Effects Of Other Confounders Research Articles

Evaluation of factors related to taste function in type 2 diabetics

Aim: The sense is an important driver of diet choice, which can lead to the development of chronic diseases such as diabetes. Although factors affecting differences in taste function between individuals have been evaluated in healthy individuals, there are limited studies investigating them in patients with type 2 diabetes. The aim of the present study was to analyse the factors affecting taste function in individuals with type 2 diabetes. 
 Material and Method: Sixty-one participants with a history of type 2 diabetes lasting at least one year and aged 19 to 75 years were enrolled. The taste function was tested using impregnated filter paper strips. 
 Results: The mean taste strip scores of the participants for sweet, salty, bitter, sour, and overall were 2.38±0.88, 1.91±0.92, 2.28±0.76, 2.18±1.01, 8.7±1.81, respectively. Age was significantly associated with the taste score for salty (r= -0.225 p= 0.041) and sour (r= -0.252 p= 0.040). It was determined that there was no effect of other confounders (gender, body mass index, fasting plasma glucose, glycosylated hemoglobin and duration of diabetes), except age, on the overall taste score in participants.
 Conclusion: Future studies with a larger number of patients may help better investigate the factors affecting taste function in type 2 diabetics.

The Relationship between Skeletal Muscle Mass and Bone Mass at Different Sites in Older Adults

Introduction: It has been well recognized that sarcopenia is closely related with osteoporosis, while the relationship between bone mass at different sites and muscle mass remains largely unexplored. This study aims to explore the relationship between bone mass at different sites and skeletal muscle mass in older adults. Methods: A total of 228 patients over 65 years old were enrolled in this study, and then 180 valid participants with accessible dual-energy X-ray absorptiometry (DXA) scanning data and absence of malignant tumors, mobility disorders, serious liver and kidney disease, and cardiac insufficiency were selected (138 male and 42 female). These individuals were further divided into control group and low skeletal muscle mass index (SMI) group. DXA scanning was used to access skeletal muscle mass and bone mass. SMI or body mass index was defined as appendicular muscle mass or weight divided by squared height, respectively. Low SMI <7.0 kg/m2 in male or <5.4 kg/m2 in female was defined as low SMI; while the bone density score at or below 2.5 standard deviations (T-score) below normal peak bone values, was regarded as osteoporosis. Results: The average age of enrolled patients was 82.72 years; the ratios of osteoporosis, low SMI, and low SMI with osteoporosis were 48.8%, 23.3%, and 15.0%, respectively. Compared with the control group, the prevalence of osteoporosis was higher, and the total bone mass and bone mass at various sites including limbs, spine, and pelvis, were all lower in low SMI group. Correlation analysis showed that SMI was positively related with total bone mass and bone mass at various sites. Covariance analysis showed that only total bone mass and appendicular bone mass decreased with decreasing SMI. After multiple adjustment, osteoporosis was positively related with the prevalence of low SMI, as evidenced by logistic regression analysis (odds ratio = 1.33, 95% confidential interval: 1.04–3.24, p = 0.045). Furthermore, compared with the highest quartile of appendicular bone mass, the lowest quartile was related with the increasing prevalence of low SMI (odds ratio = 7.29, 95% confidential interval: 1.21–67.45, p = 0.042). Conclusion: Compared with the other sites, the bone mass reduction at limbs of older adults was positively associated with skeletal muscle loss. It may be more beneficial to increase bone mass at the limbs for improved sarcopenia prevention and therapy. Further investigations are needed to explore the effects of other confounders (e.g., energy, calcium and vitamin D intake, and physical activity) on the osteoporosis and sarcopenia in older adults.

Peripapillary choroidal thickness assessed by spectral-domain optical coherence tomography in normal Japanese.

To investigate peripapillary choroidal thickness (PPCT) in normal Japanese subjects by using spectral-domain optical coherence tomography (SD-OCT) with enhanced depth imaging (EDI) technique and evaluate its association with ocular and systemic factors. Cross-sectional study. This study included 85 eyes of 85 normal Japanese subjects. Normal subjects were defined as those without retinal and optic nerve disorders of any kind. The PPCT was measured at the location of 3.4mm diameter peripapillary circle centered on the optic nerve head. It was measured as the distance between the retinal pigment epithelium and scleral-choroidal interface at the following six sectors; temporal, supra-temporal, supra-nasal, nasal, infero-nasal, and infero-temporal. Global PPCT was calculated based on these sectorial data. In addition, association between the PPCT and ocular and systemic factors were evaluated. Among the included subjects, 39 (45.9%) were men and mean age was 51.4 ± 17.6years. The mean global PPCT was 135.8 ± 40.6µm. The infero-nasal and infero-temporal sectors were significantly thinner than other sectors (all, P < 0.05). In multiple regression analysis, thinner global PPCT was significantly associated with older age (P < 0.0001) and female sex (P = 0.0330) after considering effects of other confounders. This study provided global PPCT and its profile in normal Japanese subjects by using EDI SD-OCT. These results may be used as a reference in the assessment of normal status of the PPCT. The age and sex of the subjects should be considered in interpreting the PPCT data.

Diabetes management intervention studies: lessons learned from two studies

IntroductionSeveral clinical studies investigated improvements of patient outcomes due to diabetes management interventions. However, chronic disease management is intricate with complex multifactorial behavior patterns. Such studies thus have to be well designed in order to allocate all observed effects to the defined intervention and to exclude effects of other confounders as well as possible.This article aims to provide challenges in interpreting diabetes management intervention studies and suggests approaches for optimizing study implementation and for avoiding pitfalls based on current experiences.Main bodyLessons from the STeP and ProValue studies demonstrated the difficulty in medical device studies that rely on behavioral changes in intervention group patients. To successfully engage patients, priority should be given to health care professionals being engaged, operational support in technical issues being available, and adherence being assessed in detail.Another difficulty is to avoid contamination of the control group with the intervention; therefore, strict allocation concealment should be maintained. However, randomization and blinding are not always possible. A limited effect size due to improvements regarding clinical endpoints in the control group is often caused by the Hawthorne effect. Improvements in the control group can also be caused with increased attention paid to the subjects. In order to reduce improvements in the control group, it is essential to identify the specific reasons and adjust study procedures accordingly. A pilot phase is indispensable for this. Another option is to include a third study arm to control for enhanced standard of care and study effects. Furthermore, retrospective data collection could be a feasible option. Adaptive study designs might reduce the necessity of a separate pilot study and combine the exploratory and confirmatory stages of an investigation in one single study.ConclusionThere are several aspects to consider in medical device studies when using interventions that rely on changes in behavior to achieve an effective implementation and significant study results. Improvements in the control group may reduce effect sizes and limit statistical significance; therefore, alternatives to the traditional randomized controlled trials may be considered.

Efficacy of an online course in developing competency for prescribing balanced diet by medical students: A non - inferiority trial.

In the COVID era, medical education has been hit hard. Paradoxically, the need for health professionals has increased. Online methods are being widely used, but its efficacy is rarely measured. This study was conducted to find the efficacy of an online course in developing competency among medical students to prescribe balanced diet. An online module was hosted at https://drzinia.moodlecloud.com/. A noninferiority trial was conducted among voluntary participants of the third MBBS students, in 2019. Stratified block randomization was done, so that ten students were allocated to the intervention arm of online sessions and ten students were allocated to the control arm of classroom sessions. Pretest assessments, seven assessments related to sessions conducted, and a postassessment were done. Generalized estimating equations were done to adjust for the effects of other confounders and see whether the intervention was a significant determinant of ability to prescribe balanced diet. Baseline variables were comparable in the two groups. The pretest scores were not significantly different in the two groups. The mean total marks scored by the online group (47.33/70) was not significantly different (t=0.68; p=0.50) from that of the class room group (45.70/70). The posttest scores were significantly higher than the pretest scores. Ninety-percent of students in the online course agreed that they could effectively learn through an online course. Online teaching is effective to learn the prescription of balanced diet. Similar efforts in other domains can make medical education evidence based in the current scenario.

Smoking cessation advice from healthcare professionals helps those in the contemplation and preparation stage: An application with transtheoretical model underpinning in a community-based program.

INTRODUCTIONThe efficacy of smoking cessation intervention has been proven with randomized controlled trials. Our study aims to elucidate the effects of the delivery method of smoking cessation advice on the process of stage of changes with transtheorectical model underpinning in a community setting.METHODSA total of 436 subjects were recruited in a quasi-experimental untreated control design study, with 46 receiving advice from healthcare professionals (HCP group) and 390 in the control group, in 2003, Nantou, Taiwan. A discrete time Markov model was used to quantify the multi-state process of smoking cessation in light of the transtheorectical model. Multiple polytomous logistic regression models were simultaneously applied to different transitions.RESULTSThe estimated forward transition probabilities were higher in the HCP group compared to their counterparts in the control group. On the other hand, the backward transition probabilities were smaller in the HCP group. After adjusting for confounding factors, HCP had a 4.3-fold (95% CI: 2.21–8.46) odds ratio of moving forward from the contemplation stage, and 2.4-fold odds ratio (95% CI: 1.03–4.42) from the preparation stage. Elderly people were more reluctant to change from precontemplation (AOR=0.50; 95% CI: 0.34–0.74) and contemplation (AOR=0.58; 95% CI: 0.44–0.84), but once in the preparation stage, they were more likely to take action (AOR=1.28; 95% CI: 1.01–1.83). For those in the preparation stage, longer smoking years had a negative effect on taking action (AOR=0.74; 95% CI: 0.52–0.99), but cessation advice from others enhanced the likelihood to take action (AOR=1.36; 95% CI: 1.01–1.99).CONCLUSIONSThe direct advice on smoking cessation from healthcare professionals enforced the net forward transition towards smoking cessation, especially the transition from contemplation and preparation. The proposed Markov regression model assessed the net effect of different intervention approaches allowing for the simultaneous consideration of multiple transitions and the effects of other confounders.

Neonatal microbiota development and the effect of early life antibiotics are determined by two distinct settler types

The neonatal period, during which the initial gut microbiota is acquired, is a critical phase. The healthy development of the infant’s microbiome can be interrupted by external perturbations, like antibiotics, which are associated with profound effects on the gut microbiome and various disorders later in life. The aim of this study was to investigate the development of intestinal microbiota and the effect of antibiotic exposure during the first three months of life in term infants. Fecal samples were collected from healthy infants and infants who received antibiotics in the first week of life at one week, one month, and three months after birth. Microbial composition was analyzed using IS-pro and compared between antibiotics-treated and untreated infants. In total, 98 infants, divided into four groups based on feeding type and delivery mode, were analyzed. At one week of age, samples clustered into two distinct groups, which were termed “settler types”, based on their Bacteroidetes abundance. Caesarean-born infants belonged to the low-Bacteroidetes settler type, but vaginally-born infants were divided between the two groups. The antibiotics effect was assessed within a subgroup of 45 infants, vaginally-born and exclusively breastfed, to minimize the effect of other confounders. Antibiotics administration resulted in lower Bacteroidetes diversity and/or a delay in Bacteroidetes colonization, which persisted for three months, and in a differential development of the microbiota. Antibiotics resulted in pronounced effects on the Bacteroidetes composition and dynamics. Finally, we hypothesize that stratification of children’s cohorts based on settler types may reveal group effects that might otherwise be masked.

Cell number considerations for blastocyst transfer in younger patients.

To investigate the role of the cell number at day 3 in blastocyst selection. Observational, retrospective, single-center clinical study. In part 1, 1211 single vitrified-warmed blastocyst transfer (SVBT) cycles were identified and reviewed. All the cycles were conventional in vitro fertilization (IVF) cycles and the first embryo transfer cycles. Most of patients had a risk of ovarian hyperstimulation syndrome and were young. In part 2, 864 IVF-derived blastocysts from 292 infertile couples underwent trophectoderm (TE) biopsy for preimplantation genetic testing for aneuploidies (PGT-A). No patient intervention. The first part was an analysis of the correlation between the cell number at day 3 and live birth rate (LBR) after SVBT, and the second part was an analysis of the correlation between the cell number at day 3 and euploid rate (ER) of blastocysts. In part 1, after correcting for the effects of other confounders, the cell number at day 3 had no significant effect on the LBR (OR 1.001, 95% CI 0.938-1.068). In part 2, after correcting for the effects of other confounders, the cell number at day 3 had no significant effect on the ER (OR 0.960, 95% CI 0.866-1.063). When the vitrified-warmed blastocysts obtained by conventional IVF are transferred into young patients, the cell number at day 3 is not a strong predictor of the LBR. In addition, the cell number at day 3 is not a strong predictor of ER of IVF-derived blastocysts too.

Effect of Bisphosphonates on Bone Health in Adult Renal Transplant Patients: Beyond the First Year Posttransplant-A Systematic Review and Meta-Analysis.

Background:Bone mineral density (BMD) decreases postrenal transplantation. Evidence demonstrating the effects of bisphosphonates on BMD and fracture risk beyond 1-year posttransplant is sparse in existing literature, but remains essential to enhance clinical outcomes in this population.Objective:Our study aimed to systematically review and meta-analyze the current literature on the use of any bisphosphonate in the adult renal transplant population beyond the first year of renal transplant to determine its effect on BMD and fracture incidence.Design:We conducted a systematic review and meta-analysis of primary research literature that included full-text, English-language, original randomized clinical trials (RCTs) and observational studies.Setting:Patient data were primarily captured in an outpatient setting across various studies.Patients:Our population of interest was patients older than 18 years who received deceased/living donor kidney transplantation and any bisphosphonate with a follow-up greater than 12 months posttransplantation.Measurements:The primary outcome was change in BMD from baseline. Secondary outcomes were the incidence of fractures and effects of other confounders on bone health.Methods:We included RCTs and observational studies that satisfied our inclusion criteria. Each study was analyzed for risk of bias and data were extrapolated to analyze for overall statistical significance accounting for heterogeneity of studies.Results:Sixteen studies (N = 1762) were analyzed. The follow-up ranged from 12 to 98 months. There was a nonsignificant improvement in BMD with bisphosphonate treatment persisting into the second and third years posttransplant at the lumbar spine. The calculated standardized mean BMD difference was −0.29 (−0.75 to 0.17), P = .22. Only 5 studies reported a total of 43 new fractures. Prednisone (P < .01), low body weight (P < .001), low body mass index (P < .01), and male gender (P < .05) correlated with reduced lumbar and femoral BMD.Limitations:Limitations of this review include the use of BMD as a surrogate outcome, the bias of the included studies, and the incomplete reporting data in numerous analyzed studies.Conclusions:We demonstrate no statistically significant benefit of bisphosphonate treatment on BMD beyond the first year postrenal transplantation. Despite heterogeneity of treatment, a differential nonsignificant improvement in lumbar spine BMD was consistent and may be clinically relevant.Trial Registration:PROSPERO CRD42019125593

CANCER DEATHS AND OCCUPATIONAL EXPOSURE IN A GROUP OF PLUTONIUM WORKERS

An exploratory epidemiological study was conducted for 319 deceased nuclear workers who had intakes of transuranic radionuclides and histories of employment during the time period from 1943 to 1995. The workers were employed at various facilities throughout the United States, including the Department of Energy defense facilities and uranium mining and milling sites. The majority of individuals were involved in documented radiological incidents during their careers. All had voluntarily agreed to donate their organs or whole body to the United States Transuranium and Uranium Registries. External and internal dose assessments were performed using occupational exposure histories and postmortem concentrations of transuranic radionuclides in critical organs. Statistical data analyses were performed to investigate the potential relationship between radiation exposure and causes of death within this population due to cancers of the lungs, liver, and all sites combined while controlling for the effects of other confounders. No association was found between radiation exposure and death due to cancer (α = 0.05). However, statistically significant associations were found between death due to any type of cancer and smoking (yes or no) (odds ratio = 5.41; 95% CI: 1.42 to 20.67) and rate of cigarette smoking (packs per day) (odds ratio = 2.70; 95% CI: 1.37 to 5.30).

P2-S6.15 Investigating the critical programme components of HIV prevention programme among MSM-Ts in Bangalore, Karnataka

BackgroundA number of studies in the context of HIV/STI epidemic and related vulnerability have focused on the risk reduction of HIV/STI prevalence and condom use among female sex workers (FSWs)....

Preadolescent behavior problems after prenatal cocaine exposure: Relationship between teacher and caretaker ratings (Maternal Lifestyle Study)

Background We previously reported an association between prenatal cocaine exposure (PCE) and childhood behavior problems as observed by the parent or caretaker. However, these behavior problems may not manifest in a structured environment, such as a school setting. Objective We determined whether there is an association between PCE and school behavior problems and whether ratings of behavior problems from the teacher differ from those noted by the parent or caretaker. Methods The Maternal Lifestyle Study, a multicenter study, enrolled 1388 children with and without PCE at one month of age for longitudinal assessment. Teachers masked to prenatal drug exposure status completed the Teacher Report Form (TRF/6–18) when children were 7, 9, and 11 years old. We also administered the Child Behavior Checklist-parent report (CBCL) to the parent/caretaker at same ages and then at 13 years. We performed latent growth curve modeling to determine whether high PCE will predict externalizing, internalizing, total behavior, and attention problems at 7 years of age and whether changes in problems' scores over time differ between those exposed and non-exposed from both teacher and parent report. Besides levels of PCE as predictors, we controlled for the following covariates, namely: site, child characteristics (gender and other prenatal drug exposures), family level influences (maternal age, depression and psychological symptomatology, continuing drug use, exposure to domestic violence, home environment, and socioeconomic status), and community level factors (neighborhood and community violence). Results The mean behavior problem T scores from the teacher report were significantly higher than ratings by the parent or caretaker. Latent growth curve modeling revealed a significant relationship between intercepts of problem T scores from teacher and parent ratings; i.e., children that were rated poorly by teachers were also rated poorly by their parent/caretaker or vice versa. After controlling for covariates, we found high PCE to be a significant predictor of higher externalizing behavior problem T scores from both parent and teacher report at 7 years (p = 0.034 and p = 0.021, respectively) in comparison to non-PCE children. These differences in scores from either teacher or caregiver were stable through subsequent years or did not change significantly over time. Boys had higher T scores than girls on internalizing and total problems by caretaker report; they also had significantly higher T scores for internalizing, total, and attention problems by teacher ratings; the difference was marginally significant for externalizing behavior (p = 0.070). Caretaker postnatal use of tobacco, depression, and community violence were significant predictors of all behavior problems rated by parent/caretaker, while lower scores on the home environment predicted all behavior outcomes by the teacher report. Conclusions Children with high PCE are likely to manifest externalizing behavior problems; their behavior problem scores at 7 years from either report of teacher or parent remained higher than scores of non-exposed children on subsequent years. Screening and identification of behavior problems at earlier ages could make possible initiation of intervention, while considering the likely effects of other confounders.

Reduced Morbidity in the First Year After Initiating Highly Active Antiretroviral Therapy Among Ugandan Adults

Objective: To evaluate the effect of Highly Active AntiRetroviral Therapy (HAART) and cotrimoxazole prophylaxis usage (CTX) on incidence of morbidity within the first year of HAART-eligibility. Methods: Between July 1999 and April 2006, we collected information on morbidity from an open cohort of HAARTeligible patients (according to WHO criteria). We compared morbidity among patients initiating HAART to morbidity before the stepwise introduction of HAART and CTX. We used available patients on HAART to select randomly a historical group of HAART-naive but eligible patients who had proportionally the same WHO stage and sex distribution. Patients aged 16 years or older, visited the study team 6-monthly and when ill. Patients’ demographics, WHO stage, HAART status, CTX, any new morbidity event (disease, drug-related and recurrent), haemoglobin and CD4 counts were collected from the beginning of follow up to the first year after initiating HAART or becoming HAART-eligible. We estimated the overall effect of HAART onmorbidity; adjusted for the effect of CTX by Mantel-Haenszel methods and adjusted for the effect of other confounders by negative binomial regression. Results: 219 HAART patients (median age 37 years; 73% women; 85% CTX; median Hb 11.7 g/dl and median CD4 131 cells/ul) experienced 94 events. They contributed 127 Person-Years of Observations (PYOs). 616 HAART-naive patients (median age 33 years; 70% women; 33% CTX; median Hb 11.2 g/dl and median CD4 131 cells/ml) experienced 862 events. They contributed 474 PYOs. The overall morbidity among HAART patients during their first year of treatment was 78% lower (HR = 0.22, 95% CI: 0.15—0.31) than the overall incidence among HAART-naive patients in unadjusted analysis. CTX also had a protective effect against morbidity (adjusted HR = 0.55, 95% CI: 0.38—0.79). Conclusions: Morbidity reduced significantly within the first year of initiating HAART in this setting. CTX had additional significant protection against morbidity.

Medication-related predictors of health-related quality of life in glaucoma patients enrolled in a medicare health maintenance organization

Background: Glaucoma is an important public health concern in the United States, particularly among older adults (aged ≥65 years). Pharmacologic therapy for glaucoma comsists mainly of topical eye drops containing beta-blockers or prostaglandin analogs. Objective: The goal of this study was to assess the associations between factors of topical medication use (self reported medication compliance, belief in benefit of medication use, usage difficulty, usage assistance, and complexity of medication regimen) and health-related quality of life (HRQOL) in a cross-sectional population of older patients with glaucoma. Methods: A self-administered, 48-question survey soliciting information on medication-taking behaviors, treatmen-trelated factors, and HRQOL was mailed to members of a Medicare health maintenance organization who were aged ≥65 years and had primary open-angle glaucoma. Two mailings were conducted 4 months apart; the second was sent to members whose responses to the first mailing had not yet been received. The 12-Item Short-Form Health Survey (SF-12) and the 25-Item National Eye Institute Visual Function Questionnaire (VFQ-25) were used to assess HRQOL. Other questions addressed perceptions of eye drop use in these patients. Multiple regression techniques were used to analyze associations between medication-related factors and HRQOL in this population. Results: The questionnaire was mailed to 589 patients; 375 responded (218 in the first mailing and 157 in the second mailing). A total of 358 responses were complete and analyzable (effective response rate, 62%). After controlling for the effects of other confounders, we found that self reported difficulty in using eye drops was strongly associated with decreased HRQOL (11.5% in VFQ-25 total score and 8.4% in SF-12 mental health score, P < 0.05). Other medication-related factors that were examined were not significantly associated with changes in HRQOL. Conclusion: Based on our findings, patients aged ≥65 years with glaucoma were likely to have significant comorbidity, which affected both visual and general health and well-being perception. Additionally, a significant proportion of these patients reported difficulty with use of topical medication, which was independently associated with a significant decrease in HRQOL. Care of older patients with glaucoma should incorporate strategies to minimize the difficulty associated with medication use.