Routine Clinical Care Of Patients Research Articles

Impact of pharmacogenetics on statins-induced myopathy in South Indian patients in routine clinical care

Impact of pharmacogenetics on statins-induced myopathy in South Indian patients in routine clinical care

Integrating iCBT for generalized anxiety disorder into routine clinical care: Treatment effects across the adult lifespan

The burden attributable to late-life Generalized Anxiety Disorder (GAD) is set to increase alongside the ageing population. Yet, the psychogeriatric workforce is limited in size and few studies have focused on the treatment of GAD among older patients. Internet-delivered cognitive behavioral therapy (iCBT) could be integrated into existing infrastructure and scale the psychogeriatric workforce, if shown to be effective across the adult lifespan. This study examined age-related differences in presentation, adherence and effects of iCBT for GAD among patients in routine clinical care (N=942; 18–29years (n=267); 30–39years (n=260); 40–49years (n=180); 50–59years (n=124); and 60+ years (n=111)). Compared to younger patients, older patients were less likely to present with probable GAD and MDD diagnoses (<60years vs. 60+ years) and more likely to complete treatment (<50years vs. 50+ years). iCBT produced moderate to large effect size reductions in symptom severity, distress and impairment independent of age. iCBT is therefore an effective treatment for GAD across the adult lifespan, which can be delivered in routine clinical care. Continuing to integrate iCBT into existing services has the potential to improve the capacity of the existing workforce to manage those seeking help for GAD particularly as the population ages.

Comparison of Surgeon and Therapist Shoulder Motion Measurements to Motion Capture Measurements

There is no financial information to disclose. During office visits, joint ranges of motion are often measured by surgeons using a visual estimate or therapists using a goniometer. This study aimed to assess the accuracy of these measures, and the hypotheses were: (1) poor agreement and (2) poor precision between humerothoracic external rotation (HTER) and glenohumeral cross-body adduction (GHCBA) when measured by a surgeon’s clinical estimate, an occupational therapist’s goniometer, and a motion capture system’s measurements in children with brachial plexus birth palsy (BPBP), and (3) poor correlation between HTER measured by motion capture and external rotation (ER) Mallet classification score. Twenty-six children (9.9±3.2 years) with BPBP participated in this study. A pediatric hand surgeon visually estimated each child’s passive HTER and passive GHCBA during the patient’s clinical visit. An occupational therapist measured the same parameters using a goniometer while motion capture (Vicon, Oxford, UK) measurements of thorax, scapula, and humerus orientations were simultaneously collected. One-way ANOVAs were completed to test for differences between measurement techniques, Bland-Altman plots were created to look at precision and agreement across measurements, and Spearman rho correlation was used exam the relationship between motion capture and Mallet Scale scores. Comparison of clinical estimates, goniometer measurements and motion capture measurements demonstrated no significant differences (P = 0.751) for GHCBA, while all HTER measures were significantly different from each other (P < 0.02). The GHCBA comparisons exhibited good accuracy with the Bland-Altman plots with the mean difference near zero, but poor precision with a minimum of 20° deviations from neutral (Fig. 73-1). For HTER, there was poor precision and accuracy (Fig. 73-1). Considering precision using motion capture as the gold standard, both goniometer measurements and clinical estimates overestimated HTER by 9° and 24° respectively (mean differences). There was also poor accuracy, with the smallest 95% CI across all comparisons being + 24°. External rotation position Mallet scores correlated with surgeon estimates of HTER (r = -0.43, P = 0.02), but not motion capture (r = -0.24, P = 0.229). •Compared to the gold standard motion capture measurements, the surgeon’s clinical estimates and occupational therapist’s goniometer measurements had both poor precision and accuracy for HTER and poor precision for GHCBA.•Surgeon-estimated HTER and Mallet ER scores were poorly correlated, which calls into questions the accuracy of Mallet score measurements.•Motion capture is an important tool with improved accuracy and precision of shoulder motion measurements and should be considered for routine clinical care for patients with BPBP.

BRCA1/2 reversion mutations revealed in breast and gynecologic cancers sequenced during routine clinical care using tissue or liquid biopsy.

5551 Background: Tumors with genomic alteration (GA) of BRCA1 or BRCA2 ( BRCA) may be more sensitive to platinum (Pt) therapies and PARP inhibitors (PARPi). However, secondary reversion mutations (revGA) can arise that may restore BRCA function and underlie reduced sensitivity to Pt compounds or PARPi. Methods: DNA extracted from FFPE tumor tissue or blood samples obtained during routine clinical care for patients with predominantly relapsed, refractory or metastatic breast cancer (10967) or ovarian/peritoneal cancer (8352) was analyzed by hybrid-capture, next-generation sequencing for all classes of GA: base substitutions, indels, rearrangements, and copy number changes. RevGA were any GA that could restore the reading frame if in cis with a nonsense or frameshift (fs) GA. Results: 1900/19329 (9.8% ± 0.4%) tumors had ≥1 deleterious BRCA GA. 38 samples harbored potential revGA in BRCA1 (16) or BRCA2 (22): breast carcinoma (Ca) (21), ovarian or peritoneal serous Ca (10), ovarian or peritoneal adenocarcinoma (3), and ovarian epithelial Ca NOS (4). 35/38 sequenced samples were metastases. All potential revGA were somatic and fell into 3 classes: overlapping indel (21), compensatory fs (6), and missense mutation (11). One case harbored both an overlapping indel and a missense mutation with potential to revert a nonsense alteration. For 6 patients, testing of multiple tissue samples reveals the acquisition of revGA over time. RevGA are generally observed at allele frequencies lower than the deleterious GA they may revert. Clinical histories for patients with reversion mutations will be presented. Conclusions: Genomic profiling of breast and gynecological carcinomas, using either tissue or liquid biopsies, reveals potential revGA that may restore some level of BRCA function. RevGA, although rare, can be acquired during the course of treatment. We identified potentially compensatory missense, fs and indel mutations with CGP. Comparison of allele frequencies suggests that revGA often arise as subclones. The acquisition of a revGA over time can be observed through testing of multiple samples, either tissue or liquid biopsy.

Using a smartphone app to reduce cognitive vulnerability and mild depressive symptoms: Study protocol of an exploratory randomized controlled trial.

BackgroundDepression is a major challenge worldwide, with significant increasing personal, economic, and societal costs. Although empirically supported treatments have been developed, they are not always available for patients in routine clinical care. Therefore, we need effective and widely accessible strategies to prevent the onset of the very first depressive symptoms. Mental health apps could prove a valuable solution for this desideratum. Although preliminary research has indicated that such apps can be useful in treating depression, no study has attempted to test their utility in preventing depressive symptoms. The aim of this exploratory study is to contrast the efficacy of a smartphone app in reducing cognitive vulnerability and mild depressive symptoms, as risk factors for the onset of depression, against a wait-list condition. More specifically, we aim to test an app designed to (1) decrease general cognitive vulnerability and (2) promote engagement in protective, adaptive activities, while (3) counteracting (through gamification and customization) the tendency of premature dropout from intervention.Methods/designRomanian-speaking adults (18 years and older) with access to a computer and the Internet and who own a smartphone are included in the study. Two parallel randomized clinical trials are conducted: in the first one, 50 participants free of depressive symptoms (i.e., who obtain scores ≤4 on the Patient Health Questionnaire, PHQ-9) will be included, while in the second one 50 participants with minimal depressive symptoms (i.e., who obtain PHQ-9 scores between 5 and 9) will be included. Participants undergoing therapy, presenting with substance abuse problems, psychotic symptoms, and organic brain disorders, or serious legal or health issues that would prevent them from using the app, as well as participants reporting suicidal ideation are excluded. Participants randomized to the active intervention will autonomously use the smartphone app for 4 weeks, while the others will be given access to the app after 4 weeks from randomization. The primary outcomes are (1) cognitive vulnerability factors as defined within the cognitive behavioral therapy (CBT) paradigm (i.e., dysfunctional cognitions, irrational beliefs, and negative automatic thoughts) (for the first trial), and (2) level of depressive symptomatology (for the second trial). The app includes self-help materials and exercises based on CBT for depression, presented in a tailored manner and incorporating gamification elements aimed at boosting motivation to use the app.DiscussionThis study protocol is the first to capitalize on the ubiquity of smartphones to large-scale dissemination of CBT-based strategies aimed at preventing depression in non-clinical populations.Trial registrationClinicalTrials.gov: NCT02783118. Registered on 26 May 2016.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1740-3) contains supplementary material, which is available to authorized users.

A Randomized Controlled Trial Protocol to Evaluate the Effectiveness of an Integrated Care Management Approach to Improve Adherence Among HIV-Infected Patients in Routine Clinical Care: Rationale and Design.

BackgroundAdherence to antiretroviral medications is a key determinant of clinical outcomes. Many adherence intervention trials investigated the effects of time-intensive or costly interventions that are not feasible in most clinical care settings.ObjectiveWe set out to evaluate a collaborative care approach as a feasible intervention applicable to patients in clinical care including those with mental illness and/or substance use issues.MethodsWe developed a randomized controlled trial (RCT) investigating an integrated, clinic-based care management approach to improve clinical outcomes that could be integrated into the clinical care setting. This is based on the routine integration and systematic follow-up of a clinical assessment of patient-reported outcomes targeting adherence, depression, and substance use, and adapts previously developed and tested care management approaches. The primary health coach or care management role is provided by clinic case managers allowing the intervention to be generalized to other human immunodeficiency virus (HIV) clinics that have case managers. We used a stepped-care approach to target interventions to those at greatest need who are most likely to benefit rather than to everyone to maintain feasibility in a busy clinical care setting.ResultsThe National Institutes of Health funded this study and had no role in study design, data collection, or decisions regarding whether or not to submit manuscripts for publication. This trial is currently underway, enrollment was completed in 2015, and follow-up time still accruing. First results are expected to be ready for publication in early 2017.DiscussionThis paper describes the protocol for an ongoing clinical trial including the design and the rationale for key methodological decisions. There is a need to identify best practices for implementing evidence-based collaborative care models that are effective and feasible in clinical care. Adherence efficacy trials have not led to sufficient improvements, and there remains little guidance regarding how adherence interventions should be implemented into clinical care. By focusing on improving adherence within care settings using existing staff, routine assessment of key domains, such as depression, adherence, and substance use, and feasible interventions, we propose to evaluate this innovative way to improve clinical outcomes.Trial Registration Clinicaltrials.gov NCT01505660; http://clinicaltrials.gov/ct2/show/NCT01505660 (Archived by WebCite at http://www.webcitation/ 6ktOq6Xj7)

High GDF-15 Serum Levels Independently Correlate with Poorer Overall Survival of Patients with Tumor-Free Stage III and Unresectable Stage IV Melanoma

Biomarkers are strongly needed for diagnostic surveillance of patients with metastatic melanoma. On the basis of its known association with tumor metastasis and its ability to induce cancer cachexia, we investigated serum levels of growth and differentiation factor 15 (sGDF-15) as a marker for overall survival (OS). sGDF-15 was retrospectively measured by ELISA in 761 samples obtained at distinct time points during routine clinical care of patients with stage III/IV melanoma. In the entire cohort, sGDF-15 ≥ 1.5 ng/ml was strongly associated with reduced OS after assessment. Subsequent analyses were performed separately for tumor-free stage III, tumor-free stage IV, and unresectable stage IV patients. For patients with unresectable distant metastasis (n= 206), sGDF-15 was independently associated with OS when considered together with the M-category and superior to serum level of lactate dehydrogenase. Analysis in tumor-free stage III patients during routine surveillance (n=468) revealed sGDF-15 to be associated with OS and an independent factor when considered together with S100B and the pattern of locoregional metastasis. Only in tumor-free stage IV patients (n= 87) sGDF-15 was not associated with OS. sGDF-15 should thus be further validated as a marker for early detection of recurrence in stage III patients and as a prognostic or predictive marker particularly in the context newly available treatments in unresectable stage IV patients.

Feasibility and Acceptability of Implementing Indirect Calorimetry Into Routine Clinical Care of Patients With Spinal Cord Injury.

Background: In the absence of reliable predictive equations, indirect calorimetry (IC) remains the gold standard for assessing energy requirements after spinal cord injury (SCI), but it is typically confined to a research setting. The purpose of this study is to assess the feasibility and acceptability of implementing IC into routine clinical care in an Australian SCI rehabilitation facility. Methods: Bedside IC (canopy hood) was performed, and patients completed an IC acceptability questionnaire (open-ended; yes/no; 5-point Likert scale). Fasted resting energy expenditure (REE) steady-state criteria were applied to assess data quality, and adherence to a test ≥20 minutes was recorded. Staff were surveyed to assess impact of IC on usual care. Results: Of 35 eligible patients, 9 declined (7 reported claustrophobia). One patient could not be tested before discharge and 25 underwent IC (84% male, injury level C2-L2, AIS A-D). Anxiety prevented one patient from completing IC, while another failed to fast. The remaining 23 patients achieved a steady-state REE (≥5 consecutive minutes with ≤10% coefficient of variation for VO2 and VCO2). Test-retest (n = 5) showed <10% variation in REE. Patients deemed the procedure acceptable, with 88% reporting a willingness to repeat IC. Eighty percent of patients and 90% of staff agreed it was acceptable for IC to be integrated into usual care. Conclusion: This study found that IC is a feasible and acceptable addition to the routine clinical care of patients recovering from SCI and may serve to improve accuracy of nutrition interventions for this patient population.

An observational study of inhaled-treprostinil respiratory-related safety in patients with pulmonary arterial hypertension.

Inhaled treprostinil (Tyvaso) has been shown to be a safe and effective addition to pulmonary arterial hypertension (PAH) oral therapies; however, the respiratory-related safety profile of inhaled treprostinil required further elucidation in the setting of routine clinical care. The objectives of this study were to characterize respiratory-related adverse events (AEs) associated with current or recent treatment with inhaled treprostinil and to compare the incidence of respiratory-related AEs in PAH patients treated with inhaled treprostinil with that in patients treated with other Food and Drug Administration (FDA)-approved PAH therapies. This was a long-term, prospective, observational study. All respiratory-related AEs were recorded during the study. The number of PAH patients enrolled was 1,333, 666 treated with inhaled treprostinil and 667 controls (treated with an FDA-approved PAH therapy other than inhaled treprostinil), for a total of 958 and 1,094 patient-years of exposure, respectively. In the inhaled-treprostinil group, 1,281 respiratory-related AEs were reported in 403 patients (61%), and in the control group, 1,295 respiratory-related AEs were reported in 388 patients (58%). Cough, throat irritation, nasal discomfort, and hemoptysis were the most common respiratory-related AEs (occurring in ≥2% of patients in either treatment group) that demonstrated a higher number of events per patient-year of exposure in the inhaled-treprostinil group than in the control group (risk ratio [95% confidence interval]: 1.487 [1.172-1.887], 3.777 [2.050-6.956], 2.039 [1.072-3.879], and 1.957 [1.024-3.741], respectively). Overall, inhaled treprostinil was well tolerated by PAH patients in routine clinical care, with respiratory-related AEs consistent with the known safety profile (trial registration: clinicaltrials.gov identifier: NCT01266265).

Performance of the GRACE Risk Score 2.0 Simplified Algorithm for Predicting 1-Year Death After Hospitalization for an Acute Coronary Syndrome in a Contemporary Multiracial Cohort

The GRACE Risk Score is a well-validated tool for estimating short- and long-term risk in acute coronary syndrome (ACS). GRACE Risk Score 2.0 substitutes several variables that may be unavailable to clinicians and, thus, limit use of the GRACE Risk Score. GRACE Risk Score 2.0 performed well in the original GRACE cohort. We sought to validate its performance in a contemporary multiracial ACS cohort, in particular in black patients with ACS. We evaluated the performance of the GRACE Risk Score 2.0 simplified algorithm for predicting 1-year mortality in 2,131 participants in Transitions, Risks, and Actions in Coronary Events Center for Outcomes Research and Education (TRACE-CORE), a multiracial cohort of patients discharged alive after an ACS in 2011 to 2013 from 6 hospitals in Massachusetts and Georgia. The median age of study participants was 61years, 67% were men, and 16% were black. Half (51%) of the patients experienced a non-ST-segment elevation myocardial infarction (NSTEMI) and 18% STEMI. Eighty patients (3.8%) died within 12months of discharge. The GRACE Risk Score 2.0 simplified algorithm demonstrated excellent model discrimination for predicting 1-year mortality after hospital discharge in the TRACE-CORE cohort (c-index= 0.77). The c-index was 0.94 in patients with STEMI, 0.78 in those with NSTEMI, and 0.87 in black patients with ACS. In conclusion, the GRACE Risk Score 2.0 simplified algorithm for predicting 1-year mortality exhibited excellent model discrimination across the spectrum of ACS types and racial/ethnic subgroups and, thus, may be a helpful tool to guide routine clinical care for patients with ACS.

Clinical Use of Expanded Prostate Cancer Index Composite for Clinical Practice to Assess Patient Reported Prostate Cancer Quality of Life Following Robot-Assisted Radical Prostatectomy

EPIC-CP (Expanded Prostate Cancer Index Composite for Clinical Practice) is a short questionnaire that comprehensively measures patient reported health related quality of life at the point of care. We evaluated the feasibility of using EPIC-CP in the routine clinical care of patients with prostate cancer without research infrastructure. We compared longitudinal patient and practitioner reported prostate cancer outcomes. We reviewed health related quality of life outcomes in 482 patients who underwent radical prostatectomy at our institution from 2010 to 2014. EPIC-CP was administered and interpreted in routine clinical practice without research personnel. We compared practitioner documented rates of incontinence pad use and functional erections to patient reported rates using EPIC-CP. A total of 708 EPIC-CP questionnaires were completed. Mean urinary incontinence domain scores were significantly higher (worse) than baseline (mean ± SD 0.6 ± 0.2) 3 and 6 months after treatment (mean 3.1 ± 2.3 and 2.2 ± 2.1, respectively, each p <0.05) but they returned to baseline at 12 months (mean 1.6 ± 1.7, p >0.05). Mean sexual domain scores were significantly worse than baseline (mean 2.4 ± 2.8) at all posttreatment time points (each p <0.05). Practitioners significantly overestimated incontinence pad-free rates at 3 months (48% vs 39%) and functional erection rates at 3 months (18% vs 12%), 6 months (38% vs 23%) and 12 months (45% vs 23%, each p <0.05). EPIC-CP is feasible to use in the routine clinical care of patients with prostate cancer without requiring a research infrastructure. Using EPIC-CP in clinical practice may help practitioners objectively assess and appropriately manage posttreatment side effects in patients with prostate cancer.

Regional Differences in the Care of Patients with Neovascular Age-Related Macular Degeneration, Based on the Non-Interventional OCEAN Study

Background: The main cause of blindness in the elderly in Germany is neovascular age-related macular degeneration (nAMD). In the non-interventional OCEAN study, data were prospectively collected on the routine clinical care of patients treated with the drug ranibizumab. Patients: As part of an interim analysis within the ongoing study (NCT02194803), stratification was performed by the 17 regions of the German associations of panel physicians and by areas of different population density. Only data were analysed for patients for whom the first treatment with ranibizumab was documented. Results: A total of 5,606 patients were documented. The present manuscript reviews 2,658 treatment-naive patients with nAMD, documented by 324 ophthalmologists. Most patients receiving an intravitreal injection were female (60 %). The average patient was aged 77.7 ± 8.2 years at study start. The great majority of patients had statutory health insurance (91 %). At baseline, fluorescein angiography (FLA) was performed for 72 % of patients, while optical coherence tomography (OCT) was carried out for 76 %. A combination of both was performed for 54 % of patients, varying regionally from 26 % (Saxony-Anhalt) to 100 % (Berlin). The average waiting time between the first examination and the first injection was 20.0 ± 18.5 days. With different statistical models (ANOVA adjusted, with/without interactions), significant effects on treatment delay were found for district type (population density), federal state and type of specialist. Conclusion: No major regional differences were observed in the demographic characteristics of the patient population. The main regional disparities in the care of nAMD patients were in the application of diagnostic methods and the waiting times between the first examination and the first drug administration. The regional variations in treatment delays could clearly influence the risk of worse functional outcome.

Imatinib Pharmacokinetics in a Large Observational Cohort of Gastrointestinal Stromal Tumour Patients.

Low trough imatinib concentration (C min) values have been associated with poor clinical outcomes in gastrointestinal stromal tumour (GIST) patients. This study describes the pharmacokinetics of imatinib in a large cohort of GIST patients in routine clinical care. An observational study was performed in imatinib-treated GIST patients. Patient and tumour characteristics were derived from the Dutch GIST Registry and medical records. Imatinib concentrations were measured by liquid chromatography with tandem mass spectrometry. The analyses included the occurrence of a low imatinib C min (<1000µg/L), the change in the C min over time and the correlation between exposure and response. In total, 421 plasma samples were available from 108 GIST patients. Most patients (79.6%) received an imatinib dose of 400mg. The inter- and intrapatient variabilities in C min were 54 and 23%, respectively. In the first steady-state sample, 44.4% of patients presented with C min values<1000µg/L; 32.4% of patients had values<1000µg/L in >75% of their samples. Only 33.3% of patients had C min values ≥1000µg/L in all measured samples. No decrease in C min over time was found (P>0.05). Fifty-seven (91.9%) of 62 palliative-treated patients had a tumour response (median C min 1271µg/L). Five palliative patients (8.1%) did not respond (median C min 920µg/L). Given the limited number of non-responders in this cohort, no statistically significant association with clinical benefit could be demonstrated. In routine clinical care, one third of GIST patients are systematically underexposed with a fixed dose of imatinib. Prospective clinical studies are needed to investigate the value of C min-guided imatinib dosing in GIST patients.

Semiquantitative slab view display for visual evaluation of 123I-FP-CIT SPECT.

Dopamine transporter single-photon emission computed tomography (SPECT) with I-FP-CIT is used widely in the diagnosis of clinically uncertain parkinsonian syndromes. In terms of the evaluation of FP-CIT SPECT, some practice guidelines state that visual interpretation alone is generally sufficient in clinical patient care, whereas other guidelines consider semiquantitative analysis of striatal dopamine transporter availability mandatory. This discrepancy might be because of a relative lack of widely available display tools for FP-CIT SPECT. In this study, we evaluate a semiquantitative slab view display optimized for visual evaluation of FP-CIT SPECT that might resolve the discrepancy. The reconstructed FP-CIT SPECT image was stereotactically normalized and scaled voxel by voxel to the mean uptake in the entire brain without striata. From the resulting distribution volume ratio image, a 12-mm-thick transversal slice (slab) through the striata was displayed with a standard colour table with predefined fixed thresholds on the distribution volume ratio. Visual scoring of the semiquantitative slab view was performed twice by four independent readers in 235 unselected patients. The specific binding ratio in the caudate and putamen was computed by fully automated semiquantitative analysis with predefined standard regions of interest in template space. Intrarater and inter-rater agreement of binary visual categorization as 'normal' or 'reduced' was excellent (mean Cohen's κ=0.88 and 0.83, respectively). The area under the receiver-operator characteristic curve of the specific putamen-binding ratio for differentiation between visually normal and visually reduced (majority read) was 0.96. Visual interpretation of FP-CIT SPECT on the basis of the semiquantitative slab view display provides excellent stability within and between readers as well as very high agreement with semiquantitative analysis. This suggests that the slab view display enables reliable visual interpretation of FP-CIT SPECT in clinical routine patient care.

Comportment and Communication Patterns among Hospitalist Physicians: Insight Gleaned Through Observation.

By 2014, there were more than 40,000 hospitalists delivering the majority of inpatient care in US hospitals. No empiric research has characterized hospitalist comportment and communication patterns as they care for patients. The chiefs of hospital medicine at five different hospitals were asked to identify their best hospitalists. These hospitalists were watched during their routine clinical care of patients. An observation tool was developed that focused on elements believed to be associated with excellent comportment and communication. One observer watched the physicians, taking detailed quantitative and qualitative field notes. A total of 26 hospitalists were shadowed. The mean age of the physicians was 38 years, and their average experience in hospital medicine was 6 years. The hospitalists were observed for a mean of 5 hours, during which time they saw an average of 7 patients (patient encounters observed N = 181). Physicians spent an average of 11 minutes with each patient. There was large variation in the extent to which desirable behaviors were performed. For example, most physicians (76%) started encounters with an open-ended question, and relatively few (30%) attempted to integrate nonmedical content into conversation with patients. This study represents a first step in trying to characterize comportment and communication in hospital medicine. Because hospitalists spend only a small proportion of their clinical time in direct patient care, it is imperative that excellent comportment and communication are clearly defined and established as a goal for every encounter.

Body composition analysis using abdominal scans from routine clinical care in patients with Crohn’s Disease

Objective: Crohn’s Disease is associated with body composition changes, which have important treatment and prognostic implications. Measurement of body composition usually requires dedicated scanning or measurement, with retrospective analysis of existing datasets impossible. We sought to determine whether single slice analysis of abdominal scans, obtained during routine clinical care, in patients with Crohn’s Disease accurately predicts body composition compartments.Materials and methods: Abdominal CT images of patients with Crohn’s disease were analyzed and comparison was made with total body fat-free mass, total body fat mass, femoral neck t-score, and other parameters reported from DXA, the reference method.Results: Thirty-seven subjects were identified, 15 male and 22 female, with a mean age of 43.8 years. There was significant correlation (Pearson r = 0.923, p < 0.001) between skeletal muscle area from CT and total fat-free mass measured by DXA. Similarly, total body fat mass correlated strongly (r = 0.928, p < 0.0001) with subcutaneous fat area. In this cohort of ambulatory Crohn’s Disease patients, low muscle mass/sarcopenia was prevalent and predictive of lower bone mineral density.Conclusions: Fat mass, fat-free mass, and appendicular skeletal muscle index can be predicted by analysis of a single CT slice in patients with Crohn’s Disease. Similar to published data from healthy subjects, the L3 vertebral body level provided the most robust correlation with most parameters. This study represents the first published use of routinely obtained abdominal imaging to demonstrate this relationship – and to predict body composition components – in patients with inflammatory bowel disease.

Guidelines of the Indian Association of Cardiovascular and Thoracic Anaesthesiologists and Indian College of Cardiac Anaesthesia for perioperative transesophageal echocardiography fellowship examination.

During current medical care, perioperative transesophageal echocardiography (TEE) has become a vital component of patient management, especially in cardiac operating rooms and in critical care medicine. Information derived from echocardiography has an important bearing on the patient's outcome. The Indian Association of Cardiovascular and Thoracic Anaesthesiologists (IACTA) has promoted the use of TEE during routine clinical care of patients undergoing cardiac surgery. An important mission of IACTA is to oversee training and certify anesthesiologists in the perioperative and intensive care use of TEE. The provision of “Fellowship” is by way of conducting IACTA – TEE fellowship (F-TEE) examination. This has been done annually for the past 7 years using well-established curriculums by accredited national and international societies. Now, with the transformation and reconstitution of IACTA education and research cell into the newly formed Indian College of Cardiac Anaesthesia, F-TEE is bound to meet international standards. To ensure that the examinations are conducted in a transparent and foolproof manner, the guideline committee (formulated in 2010) of IACTA has taken the onus of formulating the guidelines for the same. These guidelines have been formally reviewed and updated since 2010 and are detailed here to serve as a guide to both the examinee and examiner ensuring standardization, efficiency, and competency of the IACTA F-TEE certification process.

Statistical Analysis of Adult HIV/AIDS Patients and Modelling of AIDS Disease Progression

This study has been intended to apply the cox proportional hazard model to review the determinant factors of survival time and discrete time homogeneous semi markov model to predict the clinical progression of AIDS disease by secondary data obtained from the antiretroviral therapy unit of Dilla and Hawassa University Referral Hospitals. Patients were followed for a median of 34 months. Of total sample, 517 (68.4%) were female and 239 (31.6%) were male. In the followed up period, 110 (14.5%) patients died and 646 (85.5%) patients were censored. The cox regression result indicated that the survival time of the HIV patient was significantly connected with adherence level, age, alcohol use, CD4, condom use, functional status, marital status and WHO stage. The outcome of homogenous semi-markov model showed that the survival probability of a patient increased when CD4 count increased. The study is suggested that the above significant variables should be viewed as significant component of the routine clinical care for patients on ART and patients require checking CD4 count in the suitable day as physician arrange to know their disease stage.

Metabolic control after years of completing a clinical trial on sensor-augmented pump therapy

BackgroundSensor-augmented pump (SAP) therapy has been shown to be effective and safe for improving metabolic control in patients with type 1 diabetes mellitus (T1DM) in a number of trials. Our objective was to assess glycemic control in a group of T1DM patients on insulin pump or SAP therapy after years of participating in the SWITCH (Sensing With Insulin pump Therapy To Control HbA1c) trial and their return to routine medical monitoring. MethodsA retrospective, observational study of 20 patients who participated in the SWITCH trial at our hospital from 2008 to 2010. HbA1c values were compared at the start, during (at the end of the periods with/without SAP use – Sensor On/Sensor Off period respectively – of the cross-over design), and 3 years after study completion. HbA1c values of patients who continued SAP therapy (n=6) or only used insulin pump (n=14) were also compared. ResultsTwenty patients with T1DM (44.4±9.3 years, 60% women, baseline HbA1c level 8.43±0.55%) were enrolled into the SWITCH study). Three years after study completion, HbA1c level was 7.79±0.77 in patients on pump alone, with no significant change from the value at the end of the Off period of the study (7.85±0.57%; p=0.961). As compared to the end of the On period, HbA1c worsened less in patients who remained on SAP than in those on pump alone (0.18±0.42 vs. 0.55±0.71%; p=0.171), despite the fact that levels were similar at study start (8.41±0.60 vs. 8.47±0.45; p=0.831) and at the end of the On period (7.24±0.48 vs. 7.38±0.61; p=0.566). Frequency of CGM use in patients who continued SAP therapy was high (61.2% of the time in the last 3 months). ConclusionsOur study suggests that the additional benefit of SAP therapy achieved in a clinical trial may persist in the long term in routine clinical care of patients with T1DM.

The validity of self-rating depression scales in patients with chronic widespread pain: a Rasch analysis of the Major Depression Inventory

Background: Assessment of depression in chronic pain patients by self-rating questionnaires developed and validated for use in normal and/or psychiatric populations is common. The aim of this study was to evaluate the psychometric properties of the Major Depression Inventory (MDI) in a sample of females with chronic widespread pain (CWP).Method: A total of 263 females diagnosed with CWP and referred for rehabilitation completed the MDI as part of the baseline evaluation. Rasch analysis was applied to this dataset. Rasch measurement models allow detailed analyses of an instrument’s rating scale and further aspects of validity, including fit of individual scale items to a unidimensional model indicating assessment of a single construct (depression), as a prerequisite for measurement.Results: The Rasch analysis revealed substantial problems with the rating scale properties of the MDI and lack of unidimensionality. In contrast to somatic items, MDI items related to depressed mood and negative view of oneself were distributed at the higher end of the item difficulty measurement scale, indicating low endorsement of these items.Discussion: From the perspective of the Rasch measurement model, the MDI demonstrated insufficient psychometric properties when used to identify and quantify severity of depression in a clinical sample of females with CWP. The observed item endorsement pattern indicated that, in this study population, the relatively high depression severity scores primarily pertained to a common core of pain-related somatic symptoms. Careful consideration when interpreting questionnaire-derived scores of depression implemented in research and routine clinical care of patients with chronic pain is warranted.