Enhanced surveillance for the detection of psoriatic arthritis in a UK primary care psoriasis population: results from the TUDOR trial.

BACKGROUND: Our objective was to determine whether early detection of undiagnosed psoriatic arthritis (PsA) in a primary care psoriasis population improves outcome in physical function at 24 months post-registration. METHODS: A multicentre, prospective, parallel group cluster randomised controlled trial in patients with psoriasis was conducted. Participants with suspected inflammatory arthritis on screening were referred for an assessment of PsA (enhanced surveillance (ES) arm: at baseline, 12 and 24 months; standard care (SC) arm: at 24 months). The primary outcome measure was the Health Assessment Questionnaire Disability Index (HAQ-DI) at 24 months post registration in participants diagnosed with PsA. RESULTS: A total of 2225 participants across 135 GP practices registered: 1123 allocated to ES and 1102 to SC. The primary analysis population consisted of 87 participants with a positive diagnosis of PsA: 64 in ES, 23 in SC. The adjusted odds ratio (OR) for achieving a HAQ-DI score of 0 at 24 months post registration in ES compared with SC was 0.64 (95% CI (0.17, 2.38)), and the adjusted OR of achieving a higher (non-zero) HAQ-DI score at 24 months post registration in ES relative to SC arm was 1.12 (95% CI: 0.67, 1.86), indicating no evidence of a difference between the two treatment groups (p= 0.66). CONCLUSION: The trial was underpowered for demonstrating the prespecified treatment effect; in patients with psoriasis there was no evidence that early diagnosis of PsA by ES in primary care changes physical function at 24 months compared with SC. CLINICAL TRIAL REGISTRATION: The TUDOR trial is registered as ISRCTN38877516.

Dietary intervention in gestational diabetes: a qualitative study of the acceptability and feasibility of a novel whole-diet intervention in healthcare professionals.

Gestational diabetes is treated with medical nutrition therapy, delivered by healthcare professionals; however, the optimal diet for affected women is unknown. Randomised controlled trials, such as the DiGest (Dietary Intervention in Gestational Diabetes) trial, will address this knowledge gap, but the acceptability of whole-diet interventions in pregnancy is unclear. Whole-diet approaches reduce bias but require high levels of participant commitment and long intervention periods to generate meaningful clinical outcomes. We aimed to assess healthcare professionals' views on the acceptability of the DiGest dietbox intervention for women with gestational diabetes and to identify any barriers to adherence which could be addressed to support good recruitment and retention to the DiGest trial. Female healthcare professionals (n 16) were randomly allocated to receive a DiGest dietbox containing 1200 or 2000 kcal/d including at least one weeks' food. A semi-structured interview was conducted to explore participants' experience of the intervention. Interviews were audio-recorded, transcribed verbatim and analysed thematically using NVivo software. Based on the findings of qualitative interviews, modifications were made to the dietboxes. Participants found the dietboxes convenient and enjoyed the variety and taste of the meals. Factors which facilitated adherence included participants having a good understanding of study aims and sufficient organisational skills to facilitate weekly meal planning in advance. Barriers to adherence included peer pressure during social occasions and feelings of deprivation or hunger (affecting both standard and reduced calorie groups). Healthcare professionals considered random allocation to a whole-diet replacement intervention to be acceptable and feasible in a clinical environment and offered benefits to participants including convenience.

Nutrition supplementation plus standard of care versus standard of care alone or standard of care plus unconditional cash transfer in the prevention of chronic malnutrition in Southern Angola: study protocol for the MuCCUA study, a cluster randomized controlled trial.

BACKGROUND: Chronic malnutrition is a condition associated with negative impacts on physical and cognitive development. It is multi-causal and can start very early in life, already in utero, thus it is especially challenging to find appropriate interventions to tackle it. The government of Angola is implementing a standard of care program with potential to prevent it, and the provision of cash transfers and the supplementation with small quantity lipid-based nutrients (SQ-LNS) are also promising interventions. We aimed to evaluate the impact of the standard of care program alone and of the standard of care plus a cash transfer intervention in the lineal growth of children less than 2 years old and compare it to the effectiveness of a nutrition supplementation plus standard of care program in Southern Angola. METHODS/DESIGN: The three-arm parallel cluster randomised controlled trial is set in four communes of Huila and Cunene provinces. Clusters are villages or neighbourhoods with a population around 1075 people. A total of twelve clusters were selected per arm and forty pregnant women are expected to be recruited in each cluster. Pregnant women receive the standard of care alone, or the standard of care plus unconditional cash transfer or plus nutritional supplementation during the first 1000 days, from pregnancy to the child reaching 24 months. The primary outcome is the prevalence of stunting measured as height-for-age Z-score (HAZ) < -2 in children below 2 years. Impact will be assessed at 3, 6, 12, 18 and 24 months of children's age. Secondary outcomes include mortality, morbidity, caring, hygiene and nutrition behaviours and practices, and women and children's dietary diversity. Quantitative data are also collected on women's empowerment, household food security, expenditure and relevant clinical and social events at baseline, endline and intermediate time points. DISCUSSION: The results will provide valuable information on the impact of the standard of care intervention alone as well as combined with an unconditional cash transfer intervention compared to a nutrition supplementation plus standard of care intervention, carried out during the first 1000 days, in the children´s growth up to 2 years and related outcomes in Southern Angola. TRIAL REGISTRATION: Clinical Trials NCT05571280. Registered 7 October 2022.

The implementation of a home-based isometric wall squat intervention using ratings of perceived exertion to select and control exercise intensity: a pilot study in normotensive and pre-hypertensive adults.

PURPOSE: Isometric exercise (IE) and isometric wall squat (IWS) training have been shown to be effective methods of reducing arterial blood pressure. However, most IE interventions require methodologies and equipment that could present a barrier to participation. Therefore, this study aimed to examine the effectiveness of an accessible RPE prescribed IWS intervention. METHODS: Thirty normotensive and pre-hypertensive adults were randomly assigned to a control group or one of two 4-week home-based IWS intervention groups: the first group conducted IWS exercise where intensity was prescribed and monitored using RPE (RPE-EX), whilst the other used a previously validated HR prescription method (HR-EX). Resting and ambulatory heart rate (HR) and blood pressure (BP) were measured pre- and post-intervention. RESULTS: Minimum clinically important differences (MCID; - 5 mmHg) in SBP and/or DBP were shown in 100% of intervention participants. Statistically significant reductions were shown in resting seated BP (RPE-EX: SBP: - 9 ± 6, DBP: - 6 ± 4, MAP: - 6 ± 3 mmHg; HR-EX: SBP: - 14 ± 6, DBP: - 6 ± 4, MAP: - 8 ± 4 mmHg), supine BP (RPE-EX: SBP: - 8 (- 5), DBP: - 8 (- 7), MAP: - 8 (- 4) mmHg; HR-EX: SBP: - 5 (- 4), MAP - 5 (- 4) mmHg), and ambulatory SBP (RPE-EX: - 8 ± 6 mmHg; HR-EX: - 10 ± 4 mmHg) following the interventions. There were no statistically significant differences between intervention groups in the magnitude of BP reduction. CONCLUSION: RPE prescribed IWS exercise can provide an effective and more accessible method for reducing BP at home, providing reductions comparable to the current HR-based prescription method.

Effects of Two Early Parenting Programmes on Child Aggression and Risk for Violence in Brazil: a Randomised Controlled Trial.

Violence is a major public health problem globally, with the highest rates in low- and middle-income countries (LMICs) in the Americas and southern Africa. Parenting programmes in high-income countries can diminish risk for violence, by reducing risk factors such as child aggression and harsh parenting, and increasing protective factors such as child cognitive development and school readiness. However, there is critical need to identify low-cost programmes with replicable benefits that work in real-world LMICs contexts. A three-arm, randomised, single-blind trial evaluated effects of two low-cost, group-based parenting programmes recommended for LMICs (ACT: Raising Safe Kids; DBS: dialogic book-sharing) on child aggression (primary outcome), child development, parenting, maltreatment, and stress. Participants were 369 children with medium-high levels of aggression (mean age 3.1 years at baseline) in poor households. Interventions were implemented in city health and education services in southern Brazil. Maternal reports, filmed observations, child tasks, and hair cortisol were assessed at baseline, 1-month post-intervention, and 8-month follow-up. Intention-to-treat analyses compared each of ACT and DBS with a control group. Three hundred sixty-eight (99.7%) participants completed follow-up assessments 8 months after the interventions. There was no effect of ACT (standardised mean difference, SMD 0.11, 95% CI - 0.05, 0.27) or DBS (SMD 0.05, 95% CI - 0.11, 0.21) on the primary outcome of child aggression. ACT reduced harsh parenting behaviour post-intervention (SMD - 0.23; 95% CI - 0.46, - 0.01), but not at follow-up. DBS improved book-sharing practices at both time points (e.g., maternal sensitivity at follow-up SMD 0.33; 95% CI 0.08, 0.57). There were no benefits of either programme for other parenting, child development, or stress outcomes. Two parenting programmes in Brazil had small effects on parenting practices but did not reduce child aggression or several other important risk/protective factors for violence. Effective early interventions that reduce violence in real-world LMIC settings are highly desirable but may be challenging to achieve.

'Is Insulin Right for Me?': Web-based intervention to reduce psychological barriers to insulin therapy among adults with non-insulin-treated type 2 diabetes-A randomised controlled trial.

AIMS: To test 'Is Insulin Right for Me?', a theory-informed, self-directed, web-based intervention designed to reduce psychological barriers to insulin therapy among adults with type 2 diabetes. Further, to examine resource engagement and associations between minimum engagement and outcomes. METHODS: Double-blind, two-arm randomised controlled trial (1:1), comparing the intervention with freely available online information (control). Eligible participants were Australian adults with type 2 diabetes, taking oral diabetes medications, recruited primarily via national diabetes registry. EXCLUSION CRITERIA: prior use of injectable medicines; being 'very willing' to commence insulin. Data collections were completed online at baseline, 2-week and 6-month follow-up. PRIMARY OUTCOME: negative insulin treatment appraisal scale (ITAS) scores; secondary outcomes: positive ITAS scores and hypothetical willingness to start insulin. ANALYSES: intention-to-treat (ITT); per-protocol (PP) examination of outcomes by engagement. TRIAL REGISTRATION: ACTRN12621000191897. RESULTS: No significant ITT between-arm (intervention: n = 233; control: n = 243) differences were observed in primary (2 weeks: Mdiff [95% CI]: -1.0 [-2.9 to 0.9]; 6 months: -0.01 [-1.9 to 1.9]), or secondary outcomes at either follow-up. There was evidence of lower Negative ITAS scores at 2-week, but not 6-month, follow-up among those with minimum intervention engagement (achieved by 44%) compared to no engagement (-2.7 [-5.1 to -0.3]). CONCLUSIONS: Compared to existing information, 'Is insulin right for me?' did not improve outcomes at either timepoint. Small intervention engagement effects suggest it has potential. Further research is warranted to examine whether effectiveness would be greater in a clinical setting, following timely referral among those for whom insulin is clinically indicated.

Guidelines of the International Headache Society for Controlled Clinical Trials in Idiopathic Intracranial Hypertension.

The quality of clinical trials is essential to advance treatment, inform regulatory decisions and meta-analysis. With the increased incidence of idiopathic intracranial hypertension and the emergence of clinical trials for novel therapies in this condition, the International Headache Society Guidelines for Controlled Clinical Trials in Idiopathic Intracranial Hypertension aims to establish guidelines for designing state-of-the-art controlled clinical trials for idiopathic intracranial hypertension.

The effects of olive oil consumption on blood lipids: a systematic review and dose-response meta-analysis of randomised controlled trials.

We performed a systematic review and dose-response meta-analysis of randomised trials on the effects of olive oil consumption on blood lipids in adults. A systematic search was performed in PubMed, Scopus and Web of Science databases until May 2021. Randomised controlled trials (RCT) evaluating the effect of olive oil intake on serum total cholesterol (TC), TAG, LDL-cholesterol and HDL-cholesterol in adults were included. The mean difference (MD) and 95 % CI were calculated for each 10 g/d increment in olive oil intake using a random-effects model. A total of thirty-four RCT with 1730 participants were included. Each 10 g/d increase in olive oil consumption had minimal effects on blood lipids including TC (MD: 0·79 mg/dl; 95 % CI (-0·08, 1·66); I2 = 57 %; n 31, GRADE = low certainty), LDL-cholesterol (MD: 0·04 mg/dl, 95 % CI (-1·01, 0·94); I2 = 80 %; n 31, GRADE = very low certainty), HDL-cholesterol (MD: 0·22 mg/dl; 95 % CI (-0·01, 0·45); I2 = 38 %; n 33, GRADE = low certainty) and TAG (MD: 0·39 mg/dl; 95 % CI (-0·33, 1·11); I2 = 7 %; n 32, GRADE = low certainty). Levels of TC increased slightly with the increase in olive oil consumption up to 30 g/d (MD30 g/d: 2·76 mg/dl, 95 % CI (0·01, 5·51)) and then appeared to plateau with a slight downward curve. A trivial non-linear dose-dependent increment was seen for HDL-cholesterol, with the greatest increment at 20 g/d (MD20 g/d: 1·03 mg/dl, 95 % CI (-1·23, 3·29)). Based on existing evidence, olive oil consumption had trivial effects on levels of serum lipids in adults. More large-scale randomized trials are needed to present more reliable results.

Reducing sickness absence and stigma due to mental health difficulties: a randomised control treatment trial (RCT) of a low intensity psychological intervention and stigma reduction programme for common mental disorder (Prevail).

BACKGROUND: Common mental disorders are the leading cause of workplace absences. The Prevail intervention programme aims to reduce stigma and to educate staff and managers about evidence-based low intensity psychological interventions for common mental disorders (depression, anxiety, stress, and distress). Prevail is innovative in taking a public health approach. It is designed to be given to all employees irrespective of their past or current mental health. Prevail was evaluated in three studies examining: (1) the acceptability of the intervention and perceived usefulness; (2) whether the intervention altered stigmatic attitudes and motivation to seek help; and (3) whether the intervention reduced sickness absence, both overall and due to mental health problems. METHODS: A two-armed cluster randomised control trial (RCT) evaluated the effectiveness of Prevail. Employees (N = 1051) at a large UK government institution were randomised to an active intervention or control arm in teams identified by their managers (n = 67). Employees in the active arm received the Prevail Staff Intervention. The managers in the active arm also received the Prevail Managers Intervention. Participants' satisfaction and analysis of the Prevail Intervention were gathered by a bespoke questionnaire. Questionnaire measures of attitudes to mental health and mental health stigma were taken 1-2 weeks prior to the intervention and approximately 4 weeks post-intervention. Data relating to sickness absence were gathered via the official records in the time period 3-month post-intervention and for the same period 12 months earlier. RESULTS: Prevail was evaluated highly favourably by both the staff and their managers. Prevail produced significant reductions in self-stigma and anticipated stigma due to mental health difficulties. Crucially, sickness absence was significantly reduced by the Prevail Intervention. DISCUSSION: Prevail achieved its goals of producing a palatable and engaging intervention that altered staff's attitudes and stigmatic beliefs related to mental health and, crucially, produced a strong reduction in work-pace absenteeism. As the Prevail programme is aimed at common mental health problems and was not specialised to this particular workforce, the study provides the evidence-base for a mental health intervention programme that could be used by many organisations across the world. TRIAL REGISTRATION: ISRCTN12040087. Registered 04/05/2020. https://doi.org/10.1186/ISRCTN12040087 . A full protocol for the randomised control trial was published: Gray NS, Davies H, Snowden RJ: Reducing stigma and increasing workplace productivity due to mental health difficulties in a large government organization in the UK: a protocol for a randomised control treatment trial (RCT) of a low intensity psychological intervention and stigma reduction programme for common mental disorder (Prevail). BMC Public Health 2020, 20(1):1-9.

Protocol of a cluster randomised trial of BodyKind: a school-based body image programme for adolescents.

BACKGROUND: Poor body image is prevalent among adolescents and associated with several negative outcomes for their physical and psychological health. There is a pressing need to address this growing public health concern, yet there are few evidence-informed universal programmes for older adolescents that address contemporary body image concerns (i.e., social media). BodyKind is a four lesson, school-based, teacher led, universal body image programme that incorporates empirically supported principles of cognitive dissonance, self-compassion, compassion for others and social activism, to support positive body image development. Building on previous pilot trials in the USA, this paper outlines the protocol for a cluster randomised control trial (cRCT) and implementation evaluation of the BodyKind programme which was culturally adapted for the Irish cultural context. METHODS: We aim to recruit 600 students aged 15-17 years in Transition Year (4th year) across 26 second-level schools in Ireland. Using minimisation, schools will be randomly assigned to receive BodyKind (intervention condition, n=300) or classes as usual (waitlist control, n=300). Teachers in intervention groups will receive training and deliver the programme to students over four weeks, at a rate of one lesson per week. Primary outcomes of body appreciation, body dissatisfaction and psychological wellbeing and secondary outcomes of self-compassion, compassion for others, body ideal internalisation, social justice motives and appearance-based social media use will be assessed at pre-, post- and 2 month follow up. Mediation and moderation analyses will be conducted to identify how and for whom the intervention works best. An implementation evaluation will assess the quality of programme implementation across schools and how this may influence intervention outcomes. Waitlist control schools will receive the programme after the 2-month follow up. CONCLUSION: This study will be the first to implement a cRCT and an implementation evaluation to assess the impact of this multicomponent school-based body image programme designed to support healthy body image development. If shown to be effective, BodyKind will have the potential to improve adolescent body image and wellbeing and inform efforts to implement sustainable and scalable programmes in schools. TRIAL REGISTRATION: The trial was retrospectively registered on 10/10/2023 on ClinicalTrials.gov NCT06076993 .

The effectiveness of dance movement therapy for individuals with Down syndrome: a pilot randomised controlled trial.

BACKGROUND: Individuals with Down syndrome (DS) exhibit deficits in static and dynamic balance abilities and maladaptive functions. This study aimed to determine the effectiveness of dance movement therapy (DMT) group intervention in individuals with DS. METHODS: The 31 participating individuals with DS, aged 5-29 years, were randomly divided into intervention (n = 16) and control (n = 15) groups. Posturography was used for static balance measurement, timed up and go test for dynamic balance measurement and the Achenbach System of Empirically Based Assessment (ASEBA) questionnaire for adaptive function and behavioural problem measurement in participants before and after the DMT interventions. The intervention group underwent 60-min DMT intervention once a week for 10 times, while the control group had usual daily activities. RESULTS: The results revealed a statistically significant difference and large effect sizes in dynamic balance [(f(1, 29) = 4.52, P = 0.04, ηp 2 = 0.14)] in the intervention group compared with the control group. There were no statistically significant differences in static balance and ASEBA scores between the groups. CONCLUSIONS: This study found that the DMT interventions helped to improve the dynamic balance in individuals with DS.

Clinical and demographic predictors of unilateral spatial neglect recovery after prism therapy among stroke survivors in the sub-acute phase of recovery.

BACKGROUND AND AIMS: Unilateral Spatial Neglect (USN) affects the rehabilitation process and leads to poor outcomes after stroke. Factors that influence USN recovery following prism adaptation therapy have not been investigated. This study investigated predictors of USN recovery after prism therapy at the sub-acute phase of recovery. METHODS: This study was a randomized controlled trial. USN was assessed with the Behavioural Inattention Test and Catherine Bergego scale. Seventy-four patients with USN were divided into control and intervention group (prism). The prism group used 20 dioptre prism lenses for repeated aiming for 12 sessions while the control group used neutral lenses for aiming training. Regression analysis was conducted to establish clinical and sociodemographic factors that influence USN recovery. RESULTS: Gender, age, years of education, race, employment status, handedness, type of stroke, time since stroke and site of stroke (p > 0.005) showed no significant influence on USN recovery following PA treatment. Higher Cognitive function (OR = 1.52, CI = 1.08-2.14, p = 0.016) and group allocationng (being in the prism group) (OR = 63.10, CI = 9.70-410.59, P < 0.001) were found to significantly influence USN recovery following PA treatment session. CONCLUSIONS: A significant modulating effect on general cognitive ability was found in this study. This suggests that prism adaptation therapy's effect on neural activity and spatial neglect depends on the cognitive function of stroke survivors.Trial registration: Pan African Clinical Trial Registry identifier: PACTR201903732473573.

A randomised control trial study of early post-operative pain and intraoperative surgeon workload following laparoscopic mesh repair of midline ventral hernia by enhanced-view totally extraperitoneal and intraperitoneal onlay mesh plus approach.

Introduction: The aim of this study was to compare the peri-operative outcomes, especially intraoperative surgeon workload and early post-operative pain, following midline ventral hernia repair by laparoscopic enhanced-view totally extraperitoneal (eTEP) approach and laparoscopic intraperitoneal onlay mesh plus (IPOM plus) approach. Patients and Methods: This single-centre randomised control trial study was conducted from January 2020 to June 2022. A total of 60 adult patients undergoing elective ventral hernia surgery with small- and medium-sized midline defects were included. Intraoperative surgeon workload and early post-operative pain were systematically recorded and analysed for each procedure. Results: Out of 30 patients assigned to each group, 29 patients underwent eTEP mesh repair and 27 patients underwent successful IPOM plus repair. The intraoperative surgeon's workload, especially mental demand, physical demand, task complexity and degree of difficulty as reported and felt by the operating surgeon, was significantly higher in the eTEP mesh repair group compared to IPOM plus group (P < 0.001) with comparable operating room distractions (P = 0.039). The mean overall post-operative pain score on post-operative day 1 was slightly less in eTEP mesh repair (4.28 ± 1.12) group compared to IPOM plus group (4.93 ± 1.17), which was statistically insignificant (P = 0.042). The eTEP group had significantly longer operative time and length of hospital stay compared to the IPOM plus group. Conclusion: Our study revealed significantly longer operative time, higher surgical workload and increased length of hospital stay in the eTEP group with comparable early post-operative pain in both groups, thus making eTEP mesh repair a more difficult and challenging procedure.

'Is insulin right for me?': Feasibility of a pilot randomised controlled trial and acceptability of a web-based intervention to reduce psychological barriers to insulin therapy among adults with type 2 diabetes.

AIMS: Acceptable and accessible interventions are needed to address 'psychological insulin resistance', which is a common barrier to insulin uptake among adults with type 2 diabetes (T2D). Our aim was to test the feasibility of a randomised controlled trial (RCT) study design and acceptability of a theoretically grounded, psycho-educational, web-based resource to reduce negative insulin appraisals among adults with T2D. METHODS: A double-blinded, parallel group, two-arm pilot RCT (1:1), comparing intervention with active control (existing online information about insulin). Eligible participants were Australian adults with T2D, taking oral diabetes medications. EXCLUSION CRITERIA: prior use of injectable medicines; being 'very willing' to commence insulin. Primary outcomes: study feasibility (recruitment ease, protocol fulfilment, attrition, data completeness); secondary outcomes: intervention acceptability (intervention engagement, user feedback) and likely efficacy (negative Insulin Treatment Appraisal Scale [ITAS] scores at follow-up). Online surveys completed at baseline and 2 weeks. RESULTS: During 4-week recruitment, 76 people expressed interest: 51 eligible and 35 enrolled (intervention = 17, control = 18; median[interquartile range] age = 62[53, 69] years; 17 women). Protocol fulfilment achieved by 26 (74%) participants (n = 13 per arm), with low participant attrition (n = 6, 17%). Intervention acceptability was high (>80% endorsement, except format preference = 60%). ITAS negative scores differed between-groups at follow-up (M diff = -6.5, 95% confidence interval: -10.7 to -2.4), favouring the intervention. CONCLUSIONS: This novel web-based resource ("Is insulin right for me?") is acceptable and associated with a likely reduction in negative insulin appraisals, relative to existing resources. This pilot shows the study design is feasible and supports conduct of a fully powered RCT.

Do age-targeted messages increase cervical screening intentions in women aged 50-64 years with weak positive intentions? A randomised control trial in Great Britain.

Over 20% of women aged 50-64 in Britain have not attended cervical screening within the recommended 5-year interval. The aim of the present study was to investigate the impact of five messages, informed using strategies from the Behaviour Change Wheel, on strength of intention to attend cervical screening in women aged 50-64 with weak positive intentions to be screened when next invited. Women were randomised (2:2:1), into one of two intervention groups or a control group. The control group saw basic information about cervical screening. Intervention group 1 saw a social norms message and an outcome expectancy message. Intervention group 2 saw a risk reduction message and a response efficacy message. There was further randomisation within the two intervention groups (1:1) to test the effectiveness of message framing and age-targeted information. Lastly, both intervention groups were randomised (1:1) to see a message acknowledging the possible discomfort associated with screening and offering support, or the support message only. Data were included from 475 women, collected using an online survey in March 2022. Adjusting for baseline intention, social norms (p = .84), outcome expectancy (p = .51), risk reduction (p = .19), response efficacy (p = .23) and discomfort acknowledgement messages (p = .71) had no effect on intention strength. However, there was a significant increase in intention after reading multiple messages. These results suggest that although no single message has a significant impact on intentions, when combined, they may act together to increase intention strength. Further research will understand the impact of these messages when combined in information materials.

Effects of aerobic exercise on quality of life of people with HIV-associated neurocognitive disorder on antiretroviral therapy: a randomised controlled trial.

BACKGROUND: HIV-associated neurocognitive disorder (HAND) negatively impacts quality of life (QoL) of people living with HIV who are on antiretroviral therapy (ART). Behavioural intervention adjunct to ART may improve QoL of people with HAND. We determine the effect of a 12-week aerobic exercise programme on QoL in people with HAND who were receiving ART. TRIAL DESIGN: This was a parallel-group, randomised controlled trial with concealed allocation and intention-to-treat analysis. METHODS: We identified 73 participants diagnosed with HAND. Participants were sampled from an earlier study that examined the prevalence of HAND according to the Frascati criteria. Participants were randomised and allocated to an intervention of 12-weeks of aerobic exercise, comprising three 20-60 min sessions per week of moderate-intensity aerobic exercise using a cycle ergometer. The primary outcome was QoL, which was evaluated using the World Health Quality of Life Questionnaire (WHOQoL)-BREF. RESULTS: Participants in the exercise (n = 39) and control (n = 35) groups had similar sociodemographic characteristics (p > 0.05). Following the 12-week aerobic exercise programme, participants in the exercise group had improved physical (p < 0.001), psychological (p = 0.008) and environmental (p = 0.001) domains of the QoL (p = 0.001) and overall QoL (p = 0.001) relative to the control group. Similarly, participants in the exercise group had lower depression scores than participants in the control group. Depression scores in the exercise group were still lower 3 months post-intervention (p = 0.007). Only the improvements in physical (p = 0.02) and psychological (p = 0.007) domains of QoL were sustained at 3 months post-intervention. CONCLUSIONS: Aerobic exercise improves the QoL of people with HAND. To ensure sustained benefits, people with HAND may need to engage in long-term physical exercise. Trial registration The trial is registered with the PAN African Trial Registry (PACTR). Date: 01/09/2020, ID: PACTR202009483415745.

Non-inferiority of intranasal ketamine compared to intravenous morphine for musculoskeletal pain relief among older adults in an emergency department: a randomised controlled trial.

OBJECTIVES: ketamine has potential advantages over morphine for musculoskeletal pain relief. The aim of this study was to compare the analgesic efficacy and safety of intranasal (IN) ketamine to intravenous (IV) morphine for older adults with musculoskeletal pain in the emergency department (ED). METHODS: this was a non-inferiority, double-blind, randomised controlled trial of ED patients aged of 65 and older presenting with acute moderate to severe musculoskeletal pain defined as a score ≥5 on an 11-point numeric rating scale (NRS). Patients were randomly assigned to receive IN ketamine or IV morphine. The primary outcome was comparative reduction of NRS pain scores between ketamine and morphine groups at 30 min post-treatment. Secondary outcomes were incidence of adverse events and requirement for rescue therapy. RESULTS: seventy-four patients were eligible for analysis (37 in the IN ketamine and 37 in the IV morphine group). Mean pain score at 30 min did not differ significantly between IN ketamine and IV morphine groups (6.03 versus 5.81). Similarly, the difference in mean NRS change from baseline between IN ketamine and IV morphine groups [(-2.14, 95% CI: -2.79 to -1.48) and (-0.81, 95% CI: -2.36 to -1.26) = -0.32, 95% CI: -1.17 to -0.52] did not reach the non-inferiority margin of 1.3. Adverse events and incidence of rescue therapy also did not differ between groups. CONCLUSIONS: intranasal ketamine can provide a non-inferior analgesic effect compared to intravenous morphine for acute musculoskeletal pain in older adults with mild adverse effects and low incidence of rescue analgesic treatment.

Comparison of two different mindfulness interventions among health care students in Finland: a randomised controlled trial.

We investigated the short- and long-term effects of two different evidence-based mindfulness training on students' stress and well-being. A randomised controlled trial with three measurement points (baseline, post-intervention, and 4 months post-intervention) was conducted among undergraduate students of medicine, dentistry, psychology, and logopaedics at the University of Helsinki. The participants were randomly assigned into three groups: (1) face-to-face mindfulness training based on the Mindfulness Skills for Students course (n = 40), (2) a web-based Student Compass program using Mindfulness and Acceptance and Commitment therapy (n = 22), and (3) a control group that received mental health support as usual (n = 40). The primary outcome was psychological distress measured using the Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM). Secondary outcomes included hair cortisol concentrations and a wide range of well-being indicators. Psychological distress increased in all the groups from baseline to post-intervention, but significantly less so in the intervention groups than in the control group. At 4-month follow-up, were found no differences between the primary outcomes of the control and intervention groups, but the participants who continued practising mindfulness at least twice a week were less stressed than the others. Our results suggest that participating in a mindfulness course may mitigate health care students' psychological distress during the academic year, but only if the participants continue practising mindfulness at least twice a week.

A randomised control trial protocol of MuST for vascular access cannulation in hemodialysis patients (MuST Study): contributions for a safe nursing intervention.

BACKGROUND: The vascular access preservation and the maintenance of a complication-free fistula remains an Achilles' heel of hemodialysis in chronic kidney patients due to its substantial contribution to the morbidity and mortality. Systematic studies in the area of examining cannulation practices, achieving complication-free cannulation, and strategies to improve fistula survival are needed. For this reason, we consider it essential to create and investigate new methodologies for approaching fistula in patients on regular HD. The Multiple Single Cannulation Technique (MuST) is based on the association between the rope-ladder (RL) using the arteriovenous vessel through progressive rotation, and the buttonhole (BH) since there are three specific cannulation sites for each cannulation day during the week. The MuST is simple to implement and seems to be a very promising technique in terms of patient safety. Previous studies already showed an arteriovenous fistula survival similar to RL but significantly higher than BH. METHODS: This MuST study is a multicenter, prospective, non-blind, parallel-group, randomized controlled trial with the intervention group submitted to MuST and a control group undergoing the rope-ladder, up to 100 subjects for each group. Patients will be randomized 1:1 to one of two cannulation technique (CT), and the follow-up period of this study will be 12 months. Primary outcome is to evaluate the arteriovenous fistula survival rate at 12 months determined by the percentage of fistulas in use from the beginning of the study to the date of the first clinical intervention by angioplasty or vascular surgery, to maintain or restore patency (unassisted patency). Secondary outcome is to evaluate arteriovenous fistula survival rate at 12 month determined by the percentage of fistulas in use from the study start to the date of access abandonment due to dysfunction, patient abandonment, or death, treatment change modality or study end. We will also evaluate the assisted primary patency and include the following secondary outcomes associated with the cannulation technique: Infection, Hematoma, Aneurysm development, and pain. DISCUSSION: The study will investigate whether fistula survival can be improved when using cannulation by MuST compared to the RL. MuST study will provide important information on fistula survival when cannulated by MuST but also information related to its use in fistulas previously cannulated by other CTs. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT05081648 registered on 18 October 2021.

Aerobic exercise for HIV-associated neurocognitive disorders in individuals on antiretroviral therapy: A randomised controlled trial.

INTRODUCTION: The increasing burden of self-limiting forms of HIV-associated neurocognitive disorder (HAND) in the antiretroviral therapy era calls for adjunctive interventions. The study aimed to determine the effects of a 12-week aerobic exercise programme on HAND. METHODS: This is a parallel-group, randomized controlled trial with concealed allocation and intention-to-treat analysis. This study was a clinic-based programme. Seventy-three patients with HAND were enrolled in the trial. The intervention comprised a moderate-intensity aerobic exercise, 20-60 min per session, three times per week, for twelve weeks. The control group received exercise education. Prevalence of HAND constituted the primary outcome. HAND was identified and classified following the Frascati criteria. We computed the odds ratio and number needed-to-treat to estimate the treatment effect. RESULTS: There were 73 patients (38 in exercise and 35 in control arm). Individuals in the exercise arm recorded a significantly higher reduction in working memory deficit (OR = 5.14; CI = 2.6-10.4; NNT = 6) but not in attention-deficit (OR = 0.31, CI = 0.2-0.5; NNT = -5) compared to the control group at twelve-week. Reductions in attention deficit (OR = 1.55, 95 CI = 1.0-2.4; NNT = 5) and HAND prevalence (OR = 1.8, 95 CI = 1.2-2.8); NNT = 8) were significantly higher in the exercise group compared the control group at three-month. No significant between-group difference in functional independence was observed immediately after exercise (p > 0.05). DISCUSSION: The neuroprotective effects of aerobic exercise appear selective and vary with cognitive abilities impaired and aerobic capacity, with a greater change occurring with improved aerobic capacity. CONCLUSION: Individuals with working memory and attention deficits may benefit more from moderate-intensity aerobic exercise.