The application of radiomics in laryngeal cancer.

OBJECTIVES: Radiomics is the conversion of medical images into quantitative high-dimensional data. Laryngeal cancer, one of the most common head and neck cancers, has risen globally by 58.7%. CT, MRI and PET are acquired during the diagnostic process providing potential data for radiomic analysis and correlation with outcomes.This review aims to examine the applications of this technique to laryngeal cancer and the future considerations for translation into clinical practice. METHODS: A comprehensive systematic review-informed search of the MEDLINE and EMBASE databases was undertaken. Keywords "laryngeal cancer" OR "larynx" OR "larynx cancer" OR "head and neck cancer" were combined with "radiomic" OR "signature" OR "machine learning" OR "artificial intelligence". Additional articles were obtained from bibliographies using the "snowball method". RESULTS: The included studies (n = 15) demonstrated that radiomic features are significantly associated with various clinical outcomes (including stage, overall survival, treatment response, progression-free survival) and that predictive models incorporating radiomic features are superior to those that do not. Two studies demonstrated radiomics could improve laryngeal cancer staging whilst 12 studies affirmed its predictive capability for clinical outcomes. CONCLUSIONS: Radiomics has potential for improving multiple aspects of laryngeal cancer care; however, the heterogeneous cohorts and lack of data on laryngeal cancer exclusively inhibits firm conclusions. Large prospective well-designed studies in laryngeal cancer are required to progress this field. Furthermore, to implement radiomics into clinical practice, a unified research effort is required to standardise radiomics practice. ADVANCES IN KNOWLEDGE: This review has highlighted the value of radiomics in enhancing laryngeal cancer care (including staging, prognosis and predicting treatment response).

Early Pregnancy Hemoglobin A1C and Pregnancy Outcomes: A Population-Based Study.

OBJECTIVE: Women with prediabetes are identified from screening for overt diabetes in early pregnancy, but the clinical significance of prediabetes in pregnancy is unclear. We examined whether prediabetes in early pregnancy was associated with risks of adverse outcomes. STUDY DESIGN: We conducted a retrospective cohort study of pregnant women enrolled in Kaiser Permanente Washington from 2011 to 2014. Early pregnancy hemoglobin A1C (A1C) values, covariates, and outcomes were ascertained from electronic medical records and state birth certificates. Women with prediabetes (A1C of 5.7-6.4%) were compared with those with normal A1C levels (<5.7%) for risk of gestational diabetes mellitus (GDM) and other outcomes including preeclampsia, primary cesarean delivery, induction of labor, large/small for gestational age, preterm birth, and macrosomia. We used modified Poisson's regression to calculate adjusted relative risks (RRs) and 95% confidence intervals (CIs). RESULTS: Of 7,020 women, 239 (3.4%) had prediabetes. GDM developed in 48% of prediabetic women compared with 11% of women with normal A1C levels (adjusted RR: 2.8, 95% CI: 2.4-3.3). Prediabetes was not associated with all other adverse maternal and neonatal outcomes. CONCLUSION: Prediabetes in early pregnancy is a risk factor for GDM. Future research is needed to elucidate whether early intervention may reduce this risk.

Intra- and interobserver variability in skeletal muscle measurements using computed tomography images.

PURPOSE: The progressive loss of skeletal muscle and function (known as sarcopenia) has been shown to be associated with various adverse outcome measures. Sophisticated measurements of body composition are increasingly being incorporated into research studies to stratify patients into those with or without sarcopenia, monitor treatment effects, and predict complications. A typical approach is to select axial image(s) at the mid-lumbar level and use semi-automated software to identify and quantify the skeletal muscle area. This area is then used to estimate whole-body parameters. This approach is somewhat subjective, and in this study we investigate its reproducibility, both within and between observers. MATERIALS AND METHODS: Repeated muscle measurements were performed on a cohort of 29 patients by 3 radiologists, to examine their intra- and interobserver reproducibility. RESULTS AND DISCUSSION: Mean muscle area for the cohort was 156 cm2, with a wide range (98 - 261 cm2). There was good intraobserver agreement between measurements, with a mean absolute difference between repeated measurements on the same patient of 0.98 cm2, and a measurement variability of 2.92 cm2. Much of the variability was shown to be due to the choice of a different slice when performing the repeated measurement. Averaging two slices provided a small but non-significant improvement in comparison to the single slice approach. Interobserver results showed good agreement, though there was a small bias for one observer, who measured slightly larger volumes compared to the other two. We conclude that the approach described provides reproducible skeletal muscle area measurements, and offer three specific recommendations to minimise variability.

One-Step Approach to Identifying Gestational Diabetes Mellitus: Association With Perinatal Outcomes.

OBJECTIVE: To compare perinatal outcomes before and after a clinical guideline change from a two-step to a one-step approach to screening for gestational diabetes mellitus (GDM). METHODS: We conducted a before-after cohort study of women with singleton live birth deliveries within Kaiser Permanente Washington, a mixed-model health plan in Washington state. We used Kaiser Permanente Washington electronic health data and linked birth certificates. We compared outcomes before (January 2009-March 2011) and after (April 2012-December 2014) the guideline change among women who received prenatal care from health care providers internal to Kaiser Permanente Washington (n=4,977 before, n=6,337 after). We made the same comparison among women who received prenatal care from external health care providers (not exposed to the guideline change; n=3,386 before, n=4,454 after) to control for time trends unrelated to the guideline change. Adjusted relative risks and 95% CIs were estimated using Poisson generalized estimating equations. RESULTS: After the guideline change, receipt of the one-step approach became widespread among women cared for by Kaiser Permanente Washington internal providers (87%), and use of insulin increased 3.7-fold from 1.2% to 4.4%. Among women cared for by Kaiser Permanente Washington internal providers, GDM increased from 6.9% to 11.4%, induction of labor from 25.2% to 28.6%, neonatal hypoglycemia from 1.3% to 2.0%, and outpatient nonstress testing from 134.6 to 157.0 test days per 100 women. After accounting for background trends in outcomes (based on the women cared for by external providers), the guideline change was associated with increased incidence of GDM (relative risk [RR] 1.41, 95% CI 1.17-1.69), labor induction (RR 1.20, 95% CI 1.09-1.32), neonatal hypoglycemia (RR 1.77, 95% CI 1.14-2.75), and nonstress testing (RR 1.12, 95% CI 1.02-1.24% per 100 women). There was no association with other outcomes including cesarean delivery or macrosomia. CONCLUSION: Adopting the one-step approach was associated with a 41% increase in the diagnosis of GDM without improved maternal or neonatal outcomes.

Decision aids for benign prostatic hyperplasia and prostate cancer.

OBJECTIVES: To examine the relationships among implementing decision aids (DAs) for benign prostatic hyperplasia (BPH) and prostate cancer (PRCA), and treatment rates and costs. STUDY DESIGN: A pre-post observational evaluation of a quality improvement initiative in a healthcare system in Washington state. METHODS: Men with BPH seen in urology clinics and all men diagnosed with localized PRCA were identified for an intervention period, in which urologists were instructed to order a DA for every patient with those conditions, and a historical control period. Outcomes were 6-month rates of surgery for BPH, any active treatment (hormone therapy, radiation, or surgery) for PRCA, and total healthcare costs. Results During the intervention, DAs were delivered to 22% of men with recent BPH drug treatment, 24% of men with untreated BPH, and 56% of men with PRCA. DA implementation was associated with a 32% lower rate of surgery among men with treated BPH (rate ratio [RR], 0.68; 95% CI, 0.49-0.94) and a nonsignificant 22% lower rate of surgery among men with previously untreated BPH (RR, 0.78; 95% CI, 0.50-1.22). For PRCA, DA implementation was associated with a 27% lower rate of active treatment (RR, 0.73; 95% CI, 0.57-0.93). We found no significant associations between DA implementation and costs of care for either condition. CONCLUSIONS: Implementing patient DAs was associated with lower rates of elective surgery for previously treated BPH and active treatment for localized PRCA; however, implementation of these DAs was not associated with lower costs of care.

Comparative effectiveness of bariatric surgery vs. nonsurgical treatment of type 2 diabetes among severely obese adults.

Although all weight-loss approaches may improve insulin sensitivity in type 2 diabetes, bariatric surgery is believed to be the only reliable means of achieving diabetes remission. We conducted a retrospective cohort study to compare rates of diabetes remission, relapse and all-cause mortality among severely obese individuals with diabetes who underwent bariatric surgery vs. nonsurgically treated individuals. Severely obese adults with uncontrolled or medication-controlled diabetes who underwent bariatric surgery or received usual medical care from 2005 to 2008 in three health care delivery systems in the United States were eligible. Diabetes status was identified using pharmacy, laboratory, and diagnosis information from electronic medical records. A propensity approach and exclusion criteria identified 1395 adults with diabetes who had bariatric surgery and 62,322 who did not. Most procedures were Roux-en-Y gastric bypass (72.0% laparoscopic; 8.2% open); 4.4% were gastric banding, 2.4% sleeve gastrectomy, and 13.2% were other procedures. At two years, bariatric subjects experienced significantly higher diabetes remission rates [73.7% (95% CI: 70.6, 76.5)] compared to nonsurgical subjects [6.9% (95%CI: 6.9, 7.1)]. Age, site, duration of diabetes, hemoglobin A1c level, and intensity of diabetes medication treatment were significantly associated with remission. Bariatric subjects also experienced lower relapse rates than nonsurgical subjects (adjusted HR: 0.19; 95% CI: 0.15-0.23) with no higher risk of death (adjusted HR: 0.54; 95% CI: 0.22-1.30). We conclude that bariatric surgery can effectively induce remission of diabetes among most severely obese adults, and this treatment approach appears to be superior to nonsurgical treatment in inducing diabetes remission.

A multisite study of long-term remission and relapse of type 2 diabetes mellitus following gastric bypass.

BACKGROUND: Gastric bypass has profound effects on glycemic control in adults with type 2 diabetes mellitus. The goal of this study was to examine the long-term rates and clinical predictors of diabetes remission and relapse among patients undergoing gastric bypass. METHODS: We conducted a retrospective cohort study of adults with uncontrolled or medication-controlled type 2 diabetes who underwent gastric bypass from 1995 to 2008 in three integrated health care delivery systems in the USA. Remission and relapse events were defined by diabetes medication use and clinical laboratory measures of glycemic control. We identified 4,434 adults with uncontrolled or medication-controlled type 2 diabetes who had gastric bypass. RESULTS: Overall, 68.2 % (95 % confidence interval [CI], 66 and 70 %) experienced an initial complete diabetes remission within 5 years after surgery. Among these, 35.1 % (95 % CI, 32 and 38 %) redeveloped diabetes within 5 years. The median duration of remission was 8.3 years. Significant predictors of complete remission and relapse were poor preoperative glycemic control, insulin use, and longer diabetes duration. Weight trajectories after surgery were significantly different for never remitters, relapsers, and durable remitters (p = 0.03). CONCLUSIONS: Gastric bypass surgery is associated with durable remission of type 2 diabetes in many but not all severely obese diabetic adults, and about one third experience a relapse within 5 years of initial remission. More research is needed to understand the mechanisms of diabetes relapse, the optimal timing of surgery in effecting a durable remission, and the relationship between remission duration and incident microvascular and macrovascular events.

Introducing decision aids at Group Health was linked to sharply lower hip and knee surgery rates and costs.

Decision aids are evidence-based sources of health information that can help patients make informed treatment decisions. However, little is known about how decision aids affect health care use when they are implemented outside of randomized controlled clinical trials. We conducted an observational study to examine the associations between introducing decision aids for hip and knee osteoarthritis and rates of joint replacement surgery and costs in a large health system in Washington State. Consistent with prior randomized trials, our introduction of decision aids was associated with 26 percent fewer hip replacement surgeries, 38 percent fewer knee replacements, and 12-21 percent lower costs over six months. These findings support the concept that patient decision aids for some health conditions, for which treatment decisions are highly sensitive to both patients' and physicians' preferences, may reduce rates of elective surgery and lower costs.

Treatment adjustment and medication adherence for complex patients with diabetes, heart disease, and depression: a randomized controlled trial.

PURPOSE: Medication nonadherence, inconsistent patient self-monitoring, and inadequate treatment adjustment exacerbate poor disease control. In a collaborative, team-based, care management program for complex patients (TEAMcare), we assessed patient and physician behaviors (medication adherence, self-monitoring, and treatment adjustment) in achieving better outcomes for diabetes, coronary heart disease, and depression. METHODS: A randomized controlled trial was conducted (2007-2009) in 14 primary care clinics among 214 patients with poorly controlled diabetes (glycated hemoglobin [HbA(1c)] ≥8.5%) or coronary heart disease (blood pressure >140/90 mm Hg or low-density lipoprotein cholesterol >130 mg/dL) with coexisting depression (Patient Health Questionnaire-9 score ≥10). In the TEAMcare program, a nurse care manager collaborated closely with primary care physicians, patients, and consultants to deliver a treat-to-target approach across multiple conditions. Measures included medication initiation, adjustment, adherence, and disease self-monitoring. RESULTS: Pharmacotherapy initiation and adjustment rates were sixfold higher for antidepressants (relative rate [RR] = 6.20; P <.001), threefold higher for insulin (RR = 2.97; P <.001), and nearly twofold higher for antihypertensive medications (RR = 1.86, P <.001) among TEAMcare relative to usual care patients. Medication adherence did not differ between the 2 groups in any of the 5 therapeutic classes examined at 12 months. TEAMcare patients monitored blood pressure (RR = 3.20; P <.001) and glucose more frequently (RR = 1.28; P = .006). CONCLUSIONS: Frequent and timely treatment adjustment by primary care physicians, along with increased patient self-monitoring, improved control of diabetes, depression, and heart disease, with no change in medication adherence rates. High baseline adherence rates may have exerted a ceiling effect on potential improvements in medication adherence.

Collaborative care for patients with depression and chronic illnesses.

BACKGROUND: Patients with depression and poorly controlled diabetes, coronary heart disease, or both have an increased risk of adverse outcomes and high health care costs. We conducted a study to determine whether coordinated care management of multiple conditions improves disease control in these patients. METHODS: We conducted a single-blind, randomized, controlled trial in 14 primary care clinics in an integrated health care system in Washington State, involving 214 participants with poorly controlled diabetes, coronary heart disease, or both and coexisting depression. Patients were randomly assigned to the usual-care group or to the intervention group, in which a medically supervised nurse, working with each patient's primary care physician, provided guideline-based, collaborative care management, with the goal of controlling risk factors associated with multiple diseases. The primary outcome was based on simultaneous modeling of glycated hemoglobin, low-density lipoprotein (LDL) cholesterol, and systolic blood-pressure levels and Symptom Checklist-20 (SCL-20) depression outcomes at 12 months; this modeling allowed estimation of a single overall treatment effect. RESULTS: As compared with controls, patients in the intervention group had greater overall 12-month improvement across glycated hemoglobin levels (difference, 0.58%), LDL cholesterol levels (difference, 6.9 mg per deciliter [0.2 mmol per liter]), systolic blood pressure (difference, 5.1 mm Hg), and SCL-20 depression scores (difference, 0.40 points) (P<0.001). Patients in the intervention group also were more likely to have one or more adjustments of insulin (P=0.006), antihypertensive medications (P<0.001), and antidepressant medications (P<0.001), and they had better quality of life (P<0.001) and greater satisfaction with care for diabetes, coronary heart disease, or both (P<0.001) and with care for depression (P<0.001). CONCLUSIONS: As compared with usual care, an intervention involving nurses who provided guideline-based, patient-centered management of depression and chronic disease significantly improved control of medical disease and depression. (Funded by the National Institute of Mental Health; ClinicalTrials.gov number, NCT00468676.).

Depression and advanced complications of diabetes: a prospective cohort study.

OBJECTIVE: To prospectively examine the association of depression with risks for advanced macrovascular and microvascular complications among patients with type 2 diabetes. RESEARCH DESIGN AND METHODS: A longitudinal cohort of 4,623 primary care patients with type 2 diabetes was enrolled in 2000-2002 and followed through 2005-2007. Advanced microvascular complications included blindness, end-stage renal disease, amputations, and renal failure deaths. Advanced macrovascular complications included myocardial infarction, stroke, cardiovascular procedures, and deaths. Medical record review, ICD-9 diagnostic and procedural codes, and death certificate data were used to ascertain outcomes in the 5-year follow-up. Proportional hazard models analyzed the association between baseline depression and risks of adverse outcomes. RESULTS: After adjustment for prior complications and demographic, clinical, and diabetes self-care variables, major depression was associated with significantly higher risks of adverse microvascular outcomes (hazard ratio 1.36 [95% CI 1.05-1.75]) and adverse macrovascular outcomes (1.24 [1.0-1.54]). CONCLUSIONS: Among people with type 2 diabetes, major depression is associated with an increased risk of clinically significant microvascular and macrovascular complications over the ensuing 5 years, even after adjusting for diabetes severity and self-care activities. Clinical and public health significance of these findings rises as the incidence of type 2 diabetes soars. Further research is needed to clarify the underlying mechanisms for this association and to test interventions to reduce the risk of diabetes complications among patients with comorbid depression.

Depression and increased mortality in diabetes: unexpected causes of death.

PURPOSE: Recent evidence suggests that depression is linked to increased mortality among patients with diabetes. This study examines the association of depression with all-cause and cause-specific mortality in diabetes. METHODS: We conducted a prospective cohort study of primary care patients with type 2 diabetes at Group Health Cooperative in Washington state. We used the Patient Health Questionnaire (PHQ-9) to assess depression at baseline and reviewed medical records supplemented by the Washington state mortality registry to ascertain the causes of death. RESULTS: Among a cohort of 4,184 patients, 581 patients died during the follow-up period. Deaths occurred among 428 (12.9%) patients with no depression, among 88 (17.8%) patients with major depression, and among 65 (18.2%) patients with minor depression. Causes of death were grouped as cardiovascular disease, 42.7%; cancer, 26.9%; and deaths that were not due to cardiovascular disease or cancer, 30.5%. Infections, dementia, renal failure, and chronic obstructive pulmonary disease were the most frequent causes in the latter group. Adjusting for demographic characteristics, baseline major depression (relative to no depression) was significantly associated with all-cause mortality (hazard ratio [HR]=2.26, 95% confidence interval [CI], 1.79-2.85), with cardiovascular mortality (HR = 2.00; 95% CI, 1.37-2.94), and with noncardiovascular, noncancer mortality (HR = 3.35; 95% CI, 2.30-4.89). After additional adjustment for baseline clinical characteristics and health habits, major depression was significantly associated only with all-cause mortality (HR = 1.52; 95% CI, 1.19-1.95) and with death not caused by cancer or atherosclerotic cardiovascular disease (HR = 2.15; 95% CI, 1.43-3.24). Minor depression showed similar but nonsignificant associations. CONCLUSIONS: Patients with diabetes and coexisting depression face substantially elevated mortality risks beyond cardiovascular deaths.

Lipid screening in children and adolescents.

Despite enormous advances in research supporting lipid screening among adults, there are critical research gaps in our understanding of the potential benefit and harm of routine screening of young children and adults. Although clear clinical opportunities exist to test and treat individual children from high risk backgrounds, building the case for systematically screening all children as part of a comprehensive cardiovascular disease prevention program requires more convincing evidence that this type of screening will yield true net positive clinical and public health outcomes. This should not prevent the pediatric community from aggressive promotion of healthy lifestyles, both in the office and through effective public policy.

A state-level application of the chronic illness breakthrough series: results from two collaboratives on diabetes in Washington State.

BACKGROUND: Breakthrough Series Collaboratives addressing chronic conditions have been conducted at the national level and in single health care delivery systems but not at the state level. Two state-level collaboratives were conducted: Diabetes Collaborative I (October 1999-November 2000) included 17 clinic teams from across the state, and Diabetes Collaborative II (February 2001-March 2002) included 30 teams and 6 health plans. METHODS: Both collaboratives took place in Washington State, where a diverse group of primary care practices participated, and health insurance plans partnered with the clinic teams. Teams individually tested and implement changes in their systems of care to address all components of the Chronic Care Model. RESULTS: All 47 teams completed the collaboratives, and all but one maintained a registry throughout the 13 months. Most teams demonstrated some amount of improvement on process and outcome measures that addressed blood sugar testing and control, blood pressure control, lipid testing and control, foot exams, dilated eye exams, and self-management goals. CONCLUSION: The benefits of holding collaboratives more locally include increased technical support and increased participation, translating into wider implementation of prevention-focused, patient-centered care.

Case studies from two collaboratives on diabetes in Washington State.

Two individual teams, one from a small, rural clinic and one from a larger urban health system, were able to introduce innovations in care and realize improvement in patient outcomes.

Estrogen therapy and risk of cardiovascular events among women with type 2 diabetes.

OBJECTIVE: To evaluate the association between estrogen therapy and cardiovascular disease risk among women with type 2 diabetes. RESEARCH DESIGN AND METHODS: A retrospective, case-cohort study was conducted among 6017 women aged 45-80 years with type 2 diabetes from 1 January 1986 to 31 December 1992 at the Group Health Cooperative in Washington state. Cardiovascular outcomes, including nonfatal myocardial infarction (n = 215), coronary revascularization (n = 253), and cardiovascular deaths (n = 229), were ascertained through 31 December 1998. Use of estrogen and progestin was derived from automated pharmacy records and modeled as a time-dependent variable. Median follow-up was 6.8 years. Multivariable-adjusted relative risk (RR) and 95% CI were calculated using Cox proportional hazard models for case-cohort analyses. RESULTS: Current use of estrogen with (RR 0.43, 95% CI 0.22-0.85) or without (0.48, 0.30-0.78) progestin was associated with a decreased risk of cardiovascular events compared with never having used estrogen. Risk of cardiovascular events associated with a first episode of estrogen use (with or without progestin) of <25 months' duration (1.12, 0.49-2.54), first episode of use >or=25 months' duration (0.32, 0.06-1.70), and current use that was not the first episode of use (0.42, 0.42-0.67) indicated that recent initiation was not associated with an increase or decrease in risk. CONCLUSIONS: These results show an association of estrogen therapy, with or without progestin, with decreased risk of cardiovascular events among women with type 2 diabetes. This association should be further investigated in large randomized, controlled trials.

Increasing diabetes self-management education in community settings. A systematic review.

This report presents the results of a systematic review of the effectiveness and economic efficiency of self-management education interventions for people with diabetes and forms the basis for recommendations by the Task Force on Community Preventive Services. Data on glycemic control provide sufficient evidence that self-management education is effective in community gathering places for adults with type 2 diabetes and in the home for adolescents with type 1 diabetes. Evidence is insufficient to assess the effectiveness of self-management education interventions at the worksite or in summer camps for either type 1 or type 2 diabetes or in the home for type 2 diabetes. Evidence is also insufficient to assess the effectiveness of educating coworkers and school personnel about diabetes.

The effectiveness of disease and case management for people with diabetes. A systematic review.

This report presents the results of a systematic review of the effectiveness and economic efficiency of disease management and case management for people with diabetes and forms the basis for recommendations by the Task Force on Community Preventive Services on the use of these two interventions. Evidence supports the effectiveness of disease management on glycemic control; on screening for diabetic retinopathy, foot lesions and peripheral neuropathy, and proteinuria; and on the monitoring of lipid concentrations. This evidence is applicable to adults with diabetes in managed care organizations and community clinics in the United States and Europe. Case management is effective in improving both glycemic control and provider monitoring of glycemic control. This evidence is applicable primarily in the U.S. managed care setting for adults with type 2 diabetes. Case management is effective both when delivered in conjunction with disease management and when delivered with one or more additional educational, reminder, or support interventions.