GEM/cochrane-simplification huggingface dataset:
Abstract: No new trials were identified in this 2014 update. We included four trials (three RCTs and one quazi-RCT), with 759 children in the rapid viral testing group and 829 in the control group. Three out of the four studies were comparable in terms of young age of participants, with one study increasing the age of inclusion up to five years of age. All studies included either fever or respiratory symptoms as inclusion criteria (two required both, one required fever or respiratory symptoms, and one required only fever). All studies were comparable in terms of exclusion criteria, intervention, and outcome data. In terms of risk of bias, one study failed to utilize a random sequence generator, one study did not comment on completeness of outcome data, and only one of four studies included allocation concealment as part of the study design. None of the studies definitively blinded participants. Rapid viral testing resulted in a trend toward decreased antibiotic use in the ED, but this was not statistically significant. We found lower rates of chest radiography (RR 0.77, 95% CI 0.65 to 0.91) in the rapid viral testing group, but no effect on length of ED visits, or blood or urine testing in the ED. No study made mention of any adverse effects related to viral testing. There is insufficient evidence to support routine rapid viral testing to reduce antibiotic use in pediatric EDs. Rapid viral testing may or may not reduce rates of antibiotic use, and other investigations (urine and blood testing); these studies do not provide enough power to resolve this question. However, rapid viral testing does reduce the rate of chest X-rays in the ED. An adequately powered trial with antibiotic use as an outcome is needed.

Plain-language summary: We reviewed studies retrievable as of July 2014. We included four prospective controlled studies of previously healthy children under 18 years of age who attended an ED of an urgent care clinic because of fever and respiratory symptoms. Based on these four studies, involving 759 study participants, we found that in previously healthy children coming to the ED with fever and respiratory symptoms, a rapid viral test showed a trend towards fewer antibiotic prescriptions, but this finding was not statistically significant. However, we found that rapid viral testing reduces the use of chest X-rays. There are also blood and urine investigations that can be undertaken. The true impact of this intervention on the frequency of blood and urine testing, as well as the length of the ED visit, requires trials with larger numbers of children. None of the included studies reported harm or adverse events related to the intervention tested. The quality of the evidence was considered moderate with regard to risk of bias, indirectness, imprecision, publication bias and inconsistency. While none of the studies used blinding, the impact of the use of rapid viral testing is in its ability to provide diagnostic information. Blinding of this interventions to the clinician would be impossible and make the intervention useless.
Abstract: We found only one trial, which included 61 women, that met our inclusion criteria. This trial reported data on surgical versus clinical staging and an assessment of the two surgical staging techniques; laparoscopic (LAP) versus extraperitoneal (EXP) surgical staging. The clinical staging was either a contrast-enhanced computed tomography (CT) scan or magnetic resonance imaging (MRI) scan of the abdomen and pelvis to determine nodal status. In this trial, clinical staging appeared to significantly prolong overall and progression-free survival compared to surgical staging. There was no statistically significant difference in the number of women who experienced severe (grade 3 or 4) toxicity. There was no statistically significant difference in the risk of death, disease recurrence or progression, blood loss, severe toxicity and the duration of the operational procedure between LAP and EXP surgical staging techniques. The strength of the evidence is weak in this review as it is based on one small trial that was at moderate risk of bias. Since the last version of this review no new studies were found. From the one available RCT we found insufficient evidence that pre-treatment surgical para-aortic lymph node assessment for locally advanced cervical cancer is beneficial, and it may actually have an adverse effect on survival. However, this conclusion is based on analysis of a small single trial and therefore definitive guidance or recommendations for clinical practice cannot be made. Therefore, the decision to offer surgical pre-treatment assessment of para-aortic lymph nodes in locally advanced cervical cancer needs to be individualised. The uncertainty regarding any impact on survival from pre-treatment para-aortic lymph node assessment should be discussed openly with the women.

Plain-language summary: The purpose of this review was to assess the available literature on the effectiveness and safety of pre-treatment surgical para-aortic lymph node assessment for locally advanced cervical cancer. We found only one randomised controlled trial (RCT) that assessed non-surgical staging versus surgical staging. We found limited evidence that suggested that clinical staging may offer a survival benefit (in terms of overall and progression-free survival) compared with surgical staging, but the strength of the evidence from this small trial is weak and the trial was at moderate risk of bias. There was no statistically significant difference in any of the reported outcomes between two surgical staging techniques examined in the trial. Due to the small number of women with locally advanced cervical cancer in only one included trial there was insufficient evidence to conclude that any of the staging techniques are superior to each other. This review highlights the need for future good-quality, well-designed trials that report not only survival and severe adverse event outcomes but also examine quality of life (QoL) outcome data.
Abstract: We identified two RCTs involving 978 women with cervical cancer stage IIB to IVA. As the trials were significantly different clinically, we did not perform meta-analyses. One industry-funded trial involving 515 women compared CCRT (cisplatin) versus CCRT (cisplatin and gemcitabine) plus ACT (two additional cycles). This trial reported significant improvement in progression-free survival (PFS) and overall survival (OS) in women who were given CCRT plus ACT compared with those treated with CCRT alone: Three-year PFS was 74.4% versus 65.0% (hazard ratio (HR) 0.68, 95% confidence interval (CI) 0.49 to 0.95, P value 0.027), and three-year OS was 80% versus 69% (HR 0.68, 95% CI 0.49 to 0.95, P value 0.022). However, as the CCRT chemotherapy differed between the two arms, we considered the findings to be at high risk of bias. The second trial was a four-arm study from which we extracted data on 463 women in two study arms receiving CCRT (intravenous mitomycin C and oral 5-fluorouracil (5-FU)) or CCRT plus ACT (oral 5-FU for three cycles). The HR for OS in women who received ACT after CCRT compared with the HR for OS in those who were given CCRT alone was 1.309 (95% CI 0.795 to 2.157), and the HR for disease-free survival (DFS) was 1.125 (95% CI 0.799 to 1.586). Haematological adverse events were more common in the ACT arms of both trials. Quality of life (QoL) was not reported in either trial. With limited data from only two trials, we found insufficient evidence to support the use of ACT after CCRT. Future large trials are required to demonstrate efficacy, toxicities and QoL.

Plain-language summary: The two studies were very different; therefore we could not pool their data. One trial conducted internationally between 2002 and 2004, involving 515 women, found that cancer took longer to return in women receiving ACT (cisplatin and gemcitabine), and more women in the ACT group were alive after three years than in the standard treatment group (80% versus 69%). We considered the findings to be at high risk of bias in this trial, as women were given different drugs during standard treatment, and so the overall effect of the study treatment could not be attributed to the ACT alone. The other trial, which was conducted in several hospitals in Thailand between 1988 and 1994, involved 463 women. ACT (5-fluorouracil) did not improve the length of survival or the time taken for cancer to return in women in this trial. A trend towards increased side effects was reported in the ACT arms of both studies. We found insufficient evidence to support giving additional anticancer drugs to women who have received standard treatment for locally advanced cervical cancer, as currently only limited data are available from two very different trials.
Abstract: Two studies tested gabapentin to treat fibromyalgia pain. One was identified in previous versions of the review and is included here. We identified another study as a conference abstract, with insufficient detail to determine eligibility for inclusion; it is awaiting assessment. The one included study of 150 participants was a 12-week, multi-centre, randomised, double-blind, placebo-controlled, parallel-group study using last-observation-carried-forward imputation for withdrawals. The maximum dose was 2400 mg daily. The overall risk of bias was low, except for attrition bias. At the end of the trial, the outcome of 50% reduction in pain over baseline was not reported. The outcome of 30% or greater reduction in pain over baseline was achieved by 38/75 participants (49%) with gabapentin compared with 23/75 (31%) with placebo (very low quality). A patient global impression of change any category of "better" was achieved by 68/75 (91%) with gabapentin and 35/75 (47%) with placebo (very low quality). Nineteen participants discontinued the study because of adverse events: 12 in the gabapentin group (16%) and 7 in the placebo group (9%) (very low quality). The number of serious adverse events were not reported, and no deaths were reported (very low quality). We have only very low quality evidence and are very uncertain about estimates of benefit and harm because of a small amount of data from a single trial. There is insufficient evidence to support or refute the suggestion that gabapentin reduces pain in fibromyalgia.

Plain-language summary: In May 2016 we searched for clinical trials where gabapentin was used to treat pain due to fibromyalgia in adults. We found one study that met the requirements for this review. The study tested 1200 to 2400 mg/day of gabapentin compared with a placebo over 12 weeks, in 150 people. The study did not report the number of people with pain reduced by half at the end of week 12. At that time 5 in 10 people taking gabapentin and 3 in 10 taking the placebo had their pain reduced by at least one third. A report of feeling better to any degree was reported by 9 in 10 taking gabapentin and 5 in 10 taking placebo. About 2 in 10 people taking gabapentin stopped taking the medicine because of side effects, compared with 1 in 10 taking the placebo. The study did not report the number of people with serious side effects, but did report that there were no deaths. We rated the quality of the evidence as very low because there was only a single small study with important study limitations. Several factors reduced our confidence in the result. Very low quality evidence means that we are very uncertain about the results.
Abstract: A statistically significant benefit was observed for auranofin when compared to placebo for tender joint scores, pain, patient and physician global assessments and ESR. The standardized weighted mean difference between treatment and placebo was -0.39 (95% CI -0.54, -0.25) for tender joint scores, -0.08 (95% CI -0.22, -0.07) for swollen joint scores, and the weighed mean difference was -4.68 (95% CI -6.59, -2.77) for pain scores. The WMD for ESR was -9.85mm (95% CI -16.46, -3.25). Withdrawals from adverse reactions were 1.5 times higher in the auranofin group OR = 1.52 (95% CI 0.94, 2.46) but this result was not statistically significant. Patients receiving placebo were four times more likely to discontinue treatment because of lack of efficacy than patients receiving auranofin OR=0.29 (95% CI: 0.19, 0.43). Auranofin appears to have a small clinically and statistically significant benefit on the disease activity of patients with RA. The beneficial effects appear to be modest compared to drugs such as methotrexate or parenteral gold. Its effects on long term health status and radiological progression are not clear at this time.

Plain-language summary: The objective of this review was to evaluate the short-term efficacy of auranofin for the treatment of rheumatoid arthritis when compared to placebo. Our results show that auranofin appears to be efficacious in the short-term treatment of patients with RA (6 months), and has a small but clinically and statistically significant benefit on the disease activity of these patients. Its effects on overall health status and radiological progression are not clear at this time, but would appear to be modest. Auranofin may be most appropriate for those patients with early and mild disease who are more likely to respond to less potent (and less toxic) therapies.
Abstract: Eleven studies with a total of 3716 participants were included. A consistent and strong reduction in the risk of recurrent venous thromboembolic events was observed during prolonged treatment with VKA (risk ratio (RR) 0.20, 95% confidence interval (CI) 0.11 to 0.38) independent of the period elapsed since the index thrombotic event. A statistically significant "rebound" phenomenon (ie, an excess of recurrences shortly after cessation of prolonged treatment) was not found (RR 1.28, 95% CI 0.97 to 1.70). In addition, a substantial increase in bleeding complications was observed for patients receiving prolonged treatment during the entire period after randomization (RR 2.60, 95% CI 1.51 to 4.49). No reduction in mortality was noted during the entire study period (RR 0.89, 95% CI 0.66 to 1.21, P = 0.46). In conclusion, this review shows that treatment with VKA strongly reduces the risk of recurrent VTE for as long as they are used. However, the absolute risk of recurrent VTE declines over time, although the risk for major bleeding remains. Thus, the efficacy of VKA administration decreases over time since the index event.

Plain-language summary: The review authors searched the literature and were able to combine data from 11 randomized controlled clinical trials (3716 participants) comparing different durations of treatment with VKA in patients with a symptomatic VTE. Participants receiving prolonged treatment had around five times lower risk of recurrence of VTE. On the other hand, they had about three times higher risk of bleeding complications. Prolonged treatment did not reduce the risk of death. Prolonged use of VKA strongly reduced the risk of recurrent clots as long as they were used, but benefit decreased over time and the risk of major bleeding remained.
Abstract: We identified two studies for inclusion. Both studies were randomised cross-over trials performed in single centres. Both studies used the Premature Infant Pain Profile (PIPP) score as a measure of pain response. Different methods of evaluating PIPP scores are presented including the absolute PIPP score, a PIPP score > 10 or > 12 and an increase in PIPP ≥ 4 from the baseline value. There is a nonsignificant reduction in pain scores at one minute and a nonsignificant increase at five minutes post insertion of the speculum. PIPP score > 12 at one minute resulted in a statistically significant reduction in the number of patients who experienced pain (typical risk ratio (RR) 0.56, 95% CI 0.36 to 0.89; typical risk difference (RD) -0.23, 95% CI -0.39 to -0.86; number needed to treat to benefit (NNTB) 4). When pain was defined as an increase in PIPP > 4 there was a statistically significant reduction in the absolute number of patients who experienced pain at one minute (typical RR 0.70, 95% CI 0.52 to 0.94; typical RD -0.19, 95% CI -0.34 to -0.04; NNTB 5.3). The administration of topical proparacaine 30 seconds prior to the ophthalmological evaluation was associated with a reduction in pain scores especially at the time of speculum insertion. However, despite treatment, screening remains a painful procedure and the role of nonpharmacological and pharmacological intervention including different local anaesthetic agents should be ascertained in future randomised trials.

Plain-language summary: This review highlights that retinopathy of prematurity is a painful examination and that instillation of local anaesthetic eyedrops immediately prior to examination of the eye is associated with a reduction in pain scores, as assessed by validated pain scores. Ongoing research is required to determine the optimum local anaesthetic eyedrop and other potentially important methods of reducing pain, including swaddling, and sucrose.
Abstract: In this update we found four randomised controlled trials involving 317 participants in total. Three of them including 295 participants, 148 allocated to surgery and 147 to non-surgical treatment reported information on our primary outcome (improvement at three months of follow-up). The pooled estimate favoured surgery (RR 1.23, 95% CI 1.04 to 1.46). Two trials including 245 participants described outcome at six month follow-up, also favouring surgery (RR 1.19, 95% CI 1.02 to 1.39). Two trials reported clinical improvement at one year follow-up. They included 198 patients favouring surgery (RR 1.27, 95% CI 1.05 to 1.53). The only trial describing changes in neurophysiological parameters in both groups also favoured surgery (RR 1.44, 95% CI 1.05 to 1.97). Two trials described need for surgery during follow-up, including 198 patients. The pooled estimate for this outcome indicates that a significant proportion of people treated medically will require surgery while the risk of re-operation in surgically treated people is low (RR 0.04 favouring surgery, 95% CI 0.01 to 0.17). Complications of surgery and medical treatment were described by two trials with 226 participants. Although the incidence of complications was high in both groups, they were significantly more common in the surgical arm (RR 1.38, 95% CI 1.08 to 1.76). Surgical treatment of carpal tunnel syndrome relieves symptoms significantly better than splinting. Further research is needed to discover whether this conclusion applies to people with mild symptoms and whether surgical treatment is better than steroid injection.

Plain-language summary: This review aimed to compare surgical decompression with non-surgical treatments such as splinting or corticosteroid injections. Four trials were found and included, while three are awaiting assessment. The results suggest that surgical treatment is probably better than splinting but it is unclear whether it is better than steroid injection. Further research is needed for those with mild symptoms.
Abstract: One study met our inclusion criteria (26 children with minimal change nephrotic syndrome) and 11 were excluded (nine cross-over studies, one where albumin was not used for nephrotic syndrome and one where authors did not state whether the children had oedema). Risk of bias for the included study was unclear for selection bias, high for performance and detection bias, low for attrition bias, and high for selective reporting. The included study compared albumin plus furosemide with an equal volume of dextrose. Of our prespecified outcomes, the authors reported clinical improvement as weight change, serum sodium and adverse outcomes (blood pressure). The authors reported a greater weight loss in the albumin treated group initially but no difference overall at 10 days. However, the data in the text and the figures were inconsistent so we could not confirm the authors statements (very low certainty evidence). It is uncertain whether albumin infusion improves serum sodium when compared with an equal volume of dextrose (MD 2.00 mEq/L, 95% CI -0.09 to 4.09), systolic blood pressure (MD 2.00 mmHg, 95% CI -3.52 to 7.52) or diastolic blood pressure (MD 2.00 mmHg, 95%CI -4.29 to 8.29). Death, quality of life, and kidney function were not reported. We identified only one small study that was relevant to our review, therefore we are unable to draw any conclusions regarding the use of human albumin with or without diuretics in nephrotic syndrome. More RCTs are needed.

Plain-language summary: The review found one small RCT (26 patients) comparing human albumin plus the diuretic furosemide with placebo suitable for inclusion. We found nine studies on people with nephrotic syndrome that tested these comparisons but these were 'cross-over' studies which we judged not suitable. To find out whether there was any improvement after albumin, the study measured weight loss and serum sodium. The adverse effect measured was blood pressure. Although the authors reported increased weight loss we were not able to confirm this due to inconsistency between the data reported in the table and the text. There was no change in serum sodium or blood pressure. We judged these outcomes all to be of very low certainty. Death, quality of life, and kidney function were not reported. Because there was only one small study found we cannot tell whether albumin is effective in people with nephrotic syndrome and we do not know from the studies we looked at whether it is safe. There is no evidence in adults. We judged the evidence to be very low certainty. Therefore RCTs are needed.
Abstract: Seven trials involving 570 participants met the inclusion criteria. Two small trials compared DFO with placebo (plus standard antimalarial drugs in both groups). No evidence of benefit or harm was shown in relation to death, but the trials were small (435 participants). The risk of experiencing persistent seizures was lower with DFO compared with placebo (RR 0.80, 95% CI 0.67 to 0.95; 334 participants, 1 trial), but adverse effects were more common with DFO. One small trial involving 45 adults and children compared deferiprone with placebo (plus standard antimalarial drugs in both groups). Participants in the deferiprone group had significantly faster coma recovery (MD -27 h, 95% CI -34.20 to -19.80) and parasite clearance (MD -24 h, 95% CI -35.27 to -12.73). No adverse effects were reported for this trial. There are insufficient data to draw any conclusions for DFO and deferiprone. There are nonsignificant trends towards fewer seizures but overall harm (death) with DFO, and results from one small trial of deferiprone suggest shorter coma recovery and parasite clearance. 2008: We do not plan to update this review given the paucity of recent trials in this area and other priorities in malaria treatment research.

Plain-language summary: There are a number of different iron-chelating agents, such as desferrioxamine (DFO) and deferiprone, and all were considered in the review of trials, although DFO has to be given intravenously and so will be of little use in most malarious areas. The drugs may also display adverse effects like headaches, dizziness, muscle pain, and tiredness. The review found seven trials of DFO and deferiprone involving 570 participants. Although the drugs may have helped in part with parasite levels, there seemed to be adverse effects including concerns about possibility of an increase in death. There is insufficient evidence to support the use of iron-chelating agents as adjuncts in the treatment of malaria, and further trials are not expected.