scholarly journals The effect of preoperative stoma site marking on risk of stoma-related complications in patients with intestinal ostomy—protocol of a systematic review and meta-analysis

2021 ◽  
Vol 10 (1) ◽  
Author(s):  
Charlotte Mareike Kugler ◽  
Jessica Breuing ◽  
Tanja Rombey ◽  
Simone Hess ◽  
Peter Ambe ◽  
...  

Abstract Background An intestinal ostomy is an artificial bowel opening created on the skin. Procedure-related mortality is extremely rare. However, the presence of an ostomy may be associated with significant morbidity. Complications negatively affect the quality of life of ostomates. Preoperative stoma site marking can reduce stoma-related complications and is recommended by several guidelines. However, there is no consensus on the procedure and recommendations are based on low-quality evidence. The objective of the systematic review will be to investigate if preoperative stoma site marking compared to no preoperative marking in patients undergoing intestinal stoma surgery reduces or prevents the rate of stoma-related complications. Methods We will include (cluster-) randomised controlled trials and cohort studies that involve patients with intestinal ostomies comparing preoperative stoma site marking to no preoperative marking and report at least one patient-relevant outcome. For study identification, we will systematically search MEDLINE/PubMed, EMBASE, CENTRAL and CINHAL as well as Google Scholar, trial registries, conference proceedings and reference lists. Additionally, we will contact experts in the field. Two reviewers will independently perform study selection and data extraction. Outcomes will be prioritised based on findings from telephone interviews with five ostomates and five ostomy and wound nurses prior to conducting the review. Outcomes may include but are not limited to stoma-related complications (infection, parastomal abscess, hernia, mucocutaneous separation, dermatological complications, stoma necrosis, stenosis, retraction and prolapse) or other patient-relevant postoperative endpoints (quality of life, revision rate, dependence on professional care, mortality, length of stay and readmission). We will use the ROBINS-I or the Cochrane risk of bias tool to assess the risk of bias of the included studies. We will perform a meta-analysis and assess the certainty of evidence using the GRADE approach. Discussion With the results of the systematic review, we aim to provide information for future clinical guidelines and influence clinical routine with regard to preoperative stoma site marking in patients undergoing ostomy surgery. When the evidence of our systematic review is low, it would still be a useful basis for future clinical trials by identifying data gaps. Systematic review registration PROSPERO registration number: CRD42021226647

BMJ ◽  
2021 ◽  
pp. m4743
Author(s):  
Joshua Z Goldenberg ◽  
Andrew Day ◽  
Grant D Brinkworth ◽  
Junko Sato ◽  
Satoru Yamada ◽  
...  

Abstract Objective To determine the efficacy and safety of low carbohydrate diets (LCDs) and very low carbohydrate diets (VLCDs) for people with type 2 diabetes. Design Systematic review and meta-analysis. Data sources Searches of CENTRAL, Medline, Embase, CINAHL, CAB, and grey literature sources from inception to 25 August 2020. Study selection Randomized clinical trials evaluating LCDs (<130 g/day or <26% of a 2000 kcal/day diet) and VLCDs (<10% calories from carbohydrates) for at least 12 weeks in adults with type 2 diabetes were eligible. Data extraction Primary outcomes were remission of diabetes (HbA 1c <6.5% or fasting glucose <7.0 mmol/L, with or without the use of diabetes medication), weight loss, HbA 1c , fasting glucose, and adverse events. Secondary outcomes included health related quality of life and biochemical laboratory data. All articles and outcomes were independently screened, extracted, and assessed for risk of bias and GRADE certainty of evidence at six and 12 month follow-up. Risk estimates and 95% confidence intervals were calculated using random effects meta-analysis. Outcomes were assessed according to a priori determined minimal important differences to determine clinical importance, and heterogeneity was investigated on the basis of risk of bias and seven a priori subgroups. Any subgroup effects with a statistically significant test of interaction were subjected to a five point credibility checklist. Results Searches identified 14 759 citations yielding 23 trials (1357 participants), and 40.6% of outcomes were judged to be at low risk of bias. At six months, compared with control diets, LCDs achieved higher rates of diabetes remission (defined as HbA 1c <6.5%) (76/133 (57%) v 41/131 (31%); risk difference 0.32, 95% confidence interval 0.17 to 0.47; 8 studies, n=264, I 2 =58%). Conversely, smaller, non-significant effect sizes occurred when a remission definition of HbA 1c <6.5% without medication was used. Subgroup assessments determined as meeting credibility criteria indicated that remission with LCDs markedly decreased in studies that included patients using insulin. At 12 months, data on remission were sparse, ranging from a small effect to a trivial increased risk of diabetes. Large clinically important improvements were seen in weight loss, triglycerides, and insulin sensitivity at six months, which diminished at 12 months. On the basis of subgroup assessments deemed credible, VLCDs were less effective than less restrictive LCDs for weight loss at six months. However, this effect was explained by diet adherence. That is, among highly adherent patients on VLCDs, a clinically important reduction in weight was seen compared with studies with less adherent patients on VLCDs. Participants experienced no significant difference in quality of life at six months but did experience clinically important, but not statistically significant, worsening of quality of life and low density lipoprotein cholesterol at 12 months. Otherwise, no significant or clinically important between group differences were found in terms of adverse events or blood lipids at six and 12 months. Conclusions On the basis of moderate to low certainty evidence, patients adhering to an LCD for six months may experience remission of diabetes without adverse consequences. Limitations include continued debate around what constitutes remission of diabetes, as well as the efficacy, safety, and dietary satisfaction of longer term LCDs. Systematic review registration PROSPERO CRD42020161795.


Author(s):  
Antonio Jose Martin-Perez ◽  
María Fernández-González ◽  
Paula Postigo-Martin ◽  
Marc Sampedro Pilegaard ◽  
Carolina Fernández-Lao ◽  
...  

There is no systematic review that has identified existing studies evaluating the pharmacological and non-pharmacological intervention for pain management in patients with bone metastasis. To fill this gap in the literature, this systematic review with meta-analysis aims to evaluate the effectiveness of different antalgic therapies (pharmacological and non-pharmacological) in the improvement of pain of these patients. To this end, this protocol has been written according to the Preferred Reporting Items for Systematic review and Meta-Analysis Protocols (PRISMA-P) and registered in PROSPERO (CRD42020135762). A systematic search will be carried out in four international databases: Medline (Via PubMed), Web of Science, Cochrane Library and SCOPUS, to select the randomized controlled clinical trials. The Risk of Bias Tool developed by Cochrane will be used to assess the risk of bias and the quality of the identified studies. A narrative synthesis will be used to describe and compare the studies, and after the data extraction, random effects model and a subgroup analyses will be performed according to the type of intervention, if possible. This protocol aims to generate a systematic review that compiles and synthesizes the best and most recent evidence on the treatment of pain derived from vertebral metastasis.


Author(s):  
Serena Vi ◽  
Damon Pham ◽  
Yu Yian Marina Du ◽  
Himanshu Arora ◽  
Santosh Kumar Tadakamadla

Purpose: Mini-dental implants (MDIs) have been used to support and retain overdentures, providing patients with a less invasive placement procedure. Although lucrative, the use of MDIs to retain a maxillary overdenture is still not an established treatment modality. This systematic review aims to answer the question: Do mini-implant-retained maxillary overdentures provide a satisfactory treatment outcome for complete edentulism? Methods: A systematic search for relevant articles was conducted to include articles published until April 2021 in the following electronic databases: CINAHL, Cochrane, EMBASE, PubMed, and Web of Science. All empirical studies evaluating the biological, survival, or patient-reported outcomes after placing mini-implant-retained overdentures in maxilla were considered for inclusion. The risk of bias was assessed by utilizing the Joanna Briggs Institute critical appraisal checklist. Study screening and data extraction were conducted by three reviewers independently. Results: The electronic search retrieved 1276 titles after omitting duplicates. Twenty articles were considered for full-text review, of which six studies were included in this systematic review. The included studies evaluated a total of 173 participants with a mean age of 66.3 years. The overall mini-implant survival rate was 77.1% (95% CI: 64.7–89.5%) with a mean follow-up time of 1.79 years (range: 6 months to 3 years). Implant survival differed significantly when comparing complete and partial palatal coverage overdentures. Those with complete palatal coverage exhibited less bone loss overall compared to partial coverage overdentures. Participants of all studies reported an increase in the quality of life and in satisfaction after rehabilitation treatment with MDIs. Conclusions: The survival rate of mini-implants retaining an overdenture in the maxilla was observed to be lower than the values reported for traditional implants in the literature. Improvements were observed in all aspects in terms of patient satisfaction, quality of life, oromyofunction, and articulation after the treatment.


Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 2459-2459
Author(s):  
Jorn Gerritsma ◽  
Ilja Oomen ◽  
Sanne Meinderts ◽  
C. Ellen van der Schoot ◽  
Bart J. Biemond ◽  
...  

Introduction: Blood transfusions are an important treatment modality for patients with either acute or chronic onset anemia such as trauma, sickle cell disease, and hematological malignancies. Transfusion poses a risk for alloimmunization, which may lead to potentially lethal transfusion reactions. A promising strategy to prevent alloimmunization is extensive matching on blood groups, yet this is a costly procedure and should be reserved for patients at highest risk for alloimmunization. Identification of genetic variants that increase the risk for alloimmunization might help to identify high-risk patients and could be used as a screening tool for patients receiving multiple transfusions. Objectives: To summarize all available evidence on genetic risk factors for alloimmunization after blood transfusion. Design: Systematic review with meta-analysis of observational studies. Studies were only included in the meta-analysis if polymorphisms were tested at least 3 times, and if ethnic background of the population and the control populations were comparable between studies. Data sources: The online databases Embase, MEDLINE and the Cochrane Library were search for relevant articles with search terms: 1) transfusion, 2) alloimmunization 3) genetics. The search was last updated March 2018. Eligibility criteria: 1) Primary study that assessed the association of genetic polymorphisms with transfusion related alloimmunization, 2) a human population, 3) studies with at least 50 patients, 4) full text availability. Data extraction: Two reviewers independently screened articles for eligibility, extracted data using a standardized data extraction form. Extracted data included study setting, study population, participant demographics, baseline characteristics, study methodology, comparisons and outcome, and risk of bias. Primary outcome measure: Alloimmunization after one or more blood transfusions. Risk of bias assessment: The quality of the included studies was assessed by the Q-genie tool for genetic association studies. Results: A total of 2045 cases and 24084 controls were derived from 18 genetic case-control studies that were included in this systematic review. Most commonly studied disease group was sickle cell disease (SCD) (8 studies). Three studies included patients with different diseases and seven studies did not report the underlying disease. Eleven studies identified the association of HLA polymorphisms with alloimmunization and 8 studies focused on non-HLA variants. Overall quality of the included studies was moderate (11 studies), 2 studies were of high quality, and 5 studies were ranked as poor. HLA-DRB1*04 (Odds Ratio 7.16, 95%CI 3.87-13.22, P<0.00001) and HLA-DRB1*15 (OR 3.01, 95%CI 1.84-5.53, P<0.0001) were by meta-analysis significantly associated with anti-Fy(a) formation, although there was considerable heterogeneity (I2=78% and 55% respectively). Moreover, HLA-DRB1*10 (OR 2.64, 95%CI 1.41-4.95, P=0.002), HLA*DRB1*11 (OR 2.11, 95%CI 1.34-3.32, P=0.001), and HLA-DRB1*13 (OR 1.71, 95%CI 1.26-2.33, P=0.0006) were overall associated with anti-Kell formation. Heterogeneity was less prominent with an I2 of 0%, 54% and 19% respectively (Figure 1). No other variants were eligible for meta-analysis. Non-HLA variants were tested less extensively, as most variants were reported by only 1 study. Polymorphisms of genes in the immunomodulatory pathways were assessed most frequently. Of these variants, FC-gamma-receptor 2C.nc-ORF was associated with a decreased risk of alloimmunization in SCD (OR 0.26, 95%CI 0.11-0.64, p=0.003). All other associations that were described as significant by the original articles were summarized in Figure 2. Discussion: There is limited evidence supporting the role of genetic risk factors for alloimmunization. The results of our meta-analysis suggest that several HLA polymorphisms potentially influence antigen presentation of the Duffy(a) and Kell antigen. Once confirmed by experimental studies, these polymorphisms could be used as a screening tool for the prevention of alloimmunization among frequently transfused patients. Overall, the effect of genetic variants on alloimmunization has mostly been assessed by small studies, hampering reliable interpretation of the results. Future studies should include large and well-defined cohorts when performing genetic analysis on this complicated subject. Disclosures No relevant conflicts of interest to declare.


2021 ◽  
pp. archdischild-2020-320389
Author(s):  
Sarah Nicolas ◽  
Yohan Gallois ◽  
Marie-Noëlle Calmels ◽  
Olivier Deguine ◽  
Bernard Fraysse ◽  
...  

ObjectiveTo evaluate the treatments’ consequences for unilateral hearing loss in children.DesignSystematic review and meta-analysis (CRD42018109417). The MEDLINE, CENTRAL, ISRCTN and ClinicalTrials databases were searched between September 2018 and May 2019. Articles were screened and data were collected independently by two authors following the Cochrane and Preferred Reporting Items for Systematic review and Meta-Analysis guidelines. The risk of bias was evaluated using the Cochrane tool, the Newcastle-Ottawa Scale, the National Institute of Health, USA tool and considering the risk of confounding. In the studies with the lowest risk of bias, a meta-analysis was conducted.InterventionsValidated hearing rehabilitation devices.Patients6–15 years old children with moderate to profound unilateral hearing loss.Main outcome measuresThe primary study outcome was children’s quality of life. Academic performances were studied as an additional outcome.Results731 unique articles were identified from the primary search. Of these, 18 articles met the Population, Intervention, Control, Outcomes and Study design selection criteria. In the eight studies with the lowest risk of bias, two meta-analysis were conducted. There was not enough data on academic results to conduct a meta-analysis. In 73 children included in a fixed effect meta-analysis (two studies), no effect of treatment could be shown (g=−0.20, p=0.39). In 61 children included in a random-effect meta-analysis (six studies), a strong positive effect of hearing treatment on quality of life was demonstrated (g=1.32, p<0.05).ConclusionsThe treatment of unilateral hearing loss seems to improve children’s quality of life. Further research is needed to identify the most effective treatment and its corresponding indications.


2020 ◽  
Author(s):  
Tahereh Mokhtarian-Gilani ◽  
Nourossadat kariman ◽  
Hamid Sharif-Nia ◽  
Mahbobeh Ahmadi-Doulabi ◽  
Malihe Nasiri

Abstract Background:The postpartum quality of life refers to women's understanding of their standing in the postpartum crisis that differs depending on their health status, social support, cultural status and values, attitudes, goals and standards. The present systematic review will identify, describe, and critically assess the psychometric properties of postpartum quality of life questionnaires.Methods/Design:A systematic review will be conducted in databases including PubMed, Embase, Scopus, Web of Science, PsycINFO, and CINAHL from January 2000 to January 2020. The psychometric properties (validity and reliability) of the instruments used in the primary studies will be assessed, and the selection, methodological quality assessment and data extraction processes of the studies will be independently assessed by two reviewers with expertise in conducting systematic reviews, so as to minimize potential personal bias. Eligible resources are selected after any lack of consensus is put to debate.The risk of bias is assessed using the COSMIN RISK of Bias checklist, and to evaluate the quality of the studies, the protocol is written based on the PRISMA-P1 standards. The results of the studies will be judged based on good measurement properties, and the results of all the studies are qualitatively summarized to produce a reference for the general quality of the results. The general quality of the evidence will be determined using a modified GRADE method.Discussion:This study assessed the psychometric properties of questionnaires used for assessing postpartum quality of life and its results can be used to identify the most appropriate tool for health applications in measuring postpartum quality of life. Systematic review registration: reference number in PROSPRO CRD42020166301


2016 ◽  
Vol 2016 ◽  
pp. 1-13 ◽  
Author(s):  
Caiqiong Hu ◽  
Haibo Zhang ◽  
Wanyin Wu ◽  
Weiqing Yu ◽  
Yong Li ◽  
...  

Objective. To evaluate the effectiveness and safety of acupuncture for cancer-related pain. Methods. A systematic review of literatures published from database inception to February 2015 was conducted in eight databases. RCTs involving acupuncture for treatment of cancer-related pain were identified. Two researchers independently performed article selection, data extraction, and quality assessment of data. Results. 1,639 participants in twenty RCTs were analyzed. All selected RCTs were associated with high risk of bias. Meta-analysis indicated that acupuncture alone did not have superior pain-relieving effects as compared with conventional drug therapy. However, as compared with the drug therapy alone, acupuncture plus drug therapy resulted in increased pain remission rate, shorter onset time of pain relief, longer pain-free duration, and better quality of life without serious adverse effects. However, GRADE analysis revealed that the quality of all outcomes about acupuncture plus drug therapy was very low. Conclusions. Acupuncture plus drug therapy is more effective than conventional drug therapy alone for cancer-related pain. However, multicenter high-quality RCTs with larger sample sizes are needed to provide stronger evidence for the effectiveness of acupuncture in cancer-related pain due to the low data quality of the studies included in the current meta-analysis.


2018 ◽  
Vol 68 (suppl 1) ◽  
pp. bjgp18X697181
Author(s):  
Annabelle Machin ◽  
Randula Haththotuwa ◽  
Opeyemi Babatunde ◽  
Ian Scott ◽  
Nadia Corp ◽  
...  

BackgroundRheumatoid arthritis (RA) is the commonest inflammatory arthritis. Comorbid anxiety and depression are common, but under-recognised and under-treated. Depression in RA has been linked to reduced quality of life and treatment response and increased mortality. Past research into co-morbid mood problems in RA has mainly focused on the prevalence and impact of depression.AimTo complete a systematic review to explore the impact of anxiety on QOL and treatment outcomes in RA.MethodThe systematic review has been registered on PROSPERO. Databases (Web of Science, PsycINFO, CINAHL, Embase and Medline) have been systematically searched for relevant studies. Titles and abstracts have been independently screened by two reviewers. Data extraction and quality appraisal of studies will be carried out using a customized and piloted data extraction tool and the Newcastle-Ottawa Scale. Disagreements will be resolved through discussion or by a third reviewer. A narrative synthesis framework will be used to develop a theory of how anxiety impacts on QOL and treatment response and a meta-analysis performed.ResultsThe search has identified 6404 articles. After title screening, 284 abstracts have been reviewed and 48 full texts are being reviewed for inclusion. Full text review is ongoing, and results of the analysis will be presented.ConclusionHighlighting the impact of anxiety on outcomes in RA may suggest areas for future implementation studies to improve patient outcomes, potentially reducing associated morbidity and mortality.


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