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1.
Cochrane Database Syst Rev ; 11: CD006318, 2020 11 09.
Article in English | MEDLINE | ID: mdl-33165953

ABSTRACT

BACKGROUND: The prevalence of opiate use among pregnant women can range from 1% to 2% to as high as 21%. Just in the United States alone, among pregnant women with hospital delivery, a fourfold increase in opioid use is reported from 1999 to 2014 (Haight 2018). Heroin crosses the placenta, and pregnant, opiate-dependent women experience a six-fold increase in maternal obstetric complications such as low birth weight, toxaemia, third trimester bleeding, malpresentation, puerperal morbidity, fetal distress and meconium aspiration. Neonatal complications include narcotic withdrawal, postnatal growth deficiency, microcephaly, neuro-behavioural problems, increased neonatal mortality and a 74-fold increase in sudden infant death syndrome. This is an updated version of the original Cochrane Review first published in 2008 and last updated in 2013. OBJECTIVES: To assess the effectiveness of any maintenance treatment alone or in combination with a psychosocial intervention compared to no intervention, other pharmacological intervention or psychosocial interventions alone for child health status, neonatal mortality, retaining pregnant women in treatment, and reducing the use of substances. SEARCH METHODS: We updated our searches of the following databases to February 2020: the Cochrane Drugs and Alcohol Group Specialised Register, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, and Web of Science. We also searched two trials registers and checked the reference lists of included studies for further references to relevant randomised controlled trials (RCTs). SELECTION CRITERIA: Randomised controlled trials which assessed the efficacy of any pharmacological maintenance treatment for opiate-dependent pregnant women. DATA COLLECTION AND ANALYSIS: We used the standard methodological procedures expected by Cochrane. MAIN RESULTS: We found four trials with 271 pregnant women. Three compared methadone with buprenorphine and one methadone with oral slow-release morphine. Three out of four studies had adequate allocation concealment and were double-blind. The major flaw in the included studies was attrition bias: three out of four had a high dropout rate (30% to 40%), and this was unbalanced between groups. Methadone versus buprenorphine: There was probably no evidence of a difference in the dropout rate from treatment (risk ratio (RR) 0.66, 95% confidence interval (CI) 0.37 to 1.20, three studies, 223 participants, moderate-quality evidence). There may be no evidence of a difference in the use of primary substances between methadone and buprenorphine (RR 1.81, 95% CI 0.70 to 4.68, two studies, 151 participants, low-quality evidence). Birth weight may be higher in the buprenorphine group in the two trials that reported data MD;-530.00 g, 95%CI -662.78 to -397.22 (one study, 19 particpants) and MD: -215.00 g, 95%CI -238.93 to -191.07 (one study, 131 participants) although the results could not be pooled due to very high heterogeneity (very low-quality of evidence). The third study reported that there was no evidence of a difference. We found there may be no evidence of a difference in the APGAR score (MD: 0.00, 95% CI -0.03 to 0.03, two studies,163 participants, low-quality evidence). Many measures were used in the studies to assess neonatal abstinence syndrome. The number of newborns treated for neonatal abstinence syndrome, which is the most critical outcome, may not differ between groups (RR 1.19, 95% CI 0.87 to1.63, three studies, 166 participants, low-quality evidence). Only one study which compared methadone with buprenorphine reported side effects. We found there may be no evidence of a difference in the number of mothers with serious adverse events (AEs) (RR 1.69, 95% CI 0.75 to 3.83, 175 participants, low-quality evidence) and we found there may be no difference in the numbers of newborns with serious AEs (RR 4.77, 95% CI 0.59, 38.49,131 participants, low-quality evidence). Methadone versus slow-release morphine: There were no dropouts in either treatment group. Oral slow-release morphine may be superior to methadone for abstinence from heroin use during pregnancy (RR 2.40, 95% CI 1.00 to 5.77, one study, 48 participants, low-quality evidence). In the comparison between methadone and slow-release morphine, no side effects were reported for the mother. In contrast, one child in the methadone group had central apnoea, and one child in the morphine group had obstructive apnoea (low-quality evidence). AUTHORS' CONCLUSIONS: Methadone and buprenorphine may be similar in efficacy and safety for the treatment of opioid-dependent pregnant women and their babies. There is not enough evidence to make conclusions for the comparison between methadone and slow-release morphine. Overall, the body of evidence is too small to make firm conclusions about the equivalence of the treatments compared. There is still a need for randomised controlled trials of adequate sample size comparing different maintenance treatments.


Subject(s)
Narcotics/therapeutic use , Opiate Substitution Treatment , Opioid-Related Disorders/rehabilitation , Pregnancy Complications/rehabilitation , Birth Weight/drug effects , Buprenorphine/adverse effects , Buprenorphine/therapeutic use , Delayed-Action Preparations/adverse effects , Delayed-Action Preparations/therapeutic use , Female , Humans , Infant , Infant, Newborn , Methadone/adverse effects , Methadone/therapeutic use , Morphine/adverse effects , Morphine/therapeutic use , Narcotics/adverse effects , Narcotics/agonists , Patient Dropouts/statistics & numerical data , Pregnancy , Randomized Controlled Trials as Topic
2.
United European Gastroenterol J ; 7(5): 614-641, 2019 06.
Article in English | MEDLINE | ID: mdl-31210941

ABSTRACT

The European Society of Gastrointestinal Endoscopy (ESGE) together with the United European Gastroenterology (UEG) recently developed a short list of performance measures for small-bowel endoscopy (i.e. small-bowel capsule endoscopy and device-assisted enteroscopy) with the final goal of providing endoscopy services across Europe with a tool for quality improvement. Six key performance measures both for small-bowel capsule endoscopy and for device-assisted enteroscopy were selected for inclusion, with the intention being that practice at both a service and endoscopist level should be evaluated against them. Other performance measures were considered to be less relevant, based on an assessment of their overall importance, scientific acceptability, and feasibility. Unlike lower and upper gastrointestinal endoscopy, for which performance measures had already been identified, this is the first time small-bowel endoscopy quality measures have been proposed.


Subject(s)
Capsule Endoscopy/standards , Endoscopy, Gastrointestinal/standards , Intestinal Diseases/pathology , Intestine, Small/pathology , Quality Improvement , Humans , Inflammatory Bowel Diseases/pathology
3.
Endoscopy ; 51(6): 574-598, 2019 06.
Article in English | MEDLINE | ID: mdl-31075800

ABSTRACT

The European Society of Gastrointestinal Endoscopy (ESGE) together with the United European Gastroenterology (UEG) recently developed a short list of performance measures for small-bowel endoscopy (i. e. small-bowel capsule endoscopy and device-assisted enteroscopy) with the final goal of providing endoscopy services across Europe with a tool for quality improvement. Six key performance measures for both small-bowel capsule endoscopy and for device-assisted enteroscopy were selected for inclusion, with the intention being that practice at both a service and endoscopist level should be evaluated against them. Other performance measures were considered to be less relevant, based on an assessment of their overall importance, scientific acceptability, and feasibility. Unlike lower and upper gastrointestinal endoscopy, where performance measures had already been identified, this is the first time that small-bowel endoscopy quality measures have been proposed.

4.
United European Gastroenterol J ; 7(1): 21-44, 2019 02.
Article in English | MEDLINE | ID: mdl-30788114

ABSTRACT

The European Society of Gastrointestinal Endoscopy (ESGE) and United European Gastroenterology present a list of key performance measures for endoscopy services. We recommend that these performance measures be adopted by all endoscopy services across Europe. The measures include those related to the leadership, organization, and delivery of the service, as well as those associated with the patient journey. Each measure includes a recommendation for a minimum and target standard for endoscopy services to achieve. We recommend that all stakeholders in endoscopy take note of these ESGE endoscopy services performance measures to accelerate their adoption and implementation. Stakeholders include patients and their advocacy groups; service leaders; staff, including endoscopists; professional societies; payers; and regulators.


Subject(s)
Endoscopy, Gastrointestinal , Quality Improvement , Quality of Health Care , Endoscopy, Gastrointestinal/adverse effects , Endoscopy, Gastrointestinal/methods , Endoscopy, Gastrointestinal/standards , Europe , Health Care Surveys , Humans , Practice Guidelines as Topic , Quality Assurance, Health Care
5.
Eur J Clin Nutr ; 73(1): 9-23, 2019 01.
Article in English | MEDLINE | ID: mdl-30353122

ABSTRACT

Programmes that promote dietary behaviour change for the prevention of chronic disease must include components that are rooted in best practice and associated with effectiveness. The purpose of this overview of systematic reviews was to examine the characteristics and dietary behaviour change outcomes of nutrition interventions among populations with or at risk of non-communicable chronic diseases. Systematic reviews of randomised controlled trials (RCTs) testing dietary behaviour change interventions published between January 2006 and November 2015 were identified via searches in Cochrane Library, PubMed, EMBASE and PsycINFO. Quality of reviews were appraised using AMSTAR. Dietary behaviour change and intervention details were extracted and systematically summarised. Fifteen articles met the inclusion criteria. Dietary behaviour changes in response to nutrition interventions were significant in over half of interventions. Reducing dietary fat and increasing fruits and vegetables were the most common behaviour changes. The characteristics of nutrition interventions and their relationship to effectiveness for dietary behaviour change among chronic disease or at-risk populations were reported inconsistently. However, associative evidence exists to support more frequent contacts and the use of specific behaviour change techniques. No clear relationships were found between effectiveness and intervention setting, mode of delivery or intervention provider, although some population-specific relationships were identified. Interventions that promote long-term maintenance of dietary behaviour changes are lacking in the literature. This comprehensive umbrella review identifies specific characteristics of interventions that are associated with effectiveness in interventions that promote dietary behaviour change among different at-risk populations. In order to maximise outcomes, public health, health promotion and healthcare organisations should consider these results in order to inform the development and improvement of nutrition programmes.


Subject(s)
Diet, Healthy/methods , Feeding Behavior , Noncommunicable Diseases/prevention & control , Health Risk Behaviors , Humans , Randomized Controlled Trials as Topic , Risk Reduction Behavior , Systematic Reviews as Topic , Treatment Outcome
6.
United European Gastroenterol J ; 6(10): 1448-1460, 2018 Dec.
Article in English | MEDLINE | ID: mdl-30574315

ABSTRACT

The European Society of Gastrointestinal Endoscopy (ESGE) and United European Gastroenterology present a short list of key performance measures for endoscopic ultrasound (EUS) and endoscopic retrograde cholangiopancreatography (ERCP). We recommend that endoscopy services across Europe adopt the following seven key and one minor performance measures for EUS and ERCP, for measurement and evaluation in daily practice at centre and endoscopist level: 1 Adequate antibiotic prophylaxis before ERCP (key performance measure, at least 90%); 2 antibiotic prophylaxis before EUS-guided puncture of cystic lesions (key performance measure, at least 95%); 3 bile duct cannulation rate (key performance measure, at least 90%); 4 tissue sampling during EUS (key performance measure, at least 85%); 5 appropriate stent placement in patients with biliary obstruction below the hilum (key performance measure, at least 95%); 6 bile duct stone extraction (key performance measure, at least 90%); 7 post-ERCP pancreatitis (key performance measure, less than 10%); and 8 adequate documentation of EUS landmarks (minor performance measure, at least 90%). This present list of quality performance measures for ERCP and EUS recommended by the ESGE should not be considered to be exhaustive; it might be extended in future to address further clinical and scientific issues.

7.
Endoscopy ; 50(12): 1186-1204, 2018 12.
Article in English | MEDLINE | ID: mdl-30423593

ABSTRACT

The European Society of Gastrointestinal Endoscopy (ESGE) and United European Gastroenterology present a list of key performance measures for endoscopy services. We recommend that these performance measures be adopted by all endoscopy services across Europe. The measures include those related to the leadership, organization, and delivery of the service, as well as those associated with the patient journey. Each measure includes a recommendation for a minimum and target standard for endoscopy services to achieve. We recommend that all stakeholders in endoscopy take note of these ESGE endoscopy services performance measures to accelerate their adoption and implementation. Stakeholders include patients and their advocacy groups; service leaders; staff, including endoscopists; professional societies; payers; and regulators.


Subject(s)
Endoscopy, Gastrointestinal/standards , Quality Improvement , Quality Indicators, Health Care , Safety/standards , Endoscopy, Gastrointestinal/adverse effects , Equipment and Supplies/standards , Health Facilities/standards , Humans , Informed Consent/standards , Leadership , Patient Comfort/standards , Patient Education as Topic/standards , Patient Participation , Patient Selection , Privacy , Referral and Consultation/standards , Workforce/standards
8.
Endoscopy ; 50(11): 1116-1127, 2018 11.
Article in English | MEDLINE | ID: mdl-30340220

ABSTRACT

The European Society of Gastrointestinal Endoscopy and United European Gastroenterology present a short list of key performance measures for endoscopic ultrasound (EUS) and endoscopic retrograde cholangiopancreatography (ERCP). We recommend that endoscopy services across Europe adopt the following seven key and one minor performance measures for EUS and ERCP, for measurement and evaluation in daily practice at center and endoscopist level: 1: Adequate antibiotic prophylaxis before ERCP (key performance measure, at least 90 %); 2: Antibiotic prophylaxis before EUS-guided puncture of cystic lesions (key performance measure, at least 95 %); 3: Bile duct cannulation rate (key performance measure, at least 90 %); 4: Tissue sampling during EUS (key performance measure, at least 85 %); 5: Appropriate stent placement in patients with biliary obstruction below the hilum (key performance measure, at least 95 %); 6: Bile duct stone extraction (key performance measure, at least 90 %); 7: Post-ERCP pancreatitis (key performance measure, less than 10 %). 8: Adequate documentation of EUS landmarks (minor performance measure, at least 90 %).This present list of quality performance measures for ERCP and EUS recommended by ESGE should not be considered to be exhaustive: it might be extended in future to address further clinical and scientific issues.


Subject(s)
Cholangiopancreatography, Endoscopic Retrograde/standards , Endosonography/standards , Quality Indicators, Health Care , Antibiotic Prophylaxis/standards , Biopsy/standards , Catheterization/standards , Cholangiopancreatography, Endoscopic Retrograde/adverse effects , Common Bile Duct , Gallstones/therapy , Humans , Pancreatitis/etiology , Quality Improvement , Stents/standards
9.
Gut ; 67(8): 1464-1474, 2018 08.
Article in English | MEDLINE | ID: mdl-29208675

ABSTRACT

OBJECTIVE: Endoscopic submucosal dissection (ESD) aims to achieve en bloc resection of non-pedunculated colorectal adenomas which might be indicated in cases with superficial submucosal invasive cancers (SMIC), but the procedure is time consuming and complex. The prevalence of such cancers is not known but may determine the clinical necessity for ESD as opposed to the commonly used piecemeal mucosal resection (endoscopic mucosal resection) of colorectal adenomas. The main aim was to assess the prevalence of SMIC SM1 (ie, invasion ≤1000 µm or less than one-third of the submucosa) on colorectal lesions removed by ESD. DESIGN: A literature review was conducted using electronic databases (up to March 2017) for colorectal ESD series reporting the histology of the dissected lesions. RESULTS: 51 studies with data on 11 260 colorectal dissected lesions were included. Most resected lesions (82.2%; 95% CI 78.8% to 85.3%) were adenomas (low- and high-grade dysplasia, 26.8% and 55.4%, respectively). Overall, 15.7% were submucosal cancers, but only slightly more than half (8.0%; 95% CI 6.1% to 10.3%) had an infiltration depth of ≤1000 µm, providing a number needed to treat (NNT) to avoid one surgery of 12.5. Estimating an oncologically curative (R0; G1/2; L0/V0) resection rate of 75.3% (95% CI 52.2% to 89.4%) for malignant lesions, the prevalence of curative resection lowered to 6% (95% CI 4.2% to 7.2%) with an NNT of 16.7. CONCLUSION: The low prevalence of SMIC SM1 in lesions selected for ESD as well as the even lower rate of curative resection limits the clinical applicability of endoscopic en bloc resection. This calls for caution over an indiscriminate use of this technique in the resection of colorectal neoplasia.


Subject(s)
Adenoma/pathology , Adenoma/surgery , Colorectal Neoplasms/pathology , Colorectal Neoplasms/surgery , Humans , Intestinal Mucosa/pathology , Neoplasm Invasiveness , Prevalence
10.
Gastrointest Endosc ; 87(4): 934-943.e18, 2018 Apr.
Article in English | MEDLINE | ID: mdl-29102729

ABSTRACT

BACKGROUND AND AIMS: Per-oral endoscopic myotomy (POEM) represents a less invasive alternative to conventional laparoscopic Heller's myotomy (LHM) for patients with achalasia. It cannot be excluded, however, that the lack of fundoplication after POEM may result in a higher incidence of reflux disease, as compared with LHM. The aim of our study was to conduct a systematic review of prospective studies reporting the incidence of reflux disease developed after POEM and LHM. METHODS: A literature search with electronic databases was performed (up to February 2017) to identify full articles on the incidence of gastroesophageal reflux symptoms and endoscopic monitoring and pH monitoring findings after POEM and LHM (with fundoplication). Proportions and rates were pooled by means of random or fixed-effects models, according to the level of heterogeneity between studies. RESULTS: After we applied the selection criteria, 17 and 28 studies, including 1542 and 2581 participants who underwent POEM and LHM, respectively, were included. The pooled rate of postprocedural symptoms was 19.0% (95% confidence interval [CI], 15.7%-22.8%) after POEM and 8.8% (95% CI, 5.3%-14.1%) after LHM, respectively. The pooled rate estimate of abnormal acid exposure at pH monitoring was 39.0% (95% CI, 24.5%-55.8%) after POEM and 16.8% (95% CI, 10.2%-26.4%) after LHM, respectively. The rate of esophagitis after POEM was 29.4% (95% CI, 18.5%-43.3%) after POEM and 7.6% (95% CI, 4.1%-13.7%) after LHM. At meta-regression, heterogeneity was explained partly by the POEM approach and study population. CONCLUSION: The incidence of reflux disease appears to be significantly more frequent after POEM than after LHM with fundoplication. Monitoring pH and ensuring appropriate treatment after POEM should be considered in order to prevent long-term reflux-related adverse events.


Subject(s)
Esophageal Achalasia/surgery , Gastroesophageal Reflux/epidemiology , Gastroesophageal Reflux/etiology , Myotomy/adverse effects , Endoscopy, Gastrointestinal , Esophageal pH Monitoring , Esophagitis/epidemiology , Esophagitis/etiology , Fundoplication/adverse effects , Heller Myotomy/adverse effects , Humans , Incidence , Myotomy/methods
11.
Best Pract Res Clin Gastroenterol ; 31(4): 481-488, 2017 Aug.
Article in English | MEDLINE | ID: mdl-28842058

ABSTRACT

BACKGROUND: During the last decades data from different studies reported modifications of the topographic distribution of colorectal cancers (CRCs), with an increased frequency of tumours in proximal colonic segments. Given the documented link between adenomas and CRC, a proximal migration of adenomas over time could be expected as well. AIM: To evaluate available evidence about the prevalence of adenomas and of sessile serrated polyps across colonic segments, the changing trends in their distribution across the colon and the diagnostic performance of screening tests currently adopted in population based screening programs for lesions located in different colonic segments. METHODS: Literature search on PubMed, Embase, and Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects with reference to preferred reporting items for systematic reviews and meta-analysis (PRISMA), considering all adult human studies in English, published between January 2000 and February 2017. RESULTS: Cross-sectional analysis of endoscopy and pathology data-bases are consistently showing a trend toward an increase with age of the proportion of adenomas located in the proximal colon. Several observational studies analysed the site distribution of adenomas, testing the hypothesis of a proximal shift of these lesions, and most of them reported an increase in the proportion of right-sided adenomas over time, although a similar trend was not confirmed by others. Also the quality of the retrieved evidence was low. Both endoscopy and FIT are showing a different level of sensitivity for lesions arising in different colonic segments, depending also on screenees characteristics. CONCLUSION: Available evidence is supporting the hypothesis of an increase in the proportion of right-sided adenomas with age, while a similar increase has not been reported for SSP/A, at least among subjects aged 50 or older. The trend toward a proximalization of colorectal adenomas over time, reported by some authors, likely results from improved diagnostic performances and/or the process of population ageing.


Subject(s)
Colonic Polyps/diagnosis , Colonoscopy/methods , Colorectal Neoplasms/diagnostic imaging , Colorectal Neoplasms/diagnosis , Colorectal Neoplasms/pathology , Early Detection of Cancer , Female , Humans , Male
12.
Eur J Nucl Med Mol Imaging ; 44(10): 1622-1635, 2017 Sep.
Article in English | MEDLINE | ID: mdl-28536833

ABSTRACT

METHODS: After primary treatment, biochemical relapse (BCR) occurs in a substantial number of patients with prostate cancer (PCa). PET/CT imaging with prostate-specific membrane antigen based tracers (68Ga-PSMA) has shown promising results for BCR patients. However, a standardized image interpretation methodology has yet to be properly agreed. The aim of this study, which was promoted and funded by European Association of Nuclear Medicine (EANM), is to define standardized image interpretation criteria for 68Ga-PSMA PET/CT to detect recurrent PCa lesions in patients treated with primary curative intent therapy (radical prostatectomy or radiotherapy) who presented a biochemical recurrence. In the first phase inter-rater agreement between seven readers from seven international centers was calculated on the reading of 68Ga-PSMA PET/CT images of 49 patients with BCR. Each reader evaluated findings in five different sites of recurrence (local, loco-regional lymph nodes, distant lymph nodes, bone, and other). In the second phase the re-analysis was limited to cases with poor, slight, fair, or moderate agreement [Krippendorff's (K) alpha<0.61]. Finally, on the basis of the consensus readings, we sought to define a list of revised consensus criteria for 68Ga-PSMA PET/CT interpretation. RESULTS: Between-reader agreement for the presence of anomalous findings in any of the five sites was only moderate (K's alpha: 0.47). The agreement improved and became substantial when readers had to judge whether the anomalous findings were suggestive for a pathologic, uncertain, or non-pathologic image (K's alpha: 0.64). K's alpha calculations for each of the five sites of recurrence were also performed and evaluated. First Delphi round was thus conducted. A more detailed definition of the criteria was proposed by the project coordinator, which was then discussed and finally agreed by the seven readers. After the second Delphi round only four cases of disagreement still remained. These were evaluated for a final round, allowing a final agreement table to be written. CONCLUSION: We hope that by developing these consensus guidelines on the interpretation of 68Ga-PSMA PET/CT, clinicians reporting these studies will be able to provide more consistent clinical reports and that within clinical trials, abnormality classifications will be harmonized, allowing more robust assessment of its diagnostic performance.


Subject(s)
Edetic Acid/analogs & derivatives , Image Interpretation, Computer-Assisted/standards , Oligopeptides , Positron Emission Tomography Computed Tomography , Prostatic Neoplasms/diagnostic imaging , Consensus , Gallium Isotopes , Gallium Radioisotopes , Humans , Male , Recurrence , Reference Standards
13.
Gastrointest Endosc ; 86(1): 74-86.e17, 2017 Jul.
Article in English | MEDLINE | ID: mdl-28254526

ABSTRACT

BACKGROUND AND AIMS: Endoscopic submucosal dissection (ESD) is an endoscopic resection technique for lesions suspicious of superficial malignancy. It is performed using an ESD knife on its own (standard technique) or by the sequential use of a knife and a snare (hybrid technique). The experience with these techniques is different in Asian and non-Asian countries. We performed a systematic review and meta-analysis of available evidence on colorectal ESD. METHODS: Electronic databases were searched up to August 2016 for studies evaluating R0, en bloc resection, and adverse event rates of both techniques for the treatment of colorectal lesions. Proportions were pooled by a random effects model. RESULTS: Ninety-seven studies (71 performed in Asia) evaluated the standard technique and 12 studies (7 in Asia) the hybrid technique. The R0 resection rate of the standard technique was 82.9%, and it was significantly lower in non-Asian versus Asian countries: 71.3% versus 85.6%. The en bloc resection rate was 91% and was significantly lower in non-Asian versus Asian countries (81.2% vs 93%, respectively). Surgery was needed in 1.1% of the ESD-related adverse events, with a significant difference between non-Asian and Asian countries (3.1% vs 0.8%). The R0 and en bloc resection rates with the hybrid technique were significantly lower than those achieved with the standard technique: 60.6% and 68.4%, respectively, with similar adverse event rates. CONCLUSIONS: In non-Asian countries the standard ESD technique is still failing to achieve acceptable levels of performance. The hybrid technique showed low R0 resection rates and should not be considered as an adequate alternative to the standard technique.


Subject(s)
Colorectal Neoplasms/surgery , Endoscopic Mucosal Resection , Asia , Endoscopic Mucosal Resection/adverse effects , Endoscopic Mucosal Resection/methods , Europe , Humans , Neoplasm, Residual , North America , Postoperative Complications/surgery , Treatment Outcome
14.
J Clin Pathol ; 70(4): 282-294, 2017 Apr.
Article in English | MEDLINE | ID: mdl-28073996

ABSTRACT

BACKGROUND: False-positive histological diagnoses have the same consequences of overdiagnosis in terms of unnecessary treatment. The aim of this systematic review is to assess their frequency at needle core biopsy (CB) and/or surgical excision of the breast. METHODS: PubMed, Embase, Cochrane Library were systematically searched up to 30 October 2015. Eligibility criteria: cross-sectional studies assessing diagnostic accuracy of CB compared with surgical excision; studies assessing reproducibility of pathologists reading the same slides. OUTCOMES: false-positive rates; Misclassification of Benign as Malignant (MBM) histological diagnosis; K statistic. Independent reviewers extracted data and assessed quality using an adapted QUADAS-2 tool. RESULTS: Sixteen studies assessed CB false-positive rates. In 10 studies (41 989 screen-detected lesions), the range of false-positive rates was 0%-7.1%. Twenty-seven studies assessed pathologists' reproducibility. Studies with consecutive, random or stratified samples of all the specimens: at CB the MBM range was 0.25%-2.4% (K values 0.83-0.98); at surgical excision, it was 0.67%-1.2% (K values 0.86-0.94). Studies with enriched samples: the MBM range was 1.4%-6.2% (K values 0.57-0.86). Studies of cases selected for second opinion: the MBM range was 0.29%-12.2% (K values 0.48 and 0.50). CONCLUSIONS: High heterogeneity of the included studies precluded formal pooling estimates. When considering studies of higher sample size or methodological quality, false-positive rates and MBM are around 1%. The impact of false-positive histological diagnoses of breast cancer on unnecessary treatment, as well as that of overdiagnosis, is not negligible and is of importance in clinical practice.


Subject(s)
Breast Neoplasms/diagnosis , False Positive Reactions , Female , Humans
15.
Best Pract Res Clin Gastroenterol ; 30(6): 855-866, 2016 Dec.
Article in English | MEDLINE | ID: mdl-27938781

ABSTRACT

BACKGROUND: Several reports documented an inefficient utilisation of available resources, as well as a suboptimal compliance with surveillance recommendations. Although, evidence suggests that organisational issues can influence the quality of care delivered, surveillance protocols are usually based on non-organized approaches. METHODS: We conducted a literature search (publication date: 01/2000-06/2016) on PubMed and Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects and Cochrane Central Register of Controlled Trials for guidelines, or consensus statements, for surveys of practice, reporting information about patients, or providers attitudes and behaviours, for intervention studies to enhance compliance with guidelines. Related articles were also scrutinised. Based on the clinical relevance and burden on endoscopy services this review was focused on surveillance for Barrett's oesophagus, IBD and post-polypectomy surveillance of colonic adenomas. RESULTS: Existing guidelines are generally recognising structure and process requirements influencing delivery of surveillance interventions, while less attention had been devoted to transitions and interfaces in the care process. Available evidence from practice surveys is suggesting the need to design organizational strategies aimed to enable patients to attend and providers to deliver timely and appropriate care. Well designed studies assessing the effectiveness of specific interventions in this setting are however lacking. Indirect evidence from screening settings would suggest that the implementation of automated standardized recall systems, utilisation of clinical registries, removing financial barriers, could improve appropriateness of use and compliance with recommendations. CONCLUSIONS: Lack of sound evidence regarding utility and methodology of surveillance can contribute to explain the observed variability in providers and patients attitudes and in compliance with the recommended surveillance.


Subject(s)
Barrett Esophagus/diagnosis , Endoscopy, Gastrointestinal/standards , Practice Patterns, Physicians'/organization & administration , Barrett Esophagus/therapy , Databases, Factual , Humans , Population Surveillance
16.
J Gastrointestin Liver Dis ; 25(1): 79-86, 2016 Mar.
Article in English | MEDLINE | ID: mdl-27014757

ABSTRACT

BACKGROUND AND AIMS: Diverticular disease is a common gastrointestinal condition. Low-grade inflammation and altered intestinal microbiota have been identified as factors contributing to abdominal symptoms. Probiotics may lead to symptoms improvement by modifying the gut microbiota and are promising treatments for diverticular disease. The aim of this study was to systematically review the efficacy of probiotics in diverticular disease in terms of remission of abdominal symptoms and prevention of acute diverticulitis. METHODS: According to PRISMA, we identified studies on diverticular disease patients treated with probiotics (Pubmed, Embase, Cochrane). The quality of these studies was evaluated by the Jadad scale. Main outcomes measures were remission of abdominal symptoms and prevention of acute diverticulitis. RESULTS: 11 studies (2 double-blind randomized placebo-controlled, 5 open randomized, 4 non-randomized open studies) were eligible. Overall, diverticular disease patients were 764 (55.1% females, age 58-75 years). Three studies included patients with symptomatic uncomplicated diverticular disease, 4 studies with symptomatic uncomplicated diverticular disease in remission, 4 studies with complicated or acute diverticulitis. Mainly (72.7%) single probiotic strains had been used, most frequently Lactobacilli. Follow-up ranged from 1 to 24 months. Interventions were variable: in 8 studies the probiotic was administered together with antibiotic or anti-inflammatory agents and compared with the efficacy of the drug alone; in 3 studies the probiotic was compared with a high-fibre diet or used together with phytoextracts. As an outcome measure, 4 studies evaluated the occurrence rate of acute diverticulitis, 6 studies the reduction of abdominal symptoms, and 6 studies the recurrence of abdominal symptoms. Meta-analysis on the efficacy of probiotics in diverticular disease could not be performed due to the poor quality of retrieved studies. CONCLUSION: This systematic review showed that high-quality data on the efficacy of probiotics in diverticular disease are scant: the available data do not permit conclusions. Further investigation is required to understand how probiotics can be employed in this condition.


Subject(s)
Diverticulitis/therapy , Gastrointestinal Microbiome , Intestines/microbiology , Probiotics/therapeutic use , Diverticulitis/diagnosis , Diverticulitis/microbiology , Humans , Probiotics/adverse effects , Remission Induction , Treatment Outcome
17.
United European Gastroenterol J ; 4(1): 30-41, 2016 Feb.
Article in English | MEDLINE | ID: mdl-26966520

ABSTRACT

The European Society of Gastrointestinal Endoscopy (ESGE) and United European Gastroenterology (UEG) have a vision to create a thriving community of endoscopy services across Europe, collaborating with each other to provide high quality, safe, accurate, patient-centered and accessible endoscopic care. Whilst the boundaries of what can be achieved by advanced endoscopy are continually expanding, we believe that one of the most fundamental steps to achieving our goal is to raise the quality of everyday endoscopy. The development of robust, consensus- and evidence-based key performance measures is the first step in this vision. ESGE and UEG have identified quality of endoscopy as a major priority. This paper explains the rationale behind the ESGE Quality Improvement Initiative and describes the processes that were followed. We recommend that all units develop mechanisms for audit and feedback of endoscopist and service performance using the ESGE performance measures that will be published in future issues of this journal over the next year. We urge all endoscopists and endoscopy services to prioritize quality and to ensure that these performance measures are implemented and monitored at a local level, so that we can provide the highest possible care for our patients.

18.
Minerva Gastroenterol Dietol ; 62(2): 207-22, 2016 Jun.
Article in English | MEDLINE | ID: mdl-26940549

ABSTRACT

INTRODUCTION: Evidence on the optimal postpolypectomy surveillance strategies for subjects undergoing colorectal cancer screening as well as among IBD patients, is limited. In the absence of strong evidence, currently adopted guidelines are mainly based on experts' opinion and low quality data and they are often influenced by a safety-first approach and are not consistent. Given the lack of conclusive data from randomized controlled trials and uncertainty about the extent of risk of adenoma patients developing CRC in the future, there is uncertainty regarding cost-effectiveness of surveillance protocols. This may partly explain discrepancies in guidelines recommendations, with regard to definition of risk categories and of the recommended surveillance intervals. Uncertainty persists concerning management of patients with small advanced adenomas (size <10 mm and villous component >20% and/or high-grade dysplasia), high-risk adenomas and serrated polyps. EVIDENCE ACQUISITION: We retrieved the most recent guidelines for postpolypectomy surveillance from Europe and US and we conducted an additional PUBMED search for guidelines, systematic reviews (SR) and primary studies published after the last search update of the most recent review,8 presenting data about predictors of the risk of CRC and adenoma recurrence following polypectomy, and also about surveillance practice and surveillance related workload EVIDENCE SYNTHESIS: The findings of surveys conducted in clinical settings and population screening programs are showing a wide variability in the recommended surveillance protocols. CONCLUSIONS: To be able to adopt evidence bases approach additional information is needed about the risk of CRC and/or advanced adenomas with and without surveillance, as well as about the efficacy of endoscopic surveillance in reducing CRC risk. Indeed, the offer of colonoscopy for surveillance may not be justified if the risk of developing CRC among subjects with removed adenomas is not significantly increased compared to the general population, or, even if the risk is increased, performance of surveillance exams does not result in a reduction of this risk.


Subject(s)
Colonoscopy , Colorectal Neoplasms/prevention & control , Population Surveillance , Adenoma/surgery , Colorectal Neoplasms/surgery , Early Detection of Cancer , Humans , Practice Guidelines as Topic
19.
Int J Cancer ; 139(3): 554-73, 2016 Aug 01.
Article in English | MEDLINE | ID: mdl-27004723

ABSTRACT

The general aim of this systematic review is to mitigate breast cancer (BC) overdiagnosis and overtreatment. The specific aim is to summarize available data on the occurrence and features of indolent invasive or in situ (DCIS) BC, and precisely survival of untreated cases, prevalence of occult cancers found in autopsies, frequency of regressive BC. PubMed, Embase and Cochrane Library were systematically searched up to 3/31/2014. Eligibility criteria were: cohort studies, case-control studies, uncontrolled case series assessing survival in women with a diagnosis of BC who did not receive treatment compared to treated women; case series of autopsies estimating the prevalence of undiagnosed BC; cohort studies, case-control studies, uncontrolled case series, case reports assessing the occurrence of spontaneous regression of BC in women with a confirmed histology diagnosis. Untreated BC: 8 cohort studies and 12 case series (3593 BC) were included. In three controlled cohort studies (diagnoses 1978-2006), the 5-years overall survival was 19-43%. Occult BC: 8 case series (2279 autopsies) were included. The prevalence of invasive BC undiagnosed during lifetime range was 0-1.5%, while for DCIS the range was 0.2-14.7%. Spontaneous regression: 2 cohort studies, 3 case reports, 1 case series included. In the cohort studies the relative risk of regression for screen detected compared with nonscreened BC was estimated as 1.2 and 1.1. It seems plausible that around 10% of invasive BC are not symptomatic during life, and that one fith of BC patients if untreated would be alive after 5 years. Around 1 of 10 screen-detected BC may regress according two studies.


Subject(s)
Breast Neoplasms/epidemiology , Breast Neoplasms/pathology , Autopsy , Breast Neoplasms/mortality , Breast Neoplasms/therapy , Disease Progression , Female , Humans , Neoplasm Regression, Spontaneous , Neoplasm Staging , Patient Outcome Assessment , Prevalence , Survival Analysis
20.
Gastrointest Endosc ; 83(6): 1076-1089.e5, 2016 Jun.
Article in English | MEDLINE | ID: mdl-26802196

ABSTRACT

BACKGROUND AND AIMS: Flexible endoscopic septum division (FESD) is a rapidly evolving technique for the treatment of Zenker's diverticulum (ZD). The aim was to perform a systematic review and meta-analysis of the literature focusing on FESD for ZD, including an in-depth evaluation of its efficacy, safety, and limitations. METHODS: A comprehensive literature search was completed to identify papers that examined the efficacy and safety of FESD for ZD. Demographic, clinical, and technical information was retrieved. Main outcomes were extracted, pooled, and analyzed. Heterogeneity among studies was assessed using the I(2) statistic. A random effect model was used as the pooling method in cases of high heterogeneity; otherwise the fixed effect model was applied. Meta-regression was also performed. Main outcomes such as rates of success, adverse events, and recurrences were evaluated. RESULTS: Twenty studies with a total of 813 patients were selected. The pooled success, adverse events, and recurrence rates were 91% (95% confidence interval [CI], 86%-95%; I(2) = 69.5%), 11.3% (95% CI, 8%-16%; I(2) = 64%), and 11% (95% CI, 8%-15%; I(2) = 38.4%), respectively. Substantial heterogeneity across studies was found. However, for success rates, excluding 3 studies reduced heterogeneity to non-significant rates [I(2) = 25.6%; P = .154]. Adverse event rates decreased with larger samples (coefficient, -0.0123; 95% CI, -0.03 to -0.003; P = .017), whereas recurrence rates increased (coefficient, 0.006; 95% CI, -0.0010 to 0.0125; P = .093). Year of publication was negatively associated with success rate, whereas the opposite pattern was found for recurrence rates. CONCLUSIONS: FESD is a feasible, safe, and effective treatment for symptomatic ZD, with low adverse event and recurrence rates.


Subject(s)
Deglutition Disorders/surgery , Esophagoscopy/methods , Pharyngeal Muscles/surgery , Zenker Diverticulum/surgery , Deglutition Disorders/etiology , Esophagoscopes , Humans , Treatment Outcome , Zenker Diverticulum/complications
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