeclampsia: n = 75, GH: n = 19), 2-years postpartum depression prevalence was 3.9% (95% CI 2.3-6.4%): 4.4% after NBP, and 2.7% after preeclampsia (p = 0.53). Anxiety prevalence was higher after GH than NBP (15.8% versus 3.3%, p = 0.02). Prevalence of any mental illness (depression/anxiety/PTSD) was 5.9% (95% CI 3.8-8.8%); 5.6% after NBP, 4.1% after PE, and 15.8% after GH (p = 0.15). Although PTSD prevalence was low (1.4%), and similar between groups (p = 0.97), around 3 times more women after PE (8.1%), compared to NBP (2.5%), recalled childbirth as traumatic (p = 0.003). CONCLUSIONS: Preeclampsia, although associated with persistent perceptions of traumatic childbirth, did not alter the risk of mental illnesses at 2-years postpartum. GH (albeit in a small subgroup) was associated with increased anxiety scores. Larger, multicentre studies are required to clarify relationships between HDP and postpartum mental illness. TRIAL REGISTRATION: Retrospectively registered on 18/11/2013 with the Australian and New Zealand Clinical Trials Registry. REGISTRATION NUMBER: ACTRN 12613 00,126 0718.

Comparisons between group- and individual-based interventions to support recovery from stroke and ischaemic heart disease in the community: a scoping review.

PURPOSE: To map and summarise available literature on the effectiveness or other benefits of group- and individual-based interventions provided for adults living with stroke or ischaemic heart disease (IHD) in the community. MATERIAL AND METHODS: The review was conducted based on JBI methodology and reported using Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews. Articles were retrieved from: Medline, PsychInfo, Embase, Scopus, and CINAHL from 2002-2022. Extracted data from eligible studies included type of health outcomes (e.g., impairments), retention and adherence, social connectedness, and the costs associated with group- and individual-based interventions. RESULTS: After screening, five articles (representing 4 unique studies) comparing a group- and individual-based intervention were included (total sample size n = 87). Three types of interventions were assessed: exercise (3/5), communication (1/5), and occupational therapy (1/5). Effectiveness of group- and individual-based interventions at improving health outcomes (i.e. physical ability, communication, motivation, and quality of life) is unclear. Currently there is insufficient evidence to guide clinical practice. CONCLUSIONS: There is limited evidence comparing interventions delivered in a group and individual modality for adults living with stroke or IHD. Adequately powered studies are needed to determine if mode of delivery is equivalent or more cost effective.

Rehabilitation interventions can be offered individually or in group settings with clinicians choosing the most appropriate modality.Both group- and individual-based interventions have advantages and disadvantages, with clinical, practical, and economic factors as important considerations when deciding between the two modalities.Based on this scoping review, the authors conclude that there is currently insufficient evidence to guide clinical practice in deciding which mode of delivery (group or individual) is optimal.There is insufficient research evidence to guide clinicians in their choice between offering rehabilitation interventions for stroke or IHD in groups or individually.

Individual patient data meta-analysis of the effects of fluoxetine on functional outcomes after acute stroke.

BACKGROUND: Three large randomized controlled trials of fluoxetine for stroke recovery have been performed. We performed an individual patient data meta-analysis (IPDM) on the combined data. METHODS: Fixed effects meta-analyses were performed on the combined data set, for the primary outcome (modified Rankin scale (mRS) at 6 months), and secondary outcomes common to the individual trials. As a sensitivity analysis, summary statistics from each trial were created and combined. FINDINGS: The three trials recruited a combined total of 5907 people (mean age 69.5 years (SD 12.3), 2256 (38%) females, 2-15 days post-stroke) from Australia, New Zealand, United Kingdom, Sweden, and Vietnam; and randomized them to fluoxetine 20 mg daily or matching placebo for 6 months. Data on 5833 (98.75%) were available at 6 months. The adjusted ordinal comparison of mRS was similar in the two groups (common OR 0.96, 95% CI 0.87 to 1.05, p = 0.37). There were no statistically significant interactions between the minimization variables (baseline probability of being alive and independent at 6 months, time to treatment, motor deficit, or aphasia) and pre-specified subgroups (including age, pathological type, inability to assess mood, proxy or patient consent, baseline depression, country). Fluoxetine increased seizure risk (2.64% vs 1.8%, p = 0.03), falls with injury (6.26% vs 4.51%, p = 0.03), fractures (3.15% vs 1.39%, p < 0.0001) and hyponatremia (1.22% vs 0.61%, p = 0.01) but reduced new depression (10.05% vs 13.42%, p < 0.0001). At 12 months, there was no difference in adjusted mRS (n = 5760; common OR 0.98, 95% CI 0.89 to 1.07). Sensitivity analyses gave the same results. INTERPRETATION: Fluoxetine 20 mg daily for 6 months did not improve functional recovery. It increased seizures, falls with injury, and bone fractures but reduced depression frequency at 6 months.

Cognitive outcomes from the randomised, active-controlled Ketamine for Adult Depression Study (KADS).

BACKGROUND: Due to its rapid antidepressant effect, ketamine has recently been clinically translated for people with treatment-resistant depression. However, its cognitive profile remains unclear, particularly with repeated and higher doses. In the present study, we report the cognitive results from a recent large multicentre randomised controlled trial, the Ketamine for Adult Depression Study (KADS). METHODS: In this randomised, double-blind, active-controlled, parallel group, multicentre phase 3 trial study we investigated potential cognitive changes following repeated treatment of subcutaneous racemic ketamine compared to an active comparator, midazolam, over 4 weeks, which involved two cohorts; Cohort 1 involved a fixed dose treatment protocol (0.5 mg/kg ketamine), Cohort 2 involved a dose escalation protocol (0.5-0.9 mg/kg) based on mood outcomes. Participants with treatment-resistant Major Depressive Disorder (MDD) were recruited from 7 mood disorder centres and were randomly assigned to receive ketamine (Cohort 1 n = 33; Cohort 2 n = 53) or midazolam (Cohort 1 n = 35; Cohort 2 n = 53) in a 1:1 ratio. Cognitive measurements were assessed at baseline and at the end of randomised treatment. RESULTS: Results showed that in Cohort 1, there were no differences between ketamine and midazolam in cognitive outcomes. For Cohort 2, there was similarly no difference between conditions for cognitive outcomes. LIMITATIONS: The study included two Cohorts with different dosing regimes. CONCLUSIONS: The findings support the cognitive safety of repeated fixed and escalating doses at least in the short-term in people with treatment resistant MDD.

Statistical analysis plan for the Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke randomised controlled clinical trial.

BACKGROUND: Unplanned hospital presentations may occur post-stroke due to inadequate preparation for transitioning from hospital to home. The Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke (ReCAPS) trial was designed to test the effectiveness of receiving a 12-week, self-management intervention, comprising personalised goal setting with a clinician and aligned educational/motivational electronic messages. Primary outcome is as follows: self-reported unplanned hospital presentations (emergency department/admission) within 90-day post-randomisation. We present the statistical analysis plan for this trial. METHODS/DESIGN: Participants are randomised 1:1 in variable block sizes, with stratification balancing by age and level of baseline disability. The sample size was 890 participants, calculated to detect a 10% absolute reduction in the proportion of participants reporting unplanned hospital presentations/admissions, with 80% power and 5% significance level (two sided). Recruitment will end in December 2023 when funding is expended, and the sample size achieved will be used. Logistic regression, adjusted for the stratification variables, will be used to determine the effectiveness of the intervention on the primary outcome. Secondary outcomes will be evaluated using appropriate regression models. The primary outcome analysis will be based on intention to treat. A p-value ≤ 0.05 will indicate statistical significance. An independent Data Safety and Monitoring Committee has routinely reviewed the progress and safety of the trial. CONCLUSIONS: This statistical analysis plan ensures transparency in reporting the trial outcomes. ReCAPS trial will provide novel evidence on the effectiveness of a digital health support package post-stroke. TRIAL REGISTRATION: ClinicalTrials.gov ACTRN12618001468213. Registered on August 31, 2018. SAP version 1.13 (October 12 2023) Protocol version 1.12 (October 12, 2022) SAP revisions Nil.