Second-line drug susceptibility breakpoints for Mycobacterium tuberculosis using the MODS assay.

OBJECTIVE: To establish breakpoint concentrations for the fluoroquinolones (moxifloxacin [MFX] and ofloxacin [OFX]) and injectable second-line drugs (amikacin [AMK], kanamycin [KM] and capreomycin [CPM]) using the microscopic observation drug susceptibility (MODS) assay. SETTING: A multinational study conducted between February 2011 and August 2012 in Peru, India, Moldova and South Africa. DESIGN: In the first phase, breakpoints for the fluoroquinolones and injectable second-line drugs (n = 58) were determined. In the second phase, MODS second-line drug susceptibility testing (DST) as an indirect test was compared to MGIT™ DST (n = 89). In the third (n = 30) and fourth (n = 156) phases, we determined the reproducibility and concordance of MODS second-line DST directly from sputum. RESULTS: Breakpoints for MFX (0.5 µg/ml), OFX (1 µg/ml), AMK (2 µg/ml), KM (5 µg/ml) and CPM (2.5 µg/ml) were determined. In all phases, MODS results were highly concordant with MGIT DST. The few discrepancies suggest that the MODS breakpoint concentrations for some drugs may be too low. CONCLUSION: MODS second-line DST yielded comparable results to MGIT second-line DST, and is thus a promising alternative. Further studies are needed to confirm the accuracy of the drug breakpoints and the reliability of MODS second-line DST as a direct test.

The hepatitis C self-management programme: a randomized controlled trial.

Chronic hepatitis C (HCV) infection afflicts millions of people worldwide. While antiviral treatments are effective for some patients, many either cannot or choose not to receive antiviral treatment. Education about behavioural changes like alcohol avoidance and symptom management, in contrast, is universally recommended, particularly in HCV-infected persons from disadvantaged groups where liver risk factors are most prevalent. Self-management interventions are one option for fostering improved HCV knowledge and health-related quality of life (HRQOL). One hundred and thirty-two patients with VA with HCV (mean age of 54.6, 95% men, 41% ethnic minority, 83% unmarried, 72% unemployed/disabled, 48% homeless in last 5 years) were randomized to either a 6-week self-management workshop or an information-only intervention. The weekly 2-h self-management sessions were based on cognitive-behavioural principles and were adapted from an existing self-management programme that has been efficacious with other chronic diseases. HCV-specific modules were added. Outcomes including HRQOL, HCV knowledge, self-efficacy, depression, energy and health distress were measured at baseline and 6 weeks later. Data were analysed using ANOVA. When compared to the information-only group, participants attending the self-management workshop improved more on HCV knowledge (P < 0.001), HCV self-efficacy (P = 0.011), and SF-36 energy/vitality (P = 0.040). Similar trends were found for SF-36 physical functioning (P = 0.055) and health distress (P = 0.055). Attending the self-management programme improved disease knowledge and HRQOL 6 weeks later in this disadvantaged population. The intervention can improve the health of people with hepatitis C, independent of antiviral therapy. Future research will study longer-term outcomes, effects on antiviral treatment and costs.

What is a meaningful change in physical performance? Findings from a clinical trial in older adults (the LIFE-P study).

OBJECTIVE: Performance measures provide important information, but the meaning of change in these measures is not well known. The purpose of this research is to 1) examine the effect of treatment assignment on the relationship between self-report and performance; 2) to estimate the magnitude of meaningful change in 400-meter walk time (400MWT), 4-meter gait speed (4MGS), and Short Physical Performance Battery (SPPB) and 3) to evaluate the effect of direction of change on estimates of magnitude. DESIGN: This is a secondary analysis of data from the LIFE-P study, a single blinded randomized clinical trial. Using change over one year, we applied distribution-based and anchor-based methods for self-reported mobility to estimate minimally important and substantial change in 400MWT, 4MGS and SPPB. SETTING: Four university-based clinical research sites. PARTICIPANTS: Sedentary adults aged 70-89 whose SPPB scores were less than 10 and who were able to complete a 400MW at baseline (n=424). INTERVENTIONS: A structured exercise program versus health education. MEASUREMENTS: 400MWT, 4MGS, SPPB. RESULTS: Relationships between self-report and performance measures were consistent between treatment arms. Minimally significant change estimates were 400MWT: 20-30 seconds, 4MGS: 0.03-0.05m/s and SPPB: 0.3 - 0.8 points. Substantial changes were 400MWT: 50-60 seconds, 4MGS: 0.08m/s, SPPB: 0.4 - 1.5 points. Magnitudes of change for improvement and decline were not significantly different. CONCLUSIONS: The magnitude of clinically important change in physical performance measures is reasonably consistent using several analytic techniques and appears to be achievable in clinical trials of exercise. Due to limited power, the effect of direction of change on estimates of magnitude remains uncertain.

A cost analysis of self-management programs for people with chronic illness.

The soaring cost of health care is a national problem that needs response at multiple levels, including that of the community. Reducing or limiting health care costs through interventions that emphasize the self-management of health may promote broader health care coverage, better quality of health care, and a sense of control over one's health. Therefore, it behooves community psychologists to perform cost analyses when testing interventions for people in a community. The present study investigated the effects of social support and education interventions on psychosocial variables, health status, and health care costs in older people with osteoarthritis. Participants were 363 members of a health maintenance organization (HMO), 60 years of age and older, with osteoarthritis. Participants were randomly assigned to one of three intervention groups (social support, education, or a combination of both) or to a control group. The results indicated that feelings of helplessness decreased in the intervention groups but not in the control group. All groups showed increases in self-efficacy and overall health status. In addition, health care costs increased less in the intervention groups than in the control group. Cost analysis was used to demonstrate that the monetary savings of the intervention greatly outweighed the cost of conducting the intervention. It appears that interventions can limit health care costs while improving health and increasing feelings of control for older people with osteoarthritis. Further, this paper demonstrates how a cost-benefit focus can benefit community studies.

An exploratory study of male recovering substance abusers living in a self-help, self-governed setting.

Adult men (n = 132; 92% of the population) with histories of alcohol/drug use disorders were interviewed upon their entry to 11 Oxford Houses located in the state of Illinois. Individuals still in residence at a six-month follow-up (n = 48) were reinterviewed; prior to the follow-up interview, 42 men had left voluntarily and 42 men had been evicted for abuse or disruptive behavior. The men remaining in residence tended to be older (M age = 37 years), were disproportionately African American (56%), and were less pessimistic about their future. At the intake interview, individuals who would be evicted reported a lower expectation for abstinence social support from the other residents in Oxford House. The Oxford House model of social support for recovery from alcohol and drug dependence appears to help some residents maintain sobriety.