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

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.

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

BMJ Open ◽

10.1136/bmjopen-2019-030157 ◽

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.

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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 ◽

10.1136/bmjopen-2017-016912 ◽

2017 ◽

Vol 7 (10) ◽

pp. e016912 ◽

Cited By ~ 3

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.

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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 ◽

10.1136/bmjopen-2019-030121 ◽

2019 ◽

Vol 9 (7) ◽

pp. e030121 ◽

Cited By ~ 3

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.

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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 ◽

10.1136/bmjopen-2018-026842 ◽

2019 ◽

Vol 9 (3) ◽

pp. e026842 ◽

Cited By ~ 1

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.

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

10.1101/453191 ◽

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.

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Use of glucose for pain management in premature neonates: a systematic review and meta-analysis protocol

BMJ Open ◽

10.1136/bmjopen-2021-052901 ◽

2021 ◽

Vol 11 (12) ◽

pp. e052901

Author(s):

Débora Joyce Duarte Oliveira ◽

Kleyton Santos Medeiros ◽

Ayane Cristine Alves Sarmento ◽

Francisca Jennifer Duarte Oliveira ◽

Ana Paula Ferreira Costa ◽

...

Keyword(s):

Systematic Review ◽

Latin American ◽

Meta Analysis ◽

Subsequent Development ◽

Risk Of Bias ◽

Cochrane Central Register ◽

Premature Neonates ◽

Ethical Approval ◽

Quantitative Synthesis ◽

Registration Number

IntroductionTherapeutic management of neonatal pain is essential to reduce changes in initial and subsequent development. Although glucose has been shown to be effective in relieving pain, concentrations and dosages remain to be standardised. The objective of this systematic review and meta-analysis is to identify the efficacy of glucose as an analgesic in preterm infants.Methods and analysisThe Web of Science, Science Direct, Scopus, Cochrane Central Register of Controlled Trials, ClinicalTrials.gov, PubMed, Medline, Latin American and Caribbean Health Sciences Literature and Embase databases will be researched for randomised studies published until December 2021. This systematic review and meta-analysis will include studies investigating the use of glucose for pain control in premature neonates. The primary outcome will be pain relief. Three independent reviewers will select the studies and extract the data from original publications. The risk of bias was assessed using the Cochrane risk of bias tool. Data synthesis will be performed using the Review Manager software (RevMan V.5.2.3). We will evaluate heterogeneity based on I2 statistics. In addition, quantitative synthesis will be performed if the included studies are sufficiently homogeneous.Ethics and disseminationEthical approval for the research will not be required for this systematic review. The results of this study will be published in an international journal.Trial registration numberThis protocol was submitted to the International Prospective Register of Systematic Reviews (PROSPERO, number CRD42021236217).

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Auricular Acupuncture for Preoperative Anxiety—Protocol of Systematic Review and Meta-Analysis of Randomized Controlled Trials

Medicines ◽

10.3390/medicines7120073 ◽

2020 ◽

Vol 7 (12) ◽

pp. 73

Author(s):

Joanna Dietzel ◽

Mike Cummings ◽

Kevin Hua ◽

Klaus Hahnenkamp ◽

Benno Brinkhaus ◽

...

Keyword(s):

Systematic Review ◽

Randomized Controlled Trials ◽

Meta Analysis ◽

Postoperative Recovery ◽

Preoperative Anxiety ◽

Auricular Acupuncture ◽

Controlled Trials ◽

Cochrane Central Register ◽

Randomized Controlled ◽

Ethical Approval

Background: Preoperative anxiety causes profound psychological and physiological reactions that may lead to a worse postoperative recovery, higher intensity of acute and persistent postsurgical pain and impaired quality of life in the postoperative period. Previous randomized controlled trials (RCTs) suggest that auricular acupuncture (AA) is safe and effective in the treatment of preoperative anxiety; however there is a lack of systematic evidence on this topic. Therefore, this protocol was developed following the PRISMA guidelines to adequately evaluate the existing literature regarding the value of AA for the reduction in anxiety in patients in a preoperative setting, compared to other forms of acupuncture, pharmacological, or no control interventions and measured with questionnaires regarding anxiety and fear. Methods: The following databases will be searched: MEDLINE (PubMed), EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL), ISI Web of Science, and Scopus Database. RCTs will be included if an abstract is available in English. Data collection and analysis will be conducted by two reviewers independently. Quality and risk assessment of included studies will be done using the Cochrane 5.1.0 handbook criteria and meta-analysis of effectiveness and symptom scores will be conducted using the statistical software RevMan V.5.3. Conclusions: This systematic review will evaluate the efficacy and safety of AA for preoperative anxiety. Since all data used in this systematic review and meta-analysis have been published, this review does not require ethical approval. The results may be published in a peer-reviewed journal or be presented in relevant conferences. Registration number: PROSPERO ID CRD42020.

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Benefits of probiotics in preterm neonates in low-income and medium-income countries: a systematic review of randomised controlled trials

BMJ Open ◽

10.1136/bmjopen-2017-017638 ◽

2017 ◽

Vol 7 (12) ◽

pp. e017638 ◽

Cited By ~ 31

Author(s):

Girish Deshpande ◽

Gayatri Jape ◽

Shripada Rao ◽

Sanjay Patole

Keyword(s):

Systematic Review ◽

Mortality Rate ◽

Low Income ◽

Randomised Controlled Trials ◽

Meta Analysis ◽

Preterm Neonates ◽

Controlled Trials ◽

Cochrane Central Register ◽

Mortality And Morbidity ◽

Randomised Controlled

ObjectiveAlthough there is an overall reduction in underfive mortality rate, the progress in reducing neonatal mortality rate has been very slow. Over the last 20 years, preterm births have steadily increased in low-income and medium-income countries (LMICs) particularly in sub-Saharan Africa and South Asia. Preterm birth is associated with increased mortality and morbidity, particularly in LMICs. Based on systematic reviews of randomised controlled trials (RCTs), many neonatal units in high-income countries have adopted probiotics as standard of care for preterm neonates. We aimed to systematically review the safety and efficacy of probiotics in reducing mortality and morbidity in preterm neonates in LMICs.DesignSystematic review and meta-analysis of RCTs.Data sourcesMedline, Embase, Cochrane Central Register of Controlled Trials, Cumulative Index of Nursing and Allied Health Literature and E-abstracts from Pediatric Academic Society meetings and other paediatric and neonatal conference proceedings were searched in January 2017.Eligibility criteriaRCTs comparing probiotics versus placebo/no probiotic in preterm neonates (gestation<37 weeks) conducted in LMICs.ResultsTotal 23 (n=4783) RCTs from 4 continents and 10 LMICs were eligible for inclusion in the meta-analysis using fixed effect model. The risk of necrotising enterocolitis (NEC greater than or equal to stage II) (risk ratio (RR) 0.46 (95% CI 0.34 to 0.61), P<0.00001, numbers needed to treat (NNT) 25 (95% CI 20 to 50)), late-onset sepsis (LOS) (RR 0.80 (95% CI 0.71 to 0.91), P=0.0009, NNT 25 (95% CI 17 to 100)) and all-cause mortality (RR 0.73 (95% CI 0.59 to 0.90), P=0.003, NNT 50 (95% CI 25 to 100)) were significantly lower in probiotic supplemented neonates. The results were significant on random effects model analysis and after excluding studies with high risk of bias. No significant adverse effects were reported.ConclusionProbiotics have significant potential to reduce mortality and morbidity (eg, NEC, LOS) in preterm neonates in LMICs.

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Impact of levothyroxine in women with positive thyroid antibodies on pregnancy outcomes: a systematic review and meta-analysis of randomised controlled trials

BMJ Open ◽

10.1136/bmjopen-2020-043751 ◽

2021 ◽

Vol 11 (2) ◽

pp. e043751

Author(s):

Lorraine Lau ◽

Jamie L Benham ◽

Patricia Lemieux ◽

Jennifer Yamamoto ◽

Lois E Donovan

Keyword(s):

Systematic Review ◽

Preterm Delivery ◽

Pregnancy Outcomes ◽

Randomised Controlled Trials ◽

Meta Analysis ◽

Risk Of Bias ◽

Controlled Trials ◽

Cochrane Central Register ◽

Significant Difference ◽

Randomised Controlled

ObjectiveTo evaluate the effect of levothyroxine therapy on pregnancy outcomes compared with placebo or no treatment in women without overt hypothyroidism with presence of thyroid peroxidase antibodies (TPOAb) and/or thyroglobulin antibodies (TgAb).DesignSystematic review and meta-analysis of randomised controlled trialsStudy eligibility criteriaPrespecified criteria for inclusion were: randomised trials of levothyroxine versus control (placebo or no treatment) among women with positive TPOAb or TgAb who were pregnant or considering conception.Data sourcesOvid MEDLINE, EMBASE, CINAHL, Cochrane Database of Systematic Reviews and Cochrane Central Register of Controlled Trials were searched from 1980 to 5 November 2020.Outcome measuresPrespecified data elements were extracted and where appropriate, meta-analyses were conducted. Main outcomes include pregnancy achieved, miscarriage, preterm delivery and live birth.Risk of bias assessmentCochrane Risk of Bias Tool for Quality Assessment of Randomised Controlled Trials.ResultsFrom 3023 citations, 79 citations were identified for full-text review. Of these, six trials (total of 2263 women) were included for qualitative and quantitative analyses. Risk of bias was deemed low for only one trial. There was no significant difference in the relative risk (RR) of pregnancy achieved (RR 1.03; 95% CI 0.93 to 1.13), miscarriage (RR 0.93; 95% CI 0.76 to 1.14), preterm delivery (RR 0.66; 95% CI 0.39 to 1.10) or live births (RR 1.01; 95% CI 0.89 to 1.16) in thyroid autoimmune women treated with levothyroxine compared with controls. Sensitivity analyses of preterm birth identified study quality and timing of levothyroxine initiation as sources of heterogeneity.ConclusionsAmong pregnant women or women planning conception, with thyroid autoimmunity, there is a lack of evidence of benefit for levothyroxine use (moderate to high Grading of Recommendations, Assessment, Development and Evaluations). Recommendations to use levothyroxine in this setting need to be reconsidered.PROSPERO registration numberCRD42019130459.

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Buteyko method for people with asthma: a protocol for a systematic review and meta-analysis

BMJ Open ◽

10.1136/bmjopen-2021-049213 ◽

2021 ◽

Vol 11 (10) ◽

pp. e049213

Author(s):

Karla Morganna Pereira Pinto de Mendonça ◽

Sean Collins ◽

Tácito ZM Santos ◽

Gabriela Chaves ◽

Sarah Leite ◽

...

Keyword(s):

Systematic Review ◽

Systematic Reviews ◽

Meta Analysis ◽

Secondary Data ◽

Controlled Trials ◽

Cochrane Central Register ◽

Plain Language ◽

Randomised Controlled ◽

Meta Analyses

IntroductionButeyko method is recommended as a non-pharmacological treatment for people with asthma. Although the worldwide interest in the Buteyko method, there is a paucity of studies gathering evidence to support its use. Therefore, we aim to conduct a systematic review and meta-analysis to assess the effects of the Buteyko method in children and adults with asthma.Methods and analysisWe will search on Cochrane Central Register of Controlled Trials, MEDLINE, Embase, US National Institutes of Health Ongoing Trials Register ClinicalTrials.gov and WHO International Clinical Trials Registry Platform for studies focusing on the Buteyko method for children and adults with asthma. The searches will be carried out in September 2021 from database’s inception to the present. We will include randomised controlled trials comparing Buteyko method alone with asthma education or inactive control intervention. There will be no restriction on language. Primary outcomes include quality of life, asthma symptoms and adverse events/side effects. Two review authors will independently screen the studies for inclusion and extract data. We will assess the quality of the included studies using the ‘Risk of Bias’ tool. The certainty of the evidence will be assessed using the GRADE approach. Data synthesis will be conducted using Review Manager software. Reporting of the review will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidance and the Cochrane Handbook for Systematic Reviews of Interventions.Ethics and disseminationThis study will assess and provide evidence for the use of the Buteyko method in people with asthma. We will analyse secondary data and this does not require ethics approval. The findings will be published in peer-reviewed journals, at relevant conferences and will be shared in plain language in social media. Moreover, the findings of this review could guide the direction of healthcare practice and research.PROSPERO registration numberCRD42020193132.

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