Design and protocol for a cluster randomised trial of enhanced diagnostics for tuberculosis screening among people living with HIV in hospital in Malawi (CASTLE study)

Background: People living with HIV (PLHIV) have a high risk of death if hospitalised in low-income countries. Tuberculosis has long been the leading cause of admission and death, in part due to suboptimal diagnostics. Two promising new diagnostic tools are digital chest Xray with computer-aided diagnosis (DCXR-CAD) and urine testing with Fujifilm SILVAMP LAM (FujiLAM). Neither test has been rigorously evaluated among inpatients. Test characteristics may be complementary, with FujiLAM especially sensitive for disseminated tuberculosis and DCXR-CAD especially sensitive for pulmonary tuberculosis, making combined interventions of interest. Design and methods: An exploratory unblinded, single site, two-arm cluster randomised controlled trial, with day of admission as the unit of randomisation. A third, smaller, integrated cohort arm (4:4:1 random allocation) contributes to understanding case-mix, but not trial outcomes. Participants are adults living with HIV not currently on TB treatment. The intervention (DCXR-CAD plus urine FujiLAM plus usual care) is compared to usual care alone. The primary outcome is proportion of participants started on tuberculosis treatment by day 56, with secondary outcomes of mortality (time to event) measured to to 56 days from enrolment, proportions with undiagnosed tuberculosis at death or hospital discharge and comparing proportions with enrolment-day tuberculosis treatment initiation. Discussion: Both DCXR-CAD and FujiLAM have potential clinical utility and may have complementary diagnostic performance. To our knowledge, this is the first randomised trial to evaluate these tests among hospitalised PLHIV

Recognizing anxiety and post-traumatic stress disorder in cardiac patients

Research has established that anxiety and post-traumatic stress disorder (PTSD) are risk factors for the development of heart disease in healthy populations. In addition, anxiety and PTSD are associated with further morbidity in people with existing heart disease. This article considers whether anxiety and PTSD influence onset and recovery from heart disease. Clinical implications for cardiac nursing are considered, including screening, treatment, and referral on to specialist services

Anxiety and post-traumatic stress disorder in cardiac patients

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Goal disturbance, cognitive coping and psychological distress in HIV-infected persons

This study aims to explore the relationships between cognitive coping, goal disturbance and psychological distress in HIV-infected persons. A sample of 43 HIV positive persons completed questionnaires that assessed cognitive coping, goal frustration, depressive symptoms and quality of life. Goal frustration and, to a lesser extent, the cognitive coping strategy 'positive reappraisal' were related to psychological distress. Intervention programmes might usefully implement the topics of goal disturbance and positive reappraisa

Development and evaluation of the BRISK Scale, a brief observational measure of risk communication competence.

OBJECTIVE: To develop and evaluate a brief observational measure of clinical risk communication competence. METHODS: A 4-item checklist-type measure, the BRISK (Brief Risk Information Skill) Scale, was developed by selecting and refining items from a more comprehensive measure of clinical risk communication competence. Six volunteer raters received brief training on the measure and then used the BRISK Scale to evaluate 52 video-recorded encounters between 2nd-year medical students and standardized patients conducted as part of an Observed Structured Clinical Examination (OSCE) involving a risk communication task. Internal consistency reliability, inter-rater reliability, and criterion validity were assessed. RESULTS: Raters reported no difficulties using the BRISK Scale; scores across all raters and subjects ranged from 0 to 16 with a mean score of 6.49 (SD=3.17). The BRISK Scale showed good internal consistency reliability (α=0.64), and inter-rater reliability at the scale level (Intraclass Correlation Coefficient (ICC)=0.79 for consistency, and 0.75 for absolute agreement) and individual-item level (ICC range: 0.62-.91). Novice raters\u27 BRISK Scale scores were highly correlated (r=0.84, p CONCLUSIONS: The BRISK Scale is a promising new brief observational measure of clinical risk communication competence

Design and protocol for a cluster randomised trial of enhanced diagnostics for tuberculosis screening among people living with HIV in hospital in Malawi (CASTLE study).

BackgroundPeople living with HIV (PLHIV) have a high risk of death if hospitalised in low-income countries. Tuberculosis has long been the leading cause of admission and death, in part due to suboptimal diagnostics. Two promising new diagnostic tools are digital chest Xray with computer-aided diagnosis (DCXR-CAD) and urine testing with Fujifilm SILVAMP LAM (FujiLAM). Neither test has been rigorously evaluated among inpatients. Test characteristics may be complementary, with FujiLAM especially sensitive for disseminated tuberculosis and DCXR-CAD especially sensitive for pulmonary tuberculosis, making combined interventions of interest.Design and methodsAn exploratory unblinded, single site, two-arm cluster randomised controlled trial, with day of admission as the unit of randomisation. A third, smaller, integrated cohort arm (4:4:1 random allocation) contributes to understanding case-mix, but not trial outcomes. Participants are adults living with HIV not currently on TB treatment. The intervention (DCXR-CAD plus urine FujiLAM plus usual care) is compared to usual care alone. The primary outcome is proportion of participants started on tuberculosis treatment by day 56, with secondary outcomes of mortality (time to event) measured to to 56 days from enrolment, proportions with undiagnosed tuberculosis at death or hospital discharge and comparing proportions with enrolment-day tuberculosis treatment initiation.DiscussionBoth DCXR-CAD and FujiLAM have potential clinical utility and may have complementary diagnostic performance. To our knowledge, this is the first randomised trial to evaluate these tests among hospitalised PLHIV