Clinical outcomes of oesophagectomy in elderly versus relatively younger patients: a meta-analysis

Abstract OBJECTIVES The surgical efficacy of oesophagectomy for elderly patients (>80 years old) is still unclear. The aim of this meta-analysis was to compare the clinical outcomes of oesophagectomy between elderly and relatively younger patients. METHODS PubMed, EMBASE and the Cochrane Library were searched for relevant studies comparing the clinical outcomes of oesophagectomy for elderly and relatively younger patients. Odds ratios were extracted to obtain pooled estimates of the perioperative effect, and hazard ratios were extracted to compare survival outcomes between the 2 cohorts. RESULTS Nine studies involving 4946 patients were included in this meta-analysis. For patients older than 80 years of age, in-hospital mortality [odds ratio (OR) 2.00, 95% confidence interval (CI) 1.28–3.13; P = 0.002] and the incidence rates of cardiac (OR 1.55, 95% CI 1.10–2.20; P = 0.01) and pulmonary (OR 1.57, 95% CI 1.11–2.22; P = 0.01) complications were higher than those of relatively younger patients. The overall postoperative complication rate (OR 1.40, 95% CI 0.82–2.40; P = 0.22) and the incidence of anastomotic leak (OR 0.92, 95% CI 0.58–1.47; P = 0.73) were not significantly different between the 2 groups. Elderly patients had a worse overall 5-year survival rate (HR 2.66, 95% CI 1.65–4.28; P < 0.001) than that of relatively younger patients. The cancer-related 5-year survival rate of elderly patients was also lower than that of relatively younger patients (HR 3.37, 95% CI 2.36–4.82; P < 0.001). CONCLUSIONS Compared with relatively younger patients, elderly patients with oesophageal cancer undergoing oesophagectomy are at higher risk of in-hospital mortality and have lower survival rates. However, there is no conclusive evidence that the overall rate of complications is elevated in elderly patients.

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Efficacy and safety of erythropoietin for traumatic brain injury

BMC Neurology ◽

10.1186/s12883-020-01958-z ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

Motao Liu ◽

Amy J. Wang ◽

Yu Chen ◽

Gexin Zhao ◽

Zhifeng Jiang ◽

...

Keyword(s):

Traumatic Brain Injury ◽

Brain Injury ◽

Adverse Effects ◽

Adverse Events ◽

Hospital Mortality ◽

Meta Analysis ◽

Survival Rates ◽

Neurological Function ◽

Cochrane Library

Abstract Background Recent studies regarding the effects of erythropoietin (EPO) for treating traumatic brain injury (TBI) have been inconsistent. This study conducts a meta-analysis of randomized controlled trials (RCTs) to assess the safety and efficacy of EPO for TBI patients at various follow-up time points. Methods A literature search was performed using PubMed, Web of Science, MEDLINE, Embase, Google Scholar and the Cochrane Library for RCTs studying EPO in TBI patients published through March 2019. Non-English manuscripts and non-human studies were excluded. The assessed outcomes include mortality, neurological recovery and associated adverse effects. Dichotomous variables are presented as risk ratios (RR) with a 95% confidence interval (CI). Results A total of seven RCTs involving 1197 TBI patients (611 treated with EPO, 586 treated with placebo) were included in this study. Compared to the placebo arm, treatment with EPO did not improve acute hospital mortality or short-term mortality. However, there was a significant improvement in mid-term (6 months) follow-up survival rates. EPO administration was not associated with neurological function improvement. Regarding adverse effects, EPO treatment did not increase the incidence of thromboembolic events or other associated adverse events. Conclusions This meta-analysis indicates a slight mortality benefit for TBI patients treated with EPO at mid-term follow-up. EPO does not improve in-hospital mortality, nor does it increase adverse events including thrombotic, cardiovascular and other associated complications. Our analysis did not demonstrate a significant beneficial effect of EPO intervention on the recovery of neurological function. Future RCTs are required to further characterize the use of EPO in TBI.

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Efficacy and safety of erythropoietin for traumatic brain injury

10.21203/rs.3.rs-35889/v2 ◽

2020 ◽

Author(s):

Motao Liu ◽

Amy J. Wang ◽

Yu Chen ◽

Gexin Zhao ◽

Zhifeng Jiang ◽

...

Keyword(s):

Traumatic Brain Injury ◽

Brain Injury ◽

Adverse Effects ◽

Hospital Mortality ◽

Meta Analysis ◽

Survival Rates ◽

Neurological Function ◽

Cochrane Library ◽

Short Term Mortality

Abstract BackgroundRecent studies regarding the effects of erythropoietin (EPO) for treating traumatic brain injury (TBI) have been inconsistent. This study conducts a meta-analysis of randomized controlled trials (RCTs) to assess the safety and efficacy of EPO for TBI patients at various follow-up time points. MethodsA literature search was performed using PubMed, Web of Science, MEDLINE, Embase, Google Scholar and the Cochrane Library for RCTs studying EPO in TBI patients published through March 2019. Non-English manuscripts and non-human studies were excluded. The assessed outcomes include mortality, neurological recovery and associated adverse effects. Dichotomous variables are presented as risk ratios (RR) with a 95% confidence interval (CI). ResultsA total of seven RCTs involving 1197 TBI patients (611 treated with EPO, 586 treated with placebo) were included in this study. Compared to the placebo arm, treatment with EPO did not improve acute hospital mortality or short-term mortality. However, there was a significant improvement in mid-term (6 months) follow-up survival rates. EPO administration was not associated with neurological function improvement. Regarding adverse effects, EPO treatment did not increase the incidence of thromboembolic events or other associated adverse events.Conclusions This meta-analysis indicates a slight mortality benefit for TBI patients treated with EPO at mid-term follow-up. EPO does not improve in-hospital mortality, nor does it increase adverse events including thrombotic, cardiovascular and other associated complications. Our analysis did not demonstrate a significant beneficial effect of EPO intervention on the recovery of neurological function. Future RCTs are required to further characterize the use of EPO in TBI.

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Association between Portal Vein Thrombosis and Survival of Liver Transplant Recipients: a Systematic Review and Meta-analysis of Observational Studies

Journal of Gastrointestinal and Liver Diseases ◽

10.15403/jgld.2014.1121.qix ◽

2015 ◽

Vol 24 (1) ◽

pp. 51-59 ◽

Cited By ~ 27

Author(s):

Xingshun Qi ◽

Junna Dai ◽

Jia Jia ◽

Weirong Ren ◽

Man Yang ◽

...

Keyword(s):

Systematic Review ◽

Survival Rate ◽

Portal Vein ◽

Portal Vein Thrombosis ◽

Meta Analysis ◽

Survival Rates ◽

Cochrane Library ◽

High Quality ◽

Vein Thrombosis ◽

Significant Difference

Background & Aims: Portal vein thrombosis (PVT) increases the technical complexity of liver transplantation (LT). This systematic review and meta-analysis aim to analyze the association of pre-LT PVT with the overall survival after LT.Methods. PubMed, EMBASE, and Cochrane library databases were used to search for papers related to the association between pre-LT PVT and survival of LT recipients. The differences in the survival rates between the LT recipients with and without pre-LT PVT were expressed as odds ratios (ORs) with 95% confidence intervals (CIs).Results. Twenty-seven papers were included. Overall meta-analysis showed that the total LT recipients with pre-LT PVT had a significantly lower 1-year survival rate than those without pre-LT PVT (OR=0.733, 95%CI=0.621-0.865; P=0.0002). But no statistically significant difference was observed in the in-hospital (OR=0.713, 95%CI=0.343-1.482; P=0.365), 1-month (OR=0.679, 95%CI=0.345-1.333; P=0.261), or 5-year survival rate (OR=0.788, 95%CI=0.587-1.058; P=0.113). Additionally, the 1-year survival rate was significantly lower in the LT recipients with complete PVT than in those without PVT (OR=0.503, 95%CI=0.295-0.858; P=0.012). However, no statistically significant difference in the 1-year survival rate between them was observed in the meta-analysis of high-quality studies (OR=0.899, 95%CI=0.657-1.230; P=0.505) or that of studies in which LT was performed after 2000 (OR=0.783, 95%CI=0.566-1.083; P=0.140).Conclusion. Pre-LT PVT, especially complete PVT, decreased the 1-year survival rate after LT. However, the detrimental effect of pre-LT PVT on the survival of LT recipients became inconclusive in high-quality studies. Additionally, further well-designed cohort studies should validate the association in patients undergoing LT during the latter years.

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Preclinical efficacy of stem cell therapy for skin flap: a systematic review and meta-analysis

Stem Cell Research & Therapy ◽

10.1186/s13287-020-02103-w ◽

2021 ◽

Vol 12 (1) ◽

Author(s):

Yuan Li ◽

Qi-lin Jiang ◽

Leanne Van der Merwe ◽

Dong-hao Lou ◽

Cai Lin

Keyword(s):

Systematic Review ◽

Stem Cells ◽

Stem Cell ◽

Survival Rate ◽

Meta Analysis ◽

Skin Flap ◽

Cochrane Library ◽

Skin Flaps ◽

Cell Based Therapy ◽

Stem Cell Treatment

Abstract Background A skin flap is one of the most critical surgical techniques for the restoration of cutaneous defects. However, the distal necrosis of the skin flap severely restricts the clinical application of flap surgery. As there is no consensus on the treatment methods to prevent distal necrosis of skin flaps, more effective and feasible interventions to prevent skin flaps from necrosis are urgently needed. Stem therapy as a potential method to improve the survival rate of skin flaps is receiving increasing attention. Methods This review followed the recommendations from the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) statements. Twenty studies with 500 animals were included by searching Web of Science, EMBASE, PubMed, and Cochrane Library databases, up until October 8, 2020. Moreover, the references of the included articles were searched manually to obtain other studies. All analyses were conducted using Review Manager V.5.3 software. Results Meta-analysis of all 20 studies demonstrated stem cell treatment has significant effects on reducing necrosis of skin flap compared with the control group (SMD: 3.20, 95% CI 2.47 to 3.93). Besides, subgroup analysis showed differences in the efficacy of stem cells in improving the survival rate of skin flaps in areas of skin flap, cell type, transplant types, and method of administration of stem cells. The meta-analysis also showed that stem cell treatment had a significant effect on increasing blood vessel density (SMD: 2.96, 95% CI 2.21 to 3.72) and increasing the expression of vascular endothelial growth factor (VEGF, SMD: 4.34, 95% CI 2.48 to 6.1). Conclusions The preclinical evidence of our systematic review indicate that stem cell-based therapy is effective for promoting early angiogenesis by up regulating VEGF and ultimately improving the survival rate of skin flap. In summary, small area skin flap, the administration method of intra-arterial injection, ASCs and MSCs, and xenogenic stem cells from humans showed more effective for the survival of animal skin flaps. In general, stem cell-based therapy may be a promising method to prevent skin flap necrosis.

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A meta-analysis indicating extra-short implants (≤ 6 mm) as an alternative to longer implants (≥ 8 mm) with bone augmentation

Scientific Reports ◽

10.1038/s41598-021-87507-1 ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Xiaoran Yu ◽

Ruogu Xu ◽

Zhengchuan Zhang ◽

Yang Yang ◽

Feilong Deng

Keyword(s):

Survival Rate ◽

Clinical Outcomes ◽

Meta Analysis ◽

Risk Of Bias ◽

Bone Augmentation ◽

Moderate Quality ◽

Short Implants ◽

Significant Difference ◽

Complications Rate

AbstractExtra-short implants, of which clinical outcomes remain controversial, are becoming a potential option rather than long implants with bone augmentation in atrophic partially or totally edentulous jaws. The aim of this study was to compare the clinical outcomes and complications between extra-short implants (≤ 6 mm) and longer implants (≥ 8 mm), with and without bone augmentation procedures. Electronic (via PubMed, Web of Science, EMBASE, Cochrane Library) and manual searches were performed for articles published prior to November 2020. Only randomized controlled trials (RCTs) comparing extra-short implants and longer implants in the same study reporting survival rate with an observation period at least 1 year were selected. Data extraction and methodological quality (AMSTAR-2) was assessed by 2 authors independently. A quantitative meta-analysis was performed to compare the survival rate, marginal bone loss (MBL), biological and prosthesis complication rate. Risk of bias was assessed with the Cochrane risk of bias tool 2 and the quality of evidence was determined with the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. 21 RCTs were included, among which two were prior registered and 14 adhered to the CONSORT statement. No significant difference was found in the survival rate between extra-short and longer implant at 1- and 3-years follow-up (RR: 1.002, CI 0.981 to 1.024, P = 0.856 at 1 year; RR: 0.996, CI 0.968 to 1.025, P = 0.772 at 3 years, moderate quality), while longer implants had significantly higher survival rate than extra-short implants (RR: 0.970, CI 0.944 to 0.997, P < 0.05) at 5 years. Interestingly, no significant difference was observed when bone augmentations were performed at 5 years (RR: 0.977, CI 0.945 to 1.010, P = 0.171 for reconstructed bone; RR: 0.955, CI 0.912 to 0.999, P < 0.05 for native bone). Both the MBL (from implant placement) (WMD: − 0.22, CI − 0.277 to − 0.164, P < 0.01, low quality) and biological complications rate (RR: 0.321, CI 0.243 to 0.422, P < 0.01, moderate quality) preferred extra-short implants. However, there was no significant difference in terms of MBL (from prosthesis restoration) (WMD: 0.016, CI − 0.036 to 0.068, P = 0.555, moderate quality) or prosthesis complications rate (RR: 1.308, CI 0.893 to 1.915, P = 0.168, moderate quality). The placement of extra-short implants could be an acceptable alternative to longer implants in atrophic posterior arch. Further high-quality RCTs with a long follow-up period are required to corroborate the present outcomes.Registration number The review protocol was registered with PROSPERO (CRD42020155342).

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EXPRESS: Off-hour effect on time metrics and clinical outcomes in endovascular treatment for large vessel occlusion, a systematic review and meta-analysis

International Journal of Stroke ◽

10.1177/17474930211012545 ◽

2021 ◽

pp. 174749302110125

Author(s):

Mingming Zha ◽

Qingwen Yang ◽

Shuo Liu ◽

Min Wu ◽

Kangmo Huang ◽

...

Keyword(s):

Endovascular Treatment ◽

Clinical Outcomes ◽

Meta Analysis ◽

Working Hours ◽

Good Prognosis ◽

Large Vessel ◽

Cochrane Library ◽

Large Vessel Occlusion ◽

Vessel Occlusion ◽

Significant Difference

Background There is an ongoing debate on the off-hour effect on endovascular treatment (EVT) for acute large vessel occlusion (LVO). Aims This meta-analysis aimed to compare time metrics and clinical outcomes of acute LVO patients who presented/were treated during off-hour with those during working hours. Summary of review Structured searches on the PubMed, Embase, Web of Science, and Cochrane Library databases were conducted through February 23rd, 2021. The primary outcomes were onset to door, door to imaging, door to puncture, puncture to recanalization, procedural time, successful recanalization, symptomatic intracerebral hemorrhage (SICH), mortality in hospital, good prognosis (90-day modified Rankin Scale [mRS] score 0-2), and 90-day mortality. The secondary outcomes were imaging to puncture, onset to puncture, onset to recanalization, door to recanalization time, mRS 0-2 at discharge, and consecutive 90-day mRS score. The odds ratio (OR) and weighted mean difference (WMD) with 95% confidence interval (CI) of the outcomes were calculated using random-effect models. Heterogenicity and publication bias were analyzed. Subgroup and sensitivity analyses were conducted as appropriate. Nineteen studies published between 2014 and 2021 with a total of 14185 patients were eligible for quantitative synthesis. Patients in the off-hour group were significantly younger than those in the on-hour group and with comparable stroke severity and intravenous thrombolysis rate. The off-hour group had longer onset to door (WMD [95%CI], 12.83 [1.84-23.82] min), door to puncture (WMD [95%CI], 11.45 [5.93-16.97] min), imaging to puncture (WMD [95%CI], 10.39 [4.61-16.17] min), onset to puncture (WMD [95%CI], 25.30 [13.11-37.50] min), onset to recanalization (WMD [95%CI], 25.16 [10.28-40.04] min), and door to recanalization (WMD [95%CI], 18.02 [10.01-26.03] min) time. Significantly lower successful recanalization rate (OR [95%CI], 0.85 [0.76-0.95]; P=0.004; I2=0%) was detected in the off-hour group. No significant difference was noted regarding SICH and prognosis. But a trend towards lower OR of good prognosis was witnessed in the off-hour group (OR [95%CI], 0.92 [0.84-1.01]; P=0.084; I2=0%). Conclusions Patients who presented/were treated during off-hour were associated with excessive delays before the initiation of EVT, lower successful reperfusion rate, and a trend towards worse prognosis when compared with working hours. Optimizing the workflows of EVT during off-hour is needed.

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Cognitive function and risk for depression in old age: a meta-analysis of published literature

International Psychogeriatrics ◽

10.1017/s1041610210000049 ◽

2010 ◽

Vol 23 (4) ◽

pp. 516-525 ◽

Cited By ~ 34

Author(s):

Chang-Quan Huang ◽

Zheng-Rong Wang ◽

Yong-Hong Li ◽

Yi-Zhou Xie ◽

Qing-Xiu Liu

Keyword(s):

Cognitive Impairment ◽

Relative Risk ◽

Cognitive Function ◽

Longitudinal Studies ◽

Old Age ◽

Meta Analysis ◽

Incidence Rates ◽

Cochrane Library ◽

Cross Sectional ◽

Risk For Depression

ABSTRACTBackground: We assessed the relationship between cognitive impairment (including mild cognitive impairment with no signs of dementia, and dementia) and risk for depression in old age (60 years and older).Methods: MEDLINE, EMBASE and the Cochrane Library database were used to identify potential studies. All of the clinical studies that produced data on the association between cognitive function and risk of depression among individuals aged 55 years or older were identified and included in this review. The studies were classified into cross-sectional and longitudinal subsets. The quantitative meta-analysis of cross-sectional and longitudinal studies were performed. For prevalence and incidence rates of depression, odds risk (OR) and relative risk (RR) were calculated, respectively.Results: Since all but two studies found in the search were for individuals aged 60 years or over, we assessed and reported on results for this larger group only. In this review we included 13 cross-sectional and four prospective longitudinal studies. The quantitative meta-analysis showed that, in old age, individuals with non-dementia cognitive impairment had neither significant higher prevalence nor incidence rates of depression than those without (odds risk (OR): 1.48, 95% confidence intervals (95% CI): 0.87–2.52; relative risk (RR): 1.12, 95% CI: 0.62–2.01). In old age, individuals with dementia had both significant higher prevalence and incidence rates of depression than those without (OR: 1.82, 95% CI: 1.15–2.89; RR: 3.92, 95% CI: 1.93–7.99).Conclusions: Despite the methodological limitations of this meta-analysis, we found that in old age, there was no association between depression and cognitive impairment with no dementia; however, there was a definite association between depression and dementia and thus dementia might be a risk for depression.

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Long-term Short Implants Performance: Systematic Review and Meta-Analysis of the Essential Assessment Parameters

Brazilian Dental Journal ◽

10.1590/0103-6440201300265 ◽

2015 ◽

Vol 26 (4) ◽

pp. 325-336 ◽

Cited By ~ 12

Author(s):

Thais Marques Simek Vega Gonçalves ◽

Sergio Bortolini ◽

Matteo Martinolli ◽

Bruna Fernandes Moreira Alfenas ◽

Daiane Cristina Peruzzo ◽

...

Keyword(s):

Systematic Review ◽

Survival Rate ◽

Clinical Performance ◽

Meta Analysis ◽

Implant Failure ◽

Cochrane Library ◽

Implant Survival ◽

Implant Survival Rate ◽

Short Implants

<p>Lack of standard criteria in the outcome assessment makes it difficult to draw conclusions on the clinical performance of short implants and, under these circumstances, determine the reasons for implant failure. This study evaluated, through a systematic review of the literature and meta-analysis, the essential parameters required to assess the long-term clinical performance of short and extra-short implants. Electronic databases (Pubmed-MEDLINE, Cochrane Library Database, Embase, and Lilacs) were searched by two independent reviewers, without language limitation, to identify eligible papers. References from the selected articles were also reviewed. The review included clinical trials involving short dental implants placed in humans, published between January 2000 and March 2014, which described the parameters applied for outcome's measurements and provided data on survival rates. Thirteen methodologically acceptable studies were selected and 24 parameters were identified. The most frequent parameters assessed were the marginal bone loss and the cumulative implant survival rate, followed by implant failure rate and biological complications such as bleeding on probing and probing pocket depths. Only cumulative implant survival rate data allows meta-analysis revealing a positive effect size (from 0.052 (fixed) to 0.042 (random)), which means that short implant appears to be a successful treatment option. Mechanical complications and crown-to-implant (C/I) ratio measurement were also commonly described, however, considering the available evidence; no strong conclusions could be drawn since different methods were used to assess each parameter. By means of this literature review, a standard evaluation scheme is proposed, being helpful to regiment further investigations and comparisons on future studies.</p>

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The Effects of Different Types of Steroids on Clinical Outcomes in Neonates with Meconium Aspiration Syndrome: A Systematic Review, Meta-Analysis, and GRADE Assessment

Medicina ◽

10.3390/medicina57111281 ◽

2021 ◽

Vol 57 (11) ◽

pp. 1281

Author(s):

Nanthida Phattraprayoon ◽

Teerapat Ungtrakul ◽

Wimonchat Tangamornsuksan

Keyword(s):

Respiratory Distress ◽

Clinical Outcomes ◽

Meta Analysis ◽

Pulmonary Inflammation ◽

Neonatal Morbidity ◽

Meconium Aspiration Syndrome ◽

Cochrane Library ◽

Oxygen Requirement ◽

Meconium Aspiration ◽

Relative Risks

Background and Objectives: Meconium aspiration syndrome (MAS) is a condition caused by the aspiration of meconium-stainted amniotic fluid into the lungs, resulting in pulmonary inflammation, neonatal morbidity, and mortality. It is important that these MAS infants receive appropriate care to avoid further complications. Steroids have an anti-inflammatory effect and may be effective in the management of MAS. The objective of the this study was to evaluate the effect of different steroids on clinical outcomes in infants with MAS. Materials and Methods: We systematically searched of PubMed/Medline, Scopus, Embase, Clinical Trials.gov, and Cochrane Library databases from inception to 24 January 2021 without language restriction. Only randomized controlled trials (RCTs) evaluating the effects of steroids in neonates with MAS were included. We calculated relative risks and weighted mean differences (MDs) with 95% confidence intervals (CIs) using a random-effects model to determine the associations between MAS and steroids and GRADE approach was employed for quality of evidence. The main outcomes measures were duration of respiratory distress, oxygen requirement, hospitalization, need for mechanical ventilation, death, and adverse drug reactions. Results: Seven RCTs involving 397 patients were analyzed. Nebulized budesonide and intravenous (IV) methylprednisolone shortened the duration of respiratory distress (MD, −2.46 days; 95% CI, −3.09 to −1.83 and MD, −3.30 days; 95% CI, −4.07 to −2.52, respectively) (moderate certainty). There was a reduction in duration of oxygen requirement in nebulized budesonide use (MD, −2.40 days; 95% CI, −3.40 to −1.40) (low certainty) and IV methylprednisolone use (MD, −3.30 days; 95% CI, −4.07 to −2.52) (moderate certainty). Nebulized budesonide shortened hospitalization stay (MD, −4.47 days; 95% CI, −8.64 to −0.30 days) (low certainty) as IV methylprednisolone use (MD, −7.23 days; 95% CI, −8.19 to −6.07 days) (moderate certainty). None of steroids benefits in death (low certainty). Conclusions: Certain types of steroids may benefit the respiratory aspect, but there was no decrease in mortality in MAS infants.

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Outcomes of digital biomarker-based interventions: protocol for a systematic review of systematic reviews (Preprint)

10.2196/preprints.28204 ◽

2021 ◽

Author(s):

Hossein Motahari-Nezhad ◽

Márta Péntek ◽

László Gulácsi ◽

Zsombor Zrubka

Keyword(s):

Clinical Outcomes ◽

Systematic Reviews ◽

Meta Analysis ◽

Cochrane Library ◽

Level Of Evidence ◽

Clinical Benefits ◽

The Cochrane Library ◽

The Impact ◽

Digital Biomarkers

BACKGROUND Digital biomarkers are defined as objective, quantifiable physiological and behavioral data that are collected and measured by means of digital devices such as portables, wearables, implantables or digestibles. For their widespread adoption in publicly financed healthcare systems, it is important to understand how their benefits translate into improved patient outcomes, which is essential for demonstrating their value. OBJECTIVE To assess the quality and strength of evidence of the impact of digital biomarkers on clinical outcomes compared to interventions without digital biomarkers, reported in systematic reviews. METHODS A comprehensive search for 2019-2020 will be conducted in the PubMed and the Cochrane Library using keywords related to digital biomarkers and a filter for systematic reviews. Original full-text English publications of systematic reviews comparing clinical outcomes of interventions with and without digital biomarkers via meta-analysis will be included. The AMSTAR-2 tool will be used to assess the methodological quality of reviews. To assess the quality of evidence, we will evaluate systematic reviews using the GRADE tool. To detect the possible presence of reporting bias, we will record whether the protocol of the systematic reviews was published before the start of the study. A qualitative summary of results by digital biomarker technology and outcome will be provided. RESULTS This protocol was submitted before data collection. The next steps in this review will be initiated after the protocol is accepted for publication. CONCLUSIONS Our study will provide a comprehensive summary of the highest level of evidence available on digital biomarker interventions. Our results will help identify clinical areas where the use of digital biomarkers leads to favorable clinical outcomes. In addition, our findings will highlight areas of evidence gaps where the clinical benefits of digital biomarkers have not yet been demonstrated.

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