BACKGROUND: Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) account for >95% of bariatric procedures in United States in patients with T2DM. To date, there is no validated model to guide procedure selection based on long-term glucose control in patients with T2DM.
METHODS: A total of 659 patients with T2DM who underwent RYGB and SG at an academic center in the United States and had a minimum 5-year follow-up (2005-2011) were analyzed to generate the model. The validation dataset consisted of 241 patients from an academic center in Spain where similar criteria were applied.
RESULTS: At median postoperative follow-up of 7 years (range 5-12), diabetes remission (HbA1C <6.5% off medications) was observed in 49% after RYGB and 28% after SG (P < 0.001). Four independent predictors of long-term remission including preoperative duration of T2DM (P < 0.0001), preoperative number of diabetes medications (P < 0.0001), insulin use (P = 0.002), and glycemic control (HbA1C < 7%) (P = 0.002) were used to develop the Individualized Metabolic Surgery (IMS) score using a nomogram. Patients were then categorized into 3 stages of diabetes severity. In mild T2DM (IMS score ≤25), both procedures significantly improved T2DM. In severe T2DM (IMS score >95), when clinical features suggest limited functional β-cell reserve, both procedures had similarly low efficacy for diabetes remission. There was an intermediate group, however, in which RYGB was significantly more effective than SG, likely related to its more pronounced neurohormonal effects. Findings were externally validated and procedure recommendations for each severity stage were provided.
CONCLUSIONS: This is the largest reported cohort (n = 900) with long-term postoperative glycemic follow-up, which, for the first time, categorizes T2DM into 3 validated severity stages for evidence-based procedure selection.
Objectives: This study aimed to determine post-treatment oral cancer patients' concerns and its relationship with patients' clinical characteristics, health-related quality of life (HRQoL), psychological distress and patient satisfaction with the follow-up consultation.
Methods: A total of 85 oral cancer patients were recruited from a three-armed pragmatic RCT study on the patient concerns inventory for head and neck cancer (PCI-H&N), which was conducted at six hospital-based oral maxillofacial specialist clinics throughout Malaysia. Malaysians aged 18 years and above and on follow-ups from 1 month to 5 years or more were eligible. Patients completed the PCI-H&N, functional assessment of cancer therapy -H&N v4.0 and Distress Thermometer at pre-consultation and satisfaction questionnaire at post-consultation. The data were analysed descriptively; multiple linear regression and multivariate logistic regression analyses were used to determine possible predictors of patients' HRQoL and psychological distress.
Results: 'Recurrence or fear of cancer coming back' (31.8%) was most frequently selected. 43.5% of patients selected ≥4 concerns. A significantly high number of concerns were associated with patients of '1-month to 1-year post-treatment' (n = 84%; p = 0.001). A significant association existed between 'time after treatment completed' and patients' concerns of 'chewing/eating', 'mouth opening', 'swelling', 'weight', 'ability to perform', 'cancer treatment' and 'supplement/diet-related'. 'Chewing/eating' was predicted for low HRQoL (p < 0.0001) followed by 'appearance' and 'ability to perform recreation activities' (personal functions domain). Patients with high psychological distress levels were 14 times more likely to select 'ability to perform recreation activities' and seven times more likely to select 'feeling depressed'. No significant association was identified between patients' concerns and patients' satisfaction with the consultation.
Conclusion: Routine follow-up consultations should incorporate the PCI-H&N prompt list to enhance patient-centred care approach as the type and number of patients' concerns are shown to reflect their HRQoL and psychological distress.TRIAL REGISTRATION: NMRR-18-3624-45010 (IIR).
OBJECTIVE: To determine if surgically leveling the upper thoracic spine in patients with adolescent idiopathic scoliosis results in level shoulders postoperatively.
SUMMARY OF BACKGROUND DATA: Research has shown that preoperatively tilted proximal ribs and T1 tilt are more correlated with trapezial prominence than with clavicle angle.
METHODS: Prospectively collected Lenke 1 and 2 cases from a single center were reviewed. Clinical shoulder imbalance was measured from 2-year postoperative clinical photos. Lateral shoulder imbalance was assessed utilizing clavicle angle. Medial imbalance was assessed with trapezial angle (TA), and trapezial area ratio (TAR). First rib angle, T1 tilt, and upper thoracic curve were measured from 2-year radiographs. Angular measurements were considered level if ≤ 3° of zero. TAR was considered level if ≤ 1 standard deviation of the natural log of the ratio. Upper thoracic Cobb at 2-years was categorized as at or below the mean value (≤ 14°) versus above the mean.
RESULTS: Eighty-four patients were identified. There was no significant difference in the percentage of patients with a level clavicle angle or TAR based on first rib being level, T1 tilt being level, or upper thoracic Cobb being at/below versus above the mean (P
AIM: The study aimed to investigate the effect of P.s on atherosclerotic changes in hypercholesterolemic rabbits.
METHODS: Forty two male New Zealand white rabbits were divided into seven groups. C - control group fed normal rabbit chow, CH - cholesterol diet (1% cholesterol), W1 - 1% cholesterol with water extract of P.s (62.5 mg/kg), W2 - 1% cholesterol with water extract of P.s (125 mg/kg), W3 - 1% cholesterol with water extract of P.s (250 mg/kg), W4 - 1% cholesterol with water extract of P.s (500 mg/kg) and Smv - 1% cholesterol supplemented with simvistatin drug (1.2 mg/kg). All rabbits were treated for 10 weeks. Following 10 weeks of supplementation, the animals were sacrificed and the aortic tissue was taken for histological study.
RESULTS: Rabbits fed only with high cholesterol diet 1% cholesterol (CH) showed focal fatty streak lesions compared to the C group and 1% cholesterol supplemented with simvistatin drug (Smv) group. Atherosclerotic lesions in the 1% cholesterol group supplemented with P.s (500 mg/kg) i.e. W4 group showed significant reduction (30 + or - 6.0%, p < 0.05) in fatty streak compared to the high cholesterol group (85.6 + or - 4.1%) under Sudan IV stain. The atherosclerotic lesions under transmission electron microscope showed reduction in foam cells in the treatment groups compared to the CH groups.
CONCLUSION: Administration of P.s extract has protective effect against atheroscleros.
METHODS: STORM-C-1 is a two-stage, open-label, phase 2/3 single-arm clinical trial in six public academic and non-academic centres in Malaysia and four public academic and non-academic centres in Thailand. Patients with HCV with compensated cirrhosis (Metavir F4 and Child-Turcotte-Pugh class A) or without cirrhosis (Metavir F0-3) aged 18-69 years were eligible to participate, regardless of HCV genotype, HIV infection status, previous interferon-based HCV treatment, or source of HCV infection. Once daily ravidasvir (200 mg) and sofosbuvir (400 mg) were prescribed for 12 weeks for patients without cirrhosis and for 24 weeks for those with cirrhosis. The primary endpoint was sustained virological response at 12 weeks after treatment (SVR12; defined as HCV RNA <12 IU/mL in Thailand and HCV RNA <15 IU/mL in Malaysia at 12 weeks after the end of treatment). This trial is registered with ClinicalTrials.gov, number NCT02961426, and the National Medical Research Register of Malaysia, NMRR-16-747-29183.
FINDINGS: Between Sept 14, 2016, and June 5, 2017, 301 patients were enrolled in stage one of STORM-C-1. 98 (33%) patients had genotype 1a infection, 27 (9%) had genotype 1b infection, two (1%) had genotype 2 infection, 158 (52%) had genotype 3 infection, and 16 (5%) had genotype 6 infection. 81 (27%) patients had compensated cirrhosis, 90 (30%) had HIV co-infection, and 99 (33%) had received previous interferon-based treatment. The most common treatment-emergent adverse events were pyrexia (35 [12%]), cough (26 [9%]), upper respiratory tract infection (23 [8%]), and headache (20 [7%]). There were no deaths or treatment discontinuations due to serious adverse events related to study drugs. Of the 300 patients included in the full analysis set, 291 (97%; 95% CI 94-99) had SVR12. Of note, SVR12 was reported in 78 (96%) of 81 patients with cirrhosis and 153 (97%) of 158 patients with genotype 3 infection, including 51 (96%) of 53 patients with cirrhosis. There was no difference in SVR12 rates by HIV co-infection or previous interferon treatment.
INTERPRETATION: In this first stage, ravidasvir plus sofosbuvir was effective and well tolerated in this diverse adult population of patients with chronic HCV infection. Ravidasvir plus sofosbuvir has the potential to provide an additional affordable, simple, and efficacious public health tool for large-scale implementation to eliminate HCV as a cause of morbidity and mortality.
FUNDING: National Science and Technology Development Agency, Thailand; Department of Disease Control, Ministry of Public Health, Thailand; Ministry of Health, Malaysia; UK Aid; Médecins Sans Frontières (MSF); MSF Transformational Investment Capacity; FIND; Pharmaniaga; Starr International Foundation; Foundation for Art, Research, Partnership and Education; and the Swiss Agency for Development and Cooperation.
METHODS: Medical records of patients who were treated for LM in the Paediatric Surgical Centre Universitas Gadjah Mada from January 2015 to January 2019 were reviewed. Scoring systems were used to assess the outcomes, including reduction of size, problems of aesthetics, functional problems, complications, necessity of further interventions, and interventions' frequencies.
RESULTS: During the four-year study, we included 31 children, consisting of 6, 5, and 20 patients in Groups I, II, and III, respectively. The total score did not significantly differ between Groups I, II, and III (14.67±2.80 vs. 13.40±2.07 vs. 12.50±1.47, respectively; p=0.056). Group II scored better in aesthetic problems than other groups (p=0.001), Group III scored higher in necessity of further interventions compared to the other groups (p=0.026), and Group I was higher in interventions' frequencies than the other groups (p<0.001). However, there were no significant differences in reduction of size, functional problems, and complications among groups (p=0.554, 0.151, and 0.076, respectively).
CONCLUSIONS: There is no significant different effect of the three modalities treatment for LM, although one group might have more beneficial effects compared with the other groups due to different scoring system parameters. Further multicentre and prospective cohort studies with a larger number of patients are necessary to establish the existence and extent of our findings.