Purpose To determine the potential effectiveness of a novel 10-week manualised Practical Body Image therapy (PBI) with mirror exposure (ME), when used as an adjuvant to an intensive treatment package (TAU) in adolescent inpatients with Anorexia Nervosa (AN). To evaluate the effectiveness of ME in an adolescent population. Methods Using a randomised control design, 40 girls aged 11–17 years with AN were assigned to PBI with TAU (n = 20) and TAU alone (n = 20). Both groups completed self-report measures of body image at week 1 and week 10 of the study to measure the potential effectiveness of PBI. The PBI group completed measures at week 7 to evaluate the ME component. Results 31 participants completed the study; 16 TAU, 15 PBI. PBI participants had greater improvement in all outcomes than TAU participants. Medium effect sizes were seen for self-reported weight concern, body image avoidance in terms of clothing and body image anxiety. ME produced effect sizes in self-reported body image avoidance in terms of clothing and grooming that were greater than 0.40, n = 14. Conclusion The findings demonstrate that PBI supports an intensive inpatient treatment package and addresses elements of negative body image. PBI was beneficial for addressing body image dissatisfaction with improvements in weight concerns, body image avoidance and physical appearance trait anxiety following the ME component. The magnitude of the effect sizes is comparable to previous studies. Positive qualitative feedback indicated the intervention was acceptable to users. PBI is a promising new adjuvant treatment for AN. EMB Rating Level I: randomized controlled trial.
IntroductionResistant Gram-positive organisms, such as methicillin-resistant staphylococci, account for a significant proportion of infections following joint replacement surgery. Current surgical antimicrobial prophylaxis guidelines recommend the use of first-generation or second-generation cephalosporin antibiotics, such as cefazolin. Cefazolin, however, does not prevent infections due to these resistant organisms; therefore, new prevention strategies need to be examined. One proposed strategy is to combine a glycopeptide antibiotic with cefazolin for prophylaxis. The clinical benefit and cost-effectiveness of this combination therapy compared with usual therapy, however, have not been established.Methods and analysisThis randomised, double-blind, parallel, superiority, placebo-controlled, phase 4 trial will compare the incidence of all surgical site infections (SSIs) including superficial, deep and organ/space (prosthetic joint) infections, safety and cost-effectiveness of surgical prophylaxis with cefazolin plus vancomycin to that with cefazolin plus placebo. The study will be performed in patients undergoing joint replacement surgery. In the microbiological sub-studies, we will examine the incidence of SSIs in participants with preoperative staphylococci colonisation (Sub-Study 1) and incidence of VRE acquisition (Sub-Study 2). The trial will recruit 4450 participants over a 4-year period across 13 orthopaedic centres in Australia. The primary outcome is the incidence of SSI at 90 days post index surgery. Secondary outcomes include the incidence of SSI according to joint and microorganism and other healthcare associated infections. Safety endpoints include the incidence of acute kidney injury, hypersensitivity reactions and all-cause mortality. The primary and secondary analysis will be a modified intention-to-treat analysis consisting of all randomised participants who undergo eligible surgery. We will also perform a per-protocol analysis.Ethics and disseminationThe study protocol was reviewed and approved by The Alfred Hospital Human Research Ethics Committee (HREC/18/Alfred/102) on 9 July 2018. Study findings will be disseminated in the printed media, and learnt forums.Trial registration numberACTRN12618000642280
There is an increasing incidence of revision for periprosthetic joint infection. The addition of vancomycin to beta-lactam antimicrobial prophylaxis in joint arthroplasty may reduce surgical site infections, however, the efficacy and safety have not been established.This was a multicenter, double-blind, superiority, placebo-controlled trial. We randomized 4239 adult patients undergoing joint arthroplasty surgery to receive 1.5g vancomycin or normal saline placebo, in addition to standard cefazolin antimicrobial prophylaxis. The primary outcome was surgical site infection at 90-days from index surgery. Perioperative carriage of Staphylococcus species was also assessed.In the 4113 patients included in the modified intention-to-treat population, surgical site infections occurred in 72/2069 (3.5%) in the placebo group and 91/2044 (4. 5%) in the vancomycin group (risk ratio 1.28; 95% confidence interval 0.94 to 1.73; p value 0.11). No difference was observed between the two groups for primary hip arthroplasty procedures. A higher proportion of infections occurred in knee arthroplasty patients in the vancomycin group (63/1109 [4.7%]) compared with the placebo group (42/1124 [3.7%]; risk ratio 1.52; 95% confidence interval 1.04 to 2.23; p value 0.031). Hypersensitivity reactions occurred in 11 (0.5%) patients in the placebo group and 24 (1.2%) in the vancomycin group (risk ratio 2.20; 95% confidence interval 1.08, 4.49) and acute kidney injury in 74 (3.7%) patients in the placebo group and 42 (2.1%) in the vancomycin group (risk ratio 0.57; 95% confidence interval 0.39, 0.83). Perioperative Staphylococcus aureus carriage was detected in 1089/3748 (29.1%) of patients.This is the first randomized controlled trial examining the addition of a glycopeptide antimicrobial to standard beta-lactam surgical antimicrobial prophylaxis in joint arthroplasty. The addition of vancomycin to standard cefazolin prophylaxis was not superior to placebo for the prevention of surgical site infections in hip and knee arthroplasty surgery.
There was considerable variation in how respondents thought the scenarios might be resolved, emphasising the varying levels of appreciation of the issues and lack of a uniform approach to management. An interesting dichotomy emerged between liberal and conservative approaches. Liberal pharmacists clearly believed that all MI data is in the public domain and should be produced and evaluated on request because patients have a "right" to it. The conservative pharmacists had a more protective attitude toward the patient and believed that patients should not be given information by MI pharmacists directly; rather that it should be channelled through the patient's doctor. These two approaches are not incompatible, and may be adopted by the same pharmacist at different times. From their observations, the authors propose a basis of an ethical guideline for MI pharmacists.
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