There is uncertainty in the treatment options for resectable hypopharyngeal squamous cell carcinoma.
A systematic review of randomised controlled trials (RCTs) was performed. Cochrane Central ...Register of Controlled Trials (CENTRAL) (The Cochrane Library), MEDLINE, EMBASE, Science Citation Index, and Conference Proceedings databases and trial registries were searched until November 2020 for randomized controlled trials performed on resectable hypopharyngeal squamous cell carcinoma. Two systematic review authors independently identified studies and extracted data. The primary outcomes evaluated were overall survival, disease-free survival, any recurrence, local recurrence, loco-regional recurrence, distal recurrence and laryngectomy-free survival. The secondary outcomes were response rates following neoadjuvant treatment and comparison of treatment-related toxicity. Assessment of risk of bias was performed for the selected studies using Cochrane's tool for assessing risk of bias. The studies were evaluated for the quality of evidence using GRADE (Grading of Recommendations, Assessment, Development and Evaluations). Risk ratios (RR), rate ratios, and hazard ratios (HR) were calculated along with 95% confidence intervals (95% CI). The Meta-analysis was performed using a random-effects model.
Five RCTs met the inclusion criteria for this review. The risk of bias was unclear or high for the trials. Non-organ preservation(n = 140) versus organ preservation (n = 144) (two trials): no statistically significant difference could be identified for any of the primary outcomes. Concurrent chemoradiotherapy (n = 37) versus sequential chemotherapy followed by radiotherapy (n = 34) (one trial): no statistically significant difference was noted between the two treatment arms for overall survival, disease-free survival and loco-regional recurrence. Laryngectomy-free survival was found to be superior in concurrent chemoradiotherapy arm (HR:0.28, 95% CI 0.13, 0.57). Induction chemotherapy followed by concurrent chemoradiotherapy (n = 53) versus induction chemotherapy followed by radiotherapy (n = 60) (one trial): no statistically significant difference was noted between the treatment arms for overall survival, disease-free survival and laryngectomy-free survival. Preoperative radiotherapy (n = 24) versus postoperative radiotherapy (n = 23) (one trial): overall survival was found to be better in the postoperative radiotherapy arm (HR:2.44, 95% CI1.18, 5.03). No statistically significant difference was noted in terms of treatment-related toxicity.
There are considerable uncertainties in the management of resectable hypopharyngeal cancer.
PROSPERO registration: CRD42019155613.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
To evaluate the effect of preoperative anaemia and blood transfusion on 30-day postoperative morbidity and mortality in patients undergoing gynecological surgery.
Data were analyzed from 12,836 women ...undergoing operation in the American College of Surgeons National Surgical Quality Improvement Program. Outcomes measured were; 30-day postoperative mortality, composite and specific morbidities (cardiac, respiratory, central nervous system, renal, wound, sepsis, venous thrombosis, or major bleeding). Multivariate logistic regression models were performed using adjusted odds ratios (ORadj) to assess the independent effects of preoperative anaemia (hematocrit <36.0%) on outcomes, effect estimates were performed before and after adjustment for perioperative transfusion requirement.
The prevalence of preoperative anaemia was 23.9% (95%CI: 23.2-24.7). Adjusted for confounders by multivariate logistic regression; preoperative anaemia was independently and significantly associated with increased odds of 30-day mortality (OR: 2.40, 95%CI: 1.06-5.44) and composite morbidity (OR: 1.80, 95%CI: 1.45-2.24). This was reflected by significantly higher adjusted odds of almost all specific morbidities including; respiratory, central nervous system, renal, wound, sepsis, and venous thrombosis. Blood Transfusion increased the effect of preoperative anaemia on outcomes (61% of the effect on mortality and 16% of the composite morbidity).
Preoperative anaemia is associated with adverse post-operative outcomes in women undergoing gynecological surgery. This risk associated with preoperative anaemia did not appear to be corrected by use of perioperative transfusion.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Uterine fibroids are common, often symptomatic and a third of women need repeated time off work. Consequently 25% to 50% of women with fibroids receive surgical treatment, namely myomectomy or ...hysterectomy. Hysterectomy is the definitive treatment as fibroids are hormone dependent and frequently recurrent. Medical treatment aims to control symptoms in order to replace or delay surgery. This may improve the outcome of surgery and prevent recurrence.
To determine whether any medical treatment can be recommended in the treatment of women with fibroids about to undergo surgery and in those for whom surgery is not planned based on currently available evidence.
Two authors independently identified randomised controlled trials (RCT) of all pharmacological treatments aimed at the treatment of fibroids from a list of references obtained by formal search of MEDLINE, EMBASE, Cochrane library, Science Citation Index, and ClinicalTrials.gov until December 2013.
Two authors independently extracted data from identified studies.
A Bayesian network meta-analysis was performed following the National Institute for Health and Care Excellence-Decision Support Unit guidelines. Odds ratios, rate ratios, or mean differences with 95% credible intervals (CrI) were calculated.
A total of 75 RCT met the inclusion criteria, 47 of which were included in the network meta-analysis. The overall quality of evidence was very low. The network meta-analysis showed differing results for different outcomes.
There is currently insufficient evidence to recommend any medical treatment in the management of fibroids. Certain treatments have future promise however further, well designed RCTs are needed.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Patients with suspected common bile duct (CBD) stones are often diagnosed using endoscopic retrograde cholangiopancreatography (ERCP), an invasive procedure with risk of significant complications. ...Using endoscopic ultrasound (EUS) or Magnetic Resonance CholangioPancreatography (MRCP) first to detect CBD stones can reduce the risk of unnecessary procedures, cut complications and may save costs.
This study sought to compare the cost-effectiveness of initial EUS or MRCP in patients with suspected CBD stones.
This study is a model based cost-utility analysis estimating mean costs and quality-adjusted life years (QALYs) per patient from the perspective of the UK National Health Service (NHS) over a 1 year time horizon. A decision tree model was constructed and populated with probabilities, outcomes and cost data from published sources, including one-way and probabilistic sensitivity analyses.
Using MRCP to select patients for ERCP was less costly than using EUS to select patients or proceeding directly to ERCP ($1299 versus $1753 and $1781, respectively), with similar QALYs accruing to each option (0.998, 0.998 and 0.997 for EUS, MRCP and direct ERCP, respectively). Initial MRCP was the most cost-effective option with the highest monetary net benefit, and this result was not sensitive to model parameters. MRCP had a 61% probability of being cost-effective at $29,000, the maximum willingness to pay for a QALY commonly used in the UK.
From the perspective of the UK NHS, MRCP was the most cost-effective test in the diagnosis of CBD stones.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Acute calculus cholecystitis (ACC) has a high incidence in the general population. The presence of several areas of uncertainty, along with the availability of new evidence, prompted the current ...update of the 2016 WSES (World Society of Emergency Surgery) Guidelines on ACC.
The WSES president appointed four members as a scientific secretariat, four members as an organization committee and four members as a scientific committee, choosing them from the expert affiliates of WSES. Relevant key questions were constructed, and the task force produced drafts of each section based on the best scientific evidence from PubMed and EMBASE Library; recommendations were developed in order to answer these key questions. The quality of evidence and strength of recommendations were reviewed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) criteria (see https://www.gradeworkinggroup.org/ ). All the statements were presented, discussed and voted upon during the Consensus Conference at the 6th World Congress of the World Society of Emergency Surgery held in Nijmegen (NL) in May 2019. A revised version of the statements was voted upon via an online questionnaire until consensus was reached.
The pivotal role of surgery is confirmed, including in high-risk patients. When compared with the WSES 2016 guidelines, the role of gallbladder drainage is reduced, despite the considerable technical improvements available. Early laparoscopic cholecystectomy (ELC) should be the standard of care whenever possible, even in subgroups of patients who are considered fragile, such as the elderly; those with cardiac disease, renal disease and cirrhosis; or those who are generally at high risk for surgery. Subtotal cholecystectomy is safe and represents a valuable option in cases of difficult gallbladder removal.
ELC has a central role in the management of patients with ACC. The value of surgical treatment for high-risk patients should lead to a distinction between high-risk patients and patients who are not suitable for surgery. Further evidence on the role of clinical judgement and the use of clinical scores as adjunctive tools to guide treatment of high-risk patients and patients who are not suitable for surgery is required. The development of local policies for safe laparoscopic cholecystectomy is recommended.
Background & Aims Radiofrequency ablation (RFA) is often the preferred local ablation therapy for hepatocellular carcinoma (HCC). Percutaneous ethanol injection (PEI) is less frequently used, and ...percutaneous acetic acid injection (PAI) has been mostly abandoned. Robust evidence showing benefit of one therapy versus another is lacking. Our aim was to evaluate the evidence comparing RFA, PEI and PAI using meta-analytical techniques. Methods Literature search was undertaken until December 2008 to identify comparative studies evaluating survival, recurrence, complete necrosis of tumour and complications. Only randomized clinical trials and quasi-randomized studies were included. Adjusted indirect comparisons were made when direct comparative studies were insufficient. Results Eight studies were identified: RFA vs. PEI ( n = 5), PAI vs. PEI ( n = 2) and RFA vs. PAI vs. PEI ( n = 1) including 1035 patients with nine comparisons. RFA was superior to PEI for survival (OR 0.52; 95% CI 0.35–0.78; p = 0.001), complete necrosis of tumour and local recurrence. For tumours ⩽2 cm RFA was not significantly better than PEI. PAI did not differ significantly from PEI for survival (OR 0.55; 95% CI 0.23–1.33; p = 0.18), and local recurrence but required less sessions. PAI had similar outcomes, except local recurrence, to RFA in the direct and indirect comparison. Conclusions RFA seems to be a superior ablative therapy than PEI for HCC, particularly for tumours >2 cm. PAI did not differ significantly from PEI for all the outcomes evaluated. RFA and PAI have similar survival rates. For tumours ⩽2 cm outcome benefits comparing RFA and PEI are similar. PAI needs re-evaluation versus both PEI and RFA for tumours ⩽2 cm.
Background
Standard surgical training has traditionally been one of apprenticeship, where the surgical trainee learns to perform surgery under the supervision of a trained surgeon. This is ...time‐consuming, costly, and of variable effectiveness. Training using a virtual reality simulator is an option to supplement standard training. Virtual reality training improves the technical skills of surgical trainees such as decreased time for suturing and improved accuracy. The clinical impact of virtual reality training is not known.
Objectives
To assess the benefits (increased surgical proficiency and improved patient outcomes) and harms (potentially worse patient outcomes) of supplementary virtual reality training of surgical trainees with limited laparoscopic experience.
Search methods
We searched the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE, EMBASE and Science Citation Index Expanded until July 2012.
Selection criteria
We included all randomised clinical trials comparing virtual reality training versus other forms of training including box‐trainer training, no training, or standard laparoscopic training in surgical trainees with little laparoscopic experience. We also planned to include trials comparing different methods of virtual reality training. We included only trials that assessed the outcomes in people undergoing laparoscopic surgery.
Data collection and analysis
Two authors independently identified trials and collected data. We analysed the data with both the fixed‐effect and the random‐effects models using Review Manager 5 analysis. For each outcome we calculated the mean difference (MD) or standardised mean difference (SMD) with 95% confidence intervals based on intention‐to‐treat analysis.
Main results
We included eight trials covering 109 surgical trainees with limited laparoscopic experience. Of the eight trials, six compared virtual reality versus no supplementary training. One trial compared virtual reality training versus box‐trainer training and versus no supplementary training, and one trial compared virtual reality training versus box‐trainer training. There were no trials that compared different forms of virtual reality training. All the trials were at high risk of bias. Operating time and operative performance were the only outcomes reported in the trials. The remaining outcomes such as mortality, morbidity, quality of life (the primary outcomes of this review) and hospital stay (a secondary outcome) were not reported.
Virtual reality training versus no supplementary training: The operating time was significantly shorter in the virtual reality group than in the no supplementary training group (3 trials; 49 participants; MD ‐11.76 minutes; 95% CI ‐15.23 to ‐8.30). Two trials that could not be included in the meta‐analysis also showed a reduction in operating time (statistically significant in one trial). The numerical values for operating time were not reported in these two trials. The operative performance was significantly better in the virtual reality group than the no supplementary training group using the fixed‐effect model (2 trials; 33 participants; SMD 1.65; 95% CI 0.72 to 2.58). The results became non‐significant when the random‐effects model was used (2 trials; 33 participants; SMD 2.14; 95% CI ‐1.29 to 5.57). One trial could not be included in the meta‐analysis as it did not report the numerical values. The authors stated that the operative performance of virtual reality group was significantly better than the control group.
Virtual reality training versus box‐trainer training: The only trial that reported operating time did not report the numerical values. In this trial, the operating time in the virtual reality group was significantly shorter than in the box‐trainer group. Of the two trials that reported operative performance, only one trial reported the numerical values. The operative performance was significantly better in the virtual reality group than in the box‐trainer group (1 trial; 19 participants; SMD 1.46; 95% CI 0.42 to 2.50). In the other trial that did not report the numerical values, the authors stated that the operative performance in the virtual reality group was significantly better than the box‐trainer group.
Authors' conclusions
Virtual reality training appears to decrease the operating time and improve the operative performance of surgical trainees with limited laparoscopic experience when compared with no training or with box‐trainer training. However, the impact of this decreased operating time and improvement in operative performance on patients and healthcare funders in terms of improved outcomes or decreased costs is not known. Further well‐designed trials at low risk of bias and random errors are necessary. Such trials should assess the impact of virtual reality training on clinical outcomes.
Liver biopsy is the reference standard for diagnosing the extent of fibrosis in chronic liver disease; however, it is invasive, with the potential for serious complications. Alternatives to biopsy ...include non-invasive liver tests (NILTs); however, the cost-effectiveness of these needs to be established.
To assess the diagnostic accuracy and cost-effectiveness of NILTs in patients with chronic liver disease.
We searched various databases from 1998 to April 2012, recent conference proceedings and reference lists.
We included studies that assessed the diagnostic accuracy of NILTs using liver biopsy as the reference standard. Diagnostic studies were assessed using the Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) tool. Meta-analysis was conducted using the bivariate random-effects model with correlation between sensitivity and specificity (whenever possible). Decision models were used to evaluate the cost-effectiveness of the NILTs. Expected costs were estimated using a NHS perspective and health outcomes were measured as quality-adjusted life-years (QALYs). Markov models were developed to estimate long-term costs and QALYs following testing, and antiviral treatment where indicated, for chronic hepatitis B (HBV) and chronic hepatitis C (HCV). NILTs were compared with each other, sequential testing strategies, biopsy and strategies including no testing. For alcoholic liver disease (ALD), we assessed the cost-effectiveness of NILTs in the context of potentially increasing abstinence from alcohol. Owing to a lack of data and treatments specifically for fibrosis in patients with non-alcoholic fatty liver disease (NAFLD), the analysis was limited to an incremental cost per correct diagnosis. An analysis of NILTs to identify patients with cirrhosis for increased monitoring was also conducted.
Given a cost-effectiveness threshold of £20,000 per QALY, treating everyone with HCV without prior testing was cost-effective with an incremental cost-effectiveness ratio (ICER) of £9204. This was robust in most sensitivity analyses but sensitive to the extent of treatment benefit for patients with mild fibrosis. For HBV hepatitis B e antigen (HBeAg)-negative) this strategy had an ICER of £28,137, which was cost-effective only if the upper bound of the standard UK cost-effectiveness threshold range (£30,000) is acceptable. For HBeAg-positive disease, two NILTs applied sequentially (hyaluronic acid and magnetic resonance elastography) were cost-effective at a £20,000 threshold (ICER: £19,612); however, the results were highly uncertain, with several test strategies having similar expected outcomes and costs. For patients with ALD, liver biopsy was the cost-effective strategy, with an ICER of £822.
A substantial number of tests had only one study from which diagnostic accuracy was derived; therefore, there is a high risk of bias. Most NILTs did not have validated cut-offs for diagnosis of specific fibrosis stages. The findings of the ALD model were dependent on assuptions about abstinence rates assumptions and the modelling approach for NAFLD was hindered by the lack of evidence on clinically effective treatments.
Treating everyone without NILTs is cost-effective for patients with HCV, but only for HBeAg-negative if the higher cost-effectiveness threshold is appropriate. For HBeAg-positive, two NILTs applied sequentially were cost-effective but highly uncertain. Further evidence for treatment effectiveness is required for ALD and NAFLD.
This study is registered as PROSPERO CRD42011001561.
The National Institute for Health Research Health Technology Assessment programme.
Mental health difficulties are prevalent in autistic people with ~14%–50% having experienced depression and ~40%–80% having experienced anxiety disorders. Identifying interventions that improve ...autistic people’s mental health is a top priority. However, at present, there is no high-quality network meta-analysis of benefits and harms of different interventions. We conducted a systematic review and network meta-analysis of randomised controlled trials, searching MEDLINE, EMBASE, other databases, and trial registers until 17 October 2020. We included randomised controlled trials reporting anxiety or depression in a suitable format. We calculated effect estimates and 95% credible intervals using Bayesian network meta-analysis. Our search identified 13,794 reports, of which 71 randomised controlled trials (3630 participants) were eligible for inclusion. All trials had high risk of bias. The follow-up period ranged from 1 to 24 months. Evidence indicates uncertainty about the effects of different interventions, with more high-quality evidence needed. Available evidence suggests that some forms of cognitive behavioural therapy may decrease anxiety and depression scores in autistic children and adults; mindfulness therapy may decrease anxiety and depression scores in autistic adults with previous mental health conditions; and behavioural interventions may provide some benefit for depression in autistic children. We recommend that autistic people are given access to mental health interventions available to non-autistic people, following principles of person-centred care.
PROSPERO registration ID: CRD42019136093
Lay Abstract
Nearly three out of four autistic people experience mental health problems such as stress, anxiety or depression. The research already done does not guide us on how best to prevent or treat mental health problems for autistic people. Our aim was to look at the benefits and harms of different interventions on mental health outcomes in autistic people. We searched all the published randomised controlled trials (RCTs) about interventions for mental health conditions in autistic people until 17 October 2020. We also searched for RCTs that were not published in peer-reviewed journals. These were obtained from registers of clinical trials online. We then combined the information from all these trials using advanced statistical methods to analyse how good the interventions are. Seventy-one studies (3630 participants) provided information for this research. The studies reported how participants were responding to the intervention for only a short period of time. The trials did not report which interventions worked for people with intellectual disability. In people without intellectual disability, some forms of cognitive behavioural therapy and mindfulness therapy may be helpful. However, further research is necessary. Many trials used medications to target core features of autism rather than targeting mental health conditions, but these medications did not help autistic people. Until we have more evidence, treatment of mental health conditions in autistic people should follow the evidence available for non-autistic people. We plan to widely disseminate the findings to healthcare professionals through medical journals and conferences and contact other groups representing autistic people.
Purpose
The use of synthetic or simulated data has the potential to greatly improve the availability and volume of training data for image guided surgery and other medical applications, where access ...to real-life training data is limited.
Methods
By using the Unity game engine, complex intraoperative scenes can be simulated. The Unity Perception package allows for randomisation of paremeters within the scene, and automatic labelling, to make simulating large data sets a trivial operation. In this work, the approach has been prototyped for liver segmentation from laparoscopic video images. 50,000 simulated images were used to train a U-Net, without the need for any manual labelling. The use of simulated data was compared against a model trained with 950 manually labelled laparoscopic images.
Results
When evaluated on data from 10 separate patients, synthetic data outperformed real data in 4 out of 10 cases. Average DICE scores across the 10 cases were 0.59 (synthetic data), 0.64 (real data) and 0.75 (both synthetic and real data).
Conclusion
Synthetic data generated using this method is able to make valid inferences on real data, with average performance slightly below models trained on real data. The use of the simulated data for pre-training boosts model performance, when compared with training on real data only.
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