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Nevin Manimala Statistics

Acupuncture versus cognitive behavioral therapy for pain among cancer survivors with insomnia: an exploratory analysis of a randomized clinical trial

NPJ Breast Cancer. 2021 Nov 30;7(1):148. doi: 10.1038/s41523-021-00355-0.

ABSTRACT

Pain and insomnia often co-occur and impair the quality of life in cancer survivors. This study evaluated the effect of acupuncture versus cognitive behavioral therapy for insomnia (CBT-I) on pain severity among cancer survivors with comorbid pain and insomnia. Using data from the CHOICE trial that compared acupuncture versus CBT-I for insomnia among cancer survivors, we analyzed the effect of interventions on pain outcomes in 70 patients with moderate to severe baseline pain. Interventions were delivered over eight weeks. We assessed average pain severity (primary outcome) and pain interference at baseline, week 8, and week 20. We further defined insomnia and pain responders as patients who achieved clinically meaningful improvement in insomnia and pain outcomes, respectively, at week 8. We found that compared with baseline, the between-group difference (-1.0, 95% CI -1.8 to -0.2) was statistically significant favoring acupuncture for reduced pain severity at week 8 (-1.4, 95% CI -2.0 to -0.8) relative to CBT-I (-0.4, 95% CI-1.0 to 0.2). Responder analysis showed that 1) with acupuncture, insomnia responders reported significantly greater pain reduction from baseline to week 4, compared with insomnia non-responders (-1.5, 95% CI -2.7 to -0.3); 2) with CBT-I, pain responders reported significantly greater insomnia reduction at week 8, compared with pain non-responders (-4.7, 95% CI -8.7 to -1.0). These findings suggest that among cancer survivors with comorbid pain and insomnia, acupuncture led to rapid pain reductions, which contributed to a decrease in insomnia, whereas CBT-I had a delayed effect on pain, possibly achieved by insomnia improvement.

PMID:34848737 | DOI:10.1038/s41523-021-00355-0

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Performance of sustainable self-compacting fiber reinforced concrete with substitution of marble waste (MW) and coconut fibers (CFs)

Sci Rep. 2021 Nov 30;11(1):23184. doi: 10.1038/s41598-021-01931-x.

ABSTRACT

Self compacting concrete (SCC) is special type of concrete which is highly flowable and non-segregated and by its own mass, spreads into the formwork without any external vibrators, even in the presence of thick reinforcement. But SSC is also brittle nature like conventional concrete, which results in abrupt failure without giving any deformation (warning), which is undesirable for any structural member. Thus, self-compacting concrete (SCC) needs some of tensile reinforcement to enhance tensile strength and prevent the unsuitable abrupt failure. But fiber increased tensile strength of concrete more effectively than compressive strength. Hence, it is essential to add pozzolanic materials into fiber reinforced concrete to achieve high strength, durable and ductile concrete. This study is conducted to assess the performance of SCC with substitutions of marble waste (MW) and coconut fiber (CFs) into SCC. MW utilized as cementitious (pozzolanic) materials in percentage of 5.0 to 30% in increment of 5.0% by weight of binder and concrete is reinforced with CFs in proportion of 0.5 to 3.0% in increment of 0.5% by weight of binder. Rheological characteristics were measured through its filling and passing ability by using Slump flow, Slump T50, L-Box, and V-funnel tests while mechanical characteristics were measured through compressive strength, split tensile strength, flexure strength and bond strength (pull out) tests. Experimental investigation show that MW and CFs decrease the passing ability and filling ability of SCC. Additionally, Experimental investigation show that MW up to 20% and CFs addition 2.0% by weight of binder tend to increase the mechanical performance of SCC. Furthermore, statistical analysis (RSM) was used to optimize the combined dose of MW and CFs into SCC to obtain high strength self-compacting concrete.

PMID:34848738 | DOI:10.1038/s41598-021-01931-x

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Tranexamic acid for intracerebral haemorrhage within 2 hours of onset: protocol of a phase II randomised placebo-controlled double-blind multicentre trial

Stroke Vasc Neurol. 2021 Nov 30:svn-2021-001070. doi: 10.1136/svn-2021-001070. Online ahead of print.

ABSTRACT

RATIONALE: Haematoma growth is common early after intracerebral haemorrhage (ICH), and is a key determinant of outcome. Tranexamic acid, a widely available antifibrinolytic agent with an excellent safety profile, may reduce haematoma growth.

METHODS AND DESIGN: Stopping intracerebral haemorrhage with tranexamic acid for hyperacute onset presentation including mobile stroke units (STOP-MSU) is a phase II double-blind, randomised, placebo-controlled, multicentre, international investigator-led clinical trial, conducted within the estimand statistical framework.

HYPOTHESIS: In patients with spontaneous ICH, treatment with tranexamic acid within 2 hours of onset will reduce haematoma expansion compared with placebo.

SAMPLE SIZE ESTIMATES: A sample size of 180 patients (90 in each arm) would be required to detect an absolute difference in the primary outcome of 20% (placebo 39% vs treatment 19%) under a two-tailed significance level of 0.05. An adaptive sample size re-estimation based on the outcomes of 144 patients will allow a possible increase to a prespecified maximum of 326 patients.

INTERVENTION: Participants will receive 1 g intravenous tranexamic acid over 10 min, followed by 1 g intravenous tranexamic acid over 8 hours; or matching placebo.

PRIMARY EFFICACY MEASURE: The primary efficacy measure is the proportion of patients with haematoma growth by 24±6 hours, defined as either ≥33% relative increase or ≥6 mL absolute increase in haematoma volume between baseline and follow-up CT scan.

DISCUSSION: We describe the rationale and protocol of STOP-MSU, a phase II trial of tranexamic acid in patients with ICH within 2 hours from onset, based in participating mobile stroke units and emergency departments.

PMID:34848566 | DOI:10.1136/svn-2021-001070

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Primary care bonus payments and patient-reported access in urban Ontario: a cross-sectional study

CMAJ Open. 2021 Nov 30;9(4):E1080-E1096. doi: 10.9778/cmajo.20200235. Print 2021 Oct-Dec.

ABSTRACT

BACKGROUND: Rurality strongly correlates with higher pay-for-performance access bonuses, despite higher emergency department use and fewer primary care services than in urban settings. We sought to evaluate the relation between patient-reported access to primary care and access bonus payments in urban settings.

METHODS: We conducted a cross-sectional, secondary data analysis using Ontario survey and health administrative data from 2013 to 2017. We used administrative data to calculate annual access bonuses for eligible urban family physicians. We linked this payment data to adult (≥ 16 yr) patient data from the Health Care Experiences Survey to examine the relation between access bonus achievement (in quintiles of the proportion of bonus achieved, from lowest [Q1, reference category] to highest [Q5]) and 4 patient-reported access outcomes. The average survey response rate to the patient survey during the study period was 51%. We stratified urban geography into large, medium and small settings. In a multilevel regression model, we adjusted for patient-, physician- and practice-level covariates. We tested linear trends, adjusted for clustering, for each outcome.

RESULTS: We linked 18 893 respondents to 3940 physicians in 414 bonus-eligible practices. Physicians in small urban settings earned the highest proportion of their maximum potential access bonuses. Access bonus achievement was positively associated with telephone access (Q2 odds ratio [OR] 1.18, 95% confidence interval [CI] 0.98-1.42; Q3 OR 1.34, 95% CI 1.10-1.63; Q4 OR 1.46, 95% CI 1.19-1.79; Q5 OR 1.87, 95% CI 1.50-2.33), after hours access (Q2 OR 1.26, 95% CI 1.09-1.47; Q3 OR 1.46, 95% CI 1.23-1.74; Q4 OR 1.77, 95% CI 1.46-2.15; Q5 OR 1.88, 95% CI 1.52-2.32), wait time for care (Q2 OR 1.01, 95% CI 0.85-1.20; Q3 OR 1.17, 95% CI 0.97-1.41; Q4 OR 1.27, 95% CI 1.05-1.55; Q5 OR 1.63, 95% CI 1.32-2.00) and timeliness (Q2 OR 1.29, 95% CI 0.98-1.69; Q3 OR 1.29, 95% CI 0.94-1.77; Q4 OR 1.58, 95% CI 1.16-2.13; Q5 OR 1.98, 95% CI 1.38-2.82). When stratified by geography, we observed several of these associations in large urban settings, but not in small urban settings. Trend tests were statistically significant for all 4 outcomes.

INTERPRETATION: Although the access bonus correlated with access in larger urban settings, it did not in smaller settings, aligning with previous research questioning its utility in smaller geographies. The access bonus may benefit from a redesign that considers geography and patient experience.

PMID:34848549 | DOI:10.9778/cmajo.20200235

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Retrospective evaluation of patients with and without 14-day readmissions following hospitalization for COVID-19

J Investig Med. 2021 Nov 30:jim-2021-001986. doi: 10.1136/jim-2021-001986. Online ahead of print.

ABSTRACT

Hospitalized patients with COVID-19 must have a safe discharge plan to prevent readmissions. We assessed patients with COVID-19 admitted to hospitals belonging to a single health system between April 2020 and June 2020. Demographics, vitals and laboratory data were obtained by electronic data query and discharge processes were reviewed by manual abstraction. Over the study period, 94 out of 912 (10.3%) patients were readmitted within 14 days of discharge. Readmitted patients were older and spent more time in the intensive care unit (p<0.01). Statistical differences were noted in discharge-day heart rates, temperatures, platelet counts, and neutrophil and lymphocyte percentages between the readmitted and non-readmitted groups. Readmitted patients were less likely to be discharged home and to receive complete discharge instructions or home oxygen (p<0.01). Age, duration of intensive care unit stay, disposition destinations other than home, incomplete discharge planning and no arrangement for home oxygen may be associated with 14-day readmissions in patients with COVID-19. Certain clinical parameters on discharge day, while statistically different, may not reach clinically discriminant thresholds. Structured discharge processes may improve outcomes.

PMID:34848563 | DOI:10.1136/jim-2021-001986

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Evaluation of inappropriate antibiotic prescribing and management through pharmacist-led antimicrobial stewardship programmes: a meta-analysis of evidence

Eur J Hosp Pharm. 2021 Nov 30:ejhpharm-2021-002914. doi: 10.1136/ejhpharm-2021-002914. Online ahead of print.

ABSTRACT

PURPOSE: This meta-analysis aims to evaluate inappropriate antibiotic prescribing in the Gulf region and determine the effect of pharmacist-led antimicrobial stewardship (AMS) programmes on reducing inappropriateness.

METHOD: Articles were searched, analysed, and quality assessed through the risk of bias (ROB) quality assessment tool to select articles with a low level of bias. In step 1, 515 articles were searched, in step 2, 2360 articles were searched, and ultimately 32 articles were included by critical analysis. Statistical analysis used to determine risk ratio and standard mean differences were calculated using Review manager 5.4; 95% confidence intervals were calculated using the fixed-effect model. The I2 statistic assessed heterogeneity. In statistical heterogeneity, subgroup and sensitivity analyses, a random effect model was performed. The α threshold was 0.05. The primary outcome was inappropriateness in antibiotic prescribing in the Gulf region and reduction of inappropriateness through AMS.

RESULT: Detailed review and analysis of 18 studies of inappropriate antibiotic prescribing in the Gulf region showed the risk of inappropriateness was 43 669/100 846=43.3% (pooled RR 1.31, 95% CI 1.30 to 1.32). Test with overall effect was 58.87; in the second step 28 AMS programmes led by pharmacists showed reduced inappropriateness in AMS with pharmacist versus pre-AMS without pharmacist (RR 0.36, 95% CI 0.32 to 0.39).

CONCLUSION: Inappropriate antibiotic prescribing in the Gulf region is alarming and needs to be addressed through pharmacist-led AMS programmes.

PMID:34848531 | DOI:10.1136/ejhpharm-2021-002914

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Fragility indices for only sufficiently likely modifications

Proc Natl Acad Sci U S A. 2021 Dec 7;118(49):e2105254118. doi: 10.1073/pnas.2105254118.

ABSTRACT

The fragility index is a clinically meaningful metric based on modifying patient outcomes that is increasingly used to interpret the robustness of clinical trial results. The fragility index relies on a concept that explores alternative realizations of the same clinical trial by modifying patient measurements. In this article, we propose to generalize the fragility index to a family of fragility indices called the incidence fragility indices that permit only outcome modifications that are sufficiently likely and provide an exact algorithm to calculate the incidence fragility indices. Additionally, we introduce a far-reaching generalization of the fragility index to any data type and explain how to permit only sufficiently likely modifications for nondichotomous outcomes. All of the proposed methodologies follow the fragility index concept.

PMID:34848537 | DOI:10.1073/pnas.2105254118

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Validity and reliability of the Swedish Functional Health Literacy scale and the Swedish Communicative and Critical Health Literacy scale in patients undergoing bariatric surgery in Sweden: a prospective psychometric evaluation study

BMJ Open. 2021 Nov 30;11(11):e056592. doi: 10.1136/bmjopen-2021-056592.

ABSTRACT

OBJECTIVES: The aim was to psychometrically test and evaluate the Swedish functional health literacy scale and the Swedish communicative and critical health literacy scale in patients undergoing bariatric surgery.

DESIGN: A prospective cross-sectional psychometric study.

SETTING: Patients from three bariatric centres in Sweden were consecutively included in this study.

PARTICIPANTS: A total of 704 patients undergoing bariatric surgery filled in the questionnaires preoperatively. Inclusion criteria were scheduled for primary bariatric surgery (Roux-en-Y gastric bypass or sleeve gastrectomy) and greater than 17 years, proficiency in Swedish.

PRIMARY AND SECONDARY MEASURES: Psychometric outcomes of the Swedish Functional Health Literacy scale and the Swedish Communicative and Critical Health Literacy scale.

RESULTS: There was a higher proportion of females (74.4%, n=523) to males (25.6%, n=180). The mean age was 42 years (SD 11.5). Limited functional health literacy and limited communicative and critical health literacy (including both inadequate and problematic health literacy) was reported in 55% (n=390) and 40% (n=285), respectively. Cronbach alpha for the Swedish Functional Health Literacy scale was α=0.86 and for the Swedish Communicative and Critical Health Literacy scale, α=0.87. Construct validity showed weak to negative correlations between the Swedish Functional Health Literacy scale and income, education and SF-36/RAND36 summary scores. Confirmatory factor analysis showed a one-factor solution for the Swedish Functional Health Literacy scale and a two-factor solution for the Swedish Communicative and Critical Health Literacy scale.

CONCLUSIONS: The Swedish Functional Health Literacy scale and the Swedish Communicative and Critical Health Literacy scale are valid and reliable to use for patients undergoing bariatric surgery in a Swedish context. Measuring dimensions of health literacy can be used as a guide for the development of health literacy friendly patient information in patients undergoing bariatric surgery.

PMID:34848528 | DOI:10.1136/bmjopen-2021-056592

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Association between multimorbidity and socioeconomic deprivation on short-term mortality among patients with diffuse large B-cell or follicular lymphoma in England: a nationwide cohort study

BMJ Open. 2021 Nov 30;11(11):e049087. doi: 10.1136/bmjopen-2021-049087.

ABSTRACT

OBJECTIVES: We aimed to assess the association between multimorbidity and deprivation on short-term mortality among patients with diffuse large B-cell (DLBCL) and follicular lymphoma (FL) in England.

SETTING: The association of multimorbidity and socioeconomic deprivation on survival among patients diagnosed with DLBCL and FL in England between 2005 and 2013. We linked the English population-based cancer registry with electronic health records databases and estimated adjusted mortality rate ratios by multimorbidity and deprivation status. Using flexible hazard-based regression models, we computed DLBCL and FL standardised mortality risk by deprivation and multimorbidity at 1 year.

RESULTS: Overall, 41 422 patients aged 45-99 years were diagnosed with DLBCL or FL in England during 2005-2015. Most deprived patients with FL with multimorbidities had three times higher hazard of 1-year mortality (HR: 3.3, CI 2.48 to 4.28, p<0.001) than least deprived patients without comorbidity; among DLBCL, there was approximately twice the hazard (HR: 1.9, CI 1.70 to 2.07, p<0.001).

CONCLUSIONS: Multimorbidity, deprivation and their combination are strong and independent predictors of an increased short-term mortality risk among patients with DLBCL and FL in England. Public health measures targeting the reduction of multimorbidity among most deprived patients with DLBCL and FL are needed to reduce the short-term mortality gap.

PMID:34848510 | DOI:10.1136/bmjopen-2021-049087

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A risk-adjusted and anatomically stratified cohort comparison study of open surgery, endovascular techniques and medical management for juxtarenal aortic aneurysms-the UK COMPlex AneurySm Study (UK-COMPASS): a study protocol

BMJ Open. 2021 Nov 30;11(11):e054493. doi: 10.1136/bmjopen-2021-054493.

ABSTRACT

INTRODUCTION: In one-third of all abdominal aortic aneurysms (AAAs), the aneurysm neck is short (juxtarenal) or shows other adverse anatomical features rendering operations more complex, hazardous and expensive. Surgical options include open surgical repair and endovascular aneurysm repair (EVAR) techniques including fenestrated EVAR, EVAR with adjuncts (chimneys/endoanchors) and off-label standard EVAR. The aim of the UK COMPlex AneurySm Study (UK-COMPASS) is to answer the research question identified by the National Institute for Health Research Health Technology Assessment (NIHR HTA) Programme: ‘What is the clinical and cost-effectiveness of strategies for the management of juxtarenal AAA, including fenestrated endovascular repair?’

METHODS AND ANALYSIS: UK-COMPASS is a cohort study comparing clinical and cost-effectiveness of different strategies used to manage complex AAAs with stratification of physiological fitness and anatomical complexity, with statistical correction for baseline risk and indication biases. There are two data streams. First, a stream of routinely collected data from Hospital Episode Statistics and National Vascular Registry (NVR). Preoperative CT scans of all patients who underwent elective AAA repair in England between 1 November 2017 and 31 October 2019 are subjected to Corelab analysis to accurately identify and include every complex aneurysm treated. Second, a site-reported data stream regarding quality of life and treatment costs from prospectively recruited patients across England. Site recruitment also includes patients with complex aneurysms larger than 55 mm diameter in whom an operation is deferred (medical management). The primary outcome measure is perioperative all-cause mortality. Follow-up will be to a median of 5 years.

ETHICS AND DISSEMINATION: The study has received full regulatory approvals from a Research Ethics Committee, the Confidentiality Advisory Group and the Health Research Authority. Data sharing agreements are in place with National Health Service Digital and the NVR. Dissemination will be via NIHR HTA reporting, peer-reviewed journals and conferences.

TRIAL REGISTRATION NUMBER: ISRCTN85731188.

PMID:34848524 | DOI:10.1136/bmjopen-2021-054493