Summary
Healthcare administrative (claims) data are commonly utilized to estimate drug effects. We identified considerable heterogeneity in fracture outcome definitions in a scoping review of 57 ...studies that estimated osteoporosis drug effects on fracture risk. Better understanding of the impact of different fracture definitions on study results is needed.
Purpose
Healthcare administrative (claims) data are frequently used to estimate the real-world effects of drugs. Fracture incidence is a common outcome of osteoporosis drug studies. We aimed to describe how fractures are defined in studies that use claims data.
Methods
We searched MEDLINE (Ovid), Embase (Ovid), CINAHL (EBSCO), and gray literature for studies published in English between 2000 and 2020 that estimated fracture effectiveness (hip, humerus, radius/ulna, vertebra) or safety (atypical fracture of the femur, AFF) of osteoporosis drugs using claims data in Canada and the USA. Literature searches, screening and data abstraction were completed independently by two reviewers.
Results
We identified 57 eligible studies (52 effectiveness, 3 safety, 2 both). Hip fracture was the most common fracture site studied (93%), followed by humerus (66%), radius/ulna (59%), vertebra (61%), and AFF (9%). Half (
n
= 29) of the studies did not indicate specific data sources, codes, or cite a validation paper. Of the papers with sufficient detail, heterogeneity in fracture definitions was common. The most common definition within each fracture site was used by less than half of the studies that examined effectiveness (12 definitions in 29 hip fracture papers, 8 definitions in 17 humerus papers, 8 definitions in 13 radius/ulna papers, 9 definitions in 15 vertebra papers), and 3 definitions among 4 AFF papers.
Conclusion
There is ambiguity and heterogeneity in fracture outcome definitions in studies that leverage claims data. Better transparency in outcome reporting is needed. Future exploration of how fracture definitions impact study results is warranted.
Background and purpose
The Eastern Mediterranean Region (EMR) is experiencing a demographic shift towards rapid aging at a time of political unrest. We aimed to estimate the burden of ...neurodegenerative disorders and its relationship with sociodemographic index in the EMR countries from 1990 to 2016.
Methods
Using data from the Global Burden of Disease Study 2016, we calculated country‐specific trends for prevalence, mortality, disability‐adjusted life‐years (DALY), years of life lost and years lived with disability (YLD) for Alzheimer's disease/other dementias and Parkinson's disease in the EMR during 1990–2016.
Results
In the EMR, the age‐standardized prevalence rate of Alzheimer's disease/other dementias and Parkinson's disease was estimated at 759.8/100 000 (95% uncertainty intervals, 642.9–899.9) and 87.1/100 000 (95% uncertainty intervals, 69.8–108.2) people in 2016, demonstrating 0.01% and 42.3% change from 1990, respectively. Neurodegenerative disorders contributed to 5.4% of total DALY and 4.6% of total YLD among the older EMR population (70 years of age or older in 2016). Age‐standardized DALY due to Parkinson's disease were strongly correlated with the sociodemographic index level (r = 0.823, P < 0.001). The YLD:DALY ratio of neurodegenerative diseases declined during this period in the low‐income but not the high‐income EMR countries.
Conclusions
Our findings demonstrated an increasing trend in the burden of dementias and Parkinson's disease in most EMR countries between 1990 and 2016. With aging of the EMR populations, countries should target the modifiable risk factors of neurodegenerative diseases to control their increasing burden.
Prevalence of most common skin diseases in Europe: a population‐based study Richard, M.A.; Paul, C.; Nijsten, T. ...
JEADV. Journal of the European Academy of Dermatology and Venereology/Journal of the European Academy of Dermatology and Venereology,
July 2022, Letnik:
36, Številka:
7
Journal Article
Recenzirano
Odprti dostop
Background
The assessment of the prevalence of diseases is of primary importance in planning health policies. No complete data on the prevalence of skin diseases across European countries are ...available.
Objective
To estimate the prevalence of the most frequent skin conditions or diseases in 27 European countries (24 EU countries, plus Norway, Switzerland, and the United Kingdom).
Methods
We conducted a population‐based study on representative and extrapolable samples of the general population aged 18 years or more in each of the 27 countries surveyed. Participants were selected using stratified, proportional sampling with a replacement design. Data were collected using a web‐based online survey. All participants were asked to fill in a questionnaire with sociodemographic data and to declare if they have had one or more skin conditions or diseases during the previous 12 months.
Results
A total of 44 689 participants from 27 countries responded to the questionnaire, 21 887 (48.98%) men and 22 802 (51.02%) women. The proportion of participants who reported having suffered from at least one dermatological condition or disease during the previous 12 months was 43.35% (95% CI: 42.89%, 43.81%). The projection in the total population of the 27 countries included in the study resulted in 185 103 774 individuals affected by at least one dermatological condition or disease. Accordingly, we can estimate that more than 94 million Europeans complain of uncomfortable skin sensations like itch, burning, or dryness. The most frequent conditions were fungal skin infections (8.9%), acne (5.4%), and atopic dermatitis or eczema (5.5%). Alopecia, acne, eczema, and rosacea were more common in women, whereas men were more likely to suffer from psoriasis and sexually transmitted infections.
Conclusion
Skin diseases are an important public health concern. Their high prevalence has to be taken into account in planning access to dermatological care to address patient needs.
Abstract Background Type 2 diabetes mellitus (T2DM) may be a risk factor for gastrointestinal (GI) cancers, but variations in study designs of observational studies may have yielded biased results ...due to detection bias. Furthermore, differences in risk for GI cancer subsites have not been extensively evaluated. We aimed to determine the risk of GI cancer and its subsites in patients with T2DM and how it is affected by detection bias. Methods A matched cohort study was performed using the NCR-PHARMO database. New-users of ≥1 non-insulin anti-diabetic drug during 1998–2011 were matched with non-diabetic controls by year of birth, sex, and time between database entry and index. Cox regression analyses were performed with and without lag-period to estimate hazard ratios (HRs) for GI cancer and its subsites. Covariables included age, sex, use of other drugs and history of hospitalisation. Results An increased risk of GI cancer was observed in T2DM patients (HR 1.5, 95% confidence interval CI 1.3–1.7) compared with controls, which was attenuated in the 1-year lagged analysis (HR 1.4, 95% CI 1.2–1.7). Stratified by subsite, statistically significant increased risks of pancreatic (HR 4.7, 95% CI 3.1–7.2), extrahepatic bile duct (HR 4.2, 95% CI 1.5–11.8) and distal colon cancer (HR 1.5, 95% CI 1.1–2.1) were found, which remained statistically significantly increased in the lagged analysis. Conclusions T2DM patients had a 40% increased risk of GI cancer. Increased GI cancer risks tended to be weaker when reducing detection bias by applying a 1-year lag-period. Future observational studies should therefore include sensitivity analyses in which this bias is minimised.
Abstract
Objectives
A considerable proportion of patients with rheumatoid arthritis (RA) also suffer from hand osteoarthritis (OA). We here assess the association between conventional synthetic (cs) ...and biological (b) disease-modifying antirheumatic drugs (DMARDs) and radiographic distal interphalangeal-(DIP) OA in patients with RA.
Methods
Adult RA patients from a longitudinal Swiss registry of rheumatic diseases who had ≥ 2 hand radiographs were included at the first radiograph and followed until the outcome or the last radiograph. Patients were grouped into two cohorts based on whether DIP OA was present or absent at cohort entry (cohorts 1 and 2, respectively). Modified Kellgren-Lawrence scores (KLS) were obtained by evaluating DIP joints for the severity of osteophytes, joint space narrowing, subchondral sclerosis, and erosions. KLS ≥ 2 in ≥ 1 DIP joint indicated incident or existing OA, and increase of ≥ 1 in KLS in ≥ 1 DIP joint indicated progression in existing DIP OA. Time-varying Cox regression and generalized estimating equation (GEE) analyses were performed. We estimated hazard ratios (HRs) and odds ratios (ORs) with 95% confidence intervals (CI) of DIP OA incidence (cohort 2), or progression (cohort 1), in bDMARD monotherapy, bDMARD/csDMARD combination therapy, and past or never DMARD use, when compared to csDMARD use. In post hoc analyses, we descriptively and analytically assessed the individual KLS features in cohort 1.
Results
Among 2234 RA patients with 5928 radiographs, 1340 patients had DIP OA at baseline (cohort 1). Radiographic progression of DIP OA was characterized by new or progressive osteophyte formation (666, 52.4%), joint space narrowing (379, 27.5%), subchondral sclerosis (238, 17.8%), or erosions (62, 4.3%). bDMARD monotherapy had an increased risk of radiographic DIP OA progression compared to csDMARD monotherapy (adjusted HR 1.34 95% CI 1.07–1.69). The risk was not significant in csDMARD/bDMARD combination users (HR 1.12 95% CI 0.96–1.31), absent in past DMARD users (HR 0.96 95% CI 0.66–1.41), and significantly lower among never DMARD users (HR 0.54 95% CI 0.33–0.90). Osteophyte progression (HR 1.74 95% CI 1.11–2.74) was the most significantly increased OA feature with bDMARD use compared to csDMARD use. In 894 patients without initial DIP OA (cohort 2), the risk of incident OA did not differ between the treatment groups. The results from GEE analyses corroborated all findings.
Conclusions
These real-world RA cohort data indicate that monotherapy with bDMARDs is associated with increased radiographic progression of existing DIP OA, but not with incident DIP OA.
Summary Background Data for trends in serum cholesterol are needed to understand the effects of its dietary, lifestyle, and pharmacological determinants; set intervention priorities; and evaluate ...national programmes. Previous analyses of trends in serum cholesterol were limited to a few countries, with no consistent and comparable global analysis. We estimated worldwide trends in population mean serum total cholesterol. Methods We estimated trends and their uncertainties in mean serum total cholesterol for adults 25 years and older in 199 countries and territories. We obtained data from published and unpublished health examination surveys and epidemiological studies (321 country-years and 3·0 million participants). For each sex, we used a Bayesian hierarchical model to estimate mean total cholesterol by age, country, and year, accounting for whether a study was nationally representative. Findings In 2008, age-standardised mean total cholesterol worldwide was 4·64 mmol/L (95% uncertainty interval 4·51–4·76) for men and 4·76 mmol/L (4·62–4·91) for women. Globally, mean total cholesterol changed little between 1980 and 2008, falling by less than 0·1 mmol/L per decade in men and women. Total cholesterol fell in the high-income region consisting of Australasia, North America, and western Europe, and in central and eastern Europe; the regional declines were about 0·2 mmol/L per decade for both sexes, with posterior probabilities of these being true declines 0·99 or greater. Mean total cholesterol increased in east and southeast Asia and Pacific by 0·08 mmol/L per decade (−0·06 to 0·22, posterior probability=0·86) in men and 0·09 mmol/L per decade (−0·07 to 0·26, posterior probability=0·86) in women. Despite converging trends, serum total cholesterol in 2008 was highest in the high-income region consisting of Australasia, North America, and western Europe; the regional mean was 5·24 mmol/L (5·08–5·39) for men and 5·23 mmol/L (5·03–5·43) for women. It was lowest in sub-Saharan Africa at 4·08 mmol/L (3·82–4·34) for men and 4·27 mmol/L (3·99–4·56) for women. Interpretation Nutritional policies and pharmacological interventions should be used to accelerate improvements in total cholesterol in regions with decline and to curb or prevent the rise in Asian populations and elsewhere. Population-based surveillance of cholesterol needs to be improved in low-income and middle-income countries. Funding Bill & Melinda Gates Foundation and WHO.
Summary Background Data for trends in blood pressure are needed to understand the effects of its dietary, lifestyle, and pharmacological determinants; set intervention priorities; and evaluate ...national programmes. However, few worldwide analyses of trends in blood pressure have been done. We estimated worldwide trends in population mean systolic blood pressure (SBP). Methods We estimated trends and their uncertainties in mean SBP for adults 25 years and older in 199 countries and territories. We obtained data from published and unpublished health examination surveys and epidemiological studies (786 country-years and 5·4 million participants). For each sex, we used a Bayesian hierarchical model to estimate mean SBP by age, country, and year, accounting for whether a study was nationally representative. Findings In 2008, age-standardised mean SBP worldwide was 128·1 mm Hg (95% uncertainty interval 126·7–129·4) in men and 124·4 mm Hg (123·0–125·9) in women. Globally, between 1980 and 2008, SBP decreased by 0·8 mm Hg per decade (−0·4 to 2·2, posterior probability of being a true decline=0·90) in men and 1·0 mm Hg per decade (−0·3 to 2·3, posterior probability=0·93) in women. Female SBP decreased by 3·5 mm Hg or more per decade in western Europe and Australasia (posterior probabilities ≥0·999). Male SBP fell most in high-income North America, by 2·8 mm Hg per decade (1·3–4·5, posterior probability >0·999), followed by Australasia and western Europe where it decreased by more than 2·0 mm Hg per decade (posterior probabilities >0·98). SBP rose in Oceania, east Africa, and south and southeast Asia for both sexes, and in west Africa for women, with the increases ranging 0·8–1·6 mm Hg per decade in men (posterior probabilities 0·72–0·91) and 1·0–2·7 mm Hg per decade for women (posterior probabilities 0·75–0·98). Female SBP was highest in some east and west African countries, with means of 135 mm Hg or greater. Male SBP was highest in Baltic and east and west African countries, where mean SBP reached 138 mm Hg or more. Men and women in western Europe had the highest SBP in high-income regions. Interpretation On average, global population SBP decreased slightly since 1980, but trends varied significantly across regions and countries. SBP is currently highest in low-income and middle-income countries. Effective population-based and personal interventions should be targeted towards low-income and middle-income countries. Funding Funding Bill & Melinda Gates Foundation and WHO.
While many clinical guidelines recommend screening for osteoporosis for early detection and treatment, there is great diversity in the case-finding strategies globally. We sought to compare ...case-finding strategies, focusing on the approaches used in European and Asian countries. This article provides an overview of the current case-finding strategies in the UK, Germany (including Austria and German-speaking regions of Switzerland), China, Japan, and Korea. We conducted a review of current treatment guidelines in each country and included expert opinions from key opinion leaders. Most countries define osteoporosis among patients with a radiographically identified fracture of the hip or the vertebrae. However, for other types of fractures, or in the absence of a fracture, varying combinations of risk-factor assessment and areal bone mineral density (aBMD) assessed by dual X-ray absorptiometry are used to define osteoporosis cases. A T-score ≤ − 2.5 is accepted to identify osteoporosis in the absence of a fracture; however, not all countries accept DXA alone as the sole criteria. Additionally, the critera for requiring clinical risk factors in addition to aBMD differ across countries. In most Asian countries, aBMD scanning is only provided beyond a particular age threshold. However, all guidelines recommend fracture risk assessment in younger ages if risk factors are present. Our review identified that strategies for case-finding differ regionally, particularly among patients without a fracture. More homogenized ways of identifying osteoporosis cases are needed, in both the Eastern and the Western countries, to improve osteoporosis case-finding before a fracture occurs.
Case-finding in osteoporosis is essential to initiate treatment and minimize fracture risk. We identified differences in case-finding strategies between Eastern and Western countries. In the absence of a diagnosed fracture, varying combinations of risk factors and bone density measurements are used. Standardized case-finding strategies may help improve treatment rates.
There is little empirical evidence on children's subjective experiences of discomfort during clinical research procedures. Therefore, Institutional Review Boards have limited empirical information to ...guide their decision-making on discomforts for children in clinical research. To get more insight into what children's discomforts are during clinical research procedures, we interviewed a group of children on this topic and also asked for suggestions to reduce possible discomforts.
Forty-six children (aged 6–18) participating in clinical research studies (including needle-related procedures, food provocation tests, MRI scans, pulmonary function tests, questionnaires) were interviewed about their experiences during the research procedures. Thematic analysis was used to analyze the interviews.
The discomforts of the interviewed children could be divided into two main groups: physical and mental discomforts. The majority experienced physical discomforts during the research procedures: pain, shortness of breath, nausea, itchiness, and feeling hungry, which were often caused by needle procedures, some pulmonary procedures, and food provocation tests. Mental discomforts included anxiousness because of anticipated pain and not knowing what to expect from a research procedure, boredom and tiredness during lengthy research procedures and waiting, and embarrassment during Tanner staging. Children's suggestions to reduce the discomforts of the research procedures were providing distraction (e.g. watching a movie or listening to music), providing age-appropriate information and shortening the duration of lengthy procedures.
Our study shows that children can experience various discomforts during research procedures, and it provides information about how these discomforts can be reduced according to them. Further research is needed with larger samples to study the number of children that experience these mentioned discomforts during research procedures in a quantitative way.
•Discomfort during research procedures includes both physical and mental discomforts.•Boredom is an important discomfort for children during research.•Children suggest distraction for reducing discomfort during research procedures.
Background
A growing body of evidence indicates the importance of nutrition in cancer treatment. Ketogenic diets are one strategy that has been proposed to enhance traditional anticancer therapy. ...This review summarises the evidence concerning the effect of oral ketogenic diets on anthropometry, metabolism, quality of life (QoL) and tumour effects, at the same time as documenting adverse events and adherence in patients with cancer.
Methods
We searched electronic databases using medical subject headings (MeSH) and text words related to ketogenic diets and cancer. Adult patients following a ketogenic diet as a complementary therapy prior, alongside or after standard anticancer treatment for more than 7 days were included. Studies were assessed for quality using the Critical Appraisal Skills Programme tools (https://www.casp-uk.net).
Results
Eleven studies were included with 102 participants (age range 34–87 years) from early‐phase trials, cohort studies and case reports. Studies included participants with brain, rectal or mixed cancer sites at an early or advanced disease stage. The duration of intervention ranged from 2.4 to 134.7 weeks (0.5–31 months). Evidence was inconclusive for nutritional status and adverse events. Mixed results were observed for blood parameters, tumour effects and QoL. Adherence to diet was low (50 out of 102; 49%) and ranged from 23.5% to 100%.
Conclusions
High‐quality evidence on the effect of ketogenic diets on anthropometry, metabolism, QoL and tumour effects is currently lacking in oncology patients. Heterogeneity between studies and low adherence to diet affects the current evidence. There is an obvious gap in the evidence, highlighting the need for controlled trials to fully evaluate the intervention.
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