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Rugo H.S.,University of California at San Francisco | Melin S.A.,Wake forest University | Voigt J.,Medical Device consultants
Breast Cancer Research and Treatment | Year: 2017

Purpose: The risk of scalp metastases in patients using scalp cooling for preservation of hair during chemotherapy has been a concern but is poorly described. Methods: A systematic review and meta-analysis of longitudinal studies was undertaken to evaluate the effect of scalp cooling versus no scalp cooling on the risk of scalp metastasis in patients treated for breast cancer with chemotherapy. Electronic databases, journal specific, and hand searches of articles identified were searched. Patients were matched based on disease, treatment, lack of metastatic disease, and sex. Results: A total of 24 full-text articles were identified for review. Of these articles, ten quantified the incidence of scalp metastasis with scalp cooling over time. For scalp cooling, 1959 patients were evaluated over an estimated mean time frame of 43.1 months. For no scalp cooling, 1238 patients were evaluated over an estimated mean time frame of 87.4 months. The incidence rate of scalp metastasis in the scalp cooling group versus the no scalp cooling group was 0.61% (95% CI 0.32–1.1%) versus 0.41% (95% CI 0.13–0.94%); P = 0.43. Conclusion: The incidence of scalp metastases was low regardless of scalp cooling. This analysis suggests that scalp cooling does not increase the incidence of scalp metastases. © 2017 The Author(s)


Voigt J.D.,Medical Device consultants | Zappala S.M.,Tufts University | Vaughan E.D.,New York Medical College | Wein A.J.,Penn Medicine
Prostate | Year: 2014

Background Current diagnostic testing for prostate cancer results in numerous unnecessary biopsy procedures and creates a substantial financial burden. A statistical prediction model for prostate cancer has been developed, based on four Kallikrein markers in blood. This systematic review and meta-analysis examines the aggregated results from published studies of the Kallikrein Panel. METHODS Literature searches to identify relevant studies were conducted. A meta-analysis of the results was performed using inverse variance, mean difference with corresponding 95% confidence intervals (CI). The results of the meta-analysis were used to assess the Kallikrein Panel's effect on healthcare costs. RESULTS The Kallikrein Panel has been evaluated in more than 8,500 patients (2,780 with prostate cancer and 598 with high grade prostate cancer). Meta-analysis demonstrates a statistically significant improvement of 8-10% in predictive accuracy. In addition, 48% to 56% of current prostate biopsies could be avoided. Use of the Kallikrein Panel could result in annual US savings approaching $1 billion. CONCLUSIONS The Kallikrein Panel has the potential to improve patient outcomes and reduce costs. The panel provides significantly improved specificity. Because the Kallikrein Panel has been studied in a range of clinical settings, it is a test that could be readily and widely used in practice. Prostate 74:250-259, 2014. © 2013 Wiley Periodicals, Inc. © 2013 Wiley Periodicals, Inc.


Voigt J.,Medical Device consultants | Driver V.R.,Boston University
Wound Repair and Regeneration | Year: 2012

Hyaluronic acid (HA) is a polysaccharide common to most species and is found in many sites in the human body, including the skin and soft tissue. A systematic review of the literature and meta-analysis was performed to identify randomized controlled trials, evaluating the use of HA derivatives in healing burns, epithelial surgical, and chronic wounds. Nine studies were identified, which met the search criteria and clinical endpoints of complete healing and percent wound size reduction when using HA vs. either an active or passive comparator. It was found in the vast majority of randomized controlled trials (eight of nine) that HA derivatives significantly improved the healing of wounds vs. traditional therapies or placebo (either via complete healing or a significant reduction in wound size) occurring from burns, venous insufficiency, diabetes, neuropathic insufficiency, and surgical removal of the epithelial layer (for tattoo removal). In the other remaining trial, one formulation of HA was compared with another, with the higher concentration showing improved application characteristics. Further, it was found in a meta-analysis in subsets of patients with diabetic foot ulcers (neuropathic) that HA derivatives healed these types of wounds significantly faster than standard of care. These studies in aggregate show that HA derivatives accelerate the healing process in burns, epithelial surgical wounds, and chronic wounds. © 2012 by the Wound Healing Society.


Voigt J.D.,Medical Device consultants | Mosier M.C.,Washburn University
Journal of Arthroplasty | Year: 2012

The cost of primary total hip replacement products approaches 65% of the total reimbursement. Durability of total hip replacement resides with the acetabular component. This systematic review and meta-analysis determined if the outcomes of durability, function, and adverse events associated with cemented all-polyethylene acetabular components was similar to other acetabular designs, holding other variables constant. Randomized controlled trials only were evaluated. Two independent reviewers collected the data from 6 randomized controlled trials. Appropriate statistical analysis was performed. There was no statistical difference in regard to the outcomes at various time points (≤3, 4-8, and ≥10 years) in the 907 implants evaluated. There does, however, appear to be a trend toward abject failure with cemented all-polyethylene acetabular component implants consistent with findings of increased radiolucencies more than 10years out. The issue of increased radiolucencies over time and failure with these types of implants bears closer scrutiny. © 2012 Elsevier Inc..


Voigt J.,Medical Device consultants | Waltzman M.,Medical Device consultants | Lottenberg L.,Medical Device consultants
Pediatric Emergency Care | Year: 2012

Intraosseous (IO) vascular access is a viable primary alternative in patients requiring emergent vascular access in the hospital emergency department (ED) (eg, resuscitation, shock/septic shock) but is underutilized. OBJECTIVES: This review has 3 objectives: (1) review the evidence supporting the use of IO access; (2) determine the utilization of IO access as described in the literature; and (3) assess the level of specialty society support. METHODS: Electronic and hand searches were undertaken to identify relevant articles. English-language-only articles were identified. The Cochrane Review methodology along with data forms were used to collect and review data. The evidence evaluation process of the international consensus on emergency cardiovascular care was used to assess the evidence. Studies were combined where meta-analyses could be performed. RESULTS: In levels 2 to 5 studies, IO access performed better versus alternative access methods on the end points of time to access and successful access. Complications appeared to be comparable to other venous access methods. Randomized controlled trials are lacking. Newer IO access technologies appear to do a better job of gaining successful access more quickly. Intraosseous access is underutilized in the ED because of lack of awareness, lack of guidelines/indications, proper training, and a lack of proper equipment. CONCLUSIONS: Recommendations/guidelines from physician specialty societies involved in the ED setting are also lacking. Underutilization exists despite recommendations for IO access use from a number of important medical associations peripherally involved in the ED such as the American Academy of Pediatrics. To encourage the IO approach, IO product champions (as both supporter and user) in the ED are needed for prioritizing and assigning IO access use when warranted. In addition, specialty societies directly involved in emergent hospital care should develop clinical guidelines for IO use. © 2012 by Lippincott Williams & Wilkins.


Darouiche R.,Baylor College of Medicine | Mosier M.,Washburn University | Voigt J.,Medical Device consultants
PACE - Pacing and Clinical Electrophysiology | Year: 2012

Background: Surgical site infections (SSIs) resulting from cardiac implantable electronic device (CIED) implantation cause significant morbidity and mortality, and are increasing at a disproportionately higher rate than the rate of CIED implantation. The prophylactic administration of antibiotics and antiseptics can reduce this infection rate. The objective of this systematic review and meta-analysis was to determine whether the prophylactic administration of antibiotics and antiseptics in patients undergoing CIED implantation reduces the incidence of SSI in randomized controlled trials. We searched the Cochrane Wounds Group Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011, Issue 2), Ovid MEDLINE, Ovid EMBASE, and EBSCO CINAHL. No date or language restrictions were applied. Methods: Two review authors independently screened papers for inclusion, assessed risk of bias, and extracted data using a data collection form. Data were pooled where appropriate. Results: Fifteen studies (3,970 participants) were included in this review. For patients undergoing a CIED implant, perioperative systemic antibiotics (PSA) plus antiseptics delivered 1 hour before the procedure significantly reduced the incidence of SSI compared with no antibiotics (risk ratio [RR] 0.13; 95% confidence interval [CI] 0.05-0.36; P value < 0.00001). Furthermore, PSA plus antiseptics significantly reduced the incidence of postoperative infection compared to antibiotics delivered postoperatively (RR 0.14; 95% CI 0.03-0.60; P value 0.008). Conclusion: The evidence strongly suggests that antibiotic prophylaxis within 1 hour before CIED implantation is effective at reducing SSI. (PACE 2012; 35:1348-1360) © 2012, The Authors. Journal compilation © 2012 Wiley Periodicals, Inc.


Background: The cost of the implant as part of a total knee arthroplasty accounts for a substantial portion of the costs for the overall procedure: all-polyethylene tibial components cost considerably less than cemented metal-backed tibial components. We performed a systematic review of the literature to determine whether the clinical results of lower-cost all-polyethylene tibial components were comparable with the results of a more expensive metal-backed tibial component. Methods: We searched The Cochrane Library, MEDLINE, EMBASE, EBSCO CINAHL, the bibliographies of identified articles, orthopaedic meeting abstracts, health technology assessment web sites, and important orthopaedic journals. This search was performed for the years 1990 to the present. No language restriction was applied. We restricted our search to Level-I studies involving participants who received either an all-polyethylene or a metal-backed tibial implant. The primary outcome measures were durability, function, and adverse events. Two reviewers independently screened the papers for inclusion, assessed trial quality, and extracted data. Effects estimates were pooled with use of fixed and random-effects models of risk ratios, calculated with 95% confidence intervals. Heterogeneity was assessed with the I2 statistic. Forest plots were also generated. Results: Data on 1798 primary total knee implants from twelve studies were analyzed. In all studies, the median or mean age of the participants was greater than sixty-seven years, with a majority of the patients being female. There was no difference between patients managed with an all-polyethylene tibial component and those managed with a metal-backed tibial component in terms of adverse events. There was no significant difference between the two groups in terms of the durability of the implants at two, ten, and fifteen years postoperatively, regardless of the year or how durability was defined (revision or radiographic failure). Finally, with use of a variety of validated measures, there was no difference between the two groups in terms of functional status at two, eight, and ten years, regardless of the measure used. Conclusion: A less expensive all-polyethylene component as part of a total knee arthroplasty has results equivalent to those obtained with a cemented metal-backed tibial component. Using a total knee implant with a cemented allpolyethylene tibial component could save the healthcare system substantial money while obtaining equivalent results to more expensive cemented designs and materials. Level of Evidence: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence. Copyright © 2011 by the Journal of Bone and Joint Surgery Incorporated.


Voigt J.,Medical Device consultants | Mosier M.,Washburn University
Journal of Clinical Pathology | Year: 2013

A significant number of bone marrow biopsies are performed annually. Outcomes of patient pain and sample size of biopsy are important issues as perception of patient pain is underestimated by clinicians and sample size assists in accurate diagnosis. Manual extraction of marrow biopsy is the main method used. Recently a powered system has been introduced. The objectives of this systematic review and meta-analysis were to determine if the powered system reduces patient pain and improves sample capture. A PubMed and Cochrane search for randomised controlled trials was undertaken comparing the powered system with manual methods. Risk of bias assessment and meta-analysis of outcomes using appropriate statistical methods were performed. Five randomised controlled trials were identified. Patient pain (measured via visual analogue scale (VAS)-100 point scale) was significantly reduced using the powered system: mean difference=-6.57; 95% CI -12.93 to -0.22; p=0.04. The relative reduction in pain was 17%-25% with the powered system. Sample biopsy size (length in mm) was also significantly increased with the powered system: mean difference=3.65 mm; 95%; CI 1.61 mm to 5.68 mm; p=0.0005. The relative increase in sample size was 33% with the powered system. Operator ease of use (as measured via VAS) and adverse events were similar. Despite limited operator experience, patients experienced less pain and sample sizes were increased without an increase in adverse events with the powered system. The powered system may offer an option in obtaining samples from patients whose pain is compromised by disease and may reduce redos.


It has been assumed that less intense levels of care for managing heart failure result in a lowering of the overall costs for this care in the United States. The objective of this review was to determine whether this assumption is correct. A systematic review was performed using Medline, technology assessment Web sites, and relevant cardiovascular and heart failure journals from the year 2000 to the present. US randomized controlled trials where costs were evaluated as one of the endpoints were included. Data were collected using Cochrane Review characteristics of included studies and risk of bias assessment forms. Cost data from each trial were converted to a uniform cost definition and year. Meta-analysis was performed where appropriate. Ten trials were identified evaluating costs at various time points (3, 6, and 12 months). Meta-analysis of trials demonstrated no difference in costs for care, no matter the patient condition or settings. In high-quality trials examining costs, there may be a shifting in costs from more expensive care settings to less expensive care settings without savings to the healthcare system. Larger and longer-term trials should be undertaken to understand this issue.© 2012 Wiley Periodicals, Inc.


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