Mortality and major postoperative complications within 1 year after vascular surgery: a prospective cohort study.

INTRODUCTION: Patients undergoing vascular procedures are prone to developing postoperative complications affecting their short­term mortality. Prospective reports describing the incidence of long­term complications after vascular surgery are lacking. OBJECTIVES: We aimed to describe the incidence of complications 1 year after vascular surgery and to evaluate an association between myocardial injury after noncardiac surgery (MINS) and 1­year mortality. PATIENTS AND METHODS: This is a substudy of a large prospective cohort study Vascular Events in Noncardiac Surgery Patients Cohort Evaluation (VISION). Recruitment took place in 28 centers across 14 countries from August 2007 to November 2013. We enrolled patients aged 45 years or older undergoing vascular surgery, receiving general or regional anesthesia, and hospitalized for at least 1 night postoperatively. Plasma cardiac troponin T concentration was measured before the surgery and on the first, second, and third postoperative day. The patients or their relatives were contacted 1 year after the procedure to assess the incidence of major postoperative complications. RESULTS: We enrolled 2641 patients who underwent vascular surgery, 2534 (95.9%) of whom completed 1­year follow­up. Their mean (SD) age was 68.2 (9.8) years, and the cohort was predominantly male (77.5%). The most frequent 1­year complications were myocardial infarction (224/2534, 8.8%), amputation (187/2534, 7.4%), and congestive heart failure (67/2534, 2.6%). The 1­year mortality rate was 8.8% (223/2534). MINS occurred in 633 patients (24%) and was associated with an increased 1­year mortality (hazard ratio, 2.82; 95% CI, 2.14-3.72; P <0.001). CONCLUSIONS: The incidence of major postoperative complications after vascular surgery is high. The occurrence of MINS is associated with a nearly 3­fold increase in 1­year mortality.

Frequency of anticancer drug use at the end of life: a scoping review.

PURPOSE: Anticancer drug use at the end of life places potential extra burdens on patients and the healthcare system. Previous articles show variability in methods and outcomes; thus, their results are not directly comparable. This scoping review describes the methods and extent of anticancer drug use at end of life. METHODS: Systematic searches in Medline and Embase were conducted to identify articles reporting anticancer drug use at the end of life. RESULTS: We selected 341 eligible publications, identifying key study features including timing of research, disease status, treatment schedule, treatment type, and treatment characteristics. Among the subset of 69 articles of all cancer types published within the last 5 years, we examined the frequency of anticancer drug use across various end of life periods. CONCLUSION: This comprehensive description of publications on anticancer drug use at end of life underscores the importance of methodological factors when designing studies and comparing outcomes.

Anticancer Drugs Compared to No Anticancer Drugs in Patients with Advanced Hepatobiliary Cancer: A Mapping Review and Evidence Gap Map.

Introduction: Despite being commonly recommended, the impact of anticancer drugs (ACDs) on patient-important outcomes beyond survival for advanced hepatobiliary cancers (HBCs) may not have been sufficiently assessed. We aim to identify and map the evidence regarding ACDs versus best supportive care (BSC) for advanced HBCs, considering patient-centered outcomes. Methods: In this mapping review, we included systematic reviews, randomized controlled trials, quasi-experimental, and observational studies comparing ACDs (chemotherapy, immunotherapy, biological/targeted therapy) versus BSC for advanced HBCs. We searched MEDLINE (PubMed), EMBASE (Ovid), Cochrane Library, Epistemonikos, PROSPERO and clinicaltrials.gov for eligible studies. Two reviewers performed the screening and data extraction processes. We developed evidence maps for each type of cancer. Results: We included 87 studies (60 for advanced liver cancer and 27 for gallbladder or bile duct cancers). Most of the evidence favored ACDs for survival outcomes, and BSC for toxicity. We identified several evidence gaps for non-survival outcomes, including quality of life or quality of end-of-life care. Discussion: Patient-important outcomes beyond survival in advanced HBCs are insufficiently assessed by the available evidence. Future studies need to address these gaps to better inform decision-making processes.

Systematic Mapping Review of Orthognathic Surgery (Protocol).

Study Design: This document details the planning phase of a systematic mapping review. Objective: The objective of this mapping review is to identify, describe, and organize evidence currently available from systematic reviews and primary studies regarding different co-interventions and surgical modalities used in orthognathic surgery (OS) and their outcomes. Methods: Systematic reviews (SRs), randomized controlled trials (RCTs), and observational studies that evaluate perioperative OS co-interventions and surgical modalities will be identified in an exhaustive search of MEDLINE, EMBASE, Epistemonikos, Lilacs, Web of Science, and CENTRAL. Grey literature will also be screened. Results: Expected results include identification of all PICO questions available in the evidence regarding OS and generation of evidence bubble maps, involving a matrix of all identified co-interventions, surgical modalities, and outcomes presented in the studies. This will achieve identification of research gaps and prioritization of new research questions. Conclusions: The significance of this review will result in a systematic identification and characterization of the available evidence, leading to a reduction in research waste and a guidance of future efforts in developing studies for unsolved questions.

A methodological review finds mismatch between overall and pairwise overlap analysis in a sample of overviews.

OBJECTIVES: Overlap of primary studies is a key methodological challenge for overviews. There are limited reports of methods used to address overlap, and there is no detailed assessment of the corrected covered area (CCA) of a representative sample of overviews. To describe the approaches used to address overlap, and to estimate the overall and pairwise CCA. METHODS: We searched PubMed for overviews published in 2018. Two authors conducted the screening process. We described the strategy used for assessing overlap, and calculated overall and pairwise CCA for each overview. RESULTS: We analyzed a random sample of 30 out of 89 eligible articles. Eleven did not address the overlap. Of the remainder, most frequent strategies were visual assessment and discussion of overlap as a limitation. Median overall CCA among the included overviews was 6.7%. The pairwise analysis showed that 52.8% of SR pairs had slight overlap, while 28.3% had very high overlap. CONCLUSION: Reported strategies for addressing overlap vary considerably among overview authors. The pairwise approach for assessing the CCA revealed highly overlapped pairs of SRs in overviews with overall slight overlap and vice versa. We encourage authors to complement the overall CCA assessment with a pairwise approach.

Systemic Oncological Treatments versus Supportive Care for Patients with Advanced Hepatobiliary Cancers: An Overview of Systematic Reviews.

BACKGROUND: The trade-off between systemic oncological treatments (SOTs) and UPSC in patients with primary advanced hepatobiliary cancers (HBCs) is not clear in terms of patient-centred outcomes beyond survival. This overview aims to assess the effectiveness of SOTs (chemotherapy, immunotherapy and targeted/biological therapies) versus UPSC in advanced HBCs. METHODS: We searched for systematic reviews (SRs) in PubMed, EMBASE, the Cochrane Library, Epistemonikos and PROSPERO. Two authors assessed eligibility independently and performed data extraction. We estimated the quality of SRs and the overlap of primary studies, performed de novo meta-analyses and assessed the certainty of evidence for each outcome. RESULTS: We included 18 SRs, most of which were of low quality and highly overlapped. For advanced hepatocellular carcinoma, SOTs showed better overall survival (HR = 0.62, 95% CI 0.55-0.77, high certainty for first-line therapy; HR = 0.85, 95% CI 0.79-0.92, moderate certainty for second-line therapy) with higher toxicity (RR = 1.18, 95% CI 0.87-1.60, very low certainty for first-line therapy; RR = 1.58, 95% CI 1.28-1.96, low certainty for second-line therapy). Survival was also better for SOTs in advanced gallbladder cancer. No outcomes beyond survival and toxicity could be meta-analysed. CONCLUSION: SOTs in advanced HBCs tend to improve survival at the expense of greater toxicity. Future research should inform other patient-important outcomes to guide clinical decision making.

Available apps for stroke telerehabilitation during corona virus disease 2019 confinement in Spain.

PURPOSE: Stroke is one of the leading causes of disability in the adult population. It is feasible to think about the use of telerehabilitation devices, such as the smartphone, to respond to the growing demand, even in isolation cases, such as during confinement due to coronavirus disease in 2020. It is intended to explore the available Apps for Spanish-speaking patients with Stroke for a specific sensory-motor rehabilitation process. MATERIALS AND METHODS: A search of the available apps in Google Play and Apple Store was carried out using the keywords "Stroke", "hemiplegia" and "hemiparesis". The Apps detected have been described and evaluated by an anonymous survey among stroke survivors. RESULTS: Nine Apps have been identified and explored, four of which are available in Spanish: "NeuroRHB", "Stroke Hope Health4TheWorld", "9zest stroke recovery" and "Farmalarm". Twelve survivors with stroke have participated in the anonymous survey evaluating with the best score the App "Farmalarm". CONCLUSIONS: There are few specific Apps for the Stroke rehabilitation of sensory-motor impairments, and with important limitations that prevent their incorporation into clinical practice. The creation and adaptation of Apps for health professionals such as physiotherapists and occupational therapists and their users are recommended.Implications for rehabilitationIt is necessary to create and adapt specific telerehabilitation tools to address sensory-motor disorders.Telerehabilitation should be introduced in the clinical practice of physiotherapy and occupational therapy.Telerehabilitation via App can be a solution, easily accessible by patients, to reduce healthcare inequality, intensify the rehabilitation process and provide continuity after discharge from the hospital.

Dual neoadjuvant blockade plus chemotherapy versus monotherapy for the treatment of women with non-metastatic HER2-positive breast cancer: a systematic review and meta-analysis.

BACKGROUND: We aimed to determine the effect of dual anti-HER2 blockade compared to monotherapy on clinically important outcomes. METHODS: We carried out a systematic review updated until July 2022. The outcomes included pathological complete response (pCR), clinical response, event-free survival, and overall survival. RESULTS: We identified eleven randomized clinical trials (2836 patients). When comparing paclitaxel plus dual treatment versus paclitaxel plus trastuzumab or lapatinib, dual treatment was associated with a higher probability of achieving a pathological complete response (OR 2.88, 95% CI 2.02-4.10). Addition of a taxane to an anthracycline plus cyclophosphamide and fluorouracil, plus lapatinib or trastuzumab, showed that the dual treatment was better than lapatinib alone (OR 2.47, 95% CI 1.41-4.34), or trastuzumab alone (OR 1.89, 95% CI 1.13-3.16). Dual treatment may result in an increase in survival outcomes and tumour clinical response, although such benefits are not consistent for all the combinations studied. CONCLUSIONS: The use of dual blockade with combinations of trastuzumab and pertuzumab can be recommended for the neoadjuvant treatment of women with HER2-positive breast cancer. PROSPERO Registration number: CRD42018110273.

The value of sentinel lymph-node biopsy in women with node-positive breast cancer at diagnosis and node-negative tumour after neoadjuvant therapy: a systematic review.

PURPOSE: To conduct a systematic review to analyse the performance of the sentinel lymph-node biopsy (SLNB) in women with node-positive breast cancer at diagnosis and node-negative tumour after neoadjuvant therapy, compared to axillary lymph-node dissection. METHODS: The more relevant databases were searched. Main outcomes were false-negative rate (FNR), sentinel lymph-node identification rate (SLNIR), negative predictive value (NPV), and accuracy. We conducted meta-analyses when appropriate. RESULTS: Twenty studies were included. The pooled FNR was 0.14 (95% CI 0.11-0.17), the pooled SLNIR was 0.89 (95% CI 0.86-0.92), NPV was 0.83 (95% CI 0.79-0.87), and summary accuracy was 0.92 (95% CI 0.90-0.94). SLNB performed better when more than one node was removed and double mapping was used. CONCLUSIONS: SLNB can be performed in women with a node-negative tumour after neoadjuvant therapy. It has a better performance when used with previous marking of the affected node and with double tracer.

Methods for developing and reporting living evidence synthesis.

BACKGROUND AND OBJECTIVES: Identify currently methodological aspects proposed for planning, conducting, and reporting living evidence (LE) synthesis. Develop a preliminary checklist of key LE synthesis elements. METHODS: A survey of methodological articles describing or analyzing methods for the design, conduction, or reporting of LE synthesis. RESULTS: Twelve methodological articles were identified and analyzed. Key elements were related to: i) definition of LE and characteristics of LE synthesis, ii) methods and tools for the living process, iii) new evidence integration (methods and considerations), iv) updates dissemination and publication, v) revisiting living parameters, and vi) protocol considerations for LE synthesis. CONCLUSION: This survey displays basic methodological concepts that can drive the development of LE synthesis and identifies specific aspects with opportunities for development. The potential impact of the LE approach calls for a change in the current evidence synthesis updating processes to more open, collaborative, transparent, and efficient systems. LE approaches also challenge journal editors to shift toward more efficient processes for synthesis update dissemination, which minimizes the risks of reliability of published information.

Mapping Chilean clinical research: a protocol for a scoping review and multiple evidence gap maps.

INTRODUCTION: Clinical research broadly aims to influence decision-making in order to promote appropriate healthcare. Funding agencies should prioritise research projects according to needed research topics, methodological and cost-effectiveness considerations, and expected social value. In Chile, there is no local diagnosis regarding recent clinical research that might inform prioritisation for future research funding. This research aims to comprehensively identify and classify Chilean health research studies, elaborating evidence gap maps for the most burdensome local conditions. METHODS AND ANALYSIS: We will search in electronic databases (MEDLINE, Embase, PsycINFO, CINAHL, LILACS and WoS) and perform hand searches to retrieve, identify and classify health research studies conducted in Chile or by authors whose affiliations are based in Chile, from 2000 onwards. We will elaborate evidence matrices for the 20 conditions with the highest burden in Chile (according to the Global Burden of Disease 2019) selected from those defined under the General Regime of the Health Guarantees Act. To elaborate the evidence gap maps, we will consider prioritised interventions and core outcome sets. To identify knowledge gaps and estimate redundant research, we will contrast these gap maps with the available international evidence of high or moderate certainty of evidence, for each specific clinical question. For this purpose, we will search systematic reviews using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. ETHICS AND DISSEMINATION: No ethical approval is required to conduct this project. We will submit our results in both peer-reviewed journals and scientific conferences. We will aim to disseminate our findings through different academic platforms, social media, local press, among others. The final results will be communicated to local funding agencies and government stakeholders. DISCUSSION: We aim to provide an accurate and up-to-date picture of the research gaps-to be filled by new future findings-and the identification of redundant research, which will constitute relevant information for local decision-makers.

Influence of Core-Stability Exercises Guided by a Telerehabilitation App on Trunk Performance, Balance and Gait Performance in Chronic Stroke Survivors: A Preliminary Randomized Controlled Trial.

Stroke is one of the main causes of disability. Telerehabilitation could face the growing demand and a good strategy for post-stroke rehabilitation. The aim of this study is to examine the possible effects of therapeutic exercises performed by an App on trunk control, balance, and gait in stroke survivors. A preliminary 12-week randomized controlled trial was developed. Thirty chronic stroke survivors were randomly allocated into two groups. Both groups performed conventional physiotherapy, in addition to, the experimental group (EG) had access to a telerehabilitation App to guide home-based core-stability exercises (CSE). Trunk performance was measured with the Spanish-Trunk Impairment Scale (S-TIS 2.0) and Spanish-Function in Sitting Test. Balance and gait were measured with Spanish-Postural Assessment Scale for Stroke patient, Berg Balance Scale and an accelerometer system. In EG was observed an improvement of 2.76 points in S-TIS 2.0 (p = 0.001). Small differences were observed in balance and gait. Adherence to the use of the App was low. CSE guided by a telerehabilitation App, combined with conventional physiotherapy, seem to improve trunk function and sitting balance in chronic post-stroke. Active participation in the rehabilitation process should be increased among stroke survivors. Further confirmatory studies are necessary with a large sample size.

Systematic mapping review of orthognathic surgery.

STUDY DESIGN: Systematic mapping review AIM AND SCOPE: The objective of this mapping review was to identify, describe, and organize clinical research currently available from systematic reviews and primary studies regarding co-interventions and different surgical modalities used in orthognathic surgery (OS) and their outcomes. METHODS: Systematic reviews (SRs), randomized controlled trials, and observational studies that evaluated perioperative OS co-interventions and surgical modalities were identified in an exhaustive search of MEDLINE, EMBASE, Epistemonikos, Lilacs, Web of Science, and CENTRAL. Grey literature was also screened. RESULTS: Included were 35 SRs and 253 primary studies, 103 from SRs, and another 150 identified in our search. Overall, SR quality was rated as critically low, with only two SRs rated as of high quality. 19 questions on population, interventions, comparisons, and outcomes (PICO) extracted from the SRs focused on osteosynthesis methods, surgical cutting devices, and use of antibiotics, corticosteroids, and induced hypotension. Also identified were 15 research gaps. Evidence bubble maps were created to graphically depict the available evidence. CONCLUSION: Future high-quality research, both primary and secondary, is needed to address the knowledge gaps identified in this systematic mapping review.

The value of sentinel lymph-node biopsy after neoadjuvant therapy: an overview.

PURPOSE: We conducted a systematic review to analyse the performance of the sentinel lymph-node biopsy (SLNB) after the neoadjuvant chemotherapy, compared to axillary lymph-node dissection, in terms of false-negative rate (FNR) and sentinel lymph-node identification rate (SLNIR), sensitivity, negative predictive value (NPV), need for axillary lymph-node dissection (ALND), morbidity, preferences, and costs. METHODS: MEDLINE, Embase, Scopus, and The Cochrane Library were searched. We assessed the quality of the included systematic reviews using AMSTAR2 tool, and estimated the degree of overlapping of the individual studies on the included reviews. RESULTS: Six systematic reviews with variable quality were selected. We observed a very high overlapping degree across the included reviews. The FNR and the SLNIR were quite consistent (FNR 13-14%; SLNIR ~ 90% or higher). In women with initially clinically node-negative breast cancer, the FNR was better (6%), with similar SLNIR (96%). The included reviews did not consider the other prespecified outcomes. CONCLUSIONS: It would be reasonable to suggest performing an SLNB in patients treated with NACT, adjusting the procedure to the previous marking of the affected lymph node, using double tracer, and biopsy of at least three sentinel lymph nodes. More well-designed research is needed. PROSPERO registration number: CRD42020114403.

Graphical Representation of Overlap for OVErviews: GROOVE tool.

Overlap of primary studies among systematic reviews (SRs) is one of the main methodological challenges when conducting overviews. If not assessed properly, overlapped primary studies may mislead findings, since they may have a major influence either in qualitative analyses or in statistical weight. Moreover, overlapping SRs may represent the existence of duplicated efforts. Matrices of evidence and the calculation of the overall corrected covered area (CCA) are appropriate methods to address this issue, but they seem to be not comprehensive enough. In this article we present Graphical Representation of Overlap for OVErviews (GROOVE), an easy-to-use tool for overview authors. Starting from a matrix of evidence, GROOVE provides the number of included primary studies and SRs included in the matrix; the absolute number of overlapped and non-overlapped primary studies; and an overall CCA assessment. The tool also provides a detailed CCA assessment for each possible pair of SRs (or "nodes"), with a graphical and easy-to-read representation of these results. Additionally, it includes an advanced optional usage, incorporating structural missingness in the matrix. In this article, we show the details about how to use GROOVE, what results it achieves and how the tool obtains these results. GROOVE is intended to improve the overlap assessment by making it easier, faster, and more friendly for both authors and readers. The tool is freely available at http://doi.org/10.17605/OSF.IO/U2MS4 and https://es.cochrane.org/es/groovetool.

High-Sensitivity Troponin I after Cardiac Surgery and 30-Day Mortality.

BACKGROUND: Consensus recommendations regarding the threshold levels of cardiac troponin elevations for the definition of perioperative myocardial infarction and clinically important periprocedural myocardial injury in patients undergoing cardiac surgery range widely (from >10 times to ≥70 times the upper reference limit for the assay). Limited evidence is available to support these recommendations. METHODS: We undertook an international prospective cohort study involving patients 18 years of age or older who underwent cardiac surgery. High-sensitivity cardiac troponin I measurements (upper reference limit, 26 ng per liter) were obtained 3 to 12 hours after surgery and on days 1, 2, and 3 after surgery. We performed Cox analyses using a regression spline that explored the relationship between peak troponin measurements and 30-day mortality, adjusting for scores on the European System for Cardiac Operative Risk Evaluation II (which estimates the risk of death after cardiac surgery on the basis of 18 variables, including age and sex). RESULTS: Of 13,862 patients included in the study, 296 (2.1%) died within 30 days after surgery. Among patients who underwent isolated coronary-artery bypass grafting or aortic-valve replacement or repair, the threshold troponin level, measured within 1 day after surgery, that was associated with an adjusted hazard ratio of more than 1.00 for death within 30 days was 5670 ng per liter (95% confidence interval [CI], 1045 to 8260), a level 218 times the upper reference limit. Among patients who underwent other cardiac surgery, the corresponding threshold troponin level was 12,981 ng per liter (95% CI, 2673 to 16,591), a level 499 times the upper reference limit. CONCLUSIONS: The levels of high-sensitivity troponin I after cardiac surgery that were associated with an increased risk of death within 30 days were substantially higher than levels currently recommended to define clinically important periprocedural myocardial injury. (Funded by the Canadian Institutes of Health Research and others; VISION Cardiac Surgery ClinicalTrials.gov number, NCT01842568.).

Telerehabilitation for balance rehabilitation in the subacute stage of stroke: A pilot controlled trial.

BACKGROUND: Telerehabilitation has been proposed as an effective strategy to deliver post-stroke specific exercise. OBJECTIVE: To assess the effectiveness and feasibility of core stability exercises guided by a telerehabilitation App after hospital discharge. METHODS: Extension of a prospective controlled trial. Subacute stage stroke survivors were included at the time of hospital discharge where they had participated in a previous 5-week randomized controlled trial comparing conventional physiotherapy versus core stability exercises. After discharge, patients from the experimental group were offered access to telerehabilitation to perform core stability exercises at home (AppG), while those from the control group were subject to usual care (CG). The Spanish-version of the Trunk Impairment Scale 2.0 (S-TIS 2.0), Function in Sitting Test (S-FIST), Berg Balance Scale (BBS), Spanish-version of Postural Assessment for Stroke Patients (S-PASS), the number of falls, Brunel Balance Assessment (BBA) and Gait were assessed before and after 3 months intervention. RESULTS: A total of 49 subjects were recruited. AppG showed greater improvement in balance in both sitting and standing position and gait compared with CG, although no statistically significant differences were obtained. CONCLUSION: Core stability exercises Telerehabilitation as a home-based guide appears to improve balance in post-stroke stage. Future studies are necessary to confirm the effects as well as identifying strategies to increase telerehabilitation adherence.

European clinical practice guidelines on the use of chemotherapy for advanced oesophageal and gastric cancers: a critical review using the AGREE II and the AGREE-REX instruments.

PURPOSE: To assess the methodological quality of all relevant and recent European clinical practice guidelines (CPGs) for advanced oesophageal and gastric cancers, and to synthesise their recommendations on the use of chemotherapy. METHODS: We searched PubMed, EMBASE, guidelines repositories, and other sources from 2010 onwards. We appraised quality using AGREE-II and AGREE-REX. RESULTS: 11 CPGs were included (five high, five low, and one moderate quality). Most guidelines showed deficiencies in the domain "applicability", with only three scoring above 60%. Nine did not report having sought the views and preferences of the target population. The lowest scores for AGREE-REX were item Values and Preferences of Target Users (1.6; SD 1.3), and item Values and Preferences of Policy/Decision-Makers (1.8; SD 1.7). The domain Clinical Applicability got the highest score and the domain Implementability got the lowest. CONCLUSIONS: An urgent area of research is how to develop credible and implementable recommendations on the clinical use of CT for advanced oesophageal and gastric cancer. SYSTEMATIC REVIEW REGISTRATION: PROSPERO (CRD42021236753).