scholarly journals Tolerability of statin-based management of patients with a history of statin-associated muscle symptoms: protocol for a systematic review

BMJ Open ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. e052341
Author(s):  
Fanny Villoz ◽  
Christina Lyko ◽  
Cinzia Del Giovane ◽  
Nicolas Rodondi ◽  
Manuel R Blum

IntroductionStatin-associated muscle symptoms (SAMSs) are a major clinical issue in the primary and secondary prevention of cardiovascular events. Current guidelines advise various approaches mainly based on expert opinion. We will lead a systematic review and meta-analysis to explore the tolerability and acceptability and effectiveness of statin-based therapy management of patients with a history of SAMS. We aim to provide evidence on the tolerability and different strategies of statin-based management of patients with a history of SAMS.Methods and analysisWe will conduct a systematic review of randomised controlled trials (RCTs) and non-randomised studies with a control group. We will search in Data sources MEDLINE, EMBASE, Cochrane Central Register of Controlled Clinical Trials, Scopus, Clinicaltrials.gov and Proquest from inception until April 2021. Two independent reviewers will carry out the study selection based on eligibility criteria. We will extract data following a standard data collection form. The reviewers will use the Cochrane Collaboration’s tools and Newcastle-Ottawa Scale to appraise the study risk of bias. Our primary outcome will be tolerability and our secondary outcomes will be acceptability and effectiveness. We will conduct a qualitative analysis of all included studies. In addition, if sufficient and homogeneous data are available, we will conduct quantitative analysis. We will synthesise dichotomous data using OR with 95% CI and continuous outcomes by using mean difference or standardised mean difference (with 95% CI). We will determine heterogeneity visually with forest plots and quantitatively with I2 and Q-test. We will summarise the confidence in the quantitative estimate by using Grading of Recommendations Assessment, Development and Evaluation approach.Ethics and disseminationAs a systematic review of literature without collection of new clinical data, there will be no requirement for ethical approval. We will disseminate findings through peer-reviewed publications.PROSPERO registration numberCRD42020202619.

2020 ◽  
Author(s):  
ANDREW SENTOOGO SSEMATA ◽  
JACQUELLINE ANN NAKITENDE ◽  
SIMON KIZITO ◽  
ELIZABETH C WHIPPLE ◽  
PAUL BANGIRANA ◽  
...  

Abstract Background: Malaria is one of the major contributing risk factors for poor development of children living in low- and middle- income countries (LMICs). However, little is known about the specific domains of cognition and behaviour that are impacted by malaria, the extent of these deficits, and the different types of the malaria spectrum that are associated with these deficits. The objective of this systematic review is to determine the association of the different type of malaria infection on cognition and behavioural outcomes among children living in LMICs. Methods and analysis: We will systematically search online bibliographic databases including MEDLINE (via PubMed), CINAHL (via EBSCO), PsycINFO (via EBSCO), Embase and The Cochrane Central Register of Controlled Trials (CENTRAL) as well as Google Scholar and bibliographies of pertinent articles. We will include studies with a comparison group (e.g., clinical trials, cohort, observational, cross-sectional case–control and controlled before and after or interrupted–time–series studies) involving children under 18 years of age living in LMICs, as determined by World Bank Criteria, with either an active malaria infection or history of malaria. Included articles must also measure cognitive and/or behaviour outcomes determined by standardized psychological assessments (questionnaire-based scales and or neurocognitive assessments). Studies will be excluded if they are not in English, lack a control group, take place in a high-income country, or if a standardized instrument was not used. Two reviewers will independently review all articles to determine if they meet eligibility criteria. Any conflicts will be resolved after discussion with a third reviewer. When a list of included articles is finalized, two reviewers will extract data to populate and then cross check within an electronic table. Risk of bias and the strength of evidence and recommendations will be assessed independently using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) criteria, and a final score will be given upon consensus. For sufficiently homogeneous data on measured outcomes in multiple studies, we will investigate the possibility of pooling data to perform a meta-analysis. Discussion: This systematic review will evaluate the evidence of the association of malaria on the cognitive and behavioural outcomes. Findings from this planned review will generate insight on the domains affected by the different forms malaria infection and may inform subsequent malaria interventions and future research in paediatric care.Systematic review registration: This systematic review has been registered under the International Prospective Register of Systematic Reviews (PROSPERO; registration number: CRD42020154777)


2020 ◽  
Author(s):  
ANDREW SENTOOGO SSEMATA ◽  
JACQUELLINE ANN NAKITENDE ◽  
SIMON KIZITO ◽  
ELIZABETH C WHIPPLE ◽  
PAUL BANGIRANA ◽  
...  

Abstract Background: Malaria is one of the major contributing risk factors for poor development of children living in low- and middle- income countries (LMICs). However, little is known about the specific domains of cognition and behaviour that are impacted by malaria, the extent of these deficits, and the different types of the malaria spectrum that are associated with these deficits. The objective of this systematic review is to determine the effect of the different type of malaria infection on cognition and behaviour among children living in LMICs. Methods and analysis: We will systematically search online bibliographic databases including MEDLINE (via PubMed), CINAHL (via EBSCO), PsycINFO (via EBSCO), EMBASE and The Cochrane Central Register of Controlled Trials (CENTRAL) as well as Google Scholar and bibliographies of pertinent articles. We will include studies with a comparison group (e.g., clinical trials, cohort, observational, cross-sectional case–control and controlled before and after or interrupted–time–series studies) involving children under 18 years of age living in LMICs, as determined by World Bank Criteria, with either an active malaria infection or history of malaria. Included articles must also measure cognitive and/or behaviour outcomes determined by standardized psychological assessments (questionnaire-based scales and or neurocognitive assessments). Studies will be excluded if they are not in English, lack a control group, take place in a high-income country, or if a standardized instrument was not used. Two reviewers will independently review all articles to determine if they meet eligibility criteria. Any conflicts will be resolved after discussion with a third reviewer. When a list of included articles is finalized, two reviewers will extract data to populate and then cross check within an electronic table. Risk of bias and the strength of evidence and recommendations will be assessed independently using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) criteria, and a final score will be given upon consensus. For sufficiently homogeneous data on measured outcomes in multiple studies, we will investigate the possibility of pooling data to perform a meta-analysis. Discussion: This systematic review will evaluate the evidence of the effect of malaria on the cognitive and behavioural outcomes. Findings from this planned review will generate insight on the domains affected by the different forms malaria infection and may inform subsequent malaria interventions and future research in paediatric care.Systematic review registration: This systematic review has been registered under PROSPERO: CRD42020154777


BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e046370
Author(s):  
Aamer Imdad ◽  
Julie Melissa Ehrlich ◽  
Joseph Catania ◽  
Emily Tanner-Smith ◽  
Abigail Smith ◽  
...  

IntroductionPrevalence rates of breastfeeding remain low even though the World Health Organization (WHO) and the American Academy of Pediatrics recommend exclusive breast feeding for the first 6 months of life in combination with appropriate complementary feeding beyond six 6 months of age. There have been several studies that address the implication of drinking animal milk and/or infant formula on children’s health and development when breast feeding is not offered during the first year of life. Vast improvements have been made in infant formula design, which may increase its benefits compared with animal’s milk. The objective of this review is therefore to synthesise the most recent evidence on the effects of the consumption of animal milk compared with infant formula in non-breastfed or mixed breastfed infants aged 6–11 months.Methods and analysisWe will conduct a systematic review and meta-analysis of studies that assessed the effect of animal milk compared with formula or mixed-fed (breastmilk and formula) on infants aged 6–11 months. The primary outcomes of interest include anaemia, gastrointestinal blood loss, weight for age, height for age and weight for height. We will include randomised and non-randomised studies with a control group. We will use the Cochrane risk of bias tools to assess the risk of bias. We will use meta-analysis to pool findings if the identified studies are conceptually homogenous and data are available from more than one study. We will assess the overall quality of evidence using the Grading of Recommendations Assessment, Development, and Evaluation approach.Ethics and disseminationThis is a systematic review, so no patients will be directly involved in the design or development of this study. The findings from this systematic review will be disseminated to relevant patient populations and caregivers and will guide the WHO’s recommendations on formula consumption versus animal milk in infants aged 6–11 months.Trial registration numberCRD42020210925.


Author(s):  
Leizi Min ◽  
Dizhi Wang ◽  
Yanwei You ◽  
Yingyao Fu ◽  
Xindong Ma

Objectives: To use a quantitative approach to examine the effects of high-intensity interval training (HIIT) interventions on sleep for adults. Methods: PubMed, Ebsco, Web of Science, Cochrane Central Register of Controlled Trials, the China National Knowledge Infrastructure, and Wanfang Data were searched from their inception to December 2020. Intervention studies with a control group that examined the effects of HIIT interventions on sleep were included in this meta-analysis. The risk of bias was assessed using the tool provided by the Cochrane Handbook for Systematic Reviews of Interventions. Effect sizes (ESs), calculated as weighted mean difference (WMD) and standardized mean difference (SMD), were used to examine the effects of objective outcomes and subjective outcomes separately. Results: A large increase in sleep quality (SQ) reflected by the Pittsburgh Sleep Quality Index global scores [WMD = −0.90, 95%CI (−1.72, −0.07), p = 0.03, n = 8] and a small-to-medium favorable effect on sleep efficiency (SE) [SMD = 0.43, 95%CI (0.20, 0.65), p = 0.0002, n = 10] were found after HIIT intervention. In addition, sub-analyses results suggest that ESs were moderated by the type, duration and frequency, as well as the length of the HIIT intervention. Conclusions: HIIT may be a promising way to improve overall subjective SQ and objective SE. PROSPERO, protocol registration number: CRD42021241734.


BMJ Open ◽  
2018 ◽  
Vol 8 (7) ◽  
pp. e020183
Author(s):  
Adolf Kofi Awua ◽  
Edna Dzifa Doe

IntroductionFor a country that lacks a national cervical cancer screening/prevention programme, there is the need to assess the volume of country-specific information, and the status of research on HPV and cervical cancer, in order to provide evidence that will inform policy and further research. The aim of this protocol is to plan an intended systematic review, which is to identify research gaps, prevent unnecessary duplication of work and enable collaboration.Methods and analysisThis protocol, developed according to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols statement and registered by PROSPERO (CRD42017075583), will apply a 13-point eligibility criteria to screening and selecting peer-reviewed research articles and grey literature. These will be obtained from searches in databases, including, among others, those of the National Centre for Biotechnology Information, Cochrane Central Register of Controlled Trials, Google Scholar and the digital collections database of research publications of Universities in Ghana. Collected data will be aggregated and summarised according to emerging themes and simple descriptive statistics.Ethics and disseminationThe study will use publicly available data and will not identify authors of the publication by name. In light of these and as has been indicted, research ethics clearance is not required for evidence syntheses in such reviews. The review will be published in peer-reviewed scientific journals and presented at local and internal conferences as the opportunity becomes available.PROSPERO registration numberCRD42017075583.


2018 ◽  
Vol 2018 ◽  
pp. 1-10 ◽  
Author(s):  
Huijuan Zheng ◽  
Junping Wei ◽  
Liansheng Wang ◽  
Qiuhong Wang ◽  
Jing Zhao ◽  
...  

Low selenium status is associated with increased risk of Graves’ disease (GD). While several trials have discussed the efficacy of selenium supplementation for thyroid function, in GD patients, the effectiveness of selenium intake as adjuvant therapy remains unclear. In this systematic review and meta-analysis, we aimed to determine the efficacy of selenium supplementation on thyroid function in GD patients. Two reviewers searched PubMed, Web of Science, the Cochrane Central Register of Controlled Trials, and four Chinese databases for studies published up to October 31, 2017. RCTs comparing the effect of selenium supplementation on thyroid hyperfunction in GD patients on antithyroid medication to placebo were included. Serum free thyroxine (FT4), free triiodothyronine (FT3), thyrotrophic hormone receptor antibody (TRAb), and thyroid-stimulating hormone (TSH) levels were assessed. Ten trials involving 796 patients were included. Random-effects meta-analyses in weighted mean difference (WMD) were performed for 3, 6, and 9 months of supplementation and compared to placebo administration. Selenium supplementation significantly decreased FT4 (WMD=-0.86 [confidence interval (CI)-1.20 to -0.53]; p=0.756; I2=0.0%) and FT3 (WMD=-0.34 [CI-0.66 to -0.02]; p=0.719; I2=0.0%) levels at 3 months, compared to placebo administration; these findings were consistent at 6 but not 9 months. TSH levels were more elevated in the group of patients taking selenium than in the control group at 3 and 6, but not 9 months. TRAb levels decreased at 6 but not 9 months. At 6 months, patients on selenium supplementation were more likely than controls to show improved thyroid function; however, the effect disappeared at 9 months. Whether these effects correlate with clinically relevant measures remains to be demonstrated.


BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e036904
Author(s):  
Christian Kraef ◽  
Marc van der Meirschen ◽  
Caroline Free

ObjectiveTo determine the effectiveness of digital telemedicine interventions designed to improve outcomes in patients with multimorbidity.DesignSystematic review and meta-analysis of available literature.Data sourcesMEDLINE, EMBASE, The Cochrane Central Register of Controlled Trials, ClinicalTrials.gov, and the Database of Abstracts of Reviews of Effectiveness and hand searching. The search included articles from inception to 19 April 2019 without language restrictions. The search was updated on 7 June 2020 without additional findings.Eligibility criteriaProspective interventional studies reporting multimorbid participants employing interventions with at least one digital telemedicine component were included. Primary outcomes were patient physical or mental health outcomes, health-related quality of life scores and the utilisation of health services.ResultsOut of 5865 studies initially identified, 7 articles, reporting on 6 studies were retained (total of 699 participants). Four of these studies reported interventions including integration with usual care, two studies had interventions with no links to usual patient care. Follow-up periods lasted between 2 and 6 months. Among the studies with links to usual care, the primary outcomes were systolic blood pressure (SBP) (three studies), haemoglobin A1c (HbA1c) (three studies), total cholesterol (two studies) and self-perceived health status (one study). The evidence ranged from very low to moderate certainty. Meta-analysis showed a moderate decrease in SBP (8 mm Hg (95% CI 4.6 to 11.4)), a small to moderate decrease in HbA1c (0.46 mg/dL (95% CI 0.25 to 0.67)) and moderate decrease in total cholesterol (cholesterol 16.5 mg/dL (95% CI 8.1 to 25.0)) in the intervention groups. There was an absence of evidence for self-perceived health status. Among the studies with no links to usual care, time to hospitalisation (median time to hospitalisation 113.4 days intervention and 104.7 days control group, absolute difference 12.7 days) and the Minnesota Living with Heart Failure Questionnaire (intervention group 35.2 score points, control group 23.9 points, absolute difference 11.3, 95% CI 5.5 to 17.1) showed small reductions. The Personal Health Questionnaire (PHQ-8) showed no evidence of improvement (intervention 7.6 points, control 8.6 points, difference 1.0 points, 95% CI −22.9% to 11.9%).ConclusionDigital telemedicine interventions provided moderate evidence of improvements in measures of disease control but little evidence and no demonstrated benefits on health status. Further research is needed with clear descriptions of conditions, interventions and outcomes based on patients’ and healthcare providers’ preferences.PROSPERO registration numberCRD42019134872.


2020 ◽  
pp. 026921552095193
Author(s):  
Alberto Saavedra-García ◽  
Jose A Moral-Munoz ◽  
David Lucena-Anton

Objective: To evaluate the current evidence on the effectiveness of simultaneous combination of mirror therapy and electrical stimulation in the recovery of upper limb motor function after stroke, compared with conventional therapy, mirror therapy or electrical stimulation isolated. Data sources: Articles published in PubMed, Web of Science, Scopus, Physiotherapy Evidence Database (PEDro), Cochrane Central register of controlled trials and ScienceDirect up to July 2020. Review methods: The PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines were followed. Methodological quality was assessed using the PEDro tool. The RevMan 5.4 statistical software was used to obtain the meta-analysis, through the standardized mean difference and 95% confidence intervals (CI), and to evaluate the risk of bias. The GRADE approach was employed to assess the certainty of evidence. Results: Eight articles were included in this systematic review, seven were included in the meta-analysis. A total of 314 participants were analyzed. The overall quality of the articles included in this review was good. There was no overall significant mean difference on upper limb motor function after stroke using the Upper-Extremity Fugl-Meyer Assessment by 1.56 (95% CI = –2.08, 5.20; P = 0.40; moderate-certainty evidence) and the Box and Block Test results by 1.39 (95% CI = –2.14, 4.92; P = 0.44; high-certainty evidence). There was overall significant difference in the Action Research Arm Test by 3.54 (95% CI = 0.18, 6.90; P = 0.04; high-certainty evidence). Conclusion: Direct scientific evidence about the effectiveness of the combined therapy of mirror therapy and electrical stimulation simultaneously for the improvement of the upper limb motor function after stroke is lacking. Further high-quality and well-designed research is needed.


2017 ◽  
Vol 2017 ◽  
pp. 1-11 ◽  
Author(s):  
Bo Dong ◽  
Zeqin Chen ◽  
Xuan Yin ◽  
Danting Li ◽  
Jie Ma ◽  
...  

Objective.To evaluate the effectiveness of acupuncture as monotherapy and as an alternative therapy in treating depression-related insomnia.Data Source.Seven databases were searched starting from 1946 to March 30, 2016.Study Eligibility Criteria.Randomized-controlled trials of adult subjects (18–75 y) who had depression-related insomnia and had received acupuncture.Results.18 randomized-controlled clinical trials (RCTs) were introduced in this meta-analysis. The findings determined that the acupuncture treatment made significant improvements in PSQI score (MD = −2.37, 95% CI −3.52 to −1.21) compared with Western medicine. Acupuncture combined with Western medicine had a better effect on improving sleep quality (MD = −2.63, 95% CI −4.40 to −0.86) compared with the treatment of Western medicine alone. There was no statistical difference (MD = −2.76, 95% CI −7.65 to 2.12) between acupuncture treatment and Western medicine towards improving the HAMD score. Acupuncture combined with Western medicine (MD = −5.46, CI −8.55 to −2.38) had more effect on improving depression degree compared with the Western medicine alone.Conclusion. This systematic review indicates that acupuncture could be an alternative therapy to medication for treating depression-related insomnia.


2018 ◽  
Vol 52 (16) ◽  
pp. 1040-1046 ◽  
Author(s):  
Nadine Rasenberg ◽  
Henrik Riel ◽  
Michael S Rathleff ◽  
Sita M A Bierma-Zeinstra ◽  
Marienke van Middelkoop

BackgroundPlantar heel pain (PHP) is common. Foot orthoses are often applied as treatment for PHP, even though there is little evidence to support this.ObjectiveTo investigate the effects of different orthoses on pain, function and self-reported recovery in patients with PHP and compare them with other conservative interventions.DesignSystematic review and meta-analysis.Data sourcesA systematic literature search was conducted in MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Web of Science, CINAHL and Google Scholar up to January 2017.Eligibility criteria for selecting studiesRandomised controlled trials comparing foot orthoses with a control (defined as no intervention, sham or other type of conservative treatment) reporting on pain, function or self-reported recovery in patients with PHP.ResultsTwenty studies investigating eight different types of foot orthoses were included in the review. Most studies were of high quality. Pooled data from six studies showed no difference between prefabricated orthoses and sham orthoses for pain at short term (mean difference (MD) of 0.26 (95% CI −0.09 to 0.60)). No difference was found between sham orthoses and custom orthoses for pain at short term (MD 0.22 (95% CI −0.05 to 0.50)), nor was there a difference between prefabricated orthoses and custom orthoses for pain at short term (MD 0.03 (95% CI −0.15 to 0.22)). For the majority of other interventions, no significant differences were found.ConclusionsFoot orthoses are not superior for improving pain and function compared with sham or other conservative treatment in patients with PHP.PROSPERO registration numberCRD42015029659.


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