1.
Reporting in clinical studies on platelet-rich plasma therapy among all medical specialties: A systematic review of Level I and II studies
Nazaroff J, Oyadomari S, Brown N, Wang D
PloS one. 2021;16(4):e0250007
Abstract
BACKGROUND The clinical practice of platelet-rich plasma (PRP) therapy has grown significantly in recent years in multiple medical specialties. However, comparisons of PRP studies across medical fields remain challenging because of inconsistent reporting of protocols and characterization of the PRP being administered. The purpose of this systematic review was to determine the quantity of level I/II studies within each medical specialty and compare the level of study reporting across medical fields. METHODS The Cochrane Database, PubMed, and EMBASE databases were queried for level I/II clinical studies on PRP injections across all medical specialties. From these studies, data including condition treated, PRP processing and characterization, delivery, control group, and assessed outcomes were collected. RESULTS A total of 132 studies met the inclusion and exclusion criteria and involved 28 different conditions across 8 specialties (cardiothoracic surgery, cosmetic, dermatology, musculoskeletal (MSK), neurology, oral maxillofacial surgery, ophthalmology, and plastic surgery). Studies on PRP for MSK injuries made up the majority of the studies (74%), with knee osteoarthritis and tendinopathy being most commonly studied. Of the 132 studies, only 44 (33%) characterized the composition of PRP used, and only 23 (17%) reported the leukocyte component. MSK studies were more likely to use patient-reported outcome measures to assess outcomes, while studies from other specialties were more likely to use clinician- or imaging-based objective outcomes. Overall, 61% of the studies found PRP to be favorable over control treatment, with no difference in favorable reporting between MSK and other medical specialties. CONCLUSIONS The majority of level I/II clinical studies investigating PRP therapy across all medical specialties have been conducted for MSK injuries with knee osteoarthritis and tendinopathy being the most commonly studied conditions. Inconsistent reporting of PRP composition exists among all studies in medicine. Rigorous reporting in human clinical studies across all medical specialties is crucial for evaluating the effects of PRP and moving towards disease-specific and individualized treatment.
2.
The Statistical Fragility of Platelet-Rich Plasma in Rotator Cuff Surgery: A Systematic Review and Meta-analysis
Parisien RL, Ehlers C, Cusano A, Tornetta P 3rd, Li X, Wang D
The American journal of sports medicine. 2021;:363546521989976
Abstract
BACKGROUND The practice of evidence-based medicine relies on objective data to guide clinical decision-making with specific statistical thresholds conveying study significance. PURPOSE To determine the utility of applying the fragility index (FI) and the fragility quotient (FQ) analysis to randomized controlled trials (RCTs) evaluating the utilization of platelet-rich plasma (PRP) in rotator cuff repairs (RCRs). STUDY DESIGN Systematic review and meta-analysis. METHODS RCTs pertaining to the utilization of PRP in surgical RCRs published in 13 peer-reviewed journals from 2000 to 2020 were evaluated. The FI was determined by manipulating each reported outcome event until a reversal of significance was appreciated. The associated FQ was determined by dividing the FI by the sample size. RESULTS Of the 9746 studies screened, 19 RCTs were ultimately included for analysis. The overall FI incorporating all 19 RCTs was only 4, suggesting that the reversal of only 4 events is required to change study significance. The associated FQ was determined as 0.092. Of the 43 outcome events reporting lost to follow-up data, 13 (30.2%) represented lost to follow-up >4. CONCLUSION Our analysis suggests that RCTs evaluating PRP for surgical RCRs may lack statistical stability with only a few outcome events required to alter trial significance. Therefore, we recommend the reporting of an FI and an FQ in conjunction with P value analysis to carefully interpret the integrity of statistical stability in future comparative trials. CLINICAL RELEVANCE Clinical decisions are often informed by statistically significant results. Thus, a true understanding of the robustness of the statistical findings informing clinical decision-making is of critical importance.
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Transfusion of recently donated (fresh) red blood cells (RBCs) does not improve survival in comparison with current practice, while safety of the oldest stored units is yet to be established: a meta-analysis
Remy KE, Sun J, Wang D, Welsh J, Solomon SB, Klein HG, Natanson C, Cortes-Puch I
Vox Sanguinis. 2016;111((1):):43-54
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Abstract
BACKGROUND AND OBJECTIVES Preclinical studies generated the hypothesis that older stored red blood cells (RBCs) can increase transfusion risks. To examine the most updated and complete clinical evidence and compare results between two trial designs, we assessed both observational studies and randomized controlled trials (RCTs) studying the effect of RBC storage age on mortality. MATERIALS AND METHODS Five databases were searched through December 2014 for studies comparing mortality using transfused RBCs having longer and shorter storage times. RESULTS Analysis of six RCTs found no significant differences in survival comparing current practice (average storage age of 2 to 3 weeks) to transfusion of 1- to 10-day-old RBCs (OR 0.91, 95% CI 0.77-1.07). RBC storage age was lower in RCTs vs. observational studies (P = 0.01). The 31 observational studies found an increased risk of death (OR 1.13, 95% CI 1.03-1.24) (P = 0.01) with increasing age of RBCs, a different mortality effect than RCTs (P = 0.02). CONCLUSION RCTs established that transfusion of 1- to 10-day-old stored RBCs is not superior to current practice. The apparent discrepancy in mortality between analyses of RCTs and observational studies may in part relate to differences in hypotheses tested and ages of stored RBCs studied. Further trials investigating 1- to 10-day-old stored RBC benefits would seem of lower priority than studies to determine whether 4- to 6-week stored units have safety and efficacy equivalent to the 2- to 3-week-old stored RBCs commonly transfused today.
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Transfusion of older stored blood and risk of death: a meta-analysis
Wang D, Sun J, Solomon SB, Klein HG, Natanson C
Transfusion. 2012;52((6):):1184-95.
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Abstract
BACKGROUND Blood for transfusion is stored for up to 42 days. Older blood develops lesions and accumulates potentially injurious substances. Some studies report increasing toxicity as blood ages. We assessed the safety of transfused older versus newer stored blood. STUDY DESIGN AND METHODS PubMed, Scopus, and Embase were searched using terms new and old and red blood cell and storage through May 6, 2011, for observational and randomized controlled studies comparing outcomes using transfused blood having longer and shorter storage times. Death was the outcome of interest. RESULTS Twenty-one studies were identified, predominantly in cardiac surgery (n=6) and trauma (n=6) patients, including 409,966 patients. A test for heterogeneity of these studies' results was not significant for mortality (I(2) = 3.7%, p=0.41). Older blood was associated with a significantly increased risk of death (odds ratio, 1.16; 95% confidence interval [CI], 1.07-1.24). Using available mortality data, 97 (95% CI, 63-199) patients need to be treated with only new blood to save one life. Subgroup analysis of these trials indicated that the increased risk was not restricted to a particular type of patient, size of trial, or amount of blood transfused. CONCLUSION Based on available data, use of older stored blood is associated with a significantly increased risk of death. Copyright 2011 American Association of Blood Banks.