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1.
Soc Sci Med ; 279: 113984, 2021 May 03.
Artigo em Inglês | MEDLINE | ID: mdl-33975053

RESUMO

Realist evaluations aim to evaluate interventions by understanding the mechanisms they trigger, assessing not merely what works but what works for whom, under what conditions, and how. Significant disagreement in the literature exists as to whether randomized trials can be used as a tool for realist evaluation. INCLUSIVE, which was the first realist randomized trial explicitly designed as such, evaluated the impact of Learning Together, a school-based intervention for students aged 12-15 that included restorative practice, on bullying victimisation, mental wellbeing and psychological problems. Drawing on hypotheses generated through qualitative research, this analysis tested if school belonging was a mediator of intervention effects, and in which contexts. We estimated a series of fully longitudinal multilevel moderated mediation models including intervention allocation, student reports of school belonging at 24 months and victimisation and wellbeing outcomes at 36 months, and stratified on the basis of whether, at baseline, schools were: a) rated 'outstanding' for leadership, b) below the median for average levels of victimisation, and c) above the median on school inclusivity. Findings suggested that in unstratified models, belonging was not a mediator for any outcome; but in each of the strata defined above, belonging was a significant mediator at the student level. However, in the strata where belonging was not a mediator, the intervention still had a significant effect on each outcome. Analyses point to a strong but conditional role for belonging as a mediator of intervention pathways; in schools where belonging was not a mediator (e.g. above-median victimisation levels), other mechanisms may have been activated. This is consistent with a realist understanding of context-mechanism linkages generating outcomes. Our analyses suggest that realist evaluations can be pursued within randomized trials and that such analyses can offer more nuanced evidence regarding in which contexts interventions might effectively be implemented.

2.
Transfusion ; 2021 May 07.
Artigo em Inglês | MEDLINE | ID: mdl-33960433

RESUMO

BACKGROUND: Daratumumab, a human anti-CD38 monoclonal antibody used to treat multiple myeloma, interferes with pretransfusion testing and can mask alloantibodies. Incidence of alloimmunization in patients on daratumumab has not been well characterized, and optimal transfusion guidelines regarding prophylactic antigen matching, accounting for both patient safety and efficiency, have not been well established for these patients. METHODS: Records of patients who received daratumumab between January 1, 2014 and July 2, 2019 were reviewed. Daratumumab interference with pretransfusion testing was managed by testing with reagent red blood cells (RBCs) treated with 0.2 M dithiothreitol. When daratumumab was present during antibody testing, patients were transfused with RBC units prophylactically matched for D, C, c, E, e, and K antigens per hospital policy. RESULTS: Out of 90 patients identified, 52 received a total of 638 RBC transfusions (average of 12.3 units per patient, SD 17.2, range 1-105, median 5 among those transfused). Alloantibodies existing before daratumumab initiation were identified in seven patients. No new alloantibodies were detected in any patients after starting daratumumab treatment. CONCLUSIONS: The incidence of alloimmunization in patients receiving daratumumab is low. Whether this is due to the effect of daratumumab, underlying pathophysiology, or other factors, is unknown. Because these patients require a large number of RBC transfusions overall and have little observed alloimmunization, phenotype matching (beyond RhD) may be unnecessary. Since the use of dithiothreitol cannot rule out the presence of anti-K, we recommend transfusion of ABO-compatible units, prophylactically matched for the D and K antigens only.

3.
Lancet Planet Health ; 5(5): e263-e276, 2021 May.
Artigo em Inglês | MEDLINE | ID: mdl-33811818

RESUMO

BACKGROUND: Almost a quarter of the world's undernourished people live in India. We tested the effects of three nutrition-sensitive agriculture (NSA) interventions on maternal and child nutrition in India. METHODS: We did a parallel, four-arm, observer-blind, cluster-randomised trial in Keonjhar district, Odisha, India. A cluster was one or more villages with a combined minimum population of 800 residents. The clusters were allocated 1:1:1:1 to a control group or an intervention group of fortnightly women's groups meetings and household visits over 32 months using: NSA videos (AGRI group); NSA and nutrition-specific videos (AGRI-NUT group); or NSA videos and a nutrition-specific participatory learning and action (PLA) cycle meetings and videos (AGRI-NUT+PLA group). Primary outcomes were the proportion of children aged 6-23 months consuming at least four of seven food groups the previous day and mean maternal body-mass index (BMI). Secondary outcomes were proportion of mothers consuming at least five of ten food groups and child wasting (proportion of children with weight-for-height Z score SD <-2). Outcomes were assessed in children and mothers through cross-sectional surveys at baseline and at endline, 36 months later. Analyses were by intention to treat. Participants and intervention facilitators were not blinded to allocation; the research team were. This trial is registered at ISRCTN, ISRCTN65922679. FINDINGS: 148 of 162 clusters assessed for eligibility were enrolled and randomly allocated to trial groups (37 clusters per group). Baseline surveys took place from Nov 24, 2016, to Jan 24, 2017; clusters were randomised from December, 2016, to January, 2017; and interventions were implemented from March 20, 2017, to Oct 31, 2019, and endline surveys done from Nov 19, 2019, to Jan 12, 2020, in an average of 32 households per cluster. All clusters were included in the analyses. There was an increase in the proportion of children consuming at least four of seven food groups in the AGRI-NUT (adjusted relative risk [RR] 1·19, 95% CI 1·03 to 1·37, p=0·02) and AGRI-NUT+PLA (1·27, 1·11 to 1·46, p=0·001) groups, but not AGRI (1·06, 0·91 to 1·23, p=0·44), compared with the control group. We found no effects on mean maternal BMI (adjusted mean differences vs control, AGRI -0·05, -0·34 to 0·24; AGRI-NUT 0·04, -0·26 to 0·33; AGRI-NUT+PLA -0·03, -0·3 to 0·23). An increase in the proportion of mothers consuming at least five of ten food groups was seen in the AGRI (adjusted RR 1·21, 1·01 to 1·45) and AGRI-NUT+PLA (1·30, 1·10 to 1·53) groups compared with the control group, but not in AGRI-NUT (1·16, 0·98 to 1·38). We found no effects on child wasting (adjusted RR vs control, AGRI 0·95, 0·73 to 1·24; AGRI-NUT 0·96, 0·72 to 1·29; AGRI-NUT+PLA 0·96, 0·73 to 1·26). INTERPRETATION: Women's groups using combinations of NSA videos, nutrition-specific videos, and PLA cycle meetings improved maternal and child diet quality in rural Odisha, India. These components have been implemented separately in several low-income settings; effects could be increased by scaling up together. FUNDING: Bill & Melinda Gates Foundation, UK AID from the UK Government, and US Agency for International Development.

4.
Prev Sci ; 2021 Apr 21.
Artigo em Inglês | MEDLINE | ID: mdl-33880692

RESUMO

Whole-school interventions are a promising approach to preventing bullying and aggression while promoting broader health. The main analyses from a trial of the INCLUSIVE whole-school intervention reported reductions in bullying victimisation but not aggression and improved mental well-being. Latent transition analysis can examine how interventions 'move' people between classes defined by multiple outcomes over time. We examined at baseline what classes best defined individuals' bullying, aggression and mental well-being and what effects did the intervention have on movement between classes over time? INCLUSIVE was a two-arm cluster-randomised trial with 20 high schools per arm, with 24-month and 36-month follow-ups. We estimated sequential latent class solutions on baseline data. We then estimated a latent transition model including baseline, 24-month and 36-month follow-up measurements. Our sample comprised 8179 students (4082 control, 4097 intervention arms). At baseline, classes were (1) bullying victims, (2) aggression perpetrators, (3) extreme perpetrators and (4) neither victims nor perpetrators. Control students who were extreme perpetrators were equally likely to stay in this class (27.0% probability) or move to aggression perpetrators (25.0% probability) at 24 months. In the intervention group, fewer extreme perpetrators students remained (5.4%), with more moving to aggression perpetrators (65.1%). More control than intervention extreme perpetrators moved to neither victims nor perpetrators (35.2% vs 17.8%). Between 24 and 36 months, more intervention students moved from aggression perpetrators to neither victims nor perpetrators than controls (30.1% vs 22.3%). Our findings suggest that the intervention had important effects in transitioning students to lower-risk classes.

5.
Pediatr Pulmonol ; 2021 Apr 13.
Artigo em Inglês | MEDLINE | ID: mdl-33848402

RESUMO

The Coronavirus disease 2019 (COVID-19) pandemic profoundly impacted health care utilization. We evaluated asthma-related emergency department (ED) and inpatient health care utilization by a county-specific Medicaid population, ages 2-18, during the COVID-19 pandemic and compared it to utilization from a 3-year average including 2017-2019. All-cause ED utilization and asthma medication fill rates were evaluated during the same timeframes. Relative to the 2017-2019 3-year average, cumulative asthma-related ED visits from January through June decreased by 45.8% (p = .03) and inpatient admission rates decreased by 50.5% (p = .03). The decline in asthma-related ED utilization was greater than the reduction of overall ED use during the same time period, suggesting that the decline involved factors specific to asthma and was not due solely to avoidance of health care facilities. Fill rates for asthma controller medications decreased during this time (p = .03) and quick relief medication fill rates had no significant change (p = .31). Multiple factors may have contributed to the decrease in acute asthma health care visits. Locally, decreased air pollution and viral exposures coincided with the "Stay-at-home" order in Ohio, and increased utilization of telehealth for assessment during exacerbations may have impacted outcomes. Identification of the cause of the decline in visit rates could spur new interventions to limit the need for ED and inpatient visits for asthma patients, leading to both economic and health-associated benefits.

6.
Mol Ther ; 2021 Apr 05.
Artigo em Inglês | MEDLINE | ID: mdl-33823303

RESUMO

A self-transcribing and replicating RNA (STARR)-based vaccine (LUNAR-COV19) has been developed to prevent SARS-CoV-2 infection. The vaccine encodes an alphavirus-based replicon and the SARS-CoV-2 full-length spike glycoprotein. Translation of the replicon produces a replicase complex that amplifies and prolongs SARS-CoV-2 spike glycoprotein expression. A single prime vaccination in mice led to robust antibody responses, with neutralizing antibody titers increasing up to day 60. Activation of cell-mediated immunity produced a strong viral antigen-specific CD8+ T lymphocyte response. Assaying for intracellular cytokine staining for interferon (IFN)γ and interleukin-4 (IL-4)-positive CD4+ T helper (Th) lymphocytes as well as anti-spike glycoprotein immunoglobulin G (IgG)2a/IgG1 ratios supported a strong Th1-dominant immune response. Finally, single LUNAR-COV19 vaccination at both 2 µg and 10 µg doses completely protected human ACE2 transgenic mice from both mortality and even measurable infection following wild-type SARS-CoV-2 challenge. Our findings collectively suggest the potential of LUNAR-COV19 as a single-dose vaccine.

7.
Dev Psychopathol ; : 1-13, 2021 Mar 15.
Artigo em Inglês | MEDLINE | ID: mdl-33719996

RESUMO

Contamination, when members of a comparison or control condition are exposed to the event or intervention under scientific investigation, is a methodological phenomenon that downwardly biases the magnitude of effect size estimates. This study tested a novel approach for controlling contamination in observational child maltreatment research. Data from The Longitudinal Studies of Child Abuse and Neglect (LONGSCAN; N = 1354) were obtained to estimate the risk of confirmed child maltreatment on trajectories of internalizing and externalizing behaviors before and after controlling contamination. Baseline models, where contamination was uncontrolled, demonstrated a risk for greater internalizing (b = .29, p < .001, d = .40) and externalizing (b = .14, p = .040, d = .19) behavior trajectories. Final models, where contamination was controlled by separating the comparison condition into subgroups that did or did not self-report maltreatment, also demonstrated risks for greater internalizing (b = .37, p < .001, d = .51) and externalizing (b = .22, p = .028, d = .29) behavior trajectories. However, effect size estimates in final models were 27.5%-52.6% larger compared to baseline models. Controlling contamination in child maltreatment research can strengthen effect size estimates for child behavior problems, aiding future child maltreatment research design and analysis.

9.
J Immunother Cancer ; 9(2)2021 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-33589525

RESUMO

BACKGROUND: Modulation and depletion strategies of regulatory T cells (Tregs) constitute valid approaches in antitumor immunotherapy but suffer from severe adverse effects due to their lack of selectivity for the tumor-infiltrating (ti-)Treg population, indicating the need for a ti-Treg specific biomarker. METHODS: We employed single-cell RNA-sequencing in a mouse model of non-small cell lung carcinoma (NSCLC) to obtain a comprehensive overview of the tumor-infiltrating T-cell compartment, with a focus on ti-Treg subpopulations. These findings were validated by flow cytometric analysis of both mouse (LLC-OVA, MC38 and B16-OVA) and human (NSCLC and melanoma) tumor samples. We generated two CCR8-specific nanobodies (Nbs) that recognize distinct epitopes on the CCR8 extracellular domain. These Nbs were formulated as tetravalent Nb-Fc fusion proteins for optimal CCR8 binding and blocking, containing either an antibody-dependent cell-mediated cytotoxicity (ADCC)-deficient or an ADCC-prone Fc region. The therapeutic use of these Nb-Fc fusion proteins was evaluated, either as monotherapy or as combination therapy with anti-programmed cell death protein-1 (anti-PD-1), in both the LLC-OVA and MC38 mouse models. RESULTS: We were able to discern two ti-Treg populations, one of which is characterized by the unique expression of Ccr8 in conjunction with Treg activation markers. Ccr8 is also expressed by dysfunctional CD4+ and CD8+ T cells, but the CCR8 protein was only prominent on the highly activated and strongly T-cell suppressive ti-Treg subpopulation of mouse and human tumors, with no major CCR8-positivity found on peripheral Tregs. CCR8 expression resulted from TCR-mediated Treg triggering in an NF-κB-dependent fashion, but was not essential for the recruitment, activation nor suppressive capacity of these cells. While treatment of tumor-bearing mice with a blocking ADCC-deficient Nb-Fc did not influence tumor growth, ADCC-prone Nb-Fc elicited antitumor immunity and reduced tumor growth in synergy with anti-PD-1 therapy. Importantly, ADCC-prone Nb-Fc specifically depleted ti-Tregs in a natural killer (NK) cell-dependent fashion without affecting peripheral Tregs. CONCLUSIONS: Collectively, our findings highlight the efficacy and safety of targeting CCR8 for the depletion of tumor-promoting ti-Tregs in combination with anti-PD-1 therapy.

11.
J Clin Child Adolesc Psychol ; : 1-11, 2021 Jan 20.
Artigo em Inglês | MEDLINE | ID: mdl-33471576

RESUMO

Objective: Child maltreatment is among the strongest predictors of posttraumatic stress disorder (PTSD). However, less than 40% of children who have been maltreated are ever diagnosed with PTSD, suggesting that exposure to child maltreatment alone is insufficient to explain this risk. This study examined whether epigenetic age acceleration, a stress-sensitive biomarker derived from DNA methylation, explains variation in PTSD diagnostic status subsequent to child maltreatment.Method: Children and adolescents (N = 70; 65.7% female), 8-15 years of age (M = 12.00, SD = 2.37) and exposed to substantiated child maltreatment within the 12 months prior to study entry, were enrolled. Participants provided epithelial cheek cells via buccal swab for genotyping and quantification of epigenetic age acceleration within a case-control design. PTSD diagnostic status was determined using the Child PTSD Symptoms Scale according to the DSM-IV-TR algorithm.Results: Epigenetic age acceleration predicted current PTSD status, revealing an effect size magnitude in the moderate range, OR = 2.35, 95% CI: 1.22- 4.51, after adjusting for sample demographics, polygenic risk for PTSD, and lifetime exposure to other childhood adversities. Supplemental analyses demonstrated that epigenetic age acceleration was related to a greater severity of PTSD arousal symptoms (r =.29, p =.015). There were no differential effects for child maltreatment subtype on epigenetic age acceleration or PTSD status.Conclusions: The biological embedding of child maltreatment may explain variation in PTSD diagnostic status and serve as a novel approach for informing selective prevention or precision-based therapeutics for those at risk for PTSD.

12.
J Asthma ; : 1-6, 2021 Jan 16.
Artigo em Inglês | MEDLINE | ID: mdl-33385211

RESUMO

OBJECTIVE: Asthma is a common chronic medical condition that can require treatment with multiple inhaled medications. Our quality improvement group established a standard asthma teaching protocol with respiratory therapists utilizing the teach back method. We aimed to increase the percentage of pulmonary asthma clinic visits receiving this education from a baseline of 42.7% in 2016 to 80% by December 2019. METHODS: Multiple interventions were put in place and data was collected monthly from the electronic medical record system. Data was recorded in statistical process control charts using a p chart. Nelson's established rules for determining special versus common cause variation were used. RESULTS: Over the three-year project the percentage of asthma clinic visits receiving the standardized respiratory therapist driven teach back asthma education increased to 82.3%. CONCLUSION: Utilizing a standardized approach, it's possible to deliver standardized asthma education in a busy pulmonary clinic.

13.
Transfusion ; 61(3): 979-985, 2021 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-33475168

RESUMO

BACKGROUND: We report a case of apparent mother-child ABO group noninheritance. A Caucasian mother initially typed as group O and her infant group AB. Investigation ruled out preanalytical causes such as mislabeled samples and in vitro fertilization. MATERIALS AND METHODS: Red blood cells were characterized by routine serologic testing. Genomic data were analyzed by targeted polymerase chain reaction-restriction fragment length polymorphism and Sanger sequencing. Transferase structures were modeled using PyMOL molecular visualization software. RESULTS: Serologic testing initially demonstrated the mother was group O, father group AB, and infant group AB. Further testing of the maternal sample with anti-A,B demonstrated weak A expression. Molecular testing revealed the maternal sample had an ABO*O.01.01 allele in trans to an A allele, ABO*AW.29 (c.311T>A, p.Ile104Asn), determined by gene sequencing. The sample from the infant carried the same ABO*AW.29 allele in trans to a B allele, ABO*B.01. CONCLUSION: ABO genotyping revealed an A transferase encoded by ABO*AW.29, with apparent variable activity. Although A antigen expression is well known to be weak in newborns, it was robust on the red blood cells (RBCs) of the AB infant and undetectable with anti-A on the mother. Variable expression of weak subgroups may reflect competition or enhancement by a codominant allele, as well as glycan chain maturation on red cells. Previous examples in group AB mothers with Aweak infants suggested that the decreased expression is primarily due to glycan immaturity. To our knowledge, this is the first reported case of the ABO*AW.29 allele presenting with weak A expression in a group Aweak mother and robust A expression in a group AB infant, suggesting the in trans allele is an important factor in determining transferase activity and may override age-related effects.

15.
Injury ; 2021 Jan 07.
Artigo em Inglês | MEDLINE | ID: mdl-33478798

RESUMO

INTRODUCTION: Many geriatric hip fracture patients utilize significant healthcare resources and require an extensive recovery period after surgery. There is an increasing awareness that measuring frailty in geriatric patients may be useful in predicting mortality and perioperative complications and may be useful in helping guide treatment decisions. The primary purpose of the study is to investigate whether the frailty index predicts discharge disposition from the hospital and discharge facility and length of stay. METHODS: In this retrospective cohort study, patients aged 65 years and older presenting to a level 1 trauma center with a hip fracture and a calculated frailty index were eligible for inclusion. The primary outcome was discharge disposition. Secondary outcomes were hospital and discharge facility length of stay, 90-day hospital mortality and readmissions, and return to home. RESULTS: A total of 313 patients were included. The frailty index was a robust predictor of discharge to a skilled nursing facility (OR 1.440 per 0.1 point increase). Patients with a higher frailty index were at higher risk of 90-day mortality and less likely to return to home at the end of follow-up. There was a very weak correlation between the frailty index and hospital length of stay (ρ=0.30) and rehab length of stay (ρ=0.26). CONCLUSION: The frailty index can be used to predict discharge destination from both the hospital and rehabilitation facility, 90-day mortality, and return to home after rehabilitation. In this study, the frailty index had a very weak correlation with length of stay in the hospital and in discharge destination. The frailty index can be used to help guide medical decision making, goals of care discussions, and to determine which patients benefit from intensive rehabilitation.

16.
Malar J ; 20(1): 18, 2021 Jan 06.
Artigo em Inglês | MEDLINE | ID: mdl-33407454

RESUMO

BACKGROUND: Accurate measurement of anti-malarial drug concentrations in therapeutic efficacy studies is essential to distinguish between inadequate drug exposure and anti-malarial drug resistance, and to inform optimal anti-malarial dosing in key target population groups. METHODS: A sensitive and selective LC-MS/MS method was developed and validated for the simultaneous determination of amodiaquine and its active metabolite, desethylamodiaquine, and used to describe their pharmacokinetic parameters in Ghanaian patients with uncomplicated falciparum malaria treated with the fixed-dose combination, artesunate-amodiaquine. RESULTS: The day-28 genotype-adjusted adequate clinical and parasitological response rate in 308 patients studied was > 97% by both intention-to-treat and per-protocol analysis. After excluding 64 patients with quantifiable amodiaquine concentrations pre-treatment and 17 with too few quantifiable concentrations, the pharmacokinetic analysis included 227 patients (9 infants, 127 aged 1-4 years, 91 aged ≥ 5 years). Increased median day-3 amodiaquine concentrations were associated with a lower risk of treatment failure [HR 0.87 (95% CI 0.78-0.98), p = 0.021]. Amodiaquine exposure (median AUC0-∞) was significantly higher in infants (4201 ng h/mL) and children aged 1-5 years (1994 ng h/mL) compared to older children and adults (875 ng h/mL, p = 0.001), even though infants received a lower mg/kg amodiaquine dose (median 25.3 versus 33.8 mg/kg in older patients). Desethylamodiaquine AUC0-∞ was not significantly associated with age. No significant safety concerns were identified. CONCLUSIONS: Efficacy of artesunate-amodiaquine at currently recommended dosage regimens was high across all age groups. Reassuringly, amodiaquine and desethylamodiaquine exposure was not reduced in underweight-for-age young children or those with high parasitaemia, two of the most vulnerable target populations. A larger pharmacokinetic study with close monitoring of safety, including full blood counts and liver function tests, is needed to confirm the higher amodiaquine exposure in infants, understand any safety implications and assess whether dose optimization in this vulnerable, understudied population is needed.

17.
JMIR Res Protoc ; 9(12): e20940, 2020 Dec 07.
Artigo em Inglês | MEDLINE | ID: mdl-33283762

RESUMO

BACKGROUND: Violence against children in schools is a global public health problem. There is growing evidence that school-based interventions can be effective in reducing violence against children in schools. However, there is little evidence on the long-term impact of such interventions. The Good School Toolkit, developed by Raising Voices, a Uganda-based nonprofit organization, is a whole-school violence prevention intervention that aims to change the operational culture of primary schools. In 2014, the Good School Toolkit was evaluated through a cluster randomized controlled trial (Good Schools Study) and found to reduce teacher-to-student and student-to-student violence. OBJECTIVE: This protocol describes quantitative analyses to explore long-term outcomes of the Good School Toolkit intervention among adolescents in Uganda, including the extent to which it is associated with peer-violence victimization (primary outcome) and peer-violence perpetration, intimate-partner violence, acceptance of teacher-violence, equitable gender attitudes, agency, self-regulation, peer connectedness, social assets, psychological assets, and retention in school (secondary outcomes). METHODS: This is a nonrandomized quasi-experimental 4-year follow-up study of adolescents who attended the 42 Good Schools Study primary schools in 2014; 21 schools initiated the Good School Toolkit intervention during the trial from 2012, and 19 schools initiated the intervention after the trial (during the later delivery phase) from 2015; 2 schools did not implement the intervention. Students in the final school grade (Primary 7) during 2014 of the 19 primary schools in the later delivery phase are expected to have left school prior to toolkit delivery in 2015. Wave 1 data were collected in 2014 from 3431 grade Primary 5 to Primary 7 school students aged 11-14 years; these students were followed up in 2018-2019 when aged 16-19 years and invited to participate in the Wave 2 survey. Data were collected in face-to-face interviews by trained Ugandan field researchers. Toolkit exposure groups are defined as exposed during the Good Schools Study trial (from 2012), as exposed during later delivery (from 2015), or not exposed including those expected to have completed Primary 7 prior to later delivery or from the 2 schools that did not implement the toolkit. Associations between outcomes at Wave 2 and toolkit exposure groups will be analyzed using mixed-effect multivariable logistic and linear regression models for binary and continuous outcomes, respectively. This analysis is exploratory and aims to generate hypotheses on if, and under what circumstances, the toolkit influences later adolescent outcomes. RESULTS: Data collection was completed in August 2019. CONCLUSIONS: To our knowledge, this is the first long-term follow-up study of adolescents exposed to a school-based violence-prevention intervention in sub-Saharan Africa. If the intervention reduces violence and improves other outcomes in later adolescence, then this study supports primary school interventions as key to achieving long-term population impacts. The pattern of effects will inform where reinforced or additional interventions are needed. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/20940.

18.
BMJ Open ; 10(12): e038174, 2020 Dec 02.
Artigo em Inglês | MEDLINE | ID: mdl-33268402

RESUMO

OBJECTIVES: Primary objective: to assess nine data quality metrics for 14 maternal and newborn health data elements, following implementation of an integrated, district-focused data quality intervention. SECONDARY OBJECTIVE: to consider whether assessing the data quality metrics beyond completeness and accuracy of facility reporting offered new insight into reviewing routine data quality. DESIGN: Before-and-after study design. SETTING: Primary health facilities in Gombe State, Northeastern Nigeria. PARTICIPANTS: Monitoring and evaluation officers and maternal, newborn and child health coordinators for state-level and all 11 local government areas (district-equivalent) overseeing 492 primary care facilities offering maternal and newborn care services. INTERVENTION: Between April 2017 and December 2018, we implemented an integrated data quality intervention which included: introduction of job aids and regular self-assessment of data quality, peer-review and feedback, learning workshops, work planning for improvement, and ongoing support through social media. OUTCOME MEASURES: 9 metrics for the data quality dimensions of completeness and timeliness, internal consistency of reported data, and external consistency. RESULTS: The data quality intervention was associated with improvements in seven of nine data quality metrics assessed including availability and timeliness of reporting, completeness of data elements, accuracy of facility reporting, consistency between related data elements, and frequency of outliers reported. Improvement differed by data element type, with content of care and commodity-related data improving more than contact-related data. Increases in the consistency between related data elements demonstrated improved internal consistency within and across facility documentation. CONCLUSIONS: An integrated district-focused data quality intervention-including regular self-assessment of data quality, peer-review and feedback, learning workshops, work planning for improvement, and ongoing support through social media-can increase the completeness, accuracy and internal consistency of facility-based routine data.

19.
BMJ Open ; 10(12): e039546, 2020 Dec 02.
Artigo em Inglês | MEDLINE | ID: mdl-33268410

RESUMO

OBJECTIVE: Post-randomisation exclusions in randomised controlled trials are common and may include participants identified as not meeting trial eligibility criteria after randomisation. We report how a decision might be reached and reported on, to include or exclude these participants. We illustrate using a motivating scenario from the BREATHE trial (Trial registration ClinicalTrials.gov, NCT02426112) evaluating azithromycin for the treatment of chronic lung disease in people aged 6-19 years with HIV in Zimbabwe and Malawi. KEY POINTS: Including all enrolled and randomised participants in the primary analysis of a trial ensures an unbiased estimate of the intervention effect using intention-to-treat principles, and minimises the effects of confounding through balanced allocation to trial arm. Ineligible participants are sometimes enrolled, due to measurement or human error. Of 347 participants enrolled into the BREATHE trial, 11 (3.2%) were subsequently found to be ineligible based on lung function criteria. We assumed no safety risk of azithromycin treatment; their inclusion in the trial and subsequent analysis of the intervention effect therefore mirrors clinical practice. Senior trial investigators considered diurnal variations in the measurement of lung function, advantages of retaining a higher sample size and advice from the Data Safety and Monitoring Board and Trial Steering Committee, and decided to include these participants in primary analysis. We planned and reported analyses including and excluding these participants, and in our case the interpretation of treatment effect was consistent. CONCLUSION: The decision, by senior investigators, on whether to exclude enrolled participants, should reflect issues of safety, treatment efficacy, statistical power and measurement error. As long as decisions are made prior to finalising the statistical analysis plan for the trial, the risk of exclusions creating bias should be minimal. The decision taken should be transparently reported and a sensitivity analysis can present the opposite decision.

20.
BMJ Case Rep ; 13(12)2020 Dec 17.
Artigo em Inglês | MEDLINE | ID: mdl-33334748

RESUMO

While cardiac myxomas are the most common primary cardiac tumours, their overall incidence remains rare. Most cases (90%) are sporadic and occur in the third-sixth decades of life with a female predominance and have a specific predilection for the left atrium (75%). While often asymptomatic, clinical presentations depend on the tumour size, architecture and location. Echocardiography remains the mainstay for diagnostic evaluation. Tumour resection is the only definitive treatment. Histopathology using H&E and immunohistochemical stains, such as calretinin and CD34, confirms the diagnosis. We present a case of a patient with reported history of asthma who presented with recurrent acute on chronic shortness of breath refractory to inhaler therapy, multiple outpatient visits and hospitalisations for 'asthma exacerbations'. After further evaluation, she was diagnosed with a left atrial myxoma attached to the inferior aspect of the intra-atrial septum complicated by severe functional mitral stenosis.


Assuntos
Dispneia/etiologia , Neoplasias Cardíacas/diagnóstico , Estenose da Valva Mitral/diagnóstico , Mixoma/diagnóstico , Asma/diagnóstico , Ponte Cardiopulmonar , Angiografia por Tomografia Computadorizada , Diagnóstico Diferencial , Dispneia/cirurgia , Ecocardiografia , Eletrocardiografia , Feminino , Átrios do Coração/diagnóstico por imagem , Átrios do Coração/patologia , Neoplasias Cardíacas/complicações , Neoplasias Cardíacas/patologia , Neoplasias Cardíacas/cirurgia , Humanos , Pessoa de Meia-Idade , Estenose da Valva Mitral/etiologia , Estenose da Valva Mitral/cirurgia , Mixoma/complicações , Mixoma/patologia , Mixoma/cirurgia , Esternotomia , Resultado do Tratamento
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