PURPOSE: To evaluate the accuracy, safety, and diagnostic outcome of fluoroscopic guided and CT transpedicular biopsy techniques.
STUDY DESIGN: Prospective randomized trial.
PATIENT SAMPLE: Sixty consecutive patients with clinical symptoms and radiological features suggestive of spinal infection or malignancy were recruited and randomized into fluoroscopic or CT guided spinal biopsy groups. Both groups were similar in terms of patient demographics, distribution of spinal infections and malignancy cases, and the level of biopsies.
OUTCOME MEASURES: The primary outcome measure was diagnostic accuracy of both methods, determined based on true positive, true negative, false positive, and false negative biopsy findings. Secondary outcome measures included radiation exposure to patients and doctors, complications, and postbiopsy pain score.
METHODS: A transpedicular approach was performed with an 8G core biopsy needle. Specimens were sent for histopathological and microbiological examinations. Diagnosis was made based on biopsy results, clinical criteria and monitoring of disease progression during a 6-month follow up duration. Clinical criteria included presence of risk factors, level of inflammatory markers and magnetic resonance imaging findings. Radiation exposure to patients and doctors was measured with dosimeters.
RESULTS: There was no significant difference between the diagnostic accuracy of fluoroscopic and CT guided spinal biopsy (p=0.67) or between the diagnostic accuracy of spinal infection and spinal tumor in both groups (p=0.402 for fluoroscopy group and p=0.223 for CT group). Radiation exposure to patients was approximately 26 times higher in the CT group. Radiation exposure to doctors in the CT group was approximately 2 times higher compared to the fluoroscopic group if a lead shield was not used. Lead shields significantly reduced radiation exposure to doctors anywhere from 2 to 8 times. No complications were observed for either group and the differences in postbiopsy pain scores were not significant.
CONCLUSIONS: The accuracy, procedure time, complication rate and pain score for both groups were similar. However, radiation exposure to patients and doctors were significantly higher in the CT group without lead protection. With lead protection, radiation to doctors reduced significantly.
METHODS: We used the TyG index as a surrogate measure for insulin resistance. Fasting triglycerides and fasting plasma glucose were measured at the baseline visit in 141 243 individuals aged 35-70 years from 22 countries in the Prospective Urban Rural Epidemiology (PURE) study. The TyG index was calculated as Ln (fasting triglycerides [mg/dL] x fasting plasma glucose [mg/dL]/2). We calculated hazard ratios (HRs) using a multivariable Cox frailty model with random effects to test the associations between the TyG index and risk of cardiovascular diseases and mortality. The primary outcome of this analysis was the composite of mortality or major cardiovascular events (defined as death from cardiovascular causes, and non-fatal myocardial infarction, or stroke). Secondary outcomes were non-cardiovascular mortality, cardiovascular mortality, all myocardial infarctions, stroke, and incident diabetes. We also did subgroup analyses to examine the magnitude of associations between insulin resistance (ie, the TyG index) and outcome events according to the income level of the countries.
FINDINGS: During a median follow-up of 13·2 years (IQR 11·9-14·6), we recorded 6345 composite cardiovascular diseases events, 2030 cardiovascular deaths, 3038 cases of myocardial infarction, 3291 cases of stroke, and 5191 incident cases of type 2 diabetes. After adjusting for all other variables, the risk of developing cardiovascular diseases increased across tertiles of the baseline TyG index. Compared with the lowest tertile of the TyG index, the highest tertile (tertile 3) was associated with a greater incidence of the composite outcome (HR 1·21; 95% CI 1·13-1·30), myocardial infarction (1·24; 1·12-1·38), stroke (1·16; 1·05-1·28), and incident type 2 diabetes (1·99; 1·82-2·16). No significant association of the TyG index was seen with non-cardiovascular mortality. In low-income countries (LICs) and middle-income countries (MICs), the highest tertile of the TyG index was associated with increased hazards for the composite outcome (LICs: HR 1·31; 95% CI 1·12-1·54; MICs: 1·20; 1·11-1·31; pinteraction=0·01), cardiovascular mortality (LICs: 1·44; 1·15-1·80; pinteraction=0·01), myocardial infarction (LICs: 1·29; 1·06-1·56; MICs: 1·26; 1·10-1·45; pinteraction=0·08), stroke (LICs: 1·35; 1·02-1·78; MICs: 1·17; 1·05-1·30; pinteraction=0·19), and incident diabetes (LICs: 1·64; 1·38-1·94; MICs: 2·68; 2·40-2·99; pinteraction <0·0001). In contrast, in high-income countries, higher TyG index tertiles were only associated with an increased hazard of incident diabetes (2·95; 2·25-3·87; pinteraction <0·0001), but not of cardiovascular diseases or mortality.
INTERPRETATION: The TyG index is significantly associated with future cardiovascular mortality, myocardial infarction, stroke, and type 2 diabetes, suggesting that insulin resistance plays a promoting role in the pathogenesis of cardiovascular and metabolic diseases. Potentially, the association between the TyG index and the higher risk of cardiovascular diseases and type 2 diabetes in LICs and MICs might be explained by an increased vulnerability of these populations to the presence of insulin resistance.
FUNDING: Full funding sources are listed at the end of the paper (see Acknowledgments).
METHODS: This prospective study included a derivation cohort before validation in multiple international cohorts. The derivation cohort was a cross-sectional, multicentre study of patients aged 18 years or older, scheduled to have a liver biopsy for suspicion of NAFLD at seven tertiary care liver centres in England. This was a prespecified secondary outcome of a study for which the primary endpoints have already been reported. Liver stiffness measurement (LSM) by vibration-controlled transient elastography and controlled attenuation parameter (CAP) measured by FibroScan device were combined with aspartate aminotransferase (AST), alanine aminotransferase (ALT), or AST:ALT ratio. To identify those patients with NASH, an elevated NAS, and significant fibrosis, the best fitting multivariable logistic regression model was identified and internally validated using boot-strapping. Score calibration and discrimination performance were determined in both the derivation dataset in England, and seven independent international (France, USA, China, Malaysia, Turkey) histologically confirmed cohorts of patients with NAFLD (external validation cohorts). This study is registered with ClinicalTrials.gov, number NCT01985009.
FINDINGS: Between March 20, 2014, and Jan 17, 2017, 350 patients with suspected NAFLD attending liver clinics in England were prospectively enrolled in the derivation cohort. The most predictive model combined LSM, CAP, and AST, and was designated FAST (FibroScan-AST). Performance was satisfactory in the derivation dataset (C-statistic 0·80, 95% CI 0·76-0·85) and was well calibrated. In external validation cohorts, calibration of the score was satisfactory and discrimination was good across the full range of validation cohorts (C-statistic range 0·74-0·95, 0·85; 95% CI 0·83-0·87 in the pooled external validation patients' cohort; n=1026). Cutoff was 0·35 for sensitivity of 0·90 or greater and 0·67 for specificity of 0·90 or greater in the derivation cohort, leading to a positive predictive value (PPV) of 0·83 (84/101) and a negative predictive value (NPV) of 0·85 (93/110). In the external validation cohorts, PPV ranged from 0·33 to 0·81 and NPV from 0·73 to 1·0.
INTERPRETATION: The FAST score provides an efficient way to non-invasively identify patients at risk of progressive NASH for clinical trials or treatments when they become available, and thereby reduce unnecessary liver biopsy in patients unlikely to have significant disease.
FUNDING: Echosens and UK National Institute for Health Research.
METHODS: DIAMOND was a randomised, double-blind, placebo-controlled crossover trial done at six hospitals in Canada, Malaysia, and the Netherlands. Eligible participants were adult patients (aged 18-75 years) with chronic kidney disease, without a diagnosis of diabetes, with a 24-h urinary protein excretion greater than 500 mg and less than or equal to 3500 mg and an estimated glomerular filtration rate (eGFR) of at least 25 mL/min per 1·73 m2, and who were on stable renin-angiotensin system blockade. Participants were randomly assigned (1:1) to receive placebo and then dapagliflozin 10 mg per day or vice versa. Each treatment period lasted 6 weeks with a 6-week washout period in between. Participants, investigators, and study personnel were masked to assignment throughout the trial and analysis. The primary outcome was percentage change from baseline in 24-h proteinuria during dapagliflozin treatment relative to placebo. Secondary outcomes were changes in measured GFR (mGFR; via iohexol clearance), bodyweight, blood pressure, and concentrations of neurohormonal biomarkers. Analyses were done in accordance with the intention-to-treat principle. This study is registered with ClinicalTrials.gov, NCT03190694.
FINDINGS: Between Nov 22, 2017, and April 5, 2019, 58 patients were screened, of whom 53 (mean age 51 years [SD 13]; 32% women) were randomly assigned (27 received dapagliflozin then placebo and 26 received placebo then dapagliflozin). One patient discontinued during the first treatment period. All patients were included in the analysis. Mean baseline mGFR was 58·3 mL/min per 1·73 m2 (SD 23), median proteinuria was 1110 mg per 24 h (IQR 730-1560), and mean HbA1c was 5·6% (SD 0·4). The difference in mean proteinuria change from baseline between dapagliflozin and placebo was 0·9% (95% CI -16·6 to 22·1; p=0·93). Compared with placebo, mGFR was changed with dapagliflozin treatment by -6·6 mL/min per 1·73 m2 (-9·0 to -4·2; p<0·0001) at week 6. This reduction was fully reversible within 6 weeks after dapagliflozin discontinuation. Compared with placebo, bodyweight was reduced by 1·5 kg (0·03-3·0; p=0·046) with dapagliflozin; changes in systolic and diastolic blood pressure and concentrations of neurohormonal biomarkers did not differ significantly between dapagliflozin and placebo treatment. The numbers of patients who had one or more adverse events during dapagliflozin treatment (17 [32%] of 53) and during placebo treatment (13 [25%] of 52) were similar. No hypoglycaemic events were reported and no deaths occurred.
INTERPRETATION: 6-week treatment with dapagliflozin did not affect proteinuria in patients with chronic kidney disease without diabetes, but did induce an acute and reversible decline in mGFR and a reduction in bodyweight. Long-term clinical trials are underway to determine whether SGLT2 inhibitors can safely reduce the rate of major clinical kidney outcomes in patients with chronic kidney disease with and without diabetes.
FUNDING: AstraZeneca.
METHODS: The PURE study is a prospective cohort study of 127 594 adults aged 35-70 years from 20 high-income, middle-income, and low-income countries. Diet was assessed at baseline using country-specific validated food frequency questionnaires. The glycaemic index and the glycaemic load were estimated on the basis of the intake of seven categories of carbohydrate-containing foods. Participants were categorised into quintiles of glycaemic index and glycaemic load. The primary outcome was incident type 2 diabetes. Multivariable Cox Frailty models with random intercepts for study centre were used to calculate hazard ratios (HRs).
FINDINGS: During a median follow-up of 11·8 years (IQR 9·0-13·0), 7326 (5·7%) incident cases of type 2 diabetes occurred. In multivariable adjusted analyses, a diet with a higher glycaemic index was significantly associated with a higher risk of diabetes (quintile 5 vs quintile 1; HR 1·15 [95% CI 1·03-1·29]). Participants in the highest quintile of the glycaemic load had a higher risk of incident type 2 diabetes compared with those in the lowest quintile (HR 1·21, 95% CI 1·06-1·37). The glycaemic index was more strongly associated with diabetes among individuals with a higher BMI (quintile 5 vs quintile 1; HR 1·23 [95% CI 1·08-1·41]) than those with a lower BMI (quintile 5 vs quintile 1; 1·10 [0·87-1·39]; p interaction=0·030).
INTERPRETATION: Diets with a high glycaemic index and a high glycaemic load were associated with a higher risk of incident type 2 diabetes in a multinational cohort spanning five continents. Our findings suggest that consuming low glycaemic index and low glycaemic load diets might prevent the development of type 2 diabetes.
FUNDING: Full funding sources are listed at the end of the Article.
MATERIAL AND METHODS: A total of 34 chronic renal disease patients (stage 3 and 4) were recruited in a randomized controlled trial. Handgrip exercise was performed for 8 weeks in the intervention group. Handgrip-strength measurement and distal forearm cephalic vein diameter of a non-dominant hand with and without tourniquet was recorded (measurement is taken 1 cm proximal to the radial styloid).
RESULTS: After 8 weeks, the mean cephalic vein diameter in the intervention group increased from 1.77 and 1.97 mm to 2.15 and 2.43 mm, without and with a tourniquet, respectively (p < 0.05). There is also a significant change in the mean diameter of distal forearm cephalic vein (p < 0.05) in the intervention group when measured in both the absence (mean change 0.39 ± 0.06 mm vs 0.01 ± 0.02 mm) and the presence of tourniquet (mean change 0.47 ± 0.07 mm vs 0.01 ± 0.01 mm).
CONCLUSION: These findings suggest that non-invasive handgrip exercise can increase in the diameter of the distal forearm cephalic vein, thereby increasing the rate of successful arteriovenous fistula creation.
METHODS: Prospective, surveillance study on peripheral venous catheter-associated bloodstream infections conducted from 1 September 2013 to 31 May 2019 in 262 intensive care units, members of the International Nosocomial Infection Control Consortium, from 78 hospitals in 32 cities of 8 countries in the South-East Asia Region: China, India, Malaysia, Mongolia, Nepal, Philippines, Thailand, and Vietnam. For this research, we applied definition and criteria of the CDC NHSN, methodology of the INICC, and software named INICC Surveillance Online System.
RESULTS: We followed 83,295 intensive care unit patients for 369,371 bed-days and 376,492 peripheral venous catheter-days. We identified 999 peripheral venous catheter-associated bloodstream infections, amounting to a rate of 2.65/1000 peripheral venous catheter-days. Mortality in patients with peripheral venous catheter but without peripheral venous catheter-associated bloodstream infections was 4.53% and 12.21% in patients with peripheral venous catheter-associated bloodstream infections. The mean length of stay in patients with peripheral venous catheter but without peripheral venous catheter-associated bloodstream infections was 4.40 days and 7.11 days in patients with peripheral venous catheter and peripheral venous catheter-associated bloodstream infections. The microorganism profile showed 67.1% were Gram-negative bacteria: Escherichia coli (22.9%), Klebsiella spp (10.7%), Pseudomonas aeruginosa (5.3%), Enterobacter spp. (4.5%), and others (23.7%). The predominant Gram-positive bacteria were Staphylococcus aureus (11.4%).
CONCLUSIONS: Infection prevention programs must be implemented to reduce the incidence of peripheral venous catheter-associated bloodstream infections.
METHODS: From October 2015 to September 2016, 202 patients with chronic kidney disease (CKD), stages 4 and 5, underwent arteriovenous fistula creation at the Universiti Sains Malaysia Hospital, Malaysia. Nine patients, with severe atherosclerosis of the distal artery, but with satisfactory veins, underwent forearm loop arteriovenous fistula creation. Maturation of the fistula was based on the classification by the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF KDOQI).
RESULTS: All nine patients who underwent forearm loop arteriovenous fistula have had diabetes mellitus for more than 10 years. Only one fistula failed to mature within 6 weeks. Two arteriovenous fistulas thrombosed at 3 and 5 months, respectively, after the commencement of haemodialysis. However, the other six matured fistulas are still functioning well after a year of regular usage.
CONCLUSIONS: Distal forearm arteries in diabetics may be severely atherosclerotic. Forearm loop arteriovenous fistula can be considered as the primary access for cases decided as inconvenient for fistula creation due to severe occlusive atherosclerotic disease of the forearm arteries; in order to preserve upper arm veins for future access procedures.
METHODS: A prospective, observational single-centre study was conducted where 116 consecutive patients in a specialised heart failure clinic underwent level 1, attended polysomnography (PSG).
RESULTS: The prevalence of SDB was 78% using the apnoea-hypopnea index (AHI), AHI ⩾ 5/h threshold, and 59% with the AHI ⩾ 15/h threshold. Obstructive sleep apnoea (OSA) was the predominant type of SDB and was associated with increased body mass index and neck circumference. STOP-BANG was predictive of SDB, especially in men. Central sleep apnoea (CSA) patients had worse sleep indexes and lower awake arterial carbon dioxide. SDB was also homogenously present in preserved ejection fraction (EF) CHF.
CONCLUSION: Most of the CHF patients were found to have SDB with the utility of PSG. Local CHF guidelines should include sleep testing for all patients with CHF.The study is registered on ClinicalTrials.gov (NCT05332223) as 'The Epidemiological Characteristics of SDB in Patients with Reduced or Preserved EF CHF'.
METHODS: This was a prospective randomized comparative trial. Women who required vacuum assisted vaginal delivery were randomized into the Kiwi Omnicup (KO) group and the Malmstrom metal cup (MM) group. The vacuum assisted deliveries were conducted according to hospital protocol. Details of the procedure and delivery outcomes including success and complications were analyzed.
RESULTS: One hundred and sixty-four women were recruited - 85 were assigned to vacuum assisted delivery using the KO and 79 the MM. One hundred percent delivery success was achieved with no significant differences between the two instruments in terms of maternal morbidity (P = 0.66). Six women in the MM group sustained post delivery complications in comparison to five in the KO group. Three babies were diagnosed with birth asphyxia in each group. More babies in the MM group were admitted to the Neonatal Intensive Care Unit (NICU) (10 babies versus 5 babies) and suffered complications (14 versus 12 babies), compared to the KO group, although the difference was not statistically significant. There were no intrapartum or neonatal deaths and of those admitted to the NICU, all were discharged within a week without any serious consequences.
CONCLUSION: Kiwi Omnicup is an effective alternative to the currently available Malmstrom metal cup for vacuum assisted delivery with no increase in maternal or neonatal morbidity or mortality.
METHODS: A prospective randomized study involving 55 patients in the epidural group and 68 in the control pethidine--inhalational entonox group.
RESULTS: There were significantly more obstetric interventions (instrumental deliveries) in the epidural group (p < 0.01). The total duration of labour and the duration of the second stage was prolonged in the epidural group (p < 0.01). There were more malpositions at the second stage of labour in the epidural group (p < 0.02). There were no differences in fetal outcome (Apgar scores and Special Care Nursery admissions). Patients in the epidural group were consistently happier with their method of pain relief (p < 0.01). Two patients required blood patches while another 2 patients had persistent backache post epidural analgesia.
CONCLUSION: Epidural analgesia in primigravidae in spontaneous labour at term led to an increased instrumental delivery rate, prolonged duration of labour, greater rate of malpositions in the second stage, increased oxytocin requirements but with no difference in fetal outcomes but with happier mothers as compared to the control group.
METHODS: This is a prospective randomized study for evaluation of 84 etonogestrel implant (Implanon) users with prolonged or frequent bleeding. They were assigned to either receiving a COCP containing 20 mcg ethinyl estradiol/150 mg desogestrel for two continuous cycle or NSAID; mefenamic acid 500 mg TDS for 5 days, 21 days apart for two cycles. Bleeding pattern during the treatment was recorded and analyzed.
RESULTS: A total of 32 women (76.2%) in COCP group and 15 women (35.7%) in NSAID group stop bleeding within 7 days after the initiation of treatment which was statistically significant (P
METHODOLOGY: A prospective comparison of subjective global assessment (SGA), and anthropometry (mid-arm muscle circumference, MAMC; triceps skinfold thickness, TST) between elderly stroke patients on long-term NG feeding and matched controls was performed. Selected clinicians and carers of patients were interviewed to assess their knowledge and attitudes to gastrostomy feeding.
RESULTS: 140 patients (70 NG, 70 oral) were recruited between September 2010 and February 2011. Nutritional status was poorer in the NG compared to the oral group (SGA grade C 38.6% NG vs 0% oral, p<0.001; TST males 10.7 + 3.7 mm NG vs 15.4 + 4.6 mm oral, p<0.001; MAMCmales 187.9 + 40.4 mm NG vs 228.7 + 31.8 mm oral, p<0.001). 45 (64.3%) patients on long-term NG feeding reported complications, mainly consisting of dislodgement (50.5%), aspiration of feed content (8.6%) and trauma from insertion (4.3%). Among 20 clinicians from relevant speciliaties who were interviewed, only 11 (55%) clinicians would routinely recommend a PEG. All neurologists (100%) would recommend a PEG, whilst the response was mixed among non-neurologists. Among carers, lack of information (47.1%) was the commonest reason stated for not choosing a PEG.
CONCLUSION: Elderly patients with stroke on long term NG feeding have a poor nutritional status. Lack of recommendation by clinicians appears to be a major barrier to PEG feeding in these patients.