The Statistical Fragility of Platelet-Rich Plasma in Rotator Cuff Surgery: A Systematic Review and Meta-analysis

2021 ◽  
pp. 036354652198997
Author(s):  
Robert L. Parisien ◽  
Cooper Ehlers ◽  
Antonio Cusano ◽  
Paul Tornetta ◽  
Xinning Li ◽  
...  

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.


2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 41-41
Author(s):  
Sahil D Doshi ◽  
Morgan RL Lichtenstein ◽  
Melissa Parsons Beauchemin ◽  
Rohit R. Raghunathan ◽  
Cynthia Law ◽  
...  

41 Background: Oral anti-cancer drugs (OACDs) have become increasingly prescribed over the last 10 years and require a significant amount of care coordination. Preliminary administrative database studies have shown that 10-15% of prescriptions are never received by the patient, but the reasons behind this are poorly understood. In this study, we prospectively identified failure to receive (FR) cases in which OACD prescriptions were never received by patients, examined underlying reasons for FR, and assessed clinical and process-related factors associated with FR. Methods: We prospectively collected data on new OACD prescriptions for adult oncology patients at a large, urban academic cancer center from 1/1/2018 to 12/31/2019. We collected patient demographic, clinical, and insurance data, OACD delivery date, and interactions with payers and financial assistance groups. FR was defined as failure to receive a prescribed OACD. Reasons for FR were confirmed by manual chart review and classified into seven categories: clinical deterioration, financial access, provider-driven clinical decision making, patient-directed change, transfer of care, lost to follow up, and other. We calculated the relative proportion of each FR category and used multivariable logistic regression to identify factors associated with FR, including initiation of a prior authorization and drug class. Results: The cohort included 1,080 patients who were prescribed 1,269 new OACDs. Of these prescriptions, 13% (N=163) were categorized as FR. Among the 158 patients with FR, average patient age was 66 years, 55% identified as non-Hispanic white, 61% had any Medicare plan, 11% had Medicaid only, and 25% had commercial insurance. Overall, 18% of FR cases were attributed to clinical deterioration, 13% to financial access, 29% to provider-driven clinical decision making, 17% to patient-directed change, 13% to transfer of care, and 5% were lost to follow up. Univariate analysis showed that FR was less likely in cases where prior authorization was initiated (p < 0.001) and multivariate analysis confirmed this result (OR 0.47 [CI 0.33-0.66], p < 0.001). Conclusions: Though the majority of oncology patients prescribed OACDs received the drug, 13% of patients in our study experienced FR. FR is associated with a lack of prior authorization initiation, which may reflect barriers to access, a change in clinical decision-making, or patient choice. Ultimately, FR is multifactorial and may be appropriate in some cases. More work is needed to determine whether improved access would increase uptake in some patients. [Table: see text]



Author(s):  
Hamidreza Dehghan ◽  
Maryam Morshediam ◽  
Arezoo Dehghani ◽  
Masoud Mirzaei ◽  
Farhad Fatehi

Background: Diabetes is one of the most serious health challenges of the 21st century. The number of adults with diabetes has roughly tripled in the last 20 years. The increased burden of chronic diseases and scarce health resources compel healthcare systems to make modern patients more self-sufficient by requiring them to play a more active part in the treatment and management of their disease. Tele-home-care is a method of distance intervention through the transmission of electronic data for follow-up, education, prevention, clinical decision-making, and treatment modulation that has a high potential for the population with diabetes. Previous studies have not systematically evaluated the effects of different features of long-distance caregiving on diabetes at different stages of disease severity. Objectives: The present study describes a protocol for a systematic review and meta-analysis for summarizing the evidence comparing telehomecare interventions on diabetes management and its complications. Methods: PubMed, Scopus, ISI Web of Science, Cochrane databases, HTA (Health Technology Assessment), NHS EED (NHS Economic Evaluation Database), DARE (Database of Abstract of  Reviews of Effects), Embase, and SID will be searched using medical subject heading (MeSH) keywords. Controlled clinical trials in patients with type 1 diabetes, type 2 diabetes, and gestational diabetes will be selected based on predefined eligibility criteria. The risk of bias in studies will be checked using the JADAD score. The mean difference and its standard deviation will be calculated to be used as effect size. A random-effects meta-analysis was performed to pool the results. Subgroup analysis and meta-regression will be conducted to explore the possible sources of heterogeneity. Conclusion: The systematic review and meta-analysis provided by the results of a systematic review can be useful to endocrinologists, physicians, public health policymakers, and the general population.



2021 ◽  
Vol 10 (1) ◽  
Author(s):  
Hafte Kahsay Kebede ◽  
Lillian Mwanri ◽  
Paul Ward ◽  
Hailay Abrha Gesesew

Abstract Background It is known that ‘drop out’ from human immunodeficiency virus (HIV) treatment, the so called lost-to-follow-up (LTFU) occurs to persons enrolled in HIV care services. However, in sub-Saharan Africa (SSA), the risk factors for the LTFU are not well understood. Methods We performed a systematic review and meta-analysis of risk factors for LTFU among adults living with HIV in SSA. A systematic search of literature using identified keywords and index terms was conducted across five databases: MEDLINE, PubMed, CINAHL, Scopus, and Web of Science. We included quantitative studies published in English from 2002 to 2019. The Joanna Briggs Institute Meta-Analysis of Statistics Assessment and Review Instrument (JBI-MAStARI) was used for methodological validity assessment and data extraction. Mantel Haenszel method using Revman-5 software was used for meta-analysis. We demonstrated the meta-analytic measure of association using pooled odds ratio (OR), 95% confidence interval (CI) and heterogeneity using I2 tests. Results Thirty studies met the search criteria and were included in the meta-analysis. Predictors of LTFU were: demographic factors including being: (i) a male (OR = 1.2, 95% CI 1.1–1.3, I2 = 59%), (ii) between 15 and 35 years old (OR = 1.3, 95% CI 1.1–1.3, I2 = 0%), (iii) unmarried (OR = 1.2, 95% CI 1.2–1.3, I2 = 21%), (iv) a rural dweller (OR = 2.01, 95% CI 1.5–2.7, I2 = 40%), (v) unemployed (OR = 1.2, 95% CI 1.04–1.4, I2 = 58%); (vi) diagnosed with behavioral factors including illegal drug use(OR = 13.5, 95% CI 7.2–25.5, I2 = 60%), alcohol drinking (OR = 2.9, 95% CI 1.9–4.4, I2 = 39%), and tobacco smoking (OR = 2.6, 95% CI 1.6–4.3, I2 = 74%); and clinical diagnosis of mental illness (OR = 3.4, 95% CI 2.2–5.2, I2 = 1%), bed ridden or ambulatory functional status (OR = 2.2, 95% CI 1.5–3.1, I2 = 74%), low CD4 count in the last visit (OR = 1.4, 95% CI 1.1–1.9, I2 = 75%), tuberculosis co-infection (OR = 1.2, 95% CI 1.02–1.4, I2 = 66%) and a history of opportunistic infections (OR = 2.5, 95% CI 1.7–2.8, I2 = 75%). Conclusions The current review identifies demographic, behavioral and clinical factors to be determinants of LTFU. We recommend strengthening of HIV care services in SSA targeting the aforementioned group of patients. Trial registration Protocol: the PROSPERO Registration Number is CRD42018114418



2020 ◽  
Vol 7 (1) ◽  
Author(s):  
P. G. Robinson ◽  
T. Williamson ◽  
I. R. Murray ◽  
K. Al-Hourani ◽  
T. O. White

Abstract Purpose The purpose of this study was to perform a systematic review of the reparticipation in sport at mid-term follow up in athletes who underwent biologic treatment of chondral defects in the knee and compare the rates amongst different biologic procedures. Methods A search of PubMed/Medline and Embase was performed in May 2020 in keeping with Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) guidelines. The criteria for inclusion were observational, published research articles studying the outcomes and rates of participation in sport following biologic treatments of the knee with a minimum mean/median follow up of 5 years. Interventions included microfracture, osteochondral autograft transfer (OAT), autologous chondrocyte implantation (ACI), matrix-induced autologous chondrocyte implantation (MACI), osteochondral allograft, or platelet rich plasma (PRP) and peripheral blood stem cells (PBSC). A random effects model of head-to-head evidence was used to determine rates of sporting participation following each intervention. Results There were twenty-nine studies which met the inclusion criteria with a total of 1276 patients (67% male, 33% female). The mean age was 32.8 years (13–69, SD 5.7) and the mean follow up was 89 months (SD 42.4). The number of studies reporting OAT was 8 (27.6%), ACI was 6 (20.7%), MACI was 7 (24.1%), microfracture was 5 (17.2%), osteochondral allograft was 4 (13.8%), and one study (3.4%) reported on PRP and PBSC. The overall return to any level of sport was 80%, with 58.6% returning to preinjury levels. PRP and PBSC (100%) and OAT (84.4%) had the highest rates of sporting participation, followed by allograft (83.9%) and ACI (80.7%). The lowest rates of participation were seen following MACI (74%) and microfracture (64.2%). Conclusions High rates of re-participation in sport are sustained for at least 5 years following biologic intervention for chondral injuries in the knee. Where possible, OAT should be considered as the treatment of choice when prolonged participation in sport is a priority for patients. However, MACI may achieve the highest probability of returning to the same pre-injury sporting level. Level of evidence IV



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