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International Journal of Dermatology Sep 2021There is a lack of validated tools to measure fatigue in patients with inflammatory skin, neuropsychiatric, and medical disorders. The use of nonvalidated tools may... (Review)
Review
There is a lack of validated tools to measure fatigue in patients with inflammatory skin, neuropsychiatric, and medical disorders. The use of nonvalidated tools may compromise the quality of data. The purpose of this meta-review was to evaluate existing fatigue scales commonly used to assess fatigue in other inflammatory conditions and to identify if there are scales that have been validated in dermatologic conditions. The PubMed/MEDLINE and SCOPUS databases were systematically searched from inception through March 10, 2020, in accordance with the PRISMA statement. Validated tools were identified and assessed according to their main measurement properties. The literature search identified 403 references, and eight studies were eligible and assessed in this review. The unidimensional fatigue scales included were the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F), Brief Fatigue Inventory, Fatigue Severity Scale, Numerical Rating Scale - Fatigue, and Visual Analog Scale - Fatigue. The multidimensional fatigue scales found were the Checklist Individual Strength, Chalder Fatigue Scale, Multidimensional Assessment of Fatigue, Multidimensional Fatigue Inventory Scale, and Piper Fatigue Scale. To measure fatigue, a brief scale with the ability to detect change is needed as there is a growing interest in evaluating this dimension of treatment response. In addition, a good content validity is also needed. From this systematic review, none of the selected scales have had content validation, even though the FACIT was validated in patients with psoriatic arthritis. Validation studies in specific disorders are urgently warranted.
Topics: Checklist; Chronic Disease; Fatigue; Humans; Pain Measurement; Reproducibility of Results; Severity of Illness Index
PubMed: 33301180
DOI: 10.1111/ijd.15341 -
BMJ (Clinical Research Ed.) May 2016To provide an overview of prediction models for risk of cardiovascular disease (CVD) in the general population. (Review)
Review
OBJECTIVE
To provide an overview of prediction models for risk of cardiovascular disease (CVD) in the general population.
DESIGN
Systematic review.
DATA SOURCES
Medline and Embase until June 2013.
ELIGIBILITY CRITERIA FOR STUDY SELECTION
Studies describing the development or external validation of a multivariable model for predicting CVD risk in the general population.
RESULTS
9965 references were screened, of which 212 articles were included in the review, describing the development of 363 prediction models and 473 external validations. Most models were developed in Europe (n=167, 46%), predicted risk of fatal or non-fatal coronary heart disease (n=118, 33%) over a 10 year period (n=209, 58%). The most common predictors were smoking (n=325, 90%) and age (n=321, 88%), and most models were sex specific (n=250, 69%). Substantial heterogeneity in predictor and outcome definitions was observed between models, and important clinical and methodological information were often missing. The prediction horizon was not specified for 49 models (13%), and for 92 (25%) crucial information was missing to enable the model to be used for individual risk prediction. Only 132 developed models (36%) were externally validated and only 70 (19%) by independent investigators. Model performance was heterogeneous and measures such as discrimination and calibration were reported for only 65% and 58% of the external validations, respectively.
CONCLUSIONS
There is an excess of models predicting incident CVD in the general population. The usefulness of most of the models remains unclear owing to methodological shortcomings, incomplete presentation, and lack of external validation and model impact studies. Rather than developing yet another similar CVD risk prediction model, in this era of large datasets, future research should focus on externally validating and comparing head-to-head promising CVD risk models that already exist, on tailoring or even combining these models to local settings, and investigating whether these models can be extended by addition of new predictors.
Topics: Cardiovascular Diseases; Female; Humans; Male; Models, Theoretical; Predictive Value of Tests; Risk Assessment; Risk Factors
PubMed: 27184143
DOI: 10.1136/bmj.i2416 -
Journal of Biomedical Informatics May 2020This review aims to: 1) evaluate the quality of model reporting, 2) provide an overview of methodology for developing and validating Early Warning Score Systems (EWSs)... (Review)
Review
OBJECTIVES
This review aims to: 1) evaluate the quality of model reporting, 2) provide an overview of methodology for developing and validating Early Warning Score Systems (EWSs) for adult patients in acute care settings, and 3) highlight the strengths and limitations of the methodologies, as well as identify future directions for EWS derivation and validation studies.
METHODOLOGY
A systematic search was conducted in PubMed, Cochrane Library, and CINAHL. Only peer reviewed articles and clinical guidelines regarding developing and validating EWSs for adult patients in acute care settings were included. 615 articles were extracted and reviewed by five of the authors. Selected studies were evaluated based on the Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis (TRIPOD) checklist. The studies were analyzed according to their study design, predictor selection, outcome measurement, methodology of modeling, and validation strategy.
RESULTS
A total of 29 articles were included in the final analysis. Twenty-six articles reported on the development and validation of a new EWS, while three reported on validation and model modification. Only eight studies met more than 75% of the items in the TRIPOD checklist. Three major techniques were utilized among the studies to inform their predictive algorithms: 1) clinical-consensus models (n = 6), 2) regression models (n = 15), and 3) tree models (n = 5). The number of predictors included in the EWSs varied from 3 to 72 with a median of seven. Twenty-eight models included vital signs, while 11 included lab data. Pulse oximetry, mental status, and other variables extracted from electronic health records (EHRs) were among other frequently used predictors. In-hospital mortality, unplanned transfer to the intensive care unit (ICU), and cardiac arrest were commonly used clinical outcomes. Twenty-eight studies conducted a form of model validation either within the study or against other widely-used EWSs. Only three studies validated their model using an external database separate from the derived database.
CONCLUSION
This literature review demonstrates that the characteristics of the cohort, predictors, and outcome selection, as well as the metrics for model validation, vary greatly across EWS studies. There is no consensus on the optimal strategy for developing such algorithms since data-driven models with acceptable predictive accuracy are often site-specific. A standardized checklist for clinical prediction model reporting exists, but few studies have included reporting aligned with it in their publications. Data-driven models are subjected to biases in the use of EHR data, thus it is particularly important to provide detailed study protocols and acknowledge, leverage, or reduce potential biases of the data used for EWS development to improve transparency and generalizability.
Topics: Adult; Early Warning Score; Humans; Intensive Care Units; Models, Statistical; Prognosis; Vital Signs
PubMed: 32278089
DOI: 10.1016/j.jbi.2020.103410 -
Journal of Medical Systems Jan 2022In clinical practice, assessing digital health literacy is important to identify patients who may encounter difficulties adapting to digital health using digital...
In clinical practice, assessing digital health literacy is important to identify patients who may encounter difficulties adapting to digital health using digital technology and service. We developed the Digital Health Technology Literacy Assessment Questionnaire (DHTL-AQ) to assess the ability to use digital health technology, services, and data. The DHTL-AQ was developed in three phases. In the first phase, the conceptual framework and domains and items were generated from a systematic literature review using relevant theory and surveys. In the second phase, a cross-sectional survey with 590 adults age ≥ 18 years was conducted at an academic hospital in Seoul, Korea in January and February 2020 to test face validity of the items. Then, psychometric validation was conducted to determine the final items and cut-off scores of the DHTL-AQ. The eHealth literacy scale, the Newest Vital Sign, and 10 mobile app task ability assessments were examined to test validity. The final DHTL-AQ includes 34 items in two domains (digital functional and digital critical literacy) and 4 categories (Information and Communications Technology terms, Information and Communications Technology icons, use of an app, evaluating reliability and relevance of health information). The DHTL-AQ had excellent internal consistency (overall Cronbach's α = 0.95; 0.87-0.94 for subtotals) and acceptable model fit (CFI = 0.821, TLI = 0.807, SRMR = 0.065, RMSEA = 0.090). The DHTL-AQ was highly correlated with task ability assessment (r = 0.7591), and moderately correlated with the eHealth literacy scale (r = 0.5265) and the Newest Vital Sign (r = 0.5929). The DHTL-AQ is a reliable and valid instrument to measure digital health technology literacy.
Topics: Adolescent; Adult; Biomedical Technology; Cross-Sectional Studies; Digital Technology; Humans; Psychometrics; Reproducibility of Results; Surveys and Questionnaires
PubMed: 35072816
DOI: 10.1007/s10916-022-01800-8 -
Clinical Microbiology and Infection :... Aug 2021Only clinically validated HPV assays can be accepted in cervical cancer screening. (Meta-Analysis)
Meta-Analysis
BACKGROUND
Only clinically validated HPV assays can be accepted in cervical cancer screening.
OBJECTIVES
To update the list of high-risk HPV assays that fulfil the 2009 international validation criteria (Meijer-2009).
DATA SOURCES
PubMed/Medline, Embase, Scopus, references from selected studies; published in January 2014 to August 2020.
STUDY ELIGIBILITY CRITERIA
HPV test validation studies and primary screening studies, involving testing with an index HPV test and a comparator HPV test with reporting of disease outcome (occurrence of histologically confirmed cervical precancer; CIN2+).
PARTICIPANTS
Women participating in cervical cancer screening.
INTERVENTIONS
Testing with an index and a comparator HPV test of clinician-collected cervical specimens and assessment of disease outcome (
validation guidelines, or tests with consistent previous validations. METHODS
Assessment of relative clinical accuracy (including non-inferiority statistics index vs comparator assay) and test reproducibility in individual studies; random effects meta-analyses of the relative clinical sensitivity and specificity of index vs comparator tests.
RESULTS
Seven hrHPV DNA tests consistently fulfilled all validation criteria in multiple studies using predefined test positivity cut-offs (Abbott RealTime High Risk HPV, Anyplex II HPV HR Detection, BD Onclarity HPV Assay, Cobas 4800 HPV Test, HPV-Risk Assay, PapilloCheck HPV-Screening Test and Xpert HPV). Another assay (Alinity m HR HPV Assay) was fully validated in one validation study. The newer Cobas 6800 HPV Test, was validated in two studies against Cobas 4800. Other tests partially fulfilled the international validation criteria (Cervista HPV HR Test, EUROArray HPV, Hybribio's 14 High-Risk HPV, LMNX Genotyping Kit GP HPV, MALDI-TOF, RIATOL qPCR and a number of other in-house developed assays) since the non-inferior accuracy was reached after a posteriori cut-off optimization, inconsistent accuracy findings in different studies, and/or insufficient reproducibility assessment. The APTIMA HPV Assay targeting E6/E7 mRNA of hrHPV was fully validated in one formal validation study and showed slightly lower pooled sensitivity but higher specificity than the standard comparator tests in seven screening studies. However, the current international validation criteria relate to DNA assays. The additional requirement for longitudinal performance data required for non-DNA based HPV assays was not assessed in this review.
CONCLUSIONS
Eleven hrHPV DNA assays fulfil all requirements for use in cervical cancer screening using clinician-collected specimens.
Topics: Alphapapillomavirus; Early Detection of Cancer; Female; Genotyping Techniques; Humans; Papillomaviridae; Papillomavirus Infections; Reproducibility of Results; Sensitivity and Specificity; Uterine Cervical Neoplasms
PubMed: 33975008
DOI: 10.1016/j.cmi.2021.04.031 -
Neuropsychobiology 2023The utility of heart rate variability (HRV) for characterizing psychological stress is primarily impacted by methodological considerations such as study populations,... (Review)
Review
The utility of heart rate variability (HRV) for characterizing psychological stress is primarily impacted by methodological considerations such as study populations, experienced versus induced stress, and method of stress assessment. Here, we review studies on the associations between HRV and psychological stress, examining the nature of stress, ways stress was assessed, and HRV metrics used. The review was performed according to the PRISMA guidelines on select databases. Studies that examined the HRV-stress relationship via repeated measurements and validated psychometric instruments were included (n = 15). Participant numbers and ages ranged between 10 and 403 subjects and 18 and 60 years, respectively. Both experimental (n = 9) and real-life stress (n = 6) have been explored. While RMSSD was the most reported HRV metric (n = 10) significantly associated with stress, other metrics, including LF/HF (n = 7) and HF power (n = 6) were also reported. Various linear and nonlinear HRV metrics have been utilized, with nonlinear metrics used less often. The most frequently used psychometric instrument was the State-Trait Anxiety Inventory (n = 10), though various other instruments have been reported. In conclusion, HRV is a valid measure of the psychological stress response. Standard stress induction and assessment protocols combined with validated HRV measures in different domains will improve the validity of findings.
Topics: Humans; Adult; Heart Rate; Stress, Psychological
PubMed: 37290411
DOI: 10.1159/000530376 -
The reliability and validity of ultrasound to quantify muscles in older adults: a systematic review.Journal of Cachexia, Sarcopenia and... Oct 2017This review evaluates the reliability and validity of ultrasound to quantify muscles in older adults. The databases PubMed, Cochrane, and Cumulative Index to Nursing and... (Meta-Analysis)
Meta-Analysis Review
This review evaluates the reliability and validity of ultrasound to quantify muscles in older adults. The databases PubMed, Cochrane, and Cumulative Index to Nursing and Allied Health Literature were systematically searched for studies. In 17 studies, the reliability (n = 13) and validity (n = 8) of ultrasound to quantify muscles in community-dwelling older adults (≥60 years) or a clinical population were evaluated. Four out of 13 reliability studies investigated both intra-rater and inter-rater reliability. Intraclass correlation coefficient (ICC) scores for reliability ranged from -0.26 to 1.00. The highest ICC scores were found for the vastus lateralis, rectus femoris, upper arm anterior, and the trunk (ICC = 0.72 to 1.000). All included validity studies found ICC scores ranging from 0.92 to 0.999. Two studies describing the validity of ultrasound to predict lean body mass showed good validity as compared with dual-energy X-ray absorptiometry (r = 0.92 to 0.96). This systematic review shows that ultrasound is a reliable and valid tool for the assessment of muscle size in older adults. More high-quality research is required to confirm these findings in both clinical and healthy populations. Furthermore, ultrasound assessment of small muscles needs further evaluation. Ultrasound to predict lean body mass is feasible; however, future research is required to validate prediction equations in older adults with varying function and health.
Topics: Age Factors; Aged; Aged, 80 and over; Body Composition; Humans; Muscle, Skeletal; Organ Size; Reproducibility of Results; Sarcopenia; Ultrasonography
PubMed: 28703496
DOI: 10.1002/jcsm.12210 -
JAMA Pediatrics Dec 2019Because children in a preverbal stage of development are unable to voice their feelings, they completely depend on their caregiving team for the interpretation and...
IMPORTANCE
Because children in a preverbal stage of development are unable to voice their feelings, they completely depend on their caregiving team for the interpretation and management of their pain and discomfort. Thus, accurately validated scales to assess pain and sedation levels are crucial.
OBJECTIVE
To provide clinicians a complete overview on the validity and reliability of the existing pain and sedation scales for different target populations (preterm infants, term infants, and toddlers) and in different clinical contexts.
EVIDENCE REVIEW
BIOSIS Previews, Cumulative Index to Nursing and Allied Health Literature, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Embase, MEDLINE, PsycCRITIQUES, PsycINFO, PSYNDEXplus Literature and Audiovisual Media, and PSYNDEXplus Tests were the databases screened from their inception to August 2018. All studies examining the validity or reliability of a given pain or sedation scale for patients in a preverbal stage of development were included in this systematic review. Those scales that were tested for at least construct validity, internal consistency, and interrater reliability were subsequently scored using the consensus-based standards for the selection of health measurement instruments (COSMIN) checklist.
FINDINGS
In total, 89 validation articles comprising 65 scales were included. Fifty-seven scales (88%) were useful for assessing pain, 13 scales (20%) for assessing sedation, and 4 scales (6%) for assessing both conditions. Forty-two (65%) were behavioral scales, and 23 (35%) were multidimensional scales. Eleven scales (17%) were validated for infants on mechanical ventilation. Thirty-seven scales (57%) were validated for preterm infants, 24 scales (37%) for term and preterm infants, 7 scales (11%) for term-born children, 7 scales (11%) for preterm infants, term infants, and toddlers, and 17 scales (26%) for term infants and toddlers. Twenty-eight scales (43%) considered construct validity, internal consistency, and interrater reliability.
CONCLUSIONS AND RELEVANCE
Clinicians should consider using scales that are validated for at least construct validity, internal consistency, and interrater reliability, combining this information with the population of interest and the construct the scale is intended to measure.
Topics: Child; Child, Preschool; Conscious Sedation; Humans; Infant; Infant, Newborn; Infant, Premature; Pain
PubMed: 31609437
DOI: 10.1001/jamapediatrics.2019.3351 -
British Journal of Clinical Pharmacology Apr 2021Numerous algorithms have been developed to guide warfarin dosing and improve clinical outcomes. We reviewed the algorithms available for various populations and the... (Review)
Review
AIMS
Numerous algorithms have been developed to guide warfarin dosing and improve clinical outcomes. We reviewed the algorithms available for various populations and the covariates, performances and risk of bias of these algorithms.
METHODS
We systematically searched MEDLINE up to 20 May 2020 and selected studies describing the development, external validation or clinical utility of a multivariable warfarin dosing algorithm. Two investigators conducted data extraction and quality assessment.
RESULTS
Of 10 035 screened records, 266 articles were included in the review, describing the development of 433 dosing algorithms, 481 external validations and 52 clinical utility assessments. Most developed algorithms were for dose initiation (86%), developed by multiple linear regression (65%) and mostly applicable to Asians (49%) or Whites (43%). The most common demographic/clinical/environmental covariates were age (included in 401 algorithms), concomitant medications (270 algorithms) and weight (229 algorithms) while CYP2C9 (329 algorithms), VKORC1 (319 algorithms) and CYP4F2 (92 algorithms) variants were the most common genetic covariates. Only 26% and 7% algorithms were externally validated and evaluated for clinical utility, respectively, with <2% of algorithm developments and external validations being rated as having a low risk of bias.
CONCLUSION
Most warfarin dosing algorithms have been developed in Asians and Whites and may not be applicable to under-served populations. Few algorithms have been externally validated, assessed for clinical utility, and/or have a low risk of bias which makes them unreliable for clinical use. Algorithm development and assessment should follow current methodological recommendations to improve reliability and applicability, and under-represented populations should be prioritized.
Topics: Algorithms; Anticoagulants; Cytochrome P-450 CYP2C9; Dose-Response Relationship, Drug; Genotype; Humans; Pharmacogenetics; Reproducibility of Results; Vitamin K Epoxide Reductases; Warfarin
PubMed: 33080066
DOI: 10.1111/bcp.14608 -
International Journal of Environmental... Jul 2022Three-dimensional facial imaging systems are a useful tool that is gradually replacing two-dimensional imaging and traditional anthropometry with calipers. In this... (Review)
Review
Three-dimensional facial imaging systems are a useful tool that is gradually replacing two-dimensional imaging and traditional anthropometry with calipers. In this varied and growing landscape of new devices, Canfield (Canfield Scientific, Parsippany, NJ, USA) has proposed a series of static and portable 3D imaging systems. The aim of this systematic review was to evaluate the current literature regarding the validation of Canfield's Vectra imaging systems. A search strategy was developed on electronic databases including PubMed, Web of Science and Scopus by using specific keywords. After the study selection phase, a total of 10 articles were included in the present review. A total of 10 articles were finally included in the present review. For six articles, we conducted a validation of the Vectra static devices, focusing especially on the Vectra M5, Vectra M3 and Vectra XT. For four articles, we validated the Vectra H1 portable system. All of the reviewed articles concluded that Canfield's Vectra 3D imaging systems are capable of capturing accurate and reproducible stereophotogrammetric images. Minor errors were reported, particularly in the acquisition of the perioral region, but all the evaluated devices are considered to be valid and accurate tools for clinicians.
Topics: Anthropometry; Face; Imaging, Three-Dimensional; Photogrammetry; Reproducibility of Results
PubMed: 35886670
DOI: 10.3390/ijerph19148820