scholarly journals The strategic biomarker roadmap for the validation of Alzheimer’s diagnostic biomarkers: methodological update

Author(s):  
Marina Boccardi ◽  
Alessandra Dodich ◽  
Emiliano Albanese ◽  
Angèle Gayet-Ageron ◽  
Cristina Festari ◽  
...  

Abstract Background The 2017 Alzheimer’s disease (AD) Strategic Biomarker Roadmap (SBR) structured the validation of AD diagnostic biomarkers into 5 phases, systematically assessing analytical validity (Phases 1–2), clinical validity (Phases 3–4), and clinical utility (Phase 5) through primary and secondary Aims. This framework allows to map knowledge gaps and research priorities, accelerating the route towards clinical implementation. Within an initiative aimed to assess the development of biomarkers of tau pathology, we revised this methodology consistently with progress in AD research. Methods We critically appraised the adequacy of the 2017 Biomarker Roadmap within current diagnostic frameworks, discussed updates at a workshop convening the Alzheimer’s Association and 8 leading AD biomarker research groups, and detailed the methods to allow consistent assessment of aims achievement for tau and other AD diagnostic biomarkers. Results The 2020 update applies to all AD diagnostic biomarkers. In Phases 2–3, we admitted a greater variety of study designs (e.g., cross-sectional in addition to longitudinal) and reference standards (e.g., biomarker confirmation in addition to clinical progression) based on construct (in addition to criterion) validity. We structured a systematic data extraction to enable transparent and formal evidence assessment procedures. Finally, we have clarified issues that need to be addressed to generate data eligible to evidence-to-decision procedures. Discussion This revision allows for more versatile and precise assessment of existing evidence, keeps up with theoretical developments, and helps clinical researchers in producing evidence suitable for evidence-to-decision procedures. Compliance with this methodology is essential to implement AD biomarkers efficiently in clinical research and diagnostics.


2019 ◽  
Vol 27 (4) ◽  
pp. 340-347 ◽  
Author(s):  
Rebecca L. Hartley ◽  
Anna R. Todd ◽  
Alan R. Harrop ◽  
Frankie O. G. Fraulin

Background: Pediatric hand fractures are common, but few require surgery; therefore, these fractures are often perceived to be overreferred. Our objective is to systematically identify and describe pediatric hand fracture referring practices. Method: A scoping review was performed, searching electronic databases and grey literature up to January 2018 to identify referring practices for children (17 years and younger) with hand fractures (defined as radiographically confirmed fractures distal to the carpus) to hand surgeons. All study designs were included, and study selection and data extraction were independently performed in duplicate by 2 reviewers. Outcomes included referring rates, necessity of referral, referring criteria, and management of fractures. Results: Twenty (10 cross-sectional, 7 prospective cohorts, and 3 narrative reviews) studies reporting on referring practices or management of 21,624 pediatric hand fractures were included. Proportion of pediatric hand fractures referred to hand surgeons ranged from 6.5% to 100%. Unnecessary referral, defined as those fractures within the scope of primary care management, ranged from 27% to 78.1%. Ten studies reported referring criteria, with 14 unique criteria identified. The most common referring criteria were displacement (36.4%), loss of joint congruity (36.4%), and instability (36.4%). The most common justification for these criteria was increased likelihood of requiring surgery. The most common initial management was immobilization (66%-100%). Final management was provided by orthopedic or plastic hand surgeons with 0% to 32.9% of fractures requiring surgery. Conclusion: Referring practices vary widely in the literature. Major gaps in the literature include objective measures and justification for referring criteria and primary care education on hand fracture referring practices.



Author(s):  
Hugo G. B. Nijmeijer ◽  
Noud M. Keijsers ◽  
Wendy J. Huinck ◽  
Emmanuel A. M. Mylanus

Abstract Purpose This scoping review examines the available evidence on the effect of unilateral cochlear implantation (CI) in adults with postlingual bilateral hearing loss on societal-related outcomes in terms of work, autonomy and participation. Methods Five databases were searched (Pubmed, Web of Science, Embase, PsycINFO and Cochrane Library). Publications were screened in three steps on inclusion criteria. Of the 4230 screened publications, 110 met the inclusion criteria and were assessed for data extraction regarding outcomes “work”, “autonomy”, “participation”. Study characteristics and key findings are presented and narratively described. Results Twenty-seven publications were included and categorized into retrospective (n = 3), cross-sectional (n = 18) or prospective (n = 6) study designs. Measurement or identification of number of outcomes (no) were related to work (no = 20), participation (no = 9) and autonomy or independency (no = 10). Most studies indicated benefits of CI on these outcomes. However, some studies did not or indicated additional barriers for benefits. Eleven publications primarily aimed to study one or more of our primary outcomes. Conclusion In this literature search, scientific databases are reviewed. The results indicate that there is a relatively small body of evidence regarding the effect of CI on the outcomes “work”, “autonomy” and “participation”. Even though there are some limitations of the current study including some overlap in outcome definitions, most included studies indicate a beneficial effect of CI on work, autonomy and participation. The lack of consensus in definitions and the small body of evidence indicates a need for additional prospective studies investigating the societal outcomes of CI in postlingually deafened adults.



2020 ◽  
Vol 6 ◽  
Author(s):  
Sebastian Rosch ◽  
Karl-Philipp Rommel ◽  
Markus Scholz ◽  
Holger Thiele ◽  
Philipp Lurz

Heart failure with preserved ejection fraction (HFpEF) is increasing in incidence and has a higher prevalence compared with heart failure with reduced ejection fraction. So far, no effective treatment of HFpEF is available, due to its complex underlying pathophysiology and clinical heterogeneity. This article aims to provide an overview and a future perspective of transcriptomic biomarker research in HFpEF. Detailed characterisation of the HFpEF phenotype and its underlying molecular pathomechanisms may open new perspectives regarding early diagnosis, improved prognostication, new therapeutic targets and tailored therapies accounting for patient heterogeneity, which may improve quality of life. A combination of cross-sectional and longitudinal study designs with sufficiently large sample sizes are required to support this concept.



2021 ◽  
Vol 17 (1) ◽  
Author(s):  
Abdou Fatawou Modiyinji ◽  
Jean Joel Bigna ◽  
Sebastien Kenmoe ◽  
Fredy Brice N. Simo ◽  
Marie A. Amougou ◽  
...  

Abstract Background Hepatitis E virus (HEV) is a major cause of acute hepatitis in humans worldwide and have high burden in the resource-limited countries. Better knowledge of the epidemiology of hepatitis in animals in Africa can help to understand the epidemiology among humans. The objective of this study was to summarize the prevalence of HEV infection and distribution of HEV genotypes among animals in Africa. Methods In this systematic review and meta-analysis, we comprehensively searched PubMed, EMBASE, African Journals Online, and Africa Index Medicus from January 1st, 2000 to March 22th, 2020 without any language restriction. We considered cross-sectional studies of HEV infection in animals in Africa. Study selection, data extraction, and methodological quality of included studies were done independently by two investigators. Prevalence data were pooled using the random-effects meta-analysis. This review was registered in PROSPERO, CRD42018087684. Results Twenty-five studies (13 species and 6983 animals) were included. The prevalence (antibodies or ribonucleic acid [RNA]) of HEV infection in animals varied widely depending on biological markers of HEV infection measured: 23.4% (95% confidence interval; 12.0–37.2) for anti-HEV immunoglobulins G, 13.1% (3.1–28.3) for anti-HEV immunoglobulins M, and 1.8% (0.2–4.3) for RNA; with substantial heterogeneity. In subgroup analysis, the immunoglobulins G seroprevalence was higher among pigs 37.8% (13.9–65.4). The following HEV genotypes were reported in animals: Rat-HEV genotype 1 (rats and horses), HEV-3 (pigs), HEV-7 (dromedaries), and Bat hepeviruses (bats). Conclusions We found a high prevalence of HEV infection in animals in Africa and HEV genotypes close to that of humans. Some animals in Africa could be the reservoir of HEV, highlighting the need of molecular epidemiological studies for investigating zoonotic transmission.



2021 ◽  
pp. 004947552110052
Author(s):  
Sandeep Moola ◽  
Deepti Beri ◽  
Abdul Salam ◽  
Jagnoor Jagnoor ◽  
Arun Teja ◽  
...  

Leptospirosis is a zoonotic disease of public health importance in India. A country-level evidence gap map was developed to identify gaps on epidemiology of leptospirosis. It is the first such on leptospirosis globally and on any single disease condition in India. The steps for development of evidence gap map were development of a framework to map evidence, retrieval of evidence, data extraction parameters and mapping of available evidence in evidence gap map framework. The prevalence evidence gap map consisted of 157 studies (102 in humans, 55 in animals, and 12 in both). The evidence gap map on risk factors had 120 studies (102 in humans, 11 in animals and 7 in both). There were inter-state differences in availability of research and disparity between animal and human research. Research on high-risk groups was limited and studies did not use the One Health approach to identify epidemiology, which can help understand the issue more comprehensively. The study demonstrates the potential of evidence gap maps to inform research priorities.



2021 ◽  
pp. 1-9
Author(s):  
William M. Jackson ◽  
Nicholas Davis ◽  
Johanna Calderon ◽  
Jennifer J. Lee ◽  
Nicole Feirsen ◽  
...  

Abstract Context: People with CHD are at increased risk for executive functioning deficits. Meta-analyses of these measures in CHD patients compared to healthy controls have not been reported. Objective: To examine differences in executive functions in individuals with CHD compared to healthy controls. Data sources: We performed a systematic review of publications from 1 January, 1986 to 15 June, 2020 indexed in PubMed, CINAHL, EMBASE, PsycInfo, Web of Science, and the Cochrane Library. Study selection: Inclusion criteria were (1) studies containing at least one executive function measure; (2) participants were over the age of three. Data extraction: Data extraction and quality assessment were performed independently by two authors. We used a shifting unit-of-analysis approach and pooled data using a random effects model. Results: The search yielded 61,217 results. Twenty-eight studies met criteria. A total of 7789 people with CHD were compared with 8187 healthy controls. We found the following standardised mean differences: −0.628 (−0.726, −0.531) for cognitive flexibility and set shifting, −0.469 (−0.606, −0.333) for inhibition, −0.369 (−0.466, −0.273) for working memory, −0.334 (−0.546, −0.121) for planning/problem solving, −0.361 (−0.576, −0.147) for summary measures, and −0.444 (−0.614, −0.274) for reporter-based measures (p < 0.001). Limitations: Our analysis consisted of cross-sectional and observational studies. We could not quantify the effect of collinearity. Conclusions: Individuals with CHD appear to have at least moderate deficits in executive functions. Given the growing population of people with CHD, more attention should be devoted to identifying executive dysfunction in this vulnerable group.



Author(s):  
Rachel J. Viggars ◽  
Andrew Finney ◽  
Barnabas Panayiotou

Summary Background More people are living with frailty and requiring additional health and support services. To improve their management, the “Frailty: Core Capability Framework” in the United Kingdom recommends frailty education for older individuals, their families, carers and health professionals. We performed a systematic review of specific educational programmes for these groups. Methods Electronic databases were searched using dedicated search terms and inclusion criteria. To improve accuracy, two reviewers carried out the screening and selection of research papers. Information from included studies was collected using a tailored data extraction template, and quality appraisal tools were used to assess the rigour of the studies. The findings were analysed to identify key themes. Results A total of 11 studies met the criteria and were included in the review. The study populations ranged from 12 to 603 and the research designs were heterogeneous (6 qualitative; 2 randomised controlled trials; 1 quasi-experimental; 1 mixed methods; 1 cross-sectional study). Whilst some methodological shortcomings were identified, all studies contributed valuable information. The results underwent narrative synthesis, which elucidated four thematic domains: (1) accessibility of educational programmes, (2) empowerment, (3) self-care, and (4) health promotion (especially exercise and nutrition). Conclusion Educational programmes for older people, their carers and health professionals are important for effective frailty prevention and management. To be maximally beneficial, they should be easily accessible to all target populations and include empowerment, self-care and health promotion. Further research should explore the formulation of widely applicable, user-friendly programmes and delivery formats that can be tailored to different client groups.



2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Katie O’Hearn ◽  
Cameron MacDonald ◽  
Anne Tsampalieros ◽  
Leo Kadota ◽  
Ryan Sandarage ◽  
...  

Abstract Background Standard practice for conducting systematic reviews (SRs) is time consuming and involves the study team screening hundreds or thousands of citations. As the volume of medical literature grows, the citation set sizes and corresponding screening efforts increase. While larger team size and alternate screening methods have the potential to reduce workload and decrease SR completion times, it is unknown whether investigators adapt team size or methods in response to citation set sizes. Using a cross-sectional design, we sought to understand how citation set size impacts (1) the total number of authors or individuals contributing to screening and (2) screening methods. Methods MEDLINE was searched in April 2019 for SRs on any health topic. A total of 1880 unique publications were identified and sorted into five citation set size categories (after deduplication): < 1,000, 1,001–2,500, 2,501–5,000, 5,001–10,000, and > 10,000. A random sample of 259 SRs were selected (~ 50 per category) for data extraction and analysis. Results With the exception of the pairwise t test comparing the under 1000 and over 10,000 categories (median 5 vs. 6, p = 0.049) no statistically significant relationship was evident between author number and citation set size. While visual inspection was suggestive, statistical testing did not consistently identify a relationship between citation set size and number of screeners (title-abstract, full text) or data extractors. However, logistic regression identified investigators were significantly more likely to deviate from gold-standard screening methods (i.e. independent duplicate screening) with larger citation sets. For every doubling of citation size, the odds of using gold-standard screening decreased by 15 and 20% at title-abstract and full text review, respectively. Finally, few SRs reported using crowdsourcing (n = 2) or computer-assisted screening (n = 1). Conclusions Large citation set sizes present a challenge to SR teams, especially when faced with time-sensitive health policy questions. Our study suggests that with increasing citation set size, authors are less likely to adhere to gold-standard screening methods. It is possible that adjunct screening methods, such as crowdsourcing (large team) and computer-assisted technologies, may provide a viable solution for authors to complete their SRs in a timely manner.



1994 ◽  
Vol 165 (5) ◽  
pp. 593-598 ◽  
Author(s):  
Judy Harrison ◽  
Peter Maguire

BackgroundA significant proportion of cancer patients experience psychiatric morbidity in association with diagnosis and treatment. If this morbidity is to be reduced, a better understanding is needed of the factors which influence adjustment to cancer.MethodA review of the literature was carried out to explore those factors associated with poor psychological adjustment to cancer. These are described under four headings: characteristics of the patient; disease and treatment variables; the interaction between patient and illness; and environmental factors.ResultsA number of risk factors for psychiatric morbidity can be identified from each of the four areas. Methodological limitations are highlighted, in particular the preponderance of cross-sectional study designs.ConclusionsIncreased awareness of the risk factors for psychiatric morbidity should lead to earlier detection and more appropriate treatment. Future research should focus on those risk factors which are potentially modifiable.



BMJ Open ◽  
2017 ◽  
Vol 7 (9) ◽  
pp. e017567
Author(s):  
Shimels Hussien Mohammed ◽  
Mulugeta Molla Birhanu ◽  
Tesfamichael Awoke Sissay ◽  
Tesfa Dejenie Habtewold ◽  
Balewgizie Sileshi Tegegn ◽  
...  

IntroductionIndividuals living in poor neighbourhoods are at a higher risk of overweight/obesity. There is no systematic review and meta-analysis study on the association of neighbourhood socioeconomic status (NSES) with overweight/obesity. We aimed to systematically review and meta-analyse the existing evidence on the association of NSES with overweight/obesity.Methods and analysisCross-sectional, case–control and cohort studies published in English from inception to 15 May 2017 will be systematically searched using the following databases: PubMed, EMBASE, Web of Sciences and Google Scholar. Selection, screening, reviewing and data extraction will be done by two reviewers, independently and in duplicate. The Newcastle–Ottawa Scale (NOS) will be used to assess the quality of evidence. Publication bias will be checked by visual inspection of funnel plots and Egger’s regression test. Heterogeneity will be checked by Higgins’s method (I2statistics). Meta-analysis will be done to estimate the pooled OR. Narrative synthesis will be performed if meta-analysis is not feasible due to high heterogeneity of studies.Ethics and disseminationEthical clearance is not required as we will be using data from published articles. Findings will be communicated through a publication in a peer-reviewed journal and presentations at professional conferences.PROSPERO registration numberCRD42017063889.



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