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Scientific Reports Dec 2022Transcutaneous auricular vagus nerve stimulation (taVNS) has been investigated as a novel neuromodulation tool. Although taVNS is generally considered safe with only... (Meta-Analysis)
Meta-Analysis
Transcutaneous auricular vagus nerve stimulation (taVNS) has been investigated as a novel neuromodulation tool. Although taVNS is generally considered safe with only mild and transient adverse effects (AEs), those specifically caused by taVNS have not yet been investigated. This systematic review and meta-analysis on taVNS aimed to (1) systematically analyze study characteristics and AE assessment, (2) characterize and analyze possible AEs and their incidence, (3) search for predictable risk factors, (4) analyze the severity of AE, and (5) suggest an evidence-based taVNS adverse events questionnaire for safety monitoring. The articles searched were published through April 7, 2022, in Medline, Embase, Web of Science, Cochrane, and Lilacs databases. In general, we evaluated 177 studies that assessed 6322 subjects. From these, 55.37% of studies did not mention the presence or absence of any AEs; only 24.86% of the studies described that at least one adverse event occurred. In the 35 studies reporting the number of subjects with at least one adverse event, a meta-analytic approach to calculate the risk differences of developing an adverse event between active taVNS and controls was used. The meta-analytic overall adverse events incidence rate was calculated for the total number of adverse events reported on a 100,000 person-minutes-days scale. There were no differences in risk of developing an adverse event between active taVNS and controls. The incidence of AE, in general, was 12.84/100,000 person-minutes-days of stimulation, and the most frequently reported were ear pain, headache, and tingling. Almost half of the studies did not report the presence or absence of any AEs. We attribute this to the absence of AE in those studies. There was no causal relationship between taVNS and severe adverse events. This is the first systematic review and meta-analysis of transcutaneous auricular stimulation safety. Overall, taVNS is a safe and feasible option for clinical intervention.
Topics: Humans; Vagus Nerve Stimulation; Transcutaneous Electric Nerve Stimulation; Vagus Nerve; Pain Management; Headache
PubMed: 36543841
DOI: 10.1038/s41598-022-25864-1 -
JAMA Psychiatry Jun 2018With a prevalence of 4% to 13% in the United States, autoimmune thyroiditis (AIT) is a major health problem. Besides somatic complications, patients with AIT can also... (Meta-Analysis)
Meta-Analysis
IMPORTANCE
With a prevalence of 4% to 13% in the United States, autoimmune thyroiditis (AIT) is a major health problem. Besides somatic complications, patients with AIT can also experience psychiatric disorders. The extent of these organic psychiatric diseases in patients with AIT, however, is so far not commonly known.
OBJECTIVE
To provide meta-analytic data on the association of depression and anxiety with AIT.
DATA SOURCES
Google Scholar, the EBSCO Host databases, the Web of Knowledge, and PubMed were searched from inception through December 5, 2017. Articles identified were reviewed and reference lists were searched manually.
STUDY SELECTION
Case-control studies that reported the association between AIT and either depression or anxiety disorders or both were included.
DATA EXTRACTION AND SYNTHESIS
Data extraction was performed by multiple observers following the PRISMA guidelines. Two univariate random-effects meta-analyses were performed, and moderators were tested with Bonferroni-corrected meta-regression analysis. Heterogeneity was assessed with the I2 statistic. Sensitivity analyses tested the robustness of the results. Small study effects were assessed with funnel plots and the Egger test.
MAIN OUTCOMES AND MEASURES
The odds ratio of patients with AIT and depression compared with a healthy control group, as well as the odds ratio of patients with AIT and anxiety disorders compared with a healthy control group.
RESULTS
Nineteen studies comprising 21 independent samples were included, with a total of 36 174 participants (35 168 for depression and 34 094 for anxiety). Patients with AIT, Hashimoto thyroiditis, or subclinical or overt hypothyroidism had significantly higher scores on standardized depression instruments, with an odds ratio of 3.56 (95% CI, 2.14-5.94; I2 = 92.1%). For anxiety disorders, patients with AIT, Hashimoto thyroiditis, or subclinical or overt hypothyroidism had an odds ratio of 2.32 (95% CI, 1.40-3.85; I2 = 89.8%). Funnel plot asymmetry was detected for studies of depression. Study quality assessed with the Newcastle-Ottawa Scale for case-control studies (mean [SD] score: anxiety, 5.77 [1.17]; depression, 5.65 [1.14]; of a possible maximum score of 9) and proportion of females did not modulate the meta-analytic estimate, whereas mean age did.
CONCLUSIONS AND RELEVANCE
This meta-analysis establishes the association between AIT and depression and anxiety disorders. Patients with AIT exhibit an increased chance of developing symptoms of depression and anxiety or of receiving a diagnosis of depression and anxiety disorders. This finding has important implications for patients and could lead to the choice of early treatment-and not only psychotherapeutic treatment-of the organic disorder.
Topics: Anxiety Disorders; Depressive Disorder; Humans; Thyroiditis, Autoimmune
PubMed: 29800939
DOI: 10.1001/jamapsychiatry.2018.0190 -
PloS One 2020The association between sodium-glucose cotransporter 2 inhibitors (SGLT2i's) and lower extremity amputation is unclear. (Meta-Analysis)
Meta-Analysis
BACKGROUND
The association between sodium-glucose cotransporter 2 inhibitors (SGLT2i's) and lower extremity amputation is unclear.
PURPOSE
To systematically review randomized control trials (RCTs) and observational studies quantifying risk of lower extremity amputations associated with SGLT2i use.
DATA SOURCES AND STUDY SELECTION
We searched PubMed, EMBASE, Scopus, and the Cochrane Central Register of Controlled Trials from January 2011 to February 2020 for RCTs and observational studies including lower extremity amputation outcomes for individuals with type 2 diabetes mellitus treated with SGLT2i's vs. alternative treatments or placebo.
DATA EXTRACTION AND SYNTHESIS
Two reviewers independently extracted data.
MAIN OUTCOMES AND MEASURES
Our primary outcome was risk of lower limb amputation. Secondary outcomes included peripheral arterial disease, peripheral vascular disease, venous ulcerations, and diabetic foot infections. We also evaluated the risk of bias. We conducted random and fixed effects relative risk meta-analysis of RCTs.
RESULTS
After screening 2,006 studies, 12 RCTs and 18 observational studies were included, of which 7 RCTs and 18 observational studies had at least one event. The random effects meta-analysis of 7 RCTs suggested the absence of a statistically significant association between SGLT2i exposure with evidence of substantial statistical heterogeneity (n = 424/23,716 vs n = 267/18,737 in controls; RR 1.28, CI's 0.93-1.76; I2 = 62.0%; p = 0.12) whereas fixed effects analysis showed an increased risk with statistical heterogeneity (RR 1.27, 1.09-1.48; I2 = 62%; p = 0.003). Subgroup analysis of canagliflozin vs placebo showed a statistically significantly increased risk in a fixed effects meta-analysis (n = 2 RCTs, RR 1.59, 1.26-2.01; I2 = 88%; p = 0.0001) whereas the meta-analysis of dapagliflozin or empagliflozin (n = 2 RCTs each) and a single RCT for ertugliflozin did not show a significantly increased risk. The findings from observational studies were too heterogeneous to be pooled in a meta-analysis and draw meaningful conclusions. Both randomized and observational studies were of generally good methodological quality.
CONCLUSIONS
Overall, there was no consistent evidence of SGLT2i exposure and increased risk of amputation. The increased risk of amputation seen in the large, long-term Canagliflozin Cardiovascular Assessment Study (CANVAS) trial for canagliflozin, and select observational studies, merits continued exploration.
Topics: Amputation, Surgical; Benzhydryl Compounds; Glucosides; Humans; Lower Extremity; Peripheral Arterial Disease; Randomized Controlled Trials as Topic; Risk; Sodium-Glucose Transporter 2 Inhibitors; Sulfonylurea Compounds
PubMed: 32502190
DOI: 10.1371/journal.pone.0234065 -
Lung Cancer (Amsterdam, Netherlands) Mar 2023To quantify the long-term comparative efficacy and safety of nivolumab in combination with ipilimumab (NIVO + IPI) relative to other immunotherapy (IO)-based regimens... (Meta-Analysis)
Meta-Analysis
Long-term comparative efficacy and safety of nivolumab plus ipilimumab relative to other first-line therapies for advanced non-small-cell lung cancer: A systematic literature review and network meta-analysis.
OBJECTIVES
To quantify the long-term comparative efficacy and safety of nivolumab in combination with ipilimumab (NIVO + IPI) relative to other immunotherapy (IO)-based regimens and chemotherapy in patients with first-line advanced non-small cell lung cancer (aNSCLC).
METHODS
Phase 3 randomized controlled-trials (RCTs) with minimum 3-year follow-up evaluating IO-based regimens approved for first-line aNSCLC were identified via systematic literature review. Analytic populations were defined by levels of PD-L1 expression and histology. Due to presence of proportional hazards violations, time-varying hazard ratios (HRs) of overall survival (OS) and progression-free survival (PFS) were estimated via Bayesian fractional polynomial network meta-analysis. For safety endpoints, odds ratios (ORs) were estimated using indirect treatment comparisons (ITCs).
RESULTS
CheckMate 227, KEYNOTE-189, KEYNOTE-407, KEYNOTE-024, KEYNOTE-042, and IMpower150 were included in the base case analysis. For OS and PFS, HRs of NIVO + IPI relative to other IO-based regimens trended downward over time across analytic populations. The 36-month OS HRs of NIVO + IPI versus comparators were: 0.69 (95 % credible interval: 0.47, 1.00) versus pembrolizumab + chemotherapy and 0.65 (0.45, 0.93) versus atezolizumab + bevacizumab + chemotherapy in the non-squamous and PD-L1 all-comers population; 0.73 (0.53, 1.02) versus pembrolizumab + chemotherapy in the squamous and PD-L1 all-comers population; and 1.05 (0.83, 1.32) versus pembrolizumab in the mixed histology and PD-L1 ≥ 50 % population. For PFS, 36-month HR point estimates ranged from 0.46 to 0.85 (only statistically significant versus pembrolizumab + chemotherapy in the squamous population; 0.46 [0.31, 0.69]). Adverse events (AEs) leading to discontinuation were not statistically significantly different between NIVO + IPI and pembrolizumab + chemotherapy, nor between NIVO + IPI and pembrolizumab monotherapy, although treatment-related grade ≥ 3 AEs were higher with NIVO + IPI than pembrolizumab monotherapy (OR = 2.21 [1.30, 3.75]).
CONCLUSIONS
This study indicates trends towards long-term benefit with NIVO + IPI compared with other IO-based combinations, with manageable toxicities.
Topics: Humans; Nivolumab; Ipilimumab; Carcinoma, Non-Small-Cell Lung; B7-H1 Antigen; Network Meta-Analysis; Lung Neoplasms; Antineoplastic Combined Chemotherapy Protocols
PubMed: 36669321
DOI: 10.1016/j.lungcan.2023.01.006 -
Alzheimer's & Dementia : the Journal of... Nov 2019Several microRNAs (miRNAs) have been implicated in Alzheimer's disease pathogenesis, but the evidence from individual case-control studies remains inconclusive. (Meta-Analysis)
Meta-Analysis
INTRODUCTION
Several microRNAs (miRNAs) have been implicated in Alzheimer's disease pathogenesis, but the evidence from individual case-control studies remains inconclusive.
METHODS
A systematic literature review was performed, followed by standardized multistage data extraction, quality control, and meta-analyses on eligible data for brain, blood, and cerebrospinal fluid specimens. Results were compared with miRNAs reported in the abstracts of eligible studies or recent qualitative reviews to assess novelty.
RESULTS
Data from 147 independent data sets across 107 publications were quantitatively assessed in 461 meta-analyses. Twenty-five, five, and 32 miRNAs showed studywide significant differential expression (α < 1·08 × 10) in brain, cerebrospinal fluid, and blood-derived specimens, respectively, with 5 miRNAs showing differential expression in both brain and blood. Of these 57 miRNAs, 13 had not been reported in the abstracts of previous original or review articles.
DISCUSSION
Our systematic assessment of differential miRNA expression is the first of its kind in Alzheimer's disease and highlights several miRNAs of potential relevance.
Topics: Alzheimer Disease; Biomarkers; Brain; Case-Control Studies; Epigenomics; Humans; MicroRNAs
PubMed: 31495604
DOI: 10.1016/j.jalz.2019.06.4952 -
Annals of Internal Medicine Oct 2019Whether health care provider burnout contributes to lower quality of patient care is unclear. (Meta-Analysis)
Meta-Analysis
BACKGROUND
Whether health care provider burnout contributes to lower quality of patient care is unclear.
PURPOSE
To estimate the overall relationship between burnout and quality of care and to evaluate whether published studies provide exaggerated estimates of this relationship.
DATA SOURCES
MEDLINE, PsycINFO, Health and Psychosocial Instruments (EBSCO), Mental Measurements Yearbook (EBSCO), EMBASE (Elsevier), and Web of Science (Clarivate Analytics), with no language restrictions, from inception through 28 May 2019.
STUDY SELECTION
Peer-reviewed publications, in any language, quantifying health care provider burnout in relation to quality of patient care.
DATA EXTRACTION
2 reviewers independently selected studies, extracted measures of association of burnout and quality of care, and assessed potential bias by using the Ioannidis (excess significance) and Egger (small-study effect) tests.
DATA SYNTHESIS
A total of 11 703 citations were identified, from which 123 publications with 142 study populations encompassing 241 553 health care providers were selected. Quality-of-care outcomes were grouped into 5 categories: best practices (n = 14), communication (n = 5), medical errors (n = 32), patient outcomes (n = 17), and quality and safety (n = 74). Relations between burnout and quality of care were highly heterogeneous (I2 = 93.4% to 98.8%). Of 114 unique burnout-quality combinations, 58 indicated burnout related to poor-quality care, 6 indicated burnout related to high-quality care, and 50 showed no significant effect. Excess significance was apparent (73% of studies observed vs. 62% predicted to have statistically significant results; P = 0.011). This indicator of potential bias was most prominent for the least-rigorous quality measures of best practices and quality and safety.
LIMITATION
Studies were primarily observational; neither causality nor directionality could be determined.
CONCLUSION
Burnout in health care professionals frequently is associated with poor-quality care in the published literature. The true effect size may be smaller than reported. Future studies should prespecify outcomes to reduce the risk for exaggerated effect size estimates.
PRIMARY FUNDING SOURCE
Stanford Maternal and Child Health Research Institute.
Topics: Burnout, Professional; Health Personnel; Humans; Quality of Health Care
PubMed: 31590181
DOI: 10.7326/M19-1152 -
Annals of Internal Medicine Nov 2019This article has been corrected. The original version (PDF) is appended to this article as a Supplement. (Meta-Analysis)
Meta-Analysis
UNLABELLED
This article has been corrected. The original version (PDF) is appended to this article as a Supplement.
BACKGROUND
Dietary guidelines generally recommend limiting intake of red and processed meat. However, the quality of evidence implicating red and processed meat in adverse health outcomes remains unclear.
PURPOSE
To evaluate the association between red and processed meat consumption and all-cause mortality, cardiometabolic outcomes, quality of life, and satisfaction with diet among adults.
DATA SOURCES
EMBASE (Elsevier), Cochrane Central Register of Controlled Trials (Wiley), Web of Science (Clarivate Analytics), CINAHL (EBSCO), and ProQuest from inception until July 2018 and MEDLINE from inception until April 2019, without language restrictions, as well as bibliographies of relevant articles.
STUDY SELECTION
Cohort studies with at least 1000 participants that reported an association between unprocessed red or processed meat intake and outcomes of interest.
DATA EXTRACTION
Teams of 2 reviewers independently extracted data and assessed risk of bias. One investigator assessed certainty of evidence, and the senior investigator confirmed the assessments.
DATA SYNTHESIS
Of 61 articles reporting on 55 cohorts with more than 4 million participants, none addressed quality of life or satisfaction with diet. Low-certainty evidence was found that a reduction in unprocessed red meat intake of 3 servings per week is associated with a very small reduction in risk for cardiovascular mortality, stroke, myocardial infarction (MI), and type 2 diabetes. Likewise, low-certainty evidence was found that a reduction in processed meat intake of 3 servings per week is associated with a very small decrease in risk for all-cause mortality, cardiovascular mortality, stroke, MI, and type 2 diabetes.
LIMITATION
Inadequate adjustment for known confounders, residual confounding due to observational design, and recall bias associated with dietary measurement.
CONCLUSION
The magnitude of association between red and processed meat consumption and all-cause mortality and adverse cardiometabolic outcomes is very small, and the evidence is of low certainty.
PRIMARY FUNDING SOURCE
None. (PROSPERO: CRD42017074074).
Topics: Cardiovascular Diseases; Diabetes Mellitus, Type 2; Diet; Humans; Meat Products; Myocardial Infarction; Red Meat; Stroke
PubMed: 31569213
DOI: 10.7326/M19-0655 -
Nurse Education in Practice Nov 2019Resilience is a term commonly used to describe the ability to turn adversity into opportunities and learn from demanding situations. There seems to be a need to identify...
Resilience is a term commonly used to describe the ability to turn adversity into opportunities and learn from demanding situations. There seems to be a need to identify support strategies for developing resilience among nursing students in order to strengthen their professional practice. The aim of this review was to synthesize qualitative research exploring how resilience can be developed in nursing students. The review question was: How can nurse educators support students' development of resilience? Relevant publications were identified by systematic data searches in May 2017 in the following electronic databases: MEDLINE, CINAHL, Scopus, Embase, PubMed, PsycInfo, Webb of Science, ProQuest, Academic and Eric. Eight qualitative research studies in English that explored resilience in the context of nursing education were included. Five descriptive themes emerged: Demonstrating caring relationships, Recognizing resources and power, Acknowledging uncertainty, Reframing burdensome experiences and Adjusting frames for learning. In addition, two overarching analytic themes emerged: An educational culture of trustworthiness and Readiness to care. In conclusion, a learning culture characterized by trustworthiness appears to be a catalyst for developing resilience in nursing students. A variety of support strategies in nursing education contribute to resilience in nursing students, thus influencing their readiness to care.
Topics: Education, Nursing, Baccalaureate; Humans; Professional Practice; Qualitative Research; Resilience, Psychological; Students, Nursing; Trust
PubMed: 31726329
DOI: 10.1016/j.nepr.2019.102621 -
The Cochrane Database of Systematic... Aug 2022Elevated blood pressure, or hypertension, is the leading cause of preventable deaths globally. Diets high in sodium (predominantly sodium chloride) and low in potassium... (Review)
Review
BACKGROUND
Elevated blood pressure, or hypertension, is the leading cause of preventable deaths globally. Diets high in sodium (predominantly sodium chloride) and low in potassium contribute to elevated blood pressure. The WHO recommends decreasing mean population sodium intake through effective and safe strategies to reduce hypertension and its associated disease burden. Incorporating low-sodium salt substitutes (LSSS) into population strategies has increasingly been recognised as a possible sodium reduction strategy, particularly in populations where a substantial proportion of overall sodium intake comes from discretionary salt. The LSSS contain lower concentrations of sodium through its displacement with potassium predominantly, or other minerals. Potassium-containing LSSS can potentially simultaneously decrease sodium intake and increase potassium intake. Benefits of LSSS include their potential blood pressure-lowering effect and relatively low cost. However, there are concerns about potential adverse effects of LSSS, such as hyperkalaemia, particularly in people at risk, for example, those with chronic kidney disease (CKD) or taking medications that impair potassium excretion.
OBJECTIVES
To assess the effects and safety of replacing salt with LSSS to reduce sodium intake on cardiovascular health in adults, pregnant women and children.
SEARCH METHODS
We searched MEDLINE (PubMed), Embase (Ovid), Cochrane Central Register of Controlled Trials (CENTRAL), Web of Science Core Collection (Clarivate Analytics), Cumulative Index to Nursing and Allied Health Literature (CINAHL, EBSCOhost), ClinicalTrials.gov and WHO International Clinical Trials Registry Platform (ICTRP) up to 18 August 2021, and screened reference lists of included trials and relevant systematic reviews. No language or publication restrictions were applied.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) and prospective analytical cohort studies in participants of any age in the general population, from any setting in any country. This included participants with non-communicable diseases and those taking medications that impair potassium excretion. Studies had to compare any type and method of implementation of LSSS with the use of regular salt, or no active intervention, at an individual, household or community level, for any duration.
DATA COLLECTION AND ANALYSIS
Two review authors independently screened titles, abstracts and full-text articles to determine eligibility; and extracted data, assessed risk of bias (RoB) using the Cochrane RoB tool, and assessed the certainty of the evidence using GRADE. We stratified analyses by adults, children (≤ 18 years) and pregnant women. Primary effectiveness outcomes were change in diastolic and systolic blood pressure (DBP and SBP), hypertension and blood pressure control; cardiovascular events and cardiovascular mortality were additionally assessed as primary effectiveness outcomes in adults. Primary safety outcomes were change in blood potassium, hyperkalaemia and hypokalaemia.
MAIN RESULTS
We included 26 RCTs, 16 randomising individual participants and 10 randomising clusters (families, households or villages). A total of 34,961 adult participants and 92 children were randomised to either LSSS or regular salt, with the smallest trial including 10 and the largest including 20,995 participants. No studies in pregnant women were identified. Studies included only participants with hypertension (11/26), normal blood pressure (1/26), pre-hypertension (1/26), or participants with and without hypertension (11/26). This was unknown in the remaining studies. The largest study included only participants with an elevated risk of stroke at baseline. Seven studies included adult participants possibly at risk of hyperkalaemia. All 26 trials specifically excluded participants in whom an increased potassium intake is known to be potentially harmful. The majority of trials were conducted in rural or suburban settings, with more than half (14/26) conducted in low- and middle-income countries. The proportion of sodium chloride replacement in the LSSS interventions varied from approximately 3% to 77%. The majority of trials (23/26) investigated LSSS where potassium-containing salts were used to substitute sodium. In most trials, LSSS implementation was discretionary (22/26). Trial duration ranged from two months to nearly five years. We assessed the overall risk of bias as high in six trials and unclear in 12 trials. LSSS compared to regular salt in adults: LSSS compared to regular salt probably reduce DBP on average (mean difference (MD) -2.43 mmHg, 95% confidence interval (CI) -3.50 to -1.36; 20,830 participants, 19 RCTs, moderate-certainty evidence) and SBP (MD -4.76 mmHg, 95% CI -6.01 to -3.50; 21,414 participants, 20 RCTs, moderate-certainty evidence) slightly. On average, LSSS probably reduce non-fatal stroke (absolute effect (AE) 20 fewer/100,000 person-years, 95% CI -40 to 2; 21,250 participants, 3 RCTs, moderate-certainty evidence), non-fatal acute coronary syndrome (AE 150 fewer/100,000 person-years, 95% CI -250 to -30; 20,995 participants, 1 RCT, moderate-certainty evidence) and cardiovascular mortality (AE 180 fewer/100,000 person-years, 95% CI -310 to 0; 23,200 participants, 3 RCTs, moderate-certainty evidence) slightly, and probably increase blood potassium slightly (MD 0.12 mmol/L, 95% CI 0.07 to 0.18; 784 participants, 6 RCTs, moderate-certainty evidence), compared to regular salt. LSSS may result in little to no difference, on average, in hypertension (AE 17 fewer/1000, 95% CI -58 to 17; 2566 participants, 1 RCT, low-certainty evidence) and hyperkalaemia (AE 4 more/100,000, 95% CI -47 to 121; 22,849 participants, 5 RCTs, moderate-certainty evidence) compared to regular salt. The evidence is very uncertain about the effects of LSSS on blood pressure control, various cardiovascular events, stroke mortality, hypokalaemia, and other adverse events (very-low certainty evidence). LSSS compared to regular salt in children: The evidence is very uncertain about the effects of LSSS on DBP and SBP in children. We found no evidence about the effects of LSSS on hypertension, blood pressure control, blood potassium, hyperkalaemia and hypokalaemia in children.
AUTHORS' CONCLUSIONS
When compared to regular salt, LSSS probably reduce blood pressure, non-fatal cardiovascular events and cardiovascular mortality slightly in adults. However, LSSS also probably increase blood potassium slightly in adults. These small effects may be important when LSSS interventions are implemented at the population level. Evidence is limited for adults without elevated blood pressure, and there is a lack of evidence in pregnant women and people in whom an increased potassium intake is known to be potentially harmful, limiting conclusions on the safety of LSSS in the general population. We also cannot draw firm conclusions about effects of non-discretionary LSSS implementations. The evidence is very uncertain about the effects of LSSS on blood pressure in children.
Topics: Adult; Child; Female; Humans; Hyperkalemia; Hypertension; Hypokalemia; Potassium; Pregnancy; Pregnant Women; Randomized Controlled Trials as Topic; Sodium; Sodium Chloride; Sodium Chloride, Dietary; Stroke
PubMed: 35944931
DOI: 10.1002/14651858.CD015207 -
Journal of Medical Internet Research Jun 2019With the advancement in information technology and mobile internet, digital health interventions (DHIs) are improving the care of cardiovascular diseases (CVDs). The...
BACKGROUND
With the advancement in information technology and mobile internet, digital health interventions (DHIs) are improving the care of cardiovascular diseases (CVDs). The impact of DHIs on cost-effective management of CVDs has been examined using the decision analytic model-based health technology assessment approach.
OBJECTIVE
The aim of this study was to perform a systematic review of the decision analytic model-based studies evaluating the cost-effectiveness of DHIs on the management of CVDs.
METHODS
A literature review was conducted in Medline, Embase, Cumulative Index to Nursing and Allied Health Literature Complete, PsycINFO, Scopus, Web of Science, Center for Review and Dissemination, and Institute for IEEE Xplore between 2001 and 2018. Studies were included if the following criteria were met: (1) English articles, (2) DHIs that promoted or delivered clinical interventions and had an impact on patients' cardiovascular conditions, (3) studies that were modeling works with health economic outcomes of DHIs for CVDs, (4) studies that had a comparative group for assessment, and (5) full economic evaluations including a cost-effectiveness analysis, cost-utility analysis, cost-benefit analysis, and cost-consequence analysis. The primary outcome collected was the cost-effectiveness of the DHIs, presented by incremental cost per additional quality-adjusted life year (QALY). The quality of each included study was evaluated using the Consolidated Health Economic Evaluation Reporting Standards.
RESULTS
A total of 14 studies met the defined criteria and were included in the review. Among the included studies, heart failure (7/14, 50%) and stroke (4/14, 29%) were two of the most frequent CVDs that were managed by DHIs. A total of 9 (64%) studies were published between 2015 and 2018 and 5 (36%) published between 2011 and 2014. The time horizon was ≤1 year in 3 studies (21%), >1 year in 10 studies (71%), and 1 study (7%) did not declare the time frame. The types of devices or technologies used to deliver the health interventions were short message service (1/14, 7%), telephone support (1/14, 7%), mobile app (1/14, 7%), video conferencing system (5/14, 36%), digital transmission of physiologic data (telemonitoring; 5/14, 36%), and wearable medical device (1/14, 7%). The DHIs gained higher QALYs with cost saving in 43% (6/14) of studies and gained QALYs at a higher cost at acceptable incremental cost-effectiveness ratio (ICER) in 57% (8/14) of studies. The studies were classified as excellent (0/14, 0%), good (9/14, 64%), moderate (4/14, 29%), and low (1/14, 7%) quality.
CONCLUSIONS
This study is the first systematic review of decision analytic model-based cost-effectiveness analyses of DHIs in the management of CVDs. Most of the identified studies were published recently, and the majority of the studies were good quality cost-effectiveness analyses with an adequate duration of time frame. All the included studies found the DHIs to be cost-effective.
Topics: Cardiovascular Diseases; Cost-Benefit Analysis; Humans; Telemedicine
PubMed: 31210136
DOI: 10.2196/13166