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Journal of Asthma and Allergy 2024
PubMed: 38860029
DOI: 10.2147/JAA.S451689 -
Frontiers in Psychiatry 2024Family interventions (FI) are recommended as part of the treatment for psychotic disorders, but the implementation in mental health services is generally poor. Recently,...
Implementation of guidelines on Family Involvement for persons with Psychotic disorders: a pragmatic cluster randomized trial. Effect on relatives' outcomes and family interventions received.
BACKGROUND
Family interventions (FI) are recommended as part of the treatment for psychotic disorders, but the implementation in mental health services is generally poor. Recently, The Implementation of guidelines on Family Involvement for persons with Psychotic disorders (IFIP) trial, demonstrated significant improvements in implementation outcomes at cluster-level. This sub-study aims to examine the effectiveness of the IFIP intervention on relatives' outcomes and received FI.
METHODS
A cluster randomized controlled trial, was conducted in 15 Norwegian Community Mental Health Center (CMHC) units that were randomized to either the IFIP intervention, including implementation interventions and clinical interventions, or treatment as usual (TAU). The clinical interventions consisted of FI: basic family involvement and support (BFIS) to all patients and family psychoeducation (FPE) to as many as possible. Patients with psychotic disorders and their closest relative were invited to fill in questionnaires at inclusion and 6 months and 12 months follow-up. Received FI was reported by both relatives and clinicians. The relatives' primary outcome was satisfaction with health service support, measured by the Carer well-being and support questionnaire part B (CWS-B). The relatives' secondary outcomes were caregiver experiences, expressed emotions and quality of life. Patients' outcomes will be reported elsewhere.
RESULTS
In total 231 patient/relative pairs from the CMHC units were included (135 intervention; 96 control).The relatives in the intervention arm received an increased level of BFIS (p=.007) and FPE (p < 0.05) compared to the relatives in the control arm, including involvement in crisis planning. The primary outcome for relatives' satisfaction with health service support, showed a non-significant improvement (Cohen's d = 0.22, p = 0.08). Relatives experienced a significant reduced level of patient dependency (Cohen's d = -0.23, p = 0.03).
CONCLUSION
The increased support from clinicians throughout FI reduced the relatives' perceived level of patient dependency, and may have relieved the experience of responsibility and caregiver burden. The COVID-19 pandemic and the complex and pioneering study design have weakened the effectiveness of the IFIP intervention, underscoring possible potentials for further improvement in relatives' outcomes.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov, identifier NCT03869177.
PubMed: 38855639
DOI: 10.3389/fpsyt.2024.1381007 -
Digital Health 2024Depression is a common and disabling condition. Digital apps may augment or facilitate care, particularly in under-served populations. We tested the efficacy of juli, a...
BACKGROUND
Depression is a common and disabling condition. Digital apps may augment or facilitate care, particularly in under-served populations. We tested the efficacy of juli, a digital self-management app for depression in a fully remote randomised controlled trial.
METHODS
A pragmatic randomised controlled trial that included participants aged > 18 who self-identified as having depression and scored > 5 on the Patient Health Questionnaire-8. Participants were randomly assigned (1:1) to receive juli for 8 weeks or a limited attention-placebo control app. Our primary outcome was the difference in Patient Health Questionnaire-8 scores at 8 weeks. Secondary outcomes were remission, minimal clinically important difference, worsening of depression, and health-related quality of life. Analyses were per-protocol (primary), and modified and full intention-to-treat (secondary). The trial was registered at ISRCTN (ISRCTN12329547).
RESULTS
Between May 2021 and January 2023, we randomised 908 participants. 662 completed the week 2 outcome assessment and were included in the modified intention-to-treat analysis, and 456 completed the week 8 outcome assessments (per-protocol). In the per-protocol analysis, the juli group had a greater reduction in Patient Health Questionnaire-8 score (10.78, standard deviation 6.26) than the control group (11.88, standard deviation 5.73) by week 8 (baseline adjusted β-coefficient -0.94, 95% CI: -1.87 to -0.22, = 0.045). Achieving remission and a minimal clinically important difference was more likely in the juli group at 8 weeks (adjusted odds ratios 2.22, 95% CI: 1.45-3.39, < 0.001 and 1.56, 95% CI: 1.08-2.27, = 0.018, respectively). There were no between-group differences in health-related quality of life or worsening of depression. Modified and full intention-to-treat analyses found similar results, but the primary outcome was non-significant.
CONCLUSION
The use of juli for 8 weeks resulted in a small reduction in symptoms of depression compared with an attention-placebo control. The juli app is a digital self-management tool that could increase the accessibility of evidence-based depression treatments.
PubMed: 38854919
DOI: 10.1177/20552076241260409 -
Frontiers in Cardiovascular Medicine 2024To explore the population-wide impacts of an evidence-based high-risk strategy for prevention of cardiovascular diseases in resource-poor populations.
Population-wide impact of a pragmatic program to identify and manage individuals at high-risk of cardiovascular disease: a cluster randomized trial in 120 villages from Northern China.
OBJECTIVES
To explore the population-wide impacts of an evidence-based high-risk strategy for prevention of cardiovascular diseases in resource-poor populations.
METHODS
A cluster randomized controlled trial was conducted among 120 villages in rural China, with 60 on intervention and 60 on usual care as controls, for 2 years. The intervention emphasized training village doctors to identify high-risk individuals and administering standardized treatments focusing on hypertension management. A random sample of 20 men aged ≥50 years and 20 women aged ≥60 years was drawn from each village before randomization for the baseline survey, and another independent random sample with the same age and sex distribution was drawn at 2 years for the post-intervention survey. The primary outcome was the population mean systolic blood pressure (SBP). Secondary outcomes included the proportions of patients who received regular primary care, antihypertensive medications, aspirin, or lifestyle advice.
RESULTS
A total of 5,654 high cardiovascular risk individuals were identified and managed by village doctors in intervention villages for 15 months on average, with mean SBP lowered by 19.8 mmHg and the proportion with blood pressure under control increased from 22.1% to 72.7%. The primary analysis of the two independent samples (5,050 and 4,887 participants each) showed that population-wide mean SBP in intervention villages did not differ from that in control villages at 2 years (mean difference = 1.0 mmHg, 95% CI: -2.19, 4.26; = 0.528), though almost all secondary outcomes concerning primary care indicators significantly increased in intervention villages.
CONCLUSIONS
In our study, the pragmatic cardiovascular risk management program targeting on high-risk individuals significantly improved the quality of primary care. However, its impact on population blood pressure level and the burden of hypertension-related diseases appeared very limited.
CLINICAL TRIAL REGISTRATION
ClinicalTrial.gov identifier, NCT01259700.
PubMed: 38854653
DOI: 10.3389/fcvm.2024.1372298 -
European Stroke Journal Jun 2024Novel therapeutic approaches are needed in stroke recovery. Whether pharmacological therapies are beneficial for enhancing stroke recovery is unclear. Dopamine is a...
RATIONALE
Novel therapeutic approaches are needed in stroke recovery. Whether pharmacological therapies are beneficial for enhancing stroke recovery is unclear. Dopamine is a neurotransmitter involved in motor learning, reward, and brain plasticity. Its prodrug levodopa is a promising agent for stroke recovery.
AIM AND HYPOTHESIS
To investigate the hypothesis that levodopa, in addition to standardized rehabilitation therapy based on active task training, results in an enhancement of functional recovery in acute ischemic or hemorrhagic stroke patients compared to placebo.
DESIGN
ESTREL (nhancement of troke habilitation with ) is a randomized (ratio 1:1), multicenter, placebo-controlled, double-blind, parallel-group superiority trial.
PARTICIPANTS
610 participants (according to sample size calculation) with a clinically meaningful hemiparesis will be enrolled ⩽7 days after stroke onset. Key eligibility criteria include (i) in-hospital-rehabilitation required, (ii) capability to participate in rehabilitation, (iii) previous independence in daily living.
INTERVENTION
Levodopa 100 mg/carbidopa 25 mg three times daily, administered for 5 weeks in addition to standardized rehabilitation. The study intervention will be initiated within 7 days after stroke onset.
COMPARISON
Matching placebo plus standardized rehabilitation.
OUTCOMES
The primary outcome is the between-group difference of the Fugl-Meyer-Motor Assessment (FMMA) total score measured 3 months after randomization. Secondary outcomes include patient-reported health and wellbeing (PROMIS 10 and 29), patient-reported assessment of improvement, Rivermead Mobility Index, modified Rankin Scale, National Institutes of Health Stroke Scale (NIHSS), and as measures of harm: mortality, recurrent stroke, and serious adverse events.
CONCLUSION
The ESTREL trial will provide evidence of whether the use of Levodopa in addition to standardized rehabilitation in stroke patients leads to better functional recovery compared to rehabilitation alone.
PubMed: 38853524
DOI: 10.1177/23969873241255867 -
International Journal of Medical... May 2024The Clinical Classification Software Refined (CCSR) is a tool that groups many thousands of International Classification of Diseases 10th Revision (ICD-10) diagnosis...
BACKGROUND
The Clinical Classification Software Refined (CCSR) is a tool that groups many thousands of International Classification of Diseases 10th Revision (ICD-10) diagnosis codes into approximately 500 clinically meaningful categories, simplifying analyses. However, CCSR was developed for use in the United States and may not work well with other country-specific ICD-10 coding systems.
METHOD
We developed an algorithm for semi-automated matching of Canadian ICD-10 codes (ICD-10-CA) to CCSR categories using discharge diagnoses from adult admissions at 7 hospitals between Apr 1, 2010 and Dec 31, 2020, and manually validated the results. We then externally validated our approach using inpatient hospital encounters in Denmark from 2017 to 2018.
KEY RESULTS
There were 383,972 Canadian hospital admissions with 5,186 distinct ICD-10-CA diagnosis codes and 1,855,837 Danish encounters with 4,612 ICD-10 diagnosis codes. Only 46.6% of Canadian codes and 49.4% of Danish codes could be directly categorized using the official CCSR tool. Our algorithm facilitated the mapping of 98.5% of all Canadian codes and 97.7% of Danish codes. Validation of our algorithm by clinicians demonstrated excellent accuracy (97.1% and 97.0% in Canadian and Danish data, respectively). Without our algorithm, many common conditions did not match directly to a CCSR category, such as 96.6% of hospital admissions for heart failure.
CONCLUSION
The GEMINI CCSR matching algorithm (available as an open-source package at https://github.com/GEMINI-Medicine/gemini-ccsr) improves the categorization of Canadian and Danish ICD-10 codes into clinically coherent categories compared to the original CCSR tool. We expect this approach to generalize well to other countries and enable a wide range of research and quality measurement applications.
PubMed: 38851134
DOI: 10.1016/j.ijmedinf.2024.105508 -
Trials Jun 2024Chemotherapy with lomustine is widely considered as standard treatment option for progressive glioblastoma. The value of adding radiotherapy to second-line chemotherapy...
BACKGROUND
Chemotherapy with lomustine is widely considered as standard treatment option for progressive glioblastoma. The value of adding radiotherapy to second-line chemotherapy is not known.
METHODS
EORTC-2227-BTG (LEGATO, NCT05904119) is an investigator-initiated, pragmatic (PRECIS-2 score: 34 out of 45), randomized, multicenter phase III trial in patients with first progression of glioblastoma. A total of 411 patients will be randomized in a 1:1 ratio to lomustine (110 mg/m every 6 weeks) or lomustine (110 mg/m every 6weeks) plus radiotherapy (35 Gy in 10 fractions). Main eligibility criteria include histologic confirmation of glioblastoma, isocitrate dehydrogenase gene (IDH) wild-type per WHO 2021 classification, first progression at least 6 months after the end of prior radiotherapy, radiologically measurable disease according to RANO criteria with a maximum tumor diameter of 5 cm, and WHO performance status of 0-2. The primary efficacy endpoint is overall survival (OS) and secondary endpoints include progression-free survival, response rate, neurocognitive function, health-related quality of life, and health economic parameters. LEGATO is funded by the European Union's Horizon Europe Research program, was activated in March 2024 and will enroll patients in 43 sites in 11 countries across Europe with study completion projected in 2028.
DISCUSSION
EORTC-2227-BTG (LEGATO) is a publicly funded pragmatic phase III trial designed to clarify the efficacy of adding reirradiation to chemotherapy with lomustine for the treatment of patients with first progression of glioblastoma.
TRIAL REGISTRATION
ClinicalTrials.gov NCT05904119. Registered before start of inclusion, 23 May 2023.
Topics: Glioblastoma; Humans; Lomustine; Brain Neoplasms; Disease Progression; Antineoplastic Agents, Alkylating; Multicenter Studies as Topic; Progression-Free Survival; Quality of Life; Randomized Controlled Trials as Topic; Chemoradiotherapy; Clinical Trials, Phase III as Topic; Pragmatic Clinical Trials as Topic; Time Factors
PubMed: 38849943
DOI: 10.1186/s13063-024-08213-7 -
Lancet (London, England) Jun 2024After surgery for a broken ankle, patients are usually instructed to avoid walking for 6 weeks (delayed weight-bearing). Walking 2 weeks after surgery (early... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
After surgery for a broken ankle, patients are usually instructed to avoid walking for 6 weeks (delayed weight-bearing). Walking 2 weeks after surgery (early weight-bearing) might be a safe and preferable rehabilitation strategy. This study aimed to determine the clinical and cost effectiveness of an early weight-bearing strategy compared with a delayed weight-bearing strategy.
METHODS
This was a pragmatic, multicentre, randomised, non-inferiority trial including 561 participants (aged ≥18 years) who received acute surgery for an unstable ankle fracture in 23 UK National Health Service (NHS) hospitals who were assigned to either a delayed weight-bearing (n=280) or an early weight-bearing rehabilitation strategy (n=281). Patients treated with a hindfoot nail, those who did not have protective ankle sensation (eg, peripheral neuropathy), did not have the capacity to consent, or did not have the ability to adhere to trial procedures were excluded. Neither participants nor clinicians were masked to the treatment. The primary outcome was ankle function measured using the Olerud and Molander Ankle Score (OMAS) at 4 months after randomisation, in the per-protocol population. The pre-specified non-inferiority OMAS margin was -6 points and superiority testing was included in the intention-to-treat population in the event of non-inferiority. The trial was prospectively registered with ISRCTN Registry, ISRCTN12883981, and the trial is closed to new participants.
FINDINGS
Primary outcome data were collected from 480 (86%) of 561 participants. Recruitment was conducted between Jan 13, 2020, and Oct 29, 2021. At 4 months after randomisation, the mean OMAS score was 65·9 in the early weight-bearing and 61·2 in the delayed weight-bearing group and adjusted mean difference was 4·47 (95% CI 0·58 to 8·37, p=0·024; superiority testing adjusted difference 4·42, 95% CI 0·53 to 8·32, p=0·026) in favour of early weight-bearing. 46 (16%) participants in the early weight-bearing group and 39 (14%) in the delayed weight-bearing group had one or more complications (adjusted odds ratio 1·18, 95% CI 0·80 to 1·75, p=0·40). The mean costs from the perspective of the NHS and personal social services in the early and delayed weight-bearing groups were £725 and £785, respectively (mean difference -£60 [95% CI -342 to 232]). The probability that early weight-bearing is cost-effective exceeded 80%.
INTERPRETATION
An early weight-bearing strategy was found to be clinically non-inferior and highly likely to be cost-effective compared with the current standard of care (delayed weight-bearing).
FUNDING
National Institute for Health and Care Research (NIHR), NIHR Barts Biomedical Research Centre, and NIHR Applied Research Collaboration Oxford and Thames Valley.
Topics: Humans; Weight-Bearing; Female; Male; Ankle Fractures; Middle Aged; Adult; Cost-Benefit Analysis; Time Factors; Treatment Outcome; Walking; United Kingdom; Aged
PubMed: 38848738
DOI: 10.1016/S0140-6736(24)00710-4 -
JAMA Network Open Jun 2024Rifampin-resistant tuberculosis treatment regimens require electrocardiographic (ECG) monitoring due to the use of multiple QTc-prolonging agents. Formal 12-lead ECG...
IMPORTANCE
Rifampin-resistant tuberculosis treatment regimens require electrocardiographic (ECG) monitoring due to the use of multiple QTc-prolonging agents. Formal 12-lead ECG devices represent a significant burden in resource-constrained clinics worldwide and a potential barrier to treatment scale-up in some settings.
OBJECTIVE
To evaluate the diagnostic accuracy of a handheld 6-lead ECG device within resource-constrained clinics.
DESIGN, SETTING, AND PARTICIPANTS
This diagnostic study was performed within a multicenter, pragmatic (broad eligibility criteria with no exclusions for randomized participants), phase 3 rifampin-resistant tuberculosis treatment trial (BEAT Tuberculosis [Building Evidence for Advancing New Treatment for Tuberculosis]) in South Africa. A total of 192 consecutive trial participants were assessed, and 191 were recruited for this substudy between January 21, 2021, and March 27, 2023. A low proportion (3 of 432 [0.7%]) of all screened trial participants were excluded due to a QTc interval greater than 450 milliseconds. Triplicate reference standard 12-lead ECG results were human calibrated with readers blinded to 6-lead ECG results.
MAIN OUTCOMES AND MEASURES
Diagnostic accuracy, repeatability, and feasibility of a 6-lead ECG device.
RESULTS
A total of 191 participants (median age, 36 years [IQR, 28-45 years]; 81 female participants [42.4%]; 91 participants [47.6%] living with HIV) with a median of 4 clinic visits (IQR, 3-4 visits) contributed 2070 and 2015 12-lead and 6-lead ECG assessments, respectively. Across 170 participants attending 489 total clinic visits where valid triplicate QTc measurements were available for both devices, the mean 12-lead QTc measurement was 418 milliseconds (range, 321-519 milliseconds), and the mean 6-lead QTc measurement was 422 milliseconds (range, 288-574 milliseconds; proportion of variation explained, R2 = 0.4; P < .001). At a QTc interval threshold of 500 milliseconds, the 6-lead ECG device had a negative predictive value of 99.8% (95% CI, 98.8%-99.9%) and a positive predictive value of 16.7% (95% CI, 0.4%-64.1%). The normal expected range of within-individual variability of the 6-lead ECG device was high (±50.2 milliseconds [coefficient of variation, 6.0%]) relative to the 12-lead ECG device (±22.0 milliseconds [coefficient of variation, 2.7%]). The mean (SD) increase in the 12-lead QTc measurement during treatment was 10.1 (25.8) milliseconds, with 0.8% of clinic visits (4 of 489) having a QTc interval of 500 milliseconds or more.
CONCLUSIONS AND RELEVANCE
This study suggests that simplified, handheld 6-lead ECG devices are effective triage tests that could reduce the need to perform 12-lead ECG monitoring in resource-constrained settings.
Topics: Humans; Female; Male; Adult; Electrocardiography; South Africa; Middle Aged; Long QT Syndrome; Reproducibility of Results; Tuberculosis, Multidrug-Resistant; Resource-Limited Settings
PubMed: 38848063
DOI: 10.1001/jamanetworkopen.2024.15576 -
PloS One 2024Family group conferences (FGCs) in child welfare bring immediate and wider family members together to decide on the best way to meet a child's needs. Unlike...
BACKGROUND
Family group conferences (FGCs) in child welfare bring immediate and wider family members together to decide on the best way to meet a child's needs. Unlike professionally led meetings, the aim is for decisions to be made by or with family members. Qualitative and mixed-method research with FGC participants tends to show positive experiences: most participants feel their voices are heard; FGCs facilitate family-driven solutions and closer relationships-within families and with social workers. Although there is existing literature on FGCs, there is a paucity of robust comparative UK evaluations, i.e., randomised controlled trials or quasi-experimental studies. Comparative studies internationally have focused on a narrow range of outcomes, not recognised the importance of context, and paid little attention to the quality of delivery. Some qualitative studies have considered process and context but there is scant measurement of these. The aims of this study are, firstly, to establish how FGCs improve outcomes for families and what factors vary their quality, and, secondly, to assess longer-term outcomes in terms of service use and associated costs.
METHODS
Given the importance of process and context, evaluation informed by realist and complex systems approaches is needed. This multi-method evaluation includes a survey of FGC services in all UK local authorities (n = 212) to map service provision; co-design of programme theory and evaluation measures with family members who have experienced an FGC (n = 16-24) and practitioners (n = 16-24) in two sites; a prospective single-arm study of FGC variability and outcomes after six months; and comparison of service use and costs in FGC participants (n≥300 families) and a control group (n≥1000) after two years using a quasi-experiment.
DISCUSSION
This is a pragmatic evaluation of an existing intervention, to identify what mechanisms and contexts influence effective process and longer-term outcomes. The study is registered with Research Registry (ref. 7432).
Topics: Humans; Family; Child; Female; Child Welfare; United Kingdom; Male; Surveys and Questionnaires
PubMed: 38843190
DOI: 10.1371/journal.pone.0300834