Significant Treatment Changes Research Articles

The real-world observational prospective study of health outcomes with dulaglutide and liraglutide in patients with type 2 diabetes (TROPHIES): Final, 24-month analysis of time to first significant treatment change, treatment persistence and clinical outcomes.

To present the final results of the TROPHIES study (The real-world observational prospective study of health outcomes with dulaglutide and liraglutide in patients with type 2 diabetes). The prospective, real-world TROPHIES study included patients with type 2 diabetes initiating their first injectable glucose-lowering medication (GLM), dulaglutide or liraglutide, in France, Germany and Italy. The primary endpoint was the time spent on dulaglutide or liraglutide until a significant treatment change over 24 months. Other endpoints measured persistence with treatment, clinical outcomes (glycated haemoglobin [HbA1c] and weight) and treatment patterns. Kaplan-Meier estimates of time to first significant treatment change and persistence with treatment were generated. Propensity-score-based inverse probability of treatment weighting (IPTW) was used to adjust for baseline imbalances in the comparison between cohorts. The 286 of 1014 patients (28.2%) in the dulaglutide cohort and 448 of 991 patients (45.2%) in the liraglutide cohort had a significant treatment change over 24 months. By IPTW analysis, dulaglutide-initiating patients were less likely to have a significant treatment change (hazard ratio [HR] 0.54, 95% confidence interval [CI] 0.46-0.63) and more likely to be persistent with treatment (HR 0.69, 95% CI 0.56-0.86) over 24 months than liraglutide-initiating patients. Dulaglutide and liraglutide yielded similar HbA1c (-11.80 mmol/mol [1.08%] and -11.91 mmol/mol [1.09%]) and weight (-3.5 kg and -3.3 kg) reductions from baseline to 24 months. Few changes in patterns of treatment with other GLMs were observed in the two cohorts. Dulaglutide-initiating patients had a longer time spent without any significant treatment change and higher persistence than those initiating liraglutide. Treatment with either glucagon-like peptide-1 receptor agonist yielded similar and clinically meaningful reductions in HbA1c and body weight.

Preliminary experience with a new institutional tumor board dedicated to patients with neuroendocrine neoplasms.

PurposeTo determine the decision patterns of a neuroendocrine neoplasm (NEN) tumor board (TB) and the factors behind those.MethodsWe retrospectively reviewed all NEN-TB recommendations from 07/2018 to 12/2021 and recorded patient characteristics, TB outcomes and associations between them.ResultsA total of 652 patient entries were identified. Median age of participants was 61 years and an equal number of men and women were presented. Most patients (33.4%) had tumors originating in the small bowel with 16.8% of high grade and 25.9% of pancreatic origin. Imaging was reviewed 97.2% of the time, with most frequently reviewed modalities being PET (55.3%) and CT (44.3%). Imaging review determined that there was no disease progression 20.8% of the time and significant treatment changes were recommended in 36.1% of patients. Major pathology amendments occurred in 3.7% of cases and a clinical trial was identified in 2.6%. There was no association between patient or disease presentation with the tumor board outcomes. There was a slight decrease in number of patients discussed per session, from 10.0 to 8.2 (p < 0.001) when the TB transitioned to a virtual format during the COVID-19 pandemic but all other factors remained unchanged.ConclusionNEN-TB relies heavily on image review, can impact significant treatment changes in patients with rare tumors like NENs, and was not affected by the switch to a virtual format. Finally, none of the examined factors were predictive of the tumor board recommendations.

746-P: The Real-World Observational Prospective Study of Health Outcomes with Dulaglutide and Liraglutide in Type 2 Diabetes Patients (TROPHIES) : Final 24-Month Primary Endpoint Analysis

TROPHIES was a 24-month, prospective, non-comparative, observational study in adult patients with T2D initiating their first injectable glucose-lowering treatment with once-weekly dulaglutide (DU; N=1,014) or once-daily liraglutide (LIRA; N=991) in France, Germany, and Italy. Primary objective: to assess the time patients remained on their first GLP-1 RA without a significant treatment change due to treatment- or diabetes-related factors. Kaplan-Meier (KM) probability (95% CI) of no significant treatment change at 24 months was 0.71 (0.68-0.74) and 0.53 (0.49-0.56) in the DU and LIRA cohorts, respectively (Figure) . Two-hundred and eighty-six (28.2%) and 448 (45.2%) patients receiving DU and LIRA, respectively, had a significant treatment change. The main driver of treatment change in the DU and LIRA cohorts was intensification with an add-on therapy (insulin or OAD) and intensification with dose increase of GLP-1 RA, respectively. KM probability (95% CI) of GLP-1 RA persistence at 24 months was high in both cohorts: DU 0.82 (0.80-0.85) ; LIRA 0.75 (0.72-0.78) . In summary, the probabilities of no significant treatment change over 24 months were estimated as higher in the DU cohort than in the LIRA cohort in this non-comparative analysis, with good persistence in both cohorts. Disclosure F. Giorgino: Advisory Panel; AstraZeneca, Boehringer Ingelheim International GmbH, Novo Nordisk. Consultant; Lilly Diabetes, Sanofi. Research Support; Lilly Diabetes, Roche Diabetes Care, Takeda Pharmaceutical Company Limited. B. Guerci: Advisory Panel; Amgen Inc., Medtronic. Board Member; Abbott Diagnostics, AstraZeneca, Bayer AG, Eli Lilly and Company, Novartis Pharmaceuticals Corporation. Consultant; Boehringer Ingelheim International GmbH, Intercept Pharmaceuticals, Inc., Novo Nordisk. L. Garcia-Perez: Employee; Eli Lilly and Company. Stock/Shareholder; Eli Lilly and Company. M. Fuechtenbusch: Advisory Panel; Berlin-Chemie AG. Consultant; Boehringer Ingelheim International GmbH, Eli Lilly and Company, Merck Sharp &amp; Dohme Corp. Speaker's Bureau; AstraZeneca, Novo Nordisk. J. Lebrec: Consultant; Eli Lilly and Company. M. Orsini Federici: Employee; Eli Lilly and Company. A. Dib: Employee; Eli Lilly and Company. Stock/Shareholder; Eli Lilly and Company. E. Heitmann: None. M. Yu: Employee; Eli Lilly and Company. Stock/Shareholder; Eli Lilly and Company. K. Boye: Employee; Eli Lilly and Company. Stock/Shareholder; Eli Lilly and Company.

726-P: The Real-World Observational Prospective Study of Health Outcomes with Dulaglutide and Liraglutide in Type 2 Diabetes Patients (TROPHIES) : Final 24-Month Clinical Characteristics and Treatment Pattern Analyses

TROPHIES was a 24-month, prospective, non-comparative, observational study in adult patients with T2D initiating their first injectable glucose-lowering treatment with once-weekly dulaglutide (DU; N=1,014) or once-daily liraglutide (LIRA; N=991) in France, Germany, and Italy. Secondary objectives included assessments of HbA1c, body weight and treatment patterns. Clinical characteristics of the DU and LIRA cohorts at 24 months are described in the Table. Most patients receiving DU (856/1,014) initiated treatment at 1.5 mg/week and, among 286 patients with a significant treatment change, 237 were still receiving 1.5 mg/week. In the LIRA cohort, most patients (809/991) initiated at the starting dose 0.6 mg/day and 45% increased dose to 1.2 mg/day by Day 90; however, 17% of patients were already receiving 1.8 mg/day by Day 90. At the first significant treatment change 285/448 patients in the LIRA cohort were receiving 1.2 mg/day. Insulin was initiated by 79 and 97 patients in the DU and LIRA cohorts, respectively. Both treatments showed clinically meaningful effectiveness on HbA1c and weight, maintained over the 24-month study period. Disclosure B. Guerci: Advisory Panel; Amgen Inc., Medtronic. Board Member; Abbott Diagnostics, AstraZeneca, Bayer AG, Eli Lilly and Company, Novartis Pharmaceuticals Corporation. Consultant; Boehringer Ingelheim International GmbH, Intercept Pharmaceuticals, Inc., Novo Nordisk. F. Giorgino: Advisory Panel; AstraZeneca, Boehringer Ingelheim International GmbH, Novo Nordisk. Consultant; Lilly Diabetes, Sanofi. Research Support; Lilly Diabetes, Roche Diabetes Care, Takeda Pharmaceutical Company Limited. K. Boye: Employee; Eli Lilly and Company. Stock/Shareholder; Eli Lilly and Company. M. Fuechtenbusch: Advisory Panel; Berlin-Chemie AG. Consultant; Boehringer Ingelheim International GmbH, Eli Lilly and Company, Merck Sharp &amp; Dohme Corp. Speaker's Bureau; AstraZeneca, Novo Nordisk. E. Heitmann: None. J. Lebrec: Consultant; Eli Lilly and Company. A. Dib: Employee; Eli Lilly and Company. Stock/Shareholder; Eli Lilly and Company. M. Orsini Federici: Employee; Eli Lilly and Company. M. Yu: Employee; Eli Lilly and Company. Stock/Shareholder; Eli Lilly and Company. L. Garcia-Perez: Employee; Eli Lilly and Company. Stock/Shareholder; Eli Lilly and Company.

A likelihood-based convolution approach to estimate major health events in longitudinal health records data: an external validation study.

In electronic health record data, the exact time stamp of major health events, defined by significant physiologic or treatment changes, is often missing. We developed and externally validated a method that can accurately estimate these time stamps based on accurate time stamps of related data elements. A novel convolution-based change detection methodology was developed and tested using data from the national deidentified clinical claims OptumLabs data warehouse, then externally validated on a single center dataset derived from the M Health Fairview system. We applied the methodology to estimate time to liver transplantation for waitlisted candidates. The median error between estimated date within the period of the actual true date was zero days, and median error was 92% and 84% of the transplants, in development and validation samples, respectively. The proposed method can accurately estimate missing time stamps. Successful external validation suggests that the proposed method does not need to be refit to each health system; thus, it can be applied even when training data at the health system is insufficient or unavailable. The proposed method was applied to liver transplantation but can be more generally applied to any missing event that is accompanied by multiple related events that have accurate time stamps. Missing time stamps in electronic healthcare record data can be estimated using time stamps of related events. Since the model was developed on a nationally representative dataset, it could be successfully transferred to a local health system without substantial loss of accuracy.

Mindfulness-based stress reduction improves irritable bowel syndrome (IBS) symptoms via specific aspects of mindfulness.

Irritable bowel syndrome (IBS) is a common and often debilitating chronic gastrointestinal disorder characterized by abdominal pain and altered bowel habits. Pharmacological treatments are often ineffective, leading to the development of a variety of behavioral interventions. Mindfulness-based stress reduction (MBSR) is one such program that has shown efficacy in reducing gastrointestinal (GI) symptoms and improving quality of life (QOL). This single-arm intervention study examines the association of clinical outcomes with changes in specific aspects of mindfulness. Adults with IBS (53 women, 15 men) participated in an 8-week MBSR class. Primary outcomes of GI symptom severity, quality of life, and GI-specific anxiety, as well as specific aspects of mindfulness using the Five Factor Mindfulness Questionnaire (FFMQ), were assessed at baseline, post-treatment, and 6-month follow-up. Gastrointestinal symptom responder rate was 71%, and there was a significant pre-post treatment change for three of the five FFMQ scales. Regression analysis indicated that change in the Act with Awareness (P=.02) facet of mindfulness was the strongest predictor of GI symptom and QOL improvement. Mindfulness-based stress reduction training was associated with robust improvements in GI symptoms and associated problems in participants with IBS. Although significant increases in 3 of the 5 measured facets of mindfulness were found, regression analyses suggest that increases in the ability to retain present moment focus and act with awareness may be particularly important for improving outcomes in individuals with IBS. These results may inform the refinement of mindfulness-based protocols specifically for treatment of IBS.

Effects of clear aligner therapy for Class II malocclusion on upper airway morphology and daytime sleepiness in adults: A case series

To evaluate the effects of clear aligner therapy (CAT) on the upper airway dimensions and on daytime sleepiness in adults with dentoskeletal Class II malocclusion. This study was conducted from August 2017 to February 2019. Inclusion criteria were healthy adults≥18years old, Angle Class II division 1 malocclusion, first-molar relationship of end-to-end or greater, overjet<10mm, and presenting for multi-arch comprehensive orthodontic treatment with aligners. Treatment mechanics included mandibular dentoalveolar advancement with Class II elastics without maxillary sequential distalization programmed into aligners. Post-treatment changes in dentoskeletal and upper airway dimensions were assessed using CBCT images. The treatment effect on daytime sleepiness was evaluated using an Epworth Sleepiness Scale (ESS). Eight subjects were included in this pilot study (mean age at treatment initiation=44.6years [SD=15.3]). The mean treatment duration was 12.2months (SD=3.4). No statistically significant treatment changes were observed in upper airway dimensions or dentoskeletal cephalometric analyses. Subjects with excessive daytime sleepiness at pre-treatment reported an improvement post-treatment, but no significant difference in the mean ESS score was found. Treatment of Class II division 1 malocclusion in adults by mandibular dentoalveolar advancement using CAT has no statistically significant effects on the airway and dentoskeletal measurements, or daytime sleepiness.

PDB116 THE REAL-WORLD OBSERVATIONAL PROSPECTIVE STUDY OF HEALTH OUTCOMES WITH DULAGLUTIDE & LIRAGLUTIDE IN TYPE 2 DIABETES PATIENTS (TROPHIES): DESIGN AND BASELINE CHARACTERISTICS

Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are usually recommended as the first injectable therapy for type 2 diabetes (T2D). Although randomized clinical trials are the standard for assessing efficacy and safety, observational studies are valuable to understand GLP-1 RA use in clinical practice. The TROPHIES study design and baseline characteristics of patients are described in this abstract. TROPHIES is a 24-month, prospective, observational study in France, Germany and Italy in adult patients with T2D initiating their first injectable glucose-lowering treatment with once-weekly dulaglutide or once-daily liraglutide. The primary outcome, time on the first GLP-1 RA without significant treatment change due to T2D-related factors, is defined as discontinuation of this GLP-1RA or intensification of glucose-lowering treatment. At baseline, demographics, duration of T2D, HbA1c levels, reported HbA1c targets, pre-existing diabetes-related diagnoses and concomitantly used oral glucose-lowering medications were assessed. To date, data from 2065 patients initiating dulaglutide (1089) or liraglutide (976) have been analyzed. In patients initiating dulaglutide or liraglutide, mean age was 58.9 and 59.4 years, 55.3% and 57.4% were male, mean duration of T2D was 8.7 and 8.3 years, and mean BMI was 33.8 and 34.1 kg/m2, respectively. Mean baseline HbA1c level was 8.2% (dulaglutide) and 8.3% (liraglutide) and exceeded the reported mean HbA1c target (6.9%). Macrovascular and microvascular diabetes-related conditions were reported in 8.2% and 17.7% (dulaglutide) and 11.5% and 15.5% (liraglutide) of patients, respectively. Of the patients initiating dulaglutide or liraglutide, 27.5% and 25.5% had taken ≥2 concomitant oral glucose-lowering medications, respectively, and biguanides were the most common. In patients of both groups, BMI reflected obesity. HbA1c levels exceeded the reported targets justifying treatment intensification with GLP-1 RA after ∼8.5 years of diabetes. Thus, this study helps to understand profiles of patients being prescribed dulaglutide or liraglutide in France, Germany and Italy.

Differences in perception of breast cancer treatment between patients, physicians, and nurses and unmet information needs in Japan

PurposeDiscrepancies exist between healthcare provider and patient perceptions surrounding breast cancer treatment. Significant treatment changes in the last 10 years have made re-evaluation of these perceptions necessary.MethodsPhysicians and nurses involved in breast cancer treatment, and patients who had received breast cancer chemotherapy (past 5 years), were questioned using an Internet survey. Participants ranked physical concerns (treatment side effects), psychological concerns, priorities for treatment selection, and side effects to be avoided during treatment. Patients were asked about desired treatment information/information sources. Rankings were calculated using the mean value of scores. Spearman’s rank correlation was used to determine the concordance of rankings among groups.ResultsSurvey respondents included 207 patients, 185 physicians, and 150 nurses. Patients and nurses similarly ranked distressing physical concerns; physician rankings differed. Quality of life (QoL) and treatment response ranked high with physicians and patients when considering future treatment; nurses prioritized QoL. All three groups generally agreed on ranking of psychological concerns experienced during chemotherapy, explanation of treatment options, and how treatment decisions were made, although more patients thought treatment decisions should be made independently. Healthcare providers reported providing explanations of treatment side effects and information on physical/psychological support options while patients felt both were lacking. Concordance was calculated as 0.47 (patient–physician), 0.83 (patient–nurse), and 0.76 (physician–nurse). Patients desired additional information, preferring healthcare providers as the source.ConclusionsSpecific areas for improvement in breast cancer patient care were identified; programs should be implemented to address unmet needs and improve treatment in these areas.

Treatment effects of two different appliances on pharyngeal airway space in mixed dentition Malay children

BackgroundTreatment of Class III malocclusion is related to redirecting the growth of mandible, which may have an impact on the pharyngeal airway. ObjectiveTo evaluate and compare the treatment effect of Reverse Twin-Block (RTB) and Reverse Pull Face Mask (RPFM) on Pharyngeal Airway Space (PAS) in early and late mixed dentition Class III samples. MethodsNinety-five mixed dentition Malay children with Class III malocclusion were included in this study. Data consists of 190 pre- and post-treatment lateral cephalograms of early (8–9 years) and late (10–11 years) mixed dentition Class III samples. forty-nine samples were under RTB and forty-six samples were under RPFM. Treatment changes were evaluated by McNamara airway analysis and changes in tongue and hyoid bone position. ResultsBoth upper and lower pharyngeal airway width were increased after treatment with RTB and RPFM ruling out the chance of airway constriction. There was also posterior positioning of the tongue and hyoid bone indicating mandibular retrusion. No significant treatment changes were found on the Pharyngeal Airway Space by the factor age, gender or type of appliance. ConclusionsBoth RTB and RPFM increased the Pharyngeal Airway Space and produced similar treatment effect. As age does not affect the treatment outcome significantly, treatment can be delayed until late mixed dentition stage.

Considering tumour volume for motion corrected DWI of colorectal liver metastases increases sensitivity of ADC to detect treatment-induced changes

ADC is a potential post treatment imaging biomarker in colorectal liver metastasis however measurements are affected by respiratory motion. This is compounded by increased statistical uncertainty in ADC measurement with decreasing tumour volume. In this prospective study we applied a retrospective motion correction method to improve the image quality of 15 tumour data sets from 11 patients. We compared repeatability of ADC measurements corrected for motion artefact against non-motion corrected acquisition of the same data set. We then applied an error model that estimated the uncertainty in ADC repeatability measurements therefore taking into consideration tumour volume. Test-retest differences in ADC for each tumour, was scaled to their estimated measurement uncertainty, and 95% confidence limits were calculated, with a null hypothesis that there is no difference between the model distribution and the data. An early post treatment scan (within 7 days of starting treatment) was acquired for 12 tumours from 8 patients. When accounting for both motion artefact and statistical uncertainty due to tumour volumes, the threshold for detecting significant post treatment changes for an individual tumour in this data set, reduced from 30.3% to 1.7% (95% limits of agreement). Applying these constraints, a significant change in ADC (5th and 20th percentiles of the ADC histogram) was observed in 5 patients post treatment. For smaller studies, motion correcting data for small tumour volumes increased statistical efficiency to detect post treatment changes in ADC. Lower percentiles may be more sensitive than mean ADC for colorectal metastases.

Abstract P1-03-01: Differential distant disease-free intervals for mammography detected vs. clinical presentation invasive breast cancer: Early detection or lead time bias?

Abstract Background: Distant recurrence metastatic breast cancer (rMBC) incidence has declined with coincident improved breast cancer (BC) survival over time. Lead time is time from screening diagnosis to diagnosis that would have been made without screening. The purpose of screening is to detect disease at an early more treatable stage. Lead time bias would indicate early detection led only to a perceived increase in survival time without affecting the course of BC progression. Our objective was to evaluate detection method and treatment changes to distant recurrence and survival over time. Methods: In a longitudinal institutional cohort 1990-2011, we reviewed primary invasive stage I-III BC patients (n = 7991) for initial BC detection method by mammography (MamD) or patient/physician (ClinP), distant recurrence (rMBC), time from initial diagnosis to distant recurrence (DDFI) and distant disease specific survival (DDSS), follow up through 2016 updated annually. 856 patients with distant recurrence were identified and confirmed by imaging, biopsy or both. Diagnosis year time periods were set to coincide with significant treatment changes over time (1990-98, 1999-2004, 2005-2011). Chi square, mean ANOVA, DDSS and Cox proportional hazards analysis were conducted. Results: 48% of the cohort were ClinP and 52% MamD with MamD BC increasing over time [1990-98 45%, 2005-2011 54%, p&amp;lt;.001]. 72% of rMBC patients were ClinP BC. ClinP BC had shorter distant recurrence time, 4.99 years vs. 6.05 MamD BC (p = .001). Mean time from rMBC diagnosis to death was 2.88 years with no significant difference by detection method. In a Cox proportional hazards model adjusted for race, reduced risk of rMBC was observed for stage I/II, recent diagnostic years, hormone receptor positive, MamD, and low histologic grade [TNM I HzR .11, 95% CI .09, .14; TNM II HzR = .36, 95% CI = .31, .43; 1990-2004 HzR = .63, 95% CI = .53, .75; 2005-2011 HzR = .49, 95% CI = .41, .58; HR+ HzR = .70, 95% CI = .59, .82; MamD HzR = .68, 95% CI = .58, .81; low histologic grade HzR = .80, 95% CI = .67, .96; age &amp;gt;40 HzR = .79, 95% CI = .65, .96]. No difference was observed for DDSS by detection method [5-year DDSS: ClinP = 22%, MamD = 21%; log rank test = .019, p = .892]. Conclusion: At initial diagnosis, the majority of rMBC cases are symptomatic, have shorter DDFI but DDSS equal to MamD BC. MamD BC cases have lower rMBC incidence and longer DDFI possibly due to more responsive earlier diagnosed initial disease, slower progression disease or as yet unidentified biologic/genomic differences. Lead time bias may partially explain lower rMBC incidence given the benefits owed to treatment of MamD invasive BC which preclude disease progression to clinically evident BC. Mammography detected/non-symptomatic and clinically detected/symptomatic BC have differential incidence of and time to distant recurrence but no difference in DDSS. Mammography detection appears to confer a distant disease risk reduction advantage independent of other known prognostic factors but the disease has the same virulence once it becomes metastatic. Our results indicate treatment changes by diagnosis year proxy and mammography detection are both associated with decreased rMBC risk. Citation Format: Kaplan HG, Malmgren JA, Atwood MK. Differential distant disease-free intervals for mammography detected vs. clinical presentation invasive breast cancer: Early detection or lead time bias? [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P1-03-01.

Corrigendum: Effects on Subclinical Heart Failure in Type 2 Diabetic Subjects on Liraglutide Treatment vs. Glimepiride Both in Combination with Metformin: A Randomized Open Parallel-Group Study.

[This corrects the article on p. 325 in vol. 8, PMID: 29184539.].

Gadolinium-Based Contrast Agent During Pelvic MRI: Contribution to Patient Management in Rectal Cancer.

Few publications exist regarding gadolinium-enhanced sequences in rectal MRI. None have evaluated its potential impact on patient management. This study aimed to assess whether gadolinium-enhanced sequences, including dynamic contrast enhancement, change radiologic interpretation and clinical management of rectal cancer. This is a retrospective analysis of 100 rectal MRIs (50 baseline and 50 postneoadjuvant treatment), both without and with gadolinium-enhanced sequences. Treatment plans were rendered based on each radiologic interpretation for each case by a single experienced surgeon. Differences in radiologic interpretation and management were statistically analyzed. The study was conducted at the Memorial Sloan Kettering Cancer Center. Patients undergoing rectal MRI between 2011 and 2015 for baseline tumor staging and/or postneoadjuvant restaging were included. Primary outcome measures were changes in radiologic tumor stage, tumor margins, and surgical planning with the use of gadolinium at baseline and postneoadjuvant time points. At baseline, tumor downstaging occurred in 8 (16%) of 50 and upstaging in 4 (8%) of 50 with gadolinium. Postneoadjuvant treatment, upstaging occurred in 1 (2%) of 50 from T2 to T3a. At baseline, mean distances from tumor to anorectal ring, anal verge, and mesorectal fascia were not statistically different with gadolinium. However, in 7 patients, differences could have resulted in treatment changes, accounted for by changes in relationships to anterior peritoneal reflection (n = 4), anorectal ring (n = 2), or anal verge (n = 1). Postneoadjuvant treatment, distances to anorectal ring and anal verge (in centimeters) were statistically smaller with gadolinium (p = 0.0017 and p = 0.0151) but could not have resulted in clinically significant treatment changes. This study was limited by its retrospective design. The use of gadolinium at baseline MRI could have altered treatment in 24% of patients because of differences in tumor stage or position. Postneoadjuvant treatment, gadolinium resulted in statistically smaller distances to sphincters, which could influence surgical decision for sphincter-preserving rectal resection. See Video Abstract at http://links.lww.com/DCR/A444.

Effects on Subclinical Heart Failure in Type 2 Diabetic Subjects on Liraglutide Treatment vs. Glimepiride Both in Combination with Metformin: A Randomized Open Parallel-Group Study.

We aimed to investigate the effect of liraglutide treatment on heart function in type 2 diabetes (T2D) patients with subclinical heart failure. Randomized open parallel-group trial. 62 T2D patients (45 male) with subclinical heart failure were randomized to either once daily liraglutide 1.8 mg, or glimepiride 4 mg, both add on to metformin 1 g twice a day. Mitral annular systolic (s') and early diastolic (e') velocities were measured at rest and during bicycle ergometer exercise, using tissue Doppler echocardiography. The primary endpoint was 18-week treatment changes in longitudinal functional reserve index (LFRIdiastolic/systolic). Clinical characteristics between groups (liraglutide = 33 vs. glimepiride = 29) were well matched. At baseline left ventricle ejection fraction (53.7 vs. 53.6%) and global longitudinal strain (-15.3 vs. -16.5%) did not differ between groups. There were no significant differences in mitral flow velocities between groups. For the primary endpoint, there was no treatment change [95% confidence interval] for: LFRIdiastolic (-0.18 vs. -0.53 [-0.28, 2.59; p = 0.19]), or LFRIsystolic (-0.10 vs. -0.18 [-1.0, 1.7; p = 0.54]); for the secondary endpoints, there was a significant treatment change in respect of body weight (-3.7 vs. -0.2 kg [-5.5, -1.4; p = 0.001]), waist circumference (-3.1 vs. -0.8 cm [-4.2, -0.4; p = 0.019]), and heart rate (HR) (6.3 vs. -2.3 bpm [-3.0, 14.2; p = 0.003]), with no such treatment change in hemoglobin A1c levels (-11.0 vs. -9.2 mmol/mol [-7.0, 2.6; p = 0.37]), between groups. 18-week treatment of liraglutide compared with glimepiride did not improve LFRIdiastolic/systolic, but however increased HR. There was a significant treatment change in body weight reduction in favor for liraglutide treatment.

TYPE 2 DIABETES;

Background: The data among vitamin D supplementation on glycemic control isvariable and contradictory in various clinical studies. Objectives: To determine the efficacy of vitD supplementation on glycemic control in type 2 diabetic patients. Study Design: Case controlstudy. Setting: Private Clinical Set up of District, Rahim Yar Khan. Period: August to October2016. Patients and methods: 100 cases of type 2 diabetes were randomly divided into groupA and group B each contained 50 patients .The cases in group A were treated with vitamin D3at the dose of 50,000 units per week orally while cases in group B were treated with placeboalong with the standard doses of anti-diabetic drugs. The value of HbA1c and Vit D wereassayed pre and post treatment by high performance liquid chromatography. Results: Therewas significant post treatment changes observed in vitamin D level in group A vs group B inmales 20.46±2.45 vs 15.16±1.47 (p= 0.001) and females 18.32±1.44 vs 13.95±2.48 (p= 0.09)There was significant post treatment changes in HbA1c in males 6.65±0.12 vs 8.34±0.71 (p=0.01) and in females 6.81±0.43 vs 8.04±0.71 (p= 0.03) in group A and group B respectively.Similarly better improvement in vitamin D and HbA1c level was seen with respect to aged group30-50 years and duration of diabetes less than 5 years. Conclusion: Vitamin D is deficient in ourpopulation and its supplementation not only improves its own level but also glycemic control intype 2 diabetic patients.

English

Background: The data among vitamin D supplementation on glycemic control isvariable and contradictory in various clinical studies. Objectives: To determine the efficacy of vitD supplementation on glycemic control in type 2 diabetic patients. Study Design: Case controlstudy. Setting: Private Clinical Set up of District, Rahim Yar Khan. Period: August to October2016. Patients and methods: 100 cases of type 2 diabetes were randomly divided into groupA and group B each contained 50 patients .The cases in group A were treated with vitamin D3at the dose of 50,000 units per week orally while cases in group B were treated with placeboalong with the standard doses of anti-diabetic drugs. The value of HbA1c and Vit D wereassayed pre and post treatment by high performance liquid chromatography. Results: Therewas significant post treatment changes observed in vitamin D level in group A vs group B inmales 20.46±2.45 vs 15.16±1.47 (p= 0.001) and females 18.32±1.44 vs 13.95±2.48 (p= 0.09)There was significant post treatment changes in HbA1c in males 6.65±0.12 vs 8.34±0.71 (p=0.01) and in females 6.81±0.43 vs 8.04±0.71 (p= 0.03) in group A and group B respectively.Similarly better improvement in vitamin D and HbA1c level was seen with respect to aged group30-50 years and duration of diabetes less than 5 years. Conclusion: Vitamin D is deficient in ourpopulation and its supplementation not only improves its own level but also glycemic control intype 2 diabetic patients.

Histopathologic review of 400 biopsies and resection specimens of trunk and extremity-based soft tissue tumors

To review various pathologic parameters in diagnosed cases of trunk and extremity-based soft tissue tumors (STTs), in order to identify concordance rate between initial biopsy and resection specimen and discrepancies between initial and review diagnosis, by a specialist pathologist. Over a 2-year-period, 400 retrospectively diagnosed STTs (553 specimens) including referral and "in-house" cases were studied. The reviewing specialist pathologist was blinded to the initial diagnoses. Discordances including discrepancies and deficiencies were defined as major and minor. Major discrepancies included those that could lead to significant treatment changes. True discrepancies were those related to sampling issues between the biopsies and resection specimens. Deficiencies relating to tumor subtyping, sarcoma grading, documentation of tumor size, and marginal status (in resections) were subdivided as major and minor. Most cases (328, 82%) were sarcomas (most common, synovial sarcoma; most common Stage, III), followed by benign tumors (36, 9%) (most common, schwannoma) and intermediate malignancies (32, 8%) (most common, fibromatosis). Within STTs, liposarcomas, neural tumors, and undifferentiated pleomorphic sarcomas were relatively more frequently associated with discrepancies. Percentage of cases with major discordances between the referral reports (100 cases) and review diagnosis was 60%. Percentage of cases with major discordances between the specialist and other oncopathologists was 11%. True discrepancies were observed in 20 (5%) cases. The association of type of specimen with the rate of discordance was not significant (P = 0.114). Diagnoses of STTs are fraught with errors mostly from general pathologists, followed by nonspecialist oncopathologists. These findings reinforce the need for reporting of STTs, especially sarcomas, by specialist pathologists.

Comparative evaluation of soft tissue changes one year post-treatment in Twin Block and FORSUS FRD treated patients

BackgroundThe objective of this study was to compare and evaluate the effects of two functional treatment modalities, namely, Twin Block (TB) and FORSUS fatigue resistant device (FORSUS FRD) on facial soft tissues before and at one-year post-treatment. MethodsThis was a retrospective cephalometric study involving 10 patients with skeletal class II abnormalities in each group. The mean age of patients was 12.5±1.5 and 13.5±1 years and treatment duration 20±2 and 18±2 months, respectively for TB and FORSUS FRD groups, respectively. The pre-treatment (T0) and one-year post-treatment cephalograms (T1) were compared for evaluation. Data were analysed using a paired t-test and independent sample t-test for within-group and between-group comparisons, respectively. ResultsThe groups were compared at T0 and T1, and treatment/observation differences (T1−T0) were evaluated with paired samples t-test at P<0.05 level and unpaired sample t-test for group comparison. Statistically significant treatment changes were found for soft tissue changes in both TB and FORSUS FRD groups. Between the two groups, TB showed significant increase in the LAFH compared to the FORSUS FRD group. ConclusionStatistically significant soft tissue changes were observed after TB and FORSUS FRD appliance therapy, resulting in improvement of facial balance and aesthetics. Both, TB and FORSUS FRD, have similar effects on soft tissues, but the effect of TB on LAFH and that of FORSUS on mentolabial sulcus was more profound.

Predictors of treatment attrition and treatment length in Parent‐Child Interaction Therapy in Taiwanese families

Parent–Child Interaction Therapy (PCIT) has been used successfully in the United States and in other countries around the world, but its use in Asian countries has been more limited. The present study is the first of its kind to examine the predictors of treatment attrition and length in a sample of Taiwanese caregivers and their children. It is also the first to examine PCIT outcomes in Taiwanese families. Maladaptive personality characteristics of the caregiver were the best predictor of attrition, followed by single-parent, removal of the child from the home, and lower levels of caregiver education. Treatment length was predicted by child minority status and parent–child interactions (i.e., parent commands and negative parent talk). In terms of outcomes, statistically significant treatment changes were noted for all treatment outcome variables at post-treatment and at 3-month follow-up. These findings suggest that PCIT is a promising intervention for this population. The predictors of treatment attrition and length can be used when Taiwanese caregiver–child dyads present for services so that additional assistance can be provided prior to or during treatment to increase adherence to the recommended number of treatment sessions for maximal impact. Future studies may replicate the present study with a larger clinical sample to examine the long-term effects of PCIT and to include a no-treatment control condition to afford a more robust empirical evaluation.