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Nevin Manimala Statistics

Comparing two implementation strategies for implementing and sustaining a case management practice serving homeless-experienced veterans: a protocol for a type 3 hybrid cluster-randomized trial

Implement Sci. 2022 Oct 3;17(1):67. doi: 10.1186/s13012-022-01236-1.

ABSTRACT

BACKGROUND: The Veterans Health Administration (VA) Grant and Per Diem case management “aftercare” program provides 6 months of case management for homeless-experienced veterans (HEVs) undergoing housing transitions. To standardize and improve aftercare services, we will implement critical time intervention (CTI), an evidence-based, structured, and time-limited case management practice. We will use two strategies to support the implementation and sustainment of CTI at 32 aftercare sites, conduct a mixed-methods evaluation of this implementation initiative, and generate a business case analysis and implementation playbook to support the continued spread and sustainment of CTI in aftercare.

METHODS: We will use the Replicating Effective Programs (REP) implementation strategy to support CTI implementation at 32 sites selected by our partners. Half (n=16) of these sites will also receive 9 months of external facilitation (EF, enhanced REP). We will conduct a type 3 hybrid cluster-randomized trial to compare the impacts of REP versus enhanced REP. We will cluster potential sites into three implementation cohorts staggered in 9-month intervals. Within each cohort, we will use permuted block randomization to balance key site characteristics among sites receiving REP versus enhanced REP; sites will not be blinded to their assigned strategy. We will use mixed methods to assess the impacts of the implementation strategies. As fidelity to CTI influences its effectiveness, fidelity to CTI is our primary outcome, followed by sustainment, quality metrics, and costs. We hypothesize that enhanced REP will have higher costs than REP alone, but will result in stronger CTI fidelity, sustainment, and quality metrics, leading to a business case for enhanced REP. This work will lead to products that will support our partners in spreading and sustaining CTI in aftercare.

DISCUSSION: Implementing CTI within aftercare holds the potential to enhance HEVs’ housing and health outcomes. Understanding effective strategies to support CTI implementation could assist with a larger CTI roll-out within aftercare and support the implementation of other case management practices within and outside VA.

TRIAL REGISTRATION: This project was registered with ClinicalTrials.gov as “Implementing and sustaining Critical Time Intervention in case management programs for homeless-experienced Veterans.” Trial registration NCT05312229 , registered April 4, 2022.

PMID:36192785 | DOI:10.1186/s13012-022-01236-1

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Trends in mortality in septic patients according to the different organ failure during 15 years

Crit Care. 2022 Oct 3;26(1):302. doi: 10.1186/s13054-022-04176-w.

ABSTRACT

BACKGROUND: The incidence of sepsis can be estimated between 250 and 500 cases/100.000 people per year and is responsible for up to 6% of total hospital admissions. Identified as one of the most relevant global health problems, sepsis is the condition that generates the highest costs in the healthcare system. Important changes in the management of septic patients have been included in recent years; however, there is no information about how changes in the management of sepsis-associated organ failure have contributed to reduce mortality.

METHODS: A retrospective analysis was conducted from hospital discharge records from the Minimum Basic Data Set Acute-Care Hospitals (CMBD-HA in Catalan language) for the Catalan Health System (CatSalut). CMBD-HA is a mandatory population-based register of admissions to all public and private acute-care hospitals in Catalonia. Sepsis was defined by the presence of infection and at least one organ dysfunction. Patients hospitalized with sepsis were detected, according ICD-9-CM (since 2005 to 2017) and ICD-10-CM (2018 and 2019) codes used to identify acute organ dysfunction and infectious processes.

RESULTS: Of 11.916.974 discharges from all acute-care hospitals during the study period (2005-2019), 296.554 had sepsis (2.49%). The mean annual sepsis incidence in the population was 264.1 per 100.000 inhabitants/year, and it increased every year, going from 144.5 in 2005 to 410.1 in 2019. Multiorgan failure was present in 21.9% and bacteremia in 26.3% of cases. Renal was the most frequent organ failure (56.8%), followed by cardiovascular (24.2%). Hospital mortality during the study period was 19.5%, but decreases continuously from 25.7% in 2005 to 17.9% in 2019 (p < 0.0001). The most important reduction in mortality was observed in cases with cardiovascular failure (from 47.3% in 2005 to 31.2% in 2019) (p < 0.0001). In the same way, mean mortality related to renal and respiratory failure in sepsis was decreased in last years (p < 0.0001).

CONCLUSIONS: The incidence of sepsis has been increasing in recent years in our country. However, hospital mortality has been significantly reduced. In septic patients, all organ failures except liver have shown a statistically significant reduction on associated mortality, with cardiovascular failure as the most relevant.

PMID:36192781 | DOI:10.1186/s13054-022-04176-w

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The reporting of pilot and feasibility studies in the top dental specialty journals is suboptimal

Pilot Feasibility Stud. 2022 Oct 4;8(1):224. doi: 10.1186/s40814-022-01182-1.

ABSTRACT

BACKGROUND: Pilot and feasibility studies (PAFS) are smaller investigations seeking to assess the feasibility of conducting a larger more definitive study. In late 2016, the CONSORT statement was extended to disseminate good practices for reporting of randomized pilot and feasibility trials. In this quality assurance review, we assessed whether PAFS in the top dental speciality journals adhere to good practices of conduct and reporting, by prioritizing assessment of feasibility and stating pre-defined progression criteria to inform the decision to pursue funding for a larger trial.

METHODS: With the help of a librarian, we searched MEDLINE and EMBASE from 2017 to 2020, inclusive, for PAFS in the top 3 journals from each of the 10 dental specialties. We collected data on methodological and general characteristics of the studies, their objectives, and reporting of items recommended in the CONSORT extension.

RESULTS: Of the 111 trials included, 51.4% (95% CI 41.7-61.0%) stated some indication of intent to assess feasibility while zero reported progression criteria; 74.8% (95% CI 65.6-82.5%) of trials used the terms “pilot” or “feasibility” in their titles and 82.9% (95% CI 74.6-89.4%) of studies stated there is a need for a future trial, but only 9.0% (95% CI 4.4-15.9%) stated intent to proceed to one. Most of the studies, 53.2% (95% CI 43.4-62.7%), reported hypothesis testing without cautioning readers on the generalizability of the results. Studies that used the terms “pilot” or “feasibility” in their title were less likely to have feasibility objectives, compared to trials that did not, with an odds ratio (OR) of 0.310 (95% CI 0.103-0.930; p = 0.037). Compared to trials that did not conduct hypothesis testing, trials that conducted hypothesis testing were significantly less likely to assess feasibility, among them, trials that cautioned readers on the generalizability of their results had an OR of 0.038 (95% CI 0.005-0.264; p < 0.001) and trials that did not caution readers on the generalizability of their results had an OR of 0.043 (95% CI 0.008-0.238; p = 0.001).

CONCLUSION: Many PAFS in dentistry are not conducted with the intent of assessing feasibility, nor do they state progression criteria, and few report intent to proceed to a future trial. Misconceptions about PAFS can lead to them being poorly conducted and reported, which has economic and ethical implications. Research ethics boards, funding agencies, and journals need to raise their standards for the conduct and reporting of PAFS, and resources should be developed to address misconceptions and help guide researchers on the best practices for their conduct and reporting.

PMID:36192777 | DOI:10.1186/s40814-022-01182-1

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Hospital outcomes for patients with pulmonary arterial hypertension in sepsis and septic shock

BMC Pulm Med. 2022 Oct 3;22(1):374. doi: 10.1186/s12890-022-02145-1.

ABSTRACT

BACKGROUND: Pulmonary arterial hypertension (PAH) is associated with increased morbidity and mortality risk. The risk for adverse outcomes in patients with PAH in sepsis or septic shock (SSS) is uncertain.

METHODS: Adult patients diagnosed with SSS were identified in the National Readmissions Database over the years 2016-2017. A 2:1 ratio nearest propensity matching method was employed for several demographic, social, and clinical variables. In-hospital outcomes were compared between patients with PAH and those without, using t-test and chi-squared test as appropriate. Patients with cardiogenic shock were excluded. Relevant ICD-10 codes were used, and statistical significance was set at 0.05.

RESULTS: A total of 1,134 patients with PAH and sepsis/septic shock were identified, with a mean age of 65 years and 67% identifying as females. Patients with PAH had a higher prevalence of some chronic conditions, including chronic pulmonary disease, renal failure, congestive heart failure, coronary artery disease, obesity, coagulation disease. The prevalence of type 2 diabetes mellitus and alcohol use was lower in this cohort. After matching, patients with PAH and SSS, when compared to those with SSS and without PAH, had an increased occurrence of acute heart failure (24.1% vs. 19.6%, p = 0.003), amongst clinical outcomes. The differences in the occurrence of death, vasopressor use, paroxysmal atrial fibrillation, acute myocardial infarction, acute kidney injury, and stroke outcomes were not statistically different between the two groups. Patients with PAH, however, had a longer hospital stay (13.5 days vs. 10.9 days, p < 0.001) and hospital costs ($164,252 vs. $129,185, p < 0.001).

CONCLUSION: Patients with PAH have worse outcomes for acute heart failure in sepsis or septic shock. Other mortality and morbidity outcomes are not statistically different. PAH is also associated with a longer hospital stay and increased hospital costs. These findings should be interpreted recognizing the inclusion of patients with re-admissions and the administrative nature of the database.

PMID:36192765 | DOI:10.1186/s12890-022-02145-1

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Non-infectious sternal dehiscence after coronary artery bypass surgery

J Cardiothorac Surg. 2022 Oct 3;17(1):249. doi: 10.1186/s13019-022-02015-1.

ABSTRACT

INTRODUCTION: Non-infectious sternal dehiscence (NISD) is a known complication following coronary artery bypass grafting (CABG), with previous studies estimating an incidence of 0.4-1% of surgeries. We aimed to study the incidence of NISD together with short- and long-term outcomes in a whole-nation cohort of patients.

MATERIALS AND METHODS: A retrospective study on consecutive CABG patients diagnosed with NISD at Landspitali from 2001 to 2020. Patients diagnosed with infectious mediastinitis (n = 20) were excluded. NISD patients were compared to patients with an intact sternum regarding patient demographics, cardiovascular risk factors, intra- and postoperative data, and estimated overall survival. The median follow-up was 9.5 years.

RESULTS: Twenty out of 2280 eligible patients (0.88%) developed NISD, and the incidence did not change over the study period (p = 0.98). The median time of diagnosis was 12 days postoperatively (range, 4-240). All patients were re-operated using a Robicsek-rewiring technique, with two cases requiring a titanium plate for fixation. Patients with NISD were older, had a higher BMI and EuroSCORE II, lower LVEF, and more often had a history of COPD, MI, and diabetes compared to those without NISD. Length of stay was extended by 15 days for NISD patients, but short and long-term survival was not statistically different between the groups.

CONCLUSIONS: The incidence of NISD was low and in line with previous studies. Although the length of hospital stay was extended, both short- and long-term survival of NISD patients was not significantly different from patients with an intact sternum.

PMID:36192764 | DOI:10.1186/s13019-022-02015-1

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Nevin Manimala Statistics

Eco-friendly resolution of spectrally overlapping signals of a combined triple-action over-the-counter pharmaceutical formulation for symptomatic management of COVID-19 pandemic: application to content uniformity testing

BMC Chem. 2022 Oct 3;16(1):73. doi: 10.1186/s13065-022-00868-0.

ABSTRACT

Currently, all researchers are concentrating their efforts on countering the COVID-19 pandemic. The majority of patients are managed at home, according to recent statistics. An OTC triple action combination comprising paracetamol (PAR), aspirin (ASP), and diphenhydramine (DIPH) is commonly given for pain relief, fever control, and as a night-time sleep aid. This combination is currently recommended for COVID-19 patients as part of symptomatic treatment and management. In this work, three smart, simple, accurate, eco-friendly, and cost-effective spectrophotometric methods are developed for simultaneous determination of PAR, ASP, and DIPH in their combined over-the-counter caplet dosage form without any prior separation steps. The first method is the first derivative spectrophotometry (D1) which determined PAR at 259.7 nm. The second one is the dual-wavelength in ratio spectra (DWRS) for determination of ASP at 214.1 and 220.1 nm after using 10.0 μg/mL of PAR as a divisor, where PAR was a constant, and the wavelengths difference equal to zero for DIPH. The third method is the double divisor-ratio difference spectrophotometric one (DD-RD) which was based on using the sum of 15.0 µg/mL of each of PAR and ASP as a double divisor, and the difference in amplitudes was measured at two wavelengths ∆P(214.5-226.0) for determination of DIPH. The developed methods have been validated as per ICH guidelines. Furthermore, the three suggested methods were employed successfully to assay marketed pharmaceutical formulation and to investigate the content uniformity of the dosage units in accordance with the United States Pharmacopeia’s guidelines. Finally, the greenness profile of the proposed methods was assessed and compared with the reported method using the analytical eco-scale system, national environmental method index (NEMI), green analytical procedure index (GAPI), and analytical greenness (AGREE) metric. The results from the proposed methods statistically agreed with those obtained by the reported one, with no significant differences in accuracy and precision.

PMID:36192758 | DOI:10.1186/s13065-022-00868-0

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Native T1 mapping detects both acute clinical rejection and graft dysfunction in pediatric heart transplant patients

J Cardiovasc Magn Reson. 2022 Oct 3;24(1):51. doi: 10.1186/s12968-022-00875-z.

ABSTRACT

BACKGROUND: Cardiovascular magnetic resonance (CMR) is emerging as an important tool for cardiac allograft assessment. Native T1 mapping may add value in identifying rejection and in assessing graft dysfunction and myocardial fibrosis burden. We hypothesized that CMR native T1 values and features of textural analysis of T1 maps would identify acute rejection, and in a secondary analysis, correlate with markers of graft dysfunction, and with fibrosis percentage from endomyocardial biopsy (EMB).

METHODS: Fifty cases with simultaneous EMB, right heart catheterization, and 1.5 T CMR with breath-held T1 mapping via modified Look-Locker inversion recovery (MOLLI) in 8 short-axis slices and subsequent quantification of mean and peak native T1 values, were performed on 24 pediatric subjects. A single mid-ventricular slice was used for image texture analysis using nine gray-level co-occurrence matrix features. Digital quantification of Masson trichrome stained EMB samples established degree of fibrosis. Markers of graft dysfunction, including serum brain natriuretic peptide levels and hemodynamic measurements from echocardiography, catheterization, and CMR were collated. Subjects were divided into three groups based on degree of rejection: acute rejection requiring new therapy, mild rejection requiring increased ongoing therapy, and no rejection with no change in treatment. Statistical analysis included student’s t-test and linear regression.

RESULTS: Peak and mean T1 values were significantly associated with acute rejection, with a monotonic trend observed with increased grade of rejection. Texture analysis demonstrated greater spatial heterogeneity in T1 values, as demonstrated by energy, entropy, and variance, in cases requiring treatment. Interestingly, 2 subjects who required increased therapy despite low grade EMB results had abnormal peak T1 values. Peak T1 values also correlated with increased BNP, right-sided filling pressures, and capillary wedge pressures. There was no difference in histopathological fibrosis percentage among the 3 groups; histopathological fibrosis did not correlate with T1 values or markers of graft dysfunction.

CONCLUSION: In pediatric heart transplant patients, native T1 values identify acute rejection requiring treatment and may identify graft dysfunction. CMR shows promise as an important tool for evaluation of cardiac grafts in children, with T1 imaging outperforming biopsy findings in the assessment of rejection.

PMID:36192743 | DOI:10.1186/s12968-022-00875-z

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Evidence of transgenerational effects on autism spectrum disorder using multigenerational space-time cluster detection

Int J Health Geogr. 2022 Oct 3;21(1):13. doi: 10.1186/s12942-022-00313-4.

ABSTRACT

BACKGROUND: Transgenerational epigenetic risks associated with complex health outcomes, such as autism spectrum disorder (ASD), have attracted increasing attention. Transgenerational environmental risk exposures with potential for epigenetic effects can be effectively identified using space-time clustering. Specifically applied to ancestors of individuals with disease outcomes, space-time clustering characterized for vulnerable developmental stages of growth can provide a measure of relative risk for disease outcomes in descendants.

OBJECTIVES: (1) Identify space-time clusters of ancestors with a descendent with a clinical ASD diagnosis and matched controls. (2) Identify developmental windows of ancestors with the highest relative risk for ASD in descendants. (3) Identify how the relative risk may vary through the maternal or paternal line.

METHODS: Family pedigrees linked to residential locations of ASD cases in Utah have been used to identify space-time clusters of ancestors. Control family pedigrees of none-cases based on age and sex have been matched to cases 2:1. The data have been categorized by maternal or paternal lineage at birth, childhood, and adolescence. A total of 3957 children, both parents, and maternal and paternal grandparents were identified. Bernoulli space-time binomial relative risk (RR) scan statistic was used to identify clusters. Monte Carlo simulation was used for statistical significance testing.

RESULTS: Twenty statistically significant clusters were identified. Thirteen increased RR (> 1.0) space-time clusters were identified from the maternal and paternal lines at a p-value < 0.05. The paternal grandparents carry the greatest RR (2.86-2.96) during birth and childhood in the 1950’s-1960, which represent the smallest size clusters, and occur in urban areas. Additionally, seven statistically significant clusters with RR < 1 were relatively large in area, covering more rural areas of the state.

CONCLUSION: This study has identified statistically significant space-time clusters during critical developmental windows that are associated with ASD risk in descendants. The geographic space and time clusters family pedigrees with over 3 + generations, which we refer to as a person’s geographic legacy, is a powerful tool for studying transgenerational effects that may be epigenetic in nature. Our novel use of space-time clustering can be applied to any disease where family pedigree data is available.

PMID:36192740 | DOI:10.1186/s12942-022-00313-4

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Sero-prevalence of malaria and the knowledge, attitudes and practices relating to the prevention of malaria among indigenous people living in the central forest spine in Peninsular Malaysia: a mixed-methods study

Malar J. 2022 Oct 3;21(1):281. doi: 10.1186/s12936-022-04293-5.

ABSTRACT

BACKGROUND: Malaria is still a major public health threat in some parts of the world. Many countries are targeting to achieve malaria free status country. This study aimed to determine the sero-prevalence of malaria and the knowledge, attitudes and practices relating to the prevention of malaria among the indigenous adults living in the central forest spine in Peninsular Malaysia.

METHODS: A mixed method study was conducted in indigenous settlements in 2020. Blood film for malaria parasite (BFMP) was used to diagnose malaria in this study. A structured questionnaire was used to collect data from the participants. For the qualitative data, in-depth interviews were conducted and data was collected until data saturation was reached. Multiple linear regression was used to determine the predictors after adjusting for confounders. A p-value of < 0.05 is considered as statistically significant. Meaningful statements from the in-depth interviews were assigned to the relevant codes using NVivo version 12 software.

RESULTS: A total of 284 indigenous people participated in the study. The prevalence of malaria in this study was 0%. Those in the middle age group between 25 and 41 years and tested positive for malaria previously were significantly more likely to have better knowledge and attitude scores. Significant correlations were also observed between knowledge-attitude and knowledge-practice. For the qualitative results, most of the respondents were unsure of monkey malaria, but all were aware of human malaria.

CONCLUSION: The present study highlighted the absence of malaria in the study population and relatively good knowledge, attitudes and practices relating to the prevention of malaria.

PMID:36192733 | DOI:10.1186/s12936-022-04293-5

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The effects of nutritional support team intervention on postoperative immune function, nutritional statuses, inflammatory responses, clinical outcomes of elderly patients with gastric cancer

BMC Surg. 2022 Oct 3;22(1):353. doi: 10.1186/s12893-022-01784-9.

ABSTRACT

BACKGROUND: To explore the effects of nutrition support team (NST) intervention on elderly patients with gastric cancer (GC).

METHODS: The elderly GC patients (tumor stage I/II/III), admitted to our department from January 2015 to September 2021, were retrospectively analyzed and divided into NST group and traditional nutrition (TN) group according to nutritional management methods. The immune, inflammatory, nutrition-related indices, postoperative recovery and long-term prognosis of two groups were analyzed.

RESULTS: A total of 258 elderly GC patients were included (NST group, n = 125; TN group, n = 133). After propensity score matching (PSM) in ratio of 1:1, 73 pairs of patients were matched. There were statistically significant differences in CD3 and CD4 level postoperative one month and IgG level postoperative one week between NST group and TN group (P < 0.05). There was no significant differences in serum CRP and IL-6 levels preoperative one day, postoperative one week and one month between two groups (P > 0.05). There were significant differences in body mass index (BMI) between the two groups postoperative one month (P < 0.05). The rate of infectious complications in TN group was significantly higher than that in NST group (P < 0.05). There was no statistically significant differences in 3-year relapse-free survival (RFS) or 3-year overall survival (OS) between NST group and TN group (P > 0.05).

CONCLUSIONS: Compared with TN management, NST intervention might be benefit to the immune function recovery and nutritional status, but there was no evidence that NST could improve the prognosis of elderly GC patients.

PMID:36192732 | DOI:10.1186/s12893-022-01784-9