The objective of the study is to assess the interrater reliability (IRR) and usability of the revised Cochrane risk of bias tool for randomized trials (RoB 2).
This is a cross-sectional study. Four ...raters independently applied RoB 2 on the primary outcome of a random sample of individually randomized parallel-group trials (randomized controlled trials (RCTs)). We calculated the Fleiss’ kappa for multiple raters, the time needed to complete the tool, and discussed the application of RoB 2 to identify difficulties and reasons for disagreement.
A total of 70 outcomes from 70 RCTs were included. IRR was slight for overall judgment (IRR 0.16, 95% confidence interval (CI) 0.08–0.24); individual domain analysis gave IRR as moderate for “randomization process” (IRR 0.45, 95% CI 0.37–0.53), slight for “deviations from intended intervention” for RCTs assessing the effect of the assignment to an intervention (IRR 0.04, 95% CI −0.06 to 0.14), fair for those assessing the effect of adhering (IRR 0.21, 95% CI 0.11–0.31), and fair for the other domains, ranging from 0.22 (95% CI 0.14–0.30) for “missing outcome data” to 0.30 (95% CI 0.22–0.38) for “selection of reported results”. Mean time to apply the tool was 28 minutes (standard deviation 13.4) per study outcome. The main difficulties were due to poor knowledge of the subject matter of primary studies, new terminology, different approaches for some domains compared with the previous tool, and way of formulating signaling questions.
RoB 2 is a detailed and comprehensive tool but difficult and demanding, even for raters with substantial expertise in systematic reviews. Calibration exercises and intensive training are needed before its application, to improve reliability.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Summary Background Screening for human papillomavirus (HPV) infection is more effective in reducing the incidence of cervical cancer than screening using Pap smears. Moreover, HPV testing can be done ...on a vaginal sample self-taken by a woman, which offers an opportunity to improve screening coverage. However, the clinical accuracy of HPV testing on self-samples is not well-known. We assessed whether HPV testing on self-collected samples is equivalent to HPV testing on samples collected by clinicians. Methods We identified relevant studies through a search of PubMed, Embase, and CENTRAL. Studies were eligible for inclusion if they fulfilled all of the following selection criteria: a cervical cell sample was self-collected by a woman followed by a sample taken by a clinician; a high-risk HPV test was done on the self-sample (index test) and HPV-testing or cytological interpretation was done on the specimen collected by the clinician (comparator tests); and the presence or absence of cervical intraepithelial neoplasia grade 2 (CIN2) or worse was verified by colposcopy and biopsy in all enrolled women or in women with one or more positive tests. The absolute accuracy for finding CIN2 or worse, or CIN grade 3 (CIN3) or worse of the index and comparator tests as well as the relative accuracy of the index versus the comparator tests were pooled using bivariate normal models and random effect models. Findings We included data from 36 studies, which altogether enrolled 154 556 women. The absolute accuracy varied by clinical setting. In the context of screening, HPV testing on self-samples detected, on average, 76% (95% CI 69–82) of CIN2 or worse and 84% (72–92) of CIN3 or worse. The pooled absolute specificity to exclude CIN2 or worse was 86% (83–89) and 87% (84–90) to exclude CIN3 or worse. The variation of the relative accuracy of HPV testing on self-samples compared with tests on clinician-taken samples was low across settings, enabling pooling of the relative accuracy over all studies. The pooled sensitivity of HPV testing on self-samples was lower than HPV testing on a clinician-taken sample (ratio 0·88 95% CI 0·85–0·91 for CIN2 or worse and 0·89 0·83–0·96 for CIN3 or worse). Also specificity was lower in self-samples versus clinician-taken samples (ratio 0·96 0·95–0·97 for CIN2 or worse and 0·96 0·93–0·99 for CIN3 or worse). HPV testing with signal-based assays on self-samples was less sensitive and specific than testing on clinician-based samples. By contrast, some PCR-based HPV tests generally showed similar sensitivity on both self-samples and clinician-based samples. Interpretation In screening programmes using signal-based assays, sampling by a clinician should be recommended. However, HPV testing on a self-sample can be suggested as an additional strategy to reach women not participating in the regular screening programme. Some PCR-based HPV tests could be considered for routine screening after careful piloting assessing feasibility, logistics, population compliance, and costs. Funding The 7th Framework Programme of the European Commission, the Belgian Foundation against Cancer, the International Agency for Research on Cancer, and the German Guideline Program in Oncology.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Prevention of preterm birth (PTB) with progestogens after an episode of threatened preterm labour is still controversial. As different progestogens have distinct molecular structures and biological ...effects, we conducted a systematic review and pairwise meta-analysis to investigate the individual role played by 17-alpha-hydroxyprogesterone caproate (17-HP), vaginal progesterone (Vaginal P) and oral progesterone (Oral P).
The search was performed in MEDLINE, ClinicalTrials.gov and the Cochrane Central Register of Controlled Trials (CENTRAL) up to 31 October 2021. Published RCTs comparing progestogens to placebo or no treatment for maintenance tocolysis were considered. We included women with singleton gestations, excluding quasi-randomized trials, studies on women with preterm premature rupture of membrane, or receiving maintenance tocolysis with other drugs. Primary outcomes were preterm birth (PTB) < 37 weeks' and < 34 weeks'. We assessed risk of bias and evaluated certainty of evidence with the GRADE approach.
Seventeen RCTs including 2152 women with singleton gestations were included. Twelve studies tested vaginal P, five 17-HP, and only 1 oral P. PTB < 34 weeks' did not differ among women receiving vaginal P (RR 1.21, 95%CI 0.91 to 1.61, 1077 participants, moderate certainty of evidence), or oral P (RR 0.89, 95%CI 0.38 to 2.10, 90 participants, low certainty of evidence) as opposed to placebo. Instead, 17-HP significantly reduced the outcome (RR 0.72, 95% CI 0.54 to 0.95, 450 participants, moderate certainty of evidence). PTB < 37 weeks' did not differ among women receiving vaginal P (RR 0.95, 95%CI 0.72 to 1.26, 8 studies, 1231 participants, moderate certainty of evidence) or 17-HP (RR 0.86, 95%CI 0.60 to 1.21, 450 participants, low certainty of evidence) when compared to placebo/no treatment. Instead, oral P significantly reduced the outcome (RR 0.58, 95% CI 0.36 to 0.93, 90 participants, low certainty of evidence).
With a moderate certainty of evidence, 17-HP prevents PTB < 34 weeks' gestation among women that remained undelivered after an episode of threatened preterm labour. However, data are insufficient to generate recommendations in clinical practice. In the same women, both 17-HP and vaginal P are ineffective in the prevention of PTB < 37 weeks'.
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Introduction: Five anti-tumor necrosis factor (anti-TNF) agents have received regulatory approval for use in rheumatology: adalimumab, golimumab, infliximab, certolizumab, and etanercept. Apart from ...their well-documented therapeutic value, it is still uncertain to what extent they are associated with an increased risk of infectious adverse events.
Areas covered: We conducted a systematic review and meta-analysis of published randomized studies to determine the effect of anti-TNF drugs on the occurrence of infectious adverse events (serious infections; tuberculosis; opportunistic infections; any infection). We searched Medline, Embase, and the Cochrane Library up to May 2014 to identify eligible studies in adult patients with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis that evaluated anti-TNF drugs compared with placebo or no treatment.
Expert opinion: Our study encompassed data from 71 randomized controlled trials involving 22,760 participants (range of follow-up: 1-36 months) and seven open label extension studies with 2,236 participants (range of follow-up: 6-48 months). Quantitative synthesis of the available data found statistically significant increases in the occurrence of any infections (20%), serious infections (40%), and tuberculosis (250%) associated with anti-TNF drug use, while the data for opportunistic infections were scarce. The quality of synthesized evidence was judged as moderate. Further evidence from registries and long-term epidemiological studies are needed to better define the relationship between anti-TNF agents and infection complications.
The scientific community has been re-evaluating the clinical relevance of hysteroscopy in the diagnosis and treatment of uterine factors and its role in the infertility work-up, thanks to its ...potential capability to improve reproductive outcomes and reduce time to pregnancy.
The objective of this systematic review and meta-analysis was to assess the efficacy of diagnostic and operative hysteroscopy in improving the live birth rate (LBR) of infertile women, with and without intrauterine abnormalities, at any stage of the infertility work-up.
PubMed, Embase, the Cochrane Library and the Clinical Trials Registry using Medical Subject Headings and free text terms were searched up to June 2014, without language or year restrictions. Randomized controlled trials (RCTs) enrolling infertile women with no suspected intrauterine cavity abnormalities and comparing hysteroscopy versus no hysteroscopy at any stage of the diagnostic work-up, but prior to the first attempt of standard IVF or ICSI or after (one or more) failed attempts of IVF/ICSI were included. RCTs enrolling infertile women with intrauterine abnormalities and comparing operative versus diagnostic hysteroscopy were also included. Risk of bias was assessed using the criteria recommended by the Cochrane Collaboration and the overall quality of evidence was assessed using the GRADE approach. Results were pooled by meta-analysis using the random effect model.
The primary outcome evaluated was the LBR, while secondary outcomes were pregnancy rate, miscarriage rate and procedure-related complications. Five hundred and eighty-eight records were retrieved after removing duplicates. Nine studies were included, with 2976 participants. Four studies included infertile women with one or more failed IVF/ICSI cycles. Two studies included infertile women who were candidates for their first IVF/ICSI. One study included candidates both for first IVF/ICSI and with one or more failed IVF/ICSI cycles. Two studies included infertile women affected by uterine fibroids and endometrial polyps, who had not received IVF/ICSI nor were candidates. Seven studies were included in the meta-analysis. Comparing hysteroscopy with no hysteroscopy prior to any (first or subsequent) IVF/ICSI attempt in infertile women without intrauterine abnormalities, there was very low-quality evidence that hysteroscopy increased LBR (relative risk (RR) 1.48, 95% confidence interval (CI) 1.20-1.81; three studies with 1088 participants) and moderate quality evidence that it increased pregnancy rate (RR 1.45, 95% CI 1.26-1.67; seven studies, 2545 participants). Results on pregnancy rate were confirmed in the subgroup analysis of five studies including only women with one or more implantation failures (RR 1.41, 95% CI 1.14-1.75) and three studies where hysteroscopy was performed before the first IVF/ICSI attempt (RR 1.55, 95% CI 1.26-1.91). Comparing operative hysteroscopy for intrauterine abnormalities in infertile women with already diagnosed polyps or fibroids, there was low-quality evidence that operative hysteroscopy increases pregnancy rate (RR 2.13, 95% CI 1.56-2.92). None of the studies comparing operative versus diagnostic hysteroscopy assessed LBR.
Robust and high-quality RCTs are still needed before hysteroscopy can be regarded as a first-line procedure in all infertile women, especially during the basal clinical assessment of the couple, when assisted reproductive treatment is not indicated yet.
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.
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.
This review elaborates on the accuracy and feasibility of human papillomavirus (HPV) self‐sampling, i.e., offering self‐sampling of (cervico‐)vaginal cell material by women themselves in nonclinical ...settings for high‐risk HPV (hrHPV) detection in the laboratory, for cervical screening. To that end a bibliographic database search (PubMed) was performed to identify studies (published between January 1992 and January 2012) that compared clinical accuracy of HPV testing on self‐sampled material with that of cytology or HPV testing on clinician‐taken samples, and studies comparing response to offering HPV self‐sampling with a recall invitation. Overall, hrHPV testing on self‐samples appeared to be at least as, if not more, sensitive for cervical intraepithelial neoplasia grade 2 or worse (CIN2+) as cytology on clinician‐obtained cervical samples, though often less specific. In most studies, hrHPV testing on self‐ and clinician‐sampled specimens is similarly accurate with respect to CIN2+ detection. Variations in clinical performance likely reflect the use of different combinations of collection devices and HPV tests. Because it is known that underscreened women are at increased risk of cervical cancer, targeting non‐attendees of the screening program could improve the effectiveness of cervical screening. In developed countries offering self‐sampling has shown to be superior to a recall invitation for cytology in re‐attracting original non‐attendees into the screening program. Additionally, self‐testing has shown to facilitate access to cervical screening for women in low resource areas. This updated review of the literature suggests that HPV self‐sampling could be an additional strategy that can improve screening performance compared to current cytology‐based call‐recall programs.
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BFBNIB, FZAB, GIS, IJS, KILJ, NLZOH, NUK, OILJ, SAZU, SBCE, SBMB, UL, UM, UPUK
STUDY DESIGN.A Cochrane systematic review.
OBJECTIVE.To evaluate the efficacy of bracing for adolescents with AIS versus no treatment or other treatments, on quality of life, disability, pulmonary ...disorders, progression of the curve, psychological, and cosmetic issues.
SUMMARY OF BACKGROUND DATA.Idiopathic scoliosis is a three-dimensional deformity of the spine. The most common form is diagnosed in adolescence. Although adolescent idiopathic scoliosis (AIS) can progress during growth and cause a surface deformity, it is usually not symptomatic.
METHODS.We searched CENTRAL, MEDLINE, EMBASE, five other databases, and two trials registers up to February 2015. We also checked reference lists and hand searched grey literature. Randomized controlled trials (RCTs) and prospective controlled cohort studies comparing braces with no treatment, other treatment, surgery, and different types of braces for adolescent with AIS. We used standard methodological procedures expected by the Cochrane Collaboration.
RESULTS.We included seven studies. Five were planned as RCTs, two as prospective controlled clinical trials. One RCT failed completely, another was continued as an observational study. There was very low quality evidence from one small RCT that quality of life (QoL) during treatment did not differ significantly between rigid bracing and observation.
CONCLUSION.Two studies showed that bracing did not change QoL during treatment, and QoL, back pain psychological and cosmetic issues in the long term (16 years.) All articles showed that bracing prevented curve progression. The high rate of failure of RCTs demonstrates the huge difficulties in performing RCTs in a field where parents reject randomization of their children.Level of Evidence1
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.
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