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OBJECTIVE: The objective was to systematically review all studies focusing on barriers, facilitators, and tools currently available for shared decision making (SDM) in emergency departments (EDs). BACKGROUND: Implementing SDM in EDs seems particularly challenging, considering the fast-paced environment and sometimes life-threatening situations. Over 10 years ago, a previous review revealed only a few patient decision aids (PtDAs) available for EDs. METHODS: Literature searches were conducted in MEDLINE, Embase, and Cochrane library, up to November 2023. Observational and interventional studies were included to address barriers or facilitators for SDM or to investigate effects of PtDAs on the level of SDM for patients visiting an ED. RESULTS: We screened 1946 studies for eligibility, of which 33 were included. PtDAs studied in EDs address chest pain, syncope, analgesics usage, lumbar puncture, ureterolithiasis, vascular access, concussion/brain bleeding, head-CT choice, coaching for elderly people, and activation of patients with appendicitis. Only the primary outcome was meta-analyzed, showing that PtDAs significantly increased the level of SDM (18.8 on the 100-point OPTION scale; 95% CI 12.5-25.0). PtDAs also tended to increase patient knowledge, decrease decisional conflict and decrease health care services usage, with no obvious effect on overall patient satisfaction. Barriers and facilitators were identified on three levels: (1) patient level-emotions, health literacy, and their own proactivity; (2) clinician level-fear of medicolegal consequences, lack of SDM skills or knowledge, and their ideas about treatment superiority; and (3) system level-time constraints, institutional guidelines, and availability of PtDAs. CONCLUSIONS: Circumstances in EDs are generally less favorable for SDM. However, PtDAs for conditions seen in EDs are helpful in overcoming barriers to SDM and are welcomed by patients. Even in EDs, SDM is feasible and supported by an increasing number of tools for patients and physicians.
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OBJECTIVES/BACKGROUND: High-output stoma is one of the most common major morbidities in young children with an enterostomy that could lead to intestinal failure. Management of high-output enterostomy in children is mostly based on personal experience. This systematic review aims to clarify the evidence-based therapeutic approach of high-output enterostomy in children. METHODS: A systematic review was performed using Pubmed, Embase (Ovid), and Cochrane Library to identify studies published until March 20, 2023, following the 2020 Preferred Reporting Items for Systematic Reviews and Meta-Analyses guideline. The study population comprised children (i.e., age <18 years) with high-output enterostomy (i.e., jejuno-, ileo-, and/or colostomy), regardless of underlying aetiology. Interventions comprised any (non)pharmacological and/or surgical treatment. Interventions were compared with each other, placebos, and/or no interventions. Primary outcome was reduction of enterostomy output. Secondary outcomes were morbidity, mortality, quality of life, associated healthcare costs, and adverse events. RESULTS: The literature search identified 4278 original articles of which 366 were screened on full text, revealing that none of the articles met the inclusion criteria. CONCLUSION: This first systematic review on management of high-output enterostomy in children revealed that any evidence on the primary and secondary outcomes is lacking. There is an urgent need for evidence on conservative treatment strategies including fluid restrictions, dietary advices, oral rehydration solution, chyme re-infusion, and pharmacological and surgical treatments of high-output enterostomy in children, aiming to reduce the risk for short- and long-term complications. Till more evidence is available, a systematic and multidisciplinary step-up approach is needed. Therefore, a therapeutic work-up is proposed that could guide the care.
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Enterostomía , Humanos , Enterostomía/métodos , Niño , Preescolar , Insuficiencia Intestinal/terapia , Insuficiencia Intestinal/cirugía , Medicina Basada en la Evidencia , Calidad de Vida , LactanteRESUMEN
BACKGROUND: Crohn's disease [CD] is frequently associated with the development of strictures and penetrating complications. Intestinal ultrasound [IUS] is a non-invasive imaging modality ideal for point-of-care assessment. In this systematic review and meta-analysis we provide a current overview on the diagnostic accuracy of IUS and its advanced modalities in the detection of intra-abdominal complications in CD compared to endoscopy, cross-sectional imaging, surgery, and pathology. METHOD: We conducted a literature search for studies describing the diagnostic accuracy of IUS in adult patients with CD-related intra-abdominal complications. Quality of the included studies was assessed with the QUADAS-2 tool. Meta-analysis was performed for both conventional IUS [B-mode] and oral contrast IUS [SICUS]. RESULTS: Of the 1498 studies we identified, 68 were included in this review and 23 studies [3863 patients] were used for the meta-analysis. Pooled sensitivities and specificities for strictures, inflammatory masses, and fistulas by B-mode IUS were 0.81 and 0.90, 0.87 [sensitivities] and 0.95, and 0.67 and 0.97 [specificities], respectively. Pooled overall log diagnostic odds ratios were 3.56, 3.97 and 3.84, respectively. Pooled sensitivity and specificity of SICUS were 0.94 and 0.95, 0.91 and 0.97 [sensitivities], and 0.90 and 0.94 [specificities], respectively. The pooled overall log diagnostic odds ratios of SICUS were 4.51, 5.46, and 4.80, respectively. CONCLUSION: IUS is accurate for the diagnosis of intra-abdominal complications in CD. As a non-invasive, point-of-care modality, IUS is recommended as the first-line imaging tool if there is a suspicion of CD-related intra-abdominal complications.
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Enfermedad de Crohn , Ultrasonografía , Humanos , Enfermedad de Crohn/complicaciones , Enfermedad de Crohn/diagnóstico por imagen , Ultrasonografía/métodos , Constricción Patológica/etiología , Constricción Patológica/diagnóstico por imagen , Sensibilidad y Especificidad , Fístula Intestinal/etiología , Fístula Intestinal/diagnóstico por imagenRESUMEN
OBJECTIVE: There is an urgent need for accurate biomarkers to support timely diagnosis of acute mesenteric ischaemia (AMI) and thereby improve clinical outcomes. With this systematic review, the aim was to substantiate the potential diagnostic value of biomarkers for arterial occlusive AMI. DATA SOURCES: The Pubmed, Embase, and the Cochrane Library electronic databases were searched. REVIEW METHODS: A systematic review of the literature has been conducted to define the potential diagnostic value of biomarkers for arterial occlusive AMI. All studies including ≥ 10 patients describing biomarkers for macrovascular occlusive AMI between 1950 and 17 February 2023 were identified within the Pubmed, Embase, and the Cochrane Library electronic databases. There were no restrictions to any particular study design, but letters and editorials were excluded. The QUADAS-2 tool was used for the critical appraisal of quality. The study protocol was registered on Prospero (CRD42021254970). RESULTS: Fifty of 4334 studies were eligible for inclusion in this review. Ninety per cent of studies were of low quality. A total of 60 biomarkers were identified, with 24 in two or more studies and 15 in five or more studies. There was variation in reported units, normal range, and cut off values. Meta-analysis was not possible due to study heterogeneity. Biomarkers currently recommended by the European Journal of Vascular and Endovascular Surgery, European Society for Trauma and Emergency Surgery 2016, and World Society of Emergency Surgery 2017 guidelines also had heterogeneous low quality data for use in the diagnosis of AMI. CONCLUSION: This systematic review demonstrates high heterogeneity and low quality of the available evidence on biomarkers for arterial occlusive AMI. No clinical conclusions can be drawn on a biomarker or combination of biomarkers for patients suspected of arterial occlusive AMI. Restraint is advised when rejecting or determining AMI solely based on biomarkers.
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Arteriopatías Oclusivas , Isquemia Mesentérica , Humanos , Isquemia Mesentérica/diagnóstico , Isquemia Mesentérica/cirugía , BiomarcadoresRESUMEN
BACKGROUND: ICU patients lose muscle mass rapidly and maintenance of muscle mass may contribute to improved survival rates and quality of life. Protein provision may be beneficial for preservation of muscle mass and other clinical outcomes, including survival. Current protein recommendations are expert-based and range from 1.2 to 2.0 g/kg. Thus, we performed a systematic review and meta-analysis on protein provision and all clinically relevant outcomes recorded in the available literature. METHODS: We conducted a systematic review and meta-analyses, including studies of all designs except case control and case studies, with patients aged ≥18 years with an ICU stay of ≥2 days and a mean protein provision group of ≥1.2 g/kg as compared to <1.2 g/kg with a difference of ≥0.2 g/kg between protein provision groups. All clinically relevant outcomes were studied. Meta-analyses were performed for all clinically relevant outcomes that were recorded in ≥3 included studies. RESULTS: A total of 29 studies published between 2012 and 2022 were included. Outcomes reported in the included studies were ICU, hospital, 28-day, 30-day, 42-day, 60-day, 90-day and 6-month mortality, ICU and hospital length of stay, duration of mechanical ventilation, vomiting, diarrhea, gastric residual volume, pneumonia, overall infections, nitrogen balance, changes in muscle mass, destination at hospital discharge, physical performance and psychological status. Meta-analyses showed differences between groups in favour of high protein provision for 60-day mortality, nitrogen balance and changes in muscle mass. CONCLUSION: High protein provision of more than 1.2 g/kg in critically ill patients seemed to improve nitrogen balance and changes in muscle mass on the short-term and likely 60-day mortality. Data on long-term effects on quality of life are urgently needed.
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Enfermedades Musculares , Calidad de Vida , Humanos , Adolescente , Adulto , Respiración Artificial , Unidades de Cuidados Intensivos , Nitrógeno , Músculos , Enfermedad Crítica/terapia , Tiempo de InternaciónRESUMEN
Importance: Infection control guidelines have historically classified high-flow nasal oxygen and noninvasive ventilation as aerosol-generating procedures that require specialized infection prevention and control measures. Objective: To evaluate the current evidence that high-flow nasal oxygen and noninvasive ventilation are associated with pathogen-laden aerosols and aerosol generation. Data Sources: A systematic search of EMBASE and PubMed/MEDLINE up to March 15, 2023, and CINAHL and ClinicalTrials.gov up to August 1, 2023, was performed. Study Selection: Observational and (quasi-)experimental studies of patients or healthy volunteers supported with high-flow nasal oxygen or noninvasive ventilation were selected. Data Extraction and Synthesis: Three reviewers were involved in independent study screening, assessment of risk of bias, and data extraction. Data from observational studies were pooled using a random-effects model at both sample and patient levels. Sensitivity analyses were performed to assess the influence of model choice. Main Outcomes and Measures: The main outcomes were the detection of pathogens in air samples and the quantity of aerosol particles. Results: Twenty-four studies were included, of which 12 involved measurements in patients and 15 in healthy volunteers. Five observational studies on SARS-CoV-2 detection in a total of 212 air samples during high-flow nasal oxygen in 152 patients with COVID-19 were pooled for meta-analysis. There was no association between high-flow nasal oxygen and pathogen-laden aerosols (odds ratios for positive samples, 0.73 [95% CI, 0.15-3.55] at the sample level and 0.80 [95% CI, 0.14-4.59] at the patient level). Two studies assessed SARS-CoV-2 detection during noninvasive ventilation (84 air samples from 72 patients). There was no association between noninvasive ventilation and pathogen-laden aerosols (odds ratios for positive samples, 0.38 [95% CI, 0.03-4.63] at the sample level and 0.43 [95% CI, 0.01-27.12] at the patient level). None of the studies in healthy volunteers reported clinically relevant increases in aerosol particle production by high-flow nasal oxygen or noninvasive ventilation. Conclusions and Relevance: This systematic review and meta-analysis found no association between high-flow nasal oxygen or noninvasive ventilation and increased airborne pathogen detection or aerosol generation. These findings argue against classifying high-flow nasal oxygen or noninvasive ventilation as aerosol-generating procedures or differentiating infection prevention and control practices for patients receiving these modalities.
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COVID-19 , Ventilación no Invasiva , Humanos , Aerosoles y Gotitas Respiratorias , Oxígeno , Ventilación no Invasiva/métodos , SARS-CoV-2RESUMEN
OBJECTIVE: To summarize available data on defecation frequency and stool consistency of healthy children up to age 4 in order to estimate normal references values. STUDY DESIGN: Systematic review including cross-sectional, observational, and interventional studies published in English, that reported on defecation frequency and/or stool consistency in healthy children 0-4 years old. RESULTS: Seventy-five studies were included with 16â393 children and 40â033 measurements of defecation frequency and/or stool consistency. Based on visual inspection of defecation frequency data, a differentiation was made between two age categories: young infants (0-14 weeks old) and young children (15 weeks-4 years old). Young infants had a mean defecation frequency of 21.8 per week (95 % CI, 3.9-35.2) compared with 10.9 (CI, 5.7-16.7) in young children (P < .001). Among young infants, human milk-fed (HMF) infants had the highest mean defecation frequency per week (23.2 [CI, 8.8-38.1]), followed by formula-fed (FF) infants (13.7 [CI 5.4-23.9]), and mixed-fed (MF) infants (20.7 [CI, 7.0-30.2]). Hard stools were infrequently reported in young infants (1.5%) compared with young children (10.5%), and a reduction in the frequency of soft/watery stools was observed with higher age (27.0% in young infants compared with 6.2% in young children). HMF young infants had softer stools compared with FF young infants. CONCLUSIONS: Young infants (0-14 weeks old) have softer and more frequent stools compared with young children (15 weeks-4 years old).
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Defecación , Leche Humana , Lactante , Humanos , Niño , Preescolar , Recién Nacido , Estudios Transversales , Diarrea , Alimentos Formulados , HecesRESUMEN
BACKGROUND: Ankle injuries are one of the most common presentations in the ED. Although fractures can be ruled out using the Ottawa Ankle Rules, the specificity is low, which means many patients may still receive unnecessary radiographs. Even once fractures are ruled out, assessment of ankle stability is recommended to rule out ruptures, but the anterior drawer test has only moderate sensitivity and low specificity and should be performed only after swelling has receded. Ultrasound could be a reliable, cheap and radiation free alternative to diagnose fractures and ligamentous injuries. The purpose of this systematic review was to investigate the accuracy of ultrasound in diagnosing ankle injuries. METHODS: Medline, Embase and the Cochrane Library were searched up to 15 February 2022 to include studies of patients of 16 years or older presenting to the ED with acute ankle or foot injury, who underwent ultrasound and had diagnostic accuracy as outcome. No restrictions were applied for date and language. Risk of bias and quality of evidence using the Grading of Recommendations, Assessment, Development and Evaluations approach were assessed. RESULTS: Thirteen studies evaluating 1455 patients with bony injuries were included. In 10 studies, the reported sensitivity for fracture was >90%, but varied among studies between 76% (95% CI 63% to 86%) and 100% (95% CI 29% to 100%). In nine studies, the reported specificity was at least 91%, but varied between 85% (95% CI 74% to 92%) and 100% (95% CI 88% to 100%).Six studies including 337 patients examined the use of ultrasound for ligamentous injuries and found a sensitivity and specificity >94% and 100%. Overall quality of evidence for both bony and ligamentous injuries was low and very low. CONCLUSION: Ultrasound has the potential to be a reliable method for diagnosing foot and ankle injuries, however, higher grade evidence is needed. PROSPERO REGISTRATION NUMBER: CRD42020215258.
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Traumatismos del Tobillo , Servicios Médicos de Urgencia , Traumatismos de los Pies , Fracturas Óseas , Humanos , Servicio de Urgencia en Hospital , Ultrasonografía , Traumatismos del Tobillo/diagnóstico por imagen , Fracturas Óseas/diagnóstico por imagen , Sensibilidad y Especificidad , Traumatismos de los Pies/diagnóstico por imagenRESUMEN
Aims: Although digital decision aids (DAs) have been developed to improve shared decision-making (SDM), also in the cardiovascular realm, its implementation seems challenging. This study aims to systematically review the predictors of successful implementation of digital DAs for cardiovascular diseases. Methods and results: Searches were conducted in MEDLINE, Embase, PsycInfo, CINAHL, and the Cochrane Library from inception to November 2021. Two reviewers independently assessed study eligibility and risk of bias. Data were extracted by using a predefined list of variables. Five good-quality studies were included, involving data of 215 patients and 235 clinicians. Studies focused on DAs for coronary artery disease, atrial fibrillation, and end-stage heart failure patients. Clinicians reported DA content, its effectivity, and a lack of knowledge on SDM and DA use as implementation barriers. Patients reported preference for another format, the way clinicians used the DA and anxiety for the upcoming intervention as barriers. In addition, barriers were related to the timing and Information and Communication Technology (ICT) integration of the DA, the limited duration of a consultation, a lack of communication among the team members, and maintaining the hospital's number of treatments. Clinicians' positive attitude towards preference elicitation and implementation of DAs in existing structures were reported as facilitators. Conclusion: To improve digital DA use in cardiovascular diseases, the optimum timing of the DA, training healthcare professionals in SDM and DA usage, and integrating DAs into existing ICT structures need special effort. Current evidence, albeit limited, already offers advice on how to improve DA implementation in cardiovascular medicine.
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OBJECTIVES: In order to recognise and facilitate the development of excellent medical doctors (physicians and residents), it is important to first identify the characteristics of excellence. Failure to recognising excellence causes loss of talent, loss of role models and it lowers work ethos. This causes less than excellent patient care and lack of commitment to improve the healthcare system. DESIGN: Systematic review performed according to the Association for Medical Education in Europe guideline. INFORMATION SOURCES: We searched Medline, Embase, Psycinfo, ERIC and CINAHL until 14 March 2022. ELIGIBILITY CRITERIA: We included original studies describing characteristics of excellent medical doctors, using a broad approach as to what is considered excellence. Assuming that excellence will be viewed differently depending on the interplay, and that different perspectives (peers, supervisors and patients) will add to a complete picture of the excellent medical doctor, we did not limit this review to a specific perspective. DATA EXTRACTION AND SYNTHESIS: Data extraction and quality assessment were performed independently by two researchers. We used the Quality Assessment Tool for Different Designs for quality assessment. RESULTS: Eleven articles were eligible and described the characteristics from different perspectives: (1) physicians on physicians, (2) physicians on residents, (3) patients on physicians and (4) mixed group (diverse sample of participants on physicians). The included studies showed a wide range of characteristics, which could be grouped into competencies (communication, professionalism and knowledge), motivation (directed to learning and to patient care) and personality (flexibility, empathy). CONCLUSIONS: In order to define excellence of medical doctors three clusters seem important: competence, motivation and personality. This is in line with Renzulli's model of gifted behaviour. Our work adds to this model by specifying the content of these clusters, and as such provides a basis for definition and recognition of medical excellence.
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Educación Médica , Médicos , Competencia Clínica , Humanos , Aprendizaje , Profesionalismo , Lugar de TrabajoRESUMEN
OBJECTIVE: Risk stratification is increasingly based on Early Warning Score (EWS)-based models, instead of clinical judgement. However, it is unknown how risk-stratification models and EWS perform as compared with the clinical judgement of treating acute healthcare providers. Therefore, we performed a systematic review of all available literature evaluating clinical judgement of healthcare providers to the use of risk-stratification models in predicting patients' clinical outcome. METHODS: Studies comparing clinical judgement and risk-stratification models in predicting outcomes in adult patients presenting at the ED were eligible for inclusion. Outcomes included the need for intensive care unit (ICU) admission; severe adverse events; clinical deterioration and mortality. Risk of bias among the included studies was assessed using the Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2) tool. RESULTS: Six studies (6419 participants) were included of which 4 studies were judged to be at high risk of bias. Only descriptive analysis was performed as a meta-analysis was not possible due to few included studies and high clinical heterogeneity. The performance of clinical judgement and risk-stratification models were both moderate in predicting mortality, deterioration and need for ICU admission with area under the curves between 0.70 and 0.89. The performance of clinical judgement did not significantly differ from risk-stratification models in predicting mortality (n=2 studies) or deterioration (n=1 study). However, clinical judgement of healthcare providers was significantly better in predicting the need for ICU admission (n=2) and severe adverse events (n=1 study) as compared with risk-stratification models. CONCLUSION: Based on limited existing data, clinical judgement has greater accuracy in predicting the need for ICU admission and the occurrence of severe adverse events compared with risk-stratification models in ED patients. However, performance is similar in predicting mortality and deterioration. PROSPERO REGISTRATION NUMBER: CRD42020218893.
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Deterioro Clínico , Razonamiento Clínico , Adulto , Humanos , Unidades de Cuidados Intensivos , Hospitalización , Medición de RiesgoRESUMEN
PURPOSE: To systematically review the published literature on surgical margins as a risk factor for local recurrence (LR) in patients undergoing partial nephrectomy (PN) for pT1 renal cell carcinomas (RCC). EVIDENCE ACQUISITION: A systematic literature search of relevant databases (MEDLINE, Embase and the Cochrane Library) was performed according to the PRISMA criteria up to February 2022. The hypothesis was developed using the PPO method (Patients = patients with pT1 RCC undergoing PN, Prognostic factor = positive surgical margins (PSM) detected on final pathology versus negative surgical margins (NSM) and Outcome = LR diagnosed on follow-up imaging). The primary outcome was the rate of PSM and LR. The risk of bias was assessed by the QUIPS tool. EVIDENCE SYNTHESIS: After assessing 1525 abstracts and 409 full-text articles, eight studies met the inclusion criteria. The percentage of PSM ranged between 0 and 34.3%. In these patients with PSM, LR varied between 0 and 9.1%, whereas only 0-1.5% of LR were found in the NSM-group. The calculated odds ratio (95% confident intervals) varied between 0.04 [0.00-0.79] and 0.27 [0.01-4.76] and was statistically significant in two studies (0.14 [0.02-0.80] and 0.04 [0.00-0.79]). The quality analysis of the included studies resulted in an overall intermediate to high risk of bias and the level of evidence was overall very low. A meta-analysis was considered unsuitable due to the high heterogeneity between the included studies. CONCLUSION: PSM after PN in patients with pT1 RCC is associated with a higher risk of LR. However, the evidence has significant limitations and caution should be taken with the interpretation of this data.
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Carcinoma de Células Renales , Neoplasias Renales , Carcinoma de Células Renales/patología , Carcinoma de Células Renales/cirugía , Humanos , Neoplasias Renales/patología , Neoplasias Renales/cirugía , Márgenes de Escisión , Recurrencia Local de Neoplasia/patología , Nefrectomía/métodos , Pronóstico , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
BACKGROUND: Extracorporeal shockwave therapy (ESWT) is used commonly to treat pain and function in Achilles tendinopathy (AT). The aim of this study was to synthesize the evidence from (non-) randomized controlled trials, to determine the clinical effectiveness of ESWT for mid-portion Achilles tendinopathy (mid-AT) and insertional Achilles tendinopathy (ins-AT) separately. METHODS: We searched PubMed/Medline, Embase (Ovid), and Cochrane Central, up to January 2021. Unpublished studies and gray literature were searched in trial registers (ACTRN, ChiCTR, ChiCtr, CTRI, DRKS, EUCTR, IRCT, ISRCTN, JPRN UMIN, ClinicalTrials.gov, NTR, TCTR) and databases (OpenGrey.eu, NARCIS.nl, DART-Europe.org, OATD.org). Randomized controlled trials (RCTs) and non-randomized controlled clinical trials (CCTs) were eligible when investigating the clinical effectiveness of ESWT for chronic mid-AT or chronic ins-AT. We excluded studies that focused on treating individuals with systemic conditions, and studies investigating mixed cohorts of mid-AT and ins-AT, when it was not possible to perform a subgroup analysis for both clinical entities separately. Two reviewers independently performed the study selection, quality assessment, data extraction, and grading of the evidence levels. Discrepancies were resolved through discussion or by consulting a third reviewer when necessary. RESULTS: We included three RCTs on mid-AT and four RCTs on ins-AT. For mid-AT, moderate quality of evidence was found for the overall effectiveness of ESWT compared to standard care, with a pooled mean difference (MD) on the VISA-A of 9.08 points (95% CI 6.35-11.81). Subgroup analysis on the effects of ESWT additional to standard care for mid-AT resulted in a pooled MD on the VISA-A of 10.28 points (95% CI 7.43-13.12). For ins-AT, we found very low quality of evidence, indicating that, overall, ESWT has no additional value over standard care, with a standardized mean difference (SMD) of - 0.02 (95% CI - 0.27 to 0.23). Subgroup analysis to determine the effect of ESWT additional to standard care for ins-AT showed a negative effect (SMD - 0.29; 95% CI - 0.56 to - 0.01) compared to standard care alone. CONCLUSIONS: There is moderate evidence supporting the effectiveness of ESWT additional to a tendon loading program in mid-AT. Evidence supporting the effectiveness of ESWT for ins-AT is lacking. TRIAL REGISTRATION: PROSPERO Database; No. CRD42021236107.
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Importance: Pancreatic cancer is the third most common cause of cancer death; however, randomized clinical trials (RCTs) of survival in patients with resectable pancreatic cancer lack mandatory measures for reporting baseline and prognostic factors, which hampers comparisons between outcome measures. Objective: To develop a consensus on baseline and prognostic factors to be used as mandatory measurements in RCTs of resectable and borderline resectable pancreatic cancer. Evidence Review: We performed a systematic literature search of the Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, and Embase for RCTs on resectable and borderline resectable pancreatic cancer with overall survival as the primary outcome. We produced a systematic summary of all baseline and prognostic factors identified in the RCTs. A Delphi panel that included 13 experts was surveyed to reach a consensus on mandatory and recommended baseline and prognostic factors. Findings: The 42 RCTs that met inclusion criteria reported a total of 60 baseline and 19 prognostic factors. After 2 Delphi rounds, agreement was reached on 50 mandatory baseline and 20 mandatory prognostic factors for future RCTs, with a distinction between studies of neoadjuvant vs adjuvant treatment. Conclusion and Relevance: This findings of this systematic review and international expert consensus have produced this Consensus Statement on Mandatory Measurements in Pancreatic Cancer Trials for Resectable and Borderline Resectable Disease (COMM-PACT-RB). The baseline and prognostic factors comprising the mandatory measures will facilitate better comparison across RCTs and eventually will enable improved clinical practice among patients with resectable and borderline resectable pancreatic cancer.
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Neoplasias Pancreáticas , Técnica Delphi , Humanos , Terapia Neoadyuvante , Neoplasias Pancreáticas/tratamiento farmacológico , Neoplasias Pancreáticas/cirugía , Neoplasias PancreáticasRESUMEN
BACKGROUND: Pregnancy and liver cirrhosis is a rare but increasing combination. Liver cirrhosis can raise the chance of maternal and fetal mortality and morbidity, although the exact risks remain unclear. OBJECTIVE: To provide a systematic literature review and meta-analysis on maternal, fetal and obstetric complications among pregnant women with liver cirrhosis. SEARCH STRATEGY: We performed a systematic literature search in the databases PubMed/MEDLINE and EMBASE (Ovid) from inception through 25 January 2021. SELECTION CRITERIA: Studies including pregnancies with liver cirrhosis and controls were eligible. DATA COLLECTION AND ANALYSIS: Two reviewers independently evaluated study eligibility. We used the random effects model for meta-analysis. MAIN RESULTS: Our search yielded 3118 unique papers. We included 11 studies, including 2912 pregnancies in women with cirrhosis from 1982-2020. Seven studies were eligible for inclusion in the meta-analysis. The overall maternal mortality rate was 0.89%. Maternal mortality and variceal haemorrhage were lower in recent than in older studies. Most cases of maternal mortality due to variceal haemorrhage (70%) occurred during vaginal delivery. Pregnant women with liver cirrhosis had a higher chance of preterm delivery (OR 6.7, 95% CI 5.1-9.1), caesarean section (OR 2.6, 95% CI 1.7-3.9), pre-eclampsia (OR 3.8, 95% CI 2.2-6.5) and small-for-gestational-age neonates (OR 2.6, 95% CI 1.6-4.2) compared with the general obstetric population. Subgroup analyses could not be conducted. CONCLUSIONS: Liver cirrhosis in pregnant women is associated with increases in maternal mortality and obstetric and fetal complications. Large international prospective studies are needed to identify risk factors for unfavourable outcome. TWEETABLE ABSTRACT: Systematic review and meta-analysis: higher risks that pregnant women with liver cirrhosis face are quantified.
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Cesárea , Várices Esofágicas y Gástricas , Anciano , Parto Obstétrico/efectos adversos , Várices Esofágicas y Gástricas/etiología , Femenino , Hemorragia Gastrointestinal/etiología , Humanos , Recién Nacido , Cirrosis Hepática/complicaciones , Embarazo , Resultado del EmbarazoRESUMEN
Importance: Oxygen supplementation is a cornerstone treatment in pediatric critical care. Accumulating evidence suggests that overzealous use of oxygen, leading to hyperoxia, is associated with worse outcomes compared with patients with normoxia. Objectives: To evaluate the association of arterial hyperoxia with clinical outcome in critically ill children among studies using varied definitions of hyperoxia. Data Sources: A systematic search of EMBASE, MEDLINE, Cochrane Library, and ClinicalTrials.gov from inception to February 1, 2021, was conducted. Study Selection: Clinical trials or observational studies of children admitted to the pediatric intensive care unit that examined hyperoxia, by any definition, and described at least 1 outcome of interest. No language restrictions were applied. Data Extraction and Synthesis: The Meta-analysis of Observational Studies in Epidemiology guideline and Newcastle-Ottawa Scale for study quality assessment were used. The review process was performed independently by 2 reviewers. Data were pooled with a random-effects model. Main Outcomes and Measures: The primary outcome was 28-day mortality; this time was converted to mortality at the longest follow-up owing to insufficient studies reporting the initial primary outcome. Secondary outcomes included length of stay, ventilator-related outcomes, extracorporeal organ support, and functional performance. Results: In this systematic review, 16 studies (27â¯555 patients) were included. All, except 1 randomized clinical pilot trial, were observational cohort studies. Study populations included were post-cardiac arrest (n = 6), traumatic brain injury (n = 1), extracorporeal membrane oxygenation (n = 2), and general critical care (n = 7). Definitions and assessment of hyperoxia differed among included studies. Partial pressure of arterial oxygen was most frequently used to define hyperoxia and mainly by categorical cutoff. In total, 11 studies (23â¯204 patients) were pooled for meta-analysis. Hyperoxia, by any definition, showed an odds ratio of 1.59 (95% CI, 1.00-2.51; after Hartung-Knapp adjustment, 95% CI, 1.05-2.38) for mortality with substantial between-study heterogeneity (I2 = 92%). This association was also found in less heterogeneous subsets. A signal of harm was observed at higher thresholds of arterial oxygen levels when grouped by definition of hyperoxia. Secondary outcomes were inadequate for meta-analysis. Conclusions and Relevance: These results suggest that, despite methodologic limitations of the studies, hyperoxia is associated with mortality in critically ill children. This finding identifies the further need for prospective observational studies and importance to address the clinical implications of hyperoxia in critically ill children.
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Enfermedad Crítica/mortalidad , Hiperoxia , Adolescente , Niño , Preescolar , Enfermedad Crítica/terapia , Hospitalización , Humanos , Hiperoxia/sangre , Hiperoxia/etiología , Hiperoxia/mortalidad , Lactante , Recién Nacido , Unidades de Cuidado Intensivo Pediátrico , Oxígeno/sangre , Terapia por Inhalación de Oxígeno/efectos adversosRESUMEN
OBJECTIVES: The impact of deployment and combat on mental health of military personnel is well described. Less evidence is available to demonstrate and summarize the incidence, prevalence, and risks of these exposures on physical health. This study aims to (1) systematically review the available literature to determine the incidence and prevalence of physical health conditions among military personnel during and after deployment and (2) investigate the risks of deployment and combat exposure on physical health. METHODS: A systematic review using the PubMed and EMBASE databases was performed. The literature search was limited to articles written in English, published from 2000 through 2019. The quality of studies was assessed with the Joanna Briggs Institute Appraisal Checklist. The results were grouped per system or condition of physical health and presented by forest plots without a combined effect size estimate. RESULTS: Thirty-two studies were found eligible for this review. We identified a wide variety of incidence and prevalence rates of numerous physical health conditions and a high heterogeneity across the included studies. Acute respiratory symptoms, diarrhea, musculoskeletal injuries, pain, and tinnitus were found to be the most incident or prevalent conditions. Except for hearing loss, no associations with deployment and physical health problems were observed. An increased risk for asthma, headache, hearing loss, and pain was reported in relation to the combat exposure. CONCLUSION: Given the characteristics of included studies and extracted data, the magnitude of the found differences in incidence and prevalence rates is most likely to be due to methodological heterogeneity. The specific exposures (e.g., infrastructure, environmental conditions, and activities during deployment) are suggested to be the determinants of (post) deployment physical health problems and need to be addressed to decrease the impact of deployment. Findings from this systematic review highlight which conditions should be addressed in response to service members' health and wellness needs in the (post)deployment phase and may be used by clinicians, researchers, and policy-makers. However, knowledge gaps regarding the potential risk factors during deployment and combat still exist. Studies using consistent methods to define and measure the physical health conditions and specific exposures are needed.
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Personal Militar , Trastornos por Estrés Postraumático , Humanos , Incidencia , Personal Militar/psicología , Dolor/complicaciones , Prevalencia , Trastornos por Estrés Postraumático/psicologíaRESUMEN
INTRODUCTION: This systematic review aims to determine the efficacy of interventions to support the self-management for parents of children with a chronic condition. An overview of prior research, regardless of the children's diagnosis, is lacking. Therefore, this systematic review provides an overview of the most recent available scientific literature that describes interventions to support self-management for parents of children with a chronic condition. METHODS: A systematic search of Randomised Controlled Trials (RCTs) was conducted in CENTRAL, CINAHL, EMBASE, MEDLINE and PsychInfo. Studies that describe any type of self-management intervention or a combination of self-management interventions that support parents of children with a chronic condition between 0 and 18 years were included. The interventions and results were reported, hence categorized in the four areas of self-management: medical management, adjustment of lifestyle, shared decision-making and managing the consequences of a chronic condition. RESULTS: The study included 23 RCTs. Due to the heterogeneity of the included studies a meta-analysis was impossible. Twenty studies showed statistically significant effects in favour of the intervention on at least one of the outcomes. Twenty-two studies showed risk of bias. The results indicate that disease management, (parent) group training, psycho-education and the Triple P intervention are effective interventions to support self-management. There were limited studies found in the areas lifestyle adjustment and shared decision making. DISCUSSION: Effective interventions to support self-management for parents of children with a chronic condition are described, but the moderate quality of the studies hampers firm conclusions.
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Automanejo , Niño , Enfermedad Crónica , Humanos , PadresRESUMEN
OBJECTIVES: The objective of this study was to identify, map and review scope-related and user-related parameters used to evaluate the quality of flexible ureterorenoscopes. Thereby identifying key items and variability in grading systems. METHODS: A literature search of four databases (MEDLINE [Ovid], EMBASE [Ovid], Web of Science, Google scholar and the Cochrane Library) was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines encompassing articles published up to August 2020. A total of 2386 articles were screened. RESULTS: A total of 48 articles were included in this systematic scoping review. All studies had a prospective design. Five key items in the assessment of flexible ureterorenoscopy were distinguished: 'Manoeuvrability' (87.5%), 'Optics' (64.6%), 'Irrigation' (56.3%), 'Handling' (39.6%) and 'Durability' (35.4%). After regrouping, every key item could be divided into specific subcategories. However, the quality assessment showed a wide variation in denomination, method of measurement, circumstances of measurement, tools used during measurements, number of measurements performed, number of observers, and units of outcomes. CONCLUSION: The research field regarding quality assessment of ureterorenoscopes is heterogeneous. In this systematic scoping review we identified five key parameters: Manoeuvrability, Optics, Irrigation, Handling and Durability, used to grade flexible ureterorenoscopes. However, within these categories we found a wide variety in terms of method of measurements. A standardised, uniform grading tool is required to assess and compare the quality of flexible ureterorenoscopes in the future.
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Estudios de Evaluación como Asunto , Ureteroscopios , Ureteroscopía/instrumentación , HumanosRESUMEN
Introduction: Current therapies in pediatric Inflammatory Bowel Diseases (IBD) target the immune system and often fail to sustain long-term remission. There is a high need for development of alternative treatment strategies such as antibiotics in pediatric IBD.Areas covered: This study systematically assessed efficacy and safety of antibiotics in pediatric IBD. CENTRAL, EMBASE, and Medline were searched for Randomized Controlled Trials (RCTs). Quality assessment was conducted with the Cochrane risk-of-bias tool.Expert opinion: Two RCTs (n = 101, 4.4-18 years, 43% male) were included. Both studies had overall low risk of bias. In mild-to-moderate Crohn's disease, azithromycin+metronidazole (AZ+MET) (n = 35) compared to metronidazole (MET) alone (n = 38) did not induce a significantly different response (PCDAI drop ≥12.5 or remission) (p = 0.07). For induction of remission (PCDAI≤10), AZ+MET was more effective than MET (p = 0.025). In Acute Severe Colitis, mean 5-day-PUCAI was significantly lower in the antibiotic (vancomycin, amoxicillin, metronidazole, doxycycline)+intravenous-corticosteroids group (AB+IVCS) (n = 16) compared to IVCS alone (n=12) (p = 0.037), whereas remission (PUCAI<10) did not differ (p = 0.61). No significant drug-related adverse events were reported. Results of this systematic review of antibiotic use highlight the lack of evidence in pediatric IBD. More evidence is needed before widespread implementation in daily practice.