A systematic review of epidemiology and outcomes of Crohn's disease-related enterocutaneous fistulas.

BACKGROUND: Enterocutaneous fistulas (ECF) are rare sequelae of Crohn's disease (CD) that occur either postoperatively or spontaneously. ECFs are associated with high morbidity and mortality. This systematic literature review assesses the disease burden of CD-related ECF and identifies knowledge gaps around incidence/prevalence, treatment patterns, clinical outcomes, healthcare resource utilization (HCRU), and patient-reported outcomes (PROs). METHODS: English language articles published in PubMed and Embase in the past 10 years that provided data and insight into the disease burden of CD-related ECF (PROSPERO Registration number: CRD42020177732) were identified. Prespecified search and eligibility criteria guided the identification of studies by two reviewers who also assessed risk of bias. RESULTS: In total, 582 records were identified; 316 full-text articles were assessed. Of those, eight studies met a priori eligibility criteria and underwent synthesis for this review. Limited epidemiologic data estimated a prevalence of 3265 persons with ECF in the USA in 2017. Clinical response to interventions varied, with closure of ECF achieved in 10% to 62.5% of patients and recurrence reported in 0% to 50% of patients. Very little information on HCRU is available, and no studies of PROs in this specific population were identified. CONCLUSION: The frequency, natural history, and outcomes of ECF are poorly described in the literature. The limited number of studies included in this review suggest a high treatment burden and risk of substantial complications. More robust, population-based research is needed to better understand the epidemiology, natural history, and overall disease burden of this rare and debilitating complication of CD.

A systematic review of the patient burden of Crohn's disease-related rectovaginal and anovaginal fistulas.

BACKGROUND: Crohn's disease (CD)-related rectovaginal fistulas (RVFs) and anovaginal fistulas (AVFs) are rare, debilitating conditions that present a substantial disease and treatment burden for women. This systematic literature review (SLR) assessed the burden of Crohn's-related RVF and AVF, summarizing evidence from observational studies and highlighting knowledge gaps. METHODS: This SLR identified articles in PubMed and Embase that provide data and insight into the patient experience and disease burden of Crohn's-related RVF and AVF. Two trained reviewers used pre-specified eligibility criteria to identify studies for inclusion and evaluate risk of bias using the Risk Of Bias In Non-randomized Studies of Interventions (ROBINS-I) tool for observational studies. RESULTS: Of the 582 records identified, 316 full-text articles were assessed, and 16 studies met a priori eligibility criteria and were included. Few epidemiology studies were identified, with one study estimating the prevalence of RVF to be 2.3% in females with Crohn's disease. Seven of 12 treatment pattern studies reported that patients had or required additional procedures before and/or after the intervention of interest, demonstrating a substantial treatment burden. Seven of 11 studies assessing clinical outcomes reported fistula healing rates between 50 and 75%, with varying estimates based on population and intervention. CONCLUSIONS: This SLR reports the high disease and treatment burden of Crohn's-related RVF and AVF and identifies multiple evidence gaps in this field. The literature lacks robust, generalizable data, and demonstrates a compelling need for substantial, novel research into these rare and debilitating sequelae of CD. Registration The PROSPERO registration number for the protocol for this systematic literature review is CRD42020177732.

Effects of conformance to type 2 diabetes guidelines on health care resource utilization, clinical outcomes, and cost: A retrospective claims analysis.

OBJECTIVES: To determine if there is a difference in the outcomes of diabetes patients managed with high, intermediate, or low conformance to diabetes guidelines. STUDY DESIGN: Retrospective database analysis. METHODS: This was a retrospective database analysis of adults diagnosed with type 2 diabetes and with glycated hemoglobin (HbA1c) ≥7% (53 mmol/mol) who were commercially insured by, or receiving Medicare benefits through, Aetna. Subjects were classified as having high, intermediate, or low conformance to current guidelines. Six, 12, and 18 months later, health care resource utilization, clinical outcomes, and costs were assessed using multivariable regression analysis to determine whether differences existed between patients with high, intermediate, and low conformance. Regression models were adjusted using pre-index variables, and the results were expressed as incidence rate ratios (IRRs) with 95% confidence intervals (CIs). RESULTS: A total of 21,171 individuals were included in the analysis. In analyses of patients with low versus high conformance, pharmacy costs were significantly lower over 18 months of outcome assessment (P < 0.001), but diabetes-related outpatient costs were significantly higher (P < 0.001). In analyses of patients with intermediate versus high conformance, diabetes-related outpatient costs were significantly greater at 12 and 18 months (P < 0.001 for both). CONCLUSIONS: Reduced conformance to guidelines leads to higher diabetes-related costs.

Factors associated with clinical inertia in type 2 diabetes mellitus patients treated with metformin monotherapy.

Aims: To assess demographic and clinical characteristics associated with clinical inertia in a real-world cohort of type 2 diabetes mellitus patients not at hemoglobin A1c goal (<7%) on metformin monotherapy.Methods: Adult (≥18 years) type 2 diabetes mellitus patients who received care at Massachusetts General Hospital/Brigham and Women's Hospital and received a new metformin prescription between 1992 and 2010 were included in the analysis. Clinical inertia was defined as two consecutive hemoglobin A1c measures ≥7% ≥3 months apart while remaining on metformin monotherapy (i.e. without add-on therapy). The association between clinical inertia and demographic and clinical characteristics was examined via logistic regression.Results: Of 2848 eligible patients, 43% did not achieve a hemoglobin A1c goal of <7% 3 months after metformin monotherapy initiation. A sub-group of 1533 patients was included in the clinical inertia analysis, of which 36% experienced clinical inertia. Asian race was associated with an increased likelihood of clinical inertia (OR = 2.43; 95% CI = 1.48-3.96), while congestive heart failure had a decreased likelihood (OR = 0.58; 95% CI = 0.32-0.98). Chronic kidney disease and cardiovascular/cerebrovascular disease had weaker associations but were directionally similar to congestive heart failure.Conclusions: Asian patients were at an increased risk of clinical inertia, whereas patients with comorbidities appeared to have their treatment more appropriately intensified. A better understanding of these factors may inform efforts to decrease the likelihood for clinical inertia.

Impact of the severity of hypoglycemia on health - Related quality of life, productivity, resource use, and costs among US patients with type 2 diabetes.

AIMS: To explore the association between hypoglycemia severity and health-related quality of life (HRQoL), productivity, health care resource utilization (HCRU), and costs among patients with type 2 diabetes mellitus (T2DM). METHODS: Data were from the 2013 US National Health and Wellness Survey. This analysis included adults with treated T2DM. Participants were categorized based upon their self-reported experience in the previous 3 months: no hypoglycemia, non-severe hypoglycemia, or severe hypoglycemia. Validated instruments were used to measure HRQoL and productivity; HCRU was based on participant-reported health care provider (HCP) and emergency department (ED) visits and hospitalizations. Multivariable models tested for trends across the severity groups. RESULTS: The analysis included 3630 participants-1729 (47.6%) with non-severe hypoglycemia and 172 (4.7%) with severe hypoglycemia. Mental and physical component scores and utility scores were significantly associated with hypoglycemia severity (P < 0.001 for each). Similar trends were observed for absenteeism (P < 0.001), presenteeism (P = 0.005), HCP and ED visits (P ≤ 0.002), and hospitalizations (P < 0.001). Annual HCRU costs associated with increasingly severe hypoglycemia were $6908, $7132, and $15,410, respectively (P < 0.001), and productivity costs were $7248, $7493, and $12,167, respectively (P = 0.008). CONCLUSION: Hypoglycemia severity appears to be related to reduced HRQoL and productivity, which are mirrored by increased direct and indirect costs.

Severity of hypoglycaemia and health-related quality of life, work productivity and healthcare costs in patients with type 2 diabetes in Europe.

AIMS: Hypoglycaemia in patients with type 2 diabetes mellitus (T2DM) is associated with poor health outcomes, such as reduced health-related quality of life (HRQoL). This study aimed to assess the impact of hypoglycaemic events by severity on HRQoL, work productivity and healthcare costs in patients with T2DM. MATERIALS AND METHODS: European patients with T2DM selected from the National Health and Wellness Survey who were currently receiving pharmacologic therapy were stratified into 3 groups based on the reported history and severity of hypoglycaemic events (no event, nonsevere, severe) experienced in the previous 3 months. Patients' work productivity, HRQoL, healthcare resource use (HCRU) and associated costs were assessed as self-reported outcomes. RESULTS: Of 1269 patients included in the study, 652 (51.4%) patients had not experienced an event, while 533 (42.0%) and 84 (6.6%) patients had experienced nonsevere and severe hypoglycaemic events, respectively, in the previous 3 months. An increase in hypoglycaemia severity was associated with a decrease in HRQoL, and an increase in HCRU and healthcare costs. CONCLUSIONS: The impact of hypoglycaemia varies by severity and has a negative impact on HRQoL and overall HCRU and costs.

Diagnosis and treatment delays among elderly breast cancer patients with pre-existing mental illness.

PURPOSE: This study aimed to compare diagnosis and treatment delays in elderly breast cancer patients with and without pre-existing mental illness. METHODS: A retrospective cohort study was conducted using the Surveillance, Epidemiology and End Results-Medicare data including 16,636 women 68+ years, who were diagnosed with stage I-IIIa breast cancer in the United States from 2005 to 2007. Mental illness was identified using International Classification of Diseases, Ninth Revision, Clinical Modification codes recorded on inpatient and outpatient claims during the 3 years prior to breast cancer diagnosis. Patients were classified as having no mental illness, anxiety, depression, anxiety and depression, or severe mental illness (bipolar disorder, schizophrenia, and other psychotic disorder). Multivariable binomial regression was used to assess the association between mental illness and delays of ≥60 and ≥90 days after adjustment for confounders. RESULTS: Patients with comorbid anxiety and depression had an increased risk for diagnosis delay of ≥90 days from symptom recognition (RR 1.11; 95% CI 1.00, 1.23), and those with severe mental illness had an increased risk for initial treatment delay of ≥60 days from diagnosis (RR 1.36; 95% CI 1.06, 1.74). Patients with any mental illness experienced an increased risk for adjuvant chemotherapy delay of ≥90 days from last operation (RR 1.13; 95% CI 1.01, 1.26) and each category of mental illness, except depression, showed a non-significant trend for this association. CONCLUSION: Breast cancer patients with mental illness should be closely managed by a cross-functional care team, including a psychiatrist, a primary care physician, and an oncologist, to ensure adequate care is received within an appropriate timeframe.

Review of patient-reported outcome instruments measuring health-related quality of life and satisfaction in patients with type 2 diabetes treated with oral therapy.

OBJECTIVE: Treatments and their mode of administration may represent a burden for patients and can therefore impact their health-related quality of life (HRQL) or treatment/health satisfaction. Patients with type 2 diabetes mellitus (T2DM) can be treated with oral hypoglycemic agents (OHAs), injectable medications (such as insulin), or a combination of agents. This review aimed to identify patient-reported outcome (PRO) instruments measuring HRQL and/or satisfaction that could differentiate between oral medications based on medication related attributes such as efficacy, tolerability, weight loss, dosing frequency and pill burden. RESEARCH DESIGN AND METHODS: Medline, Embase, PsycINFO, Cochrane Library and the Patient-Reported Outcome and Quality of Life Questionnaires (PROQOLID) biomedical databases were searched to identify instruments and document their development methodology, content and psychometric properties (i.e. validity, reliability), responsiveness and ability to detect changes between treatments. RESULTS: Nineteen instruments were retained based on their potential to differentiate between OHAs. Ten instruments assessed HRQL, amongst which the Audit of Diabetes Dependent Quality of Life, Diabetes 39, Diabetes Health Profile and Impact of Weight on Quality of Life displayed good psychometric properties in T2DM populations and comprehensive HRQL content. Nine instruments assessed satisfaction. Both the Oral Hypoglycemic Agent Questionnaire (OHAQ) and Diabetes Medication Satisfaction (DiabMedSat) Questionnaire have highly relevant content regarding drug attributes. The OHAQ is specific to oral treatment and the DiabMedSat includes HRQL items. The Diabetes Treatment Satisfaction Questionnaire is a standard instrument that is extensively used and provides conclusive results in studies of patients with T2DM. CONCLUSIONS: Very few of the existing PRO instruments are specific to OHAs. Despite satisfaction instruments being recommended to differentiate between OHAs in studies of T2DM based on medication attributes, we find that none of the existing instruments appear to be useful in detecting differences between treatments, therefore limiting their use in clinical and observational research.