External validity of phase III trials on vaccines against SARS-CoV-2 to a middle-aged and elderly Western European population.
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ABSTRACT:
SUBMITTER: Terzikhan N
PROVIDER: S-EPMC7906827 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:ObjectiveTo study the differential distribution of transportation injury mortality by educational level in nine European settings, among people older than 30 years, during the 1990s.MethodsDeaths of men and women older than 30 years from transportation injuries were studied. Rate differences and rate ratios (RR) between high and low educational level rates were obtained.ResultsAmong men, those of low educational level had higher death rates in all settings, a pattern that was maintained in the different settings; no inequalities were found among women. Among men, in all the settings, the RR was higher in the 30-49 age group (RR 1.46, 95% CI 1.32 to 1.61) than in the age groups 50-69 and > or = 70 years, a pattern that was maintained in the different settings. For women for all the settings together, no differences were found among educational levels in the three age groups. In the different settings, only three had a high RR in the youngest age group, Finland (RR 1.33, 95% CI 1.01 to 1.74), Belgium (RR 1.38; 95% CI 1.13 to 1.67), and Austria (RR 1.49, 95% CI 0.75 to 2.96).ConclusionThis study provides new evidence on the importance of socioeconomic inequalities in transportation injury mortality across Europe. This applies to men, but not to women. Greater attention should be placed on opportunities to select intervention strategies tailored to tackle socioeconomic inequalities in transportation injuries.
| S-EPMC1730212 | biostudies-literature
Project description:ObjectivesTo assess aspects of the internal validity of recently published cluster randomised trials and explore the reporting of information useful in assessing the external validity of these trials.DesignReview of 34 cluster randomised trials in primary care published in 2004 and 2005 in seven journals (British Medical Journal, British Journal of General Practice, Family Practice, Preventive Medicine, Annals of Internal Medicine, Journal of General Internal Medicine, Pediatrics).Data sourcesNational Library of Medicine (Medline) via PubMed.Data extractionTo assess aspects of internal validity we extracted data on appropriateness of sample size calculations and analyses, methods of identifying and recruiting individual participants, and blinding. To explore reporting of information useful in assessing external validity we extracted data on cluster eligibility, cluster inclusion and retention, cluster generalisability, and the feasibility and acceptability of the intervention to health providers in clusters.Results21 (62%) trials accounted for clustering in sample size calculations and 30 (88%) in the analysis; about a quarter were potentially biased because of procedures surrounding recruitment and identification of patients; individual participants were blind to allocation status in 19 (56%) and outcome assessors were blind in 15 (44%). In almost half the reports, information relating to generalisability of clusters was poorly reported, and in two fifths there was no information about the feasibility and acceptability of the intervention.ConclusionsCluster randomised trials are essential for evaluating certain types of interventions. Issues affecting their internal validity, such as appropriate sample size calculations and analysis, have been widely disseminated and are now better addressed by researchers. Blinding of those identifying and recruiting patients to allocation status is recommended but is not always carried out. There may be fewer barriers to internal validity in trials in which individual participants are not recruited. External validity seems poorly addressed in many trials, yet is arguably as important as internal validity in judging quality as a basis for healthcare intervention.
| S-EPMC2323095 | biostudies-literature
Project description:External auditory exostoses (EAE) have been noted among the Neandertals and a few other Pleistocene humans, but until recently they have been discussed primary as minor pathological lesions with possible auditory consequences. An assessment of available western Eurasian late Middle and Late Pleistocene human temporal bones with sufficiently preserved auditory canals (n = 77) provides modest levels of EAE among late Middle Pleistocene archaic humans (?20%) and early modern humans (Middle Paleolithic: ?25%; Early/Mid Upper Paleolithic: 20.8%; Late Upper Paleolithic: 9.5%). The Neandertals, however, exhibit an exceptionally high level of EAE (56.5%; 47.8% if two anomalous cases are considered normal). The levels of EAE for the early modern humans are well within recent human ranges of variation, frequencies which are low for equatorial inland and high latitude samples but occasionally higher elsewhere. The Early/Mid Upper Paleolithic frequency is nonetheless high for a high latitude sample under interpleniglacial conditions. Given the strong etiological and environmental associations of EAE development with exposure to cold water and/or damp wind chill, the high frequency of EAE among the Neandertals implies frequent aquatic resource exploitation, more frequent than the archeological and stable isotopic evidence for Middle Paleolithic/Neandertal littoral and freshwater resource foraging implies. As such, the Neandertal data parallel a similar pattern evident in eastern Eurasian archaic humans. Yet, factors in addition to cold water/wind exposure may well have contributed to their high EAE frequencies.
| S-EPMC6693685 | biostudies-literature
Project description:ObjectiveWe used the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework to conduct a systematic review of external validity reporting in integrated primary care (IPC) interventions for mental health concerns.MethodsWe searched Medline, CINAHL, PsycINFO, the Cochrane Center Register of Controlled Trials, and relevant literature to identify publications from 1998 to 2018 reporting on open, randomized, or quasi-randomized trials of IPC interventions that targeted child (ages 0-18 years) psychological symptoms. For each publication, we extracted the information reported in each RE-AIM domain and calculated the proportion of the total studies reviewed.ResultsThirty-nine publications describing 25 studies were included in the review. Publications rarely reported some indicators of external validity, including the representativeness of participants (12%), rate of adoption clinics or providers (16%), cost of implementation (8%), or evidence of maintenance (16%). Few studies reported on key pragmatic factors such as cost or organizational change processes related to implementation and maintenance. Strengths of some studies included comparisons of multiple active treatments, use of tailorable interventions, and implementation in "real world" settings.ConclusionsAlthough IPC interventions appear efficacious under research conditions, there are significant knowledge gaps regarding the degree to which they reach and engage target recipients, what factors impact adoption and implementation of IPC interventions by clinicians, how fidelity can be maintained over time, and cost-effectiveness. Pediatric IPC researchers should embrace dissemination and implementation science methods to balance internal and external validity concerns moving forward.
| S-EPMC8202128 | biostudies-literature
Project description:BackgroundTo critically assess the external validity of randomized controlled trials (RCTs) it is important to know what older adults have been enrolled in the trials. The aim of this systematic review is to study what proportion of trials specifically designed for older patients report on somatic status, physical and mental functioning, social environment and frailty in the patient characteristics.MethodsPubMed was searched for articles published in 2012 and only RCTs were included. Articles were further excluded if not conducted with humans or only secondary analyses were reported. A random sample of 10% was drawn. The current review analyzed this random sample and further selected trials when the reported mean age was ≥ 60 years. We extracted geriatric assessments from the population descriptives or the in- and exclusion criteria.ResultsIn total 1396 trials were analyzed and 300 trials included. The median of the reported mean age was 66 (IQR 63-70) and the median percentage of men in the trials was 60 (IQR 45-72). In 34% of the RCTs specifically designed for older patients somatic status, physical and mental functioning, social environment or frailty were reported in the population descriptives or the in- and exclusion criteria. Physical and mental functioning was reported most frequently (22% and 14%). When selecting RCTs on a mean age of 70 or 80 years the report of geriatric assessments in the patient characteristics was 46% and 85% respectively but represent only 5% and 1% of the trials.ConclusionSomatic status, physical and mental functioning, social environment and frailty are underreported even in RCTs specifically designed for older patients published in 2012. Therefore, it is unclear for clinicians to which older patients the results can be applied. We recommend systematic to transparently report these relevant characteristics of older participants included in RCTs.
| S-EPMC5367677 | biostudies-literature
Project description:Sleep has been hypothesised to facilitate waste clearance from the brain. We aimed to determine whether sleep is associated with perivascular spaces on brain magnetic resonance imaging (MRI), a potential marker of impaired brain waste clearance, in a population-based cohort of middle-aged and elderly people. In 559 participants (mean [SD] age 62 [6] years, 52% women) from the population-based Rotterdam Study, we measured total sleep time, sleep onset latency, wake after sleep onset and sleep efficiency with actigraphy and polysomnography. Perivascular space load was determined with brain MRI in four regions (centrum semiovale, basal ganglia, hippocampus, and midbrain) via a validated machine learning algorithm using T2-weighted MR images. Associations between sleep characteristics and perivascular space load were analysed with zero-inflated negative binomial regression models adjusted for various confounders. We found that higher actigraphy-estimated sleep efficiency was associated with a higher perivascular space load in the centrum semiovale (odds ratio 1.10, 95% confidence interval 1.04-1.16, p = 0.0008). No other actigraphic or polysomnographic sleep characteristics were associated with perivascular space load in other brain regions. We conclude that, contrary to our hypothesis, associations of sleep with perivascular space load in this middle-aged and elderly population remained limited to an association of a high actigraphy-estimated sleep efficiency with a higher perivascular space load in the centrum semiovale.
| S-EPMC9285071 | biostudies-literature
Project description:Indirect calorimetry (IC) is considered the reference method to determine the resting energy expenditure (REE), but its use in a clinical context is limited. Alternatively, there is a number of REE predictive equations to estimate the REE. However, it has been shown that the available REE predictive equations could either overestimate or underestimate the REE as measured by IC. Moreover, the role of the weight status in the accuracy and validity of the REE predictive equations requires further attention. Therefore, this study aimed to determine the accuracy and validity of REE predictive equations in normal-weight, overweight, and obese sedentary middle-aged adults. A total of 73 sedentary middle-aged adults (53% women, 40⁻65 years old) participated in the study. We measured REE by indirect calorimetry, strictly following the standard procedures, and we compared it with the values obtained from 33 predictive equations. The most accurate predictive equations in middle-aged sedentary adults were: (i) the equation of FAO/WHO/UNU in normal-weight individuals (50.0% of prediction accuracy), (ii) the equation of Livingston in overweight individuals (46.9% of prediction accuracy), and (iii) the equation of Owen in individuals with obesity (52.9% of prediction accuracy). Our study shows that the weight status plays an important role in the accuracy and validity of different REE predictive equations in middle-aged adults.
| S-EPMC6266118 | biostudies-literature
Project description:BACKGROUND: Controlled clinical trials of health care interventions are either explanatory or pragmatic. Explanatory trials test whether an intervention is efficacious; that is, whether it can have a beneficial effect in an ideal situation. Pragmatic trials measure effectiveness; they measure the degree of beneficial effect in real clinical practice. In pragmatic trials, a balance between external validity (generalizability of the results) and internal validity (reliability or accuracy of the results) needs to be achieved. The explanatory trial seeks to maximize the internal validity by assuring rigorous control of all variables other than the intervention. The pragmatic trial seeks to maximize external validity to ensure that the results can be generalized. However the danger of pragmatic trials is that internal validity may be overly compromised in the effort to ensure generalizability. We are conducting two pragmatic randomized controlled trials on interventions in the management of hypertension in primary care. We describe the design of the trials and the steps taken to deal with the competing demands of external and internal validity. DISCUSSION: External validity is maximized by having few exclusion criteria and by allowing flexibility in the interpretation of the intervention and in management decisions. Internal validity is maximized by decreasing contamination bias through cluster randomization, and decreasing observer and assessment bias, in these non-blinded trials, through baseline data collection prior to randomization, automating the outcomes assessment with 24 hour ambulatory blood pressure monitors, and blinding the data analysis. SUMMARY: Clinical trials conducted in community practices present investigators with difficult methodological choices related to maintaining a balance between internal validity (reliability of the results) and external validity (generalizability). The attempt to achieve methodological purity can result in clinically meaningless results, while attempting to achieve full generalizability can result in invalid and unreliable results. Achieving a creative tension between the two is crucial.
| S-EPMC317298 | biostudies-literature
Project description:BackgroundMagnetic resonance imaging (MRI) of the knee is often performed in patients who have knee symptoms of unclear cause. When meniscal tears are found, it is commonly assumed that the symptoms are attributable to them. However, there is a paucity of data regarding the prevalence of meniscal damage in the general population and the association of meniscal tears with knee symptoms and with radiographic evidence of osteoarthritis.MethodsWe studied persons from Framingham, Massachusetts, who were drawn from census-tract data and random-digit telephone dialing. Subjects were 50 to 90 years of age and ambulatory; selection was not made on the basis of knee or other joint problems. We assessed the integrity of the menisci in the right knee on 1.5-tesla MRI scans obtained from 991 subjects (57% of whom were women). Symptoms involving the right knee were evaluated by questionnaire.ResultsThe prevalence of a meniscal tear or of meniscal destruction in the right knee as detected on MRI ranged from 19% (95% confidence interval [CI], 15 to 24) among women 50 to 59 years of age to 56% (95% CI, 46 to 66) among men 70 to 90 years of age; prevalences were not materially lower when subjects who had had previous knee surgery were excluded. Among persons with radiographic evidence of osteoarthritis (Kellgren-Lawrence grade 2 or higher, on a scale of 0 to 4, with higher numbers indicating more definite signs of osteoarthritis), the prevalence of a meniscal tear was 63% among those with knee pain, aching, or stiffness on most days and 60% among those without these symptoms. The corresponding prevalences among persons without radiographic evidence of osteoarthritis were 32% and 23%. Sixty-one percent of the subjects who had meniscal tears in their knees had not had any pain, aching, or stiffness during the previous month.ConclusionsIncidental meniscal findings on MRI of the knee are common in the general population and increase with increasing age.
| S-EPMC2897006 | biostudies-literature
Project description:ContextChronic diseases are growing in India and largely affecting the middle-aged and elderly population; many of them are in working age. Though a large number of studies estimated the out-of-pocket payment and financial catastrophe due to this condition, there are no nationally representative studies on productivity loss due to health problems. This paper examined the pattern and prevalence of productivity loss, due to chronic diseases among middle-aged and elderly in India.MethodsWe have used a total of 72,250 respondents from the first wave of Longitudinal Ageing Study in India (LASI), conducted in 2017-18. We have used two dependent variables, limiting paid work and ever stopped work due to ill health. We have estimated the age-sex adjusted prevalence of ever stopped working due to ill health and limiting paid work across MPCE quintile and socio- demographic characteristics. Propensity Score Matching (PSM) and logistic regression was used to examine the effect of chronic diseases on both these variables.FindingsWe estimated that among middle aged adults in 45-64 years, 3,213 individuals accounting to 6.9% (95%CI:6.46-7.24) had ever-stopped work and 6,300 individuals accounting to 22.7% (95% CI: 21.49-23.95) had limiting paid work in India. The proportion of ever-stopped and limiting work due to health problem increased significantly with age and the number of chronic diseases. Limiting paid work is higher among females (25.1%), and in urban areas (24%) whereas ever-stopped is lower among female (5.7%) (95% CI:5.16-6.25 ) and in urban areas (4.9%) (95% CI: 4.20-5.69). The study also found that stroke (21.1%) and neurological or psychiatric problems (18%) were significantly associated with both ever stopped work and limiting paid work. PSM model shows that, those with chronic diseases are 4% and 11% more likely to stop and limit their work respectively. Regression model reveals that more than one chronic conditions had a consistent and significant positive impact on stopping work for over a year (increasing productivity loss) across all three models.ConclusionIndividuals having any chronic disease has higher likelihood of ever stopped work and limiting paid work. Promoting awareness, screening and treatment at workplace is recommended to reduce adverse consequences of chronic disease in India.
| S-EPMC9756765 | biostudies-literature