Smart mandibular advancement devices for obstructive sleep apnea: a systematic literature review.

PURPOSE: The goal of this review is to provide sleep physicians, dentists, and researchers with an evidence-based overview of the literature on smart mandibular advancement devices (MADs) for the treatment of obstructive sleep apnea. METHODS: A systematic literature search was conducted by two blinded reviewers and an information specialist. A smart MAD was defined as any MAD with additional functionality besides mandibular protrusion. The bibliographic databases Medline, Embase, and Scopus were used to identify relevant publications. Studies were included if they described any stage of development of smart MADs. A total of 3162 titles and abstracts were screened for their relevance. In total, 58 articles were selected for full-text screening, 26 of which were included in this review. RESULTS: The overall quality of the available literature was low. Most of the studies were observational, clinical or applied-research articles. The authors classified MADs into two main groups: passive and active. Passive MADs measured patient data, most commonly patient compliance. Active MADs adjusted protrusion of the mandible in response to patient data and were found in various phases of technological readiness (in development, demonstration, or deployment). CONCLUSION: Innovations in smart mandibular advancement devices most frequently track patient compliance. Devices measuring other health parameters and active, feedback-controlled, devices are increasingly reported on. However, studies demonstrating their added benefit over traditional methods remain sparse. With further study, smart mandibular advancement devices have the potential to improve the efficiency of obstructive sleep apnea treatment and provide new treatment possibilities.

Effect of probiotic supplementation on the gut microbiota in very preterm infants: a systematic review.

OBJECTIVE: There is increasing evidence that probiotic supplementation in very preterm infants decreases the risk of necrotising enterocolitis (NEC), sepsis and mortality. The underlying mechanisms, including effects on the gut microbiota, are largely unknown. We aimed to systematically review the available literature on the effects of probiotic supplementation in very preterm infants on gut microbiota development. DESIGN: A systematic review in Medline, Embase, Cochrane Library, CINAHL and Web of Science. SETTING: Neonatal intensive care unit. PATIENTS: Premature infants. INTERVENTION: Probiotic supplementation. MAIN OUTCOME MEASURES: Gut microbiota. RESULTS: A total of 1046 articles were screened, of which 29 were included. There was a large heterogeneity in study design, dose and type of probiotic strains, timepoints of sample collection and analysing techniques. Bifidobacteria and lactobacilli were the most used probiotic strains. The effects of probiotics on alpha diversity were conflicting; however, beta diversity was significantly different between probiotic-supplemented infants and controls in the vast majority of studies. In most studies, probiotic supplementation led to increased relative abundance of the supplemented strains and decreased abundance of genera such as Clostridium, Streptococcus, Klebsiella and Escherichia. CONCLUSIONS: Probiotic supplementation to preterm infants seems to increase the relative abundance of the supplemented strains with a concurrent decrease of potentially pathogenic species. These probiotic-induced microbial alterations may contribute to the decreased risk of health complications such as NEC. Future trials, including omics technologies to analyse both microbiota composition and function linked to health outcomes, are warranted to identify the optimal mixture and dosing of probiotic strains. PROSPERO REGISTRATION NUMBER: CRD42023385204.

Non-sleep related outcomes of maxillomandibular advancement, a systematic review.

Maxillomandibular advancement has been shown to be an effective treatment for obstructive sleep apnea; however, the literature focuses mainly on sleep-related parameters such as apnea-hypopnea index, respiratory disturbance index and Epworth sleepiness scale. Other factors that may be important to patients, such as esthetics, patient satisfaction, nasality, swallowing problems and so forth have been reported in the literature but have not been systematically studied. Together with an information specialist, an extensive search in Medline, Embase and Scopus yielded 1592 unique articles. Titles and abstracts were screened by two blinded reviewers. In total, 75 articles were deemed eligible for full-text screening and 38 articles were included for qualitative synthesis. The most common categories of non-sleep related outcomes found were surgical accuracy, facial esthetics, functional outcomes, quality of life, patient satisfaction, and emotional health. All categories were reported using heterogenous methods, such that meta-analysis could not be performed. There was lack of consistent methods to assess these outcomes. This work is the first to systematically review non-sleep related outcomes of maxillomandibular advancement. Despite growing interest in evaluating surgical outcomes through patient subjective experiences, this review points to the need of standardized, validated methods to report these outcomes.

Systematic review on management of high-output enterostomy in children: An urgent call for evidence.

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.

Diagnostic Accuracy of Intestinal Ultrasound in the Detection of Intra-Abdominal Complications in Crohn's Disease: A Systematic Review and Meta-Analysis.

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.

The Diagnostic Value of Biomarkers in Acute Mesenteric Ischaemia Is Insufficiently Substantiated: A Systematic Review.

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.

Generation of Aerosols by Noninvasive Respiratory Support Modalities: A Systematic Review and Meta-Analysis.

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.

What are Normal Defecation Patterns in Healthy Children up to Four Years of Age? A Systematic Review and Meta-Analysis.

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 16 393 children and 40 033 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).

Hospital-to-home transitions for children with medical complexity: part 1, a systematic review of reported outcomes.

Outcome selection to evaluate interventions to support a successful transition from hospital to home of children with medical complexity (CMC) may be difficult due to the variety in available outcomes. To support researchers in outcome selection, this systematic review aimed to summarize and categorize outcomes currently reported in publications evaluating the effectiveness of hospital-to-home transitional care interventions for CMC. We searched the following databases: Medline, Embase, Cochrane library, CINAHL, PsychInfo, and Web of Science for studies published between 1 January 2010 and 15 March 2023. Two reviewers independently screened the articles and extracted the data with a focus on the outcomes. Our research group extensively discussed the outcome list to identify those with similar definitions, wording or meaning. Consensus meetings were organized to discuss disagreements, and to summarize and categorize the data. We identified 50 studies that reported in total 172 outcomes. Consensus was reached on 25 unique outcomes that were assigned to six outcome domains: mortality and survival, physical health, life impact (the impact on functioning, quality of life, delivery of care and personal circumstances), resource use, adverse events, and others. Most frequently studied outcomes reflected life impact and resource use. Apart from the heterogeneity in outcomes, we also found heterogeneity in designs, data sources, and measurement tools used to evaluate the outcomes.     Conclusion: This systematic review provides a categorized overview of outcomes that may be used to evaluate interventions to improve hospital-to-home transition for CMC. The results can be used in the development of a core outcome set transitional care for CMC.

Comparison of Patient-Controlled versus Continuous Epidural Analgesia in Adult Surgical Patients: A Systematic Review.

BACKGROUND: The advantages of PCEA over CEA have been demonstrated in obstetric patients. Whether a similar benefit applies to surgical patients is unclear. METHODS: Embase, PubMed, and Cochrane Library were searched, enabling a systematic review of studies comparing PCEA and CEA in adult surgical patients (PROSPERO: CRD42018106644). The study quality was assessed using the Cochrane risk-of-bias tool (RoB2). The primary outcome was pain scores on postoperative day one (POD1). Secondary outcomes were 24 or 48 h epidural or intravenous total analgesic dose, systemic analgesics, manual top-ups, side effects, and patient satisfaction. RESULTS: Six randomized controlled trials with high heterogeneity of study characteristics were identified with a moderate risk of bias. Two studies showed significantly reduced resting pain scores on POD1 in PCEA compared with CEA patients (36-44%, p < 0.05). Four studies found comparable pain scores between these groups. PCEA use reduced epidural medication (28% to 40% reduction, p < 0.01) in four studies. One study found a 23% reduction (p < 0.001) of top-ups in PCEA; intravenous morphine use by PCEA patients was reduced (0.16 vs. 3.45 mg per patient, p < 0.05) in one study. PCEA patients were more satisfied with analgesia (p < 0.001) in two studies. Nausea and vomiting were reduced in PCEA (p = 0.01). CONCLUSIONS: Regarding the reduction in pain scores, the effects of PCEA were not significant or clinically not relevant. However, regarding the amount of epidural drug use, the amount of required rescue systemic analgesics, patient satisfaction, and the number of required top-ups, PCEA had advantages over CEA in surgical patients.

Strategies Following Free Flap Failure in Lower Extremity Trauma: A Systematic Review.

Background: Free flap reconstructions are an important reconstructive option for soft tissue defects in mangled lower extremities. Microsurgery facilitates soft tissue coverage of defects that otherwise would result in amputation. However, the success rates of traumatic lower extremity free flap reconstructions remain lower than those in other locations. Nevertheless, post-free flap failure salvage strategies have rarely been addressed. Therefore, the current review aims to provide an overview of post-free flap failure strategies in lower extremity trauma and their subsequent outcomes. Methods: A search of Pubmed, Cochrane, and Embase databases was performed on June 9, June 2021 using the following medical subject headings (MeSH) search terms: 'lower extremity', 'leg injuries', 'reconstructive surgical procedures', 'reoperation', 'microsurgery' and 'treatment failure'. This review was conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Partial and total free flap failures after traumatic reconstruction were included. Results: Twenty-eight studies with a total of 102 free flap failures fulfilled the eligibility criteria. Following the total failure, a second free flap is the predominant reconstructive strategy (69%). In comparison to the failure rate of a first free flap (10%), the fate of a second free flap is less favorable with a failure rate of 17%. The amputation rate following flap failure is 12%. The risk of amputation increases between primary and secondary free flap failures. After partial flap loss, the preferred strategy is a split skin graft (50%). Conclusion: To our knowledge, this is the first systematic review on the outcome of salvage strategies after free flap failure in traumatic lower extremity reconstruction. This review provides valuable evidence to take into consideration in the decision-making regarding post-free flap failure strategies.

Poor-prognosis molecular subtypes in adenocarcinomas of pancreato-biliary and gynecological origin: A systematic review.

Pancreato-biliary and gynecological adenocarcinomas need better tools to predict clinical outcome. Potential prognostic mesenchymal(-like) transcriptome-based subtypes have been identified in these cancers. In this systematic review, we include studies into molecular subtyping and summarize biological and clinical features of the subtypes within and across sites of origin, searching for suggestions to improve classification and prognostication. PubMed and Embase were searched for original research articles describing potential mesenchymal(-like) mRNA-based subtypes in pancreato-biliary or gynecological adenocarcinomas. Studies limited to supervised clustering were excluded. Fourty-four studies discussing cholangiocarcinomas, gallbladder, ampullary, pancreatic, ovarian, and endometrial adenocarcinomas were included. There was overlap in molecular and clinical features in mesenchymal(-like) subtypes across all adenocarcinomas. Approaches including microdissection were more likely to identify prognosis-associated subtypes. To conclude, molecular subtypes in pancreato-biliary and gynecological adenocarcinomas share biological and clinical characteristics. Furthermore, separation of stromal and epithelial signals should be applied in future studies of biliary and gynecological adenocarcinomas.

What helps the successful implementation of digital decision aids supporting shared decision-making in cardiovascular diseases? A systematic review.

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.

Effectiveness of transmural team-based palliative care in prevention of hospitalizations in patients at the end of life: A systematic review and meta-analysis.

BACKGROUND: Team-based palliative care interventions have shown positive results for patients at the end of life in both hospital and community settings. However, evidence on the effectiveness of transmural, that is, spanning hospital and home, team-based palliative care collaborations is limited. AIM: To systematically review whether transmural team-based palliative care interventions can prevent hospital admissions and increase death at home. DESIGN: Systematic review and meta-analysis. DATA SOURCES: MEDLINE (Ovid), Embase (Ovid), CINAHL (Ebsco), PsychINFO (Ovid), and Cochrane Library (Wiley) were systematically searched until January 2021. Studies incorporating teams in which hospital and community professionals co-managed patients, hospital-based teams with community follow-up, and case-management interventions led by palliative care teams were included. Data was extracted by two researchers independently. RESULTS: About 19 studies were included involving 6614 patients, of whom 2202 received an intervention. The overall pooled odds ratio of at least one hospital (re)admissions was 0.46 (95% confidence interval (CI) 0.34-0.68) in favor of the intervention group. The highest reduction in admission was in the hospital-based teams with community follow-up: OR 0.21 (95% CI 0.07-0.66). The pooled effect on home deaths was 2.19 (95% CI 1.26-3.79), favoring the intervention, with also the highest in the hospital-based teams: OR 4.77 (95% CI 1.23-18.47). However, studies had high heterogeneity regarding intervention, study population, and follow-up time. CONCLUSION: Transmural team-based palliative care interventions, especially hospital-based teams that follow-up patients at home, show an overall effect on lowering hospital admissions and increasing the number of patients dying at home. However, broad clinical and statistical heterogeneity of included studies results in uncertainty about the effect size.

Shared decision-making and the duration of medical consultations: A systematic review and meta-analysis.

OBJECTIVE: 1) determine whether increased levels of Shared Decision-Making (SDM) affect consultation duration, 2) investigate the intervention characteristics involved. METHODS: MEDLINE, EMBASE, CINAHL and Cochrane library were systematically searched for experimental and cross-sectional studies up to December 2021. A best-evidence synthesis was performed, and interventions characteristics that increased at least one SDM-outcome, were pooled and descriptively analyzed. RESULTS: Sixty-three studies were selected: 28 randomized clinical trials, 8 quasi-experimental studies, and 27 cross-sectional studies. Overall, pooling of data was not possible due to substantial heterogeneity. No differences in consultation duration were found more often than increased or decreased durations. . Consultation times (minutes:seconds) were significantly increased only among interventions that: 1) targeted clinicians only (Mean Difference [MD] 1:30, 95% Confidence Interval [CI] 0:24-2:37); 2) were performed in primary care (MD 2:05, 95%CI 0:11-3:59; 3) used a group format (MD 2:25, 95%CI 0:45-4:05); 4) were not theory-based (MD 4:01, 95%CI 0:38-7:23). CONCLUSION: Applying SDM does not necessarily require longer consultation durations. Theory-based, multilevel implementation approaches possibly lower the risk of increasing consultation durations. PRACTICE IMPLICATIONS: The commonly heard concern that time hinders SDM implementation can be contradicted, but implementation demands multifaceted approaches and space for training and adapting work processes.

High resorption rates following glenoid augmentation procedures do not seem to lead to higher recurrence rates or worse clinical outcomes: a systematic review and meta-analysis.

PURPOSE: Bone augmentation techniques show a relatively high complication rate, which might be due to graft non-union and resorption. It is unclear which augmentation techniques demonstrate the highest amount of non-union and resorption and whether this leads to worse clinical or functional outcomes. Therefore, the aim of this review was (i) to compare non-union and resorption rates between surgical approaches, procedures, graft types, donor sites and fixation methods regarding clinical and functional outcomes and (ii) determine whether high non-union or resorption rates lead to less favorable clinical or functional outcomes. METHODS: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses statements were followed. PubMed, EMBASE (Ovid) and Cochrane Library were searched on December 15th 2021 for studies examining bone graft non-union or resorption using radiograph or CT following glenoid augmentation to treat anterior shoulder dislocation. RESULTS: The search resulted in 103 inclusions, comprising 5,128 glenoid augmentations. When comparing pooled proportions of bony union, graft fracture rate, hardware failure rate, recurrence rate, return to sports and Rowe score, most results were similar between approaches, procedures, graft types, donor sites and fixation methods. High resorption rates were seen for allograft augmentation (74.3; 95% CI: 39.8-92.7) compared to autograft augmentation (15.5; 95% CI 10.1-23.2), but this was not associated with higher recurrence rates or worse clinical outcomes. Meta-analyses (8 studies; 494 patients) demonstrated no difference in incomplete and complete non-union rates between arthroscopic and open procedures; however, both analyses showed substantial heterogeneity. Higher partial resorption rates were observed on CT (48.0; 95% CI 43.3-52.7) compared to radiograph (14.1; 95% CI 10.9-18.1). Three studies comprising 267 shoulders demonstrated a higher rate of non-union and recurrence in smokers, whereas one study comprising 38 shoulders did not. CONCLUSION: Non-union and resorption rates were similar among procedures, grafts and fixation methods. Higher resorption rates were observed in allografts, but this was not associated with higher recurrence rates or worse clinical outcomes. Pooling data demonstrated substantial heterogeneity and definitions varied among studies, warranting more standardized measuring. LEVEL OF EVIDENCE: IV.

Extracorporeal Shockwave Therapy for Mid-portion and Insertional Achilles Tendinopathy: A Systematic Review of Randomized Controlled Trials.

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.

Surgical margins after partial nephrectomy as prognostic factor for the risk of local recurrence in pT1 RCC: a systematic review and narrative synthesis.

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.

Consensus Statement on Mandatory Measurements for Pancreatic Cancer Trials for Patients With Resectable or Borderline Resectable Disease (COMM-PACT-RB): A Systematic Review and Delphi Consensus Statement.

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.

Pregnancy in women with liver cirrhosis is associated with increased risk for complications: A systematic review and meta-analysis of the literature.

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.