scholarly journals Management of Spinal Deformities and Evidence of Treatment Effectiveness

2017 ◽  
Vol 11 (1) ◽  
pp. 1521-1547 ◽  
Author(s):  
Josette Bettany-Saltikov ◽  
Deborah Turnbull ◽  
Shu Yan Ng ◽  
Richard Webb
Keyword(s):  
Surgical Treatment ◽  
Conservative Treatment ◽  
Idiopathic Scoliosis ◽  
Adult Scoliosis ◽  
Controlled Trials ◽  
Spinal Deformities ◽  
High Quality ◽  
High Quality Evidence ◽  
Adolescents And Adults ◽  
Quality Evidence

Introduction:The review evaluates the up-to-date evidence for the treatment of spinal deformities, including scoliosis and hyperkyphosis in adolescents and adults.Material and Methods:The PubMed database was searched for review articles, prospective controlled trials and randomized controlled trials related to the treatment of spinal deformities. Articles on syndromic scoliosis were excluded and so were the articles on hyperkyphosis of the spine with causes other than Scheuermann’s disease and osteoporosis. Articles on conservative and surgical treatments of idiopathic scoliosis, adult scoliosis and hyperkyphosis were also included. For retrospective papers, only studies with a follow up period exceeding 10 years were included.Results:The review showed that early-onset idiopathic scoliosis has a worse outcome than late-onset idiopathic scoliosis, which is rather benign. Patients with AIS function well as adults; they have no more health problems when compared to patients without scoliosis, other than a slight increase in back pain and aesthetic concern. Conservative treatment of adolescent idiopathic scoliosis (AIS) using physiotherapeutic scoliosis-specific exercises (PSSE), specifically PSSR and rigid bracing was supported by level I evidence. Yet to date, there is no high quality evidence (RCT`s) demonstrating that surgical treatment is superior to conservative treatment for the management of AIS. For adult scoliosis, there are only a few studies on the effectiveness of PSSEs and a conclusion cannot as yet be drawn.For hyperkyphosis, there is no high-quality evidence for physiotherapy, bracing or surgery for the treatment of adolescents and adults. However, bracing has been found to reduce thoracic hyperkyphosis, ranging from 55 to 80° in adolescents. In patients over the age of 60, bracing improves the balance score, and reduces spinal deformity and pain. Surgery is indicated in adolescents and adults in the presence of progression of kyphosis, refractory pain and loss of balance.Discussion:The available evidence reviewed has suggested that different approaches are needed towards the management of different spinal deformities. Specific exercises should be prescribed in children and adolescents with a Cobb angle in excess of 15°. In progressive curves, they should be used in conjunction with bracing. Clarity regarding differences and similarities is given as to what makes PSSE and PSSR specific exercises. As AIS is relatively benign in nature, conservative treatment should be tried when the curve is at a surgical threshold, before surgery is considered. Similarly, bracing and exercises should be prescribed for patients with hyperkyphosis, particularly when the lumbar spine is afflicted. Surgery should be considered only when the symptoms cannot be managed conservatively.Conclusion:There is at present high quality evidence in support of the conservative treatment of AIS. The current evidence supports the use of PSSE, especially those using PSSR, together with bracing in the treatment of AIS. In view of the lack of medical consequences in adults with AIS, conservative treatment should be considered for curves exceeding the formerly assumed range of conservative indications.There is, however a lack of evidence in support of any treatment of choice for hyperkyphosis in adolescents and spinal deformities in adults. Yet, conservative treatment should be considered first. Yet to date, there is no high quality evidence (RCT`s) demonstrating that surgical treatment is superior to conservative treatment for the management of AIS and hyperkyphosis. Additionally, surgery needs to be considered with caution, as it is associated with a number of long-term complications.

scholarly journals Surgery for Good Prognosis Breast Cancers

2021 ◽  
Author(s):  
Stuart A. McIntosh
Keyword(s):  
Surgical Treatment ◽  
Minimally Invasive ◽  
Good Prognosis ◽  
Surgical Approaches ◽  
Breast Cancers ◽  
Randomised Trials ◽  
High Quality ◽  
High Quality Evidence ◽  
Small Breast ◽  
Quality Evidence

Abstract Purpose of Review The introduction of mammographic screening programmes has resulted increasing numbers of women with small breast cancers with biologically favourable characteristics. Many of these cancers may represent overdiagnosis, with a resulting treatment burden for women and healthcare costs for providers. Here, current surgical approaches to the treatment of such tumours are reviewed, together with alternative approaches to their management. Recent Findings The surgical treatment of small, screen-detected breast cancers with biologically favourable characteristics has been extrapolated from the management of symptomatic breast cancers. There is no prospective randomised evidence for conventional open surgery compared with other approaches in this setting. A number of minimally invasive techniques, most notable vacuum-assisted excision, have been described for the management of these tumours, but at present, there is a lack of high-quality evidence to support their routine use. There are currently ongoing randomised trials evaluating risk-adapted surgical and minimally invasive approaches to the management of good prognosis disease. Summary It is possible that the surgical treatment of good prognosis screen-detected breast cancers may be de-escalated. However, high-quality evidence from ongoing prospective randomised trials will be required in order to change clinical practice.

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 Is there an indication for surgery in patients with spinal deformities? – A critical appraisal

2021 ◽  
Vol 77 (2) ◽  
Author(s):  
Hans-Rudolf Weiss ◽  
Xiaofeng Nan ◽  
Matthew A. Potts
Keyword(s):  
Systematic Review ◽  
Systematic Reviews ◽  
Spinal Surgery ◽  
Scoliosis Surgery ◽  
Spinal Deformities ◽  
Indication For Surgery ◽  
High Quality ◽  
High Quality Evidence ◽  
Quality Evidence

Background: High-quality evidence exists to support physiotherapy and brace treatment for scoliosis and other spinal deformities. However, according to previous systematic reviews, it seems that no evidence exists for surgery. Nevertheless, the number of research articles focussing on spinal surgery highly exceeds the number of articles focussing on conservative treatment.Objective: The purpose of this study is to conduct an updated search for systematic reviews providing high-quality evidence for spinal surgery in patients with spinal deformities.Method: A narrative review including PubMed and the Cochrane database was conducted on April 12, 2020, with the following search terms: (1) spinal deformities, surgery, systematic review and outcome; (2) kyphosis, surgery, systematic review and outcome; (3) Scheuermann’s disease, surgery, systematic review and outcome, and (4) scoliosis, surgery, systematic review and outcome.Results: No reviews containing prospective controlled or randomised controlled studies were found providing evidence for surgery.Conclusions: A general indication for spine surgery just based on the Cobb angle is not given. In view of the long-term unknown variables and the possible long-term complications of such treatment, a surgical indication for patients with spinal deformities must be reviewed on an individual basis and considered carefully. A current systematic review appears necessary in order to be able to draw final conclusions on the indication for surgery in patients with spinal deformities.Clinical implications: In view of the increasing number of surgeons with an affiliation to industry, the indication for surgery needs to be given by independent conservative specialists for spinal deformities in order to provide an objective recommendation.

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.

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 Endoscopic diagnosis and management of nonvariceal upper gastrointestinal hemorrhage (NVUGIH): European Society of Gastrointestinal Endoscopy (ESGE) Guideline – Update 2021

Endoscopy ◽  
2021 ◽  
Vol 53 (03) ◽  
pp. 300-332
Author(s):  
Ian M. Gralnek ◽  
Adrian J. Stanley ◽  
A. John Morris ◽  
Marine Camus ◽  
James Lau ◽  
...  
Keyword(s):  
High Dose ◽  
High Quality ◽  
Peptic Ulcer Hemorrhage ◽  
Strong Recommendation ◽  
Epinephrine Injection ◽  
Moderate Quality ◽  
High Quality Evidence ◽  
Mechanical Therapy ◽  
Upper Gastrointestinal ◽  
Quality Evidence

MAIN RECOMMENDATIONS 1 ESGE recommends in patients with acute upper gastrointestinal hemorrhage (UGIH) the use of the Glasgow–Blatchford Score (GBS) for pre-endoscopy risk stratification. Patients with GBS ≤ 1 are at very low risk of rebleeding, mortality within 30 days, or needing hospital-based intervention and can be safely managed as outpatients with outpatient endoscopy.Strong recommendation, moderate quality evidence. 2 ESGE recommends that in patients with acute UGIH who are taking low-dose aspirin as monotherapy for secondary cardiovascular prophylaxis, aspirin should not be interrupted. If for any reason it is interrupted, aspirin should be re-started as soon as possible, preferably within 3–5 days.Strong recommendation, moderate quality evidence. 3 ESGE recommends that following hemodynamic resuscitation, early (≤ 24 hours) upper gastrointestinal (GI) endoscopy should be performed. Strong recommendation, high quality evidence. 4 ESGE does not recommend urgent (≤ 12 hours) upper GI endoscopy since as compared to early endoscopy, patient outcomes are not improved. Strong recommendation, high quality evidence. 5 ESGE recommends for patients with actively bleeding ulcers (FIa, FIb), combination therapy using epinephrine injection plus a second hemostasis modality (contact thermal or mechanical therapy). Strong recommendation, high quality evidence. 6 ESGE recommends for patients with an ulcer with a nonbleeding visible vessel (FIIa), contact or noncontact thermal therapy, mechanical therapy, or injection of a sclerosing agent, each as monotherapy or in combination with epinephrine injection. Strong recommendation, high quality evidence. 7 ESGE suggests that in patients with persistent bleeding refractory to standard hemostasis modalities, the use of a topical hemostatic spray/powder or cap-mounted clip should be considered. Weak recommendation, low quality evidence. 8 ESGE recommends that for patients with clinical evidence of recurrent peptic ulcer hemorrhage, use of a cap-mounted clip should be considered. In the case of failure of this second attempt at endoscopic hemostasis, transcatheter angiographic embolization (TAE) should be considered. Surgery is indicated when TAE is not locally available or after failed TAE. Strong recommendation, moderate quality evidence. 9 ESGE recommends high dose proton pump inhibitor (PPI) therapy for patients who receive endoscopic hemostasis and for patients with FIIb ulcer stigmata (adherent clot) not treated endoscopically. (a) PPI therapy should be administered as an intravenous bolus followed by continuous infusion (e. g., 80 mg then 8 mg/hour) for 72 hours post endoscopy. (b) High dose PPI therapies given as intravenous bolus dosing (twice-daily) or in oral formulation (twice-daily) can be considered as alternative regimens.Strong recommendation, high quality evidence. 10 ESGE recommends that in patients who require ongoing anticoagulation therapy following acute NVUGIH (e. g., peptic ulcer hemorrhage), anticoagulation should be resumed as soon as the bleeding has been controlled, preferably within or soon after 7 days of the bleeding event, based on thromboembolic risk. The rapid onset of action of direct oral anticoagulants (DOACS), as compared to vitamin K antagonists (VKAs), must be considered in this context.Strong recommendation, low quality evidence.

scholarly journals Working towards evidence-informed policy: Public health report Stockholm

2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
V Bartelink ◽  
D Yacaman Mendez ◽  
A Lager
Keyword(s):  
Public Health ◽  
Resource Allocation ◽  
Scientific Literature ◽  
Decision Makers ◽  
High Quality ◽  
Public Health Report ◽  
The Public ◽  
Health Report ◽  
High Quality Evidence ◽  
Quality Evidence

Abstract Issue Public health problems and interventions are often addressed in sub-optimal ways by not prioritizing them based on the best available evidence. Description of the Problem The public health report 2019 for the Stockholm region aims to inform decision makers, politicians, and public health workers about the risk factors and diseases that account for the biggest part of the burden of disease with a clear focus on high quality evidence and communication of main messages. How did the public health report 2019 affect public health policy in the Stockholm region? Results The public health report 2019 influenced agenda setting, resource allocation and priority setting in the Stockholm region. Lessons We identified the following facilitating factors in the process, of which most also are supported in scientific literature, in chronological order: 1) understanding the policymaking context to be aware of windows of opportunity, 2) establishing relationships with relevant policymakers, engage with them routinely in the decision-making process, and being accessible for questions, 3) doing high-quality research by considering the latest scientific literature, multiple data sources and involving academic experts in the field, 4) communicating clear and relevant messages for generalists by translating research into easy-understandable texts and attractive figures, and 5) active dissemination of the report through multiple channels. In addition, the following barriers were identified: 1) the timeframe of the policymaking process was not in line with the research process, and 2) involving politicians in an early stage can potentially harm the objectivity of research in media messages. Key messages By focussing on major problems, high quality evidence and clear messages a public health report can contribute to more evidence-informed policy making. Engaging decision makers in the process of public health reporting is critical for the impact on agenda setting, resource allocation, and priority setting.

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

Sign in / Sign up

Export Citation Format

Share Document