Kyle Fahrbach

Weight and type 2 diabetes after bariatric surgery: systematic review and meta-analysis.

BACKGROUND The prevalence of obesity-induced type 2 diabetes mellitus is increasing worldwide. The objective of this review and meta-analysis is to determine the impact of bariatric surgery on type 2 diabetes in association with the procedure performed and the weight reduction achieved. METHODS The review includes all articles published in English from January 1, 1990, to April 30, 2006. RESULTS The dataset includes 621 studies with 888 treatment arms and 135,246 patients; 103 treatment arms with 3188 patients reported on resolution of diabetes, that is, the resolution of the clinical and laboratory manifestations of type 2 diabetes. Nineteen studies with 43 treatment arms and 11,175 patients reported both weight loss and diabetes resolution separately for the 4070 diabetic patients in these studies. At baseline, the mean age was 40.2 years, body mass index was 47.9 kg/m2, 80% were female, and 10.5% had previous bariatric procedures. Meta-analysis of weight loss overall was 38.5 kg or 55.9% excess body weight loss. Overall, 78.1% of diabetic patients had complete resolution, and diabetes was improved or resolved in 86.6% of patients. Weight loss and diabetes resolution were greatest for patients undergoing biliopancreatic diversion/duodenal switch, followed by gastric bypass, and least for banding procedures. Insulin levels declined significantly postoperatively, as did hemoglobin A1c and fasting glucose values. Weight and diabetes parameters showed little difference at less than 2 years and at 2 years or more. CONCLUSION The clinical and laboratory manifestations of type 2 diabetes are resolved or improved in the greater majority of patients after bariatric surgery; these responses are more pronounced in procedures associated with a greater percentage of excess body weight loss and is maintained for 2 years or more.

Intermediate and long-term outcomes of total ankle arthroplasty and ankle arthrodesis. A systematic review of the literature.

BACKGROUND The efficacy of total ankle replacement compared with that of ankle fusion continues to be one of the most debated topics in foot and ankle surgery. The purpose of this study was to determine whether there are sufficient objective cumulative data in the literature to compare the two procedures. A systematic review of the literature addressing the intermediate and long-term outcomes of interest in total ankle arthroplasty and ankle arthrodesis was performed. METHODS A comprehensive search of MEDLINE for all relevant articles published in English from January 1, 1990, to March 2005 was conducted. Additionally, relevant abstracts from the 2003 and 2004 annual proceedings of major orthopaedic meetings were eligible. Two reviewers evaluated each study to determine whether it was eligible for inclusion and collected the data of interest. Meta-analytic pooling of group results across studies was performed for the two procedures. The analysis of the outcomes focused on second-generation ankle implants. RESULTS The systematic review identified forty-nine primary studies, ten of which evaluated total ankle arthroplasty in a total of 852 patients and thirty-nine of which evaluated ankle arthrodesis in a total of 1262 patients. The mean AOFAS (American Orthopaedic Foot and Ankle Society) Ankle-Hindfoot Scale score was 78.2 points (95% confidence interval, 71.9 to 84.5) for the patients treated with total ankle arthroplasty and 75.6 points (95% confidence interval, 71.6 to 79.6) for those treated with arthrodesis. Meta-analytic mean results showed 38% of the patients treated with total ankle arthroplasty had an excellent result, 30.5% had a good result, 5.5% had a fair result, and 24% had a poor result. In the arthrodesis group, the corresponding values were 31%, 37%, 13%, and 13%. The five-year implant survival rate was 78% (95% confidence interval, 69.0% to 87.6%) and the ten-year survival rate was 77% (95% confidence interval, 63.3% to 90.8%). The revision rate following total ankle arthroplasty was 7% (95% confidence interval, 3.5% to 10.9%) with the primary reason for the revisions being loosening and/or subsidence (28%). The revision rate following ankle arthrodesis was 9% (95% confidence interval, 5.5% to 11.6%), with the main reason for the revisions being nonunion (65%). One percent of the patients who had undergone total ankle arthroplasty required a below-the-knee amputation compared with 5% in the ankle arthrodesis group. CONCLUSIONS On the basis of these findings, the intermediate outcome of total ankle arthroplasty appears to be similar to that of ankle arthrodesis; however, data were sparse. Comparative studies are needed to strengthen this conclusion.

Pregnancy outcomes in women with epilepsy: A systematic review and meta-analysis of published pregnancy registries and cohorts

PURPOSE To conduct a systematic review and meta-analysis to quantify the incidence of congenital malformations (CMs) and other pregnancy outcomes as a function of in utero anti-epileptic drug (AED) exposure. METHODS We performed a systematic literature review to identify all published registries and cohort studies of births from pregnant women with epilepsy (WWE) that reported incidence of CMs. Overall incidences were calculated using a random effects model. RESULTS The review included 59 studies that met inclusion/exclusion criteria, involving 65,533 pregnancies in WWE and 1,817,024 in healthy women. The calculated incidence of births with CM in WWE [7.08%; 95% CIs 5.62, 8.54] was higher than healthy women [2.28%; CIs 1.46, 3.10]. Incidence was highest for AED polytherapy [16.78%; CIs 0.51, 33.05]. The AED with the highest CM incidence was valproate, which was 10.73% [CIs 8.16, 13.29] for valproate monotherapy. CONCLUSIONS Results of this systematic literature review suggest that the overall incidence of CMs in children born of WWE is approximately threefold that of healthy women. The risk is elevated for all AED monotherapy and further elevated for AED polytherapy compared to women without epilepsy. The risk was significantly higher for children exposed to valproate monotherapy and to polytherapy of 2 or more drugs when the polytherapy combination included phenobarital, phenytoin, or valproate. Further research is needed to delineate the specific risk for each individual AED and to determine underlying mechanisms including genetic risk factors.

The effect of anemia treatment on selected health-related quality-of-life domains: a systematic review.

BACKGROUND Anemia is a reduction in the oxygen-carrying capacity of red blood cells that results in a variety of symptoms, including dyspnea, headaches, light-headedness, and fatigue. Although anemia has been associated with reduced health-related quality of life (HRQoL), its treatment has not yet been consistently shown to improve HRQoL. OBJECTIVE This systematic review of the literature was conducted to determine whether the treatment of anemia improves HRQoL domains, regardless of the type of underlying disease. METHODS Data for this review were drawn from the clinical trial databases from 2 previous systematic literature reviews of erythropoiesis-stimulating protein treatment for renal insufficiency- and cancer-related anemia, both spanning the period January 1, 1980, through December 31, 2001. MEDLINE, Cancerlit, and Current Contents/Clinical Medicine were searched using the combined terms erythropoietin, kidney failure, neoplasms, and anemia. The reference lists of all identified articles were searched manually for additional relevant papers. The review included prospective studies that reported both HRQoL and hematocrit (Hct) in patients with cancer or renal insufficiency who received treatment for anemia with an erythropoiesis-stimulating protein. HRQoL was categorized by domain (overall, energy/fatigue, physical, activity); changes in HRQoL domains were expressed as effect sizes and meta-analyzed, as were correlation coefficients. The effects on HRQoL of dropout rate, study duration, baseline Hct, and change in Hct were examined in meta-regression analyses. RESULTS Sixteen studies each were identified in patients with renal insufficiency (N = 2253) and patients with cancer (N = 10,695). The treated groups included 11,710 patients, and the control groups included 1238 patients. The baseline Hct in all treated groups averaged 26.0%: 28.3% in the group with cancer and 24.4% in the group with renal insufficiency. The mean improvement in Hct from baseline to the end of treatment was 8.3% (range, 1.0%-16.5%) in treated patients and 1.0% (range, 0.0%-3.3%) in controls. The Hct changes were similar in treated patients with cancer and treated patients with renal insufficiency, as was the HRQoL effect size (0.43). Dropout rate and study duration were not significant predictors of HRQoL changes, but change in Hct was a significant predictor in both conditions. Meta-analysis of the correlation coefficients, adjusting for HRQoL domains, showed a consistent and significant positive correlation between change in Hct and change in HRQoL (P < 0.001). CONCLUSION The consistency in both direction and magnitude of effect across many studies and thousands of patients supports the hypothesis that treatment of anemia with erythropoiesis-stimulating protein improves selected HRQoL domains in patients with renal insufficiency- or cancer-related anemia.

Studies of Swedish adjustable gastric band and Lap-Band: systematic review and meta-analysis

BACKGROUND This is the first systematic review and meta-analysis of the large body of data describing the Swedish adjustable gastric band (SAGB) and Lap-Band (LB). METHODS A systematic review was performed that included screening of studies published in any language (January 1, 1998 through April 30, 2006) identified through MEDLINE, Current Contents, or the Cochrane Library. Studies with > or =10 SAGB or LB patients reporting > or =30-day efficacy or safety outcomes were eligible for review; the data were extracted from the accepted studies. A weighted means analysis and random-effects meta-analysis of efficacy outcomes of interest were conducted. RESULTS A total of 4592 bariatric surgery studies met the initial criteria. Of these studies, 129 (28,980 patients) were accepted (33 SAGB and 104 LB studies); most had a retrospective single-center design. For 4273 patients (36 treatment groups) in 33 SAGB studies and 24,707 patients (111 groups) in 104 LB studies, the mean baseline age (39.1-40.2 yr), body mass index (43.8-45.3 kg/m2), and gender (women 79.2-82.5%) were similar. A laparoscopic technique was used in > or =88% and a pars flaccida technique in > or =41% of both groups. Early mortality was equivalent for SAGB/LB (< or =.1%). The 3-year mean SAGB and LB excess weight loss (56.36% and 50.20%, respectively) and body mass index reduction (-11.99 and -11.81 kg/m2, respectively) from baseline were statistically significant (P <.05), as was the resolution of diabetes (61.45% and 60.29%, respectively) and hypertension (62.95% and 43.58%, respectively). Although scant and inconsistently reported data precluded direct statistical comparisons, the complication rates for the 2 devices appeared comparable. In 8 directly comparative studies, meta-analysis found a significantly greater absolute weight loss (P <.05) with the SAGB at 2 years (48.4 versus 41.9 kg, mean difference -4.84, 95% confidence interval -9.47 to -0.22), although no difference was found in the percentage of excess weight loss or change in body mass index. CONCLUSION In a systematic review of the published world SAGB and LB data, at 1, 2, and 3 years, the weight loss, resolution of diabetes and hypertension, and complications appeared comparable.

A comparison of the accuracy of two minimally invasive breast biopsy methods: a systematic literature review and meta-analysis

Objective: The primary objective was to quantify and compare the accuracy and failure rates of directional vacuum assisted biopsy (DVAB) and core needle biopsy (CNB) when used under stereotactic (ST) guidance to biopsy suspicious breast lesions identified with screening mammography. Methods: We performed a systematic review of the literature published from January 1996 to July 2004, reporting all-comers populations in Western-style health care systems (i.e., North America, Europe, Australia or New Zealand), referred after screening mammography for breast biopsy using DVAB or CNB under ST guidance. Meta-analyses were conducted for DVAB and CNB, using open surgical biopsy and/or long-term clinical and/or mammogram follow-up as the diagnostic reference standard. The main outcomes of interest were those of greatest clinical relevance, i.e., miss rates and underestimation rates for malignancy. Also, technical failure rate and non-diagnostic rate were assessed for each biopsy method. Results: Thirty-five studies qualified for the review. There were 12 studies with a DVAB group (n=5,119 patients), and 25 studies with a CNB group (n=6,236). There were no studies including both a DVAB and a CNB group, thus precluding any direct, within-study comparisons of accuracy. Overall agreement rate between DVAB and the reference standard was 97.3%, and between CNB and the reference standard, 93.5%. The frequency of technical failures with CNB was slightly higher than DVAB (5.7 vs. 1.5%), as was the frequency of non-diagnostic samples (2.1 vs. 0%). Of the non-diagnostic CNB samples, 23% were subsequently found to be malignant on reference standard. In multivariate analyses using four covariates (procedure type, geographic location, reference standard, and patient position), there were no significant predictors of agreement rates, but some variables were significant predictors of miss rates. For benign to malignant upgrades, study location was a significant predictor, with more upgrades in non-NA locations. For atypia to malignant upgrades, the type of procedure was a significant predictor, with more underestimations in CNB studies. Conclusion: The best available evidence suggests that, in screening populations referred for minimally invasive breast biopsy biopsy requiring ST guidance, DVAB may provide lower miss and underestimation rates for clinically relevant diagnoses than does CNB.

Effect of amlodipine on systolic blood pressure

BACKGROUND Systolic hypertension is the most common form of hypertension, particularly in people aged >60 years. Caused by decreased compliance of large arteries, systolic hypertension is an independent risk factor for cardiovascular disease. Recent studies have demonstrated that it is more important to control systolic blood pressure (SBP) than diastolic blood pressure (DBP). OBJECTIVE The objective of this study was to perform a systematic literature review to examine the effectiveness of amlodipine in lowering SBP in a variety of patient subgroups and clinical settings. METHODS The literature review methodology included identifying, selecting, appraising, extracting, and synthesizing primary research studies. Following an a priori protocol, published literature was searched from 1980 to 2001 using 3 electronic databases. A manual review of the reference lists of recent review articles and all accepted studies was performed. Parallel-group, randomized, controlled trials that included at least 10 adults with baseline hypertension (SBP>or=140 mm Hg, DBP>or=90 mm Hg, or both), included at least 1 arm randomized to initial treatment with amlodipine monotherapy, had a minimum treatment duration of 8 weeks, and reported baseline and end-point blood pressure were included. RESULTS Of 696 citations identified, 85 primary studies met all inclusion criteria. Comparable treatment arms were pooled, and weightd mean SBP was calculated. In the amlodipine monotherapy arms, which included >5000 patients, SBP decreased by a mean of 17.5 mm Hg from baseline. The effect of amlodipine in reducing SBP was greater in elderly patients (age>or=60 years) and patients with author-defined isolated systolic hypertension. The dose was titrated to achieve the target blood pressure in 73 of 89 amlodipine treatment arms, whereas 16 treatment arms reported fixed doses. The median daily dose was 5 mg (range, 1.25-15 mg) in both the fixed-dose and dose-titration groups. CONCLUSIONS In this review of the published literature, amlodipine monotherapy was effective in reducing SBP. Antihypertensive agents such as amlodipine warrant consideration for the management of patients with inadequately controlled SBP.

Mortality and morbidity among infants at high risk for severe respiratory syncytial virus infection receiving prophylaxis with palivizumab: a systematic literature review and meta-analysis.

Objectives: A systematic literature review and meta-analysis was performed to evaluate the impact of prophylaxis with palivizumab on mortality and morbidity associated with respiratory syncytial virus infection in infants at high risk (≤35 wks of gestational age, chronic lung disease, or congenital heart disease). Data Sources: MEDLINE, EMBASE, and Current Contents were used. MEDLINE was searched from January 1, 1990 to May 16, 2007. The bibliographies of accepted studies and recent reviews and proceedings from the past 2 yrs were searched to identify additional relevant studies. Study Selection: Randomized controlled trials and prospective or retrospective cohort studies evaluating all-cause and respiratory syncytial virus-specific mortality, respiratory syncytial virus hospitalizations, and health care use in infants at high risk for respiratory syncytial virus infection receiving prophylaxis with palivizumab. Data Extraction: Data elements from each accepted study were extracted by one researcher and confirmed by a second researcher. Differences were resolved before data entry and analysis. Data Synthesis: A total of 2473 citations were screened and ten comparative studies of palivizumab prophylaxis evaluating >15,000 infants were included. Comparisons of mortality and hospitalization outcomes between infant groups using prophylaxis and not using prophylaxis were made using meta-analyses. Conclusions: Prophylaxis and nonprophylaxis infant groups appeared to be comparable at baseline. All-cause mortality during the respiratory syncytial virus season was 12 of 6380 (0.19%) for infants with prophylaxis vs. 33 of 8182 (0.53%) for infants without prophylaxis (Peto odds ratio, 0.30; 95% confidence interval, 0.17–0.55). Only five respiratory syncytial virus-specific deaths were reported, and the majority of the studies did not report respiratory syncytial virus-related deaths. The rate of respiratory syncytial virus hospitalization was significantly lower among preterm infants with prophylaxis compared with those without prophylaxis (4.1% vs. 10.4%; odds ratio, 0.35; 95% confidence interval, 0.25–0.47). Prophylaxis with palivizumab was associated with a reduction in all-cause mortality and respiratory syncytial virus hospitalization among preterm infants at high risk. Additional research on cause of death among infants at high risk is needed.

Ultrasonic and Nonultrasonic Instrumentation: A Systematic Review and Meta-analysis

OBJECTIVE To compare the efficacy and safety of ultrasonic surgical instrumentation with nonultrasonic traditional surgical techniques in various types of surgery. DATA SOURCES Electronic searches of MEDLINE, Current Contents, and the Cochrane Library were performed for the period of 1990 to June 1, 2005, using relevant search terms. A manual check of all references in accepted studies was also performed. STUDY SELECTION Only comparative studies (including randomized and nonrandomized control trials) of ultrasonic surgical instrumentation with nonultrasonic instrumentation were accepted. Procedures of interest included the following: colorectal surgery, gynecologic surgery, head and neck surgery, solid organ surgery, vessel harvesting, cholecystectomy, hemorrhoidectomy, mastectomy, and Nissen fundoplication. DATA EXTRACTION Two investigators reviewed each study: the first investigator extracted all relevant data, and consensus of each extraction was performed by a second investigator to verify the data. Data were then entered into a database and quality checked for accuracy. DATA SYNTHESIS Fifty-one primary studies that examined 4902 patients were included in this systematic review, of which 24 were randomized trials and 27 were nonrandomized studies. Comparative meta-analyses for blood loss, surgery time, and hospital length of stay were performed using a random-effects model and stratified by surgery type. Heterogeneity was tested using Q statistics. Statistical significance was defined as P < .05. CONCLUSION Meta-analysis of outcomes comparing ultrasonic with conventional nonultrasonic surgical instrumentation demonstrates significant improvement of several perioperative outcomes in procedure-specific settings when ultrasonic instrumentation is used.

Cost-efficacy comparison of biological therapies for patients with moderate to severe psoriasis in Japan

Background: Biological therapies have recently been introduced for patients with moderate to severe psoriasis in Japan. Objectives: This research aims to assess the cost efficacy of adalimumab, infliximab and ustekinumab treatments for psoriasis in a Japanese environment. Methods: A mixed-treatment comparison was performed to estimate the comparative efficacy of biological therapies using Psoriasis Area and Severity Index (PASI) scores based on data from randomized, double-blind, controlled studies. Costs included only the drug costs calculated by the approved dosing and schedule. Cost efficacy was determined by dividing the cost by the probability of achieving a PASI 75 response. Results: Infliximab had the highest probability of a PASI 75 response (83%), followed by ustekinumab 45 mg (74%) and adalimumab (59%). Infliximab was the most expensive biologic, whereas the costs of ustekinumab 45 mg and adalimumab were similar. In the first year of induction treatment, the lowest cost per responder was for ustekinumab 45 mg, followed by adalimumab and infliximab. In the subsequent year of maintenance treatment, the cost per responder of ustekinumab 45 mg remained the lowest while infliximab and adalimumab had similar cost efficacy. Conclusions: Ustekinumab was a more cost-efficient biological therapy than adalimumab or infliximab for psoriasis patients in a Japanese setting.