Tag: statistics

Diabetes Care. 2021 Nov 2:dc210278. doi: 10.2337/dc21-0278. Online ahead of print.

ABSTRACT

OBJECTIVE: The aim of the study was to evaluate remission of type 2 diabetes following a short-term intervention with insulin glargine, sitagliptin/metformin, and lifestyle approaches.

RESEARCH DESIGN AND METHODS: In this open multicenter trial, 102 patients with type 2 diabetes were randomized to 1) a 12-week intervention with sitagliptin/metformin, insulin glargine and lifestyle therapy, or 2) control group. Participants with HbA_1c <7.3% (<56 mmol/mol) at 12 weeks were asked to stop diabetes medications and were followed for evidence of relapse over 52 weeks. Diabetes relapse criteria included HbA_1c ≥6.5% (≥48 mmol/mol), ≥50% of capillary glucose readings >10 mmol/L over 1 week, and reinitiation of diabetes medications with or without abnormal fasting plasma glucose (FPG) or 2-h plasma glucose on an oral glucose tolerance test (OGTT). Time-to-relapse analysis was conducted to compare the treatment groups with (primary analysis) and without (supplementary analysis) FPG/OGTT relapse criteria.

RESULTS: With the FPG/OGTT relapse criteria included, the hazard ratio (HR) of relapse was 0.72 (95% CI 0.47-1.10) in the intervention group compared with the control group (primary analysis), and the number of participants remaining in remission was not significantly different between treatment groups at 24, 36, 48, and 64 weeks. In the supplementary analyses without these criteria, HR of relapse was 0.60 (95% CI 0.39-0.95), and the number of participants remaining in remission was significantly higher (26 vs. 10%) in the intervention group at 36 weeks.

CONCLUSIONS: Although our primary outcome was not statistically significant, the tested approach deserves further study with further optimization of its components.

PMID:34728531 | DOI:10.2337/dc21-0278

Diabetes Care. 2021 Nov 2:dc210496. doi: 10.2337/dc21-0496. Online ahead of print.

ABSTRACT

OBJECTIVE: To estimate difference in population-level glycemic control and the emergence of diabetes complications given a theoretical scenario in which non-White youth and young adults (YYA) with type 1 diabetes (T1D) receive and follow an equivalent distribution of diabetes treatment regimens as non-Hispanic White YYA.

RESEARCH DESIGN AND METHODS: Longitudinal data from YYA diagnosed 2002-2005 in the SEARCH for Diabetes in Youth Study were analyzed. Based on self-reported race/ethnicity, YYA were classified as non-White race or Hispanic ethnicity (non-White subgroup) versus non-Hispanic White race (White subgroup). In the White versus non-White subgroups, the propensity score models estimated treatment regimens, including patterns of insulin modality, self-monitored glucose frequency, and continuous glucose monitoring use. An analysis based on policy evaluation techniques in reinforcement learning estimated the effect of each treatment regimen on mean hemoglobin A_1c (HbA_1c) and the prevalence of diabetes complications for non-White YYA.

RESULTS: The study included 978 YYA. The sample was 47.5% female and 77.5% non-Hispanic White, with a mean age of 12.8 ± 2.4 years at diagnosis. The estimated population mean of longitudinal average HbA_1c over visits was 9.2% and 8.2% for the non-White and White subgroup, respectively (difference of 0.9%). Within the non-White subgroup, mean HbA_1c across visits was estimated to decrease by 0.33% (95% CI -0.45, -0.21) if these YYA received the distribution of diabetes treatment regimens of the White subgroup, explaining ∼35% of the estimated difference between the two subgroups. The non-White subgroup was also estimated to have a lower risk of developing diabetic retinopathy, diabetic kidney disease, and peripheral neuropathy with the White youth treatment regimen distribution (P < 0.05), although the low proportion of YYA who developed complications limited statistical power for risk estimations.

CONCLUSIONS: Mathematically modeling an equalized distribution of T1D self-management tools and technology accounted for part of but not all disparities in glycemic control between non-White and White YYA, underscoring the complexity of race and ethnicity-based health inequity.

PMID:34728528 | DOI:10.2337/dc21-0496

BMJ Glob Health. 2021 Nov;6(11):e007177. doi: 10.1136/bmjgh-2021-007177.

ABSTRACT

Cause-specific mortality estimates for 11 countries located in the WHO’s South East Asia Region (WHO SEAR) are generated periodically by the Global Burden of Disease (GBD) and the WHO Global Health Estimates (GHE) analyses. A comparison of GBD and GHE estimates for 2019 for 11 specific causes of epidemiological importance to South East Asia was undertaken. An index of relative difference (RD) between the estimated numbers of deaths by sex for each cause from the two sources for each country was calculated, and categorised as marginal (RD=±0%-9%), moderate (RD=±10%-19%), high (RD=±20%-39%) and extreme (RD>±40%). The comparison identified that the RD was >10% in two-thirds of all instances. The RD was ‘high’ or ‘extreme’ for deaths from tuberculosis, diarrhoea, road injuries and suicide for most SEAR countries, and for deaths from most of the 11 causes in Bangladesh, DPR Korea, Myanmar, Nepal and Sri Lanka. For all WHO SEAR countries, mortality estimates from both sources are based on statistical models developed from an international historical cause-specific mortality data series that included very limited empirical data from the region. Also, there is no scientific rationale available to justify the reliability of one set of estimates over the other. The characteristics of national mortality statistics systems for each WHO SEAR country were analysed, to understand the reasons for weaknesses in empirical data. The systems analysis identified specific limitations in structure, organisation and implementation that affect data completeness, validity of causes of death and vital statistics production, which vary across countries. Therefore, customised national strategies are required to strengthen mortality statistics systems to meet immediate and long-term data needs for health policy and research, and reduce dependence on current unreliable modelled estimates.

PMID:34728480 | DOI:10.1136/bmjgh-2021-007177

Can J Surg. 2021 Nov 2;64(6):E588-E593. doi: 10.1503/cjs.020219. Print 2021 Nov-Dec.

ABSTRACT

BACKGROUND: Given the rising prevalence of subways in combination with an increasing incidence of subway-related injuries, understanding subway-related trauma is becoming ever more relevant. The aim of this study was to characterize the potential causes, injury characteristics and outcomes of subway-related trauma at a level 1 adult trauma centre in Toronto, Ontario.

METHODS: We conducted a retrospective cohort study to identify patients who presented to the emergency department a level 1 adult trauma centre with a subway-related injury between Jan. 1, 2010, and Dec. 31, 2018. Patients were identified via International Statistical Classification of Diseases and Related Health Problems, 10th Revision E-codes (X81, Y02, V050, V051 and W17). We then further screened for descriptions of subway-related injuries. Patients whose injuries did not involve a moving subway train were excluded.

RESULTS: We identified 51 patients who presented to the emergency department after being hit by a moving subway train. The majority of incidents (39 [76%]) were due to self-harm, 10 (20%) were unintentional injuries, and 2 (4%) were due to assault. The presence of alcohol was detected in 8 patients (80%) with unintentional injuries and 3 (8%) of those with self-inflicted injuries. Thirteen patients (25%) had a systolic blood pressure less than 90 mm Hg. The median Injury Severity Score was 17 (interquartile range 9-29). Seventeen patients (33%) presented with severe injuries (Abbreviated Injury Scale score ≥ 3) in 1 body region, and 19 (37%) had severe injuries in 2 or more body regions. The most common isolated severe injury was in the lower extremity, and the most common combinations of severe injuries were in the head and lower extremity, and head and thorax. Ten patients (20%) were declared dead in the emergency department. Of the 41 patients who survived their initial presentation, 12 (29%) went directly to the operating room, and 17 (41%) were transferred to the intensive care unit. The overall mortality rate was 29%.

CONCLUSION: Patients with subway-related injuries experienced high mortality rates and severe injuries. Most incidents were due to self-harm or alcohol-related. Further research into early identification of those at risk and optimal prevention strategies is necessary to curb further incidents.

PMID:34728524 | DOI:10.1503/cjs.020219

BMJ. 2021 Nov 2;375:e068060. doi: 10.1136/bmj-2021-068060.

ABSTRACT

OBJECTIVE: To determine if inhaled and intranasal ciclesonide are superior to placebo at decreasing respiratory symptoms in adult outpatients with covid-19.

DESIGN: Randomised, double blind, placebo controlled trial.

SETTING: Three Canadian provinces (Quebec, Ontario, and British Columbia).

PARTICIPANTS: 203 adults aged 18 years and older with polymerase chain reaction confirmed covid-19, presenting with fever, cough, or dyspnoea.

INTERVENTION: Participants were randomised to receive either inhaled ciclesonide (600 μg twice daily) and intranasal ciclesonide (200 μg daily) or metered dose inhaler and nasal saline placebos for 14 days.

MAIN OUTCOME MEASURES: The primary outcome was symptom resolution at day 7. Analyses were conducted on the modified intention-to-treat population (participants who took at least one dose of study drug and completed one follow-up survey) and adjusted for stratified randomisation by sex.

RESULTS: The modified intention-to-treat population included 203 participants: 105 were randomly assigned to ciclesonide (excluding two dropouts and one loss to follow-up) and 98 to placebo (excluding three dropouts and six losses to follow-up). The median age was 35 years (interquartile range 27-47 years) and 54% were women. The proportion of participants with resolution of symptoms by day 7 did not differ significantly between the intervention group (42/105, 40%) and control group (34/98, 35%); absolute adjusted risk difference 5.5% (95% confidence interval -7.8% to 18.8%). Results might be limited to the population studied, which mainly included younger adults without comorbidities. The trial was stopped early, therefore could have been underpowered.

CONCLUSION: Compared with placebo, the combination of inhaled and intranasal ciclesonide did not show a statistically significant increase in resolution of symptoms among healthier young adults with covid-19 presenting with prominent respiratory symptoms. As evidence is insufficient to determine the benefit of inhaled and intranasal corticosteroids in the treatment of covid-19, further research is needed.

TRIAL REGISTRATION: ClinicalTrials.gov NCT04435795.

PMID:34728476 | DOI:10.1136/bmj-2021-068060

BMJ Glob Health. 2021 Nov;6(11):e006760. doi: 10.1136/bmjgh-2021-006760.

ABSTRACT

This paper describes the lessons from scaling up a verbal autopsy (VA) intervention to improve data about causes of death according to a nine-domain framework: governance, design, operations, human resources, financing, infrastructure, logistics, information technologies and data quality assurance. We use experiences from China, Myanmar, Papua New Guinea, Philippines and Solomon Islands to explore how VA has been successfully implemented in different contexts, to guide other countries in their VA implementation. The governance structure for VA implementation comprised a multidisciplinary team of technical experts, implementers and staff at different levels within ministries. A staged approach to VA implementation involved scoping and mapping of death registration processes, followed by pretest and pilot phases which allowed for redesign before a phased scale-up. Existing health workforce in countries were trained to conduct the VA interviews as part of their routine role. Costs included training and compensation for the VA interviewers, information technology (IT) infrastructure costs, advocacy and dissemination, which were borne by the funding agency in early stages of implementation. The complexity of the necessary infrastructure, logistics and IT support required for VA increased with scale-up. Quality assurance was built into the different phases of the implementation. VA as a source of cause of death data for community deaths will be needed for some time. With the right technical and political support, countries can scale up this intervention to ensure ongoing collection of quality and timely information on community deaths for use in health planning and better monitoring of national and global health goals.

PMID:34728477 | DOI:10.1136/bmjgh-2021-006760

BMJ Open Respir Res. 2021 Nov;8(1):e000974. doi: 10.1136/bmjresp-2021-000974.

ABSTRACT

BACKGROUND: Neural mechanisms may play an important role in non-eosinophilic asthma (NEA). This study compared airway sensory nerve reactivity, using capsaicin challenge, in eosinophilic asthma (EA) and NEA and non-asthmatics.

METHODS: Thirty-eight asthmatics and 19 non-asthmatics (aged 14-21 years) underwent combined hypertonic saline challenge/sputum induction, fractional exhaled nitric oxide, atopy and spirometry tests, followed by capsaicin challenge. EA and NEA were defined using a sputum eosinophil cut-point of 2.5%. Airway hyperreactivity was defined as a ≥15% drop in FEV₁ during saline challenge. Sensory nerve reactivity was defined as the lowest capsaicin concentration that evoked 5 (C5) coughs.

RESULTS: Non-eosinophilic asthmatics (n=20) had heightened capsaicin sensitivity (lower C5) compared with non-asthmatics (n=19) (geometric mean C5: 58.3 µM, 95% CI 24.1 to 141.5 vs 193.6 µM, 82.2 to 456.0; p<0.05). NEA tended to also have greater capsaicin sensitivity than EA, with the difference in capsaicin sensitivity between NEA and EA being of similar magnitude (58.3 µM, 24.1 to 141.5 vs 191.0 µM, 70.9 to 514.0) to that observed between NEA and non-asthmatics; however, this did not reach statistical significance (p=0.07). FEV₁ was significantly reduced from baseline following capsaicin inhalation in both asthmatics and non-asthmatics but no differences were found between subgroups. No associations with capsaicin sensitivity and atopy, sputum eosinophils, blood eosinophils, asthma control or treatment were observed.

CONCLUSION: NEA, but not EA, showed enhanced capsaicin sensitivity compared with non-asthmatics. Sensory nerve reactivity may therefore play an important role in the pathophysiology of NEA.

PMID:34728474 | DOI:10.1136/bmjresp-2021-000974

BMJ Open Respir Res. 2021 Nov;8(1):e001023. doi: 10.1136/bmjresp-2021-001023.

ABSTRACT

BACKGROUND: WHO defines hypoxaemia, a low peripheral arterial oxyhaemoglobin saturation (SpO₂), as <90%. Although hypoxaemia is an important risk factor for mortality of children with respiratory infections, the optimal SpO₂ threshold for defining hypoxaemia is uncertain in low-income and middle-income countries (LMICs). We derived a SpO₂ threshold for hypoxaemia from well children in Bangladesh residing at low altitude.

METHODS: We prospectively enrolled well, children aged 3-35 months participating in a pneumococcal vaccine evaluation in Sylhet district, Bangladesh between June and August 2017. Trained health workers conducting community surveillance measured the SpO₂ of children using a Masimo Rad-5 pulse oximeter with a wrap sensor. We used standard summary statistics to evaluate the SpO₂ distribution, including whether the distribution differed by age or sex. We considered the 2.5th, 5th and 10th percentiles of SpO₂ as possible lower thresholds for hypoxaemia.

RESULTS: Our primary analytical sample included 1470 children (mean age 18.6±9.5 months). Median SpO₂ was 98% (IQR 96%-99%), and the 2.5th, 5th and 10th percentile SpO₂ was 91%, 92% and 94%. No child had a SpO₂ <90%. Children 3-11 months had a lower median SpO₂ (97%) than 12-23 months (98%) and 24-35 months (98%) (p=0.039). The SpO₂ distribution did not differ by sex (p=0.959).

CONCLUSION: A SpO₂ threshold for hypoxaemia derived from the 2.5th, 5th or 10th percentile of well children is higher than <90%. If a higher threshold than <90% is adopted into LMIC care algorithms then decision-making using SpO₂ must also consider the child’s clinical status to minimise misclassification of well children as hypoxaemic. Younger children in lower altitude LMICs may require a different threshold for hypoxaemia than older children. Evaluating the mortality risk of sick children using higher SpO₂ thresholds for hypoxaemia is a key next step.

PMID:34728475 | DOI:10.1136/bmjresp-2021-001023

Cancer Epidemiol Biomarkers Prev. 2021 Nov 2:cebp.0503.2021. doi: 10.1158/1055-9965.EPI-21-0503. Online ahead of print.

ABSTRACT

BACKGROUND: Body mass index (BMI) change after a lung cancer diagnosis has been associated with non-small cell lung cancer (NSCLC) survival. This study aimed to quantify the association based on a large-scale observational study.

METHODS: Included in the study were 7,547 NSCLC patients with prospectively collected BMI data from Massachusetts General Hospital and Brigham and Women’s Hospital/Dana Faber Cancer Institute. Cox proportional hazards regression with time-dependent covariates was used to estimate effect of time varying post-diagnosis BMI change rate (% per month) on overall survival (OS), stratified by clinical subgroups. Spline analysis was conducted to quantify the non-linear association. A Mendelian Randomization (MR) analysis with a total of 3,495 patients further validated the association.

RESULTS: There was a J-shape association between post-diagnosis BMI change and OS among NSCLC patients. Specifically, a moderate BMI decrease (0.5-2.0; HR = 2.45, 95% CI = 2.25-2.67) and large BMI decrease ({>= 2.0; HR = 4.65, 95% CI = 4.15-5.20) were strongly associated with worse OS, whereas moderate weight gain (0.5-2.0) reduced the risk for mortality (HR = 0.78, 95% CI = 0.68-0.89) and large weight gain (>= 2.0) slightly increased the risk of mortality without reaching statistical significance (HR = 1.10, 95% CI = 0.86-1.42). MR analyses supported the potential causal roles of post-diagnosis BMI change in survival.

CONCLUSIONS: This study indicates that BMI change after diagnosis was associated with mortality risk.

IMPACT: Our findings, which reinforce the importance of post-diagnosis BMI surveillance, suggesting that weight loss or large weight gain maybe unwarranted.

PMID:34728470 | DOI:10.1158/1055-9965.EPI-21-0503

BMJ Open. 2021 Nov 2;11(11):e053309. doi: 10.1136/bmjopen-2021-053309.

ABSTRACT

INTRODUCTION: Abdominal surgery is associated with common complications, including decreased or poor appetite, abdominal distension, abdominal pain caused by decreased or absent gastrointestinal motility, anal arrest with flatus and defecation, and nausea and vomiting resulting from the use of anaesthetics and opioid analgesics. These complications seriously affect postoperative recovery, prolong hospital stay and aggravate patient burden. This study aims to investigate for the first time the efficacy of transcutaneous electrical acupoint stimulation (TEAS) combined with electroacupuncture (EA) therapy for rapid recovery after laparotomy for gastrointestinal surgery. There have been no clinical studies of this combination therapy.

METHODS AND ANALYSIS: This will be a prospective, single-centre, three-arm, randomised controlled trial. A total of 480 patients undergoing abdominal surgery will be stratified according to surgery type (ie, gastric or colorectal procedure) and randomised into three groups; namely, the EA, TEAS +EA and control groups. The control group will receive enhanced recovery after surgery (ERAS)-standardised perioperative management, including preoperative education, optimising the anaesthesia scheme, avoiding intraoperative hypothermia, restrictive fluid infusion and reducing surgical trauma. The EA group will receive EA stimulation at LI4, PC6, ST36, ST37 and ST39 based on the ERAS-standardised perioperative management. Moreover, the TEAS +EA group will receive ERAS-standardised perioperative management; EA stimulation at the LI4, PC6, ST36, ST37 and ST39; and TEAS stimulation at ST21 and SP15. The primary outcome will be the GI-2 (composite outcome of time to first defaecation and time to tolerance of a solid diet). Secondary outcomes will include the time of first passage of flatus, time to first defaecation, time to tolerance of a solid diet, time to first ambulation, hospital duration from operation to discharge, pain and nausea vomiting scores on the Visual Analogue Scale, medication use, incidence of postoperative complications and evaluation of treatment modality acceptability. All statistical analyses will be performed based on the intention-to-treat principle.

ETHICS AND DISSEMINATION: Ethics approval has been granted by the Ethics Committee on Biomedical Research, West China Hospital of Sichuan University (approval number: 2021; number 52). The results are expected to be published in peer-reviewed journals.

TRIAL REGISTRATION NUMBER: ChiCTR2100045646.

PMID:34728456 | DOI:10.1136/bmjopen-2021-053309