Association Of Treatment Outcome Research Articles

Therapist contribution, client reflective functioning, and alliance rupture-repair: A microprocess case study of psychodynamic therapy for pregnancy after loss.

Meta-analysis has found a significant relation between rupture-repair and client outcome (Eubanks et al., 2018). Rupture-repair processes may be particularly important in psychotherapy for pregnancy loss wherein ruptures related to client feelings of shame and inadequacy, the societal invalidation of perinatal grief, and reenactments in the therapy relationship of early attachment experiences have been theorized to be common and important events (Markin, 2024). Thus, it is important to understand what occurs on a microlevel during the process of therapy to ultimately explain the rupture resolution (RR) and treatment outcome association. In particular, while both the therapist and client are believed to contribute to ruptures and to their repair (Safran & Muran, 2000), little is known about how therapist contributions impact rupture events, rupture resolution, and treatment progress. Further, client reflective functioning (RF) may represent a set of capacities that contribute to and are increased by rupture resolution yet vary depending on the role of the therapist in the rupture. The current investigation examined how observer-rated therapist contribution to ruptures and client RF were related to rupture events, rupture resolution, and client-reported symptom change and session quality over 22 sessions of psychodynamic therapy for pregnancy after loss. Therapist contribution to ruptures predicted rupture significance, high and steady within-session client RF scores, and symptom change. Client RF and rupture resolution predicted symptom change differently, often depending on type of symptom. Importantly, client RF and rupture resolution may predict successful outcomes through ameliorating commonly reported symptoms during pregnancies after loss. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Assessing the impact of unmeasured confounding in external control arms via tipping point analyses.

e23065 Background: Estimates of the comparative efficacy of new therapies from single-arm settings can be obtained in advance of RCTs through use of external control arms (ECAs).[1] ECAs are collections of patients with the index disease who were treated outside of the single-arm trial, whose measured baseline attributes are matched to the single-arm trial patients and whose outcomes are compared to trial patients’ to estimate comparative efficacy. Without randomization, observed treatment-outcome associations may be confounded by unmeasured patient attributes. Applying established statistical methods, we estimate the magnitude and prevalence of unmeasured confounding required to move an apparently favorable hazard ratio (HR) to the “tipping point” where the new drug is no longer associated with a favorable survival statistically or clinically. Methods: Studying previously reported patients with multiple myeloma treated with an experimental therapy in a clinical trial (N = 290) and patients treated with standard of care therapy from a rigorously matched ECA (N = 290), we applied the method of Lin et al. to adjust the observed treatment effect (HR and 95% CIs) for overall survival to reflect the impact of a (set of) unmeasured confounder(s).[1,2] Lin’s formula incorporates both the unmeasured confounder’s theoretical association with mortality and its prevalence according to treatment group (i.e., single-arm trial vs. ECA). Results: The observed treatment effect for the single-arm trial treated vs. ECA patients was HR 0.76 (95% CI 0.63-0.91). We estimated the impact of an unmeasured confounder (where HR for overall survival of those patients with and without the confounder is set to 1.5) by its prevalence in each group. When the prevalence of the unmeasured confounder is balanced across groups there is no change in the observed treatment effect. When the presence of the confounder is 70% for ECA patients and absent in the trial patients, the clinical tipping point occurs with loss of the favorable HR (i.e., HR 1.02, 95% CI: 0.85-1.23). Conclusions: While novel analytic methods like ECAs have the potential to accelerate drug development, the lack of randomization raises concern for potential unmeasured confounding. Applying Lin’s method, we illustrate that the impact of unmeasured confounding on HR estimates from a single-arm trial vs.an ECA is a function of both the association with mortality and asymmetries in prevalence. Consistency in the efficacy conclusion for all clinically tenable assumptions indicates a qualitatively reliable conclusion. Friends of Cancer Research whitepaper (2019): available online at https://www.focr.org/sites/default/files/Panel-1_External_Control_Arms2019AM.pdf. Lin D, Psaty B, Kronmal R. Assessing the sensitivity of regression results to unmeasured confounders in observational studies. Biometrics.1998; 54:948–963.

A Qualitative Analysis of the Association of Treatment Outcomes, Psychosocial Factors, and Multimorbidity in Severe Hypertensive Patients Attending Health Institutions in Southeast Nigeria

Severe hypertension is associated with a two-fold increase in relative risk of death. Interventions to date fail to achieve sustained improvement in blood pressure, particularly in regional areas of high social disparity. Growing evidence points to multiple psychological, social and morbidity factors as contributors to the onset of and trajectory of hypertension. This study aims to examine the association of psychosocial factors and multimorbidity with response to treatment and treatment outcomes in the management of severe hypertensive patients providing updated knowledge and recommendations to improve their quality of care. We employed a hospital based comparative cross-sectional study using a quantitative and qualitative approach. Semi-structured questionnaires were used to collect information from 733 severe hypertensive patients attending cardiology clinics in two tertiary health institutions in southeastern Nigeria. Data collected was transcribed, coded, and analysed with IBM SPSS version 23 software with appropriate descriptive tools used in presenting findings. We observed a significant association between age of the respondents and their response to treatment. Overweight/obese respondents were 1.5times less likely to respond to treatment. These findings add to existing knowledge provoking thoughtful discussions among relevant public health actors and stakeholders to update management policies for severe hypertension.

Long-Term Impact of Various Endocrine Therapy Regimens on Mortality, Local Recurrence, and Metastasis in Breast Cancer: A 25-Year Retrospective Study

Background: This retrospective cohort study explores the long-term effects of different endocrine therapy regimens on mortality, local recurrence, and metastasis in breast cancer patients. Methods: Data from the Referral Cancer Research Center of Shahid Beheshti University of Medical Sciences were analyzed. Records of 2,262 histologically confirmed breast cancer patients, with 25 years of follow-up were included. We collected patient data, including treatment modalities, and details of the endocrine therapy, and conducted statistical analysis to assess treatment-outcome associations. Results: Patients had an average age of 49.45 years, and 99.1% were female. The average tumor size was 2.8 cm, with a 12.3% mortality rate. Positive expression of human epidermal growth factor receptor 2, progesterone receptor, and estrogen receptor was found in 17.3%, 71.8%, and 70.6% of patients, respectively. Tamoxifen was administered to 1,700 patients, letrozole to 715, and exemestane to 540, with an average endocrine therapy duration of 5.2 years. Letrozole treatment duration (P = 0.001) and lymph node involvement (P = 0.028) were independent predictive variables for local recurrence, with longer letrozole therapy associated with lower recurrence. Conclusion: Estrogen receptor expression and endocrine therapy duration are independent predictive markers for recurrence and mortality. Longer letrozole therapy predicts lower local recurrence. Endocrine therapy duration inversely relates to mortality, recurrence, and local recurrence.

An observational analysis of profile and outcome of children with malnutrition admitted at malnutrition treatment centre

ABSTRACT Introduction: Nutritional status is an important health indicator and children bear maximum burden of it. Poor nutrition during first thousand days of a child’s life can lead to stunted growth. Comorbid condition adversely affects treatment outcome of malnutrition. This study is aimed to describe the profile and treatment outcome of malnourished children. Materials and Methods: This record-based retrospective, analytical observational study was conducted from October to December 2020. Data of severe acute malnourished children who were admitted in malnutrition treatment centre during August 2017 to September 2020, collected. Totally, 264 eligible children were enrolled in the study. The data were collected through medical records of patients. Data were entered in excel spreadsheet and analysed. Results: Most of the children belonged to 6-24 months of age, almost equal proportion of male and female, and more than three-fourth of children were from rural area. The mean length of stay in hospital was 15.19 ± 6.64 days and average weight gain of children was 7.6 ± 6.7 gm/kg/day. There was significant increase in Z-score (Weight/Height) and MUAC at the time of discharge (P value <0.05). There was no significant association of treatment outcome with the presence of comorbidities (P value >0.05). Conclusion: Most vulnerable age group for malnutrition was 6 months to 2 years. Majority of children with malnutrition improve with standard treatment protocol of malnutrition. We can improve the ability of community health workers to significantly reduce child malnutrition at the primary care level and in the community by equipping them with the required knowledge, tools, and assistance.

Concomitant Proton Pump Inhibitor Use With Pembrolizumab Monotherapy vs Immune Checkpoint Inhibitor Plus Chemotherapy in Patients With Non−Small Cell Lung Cancer

Immune checkpoint inhibitor (ICI) monotherapy with pembrolizumab and ICI plus chemotherapy have been approved as first-line treatments for non-small cell lung cancer (NSCLC) for patients with a programmed cell death ligand-1 (PD-L1) tumor proportion score (TPS) of 50% or more, but the choice between these 2 therapeutic options is unclear. To clarify the association of a history of concurrent medication use with treatment outcomes for ICIs with or without chemotherapy in patients with NSCLC with a high PD-L1 TPS and to determine whether these clinical histories are biomarkers for appropriate treatment selection. This retrospective, multicenter cohort study at 13 hospitals in Japan included patients with advanced NSCLC with a PD-L1 TPS of 50% or more who had received pembrolizumab ICI monotherapy or ICI plus chemotherapy as the initial treatment between March 2017 and December 2020. The median (IQR) follow-up duration was 18.5 (9.2-31.2) months. Data were analyzed from April 2022 through May 2023. ICI monotherapy with pembrolizumab or ICI plus chemotherapy as first-line treatment. The primary analysis was the association of treatment outcomes with baseline patient characteristics, including concomitant drug history, after propensity score matching. Cox proportional hazard models were used to determine the associations of patient characteristics with survival outcomes. Logistic regression analysis was used to determine the association of concomitant medication history with treatment outcomes and other patient characteristics. A total of 425 patients with NSCLC were enrolled in the study including 271 patients (median [range] age, 72 [43-90] years; 215 [79%] men) who were treated with pembrolizumab monotherapy as the first-line treatment and 154 patients (median [range] age, 69 [36-86] years; 121 [79%] men) who were treated with ICI plus chemotherapy as the first-line treatment. In multivariable analysis, a history of proton pump inhibitor (PPI) use was independently associated with shorter progression-free survival (PFS) in the pembrolizumab monotherapy group (hazard ratio [HR], 1.38; 95% CI, 1.00-1.91; P = .048), but not in the ICI plus chemotherapy group. In patients with a PPI history, both the median (IQR) PFS (19.3 [9.0 to not reached] months vs 5.7 [2.4 to 15.2] months; HR, 0.38; 95% CI, 0.20-0.72; P = .002) and the median (IQR) overall survival (not reached [9.0 months to not reached) vs 18.4 [10.5 to 50.0] months; HR, 0.43; 95% CI, 0.20-0.92; P = .03) were significantly longer in the ICI plus chemotherapy group than in the pembrolizumab monotherapy group. In patients without a history of PPI use, both the median (IQR) PFS (18.8 months [6.6 months to not reached] vs 10.6 months [2.7 months to not reached]; HR, 0.81; 95% CI, 0.56-1.17; P = .26) and the median (IQR) overall survival (not reached [12.6 months to not reached] vs 29.9 [13.3 to 54.3] months, HR, 0.75; 95% CI, 0.48-1.18; P = .21) did not differ between groups. This cohort study found that a history of PPI use could be an important clinical factor in treatment decision-making for patients with NSCLC with a PD-L1 TPS of 50% or more.

Estimating time-varying treatment effects in longitudinal studies.

Longitudinal study designs are frequently used to investigate the effects of a naturally observed predictor (treatment) on an outcome over time. Because the treatment at each time point or wave is not randomly assigned, valid inferences of its causal effects require adjusting for covariates that confound each treatment-outcome association. But adjusting for covariates which are inevitably time-varying is fraught with difficulties. On the one hand, standard regression adjustment for variables affected by treatment can lead to severe bias. On the other hand, omitting time-varying covariates from confounding adjustment precipitates spurious associations that can lead to severe bias. Thus, either including or omitting time-varying covariates for confounding adjustment can lead to incorrect inferences. In this article, we introduce an estimation strategy from the causal inference literature for evaluating the causal effects of time-varying treatments in the presence of time-varying confounding. G-estimation of the treatment effect at a particular wave proceeds by carefully adjusting for only pre-treatment instances of all variables while dispensing with any post-treatment instances. The introduced approach has various appealing features. Effect modification by time-varying covariates can be investigated using covariate-treatment interactions. Treatment may be either continuous or noncontinuous with any mean model permitted. Unbiased estimation requires correctly specifying a mean model for either the treatment or the outcome, but not necessarily both. The treatment and outcome models can be fitted with standard regression functions. In summary, g-estimation is effective, flexible, robust, and relatively straightforward to implement. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Deaths among tuberculosis patients of the western state of India: A secondary record based analytical study on its determinants

IntroductionIndia has a significant TB burden, and ongoing attempts are being made to eradicate the disease. Globally, the number of TB deaths is declining, but not quickly enough to meet the End TB Goals. The National Strategic Plan (NSP) 2017–2025 in India set in motion an ambitious effort to expand the scope and efficacy of the National Tuberculosis Elimination Program (NTEP). MethodsA descriptive retrospective study based on secondary data was conducted on information obtained from the electronic TB notification register for 2019, abstracted from Ni-kshay. Further, descriptive analysis was undertaken to identify the factors associated with deaths and successful treatment outcomes. The binomial logistic regression model estimates the crude relative risk and a 95% confidence interval to describe the association between predictor variables and TB treatment outcomes. ResultsAfter applying the eligibility criteria for the study population, a total of 1,44,643 (88%) TB patients were included in the study. 1,35,934 (94%) TB patients had completed the treatment and survived, while 8709 (6%) TB patients died. A significant association of treatment outcomes was observed in age, gender, key population, site of diseases, type of case, type of health facilities, HIV and Diabetes. When a logistic regression was applied, the model showed the association of the independent variables with the risk of death in TB patients. ConclusionThe epidemiological factors associated with treatment outcomes among TB patients should be audited systematically. A structure of TB death surveillance and response system should be established with a mortality audit, including a community-based death review (CBDR) and a facility-based medical audit (FBMA) in case the patient is hospitalized or discharged from a hospital.

Sputum smear conversion and treatment outcomes among drug-resistant pulmonary tuberculosis patients in eastern Ethiopia: A 9-years data analysis.

Drug-resistant tuberculosis (DR-TB) has become a public health problem throughout the world and about one-third of deaths were attributed to DR-TB from antimicrobial resistance which contributes to 10% of all TB deaths. Sub-Saharan Africa, particularly Ethiopia accounts for a significant number of TB cases. However, the scanty evidence on DR-TB contributing factors could affect the level of this deadly case tackling program. Therefore, this study aimed to assess the factors affecting sputum smear conversion and treatment outcomes among patients with DR-TB in Health facilities in Eastern Ethiopia. A cross-sectional study design was employed from 10 October to 10 November 2021, in the health facilities providing DR-TB services in Harari Region and Dire Dawa city administration. The medical records of 273 DR-TB patients from 10 January 2013 to 27 December 2021, were reviewed using structured checklists. Data were entered into Epidata 3.1 version and exported to STATA 14 version for analysis. The outcome variables were Initial Sputum conversion (converted vs. not-converted) and treatment outcome (Unfavorable vs. Favorable). Sputum examination was performed using both Acid-fast bacillus (AFB) smear microscopy and Löwenstein-Jensen (LJ) culture technique. A binary logistic regression analysis was used to assess the association of independent variables with the first month sputum smear conversion, while a conditional logistic regression model was used to assess the association of treatment outcome with explanatory variables. The associations were reported using adjusted odds ratios (AORs) at a 95% confidence interval. A total of 273 DR-TB patients were included in this study. The unfavorable DR-TB treatment outcome was significantly associated with the history of chewing khat (AOR = 4.38, 95% CI = 1.62, 11.84), having bilateral lung cavity on baseline chest X-ray (AOR = 12.08, 95% CI = 1.80, 2.57), having greater than 2+ smear result at baseline (AOR = 3.79, 95% CI = 1.35, 10.59), and poor adherence (AOR = 2.9, 95% CI = 1.28, 6.82). The sputum smear non-conversion at first month was significantly associated with being Human Immune Virus (HIV)-negative (AOR = 0.37, 0.17, 0.82), having low baseline BMI (AOR = 0.54, 95% CI = 0.29, 0.97), baseline culture > 2++ (AOR = 0.15, 95% CI = 0.05, 0.49) and having greater than 2+ sputum smear result (AOR = 0.09, 95% CI = 0.012, 0.67). Patients with normal chest X-ray at baseline had 3.8 times higher chance of sputum smear conversion on first month (AOR = 3.77, 1.11, 12.77). The overall initial sputum smear conversion and the treatment success rate among DR-TB patients were 52.75 and 66.30%, respectively. The Baseline underweight, HIV-negative, baseline smear > 2+, baseline culture > 2++, and clear lung on baseline X-ray were associated with smear conversion and history of khat chewing, bilateral lung cavity at baseline, having greater than 2+ smear results at baseline, and patients with poor treatment adherence had hostile treatment outcomes. So, strengthening and implementing nutrition assessment and patient counseling during directly observed therapies (DOTs) service and drug compliance could result in early sputum conversion and better treatment outcomes. DR-TB patients with high bacterial load and abnormal lungs on radiologic examination at baseline could need special attention during their course of treatment.

Application of the E-Value to Assess Bias in Observational Research in Plastic Surgery

The E-value is a statistical measure that is used to quantify the degree of unmeasured confounding that is necessary to undermine the treatment-outcome associations established in observational studies. Despite the substantial amount of observational research that informs evidence-based practice in plastic surgery, sensitivity analyses based on the E-value have not been conducted in the field. The authors performed a systematic search of the literature to identify meta-analyses of observational studies in plastic surgery. The authors calculated E-values for various treatment-outcome associations based on the risk, odds, or hazard ratios in each study, to assess unmeasured confounding effects that may influence the validity of the conclusions. The authors then analyzed the distribution of E-values from pooled versus individual studies. The authors identified 45 meta-analyses that met the inclusion criteria, with each containing an average of three pooled assessments of observational data. The E-value of the pooled effect estimates ranged from 1.11 to 19.49, with an average value of 3.82. As for the individual effect estimates from each primary study within the meta-analyses, the E-values ranged from 1.00 to 321.50, with an average value of 8.74. The authors determined that E-values vary substantially across the literature and that unmeasured confounding may be present in a high number of observational studies. Although extant statistical techniques will continue to be necessary to control for measured confounding, the E-value is a novel concept that can facilitate more robust sensitivity analyses in plastic surgery research.

Opioid dependence and treatment outcomes among patients with burn injury

BackgroundPatients with burn injuries cause significant healthcare economic burden, often utilising extra-hospital resources, caregiving, and specialized care. MethodsWe present a retrospective cohort analysis of the hospitalized patients in the USA with a primary diagnosis of burn injury. Opioid dependence was identified using ICD-10 CM codes. The 30-day all-cause readmission rate was the main outcome while secondary outcomes were inhospital mortality rate, resource utilization which included hospital length of stay, total hospitalization costs and charges and surgical procedures for burn injury treatment as well as the most important five principal diagnoses for admission and readmission. ResultsOut of 22,348 patients included in the study, 597 had opioid dependence. Older patients (43 years, range: 38.6–47.2 years) as well as males (70.8%) were more likely to be opioid dependent. Opioid dependence was associated with higher 30-day readmission rates (aOR: 1.83, 95% confidence interval (CI): 1.30–2.57, p-value: <0.01), higher total hospitalization costs (aMD: $14,981, CI: $3820–$26,142, p-value: 0.01), total hospitalization charges (aMD: $47,078, CI: −$5093 to $89,063, p-value: 0.03), and a shorter mean length of stay (aMD: 5.13 days, CI: 2.60–7.66, p-value: <0.01). However, patients with and without opioid dependence had similar in-hospital mortality rates (aOR: 0.27, CI: 0.06–1.28, p-value: 0.10). ConclusionWe are the first to our knowledge to report the association of treatment outcomes and opioid dependence in patients hospitalized at the national level with a burn injury. We show that there were higher 30-day all-cause readmission rates and in-hospital resource utilization among patients with opioid-dependence.

The Impact of First-Line Anti-Tubercular Drugs' Pharmacokinetics on Treatment Outcome: A Systematic Review.

BackgroundTuberculosis remains the major public health problem besides tremendous efforts to combat it. Most tuberculosis patients are treated with a standard dose of first-line anti-TB drugs. The cure rate, however, varies from patient to patient. Various factors have been related to anti-TB treatment failure. In recent years, studies associating lower plasma concentrations of anti-TB drugs with poor treatment outcomes are emerging although the results are inconclusive.ObjectiveInvestigate the impact of first-line anti-tubercular drugs pharmacokinetics on treatment outcome.MethodsA systematic search of Pubmed, EMBASE, Web of Science, and the Cochrane Library for articles published in the English language between January 2010 to June 2020 was conducted to identify eligible studies describing associations of first-line anti-tubercular drug pharmacokinetics with treatment outcomes. The primary outcomes considered were pharmacokinetics parameter results and its association with treatment outcome.ResultsThe search identified 1754 articles of which twelve articles; ten prospective observational studies and two controlled clinical trials fulfilled the eligibility criteria. The majority of the studies showed target concentrations for the first-line anti-tubercular drugs below the current standard range. Among the twelve studies, eleven studies assessed rifampicin pharmacokinetics of which eight reported association of drug concentration and treatment outcomes. Similarly, four out of eight and three out of seven reported drug concentration and treatment outcome association for isoniazid and pyrazinamide, respectively. Despite the low plasma concentration, a favorable treatment outcome was achieved for the bulk of the patients. Irrespective of the inconsistency, an increase in exposure to rifampicin improved the outcome, and lower rifampicin, isoniazid, and pyrazinamide concentration are associated with poor outcome. No data are available for ethambutol associating its pharmacokinetics with treatment outcomes.ConclusionThe pharmacokinetics of first-line antitubercular drugs can influence treatment outcomes. Further controlled clinical studies are, however, required to establish these relationships.

Conducting sensitivity analysis for unmeasured confounding in observational studies using E-values: The evalue package

In this article, we introduce the evalue package, which performs sensitivity analyses for unmeasured confounding in observational studies using the methodology proposed by VanderWeele and Ding (2017, Annals of Internal Medicine 167: 268–274). evalue reports E-values, defined as the minimum strength of association on the risk-ratio scale that an unmeasured confounder would need to have with both the treatment assignment and the outcome to fully explain away a specific treatment-outcome association, conditional on the measured covariates. evalue computes E-values for point estimates (and optionally, confidence limits) for several common outcome types, including risk and rate ratios, odds ratios with common or rare outcomes, hazard ratios with common or rare outcomes, standardized mean differences in outcomes, and risk differences.

Data‐adaptive longitudinal model selection in causal inference with collaborative targeted minimum loss‐based estimation

Causal inference methods have been developed for longitudinal observational study designs where confounding is thought to occur over time. In particular, one may estimate and contrast the population mean counterfactual outcome under specific exposure patterns. In such contexts, confounders of the longitudinal treatment-outcome association are generally identified using domain-specific knowledge. However, this may leave an analyst with a large set of potential confounders that may hinder estimation. Previous approaches to data-adaptive model selection for this type of causal parameter were limited to the single time-point setting. We develop a longitudinal extension of a collaborative targeted minimum loss-based estimation (C-TMLE) algorithm that can be applied to perform variable selection in the models for the probability of treatment with the goal of improving the estimation of the population mean counterfactual outcome under a fixed exposure pattern. We investigate the properties of this method through a simulation study, comparing it to G-Computation and inverse probability of treatment weighting. We then apply the method in a real-data example to evaluate the safety of trimester-specific exposure to inhaled corticosteroids during pregnancy in women with mild asthma. The data for this study were obtained from the linkage of electronic health databases in the province of Quebec, Canada. The C-TMLE covariate selection approach allowed for a reduction of the set of potential confounders, which included baseline and longitudinal variables.

1781P - Loss of skeletal muscle mass during palliative chemotherapy is a poor prognostic factor in patients with advanced gastric cancer

BackgroundCancer causes loss of muscle mass, which is associated with a poor prognosis. Chemotherapy could also reduce muscle mass. We investigated changes of skeletal muscle mass during palliative chemotherapy and its association of treatment outcomes in patients with advanced gastric cancer (AGC). MethodsThis retrospective study consisted of 91 consecutive patients who underwent first line palliative chemotherapy in AGC. Skeletal muscle area was measured at the level of the third lumbar vertebra using computed tomography scans taken before and after chemotherapy. We assessed changes in skeletal muscle index (SMI), body mass index (BMI), and body weight and compared the chemotherapy response and survival according to the changes of body composition. ResultsIn total 91 patients, median age was 64 years (range, 31-87 years). 75.4% of patients were male and 45.1% were sarcopenia at baseline. Mean decrease of SMI from pre-chemotherapy to post-chemotherapy was -5.4±5.3 cm2/m2 (P<0.001), mean decrease of BMI was -0.6±1.9 kg/m2 (p=0.002), and mean decrease of body weight was -1.8±5.3 kg (P=0.002). Mean decrease of SMI for patient with objective response was -4.4±5.4 cm2/m2, mean decrease of SMI with stable disease was -6.0±5.2 cm2/m2 and mean decrease of SMI with progression was -5.4±5.2 cm2/m2. Response to chemotherapy was not associated with decrease in SMI (p=0.491). In multivariable analysis, sarcopenia at baseline (HR, 1.959; 95% CI, 1.190 to 3.225, p=0.008), decreased SMI (HR, 1.747; 95% CI, 1.042 to 2.929; p=0.034) and poor ECOG score (HR, 1.902; 95% CI, 1.081 to 3.346; p=0.026) were significant poor prognostic factors for survival. ConclusionsSkeletal muscle mass decreased significantly during chemotherapy in patients with AGC. However, response to chemotherapy was not associated with decrease in skeletal muscle mass. The decreased SMI was a poor prognostic factor in patients with AGC during first line palliative chemotherapy. Legal entity responsible for the studyThe authors. FundingHas not received any funding. DisclosureAll authors have declared no conflicts of interest.

Limitations and Misinterpretations of E-Values for Sensitivity Analyses of Observational Studies.

The E-value was recently introduced on the basis of earlier work as "the minimum strength of association…that an unmeasured confounder would need to have with both the treatment and the outcome to fully explain away a specific treatment-outcome association, conditional on the measured covariates." E-values have been proposed for wide application in observational studies evaluating causality. However, they have limitations and are prone to misinterpretation. E-values have a monotonic, almost linear relationship with effect estimates and thus offer no additional information beyond what effect estimates can convey. Whereas effect estimates are based on real data, E-values may make unrealistic assumptions. No general rule can exist about what is a "small enough" E-value, and users of the biomedical literature are not familiar with how to interpret a range of E-values. Problems arise for any measure dependent on effect estimates and their CIs-for example, bias due to selective reporting and dependence on choice of exposure contrast and level of confidence. The automation of E-values may give an excuse not to think seriously about confounding. Moreover, biases other than confounding may still undermine results. Instead of misused or misinterpreted E-values, the authors recommend judicious use of existing methods for sensitivity analyses with careful assumptions; systematic assessments of whether and how known confounders have been handled, along with consideration of their prevalence and magnitude; thorough discussion of the potential for unknown confounders considering the study design and field of application; and explicit caution in making causal claims from observational studies.

Conservative Treatment versus Surgery for Laryngeal Contact Granuloma: A Prospective Study

Aims: To confirm the efficacy of conservative treatment for laryngeal contact granuloma and identify factors influencing treatment outcome. Methods: In this prospective study, patients with laryngeal contact granuloma were divided into a group receiving conservative treatment and a group undergoing surgery. Efficacy was assessed by analyzing the complete response after a 48-week follow-up. The association of treatment outcome with clinical factors was then evaluated. Results: In total, 61 patients, 43 in the group receiving conservative treatment and 18 in the group undergoing surgery, were analyzed, and the complete response rate was 72.1% and 38.9%, respectively. Both univariate analysis and multivariate analysis revealed that treatment modality (p₁ = 0.015, p₂ = 0.043), voice abuse (p₁ = 0.010, p₂ = 0.010), and the size of the granuloma (p₁ = 0.031, p₂ = 0.020) were significantly associated with the complete response of laryngeal contact granuloma. Kaplan-Meier curves showed that alcohol consumption (p = 0.031), voice abuse (p < 0.001), and granuloma size (p = 0.025) were significantly related to the complete response of conservative treatment. Conclusions: This prospective study strengthens the argument for conservative treatment (instead of surgery) as the first choice for laryngeal contact granuloma. The results also suggest that voice abuse, alcohol consumption, and the size of the granuloma may predict treatment outcome.

Neutrophil and Platelet to Lymphocyte Ratios in Associating with Blood Glucose Admission Predict the Functional Outcomes of Patients with Primary Brainstem Hemorrhage

Because of a lack of markers for predicting prognosis and an underlying mechanism, patients with primary brainstem hemorrhage (PBH) are currently treated with multiple strategies, but most of them have poor outcomes in a comparison with patients with supratentorial intracranial hemorrhage. Recently, it has been reported that the neutrophil-to-lymphocyte ratio (NLR) represents a novel composite inflammatory marker to predict the prognosis of patients with intracranial hemorrhage, a majority of whom have supratentorial hemorrhage. In this report, we aim to assess the potential predictive value of NLR in patients with PBH. In addition, other available laboratory parameters, including platelet-to-lymphocyte ratio (PLR), and admission blood glucose level (ABG), will be also investigated as markers for prognosis in patients with PBH. This study retrospectively enrolled 225 patients with acute PBH who were admitted West China Hospital from January 2012 to December 2016. ABG and absolute numbers of neutrophils, lymphocytes, white blood cells, and platelets were extracted from electronic medical records. ABG, NLR, and PLR were calculated and further assessed using multivariable logistic regression analysis for understanding the associations of treatment outcomes. The comparison of predictive power of independent predictors was evaluated using receiver operating characteristic. Of 225 inpatients, NLR (odds ratio [OR], 1.82; 95% confidence interval [CI], 1.24-2.62, P < 0.01), PLR (OR, 1.43; 95% CI, 1.11-2.36; P= 0.013), and ABG (OR, 6.57; 95% CI, 2.78-15.52; P<0.01) were independently associated with 90-day status in 112 patients with unfavorable outcomes. All 3 parameters also correlated with admission Glasgow Coma Scale score (r=-0.244, P<0.001; r=-0.292, P < 0.001; r=-0.661, P < 0.01) and absolute neutrophil counts (r= 0.645, P < 0.001; r= 0.347, P < 0.001; r=0.695, P < 0.01). Meanwhile, NLR exhibits a comparable predictive power by comparing with PLR (area under the curve [AUC], 0.694; 95% CI, 0.626-0.764; P < 0.001; versus AUC, 0.662; 95% CI, 0.596-0.724; P < 0.001). In addition, ABG shows a positive predictive value (AUC, 0.784; 95% CI, 0.725-0.832; P < 0.001). The best independent predictive cutoff points were 6.65, 59.3, and 7.81 mmol/L for NLR, PLR, and ABG, respectively. Nevertheless, a combination of 3 parameters shows the best predictive ability (AUC, 0.835; 95% CI, 0.781-0.883; P < 0.001). NLR, PLR, and ABG can be used to independently predict 90-day functional outcome in patients after PBH. When combined, they have better predictive power in identifying PBH patients with a poor prognosis. To our knowledge, this study is the first to reveal the associations between NLR, PLR, and hyperglycemia and the functional outcomes of patient with PBH. In associating with previously studies on hemorrhage site, our results provide a good opportunity to elucidate the underlying mechanisms of PBH.

A study of treatment outcome of paediatric tuberculosis patients in an urban city of central India

Background: It is an established fact that healthy children build healthy nation. Proper management of Paediatric Tuberculosis is very essential for the control of tuberculosis as children also act as a source of infection within a community. The objective of the study was to determine the treatment outcome of paediatric TB patients registered under RNTCP in Bhopal city and to determine the relationship of socio-demographic profile and other selected factors with treatment outcome in Paediatric TB patients registered under RNTCP in Bhopal city.Methods: In this longitudinal study, data of all the paediatric TB patients (0 to 14 years of age group) diagnosed as TB and registered under R.N.T.C.P and fulfilling inclusion criteria during January 2013 to June 2013 were collected after obtaining informed consent from parents/guardians by using a structured questionnaire during their visit to designated microscopic centre (DMC) cum DOTS centre. The data was analysed on statistical software SPSS VS.20.Results: In our study 93.33% of paediatric patients were treatment completed, 4.84% were declared cure and 0.60% patients each were transferred out, declared treatment failure and died respectively. Educational status of mothers of paediatric patients (X2=40.569 and p=0.019, df=24), BCG vaccination (X2=11.299 and p=0.023, df=4) and nutritional status of children (X2=26.342 and p=0.049, df=16) are significantly associated with treatment outcome.Conclusions: Majority of paediatric patients were declared cured or treatment completed depending upon the result of sputum examination. In our study educational status of mothers of paediatric patients, BCG vaccination and nutritional status of children are significantly associated with treatment outcome. No association of treatment outcome was found with other selected factors such as age, gender, religion, type of family and socio economic status of paediatric patients.

Impact of Road Traffic Injury to Pediatric Traumatic Brain Injury in Southern Thailand.

Background:Motor vehicle is a major transportation in Southern Thailand as the result of road traffic injury and death. Consequently, severe disability and mortality in pediatric traumatic brain injury (TBI) were observed from traffic accident, particularly motorcycle accident. To identify the risk of intracranial injury in children, the association of treatment outcome with various factors including mechanisms of injury, clinical characteristics, and intracranial pathology can be assessed.Materials and Methods:This was a retrospective study conducted on children, who were younger than 15 years old with TBI and were enrolled from 2004 to 2015. Several clinically relevant issues were reviewed and statistically analyzed.Results:A total of 948 casualties were enrolled. Compared with falling down, the motorcycle accident was significantly associated with intracranial injury (odds ratio 1.73, 95% confidence interval [CI] 1.08–2.76). Other factors associated with intracranial injury were hemiparesis (odds ratio 5.69, 95% CI 1.44–22.36), positive of basal skull fracture signs (odds ratio 15.66, 95% CI 3.44-71.28), and fixed reaction to light of both pupils (odds ratio 5.74, 95% CI 1.71–19.23). Mortality found in thirty cases (3.2%). Furthermore, the risk of death correlated with motorcycle accident (P = 0.02) and severe head injury (P < 0.001). Neurosurgical intervention was not associated with outcome, but severe head injury, hemorrhagic shock, epidural, and subdural hematoma were impact factors.Conclusion:The findings demonstrate road traffic injury, especially motorcycle accident leading to brain injury and death. Prevention program is a necessary key to decrease mortality and disability in pediatric TBI.