technology assessment, biomedical

C-Reactive Protein Testing to Guide Antibiotic Prescribing for COPD Exacerbations

Author/s: 
Butler, Christopher C., Gillespie, David, White, Patrick, Bates, Janine, Lowe, Rachel, Thomas-Jones, Emma, Wootton, Mandy, Hood, Kerenza, Phillips, Rhiannon, Melbye, M., Llor, Carl, Cals, Jochen W.L.

BACKGROUND

Point-of-care testing of C-reactive protein (CRP) may be a way to reduce unnecessary use of antibiotics without harming patients who have acute exacerbations of chronic obstructive pulmonary disease (COPD).

METHODS

We performed a multicenter, open-label, randomized, controlled trial involving patients with a diagnosis of COPD in their primary care clinical record who consulted a clinician at 1 of 86 general medical practices in England and Wales for an acute exacerbation of COPD. The patients were assigned to receive usual care guided by CRP point-of-care testing (CRP-guided group) or usual care alone (usual-care group). The primary outcomes were patient-reported use of antibiotics for acute exacerbations of COPD within 4 weeks after randomization (to show superiority) and COPD-related health status at 2 weeks after randomization, as measured by the Clinical COPD Questionnaire, a 10-item scale with scores ranging from 0 (very good COPD health status) to 6 (extremely poor COPD health status) (to show noninferiority).

RESULTS

A total of 653 patients underwent randomization. Fewer patients in the CRP-guided group reported antibiotic use than in the usual-care group (57.0% vs. 77.4%; adjusted odds ratio, 0.31; 95% confidence interval [CI], 0.20 to 0.47). The adjusted mean difference in the total score on the Clinical COPD Questionnaire at 2 weeks was −0.19 points (two-sided 90% CI, −0.33 to −0.05) in favor of the CRP-guided group. The antibiotic prescribing decisions made by clinicians at the initial consultation were ascertained for all but 1 patient, and antibiotic prescriptions issued over the first 4 weeks of follow-up were ascertained for 96.9% of the patients. A lower percentage of patients in the CRP-guided group than in the usual-care group received an antibiotic prescription at the initial consultation (47.7% vs. 69.7%, for a difference of 22.0 percentage points; adjusted odds ratio, 0.31; 95% CI, 0.21 to 0.45) and during the first 4 weeks of follow-up (59.1% vs. 79.7%, for a difference of 20.6 percentage points; adjusted odds ratio, 0.30; 95% CI, 0.20 to 0.46). Two patients in the usual-care group died within 4 weeks after randomization from causes considered by the investigators to be unrelated to trial participation.

CONCLUSIONS

CRP-guided prescribing of antibiotics for exacerbations of COPD in primary care clinics resulted in a lower percentage of patients who reported antibiotic use and who received antibiotic prescriptions from clinicians, with no evidence of harm. (Funded by the National Institute for Health Research Health Technology Assessment Program; PACE Current Controlled Trials number, ISRCTN24346473.)

Short- and Long-Term Outcomes after Bariatric Surgery in the Medicare Population

Author/s: 
Orestis, A. Panagiotou, Markozannes, Georgios, Kowalski, Rishi, Di, Mengyang, Bond, Dale S., Ryder, Beth A., Adam, Gaelen P., Trikalinos, Thomas A.

Introduction. We conducted a technology assessment to summarize and appraise the current evidence regarding the effectiveness and safety of bariatric surgery in the Medicare-eligible population.

Data Sources. We searched six bibliographic databases and the reference lists of published clinical practice guidelines, relevant narrative and systematic reviews, and scientific information packages from manufacturers and other stakeholders on the outcomes and prediction models of different bariatric procedures studied in the Medicare-eligible population.

Results. Of 126 eligible studies, 83 described outcomes after bariatric therapy and 43 described predictors of body weight loss or absolute body weight after bariatric therapy. We did not identify any randomized clinical trials in the Medicare-eligible population. Studies examined surgical modalities. There were no studies on endoscopically-performed bariatric procedures. Only 15 studies had a design and/or analytical approach that allowed inferences for causal treatment effects on weight loss outcomes, adverse events/complications, or other non-weightloss outcomes. Bariatric surgery in the Medicare-eligible population leads to improvements in weight loss and non-weight-loss outcomes, particularly mortality, metabolic, cardiovascular, respiratory, and musculoskeletal outcomes, and polypharmacy but the strength of evidence is low to moderate. There is moderate evidence that Roux-en-Y gastric bypass performs better compared to sleeve gastrectomy or adjustable gastric banding for metabolic, cardiovascular, and renal function outcomes and for postoperative complications. Finally, no models to predict weight loss have undergone internal or external validation.

Conclusions. Relatively few nonrandomized studies examine the comparative effectiveness and safety of bariatric therapies in the Medicare population. Large gaps remain in regard to comparisons of individual bariatric surgical procedures to each other, and very limited evidence exists in regard to patient-centered outcomes such as quality of life after surgery.

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