Tag: statistics

Am J Clin Nutr. 2022 Jan 4:nqab430. doi: 10.1093/ajcn/nqab430. Online ahead of print.

ABSTRACT

BACKGROUND: Newborn oil massage is a widespread practice. Vigorous massage with potentially harmful products and forced removal of vernix may disrupt skin barrier integrity. Hospitalized, very preterm infants treated with sunflower seed oil (SSO) have demonstrated improved growth but community-based data on growth and health outcomes are lacking.

OBJECTIVE: We aimed to test whether SSO therapy enhances neonatal growth and reduces morbidity at population-level.

DESIGN: We conducted an open-label, controlled trial in rural Uttar Pradesh, India, randomly allocating 276 village clusters equally to comparison (usual care) and intervention comprised of promotion of improved massage practices exclusively with SSO, using intention-to-treat and per-protocol mixed-effects regression analysis.

RESULTS: We enrolled 13,478 and 13,109 newborn infants in demographically similar intervention and comparison arms, respectively. Adherence to exclusive SSO increased from 22.6% of intervention infants enrolled in the first study quartile to 37.2% in the last quartile. Intervention infants gained significantly more weight by 0.94 grams/kilogram/day (g/kg/d) [95% confidence interval (CI): 0.07, 1.82, p = 0.03] than comparison infants by intention-to-treat analysis. Restricted cubic spline regression revealed the largest benefits in weight gain (2-4 g/kg/day) occurred in infants <2000 g. Weight gain in intervention infants was higher by 1.31 g/kg/d (95% CI: 0.17, 2.46, p = 0.02) by per-protocol analysis. Morbidities were similar by intention-to-treat analysis but in per-protocol analysis rates of hospitalization and of any illness were reduced by 36% [odds ratio (OR): 0.64; 95% CI: 0.44, 0.94, p = 0.02] and 44% (OR: 0.56; 95% CI: 0.40, 0.77, p<0.001), respectively, in treated infants.

CONCLUSIONS: SSO therapy improved neonatal growth, and reduced morbidities when applied exclusively, across the facility-community continuum of care at population-level. Further research is needed to improve demand for recommended therapy inside hospital as well as in community settings, and to confirm these results in other settings. Clinical Trial Registry: The trial was registered at the ISRCTN (ISRCTN38965585) and CTRI (CTRI/2014/12/005282) registries with WHO UTN # U1111-1158-4665.

PMID:34982820 | DOI:10.1093/ajcn/nqab430

PLoS One. 2022 Jan 4;17(1):e0262317. doi: 10.1371/journal.pone.0262317. eCollection 2022.

ABSTRACT

Gastrointestinal disease (GI) is the most common illness in pre-weaned dairy calves. Studies have associated the fecal microbiome composition with health status, but it remains unclear how the microbiome changes across different levels of GI disease and breeds. Our objective was to associate the clinical symptoms of GI disease with the fecal microbiome. Fecal samples were collected from calves (n = 167) of different breeds (Holstein, Jersey, Jersey-cross and beef-cross) from 4-21 d of age. Daily clinical evaluations assessed health status. Calves with loose or watery feces were diagnosed with diarrhea and classified as bright-sick (BS) or depressed-sick (DS) according to behavior. Calves with normal or semiformed feces and no clinical illness were classified as healthy (H). One hundred and three fecal samples were obtained from consistently healthy calves and 64 samples were from calves with diarrhea (n = 39 BS; n = 25 DS). The V3-V4 region of 16S rRNA gene was sequenced and analyzed. Differences were identified by a linear-mixed effects model with a negative binomial error. DS and Jersey calves had a higher relative abundance of Streptococcus gallolyticus relative to H Holstein calves. In addition, DS calves had a lower relative abundance of Bifidobacterium longum and an enrichment of Escherichia coli. Species of the genus Lactobacillus, such as an unclassified Lactobacillus, Lactobacillus reuteri, and Lactobacillus salivarius were enriched in calves with GI disease. Moreover, we created a model to predict GI disease based on the fecal microbiome composition. The presence of Eggerthella lenta, Bifidobacterium longum, and Collinsella aerofaciens were associated with a healthy clinical outcome. Although lactobacilli are often associated with beneficial probiotic properties, the presence of E. coli and Lactobacillus species had the highest coefficients positively associated with GI disease prediction. Our results indicate that there are differences in the fecal microbiome of calves associated with GI disease severity and breed specificities.

PMID:34982792 | DOI:10.1371/journal.pone.0262317

PLoS One. 2022 Jan 4;17(1):e0262295. doi: 10.1371/journal.pone.0262295. eCollection 2022.

ABSTRACT

BACKGROUND: Adolescent girls face several challenges relating to menstruation and its proper management. Lack of adequate sanitary products, inadequate water supply, and privacy for changing sanitary pads continue to leave adolescent girls with limited options for safe and proper menstrual hygiene in many low-income settings, including Ethiopia. These situations are also compounded by societal myths, stigmas surrounding menstruation, and discriminatory social norms. This systematic review and meta-analysis aimed to estimate the pooled proportion of safe menstrual hygiene management among adolescent girls in Ethiopia using the available studies.

METHODS: We searched PubMed, Google Scholar, African Journal Online (AJOL), Hinari, Science Direct, ProQuest, Direct of Open Access Journals, POPLINE, and Cochrane Library database inception to May 31, 2021. Studies reporting the proportion of menstrual hygiene management among adolescent girls in Ethiopia were considered. The Cochrane Q test statistics and I2 tests were used to assess the heterogeneity of the included studies. Since the included studies revealed considerable heterogeneity, a random effect meta-analysis model was used to estimate the pooled proportion of menstrual hygiene management (MHM).

RESULTS: Of 1,045 identified articles, 22 studies were eligible for analysis (n = 12,330 participants). The pooled proportion (PP) of safe MHM in Ethiopia was 52.69% (95%CI: 44.16, 61.22). The use of commercial menstrual absorbents was common 64.63% (95%CI: 55.32, 73.93, I2 99.2%) followed by homemade cloth 53.03% (95%CI: 22.29, 83.77, I2 99.2%). Disposal of absorbent material into the latrine was the most common practice in Ethiopia 62.18% (95%CI: 52.87, 71.49, I2 98.7%). One in four girls reported missing one or more school days during menstruation (PP: 32.03%, 95%CI: 22.65%, 41.40%, I2 98.2%).

CONCLUSION: This study revealed that only half of the adolescent girls in Ethiopia had safe MHM practices. To ensure that girls in Ethiopia can manage menstruation hygienically and with dignity, strong gender-specific water, sanitation, and hygiene (WASH) facilities along with strong awareness creation activities at every level are needed.

PMID:34982805 | DOI:10.1371/journal.pone.0262295

PLoS One. 2022 Jan 4;17(1):e0262279. doi: 10.1371/journal.pone.0262279. eCollection 2022.

ABSTRACT

This study aimed to evaluate the effect of cultivation conditions in the context of light on the retention of selected vitamins, minerals and polyphenols in the stem and cap of the oyster mushroom (Pleurotus ostreatus L.). Additionally, the effect of the retention of bioactive components on the antioxidant activity of mushroom extracts was evaluated, taking into account the morphological part. Oyster mushrooms grown in the light of 200 lux had higher riboflavin content compared to mushrooms exposed to the light of lower intensity. The thiamine content of the mushrooms dropped with decreasing light intensity during cultivation. The content of biologically active compounds was found to be equal in the stem and the cap. In the case of riboflavin, it was shown that its contents in cap fractions, irrespective of the cultivation method, was statistically significantly higher than in stems. The mineral composition of caps and stems differed from each other. No differences in Zn and Cu content between the morphological parts of the mushroom studied were found. However, it was shown that the stems, regardless of the type of light, contained less iron, magnesium and sodium. Thus, it was observed that limited light exposure caused an increase in the content of total polyphenolic compounds, which did not correlate with antioxidant activity. There was no effect of the light on the antioxidant activity of mushrooms. It was also shown that stem extracts had higher antioxidant activity compared to the extracts obtained from the caps. This findings point to the possibility and potentail of use both fraction of mushrooms in the new food products development.

PMID:34982785 | DOI:10.1371/journal.pone.0262279

PLoS One. 2022 Jan 4;17(1):e0262307. doi: 10.1371/journal.pone.0262307. eCollection 2022.

ABSTRACT

Every year, billions of egg layer chicks around the world are hatched under highly stressful, industrial circumstances. Here, it is investigated how the stressful procedure in the commercial hatchery, including incubation, hatching, processing, and transport affects the chicks with regards to traits relevant for the egg production industry. These traits were compared to those of a control group hatched in a small incubator and handled gently och quietly in a quiet room without any processing and transport. The chicks were weighed at hatch and at eight additional time points: 4 days, 1 week (w), 2 w, 3 w, 5 w, 8 w, 20 w and 25 w of age. Feather pecking was studied at 15 w of age and damages to the feathers and injuries on the comb and wattle were assessed at 25 w of age. From 19 w of age, eggs were collected on three days per week, counted and weighed. Chicks from a commercial hatchery had a lower hatch weight than control chicks (p<0.001). At 20 w of age, the weight of the commercial hatched chicks was still numerically lower, although this did not reach statistical significance. Commercially hatched chicks tended to show more feather pecking behaviour at 15 w of age compared to control chicks (p<0.1), although feather condition at 25 w of age showed the opposite pattern. Regarding production, commercially hatched chickens laid fewer (p<0.05) and smaller (p<0.05) eggs than chicks hatched and handled under calm circumstances. From this experiment, it is concluded that the stressful experience in the commercial hatchery has an overall negative effect on traits relevant for the industry.

PMID:34982788 | DOI:10.1371/journal.pone.0262307

PLoS One. 2022 Jan 4;17(1):e0262072. doi: 10.1371/journal.pone.0262072. eCollection 2022.

ABSTRACT

BACKGROUND: Prior studies have established those elderly patients with chronic obstructive pulmonary disease (COPD) are at elevated risk for developing influenza-associated complications such as hospitalization, intensive-care admission, and death. This study sought to determine whether influenza vaccination could improve survival among elderly patients with COPD.

MATERIALS/METHODS: This study included Veterans (age ≥ 65 years) diagnosed with COPD that received care at the United States Veterans Health Administration (VHA) during four influenza seasons, from 2012-2013 to 2015-2016. We linked VHA electronic medical records and Medicare administrative files to Centers for Disease Control and Prevention National Death Index cause of death records as well as influenza surveillance data. A multivariable time-dependent Cox proportional hazards model was used to compare rates of mortality of recipients of influenza vaccination to those who did not have records of influenza vaccination. We estimated hazard ratios (HRs) adjusted for age, gender, race, socioeconomic status, comorbidities, and healthcare utilization.

RESULTS: Over a span of four influenza seasons, we included 1,856,970 person-seasons of observation where 1,199,275 (65%) had a record of influenza vaccination and 657,695 (35%) did not have a record of influenza vaccination. After adjusting for comorbidities, demographic and socioeconomic characteristics, influenza vaccination was associated with reduced risk of death during the most severe periods of influenza seasons: 75% all-cause (HR = 0.25; 95% CI: 0.24-0.26), 76% respiratory causes (HR = 0.24; 95% CI: 0.21-0.26), and 82% pneumonia/influenza cause (HR = 0.18; 95% CI: 0.13-0.26). A significant part of the effect could be attributed to “healthy vaccinee” bias as reduced risk of mortality was also found during the periods when there was no influenza activity and before patients received vaccination: 30% all-cause (HR = 0.70; 95% CI: 0.65-0.75), 32% respiratory causes (HR = 0.68; 95% CI: 0.60-0.78), and 51% pneumonia/influenza cause (HR = 0.49; 95% CI: 0.31-0.78). However, as a falsification study, we found that influenza vaccination had no impact on hospitalization due to urinary tract infection (HR = 0.97; 95% CI: 0.80-1.18).

CONCLUSIONS: Among elderly patients with COPD, influenza vaccination was associated with reduced risk for all-cause and cause-specific mortality.

PMID:34982781 | DOI:10.1371/journal.pone.0262072

PLoS Med. 2022 Jan 4;19(1):e1003858. doi: 10.1371/journal.pmed.1003858. eCollection 2022 Jan.

ABSTRACT

BACKGROUND: Financial incentives and audit/feedback are widely used in primary care to influence clinician behaviour and increase quality of care. While observational data suggest a decline in quality when these interventions are stopped, their removal has not been evaluated in a randomised controlled trial (RCT), to our knowledge. This trial aimed to determine whether chlamydia testing in general practice is sustained when financial incentives and/or audit/feedback are removed.

METHODS AND FINDINGS: We undertook a 2 × 2 factorial cluster RCT in 60 general practices in 4 Australian states targeting 49,525 patients aged 16-29 years for annual chlamydia testing. Clinics were recruited between July 2014 and September 2015 and were followed for up to 2 years or until 31 December 2016. Clinics were eligible if they were in the intervention group of a previous cluster RCT where general practitioners (GPs) received financial incentives (AU$5-AU$8) for each chlamydia test and quarterly audit/feedback reports of their chlamydia testing rates. Clinics were randomised into 1 of 4 groups: incentives removed but audit/feedback retained (group A), audit/feedback removed but incentives retained (group B), both removed (group C), or both retained (group D). The primary outcome was the annual chlamydia testing rate among 16- to 29-year-old patients, where the numerator was the number who had at least 1 chlamydia test within 12 months and the denominator was the number who had at least 1 consultation during the same 12 months. We undertook a factorial analysis in which we investigated the effects of removal versus retention of incentives (groups A + C versus groups B + D) and the effects of removal versus retention of audit/feedback (group B + C versus groups A + D) separately. Of 60 clinics, 59 were randomised and 55 (91.7%) provided data (group A: 15 clinics, 11,196 patients; group B: 14, 11,944; group C: 13, 11,566; group D: 13, 14,819). Annual testing decreased from 20.2% to 11.7% (difference -8.8%; 95% CI -10.5% to -7.0%) in clinics with incentives removed and decreased from 20.6% to 14.3% (difference -7.1%; 95% CI -9.6% to -4.7%) where incentives were retained. The adjusted absolute difference in treatment effect was -0.9% (95% CI -3.5% to 1.7%; p = 0.2267). Annual testing decreased from 21.0% to 11.6% (difference -9.5%; 95% CI -11.7% to -7.4%) in clinics where audit/feedback was removed and decreased from 19.9% to 14.5% (difference -6.4%; 95% CI -8.6% to -4.2%) where audit/feedback was retained. The adjusted absolute difference in treatment effect was -2.6% (95% CI -5.4% to -0.1%; p = 0.0336). Study limitations included an unexpected reduction in testing across all groups impacting statistical power, loss of 4 clinics after randomisation, and inclusion of rural clinics only.

CONCLUSIONS: Audit/feedback is more effective than financial incentives of AU$5-AU$8 per chlamydia test at sustaining GP chlamydia testing practices over time in Australian general practice.

TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12614000595617.

PMID:34982767 | DOI:10.1371/journal.pmed.1003858

PLoS Med. 2022 Jan 4;19(1):e1003855. doi: 10.1371/journal.pmed.1003855. eCollection 2022 Jan.

ABSTRACT

BACKGROUND: Hypertension is the most important cardiovascular risk factor in India, and representative studies of middle-aged and older Indian adults have been lacking. Our objectives were to estimate the proportions of hypertensive adults who had been diagnosed, took antihypertensive medication, and achieved control in the middle-aged and older Indian population and to investigate the association between access to healthcare and hypertension management.

METHODS AND FINDINGS: We designed a nationally representative cohort study of the middle-aged and older Indian population, the Longitudinal Aging Study in India (LASI), and analyzed data from the 2017-2019 baseline wave (N = 72,262) and the 2010 pilot wave (N = 1,683). Hypertension was defined as self-reported physician diagnosis or elevated blood pressure (BP) on measurement, defined as systolic BP ≥ 140 mm Hg or diastolic BP ≥ 90 mm Hg. Among hypertensive individuals, awareness, treatment, and control were defined based on self-reports of having been diagnosed, taking antihypertensive medication, and not having elevated BP, respectively. The estimated prevalence of hypertension for the Indian population aged 45 years and older was 45.9% (95% CI 45.4%-46.5%). Among hypertensive individuals, 55.7% (95% CI 54.9%-56.5%) had been diagnosed, 38.9% (95% CI 38.1%-39.6%) took antihypertensive medication, and 31.7% (95% CI 31.0%-32.4%) achieved BP control. In multivariable logistic regression models, access to public healthcare was a key predictor of hypertension treatment (odds ratio [OR] = 1.35, 95% CI 1.14-1.60, p = 0.001), especially in the most economically disadvantaged group (OR of the interaction for middle economic status = 0.76, 95% CI 0.61-0.94, p = 0.013; OR of the interaction for high economic status = 0.84, 95% CI 0.68-1.05, p = 0.124). Having health insurance was not associated with improved hypertension awareness among those with low economic status (OR = 0.96, 95% CI 0.86-1.07, p = 0.437) and those with middle economic status (OR of the interaction = 1.15, 95% CI 1.00-1.33, p = 0.051), but it was among those with high economic status (OR of the interaction = 1.28, 95% CI 1.10-1.48, p = 0.001). Comparing hypertension awareness, treatment, and control rates in the 4 pilot states, we found statistically significant (p < 0.001) improvement in hypertension management from 2010 to 2017-2019. The limitations of this study include the pilot sample being relatively small and that it recruited from only 4 states.

CONCLUSIONS: Although considerable variations in hypertension diagnosis, treatment, and control exist across different sociodemographic groups and geographic areas, reducing uncontrolled hypertension remains a public health priority in India. Access to healthcare is closely tied to both hypertension diagnosis and treatment.

PMID:34982770 | DOI:10.1371/journal.pmed.1003855

Crit Care Med. 2022 Jan 5. doi: 10.1097/CCM.0000000000005427. Online ahead of print.

ABSTRACT

OBJECTIVES: To determine whether IV vitamin C therapy reduces 28-day mortality in patients with septic shock.

DESIGN: Multicenter, double-blinded, randomized controlled trial.

SETTING: One academic medical ICU and four community ICUs.

PATIENTS: Of 167 adult patients within 24 hours of vasopressor initiation for septic shock, 126 consented to participation, and 124 received study drug and were included in analysis.

INTERVENTIONS: IV vitamin C (10 mg/mL in normal saline) administered as a 1,000-mg bolus over 30 minutes followed by continuous infusion of 250 mg/hr for 96 hours or placebo of equal volumes of normal saline.

MEASUREMENTS AND MAIN RESULTS: Of 124 subjects receiving study drug and included in analysis, 60 received vitamin C and 64 placebo. The primary outcome of all-cause 28-day mortality (vitamin C, 26.7%; placebo, 40.6%; p = 0.10) was lower in the vitamin C arm but did not reach statistical significance. Initiation of renal replacement therapy was higher in the vitamin C arm (vitamin C, 16.7%; placebo, 3.3%; p = 0.015), as was volume of fluid administration within 6 hours of study drug initiation (vitamin C, 1.07 L; placebo, 0.76 L; p = 0.03). There were no statistically significant differences in other secondary outcomes. In post hoc subgroup analysis, there was a decrease in 28-day mortality in the vitamin C arm among patients requiring positive-pressure ventilation at the time of enrollment (vitamin C, 36.3%; placebo, 60.0%; p = 0.05). This trial is registered at clinicaltrials.gov under identifier NCT03338569.

CONCLUSIONS: Vitamin C monotherapy failed to significantly reduce mortality in septic shock patients as hypothesized. Our findings do not support its routine clinical use for this purpose.

PMID:34982738 | DOI:10.1097/CCM.0000000000005427

PLoS One. 2022 Jan 4;17(1):e0259994. doi: 10.1371/journal.pone.0259994. eCollection 2022.

ABSTRACT

This paper evaluates the performance of eight tests with null hypothesis of cointegration on basis of probabilities of type I and II errors using Monte Carlo simulations. This study uses a variety of 132 different data generations covering three cases of deterministic part and four sample sizes. The three cases of deterministic part considered are: absence of both intercept and linear time trend, presence of only the intercept and presence of both the intercept and linear time trend. It is found that all of tests have either larger or smaller probabilities of type I error and concluded that tests face either problems of over rejection or under rejection, when asymptotic critical values are used. It is also concluded that use of simulated critical values leads to controlled probability of type I error. So, the use of asymptotic critical values may be avoided, and the use of simulated critical values is highly recommended. It is found and concluded that the simple LM test based on KPSS statistic performs better than rest for all specifications of deterministic part and sample sizes.

PMID:34982763 | DOI:10.1371/journal.pone.0259994