scholarly journals A systematic review and economic evaluation of bisphosphonates for the prevention of fragility fractures

2016 ◽  
Vol 20 (78) ◽  
pp. 1-406 ◽  
Author(s):  
Sarah Davis ◽  
Marrissa Martyn-St James ◽  
Jean Sanderson ◽  
John Stevens ◽  
Edward Goka ◽  
...  
Keyword(s):  
Systematic Review ◽  
Zoledronic Acid ◽  
Fracture Risk ◽  
Fragility Fractures ◽  
Clinical Effectiveness ◽  
Controlled Trials ◽  
Bisphosphonate Treatment ◽  
Oral Bisphosphonates ◽  
Oral Bisphosphonate ◽  
Significant Difference

BackgroundFragility fractures are fractures that result from mechanical forces that would not ordinarily result in fracture.ObjectivesTo evaluate the clinical effectiveness and safety of bisphosphonates [alendronic acid (Fosamax®and Fosamax®Once Weekly, Merck Sharp & Dohme Ltd), risedronic acid (Actonel®and Actonel Once a Week®, Warner Chilcott UK Ltd), ibandronic acid (Bonviva®, Roche Products Ltd) and zoledronic acid (Aclasta®, Novartis Pharmaceuticals UK Ltd)] for the prevention of fragility fracture and to assess their cost-effectiveness at varying levels of fracture risk.Data sourcesFor the clinical effectiveness review, six electronic databases and two trial registries were searched: MEDLINE, EMBASE, The Cochrane Library, Cumulative Index to Nursing and Allied Health Literature, Web of Science and BIOSIS Previews, Clinicaltrials.gov and World Health Organization International Clinical Trials Registry Platform. Searches were limited by date from 2008 until September 2014.Review methodsA systematic review and network meta-analysis (NMA) of effectiveness studies were conducted. A review of published economic analyses was undertaken and a de novo health economic model was constructed. Discrete event simulation was used to estimate lifetime costs and quality-adjusted life-years (QALYs) for each bisphosphonate treatment strategy and a strategy of no treatment for a simulated cohort of patients with heterogeneous characteristics. The model was populated with effectiveness evidence from the systematic review and NMA. All other parameters were estimated from published sources. A NHS and Personal Social Services perspective was taken, and costs and benefits were discounted at 3.5% per annum. Fracture risk was estimated from patient characteristics using the QFracture®(QFracture-2012 open source revision 38, Clinrisk Ltd, Leeds, UK) and FRAX®(web version 3.9, University of Sheffield, Sheffield, UK) tools. The relationship between fracture risk and incremental net benefit (INB) was estimated using non-parametric regression. Probabilistic sensitivity analysis (PSA) and scenario analyses were used to assess uncertainty.ResultsForty-six randomised controlled trials (RCTs) were included in the clinical effectiveness systematic review, with 27 RCTs providing data for the fracture NMA and 35 RCTs providing data for the femoral neck bone mineral density (BMD) NMA. All treatments had beneficial effects on fractures versus placebo, with hazard ratios varying from 0.41 to 0.92 depending on treatment and fracture type. The effects on vertebral fractures and percentage change in BMD were statistically significant for all treatments. There was no evidence of a difference in effect on fractures between bisphosphonates. A statistically significant difference in the incidence of influenza-like symptoms was identified from the RCTs for zoledronic acid compared with placebo. Reviews of observational studies suggest that upper gastrointestinal symptoms are frequently reported in the first month of oral bisphosphonate treatment, but pooled analyses of placebo-controlled trials found no statistically significant difference. A strategy of no treatment was estimated to have the maximum INB for patients with a 10-year QFracture risk under 1.5%, whereas oral bisphosphonates provided maximum INB at higher levels of risk. However, the PSA suggested that there is considerable uncertainty regarding whether or not no treatment is the optimal strategy until the QFracture score is around 5.5%. In the model using FRAX, the mean INBs were positive for all oral bisphosphonate treatments across all risk categories. Intravenous bisphosphonates were estimated to have lower INBs than oral bisphosphonates across all levels of fracture risk when estimated using either QFracture or FRAX.LimitationsWe assumed that all treatment strategies are viable alternatives across the whole population.ConclusionsBisphosphonates are effective in preventing fragility fractures. However, the benefit-to-risk ratio in the lowest-risk patients may be debatable given the low absolute QALY gains and the potential for adverse events. We plan to extend the analysis to include non-bisphosphonate therapies.Study registrationThis study is registered as PROSPERO CRD42013006883.FundingThe National Institute for Health Research Health Technology Assessment programme.

scholarly journals Denosumab, raloxifene, romosozumab and teriparatide to prevent osteoporotic fragility fractures: a systematic review and economic evaluation

2020 ◽  
Vol 24 (29) ◽  
pp. 1-314 ◽  
Author(s):  
Sarah Davis ◽  
Emma Simpson ◽  
Jean Hamilton ◽  
Marrissa Martyn-St James ◽  
Andrew Rawdin ◽  
...  
Keyword(s):  
Systematic Review ◽  
Cost Effectiveness ◽  
Fracture Risk ◽  
Incremental Cost ◽  
Meta Analysis ◽  
Fragility Fractures ◽  
Clinical Effectiveness ◽  
Quality Adjusted Life Year ◽  
Mineral Density ◽  
Quality Adjusted Life

Background Fragility fractures are fractures that result from mechanical forces that would not ordinarily result in fracture. Objectives The objectives were to evaluate the clinical effectiveness, safety and cost-effectiveness of non-bisphosphonates {denosumab [Prolia®; Amgen Inc., Thousand Oaks, CA, USA], raloxifene [Evista®; Daiichi Sankyo Company, Ltd, Tokyo, Japan], romosozumab [Evenity®; Union Chimique Belge (UCB) S.A. (Brussels, Belgium) and Amgen Inc.] and teriparatide [Forsteo®; Eli Lilly and Company, Indianapolis, IN, USA]}, compared with each other, bisphosphonates or no treatment, for the prevention of fragility fracture. Data sources For the clinical effectiveness review, nine electronic databases (including MEDLINE, EMBASE and the World Health Organization International Clinical Trials Registry Platform) were searched up to July 2018. Review methods A systematic review and network meta-analysis of fracture and femoral neck bone mineral density were conducted. A review of published economic analyses was undertaken and a model previously used to evaluate bisphosphonates was adapted. Discrete event simulation was used to estimate lifetime costs and quality-adjusted life-years for a simulated cohort of patients with heterogeneous characteristics. This was done for each non-bisphosphonate treatment, a strategy of no treatment, and the five bisphosphonate treatments previously evaluated. The model was populated with effectiveness evidence from the systematic review and network meta-analysis. All other parameters were estimated from published sources. An NHS and Personal Social Services perspective was taken, and costs and benefits were discounted at 3.5% per annum. Fracture risk was estimated from patient characteristics using the QFracture® (QFracture-2012 open source revision 38, Clinrisk Ltd, Leeds, UK) and FRAX® (web version 3.9, University of Sheffield, Sheffield, UK) tools. The relationship between fracture risk and incremental net monetary benefit was estimated using non-parametric regression. A probabilistic sensitivity analysis and scenario analyses were used to assess uncertainty. Results Fifty-two randomised controlled trials of non-bisphosphonates were included in the clinical effectiveness systematic review and an additional 51 randomised controlled trials of bisphosphonates were included in the network meta-analysis. All treatments had beneficial effects compared with placebo for vertebral, non-vertebral and hip fractures, with hazard ratios varying from 0.23 to 0.94, depending on treatment and fracture type. The effects on vertebral fractures and the percentage change in bone mineral density were statistically significant for all treatments. The rate of serious adverse events varied across trials (0–33%), with most between-group differences not being statistically significant for comparisons with placebo/no active treatment, non-bisphosphonates or bisphosphonates. The incremental cost-effectiveness ratios were > £20,000 per quality-adjusted life-year for all non-bisphosphonate interventions compared with no treatment across the range of QFracture and FRAX scores expected in the population eligible for fracture risk assessment. The incremental cost-effectiveness ratio for denosumab may fall below £30,000 per quality-adjusted life-year at very high levels of risk or for high-risk patients with specific characteristics. Raloxifene was dominated by no treatment (resulted in fewer quality-adjusted life-years) in most risk categories. Limitations The incremental cost-effectiveness ratios are uncertain for very high-risk patients. Conclusions Non-bisphosphonates are effective in preventing fragility fractures, but the incremental cost-effectiveness ratios are generally greater than the commonly applied threshold of £20,000–30,000 per quality-adjusted life-year. Study registration This study is registered as PROSPERO CRD42018107651. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 29. See the NIHR Journals Library website for further project information.

Efficacy of Benson’s Relaxation Technique on Anxiety and Depression among Patients Undergoing Hemodialysis: A Systematic Review

2021 ◽  
pp. 105477382110247
Author(s):  
Haya Ibrahim Ali Abu Maloh ◽  
Kim Lam Soh ◽  
Mohannad Eid AbuRuz ◽  
Seng Choi Chong ◽  
Siti Irma Fadhilah Ismail ◽  
...  
Keyword(s):  
Systematic Review ◽  
Randomized Controlled Trials ◽  
Scientific Evidence ◽  
Relaxation Technique ◽  
Anxiety And Depression ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Depression Level ◽  
Ebsco Host

This study aimed to evaluate the efficacy of Benson’s relaxation technique on anxiety and depression among patients undergoing hemodialysis. A systematic review of randomized controlled trials was conducted. Searching databases included EBSCO Host, PubMed, ProQuest, Science Direct, Sage Journals, Ovid, and Google Scholar from January 2000 to September 2020. Five randomized controlled trials were identified. Findings revealed a statistically significant decrease in anxiety score. Concerning depression; one RCT showed a statistically significant decrease and two RCTs revealed a non-significant difference in depression level. The overall quality of the RCTs was not high. Despite that the RCTs showed benefits of BRT in managing anxiety. However, this is not the same for depression. The lack of high-quality scientific evidence supporting its retinue use indicates that additional well designed randomized controlled trials in multiple countries are warranted to support the efficacy of Benson’s relaxation technique on anxiety and depression among patients undergoing hemodialysis.

scholarly journals Cemented versus uncemented fixation in total hip replacement: a systematic review and meta-analysis of randomized controlled trials

2013 ◽  
Vol 5 (1) ◽  
pp. 8 ◽  
Author(s):  
Ali Abdulkarim ◽  
Prasad Ellanti ◽  
Nicola Motterlini ◽  
Tom Fahey ◽  
John M. O’Byrne
Keyword(s):  
Systematic Review ◽  
Randomized Controlled Trials ◽  
Controlled Trials ◽  
Implant Fixation ◽  
Short Term ◽  
Optimal Method ◽  
Radiographic Findings ◽  
Total Hip ◽  
Randomized Controlled ◽  
Significant Difference

The optimal method of fixation for primary total hip replacements (THR), particularly fixation with or without the use of cement is still controversial. In a systematic review and metaanalysis of all randomized controlled trials comparing cemented versus uncemented THRS available in the published literature, we found that there is no significant difference between cemented and uncemented THRs in terms of implant survival as measured by the revision rate. Better short-term clinical outcome, particularly an improved pain score can be obtained with cemented fixation. However, the results are unclear for the long-term clinical and functional outcome between the two groups. No difference was evident in the mortality and the post operative complication rate. On the other hand, the radiographic findings were variable and do not seem to correlate with clinical findings as differences in the surgical technique and prosthesis design might be associated with the incidence of osteolysis. We concluded in our review that cemented THR is similar if not superior to uncemented THR, and provides better short term clinical outcomes. Further research, improved methodology and longer follow up are necessary to better define specific subgroups of patients in whom the relative benefits of cemented and uncemented implant fixation can be clearly demonstrated.

scholarly journals Diagnostic and therapeutic medical devices for safer blood management in cardiac surgery: systematic reviews, observational studies and randomised controlled trials

2017 ◽  
Vol 5 (17) ◽  
pp. 1-406 ◽  
Author(s):  
Gavin J Murphy ◽  
Andrew D Mumford ◽  
Chris A Rogers ◽  
Sarah Wordsworth ◽  
Elizabeth A Stokes ◽  
...  
Keyword(s):  
Systematic Review ◽  
Cardiac Surgery ◽  
Applied Research ◽  
Near Infrared ◽  
Predictive Accuracy ◽  
Clinical Effectiveness ◽  
Cost Effective ◽  
Controlled Trials ◽  
Red Cell ◽  
Red Cell Transfusion

BackgroundAnaemia, coagulopathic bleeding and transfusion are strongly associated with organ failure, sepsis and death following cardiac surgery.ObjectiveTo evaluate the clinical effectiveness and cost-effectiveness of medical devices used as diagnostic and therapeutic tools for the management of anaemia and bleeding in cardiac surgery.Methods and resultsWorkstream 1 – in the COagulation and Platelet laboratory Testing in Cardiac surgery (COPTIC) study we demonstrated that risk assessment using baseline clinical factors predicted bleeding with a high degree of accuracy. The results from point-of-care (POC) platelet aggregometry or viscoelastometry tests or an expanded range of laboratory reference tests for coagulopathy did not improve predictive accuracy beyond that achieved with the clinical risk score alone. The routine use of POC tests was not cost-effective. A systematic review concluded that POC-based algorithms are not clinically effective. We developed two new clinical risk prediction scores for transfusion and bleeding that are available as e-calculators. Workstream 2 – in the PAtient-SPecific Oxygen monitoring to Reduce blood Transfusion during heart surgery (PASPORT) trial and a systematic review we demonstrated that personalised near-infrared spectroscopy-based algorithms for the optimisation of tissue oxygenation, or as indicators for red cell transfusion, were neither clinically effective nor cost-effective. Workstream 3 – in the REDWASH trial we failed to demonstrate a reduction in inflammation or organ injury in recipients of mechanically washed red cells compared with standard (unwashed) red cells.LimitationsExisting studies evaluating the predictive accuracy or effectiveness of POC tests of coagulopathy or near-infrared spectroscopy were at high risk of bias. Interventions that alter red cell transfusion exposure, a common surrogate outcome in most trials, were not found to be clinically effective.ConclusionsA systematic assessment of devices in clinical use as blood management adjuncts in cardiac surgery did not demonstrate clinical effectiveness or cost-effectiveness. The contribution of anaemia and coagulopathy to adverse clinical outcomes following cardiac surgery remains poorly understood. Further research to define the pathogenesis of these conditions may lead to more accurate diagnoses, more effective treatments and potentially improved clinical outcomes.Study registrationCurrent Controlled Trials ISRCTN20778544 (COPTIC study) and PROSPERO CRD42016033831 (systematic review) (workstream 1); Current Controlled Trials ISRCTN23557269 (PASPORT trial) and PROSPERO CRD4201502769 (systematic review) (workstream 2); and Current Controlled Trials ISRCTN27076315 (REDWASH trial) (workstream 3).FundingThis project was funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research programme and will be published in full inProgramme Grants for Applied Research; Vol. 5, No. 17. See the NIHR Journals Library website for further project information.

scholarly journals The association of fracture risk in atrial fibrillation patients and long-term anticoagulant therapy category: a systematic review and meta-analysis

PeerJ ◽  
2021 ◽  
Vol 9 ◽  
pp. e10683
Author(s):  
Jun Chen ◽  
Lingchun Lyu ◽  
Jiayi Shen ◽  
Chunlai Zeng ◽  
Cheng Chen ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Systematic Review ◽  
Hip Fracture ◽  
Fracture Risk ◽  
Hip Fractures ◽  
Observational Studies ◽  
Meta Analysis ◽  
Cochrane Library ◽  
Hip Fracture Risk ◽  
Significant Difference

Objective Our study aimed to assess the risk of all fractures and hip fractures in patients with atrial fibrillation (AF) who took non-vitamin K antagonist oral anticoagulants (NOACs) compared to warfarin. Methods We searched PubMed, Embase, and Cochrane Library and Clinical Trials.gov Website. Reviewed related researches up to January 31, 2020, to identify studies with more than 12 months of follow-up data. The protocol for this systematic review and meta-analysis has been registered in the International Prospective Register of Systematic Reviews (PROSPERO Number: CRD42020156893). Results We included five RCT studies, and five observational studies that contained a total of 326,846 patients in our meta-analysis. Our meta-analysis showed that patients taken NOACs had no significant all fracture risk (RR = 0.91, 95% CI [0.81–1.01]) and hip fracture risk (RR = 0.92, 95% CI [0.82–1.03]) compared with those taken warfarin. Subanalysis showed that the risk of all fractures and hip fractures treated by NOACs were significant lower compared with warfarin in observational studies compared with RCT studies. Also, a subanalysis across the duration of anticoagulation showed the NOACs users have lower all fracture risk than warfarin users when the duration of anticoagulation ≤2 years (RR = 0.89, 95% CI [0.80–0.99]). Further analysis, significant lower all fracture risk in the rivaroxaban therapy (RR = 0.81; 95% CI [0.76–0.86]) compared with warfarin but no statistical significance in hip fracture. There were no significant difference of all fracture risk and hip fracture risk in dabigatran, apixaban, and edoxaban therapy compared with warfarin. Conclusion The meta-analysis demonstrated that NOACs associated with a significantly lower all fracture risk compared with warfarin when the duration of anticoagulation more than 2 years. Rivaroxaban users had lower risk of all fracture than warfarin users in AF patients. But there was no evidence to verify apixaban, edoxaban, and dabigatranin could decrease all fracture and hip fracture risk compared with warfarin.

scholarly journals Xyloglucan, Hibiscus and Propolis in the Management of Uncomplicated Lower Urinary Tract Infections: A Systematic Review and Meta-Analysis

Antibiotics ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. 14
Author(s):  
Tommaso Cai ◽  
Umberto Anceschi ◽  
Irene Tamanini ◽  
Serena Migno ◽  
Michele Rizzo ◽  
...  
Keyword(s):  
Systematic Review ◽  
Medical Device ◽  
Meta Analysis ◽  
Clinical Effectiveness ◽  
Adult Women ◽  
End Of Treatment ◽  
Significant Difference ◽  
Clinically Significant ◽  
Tract Infections ◽  
Uncomplicated Cystitis

Background: In the era of antibiotic resistance, an antibiotic-sparing approach presents an interesting alternative treatment of uncomplicated cystitis in women. Our aim is to perform a systematic review and meta-analysis to compare the effectiveness and safety profile of a medical device containing xyloglucan, hibiscus and propolis (XHP) in women with uncomplicated cystitis. Methods: Relevant databases were searched using methods recommended by the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. The primary endpoint was clinical or microbiological success, defined as the complete (cure) and/or non-complete (improvement) resolution of symptoms at the end of treatment, or microbiological resolutions. Results: After screening 21 articles, three studies were included, recruiting a total of 178 patients. All three studies used placebo as comparator. A statistically significant difference was found in terms of clinical or microbiological resolution between the medical device and the comparator (3 RCTs, 178 patients, OR: 0.13; 95% CI: 0.05–0.33; p < 0.0001). No clinically significant adverse effects have been reported. Conclusion: A medical device containing xyloglucan, hibiscus and propolis is superior to comparator regimens in terms of clinical effectiveness in adult women with microbiologically confirmed or clinical suspicion of uncomplicated cystitis and is associated with a high patient compliance.

scholarly journals Azithromycin in patients with Covid-19; a systematic review and metanalysis

2021 ◽  
Author(s):  
Luis Ayerbe ◽  
Ivo Forgnone ◽  
Carlos Risco-Risco ◽  
Maria Perez-Pinar ◽  
Salma Ayis
Keyword(s):  
Systematic Review ◽  
Clinical Severity ◽  
Future Research ◽  
Controlled Trials ◽  
Clinical Settings ◽  
Cochrane Central Register ◽  
Random Effects Models ◽  
Central Register ◽  
Significant Difference ◽  
Observational Design

Background: Azithromycin (AZM) has been widely used in the management of Covid-19. However, the evidence on its actual effects remains disperse and difficult to apply in clinical settings. This systematic review and metanalysis summarizes the studies on the beneficial and adverse effect of AZM in patients with Covid-19. Methods: The PRISMA 2020 statement criteria were followed. Randomized controlled trials (RCTs) and observational studies comparing clinical outcomes of patients treated, and not treated, with AZM, indexed until the 5th of July 2021, were searched in PubMed, Embase, The Web of Science, Scopus, The Cochrane Central Register of Controlled Trials, and MedRXivs. We used Random-effects models to estimate pooled effect size from aggregate data. Results: The initial search produced 4950 results. Finally, 16 studies, five RCTs and 11 with an observational design, with a total of 22984 patients, were included. The metanalysis showed no difference in mortality for those treated, or not, with AZM, OR: 0.95 (0.79-1.13). There was also no significant difference for those treated, and not, with AZM in need for hospital admission or time to admission from ambulatory settings, clinical severity, need for intensive care, or adverse effects. Conclusions: These results presented in this review do not support the use of AZM in the management of Covid-19. They also show that any harm caused to the patient who received it is unlikely. Future research on treatment for patients with Covid-19 may need to focus on other drugs

scholarly journals Eye Acupuncture Treatment for Stroke: A Systematic Review and Meta-Analysis

2015 ◽  
Vol 2015 ◽  
pp. 1-11 ◽  
Author(s):  
Zeng-Hua Bai ◽  
Zhi-Xing Zhang ◽  
Chun-Ri Li ◽  
Mei Wang ◽  
Meong-Ju Kim ◽  
...  
Keyword(s):  
Systematic Review ◽  
Randomized Controlled Trials ◽  
Western Medicine ◽  
Current Evidence ◽  
Effect Estimate ◽  
Controlled Trials ◽  
Search Activity ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Eye Acupuncture

There were applications of eye acupuncture for stroke patients. Unfortunately, similar to many other Traditional Chinese Medicine (TCM) treatments, it lacks comprehensive evaluation and system review for its effect and safety.Objective. This study is a systematic review to appraise the safety and effectiveness of eye acupuncture for stroke.Methods. “Eye acupuncture therapy” in eleven databases was searched by randomized controlled trials and quasi-randomized controlled trials. The search activity was ended in April 2014. The data were extracted and assessed by three independent authors. Rev Man 5.0 software was used for data analysis with effect estimate presented as relative risk (RR) and mean difference (MD) with a 95% confidence interval.Results. Sixteen trials (1120 patients) were involved with generally poor methodological quality. The study indicated that when eye acupuncture was combined with western medicine compared to western medicine, there was a significant difference in the areas of mental state, swallow function, and NDS. When eye acupuncture was combined with western medicine and rehabilitation compared to western medicine and rehabilitation, there was significant difference in the changes of SSS, FMA, and constipation symptoms evaluation. No adverse events or side effects have been reported.Conclusions. The current evidence is insufficient and the rigorously designed trials are warranted.

scholarly journals The Timing of Initiating Complementary Feeding in Preterm Infants and Its Effect on Overweight: A Systematic Review

2018 ◽  
Vol 72 (4) ◽  
pp. 307-315 ◽  
Author(s):  
Karin M. Vissers ◽  
Edith J.M. Feskens ◽  
Johannes B. van Goudoever ◽  
Arieke J. Janse
Keyword(s):  
Systematic Review ◽  
Randomized Controlled Trials ◽  
Preterm Infants ◽  
Complementary Feeding ◽  
Controlled Trial ◽  
Controlled Trials ◽  
Z Score ◽  
Term Infants ◽  
Randomized Controlled ◽  
Significant Difference

Background: What is the appropriate time to start complementary feeding for preterm infants? The answer to this question is yet under debate. The timing of initiating complementary feeding may be associated with overweight in term infants. This systematic review aimed to study the effect of the timing of initiating complementary feeding on overweight in preterm infants. Predefined search items included preterm infants, complementary feeding, overweight, and their synonyms. Summary: The search identified 15,749 articles, of which 5 articles were included. Three studies presented data of randomized controlled trials and 2 studies were cohort studies. Two randomized controlled trials found no significant difference in body mass index (BMI) Z-score between the intervention groups at 12 months of age. One randomized controlled trial presented a significant greater mean rate of growth in length per week until 12 months in the preterm weaning strategy-group compared with the current best practices. One observational study concluded that each month the infants received complementary food later, the Z-score for length and weight was reduced by 0.1. Key Messages: No clear conclusion could be drawn from the included studies. This review illustrates the need for further research to access the effect of the timing of initiating complementary feeding on overweight in preterm infants.

Use of Prophylaxis for Prevention of Venous Thromboembolism in Patients with Isolated Foot or Ankle Surgery: A Systematic Review and Meta-Analysis

2019 ◽  
Vol 119 (10) ◽  
pp. 1686-1694 ◽  
Author(s):  
Bavand Bikdeli ◽  
Renuka Visvanathan ◽  
David Jimenez ◽  
Manuel Monreal ◽  
Samuel Z. Goldhaber ◽  
...  
Keyword(s):  
Systematic Review ◽  
Venous Thromboembolism ◽  
Meta Analysis ◽  
Evidence Base ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Foot And Ankle ◽  
Vte Prophylaxis ◽  
Ankle Surgery ◽  
Significant Difference

AbstractAlthough prophylaxis for venous thromboembolism (VTE) is recommended after many surgeries, evidence base for use of VTE prophylaxis after foot or ankle surgery has been elusive, leading into varying guidelines recommendations and notable practice variations. We conducted a systematic review of the literature to determine if use of VTE prophylaxis decreased the frequency of subsequent VTE, including deep vein thrombosis (DVT) or pulmonary embolism (PE), compared with control. We searched PubMed, the Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov through May 2018, for randomized controlled trials (RCTs) or prospective controlled observational studies of VTE prophylaxis in patients undergoing foot and ankle surgery. Our search retrieved 263 studies, of which 6 were finally included comprising 1,600 patients. Patients receiving VTE prophylaxis had lower risk for subsequent DVT (risk ratio [RR]: 0.72; 95% confidence interval [CI]: 0.55–0.94) and subsequent VTE (RR: 0.72; 95% CI: 0.55–0.94). There was only one case of nonfatal PE, no cases of fatal PE, and no change in all-cause mortality (RR: 3.51; 95% CI: 0.14–84.84). There was no significant difference in the risk for bleeding (RR: 2.12; 95% CI: 0.53–8.56). Very few RCTs exist regarding the efficacy and safety of VTE prophylaxis in foot and ankle surgery. Prophylaxis appears to reduce the risk of subsequent VTE, but the event rates are low and symptomatic events are rare. Future studies should determine the subgroups of patients undergoing foot or ankle surgery in whom prophylaxis may be most useful.

Sign in / Sign up

Export Citation Format

Share Document