Poor Quality Studies Research Articles

Pulmonary CT angiography in the first wave of the COVID-19 pandemic: Comparison between patients with and without infection and with a pre-pandemic series

Background and aimsTo analyze the diagnostic performance of pulmonary CT angiography and to compare different D-dimer cutoffs for the diagnosis of acute pulmonary embolism in patients with and without SARS-CoV-2 infections. Materials and methodsWe retrospectively analysed all consecutive pulmonary CT angiography studies done for suspected pulmonary embolism in a tertiary hospital during two time periods: the first December 2020 through February 2021 and the second December 2017 through February 2018. D-dimer levels were obtained less than 24 h before the pulmonary CT angiography studies. We analysed the sensitivity, specificity, positive and negative predictive values, area under the receiver operating curve (AUC), and pattern of pulmonary embolism for six different values of D-dimer and the extent of the embolism. During the pandemic period, we also analysed whether the patients had COVID-19. ResultsAfter excluding 29 poor-quality studies, 492 studies were analysed; 352 of these were done during the pandemic, 180 in patients with COVID-19 and 172 in patients without COVID-19. The absolute frequency of pulmonary embolism diagnosed was higher during the pandemic period (34 cases during the prior period and 85 during the pandemic; 47 of these patients had COVID-19). No significant differences were found in comparing the AUCs for the D-dimer values. The optimum values calculated for the receiver operating characteristic curves differed between patients with COVID-19 (2200 mcg/l), without COVID-19 (4800 mcg/l), and diagnosed in the prepandemic period (3200 mcg/l). Peripheral distribution of the emboli was more common in patients with COVID-19 (72%) than in those without COVID-19 and than in those diagnosed before the pandemic [OR 6.6, 95% CI: 1.5–24.6, p < 0.05 when compared to central distribution]. ConclusionsThe number of CT angiography studies and the number of pulmonary embolisms diagnosed during the pandemic increased due to SARS-CoV-2 infection. The optimal d-dimer cutoffs and the distribution of the pulmonary embolisms differed between the groups of patients with and without COVID-19.

Are FGFR and IDH1-2 alterations a positive prognostic factor in intrahepatic cholangiocarcinoma? An unresolved issue.

Despite representing some of the most common and investigated molecular changes in intrahepatic cholangiocarcinoma (iCCA), the prognostic role of FGFR and IDH1/2 alterations still remains an open question. In this review we provide a critical analysis of available literature data regarding this topic, underlining the strengths and pitfalls of each study reported. Despite the overall poor quality of current available studies, a general trend toward a better overall survival for FGFR2 rearrangements and, possibly, for FGFR2-3 alterations can be inferred. On the other hand, the positive prognostic role of IDH1/2 mutation seems much more uncertain. In this scenario, better designed clinical trials in these subsets of iCCA patients are needed in order to get definitive conclusions on this issue.

Circulating Tumour DNA (ctDNA) as a Predictor of Clinical Outcome in Non-Small Cell Lung Cancer Undergoing Targeted Therapies: A Systematic Review and Meta-Analysis.

Liquid biopsy (LB) analysis using (ctDNA)/cell-free DNA (cfDNA) is an emerging alternative to tissue profiling in (NSCLC). LB is used to guide treatment decisions, detect resistance mechanisms, and predicts responses, and, therefore, outcomes. This systematic review and meta-analysis evaluated the impact of LB quantification on clinical outcomes in molecularly altered advanced NSCLC undergoing targeted therapies. We searched Embase, MEDLINE, PubMed, and Cochrane Database, between 1 January 2020 and 31 August 2022. The primary outcome was progression-free survival (PFS). Secondary outcomes included overall survival (OS), objective response rate (ORR), sensitivity, and specificity. Age stratification was performed based on the mean age of the individual study population. The quality of studies was assessed using the Newcastle-Ottawa Scale (NOS). A total of 27 studies (3419 patients) were included in the analysis. Association of baseline ctDNA with PFS was reported in 11 studies (1359 patients), while that of dynamic changes with PFS was reported in 16 studies (1659 patients). Baseline ctDNA-negative patients had a trend towards improved PFS (pooled hazard ratio [pHR] = 1.35; 95%CI: 0.83-1.87; p < 0.001; I2 = 96%) than ctDNA-positive patients. Early reduction/clearance of ctDNA levels after treatment was related to improved PFS (pHR = 2.71; 95%CI: 1.85-3.65; I2 = 89.4%) compared to those with no reduction/persistence in ctDNA levels. The sensitivity analysis based on study quality (NOS) demonstrated improved PFS only for good [pHR = 1.95; 95%CI: 1.52-2.38] and fair [pHR = 1.99; 95%CI: 1.09-2.89] quality studies, but not for poor quality studies. There was, however, a high level of heterogeneity (I2 = 89.4%) along with significant publication bias in our analysis. This large systematic review, despite heterogeneity, found that baseline negative ctDNA levels and early reduction in ctDNA following treatment could be strong prognostic markers for PFS and OS in patients undergoing targeted therapies for advanced NSCLC. Future randomised clinical trials should incorporate serial ctDNA monitoring to further establish the clinical utility in advanced NSCLC management.

Management of Intermittent Hemodialysis in the Critically Ill Patient.

Intermittent hemodialysis remains a cornerstone of extracorporeal KRT in the intensive care unit, either as a first-line therapy for AKI or a second-line therapy when patients transition from a continuous or prolonged intermittent therapy. Intermittent hemodialysis is usually provided 3 days per week in this setting on the basis that no clinical benefits have been demonstrated with more frequent hemodialysis. This should not detract from the importance of continually assessing and refining the hemodialysis prescription (including the need for extra treatments) according to dynamic changes in extracellular volume and other parameters, and ensuring that an adequate dose of hemodialysis is being delivered to the patient. Compared with other KRT modalities, the cardinal challenge encountered during intermittent hemodialysis is hemodynamic instability. This phenomenon occurs when reductions in intravascular volume, as a consequence of ultrafiltration and/or osmotic shifts, outpace compensatory plasma refilling from the extravascular space. Myocardial stunning, triggered by intermittent hemodialysis, and independent of ultrafiltration, may also contribute. The hemodynamic effect of intermittent hemodialysis is likely magnified in patients who are critically ill due to an inability to mount sufficient compensatory physiologic responses in the context of multiorgan dysfunction. Of the many interventions that have undergone testing to mitigate hemodynamic instability related to KRT, the best evidence exists for cooling the dialysate and raising the dialysate sodium concentration. Unfortunately, the evidence supporting routine use of these and other interventions is weak owing to poor study quality and limited sample sizes. Intermittent hemodialysis will continue to be an important and commonly used KRT modality for AKI in patients with critical illness, especially in jurisdictions where resources are limited. There is an urgent need to harmonize the definition of hemodynamic instability related to KRT in clinical trials and robustly test strategies to combat it in this vulnerable patient population.

Hospital length of stay prediction for general surgery and total knee arthroplasty admissions: Systematic review and meta-analysis of published prediction models.

Systematic review of length of stay (LOS) prediction models to assess the study methods (including prediction variables), study quality, and performance of predictive models (using area under receiver operating curve (AUROC)) for general surgery populations and total knee arthroplasty (TKA). LOS prediction models published since 2010 were identified in five major research databases. The main outcomes were model performance metrics including AUROC, prediction variables, and level of validation. Risk of bias was assessed using the PROBAST checklist. Five general surgery studies (15 models) and 10 TKA studies (24 models) were identified. All general surgery and 20 TKA models used statistical approaches; 4 TKA models used machine learning approaches. Risk scores, diagnosis, and procedure types were predominant predictors used. Risk of bias was ranked as moderate in 3/15 and high in 12/15 studies. Discrimination measures were reported in 14/15 and calibration measures in 3/15 studies, with only 4/39 externally validated models (3 general surgery and 1 TKA). Meta-analysis of externally validated models (3 general surgery) suggested the AUROC 95% prediction interval is excellent and ranges between 0.803 and 0.970. This is the first systematic review assessing quality of risk prediction models for prolonged LOS in general surgery and TKA groups. We showed that these risk prediction models were infrequently externally validated with poor study quality, typically related to poor reporting. Both machine learning and statistical modelling methods, plus the meta-analysis, showed acceptable to good predictive performance, which are encouraging. Moving forward, a focus on quality methods and external validation is needed before clinical application.

Prag akutne toksičnosti normobarične terapije kiseonikom - sistematski pregled

Although there is clear dose-dependence of pulmonary toxicity caused by inhalation of normobaric oxygen in animal studies, the threshold of toxicity in humans remains largely unknown. The aim of this systematic review of published clinical studies was to establish threshold in terms of total oxygen dose administered under normal pressure by inhalation that causes first clinical signs of toxicity. MEDLINE, EBSCO, The Cochrane Central Register of Controlled Trials (Central), SCIndeks, Scopus, Google Scholar, and ClinicalTrials.gov were searched from their foundation to April 2022. The systematic review was performed according to the pre-registered protocol at PROSPERO. The studies were included if describing toxic effects of normobaric oxygen therapy in humans. In total 11 human studies of poor quality were found, with either experimental or observational design. In none of the analyzed studies did oxygen therapy cause toxic effects on the respiratory tract if the concentration of oxygen in the inhaled air was below 50%, regardless of the rate of administration. The toxic consequences of inhaling oxygen at a concentration of more than 50% occurred only after oxygen was administered for more than 6 hours, at a rate of more than 7 L/min, and were mainly reflected in inflammation of the tracheobronchial mucosa, with epithelial erosions. Normobaric oxygen therapy can have toxic effects in humans if the oxygen concentration in the inhaled air is higher than 50%, if the administration rate is above 7 L/min, and if the application lasts at least 6 hours.

The Effectiveness of Telerehabilitation on Balance and Functional Mobility in Patients with Stroke: A Systematic Review and Meta-Analysis.

The aim of this systematic review and meta-analysis was to investigate the effectiveness of telerehabilitation on improving balance and functional mobility in stroke survivors. Comprehensive searching was conducted from inception to May 2022. The inclusion criteria were studies evaluating the effectiveness of telerehabilitation in stroke survivors. Data regarding participants, intervention, outcome measures, and main results were extracted. PEDro scale and the Grading of Recommendations Assessment Development and Evaluation (GRADE) were used to assess the methodological quality and quality of evidence, respectively. A total of fourteen articles) 594 patients) were included. A meta-analysis using a random-effect model was performed on thirteen studies )530 patients). Standardized mean difference (SMD) with 95% confidence interval (CI) was calculated for balance and functional mobility. Results: PEDro scale revealed ten good-quality studies, three fair-quality studies, and one poor-quality study. According to the available evidence, telerehabilitation has a small effect size in improving both balance (SMD 0.33 [95% CI 0.03 to 0.63]; P =0.03; low quality of evidence) and functional mobility (SMD 0.27 [95% CI 0.02 to 0.52]; P =0.03; low quality of evidence). Telerehabilitation may improve balance and functional mobility in stroke survivors. However, it is evident that more high-quality research is required due to the existence of low to very low-quality evidence with limited confidence in the effect estimate. PROSPERO registration number (CRD42022306410).

Pilates and improvement of balance and posture in older adults: A meta-analysis with focus on potential moderators

• Pilates training improves balance in older adults, but changes seem to be more consistent in dynamic than static balance. • Favorable adaptations in posture are less convincing due to the limited quantity of trials producing significant effect sizes. • Study quality moderated the effects on dynamic balance, with greater effect sizes reported by poorer quality trials. • Greater training volumes (duration x number of sessions) produced higher effect sizes for changes in dynamic balance and posture. The moderators of Pilates training on balance and posture in older individuals are unclear. We investigated through meta-analysis the effectiveness of Pilates to improve the balance and posture of older individuals and examine potential moderators of those effects. Electronic databases were searched by multiple reviewers until September 30th, 2021 to locate articles published in English, Spanish or Portuguese. Qualifying trials included adults aged ≥60 y and measured static/dynamic balance or posture pre-post intervention. Data on study design, sample characteristics, and features of Pilates interventions were tested as moderators of balance and posture outcomes. Twenty-seven trials included 1,017 individuals (69.2±4.7 y). Overall, sessions of 58.2±8.6 min were performed 2.1±0.5 d/wk for 12.3±9.7 wk. Information on loads was often imprecise. The effect sizes (ES) in controlled vs. uncontrolled trials were: static balance ( k =13, ES 0.270, 95% confidence interval [CI] 0.182-0.358 vs. k =4, ES 0.284, CI 0.155-0.413); dynamic balance ( k =14, ES 0.714, CI 0.428-1.000 vs. k =4, ES 0.648, CI (-0.008-1.303); posture ( k =2; ES 0.311, CI -0.106-0.729 vs. k =5, ES 0.349, CI 0.240-0.458). Trials with lower methodological quality as reflected by the median of TESTEX inventory produced greater ES for dynamic balance (ES 0.928 vs. 0.523; p<0.05). Greater training volumes (duration x number of sessions) increased ES of dynamic balance (ES 0.743 vs. 0.715) and posture (ES 0.422 vs. 0.176), the opposite occurring for static balance (ES 0.237 vs. 0.405) (p<0.05). Pilates seems to improve static and dynamic balance in older adults, while data on posture are less convincing. Poor study quality may overestimate the effects on dynamic balance. Greater training volumes appear to favor improvements in dynamic balance and posture.

Psychological Therapies for the Management of Pain Following Musculoskeletal Injury: A Systematic Review and Meta-Analysis

<h3>Objective(s)</h3> To systematically review and meta-analyze the effects of psychological interventions on pain-related outcomes following musculoskeletal injury (e.g., fracture, sprain). Musculoskeletal injury occurs in nearly one billion people per year and is a leading cause of chronic pain and disability worldwide. <h3>Data Sources</h3> We searched EMBASE, MEDLINE, PubMed, and PsycINFO (inception to April 2021) to identify studies that referenced pain, musculoskeletal injury, and psychological intervention at any age. <h3>Study Selection</h3> We identified and screened 8,498 records; reviewed 117 full texts; and included 27 eligible studies that delivered a psychological intervention targeting pain after musculoskeletal injury. Two authors independently reviewed records at each stage. <h3>Data Extraction</h3> We extracted characteristics related to study design, injury and intervention; outcome data; and risk of bias (using the Cochrane Risk of Bias tool). <h3>Data Synthesis</h3> Twenty-two randomized controlled trials (RCTs; N = 1,882) and 8 non-randomized trials (N = 416) were included. There was substantial variability in type, duration, delivery, and timing of intervention. Intervention groups had lower disability (standardized mean difference = -0.26, 95% CI [-0.49, -0.04]), depression (-0.46 [-0.65, -0.27]), anxiety (-0.41 [-0.63, -0.19]), and PTSD symptoms (-0.33 [-0.58, -0.08]) immediately post-treatment compared to control. There were no group differences in pain intensity (-0.19 [-0.41, 0.03]). At 6-month follow-up, only depression (-0.35 [-0.68, -0.02) was lower following intervention. There were insufficient data to meta-analyze 12-month follow-up data. Most studies were judged as high risk of bias. <h3>Conclusions</h3> Psychological interventions may be effective for improving disability and psychological distress immediately following musculoskeletal injury. However, extant literature is small in size, heterogenous, and characterized by poor quality studies. Overall, the interventions did not result in improved pain intensity or enduring treatment effects. Large scale and methodologically rigorous RCTs are needed to address these gaps and improve outcomes following injury. <h3>Author(s) Disclosures</h3> Stephen Wegener has a conflict of interest with Medline (speaker/honoraria). The authors declare no other conflicts of interest.

Effectiveness and safety of extended thromboprophylaxis in post-discharge patients with COVID-19: A systematic review and meta-analysis

BackgroundThe effect of extended thromboprophylaxis in improving the prognosis of adult patients with coronavirus disease 2019 (COVID-19) after discharge remains debatable. This meta-analysis was aimed to determine the advantages and disadvantages of extended thromboprophylaxis in these patients. MethodsDifferent databases such as PubMed, Embase, Web of Science, and Cochrane Library were systematically searched for studies that evaluated the effects of extended thromboprophylaxis in post-discharge patients with COVID-19 until 13 June 2022. The primary efficacy outcome was defined by the composite outcome of thromboembolism and all-cause mortality, and the safety outcome was defined by bleeding events. The odds ratios (ORs) and 95 % confidence intervals (CIs) of efficacy and safety outcomes were calculated using fixed- or random-effects model. Interaction analysis was performed to assess and compare observational studies and randomised controlled trials (RCTs). A sensitivity analysis was performed after excluding studies of poor quality. ResultsEight studies involving 10,148 patients were included. The results confirmed that extended thromboprophylaxis, primarily prophylactic use of anticoagulants for <35 days, was significantly associated with reduced composite outcome in high-risk post-discharge patients with COVID-19 (OR: 0.52; 95 % CI: 0.41–0.67, P = 0.000). Interaction analysis revealed that the effect estimates were consistent between the RCT and observational studies (Pinteraction = 0.310). Furthermore, extended thromboprophylaxis did not increase the risk of major bleeding events (OR: 1.64; 95 % CI: 0.95–2.82, P = 0.075). ConclusionIn post-discharge patients with COVID-19 at high risk of thromboembolism, extended thromboprophylaxis, primarily prophylactic use of anticoagulants for <35 days, can significantly reduce the risk of thrombosis and all-cause mortality without increasing the risk of major bleeding events. RegistrationPROSPERO CRD42022339399.

Minimally Invasive Glaucoma Surgery: Safety of Individual Devices.

Primary open-angle glaucoma progression in those already on maximal medical therapy has traditionally been treated with trabeculectomy, a surgical procedure that carries a high degree of morbidity. In the last few decades, significant advances have been made in the field of minimally invasive glaucoma surgery (MIGS) devices, which aim to defer or prevent trabeculectomy via less arduous surgical techniques in certain types of glaucoma. Although reviews have been published examining the efficacy of various MIGS techniques, no article synthesises the comparative safety of all available devices. We performed a literature review examining the safety of MIGS devices. Fifteen devices were included, variously attempting to increase aqueous outflow through the trabecular meshwork or the suprachoroidal space, shunting into the subconjunctival space, or reducing aqueous production through ciliary body ablation. Notably, the earliest product attempting to increase outflow to the suprachoroidal space, Alcon's CyPass Micro-Stent, was withdrawn from the market due to concerns regarding increased corneal endothelial cell loss at five years post-implantation. All other devices were described as well-tolerated, with the most common adverse effects including hyphaema, intraocular pressure spikes, and device migration or obstruction. MIGS devices are purported to be uniformly safe, and many studies report no statistically significant increased complications beyond those associated with cataract surgery alone. It is important to note, however, the generally poor quality of current studies, with a dearth of randomised, or even prospective, data, and a large proportion of studies funded by device producers.

Communication interventions for medically unexplained symptom conditions in general practice: A systematic review and meta-analysis of randomised controlled trials.

Medically unexplained symptoms (MUS) account for 3-50% of all General Practitioner (GP) consultations and are difficult to diagnose due to their unknown aetiology, symptom overlap between conditions, and lack of effective treatment options. MUS patients' and primary care clinicians frequently face challenges during consultations, with GPs reporting difficulty identifying and classifying MUS, whilst patients report stigma and feeling illegitimised by clinicians. Communication interventions have been proposed as a method to facilitate the doctor-patient relationship and aid the management of MUS. This systematic review aims to evaluate the effectiveness of primary care based communication interventions at improving MUS patients' and/or clinician outcomes. Four electronic databases were searched from inception to November 2021. Two researchers independently undertook screening, data extraction and quality appraisal. Given the heterogeneous nature of the studies identified, narrative syntheses were conducted, along with meta-analyses where possible to pool data. 9 papers from 10 Randomised Controlled Trials were included. The included studies displayed considerable risk of bias and poor reporting. Some limited evidence suggests that communication interventions tailored to MUS and not following a pre-specified model (such as reattribution) could improve pain, mental and physical functioning whilst reattribution training may improve clinician confidence treating MUS. However, methodological limitations mean that these findings should be interpreted with caution. A range of interventions for improving communication with MUS patients in primary care have been evaluated. However, the heterogeneous nature of existing evidence and poor study quality mean we cannot conclude whether these interventions are effective. Before considering further randomised controlled trials researchers should focus on developing a new or modified communication intervention for MUS patients and their clinicians. The systematic review was prospectively registered with PROSPERO (registration record CRD42020206437).

Physical activity interventions to improve the health and wellbeing of people experiencing homelessness: a mixed-methods systematic review

BackgroundPeople experiencing homelessness have poor health. Physical activity is known to improve health outcomes. No published systematic review of physical activity interventions in this population exists. We aimed to systematically synthesise evidence for physical activity interventions in people experiencing homelessness. MethodsWe searched EMBASE, Web of Science, CINAHL, PubMed, PsycINFO, SPORTDiscus, and Cochrane Library from Jan 1, 1970, to Feb 8, 2021, for studies only published in English. Search terms included “people experiencing homelessness” and “physical interventions”. We included quantitative and qualitative studies of people experiencing homelessness from high-income countries with physical activity interventions in any setting that was compared with or without standard of care, evaluating any health or wellbeing-related outcome—eg, cardiovascular, depression. The Joanna Briggs Institute's (JBI) critical analysis tools were used for quality assessment, with very poor-quality studies rejected. JBI mixed-methods systematic reviews methodology was followed, with qualitisation of quantitative data and convergent synthesis of evidence. The protocol is registered with PROSPERO, number CRD42020216716. FindingsWe screened 2837 records, generating 14 reports (13 studies: eight qualitative and five quantitative [one randomised control trial, three quasi-experimental, one analytical cross-sectional]) of sufficient quality from the UK, USA, Denmark, and Australia, including 403 participants. Interventions included soccer (n=6), group activities (eg, gardening [n=5]), and multi-modal individual interventions (eg, bicycle provision with safety-training [n=2]). Quantitative studies reported 19 outcomes (13 objective, six subjective) quantifying physical health (eg, VO2max; n=13), mental health (eg, Beck Depression Inventory; n=5), and social wellbeing (Outcomes Rating Scale; n=1). Nine quantitative outcomes changed substantially in favour of the intervention. No change was reported in three outcomes, and the relative change of remaining outcomes could not be quantified. Synthesis of qualitative studies found themes reporting predominantly positive perceived impact on physical and mental health and social wellbeing, which corroborated the quantitative findings through convergent synthesis. InterpretationMore qualitative than quantitative studies were identified, with qualitative evidence suggesting physical activity interventions can benefit health and wellbeing. However, quantitative evidence was either positive or inconclusive. Evidence suggests a tentative recommendation for physical activity interventions in people experiencing homelessness. FundingNational Institute for Health Research School for Public Health Research.

Oral Chronic Hyperplastic Candidiasis and Its Potential Risk of Malignant Transformation: A Systematic Review and Prevalence Meta-Analysis.

Chronic hyperplastic candidiasis (CHC) is a prototypical oral lesion caused by chronic Candida infection. A major controversy surrounding CHC is whether this oral lesion owns malignant transformation (MT) potential. The aim of the present study was to evaluate current evidence on the MT of CHC and to determine the variables which have the greatest influence on cancer development. Bibliographical searches included PubMed, Embase, Web of Science, Scopus and LILACS. The cohort studies and case series used to investigate the MT of CHC were deemed suitable for inclusion. The quality of the enrolled studies was measured by the Joanna Briggs Institute scale. Moreover, we undertook subgroup analyses, assessed small study effects, and conducted sensitivity analyses. From 338 studies, nine were finally included for qualitative/quantitative analysis. The overall MT rate for CHC across all studies was 12.1% (95% confidential interval, 4.1–19.8%). Subgroup analysis showed that the MT rate increased when pooled analysis was restricted to poor quality studies. It remains complex to affirm whether CHC is an individual and oral, potentially malignant disorder according to the retrieved evidence. Prospective cohort studies to define the natural history of CHC and a consensus statement to clarify a proper set of diagnostic criteria are strongly needed. PROSPERO ID: CRD42022319572.

Oral 24-week probiotics supplementation did not decrease cardiovascular risk markers in patients with biopsy proven NASH: A double-blind placebo-controlled randomized study

Introduction and ObjectivesCardiovascular disease (CVD) is the major cause of death in non-alcoholic fatty liver disease (NAFLD), a clinical condition without any approved pharmacological therapy. Probiotics are often indicated for the disease, but their results are controversial in part due to the poor quality of studies. Thus, we investigated the impact of 24-week probiotics supplementation on cardiovascular risk (CVR) in biopsy-proven non-alcoholic steatohepatitis (NASH) patients. Patients and MethodsDouble-blind, placebo-controlled, single-center study (NCT03467282), adult NASH, randomized for 24 weeks daily sachets of probiotic mix (109CFU of Lactobacillus acidophilus, Lactobacillus rhamnosus, Lactobacillus paracasei and Bifidobacterium lactis) or placebo. Clinical scores (atherogenic indexes, atherosclerotic cardiovascular disease-ASCVD and systematic coronary risk evaluation-SCORE), biochemistry, miR-122, miR-33a, plasminogen activator inhibitor-1 (PAI-1), intercellular adhesion molecule-1 (ICAM-1), vascular cell adhesion molecule-1 (VCAM-1), were determined before and after the intervention. ResultsForty-six patients were enrolled (23 received probiotics and 23 placebo), with a mean age of 51.7 years, most of them females and whites. Clinical and demographic features were similar between the groups at the baseline. The Median NAFLD activity score was 4.13 in both groups. Fibrosis was mild in most patients (15.2% and 65.2% F0 and F1, respectively). Treatment did not promote any clinically significant changes in body mass index or laboratory, including lipid and glucose profile. High CVR patients through atherogenic indexes decreased from baseline in both groups, as well as PAI-1 and miR-122 levels, although there was no difference between probiotics and placebo. ConclusionsA 24-week probiotic mix administration was not superior to placebo in reducing CVR markers in patients with NASH.

Responsible Research in Planning for Animal Experiments – A Mini Review

Animal experiments are routinely carried out worldwide either in educational setups or in research setups. Animal research can be basic or applied, where in the applied research the test compound/drug is tested in animals for its safety and efficacy before going into clinical trials. Planning for conducting in vivo animal experiments requires certain preliminary behind-the-scene preparations. These background preparations form the foundation for a valid and reproducible animal experiment. But often these background preparations are overlooked while planning for experiments leading to poor quality, translatability and reproducibility of animal studies. Even though many reporting guidelines are available, there is very little guidance on how to plan for animal experiments. Without better planning, better reporting is not going to help in producing valid research results. Better Planning, careful execution and proper reporting are all essential for good research. Hence, this paper discusses about the steps to follow while planning an animal experiment to produce a valid, reproducible and translatable results known as responsible research.

Prevalence of hepatitis C virus infection in patients with end-stage renal disease in Latin America and the Caribbean: a systematic review and meta-analysis.

To estimate the prevalence of hepatitis C virus (HCV) infection in patients with end-stage renal disease (ESRD) undergoing hemodialysis in Latin America and the Caribbean (LAC). Observational studies published in Spanish, Portuguese, and English language by November 25, 2021, in PubMed, Embase, Web of Science, Scopus, SciELO, and LILACS were selected by two reviewers according to predefined eligibility criteria. Study quality was assessed using the US National Heart, Lung and Blood Institute tool for observational cohort and cross-sectional studies. A meta-analysis of proportions was performed using a random-effects model based on the DerSimonian and Laird method, using R. PROSPERO N°: CRD42018107403. A total of 20 studies were included in the narrative synthesis (15 from Brazil, two from Cuba, two from Argentina, and one from Peru). Only 17 studies were included in the meta-analysis (13 from Brazil, two from Argentina, one from Cuba, and one from Peru). The overall prevalence of HCV in ESRD patients undergoing hemodialysis in LAC was 11.3% (95% confidence interval [CI]: 8.9% - 13.9%; I2: 99 %). In Brazil and Argentina, the prevalence was 6% and 26.1%, respectively. Prevalence after excluding poor-quality studies was 10.7%. The prevalence of HCV in ESRD patients undergoing hemodialysis in LAC was 11.3%. The implementation of infection control measures in hemodialysis centers in LAC is required. It is also necessary to increase the number of studies on the subject in the ESRD population in most LAC countries.

Socio-Technical Grounded Theory for Software Engineering

Grounded Theory (GT), a sociological research method designed to study social phenomena, is increasingly being used to investigate the human and social aspects of software engineering (SE). However, being written by and for sociologists, GT is often challenging for a majority of SE researchers to understand and apply. Additionally, SE researchers attempting ad hoc adaptations of traditional GT guidelines for modern socio-technical (ST) contexts often struggle in the absence of clear and relevant guidelines to do so, resulting in poor quality studies. To overcome these research community challenges and leverage modern research opportunities, this paper presents <italic xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink">Socio-Technical Grounded Theory</i> (STGT) designed to ease application and achieve quality outcomes. It defines what exactly is meant by an ST research context and presents the STGT guidelines that expand GT's philosophical foundations, provide increased clarity and flexibility in its methodological steps and procedures, define possible scope and contexts of application, encourage frequent reporting of a variety of interim, preliminary, and mature outcomes, and introduce nuanced evaluation guidelines for different outcomes. It is hoped that the SE research community and related ST disciplines such as computer science, data science, artificial intelligence, information systems, human computer/robot/AI interaction, human-centered emerging technologies (and increasingly other disciplines being transformed by rapid digitalisation and AI-based augmentation), will benefit from applying STGT to conduct quality research studies and systematically produce rich findings and mature theories with confidence.

Systematic Review of Rural and Urban Differences in Care Provided by Home Health Agencies in the United States.

Home health care agencies (HHAs) are skilled care providers for Medicare home health beneficiaries in the United States. Rural HHAs face different challenges from their urban counterparts in delivering care (eg, longer distances to travel to patient homes leading to higher fuel/travel costs and fewer number of visits in a day, impacting the quality of home health care for rural beneficiaries). We review evidence on differences in care outcomes provided by urban and rural HHAs. Systematic review guided by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and using the Newcastle-Ottawa Scale (NOS) for quality appraisal. Care provided by urban and rural HHAs. We conducted a systematic search for English-language peer-reviewed articles after 2010 on differences in urban and rural care provided by U.S. HHAs. We screened 876 studies, conducted full-text abstraction and NOS quality review on 36 articles and excluded 2 for poor study quality. Twelve studies were included; 7 focused on patient-level analyses and 5 were HHA-level. Nine studies were cross-sectional and 3 used cohorts. Urban and rural differences were measured primarily using a binary variable. All studies controlled for agency-level characteristics, and two-thirds also controlled for patient characteristics. Rural beneficiaries, compared with urban, had lower home health care utilization (4 of 5 studies) and fewer visits for physical therapy and/or rehabilitation (3 of 5 studies). Rural agencies had lower quality of HHA services (3 of 4 studies). Rural patients, compared with urban, visited the emergency room more often (2 of 2 studies) and were more likely to be hospitalized (2 of 2 studies), whereas urban patients with heart failure were more likely to have 30-day preventable hospitalizations (1 study). This review highlights similar urban/rural disparities in home health care quality and utilization as identified in previous decades. Variables used to measure the access to and quality of care by HHAs varied, so consensus was limited. Articles that used more granular measures of rurality (rather than binary measures) revealed additional differences. These findings point to the need for consistent and refined measures of rurality in studies examining urban and rural differences in care from HHAs.

Angio-TC pulmonar durante la pandemia de COVID-19: comparación en pacientes con y sin la infección y con una serie prepandémica

Background and aimsTo analyze the diagnostic performance of pulmonary CT angiography and to compare different D-dimer cutoffs for the diagnosis of acute pulmonary embolism in patients with and without SARS-CoV-2 infections. Materials and methodsWe retrospectively analyzed all consecutive pulmonary CT angiography studies done for suspected pulmonary embolism in a tertiary hospital during two time periods: the first December 2020 through February 2021 and the second December 2017 through February 2018. D-dimer levels were obtained less than 24hours before the pulmonary CT angiography studies. We analyzed the sensitivity, specificity, positive and negative predictive values, area under the receiver operating curve (AUC), and pattern of pulmonary embolism for six different values of D-dimer and the extent of the embolism. During the pandemic period, we also analyzed whether the patients had COVID-19. ResultsAfter excluding 29 poor-quality studies, 492 studies were analyzed; 352 of these were done during the pandemic, 180 in patients with COVID-19 and 172 in patients without COVID-19. The absolute frequency of pulmonary embolism diagnosed was higher during the pandemic period (34 cases during the prior period and 85 during the pandemic; 47 of these patients had COVID-19). No significant differences were found in comparing the AUCs for the D-dimer values. The optimum values calculated for the receiver operating characteristic curves differed between patients with COVID-19 (2200 mcg/L), without COVID-19 (4800 mcg/L), and diagnosed in the prepandemic period (3200 mcg/L). Peripheral distribution of the emboli was more common in patients with COVID-19 (72%) than in those without COVID-19 and than in those diagnosed before the pandemic [OR 6.6, 95% CI:1.5?24.6, p<0.05 when compared to central distribution]. ConclusionsThe number of CT angiography studies and the number of pulmonary embolisms diagnosed during the pandemic increased due to SARS-CoV-2 infection. The optimal D-dimer cutoffs and the distribution of the pulmonary embolisms differed between the groups of patients with and without COVID-19.