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The Cochrane Database of Systematic... Jul 2018Recurrent corneal erosion is a common cause of disabling ocular symptoms and predisposes the cornea to infection. It may follow corneal trauma. Measures to prevent the... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Recurrent corneal erosion is a common cause of disabling ocular symptoms and predisposes the cornea to infection. It may follow corneal trauma. Measures to prevent the development of recurrent corneal erosion following corneal trauma have not been firmly established. Once recurrent corneal erosion develops, simple medical therapy (standard treatment) may lead to resolution of the episode. However, some people continue to suffer when such therapy fails and repeated episodes of erosion develop. A number of treatment and prophylactic options are then available but there is no agreement as to the best option. This review version is an update to the original version published in 2007 and a previous update published in 2012.
OBJECTIVES
To assess the effectiveness and adverse effects of regimens for the prophylaxis of further recurrent corneal erosion episodes, the treatment of recurrent corneal erosion and prophylaxis of the development of recurrent corneal erosion following trauma.
SEARCH METHODS
We searched CENTRAL, which contains the Cochrane Eyes and Vision Trials Register; MEDLINE; Embase; LILACS; the ISRCTN registry; ClinicalTrials.gov and the ICTRP. The date of the search was 14 December 2017.
SELECTION CRITERIA
We included randomised and quasi-randomised trials that compared a prophylactic or treatment regimen with another prophylaxis/treatment or no prophylaxis/treatment for people with recurrent corneal erosion.
DATA COLLECTION AND ANALYSIS
We used standard methods expected by Cochrane. Two authors independently screened search results, extracted data and assessed risk of bias in the included studies using the Cochrane tool for assessing risk of bias. We considered the following outcome measures: resolution of symptoms after treatment; recurrence after complete or partial resolution; symptoms (pain); adverse effects (corneal haze, astigmatism). We graded the certainty of the evidence using GRADE for the three most clinically relevant comparisons.
MAIN RESULTS
We included eight randomised and two quasi-randomised controlled trials in the review, encompassing 505 participants. Seven studies were from Europe (Germany, Sweden and the UK), two from East Asia (Hong Kong and Japan) and one from Australia. Nine of the studies examined treatments for episodes of recurrent corneal erosions and one study considered prophylaxis to prevent development of recurrent corneal erosions after injury. Two of the nine treatment studies also enrolled participants in a study of prophylaxis to prevent further episodes of recurrent corneal erosions. The studies were poorly reported; we judged only one study low risk of bias on all domains.Two studies compared therapeutic contact lens with topical lubrication but one of these studies was published over 30 years ago and used a therapeutic contact lens that is no longer in common use. The more recent study was a two-centre UK study with 29 participants. It provided low-certainty evidence on resolution of symptoms after treatment with similar number of participants in both groups experiencing resolution of symptoms at four months (risk ratio (RR) 0.97, 95% confidence interval (CI) 0.62 to 1.53). There was very low-certainty evidence on recurrence after partial or total resolution at seven months' follow-up (RR 1.07, 95% CI 0.07 to 15.54). There was no evidence of an important difference in pain score (score of 3 in the contact lens group and score of 2 in the topical lubrication group, low-certainty evidence) and no adverse effects were reported. The older study, using a contact lens no longer in common use, found an increased risk of pain and complications with the contact lens compared with hypromellose drops and paraffin ointment at night.A single-centre, Australian study, with 33 participants, provided low-certainty evidence of an increased risk of recurrence with phototherapeutic keratectomy compared with alcohol delamination but with wide confidence intervals, compatible with increased or decreased risk (RR 1.27, 95% CI 0.48 to 3.37). Time to recurrence was similar in both groups (6.5 and 6 months, low-certainty evidence). On average people receiving phototherapeutic keratectomy reported less pain but confidence intervals included no difference or greater pain (mean difference (MD) -0.70, 95% CI -2.23 to 0.83, low-certainty evidence). No adverse effects were reported.A 48-participant study in Hong Kong found recurrences were less common in people given diamond burr superficial keratectomy after epithelial debridement compared with sham diamond burr treatment after epithelial debridement (RR 0.07, 95% CI 0.01 to 0.50, moderate-certainty evidence). The study did not report pain scores but adverse effects such as corneal haze (RR 0.92, 95% CI 0.06 to 13.87, low-certainty evidence) and astigmatism (0.88 versus 0.44 dioptres, moderate-certainty evidence) were similar between the groups.A study comparing transepithelial versus subepithelial excimer laser ablation in 100 people found low-certainty evidence of a small increased risk of recurrence of corneal erosion at one-year follow-up in people given the transepithelial compared with subepithelial technique, however, the confidence intervals were wide and compatible with increased or decreased risk (RR 1.20, 95% CI 0.58 to 2.48, low-certainty evidence). Other outcomes were not reported.Other treatment comparisons included in this review were only addressed by studies published two decades or more ago. The results of these studies were inconclusive: excimer laser ablation (after epithelial debridement) versus no excimer laser ablation (after epithelial debridement), epithelial debridement versus anterior stromal puncture, anterior stromal puncture versus therapeutic contact lens, oral oxytetracycline and topical prednisolone (in addition to 'standard therapy') versus oral oxytetracycline (in addition to 'standard therapy') versus 'standard therapy'.
AUTHORS' CONCLUSIONS
Well-designed, masked, randomised controlled trials using standardised methods are needed to establish the benefits of new and existing prophylactic and treatment regimes for recurrent corneal erosion. Studies included in this review have been of insufficient size and quality to provide firm evidence to inform the development of management guidelines. International consensus is also needed to progress research efforts towards evaluation of the major effective treatments for recurrent corneal erosions.
Topics: Anti-Bacterial Agents; Contact Lenses; Corneal Diseases; Corneal Injuries; Debridement; Eye Infections; Glucocorticoids; Humans; Keratectomy; Lubricant Eye Drops; Pain Measurement; Prednisolone; Randomized Controlled Trials as Topic; Recurrence; Secondary Prevention; Tetracycline
PubMed: 29985545
DOI: 10.1002/14651858.CD001861.pub4 -
Medicine Sep 2017Placental transmogrification of the lung (PTL) is rare cystic lesion. Thus, we summarized the characteristics of PTL to explore the strategy of diagnosis and treatment. (Review)
Review
OBJECTIVE
Placental transmogrification of the lung (PTL) is rare cystic lesion. Thus, we summarized the characteristics of PTL to explore the strategy of diagnosis and treatment.
METHODS
Two patients pathologically confirmed PTL were treated in our hospital. Retrospectively analysis was performed on such 2 cases and 34 cases of PTL reported in abroad. The basic information and clinical characteristics from each patient were gathered and analyzed.
RESULTS
The imaging findings of 2 patients were the pulmonary solid mass with peripheral multiple pulmonary bullae. After the improvement of preoperative examination and the multidisciplinary discussion of thoracic surgery, respiration, imaging, and anesthesia, the possibility of benign pulmonary lesions was improved in all cases. Thoracoscopic lobectomy was carried out under general anesthesia, and the intraoperative frozen pathology showed bullae of lung. Ultimately, PTL was confirmed by paraffin pathological diagnosis. Both 2 PTL patients had satisfied recovery without obvious complications or imaging abnormalities. In addition, the literature review of 34 PTL cases from PubMed database was summarized between 1995 and 2015. A total of 36 patients were retrospectively analyzed in our study. The age of 34 cases ranged from 24 to 72 years (an average age of 45.6 ± 13.5 years). Among these, 8 cases were no obvious symptoms. In addition, the other 25 cases had respiratory symptoms such as chest tightness, cough, and chest pain. Moreover, the mean size of pulmonary bulla was 6.5 ± 5.5 cm. The size of the solid lesions in 23 cases was 3.3 ± 3.4 cm (ranging from 0.5 to 15). The follow-up period was 2 to 96 months (average 27.3 ± 29.8 months).
CONCLUSION
Early diagnosis and surgical operation of PTL should be performed as soon as possible. These lesions are best treated by minimally invasive surgery, so as to preserve more normal lung tissue and avoid the pneumonectomy.
Topics: Adult; Diagnosis, Differential; Female; Humans; Lung Diseases; Male; Middle Aged; Pneumonectomy; Tomography, X-Ray Computed
PubMed: 28858088
DOI: 10.1097/MD.0000000000007733 -
The Cochrane Database of Systematic... Jul 2017Burn wounds cause high levels of morbidity and mortality worldwide. People with burns are particularly vulnerable to infections; over 75% of all burn deaths (after... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Burn wounds cause high levels of morbidity and mortality worldwide. People with burns are particularly vulnerable to infections; over 75% of all burn deaths (after initial resuscitation) result from infection. Antiseptics are topical agents that act to prevent growth of micro-organisms. A wide range are used with the intention of preventing infection and promoting healing of burn wounds.
OBJECTIVES
To assess the effects and safety of antiseptics for the treatment of burns in any care setting.
SEARCH METHODS
In September 2016 we searched the Cochrane Wounds Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE, Ovid MEDLINE (In-Process & Other Non-Indexed Citations), Ovid Embase, and EBSCO CINAHL. We also searched three clinical trials registries and references of included studies and relevant systematic reviews. There were no restrictions based on language, date of publication or study setting.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) that enrolled people with any burn wound and assessed the use of a topical treatment with antiseptic properties.
DATA COLLECTION AND ANALYSIS
Two review authors independently performed study selection, risk of bias assessment and data extraction.
MAIN RESULTS
We included 56 RCTs with 5807 randomised participants. Almost all trials had poorly reported methodology, meaning that it is unclear whether they were at high risk of bias. In many cases the primary review outcomes, wound healing and infection, were not reported, or were reported incompletely.Most trials enrolled people with recent burns, described as second-degree and less than 40% of total body surface area; most participants were adults. Antiseptic agents assessed were: silver-based, honey, Aloe Vera, iodine-based, chlorhexidine or polyhexanide (biguanides), sodium hypochlorite, merbromin, ethacridine lactate, cerium nitrate and Arnebia euchroma. Most studies compared antiseptic with a topical antibiotic, primarily silver sulfadiazine (SSD); others compared antiseptic with a non-antibacterial treatment or another antiseptic. Most evidence was assessed as low or very low certainty, often because of imprecision resulting from few participants, low event rates, or both, often in single studies. Antiseptics versus topical antibioticsCompared with the topical antibiotic, SSD, there is low certainty evidence that, on average, there is no clear difference in the hazard of healing (chance of healing over time), between silver-based antiseptics and SSD (HR 1.25, 95% CI 0.94 to 1.67; I = 0%; 3 studies; 259 participants); silver-based antiseptics may, on average, increase the number of healing events over 21 or 28 days' follow-up (RR 1.17 95% CI 1.00 to 1.37; I = 45%; 5 studies; 408 participants) and may, on average, reduce mean time to healing (difference in means -3.33 days; 95% CI -4.96 to -1.70; I = 87%; 10 studies; 979 participants).There is moderate certainty evidence that, on average, burns treated with honey are probably more likely to heal over time compared with topical antibiotics (HR 2.45, 95% CI 1.71 to 3.52; I = 66%; 5 studies; 140 participants).There is low certainty evidence from single trials that sodium hypochlorite may, on average, slightly reduce mean time to healing compared with SSD (difference in means -2.10 days, 95% CI -3.87 to -0.33, 10 participants (20 burns)) as may merbromin compared with zinc sulfadiazine (difference in means -3.48 days, 95% CI -6.85 to -0.11, 50 relevant participants). Other comparisons with low or very low certainty evidence did not find clear differences between groups.Most comparisons did not report data on infection. Based on the available data we cannot be certain if antiseptic treatments increase or reduce the risk of infection compared with topical antibiotics (very low certainty evidence). Antiseptics versus alternative antisepticsThere may be some reduction in mean time to healing for wounds treated with povidone iodine compared with chlorhexidine (MD -2.21 days, 95% CI 0.34 to 4.08). Other evidence showed no clear differences and is of low or very low certainty. Antiseptics versus non-antibacterial comparatorsWe found high certainty evidence that treating burns with honey, on average, reduced mean times to healing in comparison with non-antibacterial treatments (difference in means -5.3 days, 95% CI -6.30 to -4.34; I = 71%; 4 studies; 1156 participants) but this comparison included some unconventional treatments such as amniotic membrane and potato peel. There is moderate certainty evidence that honey probably also increases the likelihood of wounds healing over time compared to unconventional anti-bacterial treatments (HR 2.86, 95% C 1.60 to 5.11; I = 50%; 2 studies; 154 participants).There is moderate certainty evidence that, on average, burns treated with nanocrystalline silver dressings probably have a slightly shorter mean time to healing than those treated with Vaseline gauze (difference in means -3.49 days, 95% CI -4.46 to -2.52; I = 0%; 2 studies, 204 participants), but low certainty evidence that there may be little or no difference in numbers of healing events at 14 days between burns treated with silver xenograft or paraffin gauze (RR 1.13, 95% CI 0.59 to 2.16 1 study; 32 participants). Other comparisons represented low or very low certainty evidence.It is uncertain whether infection rates in burns treated with either silver-based antiseptics or honey differ compared with non-antimicrobial treatments (very low certainty evidence). There is probably no difference in infection rates between an iodine-based treatment compared with moist exposed burn ointment (moderate certainty evidence). It is also uncertain whether infection rates differ for SSD plus cerium nitrate, compared with SSD alone (low certainty evidence).Mortality was low where reported. Most comparisons provided low certainty evidence that there may be little or no difference between many treatments. There may be fewer deaths in groups treated with cerium nitrate plus SSD compared with SSD alone (RR 0.22, 95% CI 0.05 to 0.99; I = 0%, 2 studies, 214 participants) (low certainty evidence).
AUTHORS' CONCLUSIONS
It was often uncertain whether antiseptics were associated with any difference in healing, infections, or other outcomes. Where there is moderate or high certainty evidence, decision makers need to consider the applicability of the evidence from the comparison to their patients. Reporting was poor, to the extent that we are not confident that most trials are free from risk of bias.
Topics: Adult; Anti-Bacterial Agents; Anti-Infective Agents, Local; Apitherapy; Bacterial Infections; Bandages; Burns; Chlorhexidine; Disinfectants; Honey; Humans; Merbromin; Plant Preparations; Povidone-Iodine; Randomized Controlled Trials as Topic; Silver Sulfadiazine; Sodium Hypochlorite; Sulfadiazine; Wound Healing
PubMed: 28700086
DOI: 10.1002/14651858.CD011821.pub2 -
In Vivo (Athens, Greece) Jan 2017Mutations in the epidermal growth factor receptor (EGFR) tyrosine kinase domain (TKD) are associated with response and resistance to targeted therapy. The EGFR mutation... (Review)
Review
BACKGROUND
Mutations in the epidermal growth factor receptor (EGFR) tyrosine kinase domain (TKD) are associated with response and resistance to targeted therapy. The EGFR mutation status in patients with advanced oral and oropharyngeal squamous cell carcinoma (OOSCC) was evaluated. A systematic literature review was undertaken to summarize current evidence and estimate the overall prevalence of EGFR TKD mutations in patients with head and neck squamous cell carcinoma (HNSCC).
MATERIALS AND METHODS
Genomic DNA was extracted from formalin-fixed, paraffin-embedded tumor samples of 113 patients with OOSCC. Pyrosequencing was performed to investigate mutations in EGFR exons 18 to 21. Medline databases were searched for relevant studies. Studies reporting mutations in the EGFR TKD in HNSCC were eligible for inclusion in the systematic review.
RESULTS
No mutations in the EGFR TKD were observed in 113 samples of OOSCC. A total of 53 eligible studies were included in the systematic review. In total, from the review, 117 patients harboring a total of 159 EGFR TKD mutations were reported among 4122 patients with HNSCC. The overall prevalence of EGFR TKD mutations in HNSCC was 2.8%.
CONCLUSION
Large-scale studies are warranted to provide further evidence regarding the mutation status of EGFR in patients with HNSCC.
Topics: Carcinoma, Squamous Cell; ErbB Receptors; Female; Head and Neck Neoplasms; Humans; Male; Middle Aged; Mutation; Neoplasm Staging; Polymerase Chain Reaction; Prognosis; Retrospective Studies; Survival Rate
PubMed: 28064216
DOI: 10.21873/invivo.11020 -
The Cochrane Database of Systematic... Aug 2016Constipation within childhood is an extremely common problem. Despite the widespread use of osmotic and stimulant laxatives by health professionals to manage... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Constipation within childhood is an extremely common problem. Despite the widespread use of osmotic and stimulant laxatives by health professionals to manage constipation in children, there has been a long standing paucity of high quality evidence to support this practice.
OBJECTIVES
We set out to evaluate the efficacy and safety of osmotic and stimulant laxatives used to treat functional childhood constipation.
SEARCH METHODS
We searched MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, and the Cochrane IBD Group Specialized Trials Register from inception to 10 March 2016. There were no language restrictions. We also searched the references of all included studies, personal contacts and drug companies to identify studies.
SELECTION CRITERIA
Randomised controlled trials (RCTs) which compared osmotic or stimulant laxatives to placebo or another intervention, with participants aged 0 to 18 years old were considered for inclusion. The primary outcome was frequency of defecation. Secondary endpoints included faecal incontinence, disimpaction, need for additional therapies and adverse events.
DATA COLLECTION AND ANALYSIS
Relevant papers were identified and two authors independently assessed the eligibility of trials, extracted data and assessed methodological quality using the Cochrane risk of bias tool. The primary outcome was frequency of defecation. Secondary endpoints included faecal incontinence, disimpaction, need for additional therapies and adverse events. For continuous outcomes we calculated the mean difference (MD) and 95% confidence interval (CI) using a fixed-effect model. For dichotomous outcomes we calculated the risk ratio (RR) and 95% CI using a fixed-effect model. The Chi(2) and I(2) statistics were used to assess statistical heterogeneity. A random-effects model was used in situations of unexplained heterogeneity. We assessed the overall quality of the evidence supporting the primary and secondary outcomes using the GRADE criteria.
MAIN RESULTS
Twenty-five RCTs (2310 participants) were included in the review. Fourteen studies were judged to be at high risk of bias due to lack of blinding, incomplete outcome data and selective reporting. Meta-analysis of two studies (101 patients) comparing polyethylene glycol (PEG) with placebo showed a significantly increased number of stools per week with PEG (MD 2.61 stools per week, 95% CI 1.15 to 4.08). Common adverse events in the placebo-controlled studies included flatulence, abdominal pain, nausea, diarrhoea and headache. Participants receiving high dose PEG (0.7 g/kg) had significantly more stools per week than low dose PEG (0.3 g/kg) participants (1 study, 90 participants, MD 1.30, 95% 0.76 to 1.84). Meta-analysis of 6 studies with 465 participants comparing PEG with lactulose showed a significantly greater number of stools per week with PEG (MD 0.70 , 95% CI 0.10 to 1.31), although follow-up was short. Patients who received PEG were significantly less likely to require additional laxative therapies. Eighteen per cent (27/154) of PEG patients required additional therapies compared to 31% (47/150) of lactulose patients (RR 0.55, 95% CI 0.36 to 0.83). No serious adverse events were reported with either agent. Common adverse events in these studies included diarrhoea, abdominal pain, nausea, vomiting and pruritis ani. Meta-analysis of 3 studies with 211 participants comparing PEG with milk of magnesia showed that the stools per week were significantly greater with PEG (MD 0.69, 95% CI 0.48 to 0.89). However, the magnitude of this difference was quite small and may not be clinically significant. One child was noted to be allergic to PEG, but there were no other serious adverse events reported. One study found a significant difference in stools per week favouring milk of magnesia over lactulose (MD -1.51, 95% CI -2.63 to -0.39, 50 patients), Meta-analysis of 2 studies with 287 patients comparing liquid paraffin (mineral oil) with lactulose revealed a relatively large statistically significant difference in the number of stools per week favouring liquid paraffin (MD 4.94 , 95% CI 4.28 to 5.61). No serious adverse events were reported. Adverse events included abdominal pain, distention and watery stools. No statistically significant differences in the number of stools per week were found between PEG and enemas (1 study, 90 patients, MD 1.00, 95% CI -1.58 to 3.58), dietary fibre mix and lactulose (1 study, 125 patients, P = 0.481), senna and lactulose (1 study, 21 patients, P > 0.05), lactitol and lactulose (1 study, 51 patients, MD -0.80, 95% CI -2.63 to 1.03), hydrolyzed guar gum and lactulose (1 study, 61 patients, MD 1.00, 95% CI -1.80 to 3.80), PEG and flixweed (1 study, 109 patients, MD 0.00, 95% CI -0.33 to 0.33), PEG and dietary fibre (1 study, 83 patients, MD 0.20, 95% CI -0.64 to 1.04), and PEG and liquid paraffin (2 studies, 261 patients, MD 0.35, 95% CI -0.24 to 0.95).
AUTHORS' CONCLUSIONS
The pooled analyses suggest that PEG preparations may be superior to placebo, lactulose and milk of magnesia for childhood constipation. GRADE analyses indicated that the overall quality of the evidence for the primary outcome (number of stools per week) was low or very low due to sparse data, inconsistency (heterogeneity), and high risk of bias in the studies in the pooled analyses. Thus, the results of the pooled analyses should be interpreted with caution because of quality and methodological concerns, as well as clinical heterogeneity, and short follow-up. There is also evidence suggesting the efficacy of liquid paraffin (mineral oil). There is no evidence to demonstrate the superiority of lactulose when compared to the other agents studied, although there is a lack of placebo controlled studies. Further research is needed to investigate the long term use of PEG for childhood constipation, as well as the role of liquid paraffin. The optimal dose of PEG also warrants further investigation.
Topics: Adolescent; Child; Child, Preschool; Constipation; Defecation; Dietary Fiber; Enema; Female; Humans; Infant; Infant, Newborn; Lactulose; Laxatives; Magnesium Hydroxide; Male; Mineral Oil; Osmosis; Polyethylene Glycols; Randomized Controlled Trials as Topic; Senna Extract; Sennosides; Treatment Outcome
PubMed: 27531591
DOI: 10.1002/14651858.CD009118.pub3 -
The Cochrane Database of Systematic... Mar 2016Women with suspected early-stage ovarian cancer need surgical staging which involves taking samples from areas within the abdominal cavity and retroperitoneal lymph... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Women with suspected early-stage ovarian cancer need surgical staging which involves taking samples from areas within the abdominal cavity and retroperitoneal lymph nodes in order to inform further treatment. One potential strategy is to surgically stage all women with suspicious ovarian masses, without any histological information during surgery. This avoids incomplete staging, but puts more women at risk of potential surgical over-treatment.A second strategy is to perform a two-stage procedure to remove the pelvic mass and subject it to paraffin sectioning, which involves formal tissue fixing with formalin and paraffin embedding, prior to ultrathin sectioning and multiple site sampling of the tumour. Surgeons may then base further surgical staging on this histology, reducing the rate of over-treatment, but conferring additional surgical and anaesthetic morbidity.A third strategy is to perform a rapid histological analysis on the ovarian mass during surgery, known as 'frozen section'. Tissues are snap frozen to allow fine tissue sections to be cut and basic histochemical staining to be performed. Surgeons can perform or avoid the full surgical staging procedure depending on the results. However, this is a relatively crude test compared to paraffin sections, which take many hours to perform. With frozen section there is therefore a risk of misdiagnosing malignancy and understaging women subsequently found to have a presumed early-stage malignancy (false negative), or overstaging women without a malignancy (false positive). Therefore it is important to evaluate the accuracy and usefulness of adding frozen section to the clinical decision-making process.
OBJECTIVES
To assess the diagnostic test accuracy of frozen section (index test) to diagnose histopathological ovarian cancer in women with suspicious pelvic masses as verified by paraffin section (reference standard).
SEARCH METHODS
We searched MEDLINE (January 1946 to January 2015), EMBASE (January 1980 to January 2015) and relevant Cochrane registers.
SELECTION CRITERIA
Studies that used frozen section for intraoperative diagnosis of ovarian masses suspicious of malignancy, provided there was sufficient data to construct 2 x 2 tables. We excluded articles without an available English translation.
DATA COLLECTION AND ANALYSIS
Authors independently assessed the methodological quality of included studies using the Quality Assessment of Diagnostic Accuracy Studies tool (QUADAS-2) domains: patient selection, index test, reference standard, flow and timing. Data extraction converted 3 x 3 tables of per patient results presented in articles into 2 x 2 tables, for two index test thresholds.
MAIN RESULTS
All studies were retrospective, and the majority reported consecutive sampling of cases. Sensitivity and specificity results were available from 38 studies involving 11,181 participants (3200 with invasive cancer, 1055 with borderline tumours and 6926 with benign tumours, determined by paraffin section as the reference standard). The median prevalence of malignancy was 29% (interquartile range (IQR) 23% to 36%, range 11% to 63%). We assessed test performance using two thresholds for the frozen section test. Firstly, we used a test threshold for frozen sections, defining positive test results as invasive cancer and negative test results as borderline and benign tumours. The average sensitivity was 90.0% (95% confidence interval (CI) 87.6% to 92.0%; with most studies typically reporting range of 71% to 100%), and average specificity was 99.5% (95% CI 99.2% to 99.7%; range 96% to 100%).Similarly, we analysed sensitivity and specificity using a second threshold for frozen section, where both invasive cancer and borderline tumours were considered test positive and benign cases were classified as negative. Average sensitivity was 96.5% (95% CI 95.5% to 97.3%; typical range 83% to 100%), and average specificity was 89.5% (95% CI 86.6% to 91.9%; typical range 58% to 99%).Results were available from the same 38 studies, including the subset of 3953 participants with a frozen section result of either borderline or invasive cancer, based on final diagnosis of malignancy. Studies with small numbers of disease-negative cases (borderline cases) had more variation in estimates of specificity. Average sensitivity was 94.0% (95% CI 92.0% to 95.5%; range 73% to 100%), and average specificity was 95.8% (95% CI 92.4% to 97.8%; typical range 81% to 100%).Our additional analyses showed that, if the frozen section showed a benign or invasive cancer, the final diagnosis would remain the same in, on average, 94% and 99% of cases, respectively.In cases where the frozen section diagnosis was a borderline tumour, on average 21% of the final diagnoses would turn out to be invasive cancer.In three studies, the same pathologist interpreted the index and reference standard tests, potentially causing bias. No studies reported blinding pathologists to index test results when reporting paraffin sections.In heterogeneity analyses, there were no statistically significant differences between studies with pathologists of different levels of expertise.
AUTHORS' CONCLUSIONS
In a hypothetical population of 1000 patients (290 with cancer and 80 with a borderline tumour), if a frozen section positive test result for invasive cancer alone was used to diagnose cancer, on average 261 women would have a correct diagnosis of a cancer, and 706 women would be correctly diagnosed without a cancer. However, 4 women would be incorrectly diagnosed with a cancer (false positive), and 29 with a cancer would be missed (false negative).If a frozen section result of either an invasive cancer or a borderline tumour was used as a positive test to diagnose cancer, on average 280 women would be correctly diagnosed with a cancer and 635 would be correctly diagnosed without. However, 75 women would be incorrectly diagnosed with a cancer and 10 women with a cancer would be missed.The largest discordance is within the reporting of frozen section borderline tumours. Investigation into factors leading to discordance within centres and standardisation of criteria for reporting borderline tumours may help improve accuracy. Some centres may choose to perform surgical staging in women with frozen section diagnosis of a borderline ovarian tumour to reduce the number of false positives. In their interpretation of this review, readers should evaluate results from studies most typical of their population of patients.
Topics: Diagnostic Errors; False Negative Reactions; False Positive Reactions; Female; Frozen Sections; Humans; Intraoperative Period; Neoplasm Staging; Ovarian Neoplasms; Paraffin Embedding; Pelvic Neoplasms; Retrospective Studies; Sensitivity and Specificity
PubMed: 26930463
DOI: 10.1002/14651858.CD010360.pub2 -
The Cochrane Database of Systematic... Sep 2015Venous ulcers (also known as varicose or venous stasis ulcers) are a chronic, recurring and debilitating condition that affects up to 1% of the population. Best practice... (Review)
Review
BACKGROUND
Venous ulcers (also known as varicose or venous stasis ulcers) are a chronic, recurring and debilitating condition that affects up to 1% of the population. Best practice documents and expert opinion suggests that the removal of devitalised tissue from venous ulcers (debridement) by any one of six methods helps to promote healing. However, to date there has been no review of the evidence from randomised controlled trials (RCTs) to support this.
OBJECTIVES
To determine the effects of different debriding methods or debridement versus no debridement, on the rate of debridement and wound healing in venous leg ulcers.
SEARCH METHODS
In February 2015 we searched: The Cochrane Wounds Group Specialised Register; The Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid EMBASE and EBSCO CINAHL. There were no restrictions with respect to language, date of publication or study setting. In addition we handsearched conference proceedings, journals not cited in MEDLINE, and the bibliographies of all retrieved publications to identify potential studies. We made contact with the pharmaceutical industry to enquire about any completed studies.
SELECTION CRITERIA
We included RCTs, either published or unpublished, which compared two methods of debridement or compared debridement with no debridement. We presented study results in a narrative form, as meta-analysis was not possible.
DATA COLLECTION AND ANALYSIS
Independently, two review authors completed all study selection, data extraction and assessment of trial quality; resolution of disagreements was completed by a third review author.
MAIN RESULTS
We identified 10 RCTs involving 715 participants. Eight RCTs evaluated autolytic debridement and included the following agents or dressings: biocellulose wound dressing (BWD), non-adherent dressing, honey gel, hydrogel (gel formula), hydrofibre dressing, hydrocolloid dressings, dextranomer beads, Edinburgh University Solution of Lime (EUSOL) and paraffin gauze. Two RCTs evaluated enzymatic preparations and one evaluated biosurgical debridement. No RCTs evaluated surgical, sharp or mechanical methods of debridement, or debridement versus no debridement. Most trials were at a high risk of bias.Three RCTs assessed the number of wounds completely debrided. All three of these trials compared two different methods of autolytic debridement (234 participants), with two studies reporting statistically significant results: one study (100 participants) reported that 40/50 (80%) ulcers treated with dextranomer beads and 7/50 (14%) treated with EUSOL achieved complete debridement (RR 5.71, 95% CI 2.84 to 11.52); while the other trial (86 participants) reported the number of ulcers completely debrided as 31/46 (76%) for hydrogel versus 18/40 (45%) for paraffin gauze (RR 0.67, 95% CI 0.45 to 0.99). One study (48 participants) reported that by 12 weeks, 15/18 (84%) ulcers treated with BWD had achieved a 75% to 100% clean, granulating wound bed versus 4/15 (26%) treated with non-adherent petrolatum emulsion-impregnated gauze.Four trials assessed the mean time to achieve debridement: one (86 participants) compared two autolytic debridement methods, two compared autolytic methods with enzymatic debridement (71 participants), and the last (12 participants) compared autolytic with biosurgical debridement; none of the results achieved statistical significance.Two trials that assessed autolytic debridement methods reported the number of wounds healed at 12 weeks. One trial (108 participants) reported that 24/54 (44%) ulcers treated with honey healed versus 18/54 (33%) treated with hydrogel (RR (adjusted for baseline wound diameter) 1.38, 95% CI 1.02 to 1.88; P value 0.037). The second trial (48 participants) reported that 7/25 (28%) ulcers treated with BWD healed versus 7/23 (30%) treated with non-adherent dressing.Reduction in wound size was assessed in five trials (444 participants) in which two autolytic methods were compared. Results were statistically significant in one three-armed trial (153 participants) when cadexomer iodine was compared to paraffin gauze (mean difference 24.9 cm², 95% CI 7.27 to 42.53, P value 0.006) and hydrocolloid compared to paraffin gauze (mean difference 23.8 cm², 95% CI 5.48 to 42.12, P value 0.01). A second trial that assessed reduction in wound size based its results on median differences and, at four weeks, produced a statistically significantly result that favoured honey over hydrogel (P value < 0.001). The other three trials reported no statistically significant results for reduction in wound size, although one trial reported that the mean percentage reduction in wound area was greater at six and 12 weeks for BWD versus a non-adherent dressing (44% versus 24% week 6; 74% versus 54% week 12).Pain was assessed in six trials (544 participants) that compared two autolytic debridement methods, but the results were not statistically significant. No serious adverse events were reported in any trial.
AUTHORS' CONCLUSIONS
There is limited evidence to suggest that actively debriding a venous leg ulcer has a clinically significant impact on healing. The overall small number of participants, low number of studies and lack of meta-analysis in this review precludes any strong conclusions of benefit. Comparisons of different autolytic agents (hydrogel versus paraffin gauze; Dextranomer beads versus EUSOL and BWD versus non-adherent dressings) and Larvae versus hydrogel all showed statistically significant results for numbers of wounds debrided. Larger trials with follow up to healing are required.
Topics: Bandages, Hydrocolloid; Borates; Debridement; Humans; Hydrogel, Polyethylene Glycol Dimethacrylate; Randomized Controlled Trials as Topic; Sodium Hypochlorite; Varicose Ulcer; Wound Healing
PubMed: 26368002
DOI: 10.1002/14651858.CD008599.pub2 -
International Journal of Clinical and... 2015The hobnail variant of papillary thyroid carcinoma (PTC) is a rare, aggressive variant in which > 30% of the tumor cells have hobnail features. The clinical behavior and... (Review)
Review
The hobnail variant of papillary thyroid carcinoma (PTC) is a rare, aggressive variant in which > 30% of the tumor cells have hobnail features. The clinical behavior and pathologic characteristics of these tumors are still unclear due to the rarity of the entity. The present study aimed to investigate cytologic, clinical, pathological, and molecular features of the hobnail variant from our data and from the literature. We retrospectively retrieved 10 cases of hobnail variant from 2,904 consecutive PTC patients. Cytologic and histopathologic slides from those 10 patients were reviewed. We performed molecular analysis for BRAF, ALK, and TERT promoter mutations on paraffin blocks from surgical specimens, and further analyzed the clinicopathologic characteristics of all case reports published in the literature until now. Cytologically, all tumors were characterized by single cells with eccentric nuclei and tapering cytoplasm (comet-like cells), and syncytial or micropapillary clusters with apically placed nuclei resulting in a hobnail appearance in both conventional smears and liquid-based cytology. The BRAF V600E mutation was found in 8 cases (80%) whereas no cases had ALK fusion or TERT promoter mutations. In the literature review of 55 patients including our cases, most patients presented with advanced stage cancer, and disease-specific survival rates were 83%, 71%, and 54% at 5, 10, and 20 years after the initial surgery, respectively. Characteristic cytologic features can allow a preoperative diagnosis of the hobnail variant of PTC based on cytology specimens. Further studies should be performed to identify the molecular genetics of the variant.
Topics: Adult; Aged; Aged, 80 and over; Anaplastic Lymphoma Kinase; Biomarkers, Tumor; Biopsy; Carcinoma; Carcinoma, Papillary; DNA Mutational Analysis; Disease-Free Survival; Female; Genetic Predisposition to Disease; Humans; Immunohistochemistry; Male; Middle Aged; Mutation; Neoplasm Staging; Phenotype; Promoter Regions, Genetic; Proto-Oncogene Proteins B-raf; Receptor Protein-Tyrosine Kinases; Retrospective Studies; Survival Analysis; Telomerase; Thyroid Cancer, Papillary; Thyroid Neoplasms; Time Factors; Treatment Outcome; Young Adult
PubMed: 26339365
DOI: No ID Found -
The Cochrane Database of Systematic... May 2015This article describes the second update of a Cochrane review on the effectiveness of laxatives for the management of constipation in people receiving palliative care.... (Review)
Review
BACKGROUND
This article describes the second update of a Cochrane review on the effectiveness of laxatives for the management of constipation in people receiving palliative care. Previous versions were published in 2006 and 2010 where we also evaluated trials of methylnaltrexone; these trials have been removed as they are included in another review in press. In these earlier versions, we drew no conclusions on individual effectiveness of different laxatives because of the limited number of evaluations. This is despite constipation being common in palliative care, generating considerable suffering due to the unpleasant physical symptoms and the availability of a wide range of laxatives with known differences in effect in other populations.
OBJECTIVES
To determine the effectiveness and differential efficacy of laxatives used to manage constipation in people receiving palliative care.
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL; The Cochrane Library), MEDLINE, EMBASE, CINAHL and Web of Science (SCI & CPCI-S) for trials to September 2014.
SELECTION CRITERIA
Randomised controlled trials (RCTs) evaluating laxatives for constipation in people receiving palliative care.
DATA COLLECTION AND ANALYSIS
Two authors assessed trial quality and extracted data. The appropriateness of combining data from the studies depended upon clinical and outcome measure homogeneity.
MAIN RESULTS
We identified five studies involving the laxatives lactulose, senna, co-danthramer, misrakasneham, docusate and magnesium hydroxide with liquid paraffin. Overall, the study findings were at an unclear risk of bias. As all five studies compared different laxatives or combinations of laxatives, it was not possible to perform a meta-analysis. There was no evidence on whether individual laxatives were more effective than others or caused fewer adverse effects.
AUTHORS' CONCLUSIONS
This second update found that laxatives were of similar effectiveness but the evidence remains limited due to insufficient data from a few small RCTs. None of the studies evaluated polyethylene glycol or any intervention given rectally. There is a need for more trials to evaluate the effectiveness of laxatives in palliative care populations. Extrapolating findings on the effectiveness of laxatives evaluated in other populations should proceed with caution. This is because of the differences inherent in people receiving palliative care that may impact, in a likely negative way, on the effect of a laxative.
Topics: Analgesics, Opioid; Anthraquinones; Cathartics; Constipation; Humans; Lactulose; Magnesium Hydroxide; Naltrexone; Palliative Care; Paraffin; Quaternary Ammonium Compounds; Randomized Controlled Trials as Topic; Senna Extract
PubMed: 25967924
DOI: 10.1002/14651858.CD003448.pub4 -
Oncoimmunology Feb 2015Both IL-17 and Th17 cells have been ascribed tumor promoting as well as tumor suppressing functions. We reviewed the literature on correlations between IL-17 versus... (Review)
Review
Both IL-17 and Th17 cells have been ascribed tumor promoting as well as tumor suppressing functions. We reviewed the literature on correlations between IL-17 versus Th17 cells and survival in human cancer, following the PRISMA guidelines. Serum, formalin-fixed, paraffin-embedded (FFPE) tissue and peripheral blood samples were most frequently studied. High IL-17 quantities were correlated with poor prognosis, whereas high Th17 cell frequencies were correlated with improved prognosis. Since Th17 cells are a subpopulation of IL-17 cells and had a different correlation with prognosis than total IL-17, we substantiate that a distinction should be made between Th17 and other IL-17 cells.
PubMed: 25949881
DOI: 10.4161/2162402X.2014.984547