scholarly journals Structural Allograft Versus PEEK Implants in Anterior Cervical Discectomy and Fusion: A Systematic Review

2019 ◽  
Vol 10 (6) ◽  
pp. 775-783
Author(s):  
Amit Jain ◽  
Majd Marrache ◽  
Andrew Harris ◽  
Varun Puvanesarajah ◽  
Brian J. Neuman ◽  
...  
Keyword(s):  
Systematic Review ◽  
Patient Reported Outcomes ◽  
Controlled Trials ◽  
High Quality ◽  
Randomized Controlled ◽  
High Quality Evidence ◽  
Structural Allograft ◽  
Patient Reported ◽  
Spine Degeneration ◽  
Quality Evidence

Study Design: Systematic literature review. Objective: Our primary objective was to compare reported fusion rates after anterior cervical discectomy and fusion (ACDF) using structural allograft versus polyetheretherketone (PEEK) interbody devices in patients with cervical spine degeneration. Our secondary objectives were to compare differences in rates of subsidence and reoperation and in patient-reported outcomes between the 2 groups. Methods: Through a systematic review of the English-language literature using various databases, we identified 4702 articles. After we applied inclusion and exclusion criteria, 14 articles (7 randomized controlled trials, 4 prospective studies, and 3 retrospective studies) reporting fusion rates of structural allograft or PEEK interbody devices were eligible for our analysis. No randomized controlled trials compared outcomes of structural allograft versus PEEK interbody devices. Extracted data included authors, study years, study designs, sample sizes, patient ages, duration of follow-up, types of interbody devices used, fusion rates, definition of fusion, reoperation rates, subsidence rates, and patient-reported outcomes. Results: Fusion rates were 82% to 100% for allograft and 88% to 98% for PEEK interbody devices. The reported data were insufficient to perform meta-analysis. Structural allograft had the highest reported rate of reoperation (14%), and PEEK interbody devices had the highest reported subsidence rate (18%). Patient-reported outcomes improved in both groups. There was insufficient high-quality evidence to compare the associations of various PEEK modifications with fusion rates. Conclusion: Fusion rates were similar between structural allograft and PEEK interbody devices when used for ACDF for cervical spine degeneration. Currently, there is insufficient high-quality evidence to assess associations of PEEK modifications with fusion rates. Level of Evidence: II.

scholarly journals Measurement properties of patient-reported outcome measures (PROMs) in hyperhidrosis: a systematic review

2021 ◽  
Author(s):  
Michaela Gabes ◽  
Helge Knüttel ◽  
Gesina Kann ◽  
Christina Tischer ◽  
Christian J. Apfelbacher
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Measurement Properties ◽  
High Quality ◽  
High Quality Evidence ◽  
Patient Reported ◽  
Quality Evidence

Abstract Purpose To critically appraise, compare and summarize the quality of all existing PROMs that have been validated in hyperhidrosis to at least some extend by applying the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology. Thereby, we aim to give a recommendation for the use of PROMs in future clinical trials in hyperhidrosis. Methods We considered studies evaluating, describing or comparing measurement properties of PROMs as eligible. A systematic literature search in three big databases (MEDLINE, EMBASE and Web of Science) was performed. We assessed the methodological quality of each included study using the COSMIN Risk of Bias checklist. Furthermore, we applied predefined quality criteria for good measurement properties and finally, graded the quality of the evidence. Results Twenty-four articles reporting on 13 patient-reported outcome measures were included. Three instruments can be further recommended for use. They showed evidence for sufficient content validity and moderate- to high-quality evidence for sufficient internal consistency. The methodological assessment showed existing evidence gaps for eight other PROMs, which therefore require further validation studies to make an adequate decision on their recommendation. The Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) and the short-form health survey with 36 items (SF-36) were the only questionnaires not recommended for use in patients with hyperhidrosis due to moderate- to high-quality evidence for insufficient measurement properties. Conclusion Three PROMs, the Hyperhidrosis Quality of Life Index (HidroQoL), the Hyperhidrosis Questionnaire (HQ) and the Sweating Cognitions Inventory (SCI), can be recommended for use in future clinical trials in hyperhidrosis. Results obtained with these three instruments can be seen as trustworthy. Nevertheless, further validation of all three PROMs is desirable. Systematic review registration PROSPERO CRD42020170247

scholarly journals TRADE-OFFS BETWEEN EPISTEMIC AND MORAL VALUES IN EVIDENCE-BASED POLICY

2018 ◽  
Vol 35 (1) ◽  
pp. 49-78 ◽  
Author(s):  
Donal Khosrowi
Keyword(s):  
Controlled Trials ◽  
Evidence Based ◽  
Epistemic Values ◽  
High Quality ◽  
Political Values ◽  
Randomized Controlled ◽  
High Quality Evidence ◽  
Evidence Based Policy ◽  
Trade Offs ◽  
Quality Evidence

Abstract:Proponents of evidence-based policy (EBP) call for public policy to be informed by high-quality evidence from randomized controlled trials. This methodological preference aims to promote several epistemic values, e.g. rigour, unbiasedness, precision, and the ability to obtain causal conclusions. I argue that there is a trade-off between these epistemic values and several non-epistemic, moral and political values. This is because the evidence afforded by standard EBP methods is differentially useful for pursuing different moral and political values. I expand on how this challenges ideals of value-freedom and -neutrality in EBP, and offer suggestions for how EBP methodology might be revised.

scholarly journals Intensive Triangulation of Qualitative Research and Quantitative Data to Improve Recruitment to Randomized Trials: The QuinteT Approach

2019 ◽  
Vol 29 (5) ◽  
pp. 672-679 ◽  
Author(s):  
Leila Rooshenas ◽  
Sangeetha Paramasivan ◽  
Marcus Jepson ◽  
Jenny L. Donovan
Keyword(s):  
Qualitative Research ◽  
Comparative Effectiveness ◽  
Quantitative Data ◽  
Randomized Trials ◽  
Controlled Trials ◽  
High Quality ◽  
Randomized Controlled ◽  
Health Care Interventions ◽  
High Quality Evidence ◽  
Quality Evidence

Randomized controlled trials (RCTs) can provide high quality evidence about the comparative effectiveness of health care interventions, but many RCTs struggle with or fail to complete recruitment. RCTs are built on the principles of the experimental method, but their planning, conduct, and interpretation can depend on complex social, behavioral, and cultural factors that may be best understood through qualitative research. Most qualitative studies undertaken alongside RCTs involve interviews that produce data that are used in a supportive or supplicatory role, but there is potential for qualitative research to be more influential. In this article, we describe the research methods underpinning the “QuinteT” (Qualitative Research Integrated Within Trials) approach to understand and address RCT recruitment difficulties. The QuinteT Recruitment Intervention (QRI) brings together multiple qualitative strategies and quantitative data and uses triangulation to understand recruitment issues rapidly. These nuanced understandings are used to inform the implementation of collaborative actions to improve recruitment.

scholarly journals Inclusion of older patients with cancer in randomised controlled trials with patient-reported outcomes: a systematic review

2019 ◽  
pp. bmjspcare-2019-001902
Author(s):  
Francesco Sparano ◽  
Neil K Aaronson ◽  
Mirjam A G Sprangers ◽  
Peter Fayers ◽  
Andrea Pusic ◽  
...  
Keyword(s):  
Systematic Review ◽  
Older Patients ◽  
Randomised Controlled Trials ◽  
Patient Reported Outcomes ◽  
Controlled Trials ◽  
High Quality ◽  
Quality Of Life Research ◽  
Patient Reported ◽  
Randomised Controlled

ObjectivesInclusion of patient-reported outcomes (PROs) in cancer randomised controlled trials (RCTs) may be particularly important for older patients. The objectives of this systematic review were to quantify the frequency with which older patients are included in RCTs with PROs and to evaluate the quality of PRO reporting in those trials.MethodsAll RCTs with PRO endpoints, published between January 2004 and February 2019, which included a patient sample with a mean/median age ≥70 years, were considered for this systematic review. The following cancer malignancies were considered: breast, colorectal, lung, prostate, gynaecological and bladder cancer.Quality of PRO reporting was evaluated using the International Society for Quality of Life Research–PRO standards. Studies meeting at least two-thirds of these criteria were considered to have high-quality PRO reporting.ResultsOf 649 RCTs identified with a PRO endpoint, only 72 (11.1%) included older patients. Of these, 35 trials (48.6%) were conducted in patients with metastatic/advanced disease. PROs were primary endpoints in 20 RCTs (27.8%). Overall survival was the most frequently reported clinical outcome in studies of patients with metastatic/advanced cancer (n=28, 80%). One-third of the RCTs (n=24, 33.3%) were considered to have high-quality PRO reporting. Overall, the largest prevalence of RCTs with high-quality PRO reporting was observed in prostate and colorectal cancers.ConclusionsOur review indicates not only that PRO–RCT-based studies in oncology rarely include older patients but also that completeness of PRO reporting of many of them is often suboptimal.

scholarly journals Clinical Outcomes After the Nonoperative Management of Lateral Patellar Dislocations: A Systematic Review

2018 ◽  
Vol 6 (6) ◽  
pp. 232596711876627 ◽  
Author(s):  
Munim Moiz ◽  
Nick Smith ◽  
Toby O. Smith ◽  
Amit Chawla ◽  
Peter Thompson ◽  
...  
Keyword(s):  
Systematic Review ◽  
Cohort Studies ◽  
Randomized Controlled Trials ◽  
Case Series ◽  
Cochrane Library ◽  
Controlled Trials ◽  
Level Of Evidence ◽  
Randomized Controlled ◽  
Patient Reported ◽  
Quality Evidence

Background: The first-line treatment for patellar dislocations is often nonoperative and consists of physical therapy and immobilization techniques, with various adjuncts employed. However, the outcomes of nonoperative therapy are poorly described, and there is a lack of quality evidence to define the optimal intervention. Purpose: To perform a comprehensive review of the literature and assess the quality of studies presenting patient outcomes from nonoperative interventions for patellar dislocations. Study Design: Systematic review; Level of evidence, 4. Methods: The MEDLINE, AMED, Embase, CINAHL, Cochrane Library, PEDro, and SPORTDiscus electronic databases were searched through July 2017 by 3 independent reviewers. The PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines were followed. Study quality was assessed using the CONSORT (Consolidated Standards for Reporting Trials) criteria for randomized controlled trials and the Newcastle-Ottawa Scale for cohort studies and case series. Results: A total of 25 studies met our inclusion criteria, including 12 randomized controlled trials, 7 cohort studies, and 6 case series, consisting of 1066 patients. Studies were grouped according to 4 broad categories of nonoperative interventions based on immobilization, weightbearing status, quadriceps exercise type, and alternative therapies. The most commonly used outcome measure was the Kujala score, and the pooled redislocation rate was 31%. Conclusion: This systematic review found that patient-reported outcomes consistently improved after all methods of treatment but did not return to normal. Redislocation rates were high and close to the redislocation rates reported in natural history studies. There is a lack of quality evidence to advocate the use of any particular nonoperative technique for the treatment of patellar dislocations.

scholarly journals Therapeutic Evidence of Human Mesenchymal Stem Cell Transplantation for Cerebral Palsy: A Meta-Analysis of Randomized Controlled Trials

2020 ◽  
Vol 2020 ◽  
pp. 1-10
Author(s):  
Baocheng Xie ◽  
Minyi Chen ◽  
Runkai Hu ◽  
Weichao Han ◽  
Shaobo Ding
Keyword(s):  
Cerebral Palsy ◽  
Stem Cell ◽  
Mesenchymal Stem Cell ◽  
Meta Analysis ◽  
Human Mesenchymal Stem Cell ◽  
Controlled Trials ◽  
High Quality ◽  
Randomized Controlled ◽  
High Quality Evidence ◽  
Quality Evidence

Cerebral palsy (CP) is a kind of movement and posture disorder syndrome in early childhood. In recent years, human mesenchymal stem cell (hMSC) transplantation has become a promising therapeutic strategy for CP. However, clinical evidence is still limited and controversial about clinical efficacy of hMSC therapy for CP. Our aim is to evaluate the efficacy and safety of hMSC transplantation for children with CP using a meta-analysis of randomized controlled trials (RCTs). We conducted a systematic literature search including Embase, PubMed, ClinicalTrials.gov, Cochrane Controlled Trials Register databases, Chinese Clinical Trial Registry, and Web of Science from building database to February 2020. We used Cochrane bias risk assessment for the included studies. The result of pooled analysis showed that hMSC therapy significantly increased gross motor function measure (GMFM) scores (standardized mean difference SMD=1.10, 95%CI=0.66‐1.53, P<0.00001, high-quality evidence) and comprehensive function assessment (CFA) (SMD=1.30, 95%CI=0.71‐1.90, P<0.0001, high-quality evidence) in children with CP, compared with the control group. In the subgroup analysis, the results showed that hMSC therapy significantly increased GMFM scores of 3, 6, and 12 months and CFA of 3, 6, and 12 months. Adverse event (AE) of upper respiratory infection, diarrhea, and constipation was not statistically significant between the two groups. This meta-analysis synthesized the primary outcomes and suggested that hMSC therapy is beneficial, effective, and safe in improving GMFM scores and CFA scores in children with CP. In addition, subgroup analysis showed that hMSC therapy has a lasting positive benefit for CP in 3, 6, and 12 months.

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