Selection and Evaluation of Empirical Research in Technology Assessment

1989 ◽  
Vol 5 (4) ◽  
pp. 521-536 ◽  
Author(s):  
Thomas C. Chalmers ◽  
Peg Hewett ◽  
Dinah Reitman ◽  
Henry S. Sacks
Keyword(s):  
Clinical Trials ◽  
Technology Assessment ◽  
Scientific Method ◽  
Meta Analysis ◽  
Sensitivity Analyses ◽  
Controlled Trials ◽  
Data Bases ◽  
Randomized Controlled ◽  
Practice Of Medicine ◽  
Meta Analyses

Technology assessment involves application of the scientific method to the practice of medicine. Finding all of the assessment reports in a given field is not an easy task. Proper evaluation of those assessments requires the conduct of a prospective experiment in which the sources and results are blinded when the choice is made of papers to exclude and to include, and the process should be carried in duplicate. There are several available data bases for carrying out the search, but because of problems they should be supplemented by reference to the bibliographies of pertinent published articles. Clinical trials included in meta-analyses should be graded by quality and thus facilitate sensitivity analyses. Attention must be paid to the possibility of publication bias. Finally, the advent of meta-analysis makes it desirable to begin randomized controlled trials in areas of uncertainty, even when there is no possibility that individual investigators will encounter enough patients to draw valid conclusions.

scholarly journals Follicular Fluid Meiosis-Activating Sterol in Assisted Reproductive Techniques: A Systematic Review and Meta-analysis of Randomized Controlled Trials

2020 ◽  
pp. 1-16
Author(s):  
Kien Nguyen Dang ◽  
Mohammad Rashidul Hashan ◽  
Le Huu Nhat Minh ◽  
Khalid Muhammad Khalaf ◽  
Hassan Yousif Ibrahim ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Randomized Controlled Trials ◽  
Follicular Fluid ◽  
Meta Analysis ◽  
Normal Embryo ◽  
Controlled Trials ◽  
Abnormal Embryo ◽  
Randomized Controlled ◽  
Mosaic Embryo ◽  
Meta Analyses

Background: Follicular fluid meiosis-activating sterol (FFMAS) is one of several molecular compounds that has been added into in vitro maturation (IVM) technique with contradictory results. Our study aimed to investigate the effects of FFMAS in assisted reproductive technology (ART). Methods: We searched systematically in PubMed, Web of Science, Scopus, Cochrane Registry of clinical trials, WHO registry of clinical trials, clinicaltrials.gov, Google Scholar until July 2017. Meta-analysis was used to investigate the efficacy and safety outcomes of FFMAS. Following the retrieval of potential articles, two independent reviewers screened and extracted included papers rigorously. Summary odds ratios (ORs) and 95% confidence intervals (CIs) were computed for the individual outcome when data was available. Quality of included studies was assessed using Cochrane collaboration tool. Results: A total of seven randomized controlled trials involving 1198 participants with 3105 oocytes were explored in this study. Most of the studies were at low risk of bias. Our random effects model meta-analyses in maturation and abnormal embryo rate between FFMAS-exposed oocytes compared with controls revealed no significant differences (summary OR 1.00, 95% CI 0.46–2.16, [Formula: see text] value = 0.99 and summary OR was 1.31, 95% CI 0.84–2.04, [Formula: see text] value = 0.23, respectively). Beside, our study showed a significant increase in uniformly abnormal embryo rate in FFMAS group compared with vehicle control group (summary OR 1.98, 95% CI 1.09–3.61, [Formula: see text] value = 0.03). No significances were noted on meta-analyses of normal embryo rate, uniformly abnormal embryo rate, uniformly normal embryo rate, mosaic embryo rate, abnormal blastomere rate, normal blastomere rate, aneuploidy mosaic embryo rate, and chaotic mosaic embryo rate. Conclusions: FFMAS showed no efficacy in maturation process in human oocytes and there was some evidence for detrimental effects in comparison to vehicle controls. We discouraged any further trials due to safety concern.

scholarly journals Pre-Procedural Lumbar Neuraxial Ultrasound—A Systematic Review of Randomized Controlled Trials and Meta-Analysis

Healthcare ◽  
2021 ◽  
Vol 9 (4) ◽  
pp. 479
Author(s):  
Tatiana Sidiropoulou ◽  
Kalliopi Christodoulaki ◽  
Charalampos Siristatidis
Keyword(s):  
Systematic Review ◽  
Lumbar Spine ◽  
Randomized Controlled Trials ◽  
Success Rate ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Technical Failure ◽  
Obese Patients ◽  
Randomized Controlled ◽  
Meta Analyses

A pre-procedural ultrasound of the lumbar spine is frequently used to facilitate neuraxial procedures. The aim of this review is to examine the evidence sustaining the utilization of pre-procedural neuraxial ultrasound compared to conventional methods. We perform a systematic review of randomized controlled trials with meta-analyses. We search the electronic databases Medline, Cochrane Central, Science Direct and Scopus up to 1 June 2019. We include trials comparing a pre-procedural lumbar spine ultrasound to a non-ultrasound-assisted method. The primary endpoints are technical failure rate, first-attempt success rate, number of needle redirections and procedure time. We retrieve 32 trials (3439 patients) comparing pre-procedural lumbar ultrasounds to palpations for neuraxial procedures in various clinical settings. Pre-procedural ultrasounds decrease the overall risk of technical failure (Risk Ratio (RR) 0.69 (99% CI, 0.43 to 1.10), p = 0.04) but not in obese and difficult spinal patients (RR 0.53, p = 0.06) and increase the first-attempt success rate (RR 1.5 (99% CI, 1.22 to 1.86), p < 0.0001, NNT = 5). In difficult spines and obese patients, the RR is 1.84 (99% CI, 1.44 to 2.3; p < 0.0001, NNT = 3). The number of needle redirections is lower with pre-procedural ultrasounds (SMD = −0.55 (99% CI, −0.81 to −0.29), p < 0.0001), as is the case in difficult spines and obese patients (SMD = −0.85 (99% CI, −1.08 to −0.61), p < 0.0001). No differences are observed in procedural times. Ιn conclusion, a pre-procedural ultrasound provides significant benefit in terms of technical failure, number of needle redirections and first attempt-success rate. Τhe effect of pre-procedural ultrasound scanning of the lumbar spine is more significant in a subgroup analysis of difficult spines and obese patients.

The effect of almond intake on lipid profile: a systematic review and meta-analysis of randomized controlled trials

2021 ◽  
Author(s):  
Omid Asbaghi ◽  
Vihan Moodi ◽  
Amir Hadi ◽  
Elham Eslampour ◽  
Mina Shirinbakhshmasoleh ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Randomized Controlled Trials ◽  
Lipid Profile ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Randomized Controlled

A number of clinical trials have examined the effect of almond intake on the lipid profile in recent years; however, the results remain equivocal.

scholarly journals Network Meta-Analysis of Different Clinical Commonly Used Drugs for the Treatment of Hypertrophic Scar and Keloid

2021 ◽  
Vol 8 ◽  
Author(s):  
Sha Yang ◽  
Yujia J. Luo ◽  
Cong Luo
Keyword(s):  
Clinical Trials ◽  
Randomized Controlled Trials ◽  
Topical Treatment ◽  
Hypertrophic Scar ◽  
Meta Analysis ◽  
Treatment Strategies ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Randomized Controlled ◽  
Silicone Gels

Background: There is no uniform treatment for pathological scars, including keloids and hypertrophic scars, in clinic currently. Previously, multiple randomized controlled trials have examined the clinical efficacy of different treatments. Nonetheless, the results are inconsistent, and many treatments have not been directly compared. This makes it difficult to conclude which approach is more favorable, in terms of efficacy and safety, for the treatment of pathological scarring. This study aimed at evaluating the efficacy of different injection and topical treatment strategies for hypertrophic scar and keloid.Methods: Relevant literature from PubMed, Medline, Embase, Scopus, the Cochrane Central Register of Controlled Trials (CCRCT), and WHO International Clinical Trials Registry Platform (WHO-ICTRP) were searched, from database inception through November 2020. Randomized clinical trials evaluating different treatment strategies of pathological scars, including triamcinolone acetonide (TAC), verapamil (VER), 5-fluorouracil (5-FU), botulinum toxin A (BTA), bleomycin (BLM), and silicone gels were included in the study.Results: The network meta-analysis included a total of 2,009 patients from 29 studies. A network meta-analysis of injection and topical treatment strategies showed that the efficacy of TAC combined with BTA was best in the treatment of pathological scars. Combination therapies of TAC with 5-FU and TAC with BTA significantly improved the clinical efficiency. However, there was no statistically significant difference between other treatment strategies. The order of efficacy predicted by the surface under the cumulative ranking (SUCRA) curve was as follows: TAC+BTA (82.2%) &gt; TAC+5-FU (69.8%) &gt; BTA (67.3%) &gt; 5-FU+silicone (59.4%) &gt; TAC+silicone (58.3%) &gt; 5-FU (49.8%) &gt; BLM (42.0%) &gt; TAC (26.7%) &gt; VER (26.2%) &gt; silicone (18.3%). There was no publication bias revealed based on the funnel diagram.Conclusion: This study recommends intralesional injection of TAC-BTA and TAC-5-FU combined therapies. But for patients who cannot tolerate the side effects, the use of silicone gels in combination with TAC is recommended. However, these conclusions need to be further confirmed by more randomized controlled trials.

Rotational Bed Therapy to Prevent and Treat Respiratory Complications: A Review and Meta-Analysis

2007 ◽  
Vol 16 (1) ◽  
pp. 50-61 ◽  
Author(s):  
David R. Goldhill ◽  
Michael Imhoff ◽  
Barbara McLean ◽  
Carl Waldmann
Keyword(s):  
Mechanical Ventilation ◽  
Randomized Controlled Trials ◽  
Critically Ill ◽  
Critically Ill Patients ◽  
Meta Analysis ◽  
Convincing Evidence ◽  
Controlled Trials ◽  
Respiratory Complications ◽  
Randomized Controlled ◽  
Meta Analyses

• Background Immobility is associated with complications involving many body systems. • Objective To review the effect of rotational therapy (use of therapeutic surfaces that turn on their longitudinal axes) on prevention and/or treatment of respiratory complications in critically ill patients. • Methods Published articles evaluating prophylaxis and/or treatment were reviewed. Prospective randomized controlled trials were assessed for quality and included in meta-analyses. • Results A literature search yielded 15 nonrandomized, uncontrolled, or retrospective studies. Twenty prospective randomized controlled trials on rotational therapy were published between 1987 and 2004. Various types of beds were studied, but few details on the rotational parameters were reported. The usual control was manual turning of patients by nurses every 2 hours. One animal investigation and 12 clinical trials addressed the effectiveness of rotational therapy in preventing respiratory complications. Significant benefits were reported in the animal study and 4 of the trials. Significant benefits to patients were reported in 2 of another 4 studies focused on treatment of established complications. Researchers have examined the effects of rotational therapy on mucus transport, intrapulmonary shunt, hemodynamic effects, urine output, and intracranial pressure. Little convincing evidence is available, however, on the most effective rotation parameters (eg, degree, pause time, and amount of time per day). Meta-analysis suggests that rotational therapy decreases the incidence of pneumonia but has no effect on duration of mechanical ventilation, number of days in intensive care, or hospital mortality. • Conclusions Rotational therapy may be useful for preventing and treating respiratory complications in selected critically ill patients receiving mechanical ventilation.

scholarly journals Effect of folate supplementation on insulin sensitivity and type 2 diabetes: a meta-analysis of randomized controlled trials

2019 ◽  
Vol 109 (1) ◽  
pp. 29-42 ◽  
Author(s):  
Mads Vendelbo Lind ◽  
Lotte Lauritzen ◽  
Mette Kristensen ◽  
Alastair B Ross ◽  
Jane Nygaard Eriksen
Keyword(s):  
Insulin Resistance ◽  
Type 2 Diabetes ◽  
Randomized Controlled Trials ◽  
Fasting Glucose ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Folate Supplementation ◽  
Randomized Controlled ◽  
Meta Analyses

ABSTRACT Background Various mechanisms link higher total homocysteine to higher insulin resistance (IR) and risk of type 2 diabetes (T2D). Folate supplementation is recognized as a way to lower homocysteine. However, randomized controlled trials (RCTs) show inconsistent results on IR and T2D outcomes. Objective The aim of this study was to examine the effect of folate supplementation on IR and T2D outcomes. Design We conducted a systematic literature search in PubMed, Web of Science, and EMBASE and prior systematic reviews and meta-analyses and identified 29 RCTs (22,250 participants) that assessed the effect of placebo-controlled folate supplementation alone or in combination with other B vitamins on fasting glucose, insulin, homeostasis model assessment for insulin resistance (HOMA-IR), glycated hemoglobin (HbA1c), or risk of T2D. The meta-analysis was conducted using both random- and fixed-effects models to calculate weighted mean differences (WMDs) or risk ratios with 95% CIs. Subgroup analyses were conducted based on intervention type (folate alone or in combination with other B vitamins), as well as analysis based on population characteristics, duration, dose, and change in homocysteine. Results When compared with placebo, folate supplementation lowered fasting insulin (WMD: −13.47 pmol/L; 95% CI: −21.41, −5.53 pmol/L; P &lt; 0.001) and HOMA-IR (WMD: −0.57 units; 95% CI: −0.76, −0.37 units; P &lt; 0.0001), but no overall effects were observed for fasting glucose or HbA1c. Heterogeneity was low in all meta-analyses, and subgroup analysis showed no signs of effect modification except for change in homocysteine, with the most pronounced effects in trials with a change of &gt;2.5 µmol/L. Changes in homocysteine after folate supplementation correlated with changes in fasting glucose (β = 0.07; 95% CI: 0.01, 0.14; P = 0.025) and HbA1c (β = 0.46; 95% CI: 0.06, 0.85; P = 0.02). Only 2 studies examined folate supplementation on risk of T2D, and they found no change in RR (pooled RR: 0.91; 95% CI: 0.80, 1.04; P = 0.16). Conclusion Folate supplementation might be beneficial for glucose homeostasis and lowering IR, but at present there are insufficient data to conclusively determine the effect on development of T2D. This trial was registered on the Prospero database as CRD42016048254.

scholarly journals Comparable Efficacy and Better Safety of Double β-Lactam Combination Therapy versus β‑Lactam plus Aminoglycoside in Gram-Negative Bacteria in Randomized, Controlled Trials

2019 ◽  
Vol 63 (7) ◽  
Author(s):  
Yuanyuan Jiao ◽  
Bartolome Moya ◽  
Mong-Jen Chen ◽  
Alexandre P. Zavascki ◽  
Hsinyin Tsai ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Response ◽  
Risk Ratio ◽  
Sensitivity Analyses ◽  
Secondary Outcome ◽  
Controlled Trials ◽  
Gram Negative Bacteria ◽  
Gram Negative ◽  
Content Type ◽  
Randomized Controlled

ABSTRACTThere is a great need for efficacious therapies against Gram-negative bacteria. Double β-lactam combination(s) (DBL) are relatively safe, and preclinical data are promising; however, their clinical role has not been well defined. We conducted a metaanalysis of the clinical and microbiological efficacy of DBL compared to β-lactam plus aminoglycoside combinations (BLAG). PubMed, Embase, ISI Web of Knowledge, and Cochrane Controlled Trials Register database were searched through July 2018. We included randomized controlled clinical trials that compared DBL with BLAG combinations. Clinical response was used as the primary outcome and microbiological response in Gram-negative bacteria as the secondary outcome; sensitivity analyses were performed forPseudomonas aeruginosa,Klebsiellaspp., andEscherichia coli. Heterogeneity and risk of bias were assessed. Safety results were classified by systems and organs. Thirteen studies evaluated 2,771 cases for clinical response and 665 cases for microbiological response in various Gram-negative species. DBL achieved slightly, but not significantly, better clinical response (risk ratio, 1.05; 95% confidence interval [CI], 0.99 to 1.11) and microbiological response in Gram-negatives (risk ratio, 1.11; 95% CI, 0.99 to 1.25) compared with BLAG. Sensitivity analyses by pathogen showed the same trend. No significant heterogeneity across studies was found. DBL was significantly safer than BLAG regarding renal toxicity (6.6% versus 8.8%,P = 0.0338) and ototoxicity (0.7 versus 3.1%,P = 0.0137). Other adverse events were largely comparable. Overall, empirically designed DBL showed comparable clinical and microbiological responses across different Gram-negative species, and were significantly safer than BLAG. Therefore, DBL should be rationally optimized via the latest translational approaches, leveraging mechanistic insights and newer β-lactams for future evaluation in clinical trials.

Dietary saturated fat and heart disease: a narrative review

2019 ◽  
Vol 78 (6) ◽  
pp. 474-485 ◽  
Author(s):  
Jeffery L Heileson
Keyword(s):  
Heart Disease ◽  
Randomized Controlled Trials ◽  
Observational Studies ◽  
Meta Analysis ◽  
Saturated Fat ◽  
Heart Association ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Disease Outcomes ◽  
Meta Analyses

Abstract The American Heart Association (AHA) recently published a meta-analysis that confirmed their 60-year-old recommendation to limit saturated fat (SFA, saturated fatty acid) and replace it with polyunsaturated fat to reduce the risk of heart disease based on the strength of 4 Core Trials. To assess the evidence for this recommendation, meta-analyses on the effect of SFA consumption on heart disease outcomes were reviewed. Nineteen meta-analyses addressing this topic were identified: 9 observational studies and 10 randomized controlled trials. Meta-analyses of observational studies found no association between SFA intake and heart disease, while meta-analyses of randomized controlled trials were inconsistent but tended to show a lack of an association. The inconsistency seems to have been mediated by the differing clinical trials included. For example, the AHA meta-analysis only included 4 trials (the Core Trials), and those trials contained design and methodological flaws and did not meet all the predefined inclusion criteria. The AHA stance regarding the strength of the evidence for the recommendation to limit SFAs for heart disease prevention may be overstated and in need of reevaluation.

scholarly journals Almond Consumption and Risk Factors for Cardiovascular Disease: A Systematic Review and Meta-analysis of Randomized Controlled Trials

2019 ◽  
Vol 10 (6) ◽  
pp. 1076-1088 ◽  
Author(s):  
Michelle A Lee-Bravatti ◽  
Jifan Wang ◽  
Esther E Avendano ◽  
Ligaya King ◽  
Elizabeth J Johnson ◽  
...  
Keyword(s):  
Risk Factors ◽  
Systematic Review ◽  
Blood Pressure ◽  
Cardiovascular Disease ◽  
Body Weight ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Meta Analyses

ABSTRACT Evidence suggests that eating nuts may reduce the risk of cardiovascular disease (CVD). We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) evaluating almond consumption and risk factors for CVD. MEDLINE, Cochrane Central, Commonwealth Agricultural Bureau, and previous systematic reviews were searched from 1990 through June 2017 for RCTs of ≥3 wk duration that evaluated almond compared with no almond consumption in adults who were either healthy or at risk for CVD. The most appropriate stratum was selected with an almond dose closer to 42.5 g, with a control most closely matched for macronutrient composition, energy intake, and similar intervention duration. The outcomes included risk factors for CVD. Random-effects model meta-analyses and subgroup meta-analyses were performed. Fifteen eligible trials analyzed a total of 534 subjects. Almond intervention significantly decreased total cholesterol (summary net change: −10.69 mg/dL; 95% CI: −16.75, −4.63 mg/dL), LDL cholesterol (summary net change: −5.83 mg/dL; 95% CI: −9.91, −1.75 mg/dL); body weight (summary net change: −1.39 kg; 95% CI: −2.49, −0.30 kg), HDL cholesterol (summary net change: −1.26 mg/dL; 95% CI: −2.47, −0.05 mg/dL), and apolipoprotein B (apoB) (summary net change: −6.67 mg/dL; 95% CI: −12.63, −0.72 mg/dL). Triglycerides, systolic blood pressure, apolipoprotein A1, high-sensitivity C-reactive protein, and lipoprotein (a) showed no difference between almond and control in the main and subgroup analyses. Fasting blood glucose, diastolic blood pressure, and body mass index significantly decreased with almond consumption of >42.5 g compared with ≤42.5 g. Almond consumption may reduce the risk of CVD by improving blood lipids and by decreasing body weight and apoB. Substantial heterogeneity in eligible studies regarding almond interventions and dosages precludes firmer conclusions.

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