Health literacy of caregivers of adult care recipients: A systematic scoping review

Caregivers play a vital role in providing support to adults with a chronic condition, or cognitive or physical impairment. Low health literacy in caregivers has the potential to impact adequate care provision, and consequently, care recipient health outcomes. The aim of the study was to systematically review literature related to health literacy of caregivers of adult care recipients, and examine its relationship with care recipient, and caregiver, health outcomes. Electronic databases were searched for relevant English‐language publications that assessed health literacy in caregivers. Included studies were abstracted into evidence tables and assessed using an eight‐item quality scale. The search identified 2717 new titles and abstracts, with 67 shortlisted for full review. Twelve papers from 2003 to 2015 met the inclusion criteria. The prevalence of limited health literacy in caregivers ranged from 0% to 52.5% depending on the measure and cut‐off criteria used. Associations were found between low caregiver health literacy and (i) poorer care recipient self‐management behaviours; (ii) increased care recipient use of health services; and (iii) increased caregiver burden. The quality of the studies ranged from fair to excellent. Low health literacy in caregivers differed depending on the measures and scoring criteria used. Evidence to support the relationship between caregiver health literacy and care recipient, and caregiver health outcomes was limited to single studies. Recommendations for further research include: the development of caregiver health literacy measures across different populations; examination of associations between caregiver health literacy and care recipient outcomes; and the development of interventions designed to improve caregiver health literacy.     

School Wellness Committees Are Associated With Lower Body Mass Index Z‐Scores and Improved Dietary Intakes in US Children: The Healthy Communities Study

BACKGROUND

Our objective was to examine the association between school wellness committees and implementation of nutrition wellness policies and children's weight status and obesity‐related dietary outcomes.

METHODS

A cross‐sectional study was conducted of 4790 children aged 4‐15 years recruited from 130 communities in the Healthy Communities Study. Multilevel statistical models assessed associations between school wellness policies and anthropometric (body mass index z‐score [BMIz]) and nutrition measures, adjusting for child and community‐level covariates.

RESULTS

Children had lower BMI z‐scores (?0.11, 95% confidence interval [CI]: ?0.19, ?0.03) and ate breakfast more frequently (0.14 days/week, 95% CI: 0.02‐0.25) if attending a school with a wellness committee that met once or more in the past year compared to attending a school with a wellness committee that did not meet/did not exist. Children had lower added sugar (p < .0001), lower energy‐dense foods (p = .0004), lower sugar intake from sugar‐sweetened beverages (p = .0002), and lower dairy consumption (p = .001) if attending a school with similar or stronger implementation of the nutrition components of the school wellness policies compared to other schools in the district.

CONCLUSIONS

A more active wellness committee was associated with lower BMI z‐scores in US schoolchildren. Active school engagement in wellness policy implementation appears to play a positive role in efforts to reduce childhood obesity.

     

Dengue vaccination during pregnancy – An overview of clinical trials data

BackgroundThe live, attenuated, tetravalent dengue vaccine (CYD-TDV) is licensed in several endemic countries and contraindicated during pregnancy. Inadvertent vaccination during pregnancy may occur during clinical trials that include women of childbearing age. The potential risk associated with dengue vaccination in pregnancy remains unknown. We describe pregnancy outcomes following inadvertent dengue vaccination in pregnancy from CYD-TDV trial data.MethodsData were collected from trials conducted as part of the CYD-TDV clinical development. Women who received CYD-TDV or placebo during the pre-specified pregnancy risk window (from 30 days before the date of their last menstrual period to end of pregnancy) were considered as exposed; pregnancies occurring in non-risk periods during the trials were considered to be non-exposed. Pregnancy losses were defined as abortion (spontaneous or unspecified), death in utero, and stillbirth.Results615 pregnancies were reported from 19 CYD-TDV trials: 404 in the CYD-TDV arm, and 211 in the placebo arm. Exposure could not be determined for 7 pregnancies (5, CYD-TDV; 2, placebo). In the CYD-TDV arm, 58 pregnancies were considered as exposed. Most of these (n = 47, 81%) had healthy live births; 6 (10.3%) had pregnancy losses; 3 underwent elective termination and 2 had unknown outcome. In the placebo group, 30 pregnancies were considered exposed. Most of these (n = 25, 83%) had healthy births; 4 (13.3%) had pregnancy losses; and 1 had elective termination. Among non-exposed pregnancies, most resulted in healthy live births; 23/341 (6.7%) in the CYD-TDV group and 17/179 (9.5%) in the placebo group had pregnancy losses. Most reported pregnancy losses were in women considered high-risk for adverse pregnancy outcome, primarily due to young age.ConclusionIn the small dataset assessed, no evidence of increased adverse pregnancy outcomes has been identified from inadvertent immunization of women in early pregnancy with CYD-TDV compared with the control group.     

Influenza vaccine effectiveness to prevent influenza-related hospitalizations and serious outcomes in Canadian adults over the 2011/12 through 2013/14 influenza seasons: A pooled analysis from the Canadian Immunization Research Network (CIRN) Serious Outcomes Surveillance (SOS Network)

BackgroundOngoing assessment of influenza vaccine effectiveness (VE) is critical to inform public health policy. This study aimed to determine the VE of trivalent influenza vaccine (TIV) for preventing influenza-related hospitalizations and other serious outcomes over three consecutive influenza seasons.MethodsThe Serious Outcomes Surveillance (SOS) Network of the Canadian Immunization Research Network (CIRN) conducted active surveillance for influenza in adults ≥16 years (y) of age during the 2011/2012, 2012/2013 and 2013/2014 seasons in hospitals across Canada. A test-negative design was employed: cases were polymerase chain reaction (PCR)-positive for influenza; controls were PCR-negative for influenza and were matched to cases by date, admission site, and age (≥65 y or <65 y). All cases and controls had demographic and clinical characteristics (including influenza immunization status) obtained from the medical record. VE was estimated as 1-OR (odds ratio) in vaccinated vs. unvaccinated patients × 100%. The primary outcome was VE of TIV for preventing laboratory-confirmed influenza-related hospitalization; secondary outcomes included VE of TIV for preventing influenza-related intensive care unit (ICU) admission/mechanical ventilation, and influenza-related death.ResultsOverall, 3394 cases and 4560 controls were enrolled; 2078 (61.2%) cases and 2939 (64.5%) controls were ≥65 y. Overall matched, adjusted VE was 41.7% (95% Confidence Interval (CI): 34.4–48.3%); corresponding VE in adults ≥65 y was 39.3% (95% CI: 29.4–47.8%) and 48.0% (95% CI: 37.5–56.7%) in adults <65 y, respectively. VE for preventing influenza-related ICU admission/mechanical ventilation in all ages was 54.1% (95% CI: 39.8–65.0%); in adults ≥65 y, VE for preventing influenza-related death was 74.5% (95% CI: 44.0–88.4%).ConclusionsWhile effectiveness of TIV to prevent serious outcomes varies year to year, we demonstrate a statistically significant and clinically important TIV VE for preventing hospitalization and other serious outcomes over three seasons. Public health messaging should highlight the overall benefit of influenza vaccines over time while acknowledging year to year variability.ClinicalTrials.gov Identifier: NCT01517191.     

Clinical Features,Treatment, and Visual Outcomes of Japanese Patients with Posterior Scleritis

ABSTRACT

Purpose: The purpose of this study is to describe clinical features and visual outcomes of Japanese patients with posterior scleritis.

Methods: Clinical records of 10 patients (13 eyes) presenting between 2006 and 2016 were retrospectively reviewed.

Results: The mean age was 50.1 ± 20.8 years; 50% were women, and three patients had bilateral disease. Associated anterior scleritis (11 eyes, 85%) and serous retinal detachment (8 eyes, 62%) were common at presentation. Treatment consisted of corticosteroids (all patients) and immunosuppressive agents (seven patients). The mean subfoveal choroidal thickness was significantly reduced over follow-up [611 μm at baseline, 298 μm (p < 0.01) at 1 month, and 238 μm (p < 0.01) at 1 year]. Recurrent inflammation was observed in six patients. A best-corrected visual acuity of 0.8 or better was achieved in all 13 eyes at 3 years and 71% of eyes at 5 years.

Conclusion: Although 60% of patients with posterior scleritis had recurrence, visual outcomes were favorable.     

Beyond intraocular pressure: Optimizing patient-reported outcomes in glaucoma

Glaucoma, an irreversible blinding condition affecting 3–4% adults aged above 40 years worldwide, is set to increase with a rapidly aging global population. Raised intraocular pressure (IOP) is a major risk factor for glaucoma where the treatment paradigm is focused on managing IOP using medications, laser, or surgery regimens. However, notwithstanding IOP and other clinical parameters, patient-reported outcomes, including daily functioning, emotional well-being, symptoms, mobility, and social life, remain the foremost concerns for people being treated for glaucoma. These outcomes are measured using objective patient-centered outcome measures (PCOMs) and subjective patient-reported outcome measures (PROMs). Studies using PCOMs have shown that people with glaucoma have several mobility, navigational and coordination challenges; reading and face recognition deficits; and are slower in adapting to multiple real-world situations when compared to healthy controls. Similarly, studies have consistently demonstrated, using PROMs, that glaucoma substantially and negatively impacts on peoples’ self-reported visual functioning, mobility, independence, emotional well-being, self-image, and confidence in healthcare, compared to healthy individuals, particularly in those with late-stage disease undergoing a heavy treatment regimen. The patient-centred effectiveness of current glaucoma treatment paradigms is equivocal due to a lack of well-designed randomized controlled trials; short post-treatment follow-up periods; an inappropriate selection or availability of PROMs; and/or an insensitivity of currently available PROMs to monitor changes especially in patients with newly diagnosed early-stage glaucoma. We provide a comprehensive, albeit non-systematic, critique of the psychometric properties, limitations, and recent advances of currently available glaucoma-specific PCOMs and PROMs. Finally, we propose that item banking and computerized adaptive testing methods can address the multiple limitations of paper-pencil PROMs; customize their administration; and have the potential to improve healthcare outcomes for people with glaucoma.     

Development of the Cystic Fibrosis Questionnaire-Revised-8 Dimensions: Estimating Utilities From the Cystic Fibrosis Questionnaire-Revised

ObjectivesCystic fibrosis (CF) limits survival and negatively affects health-related quality of life (HRQOL). Cost-effectiveness analysis (CEA) may be used to make reimbursement decisions for new CF treatments; nevertheless, generic utility measures used in CEA, such as EQ-5D, are insensitive to meaningful changes in lung function and HRQOL in CF. Here we develop a new, CF disease–specific, preference-based utility measure based on the adolescent/adult version of the Cystic Fibrosis Questionnaire-Revised (CFQ-R), a widely used, CF-specific, patient-reported measure of HRQOL.MethodsBlinded CFQ-R data from 4 clinical trials (NCT02347657, NCT02392234, NCT01807923, and NCT01807949) were used to identify discriminating items for a classification system using psychometric (eg, factor and Rasch) analyses. Thirty-two health states were selected for a time trade-off (TTO) exercise with a representative sample of the UK general population. TTO utilities were used to estimate a preference-based scoring algorithm by regression analysis (tobit models with robust standard errors clustered on participants with censoring at −1).ResultsA classification system with 8 dimensions (CFQ-R-8 dimensions; physical functioning, vitality, emotion, role functioning, breathing difficulty, cough, abdominal pain, and body image) was generated. TTO was completed by 400 participants (mean age, 47.3 years; 49.8% female). Among the regression models evaluated, the tobit heteroscedastic–ordered model was preferred, with a predicted utility range from 0.236 to 1, no logical inconsistencies, and a mean absolute error of 0.032.ConclusionThe CFQ-R-8 dimensions is the first disease-specific, preference-based scoring algorithm for CF, enabling estimation of disease-specific utilities for CEA based on the well-validated and widely used CFQ-R.     

A Review of Labeling Based on Patient-Reported Outcome Endpoints for New Oncology Drugs Approved by the European Medicines Agency (2017-2021)

ObjectiveA review of new oncology indications approved by the European Medicines Agency (EMA) for 2012-2016 showed that 33% of new drugs had labeling based on patient-reported outcomes (PROs). We reviewed labeling text based on PRO endpoints for new oncology indications approved during 2017-2021.MethodsNew oncology drugs approved by EMA to treat indications of cancers during 2017-2021 were identified from the EMA website. PRO-related language reported in EMA summaries of product characteristics (SmPCs) were summarized and compared with similar findings reported for oncology indications approved during 2012-2016.ResultsReview documents by the EMA during 2017-2021 were available for 49 new oncology drugs for 70 cancer indications. Submissions for 52 (74.3%) of the 70 indications included PRO data for EMA review. Of all submissions, 14 (20.0%) approvals contained PRO-related language in the SmPC. Broad concepts such as health-related quality of life were most common and found in 8 of 14 (57.1%) PRO-related labels.ConclusionPRO-related language appeared in SmPCs for 20% of all indications of new oncology drugs approved by EMA during 2017-2021 compared with approximately 33% of EMA approvals during 2012-2016. PRO-related labeling during the same periods showed a greater decline (from 47% to 27%) for indications of new oncology drugs that also included PRO data. One possible reason for this decline may be the increase in open-label studies from 62% between 2012 and 2016 to approximately 79% between 2017 and 2021.     

299例孕妇胎心监护无负荷试验中Ⅴ型减速波形的临床分析

目的:探讨孕妇胎心监护无负荷试验中V型减速与脐带、羊水及围生儿结局的关系。方法:运用临床资料收集的方法,回顾性总结增城市妇幼保健院2006年1月～2009年10月在该院分娩产妇临产前的胎心监护记录,出现V型减速299例(A组),未出现V型减速的产妇13600例(B组),将两组临床资料进行比较。结果:无负荷试验中V型减速的发生率为2.20%。临产前无负荷试验中出现V型减速的产妇中,各种脐带异常发生率为72.58%,羊水过少发生率为25.75%,羊水Ⅲ度污染发生率为13.38%,胎儿窘迫和新生儿窒息发生率分别为41.81%和10.70%,均显著高于未出现该减速的产妇。结论:临产前无负荷试验出现V型减速的产妇应警惕合并脐带异常和羊水异常,严密监测,及时识别,以防止发生胎儿窘迫和胎死宫内,从而降低围生儿的死亡率。     

On the conditional logistic estimator in two‐arm experimental studies with non‐compliance and before–after binary outcomes

The behavior of the conditional logistic estimator is analyzed under a causal model for two‐arm experimental studies with possible non‐compliance in which the effect of the treatment is measured by a binary response variable. We show that, when non‐compliance may only be observed in the treatment arm, the effect (measured on the logit scale) of the treatment on compliers and that of the control on non‐compliers can be identified and consistently estimated under mild conditions. The same does not happen for the effect of the control on compliers. A simple correction of the conditional logistic estimator is then proposed, which allows us to considerably reduce the bias in estimating this quantity and the causal effect of the treatment over control on compliers. A two‐step estimator results on the basis of which we can also set up a Wald test for the hypothesis of absence of a causal effect of the treatment. The asymptotic properties of the estimator are studied by exploiting the general theory on maximum likelihood estimation of misspecified models. Finite‐sample properties of the estimator and of the related Wald test are studied by simulation. The extension of the approach to the case of missing responses is also outlined. The approach is illustrated by an application to a dataset deriving from a study on the efficacy of a training course on the breast self examination practice. Copyright © 2010 John Wiley & Sons, Ltd.