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The Cochrane Database of Systematic... Sep 2015Nuts contain a number of nutritional attributes which may be cardioprotective. A number of epidemiological studies have shown that nut consumption may have a beneficial... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Nuts contain a number of nutritional attributes which may be cardioprotective. A number of epidemiological studies have shown that nut consumption may have a beneficial effect on people who have cardiovascular disease (CVD) risk factors. However, results from randomised controlled trials (RCTs) are less consistent.
OBJECTIVES
To determine the effectiveness of nut consumption for the primary prevention of CVD.
SEARCH METHODS
We searched the following electronic databases: the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, Web of Science Core Collection, CINAHL, Database of Abstracts of Reviews of Effects (DARE), Health Technology Assessment Database (HTA) and Health Economics Evaluations Database (HEED) up to 30 July 2015. We searched trial registers and reference lists of reviews for further studies. We did not apply any language restrictions.
SELECTION CRITERIA
We included RCTs of dietary advice to increase nut consumption or provision of nuts to increase consumption lasting at least three months and including healthy adults or adults at moderate and high risk of CVD. The comparison group was no intervention or minimal intervention. The outcomes of interest were CVD clinical events and CVD risk factors.
DATA COLLECTION AND ANALYSIS
Two review authors independently selected trials for inclusion, abstracted the data and assessed the risk of bias in included trials.
MAIN RESULTS
We included five trials (435 participants randomised) and one ongoing trial. One study is awaiting classification. All trials examined the provision of nuts to increase consumption rather than dietary advice. None of the included trials reported on the primary outcomes, CVD clinical events, but trials were small and short term. All five trials reported on CVD risk factors. Four of these trials provided data in a useable format for meta-analyses, but heterogeneity precluded meta-analysis for most of the analyses. Overall trials were judged to be at unclear risk of bias.There were variable and inconsistent effects of nut consumption on CVD risk factors (lipid levels and blood pressure). Three trials monitored adverse events. One trial reported an allergic reaction to nuts and three trials reported no significant weight gain with increased nut consumption. None of the included trials reported on other secondary outcomes, occurrence of type 2 diabetes as a major risk factor for CVD, health-related quality of life and costs.
AUTHORS' CONCLUSIONS
Currently there is a lack of evidence for the effects of nut consumption on CVD clinical events in primary prevention and very limited evidence for the effects on CVD risk factors. No conclusions can be drawn and further high quality longer term and adequately powered trials are needed to answer the review question.
Topics: Blood Pressure; Cardiovascular Diseases; Humans; Lipids; Nuts; Primary Prevention; Randomized Controlled Trials as Topic
PubMed: 26411417
DOI: 10.1002/14651858.CD011583.pub2 -
Clinical Trials (London, England) Dec 2015The registry ClinicalTrials.gov was created to provide investigators and patients an accessible database of relevant clinical trials. (Review)
Review
BACKGROUND/AIMS
The registry ClinicalTrials.gov was created to provide investigators and patients an accessible database of relevant clinical trials.
METHODS
To understand the state of sickle cell disease clinical trials, a comprehensive review of all 174 "closed," "interventional" sickle cell trials registered at ClinicalTrials.gov was completed in January 2015.
RESULTS
The majority of registered sickle cell disease clinical trials listed an academic center as the primary sponsor and were an early phase trial. The primary outcome for sickle cell disease trials focused on pain (23%), bone marrow transplant (BMT) (13%), hydroxyurea (8%), iron overload (8%), and pulmonary hypertension (8%). A total of 52 trials were listed as terminated or withdrawn, including 25 (14% of all trials) terminated for failure to enroll participants. At the time of this review, only 19 trials uploaded results and 29 trials uploaded a manuscript in the ClinicalTrials.gov database. A systematic review of pubmed.gov revealed that only 35% of sickle cell studies completed prior to 2014 resulted in an identified manuscript. In comparison, of 80 thalassemia trials registered in ClinicalTrials.gov, four acknowledged failure to enroll participants as a reason for trial termination or withdrawal, and 48 trials (60%) completed prior to 2014 resulted in a currently identified manuscript.
CONCLUSION
ClinicalTrials.gov can be an important database for investigators and patients with sickle cell disease to understand the current available research trials. To enhance the validity of the website, investigators must update their trial results and upload trial manuscripts into the database. This study, for the first time, quantifies outcomes of sickle cell disease trials and provides support to the belief that barriers exist to successful completion, publication, and dissemination of sickle cell trial results.
Topics: Anemia, Sickle Cell; Clinical Trials as Topic; Databases, Factual; Early Termination of Clinical Trials; Healthcare Disparities; Humans; Registries
PubMed: 26085544
DOI: 10.1177/1740774515590811 -
Trials Apr 2021Patient-reported outcomes (PROs) are used in clinical trials to assess the effectiveness and tolerability of interventions. Inclusion of participants from different... (Review)
Review
BACKGROUND
Patient-reported outcomes (PROs) are used in clinical trials to assess the effectiveness and tolerability of interventions. Inclusion of participants from different ethnic backgrounds is essential for generalisability of cancer trial results. PRO data collection should include appropriately translated patient-reported outcome measures (PROMs) to minimise missing data and sample attrition.
METHODS
Protocols and/or publications from cancer clinical trials using a PRO endpoint and registered on the National Institute for Health Research Portfolio were systematically reviewed for information on recruitment, inclusion of ethnicity data, and use of appropriately translated PROMs. Semi-structured interviews were conducted with key stakeholders to explore barriers and facilitators for optimal PRO trial design, diverse recruitment and reporting, and use of appropriately translated PROMs.
RESULTS
Eighty-four trials met the inclusion criteria, only 14 (17%) (n = 4754) reported ethnic group data, and ethnic group recruitment was low, 611 (13%). Although 8 (57%) studies were multi-centred and multi-national, none reported using translated PROMs, although available for 7 (88%) of the studies. Interviews with 44 international stakeholders identified a number of perceived barriers to ethnically diverse recruitment including diverse participant engagement, relevance of ethnicity to research question, prominence of PROs, and need to minimise investigator burden. Stakeholders had differing opinions on the use of translated PROMs, the impact of trial designs, and recruitment strategies on diverse recruitment. Facilitators of inclusive research were described and examples of good practice identified.
CONCLUSIONS
Greater transparency is required when PROs are used as primary or secondary outcomes in clinical trials. Protocols and publications should demonstrate that recruitment was accessible to diverse populations and facilitated by trial design, recruitment strategies, and appropriate PROM usage. The use of translated PROMs should be made explicit when used in cancer clinical trials.
Topics: Clinical Trials as Topic; Humans; Neoplasms; Patient Reported Outcome Measures; Research Personnel
PubMed: 33902699
DOI: 10.1186/s13063-021-05255-z -
Rheumatology (Oxford, England) Sep 2017Skin involvement in SSc is an important marker of disease activity, severity and prognosis, making the assessment of skin a key issue in SSc clinical research. We... (Review)
Review
Skin involvement in SSc is an important marker of disease activity, severity and prognosis, making the assessment of skin a key issue in SSc clinical research. We reviewed the published data assessing skin involvement in clinical trials and summarized the major conclusions important in SSc clinical research. A systematic literature review identified randomized controlled trials using skin outcomes in SSc. Analysis examined the validity of the different skin measures based on literature findings. Twenty-two randomized controlled trials were found. The average study duration was 10.2 (s.d. 4.5) months, mean (s.d.) sample size 32.4 (32.6) and 26.7 (27.8) in intervention and control arms, respectively. The 17-site modified Rodnan skin score is a fully validated primary outcome measure in diffuse cutaneous SSc. Skin histology seems to be an appropriate method for evaluation of skin thickness. These findings have important implications for clinical trial design targeting skin involvement in SSc.
Topics: Clinical Trials as Topic; Disease Management; Humans; Scleroderma, Systemic; Skin Diseases
PubMed: 28992173
DOI: 10.1093/rheumatology/kex202 -
Epilepsy & Behavior : E&B Feb 2021To perform a systematic review and meta-analysis to summarize and quantitatively evaluate the electroencephalogram (EEG) findings in patients with coronavirus disease... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
To perform a systematic review and meta-analysis to summarize and quantitatively evaluate the electroencephalogram (EEG) findings in patients with coronavirus disease 2019 (COVID-19).
METHODS
The MEDLINE, CENTRAL, and ClinicalTrials.Gov databases were comprehensively assessed and searched for observational studies with EEG findings in patients with COVID-19. Pooled proportions of EEG findings with 95% confidence intervals (CIs) were assessed using a random effects model. The quality of assessment for each study, heterogeneity between the studies, and publication bias were also evaluated.
RESULTS
In total, 12 studies with 308 patients were included in the meta-analysis. Abnormal background activity and generalized slowing in the pooled proportions were common findings among the patients with COVID-19 (96.1% [95% CI: 89.4-99.9]; I = 60%; p < 0.01 and 92.3% [95% CI: 81.2-99.3]; I = 74%; p < 0.01, respectively). The proportion of patients with epileptiform discharges (EDs) was 20.3% ([95% CI: 9.85-32.9]; I = 78%; p < 0.01). The proportion of EDs varied between patients with a history of epilepsy or seizures (59.5% [95% CI: 33.9-83.2]; I = 0%; p = 0.49) and patients without them (22.4% [95% CI: 10.4-36.4]; I = 46%; p = 0.07). The findings of seizures and status epilepticus on EEG were observed in 2.05% ([95% CI: 0.02-6.04]; I = 39%; p = 0.08) and 0.80% ([95% CI: 0.00.-3.69]; I = 28%; p = 0.17) of the patients, respectively.
CONCLUSION
The proportion of abnormal background activity in patients with COVID-19 was high (96.1%). Epileptiform discharges were present in 20.3% of the cases and the proportion varied between people who had a history of epilepsy/seizure and those who did not. However, the proportion of seizures and status epilepticus on EEG was low (2.05% and 0. 80%, respectively).
Topics: COVID-19; Clinical Trials as Topic; Electroencephalography; Epilepsy; Humans
PubMed: 33342709
DOI: 10.1016/j.yebeh.2020.107682 -
Annals of Palliative Medicine Nov 2021Vascular punctures are widely used in clinical applications; however, clinical trials have identified complications and poor prognosis for patients undergoing common... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Vascular punctures are widely used in clinical applications; however, clinical trials have identified complications and poor prognosis for patients undergoing common peripheral vein puncture as compared to ultrasound-guided peripheral venipuncture and catheterization. Ultrasound-guided peripheral venipuncture and catheterization is accurate, simple, has fewer associated complications, and will gradually take the place of common peripheral vein puncture.
METHODS
To study the safety of ultrasound-guided peripheral venous catheterization, a meta-analysis was conducted of relevant articles dating from establishment date of the database (such as PubMed, MEDLINE and EMBASE) to March 2021, with the search keywords being peripheral venipuncture, ultrasound guidance, vascular injury rate, and hematoma formation rate. A total of 8 trials were used to determine accuracy indicators, which included puncture failure rate, arterial injury rate, hematoma formation rate, pneumothorax incidence rate, and hemothorax incidence rate.
RESULTS
There were statistically significant differences between the two methods for peripheral venipuncture and catheterization in terms of puncture failure rate [odds ratio (OR) =0.08; 95% CI: 0.04-0.16; P<0.00001], incidence of vascular injury (OR =0.15; 95% CI: 0.07-0.32; P<0.00001), probability of hematoma formation during the puncture process (OR =0.24; 95% CI: 0.08-0.69; P=0.008), and probability of pneumothorax during puncture (OR =0.10; 95% CI: 0.02-0.55; P=0.008).
DISCUSSION
Eight articles were included for meta-analysis. Ultrasound-guided peripheral venipuncture and catheterization is a commonly used puncture method for patients needing rapid fluid infusion with pressure or a pressure pump, repeated transfusion of blood product, or multiple daily venous blood drawing test. The results were very clear, and the puncture failure rate and other complications of ultrasound-guided peripheral venipuncture catheterization were low.
Topics: Catheterization, Central Venous; Clinical Trials as Topic; Humans; Incidence; Phlebotomy; Ultrasonography; Ultrasonography, Interventional
PubMed: 34872297
DOI: 10.21037/apm-21-3163 -
Otolaryngology--head and Neck Surgery :... Jan 2016To analyze existing tinnitus treatment trials with regard to eligibility criteria, outcome measures, study quality, and external validity and to recognize the effect of... (Review)
Review
OBJECTIVE
To analyze existing tinnitus treatment trials with regard to eligibility criteria, outcome measures, study quality, and external validity and to recognize the effect of patient demographics, symptom duration, severity, and otologic comorbidity on research findings to help practitioners apply them to patient encounters.
DATA SOURCES
Systematic literature search conducted by an information specialist for development of the American Academy of Otolaryngology-Head and Neck Surgery Foundation's tinnitus clinical practice guideline.
REVIEW METHODS
Articles were assessed for eligibility with the PRISMA protocol (Preferred Reporting Items for Systematic Reviews and Meta-analyses) and data extracted by 2 independent investigators. Studies were assessed for methodological quality, inclusion and exclusion criteria, patient demographics, and outcome measures.
RESULTS
A total of 147 randomized trials met inclusion criteria. Nearly all studies took place in a specialist setting. More than 50% did not explicitly define tinnitus, and 44% used a subjective severity threshold, such as "severely disturbing." Fifty-four percent required symptom duration of at least 6 months for study eligibility, and up to 33% excluded patients with "organic" hearing loss or otologic conditions. Mean age was 52.2 years, and median follow-up was 3 months. Only 20% had a low risk of bias.
CONCLUSION
Randomized trials of tinnitus interventions are most applicable to older adults with tinnitus lasting ≥ 6 months who are evaluated in specialty settings. High risk of bias, short follow-up, and outcome reporting raise concerns about the validity of findings and may influence how clinicians apply trial results to individual patients and establish treatment expectations, thus demonstrating the need for further quality research in this field.
Topics: Humans; Patient Selection; Practice Guidelines as Topic; Randomized Controlled Trials as Topic; Tinnitus; Treatment Outcome
PubMed: 26459245
DOI: 10.1177/0194599815608160 -
The Cochrane Database of Systematic... Sep 2018Impaired mucociliary clearance characterises lung disease in cystic fibrosis (CF). Hypertonic saline enhances mucociliary clearance and may lessen the destructive... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Impaired mucociliary clearance characterises lung disease in cystic fibrosis (CF). Hypertonic saline enhances mucociliary clearance and may lessen the destructive inflammatory process in the airways. This is an update of a previously published review.
OBJECTIVES
To investigate efficacy and tolerability of treatment with nebulised hypertonic saline on people with CF compared to placebo and or other treatments that enhance mucociliary clearance.
SEARCH METHODS
We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Cystic Fibrosis Trials Register, comprising references identified from comprehensive electronic database searches, handsearches of relevant journals and abstract books of conference proceedings. We also searched ongoing trials databases.Date of most recent searches: 08 August 2018.
SELECTION CRITERIA
Randomised and quasi-randomised controlled trials assessing hypertonic saline compared to placebo or other mucolytic therapy, for any duration or dose regimen in people with CF (any age or disease severity).
DATA COLLECTION AND ANALYSIS
Two authors independently reviewed all identified trials and data, and assessed trial quality. The quality of the evidence was assessed using GRADE.
MAIN RESULTS
A total of 17 trials (966 participants, aged 4 months to 63 years) were included; 19 trials were excluded, three trials are ongoing and 16 are awaiting classification. We judged 14 of the 17 included trials to have a high risk of bias due to participants ability to discern the taste of the solutions.Hypertonic saline 3% to 7% versus placeboAt four weeks, we found very low-quality evidence from three placebo-controlled trials (n = 225) that hypertonic saline (3% to 7%, 10 mL twice-daily) increased the mean change from baseline of the forced expiratory volume at one second (FEV) (% predicted) by 3.44% (95% confidence interval (CI) 0.67 to 6.21), but there was no difference between groups in lung clearance index in one small trial (n = 10). By 48 weeks the effect was slightly smaller in one trial (n = 134), 2.31% (95% CI -2.72 to 7.34) (low-quality evidence). No deaths occurred in the trials. Two trials reporting data on exacerbations were not combined as the age difference between the participants in the trials was too great. One trial (162 adults) found 0.5 fewer exacerbations requiring antibiotics per person in the hypertonic saline group; the second trial (243 children, average age of two years) found no difference between groups (low-quality evidence). There was insufficient evidence reported across the trials to determine the rate of different adverse events such as cough, chest tightness, tonsillitis and vomiting (very low-quality evidence). Four trials (n = 80) found very low-quality evidence that sputum clearance was better with hypertonic saline.A further trial was performed in adults with an acute exacerbation of lung disease (n = 132). The effects of hypertonic saline on short-term lung function, 5.10% higher (14.67% lower to 24.87% higher) and the time to the subsequent exacerbation post-discharge, hazard ratio 0.86 (95% CI 0.57 to 1.30) are uncertain (low-quality evidence). No deaths were reported. Cough and wheeze were reported but no serious adverse events (very low-quality evidence).Hypertonic saline versus mucus mobilising treatments Three trials compared a similar dose of hypertonic saline to recombinant deoxyribonuclease (rhDNase); two (61 participants) provided data for inclusion in the review. There was insufficient evidence from one three-week trial (14 participants) to determine the effects of hypertonic saline on FEV % predicted, mean difference (MD) 1.60% (95% CI -7.96 to 11.16) (very low-quality evidence). In the second trial, rhDNase led to a greater increase in FEV % predicted than hypertonic saline (5 mL twice daily) at 12 weeks in participants with moderate to severe lung disease, MD 8.00% (95% CI 2.00 to 14.00) (low-quality evidence). One cross-over trial (47 participants) reported 15 exacerbations during treatment with hypertonic saline and 18 exacerbations in the rhDNase group (low-quality evidence). Increased cough was reported in 13 participants using hypertonic saline and 17 on daily rhDNase in one cross-over trial of 47 people (low-quality evidence). There was insufficient evidence to assess rates of other adverse events reported. No deaths were reported.One trial (12 participants) compared hypertonic saline to amiloride and one (29 participants) to sodium-2-mercaptoethane sulphonate. Neither trial found a difference between treatments in any measures of sputum clearance; additionally the comparison of hypertonic saline and sodium-2-mercaptoethane sulphonate reported no differences in courses of antibiotics or adverse events (very low-quality evidence).One trial (12 participants) compared hypertonic saline to mannitol but did not report lung function at relevant time points for this review; there were no differences in sputum clearance, but mannitol was reported to be more 'irritating' (very low-quality evidence).
AUTHORS' CONCLUSIONS
Regular use of nebulised hypertonic saline by adults and children over the age of 12 years with CF results in an improvement in lung function after four weeks (very low-quality evidence from three trials), but this was not sustained at 48 weeks (low-quality evidence from one trial). The review did show that nebulised hypertonic saline reduced the frequency of pulmonary exacerbations (although we found insufficient evidence for this outcome in children under six years of age) and may have a small effect on improvement in quality of life in adults.Evidence from one small cross-over trial in children indicates that rhDNase may lead to better lung function at three months; qualifying this we highlight that while the study did demonstrate that the improvement in FEV was greater with daily rHDNase, there were no differences seen in any of the secondary outcomes.Hypertonic saline does appear to be an effective adjunct to physiotherapy during acute exacerbations of lung disease in adults. However, for the outcomes assessed, the quality of the evidence ranged from very low to at best moderate, according to the GRADE criteria.
Topics: Administration, Inhalation; Controlled Clinical Trials as Topic; Cystic Fibrosis; Forced Expiratory Volume; Humans; Mucociliary Clearance; Nebulizers and Vaporizers; Randomized Controlled Trials as Topic; Saline Solution, Hypertonic
PubMed: 30260472
DOI: 10.1002/14651858.CD001506.pub4 -
The Cochrane Database of Systematic... Apr 2015Telerehabilitation, an emerging method, extends rehabilitative care beyond the hospital, and facilitates multifaceted, often psychotherapeutic approaches to modern... (Review)
Review
BACKGROUND
Telerehabilitation, an emerging method, extends rehabilitative care beyond the hospital, and facilitates multifaceted, often psychotherapeutic approaches to modern management of patients using telecommunication technology at home or in the community. Although a wide range of telerehabilitation interventions are trialed in persons with multiple sclerosis (pwMS), evidence for their effectiveness is unclear.
OBJECTIVES
To investigate the effectiveness and safety of telerehabilitation intervention in pwMS for improved patient outcomes. Specifically, this review addresses the following questions: does telerehabilitation achieve better outcomes compared with traditional face-to-face intervention; and what types of telerehabilitation interventions are effective, in which setting and influence which specific outcomes (impairment, activity limitation and participation)?
SEARCH METHODS
We performed a literature search using the Cochrane Multiple Sclerosis and Rare Diseases of the Central Nervous System Review Group Specialised Register( 9 July, 2014.) We handsearched the relevant journals and screened the reference lists of identified studies, and contacted authors for additional data.
SELECTION CRITERIA
Randomised controlled trials (RCTs) and controlled clinical trials (CCTs) that reported telerehabilitation intervention/s in pwMS and compared them with some form of control intervention (such as lower level or different types of intervention, minimal intervention, waiting-list controls or no treatment (or usual care); interventions given in different settings) in adults with MS.
DATA COLLECTION AND ANALYSIS
Two review authors independently selected studies and extracted data. Three review authors assessed the methodological quality of studies using the GRADEpro software (GRADEpro 2008) for best-evidence synthesis. A meta-analysis was not possible due to marked methodological, clinical and statistical heterogeneity between included trials and between measurement tools used. Hence, we performed a best-evidence synthesis using a qualitative analysis.
MAIN RESULTS
Nine RCTs, one with two reports, (N = 531 participants, 469 included in analyses) investigated a variety of telerehabilitation interventions in adults with MS. The mean age of participants varied from 41 to 52 years (mean 46.5 years) and mean years since diagnosis from 7.7 to 19.0 years (mean 12.3 years). The majority of the participants were women (proportion ranging from 56% to 87%, mean 74%) and with a relapsing-remitting course of MS. These interventions were complex, with more than one rehabilitation component and included physical activity, educational, behavioural and symptom management programmes.All studies scored 'low' on the methodological quality assessment. Overall, the review found 'low-level' evidence for telerehabilitation interventions in reducing short-term disability and symptoms such as fatigue. There was also 'low-level' evidence supporting telerehabilitation in the longer term for improved functional activities, impairments (such as fatigue, pain, insomnia); and participation measured by quality of life and psychological outcomes. There were limited data on process evaluation (participants'/therapists' satisfaction) and no data available for cost effectiveness. There were no adverse events reported as a result of telerehabilitation interventions.
AUTHORS' CONCLUSIONS
There is currently limited evidence on the efficacy of telerehabilitation in improving functional activities, fatigue and quality of life in adults with MS. A range of telerehabilitation interventions might be an alternative method of delivering services in MS populations. There is insufficient evidence to support on what types of telerehabilitation interventions are effective, and in which setting. More robust trials are needed to build evidence for the clinical and cost effectiveness of these interventions.
Topics: Adult; Humans; Middle Aged; Multiple Sclerosis; Randomized Controlled Trials as Topic; Telemedicine; Treatment Outcome
PubMed: 25854331
DOI: 10.1002/14651858.CD010508.pub2 -
World Neurosurgery May 2017Cement leakage is the most common complication of vertebroplasty and kyphoplasty. So far, the reported risk factors remain conflicting because of limited data and lack... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Cement leakage is the most common complication of vertebroplasty and kyphoplasty. So far, the reported risk factors remain conflicting because of limited data and lack of uniform measurement and evaluation. Here, we performed a systematic review and meta-analysis of potential risk factors for cement leakage after vertebroplasty or kyphoplasty.
METHODS
Relevant literature was retrieved using PubMed, EMBASE, Cochrane Controlled Trial Register, and MEDLINE with no language restriction, supplemented by a hand search of the reference lists of selected articles. A fixed-effects model was used if homogeneity existed among included studies; otherwise, a random-effects model was used. The results were presented with weighted mean difference for continuous outcomes and odds ratio (OR) for dichotomous outcomes with a 95% confidence interval (CI).
RESULTS
Twenty-two studies consisting of 2872 patients with 4187 vertebrae were included in the meta-analysis. The incidences of cement leakage for percutaneous vertebroplasty and percutaneous balloon kyphoplasty were 54.7% and 18.4%, respectively. The significant risk factors for new vertebral compression fractures were intravertebral cleft (OR, 1.40; 95% CI, 1.09-1.78; P < 0.01), cortical disruption (OR, 5.56; 95% CI, 1.84-16.81; P < 0.01), cement viscosity (OR, 3.32; 95% CI, 1.36-8.07; P < 0.01) and injected cement volume (weighted mean difference, 0.59; 95% CI, 0.02-1.17; P < 0.05). Age, sex and fracture type, operation level, and surgical approach were not significant risk factors.
CONCLUSIONS
The results of this meta-analysis suggest that patients with intravertebral cleft, cortical disruption, low cement viscosity, and high volume of injected cement may be at high risk for cement leakage after vertebroplasty or kyphoplasty. Rigorous patient selection and individual therapeutic strategy irrespective of age, sex and fracture type, operation level, and surgical approach may reduce the occurrence of cement leakage. Given the inherent limitation of the meta-analysis, more large sample-sized randomized controlled trials are needed to further validate the present findings.
Topics: Bone Cements; Clinical Trials as Topic; Extravasation of Diagnostic and Therapeutic Materials; Fractures, Compression; Humans; Kyphoplasty; Risk Factors; Treatment Outcome; Vertebroplasty
PubMed: 28192270
DOI: 10.1016/j.wneu.2017.01.124