Does Cognitive Behavioral Therapy for Youth Anxiety Outperform Usual Care in Community Clinics? An Initial Effectiveness Test

Objective: Most tests of cognitive behavioral therapy (CBT) for youth anxiety disorders have shown beneficial effects, but these have been efficacy trials with recruited youths treated by researcher-employed therapists. One previous (nonrandomized) trial in community clinics found that CBT did not outperform usual care (UC). The present study used a more stringent effectiveness design to test CBT versus UC in youths referred to community clinics, with all treatment provided by therapists employed in the clinics. Method: A randomized controlled trial methodology was used. Therapists were randomized to training and supervision in the Coping Cat CBT program or UC. Forty-eight youths (56% girls, 8 to 15 years of age, 38% Caucasian, 33% Latino, 15% African-American) diagnosed with DSM-IV anxiety disorders were randomized to CBT or UC. Results: At the end of treatment more than half the youths no longer met criteria for their primary anxiety disorder, but the groups did not differ significantly on symptom (e.g., parent report, eta-square = 0.0001; child report, eta-square = 0.09; both differences favoring UC) or diagnostic (CBT, 66.7% without primary diagnosis; UC, 73.7%; odds ratio 0.71) outcomes. No differences were found with regard to outcomes of comorbid conditions, treatment duration, or costs. However, youths receiving CBT used fewer additional services than UC youths (χ21 = 8.82, p = .006). Conclusions: CBT did not produce better clinical outcomes than usual community clinic care. This initial test involved a relatively modest sample size; more research is needed to clarify whether there are conditions under which CBT can produce better clinical outcomes than usual clinical care.Psycholog

Illustrating risk difference and number needed to treat from a randomized controlled trial of spinal manipulation for cervicogenic headache

<p>Abstract</p> <p>Background</p> <p>The number needed to treat (NNT) for one participant to benefit is considered a useful, clinically meaningful way of reporting binary outcomes from randomized trials. Analysis of continuous data from our randomized controlled trial has previously demonstrated a significant and clinically important difference favoring spinal manipulation over a light massage control.</p> <p>Methods</p> <p>Eighty participants were randomized to receive spinal manipulation or a light massage control (n = 40/group). Improvements in cervicogenic headache pain (primary outcome), disability, and number in prior four weeks were dichotomized into binary outcomes at two thresholds: 30% representing minimal clinically important change and 50% representing clinical success. Groups were compared at 12 and 24-week follow-up using binomial regression (generalized linear models) to compute the adjusted risk difference (RD) between groups and number needed to treat (NNT) after adjusting for baseline differences between groups. Results were compared to logistic regression results.</p> <p>Results</p> <p>For headache pain, clinically important improvement (30% or 50%) was more likely for spinal manipulation: adjusted RD = 17% to 27% and NNT = 3.8 to 5.8 (p = .005 to .028). Some statistically significant results favoring manipulation were found for headache disability and number.</p> <p>Conclusion</p> <p>Spinal manipulation demonstrated a benefit in terms of a clinically important improvement of cervicogenic headache pain. The use of adjusted NNT is recommended; however, adjusted RD may be easier to interpret than NNT. The study demonstrated how results may depend on the threshold for dichotomizing variables into binary outcomes.</p> <p>Trial Registration</p> <p>ClinicalTrials.gov NLM identifier NCT00246350.</p

The importance of adjusting for potential confounders in Bayesian hierarchical models synthesising evidence from randomised and non-randomised studies: an application comparing treatments for abdominal aortic aneurysms

<p>Abstract</p> <p>Background</p> <p>Informing health care decision making may necessitate the synthesis of evidence from different study designs (e.g., randomised controlled trials, non-randomised/observational studies). Methods for synthesising different types of studies have been proposed, but their routine use requires development of approaches to adjust for potential biases, especially among non-randomised studies. The objective of this study was to extend a published Bayesian hierarchical model to adjust for bias due to confounding in synthesising evidence from studies with different designs.</p> <p>Methods</p> <p>In this new methodological approach, study estimates were adjusted for potential confounders using differences in patient characteristics (e.g., age) between study arms. The new model was applied to synthesise evidence from randomised and non-randomised studies from a published review comparing treatments for abdominal aortic aneurysms. We compared the results of the Bayesian hierarchical model adjusted for differences in study arms with: 1) unadjusted results, 2) results adjusted using aggregate study values and 3) two methods for downweighting the potentially biased non-randomised studies. Sensitivity of the results to alternative prior distributions and the inclusion of additional covariates were also assessed.</p> <p>Results</p> <p>In the base case analysis, the estimated odds ratio was 0.32 (0.13,0.76) for the randomised studies alone and 0.57 (0.41,0.82) for the non-randomised studies alone. The unadjusted result for the two types combined was 0.49 (0.21,0.98). Adjusted for differences between study arms, the estimated odds ratio was 0.37 (0.17,0.77), representing a shift towards the estimate for the randomised studies alone. Adjustment for aggregate values resulted in an estimate of 0.60 (0.28,1.20). The two methods used for downweighting gave odd ratios of 0.43 (0.18,0.89) and 0.35 (0.16,0.76), respectively. Point estimates were robust but credible intervals were wider when using vaguer priors.</p> <p>Conclusions</p> <p>Covariate adjustment using aggregate study values does not account for covariate imbalances between treatment arms and downweighting may not eliminate bias. Adjustment using differences in patient characteristics between arms provides a systematic way of adjusting for bias due to confounding. Within the context of a Bayesian hierarchical model, such an approach could facilitate the use of all available evidence to inform health policy decisions.</p

Poverty in the Social World of the Wise

Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/68560/2/10.1177_030908928701203704.pd

Patients' Experience of therapeutic footwear whilst living at risk of neuropathic diabetic foot ulceration: an interpretative phenomenological analysis (IPA).

BACKGROUND: Previous work has found that people with diabetes do not wear their therapeutic footwear as directed, but the thinking behind this behaviour is unclear. Adherence to therapeutic footwear advice must improve in order to reduce foot ulceration and amputation risk in people with diabetes and neuropathy. Therefore this study aimed to explore the psychological influences and personal experiences behind the daily footwear selection of individuals with diabetes and neuropathy. METHODS: An interpretative phenomenological analysis (IPA) approach was used to explore the understanding and experience of therapeutic footwear use in people living at risk of diabetic neuropathic foot ulceration. This study benefited from the purposive selection of a small sample of four people and used in-depth semi structured interviews because it facilitated the deep and detailed examination of personal thoughts and feelings behind footwear selection. FINDINGS: Four overlapping themes that interact to regulate footwear choice emerged from the analyses: a) Self-perception dilemma; resolving the balance of risk experienced by people with diabetes and neuropathy day to day, between choosing to wear footwear to look and feel normal and choosing footwear to protect their feet from foot ulceration; b) Reflective adaption; The modification and individualisation of a set of values about footwear usage created in the minds of people with diabetes and neuropathy; c) Adherence response; The realignment of footwear choice with personal values, to reinforce the decision not to change behaviour or bring about increased footwear adherence, with or without appearance management; d) Reality appraisal; A here and now appraisal of the personal benefit of footwear choice on emotional and physical wellbeing, with additional consideration to the preservation of therapeutic footwear. CONCLUSION: For some people living at risk of diabetic neuropathic foot ulceration, the decision whether or not to wear therapeutic footwear is driven by the individual 'here and now', risks and benefits, of footwear choice on emotional and physical well-being for a given social context

Informatic Tools and Approaches in Postmarketing Pharmacovigilance Used by FDA

The safety profile of newly approved drugs and therapeutic biologics is less well developed by pre-marketing clinical testing than is the efficacy profile. The full safety profile of an approved product is established during years of clinical use. For nearly 40 years, the FDA has relied on the voluntary reporting of adverse events by healthcare practitioners and patients to help establish the safety of marketed products. Epidemiologic studies, including case series, secular trends, case-control and cohort studies, are used to supplement the investigation of a safety signal. Ideally, active surveillance systems would supplement the identification and exploration of safety signals. The FDA has implemented a number of initiatives to help identify safety problems with drugs and continues to evaluate their efforts

Medicines information and adherence in HIV/AIDS patients

Background: Providing written medicines information is being legislated in an increasing number of countries worldwide, with the patient information leaflet (PIL) being the most widely used method for conveying health information. The impact of providing such information on adherence to therapy is reportedly unpredictable. Therapy for human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS) and related opportunistic infections usually involves polytherapy and complex regimens, both of which are risk factors for non-adherence. The objective of this study was to assess the impact of medicines information on adherence to chronic co-trimoxazole therapy in low-literate HIV/AIDS patients. Methods: Two different PILs were designed for co-trimoxazole tablets and were available in both English and isiXhosa. Participants were randomly allocated to a control group (receiving no PIL), group A (receiving a 'complex PIL') and group B (receiving a 'simple PIL' incorporating pictograms). At the first interview, demographic data were collected and the time, date and day that the participant would take his/her first tablet of the month's course was also documented. In a follow-up interview adherence to therapy was assessed using two methods; self-report and tablet count. Results: The medicines information materials incorporating simple text and pictograms resulted in significantly improved adherence to therapy in the short term, whereas a non-significant increase in adherence was associated with the availability of the more complex information. This was shown by both the self-reported assessment as well as the tablet count. Conclusion: This research suggests that appropriately designed written material can have a positive impact in improving adherence and, together with verbal consultation, are essential for enabling patients to make appropriate decisions about their medicine taking

Road Trauma in Teenage Male Youth with Childhood Disruptive Behavior Disorders: A Population Based Analysis

Donald Redelmeier and colleagues conducted a population-based case-control study of 16-19-year-old males hospitalized for road trauma or appendicitis and showed that disruptive behavior disorders explained a significant amount of road trauma in this group