Corrigendum: A systematic review and economic evaluation of bisphosphonates for the prevention of fragility fractures

Abstract Background Fragility fractures are fractures that result from mechanical forces that would not ordinarily result in fracture. Objectives To evaluate the clinical effectiveness and safety of bisphosphonates [alendronic acid (Fosamax® and Fosamax® Once Weekly, Merck Sharp & Dohme Ltd), risedronic acid (Actonel® and Actonel Once a Week®, Warner Chilcott UK Ltd), ibandronic acid (Bonviva®, Roche Products Ltd) and zoledronic acid (Aclasta®, Novartis Pharmaceuticals UK Ltd)] for the prevention of fragility fracture and to assess their cost-effectiveness at varying levels of fracture risk. Data sources For the clinical effectiveness review, six electronic databases and two trial registries were searched: MEDLINE, EMBASE, The Cochrane Library, Cumulative Index to Nursing and Allied Health Literature, Web of Science and BIOSIS Previews, Clinicaltrials.gov and World Health Organization International Clinical Trials Registry Platform. Searches were limited by date from 2008 until September 2014. Review methods A systematic review and network meta-analysis (NMA) of effectiveness studies were conducted. A review of published economic analyses was undertaken and a de novo health economic model was constructed. Discrete event simulation was used to estimate lifetime costs and quality-adjusted life-years (QALYs) for each bisphosphonate treatment strategy and a strategy of no treatment for a simulated cohort of patients with heterogeneous characteristics. The model was populated with effectiveness evidence from the systematic review and NMA. All other parameters were estimated from published sources. A NHS and Personal Social Services perspective was taken, and costs and benefits were discounted at 3.5% per annum. Fracture risk was estimated from patient characteristics using the QFracture® (QFracture-2012 open source revision 38, Clinrisk Ltd, Leeds, UK) and FRAX® (web version 3.9, University of Sheffield, Sheffield, UK) tools. The relationship between fracture risk and incremental net benefit (INB) was estimated using non-parametric regression. Probabilistic sensitivity analysis (PSA) and scenario analyses were used to assess uncertainty. Results Forty-six randomised controlled trials (RCTs) were included in the clinical effectiveness systematic review, with 27 RCTs providing data for the fracture NMA and 35 RCTs providing data for the femoral neck bone mineral density (BMD) NMA. All treatments had beneficial effects on fractures versus placebo, with hazard ratios varying from 0.41 to 0.92 depending on treatment and fracture type. The effects on vertebral fractures and percentage change in BMD were statistically significant for all treatments. There was no evidence of a difference in effect on fractures between bisphosphonates. A statistically significant difference in the incidence of influenza-like symptoms was identified from the RCTs for zoledronic acid compared with placebo. Reviews of observational studies suggest that upper gastrointestinal symptoms are frequently reported in the first month of oral bisphosphonate treatment, but pooled analyses of placebo-controlled trials found no statistically significant difference. A strategy of no treatment was estimated to have the maximum INB for patients with a 10-year QFracture risk under 1.5%, whereas oral bisphosphonates provided maximum INB at higher levels of risk. However, the PSA suggested that there is considerable uncertainty regarding whether or not no treatment is the optimal strategy until the QFracture score is around 5.5%. In the model using FRAX, the mean INBs were positive for all oral bisphosphonate treatments across all risk categories. Intravenous bisphosphonates were estimated to have lower INBs than oral bisphosphonates across all levels of fracture risk when estimated using either QFracture or FRAX. Limitations We assumed that all treatment strategies are viable alternatives across the whole population. Conclusions Bisphosphonates are effective in preventing fragility fractures. However, the benefit-to-risk ratio in the lowest-risk patients may be debatable given the low absolute QALY gains and the potential for adverse events. We plan to extend the analysis to include non-bisphosphonate therapies. Study registration This study is registered as PROSPERO CRD42013006883. Funding The National Institute for Health Research Health Technology Assessment programme

The Complex Relationship between Body and Mind as a Key for a Renewed Catholic Reflection on Diaconal Work

status: publishe

Documenting social determinants of health-related clinical activities using standardized medical vocabularies

Objectives:Growing recognition that health is shaped by social and economic circumstances has resulted in a rapidly expanding set of clinical activities related to identifying, diagnosing, and intervening around patients' social risks in the context of health care delivery. The objective of this exploratory analysis was to identify existing documentation tools in common US medical coding systems reflecting these emerging clinical practices to improve patients' social health. Materials and Methods:We identified 20 social determinants of health (SDH)-related domains used in 6 published social health assessment tools. We then used medical vocabulary search engines to conduct three independent searches for codes related to these 20 domains included in common medical coding systems (LOINC, SNOMED CT, ICD-10-CM, and CPT). Each of the 3 searches focused on one of three clinical activities: Screening, Assessment/Diagnosis, and Treatment/Intervention. Results:We found at least 1 social Screening code for 18 of the 20 SDH domains, 686 social risk Assessment/Diagnosis codes, and 243 Treatment/Intervention codes. Fourteen SDH domains (70%) had codes across all 3 clinical activity areas. Discussion:Our exploratory analysis revealed 1095 existing codes in common medical coding vocabularies that can facilitate documentation of social health-related clinical activities. Despite a large absolute number of codes, there are addressable gaps in the capacity of current medical vocabularies to document specific social risk factor screening, diagnosis, and interventions activities. Conclusions:Findings from this analysis should help inform efforts both to develop a comprehensive set of SDH codes and ultimately to improve documentation of SDH-related activities in clinical settings

Communicating migration – Pope Francis’ strategy of reframing refugee issues

One of the most frequent topics in Pope Francis’ public interventions, either orally or in writing, regards refugees and migrants. His teachings speak about a humble Church on a mission to assist the poor and those on the peripheries, and refugees and migrants occupy the center: they are the core and trademark of Francis’ pontificate. This reality, however, is not a mere coincidence neither is it caused by improvisation. Since his trip to Lampedusa in 2013—the first of his pontificate—Francis has shown he has a strategy for the refugee and migrant issue. He is consistent and has a well-prepared message. He wants the Catholic Church to be a key player in the international arena, through the Vatican Dicastery for Integral Human Development (created by Pope Francis himself) to raise awareness of this issue and to persuade countries, supranational institutions, and public opinion in general, to contribute to finding and providing solutions. This article aims to describe the communication strategy of Pope Francis on migrants and refugees; to show how his efforts are reframing this issue; and, finally, to illustrate with examples how those working closely with the Pope are implementing it