Nevin Manimala

Cancer Med. 2022 Sep 7. doi: 10.1002/cam4.5211. Online ahead of print.

ABSTRACT

BACKGROUND: While rhabdomyosarcoma (RMS) is the most common soft tissue sarcoma in children and adolescents, past epidemiology studies of this malignancy used data that covered <30% of the US population. Therefore, we evaluated RMS incidence using data from U.S. Cancer Statistics (USCS) and survival trends using the National Program of Cancer Registries (NPCR), which covers 100% and 94% of the U.S. population, respectively.

METHODS: Incidence and survival were assessed for pediatric patients diagnosed with RMS during 2003-2017 and 2001-2016, respectively. Both demographic and clinical variables were evaluated. Age-adjusted incidence rates, average annual percent change (AAPC), and 5-year relative survival (RS) were calculated, all with corresponding 95% confidence intervals (CIs). Cox regression models were used to evaluate the impact of demographic and clinical variables on survival.

RESULTS: We identified 5656 primary RMS cases in USCS during 2003-2017. The age-adjusted incidence rate was 4.58 per 1 million (95% CI: 4.46-4.70) with an AAPC of 0.3% (95% CI: -0.7 to 1.2%). In NPCR, 5-year RS for all cases was 68.0% (95% CI: 66.6-69.3%). In multivariable analyses, non-Hispanic (NH) Black cases had worse survival compared with NH White cases (hazard ratio [HR] = 1.16, 95% CI: 1.01-1.33).

CONCLUSION: The incidence and survival rates were stable in the largest and most comprehensive population-based analysis for pediatric RMS cases in the U.S. Additionally, we observed a survival disparity among NH Black cases. Findings from this study could inform interventions to address disparities, risk stratification strategies, and clinical trial design.

PMID:36069287 | DOI:10.1002/cam4.5211

Laryngoscope. 2022 Sep 7. doi: 10.1002/lary.30374. Online ahead of print.

ABSTRACT

OBJECTIVE: To assess the efficacy of interarytenoid injection augmentation (IAIA) and the ability of IAIA to predict response to interarytenoid suture augmentation (IASA) based on diet advancement on video fluoroscopic swallow studies (VFSS).

METHODS: Retrospective cohort analysis of patients with persistent pharyngeal dysphagia at a tertiary children’s hospital with VFSS pre- and post-IAIA were included between March 2011 and June 2019.

RESULTS: Median age of the 229 patients was 2.2 years (5.8 months-19 years). Interarytenoid mucosal height (IAMH) was found to be above the false vocal folds in 112 patients (53.4%) and at true vocal folds in 10 (4.9%) patients. On VFSS post-IAIA, 95 (41.5%) patients were successfully advanced in recommended diet consistency, 115 (50.2%) were stable, and 19 (8.3%) needed thicker consistency. Paired t-tests on pre- and post-operative consistency scores showed significant improvement, p-value of <0.0001, 95% confidence interval (CI; 0.50-0.85). Poisson regression found no covariates with significant association with improvement on IAIA. For IASA patients, 35/60 (58.3%) improved on post-op VFSS. Paired t-tests on pre- and post-operative consistency scores showed significant improvement, p-value of <0.0001, 95% CI (0.63-1.33). Positive predictive value for IAIA predicting response to IASA was 77% with positive likelihood ratio of 2.3. The response to IAIA versus no response to IAIA likelihood ratios were found to have a statistically significant difference (p < 0.05).

CONCLUSIONS: Our study suggests IAIA yields objective improvement in swallow function on VFSS in nearly half of our patients and may be a reliable diagnostic tool to predict response to IASA in patients with persistent pharyngeal dysphagia with or without a laryngeal cleft.

LEVEL OF EVIDENCE: Level 3 Laryngoscope, 2022.

PMID:36069277 | DOI:10.1002/lary.30374

Andrology. 2022 Sep 6. doi: 10.1111/andr.13280. Online ahead of print.

ABSTRACT

BACKGROUND: Elevated intrascrotal temperature has been suggested as a risk factor for testicular cancer, which is the most common neoplasm among young men. Varicocele was linked to increased intrascrotal temperature, but whether it is associated with testicular cancer is unclear.

OBJECTIVE: To explore the possible association between varicocele at adolescence and the incidence of testicular cancer at adulthood.

DESIGN, SETTING AND PARTICIPANTS: This nationwide, population-based, historical cohort study includes 1,521,661 Israeli male adolecents (mean age 17.5 ± 0.4 years), who were screened for varicocele during the years 1967-2012, as part of their medical assessment prior to compulsory military service. The mean follow-up was 18± 4.2 years.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The diagnosis of testicular cancer was ascertained from linkage of records to the the Israeli National Cancer Registry. Survival analysis was applied.

RESULTS: In total, 53,210 adolescents were diagnosed with varicocele stage 2 and 3 prior to military service. Of 1,988 (0.13% of the total cohort) men who were diagnosed with testicular cancer during follow up, 54 (0.1%) had varicocele prior to military service while 1934(99.9%) did not, p = 0.213. The age at cancer diagnosis and the distribution of seminomas vs. non-seminomas did not differ significantly between those with and without varicocele in adolescence. In a multivariable analysis controlling for sociodemographic factors, varicocele was not associated with testicular cancer, odds ratio = 0.816 (CI 0.615-1.083).

CONCLUSIONS: Varicocele in adolecents was not found to be associated with testicular cancer in young adults.

PATIENT SUMMARY: In light of the theoretical association between varicocele and testicular cancer, we conducted this large population study. We found no association between varicocele in young adoulthoot and testicular cancer later in life. This article is protected by copyright. All rights reserved.

PMID:36068656 | DOI:10.1111/andr.13280

Int J Nurs Pract. 2022 Sep 6:e13104. doi: 10.1111/ijn.13104. Online ahead of print.

ABSTRACT

BACKGROUND: Case management has been regarded as the front line of necessary change for fragmented healthcare system.

AIM: This study proposed a case management intervention that is suitable for Chinese colorectal cancer patients and explored its effectiveness over a 12-month follow-up.

METHODS: A quasi-experimental study was conducted in an oncology hospital in China. A total of 188 patients were recruited from May 2015 to February 2017; 85 patients in the control group and 80 patients in the intervention group were included in data analysis. The intervention group was managed for 1 year by a case manager who organized the multidisciplinary team, provided regular assessment, a consulting service and referrals. Quality of life, anxiety and depression, symptom distress, treatment adherence and unplanned readmission rates were measured.

RESULTS: Repeated measurement ANOVA showed significant intervention and time effects in global quality of life, anxiety and depression, symptom distress and oral chemotherapy adherence. The intervention group showed statistically significantly better overall treatment adherence and lower unplanned readmission rate.

CONCLUSION: Nurse-led case management was effective in improving psychosocial outcomes, treatment adherence and unplanned readmission rate of colorectal cancer patients. A case management model is feasible and effective in colorectal cancer patients and in hospital-dominated healthcare systems where primary care is underutilized.

PMID:36068655 | DOI:10.1111/ijn.13104

BMC Musculoskelet Disord. 2022 Sep 6;22(Suppl 2):1068. doi: 10.1186/s12891-022-05726-7.

ABSTRACT

BACKGROUND: Hip megaprostheses are a long known reconstructive method in the treatment of proximal femur metastases. The use of cemented or uncemented stems is still matter of debate. The aim of this study to compare cemented and uncemented megaprostheses on functional outcomes and complications, in order to establish the role of cementation.

METHODS: We retrospectively analysed 51 metastatic patients with proximal femur metastases treated with endoprosthetic reconstruction by megaprostheses, 25 with cementless stems and 26 with cemented ones with different megaprosthetic implants. The primary endpoint was MSTS score, and the secondary endpoint was to state the incidence of surgical and clinical complications in the two groups. An un-paired T test was used to compare anthropometric, anamnestic data, and MSTS. Chi-square test was performed for evaluation of complication in the two group. Multiple linear regression was used to match the functional outcomes and complications’ incidence in the population study. Logistic regression was performed to analyse the odds ratio of different parameters and their role in the incidence of complications.

RESULTS: The mean follow-up was 50.1 months (+ 12.5). In thirty case right side was involved. No statistical differences were noticed between Group A and B regard the age, gender, active fracture/impending fracture. Comparing the MSTS results within the two groups at last follow-up, the score cemented group was higher than cementless one (17.9 + 7.8 vs 24.2 + 5.3; statistical significance p = 0.001). Regarding surgical complications a logistic regression was performed to analyse the odds ratio of age, cementation and length of resection; cementation confirm and odds ratio of 11 times in the incidence of surgical complications.

CONCLUSIONS: Cementation seems to be more liable to complications onset, while improves functional score in metastatic patients compared to uncemented megaprostheses. More studies have to be conducted in order to create a protocol and establish criteria to use cemented or uncemented stems in a frail population like metastatic patients.

PMID:36068628 | DOI:10.1186/s12891-022-05726-7

Infect Dis Poverty. 2022 Sep 6;11(1):95. doi: 10.1186/s40249-022-01019-2.

ABSTRACT

BACKGROUND: The continuous mutation of severe acute respiratory syndrome coronavirus 2 has made the coronavirus disease 2019 (COVID-19) pandemic complicated to predict and posed a severe challenge to the Beijing 2022 Winter Olympics and Winter Paralympics held in February and March 2022.

METHODS: During the preparations for the Beijing 2022 Winter Olympics, we established a dynamic model with pulse detection and isolation effect to evaluate the effect of epidemic prevention and control measures such as entry policies, contact reduction, nucleic acid testing, tracking, isolation, and health monitoring in a closed-loop management environment, by simulating the transmission dynamics in assumed scenarios. We also compared the importance of each parameter in the combination of intervention measures through sensitivity analysis.

RESULTS: At the assumed baseline levels, the peak of the epidemic reached on the 57th day. During the simulation period (100 days), 13,382 people infected COVID-19. The mean and peak values of hospitalized cases were 2650 and 6746, respectively. The simulation and sensitivity analysis showed that: (1) the most important measures to stop COVID-19 transmission during the event were daily nucleic acid testing, reducing contact among people, and daily health monitoring, with cumulative infections at 0.04%, 0.14%, and 14.92% of baseline levels, respectively (2) strictly implementing the entry policy and reducing the number of cases entering the closed-loop system could delay the peak of the epidemic by 9 days and provide time for medical resources to be mobilized; (3) the risk of environmental transmission was low.

CONCLUSIONS: Comprehensive measures under certain scenarios such as reducing contact, nucleic acid testing, health monitoring, and timely tracking and isolation could effectively prevent virus transmission. Our research results provided an important reference for formulating prevention and control measures during the Winter Olympics, and no epidemic spread in the closed-loop during the games indirectly proved the rationality of our research results.

PMID:36068625 | DOI:10.1186/s40249-022-01019-2

Trials. 2022 Sep 6;23(1):755. doi: 10.1186/s13063-022-06667-1.

ABSTRACT

BACKGROUND: South Asians are at high risk of type 2 diabetes (T2D). Lifestyle modification is effective at preventing T2D amongst South Asians, but the approaches to screening and intervention are limited by high costs, poor scalability and thus low impact on T2D burden. An intensive family-based lifestyle modification programme for the prevention of T2D was developed. The aim of the iHealth-T2D trial is to compare the effectiveness of this programme with usual care.

METHODS: The iHealth-T2D trial is designed as a cluster randomised controlled trial (RCT) conducted at 120 sites across India, Pakistan, Sri Lanka and the UK. A total of 3682 South Asian men and women with age between 40 and 70 years without T2D but at elevated risk for T2D [defined by central obesity (waist circumference ≥ 95 cm in Sri Lanka or ≥ 100 cm in India, Pakistan and the UK) and/or prediabetes (HbA1c ≥ 6.0%)] were included in the trial. Here, we describe in detail the statistical analysis plan (SAP), which was finalised before outcomes were available to the investigators. The primary outcome will be evaluated after 3 years of follow-up after enrolment to the study and is defined as T2D incidence in the intervention arm compared to usual care. Secondary outcomes are evaluated both after 1 and 3 years of follow-up and include biochemical measurements, anthropometric measurements, behavioural components and treatment compliance.

DISCUSSION: The iHealth-T2D trial will provide evidence of whether an intensive family-based lifestyle modification programme for South Asians who are at high risk for T2D is effective in the prevention of T2D. The data from the trial will be analysed according to this pre-specified SAP.

ETHICS AND DISSEMINATION: The trial was approved by the international review board of each participating study site. Study findings will be disseminated through peer-reviewed publications and in conference presentations.

TRIAL REGISTRATION: EudraCT 2016-001,350-18 . Registered on 14 April 2016.

CLINICALTRIALS: gov NCT02949739 . Registered on 31 October 2016.

PMID:36068618 | DOI:10.1186/s13063-022-06667-1

J Neuroinflammation. 2022 Sep 6;19(1):218. doi: 10.1186/s12974-022-02582-z.

ABSTRACT

BACKGROUND: Triggering receptor expressed on myeloid cell 1 (Trem1) is an important regulator of cellular inflammatory responses. Neuroinflammation is a common thread across various neurological diseases. Soluble Trem1 (sTrem1) in plasma is associated with the development of central nervous system disorders. However, the extent of any causative effects of plasma sTrem1 on the risk of these disorders is still unclear.

METHOD: Genetic variants for plasma sTrem1 levels were selected as instrumental variables. Summary-level statistics of neurological disorders, including Alzheimer’s disease (AD), Parkinson’s disease (PD), amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), epilepsy, cerebrovascular diseases, and migraine were collected from genome-wide association studies (GWASs). Whether plasma sTrem1 was causally associated with neurological disorders was assessed using a two-sample Mendelian randomization (MR) analysis, with false discovery rate (FDR)-adjusted methods applied.

RESULTS: We inferred suggestive association of higher plasma sTrem1 with the risk of AD (odds ratio [OR] per one standard deviation [SD] increase = 1.064, 95% CI 1.012-1.119, P = 0.014, P_FDR = 0.056). Moreover, there was significant association between plasma sTrem1 level and the risk of epilepsy (OR per one SD increase = 1.044, 95% CI 1.016-1.072, P = 0.002, P_FDR = 0.032), with a modest statistical power of 41%. Null associations were found for plasma sTrem1 with other neurological diseases and their subtypes.

CONCLUSIONS: Taken together, this study indicates suggestive association between plasma sTrem1 and AD. Moreover, higher plasma sTrem1 was associated with the increased risk of epilepsy. The findings support the hypothesis that sTrem1 may be a vital element on the causal pathway to AD and epilepsy.

PMID:36068612 | DOI:10.1186/s12974-022-02582-z

BMC Public Health. 2022 Sep 6;22(1):1688. doi: 10.1186/s12889-022-14095-8.

ABSTRACT

BACKGROUND: The World Health Organization (WHO) considers that the heterogeneity of concepts and definitions of migrants is an obstacle to obtaining evidence to inform public health policies. There is no recent data on the health status of only asylum seekers who have recently arrived in their Western host country. The purpose of this study was to determine the health status of asylum seekers and search for explanatory factors for this health status.

METHODS: This cross-sectional observational study screened the mental and somatic health of adult asylum seekers who had arrived in France within the past 21 days and went to the Marseille single center between March 1 and August 31, 2021. In order to study the explanatory factors of the asylum seekers’ health status, a multivariate analysis was performed using a logistic regression model to predict the health status. Factors taken into account were those significantly associated with outcome (level < 0.05) in univariate analysis.

RESULTS: In total, 419 asylum seekers were included and 96% CI95%[93;97.3] had at least one health disorder. Concerning mental health, 89% CI95% [85.1;91.4] had a mental disorder and in terms of somatic health exclusively, 66% CI95% [61.4;70.6] had at least one somatic disorder. Women were more likely to have a somatic disease OR = 1.80 [1.07; 3.05]. We found a statistically significant association between the presence of at least one disorder and sleeping in a public space OR = 3.4 [1.02;11.28] p = 0.046. This association is also found for mental disorders OR = 2.36 [1.16;4.84], p = 0.018.

CONCLUSIONS: Due to the high prevalence of health disorders our study found, asylum seekers are a population with many care needs when they arrive in their host country. The main factors linked to a poor health status seem to be related to a person’s sex, geographical origin and sleeping in a public space.

PMID:36068557 | DOI:10.1186/s12889-022-14095-8

Trials. 2022 Sep 6;23(1):754. doi: 10.1186/s13063-022-06664-4.

ABSTRACT

BACKGROUND: Platform trials are well-known for their ability to investigate multiple arms on heterogeneous patient populations and their flexibility to add/drop treatment arms due to efficacy/lack of efficacy. Because of their complexity, it is important to develop highly optimized, transparent, and rigorous designs that are cost-efficient, offer high statistical power, maximize patient benefit, and are robust to changes over time.

METHODS: To address these needs, we present a Bayesian platform trial design based on a beta-binomial model for binary outcomes that uses three key strategies: (1) hierarchical modeling of subgroups within treatment arms that allows for borrowing of information across subgroups, (2) utilization of response-adaptive randomization (RAR) schemes that seek a tradeoff between statistical power and patient benefit, and (3) adjustment for potential drift over time. Motivated by a proposed clinical trial that aims to find the appropriate treatment for different subgroup populations of ischemic stroke patients, extensive simulation studies were performed to validate the approach, compare different allocation rules, and study the model operating characteristics.

RESULTS AND CONCLUSIONS: Our proposed approach achieved high statistical power and good patient benefit and was also robust against population drift over time. Our design provided a good balance between the strengths of both the traditional RAR scheme and fixed 1:1 allocation and may be a promising choice for dichotomous outcomes trials investigating multiple subgroups.

PMID:36068547 | DOI:10.1186/s13063-022-06664-4