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The Cochrane Database of Systematic... Aug 2019Gliomas are brain tumours arising from glial cells with an annual incidence of 4 to 11 people per 100,000. In this review we focus on gliomas with low aggressive...
BACKGROUND
Gliomas are brain tumours arising from glial cells with an annual incidence of 4 to 11 people per 100,000. In this review we focus on gliomas with low aggressive potential in the short term, i.e. low-grade gliomas. Most people with low-grade gliomas are treated with surgery and may receive radiotherapy thereafter. However, there is concern about the possible long-term effects of radiotherapy, especially on neurocognitive functioning.
OBJECTIVES
To evaluate the long-term neurocognitive and other side effects of radiotherapy (with or without chemotherapy) compared with no radiotherapy, or different types of radiotherapy, among people with glioma (where 'long-term' is defined as at least two years after diagnosis); and to write a brief economic commentary.
SEARCH METHODS
We searched the following databases on 16 February 2018 and updated the search on 14 November 2018: Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 11) in the Cochrane Library; MEDLINE via Ovid; and Embase via Ovid. We also searched clinical trial registries and relevant conference proceedings from 2014 to 2018 to identify ongoing and unpublished studies.
SELECTION CRITERIA
Randomised and non-randomised trials, and controlled before-and-after studies (CBAS). Participants were aged 16 years and older with cerebral glioma other than glioblastoma. We included studies where patients in at least one treatment arm received radiotherapy, with or without chemotherapy, and where neurocognitive outcomes were assessed two or more years after treatment.
DATA COLLECTION AND ANALYSIS
Two review authors independently extracted data and assessed risk of bias. We assessed the certainty of findings using the GRADE approach.
MAIN RESULTS
The review includes nine studies: seven studies were of low-grade glioma and two were of grade 3 glioma. Altogether 2406 participants were involved but there was high sample attrition and outcome data were available for a minority of people at final study assessments. In seven of the nine studies, participants were recruited to randomised controlled trials (RCTs) in which longer-term follow-up was undertaken in a subset of people that had survived without disease progression. There was moderate to high risk of bias in studies due to lack of blinding and high attrition, and in two observational studies there was high risk of selection bias. Paucity of data and risk of bias meant that evidence was of low to very low certainty. We were unable to combine results in meta-analysis due to diversity in interventions and outcomes.The studies examined the following five comparisons.Radiotherapy versus no adjuvant treatmentTwo observational studies contributed data. At the 12-year follow-up in one study, the risk of cognitive impairment (defined as cognitive disability deficits in at least five of 18 neuropsychological tests) was greater in the radiotherapy group (risk ratio (RR) 1.95, 95% confidence interval (CI) 1.02 to 3.71; n = 65); at five to six years the difference between groups did not reach statistical significance (RR 1.38, 95% CI 0.92 to 2.06; n = 195). In the other study, one subject in the radiotherapy group had cognitive impairment (defined as significant deterioration in eight of 12 neuropsychological tests) at two years compared with none in the control group (very low certainty evidence).With regard to neurocognitive scores, in one study the radiotherapy group was reported to have had significantly worse mean scores on some tests compared with no radiotherapy; however, the raw data were only given for significant findings. In the second study, there were no clear differences in any of the various cognitive outcomes at two years (n = 31) and four years (n = 15) (very low certainty evidence).Radiotherapy versus chemotherapyOne RCT contributed data on cognitive impairment at up to three years with no clear difference between arms (RR 1.43, 95% CI 0.36 to 5.70, n = 117) (low-certainty evidence).High-dose radiotherapy versus low-dose radiotherapyOnly one of two studies reporting this comparison contributed data, and at two and five years there were no clear differences between high- and low-dose radiotherapy arms (very low certainty evidence).Conventional radiotherapy versus stereotactic conformal radiotherapyOne study involving younger people contributed limited data from the subgroup aged 16 to 25 years. The numbers of participants with neurocognitive impairment at five years after treatment were two out of 12 in the conventional arm versus none out of 11 in the stereotactic conformal radiotherapy arm (RR 4.62, 95% CI 0.25 to 86.72; n = 23; low-certainty evidence).Chemoradiotherapy versus radiotherapyTwo RCTs tested for cognitive impairment. One defined cognitive impairment as a decline of more than 3 points in MMSE score compared with baseline and reported data from 2-year (110 participants), 3-year (91 participants), and 5-year (57 participants) follow-up with no clear difference between the two arms at any time point. A second study did not report raw data but measured MMSE scores over five years in 126 participants at two years, 110 at three years, 69 at four years and 53 at five years. Authors concluded that there was no difference in MMSE scores between the two study arms (P = 0.4752) (low-certainty evidence).Two RCTs reported quality of life (QoL) outcomes for this comparison. One reported no differences in Brain-QoL scores between study arms over a 5-year follow-up period (P = 0.2767; no raw data were given and denominators were not stated). The other trial reported that the long-term results of health-related QoL showed no difference between the arms but did not give the raw data for overall HRQoL scores (low-certainty evidence).We found no comparative data on endocrine dysfunction; we planned to develop a brief economic commentary but found no relevant economic studies for inclusion.
AUTHORS' CONCLUSIONS
Radiotherapy for gliomas with a good prognosis may increase the risk of neurocognitive side effects in the long term; however the magnitude of the risk is uncertain. Evidence on long-term neurocognitive side effects associated with chemoradiotherapy is also uncertain. Neurocognitive assessment should be an integral part of long-term follow-up in trials involving radiotherapy for lower-grade gliomas to improve the certainty of evidence regarding long-term neurocognitive effects. Such trials should also assess other potential long-term effects, including endocrine dysfunction, and evaluate costs and cost effectiveness.
Topics: Antineoplastic Agents; Cognition Disorders; Glioma; Humans; Radiation Injuries; Radiosurgery; Radiotherapy; Randomized Controlled Trials as Topic
PubMed: 31425631
DOI: 10.1002/14651858.CD013047.pub2 -
Surgery Apr 2024Failure to rescue is the rate of death amongst patients with postoperative complications and has been proposed as a perioperative quality indicator. However, variation...
BACKGROUND
Failure to rescue is the rate of death amongst patients with postoperative complications and has been proposed as a perioperative quality indicator. However, variation in its definition has limited comparisons between studies. We systematically reviewed all surgical literature reporting failure to rescue rates and examined variations in the definition of the 'numerator,' 'denominator,' and timing of failure to rescue measurement.
METHODS
Databases were searched from inception to 31 December 2022. All studies reporting postoperative failure to rescue rates as a primary or secondary outcome were included. We examined the complications included in the failure to rescue denominator, the percentage of deaths captured by the failure to rescue numerator, and the timing of measurement for complications and mortality.
RESULTS
A total of 359 studies, including 212,048,069 patients, were analyzed. The complications included in the failure to rescue denominator were reported in 295 studies (82%), with 131 different complications used. The median number of included complications per study was 10 (interquartile range 8-15). Studies that included a higher number of complications in the failure-to-rescue denominator reported lower failure-to-rescue rates. Death was included as a complication in the failure to rescue the denominator in 65 studies (18%). The median percentage of deaths captured by the failure to rescue calculation when deaths were not included in the denominator was 79%. Complications (52%) and mortality (40%) were mostly measured in-hospital, followed by 30-days after surgery.
CONCLUSION
Failure to rescue is an important concept in the study of postoperative outcomes, although its definition is highly variable and poorly reported. Researchers should be aware of the advantages and disadvantages of different approaches to defining failure to rescue.
Topics: Humans; Postoperative Complications; Hospital Mortality; Retrospective Studies
PubMed: 38245447
DOI: 10.1016/j.surg.2023.12.006 -
Annals of Cardiac Anaesthesia Apr 2024The potential benefits of epidural anesthesia on mortality, atrial fibrillation, and pulmonary complications must be weighed against the risk of epidural hematoma...
The potential benefits of epidural anesthesia on mortality, atrial fibrillation, and pulmonary complications must be weighed against the risk of epidural hematoma associated with intraoperative heparinization. This study aims to provide an updated assessment of the clinical risks of epidural anesthesia in cardiac surgery, focusing on the occurrence of epidural hematomas and subsequent paralysis. A systematic search of Embase, Medline, Ovid Central, Web of Science, and PubMed was conducted to identify relevant publications between 1966 and 2022. Two independent reviewers assessed the eligibility of the retrieved manuscripts. Studies reporting adult patients undergoing cardiac surgery with epidural catheterization were included. The incidence of hematomas was calculated by dividing the number of hematomas by the total number of patients in the included studies. Risk calculations utilized various denominators based on the rigor of trial designs, and the risks of hematoma and paralysis were compared to other commonly encountered risks. The analysis included a total of 33,089 patients who underwent cardiac surgery with epidural catheterization. No epidural hematomas were reported across all published RCTs, prospective, and retrospective trials. Four case reports associated epidural hematoma with epidural catheterization and perioperative heparinization. The risks of epidural hematoma and subsequent paralysis were estimated at 1:7643 (95% CI 1:3860 to 380,916) and 1:10,190 (95% CI 1:4781 to 0:1), respectively. The risk of hematoma is similar to the non-obstetric population (1:5405; 95% CI 1:4784 to 6134). The risk of hematoma in cardiac surgery patients receiving epidural anesthesia is therefore similar to that observed in some other surgical non-obstetric populations commonly exposed to epidural catheterization.
Topics: Adult; Humans; Prospective Studies; Retrospective Studies; Cardiac Surgical Procedures; Hematoma; Risk Assessment; Paralysis
PubMed: 38607874
DOI: 10.4103/aca.aca_160_23 -
The American Journal of Tropical... Mar 2021Antimalarials, in particular artemisinin-based combination therapies (ACTs), are critical tools in reducing the global burden of malaria, which is concentrated in...
Antimalarials, in particular artemisinin-based combination therapies (ACTs), are critical tools in reducing the global burden of malaria, which is concentrated in sub-Saharan Africa. Performing and reporting antimalarial efficacy studies in a transparent and standardized fashion permit comparison of efficacy outcomes across countries and time periods. This systematic review summarizes study compliance with WHO laboratory and reporting guidance pertaining to antimalarial therapeutic efficacy studies and evaluates how well studies from sub-Saharan Africa adhered to these guidelines. We included all published studies (January 2020 or before) performed in sub-Saharan Africa where ACT efficacy for treatment of uncomplicated Plasmodium falciparum infection was reported. The primary outcome was a composite indicator for study methodology consistent with WHO guidelines for statistical analysis of corrected efficacy, defined as an article presenting a Kaplan-Meier survival analysis of corrected efficacy or reporting a per-protocol analysis where new infections were excluded from the numerator and denominator. Of 581 articles screened, we identified 279 for the review. Molecular correction was used in 83% (232/279) to distinguish new infections from recrudescences in subjects experiencing recurrent parasitemia. Only 45% (99/221) of articles with therapeutic efficacy as a primary outcome and performing molecular correction reported corrected efficacy outcomes calculated in a way consistent with WHO recommendations. These results indicate a widespread lack of compliance with WHO-recommended methods of analysis, which may result in biases in how antimalarial effectiveness is being measured and reported from sub-Saharan Africa.
Topics: Africa South of the Sahara; Analysis of Variance; Antimalarials; Artemisinins; Data Interpretation, Statistical; Drug Resistance; Guideline Adherence; Guidelines as Topic; Humans; Kaplan-Meier Estimate; Malaria, Falciparum; Plasmodium falciparum; Recurrence; Treatment Outcome
PubMed: 33724925
DOI: 10.4269/ajtmh.20-1481 -
Journal of Atrial Fibrillation 2019Endocardial LAAO has been increasingly utilized in atrial fibrillation (AF) patients who are not suitable for long term oral anticoagulation. While overall procedural...
Endocardial LAAO has been increasingly utilized in atrial fibrillation (AF) patients who are not suitable for long term oral anticoagulation. While overall procedural complications have decreased, rare complications like contiguous vessel and valve injury may be more frequently seen in the future with increase in the procedure volume. We performed a systematic search using predefined terms which reviewed all cases published in literature of contiguous vessel (pulmonary artery, pulmonary vein and left circumflex artery) and mitral valve injury caused by LAAO devices. Our results showed that Amplatzer Cardiac Plug (ACP) and Amplatzer Amulet devices were the most commonly used devices. Pulmonary artery perforation was the most commonly seen collateral vessel injury associated with LAAO. Close proximity of left atrial appendage to pulmonary artery was noted in all cases of pulmonary artery injury. Pulmonary artery injury commonly manifests as pericardial tamponade with hemodynamic collapse and is often fatal. Most common denominator of all the reviewed cases was the presence of an oversized LAAO device. In conclusion, collateral vessels and valve injury can be seen after LAAO mostly with double lobe devices such as ACP or Amulet. Increased awareness by the operators along with proper imaging and investigations could potentially mitigate such rare complications associated with LAAO.
PubMed: 32002118
DOI: 10.4022/jafib.2256 -
Journal of Human Nutrition and... Jun 2020The aim of this project was to systematically review UK evidence on the effectiveness of long-term (≥12 months) weight management services (WMSs) for weight loss and...
INTRODUCTION
The aim of this project was to systematically review UK evidence on the effectiveness of long-term (≥12 months) weight management services (WMSs) for weight loss and weight maintenance for adults (≥16 years) with severe obesity (body mass index ≥35 kg m ), who would generally be eligible for Tier 3 services.
METHODS
Four data sources were searched from 1999 to October 2018.
RESULTS
Our searches identified 20 studies, mostly noncomparative studies: 10 primary care interventions, nine in secondary care specialist weight management clinics and one commercial setting intervention. A programme including a phase of low energy formula diet (810-833 kcal day ) showed the largest mean (SD) weight change at 12 months of -12.4 (11.4) kg for complete cases, with 25.3% dropout. Limitations or differences in evaluation and reporting (particularly for denominators), unclear dropout rates, and differences between participant groups in terms of comorbidities and psychological characteristics, made comparisons between WMSs and inferences challenging.
CONCLUSIONS
There is a persistent and clear need for guidance on long-term weight data collection and reporting methods to allow comparisons across studies and services for participants with severe obesity. Data could also include quality of life, clinical outcomes, adverse events, costs and economic outcomes. A randomised trial comparison of National Health Service Tier 3 services with commercial WMSs would be of value.
Topics: Adolescent; Adult; Bariatrics; Behavior Therapy; Body Mass Index; Diet, Reducing; Female; Humans; Male; Middle Aged; Obesity, Morbid; State Medicine; Treatment Outcome; United Kingdom; Weight Reduction Programs; Young Adult
PubMed: 32027072
DOI: 10.1111/jhn.12732 -
BMJ Open Jan 2020To synthesise international evidence for demand, use and outcomes of primary care out-of-hours health services (OOHS).
OBJECTIVE
To synthesise international evidence for demand, use and outcomes of primary care out-of-hours health services (OOHS).
DESIGN
Systematic scoping review.
DATA SOURCES
CINAHL; Medline; PsyARTICLES; PsycINFO; SocINDEX; and Embase from 1995 to 2019.
STUDY SELECTION
English language studies in UK or similar international settings, focused on services in or directly impacting primary care.
RESULTS
105 studies included: 54% from mainland Europe/Republic of Ireland; 37% from UK. Most focused on general practitioner-led out-of-hours cooperatives. Evidence for increasing patient demand over time was weak due to data heterogeneity, infrequent reporting of population denominators and little adjustment for population sociodemographics. There was consistent evidence of higher OOHS use in the evening compared with overnight, at weekends and by certain groups (children aged <5, adults aged >65, women, those from socioeconomically deprived areas, with chronic diseases or mental health problems). Contact with OOHS was driven by problems perceived as urgent by patients. Respiratory, musculoskeletal, skin and abdominal symptoms were the most common reasons for contact in adults; fever and gastrointestinal symptoms were the most common in the under-5s. Frequent users of daytime services were also frequent OOHS users; difficulty accessing daytime services was also associated with OOHS use. There is some evidence to suggest that OOHS colocated in emergency departments (ED) can reduce demand in EDs.
CONCLUSIONS
Policy changes have impacted on OOHS over the past two decades. While there are generalisable lessons, a lack of comparable data makes it difficult to judge how demand has changed over time. Agreement on collection of OOHS data would allow robust comparisons within and across countries and across new models of care. Future developments in OOHS should also pay more attention to the relationship with daytime primary care and other services.
PROSPERO REGISTRATION NUMBER
CRD42015029741.
Topics: After-Hours Care; Emergencies; General Practitioners; Health Services Needs and Demand; Humans; Primary Health Care
PubMed: 31959608
DOI: 10.1136/bmjopen-2019-033481