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Clinical Drug Investigation Mar 2016Iron deficiency is very common in a number of medical conditions. Ferric carboxymaltose is a new stable iron preparation that can be administered in single infusions... (Meta-Analysis)
Meta-Analysis Review
Efficacy and Safety of Ferric Carboxymaltose and Other Formulations in Iron-Deficient Patients: A Systematic Review and Network Meta-analysis of Randomised Controlled Trials.
BACKGROUND
Iron deficiency is very common in a number of medical conditions. Ferric carboxymaltose is a new stable iron preparation that can be administered in single infusions over short periods of time. The aim of this study was to conduct a systematic review of randomised controlled trials (RCTs) regarding the efficacy and safety of the novel complex compared with other iron formulations. In addition, the feasibility of a network meta-analysis for indirect comparisons was investigated.
METHODS
A systematic literature review was performed for published RCTs on the use of ferric carboxymaltose in iron deficiency between July and October 2014. Indirect comparisons were also addressed using terms referring to competing iron formulations. We further supported the qualitative results of the systematic review by a network meta-analysis that allows pooling the evidence around different intervention outcomes in the absence of trials involving a direct comparison.
RESULTS
The initial search yielded 1027 citations, which was decreased to 21 studies eligible for inclusion in the review. Studies were heterogeneous in the number of patients randomised, iron deficiency-related conditions addressed, trial inclusion criteria, time horizon, treatment dosage and outcomes assessed. Six studies with the same time horizon (i.e. 6 weeks) were included in the network meta-analysis. Considering the differences between final and initial outcome values for each iron formulation, the mean difference of these differences (delta) was estimated for each couple of treatments involving ferric carboxymaltose. Significant improvements in serum ferritin (µg/l) were obtained with ferric carboxymaltose compared to oral iron (delta 172.8; 95 % CI 66.7-234.4) and in haemoglobin (g/dl) with respect to ferric gluconate (delta 0.6; 95 % CI 0.2-0.9), oral iron (delta 0.8; 95 % CI 0.6-0.9) and placebo (delta 2.1; 95 % CI 1.2-3.0).
CONCLUSIONS
All currently available intravenous iron preparations appear to be safe and effective, but ferric carboxymaltose seems to provide a better and quicker correction of haemoglobin and serum ferritin levels in iron-deficient patients.
Topics: Administration, Intravenous; Chemistry, Pharmaceutical; Ferric Compounds; Hemoglobins; Humans; Iron Deficiencies; Maltose; Randomized Controlled Trials as Topic
PubMed: 26692005
DOI: 10.1007/s40261-015-0361-z -
Expert Review of Pharmacoeconomics &... 2015The aim of this study was to review and critically assess the health economics literature on post-treatment follow-up for adult cancer survivors. A systematic search was... (Review)
Review
The aim of this study was to review and critically assess the health economics literature on post-treatment follow-up for adult cancer survivors. A systematic search was performed using PubMed, EMBASE and the Cochrane Library. The Consolidated Health Economic Evaluation Reporting Standards checklist was adopted to assess the quality of the included studies. Thirty-nine articles met the eligibility criteria. Around two thirds of the studies addressed the most common cancers (i.e., breast, colorectal, cervical and lung); 21 were based on a single clinical study, while the rest were modeling papers. All types of economic evaluations were represented other than cost-benefit analysis. The overall quality was generally high with an average proportion of 74% of checklist criteria fulfilled. The cost-effectiveness results supported the current trend towards less intensive, primary care-based and risk-adapted follow-up schemes.
Topics: Adult; Aftercare; Checklist; Cost-Benefit Analysis; Humans; Models, Economic; Neoplasms; Primary Health Care; Survivors
PubMed: 26449255
DOI: 10.1586/14737167.2015.1087316 -
Expert Review of Pharmacoeconomics &... Oct 2014Assessing the value of health technologies, through health technology assessment is critically dependent on the existence of relevant and robust clinical data on the... (Review)
Review
Assessing the value of health technologies, through health technology assessment is critically dependent on the existence of relevant and robust clinical data on the efficacy, safety and ideally, effectiveness of the technologies concerned. However, in the case of medical devices, such clinical data may not always be available, because of the different nature of the regulatory requirements in different jurisdictions. Therefore, we conducted a systematic review of the regulatory requirements in seven major jurisdictions in order to identify current challenges and to suggest possible improvements. There are differences in the requirements across jurisdictions and in the balance between pre-market and post-market controls. Several improvements are required in order to generate adequate clinical data for health technology assessment.
Topics: Cost-Benefit Analysis; Device Approval; Equipment and Supplies; Evidence-Based Medicine; Government Regulation; Health Care Costs; Humans; Medical Device Legislation; Patient Safety; Product Surveillance, Postmarketing; Risk Assessment; Technology Assessment, Biomedical
PubMed: 25196848
DOI: 10.1586/14737167.2014.950233 -
The Cochrane Database of Systematic... Oct 2012It is not clear which fixation of total knee arthroplasty obtains the best clinical, functional and radiographic results in people with osteoarthritis and other... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
It is not clear which fixation of total knee arthroplasty obtains the best clinical, functional and radiographic results in people with osteoarthritis and other non-traumatic diseases, such as rheumatoid arthritis.
OBJECTIVES
To assess the benefits and harms of cemented, cementless and hybrid knee prostheses fixation techniques in participants with primary osteoarthritis (osteoarthritis following trauma was not included) and other non-traumatic diseases, such as rheumatoid arthritis.
SEARCH METHODS
We searched CENTRAL (2011, issue 10), MEDLINE via PubMed, EMBASE, Current Controlled Trials, LILACS, The Cumulative Index to Nursing and Allied Health Literature, SPORTDiscus, Health Technology Assessment Database and the Database of Abstracts of Reviews of Effectiveness, all from implementation to October 2011, along with handsearches of high-yield journals and reference lists of articles. No language restrictions were applied.
SELECTION CRITERIA
Randomized controlled trials (RCTs) evaluating cemented, cementless and hybrid fixation. Participants included patients that were 18 years or older with osteoarthritis and other non-traumatic diseases who were undergoing primary total knee arthroplasty.
DATA COLLECTION AND ANALYSIS
Three authors independently selected the eligible trials, assessed the trial quality, risk of bias and extracted data. Researchers were contacted to obtain missing information.
MAIN RESULTS
Five RCTs and 297 participants were included in this review. Using meta-analysis on roentgen stereophotogrammetric analysis (RSA) we observed that cemented fixation of the tibial components demonstrated smaller displacement in relation to cementless fixation (with and without hydroxyapatite) after a follow-up of two years (maximum total point-motion, N = 167, two RCTs, mean difference (MD) = 0.52 mm, 95% confidence interval (CI) 0.31 to 0.74). However, the risk of future aseptic loosening with uncemented fixation was approximately half that of cemented fixation according to the arthroplasty instability classification (moderate quality as assessed by GRADE) inferred from RSA (N = 216, three RCTs, risk ratio (RR) = 0.47, 95% CI 0.24 to 0.92) with a 16% absolute risk difference between groups. The number needed to treat for an additional beneficial outcome (NNTB) to prevent future aseptic loosening was 7 (95% CI 5 to 44). There was a low risk of bias for RSA among the studies included. It was not possible to perform meta-analysis on patient-important outcomes, such as the survival rate of the implant (any change of a component), patient global assessments, functional measures, pain, health-related quality of life measures and adverse events. Almost all included studies recorded functional measures of Knee Society and Hospital for Special Surgery knee scores, but the authors of each study found no significant difference between the groups.
AUTHORS' CONCLUSIONS
There was a smaller displacement of the cemented tibial component in relation to the cementless fixation in studies with osteoarthritis and rheumatoid arthritis participants who underwent primary total knee prosthesis with a follow-up of two years; however, the cemented fixation presented a greater risk of future aseptic loosening than cementless fixation.
Topics: Arthritis, Rheumatoid; Arthroplasty, Replacement, Knee; Biocompatible Materials; Bone Cements; Durapatite; Humans; Knee Prosthesis; Osteoarthritis, Knee; Prosthesis Failure; Radiostereometric Analysis; Randomized Controlled Trials as Topic; Time Factors; Treatment Outcome
PubMed: 23076921
DOI: 10.1002/14651858.CD006193.pub2 -
The Journal of Manual & Manipulative... 2008The high frequency of static and dynamic palpation methods used during evaluation of SIJ problems in clinical practice demands an understanding of the factual quantity...
The high frequency of static and dynamic palpation methods used during evaluation of SIJ problems in clinical practice demands an understanding of the factual quantity of movement at the SIJ. The objective of this systematic literature review was to synthesize three-dimensional (3-D) motion of the sacroiliac joint (SIJ) during various functional static postures and movements and to determine the clinical utility of movement during examination. A computer-based search was performed by means of OVID, which included Medline (February 1966 to April 2007) and CINAHL (February 1982 to April 2007) using the key words Pelvis, Kinematics, Imaging, Three-dimensional, and Stereophotogrammetric. Articles included in-vivo or in-vitro studies that investigated human SIJs with 3-D analysis. Three-dimensional analyses conducted using mathematical modeling, computerized modeling, and/or skin markers were not included because of concerns of transferability and validity. Studies that failed to report standard error of measurement (SEM) or defined tabulated values for translations or rotations using the Cartesian coordinate system were not considered for this study. Studies included for review were analyzed by the SBC biomechanical checklist to measure the quality of procedural design. Seven manuscripts were eligible for inclusion in this study. Rotation ranged between -1.1 to 2.2 degrees along the X-axis, -0.8 to 4.0 degrees along the Y-axis, and -0.5 to 8.0 degrees along the Z-axis. Translation ranged between -0.3 to 8.0 millimeters (mm) along the X-axis, -0.2 to 7.0 mm along the Y-axis, -0.3 to 6.0 mm along the Z-axis. Motion of the SIJ is limited to minute amounts of rotation and of translation suggesting that clinical methods utilizing palpation for diagnosing SIJ pathology may have limited clinical utility.
PubMed: 19119382
DOI: 10.1179/106698108790818639