Dataset Information

Prevalence of unrecognized or "silent" myocardial ischemia in chronic kidney disease patients: Protocol for a systematic review and meta-analysis.

ABSTRACT:

Introduction

Chronic kidney disease (CKD) patients are at an extremely high risk of silent myocardial ischemia (SMI). However, there is a dearth of evidence on the worldwide prevalence of this very lethal and yet unrecognizable complication of CKD. The proposed systematic review and meta-analysis aims to estimate the global prevalence of SMI among CKD patients.

Methods and analyses

This protocol was conceived according to the preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) statement. The systematic review will involve all observational studies and clinical trials published until April 30, 2021, and reporting on the prevalence of SMI in CKD patients. Electronic sources including MEDLINE, Embase, Web of Science, and Cochrane database of systematic reviews will be perused for potentially eligible studies, restricted to only studies published in English or French. Two investigators will independently select studies and use a pre-pilot tested form to extract data. Further, they will independently perform a qualitative assessment of the risk of bias and overall quality of the selected studies, followed by a quantitative assessment using funnel plots and Egger's tests. The heterogeneity between studies will be assessed with the Cochrane's Q statistic, and the I2 statistic will measure the percentage of variation across studies that is due to their heterogeneity rather than chance; the I2 will decide if a meta-analysis can be conducted. In case it cannot be conducted, a descriptive analysis will be performed. Otherwise, study-specific estimates will be pooled using either a fixed-effects or a random-effects model, depending on the value of the I2 statistic. Subgroup and random effects meta-regression analyses will further investigate the potential sources of heterogeneity. Finally, sensitivity analyses will be performed to measure the impact of low-quality studies on the results of the meta-analysis, and power calculations will determine the probability that we will detect a true effect if it does exist.

Prospero registration number

CRD42020211929.

Strengths and limitations of this study

The intended systematic review and meta-analysis will fill the knowledge gap on the global prevalence of silent myocardial ischemia (SMI) in CKD patients. The eligible studies will be identified through a methodic literature search followed by a rigorous screening process; we will then use robust meta-analysis tools to pool the data and provide reliable estimates of the global prevalence of SMI in CKD patients. Two major limitations could be: the predominance of clinical trials that might limit the generalizability of the findings, given that some informative patients might have been sidelined by the strict inclusion criteria of these studies; the high probability of type 1 error originating from the important number of subgroup and sensitivity analyses.

SUBMITTER: Fokoua-Maxime CD

PROVIDER: S-EPMC8412314 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:IntroductionMyocardial ischemia (MI) is a top ranked cause of death among diabetic patients, yet it is mostly asymptomatic or "silent". There is a need for summary epidemiologic measures on this highly lethal and unnoticeable complication of diabetes. The proposed systematic review and meta-analysis aims to estimate of the global prevalence of silent MI among diabetic patients.Methods and analysisThis protocol was prepared according to the preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) statement. The systematic review will include all observational studies published until March 23, 2021 and reporting on the prevalence of silent MI in diabetic patients. Electronic sources including MEDLINE(PubMed), Embase, Cochrane Library, and Web of Science will be searched for potentially eligible studies, restricted to only studies published in English. Two investigators will select studies and use a pre-pilot tested form to extract data. Further, they will independently perform a qualitative assessment of the risk of bias and overall quality of the selected studies, followed by a quantitative assessment using funnel plots and Egger's tests. The heterogeneity between studies will be assessed with the Cochrane's Q statistic, and the I2 statistic will measure the percentage of variation across studies that is due to their heterogeneity rather than chance; it will decide if a meta-analysis can be conducted. In case a meta-analysis cannot be conducted, a descriptive analysis will be performed. Otherwise, study-specific estimates will be pooled using either a fixed-effects or a random-effects model depending on the value of the I2 statistic. Subgroup and random effects meta-regression analyses will be used to further investigate the potential sources of heterogeneity. Finally, sensitivity analyses will be performed to measure the impact of low-quality studies on the results of the meta-analysis, and power calculations will determine the probability that we will detect a true effect if it does exist.Strengths and limitations of this studyThe intended review will provide an up-to-date summary of the global prevalence of silent MI in diabetic patients. We will conduct a thorough literature search for eligible studies, and we will use robust meta-analysis tools to provide reliable estimates of the global prevalence of silent MI in diabetic patients. Two major limitations could be: the predominance of clinical trials that might limit the generalizability of the findings, given that the strict inclusion criteria of these studies might have excluded other patients; the risk of type 1 error emanating from the high number of subgroup and sensitivity analyses.Prospero registration numberCRD42019138136.

Project description:BackgroundMost guidelines recommend a systematic screening of asymptomatic high risk patients with diabetes for silent ischemia, but the clinical benefit of this strategy has not been demonstrated compared with the simple control of cardiovascular risk factors. We sought to determine whether referring asymptomatic diabetic patients for screening of silent ischemia decreases the risk of cardiovascular events compared with usual care.MethodsDYNAMIT was a prospective, randomized, open, blinded end-point multicenter trial run between 2000 and 2005, with a 3.5 year mean follow-up in ambulatory care in 45 French hospitals. The study included 631 male and female with diabetes aged 63.9 ± 5.1 years, with no evidence of coronary artery disease and at least 2 additional cardiovascular risk factors, receiving appropriate medical treatment. The patients were randomized centrally to either screening for silent ischemia using a bicycle exercise test or Dipyridamole Single Photon Emission Computed Tomography (N = 316), or follow-up without screening (N = 315). The main study end point was time to death from all causes, non-fatal myocardial infarction, non-fatal stroke, or heart failure requiring hospitalization or emergency service intervention. The results of a meta-analysis of DYNAMIT and DIAD, a similar study, are also presented.ResultsThe study was discontinued prematurely because of difficulties in recruitment and a lower-than expected event rate. Follow-up was complete for 98.9% patients regarding mortality and for 97.5% regarding the main study end point. Silent ischemia detection procedure was positive or uncertain in 68 (21.5%) patients of the screening group. There was no significant difference between the screening and the usual care group for the main outcome (hazard ratio = 1.00 95%CI 0.59 to 1.71). The meta-analysis of these and DIAD results gave similar results, with narrower confidence intervals for each endpoint.ConclusionsThese results suggest that the systematic detection of silent ischemia in high-risk asymptomatic patients with diabetes is unlikely to provide any major benefit on hard outcomes in patients whose cardiovascular risk is controlled by an optimal medical treatment.Trial registrationClinicalTrials.gov: NCT00627783.

Project description:BackgroundPolypharmacy, often defined as the concomitant use of ≥ 5 medications, has been identified as a significant global public health threat. Aging and multimorbidity are key drivers of polypharmacy and have been linked to a broad range of adverse health outcomes and mortality. Patients with chronic kidney disease (CKD) are particularly at high risk of polypharmacy and use of potentially inappropriate medications given the numerous risk factors and complications associated with CKD. The aim of this systematic review will be to assess the prevalence of polypharmacy among adult patients with CKD, and the potential association between polypharmacy and adverse health outcomes within this population.Methods/designWe will search empirical databases such as MEDLINE, Embase, Cochrane Library, CINAHL, Web of Science, and PsycINFO and grey literature from inception onwards (with no language restrictions) for observational studies (e.g., cross-sectional or cohort studies) reporting the prevalence of polypharmacy in adult patients with CKD (all stages including dialysis). Two reviewers will independently screen all citations, full-text articles, and extract data. Potential conflicts will be resolved through discussion. The study methodological quality will be appraised using an appropriate tool. The primary outcome will be the prevalence of polypharmacy. Secondary outcomes will include any adverse health outcomes (e.g., worsening kidney function) in association with polypharmacy. If appropriate, we will conduct random effects meta-analysis of observational data to summarize the pooled prevalence of polypharmacy and the associations between polypharmacy and adverse outcomes. Statistical heterogeneity will be estimated using Cochran's Q and I2 index. Additional analyses will be conducted to explore the potential sources of heterogeneity (e.g., sex, kidney replacement therapy, multimorbidity).DiscussionGiven that polypharmacy is a major and a growing public health issue, our findings will highlight the prevalence of polypharmacy, hazards associated with it, and medication thresholds associated with adverse outcomes in patients with CKD. Our study will also draw attention to the prognostic importance of improving medication practices as a key priority area to help minimize the use of inappropriate medications in patients with CKD.Systematic review registrationPROSPERO registration number: [ CRD42020206514 ].

Project description:BackgroundChronic pain is a common and distressing symptom reported by patients with chronic kidney disease (CKD). Clinical practice and research in this area do not appear to be advancing sufficiently to address the issue of chronic pain management in patients with CKD.ObjectivesTo determine the prevalence and severity of chronic pain in patients with CKD.DesignSystematic review and meta-analysis.SettingInterventional and observational studies presenting data from 2000 or later. Exclusion criteria included acute kidney injury or studies that limited the study population to a specific cause, symptom, and/or comorbidity.PatientsAdults with glomerular filtration rate (GFR) category 3 to 5 CKD including dialysis patients and those managed conservatively without dialysis.MeasurementsData extracted included title, first author, design, country, year of data collection, publication year, mean age, stage of CKD, prevalence of pain, and severity of pain.MethodsDatabases searched included MEDLINE, CINAHL, EMBASE, and Cochrane Library, last searched on February 3, 2020. Two reviewers independently screened all titles and abstracts, assessed potentially relevant articles, and extracted data. We estimated pooled prevalence of overall chronic pain, musculoskeletal pain, bone/joint pain, muscle pain/soreness, and neuropathic pain and the I 2 statistic was computed to measure heterogeneity. Random effects models were used to account for variations in study design and sample populations and a double arcsine transformation was used in the model calculations to account for potential overweighting of studies reporting either very high or very low prevalence measurements. Pain severity scores were calibrated to a score out of 10, to compare across studies. Weighted mean severity scores and 95% confidence intervals were reported.ResultsSixty-eight studies representing 16 558 patients from 26 countries were included. The mean prevalence of chronic pain in hemodialysis patients was 60.5%, and the mean prevalence of moderate or severe pain was 43.6%. Although limited, pain prevalence data for peritoneal dialysis patients (35.9%), those managed conservatively without dialysis (59.8%), those following withdrawal of dialysis (39.2%), and patients with earlier GFR category of CKD (61.2%) suggest similarly high prevalence rates.LimitationsStudies lacked a consistent approach to defining the chronicity and nature of pain. There was also variability in the measures used to determine pain severity, limiting the ability to compare findings across populations. Furthermore, most studies reported mean severity scores for the entire cohort, rather than reporting the prevalence (numerator and denominator) for each of the pain severity categories (mild, moderate, and severe). Mean severity scores for a population do not allow for "responder analyses" nor allow for an understanding of clinically relevant pain.ConclusionsChronic pain is common and often severe across diverse CKD populations providing a strong imperative to establish chronic pain management as a clinical and research priority. Future research needs to move toward a better understanding of the determinants of chronic pain and to evaluating the effectiveness of pain management strategies with particular attention to the patient outcomes such as overall symptom burden, physical function, and quality of life. The current variability in the outcome measures used to assess pain limits the ability to pool data or make comparisons among studies, which will hinder future evaluations of the efficacy and effectiveness of treatments. Recommendations for measuring and reporting pain in future CKD studies are provided.Trial registrationPROSPERO Registration number CRD42020166965.