Automated symptom and treatment side effect monitoring for improved quality of life among adults with diabetic peripheral neuropathy in primary care: a pragmatic, cluster, randomized, controlled trial.

AIMS: To evaluate the effectiveness of automated symptom and side effect monitoring on quality of life among individuals with symptomatic diabetic peripheral neuropathy. METHODS: We conducted a pragmatic, cluster randomized controlled trial (July 2014 to July 2016) within a large healthcare system. We randomized 1834 primary care physicians and prospectively recruited from their lists 1270 individuals with neuropathy who were newly prescribed medications for their symptoms. Intervention participants received automated telephone-based symptom and side effect monitoring with physician feedback over 6 months. The control group received usual care plus three non-interactive diabetes educational calls. Our primary outcomes were quality of life (EQ-5D) and select symptoms (e.g. pain) measured 4-8 weeks after starting medication and again 8 months after baseline. Process outcomes included receiving a clinically effective dose and communication between individuals with neuropathy and their primary care provider over 12 months. Interviewers collecting outcome data were blinded to intervention assignment. RESULTS: Some 1252 participants completed the baseline measures [mean age (sd): 67 (11.7), 53% female, 57% white, 8% Asian, 13% black, 20% Hispanic]. In total, 1179 participants (93%) completed follow-up (619 control, 560 intervention). Quality of life scores (intervention: 0.658 ± 0.094; control: 0.653 ± 0.092) and symptom severity were similar at baseline. The intervention had no effect on primary [EQ-5D: -0.002 (95% CI -0.01, 0.01), P = 0.623; pain: 0.295 (-0.75, 1.34), P = 0.579; sleep disruption: 0.342 (-0.18, 0.86), P = 0.196; lower extremity functioning: -0.079 (-1.27, 1.11), P = 0.896; depression: -0.462 (-1.24, 0.32); P = 0.247] or process outcomes. CONCLUSIONS: Automated telephone monitoring and feedback alone were not effective at improving quality of life or symptoms for people with symptomatic diabetic peripheral neuropathy. TRIAL REGISTRATION: ClinicalTrials.gov (NCT02056431).

Short term health-related quality of life improvement during opioid agonist treatment.

BACKGROUND: Opioid dependence is associated with high levels of morbidity, yet sparse data exists regarding the health-related quality of life (HRQoL) of individuals with opioid dependence, particularly following treatment initiation. To inform cost-effectiveness analyses of treatment modalities, this study investigates short-term changes in HRQoL following enrollment into opioid agonist treatment (OAT), across treatment modalities and patient subgroups. METHODS: Data was analyzed from the Starting Treatment with Agonist Replacement Therapies (START) and Prescription Opioid Addiction Treatment Studies (POATS) randomized controlled trials. Participants included individuals dependent on prescription opioids (POs) or heroin, receiving limited-term or time-unlimited treatment. PO- or heroin-users in START received buprenorphine/naloxone (BUP/NX) or methadone (MET) over 24 weeks. PO-users in POATS received psychosocial care and short-term (4-week) taper with BUP/NX, with non-responders offered subsequent extended (12-week) stabilization and taper. HRQoL was assessed using the short-form SF-6D while in and out of OAT, with distinction between MMT and BUP/NX in START. Linear mixed effects regression models were fitted to determine the independent effects of OAT on HRQoL and characterize HRQoL trajectories. RESULTS: Treatment had a similar immediate and modest positive association with HRQoL in each patient subgroup. The association of OAT on HRQoL was statistically significant in each model, with effect sizes between 0.039 (heroin-users receiving BUP/NX) and 0.071 (PO-users receiving MET). After initial improvement, HRQoL decreased slightly, or increased at a diminished rate. CONCLUSIONS: OAT, whether delivered in time-limited or unlimited form, using BUP/NX or MET, is associated with modest immediate HRQoL improvements, with diminishing benefits thereafter.

Association of diabetes-related emotional distress with diabetes treatment in primary care patients with Type 2 diabetes.

AIMS: To characterize the determinants of diabetes-related emotional distress by treatment modality (diet only, oral medication only, or insulin). METHODS: A total of 815 primary care patients with Type 2 diabetes completed the Problem Areas in Diabetes (PAID) Scale and other questions. We linked survey data to a diabetes clinical research database and used linear regression models to assess the associations of treatment with PAID score. RESULTS: PAID scores were significantly higher among insulin-treated (24.6) compared with oral-treated (17.8, P < 0.001) or diet-treated patients (14.7, P < 0.001), but not different between oral- vs. diet-treated patients (P = 0.2). Group scores remained similar, but the statistical significance of their differences was reduced and ultimately eliminated after sequential adjustment for diabetes severity, HbA(1c), body mass index, regimen adherence, and self-blood-glucose monitoring. Insulin-treated patients reported significantly higher distress than oral- or diet-treated patients on 16 of 20 PAID items. 'Worrying about the future' and 'guilt/anxiety when ... off track with diabetes' were the top two serious problems (PAID >or= 5) in all treatment groups. Not accepting diabetes diagnosis was a top concern for oral- and diet-treated patients, and unclear management goals distressed diet-treated patients. CONCLUSIONS: Primary care patients treated with insulin reported higher diabetes-related emotional distress compared with oral- or diet-treated patients. Greater distress was largely explained by greater disease severity and self-care burdens. To improve diabetes-specific quality of life, clinicians should address patients' sense of worry and guilt, uncertain acceptance of diabetes diagnosis, and unclear treatment goals.

Correlates of health-related quality of life in type 2 diabetes.

AIMS/HYPOTHESIS: We assessed the impact of medical comorbidities, depression, and treatment intensity on quality of life in a large primary care cohort of patients with type 2 diabetes. METHODS: We used the Health Utilities Index-III, an instrument that measures health-related quality of life based on community preferences in units of health utility (scaled from 0=death to 1.0=perfect health), in 909 primary care patients with type 2 diabetes. Demographic and clinical correlates of health-related quality of life were assessed. RESULTS: The median health utility score for this population was 0.70 (interquartile range 0.39-0.88). In univariate analyses, older age, female sex, low socioeconomic status, cardiovascular disease, microvascular complications, congestive heart failure, peripheral vascular disease, chronic lung disease, depression, insulin use and number of medications correlated with decreased quality of life, while obesity, hypertension and hypercholesterolaemia did not. In multiple regression analyses, microvascular complications, heart failure and depression were most strongly related to decreased health-related quality of life, independently of duration of diabetes; in these models, diabetes patients with depression had a utility of 0.59, while patients without symptomatic comorbidities did not have a significantly reduced quality of life. Treatment intensity remained a significant negative correlate of quality of life in multivariable models. CONCLUSIONS/INTERPRETATION: Patients with type 2 diabetes have a substantially decreased quality of life in association with symptomatic complications. The data suggest that treatment of depression and prevention of complications have the greatest potential to improve health-related quality of life in type 2 diabetes.

Predictors of hazardous child seating behavior in fatal motor vehicle crashes: 1990 to 1998.

OBJECTIVE: Motor vehicle crashes are the leading cause of death in children ages 5 to 14. Children seated in the front seats of vehicles are at increased risk of death and injury in crashes, particularly in vehicles with passenger-side air bags. This study identifies factors associated with the seating of children in the front seats of vehicles involved in fatal crashes between 1990 and 1998. METHODS: Using 1990 to 1998 data from the Fatal Analysis Reporting System, a US census of motor vehicle crashes involving a fatality, multivariable logistic regression was used to model the association between child seating behavior and vehicle, driver, and occupant characteristics. RESULTS: The proportion of vehicles carrying children in the front declined from 42% to 31% over the 9-year period. Controlling for driver and vehicle characteristics, the risk of front-seating declined between 1990 and 1998, and this risk was smaller in vehicles carrying only younger children (

Where children sit in cars: the impact of Rhode Island's new legislation.

OBJECTIVES: This study evaluated the impact of Rhode Island's legislation requiring children younger than 6 years to sit in the rear of motor vehicles. METHODS: Roadside observations were conducted in Rhode Island and Massachusetts in 1997 and 1998. Multivariate regression was used to evaluate the proportion of vehicles carrying a child in the front seat. RESULTS: Data were collected on 3226 vehicles carrying at least 1 child. In 1998, Rhode Island vehicles were less likely to have a child in the front seat than in 1997 (odds ratio = 0.6; 95% confidence interval = 0.5, 0.7), whereas no significant changes in child passenger seating behavior occurred in Massachusetts during that period. CONCLUSIONS: Rhode Island's legislation seems to have promoted safer child passenger seating behavior.

The effect of passenger airbags on child seating behavior in motor vehicles.

Objective. The purpose of this study was to determine the effect of the presence of passenger airbags on places where children sit when traveling in motor vehicles. Methodology. An observational and driver interview survey of 503 passenger vehicles was conducted in five New England states at randomly selected long- and short-distance travel sites during the summer of 1998. Each vehicle was occupied by at least 1 child <13 years of age. Seating position, vehicle information, and driver and passenger characteristics were collected. Logistic regression analysis was used to identify the association between the presence of passenger airbags in vehicles and the seating positions of children. Results. Controlling for the effects of the driver and vehicle characteristics, children <13 years of age were less likely to be observed riding in the front right seat when a passenger airbag was present in the vehicle (odds ratio:.34; 95% confidence interval:.19-.61). Of the vehicles carrying children, 23% had at least 1 child riding in the front seat. Children rode in the front seat in 17% of vehicles with a passenger airbag, and in 30% of those without a passenger airbag. Half of all vehicles without a teenage or adult passenger carried a child in the front seat. In 91% of vehicles with a child riding in the front seat, there was at least one available seat in the rear. Driver safety belt use, younger child age, and the presence of an adult passenger in the vehicle were all associated with children being seated in the rear. Conclusions. Some New England drivers are protecting children from the risks of passenger airbags by seating them in the rear. There remains, however, a substantial number of children who are being exposed to the risk of passenger airbag deployment.