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Quality of life and cost-effectiveness analysis of topical tranexamic acid and fibrin glue in femur fracture surgery
Merchán-Galvis A, Posso M, Canovas E, Jordán M, Aguilera X, Martinez-Zapata MJ
BMC musculoskeletal disorders. 2022;23(1):827
Abstract
BACKGROUND We assessed quality of life (QoL) of patients undergoing surgery for proximal femur fracture and performed a cost-effectiveness analysis of haemostatic drugs for reducing postoperative bleeding. METHODS We analysed data from an open, multicentre, parallel, randomized controlled clinical trial (RCT) that assessed the efficacy and safety of tranexamic acid (TXA group) and fibrin glue (FG group) administered topically prior to surgical closure, compared with usual haemostasis methods (control group). For this study we conducted a cost-effectiveness analysis of these interventions from the Spanish Health System perspective, using a time horizon of 12 months. The cost was reported in $US purchasing power parity (USPPP). We calculated the incremental cost-effectiveness ratio (ICER) per QALY (quality-adjusted life-year). RESULTS We included 134 consecutive patients from February 2013 to March 2015: 42 patients in the TXA group, 46 in the FG group, and 46 in the control group. Before the fracture, EuroQol visual analogue scale (EQ-VAS) health questionnaire score was 68.6. During the 12 months post-surgery, the intragroup EQ-VAS improved, but without reaching pre-fracture values. There were no differences between groups for EQ-VAS and EuroQol 5 dimensions 5 levels (EQ-5D-5L) health questionnaire score, nor in hospital stay costs or medical complication costs. Nevertheless, the cost of one FG treatment was significantly higher (399.1 $USPPP) than the cost of TXA (12.9 $USPPP) or usual haemostasis (0 $USPPP). When comparing the cost-effectiveness of the interventions, FG was ruled out by simple dominance since it was more costly (13,314.7 $USPPP) than TXA (13,295.2 $USPPP) and less effective (utilities of 0.0532 vs. 0.0734, respectively). TXA compared to usual haemostasis had an ICER of 15,289.6 $USPPP per QALY). CONCLUSIONS There were no significant differences between the intervention groups in terms of postoperative changes in QoL. However, topical TXA was more cost-effective than FG or usual haemostasis. TRIAL REGISTRATION ClinicalTrials.gov: NCT02150720. Date of registration 30/05/2014. Retrospectively registered.
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Leukodepleted Packed Red Blood Cells Transfusion in Patients Undergoing Major Cardiovascular Surgical Procedure: Systematic Review and Meta-Analysis
Simancas-Racines D, Arevalo-Rodriguez I, Urrutia G, Buitrago-Garcia D, Nunez-Gonzalez S, Martinez-Zapata MJ, Madrid E, Bonfill X, Hidalgo-Ottolenghi R
Cardiology research and practice. 2019;2019:7543917
Abstract
Background: Leukocytes contained in the allogeneic packed red blood cell (PRBC) are the cause of certain adverse reactions associated with blood transfusion. Leukoreduction consists of eliminating leukocytes in all blood products below the established safety levels for any patient type. In this systematic review, we appraise the clinical effectiveness of allogeneic leukodepleted (LD) PRBC transfusion for preventing infections and death in patients undergoing major cardiovascular surgical procedures. Methods: We searched randomized controlled trials (RCT), enrolling patients undergoing a major cardiovascular surgical procedure and transfused with LD-PRBC. Data were extracted, and risk of bias was assessed according to Cochrane guidelines. In addition, trial sequential analysis (TSA) was used to assess the need of conducting additional trials. Quality of the evidence was assessed using the GRADE approach. Results: Seven studies met the eligibility criteria. Quality of the evidence was rated as moderate for both outcomes. The risk ratio for death from any cause comparing the LD-PRBC versus non-LD-PRBC group was 0.69 (CI 95% = 0.53 to 0.90; I (2) = 0%). The risk ratio for infection in the same comparison groups was 0.77 (CI 95% = 0.66 to 0.91; I (2) = 0%). TSA showed a conclusive result in this outcome. Conclusions: We found evidence that supports the routine use of leukodepletion in patients undergoing a major cardiovascular surgical procedure requiring PRBC transfusion to prevent death and infection. In the case of infection, the evidence should be considered sufficient and conclusive and hence indicated that further trials would not be required.
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3.
Quality of clinical practice guidelines about red blood cell transfusion
Simancas-Racines D, Montero-Oleas N, Vernooij RWM, Arevalo-Rodriguez I, Fuentes P, Gich I, Hidalgo R, Martinez-Zapata MJ, Bonfill X, Alonso-Coello P
Journal of evidence-based medicine. 2018
Abstract
BACKGROUND Red blood cell (RBC) transfusions are essential in health care. The quality of recommendations included in clinical practice guidelines (CPG), regarding this intervention, has not been systematically evaluated. This paper systematically assessed CPGs for RBC-transfusion, to appraise their methodological quality, to explore changes in quality over time, and to assess the consistency of the hemoglobin threshold (HT) recommendations. METHODS We searched for CPGs that included recommendations of RBC-transfusion in generic databases, compiler entities, registries, clearinghouses and guideline developers. Three reviewers extracted data on CPGs characteristics and HT recommendations, independently appraised the quality of the studies using AGREE II and resolved disagreements by consensus. RESULTS We examined 16 CPGs. Mean scores (mean +/- SD) were: scope and purpose (59.4% +/- 19.8%), stakeholder involvement (43.2% +/- 22.6%), rigor of development (50% +/- 25%), clarity of presentation (74.4% +/- 12.6%), applicability (19.4% +/- 18.8%), and editorial independence (41% +/- 30%). Seven CPGs recommended a restrictive strategy for RBC transfusion; four CPGs gave a guarded statement considering an HT of 7 g/dL, as safe to prescribe an RBC transfusion. Eight CPGs did not provide an HT stating that RBC transfusions should not be prescribed by HT alone. CONCLUSIONS Only 3 out of the 16 evaluated CPGs were "recommended" by the independent evaluators. Four domains "stakeholder involvement," "rigor of development," applicability," and "editorial independence" had serious shortcomings. Recommendations about the use of an HT for RBC-transfusion were heterogeneous among guidelines. Greater efforts are needed to provide high-quality CPGs in the RBC-transfusion practice.
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4.
Autologous platelet-rich plasma for treating chronic wounds
Martinez-Zapata MJ, Marti-Carvajal AJ, Sola I, Exposito JA, Bolibar I, Rodriguez L, Garcia J, Zaror C
The Cochrane Database of Systematic Reviews. 2016;((5)):CD006899.
Abstract
BACKGROUND Autologous platelet-rich plasma (PRP) is a treatment that contains fibrin and high concentrations of growth factors with the potential to improve the healing of chronic wounds. This is the first update of a review first published in 2012. OBJECTIVES To determine whether autologous PRP promotes the healing of chronic wounds. SEARCH METHODS In June 2015, for this first update, we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library): Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid EMBASE; and EBSCO CINAHL. We also searched for ongoing and unpublished clinical trials in the WHO International Clinical Trials Registry Platform (ICTRP) (searched January 2015). We did not impose any restrictions with respect to language, date of publication, or study setting. SELECTION CRITERIA We included randomised controlled trials (RCTs) that compared autologous PRP with placebo or alternative treatments for any type of chronic wound in adults. We did not apply any date or language restrictions. DATA COLLECTION AND ANALYSIS We used standard Cochrane methodology, including two reviewers independently selecting studies for inclusion, extracting data, and assessing risk of bias. MAIN RESULTS The search identified one new RCT, making a total of 10 included RCTs (442 participants, 42% women). The median number of participants per RCT was 29 (range 10 to 117). Four RCTs recruited people with a range of chronic wounds; three RCTs recruited people with venous leg ulcers, and three RCTs considered foot ulcers in people with diabetes. The median length of treatment was 12 weeks (range 8 to 40 weeks).It is unclear whether autologous PRP improves the healing of chronic wounds generally compared with standard treatment (with or without placebo) (risk ratio (RR) 1.19, 95% confidence interval (CI) 0.95 to 1.50; I2 = 27%, low quality evidence, 8 RCTs, 391 participants). Autologous PRP may increase the healing of foot ulcers in people with diabetes compared with standard care (with or without placebo) (RR 1.22, 95% CI 1.01 to 1.49; I2 = 0%, low quality evidence, 2 RCTs, 189 participants). It is unclear if autologous PRP affects the healing of venous leg ulcers (RR 1.02, 95% CI 0.81 to 1.27; I2 = 0% ). It is unclear if there is a difference in the risk of adverse events in people treated with PRP or standard care (RR 1.05, 95% CI 0.29 to 3.88; I2 = 0%, low quality evidence from 3 trials, 102 participants). AUTHORS' CONCLUSIONS PRP may improve the healing of foot ulcers associated with diabetes, but this conclusion is based on low quality evidence from two small RCTs. It is unclear whether PRP influences the healing of other chronic wounds. The overall quality of evidence of autologous PRP for treating chronic wounds is low. There are very few RCTs evaluating PRP, they are underpowered to detect treatment effects, if they exist, and are generally at high or unclear risk of bias. Well designed and adequately powered clinical trials are needed.
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5.
Efficacy of autologous platelet-rich plasma for the treatment of muscle rupture with haematoma: a multicentre, randomised, double-blind, placebo-controlled clinical trial
Martinez-Zapata MJ, Orozco L, Balius R, Soler R, Bosch A, Rodas G, Til L, Peirau X, Urrutia G, Gich I, et al
Blood Transfusion [Trasfusione Del Sangue]. 2015;:1-10.
Abstract
BACKGROUND The goals of the treatment of muscle injuries are to shorten the time of healing and to avoid relapses. The aim of this study was to assess the efficacy of autologous platelet-rich plasma (PRP) in the healing of muscle injuries. MATERIALS AND METHODS A multicentre, randomised, double-blind, parallel, controlled clinical trial was conducted in 71 patients (81.8% males) aged 45.6 (SD=10.0) years with muscle tears in the legs and haematoma. The haematoma was evacuated in all patients. Thirty-three patients were randomised to a single dose of autologous PRP and 38 patients to simulation of PRP administration. The primary end-point was time to complete recovery of muscle injury. Secondary end-points were pain, relapses, ultrasound parameters, and adverse events. The total follow-up per patient was 12 months. RESULTS Time to complete recovery after the treatment was 31.63 days (SD=15.38) in the PRP group, and 38.43 days (SD=18.58) in the control group (p=0.261). Pain decreased over time in both groups without statistical differences between them. Eight patients relapsed (seven in the control group, and one in the PRP group). There were no adverse effects related to the interventions. DISCUSSION Autologous PRP did not significantly improve the time to healing compared to that in the control group.