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Circulation Aug 2020To quantify the association between effects of interventions on carotid intima-media thickness (cIMT) progression and their effects on cardiovascular disease (CVD) risk. (Meta-Analysis)
Meta-Analysis
BACKGROUND
To quantify the association between effects of interventions on carotid intima-media thickness (cIMT) progression and their effects on cardiovascular disease (CVD) risk.
METHODS
We systematically collated data from randomized, controlled trials. cIMT was assessed as the mean value at the common-carotid-artery; if unavailable, the maximum value at the common-carotid-artery or other cIMT measures were used. The primary outcome was a combined CVD end point defined as myocardial infarction, stroke, revascularization procedures, or fatal CVD. We estimated intervention effects on cIMT progression and incident CVD for each trial, before relating the 2 using a Bayesian meta-regression approach.
RESULTS
We analyzed data of 119 randomized, controlled trials involving 100 667 patients (mean age 62 years, 42% female). Over an average follow-up of 3.7 years, 12 038 patients developed the combined CVD end point. Across all interventions, each 10 μm/y reduction of cIMT progression resulted in a relative risk for CVD of 0.91 (95% Credible Interval, 0.87-0.94), with an additional relative risk for CVD of 0.92 (0.87-0.97) being achieved independent of cIMT progression. Taken together, we estimated that interventions reducing cIMT progression by 10, 20, 30, or 40 μm/y would yield relative risks of 0.84 (0.75-0.93), 0.76 (0.67-0.85), 0.69 (0.59-0.79), or 0.63 (0.52-0.74), respectively. Results were similar when grouping trials by type of intervention, time of conduct, time to ultrasound follow-up, availability of individual-participant data, primary versus secondary prevention trials, type of cIMT measurement, and proportion of female patients.
CONCLUSIONS
The extent of intervention effects on cIMT progression predicted the degree of CVD risk reduction. This provides a missing link supporting the usefulness of cIMT progression as a surrogate marker for CVD risk in clinical trials.
Topics: Carotid Artery, Common; Carotid Intima-Media Thickness; Female; Heart Disease Risk Factors; Humans; Male; Middle Aged; Myocardial Infarction; Randomized Controlled Trials as Topic; Stroke
PubMed: 32546049
DOI: 10.1161/CIRCULATIONAHA.120.046361 -
The Journal of Pain 2020Fibromyalgia is a debilitating condition characterized by chronic widespread pain. It is believed to be caused by dysfunction of the central nervous system (CNS) but... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Fibromyalgia is a debilitating condition characterized by chronic widespread pain. It is believed to be caused by dysfunction of the central nervous system (CNS) but current treatments are largely ineffective. Transcranial direct current stimulation (tDCS), a neuromodulation technique that targets the CNS, may offer a new line of treatment.
OBJECTIVE
To systematically review the most up-to-date literature and perform a meta-analysis of the effects of tDCS on pain intensity in fibromyalgia.
METHODS
The following databases were searched from inception: Medline (Ovid), PsychInfo, CINAHL, Cochrane Library, and Web of Science. Studies were eligible if they were randomized controlled trials, quasi-randomized trials, and nonrandomized. Crossover and parallel-group design studies were included. Risk of bias was assessed for all included studies. Meta-analysis was conducted on studies investigating pain intensity after tDCS in participants with fibromyalgia and analyzed using standardized mean difference and 95% confidence intervals.
RESULTS
Fourteen clinical studies were included. Ten were controlled trials and 4 were within-subjects crossover studies. Meta-analysis of data from 8 controlled trials provides tentative evidence of pain reduction when active tDCS is delivered compared to sham. However, substantial statistical heterogeneity and high risk of bias of primary studies prevent more conclusive recommendations being made.
CONCLUSIONS
tDCS is a safe intervention with the potential to lower pain intensity in fibromyalgia. However, there is a need for more empirical research of the neural target sites and optimum stimulation parameters to achieve the greatest effects before conducting further clinical studies.
PERSPECTIVE
This systematic review and meta-analysis synthesizes current evidence for the clinical effectiveness of tDCS in the treatment of fibromyalgia pain. There is only tentative evidence of pain reduction when active tDCS is compared to sham. High heterogeneity and risk of bias across studies suggest a need for further empirical research.
Topics: Chronic Pain; Clinical Trials as Topic; Fibromyalgia; Humans; Pain Management; Transcranial Direct Current Stimulation; Treatment Outcome
PubMed: 31982685
DOI: 10.1016/j.jpain.2020.01.003 -
International Journal of Environmental... Jul 2022Velocity-based training (VBT) is a rising auto-regulation method that dynamically regulates training loads to promote resistance training. However, the role of VBT in... (Meta-Analysis)
Meta-Analysis
Velocity-based training (VBT) is a rising auto-regulation method that dynamically regulates training loads to promote resistance training. However, the role of VBT in improving various athletic performances is still unclear. Hence, the presented study aimed to examine the role of VBT in improving lower limbs’ maximum strength, strength endurance, jump, and sprint performance among trained individuals. A systematic literature search was performed to identify studies on VBT for lower limb strength training via databases, including PubMed, Web of Science, Embase, EBSCO, Cochrane, CNKI (in Chinese), and Wanfang Database (in Chinese). Controlled trials that deployed VBT only without extra training content were considered. Eventually, nine studies with a total of 253 trained males (at least one year of training experience) were included in the meta-analysis. The pooled results suggest that VBT may effectively enhance lower limbs’ maximum strength (SMD = 0.76; p < 0.001; I2 = 0%), strength endurance (SMD = 1.19; p < 0.001; I2 = 2%), countermovement jump (SMD = 0.53; p < 0.001; I2 = 0%), and sprint ability (SMD of sprint time = −0.40; p < 0.001; I2 = 0%). These findings indicate the positive role of VBT in serving athletic training. Future research is warranted to focus on the effect of velocity loss of VBT on athletic performance.
Topics: Athletic Performance; Controlled Clinical Trials as Topic; Humans; Lower Extremity; Male; Muscle Strength; Resistance Training
PubMed: 35954603
DOI: 10.3390/ijerph19159252 -
The Cochrane Database of Systematic... Nov 2021Lamellar macular holes (LMHs) are small, partial-thickness defects of the macula defined by characteristic features on optical coherence tomography (OCT), including a... (Review)
Review
BACKGROUND
Lamellar macular holes (LMHs) are small, partial-thickness defects of the macula defined by characteristic features on optical coherence tomography (OCT), including a newly recognised type of epiretinal membrane termed 'epiretinal proliferation'. There may be a rationale to recommend surgery for individuals with LMHs, particularly those with functional or anatomical deterioration, or poor baseline vision causing significant disability, to stabilise the LMH and prevent further visual deterioration; however, there is currently no evidence-based consensus.
OBJECTIVES
To assess the effect of surgical interventions on post-operative visual and anatomical outcomes in people with a confirmed LMH.
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE Ovid, Embase Ovid, Scopus SciVerse, ISRCTN registry, US National Institutes of Health Ongoing Trials Register, ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). We also searched reference lists of included trials to identify other eligible trials which our search strategy may have missed. The date of the search was 20 July 2021.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) involving participants with a confirmed LMH diagnosis which reported one or more surgical intervention(s), alone or in combination, in at least one arm of the RCT.
DATA COLLECTION AND ANALYSIS
We used standard methods as expected by Cochrane. Two study authors independently extracted data and assessed the risk of bias for included trials. Trial authors were contacted for further information and clarification.
MAIN RESULTS
A single RCT was eligible for inclusion. Thirty-six participants were randomised in a 2:1 ratio; 24 were allocated to undergo surgery (pars plana vitrectomy, peeling of the epiretial proliferation followed by fovea-sparing removal of the internal limiting membrane) and 12 (10 following two participant dropouts) to observation. Overall, the certainty of the evidence was low for all outcomes due to selection and detection bias, and the low number of participants enrolled in the study which may affect the accuracy of results and reliability of conclusions. At six-month follow-up, change in vision was better in the surgery group (-0.27 logMAR improvement) than observation (0.02 worsening) (mean difference (MD): -0.29 logMAR, 95% confidence intervals (CI): -0.33 to -0.25). Central retinal thickness increased in the surgery group over 6 months 126 μm increase) compared with observation group (decrease by 11μm) (MD: 137 μm, 95% CI: 125.87 μm to 148.13 μm). Finally, at six-month follow-up, retinal sensitivity was better in the surgery group (3.03 dB increase) compared with the observation group (0.06 dB decrease) (MD: 3.09 dB, 95% CI: 2.07 to 4.11 dB). Vision-related quality of life and metamorphopsia were not reported. No adverse outcomes or complications were reported in the study, however, authors could not provide information on whether any individuals developed deterioration in vision of 0.2 logMAR or worse.
AUTHORS' CONCLUSIONS
The included single trial demonstrated improvements in visual and anatomical outcome measures for participants with a LMH who underwent surgery compared with observation only. Therefore, we can conclude that participants who undergo surgery may achieve superior post-operative best corrected visual acuity and anatomical outcomes compared with observation only. However, the results of a single and small RCT provides limited evidence to support or refute surgery as an effective management option for LMHs. Future RCTs with a larger number of participants and with fewer methodological limitations and biases are necessary to inform future clinical practice.
Topics: Humans; Macula Lutea; Randomized Controlled Trials as Topic; Retina; Retinal Perforations; Visual Acuity; Vitrectomy
PubMed: 34748208
DOI: 10.1002/14651858.CD013678.pub2 -
Medicina (Kaunas, Lithuania) Oct 2022: The positive implications of using free light chains in diagnosing multiple sclerosis have increasingly gained considerable interest in medical research and the... (Meta-Analysis)
Meta-Analysis Review
: The positive implications of using free light chains in diagnosing multiple sclerosis have increasingly gained considerable interest in medical research and the scientific community. It is often presumed that free light chains, particularly kappa and lambda free light chains, are of practical use and are associated with a higher probability of obtaining positive results compared to oligoclonal bands. The primary purpose of the current paper was to conduct a systematic review to assess the up-to-date methods for diagnosing multiple sclerosis using kappa and lambda free light chains. : An organized literature search was performed across four electronic sources, including Google Scholar, Web of Science, Embase, and MEDLINE. The sources analyzed in this systematic review and meta-analysis comprise randomized clinical trials, prospective cohort studies, retrospective studies, controlled clinical trials, and systematic reviews. : The review contains 116 reports that includes 1204 participants. The final selection includes a vast array of preexisting literature concerning the study topic: 35 randomized clinical trials, 21 prospective cohort studies, 19 retrospective studies, 22 controlled clinical trials, and 13 systematic reviews. : The incorporated literature sources provided integral insights into the benefits of free light chain diagnostics for multiple sclerosis. It was also evident that the use of free light chains in the diagnosis of clinically isolated syndrome (CIS) and multiple sclerosis is relatively fast and inexpensive in comparison to other conventional state-of-the-art diagnostic methods, e.g., using oligoclonal bands (OCBs).
Topics: Humans; Oligoclonal Bands; Multiple Sclerosis; Retrospective Studies; Prospective Studies; Immunoglobulin kappa-Chains; Immunoglobulin lambda-Chains; Immunoglobulin Light Chains; Randomized Controlled Trials as Topic
PubMed: 36363469
DOI: 10.3390/medicina58111512 -
The Cochrane Database of Systematic... Jan 2016Discharge planning is a routine feature of health systems in many countries. The aim of discharge planning is to reduce hospital length of stay and unplanned readmission... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Discharge planning is a routine feature of health systems in many countries. The aim of discharge planning is to reduce hospital length of stay and unplanned readmission to hospital, and to improve the co-ordination of services following discharge from hospital.This is the third update of the original review.
OBJECTIVES
To assess the effectiveness of planning the discharge of individual patients moving from hospital.
SEARCH METHODS
We updated the review using the Cochrane Central Register of Controlled Trials (CENTRAL) (2015, Issue 9), MEDLINE, EMBASE, CINAHL, the Social Science Citation Index (last searched in October 2015), and the US National Institutes of Health trial register (ClinicalTrials.gov).
SELECTION CRITERIA
Randomised controlled trials (RCTs) that compared an individualised discharge plan with routine discharge care that was not tailored to individual participants. Participants were hospital inpatients.
DATA COLLECTION AND ANALYSIS
Two authors independently undertook data analysis and quality assessment using a pre-designed data extraction sheet. We grouped studies according to patient groups (elderly medical patients, patients recovering from surgery, and those with a mix of conditions) and by outcome. We performed our statistical analysis according to the intention-to-treat principle, calculating risk ratios (RRs) for dichotomous outcomes and mean differences (MDs) for continuous data using fixed-effect meta-analysis. When combining outcome data was not possible because of differences in the reporting of outcomes, we summarised the reported data in the text.
MAIN RESULTS
We included 30 trials (11,964 participants), including six identified in this update. Twenty-one trials recruited older participants with a medical condition, five recruited participants with a mix of medical and surgical conditions, one recruited participants from a psychiatric hospital, one from both a psychiatric hospital and from a general hospital, and two trials recruited participants admitted to hospital following a fall. Hospital length of stay and readmissions to hospital were reduced for participants admitted to hospital with a medical diagnosis and who were allocated to discharge planning (length of stay MD - 0.73, 95% CI - 1.33 to - 0.12, 12 trials, moderate certainty evidence; readmission rates RR 0.87, 95% CI 0.79 to 0.97, 15 trials, moderate certainty evidence). It is uncertain whether discharge planning reduces readmission rates for patients admitted to hospital following a fall (RR 1.36, 95% CI 0.46 to 4.01, 2 trials, very low certainty evidence). For elderly patients with a medical condition, there was little or no difference between groups for mortality (RR 0.99, 95% CI 0.79 to 1.24, moderate certainty). There was also little evidence regarding mortality for participants recovering from surgery or who had a mix of medical and surgical conditions. Discharge planning may lead to increased satisfaction for patients and healthcare professionals (low certainty evidence, six trials). It is uncertain whether there is any difference in the cost of care when discharge planning is implemented with patients who have a medical condition (very low certainty evidence, five trials).
AUTHORS' CONCLUSIONS
A discharge plan tailored to the individual patient probably brings about a small reduction in hospital length of stay and reduces the risk of readmission to hospital at three months follow-up for older people with a medical condition. Discharge planning may lead to increased satisfaction with healthcare for patients and professionals. There is little evidence that discharge planning reduces costs to the health service.
Topics: Aftercare; Controlled Clinical Trials as Topic; Health Care Costs; Humans; Intention to Treat Analysis; Length of Stay; Outcome Assessment, Health Care; Patient Discharge; Patient Readmission; Randomized Controlled Trials as Topic
PubMed: 26816297
DOI: 10.1002/14651858.CD000313.pub5 -
Medicine Dec 2021Acupuncture is widely used for oligospermia and asthenozoospermia in China, but its effect is unclear. We aimed to determine the effectiveness and safety of acupuncture... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Acupuncture is widely used for oligospermia and asthenozoospermia in China, but its effect is unclear. We aimed to determine the effectiveness and safety of acupuncture in treating oligospermia and asthenozoospermia.
METHODS
An electronic search for randomized controlled trials evaluating acupuncture treatment in patients with oligospermia and asthenozoospermia published from database inception to October 2018 was conducted in PubMed, EMBASE, the Chinese Biomedical Literature Database, the Chinese Scientific Journal Database (VIP Database), the Wan-Fang Database, the China National Knowledge Infrastructure and the Cochrane Library. We established search terms related to 3 areas (oligospermia, asthenozoospermia, and acupuncture). Two authors independently screened all identified citations and extracted the data. The methodological quality of the included trials was assessed using the Cochrane criteria.
RESULTS
Seven studies with a total of 527 subjects were screened according to inclusion and exclusion standards, and most of the studies had significant methodological weaknesses. Seven randomized controlled trials tested the effects of acupuncture compared with placebo acupuncture and conventional medications in patients with oligospermia and asthenozoospermia. The results of this study suggest that acupuncture alone has no clear superiority in improving sperm motility (standard mean difference [SMD] = 1.13, 95% confidence interval [CI]: -0.64 to 2.89), the sperm concentration (SMD = 0.32, 95% CI: 0.27-0.92) or semen volume compared with placebo acupuncture. No significant difference was found between acupuncture alone and conventional medications in improving sperm motility (SMD = -0.53, 95% CI: -2.54 to 1.48), the sperm concentration (SMD = -1.10, 95% CI: -1.48 to -0.72) or semen volume. However, adjuvant acupuncture may enhance the effect of medications on improving sperm motility (SMD = 4.10, 95% CI: 1.09-7.12) and the sperm concentration (SMD = 1.07, 95% CI: 0.739-1.40), but the study heterogeneity was too high to establish robust conclusions.
CONCLUSION
These results suggest that the current evidence does not support acupuncture as an effective treatment for oligospermia and asthenozoospermia; therefore, acupuncture is not currently recommended as a treatment for these conditions. However, owing to the high risk of bias among the included studies, the evidence is limited, and more large-scale, high-quality clinical trials are needed in the future.
TRIAL REGISTRATION NUMBER
PROSPERO CRD42018083885.
Topics: Acupuncture Therapy; Asthenozoospermia; Humans; Male; Oligospermia; Randomized Controlled Trials as Topic; Sperm Motility; Treatment Outcome
PubMed: 35049183
DOI: 10.1097/MD.0000000000027816 -
BMC Musculoskeletal Disorders Jan 2018Dupuytren's disease (DD) is a common and progressive, fibroproliferative disorder of the palmar and digital fascia of the hand. Various treatments have been recommended... (Review)
Review
BACKGROUND
Dupuytren's disease (DD) is a common and progressive, fibroproliferative disorder of the palmar and digital fascia of the hand. Various treatments have been recommended for advanced disease or to retard progression of early disease and to prevent deterioration of the finger contracture and quality of life. Recent studies have tried to evaluate the clinical and cost-effectiveness of therapies for DD, but there is currently no systematic assessment and appraisal of the economic evaluations.
METHODS
A systematic literature review was conducted, following PRISMA guidelines, to identify studies reporting economic evaluations of interventions for managing DD. Databases searched included the Ovid MEDLINE/Embase (without time restriction), National Health Service (NHS) Economic Evaluation Database (all years) and the National Institute for Health Research (NIHR) Journals Library) Health Technology Assessment (HTA). Cost-effectiveness analyses of treating DD were identified and their quality was assessed using the CHEERS assessment tool for quality of reporting and Phillips checklist for model evaluation.
RESULTS
A total of 103 studies were screened, of which 4 met the study inclusion criteria. Two studies were from the US, one from the UK and one from Canada. They all assessed the same interventions for advanced DD, namely collagenase Clostridium histolyticum injection, percutaneous needle fasciotomy and partial fasciectomy. All studies conducting a cost-utility analysis, two implemented a decision analytic model and two a Markov model approach. None of them were based on a single randomised controlled trial, but rather synthesised evidence from various sources. Studies varied in their time horizon, sources of utility estimates and perspective of analysis. The overall quality of study reporting was good based on the CHEERS checklist. The quality of the model reporting in terms of model structure, data synthesis and model consistency varied across the included studies.
CONCLUSION
Cost-effectiveness analyses for patients with advanced DD are limited and have applied different approaches with respect to modelling. Future studies should improve the way they are conducted and report their findings according to established guidance for conducting economic modelling of health care technologies.
TRIAL REGISTRATION
The protocol was registered ( CRD42016032989 ; date 08/01/2016) with the PROSPERO international prospective register of systematic reviews.
Topics: Clinical Trials as Topic; Cost-Benefit Analysis; Databases, Factual; Disease Management; Dupuytren Contracture; Humans
PubMed: 29370792
DOI: 10.1186/s12891-018-1949-2 -
Journal of Surgical Oncology Feb 2018The field of cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) has suffered from a lack of clinical trials to validate its expanding use. (Review)
Review
BACKGROUND
The field of cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) has suffered from a lack of clinical trials to validate its expanding use.
OBJECTIVE
To evaluate published and ongoing clinical trials seeking to better define role of CRS/HIPEC in the treatment of peritoneal surface malignancies.
METHODS
Systematic review by PubMed search was performed using terms "Clinical trial," "intraperitoneal chemotherapy," and "HIPEC." ClinicalTrials.gov and EudraCT registries were searched for active clinical trials. Eligibility included CRS/HIPEC trials investigating adult patient populations from published clinical reports and/or trials currently accruing or at completion.
RESULTS
Thirteen published trials and 57 active clinical trials were included for review.
CONCLUSIONS
Published and ongoing U.S. and international clinical trials for CRS and HIPEC are defining important parameters that include improving patient selection, strategic sequences of treatment, cytoreductive strategies, chemotherapeutics, optimal hyperthermic temperature and timing, and toxicity profiles. Main barriers or limitations to trial development remain patient enrollment, trial design, and oncologic community collaboration. Overall progress is positive with increasing number of clinical trials throughout the world. Collaboration between surgeons and the wider oncologic community will be crucial to validate this important treatment strategy.
Topics: Chemotherapy, Cancer, Regional Perfusion; Clinical Trials as Topic; Cytoreduction Surgical Procedures; Humans; Hyperthermia, Induced; Meta-Analysis as Topic; Peritoneal Neoplasms; Prognosis; Survival Rate
PubMed: 29120491
DOI: 10.1002/jso.24813 -
PloS One 2023Some patients have insufficient treatment response to conventional disease-modifying antirheumatic drugs (cDMARD); although biologics have proven to be an effective... (Meta-Analysis)
Meta-Analysis
BACKGROUND AND OBJECTIVES
Some patients have insufficient treatment response to conventional disease-modifying antirheumatic drugs (cDMARD); although biologics have proven to be an effective treatment for RA, the effects that bDMARDs have on integumentary, cardiac, and immune systems and the high costs associated with these treatments, make that mesenchymal stem cell-based therapies (MSCs) for RA are being considered potential treatment methods. This work analyses the performance in safety and efficacy terms of MSCs techniques.
METHODS AND FINDING
A literature search was performed in PubMed, EMBASE, Cochrane Library, Web of Science, and Open Grey databases from inception to October 28, 2022. Three randomized controlled trials (RCTs) and one non-randomized controlled trial (non-RCTs), including 358 patients met our inclusion criteria and were included in qualitative synthesis; only RCTs were eligible for quantitative synthesis (meta-analysis). Meta-analysis of adverse events (AE) in RCTs showed no significant differences in the incidence of AE in the MSCs group compared to the control group (Risk ratio: 2.35; 95% CI, 0.58 to 9.58; I2 = 58.80%). The pooled Risk ratio for non-serious and serious adverse events showed no statistical difference between intervention and control groups concerning the incidence of non-serious and serious adverse events (Risk ratio: 2.35; 95% CI, 0.58 to 9.51; I2 = 58.62%) and (Risk ratio: 1.10; 95% CI, 0.15 to 7.97; I2 = 0.0%) respectively. The Health Assessment Questionnaire (HAQ) and Disease Activity Score (DAS28) decreased in agreement with the decreasing values of C-reactive protein (CRP) and Erythrocyte sedimentation rate (ESR). Additionally, a trend toward clinical efficacy was observed; however, this improvement was not shown in the studies after 12 months of follow-up without continuous treatment administration.
CONCLUSION
This Systematic review and meta-analysis showed a favorable safety profile, without life-threatening events in subjects with RA, and a trend toward clinical efficacy that must be confirmed through high-quality RCTs, considerable sample size, and extended follow-up in subjects with RA.
Topics: Humans; Antirheumatic Agents; Arthritis, Rheumatoid; Methotrexate; Treatment Outcome; Controlled Clinical Trials as Topic
PubMed: 37498842
DOI: 10.1371/journal.pone.0284828