Months In Group Research Articles

Necessity of Temporal Artery Biopsy for Giant Cell Arteritis: A Systematic Review.

Background:Temporal artery biopsy (TAB) is currently the gold standard procedure to diagnose giant cell arteritis. Despite low sensitivity, TAB is routinely performed even if a clinical diagnosis has already been made. The objective of this study was to determine the usefulness of TAB for giant cell arteritis management.Methods:We performed a systematic review to identify studies that compared steroid treatment between TAB+ and TAB− patients. EMBASE, MEDLINE, and the Cochrane Central Register of Controlled Trials were searched from inception until April 4, 2020. Titles, abstracts, and full texts were reviewed by two independent reviewers and conflicts resolved by consensus. Studies reporting TAB result and steroid treatment were included. Information pertaining to steroid treatment was compared between TAB+ and TAB− groups. Steroid duration was compared by grouping patients in a less than 6 month group, a 6–24 month group, and a more than 24 month group.Results:An estimated 5288 abstracts were screened and 13 studies involving 1355 patients were included. Rate of prebiopsy steroid treatment was higher in TAB+ patients compared with TAB− patients [93% versus 63% (P < 0.001)]. The TAB+ group was more likely to be started on steroids prebiopsy [28% versus 8% (P < 0.001)]. TAB+ and TAB− patients had similar steroid duration for all groups [<6-month group 17% versus 19% (P-0.596), the 6-24-month group 16% versus 19% (P-0.596), and the >24-month group 66% versus 63% (P-0.642)].Conclusion:TAB results have minimal impact on treatment, and the utility should be reconsidered when a clinical diagnosis of giant cell arteritis is possible.

Acquisition of Tok Pisin phonology in the multilingual highlands of Papua New Guinea

Purpose: Papua New Guinea (PNG) has extreme linguistic diversity reflected in its three national languages and sociolinguistic diversity comprising over 380 vernaculars or Tokples, English and the lingua francas, which include Tok Pisin (TP). This first clinical cross-sectional study of consonant acquisition in TP-speaking children sought to identify universal features and the impact of age on phonological development. Method: A local picture naming task was developed and used to elicit a speech sample from 80 children (aged 3;0–6;11). Phonetic and phonemic inventories and developmental phonological processes were analysed across the sample and also in 12-month age groups. Result: Statistically significant differences were found between the Percentage Consonants Correct (PCC) of the 3YO and other age groups. Mean PCC increased with age, but high variation within age groups meant differences were not statistically significant. Universal features observed included the early acquisition of plosives and late mastery of /r/. Language-specific features included processes such as fricatisation and earlier acquisition of /ʤ/ before /s/. Creolisation was seen in morphophonemic condensation and the influence of loanwords. Conclusion: This study demonstrates both universal and language-specific features amidst wide diversity influencing phonological acquisition in creolising TP. This first phonological study of TP consonant development will inform future clinical speech-language pathology practice in PNG.

A prospective cohort study of head circumference and its association with neurodevelopmental outcomes in infants and young children in rural Guatemala.

Microcephaly, an anthropometric marker of reduced brain volume and predictor of developmental disability, is rare in high-income countries. Recent reports show the prevalence of microcephaly to be much higher in lower resource settings. We calculated the prevalence of microcephaly in infants and young children (n = 642; age range = 0.1-35.9 months), examined trends in occipitofrontal circumference (OFC) growth in the year after birth and evaluated the relationship between OFC and performance on the Mullen Scales of Early Learning (MSEL) in rural Guatemala. Multivariable regression analyses adjusted for age were performed: (1) a model comparing concurrent MSEL performance and OFC at all visits per child, (2) concurrent OFC and MSEL performance by age group, and (3) OFC at enrollment and MSEL at final visit by age group. Prevalence of microcephaly ranged from 10.1% to 25.0%. OFC z-score decreased for most infants throughout the first year after birth. A significant positive association between continuous OFC measurement and MSEL score suggested that children with smaller OFC may do worse on ND tests conducted both concurrently and ∼1 year later. Results were variable when analyzed by OFC cutoff scores and stratified by 6-month age groups. OFC should be considered for inclusion in developmental screening assessments at the individual and population level, especially when performance-based testing is not feasible.

Efficacy of 12-months oral itraconazole versus 6-months oral itraconazole to prevent relapses of chronic pulmonary aspergillosis: an open-label, randomised controlled trial in India

Chronic pulmonary aspergillosis has a 5-year mortality of 50-80% globally, and the optimal duration of treatment for chronic pulmonary aspergillosis remains unclear. We aimed to compare the effect of 6-months of oral itraconazole with 12-months of oral itraconazole on chronic pulmonary aspergillosis clinical outcomes. In this single-centre, open-label, randomised controlled trial conducted in one chest clinic in Chandigarh, India, we screened consecutive patients with chronic pulmonary aspergillosis who were naive to antifungal treatment and randomised eligible patients, using block randomisation, to receive a starting dose of 400 mg/day of oral itraconazole for either 6 months or 12 months. There was no masking of participants or investigators. We excluded patients who were unable to provide informed consent; had an intake of any antifungal drugs for more than 3 weeks in the preceding 6 months; had active Mycobacterium tuberculosis or non-tuberculous mycobacterial pulmonary disease; and had allergic, subacute, or invasive forms of aspergillosis. The primary outcome was the proportion of patients having relapse 2 years after treatment initiation. We performed an intention-to-treat analysis for all outcomes. The study is registered with ClinicalTrials.gov, NCT03920527. We recruited participants between July 1, 2019, and Aug 31, 2021. We screened 250 patients, of which 164 were included in the trial. 81 patients were randomised to the 6-month group and 83 patients were randomised to the 12-month group. The study population was 78 (48%) women and 86 (52%) men, and the mean age of participants was 44·3 (SD 13·3) years. The proportion of patients experiencing relapse was significantly lower in the 12-month group, 31 (38%) had a relapse in the 6-month group compared with 8 (10%) in the 12-month group, with an absolute risk reduction of 0.29 [95% CI 0·16-0·40]. The mean time to first relapse was 23 months in the 12-month group, which is significantly longer than the mean of 18 months in the 6-month group (p<0.0001). There were 16 deaths in total, eight in each group. Ten (12%) of 81 patients in the 6-months group and 18 (22%) of 83 patients in the 12-months group had adverse effects, with none requiring treatment modification. Nausea and anorexia were the most common adverse events in both groups. Treatment of chronic pulmonary aspergillosis with 12 months of oral itraconazole was superior to 6 months of oral itraconazole in reducing relapses at 2 years. Itraconazole should be given for at least 12 months for treating chronic pulmonary aspergillosis. None. For the Hindi translation of the abstract see Supplementary Materials section.

Long-term safety and efficacy of bisphosphonate therapy in advanced lung cancer with bone metastasis.

Aim: This retrospective, observational study evaluated the long-term (>12months) safety and effectiveness of bisphosphonate. Methods: Data collected for 359 patients included quantity and proportion of adverse events (AEs) and skeletal-related events (SREs), and times to first AE and first SRE. Results: Patients in the ≤24-month group experienced significantly fewer AEs compared with the >24-month treatment group (p=0.008), and treatment for >24 months was a potential risk factor for AEs (p=0.05). Neither the proportion nor the risk of SRE was significantly associated with therapy duration (p=0.525 and 0.084, respectively). Conclusion: Bisphosphonate treatment beyond 2 years may increase the risk of AEs, but may prolong SRE-free survival early after 24months, compared with medication administered for ≤24months.

Science, Medicine, and the Anesthesiologist

Science, Medicine, and the Anesthesiologist

SHINE trial of shorter course tuberculosis treatment

Journal of Paediatrics and Child HealthVolume 58, Issue 5 p. 935-935 Heads UpFree Access SHINE trial of shorter course tuberculosis treatment First published: 02 April 2022 https://doi.org/10.1111/jpc.15957 edited by Craig Mellis (craig.mellis@sydney.edu.au) [Correction added on 12 April 2022, after first online publication: Figure 1 has been removed from the article.] AboutSectionsPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinked InRedditWechat The World Health Organization (WHO) estimates that 1.1 million children worldwide became ill with tuberculosis (TB) in 2020. Treatment adherence is a possible issue in the development of multidrug-resistant TB. The SHINE trial randomised 1204 African and Indian children (median age 3.5 years, range 2 months to 15 years) diagnosed with respiratory sample smear-negative, ‘non-severe’ TB to either 4 or 6 months of anti-tuberculous treatment using child-friendly fixed dose combinations (8 weeks of isoniazid, rifampicin and pyrazinamide ± ethambutol followed by 8 or 16 weeks of isoniazid and rifampicin).1 Of these, 52% were male, 11% had human immunodeficiency virus (HIV) infection, and 14% had bacteriologically confirmed TB. Retention (95% at 72 weeks) and treatment adherence (94%) were very high. The primary endpoint, unfavourable outcome (treatment failure or death), occurred in 16 participants (3%) in the 4-month group compared with 18 (3%) in the 6-month group (adjusted difference, −0.4%; 95% CI, −2.2 to 1.5). Adverse events mainly occurred in the first 8 weeks of treatment and were equally common (8%) in both groups. As a result of the SHINE trial, new WHO guidelines recommend that children with non-severe TB can now receive 4 months of anti-TB treatment. The challenges are accurate classification of ‘non-severe’ disease in resource-limited settings where disease burdens are highest, and whether clinicians in developed countries will feel comfortable treating for 4 months before more clinical experience accumulates. Reference 1Turkova A, Wills GH, Wobudeya E et al. Shorter treatment for nonsevere tuberculosis in African and Indian children. N. Engl J Med 2022; 399: 911– 22. CrossrefWeb of Science®Google Scholar Reviewers: David Isaacs (david.isaacs@health.nsw.gov.au) and Ben Marais (ben.marais@health.nsw.gov.au), Children's Hospital at Westmead and University of Sydney Volume58, Issue5May 2022Pages 935-935 ReferencesRelatedInformation

Developmental changes in cardiac expression of KCNQ1 and SCN5A spliceoforms: Implications for sudden unexpected infant death.

Sudden unexpected infant death (SUID) occurs unpredictably and remains unexplained after scene investigation and autopsy. Approximately 1 in 7 cases of SUID can be related to a cardiac cause, and developmental regulation of cardiac ion channel genes may contribute to SUID. The goal of this study was to investigate the developmental changes in the spliceoforms of SCN5A and KCNQ1, 2 genes implicated in SUID. Using reverse transcription quantitative real-time polymerase chain reaction, we quantified expression of SCN5A (adult and fetal) and KCNQ1 (KCNQ1a and b) spliceoforms in 153 human cardiac tissue samples from decedents that succumbed to SUID ("unexplained") and other known causes of death ("explained noncardiac"). There is a stepwise increase in the adult/fetal SCN5A spliceoform ratio from <2 months (4.55 ± 0.36; n = 51) through infancy and into adulthood (17.41 ± 3.33; n = 5). For KCNQ1, there is a decrease in the ratio of KCNQ1b to KCNQ1a between the <2-month (0.37 ± 0.02; n = 46) and the 2- to 4-month (0.28 ± 0.02; n = 52) age groups. When broken down by sex, race, or cause of death, there were no differences in SCN5A or KCNQ1 spliceoform expression, except for a higher ratio of KCNQ1b to KCNQ1a at 5-12 months of age for SUID females (0.40 ± 0.04; n = 9) than for males (0.25 ± 0.03; n = 6) and at <2 months of age for SUID white (0.42 ± 0.03; n = 19) than for black (0.33 ± 0.05; n = 9) infants. This study documents the developmental changes in SCN5A and KCNQ1 spliceoforms in humans. Our data suggest that spliceoform expression ratios change significantly throughout the first year of life.

Viral Etiology of Acute Respiratory Infections During 2014–2016 in Riyadh, Saudi Arabia

Aim: Viral etiology of respiratory infections is not well understood in Saudi Arabia. This study was conceptualized to understand viral etiology in children with acute respiratory tract infections (ARTI) from Riyadh. Patients &amp; methods: Respiratory viruses were detected by real-time PCR in nasopharyngeal aspirates or swab from 580 children aged ≤5 years. Results: Respiratory viruses were detected in 64% of the samples with 6% mixed viral infections. Respiratory syncytial virus, adenovirus, influenza, parainfluenza and human metapneumovirus infections accounted for 42, 20, 16, 12 and 10%, respectively. Maximum prevalence (37%) was among the lowest age group followed by 30% among the 7- to 12-month age group. Conclusion: The prevalence and determinants of viral etiology are in line with the previous report from the region. No major shift in the viral etiologies was observed in the 2-year study period.

Cost-effectiveness of a physical activity and behaviour maintenance programme on functional mobility decline in older adults: an economic evaluation of the REACT (Retirement in Action) trial

SummaryBackgroundMobility limitations in older populations have a substantial impact on health outcomes, quality of life, and social care costs. The Retirement in Action (REACT) randomised controlled trial assessed a 12-month community-based group physical activity and behaviour maintenance intervention to help prevent decline in physical functioning in older adults at increased risk of mobility limitation. We aimed to do an economic evaluation of the REACT trial to investigate whether the intervention is cost-effective.MethodsIn this health economic evaluation, we did cost-effectiveness and cost-utility analyses of the REACT programme versus standard care on the basis of resource use, primary outcome, and health-related quality-of-life data measured in the REACT trial. We also developed a decision analytic Markov model that forecasts the mobility of recipients beyond the 24-month follow-up of the trial and translated this into future costs and potential benefit to health-related quality of life using the National Health Service and Personal Social Services perspective. Participants completed questionnaire booklets at baseline, and at 6, 12, and 24 months after randomisation, which included a resource use questionnaire and the EQ-5D-5L and 36-item short-form survey (SF-36) health-related quality-of-life instruments. The cost of delivering the intervention was estimated by identifying key resources, such as REACT session leader time, time of an individual to coordinate the programme, and venue hire. EQ-5D-5L and SF-36 responses were converted to preference-based utility values, which were used to estimate quality-adjusted life-years (QALYs) over the 24-month trial follow-up using the area-under-the-curve method. We used generalised linear models to examine the effect of the REACT programme on costs and QALYs and adjust for baseline covariates. Costs and QALYs beyond 12 months were discounted at 3·5% per year. This is a pre-planned analysis of the REACT trial; the trial itself is registered with ISRCTN (ISRCTN45627165).FindingsThe 12-month REACT programme was estimated to cost £622 per recipient to deliver. The most substantial cost components are the REACT session leader time (£309 per participant), venue hire (£109), and the REACT coordinator time (£80). The base-case analysis of the trial-based economic evaluation showed that reductions in health and social care usage due to the REACT programme could offset the REACT delivery costs (£3943 in the intervention group vs £4043 in the control group; difference: –£103 [95% CI −£695 to £489]) with a health benefit of 0·04 QALYs (0·009–0·071; 1·354 QALYs in the intervention group vs 1·314 QALYs in the control group) within the 24-month timeframe of the trial.InterpretationThe REACT programme could be considered a cost-effective approach for improving the health-related quality of life of older adults at risk of mobility limitations.FundingNational Institute for Health Research Public Health Research Programme.

Cost-Effectiveness Analysis of Follow-Up Schedule for Hepatocellular Carcinoma after Radiofrequency Ablation.

Methods A Markov model was established to evaluate the cost-effectiveness of every 2 months or 2-3 months (2- to 3-month group) versus every 3 months or 3-4 months (3- to 4-month group) posttreatment surveillance in the first two years for HCC after RFA. Transition probabilities and utility values were derived from the literature review. Costs of follow-up were estimated from our institution. The incremental cost-effectiveness ratio (ICER), which was less than $10888 per quality-adjusted life-year (QALY), was considered cost-effective. Sensitivity analyses were performed to determine the uncertainty of the model. Results The 2- to 3-month group gained 1.196 QALYs at a cost of $2212.66, while the effectiveness and cost of the 3- to 4-month group were 1.029 QALYs and $1268.92, respectively. The ICER of the 2- to 3-month group versus the 3- to 4-month group was $5651.14 per QALY gained, which was less than the willingness-to-pay threshold of 1-time gross domestic product per capita of China ($10888/QALY). One-way sensitivity analysis showed that the model was most sensitive to the utility of progression-free survival. The probabilistic sensitivity analysis demonstrated that the 2- to 3-month group had a higher probability of being more cost-effective than the 3- to 4-month group when willingness to pay was over $1088.8. Conclusions Every 2 months or 2-3 months of follow-up intervals were more cost-effective than 3 months or 3-4 months of follow-up intervals. Thus, the intensive follow-up interval in the first two years was recommended for Child-Pugh class A or B HCC patients within the Milan criteria following RFA.

Feasibility and Pilot Testing of Mobile Health Apps to Supplement 2 Healthy Lifestyle Interventions in Chronic Traumatic Brain Injury

To determine the feasibility of mobile health (mHealth) apps for enhancing participation of people with chronic traumatic brain injury (TBI) in the Group Lifestyle Balance (GLB-TBI) weight loss intervention and Brain Health Group (BHG-TBI) active control intervention. Community. n = 56 overweight/obese adults with moderate-severe TBI. The GLB-TBI is a 12-month group- and community-based program to promote healthy eating and physical activity. The BHG-TBI is a 12-month group- and community-based program to promote general brain health, designed as an active control condition matched on time, structure, and perceived benefit to the GLB-TBI. In a randomized controlled trial testing the efficacy of the GLB-TBI for weight loss, participants used a group-specific mHealth app providing daily tips customized according to their intervention allocation. Compliance (percentage of daily prompts read and completed) and participant-reported satisfaction and usability. In conjunction with relevant stakeholders, we developed the content and structure of the GLB-TBI and BHG-TBI apps based on core curriculum components. We incorporated cognitive strategies (app notifications) to address potential cognitive impairment common after TBI. Both apps delivered brief daily educational and motivational "tips" derived directly from their respective curricula. Daily use of the apps varied greatly across participants, with most participants who used the apps completing 10% to 50% of daily content. Participants found the apps to be easy to use, but only some found them helpful. App use was substantially different for those who participated in the intervention during (2020) versus before (2019) the COVID-19 pandemic. Although enhancing an intensive lifestyle intervention with mHealth technology may be helpful, further refinement is needed to optimize the frequency and delivery methods of mHealth content. Although one might expect remote app use to have been higher during the pandemic, we observed the opposite, potentially due to less hands-on training and ongoing support to use the app and/or general technology fatigue with social distancing.

Assessment of dynamic hepatic and renal imaging changes in COVID-19 survivors using T1 mapping and IVIM-DWI.

PurposeTo explore the imaging changes of the liver and kidneys in COVID-19 survivors using variable flip angle (VFA) T1 mapping and intravoxel incoherent motion-diffusion weighted imaging (IVIM-DWI).MethodsThis prospective study included 37 discharged COVID-19 participants and 24 age-matched non-COVID-19 volunteers who underwent abdominal MRI with VFA T1 mapping and IVIM-DWI sequencing as a COVID-19 group and control group, respectively. Among those discharged COVID-19 participants, 23 patients underwent two follow-up MRI scans, and were enrolled as the 3-month follow-up group and 1-year follow-up group, respectively. The demographics, clinical characteristics, and laboratory tests were collected. Imaging parameters of the liver and kidneys were measured. All collected values were compared among different groups.ResultsThe 3-month follow-up group had the lowest hepatic T1 value, which was significantly lower than the value in the control group (P < 0.001). Additionally, the 3-month follow-up group had the highest hepatic ADC and D values, cortical ADC and f values, which were significantly higher than those in the control group (for all, P < 0.05). The hepatic D value in the 1-year follow-up group decreased significantly in comparison with that in the 3-month follow-up group (P = 0.001). Compared to non-severe patients, severe cases had significantly higher hepatic D* and f*D* values (P = 0.031, P = 0.015, respectively).ConclusionThe dynamic alterations of hepatic and renal imaging parameters detected with T1 mapping and IVIM-DWI suggested that COVID-19 survivors might develop mild, non-symptomatic liver and kidney impairments, of which liver impairment could probably relieve over time and kidney impairment might be long-existing.Graphical abstract Supplementary InformationThe online version contains supplementary material available at 10.1007/s00261-022-03471-y.

Shorter Treatment for Nonsevere Tuberculosis in African and Indian Children

BackgroundTwo thirds of children with tuberculosis have nonsevere disease, which may be treatable with a shorter regimen than the current 6-month regimen.MethodsWe conducted an open-label, treatment-shortening, noninferiority trial involving children with nonsevere, symptomatic, presumably drug-susceptible, smear-negative tuberculosis in Uganda, Zambia, South Africa, and India. Children younger than 16 years of age were randomly assigned to 4 months (16 weeks) or 6 months (24 weeks) of standard first-line antituberculosis treatment with pediatric fixed-dose combinations as recommended by the World Health Organization. The primary efficacy outcome was unfavorable status (composite of treatment failure [extension, change, or restart of treatment or tuberculosis recurrence], loss to follow-up during treatment, or death) by 72 weeks, with the exclusion of participants who did not complete 4 months of treatment (modified intention-to-treat population). A noninferiority margin of 6 percentage points was used. The primary safety outcome was an adverse event of grade 3 or higher during treatment and up to 30 days after treatment.ResultsFrom July 2016 through July 2018, a total of 1204 children underwent randomization (602 in each group). The median age of the participants was 3.5 years (range, 2 months to 15 years), 52% were male, 11% had human immunodeficiency virus infection, and 14% had bacteriologically confirmed tuberculosis. Retention by 72 weeks was 95%, and adherence to the assigned treatment was 94%. A total of 16 participants (3%) in the 4-month group had a primary-outcome event, as compared with 18 (3%) in the 6-month group (adjusted difference, −0.4 percentage points; 95% confidence interval, −2.2 to 1.5). The noninferiority of 4 months of treatment was consistent across the intention-to-treat, per-protocol, and key secondary analyses, including when the analysis was restricted to the 958 participants (80%) independently adjudicated to have tuberculosis at baseline. A total of 95 participants (8%) had an adverse event of grade 3 or higher, including 15 adverse drug reactions (11 hepatic events, all but 2 of which occurred within the first 8 weeks, when the treatments were the same in the two groups).ConclusionsFour months of antituberculosis treatment was noninferior to 6 months of treatment in children with drug-susceptible, nonsevere, smear-negative tuberculosis. (Funded by the U.K. Medical Research Council and others; SHINE ISRCTN number, ISRCTN63579542.)

Giving Ideas Some Legs or Legs Some Ideas? Children's Motor Creativity Is Enhanced by Physical Activity Enrichment: Direct and Mediated Paths.

Approaches to foster motor creativity differ according to whether creative movements are assumed to be enacted creative ideas, or solutions to emerging motor problems that arise from task and environmental constraints. The twofold aim of the current study was to investigate whether (1) an enriched physical education (PE) intervention delivered with a joint constraints-led and cognitive stimulation approach fosters motor creativity, and the responsiveness to the intervention is moderated by baseline motor and cognitive skills and sex; (2) the intervention may benefit motor creativity through gains in motor coordination, executive function, and creative thinking. Ninety-five children, aged 6–9 years, participated in a 6-month group randomized trial with specialist-led enriched PE vs. generalist-led conventional PE. Before and after the intervention, Bertsch’s Test of Motor Creativity, Movement Assessment Battery for Children, Random Number Generation task and Torrance Test of Creative Thinking were administered. Linear mixed models were run accounting for the random effects of data clusters. Multiple mediation analysis was performed to assess whether motor coordination, executive function and creative thinking mediated any improvement of motor creativity. Results showed that (1) specialist-led enriched PE, compared to generalist-led conventional practice, elicited a more pronounced improvement in all motor creativity dimensions (fluency, flexibility, and originality) independently of baseline levels of motor and cognitive skills and sex; and (2) improved motor creativity was partially mediated by improved motor coordination and, as regards motor flexibility, also by improved inhibitory ability. In conclusion, enriching PE with tailored manipulations of constraints and variability may enhance the ability to create multiple and original task-pertinent movements both directly and through indirect paths. The results are discussed extending to motor creativity a theoretical framework that distinguishes different creativity modes. The intervention may have fostered the generation of creative movements directly through the exposure to variation in constraints, activating the sensorimotor ‘flow’ mode of creativity that bypasses higher-order cognition, but also indirectly through a systematic and conscious convergence on solutions, activating the ‘deliberate’ mode of creativity that relies on inhibition to reject common or task-inappropriate movement categories.

Comparison of Clopidogrel Monotherapy After 1 to 2 Months of Dual Antiplatelet Therapy With 12 Months of Dual Antiplatelet Therapy in Patients With Acute Coronary Syndrome

Clopidogrel monotherapy after short dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) has not yet been fully investigated in patients with acute coronary syndrome (ACS). To test the hypothesis of noninferiority of 1 to 2 months of DAPT compared with 12 months of DAPT for a composite end point of cardiovascular and bleeding events in patients with ACS. This multicenter, open-label, randomized clinical trial enrolled 4169 patients with ACS who underwent successful PCI using cobalt-chromium everolimus-eluting stents at 96 centers in Japan from December 2015 through June 2020. These data were analyzed from June to July 2021. Patients were randomized either to 1 to 2 months of DAPT followed by clopidogrel monotherapy (n = 2078) or to 12 months of DAPT with aspirin and clopidogrel (n = 2091). The primary end point was a composite of cardiovascular (cardiovascular death, myocardial infarction [MI], any stroke, or definite stent thrombosis) or bleeding (Thrombolysis in MI major or minor bleeding) events at 12 months, with a noninferiority margin of 50% on the hazard ratio (HR) scale. The major secondary end points were cardiovascular and bleeding components of the primary end point. Among 4169 randomized patients, 33 withdrew consent. Of the 4136 included patients, the mean (SD) age was 66.8 (11.9) years, and 856 (21%) were women, 2324 (56%) had ST-segment elevation MI, and 826 (20%) had non-ST-segment elevation MI. A total of 4107 patients (99.3%) completed the 1-year follow-up in June 2021. One to 2 months of DAPT was not noninferior to 12 months of DAPT for the primary end point, which occurred in 65 of 2058 patients (3.2%) in the 1- to 2-month DAPT group and in 58 of 2057 patients (2.8%) in the 12-month DAPT group (absolute difference, 0.37% [95% CI, -0.68% to 1.42%]; HR, 1.14 [95% CI, 0.80-1.62]; P for noninferiority = .06). The major secondary cardiovascular end point occurred in 56 patients (2.8%) in the 1- to 2-month DAPT group and in 38 patients (1.9%) in the 12-month DAPT group (absolute difference, 0.90% [95% CI, -0.02% to 1.82%]; HR, 1.50 [95% CI, 0.99-2.26]). The major secondary bleeding end point occurred in 11 patients (0.5%) in the 1- to 2-month DAPT group and 24 patients (1.2%) in the 12-month DAPT group (absolute difference, -0.63% [95% CI, -1.20% to -0.06%]; HR, 0.46 [95% CI, 0.23-0.94]). In patients with ACS with successful PCI, clopidogrel monotherapy after 1 to 2 months of DAPT failed to attest noninferiority to standard 12 months of DAPT for the net clinical benefit with a numerical increase in cardiovascular events despite reduction in bleeding events. The directionally different efficacy and safety outcomes indicate the need for further clinical trials. ClinicalTrials.gov Identifiers: NCT02619760 and NCT03462498.

Long-Term Biocompatibility of a Highly Viscously Thiol-Modified Cross-Linked Hyaluronate as a Novel Vitreous Body Substitute.

Purpose: In surgical ophthalmology, the treatment of complicated retinal and vitreous diseases is one of the central challenges. For this purpose, the vitreous body is removed as part of the standard therapy and replaced by a temporary tamponade to stabilize the position of the retina. Since the tamponading properties of previous materials such as silicone oils, gases, or semi-fluorinated alkanes are a combination of their surface tension and their buoyancy vector, they cannot completely fill the vitreous cavity. The aim of this work was to test in vivo a novel vitreous body substitute (ViBos strong) based on cross-linked hyaluronic acid for its compatibility. Methods: A pars plana vitrectomy with posterior vitreous detachment was performed in the right eye of 18 pigmented rabbits, with subsequent injection of ViBos strong. Follow-up examination included slit-lamp examination, funduscopy, intraocular pressure measurements (IOP), optical coherence tomography (OCT), and electroretinogram (ERG) measurements. The rabbits were sacrificed at three different time points (1, 3, and 6 months; each 6 animals) and examined macroscopically and prepared for histological examination (HE staining) and immunohistochemistry (Brn3a and glial fibrillary acidic protein (GFAP)). Results: ViBos strong demonstrated good intraoperative handling and remained stable for at least 1 month and degraded slowly over 6 months. IOP was within clinical acceptable values at all follow-up examinations. Retinal function was well preserved after instillation of the hydrogel and comparable to the untreated eye after 6 months in OCT, ERG, and histological examinations. An increase in the GFAP expression was found in the surgery eyes, with a peak in the 3-month group. The Brn3a expression was not significantly affected by vitrectomy with ViBos strong. Conclusion: Highly viscously thiol-modified cross-linked hyaluronate showed a good biocompatibility in rabbit eyes over 6 months after vitrectomy, making it a promising potential as a vitreous substitute.

Persuasive Technologies and Social Interactions in Professional Environments: Embedded Qualitative Case Study.

BackgroundAlthough previous studies have highlighted the impact of interactions on the web in the context of patient–health care professional (HCP) dyads, this paper extends that context to a triad that includes the role of employers and associated settings with social groups.ObjectiveThis study aims to evaluate how the interactions between individuals and the social use of the platform affect individuals’ use of persuasive technology and, in turn, their work environment actions and responses, by implementing a persuasive technology health and wellness platform in a work environment.MethodsFor 8 months, we deployed a persuasive technology platform with different combinations of health-related features and content in 1 embedded case design with 8 fire stations for a small Canadian city (total number of participant firefighters, n=141) assigned to 1 of 2 treatments—interactive or static webpages. We used text-based content analysis techniques for outcome measures, drawn from a total of 29 participant exit interviews. In addition, medical assessments were conducted at baseline, midpoint, and end point by 7 HCPs and 1 researcher (BM), who also served as the data steward and managed the study.ResultsOur results reveal that group, social, and work influences introduce new elements to the use of persuasive technology, which interact to foster higher levels of individual success. The platform in our study served as part of a larger social system, providing information that facilitated new behaviors at work and home. The 8-month group programs centered on exercise, nutrition, and smoking cessation. Groups of participants coached by certified professionals showed significant increases in sodium awareness, levels of actual exercise, and consistency of activities. As a result of the study, of 141 people, 15 (10.6%) were notified of serious medical health issues and 29 (20.6%) underwent blood work assessments and a privacy shield (protected by federal law) was enacted to protect employees from losing their employment based on any health concerns disclosed.ConclusionsThe persuasive technology platform, in combination with self-management and professional management and social interactions, significantly altered work management behaviors. Interactions among individual outcomes, group influences, and social situations strongly influenced individuals’ behaviors in their work and home environments. Three things further improved the positive results that we observed: privacy shields (which allowed employees to reveal health concerns without fear of professional consequences), individual private activities aligned with group activities, and integration between HCP work with localized, organizational work roles.

The impact of Strong Families, Strong Communities on relationship functioning in low-income African American and Hispanic individuals: Findings from a federally funded randomized control trial.

Low-income minorities face many complex barriers to building stable and healthy relationships. AVANCE Houston, a non-profit community-based organization in Houston, Texas, developed the Strong Families, Strong Communities (SFSC) program to address such barriers by providing interactive healthy marriage and relationship skills workshops to low-income English- and Spanish-speaking Hispanic and English-speaking African American individuals. Using a randomized control trial (RCT) design with random assignment to the 7-week treatment group (n=649) or a 12-month wait-list control group (n=600), we examined the impact of the program on four dimensions of relationship functioning: relationship satisfaction, connectedness, and quality; and conflict resolution, at post-test and then 6 and 12months later. Using a repeated measure multilevel model with a difference-in-difference impact estimate, we found that all four dimensions of relationship functioning improved with small effect sizes that were larger than those found in previous relationship education programs for low-income individuals (Cohen's d's of 0.18 for relationship satisfaction, 0.24 for connectedness, 0.19 for quality, and 0.20 for conflict resolution). Findings from this study provide evidence of program effectiveness on dimensions of relationship functioning for low-income minorities, comparable to or better than those seen in other healthy marriage program RCTs. The findings of this impact evaluation are promising regarding the impact of programs like SFSC on dimensions of relationship functioning in low-income Hispanic and African American participants.

Self-reported quality of life in children with ventricular assist devices.

We sought to describe QOL in children with VAD and to identify factors associated with impaired QOL. There were 82 children (6-19years) in the Pediatric Interagency Registry for Mechanical Circulatory Support who completed the PedsQL +/- a VAD-specific QOL assessment pre-VAD implant (n=18), 3months post-VAD (n=63), and/or 6months post-VAD (n=38). Significantly impaired QOL is a score >1 SD below norms. Study patients were 59% male, 67% Caucasian, with cardiomyopathy diagnosis in 82%, and median age at implant of 14 y (IQR 11-17). PedsQL scores were lower than norms for physical (p<.0001) and psychosocial (p<.01) QOL in pre- and post-VAD groups. Compared to chronic health condition and complex or severe heart disease groups, PedsQL scores were lower for physical and psychosocial QOL in the pre-VAD group (p<.0001); however, psychosocial QOL was not significantly different in post-VAD groups. Psychosocial QOL was impaired in 67%, 40%, and 24% in pre-VAD, 3-month, and 6-month post-VAD groups, respectively. Total and psychosocial QOL scores were significantly higher in the 3-month and 6-month post-VAD group than pre-VAD (all p≤.02). VAD patients were most bothered by their inability to participate in usual play activities. Impaired QOL 3months post-VAD was associated with inotropic support >2weeks/ongoing post-VAD (p=.04). Physical QOL is significantly impaired in most children pre- and post-VAD. However, psychosocial QOL is not significantly impaired in most children post-VAD suggesting VAD implantation may improve psychosocial QOL in children.