The ethics of child maltreatment surveys in relation to participant distress: Implications of social science evidence, ethical guidelines, and law.

Epidemiological surveys measuring the prevalence of child maltreatment generate essential knowledge that is required to enhance human rights, promote gender equality, and reduce child abuse and neglect and its effects. Yet, evidence suggests Institutional Review Boards (IRBs) may assess the risk of these studies using higher than normal thresholds, based on a perception they may cause high distress to participants. It is essential for IRBs and researchers to have an accurate understanding of the nature and extent of participant distress associated with these studies, and of the duties of researchers towards survey participants, so that meritorious research is endorsed and duties to participants discharged. Assessment by IRBs of the ethics of such research must be appropriately informed by scientific evidence, ethical principles, and legal requirements. This article adds to knowledge by considering participant distress in child maltreatment surveys and its appropriate ethical and operational treatment. We provide an updated overview of scientific evidence of the frequency and severity of distress in studies of child maltreatment, a review of ethical requirements including a focus on beneficence and participant welfare, and a new analysis of researchers' legal duties towards participants. Our analyses demonstrate that participant distress is infrequent and transitory, that researchers can satisfy ethical requirements towards participants, and that legal liability does not extend to emotional distress. Informed by these bodies of knowledge, we distil key principles of good epidemiological practice to provide solutions to operational requirements in these surveys, which both fulfil ethical requirements to participants, and demonstrate trauma-informed practice.

Global Disability Burdens of Diabetes-Related Lower-Extremity Complications in 1990 and 2016.

OBJECTIVE: No study has reported global disability burden estimates for individual diabetes-related lower-extremity complications (DRLECs). The Global Burden of Disease (GBD) study presents a robust opportunity to address this gap. RESEARCH DESIGN AND METHODS: GBD 2016 data, including prevalence and years lived with disability (YLDs), for the DRLECs of diabetic neuropathy, foot ulcer, and amputation with and without prosthesis were used. The GBD estimated prevalence using data from systematic reviews and DisMod-MR 2.1, a Bayesian meta-regression tool. YLDs were estimated as the product of prevalence estimates and disability weights for each DRLEC. We reported global and sex-, age-, region-, and country-specific estimates for each DRLEC for 1990 and 2016. RESULTS: In 2016, an estimated 131 million people (1.8% of the global population) had DRLECs. An estimated 16.8 million YLDs (2.1% global YLDs) were caused by DRLECs, including 12.9 million (95% uncertainty interval 8.30-18.8) from neuropathy only, 2.5 million (1.7-3.6) from foot ulcers, 1.1 million (0.7-1.4) from amputation without prosthesis, and 0.4 million (0.3-0.5) from amputation with prosthesis. Age-standardized YLD rates of all DRLECs increased by between 14.6% and 31.0% from 1990 estimates. Male-to-female YLD ratios ranged from 0.96 for neuropathy only to 1.93 for foot ulcers. The 50- to 69-year-old age-group accounted for 47.8% of all YLDs from DRLECs. CONCLUSIONS: These first-ever global estimates suggest that DRLECs are a large and growing contributor to the disability burden worldwide and disproportionately affect males and middle- to older-aged populations. These findings should facilitate policy makers worldwide to target strategies at populations disproportionately affected by DRLECs.

Comparison of EQ-5D-5L and SPVU-5D for measuring quality of life in patients with venous leg ulcers in an Australian setting.

PURPOSE: Given the importance of measuring health-related quality of life (HRQoL) for cost-utility studies, this study aimed to determine the validity and responsiveness of two preference-based HRQoL instruments, the EuroQol-five dimensions-five levels questionnaire (EQ-5D-5L) and the Sheffield Preference-based Venous Ulcer questionnaire (SPVU-5D) in patients with venous leg ulcers (VLUs) in an Australian setting. METHODS: This study analysed de-identified data collected from 80 patients with VLUs recruited by a prospective study in Brisbane, Queensland, Australia. Patients were asked to complete EQ-5D-5L and SPVU-5D surveys at baseline, 1-month, 3-month and 6-month follow-up as part of the prospective study. Baseline data and follow-up data were pooled to test the construct validity and level of agreement of the two instruments. Follow-up data were used to test the responsiveness. RESULTS: The ceiling effects were negligible for EQ-5D-5L and SPVU-5D utility scores. Both instruments were able to discriminate between healed VLU and unhealed VLU and showed great responsiveness when healing status changed over time. Weak to strong correlations were found between dimensions of EQ-5D-5L and SPVU-5D. The utility scores produced from EQ-5D-5L were generally lower. CONCLUSIONS: This study found that both EQ-5D-5L and SPVU-5D were valid and responsive in detecting change of VLU healing status among a small Australian population. Both instruments may be used in economic evaluation studies that involve patients with healed or unhealed VLUs. However, given the limitations presented in this study, further research is necessary to make sound recommendations on the preferred instrument in economic evaluation of VLU-related interventions.

Using the best available data to estimate the cost of antimicrobial resistance: a systematic review.

Background: Valuation of the economic cost of antimicrobial resistance (AMR) is important for decision making and should be estimated accurately. Highly variable or erroneous estimates may alarm policy makers and hospital administrators to act, but they also create confusion as to what the most reliable estimates are and how these should be assessed. This study aimed to assess the quality of methods used in studies that quantify the costs of AMR and to determine the best available evidence of the incremental cost of these infections. Methods: In this systematic review, we searched PubMed, Embase, Cinahl, Cochrane databases and grey literature sources published between January 2012 and October 2016. Articles reporting the additional burden of Enterococcus spp., Escherichia coli (E. coli), Klebsiella pneumoniae (K. pneumoniae), Pseudomonas aeruginosa (P. aeruginosa) and Staphylococcus aureus (S. aureus) resistant versus susceptible infections were sourced. The included studies were broadly classified as reporting oncosts from the healthcare/hospital/hospital charges perspective or societal perspective. Risk of bias was assessed based on three methodological components: (1) adjustment for length of stay prior to infection onset and consideration of time-dependent bias, (2) adjustment for comorbidities or severity of disease, and (3) adjustment for inappropriate antibiotic therapy. Results: Of 1094 identified studies, we identified 12 peer-reviewed articles and two reports that quantified the economic burden of clinically important resistant infections. Two studies used multi-state modelling to account for the timing of infection minimising the risk of time dependent bias and these were considered to generate the best available cost estimates. Studies report an additional CHF 9473 per extended-spectrum beta-lactamases -resistant Enterobacteriaceae bloodstream infections (BSI); additional €3200 per third-generation cephalosporin resistant Enterobacteriaceae BSI; and additional €1600 per methicillin-resistant S. aureus (MRSA) BSI. The remaining studies either partially adjusted or did not consider the timing of infection in their analysis. Conclusions: Implementation of AMR policy and decision-making should be guided only by reliable, unbiased estimates of effect size. Generating these estimates requires a thorough understanding of important biases and their impact on measured outcomes. This will ensure that researchers, clinicians, and other key decision makers concerned with increasing public health threat of AMR are accurately guided by the best available evidence.

A systematic review: Impact of endocrine disrupting chemicals exposure on fecundity as measured by time to pregnancy.

BACKGROUND: Emerging scientific evidence suggests that exposure to environmental pollutants is associated with negative effects on fecundity as measured by time to pregnancy (TTP). OBJECTIVES: To conduct a systematic review of the literature on the association between selected endocrine disrupting chemicals (EDCs), and fecundity as measured by TTP in humans. Compounds included in this review are: brominated flame retardants (BFRs) such as hexabromocyclododecane, tetrabromobiphenol A and polybrominated diphenyl ethers; organophosphates flame retardants (OPFRs); and phthalates. METHODS: Scopus, MEDLINE via Ebscohost and EMBASE databases were searched for articles exploring the relationships between selected EDCs and fecundity as measured by time to pregnancy. We assessed the quality of included studies and evidence for causality was graded using the criteria developed by the World Cancer Research Fund. RESULTS: 14 studies of 191 full-text articles assessed for eligibility were included for qualitative synthesis. Five studies examined BFRs and 10 studies examined phthalates. Among the fourteen, one study assessed both BFRs and phthalates. There were no studies which investigated fecundity as measured by TTP on HBCD, TBBPA, or OPFRs. We recorded plausible fecundity outcomes as measured by TTP related to some of these EDCs. BFRs or phthalates increased TTP. However, results were inconsistent. CONCLUSION: We recorded mostly weak associations between exposure to selected EDCs and fecundity. However, evidence was considered limited to conclude a causal relationship due to inconsistency of results. The health risks posed by these chemicals in exposed populations are only beginning to be recognized and prospective measurement of the environmental effects of the chemicals in large cohort studies are urgently needed to confirm these relationships and inform policies aimed at exposure prevention.

Health benefits of an innovative model of care for chronic wounds patients in Queensland.

Wound management in Australia suffers from a lack of adequate coordination and communication between sectors that impacts patient outcomes and costs. Wound Innovations is a specialist service comprising of a transdisciplinary team that aims to streamline and improve patient care and outcomes. We compared patient experiences and outcomes prior to accessing this specialist service, and the 3 months following their enrolment at the clinic. Information on patient experiences, wound history, and outcomes was collected through interviews and a review of medical records for the 12 months prior to enrolment at the clinic. Wound progress, quality of life (QoL) outcomes, and service use were tracked during the 3-month prospective phase. A sample of 29 participants was recruited. 40% healed completely by 3 months, with the average time to healing being 8 weeks. The average QoL score at baseline was 0.69 (from a score of 1, being best health imaginable). At 3 months, the average QoL score increased significantly to 0.84 (P ≤0.001). On average, participants attended the clinic 4.6 times. The average decrease in wound size was 85.4% (95% CI [75.7%, 95%]). Accessing wound care treatment at a specialist, multidisciplinary wound clinic leads to an increase in QoL and access to consistent evidence-based practices.

Economic Evaluations of Guideline-Based Care for Chronic Wounds: a Systematic Review.

OBJECTIVES: The aim of this study was to review all published economic evaluations of guideline-based care for chronic wounds and to assess how useful these studies are for decision making in health services. METHODS: Embase, PubMed, Scopus, Health Technology Assessment (HTA) and National Health Service Economic Evaluation Database (NHS EED) were searched on April 16th, 2018. We included studies that evaluated the economic impact and health outcomes associated with implementing evidence-based guidelines as a bundle of care for the prevention and/or treatment of chronic wounds. Information was extracted from each eligible study and organized by the type of chronic wound. The quality of published economic evaluation studies was assessed using the Consolidated Health Economic Evaluation Reporting Standards (CHEERS). RESULTS: A total of 24 economic evaluation studies met the inclusion criteria, of which 12 applied decision analytic models. The compliance with the CHEERS checklist ranged between 43 and 83%. LIMITATIONS: We may have missed some economic evaluation studies despite the use of broad search terms. The quality assessment was conducted based on judgment. Using the CHEERS checklist may reflect the way evaluations were reported rather than conducted. CONCLUSIONS AND IMPLICATIONS OF KEY FINDINGS: We found that guideline-based care may be cost-saving or cost-effective in most circumstances. The quality and usefulness of reviewed studies for decision making were variable. Better information and higher-quality economic evaluations will increase decision makers' confidence to promote guideline-based care. SYSTEMATIC REVIEW REGISTRATION NUMBER: PROSPERO CRD42017051859.

Cost-effectiveness analysis of guideline-based optimal care for venous leg ulcers in Australia.

BACKGROUND: Venous leg ulcers (VLUs) are expensive to treat and impair quality of life of affected individuals. Although improved healing and reduced recurrence rates have been observed following the introduction of evidence-based guidelines, a significant evidence-practice gap exists. Compression is the recommended first-line therapy for treatment of VLUs but unlike many other developed countries, the Australian health system does not subsidise compression therapy. The objective of this study is to estimate the cost-effectiveness of guideline-based care for VLUs that includes public sector reimbursement for compression therapy for affected individuals in Australia. METHODS: A Markov model was designed to simulate the progression of VLU for patients receiving guideline-based optimal prevention and treatment, with reimbursement for compression therapy, and then compared to usual care in each State and Territory in Australia. Model inputs were derived from published literature, expert opinion, and government documents. The primary outcomes were changes to costs and health outcomes from a decision to implement guideline-based optimal care compared with the continuation of usual care. Sensitivity analyses were performed to test the robustness of model results. RESULTS: Guideline-based optimal care incurred lower total costs and improved quality of life of patients in all States and Territories in Australia regardless of the health service provider. We estimated that providing compression therapy products to affected individuals would cost the health system an additional AUD 270 million over 5 years but would result in cost savings of about AUD 1.4 billion to the health system over the same period. An evaluation of unfavourable values for key model parameters revealed a wide margin of confidence to support the findings. CONCLUSIONS: This study shows that guideline-based optimal care would be a cost-effective and cost-saving strategy to manage VLUs in Australia. Results from this study support wider adoption of guideline-based care for VLUs and the reimbursement of compression therapy. Other countries that face similar issues may benefit from investing in guideline-based wound care.