scholarly journals Reporting of “dialysis adequacy” as an outcome in randomised trials conducted in adults on haemodialysis: a systematic review

2018 ◽  
Author(s):  
Sanne Steyaert ◽  
Els Holvoet ◽  
Evi Nagler ◽  
Simon Malfait ◽  
Wim Van Biesen
Keyword(s):  
Systematic Review ◽  
Decision Making ◽  
Outcome Measures ◽  
Health Care Professionals ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Structured Interviews ◽  
Dialysis Adequacy ◽  
Registration Number ◽  
Randomised Controlled

ABSTRACTBackgroundClinical trials are most informative for evidence-based decision-making when they consistently measure and report outcomes of relevance to stakeholders, especially patients, clinicians, and policy makers. However, sometimes terminology used is interpreted differently by different stakeholders, which might lead to confusion during shared decision making. The construct dialysis adequacy is frequently used, suggesting it is an important outcome both for health care professionals as for patients.ObjectiveTo assess the scope and consistency of the construct dialysis adequacy as reported in randomised controlled trials in hemodialysis, and evaluate whether these align to the insights and understanding of this construct by patients.MethodsTo assess scope and consistency of dialysis adequacy by professionals, we performed a systematic review searching the Cochrane Central Register of Controlled Trials (CENTRAL) up to July 2017. We identified all randomised controlled trails (RCT) including patients on hemodialysis and reporting dialysis adequacy, adequacy or adequacy of dialysis and extracted and classified all reported outcomes. To explore interpretation and meaning of the construct of adequacy by patients, we conducted 10 semi-structured interviews with HD patients using thematic analysis. Belgian registration number B670201731001.FindingsFrom the 31 included trials, we extracted and classified 98 outcome measures defined by the authors as adequacy of dialysis, of which 94 (95%) were biochemical, 3 (3%) non-biochemical surrogate and 2 (2%) patient-relevant. The three most commonly reported measures were all biochemical. None of the studies defined adequacy of dialysis as a patient relevant outcome such as survival or quality of life.Patients had a substantially different understanding of the construct dialysis adequacy than the biochemical interpretation reported in the literature. Being alive, time spent while being on dialysis, fatigue and friendliness of staff were the most prominent themes that patients linked to the construct of dialysis adequacy.Conclusion Adequacy of dialysis as reported in the literature refers to biochemical outcome measures, most of which are not related with patient relevant outcomes. For patients, adequate dialysis is a dialysis that enables them to spend as much quality time in their life as possible.

scholarly journals Right versus left thoracic approach oesophagectomy for oesophageal cancer: a systematic review and meta-analysis protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (7) ◽  
pp. e030157
Author(s):  
Tianci Chai ◽  
Zhimin Shen ◽  
Sui Chen ◽  
Yuhan Lin ◽  
Zhenyang Zhang ◽  
...  
Keyword(s):  
Systematic Review ◽  
Oesophageal Cancer ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Malignant Tumours ◽  
Central Register ◽  
Registration Number ◽  
Thoracic Approach ◽  
Randomised Controlled

IntroductionOesophageal cancer is one of the most common malignant tumours and has been identified as one of the leading causes of cancer death worldwide. Surgery is considered to be the optimal treatment for patients with resectable oesophageal cancer. Oesophagectomy for oesophageal cancer can significantly extend the survival period of patients and provide a potential opportunity for a cure. However, there is still controversy regarding which thoracic approach (right or left) during oesophagectomy for oesophageal cancer can lead to better surgical outcomes globally. This systematic review and meta-analysis will be performed to determine which thoracic approach during oesophagectomy will achieve longer patient survival and will be more beneficial for patients.Methods and analysisWe will search PubMed, Web of Science, Embase, Cancerlit, the Cochrane Central Register of Controlled Trials and Google Scholar databases for relevant clinical trials published in any language before 1 October 2019. Randomised controlled trials (RCTs), quasi-RCTs, propensity score-matched comparative studies and prospective cohort studies of interest, published or unpublished, that meet the inclusion criteria will be included. Subgroup analysis of the type of operation, tumour pathological stage and ethnicity will be performed.PROSPERO registration numberCRD42019124133.Ethics and disseminationBecause this study will be based on published or unpublished records and studies, there is no need for ethics approval. The results of the study will be published in a peer-reviewed journal.

scholarly journals Self-care interventions in stroke survivor–caregiver dyads: a protocol for systematic review and meta-analysis

BMJ Open ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e051860
Author(s):  
Wenna Wang ◽  
Beilei Lin ◽  
Yongxia Mei ◽  
Zhenxiang Zhang ◽  
Bing Zhou
Keyword(s):  
Systematic Review ◽  
Meta Analysis ◽  
Self Care ◽  
Stroke Survivor ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Systematic Assessment ◽  
Ethical Approval ◽  
Registration Number ◽  
Randomised Controlled

IntroductionStroke is known as one of the leading causes of mortality and disability worldwide. Self-care plays a significant role in improving the quality of life, self-efficacy and many other outcomes of stroke survivors. However, it is a dyadic phenomenon where patient self-care and the caregiver contribution to self-care are inter-related in terms of predictors and outcomes. Currently, there is still no systematic assessment conducted to examine the overall effectiveness of self-care interventions carried out in stroke survivor–caregiver dyads and explore the effect on stroke survivor and/or caregiver outcomes.MethodsWe plan to conduct a systematic review and meta-analysis of the evidence regarding the self-care interventions carried out in stroke survivor–caregiver dyads. We will undertake a systematic search of multiple databases including PubMed, Web of Science, CINAHL, PsycINFO, EMBASE, Cochrane Central Register of Controlled Trials and four Chinese databases (CNKI, CBM, WANFANG and VIP) from inception to July 2021 for the purpose of collecting the relevant articles. The eligible studies are defined as those original researches, written in English or Chinese, on self-care interventions in stroke survivor–caregiver dyad samples. Two independent researchers will be deployed to identify the eligible trials according to the selection criteria and extract the relevant data. The Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols checklist has been used for this protocol. We will use the Cochrane Risk for Bias tool to assess the risk of bias for randomised controlled trials.Ethics and disseminationIn our review, any identifiable patient data will be excluded, which removes the need for ethical approval and participant consent. The final results of our study will be published in an open-access peer-reviewed journal, and abstract will be presented at suitable national/international conferences.PROSPERO registration numberCRD42021239824.

scholarly journals Effectiveness of strategies for nutritional therapy for patients with type 2 diabetes and/or hypertension in primary care: protocol of a systematic review of randomised controlled trials

BMJ Open ◽  
2019 ◽  
Vol 9 (9) ◽  
pp. e030450 ◽  
Author(s):  
Julia Simões Corrêa Galendi ◽  
Renata Giacomini Occhiuto Ferreira Leite ◽  
Adriana Lúcia Mendes ◽  
Vania dos Santos Nunes-Nogueira
Keyword(s):  
Systematic Review ◽  
Type 2 Diabetes ◽  
Primary Care ◽  
Latin American ◽  
Randomised Controlled Trials ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Registration Number ◽  
Randomised Controlled

IntroductionDespite the increasing number of drugs available and various guidelines on the management of type 2 diabetes mellitus (T2DM) and hypertension, an expressive number of patients continue with these diseases uncontrolled. Nutrition therapy (NT) plays a fundamental role in the prevention and management of these comorbidities, as well as in the prevention of complications related to them. The objective of this review is to evaluate the effectiveness of NT strategies in the management of patients with T2DM and/or hypertension in primary care. The selected strategies did not substitute pharmaceutical treatment but instead focused on preventing a sedentary lifestyle and stimulating healthy nutrition.Methods and analysisWe will perform a systematic review according to Cochrane methodology of randomised controlled trials, wherein patients with T2DM and/or hypertension were allocated into one of the two groups: NT strategy, which may be of dietary quality or energy restriction, and conventional treatment. The primary outcomes will be glycaemic and blood pressure (BP) control, measured by final glycosylated hemoglobin (HbA1c) (%) and BP (mm Hg), respectively. Four general and adaptive search strategies have been created for the Embase, Medline, Latin American and Caribbean Health Sciences Literature (LILACS) and Cochrane Central Register of Controlled Trials (CENTRAL) electronic databases. Two reviewers will independently select eligible studies, assess the risk of bias and extract data from the included studies. Similar outcomes measured in at least two trials will be plotted in the meta-analysis using Review Manager V.5.3. The quality of evidence of the effect estimate of the intervention will be generated according to the Grading of Recommendations Assessment, Development, and Evaluation Working Group.Ethics and disseminationAs no primary data collection will be undertaken, formal ethical assessment is not required. We plan to present the results of this systematic review in a peer-reviewed scientific journal, conferences and the popular press.PROSPERO registration numberOur systematic review protocol was registered with the International Prospective Register of Systematic Reviews (PROSPERO) on 20 December 2018 (Registration number CRD42018118117).

scholarly journals Effects of advanced life support versus basic life support on the mortality rates of patients with trauma in prehospital settings: a study protocol for a systematic review and meta-analysis

BMJ Open ◽  
2017 ◽  
Vol 7 (10) ◽  
pp. e016912 ◽  
Author(s):  
Yutaka Kondo ◽  
Tatsuma Fukuda ◽  
Ryo Uchimido ◽  
Toru Hifumi ◽  
Kei Hayashida
Keyword(s):  
Systematic Review ◽  
Basic Life Support ◽  
Life Support ◽  
Meta Analysis ◽  
Advanced Life Support ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Evaluation Approach ◽  
Registration Number ◽  
Randomised Controlled

IntroductionAdvanced life support (ALS) is thought to be associated with improved survival in prehospital trauma care when compared with basic life support (BLS). However, evidence on the benefits of prehospital ALS for patients with trauma is controversial. Therefore, we aim to clarify if ALS improves mortality in patients with trauma when compared with BLS by conducting a systematic review and meta-analysis of the recent literature.Methods and analysisWe will perform searches in PubMed, Embase and the Cochrane Central Register of Controlled Trials for published observational studies, controlled before-and-after studies, randomised controlled trials and other controlled trials conducted in humans and published until March 2017. We will screen search results, assess study selection, extract data and assess the risk of bias in duplicate; disagreements will be resolved through discussions. Data from clinically homogeneous studies will be pooled using a random-effects meta-analysis, heterogeneity of effects will be assessed using the χ2test of homogeneity, and any observed heterogeneity will be quantified using the I2statistic. Last, the Grading of Recommendations Assessment, Development and Evaluation approach will be used to rate the quality of the evidence.Ethics and disseminationOur study does not require ethical approval as it is based on findings of previously published articles. Results will be disseminated through publication in a peer-reviewed journal, presentations at relevant conferences and publications for patient information.Trial registration numberPROSPERO (International Prospective Register of Systematic Reviews) registration number CRD42017054389.

Functional cortical changes associated with shoulder instability – a systematic review

2021 ◽  
pp. 175857322110190
Author(s):  
Morissa F Livett ◽  
Deborah Williams ◽  
Hayley Potter ◽  
Melinda Cairns
Keyword(s):  
Systematic Review ◽  
Joint Instability ◽  
Glenohumeral Joint ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Cortical Function ◽  
High Quality Research ◽  
Central Register ◽  
Rehabilitative Measures ◽  
Randomised Controlled

Background Glenohumeral joint instability is associated with structural deficits and/or alterations in sensory and motor processing; however, a proportion of patients with glenohumeral joint instability fail to respond to surgical and rehabilitative measures. This systematic review aimed to establish if functional cortical changes occur in patients with glenohumeral joint instability. Methods AMED, CINAHL, Cochrane Central Register of Controlled Trials, Embase, Medline, PEDro, Pubmed, PsychINFO and Scopus were searched from inception to 17 March 2021. Randomised controlled trials and non-randomised trials were included and quality was appraised using the Downs and Black tool. Results One thousand two hundred seventy-nine records were identified of which five were included in the review. All studies showed altered cortical function when comparing instability patients with healthy controls and included areas associated with higher cortical functions. Discussion The findings of this systematic review offer some insight as to why interventions addressing peripheral pathoanatomical factors in patients with glenohumeral joint instability may fail in some cases due to functional cortical changes. However, data are of moderate to high risk of bias. Further high-quality research is required to ascertain the degree of functional cortical changes associated with the type and duration of glenohumeral joint instability.

scholarly journals Fluid resuscitation in paediatric burns: how do we get it right? A systematic review of the evidence

2018 ◽  
Vol 104 (3) ◽  
pp. 280-285 ◽  
Author(s):  
Christopher Stutchfield ◽  
Anna Davies ◽  
Amber Young
Keyword(s):  
Systematic Review ◽  
Fluid Resuscitation ◽  
Primary Data ◽  
Controlled Trials ◽  
Burn Shock ◽  
Cochrane Central Register ◽  
Study Protocols ◽  
Central Register ◽  
Affect Patient Outcome ◽  
Randomised Controlled

BackgroundOptimal fluid resuscitation in children with major burns is crucial to prevent or minimise burn shock and prevent complications of over-resuscitation.ObjectivesTo identify studies using endpoints to guide fluid resuscitation in children with burns, review the range of reported endpoint targets and assess whether there is evidence that targeted endpoints impact on outcome.DesignSystematic review.MethodsMedline, Embase, Cinahl and the Cochrane Central Register of Controlled Trials databases were searched with no restrictions on study design or date. Search terms combined burns, fluid resuscitation, endpoints, goal-directed therapy and related synonyms. Studies reporting primary data regarding children with burns (<16 years) and targeting fluid resuscitation endpoints were included. Data were extracted using a proforma and the results were narratively reviewed.ResultsFollowing screening of 777 unique references, 7 studies fulfilled the inclusion criteria. Four studies were exclusively paediatric. Six studies used urine output (UO) as the primary endpoint. Of these, one set a minimum UO threshold, while the remainder targeted a range from 0.5–1.0 mL/kg/hour to 2–3 mL/kg/hour. No studies compared different UO targets. Heterogeneous study protocols and outcomes precluded comparison between the UO targets. One study targeted invasive haemodynamic variables, but this did not significantly affect patient outcome.ConclusionsFew studies have researched resuscitation endpoints for children with burns. Those that have done so have investigated heterogeneous endpoints and endpoint targets. There is a need for future randomised controlled trials to identify optimal endpoints with which to target fluid resuscitation in children with burns.

scholarly journals Lowering blood pressure after acute intracerebral haemorrhage: protocol for a systematic review and meta-analysis using individual patient data from randomised controlled trials participating in the Blood Pressure in Acute Stroke Collaboration (BASC)

BMJ Open ◽  
2019 ◽  
Vol 9 (7) ◽  
pp. e030121 ◽  
Author(s):  
Tom J Moullaali ◽  
Xia Wang ◽  
Lisa J Woodhouse ◽  
Zhe Kang Law ◽  
Candice Delcourt ◽  
...  
Keyword(s):  
Systematic Review ◽  
Blood Pressure ◽  
Acute Stroke ◽  
Intracerebral Haemorrhage ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Patient Data ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Randomised Controlled

IntroductionConflicting results from multiple randomised trials indicate that the methods and effects of blood pressure (BP) reduction after acute intracerebral haemorrhage (ICH) are complex. The Blood pressure in Acute Stroke Collaboration is an international collaboration, which aims to determine the optimal management of BP after acute stroke including ICH.Methods and analysisA systematic review will be undertaken according to the Preferred Reporting Items for Systematic review and Meta-Analysis of Individual Participant Data (IPD) guideline. A search of Cochrane Central Register of Controlled Trials, EMBASE and MEDLINE from inception will be conducted to identify randomised controlled trials of BP management in adults with acute spontaneous (non-traumatic) ICH enrolled within the first 7 days of symptom onset. Authors of studies that meet the inclusion criteria will be invited to share their IPD. The primary outcome will be functional outcome according to the modified Rankin Scale. Safety outcomes will be early neurological deterioration, symptomatic hypotension and serious adverse events. Secondary outcomes will include death and neuroradiological and haemodynamic variables. Meta-analyses of pooled IPD using the intention-to-treat dataset of included trials, including subgroup analyses to assess modification of the effects of BP lowering by time to treatment, treatment strategy and patient’s demographic, clinical and prestroke neuroradiological characteristics.Ethics and disseminationNo new patient data will be collected nor is there any deviation from the original purposes of each study where ethical approvals were granted; therefore, further ethical approval is not required. Results will be reported in international peer-reviewed journals.PROSPERO registration numberCRD42019141136.

scholarly journals Effectiveness of complex multiple-risk lifestyle interventions in reducing symptoms of depression: a study protocol for a systematic review and meta-analysis of randomised controlled trials

BMJ Open ◽  
2019 ◽  
Vol 9 (3) ◽  
pp. e026842 ◽  
Author(s):  
Irene Gómez-Gómez ◽  
Emma Motrico ◽  
Patricia Moreno-Peral ◽  
Alina Rigabert ◽  
Sonia Conejo-Cerón ◽  
...  
Keyword(s):  
Systematic Review ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Depression Symptoms ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Lifestyle Interventions ◽  
Symptoms Of Depression ◽  
Multiple Risk ◽  
Randomised Controlled

IntroductionMany studies have explored the impact of lifestyle interventions on depression. However, little is known about the effectiveness of complex multiple-risk lifestyle interventions in reducing symptoms of depression. Our objective is to assess the effectiveness of complex multiple-risk lifestyle interventions in reducing depressive symptoms in the adult population by the acquisition of at least two healthy habits—healthy diet, physical activity and/or smoking cessation. For such purpose, a systematic review and meta-analysis of randomised controlled trials will be conducted.Method and analysisMEDLINE (through Ovid and PubMed), Scopus, Cochrane Central Register of Controlled Trials, Web of Science, PsycINFO, OpenGrey Register (System for Information on Grey Literature in Europe) and the International Clinical Trials Registry Platform will be searched for relevant articles. Additionally, a supplementary manual search will be performed using lists of references, references to expert authors and other systematic reviews and/or meta-analyses. Study selection, data extraction (target habits, country, target populations, conditions and statistical data to name a few) and assessment of the risk of bias will be performed separately by two independent researchers. The primary outcome measure will be the reduction of depression symptoms, as measured by validated instruments. We will calculate pooled standardised mean differences and 95% CIs using random-effect models. Heterogeneity, sensitivity and publication bias will be assessed, and sub-group analysis will be performed. Heterogeneity will be explored by random-effects meta-regression analysis.Ethics and disseminationEthical approval is not required for this study. The results of this systematic review and meta-analysis will be presented in relevant conferences and published in a peer-review journal. The findings of this study could have important clinical and scientific implications for the improvement of symptoms of depression.PROSPERO registration numberCRD42018100253; Pre-results.

scholarly journals Clinical outcomes and outcome measurement tools reported in randomised controlled trials of treatment for snakebite envenoming: A systematic review

2021 ◽  
Vol 15 (8) ◽  
pp. e0009589
Author(s):  
Michael Abouyannis ◽  
Dinesh Aggarwal ◽  
David G. Lalloo ◽  
Nicholas R. Casewell ◽  
Mainga Hamaluba ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Outcome Measures ◽  
Randomised Controlled Trials ◽  
Core Outcome Set ◽  
Controlled Trials ◽  
Study Protocols ◽  
Outcome Set ◽  
Secondary Analyses ◽  
Randomised Controlled

Background Snakebite is a priority neglected tropical disease and causes a range of complications that vary depending on the snake species. Randomised clinical trials have used varied outcome measures that do not allow results to be compared or combined. In accordance with the Core Outcomes Measurements in Effectiveness Trials (COMET) initiative, this systematic review aims to support the development of a globally relevant core outcome set for snakebite. Methods All randomised controlled trials, secondary analyses of randomised controlled trials and study protocols investigating the efficacy of therapeutics for human snakebite envenoming were eligible for inclusion. Study screening and data extraction were conducted in duplicate by two independent reviewers. All primary and secondary outcome measures were extracted and compiled, as were adverse event outcome measures. Similar outcome measures were grouped into domains. The study was prospectively registered with PROSPERO: CRD42020196160. Results This systematic review included 43 randomised controlled trials, two secondary analyses and 13 study protocols. A total of 382 outcome measures were extracted and, after duplicates were merged, there were 153 unique outcomes. The most frequently used outcome domain (‘venom antigenaemia’) was included in less than one third of the studies. The unique outcomes were classified into 60 outcome domains. Patient-centred outcomes were used in only three of the studies. Discussion Significant heterogeneity in outcome measures exists in snakebite clinical trials. Consensus is needed to select outcome measures that are valid, reliable, patient-centred and feasible. The results of this systematic review strongly support the development of a core outcome set for use in snakebite clinical trials.

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