Chante Karimkhani

Mobile medical and health apps: state of the art, concerns, regulatory control and certification

This paper examines the state of the art in mobile clinical and health-related apps. A 2012 estimate puts the number of health-related apps at no fewer than 40,000, as healthcare professionals and consumers continue to express concerns about the quality of many apps, calling for some form of app regulatory control or certification to be put in place. We describe the range of apps on offer as of 2013, and then present a brief survey of evaluation studies of medical and health-related apps that have been conducted to date, covering a range of clinical disciplines and topics. Our survey includes studies that highlighted risks, negative issues and worrying deficiencies in existing apps. We discuss the concept of ‘apps as a medical device’ and the relevant regulatory controls that apply in USA and Europe, offering examples of apps that have been formally approved using these mechanisms. We describe the online Health Apps Library run by the National Health Service in England and the calls for a vetted medical and health app store. We discuss the ingredients for successful apps beyond the rather narrow definition of ‘apps as a medical device’. These ingredients cover app content quality, usability, the need to match apps to consumers’ general and health literacy levels, device connectivity standards (for apps that connect to glucometers, blood pressure monitors, etc.), as well as app security and user privacy. ‘Happtique Health App Certification Program’ (HACP), a voluntary app certification scheme, successfully captures most of these desiderata, but is solely focused on apps targeting the US market. HACP, while very welcome, is in ways reminiscent of the early days of the Web, when many “similar” quality benchmarking tools and codes of conduct for information publishers were proposed to appraise and rate online medical and health information. It is probably impossible to rate and police every app on offer today, much like in those early days of the Web, when people quickly realised the same regarding informational Web pages. The best first line of defence was, is, and will always be to educate consumers regarding the potentially harmful content of (some) apps.

Global Burden of Skin Disease as Reflected in Cochrane Database of Systematic Reviews

IMPORTANCE Research prioritization should be guided by impact of disease. OBJECTIVE To determine whether systematic reviews and protocol topics in Cochrane Database of Systematic Reviews (CDSR) reflect disease burden, measured by disability-adjusted life years (DALYs) from the Global Burden of Disease (GBD) 2010 project. DESIGN, SETTING, AND PARTICIPANTS Two investigators independently assessed 15 skin conditions in the CDSR for systematic review and protocol representation from November 1, 2013, to December 6, 2013. The 15 skin diseases were matched to their respective DALYs from GBD 2010. An official publication report of all reviews and protocols published by the Cochrane Skin Group (CSG) was also obtained to ensure that no titles were missed. There were no study participants other than the researchers, who worked with databases evaluating CDSR and GBD 2010 skin condition disability data. MAIN OUTCOMES AND MEASURES Relationship of CDSR topic coverage (systematic reviews and protocols) with percentage of total 2010 DALYs, 2010 DALY rank, and DALY percentage change from 1990 to 2010 for 15 skin conditions. RESULTS All 15 skin conditions were represented by at least 1 systematic review in CDSR; 69% of systematic reviews and 67% of protocols by the CSG covered the 15 skin conditions. Comparing the number of reviews/protocols and disability, dermatitis, melanoma, nonmelanoma skin cancer, viral skin diseases, and fungal skin diseases were well matched. Decubitus ulcer, psoriasis, and leprosy demonstrated review/protocol overrepresentation when matched with corresponding DALYs. In comparison, acne vulgaris, bacterial skin diseases, urticaria, pruritus, scabies, cellulitis, and alopecia areata were underrepresented in CDSR when matched with corresponding DALYs. CONCLUSIONS AND RELEVANCE Degree of representation in CDSR is partly correlated with DALY metrics. The number of published reviews/protocols was well matched with disability metrics for 5 of the 15 studied skin diseases, while 3 skin diseases were overrepresented, and 7 were underrepresented. Our results provide high-quality and transparent data to inform future prioritization decisions.

Global burden of cutaneous leishmaniasis: a cross-sectional analysis from the Global Burden of Disease Study 2013.

BACKGROUND High-quality epidemiological studies evaluating the burden of cutaneous leishmaniasis worldwide are lacking. We compared the burden of cutaneous leishmaniasis in each country to the overall global burden and assessed the equality of cutaneous leishmaniasis burden across different countries and regions. METHODS Data were extracted from scientific literature, hospital sources, country reports, and WHO sources on the prevalence of sequalae of both acute and chronic cutaneous leishmaniasis. Prevalence data were combined with a disability weight to yield years lived with disability. Disability-adjusted life-years (DALYs) are a sum of the years lived with disability and years of life lost (or mortality, assumed to be zero). We compared DALYs due to cutaneous leishmaniasis for 152 countries using standard Z score analysis with Bonferroni correction (p<0·003) and generation of Lorenz curves with a Gini coefficient. FINDINGS In 2013, the global mean age-standardised DALYs for cutaneous leishmaniasis was 0·58 per 100 000 people. Nine countries had significantly greater DALYs from cutaneous leishmaniasis than the mean: Afghanistan (87·0), Sudan (20·2), Syria (9·2), Yemen (6·2), Iraq (6·0), Burkina Faso (4·8), Bolivia (4·6), Haiti (4·1), and Peru (4·0). The Gini coefficient was 0·89. Andean Latin America, North Africa and Middle East, western sub-Saharan Africa, and south Asia had the highest DALYs from cutaneous leishmaniasis. Among males, Palestine had the highest incidence rates (616·2 cases per 100 000 people) followed by Afghanistan (566·4), Syria (357·1), and Nicaragua (354·8). Among females, Afghanistan had the highest incidence rates (623·9) followed by Syria (406·3), Palestine (222·1), and Nicaragua (180·8). Similar proportions of males and females had cutaneous leishmaniasis in most countries with a high incidence. INTERPRETATION The burden from cutaneous leishmaniasis mainly falls on countries in Africa and the Middle East. Global and national data on the burden of cutaneous leishmaniasis disease are pivotal to promote field studies and initiate behavioural change. FUNDING Bill & Melinda Gates Foundation.

Global skin disease morbidity and mortality an update from the global burden of disease study 2013

Importance Disability secondary to skin conditions is substantial worldwide. The Global Burden of Disease Study 2013 includes estimates of global morbidity and mortality due to skin diseases. Objective To measure the burden of skin diseases worldwide. Data Sources For nonfatal estimates, data were found by literature search using PubMed and Google Scholar in English and Spanish for years 1980 through 2013 and by accessing administrative data on hospital inpatient and outpatient episodes. Data for fatal estimates were based on vital registration and verbal autopsy data. Study Selection Skin disease data were extracted from more than 4000 sources including systematic reviews, surveys, population-based disease registries, hospital inpatient data, outpatient data, cohort studies, and autopsy data. Data metrics included incidence, prevalence, remission, duration, severity, deaths, and mortality risk. Data Extraction and Synthesis Data were extracted by age, time period, case definitions, and other study characteristics. Data points were modeled with Bayesian meta-regression to generate estimates of morbidity and mortality metrics for skin diseases. All estimates were made with 95% uncertainty intervals. Main Outcomes and Measures Disability-adjusted life years (DALYs), years lived with disability, and years of life lost from 15 skin conditions in 188 countries. Results Skin conditions contributed 1.79% to the global burden of disease measured in DALYs from 306 diseases and injuries in 2013. Individual skin diseases varied in size from 0.38% of total burden for dermatitis (atopic, contact, and seborrheic dermatitis), 0.29% for acne vulgaris, 0.19% for psoriasis, 0.19% for urticaria, 0.16% for viral skin diseases, 0.15% for fungal skin diseases, 0.07% for scabies, 0.06% for malignant skin melanoma, 0.05% for pyoderma, 0.04% for cellulitis, 0.03% for keratinocyte carcinoma, 0.03% for decubitus ulcer, and 0.01% for alopecia areata. All other skin and subcutaneous diseases composed 0.12% of total DALYs. Conclusions and Relevance Skin and subcutaneous diseases were the 18th leading cause of global DALYs in Global Burden of Disease 2013. Excluding mortality, skin diseases were the fourth leading cause of disability worldwide.

The global burden of scabies: a cross-sectional analysis from the Global Burden of Disease Study 2015

Summary Background Numerous population-based studies have documented high prevalence of scabies in overcrowded settings, particularly among children and in tropical regions. We provide an estimate of the global burden of scabies using data from the Global Burden of Disease (GBD) Study 2015. Methods We identified scabies epidemiological data sources from an extensive literature search and hospital insurance data and analysed data sources with a Bayesian meta-regression modelling tool, DisMod-MR 2·1, to yield prevalence estimates. We combined prevalence estimates with a disability weight, measuring disfigurement, itch, and pain caused by scabies, to produce years lived with disability (YLDs). With an assumed zero mortality from scabies, YLDs were equivalent to disability-adjusted life-years (DALYs). We estimated DALYs for 195 countries divided into 21 world regions, in both sexes and 20 age groups, between 1990 and 2015. Findings Scabies was responsible for 0·21% of DALYs from all conditions studied by GBD 2015 worldwide. The world regions of east Asia (age-standardised DALYs 136·32), southeast Asia (134·57), Oceania (120·34), tropical Latin America (99·94), and south Asia (69·41) had the greatest burden of DALYs from scabies. Mean percent change of DALY rate from 1990 to 2015 was less than 8% in all world regions, except North America, which had a 23·9% increase. The five individual countries with greatest scabies burden were Indonesia (age-standardised DALYs 153·86), China (138·25), Timor-Leste (136·67), Vanuatu (131·59), and Fiji (130·91). The largest standard deviations of age-standardised DALYs between the 20 age groups were observed in southeast Asia (60·1), Oceania (58·3), and east Asia (56·5), with the greatest DALY burdens in children, adolescents, and the elderly. Interpretation The burden of scabies is greater in tropical regions, especially in children, adolescents, and elderly people. As a worldwide epidemiological assessment, GBD 2015 provides broad and frequently updated measures of scabies burden in terms of skin effects. These global data might help guide research protocols and prioritisation efforts and focus scabies treatment and control measures. Funding Bill & Melinda Gates Foundation.

The global burden of psoriatic skin disease

DEAR EDITOR, Psoriasis is a common chronic inflammatory disorder of the skin frequently characterized by relapsing thick scaling plaques, with or without nail and joint involvement. While not life-threatening, psoriasis may cause substantial disability subsequent to both physical discomfort (e.g. pruritus, arthralgias, etc.) and psychosocial harm. Although prior research has evaluated the prevalence of psoriasis in various regions and countries, adequate understanding of geographical variation in psoriasis epidemiology has been hindered by variability in study design, outcome measures, population sampling techniques and, importantly, lack of emphasis on psoriasis-associated disease burden. However, a recent enterprise has attempted to provide new insights into global disease burden resulting from psoriasis and other dermatological disorders. The Global Burden of Disease Study (GBD) 2010 is a comprehensive database of worldwide epidemiological information regarding diseasespecific burden stratified by age, sex, geography and time. GBD 2010 provides disability estimates for 291 diseases and injuries, along with 67 risk factors, from 1990 to 2010. Given this novel resource, we sought to evaluate temporal trends and geographical variation in psoriasis-associated disease burden in order to narrow an important knowledge gap concerning the consequences of this disorder across time, diverse world regions and sociodemographic populations. We used GBD 2010 to conduct a cross-sectional study of geographical regions with prevalent psoriasis (Table S1; see Supporting Information). A detailed description of GBD 2010 development, design and implementation has been described previously. The primary outcome was regional burden of disease associated with psoriasis, as measured by disabilityadjusted life years (DALYs). This metric combines years lost to disability (a morbidity component) with years of life lost (a mortality component), such that one DALY is equivalent to 1 year of healthy life lost. The DALY metric includes a constant value disability weight, which ranges from 0 to 1 and is derived from an analysis of the comparative impact of itch and disfigurement against other conditions by international volunteer panels. The disability weight for psoriasis was 0 054. The following metrics were obtained for psoriasis in 21 geographical regions (Table S1; see Supporting Information): age-adjusted DALY rates per 100 000 persons and associated 95% confidence intervals (CIs), median percentage change in psoriasis-associated DALY rates from 1990 to 2010 and percentage of total global DALYs (across all conditions and regions). These data are available for public access at GBD websites. Geographical differences in psoriasis-associated DALY rates were compared using standard Z-scores. The equality of psoriasis disease burden distribution across geographical regions was evaluated using the Lorenz curve and associated Gini coefficient (range 0–1, where values closer to 1 indicate greater inequality in disease burden distribution). All analyses were performed using Excel 2013 (Microsoft, Redmond, WA, U.S.A.) and Stata SE 13.1 (StataCorp, College Station, TX, U.S.A.), and all statistical tests were two-tailed with a = 0 05.

Global mortality from conditions with skin manifestations

BACKGROUND Global Burden of Disease Study is a research database containing systematically compiled information from vital statistics and epidemiologic literature to inform research, public policy, and resource allocation. OBJECTIVE We sought to compare mortality among conditions with skin manifestations in 50 developed and 137 developing countries from 1990 to 2010. METHODS This was a cross-sectional study to calculate mean age-standardized mortality (per 100,000 persons) across countries for 10 disease categories with skin manifestations. We compared differences in mortality from these disorders by time period (year 1990 vs year 2010) and by developing versus developed country status. RESULTS Melanoma death rates were 5.6 and 4.7 times greater in developed compared with developing countries in 1990 and 2010, respectively. Measles death rates in 1990 and 2010 were 345 and 197 times greater in developing countries, and corresponding syphilis death rates were 33 and 45 times greater. LIMITATIONS Inability to adjust for patient-, provider-, and geographic-level confounders may limit the accuracy and generalizability of these results. CONCLUSION The mortality burden from skin-related conditions differs between developing and developed countries, with the greatest differences observed for melanoma, measles, and syphilis. These results may help prioritize and optimize efforts to prevent and treat these disorders.

Comparing cutaneous research funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases with 2010 Global Burden of Disease results.

Importance Disease burden data helps guide research prioritization. Objective To determine the extent to which grants issued by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) reflect disease burden, measured by disability-adjusted life years (DALYs) from Global Burden of Disease (GBD) 2010 project. Design Two investigators independently assessed 15 skin conditions studied by GBD 2010 in the NIAMS database for grants issued in 2013. The 15 skin diseases were matched to their respective DALYs from GBD 2010. Setting The United States NIAMS database and GBD 2010 skin condition disability data. Main Outcome(s) and Measure(s) Relationship of NIAMS grant database topic funding with percent total GBD 2010 DALY and DALY rank for 15 skin conditions. Results During fiscal year 2013, 1,443 NIAMS grants were issued at a total value of

Global Burden of Eye and Vision Disease as Reflected in the Cochrane Database of Systematic Reviews

424 million. Of these grants, 17.7% covered skin topics. Of the total skin disease funding, 82% (91 grants) were categorized as “general cutaneous research.” Psoriasis, leprosy, and “other skin and subcutaneous diseases” (ie; immunobullous disorders, vitiligo, and hidradenitis suppurativa) were over-represented when funding was compared with disability. Conversely, cellulitis, decubitus ulcer, urticaria, acne vulgaris, viral skin diseases, fungal skin diseases, scabies, and melanoma were under-represented. Conditions for which disability and funding appeared well-matched were dermatitis, squamous and basal cell carcinoma, pruritus, bacterial skin diseases, and alopecia areata. Conclusions and Relevance Degree of representation in NIAMS is partly correlated with DALY metrics. Grant funding was well-matched with disability metrics for five of the 15 studied skin diseases, while two skin diseases were over-represented and seven were under-represented. Global burden estimates provide increasingly transparent and important information for investigating and prioritizing national research funding allocations.

Alignment of systematic reviews published in the Cochrane Database of Systematic Reviews and the Database of Abstracts and Reviews of Effectiveness with global burden-of-disease data: a bibliographic analysis

IMPORTANCE Eye and vision disease burden should help guide ophthalmologic research prioritization. The Global Burden of Disease (GBD) Study 2010 compiled data from 1990 to 2010 on 291 diseases and injuries, 1160 disease and injury sequelae, and 67 risk factors in 187 countries. The Cochrane Database of Systematic Reviews (CDSR) is a resource for systematic reviews in health care, with peer-reviewed systematic reviews that are published by Cochrane Review Groups. OBJECTIVE To determine whether systematic review and protocol topics in the CDSR reflect disease burden, measured by disability-adjusted life-years (DALYs), from the GBD 2010 project. This is one of a series of projects mapping GBD 2010 medical field disease burdens to corresponding systematic reviews in the CDSR. DESIGN AND SETTING Two investigators independently assessed 8 ophthalmologic conditions in the CDSR for systematic review and protocol representation according to subject content. The 8 diseases were matched to their respective DALYs from the GBD 2010 project. MAIN OUTCOMES AND MEASURES Cochrane Database of Systematic Reviews systematic review and protocol representation and percentage of total 2010 DALYs. RESULTS All 8 ophthalmologic conditions were represented by at least 1 systematic review in the CDSR. A total of 91.4% of systematic reviews and protocols focused on these conditions were from the Cochrane Eyes and Vision Group. Comparing the number of reviews and protocols with disability, only cataract was well matched; glaucoma, macular degeneration, and other vision loss were overrepresented. In comparison, trachoma, onchocerciasis, vitamin A deficiency, and refraction and accommodation disorders were underrepresented. CONCLUSIONS AND RELEVANCE These results prompt further investigation into why certain diseases are overrepresented or underrepresented in the CDSR relative to their DALY. With regard to ophthalmologic conditions, this study encourages that certain conditions get more focus to create a better representation of what is causing the most disability and mortality within this research database. These results provide high-quality and transparent data to inform future prioritization decisions.