Targeted literature review of current treatments and unmet need in moderate rheumatoid arthritis in the United Kingdom.

OBJECTIVES: The burden and treatment landscape of RA is poorly understood. This research aimed to identify evidence on quality of life, caregiver burden, economic burden, treatment patterns and clinical outcomes for patients with moderate RA in the United Kingdom. METHODS: A systematic literature review was performed across multiple databases and screened against pre-defined inclusion criteria. RESULTS: A total of 2610 records were screened; seven studies presenting evidence for moderate RA were included. These patients were found to incur substantial burden, with moderate to severe levels of disability. Compared with patients in remission, moderate RA patients reported higher levels of disability and decreased EQ-5D utility scores. The majority of patients did not feel that their current therapy adequately controlled their disease or provided sufficient symptom relief. In the United Kingdom, the National Institute for Health and Care Excellence (NICE) have not approved advanced therapies (such as biological disease-modifying anti-rheumatic drugs) for patients with moderate disease, which restricts access for these patients. CONCLUSION: The evidence available on the burden of moderate RA is limited. Despite current treatments, moderate RA still has a substantial negative impact, given that a DAS28 disease activity score defined as being in the moderate range does not qualify them for access to advanced therapies in the United Kingdom. For these patients, there is a particular need for further studies that investigate their burden and the impact of treating them earlier. Such information would help guide future treatment decisions and ensure the most effective use of resources to gain the best outcomes for patients with moderate RA.

The Suitability of End Point Designs for Health Technology Assessment in Chronic Pain Studies.

OBJECTIVES: To identify the pain instruments and study end points most commonly used in clinical trial settings and to provide insight into the extent to which outcome measures in clinical studies are meeting payer needs. METHODS: A literature review was conducted to identify published clinical studies and ongoing/recently completed registered trials in chronic pain. Inclusion criteria were interventional study, chronic pain in adults, and pain measured within the primary end point. RESULTS: Of 1256 PubMed citations and 3006 clinical trial registry entries, 356 reported large clinical studies in pain populations (e.g., malignant, neuropathic, functional, and musculoskeletal). Studies were designed for superiority in 28% of PubMed citations and 8% of registry entries. The primary end points of most studies were single-dimension pain instruments, such as the numerical rating scale (n = 131) and the visual analogue scale (n = 69). In cases in which multidimensional pain end points were used, this was most commonly the Brief Pain Inventory (n = 37). Payer-relevant end points were typically limited to secondary end points, and were limited and/or reported inconsistently in published studies and ongoing/recently completed studies: preference-weighted quality of life (36% and 42%), resource use (2% and 8%), physical function (28% and 39%), and psychological function (25% and 24%). CONCLUSIONS: Most pain trials were not designed to show superiority to an active comparator, and they used single-dimension pain scales as their primary end point in combination with a broader selection of secondary end points. The inclusion of payer-relevant end points among clinical trials was inconsistent.

Burden of paediatric influenza in Western Europe: a systematic review.

BACKGROUND: Influenza illness in children causes significant clinical and economic burden. Although some European countries have adopted influenza immunisation policies for healthy children, the debate about paediatric influenza vaccination in most countries of the European Union is ongoing. Our aim was to summarise influenza burden (in terms of health outcomes and economic burden) in children in Western Europe via a systematic literature review. METHODS: We conducted a systematic literature search of PubMed, EMBASE, and the Cochrane Library (1970-April 2011) and extracted data on influenza burden in children (defined as aged ≤ 18 years) from 50 publications (13 reporting laboratory-confirmed influenza; 37 reporting influenza-like illness). RESULTS: Children with laboratory-confirmed influenza experienced hospitalisations (0.3%-20%), medical visits (1.7-2.8 visits per case), antibiotic prescriptions (7%-55%), and antipyretic or other medications for symptomatic relief (76%-99%); young children and those with severe illness had the highest rates of health care use. Influenza in children also led to absenteeism from day care, school, or work for the children, their siblings, and their parents. Average (mean or median) length of absence from school or day care associated with confirmed influenza ranged from 2.8 to 12.0 days for the children, from 1.3 to 6.0 days for their siblings, and from 1.3 to 6.3 days for their parents. Influenza negatively affected health-related quality of life in children with asthma, including symptoms and activities; this negative effect was smaller in vaccinated children than in non-vaccinated children. CONCLUSIONS: Influenza burden in children is substantial and has a significant direct impact on the ill children and an indirect impact on their siblings and parents. The identified evidence regarding the burden of influenza may help inform both influenza antiviral use in children and paediatric immunisation policies in European countries.

Using Social Media to Collect Dietary Information for Public Health Policy.

There is no regular, routine measurement of food and nutrient intake regionally in the UK. Our goal was to identify a method to support policy makers tracking the local population food intakes. The aim of this study was to test the feasibility of using social media to obtain a large sample in a short time, with a regional focus; collecting dietary information using online tools. A Facebook (FB) boost approach was used to recruit a regional (Yorkshire and Humberside) sample of adults to complete a brief online survey followed by a detailed measure of food and nutrient intakes for the previous day using myfood24®. The FB posts were boosted for 21 days and reached 76.9 k individuals. 1428 participants completed the main questionnaire and 673 participants completed the diet diary. The majority of respondents were older women. 22% of respondents reported experiencing moderate food insecurity during 2021. Overall nutrient values recorded were similar to national survey data. Intakes of fibre and iron were low. Despite some challenges, this study has demonstrated the potential to use social media, in this case Facebook, to recruit a large sample in a short timeframe. Participants were able to use online tools to report food and nutrient intakes. This data is relevant to local and national policy makers to monitor and evaluate public health programmes.

Dietary risk factors for hip fracture in adults: An umbrella review of meta-analyses of prospective cohort studies.

AIM: To summarise the totality of evidence regarding dietary risk factors for hip fracture in adults, evaluating the quality of evidence, to provide recommendations for practice and further research. DESIGN: Systematic review of meta-analyses of prospective cohort studies. ELIGIBILITY CRITERIA: Systematic reviews with meta-analyses reporting summary risk estimates for associations between hip fracture incidence and dietary exposures including oral intake of a food, food group, beverage, or nutrient, or adherence to dietary patterns. INFORMATION SOURCES: Medline, Embase, Web of Science, and the Cochrane Library from inception until November 2020. DATA SYNTHESIS: The methodological quality of systematic reviews and meta-analyses was assessed using AMSTAR-2, and the quality of evidence for each association was assessed using GRADE. Results were synthesised descriptively. RESULTS: Sixteen systematic reviews were identified, covering thirty-four exposures, including dietary patterns (n = 2 meta-analyses), foods, food groups, or beverages (n = 16), macronutrients (n = 3), and micronutrients (n = 13). Identified meta-analyses included 6,282 to 3,730,424 participants with between 322 and 26,168 hip fractures. The methodological quality (AMSTAR-2) of all systematic reviews was low or critically low. The quality of evidence (GRADE) was low for an inverse association between hip fracture incidence and intake of fruits and vegetables combined (adjusted summary relative risk for higher vs lower intakes: 0.92 [95% confidence interval: 0.87 to 0.98]), and very low for the remaining thirty-three exposures. CONCLUSION: Dietary factors may play a role in the primary prevention of hip fracture, but the methodological quality of systematic reviews and meta-analyses was below international standards, and there was a lack of high-quality evidence. More long-term cohort studies reporting absolute risks and robust, well-conducted meta-analyses with dose-response information are needed before policy guidelines can be formed. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42020226190.

Disease Burden in the Treatment of Age-Related Macular Degeneration: Findings From a Time-and-Motion Study.

PURPOSE: To examine the time burden of managing neovascular age-related macular degeneration (AMD) imposed on physicians, staff, patients, and caregivers. DESIGN: Mixed-methods, prospective, observational time-and-motion study. METHODS: The multicenter study was conducted from March 2011 through August 2012. Retina specialists administering ≥50 vascular endothelial growth factor (VEGF)-inhibitor injections monthly were surveyed and completed records for ≥5 patients scheduled for office visits within 3 weeks for anti-VEGF injection or monitoring. A survey was administered to 75 neovascular AMD patients aged ≥50 years who received ≥1 anti-VEGF injection in the past 6 months. Telephone interviews were conducted with 13 neovascular AMD patient caregivers. RESULTS: Fifty-six physicians provided data for 221 patients with neovascular AMD. Patients accounted for 20% of the health care staff's time per week, with an average of 23 staff members. An average patient visit for neovascular AMD was 90 minutes (range: 13 minutes to >4 hours). Patients reported an average time per visit of almost 12 hours, including preappointment preparation (16 minutes), travel (66 minutes), waiting time (37 minutes), treatment time (43 minutes), and postappointment recovery (9 hours). Patients stated that caregivers took time away from work (22%) and personal activities (28%) to provide transportation to appointments. CONCLUSIONS: Neovascular AMD management imposes a substantial time burden on physicians, staff, patients, and caregivers. There may be a need for additional support and/or reimbursement for services required by patients and caregivers and provided by physicians.

A systematic literature review of utility weights in wet age-related macular degeneration.

OBJECTIVE: The objective of the study was to conduct a systematic review of utility weight estimates relevant to economic models for wet age-related macular degeneration (wAMD). METHODS: A systematic literature search of PubMed, Embase, the Cochrane Library, and EconLit was performed (January 1995-December 2010) and then updated (October 2010-May 2012; February 2012-July 2013) identifying articles reporting utilities in patients with wAMD and visual impairment. Extracted studies were also assessed for compliance with the NICE reference case. RESULTS: Of 2415 articles identified from the searches, 212 articles were reviewed in full, and 17 selected for data extraction. Most studies used time trade-off (TTO) techniques to estimate utilities; other methods included standard gamble, EuroQoL Health Questionnaire 5 Dimensions (EQ-5D); Short-Form 6D Health Status Questionnaire (SF-6D); and Health Utilities Index Mark III (HUI3). Correlation between utility estimates and visual acuity (VA) differed between the instruments. Time trade-off methods were more sensitive to VA changes than standard gamble methods. HUI3 estimates were most highly correlated with VA changes, followed by TTO; no trend was observed between VA and EQ-5D or SF-6D utility weights. Six of the 17 studies complied with the NICE reference case. CONCLUSIONS: Several instruments have been used to elicit utilities from patients with wAMD. Because TTO methods were more sensitive to VA changes than standard gamble and HUI3 estimates were most highly correlated with VA changes, TTO and HUI3 may be suitable methods for economic evaluations in these patients. The EQ-5D and SF-6D were poor indicators of the impact of VA on HRQL.

Epidemiology of chronic obstructive pulmonary disease: a literature review.

The aim of this study is to quantify the burden of chronic obstructive pulmonary disease (COPD)--incidence, prevalence, and mortality--and identify trends in Australia, Canada, France, Germany, Italy, Japan, The Netherlands, Spain, Sweden, the United Kingdom, and the United States of America. A structured literature search was performed (January 2000 to September 2010) of PubMed and EMBASE, identifying English-language articles reporting COPD prevalence, incidence, or mortality. Of 2838 articles identified, 299 full-text articles were reviewed, and data were extracted from 133 publications. Prevalence data were extracted from 80 articles, incidence data from 15 articles, and mortality data from 58 articles. Prevalence ranged from 0.2%-37%, but varied widely across countries and populations, and by COPD diagnosis and classification methods. Prevalence and incidence were greatest in men and those aged 75 years and older. Mortality ranged from 3-111 deaths per 100,000 population. Mortality increased in the last 30-40 years; more recently, mortality decreased in men in several countries, while increasing or stabilizing in women. Although COPD mortality increased over time, rates declined more recently, likely indicating improvements in COPD management. In many countries, COPD mortality has increased in women but decreased in men. This may be explained by differences in smoking patterns and a greater vulnerability in women to the adverse effects of smoking.

Clinical burden and incremental cost of fractures in postmenopausal women in the United Kingdom.

This cohort study of postmenopausal women in the United Kingdom aged ≥50years determined the incremental cost of health care and clinical outcomes in the 12months following incident, selected fractures (non-vertebral non-hip [NVNHF], vertebral [VF] and multiple [MF]). Incremental costs and outcomes of the fracture cohorts were compared with those of cohorts comprised of women without fractures who were individually matched on age and comorbidity. Cohorts were identified from The Health Improvement Network database, a primary health care database, from 2001 to 2005. We estimated 1-year incremental costs (hospitalizations; general practice, accident/emergency, and referral visits; and prescription medications) associated with each fracture type. Descriptive analyses examined occurrence of subsequent fractures and death. No long-term health care costs or outcomes were assessed. Overall, 14,030 women had NVNHF, 1471 had VF, and 193 had MF. The risk of death was greater for women with fractures than for women in the non-fracture cohorts. Mean incremental cost for fractures compared with no fractures was £1152 for VF; £690 for NVNHF, and £2581 for MF. Of the total incremental cost, hospitalizations represented 54%-90% and medications represented 7%-29%. In all fracture cohorts, most of the total annual costs were concentrated in the 6months after the date of fracture. Fractures among postmenopausal women represent an important burden to the health system due to the increase in health resource utilization and related costs. In this study, hospitalizations were the main driver of the overall incremental cost during the 12months following the fracture. Mortality in women in the selected fracture cohorts was higher than in women in the non-fracture cohorts.

Study of the incremental cost and clinical burden of hip fractures in postmenopausal women in the United Kingdom.

OBJECTIVE: To determine the incremental cost of healthcare and clinical outcomes in the 12 months following incident hip fractures among postmenopausal women in the UK. METHODS: Retrospective cohort study of women aged 50 years or older hospitalized for an incident hip fracture within 1 week of the fracture date who were age- and comorbidity-matched to women without fracture. Cohorts were identified in the Health Improvement Network database, and followed up for 1 year. RESULTS: Among 2,427 women who had a hip fracture and a recorded hospitalization, the mean [SD] age was 81 [9.3] years. About 18% of women without fractures were hospitalized during follow-up and 18% of women with hip fractures and 4% of women without fractures had at least one emergency admission (RR, 4.7; 95% CI, 3.8-5.8). There were no major differences in use of general practitioner visit, referral visits, or in prescription of medications. Mortality was 18% in the hip fracture cohort and 7% in the non-fracture cohort (RR, 2.5; 95% CI, 2.1-3.0). The overall 1-year mean incremental cost of hip fractures was £4,222 (95% CI, £4,105-4,339); most of this cost (97%) was for hospitalizations, with an increment of £4,095. About 98% of the incremental cost occurred in the first 6 months following hip fracture. CONCLUSIONS: The results of this study indicate that the cost and clinical burden associated with hip fractures in postmenopausal women in the UK are considerable. The incremental cost is mostly related to the cost of hospitalization and treatment of the hip fracture. Key limitations were the inclusion of only those women with a recorded hospitalization, and that costs associated with rehabilitation services, social services, and long-term care were not recorded in this study, although these are important contributors to the total cost of fractures.

The From The Heart study: a global survey of patient understanding of cholesterol management and cardiovascular risk, and physician-patient communication.

OBJECTIVES: Cardiovascular disease (CVD) is the leading cause of mortality worldwide. A high level of low-density lipoprotein cholesterol (LDL-C) is a major CVD risk factor. Guidelines recommend effective cholesterol management and set LDL-C goals, yet deficiencies exist in physician implementation of these recommendations and in patient uptake of the advice. However, little is known of patient perceptions about CVD risk. METHODS: Patients and physicians were randomly selected from ten countries to complete a confidential, semi-structured questionnaire. RESULTS: Response rates were 27% (n = 750) for physicians and 83% (n = 1547) for patients. Patients believed cancer (43%) to be a greater cause of mortality than heart attack or stroke (34%). Despite 77% of patients claiming to be satisfied with information on high cholesterol, only 26% were aware that heart attack was a possible consequence, and only 35% of patients thought they had achieved their cholesterol goals. Virtually all physicians (99%) claimed to inform patients of their cholesterol level, while 18% of patients reported that they were not informed. Although patients and physicians were selected at random, limitations of this survey relate typically to the reliability of physician and patient responses and the possibility that the survey population may not represent the overall population. A broad range of patients' backgrounds and a high response rate (83%) suggest these effects would be minimal in the patient population. CONCLUSIONS: The From The Heart study has shown surprisingly poor knowledge of CVD risk amongst patients with elevated cholesterol. This may contribute to poor concordance with recommendations and treatment.