Group interventions for co-morbid insomnia and osteoarthritis pain in primary care: the lifestyles cluster randomized trial design.

Six weekly sessions of group cognitive-behavioral therapy for insomnia and osteoarthritis pain (CBT-PI), and for osteoarthritis pain alone (CBT-P) were compared to an education only control (EOC). Basic education about pain and sleep was comparable, so EOC controlled for information and group participation. Active interventions differed from EOC in training pain coping skills (CBT-P and CBT-PI) and sleep enhancement techniques (CBT-PI). Persons with osteoarthritis age 60 or older were screened for osteoarthritis pain and insomnia severity via mailed survey. Primary outcomes were pain severity (pain intensity and interference ratings from the Graded Chronic Pain Scale) and insomnia severity (Insomnia Severity Index). Secondary outcomes were arthritis pain (AIMS-2 symptom scale) and sleep efficiency assessed by wrist actigraphy. Ancillary outcomes included: cognitive function, depression, and health care use. A clustered randomized design provided adequate power to identify moderate effects on primary outcomes (effect size>0.35). Modified intent to treat analyses, including all participants who attended the first session, assessed effects across CBT-PI, CBT-P, and EOC groups. Treatment effects were assessed post-intervention (2 months) and at 9 months, with durability of intervention effects evaluated at 18 months. The trial was executed in 6 primary clinics, randomizing 367 participants, with 93.2% of randomized patients attending at least 4 group sessions. Response rates for post-intervention and 9 month assessments were 96.7% and 92.9% respectively. This hybrid efficacy-effectiveness trial design evaluates whether interventions yield specific benefits for clinical and behavioral outcomes relative to an education only control when implemented in a primary care setting.

Population-based outreach for Chlamydia screening in men: results from a randomized trial.

OBJECTIVE: To evaluate the feasibility and efficacy of population-based outreach strategies to improve genital Chlamydia trachomatis (CT) screening in men. STUDY DESIGN: In a randomized trial, male enrollees ages 21-25 (n = 8820) were selected from the automated files of Group Health Cooperative and randomized to: a letter + test-request card for a CT urine home sampling kit (arm 1, n = 2940); a letter + mail-back sampling kit (arm 2, n = 2940); or a usual care control (arm 3, n = 2940). One reminder was sent to arms 1 and 2. The outcome was CT testing rates in the 4 months postrandomization. RESULTS: 105 of 2940 (3.6%) men in arm 1 and 230 of 2940 (7.8%) in arm 2 returned mailed specimens. All 335 respondents were sexually experienced, 43% had >2 sex partners in the past year, and 80% reported no genitourinary symptoms. Compared to arm 3, the relative risk of being tested was 5.6 (95% confidence interval (CI) 3.6-8.7) for arm 1 and 11.1 (95% CI 7.3-16.9) for arm 2. Arm 2 was significantly more likely to be tested than arm 1. CT prevalence for mailed-back specimens was 1.0% (1 of 105) for arm 1 and 2.6% (6 of 230) for arm 2; 70% of all positive intervention tests were from mailed samples. CONCLUSIONS: Both strategies resulted in significantly higher CT testing than usual care, but the intervention response rate was low (5.7% overall). Direct kit mailing performed best. In US populations, the value of mailed outreach strategies to men must be considered in the context of other CT screening priorities.

Diabetes and the risk of acute urinary tract infection among postmenopausal women.

OBJECTIVE: To examine whether the presence of diabetes alters the risk of acute urinary tract infection (UTI) in postmenopausal women. RESEARCH DESIGN AND METHODS: A case-control study of the Group Health Cooperative of Puget Sound (GHC), a staff-model nonprofit health maintenance organization in Washington State, was conducted. Subjects were women aged 55-75 years who had been members of GHC for at least 1 year and who had had an acute symptomatic UTI within the preceding month. Laboratory files were used to identify women with a urine culture that grew > or =10(5) colonies of a urinary pathogen. Medical records were reviewed to confirm the presence of acute, clinically symptomatic UTI. Control subjects were randomly selected from the GHC enrollment file, screened to remove women with recent UTI, and frequency matched to cases by age within 2 years. An interviewer ascertained self-reported clinician-diagnosed diabetes. Diagnosis of diabetes was confirmed by the GHC diabetes registry. A subsample of women underwent measurement of postvoid residual bladder volume (n = 748) and culture of vaginal flora (n = 454). RESULTS: Of the 901 case and 913 control subjects, diabetes was reported in 13.1 and 6.8%, respectively. The health plan diabetes registry confirmed the diagnosis in 92% of women who self-reported the condition. The age-adjusted odds ratio (OR) for UTI in relation to self-reported clinician-diagnosed diabetes was 2.2 (95% CI 1.6-3.0). Adjustment for frequency of sexual intercourse and history of UTI had little effect on this estimate. Compared with nondiabetic women, higher UTI odds were seen in subjects who used oral hypoglycemic agents (OR 2.9 [95% CI 1.7-5.1]) and insulin (2.6 [1.5-4.6]) but not in subjects with untreated diabetes or diabetes treated by lifestyle changes (1.3 [0.7-2.3]). No significant difference was seen in the OR for UTI in diabetic women with disease of shorter duration (<10 years, OR 1.9) or longer duration (> or =10 years, OR 2.6) or in relation to HbA(1c) level. Similar microbiologic pathogens were seen in diabetic and nondiabetic women. No significant differences were seen by diabetes status in mean postvoid residual bladder volume or vaginal flora. CONCLUSIONS: Diabetes under pharmacologic treatment is associated with increased risk of clinically apparent UTI in postmenopausal women.