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PloS One 2017The aim of this systematic review was to document efficacy, safety and quality of evidence of analgesic interventions after total knee arthroplasty (TKA). (Meta-Analysis)
Meta-Analysis Review
INTRODUCTION
The aim of this systematic review was to document efficacy, safety and quality of evidence of analgesic interventions after total knee arthroplasty (TKA).
METHODS
This PRISMA-compliant and PROSPERO-registered review includes all-language randomized controlled trials of medication-based analgesic interventions after TKA. Bias was evaluated according to Cochrane methodology. Outcomes were opioid consumption (primary), pain scores at rest and during mobilization, adverse events, and length of stay. Interventions investigated in three or more trials were meta-analysed. Outcomes were evaluated using forest plots, Grading of Recommendations Assessment, Development and Evaluation (GRADE), L'Abbe Plots and trial sequential analysis.
RESULTS
The included 113 trials, investigating 37 different analgesic interventions, were characterized by unclear/high risk of bias, low assay sensitivity and considerable differences in pain assessment tools, basic analgesic regimens, and reporting of adverse events. In meta-analyses single and continuous femoral nerve block (FNB), intrathecal morphine, local infiltration analgesia, intraarticular injection of local anaesthetics, non-steroidal anti-inflammatory drugs, and gabapentinoids demonstrated significant analgesic effects. The 24-hour morphine-sparing effects ranged from 4.2 mg (CI: 1.3, 7.2; intraarticular local anaesthetics), to 16.6 mg (CI: 11.2, 22; single FNB). Pain relieving effects at rest at 6 hours ranged from 4 mm (CI: -10, 2; gabapentinoids), to 19 mm (CI: 8, 31; single FNB), and at 24 hours from 3 mm (CI: -2, 8; gabapentinoids), to 16 mm (CI: 8, 23; continuous FNB). GRADE-rated quality of evidence was generally low.
CONCLUSION
A low quality of evidence, small sample sizes and heterogeneity of trial designs prohibit designation of an optimal procedure-specific analgesic regimen after TKA.
Topics: Arthroplasty, Replacement, Knee; Clinical Trials as Topic; Combined Modality Therapy; Humans; Pain Management; Pain Measurement; Pain, Postoperative; Treatment Outcome
PubMed: 28273133
DOI: 10.1371/journal.pone.0173107 -
Journal of Neurointerventional Surgery Apr 2018Flow arrest with balloon guide catheters (BGCs) is becoming increasingly recognized as critical to optimizing patient outcomes for mechanical thrombectomy. We performed... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND AND PURPOSE
Flow arrest with balloon guide catheters (BGCs) is becoming increasingly recognized as critical to optimizing patient outcomes for mechanical thrombectomy. We performed a systematic review and meta-analysis of the literature for studies that compared angiographic and clinical outcomes for patients who underwent mechanical thrombectomy with and without BGCs.
MATERIALS AND METHODS
In April 2017 a literature search on BGC and mechanical thrombectomy for stroke was performed. All studies included patients treated with and without BGCs using modern techniques (ie, stent retrievers). Using random effects meta-analysis, we evaluated the following outcomes: first-pass recanalization, Thrombolysis In Cerebral Infarction (TICI) 3 recanalization, TICI 2b/3 recanalization, favorable outcome (modified Rankin Scale (mRS) 0-2), mortality, and mean number of passes and procedure time.
RESULTS
Five non-randomized studies of 2022 patients were included (1083 BGC group and 939 non-BGC group). Compared with the non-BGC group, patients treated with BGCs had higher odds of first-pass recanalization (OR 2.05, 95% CI 1.65 to 2.55), TICI 3 (OR 2.13, 95% CI 1.43 to 3.17), TICI 2b/3 (OR 1.54, 95% CI 1.21 to 1.97), and mRS 0-2 (OR 1.84, 95% CI 1.52 to 2.22). BGC-treated patients also had lower odds of mortality (OR 0.52, 95% CI 0.37 to 0.73) compared with non-BGC patients. The mean number of passes was significantly lower for BGC-treated patients (weighted mean difference -0.34, 95% CI-0.47 to -0.22). Mean procedure time was also significantly shorter for BGC-treated patients (weighted mean difference -7.7 min, 95% CI-9.0to -6.4).
CONCLUSIONS
Non-randomized studies suggest that BGC use during mechanical thrombectomy for acute ischemic stroke is associated with superior clinical and angiographic outcomes. Further randomized trials are needed to confirm the results of this study.
Topics: Aged; Brain Ischemia; Catheterization; Clinical Trials as Topic; Female; Humans; Male; Middle Aged; Stents; Stroke; Thrombectomy; Treatment Outcome
PubMed: 28754806
DOI: 10.1136/neurintsurg-2017-013179 -
Journal of General Internal Medicine Nov 2013To perform a systematic review and meta-analysis of clinical trials evaluating the efficacy and safety of midodrine in orthostatic hypotension (OH). (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
To perform a systematic review and meta-analysis of clinical trials evaluating the efficacy and safety of midodrine in orthostatic hypotension (OH).
METHODS
We searched major databases and related conference proceedings through June 30, 2012. Two reviewers independently selected studies and extracted data. Random-effects meta-analysis was used to pool the outcome measures across studies.
RESULTS
Seven trials were included in the efficacy analysis (enrolling 325 patients, mean age 53 years) and two additional trials were included in the safety analysis. Compared to placebo, the mean change in systolic blood pressure was 4.9 mmHg (p = 0.65) and the mean change in mean arterial pressure from supine to standing was -1.7 mmHg (p = 0.45). The change in standing systolic blood pressure before and after giving midodrine was 21.5 mmHg (p < 0.001). A significant improvement was seen in patients' and investigators' global assessment symptoms scale (a mean difference of 0.70 [95 % CI 0.30-1.09; p < 0.001] and 0.80 [95 % CI 0.76-0.85; p < 0.001], respectively). There was a significant increase in risk of piloerection, scalp pruritis, urinary hesitancy/retention, supine hypertension and scalp paresthesia after giving midodrine. The quality of evidence was limited by imprecision, heterogeneity and increased risk of bias.
CONCLUSION
There is insufficient and low quality evidence to support the use of midodrine for OH.
Topics: Blood Pressure; Clinical Trials as Topic; Humans; Hypotension, Orthostatic; Midodrine; Vasoconstrictor Agents
PubMed: 23775146
DOI: 10.1007/s11606-013-2520-3 -
Trials Nov 2015Tuberculosis (TB) remains a major killer amongst the infectious diseases. Current treatment involves a four-drug regimen for at least 6 months. New drugs and regimens... (Meta-Analysis)
Meta-Analysis Review
Tuberculosis (TB) remains a major killer amongst the infectious diseases. Current treatment involves a four-drug regimen for at least 6 months. New drugs and regimens are required to shorten treatment duration, reduce toxicity and combat drug resistance, but the optimal methodology to define the critical path for novel regimens is not well defined. We undertook a systematic review to summarise outcomes reported in Phase II trials of patients with newly diagnosed pulmonary TB to assess the need for a core outcome set. A systematic search of databases (PubMed, MEDLINE, EMBASE and LILACs) was conducted on 1 May 2015 to retrieve relevant peer-reviewed articles. Reference lists of included studies were also searched. This systematic review considered all reported outcomes. Risk of bias was considered via sequence generation, allocation concealment, blinding, reasons for exclusions, and selective reporting. Of 55 included studies, 20 were Phase IIB studies based on culture conversion, 32 were Phase IIA studies based on quantitative bacteriology, and three considered alternative outcomes. Large variation in reported outcomes and trial characteristics was observed across the included studies. Bacteriological results were as often expressed in terms of positivity as negativity, with varying definitions of culture conversion. Variation in reporting was particularly marked for Phase IIA studies, where multiple time intervals were typically selected for analysis and sometimes resulted in differing interpretations of the efficacy of drugs or regimens. Within both Phase IIA and IIB studies, there was variation in the time points at which the study participants were sampled, as well as in the bacteriological media and methods used. For successful future meta-analysis of early-phase studies, the findings of this review suggest that development of a core outcome set would be desirable. This would enable trial results to be more easily compared and combined, potentially leading to more effective development of new treatment strategies for patients with TB. Pending development of, and agreement on, such a core outcome set, we suggest some interim recommendations for reporting of future phase II studies of pulmonary tuberculosis.
Topics: Antitubercular Agents; Bacteriological Techniques; Clinical Trials, Phase II as Topic; Drug Resistance, Bacterial; Endpoint Determination; Humans; Predictive Value of Tests; Quality Control; Randomized Controlled Trials as Topic; Research Design; Time Factors; Treatment Outcome; Tuberculosis, Pulmonary
PubMed: 26566930
DOI: 10.1186/s13063-015-1050-1 -
Allergy Jul 2011Ocular allergy represents one of the most common conditions encountered by allergists and ophthalmologists. However, there is wide variability of study designs in... (Review)
Review
BACKGROUND
Ocular allergy represents one of the most common conditions encountered by allergists and ophthalmologists. However, there is wide variability of study designs in clinical trials of allergic conjunctivitis, which results in conflicting evidence on their optimal management. We conducted a systematic review of clinical trials to critically evaluate their quality and to highlight biases to be avoided in future clinical research in ocular allergy.
METHODS
Clinical trials in allergic conjunctivitis performed since 1965 were retrieved, and data on patients, interventions, comparison of interventions, and outcomes were extracted. Four authors independently assessed articles for inclusion in the systematic review and assessed trials' quality using the Jadad scale.
RESULTS
Three hundred and sixty-two trials were included in the study. Only a minority of trials fulfilled all the criteria of proper clinical trial design. In most of the studies, there was a very limited use of objective (quantifiable) parameters for both patients' selection and evaluation of drug efficacy and safety. Several outcomes of primary importance, such as disease relapses and recurrence rate, were omitted in clinical trials of allergic conjunctivitis.
CONCLUSIONS
Evidence coming out of clinical trials in ocular allergy is limited, and this affects the strength of recommendations to health care providers and policy makers for optimal management. Standardized diagnostic criteria for patient selection and quantifiable primary outcomes are recommended to improve the design of future clinical trials in allergic conjunctivitis.
Topics: Anti-Allergic Agents; Clinical Trials as Topic; Conjunctivitis, Allergic; Histamine Antagonists; Humans; Research Design; Treatment Outcome
PubMed: 21261658
DOI: 10.1111/j.1398-9995.2010.02536.x -
Critical Care (London, England) Sep 2013The goal of non-operative management (NOM) for blunt splenic trauma (BST) is to preserve the spleen. The advantages of NOM for minor splenic trauma have been extensively... (Review)
Review
INTRODUCTION
The goal of non-operative management (NOM) for blunt splenic trauma (BST) is to preserve the spleen. The advantages of NOM for minor splenic trauma have been extensively reported, whereas its value for the more severe splenic injuries is still debated. The aim of this systematic review was to evaluate the available published evidence on NOM in patients with splenic trauma and to compare it with the operative management (OM) in terms of mortality, morbidity and duration of hospital stay.
METHODS
For this systematic review we followed the "Preferred Reporting Items for Systematic Reviews and Meta-analyses" statement. A systematic search was performed on PubMed for studies published from January 2000 to December 2011, without language restrictions, which compared NOM vs. OM for splenic trauma injuries and which at least 10 patients with BST.
RESULTS
We identified 21 non randomized studies: 1 Clinical Controlled Trial and 20 retrospective cohort studies analyzing a total of 16,940 patients with BST. NOM represents the gold standard treatment for minor splenic trauma and is associated with decreased mortality in severe splenic trauma (4.78% vs. 13.5% in NOM and OM, respectively), according to the literature. Of note, in BST treated operatively, concurrent injuries accounted for the higher mortality. In addition, it was not possible to determine post-treatment morbidity in major splenic trauma. The definition of hemodynamic stability varied greatly in the literature depending on the surgeon and the trauma team, representing a further bias. Moreover, data on the remaining analyzed outcomes (hospital stay, number of blood transfusions, abdominal abscesses, overwhelming post-splenectomy infection) were not reported in all included studies or were not comparable, precluding the possibility to perform a meaningful cumulative analysis and comparison.
CONCLUSIONS
NOM of BST, preserving the spleen, is the treatment of choice for the American Association for the Surgery of Trauma grades I and II. Conclusions are more difficult to outline for higher grades of splenic injury, because of the substantial heterogeneity of expertise among different hospitals, and potentially inappropriate comparison groups.
Topics: Abdominal Injuries; Clinical Trials as Topic; Disease Management; Humans; Patient Safety; Spleen; Treatment Outcome; Wounds, Nonpenetrating
PubMed: 24004931
DOI: 10.1186/cc12868 -
Rheumatology (Oxford, England) Sep 2017SSc is clinically and pathogenetically heterogeneous. Consensus standards for trial design and outcome measures are needed. International experts experienced in SSc... (Review)
Review
SSc is clinically and pathogenetically heterogeneous. Consensus standards for trial design and outcome measures are needed. International experts experienced in SSc clinical trial design and a researcher experienced in systematic literature review screened the PubMed and Cochrane Central Register of Controlled Trials in order to develop points to consider when planning a clinical trial for muscle involvement in SSc. The experts conclude that SSc-associated muscle involvement is heterogeneous and lacks a universally accepted gold-standard for measuring therapeutic response. Although outcome studies are currently limited by the inability to clearly distinguish active, reversible muscle inflammation from irreversible muscle damage and extramuscular organ involvement, strong consideration should be given to enrolling patients with a myopathy that features several elements of likely reversibility such as muscle weakness, biopsy-proven active inflammation, an MRI indicating muscle inflammation and a baseline serum creatinine kinase above three times the upper limit of normal to prevent floor effect. Randomized controlled trials are preferred, with a duration of at least 24 weeks. Outcome measures should include a combination of elements that are likely to be reversible, such as muscle weakness, biopsy-proven active inflammation, creatinine kinase/aldolase and a quality of life questionnaire. The individual measurements might require a short pre-study for further validation. A biological sample repository is recommended.
Topics: Clinical Trials as Topic; Disease Management; Humans; Muscular Diseases; Scleroderma, Systemic
PubMed: 28992167
DOI: 10.1093/rheumatology/kex196 -
Current Stem Cell Research & Therapy Feb 2018Osteoarthritis (OA) is a major global burden creating significant morbidity worldwide. Current curative therapies are expensive, challenging to access and have... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Osteoarthritis (OA) is a major global burden creating significant morbidity worldwide. Current curative therapies are expensive, challenging to access and have significant risks, making them infeasible and difficult in many cases. Mesenchymal stem cells (MSCs) can be applied to joints and may regenerate the cartilage damaged in OA, this therapy may be advantageous to existing treatments.
OBJECTIVE
We systematically reviewed clinical trials of MSCs for cartilage repair and provide an overview of the literature in this area here. MEDLINE, Embase, CENTRAL, clinicaltrials.gov and Open- Grey were searched for controlled trials and case series with >5 patents involving MSC therapy for cartilage repair. The controlled trials were meta-analysed and the primary outcome measure was improvement in pain over the control group. A narrative synthesis was composed for the case series.
RESULTS
A significant reduction in pain was found with the use of MSCs over controls: Standardised mean difference=-1.27 (95% Confidence intervals -1.95 to -0.58). However, the data was extremely heterogeneous with I2=95%, this may be attributed to differing therapies, clinical indication for treatment and joints treated amongst others. Case series showed improvements in treated patients with a variety of differing treatments and by many outcomes. There were no severe adverse outcomes found across all studies that could be attributed to MSCs, implying their safety.
CONCLUSION
We conclude that MSCs have significant potential for the treatment of OA, however, larger, more consistent trials are needed for conclusive analysis.
Topics: Clinical Trials as Topic; Female; Humans; Male; Mesenchymal Stem Cell Transplantation; Osteoarthritis; Regenerative Medicine; Treatment Outcome
PubMed: 28914207
DOI: 10.2174/1574888X12666170915120620 -
Current Neurology and Neuroscience... Dec 2011Determining the optimal amount and intensity of treatment is essential to the design and implementation of any treatment program for aphasia. A growing body of evidence,... (Review)
Review
Determining the optimal amount and intensity of treatment is essential to the design and implementation of any treatment program for aphasia. A growing body of evidence, both behavioral and biological, suggests that intensive therapy positively impacts outcomes. We update a systematic review of treatment studies that directly compares conditions of higher and lower intensity treatment for aphasia. We identify five studies published since 2006, review them for methodologic quality, and synthesize their findings with previous ones. For both acute and chronic aphasia, results at the language impairment and communication activity/participation levels tend to be more equivocal than previously demonstrated, with no clear differences between intensive and nonintensive treatment emerging across studies. Future research directions are discussed including research design, definitions of treatment intensity, and behavioral and biological measurement of short- and long-term changes following implementation of an intensive treatment.
Topics: Aphasia; Behavior; Clinical Trials as Topic; Communication; Humans; Learning; Nervous System Diseases; Quality of Health Care; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 21960063
DOI: 10.1007/s11910-011-0227-6 -
World Neurosurgery Jul 2018The PulseRider is an innovative stent-like device designed for the treatment of intracranial bifurcation aneurysms. The aim of this study was to assess the current... (Review)
Review
BACKGROUND
The PulseRider is an innovative stent-like device designed for the treatment of intracranial bifurcation aneurysms. The aim of this study was to assess the current evidence on safety and effectiveness of the PulseRider.
METHODS
A systematic review was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The following databases were searched: PubMed, Ovid MEDLINE, and Scopus. The search strategy consisted of "pulserider," "bifurcation aneurysm," and "endovascular" in both AND and OR combinations. Studies included were original research articles in peer-reviewed journals. The manuscripts were thoroughly examined for study design, outcomes, and results.
RESULTS
Three studies were identified describing use of the PulseRider device in the treatment of 63 patients with 63 bifurcation aneurysms. We identified 2 multicenter case series and 1 single-arm clinical trial. The majority of aneurysms treated were located at the basilar tip (37, 58.7%). All devices were successfully deployed, and there were 5 intraoperative complications (7.9%), including 2 intraoperative aneurysm ruptures, 1 vessel dissection, and 2 thrombus formations. Immediate complete aneurysm occlusion was achieved in 61.9% (39/63) of cases and at the 6-month imaging follow-up, 66.7% (42/63) achieved complete aneurysm occlusion. One recanalization was reported in 1 of the multicenter case series within the 6-month follow-up.
CONCLUSIONS
The PulseRider is safe and probably effective for the treatment of intracranial bifurcation aneurysms, sometimes not amenable for stent-assisted coiling. However, current evidence is limited to a small sample and short follow-up. In addition, the device has not been compared with other treatment modalities.
Topics: Clinical Trials as Topic; Endovascular Procedures; Humans; Intracranial Aneurysm; Self Expandable Metallic Stents; Treatment Outcome
PubMed: 29698797
DOI: 10.1016/j.wneu.2018.04.102