The Evidence Base of Neuropsychological Rehabilitation in Acquired Brain Impairment (ABI): How Good is the Research?

2006 ◽  
Vol 7 (2) ◽  
pp. 119-132 ◽  
Author(s):  
Michael Perdices ◽  
Regina Schultz ◽  
Robyn Tate ◽  
Skye McDonald ◽  
Leanne Togher ◽  
...  
Keyword(s):  
Research Design ◽  
Methodological Quality ◽  
Case Series ◽  
Evidence Base ◽  
Speech Disorders ◽  
Single Subject ◽  
Target Area ◽  
Level Of Evidence ◽  
Significant Difference

AbstractIn the context of evidence-based clinical practice (EBCP), the reliability of empirical data is largely determined by the methodological quality of research design. PsycBITE™ (Psychological Database of Brain Impairment Treatment Efficacy) is a web-based database listing all published, empirical reports on the effectiveness of nonpharmacological interventions for the psychological consequences of acquired brain impairment (ABI). The aim of this study was to survey the listings of PsycBITE™ and examine the methodological quality of the reports it contains. Reports listed in PsycBITE™ include systematic reviews (SRs), randomised controlled trials (RCTs), non-RCTs, case series (CSs) and single-subject designs (SSDs). They are indexed according to research design, neurological group, patient age group, target area and intervention type. The PEDro Scale is used to rate the methodological quality of RCTs, nonRCTs and CSs, with maximum obtainable methodological quality rating (MQR) of 10/10, 8/10 and 2/10 respectively. A search identified 1298 reports indexed in PsycBITE™. The largest proportion was SSDs (39%), followed by CSs (22%), RCTs (21%), non-RCTs (11%) and SRs (7%). The majority of reports was concerned with stroke (41%), traumatic brain injury (29%) and Alzheimer's and related dementias (22%). The most frequently investigated deficits were communication/language/speech disorders (24%); independent/self-care activities (19%); behaviour problems (17%); memory impairments (17%); anxiety, depression, stress, adjustment (15%). Approximately half of the RCTs, non-RCTs and CSs were rated for methodological quality. Mean MQR scores for RCTs, non-RCTs and CSs were 4.49, 2.85 and 1.15 respectively. While some PEDro criteria were met by a high proportion of RCTs and non-RCTs (≥ 70%), other criteria were only met by a small proportion of reports (as low as 1.6%). There was no significant difference in MQR scores between RCTs focusing on different neurological groups or target areas. Furthermore, there was no discernible improvement in MQR score for RCTs published over the last three decades. The methodological quality of studies investigating the efficacy of rehabilitation interventions in ABI has been consistently modest over several decades. This is largely attributable to poor adherence to fundamental tenets of research design, and requires urgent remediation. RCTs (and to a lesser extent, non-RCTs) are research methodologies which can potentially yield a high level of evidence, but only if they are adequately designed. PsycBITE™ has the facility to raise awareness of these issues and be instrumental in promoting EBCP in the field of ABI.

scholarly journals Methodological quality and synthesis of case series and case reports

2018 ◽  
Vol 23 (2) ◽  
pp. 60-63 ◽  
Author(s):  
Mohammad Hassan Murad ◽  
Shahnaz Sultan ◽  
Samir Haffar ◽  
Fateh Bazerbachi
Keyword(s):  
Methodological Quality ◽  
Medical Literature ◽  
Case Reports ◽  
Case Series ◽  
Evidence Based ◽  
Level Of Evidence ◽  
Increased Risk ◽  
Study Designs ◽  
Inform Decision Making

Case reports and case series are uncontrolled study designs known for increased risk of bias but have profoundly influenced the medical literature and continue to advance our knowledge. In this guide, we present a framework for appraisal, synthesis and application of evidence derived from case reports and case series. We propose a tool to evaluate the methodological quality of case reports and case series based on the domains of selection, ascertainment, causality and reporting and provide signalling questions to aid evidence-based practitioners and systematic reviewers in their assessment. We suggest using evidence derived from case reports and case series to inform decision-making when no other higher level of evidence is available.

GLUCOSAMINYLMURAMYLDIPEPTIDE: REVIEW OF USE AND EFFECTIVENESS EVALUATION IN PEDIATRIC PRACTICE

2021 ◽  
Vol 100 (2) ◽  
pp. 157-166
Author(s):  
A.P. Prodeus ◽  
◽  
G.N. Gildeeva ◽  
D.R. Mamilyaeva ◽  
I.G. Kozlov ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Methodological Quality ◽  
Good Clinical Practice ◽  
Evidence Base ◽  
Efficacy And Safety ◽  
Level Of Evidence ◽  
Old Patients ◽  
Scope Of Application ◽  
Based Medicine

A review of the accumulated data on the use of glucosaminylmuramyldipeptide (GMDP, Likopid drug) and the assessment of its effectiveness in children are presented. Objective of the research: to systematize the results of clinical trials of the efficacy and safety of GMDP therapy in neonatology and pediatrics. Materials and methods. Publications were searched for in Pubmed/MEDLINE, ScienceDirect, Cochrane, Elibrary.ru, registers of clinical trials and in open sources on the Internet. The authors assessed the level of evidence for reliability and the methodological quality of the studies. Results. The screening resulted in selection of 38 clinical trials with satisfactory methodological quality and a total of 2,692 0-18 year old patients. The effectiveness of use of GMDP (Likopid) as part of complex therapy for infectious diseases of the respiratory tract (2A), allergy-related diseases (2A), herpesvirus infection (3B), dysbiosis/dysbacteriosis (3B), and newborn respiratory distress syndrome (2B) has been demonstrated. The safety assessment is given in 7 studies, of which 5 confirmed absence of any adverse events. Scope of application. The results of the review enable practitioners to prescribe GMDP (Likopid) based on the levels of evidence. The existence of evidence base for the use of GMDP in newborns allows us to raise the question of restoring appropriate indications in the Instructions for Medical Use. Conclusions. For a number of nosologies, further studies of modern design, based on the principles of evidence-based medicine, are required to assess the efficacy and safety of GMDP for good clinical practice in neonatology and pediatrics.

scholarly journals Association of variants within the GST and other genes with anti-tubercular agents related toxicity: a systematic review and meta-analysis

2019 ◽  
Author(s):  
Marty Richardson ◽  
Jamie Kirkham ◽  
Kerry Dwan ◽  
Derek J Sloan ◽  
Geraint Davies ◽  
...  
Keyword(s):  
Systematic Review ◽  
Genetic Variants ◽  
Methodological Quality ◽  
Meta Analysis ◽  
Evidence Base ◽  
Wild Type ◽  
Mutant Type ◽  
Significant Difference ◽  
Homozygous Mutant

AbstractBackgroundIndividuals receiving treatment with anti-tuberculosis (TB) drugs may experience serious side-effects, such as anti-TB drug-induced hepatotoxicity (ATDH). Genetic variants, such as polymorphisms of the GST gene and other genes, may increase the risk of experiencing such toxicity events. This systematic review and meta-analysis provides a comprehensive evaluation of the evidence base for associations between variants of the GST gene and other genes and toxicity outcomes related to anti-TB drugs.MethodsWe searched for relevant studies in MEDLINE, PubMed, EMBASE, BIOSIS and Web of Science. We pooled effect estimates for each genotype on each outcome, and stratified all analyses by country. We qualitatively assessed the methodological quality of the included studies.ResultsWe included data from 28 distinct cohorts of patients in the review. The methodological quality of included studies was variable, with several important areas of concern. For GSTM1, patients with the homozygous null genotype were significantly more likely to experience hepatotoxicity than patients with heterozygous or homozygous present genotype (odds ratio [OR]=1.44, 95% confidence interval [CI] 1.15, 1.82). Moderate heterogeneity was observed in this analysis (I2=51.2%). No significant difference was observed for the GSTT1 null polymorphism. For the rs3814057 polymorphism of the PXR gene, both heterozygous genotype and homozygous mutant-type significantly increased hepatotoxicity risk compared with homozygous wild-type (heterozygous versus homozygous wild-type: OR=1.98, 95% CI 1.06, 3.69; I2=0%; homozygous mutant-type versus homozygous wild-type: OR=2.18, 95% CI 1.07, 4.44; I2=0%).ConclusionsWe found that it is challenging to perform robust synthesis of the evidence base for associations between GST and other genetic variants and toxicity related to anti-TB drugs. We identified significant associations between the GSTM1 null and PXR rs3814057 polymorphisms and ATDH. To the best of our knowledge, no meta-analyses on genetic variants other than variants of the NAT2, CYP2E1, GSTM1 and GSTT1 genes have been published. Our results therefore add to the existing understanding of the association between genetic variants and hepatotoxicity.

Combining Microfractures, Autologous Bone Graft, and Autologous Matrix-Induced Chondrogenesis for the Treatment of Juvenile Osteochondral Talar Lesions

2017 ◽  
Vol 38 (5) ◽  
pp. 485-495 ◽  
Author(s):  
Riccardo D’Ambrosi ◽  
Camilla Maccario ◽  
Chiara Ursino ◽  
Nicola Serra ◽  
Federico Giuseppe Usuelli
Keyword(s):  
Bone Graft ◽  
Repeated Measures ◽  
Osteochondral Lesion ◽  
Young Patients ◽  
Case Series ◽  
Autologous Bone Graft ◽  
Lesion Size ◽  
Level Of Evidence ◽  
Significant Difference ◽  
Autologous Bone

Background: The purpose of this study was to evaluate the clinical and radiologic outcomes of patients younger than 20 years, treated with the arthroscopic-talus autologous matrix-induced chondrogenesis (AT-AMIC) technique and autologous bone graft for osteochondral lesion of the talus (OLT). Methods: Eleven patients under 20 years (range 13.3-20.0) underwent the AT-AMIC procedure and autologous bone graft for OLTs. Patients were evaluated preoperatively (T0) and at 6 (T1), 12 (T2), and 24 (T3) months postoperatively, using the American Orthopaedic Foot & Ankle Society Ankle and Hindfoot (AOFAS) score, the visual analog scale and the SF-12 respectively in its Mental and Physical Component Scores. Radiologic assessment included computed tomographic (CT) scan, magnetic resonance imaging (MRI) and intraoperative measurement of the lesion. A multivariate statistical analysis was performed. Results: Mean lesion size measured during surgery was 1.1 cm3 ± 0.5 cm3. We found a significant difference in clinical and radiologic parameters with analysis of variance for repeated measures ( P < .001). All clinical scores significantly improved ( P < .05) from T0 to T3. Lesion area significantly reduced from 119.1 ± 29.1 mm2 preoperatively to 77.9 ± 15.8 mm2 ( P < .05) at final follow-up as assessed by CT, and from 132.2 ± 31.3 mm2 to 85.3 ± 14.5 mm2 ( P < .05) as assessed by MRI. Moreover, we noted an important correlation between intraoperative size of the lesion and body mass index (BMI) ( P = .011). Conclusions: The technique can be considered safe and effective with early good results in young patients. Moreover, we demonstrated a significant correlation between BMI and lesion size and a significant impact of OLTs on quality of life. Level of Evidence: Level IV, retrospective case series.

Exercise-Induced Scalenus Syndrome

2008 ◽  
Vol 36 (2) ◽  
pp. 369-374 ◽  
Author(s):  
Panagiotis Baltopoulos ◽  
Charalampos Tsintzos ◽  
George Prionas ◽  
Maria Tsironi
Keyword(s):  
Quality Of Life ◽  
Thoracic Outlet Syndrome ◽  
Surgical Intervention ◽  
Case Series ◽  
Signs And Symptoms ◽  
Underlying Mechanism ◽  
Level Of Evidence ◽  
Full Activity ◽  
Exercise Induced

Background Thoracic outlet syndrome is described as a group of distinct disorders producing signs and symptoms attributed to compression of nerves and blood vessels in the thoracic outlet region. Purpose To describe the exercise-induced scalenus anticus syndrome attributed to the anterior scalenus hypertrophy as a thoracic outlet syndrome underlying mechanism and to give recommendations for a safe and effective surgical treatment. Study Design Case series; Level of evidence, 4. Methods Twelve young professional athletes admitted for thoracic outlet syndrome (8 cases of neurologic thoracic outlet syndrome, 4 cases of mixed neurologic and vascular thoracic outlet syndrome) who reported numbness, tingling, early fatigue, muscle weakness, and pain were enrolled in the study. Scalenus hypertrophy was suspected to be the causative factor. Scalenectomy was performed in all cases. Results All patients had moderate to severe hypertrophy of the anterior scalenus muscle. Scalenectomy was performed, and there were no intraoperative or postoperative complications. Full activity was quickly achieved, and no recurrence of symptoms was documented. Conclusion Surgical intervention for scalenus anticus syndrome can allow an athlete to return to full activity and improve quality of life. Surgical intervention seems to be the treatment of choice in terms of restoring quality of life and physical activity.

Treatment Efficacy

1996 ◽  
Vol 39 (5) ◽  
Author(s):  
Audrey L. Holland ◽  
Davida S. Fromm ◽  
Frank DeRuyter ◽  
Margo Stein
Keyword(s):  
Program Evaluation ◽  
Small Group ◽  
Research Design ◽  
Treatment Efficacy ◽  
Single Subject ◽  
Efficacy Data ◽  
Evaluation Data ◽  
Quality Of Evidence ◽  
Efficacy Of Treatment

This article presents a brief overview of aphasia, followed by a summary of research studies and program evaluation data addressed to answering the question of the efficacy of treatment for aphasia. Selected studies are reviewed in terms of the quality of evidence they present. In addition, a number of questions that remain unanswered are also presented. Several tables, designed to provide clarifying information concerning several aspects of research design (number and types of patients studied, examples of well-designed small-group or single-subject studies, clinical techniques for which efficacy data are available), are included. The conclusion of this review is that, generally, treatment for aphasia is efficacious.

scholarly journals Assessment and Trends in the Methodological Quality of the Top 50 Most Cited Articles in Shoulder Instability

2020 ◽  
Vol 8 (12) ◽  
pp. 232596712096708
Author(s):  
Avinesh Agarwalla ◽  
Kaisen Yao ◽  
Anirudh K. Gowd ◽  
Nirav H. Amin ◽  
J. Martin Leland ◽  
...  
Keyword(s):  
Bone Loss ◽  
Shoulder Instability ◽  
Methodological Quality ◽  
Surgical Techniques ◽  
Case Series ◽  
Cross Sectional Study ◽  
Retrospective Case ◽  
Level Of Evidence ◽  
Cross Sectional ◽  
Number Of Citations

Background: Citation counts have often been used as a surrogate for the scholarly impact of a particular study, but they do not necessarily correlate with higher-quality investigations. In recent decades, much of the literature regarding shoulder instability is focused on surgical techniques to correct bone loss and prevent recurrence. Purpose: To determine (1) the top 50 most cited articles in shoulder instability and (2) if there is a correlation between the number of citations and level of evidence or methodological quality. Study Design: Cross-sectional study. Methods: A literature search was performed on both the Scopus and the Web of Science databases to determine the top 50 most cited articles in shoulder instability between 1985 and 2019. The search terms used included “shoulder instability,” “humeral defect,” and “glenoid bone loss.” Methodological scores were calculated using the Modified Coleman Methodology Score (MCMS), Jadad scale, and Methodological Index for Non-Randomized Studies (MINORS) score. Results: The mean number of citations and mean citation density were 222.7 ± 123.5 (range, 124-881.5) and 16.0 ± 7.9 (range, 6.9-49.0), respectively. The most common type of study represented was the retrospective case series (evidence level, 4; n = 16; 32%) The overall mean MCMS, Jadad score, and MINORS score were 61.1 ± 10.1, 1.4 ± 0.9, and 16.0 ± 3.0, respectively. There were also no correlations found between mean citations or citation density versus each of the methodological quality scores. Conclusion: The list of top 50 most cited articles in shoulder instability comprised studies with low-level evidence and low methodological quality. Higher-quality study methodology does not appear to be a significant factor in whether studies are frequently cited in the literature.

scholarly journals Low-Intensity Electromagnetic Millimeter Waves for Pain Therapy

2006 ◽  
Vol 3 (2) ◽  
pp. 201-207 ◽  
Author(s):  
Taras I. Usichenko ◽  
Hardy Edinger ◽  
Vasyl V. Gizhko ◽  
Christian Lehmann ◽  
Michael Wendt ◽  
...  
Keyword(s):  
Pain Relief ◽  
Methodological Quality ◽  
Large Scale ◽  
Case Series ◽  
Treatment Method ◽  
Rapid Onset ◽  
Acupuncture Points ◽  
Non Invasive ◽  
Review Criteria

Millimeter wave therapy (MWT), a non-invasive complementary therapeutic technique is claimed to possess analgesic properties. We reviewed the clinical studies describing the pain-relief effect of MWT. Medline-based search according to review criteria and evaluation of methodological quality of the retrieved studies was performed. Of 13 studies, 9 of them were randomized controlled trials (RCTs), only three studies yielded more than 3 points on the Oxford scale of methodological quality of RCTs. MWT was reported to be effective in the treatment of headache, arthritic, neuropathic and acute postoperative pain. The rapid onset of pain relief during MWT lasting hours to days after, remote to the site of exposure (acupuncture points), was the most characteristic feature in MWT application for pain relief. The most commonly used parameters of MWT were the MW frequencies between 30 and 70 GHz and power density up to 10 mW cm−2. The promising results from pilot case series studies and small-size RCTs for analgesic/hypoalgesic effects of MWT should be verified in large-scale RCTs on the effectiveness of this treatment method.

Rating the methodological quality of single-subject designs andn-of-1 trials: Introducing the Single-Case Experimental Design (SCED) Scale

2008 ◽  
Vol 18 (4) ◽  
pp. 385-401 ◽  
Author(s):  
Robyn L Tate ◽  
Skye Mcdonald ◽  
Michael Perdices ◽  
Leanne Togher ◽  
Regina Schultz ◽  
...  
Keyword(s):  
Experimental Design ◽  
Methodological Quality ◽  
Single Case ◽  
Single Subject ◽  
Single Subject Designs

scholarly journals Effectiveness of shockwave therapy in the treatment of plantar fasciitis

2020 ◽  
Vol 28 (1) ◽  
pp. 7-11
Author(s):  
Renan Gonçalves Leão ◽  
Marina Mayumi Azuma ◽  
Gustavo Henrique Carillo Ambrosio ◽  
Flavio Faloppa ◽  
Eduardo Shoiti Takimoto ◽  
...  
Keyword(s):  
Plantar Fasciitis ◽  
Case Series ◽  
Sao Paulo ◽  
São Paulo ◽  
Post Intervention ◽  
Level Of Evidence ◽  
Shockwave Therapy ◽  
Case Series Study ◽  
Sf 36

ABSTRACT Objective: To evaluate the effectiveness of single-dose focal shockwave therapy in plantar fasciitis treatment. Methods: a primary, prospective study of a series of cases, conducted in the city of São Paulo, Brazil, by the Department of Orthopedics and Traumatology of the Universidade Federal de São Paulo, in Hospital São Paulo. All outcomes were measured at the time of inclusion of the patient in the study and at the post-intervention moments as it follows: three, six and twelve weeks. The VAS, AOFAS and SF-36 scales were applied by teams other than those who performed the SWT. Results: Data from 56 patients were collected during 2017 and 2018. There was improvement of the parameter evaluated (p < 0.005 and 95%CI) in all the periods in which the patients were reevaluated (3, 6 and 12 weeks), progressive improvement were observed in the three outcomes evaluated. Conclusion: Shock wave therapy was effective for plantar fasciitis treatment according to the proposed protocol considering pain, function and quality of life. Level of Evidence Ic, Case-series Study.

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