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  • Allen, Natalie E., et al. (författare)
  • Interventions for preventing falls in Parkinson's disease
  • 2022
  • Ingår i: Cochrane Database of Systematic Reviews. - : John Wiley & Sons. - 1469-493X. ; :6
  • Forskningsöversikt (refereegranskat)abstract
    • Background Most people with Parkinson's disease (PD) experience at least one fall during the course of their disease. Several interventions designed to reduce falls have been studied. An up-to-date synthesis of evidence for interventions to reduce falls in people with PD will assist with informed decisions regarding fall-prevention interventions for people with PD. Objectives To assess the effects of interventions designed to reduce falls in people with PD. Search methods CENTRAL, MEDLINE, Embase, four other databases and two trials registers were searched on 16 July 2020, together with reference checking, citation searching and contact with study authors to identify additional studies. We also conducted a top-up search on 13 October 2021. Selection criteria We included randomised controlled trials (RCTs) of interventions that aimed to reduce falls in people with PD and reported the effect on falls. We excluded interventions that aimed to reduce falls due to syncope. Data collection and analysis We used standard Cochrane Review procedures. Primary outcomes were rate of falls and number of people who fell at least once. Secondary outcomes were the number of people sustaining one or more fall-related fractures, quality of life, adverse events and economic outcomes. The certainty of the evidence was assessed using GRADE. Main results This review includes 32 studies with 3370 participants randomised. We included 25 studies of exercise interventions (2700 participants), three studies of medication interventions (242 participants), one study of fall-prevention education (53 participants) and three studies of exercise plus education (375 participants). Overall, participants in the exercise trials and the exercise plus education trials had mild to moderate PD, while participants in the medication trials included those with more advanced disease. All studies had a high or unclear risk of bias in one or more items. Illustrative risks demonstrating the absolute impact of each intervention are presented in the summary of findings tables. Twelve studies compared exercise (all types) with a control intervention (an intervention not thought to reduce falls, such as usual care or sham exercise) in people with mild to moderate PD. Exercise probably reduces the rate of falls by 26% (rate ratio (RaR) 0.74, 95% confidence interval (CI) 0.63 to 0.87; 1456 participants, 12 studies; moderate-certainty evidence). Exercise probably slightly reduces the number of people experiencing one or more falls by 10% (risk ratio (RR) 0.90, 95% CI 0.80 to 1.00; 932 participants, 9 studies; moderate-certainty evidence). We are uncertain whether exercise makes little or no difference to the number of people experiencing one or more fall-related fractures (RR 0.57, 95% CI 0.28 to 1.17; 989 participants, 5 studies; very low-certainty evidence). Exercise may slightly improve health-related quality of life immediately following the intervention (standardised mean difference (SMD) -0.17, 95% CI -0.36 to 0.01; 951 participants, 5 studies; low-certainty evidence). We are uncertain whether exercise has an effect on adverse events or whether exercise is a cost-effective intervention for fall prevention. Three studies trialled a cholinesterase inhibitor (rivastigmine or donepezil). Cholinesterase inhibitors may reduce the rate of falls by 50% (RaR 0.50, 95% CI 0.44 to 0.58; 229 participants, 3 studies; low-certainty evidence). However, we are uncertain if this medication makes little or no difference to the number of people experiencing one or more falls (RR 1.01, 95% CI 0.90 to 1.14230 participants, 3 studies) and to health-related quality of life (EQ5D Thermometer mean difference (MD) 3.00, 95% CI -3.06 to 9.06; very low-certainty evidence). Cholinesterase inhibitors may increase the rate of non fall-related adverse events by 60% (RaR 1.60, 95% CI 1.28 to 2.01; 175 participants, 2 studies; low-certainty evidence). Most adverse events were mild and transient in nature. No data was available regarding the cost-effectiveness of medication for fall prevention. We are uncertain of the effect of education compared to a control intervention on the number of people who fell at least once (RR 10.89, 95% CI 1.26 to 94.03; 53 participants, 1 study; very low-certainty evidence), and no data were available for the other outcomes of interest for this comparison We are also uncertain (very low-certainty evidence) whether exercise combined with education makes little or no difference to the number of falls (RaR 0.46, 95% CI 0.12 to 1.85; 320 participants, 2 studies), the number of people sustaining fall-related fractures (RR 1.45, 95% CI 0.40 to 5.32,320 participants, 2 studies), or health-related quality of life (PDQ39 MD 0.05, 95% CI -3.12 to 3.23, 305 participants, 2 studies). Exercise plus education may make little or no difference to the number of people experiencing one or more falls (RR 0.89, 95% CI 0.75 to 1.07; 352 participants, 3 studies; low-certainty evidence). We are uncertain whether exercise combined with education has an effect on adverse events or is a cost-effective intervention for fall prevention. Authors' conclusions Exercise interventions probably reduce the rate of falls, and probably slightly reduce the number of people falling in people with mild to moderate PD. Cholinesterase inhibitors may reduce the rate of falls, but we are uncertain if they have an effect on the number of people falling. The decision to use these medications needs to be balanced against the risk of non fall-related adverse events, though these adverse events were predominantly mild or transient in nature. Further research in the form of large, high-quality RCTs are required to determine the relative impact of different types of exercise and different levels of supervision on falls, and how this could be influenced by disease severity. Further work is also needed to increase the certainty of the effects of medication and further explore falls prevention education interventions both delivered alone and in combination with exercise.
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  • Atieh, Momen A, et al. (författare)
  • Interventions for replacing missing teeth: alveolar ridge preservation techniques for dental implant site development.
  • 2015
  • Ingår i: The Cochrane database of systematic reviews. - 1469-493X. ; :5
  • Tidskriftsartikel (refereegranskat)abstract
    • Alveolar bone changes following tooth extraction can compromise prosthodontic rehabilitation. Alveolar ridge preservation (ARP) has been proposed to limit these changes and improve prosthodontic and aesthetic outcomes when implants are used.To assess the clinical effects of various materials and techniques for ARP after tooth extraction compared with extraction alone or other methods of ARP, or both, in patients requiring dental implant placement following healing of extraction sockets.The following electronic databases were searched: the Cochrane Oral Health Group's Trials Register (to 22 July 2014), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, 2014, Issue 6), MEDLINE via OVID (1946 to 22 July 2014), EMBASE via OVID (1980 to 22 July 2014), LILACS via BIREME (1982 to 22 July 2014), the Meta Register of Current Controlled Trials (to 22 July 2014), ClinicalTrials.gov (to 22 July 2014), the World Health Organization International Clinical Trials Registry Platform (to 22 July 2014), Web of Science Conference Proceedings (1990 to 22 July 2014), Scopus (1966 to 22 July 2014), ProQuest Dissertations and Theses (1861 to 22 July 2014) and OpenGrey (to 22 July 2014). A number of journals were also handsearched. Trial authors were contacted to identify unpublished randomised controlled trials. There were no restrictions regarding language and date of publication in the searches of the electronic databases.We included all randomised controlled trials (RCTs) on the use of alveolar ridge preservation techniques with at least six months of follow-up. Outcome measures were: changes in the bucco-lingual/palatal width of alveolar ridge, changes in the vertical height of the alveolar ridge, complications, the need for additional augmentation prior to implant placement, aesthetic outcomes, implant failure rates, peri-implant marginal bone level changes, changes in probing depths and clinical attachment levels at teeth adjacent to the extraction site, and complications of future prosthodontic rehabilitation.Two review authors extracted data independently and assessed risk of bias for each included trial. Corresponding authors were contacted to obtain missing information. Results were combined using random-effects models with mean differences (MD) for continuous outcomes and risk ratios (RR) for dichotomous outcomes, with 95% confidence intervals (95% CI). We constructed 'Summary of findings' tables to present the main findings.A total of 50 trials were potentially eligible for inclusion, of which 42 trials were excluded. We included eight RCTs with a total of 233 extraction sites in 184 participants. One trial was judged to be at unclear risk of bias and the remaining trials were at high risk of bias. From two trials comparing xenograft with extraction alone (70 participants, moderate quality evidence), there was some evidence of a reduction in loss of alveolar ridge height (MD -2.60 mm; 95% CI -3.43 to -1.76) and width (MD -1.97 mm; 95% CI -2.48 to -1.46). This was also found in one trial comparing allograft with extraction (24 participants, low quality evidence): ridge height (MD -2.20 mm; 95% CI -0.75 to -3.65) and width (MD - 1.40 mm; 95% CI 0.00 to -2.80) and height. From two RCTs comparing alloplast versus xenograft no evidence was found that either ridge preservation technique caused a smaller reduction in loss of ridge height (MD -0.35 mm; 95% CI -0.86 to 0.16) or width (MD -0.44 mm; 95% CI -0.90 to 0.02; two trials (55 participants); moderate quality evidence). There was insufficient evidence to determine whether there are clinically significant differences between different ARP techniques and extraction based on the need for additional augmentation prior to implant placement, complications, implant failure, or changes in peri-implant marginal bone levels and probing depths of neighbouring teeth. We found no trials which evaluated parameters relating to clinical attachment levels, specific aesthetic or prosthodontic outcomes.There is limited evidence that ARP techniques may minimise the overall changes in residual ridge height and width six months after extraction. There is also lack of evidence of any differences in implant failure, aesthetic outcomes or any other clinical parameters due to the lack of information or long-term data. There is no convincing evidence of any clinically significant difference between different grafting materials and barriers used for ARP. Further long term RCTs that follow CONSORT guidelines (www.consort-statement.org) are necessary.
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  • Axelsson, Inge, 1947-, et al. (författare)
  • Inhaled corticosteroids in children with persistent asthma : effects of different drugs and delivery devices on growth
  • 2019
  • Ingår i: Cochrane Database of Systematic Reviews. - : John Wiley & Sons. - 1469-493X. ; :6
  • Forskningsöversikt (refereegranskat)abstract
    • Background: Inhaled corticosteroids (ICS) are the most effective treatment for children with persistent asthma. Although treatment with ICS is generally considered to be safe in children, the potential adverse effects of these drugs on growth remains a matter of concern for parents and physicians.Objectives: To assess the impact of different inhaled corticosteroid drugs and delivery devices on the linear growth of children with persistent asthma.Search methods: We searched the Cochrane Airways Trials Register, which is derived from systematic searches of bibliographic databases including CENTRAL, MEDLINE, Embase, CINAHL, AMED and PsycINFO. We handsearched respiratory journals and meeting abstracts. We also conducted a search of ClinicalTrials.gov and manufacturers' clinical trial databases, or contacted the manufacturer, to search for potential relevant unpublished studies. The literature search was initially conducted in September 2014, and updated in November 2015, September 2018, and April 2019.Selection criteria: We selected parallel‐group randomized controlled trials of at least three months' duration. To be included, trials had to compare linear growth between different inhaled corticosteroid molecules at equivalent doses, delivered by the same type of device, or between different devices used to deliver the same inhaled corticosteroid molecule at the same dose, in children up to 18 years of age with persistent asthma.Data collection and analysis: At least two review authors independently selected studies and assessed risk of bias in included studies. The data were extracted by one author and checked by another. The primary outcome was linear growth velocity. We conducted meta‐analyses using Review Manager 5.3 software. We used mean differences (MDs) and 95% confidence intervals (CIs ) as the metrics for treatment effects, and the random‐effects model for meta‐analyses. We did not perform planned subgroup analyses due to there being too few included trials.Main results: We included six randomized trials involving 1199 children aged from 4 to 12 years (per‐protocol population: 1008), with mild‐to‐moderate persistent asthma. Two trials were from single hospitals, and the remaining four trials were multicentre studies. The duration of trials varied from six to 20 months.One trial with 23 participants compared fluticasone with beclomethasone, and showed that fluticasone given at an equivalent dose was associated with a significant greater linear growth velocity (MD 0.81 cm/year, 95% CI 0.46 to 1.16, low certainty evidence). Three trials compared fluticasone with budesonide. Fluticasone given at an equivalent dose had a less suppressive effect than budesonide on growth, as measured by change in height over a period from 20 weeks to 12 months (MD 0.97 cm, 95% CI 0.62 to 1.32; 2 trials, 359 participants; moderate certainty evidence). However, we observed no significant difference in linear growth velocity between fluticasone and budesonide at equivalent doses (MD 0.39 cm/year, 95% CI ‐0.94 to 1.73; 2 trials, 236 participants; very low certainty evidence).Two trials compared inhalation devices. One trial with 212 participants revealed a comparable linear growth velocity between beclomethasone administered via hydrofluoroalkane‐metered dose inhaler (HFA‐MDI) and beclomethasone administered via chlorofluorocarbon‐metered dose inhaler (CFC‐MDI) at an equivalent dose (MD ‐0.44 cm/year, 95% CI ‐1.00 to 0.12; low certainty evidence). Another trial with 229 participants showed a small but statistically significant greater increase in height over a period of six months in favour of budesonide via Easyhaler, compared to budesonide given at the same dose via Turbuhaler (MD 0.37 cm, 95% CI 0.12 to 0.62; low certainty evidence).Authors' conclusions: This review suggests that the drug molecule and delivery device may impact the effect size of ICS on growth in children with persistent asthma. Fluticasone at an equivalent dose seems to inhibit growth less than beclomethasone and budesonide. Easyhaler is likely to have less adverse effect on growth than Turbuhaler when used for delivery of budesonide. However, the evidence from this systematic review of head‐to‐head trials is not certain enough to inform the selection of inhaled corticosteroid or inhalation device for the treatment of children with persistent asthma. Further studies are needed, and pragmatic trials and real‐life observational studies seem more attractive and feasible.
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  • Bedenis, Rachel, et al. (författare)
  • Antiplatelet agents for preventing thrombosis after peripheral arterial bypass surgery
  • 2015
  • Ingår i: Cochrane Database of Systematic Reviews. - 1469-493X. ; :2, s. 000535-000535
  • Forskningsöversikt (refereegranskat)abstract
    • Background Peripheral arterial disease (PAD) may cause occlusions (blockages) in the main arteries of lower limbs. One treatment option is bypass surgery using autologous (the patient's own tissue) vein graft or prosthetic (artificial) graft. A number of factors influence occlusion rates in these patients, including the material used. To prevent graft occlusion patients are usually treated with antiplatelet, antithrombotic drugs, or a combination of both. Objectives To determine the effects of antiplatelet agents for the prevention of thrombosis in people with lower limb atherosclerosis who were undergoing femoropopliteal or femorodistal bypass grafting. Outcomes included the overall success of therapy (graft patency and limb salvage rates) and complications of treatment. Search methods For this update the Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator searched the Specialised Register (last searched June 2014) and the Cochrane Central Register of Controlled Trials (CENTRAL) (2014, Issue 5). We sought additional trials through screening the reference lists of relevant papers. Selection criteria Two review authors, RB and AL, independently reviewed studies found in the search and evaluated them based on the inclusion and exclusion criteria, resolving disagreements through discussion. Data collection and analysis RB and AL independently extracted details of the selected studies for the update. We compared the treatment and control groups for important prognostic factors and differences described. If any data were unavailable, we sought further information from study authors. We synthesised data by comparing group results. We addressed unit of analysis issues by subgroup analysis. Main results We include 16 studies with 5683 randomised participants. Nine different treatment groups were evaluated: aspirin (ASA) or aspirin and dipyridamole (ASA/DIP) versus placebo or nothing (six studies); ASA or ASA/DIP versus pentoxifylline (two studies); ASA/DIP versus indobufen (one study); ASA or ASA/DIP versus vitamin K antagonists (two studies); ASA/DIP versus low molecular weight heparin (one study); ticlopidine versus placebo (one study); ASA versus prostaglandin E1 (one study); ASA versus naftidrofuryl (one study); and clopidogrel and ASA versus ASA alone (one study). The treatment comparisons were evaluated separately, and, where possible, we performed subgroup analysis for venous grafts and prosthetic grafts and at different follow-up time points. The quality of evidence was low to moderate as many of the treatment comparisons had very few studies to contribute data, several of the included studies had unit of analysis issues, the treatment dosages varied between studies, and data for many outcomes important to this review were not given in any of the studies, or differed greatly between studies. Overall study quality was moderate, with the largest problem being that the majority of studies did not describe their methods of randomisation, allocation concealment or blinding of outcome assessors, leading to risk ratings of 'unclear'. The other main issue with study quality was studies not blinding participants or personnel. The treatment comparison with the most number of included studies, which allowed for robust conclusions, was that of aspirin (ASA) or ASA and dipyridamole (ASA/DIP) versus placebo or nothing, covered by six studies. For this treatment group, there was improved graft patency in the ASA or ASA/DIP treatment group, odds ratio (OR) 0.42 (95% confidence interval (CI) 0.22 to 0.83; P = 0.01; 952 participants). This effect was not seen for venous grafts alone at any of the time points, but was observed for all time points in prosthetic grafts, including the final time point of 12 months (OR 0.19, 95% CI 0.10 to 0.36; P < 0.00001; 222 participants). Only a single study evaluated secondary patency, for which there was no difference between treatment groups. For the comparison ASA or ASA/DIP versus placebo or nothing there was no difference for any of the side effects, including general, gastrointestinal, bleeding and wound/graft infection. Amputations, cardiovascular events and mortality were also similar between the treatment groups. The comparison of ASA or ASA/DIP versus vitamin K antagonists included two studies, one of which was very large, with over 2000 participants. There were no differences between treatment for primary graft patency at three, six, 12 or 24 months, and there was also no evidence of a difference for limb amputation, cardiovascular events or mortality. One large study (851 participants) evaluated clopidogrel and ASA versus ASA alone, and for all grafts there was no evidence of a difference of primary patency at 24 months. There was evidence of increased total bleeding in the clopidogrel and ASA group (OR 2.65, 95% CI 1.69 to 4.15) from an increase in mild (OR 2.34, 95% CI 1.37 to 4.00), and moderate bleeding (OR 4.13, 95% CI 1.37 to 12.45), but no difference in severe or fatal bleeding. There was no difference between the treatment groups for limb amputation or mortality. For the remaining treatment comparisons there is not currently enough evidence to draw any robust conclusions about the efficacy or safety of the treatment on graft patency after peripheral bypass. Authors' conclusions Antiplatelet therapy with aspirin or with aspirin plus dipyridamole had a beneficial effect on primary patency of peripheral bypass grafts compared to placebo or no treatment. This effect was not evident when evaluating venous grafts alone, but antiplatelet therapy did have a beneficial effect on patency in those who had prosthetic grafts. There was no evidence of differences in side effects (including general, gastrointestinal, bleeding or infection), amputation, cardiovascular events or mortality between the treatment groups. However, the number of participants included in this analysis might be too small to detect a statistically significant effect for side effects, amputation, cardiovascular morbidity or mortality. We found no difference in primary graft patency when aspirin or aspirin with dipyridamole was compared to a vitamin K antagonist or when clopidogrel with aspirin was compared to aspirin alone. However, there was evidence of increase bleeding in the clopidogrel with aspirin group for the latter comparison. The remaining six treatment comparisons did not include enough data to draw any robust conclusions about their efficacy or safety at this time.
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  • Bruschettini, Matteo, et al. (författare)
  • Antithrombin for the prevention of intraventricular hemorrhage in very preterm infants
  • 2016
  • Ingår i: Cochrane Database of Systematic Reviews. - 1469-493X. ; :3
  • Forskningsöversikt (refereegranskat)abstract
    • BACKGROUND: Preterm birth remains the major risk factor for the development of intraventricular hemorrhage, an injury that occurs in 25% of very low birth weight infants. Intraventricular hemorrhage is thought to be venous in origin and intrinsic thromboses in the germinal matrix are likely to play a triggering role. Antithrombin, a glycoprotein synthesized in the liver, is the major plasma inhibitor of thrombin thus modulating blood coagulation. Very low birth weight newborn infants have low levels of antithrombin and the risk of developing intraventricular hemorrhage is increased by the presence of hypercoagulability in the first hours of life. The administration of anticoagulants such as antithrombin may offset the increased risk of developing intraventricular hemorrhage. Anticoagulants may also reduce the risk of developing parenchymal venous infarct, a condition known to complicate intraventricular hemorrhage.OBJECTIVES: To assess whether the prophylactic administration of antithrombin (started within the first 24 hours after birth) reduces the incidence of germinal matrix-intraventricular hemorrhage in very preterm neonates when compared to placebo, no treatment, or heparin.SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (The Cochrane Library 2015), MEDLINE (1996 to 22 November 2015), EMBASE (1980 to 22 November 2015), and CINAHL (1982 to 22 November 2015). No language restrictions were applied. We searched the abstracts of the major congresses in the field (Perinatal Society of Australia and New Zealand and Pediatric Academic Societies) from 2000 to 2015.SELECTION CRITERIA: Randomised controlled trials, quasi-randomised controlled trials and cluster trials comparing the administration of early, i.e. within the first 24 hours of life, antithrombin in very preterm infants (gestational age < 32 weeks, any birth weight).DATA COLLECTION AND ANALYSIS: For each of the included trials, two authors independently extracted data (e.g. number of participants, birth weight, gestational age, antithrombin formulation (plasma-derived or recombinant), mode of administration, and duration of therapy, etc.) and assessed the risk of bias (e.g. adequacy of randomization, blinding, completeness of follow-up). The primary outcomes considered in this review are intraventricular hemorrhage and severe intraventricular hemorrhage.MAIN RESULTS: Two randomized controlled trials, for a total of 182 infants, met the inclusion criteria of this review. Both trials compared antithrombin with placebo. We found no significant differences in the rates of intraventricular hemorrhage (typical RR 1.30, CI 95% 0.87 to 1.93, typical RD 0.09, 95% CI -0.05 to 0.23; 2 studies, 175 infants; I² = 18% for RR and I² = 42% for RD) and severe intraventricular hemorrhage (typical RR 1.04, CI 95% 0.55 to 1.94; typical RD 0.01, 95% CI -0.11 to 0.12; 2 studies, 175 infants; I² = 0% for RR and I² = 0% for RD). Among secondary outcomes, we found no significant differences in terms of neonatal mortality (typical RR 2.00, CI 95% 0.62 to 6.45; typical RD 0.04, 95% CI -0.03 to 0.12; 2 studies, 182 infants; I² = 46% for RR and I² = 61% for RD) and in the other specified outcomes, such as bronchopulmonary dysplasia. The quality of the evidence supporting these findings is limited due to the imprecision of the estimates.AUTHORS' CONCLUSIONS: The administration of antithrombin seems not to reduce the incidence and severity of intraventricular hemorrhage in very preterm infants. Limited evidence is available on other clinically relevant outcomes. Given the imprecision of the estimate, the results of this systematic review are consistent with either a benefit or a detrimental effect of antithrombin and do not provide a definitive answer to the review question.
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  • Bruschettini, Matteo, et al. (författare)
  • Heparin for the prevention of intraventricular haemorrhage in preterm infants
  • 2016
  • Ingår i: Cochrane Database of Systematic Reviews. - 1469-493X. ; 2016:5
  • Forskningsöversikt (refereegranskat)abstract
    • Background: Preterm birth remains the major risk factor for the development of intraventricular haemorrhage, an injury that occurs in 25% of very low birth weight infants. Intraventricular haemorrhage is thought to be venous in origin and intrinsic thromboses in the germinal matrix are likely to play a triggering role. Heparin activates antithrombin and promotes the inactivation of thrombin and other target proteinases. The administration of anticoagulants such as heparin may offset the increased risk of developing intraventricular haemorrhage and may also reduce the risk of developing parenchymal venous infarct, a condition known to complicate intraventricular haemorrhage. Objectives: To assess whether the prophylactic administration of heparin reduces the incidence of germinal matrix-intraventricular haemorrhage in very preterm neonates when compared to placebo, no treatment, or other anticoagulants. Search methods: We searched the Cochrane Central Register of Controlled Trials (The Cochrane Library 2015), MEDLINE (1996 to 22 November 2015), EMBASE (1980 to 22 November 2015) and CINAHL (1982 to 22 November 2015), applying no language restrictions. We searched the abstracts of the major congresses in the field (Perinatal Society of Australia and New Zealand and Pediatric Academic Societies) from 2000 to 2015. Selection criteria: Randomised controlled trials, quasi-randomised controlled trials and cluster trials comparing the administration of early, i.e. within the first 24 hours of life, heparin in very preterm infants (gestational age <32 weeks). Data collection and analysis: For each of the included trials, two authors independently extracted data (e.g. number of participants, birth weight, gestational age, dose of heparin, mode of administration, and duration of therapy, etc.) and assessed the risk of bias (e.g. adequacy of randomisation, blinding, completeness of follow up). The primary outcomes considered in this review are intraventricular haemorrhage, severe intraventricular haemorrhage and neonatal mortality. Main results: Two randomised controlled trials enrolling a total of 155 infants met the inclusion criteria of this review. Both trials compared low-dose heparin to the same solution without heparin in very preterm newborns requiring umbilical catheterisation. No trials were identified that specifically studied the use of heparin in infants at risk of germinal matrix-intraventricular haemorrhage. We found no differences in the rates of intraventricular haemorrhage (typical RR 0.93, 95% CI 0.61 to 1.41; typical RD -0.03, 95% CI -0.17 to 0.12; 2 studies, 155 infants; I2 = 57% for RR and I2 = 65% for RD), severe intraventricular haemorrhage (typical RR 1.01, 95% CI 0.46 to 2.23; typical RD 0.00, 95% CI -0.11 to 0.11; 2 studies, 155 infants; I2 = 0% for RR and I2 = 0% for RD) and neonatal mortality (typical RR 0.69, 95% CI 0.28 to 1.67; typical RD -0.04, 95% CI -0.14 to 0.06; 2 studies, 155 infants; I2 = 28% for RR and I2 = 50% for RD). We judged the quality of the evidence supporting these findings as very low (rates of intraventricular haemorrhage) and low (severe intraventricular haemorrhage and neonatal mortality) mainly because of limitations in the study designs and the imprecision of estimates. We found very few data on other relevant outcomes, such as bronchopulmonary dysplasia, pulmonary haemorrhage and patent ductus arteriosus; and no study assessing long-term outcomes (e.g. neurodevelopmental disability). Authors' conclusions: There is very limited data on the effect of prophylactic administration of heparin on the incidence and severity of IVH in very preterm neonates. Both the identified trials used heparin in the context of maintaining umbilical line patency and not specifically as an agent to prevent germinal matrix-intraventricular haemorrhage. Given the imprecision of our estimates, the results of this systematic review are consistent with either a benefit or a detrimental effect of heparin and do not provide a definitive answer to the review question. Limited evidence is available on other clinically relevant outcomes.
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  • Bruschettini, Matteo, et al. (författare)
  • Needle aspiration versus intercostal tube drainage for pneumothorax in the newborn.
  • 2019
  • Ingår i: Cochrane Database of Systematic Reviews. - 1469-493X. ; :1
  • Forskningsöversikt (refereegranskat)abstract
    • Pneumothorax occurs more frequently in the neonatal period than at any other time of life and is associated with increased mortality and morbidity. It may be treated with either needle aspiration or insertion of a chest tube. The former consists of aspiration of air with a syringe through a needle or an angiocatheter, usually through the second or third intercostal space in the midclavicular line. The chest tube is usually placed in the anterior pleural space passing through the sixth intercostal space into the pleural opening, turned anteriorly and directed to the location of the pneumothorax, and then connected to a Heimlich valve or an underwater seal with continuous suction.
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  • Bruschettini, Matteo, et al. (författare)
  • Transcutaneous carbon dioxide monitoring for the prevention of neonatal morbidity and mortality.
  • 2016
  • Ingår i: Cochrane Database of Systematic Reviews. - 1469-493X. ; 2016:2
  • Forskningsöversikt (refereegranskat)abstract
    • Carbon dioxide (CO2) measurement is a fundamental evaluation in a neonatal intensive care unit (NICU), as both low and high values of CO2 might have detrimental effects on neonatal morbidity and mortality. Though measurement of CO2 in the arterial blood gas is the most accurate way to assess the amount of CO2, it requires blood sampling and it does not provide a continuous monitoring of CO2.
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  • Burdett, S., et al. (författare)
  • Adjuvant chemotherapy for resected early-stage non-small cell lung cancer
  • 2015
  • Ingår i: Cochrane Database of Systematic Reviews. - 1469-493X. ; :3
  • Forskningsöversikt (refereegranskat)abstract
    • Background To evaluate the effects of administering chemotherapy following surgery, or following surgery plus radiotherapy (known as adjuvant chemotherapy) in patients with early stage non-small cell lung cancer (NSCLC), we performed two systematic reviews andmeta-analyses of all randomised controlled trials using individual participant data. Results were first published in The Lancet in 2010. Objectives To compare, in terms of overall survival, time to locoregional recurrence, time to distant recurrence and recurrence-free survival: A. Surgery versus surgery plus adjuvant chemotherapy B. Surgery plus radiotherapy versus surgery plus radiotherapy plus adjuvant chemotherapy in patients with histologically diagnosed early stage NSCLC. (2) To investigate whether or not predefined patient subgroups benefit more or less from cisplatin-based chemotherapy in terms of survival. Search methods We supplemented MEDLINE and CANCERLIT searches (1995 to December 2013) with information from trial registers, hand-searching relevant meeting proceedings and by discussion with trialists and organisations. Selection criteria We included trials of a) surgery versus surgery plus adjuvant chemotherapy; and b) surgery plus radiotherapy versus surgery plus radiotherapy plus adjuvant chemotherapy, provided that they randomised NSCLC patients using a method which precluded prior knowledge of treatment assignment. Data collection and analysis We carried out a quantitative meta-analysis using updated information from individual participants from all randomised trials. Data from all patients were sought from those responsible for the trial. We obtained updated individual participant data (IPD) on survival, and date of last follow-up, as well as details of treatment allocated, date of randomisation, age, sex, histological cell type, stage, and performance status. To avoid potential bias, we requested information for all randomised patients, including those excluded from the investigators' original analyses. We conducted all analyses on intention-to-treat on the endpoint of survival. For trials using cisplatin-based regimens, we carried out subgroup analyses by age, sex, histological cell type, tumour stage, and performance status. Main results We identified 35 trials evaluating surgery plus adjuvant chemotherapy versus surgery alone. IPD were available for 26 of these trials and our analyses are based on 8447 participants (3323 deaths) in 34 trial comparisons. There was clear evidence of a benefit of adding chemotherapy after surgery (hazard ratio (HR)= 0.86, 95% confidence interval (CI)= 0.81 to 0.92, p< 0.0001), with an absolute increase in survival of 4% at five years. We identified 15 trials evaluating surgery plus radiotherapy plus chemotherapy versus surgery plus radiotherapy alone. IPD were available for 12 of these trials and our analyses are based on 2660 participants (1909 deaths) in 13 trial comparisons. There was also evidence of a benefit of adding chemotherapy to surgery plus radiotherapy (HR= 0.88, 95% CI= 0.81 to 0.97, p= 0.009). This represents an absolute improvement in survival of 4% at five years. For both meta-analyses, we found similar benefits for recurrence outcomes and there was little variation in effect according to the type of chemotherapy, other trial characteristics or patient subgroup. We did not undertake analysis of the effects of adjuvant chemotherapy on quality of life and adverse events. Quality of life information was not routinely collected during the trials, but where toxicity was assessed and mentioned in the publications, it was thought to be manageable. We considered the risk of bias in the included trials to be low. Authors' conclusions Results from 47 trial comparisons and 11,107 patients demonstrate the clear benefit of adjuvant chemotherapy for these patients, irrespective of whether chemotherapy was given in addition to surgery or surgery plus radiotherapy. This is the most up-to-date and complete systematic review and individual participant data (IPD) meta-analysis that has been carried out.
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  • Byber, Katarzyna, et al. (författare)
  • Humidification of indoor air for preventing or reducing dryness symptoms or upper respiratory infections in educational settings and at the workplace
  • 2021
  • Ingår i: Cochrane Database of Systematic Reviews. - : John Wiley & Sons. - 1469-493X. ; :12
  • Forskningsöversikt (refereegranskat)abstract
    • Background: Indoor exposure to dry air during heating periods has been associated with dryness and irritation symptoms of the upper respiratory airways and the skin. The irritated or damaged mucous membrane poses an important entry port for pathogens causing respiratory infections.Objectives: To determine the effectiveness of interventions that increase indoor air humidity in order to reduce or prevent dryness symptoms of the eyes, the skin and the upper respiratory tract (URT) or URT infections, at work and in educational settings.Search methods: The last search for all databases was done in December 2020. We searched Ovid MEDLINE, Embase, CENTRAL (Cochrane Library), PsycINFO, Web of Science, Scopus and in the field of occupational safety and health: NIOSHTIC-2, HSELINE, CISDOC and the In-house database of the Division of Occupational and Environmental Medicine, University of Zurich. We also contacted experts, screened reference lists of included trials, relevant reviews and consulted the WHO International Clinical Trials Registry Platform (ICTRP).Selection criteria: We included controlled studies with a parallel group or cross-over design, quasi-randomised studies, controlled before-and-after and interrupted time-series studies on the effects of indoor air humidification in reducing or preventing dryness symptoms and upper respiratory tract infections as primary outcomes at workplace and in the educational setting. As secondary outcomes we considered perceived air quality, other adverse events, sick leave, task performance, productivity and attendance and costs of the intervention.Data collection and analysis: Two review authors independently screened titles, abstracts and full texts for eligibility, extracted data and assessed the risks of bias of included studies. We synthesised the evidence for the primary outcomes 'dry eye', 'dry nose', 'dry skin', for the secondary outcome 'absenteeism', as well as for 'perception of stuffiness' as the harm-related measure. We assessed the certainty of evidence using the GRADE system.Main results: We included 13 studies with at least 4551 participants, and extracted the data of 12 studies with at least 4447 participants. Seven studies targeted the occupational setting, with three studies comprising office workers and four hospital staff. Three of them were clustered cross-over studies with 846 participants (one cRCT), one parallel-group controlled trial (2395 participants) and three controlled before-and-after studies with 181 participants. Five studies, all CTs, with at least 1025 participants, addressing the educational setting, were reported between 1963 and 1975, and in 2018. In total, at least 3933 (88%) participants were included in the data analyses. Due to the lack of information, the results of the risk of bias assessment remained mainly unclear and the assessable risks of bias of included studies were considered as predominantly high. Primary outcomes in occupational setting: We found that indoor air humidification at the workplace may have little to no effect on dryness symptoms of the eye and nose (URT). The only cRCT showed a significant decrease in dry eye symptoms among working adults (odds ratio (OR) 0.54, 95% confidence interval (CI) 0.37 to 0.79) with a low certainty of the evidence. The only cluster non-randomised cross-over study showed a non-significant positive effect of humidification on dryness nose symptoms (OR 0.87, 95% CI 0.53 to 1.42) with a low certainty of evidence. We found that indoor air humidification at the workplace may have little and non-significant effect on dryness skin symptoms. The pooled results of two cluster non-RCTs showed a non-significant alleviation of skin dryness following indoor air humidification (OR 0.66, 95% CI 0.33 to 1.32) with a low certainty of evidence. Similarly, the pooled results of two before-after studies yielded no statistically significant result (OR 0.69, 95% CI 0.33 to 1.47) with very low certainty of evidence No studies reported on the outcome of upper respiratory tract infections. No studies conducted in educational settings investigated our primary outcomes. Secondary outcomes in occupational setting: Perceived stuffiness of the air was increased during the humidification in the two cross-over studies (OR 2.18, 95% CI 1.47 to 3.23); (OR 1.70, 95% CI 1.10 to 2.61) with low certainty of evidence. Secondary outcomes in educational setting: Based on different measures and settings of absenteeism, four of the six controlled studies found a reduction in absenteeism following indoor air humidification (OR 0.54, 95% CI 0.45 to 0.65; OR 0.38, 95% CI 0.15 to 0.96; proportion 4.63% versus 5.08%).Authors' conclusions: Indoor air humidification at the workplace may have little to no effect on dryness symptoms of the eyes, the skin and the URT. Studies investigating illness-related absenteeism from work or school could only be summarised narratively, due to different outcome measures assessed. The evidence suggests that increasing humidification may reduce the absenteeism, but the evidence is very uncertain. Future RCTs involving larger sample sizes, assessing dryness symptoms more technically or rigorously defining absenteeism and controlling for potential confounders are therefore needed to determine whether increasing indoor air humidity can reduce or prevent dryness symptoms of the eyes, the skin, the URT or URT infections at work and in educational settings over time.
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  • Byrne, Molly, et al. (författare)
  • Sexual counselling for sexual problems in patients with cardiovascular disease
  • 2016
  • Ingår i: Cochrane Database of Systematic Reviews. - : WILEY-BLACKWELL. - 1469-493X. ; :2, s. 1-39
  • Forskningsöversikt (refereegranskat)abstract
    • BACKGROUND: Sexual problems are common among people with cardiovascular disease. Although clinical guidelines recommend sexual counselling for patients and their partners, there is little evidence on its effectiveness.OBJECTIVES: To evaluate the effectiveness of sexual counselling interventions (in comparison to usual care) on sexuality-related outcomes in patients with cardiovascular disease and their partners.SEARCH METHODS: We searched CENTRAL, MEDLINE, EMBASE, and three other databases up to 2 March 2015 and two trials registers up to 3 February 2016.SELECTION CRITERIA: Randomised controlled trials (RCTs) and quasi-RCTs, including individual and cluster RCTs. We included studies that compared any intervention to counsel adult cardiac patients about sexual problems with usual care.DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane.MAIN RESULTS: We included three trials with 381 participants. We were unable to pool the data from the included studies due to the differences in interventions used; therefore we synthesised the trial findings narratively.Two trials were conducted in the USA and one was undertaken in Israel. All trials included participants who were admitted to hospital with myocardial infarction (MI), and one trial also included participants who had undergone coronary artery bypass grafting. All trials followed up participants for a minimum of three months post-intervention; the longest follow-up timepoint was five months.One trial (N = 92) tested an intensive (total five hours) psychotherapeutic sexual counselling intervention delivered by a sexual therapist. One trial (N = 115) used a 15-minute educational video plus written material on resuming sexual activity following a MI. One trial (N = 174) tested the addition of a component that focused on resumption of sexual activity following a MI within a hospital cardiac rehabilitation programme.The quality of the evidence for all outcomes was very low.None of the included studies reported any outcomes from partners.Two trials reported sexual function. One trial compared intervention and control groups on 12 separate sexual function subscales and used a repeated measures analysis of variance (ANOVA) test. They reported statistically significant differences in favour of the intervention. One trial compared intervention and control groups using a repeated measures analysis of covariance (ANCOVA), and concluded: "There were no significant differences between the two groups [for sexual function] at any of the time points".Two trials reported sexual satisfaction. In one trial, the authors compared sexual satisfaction between intervention and control and used a repeated measured ANOVA; they reported "differences were reported in favour of the intervention". One trial compared intervention and control with a repeated measures ANCOVA and reported: "There were no significant differences between the two groups [for sexual satisfaction] at any of the timepoints".All three included trials reported the number of patients returning to sexual activity following MI. One trial found some evidence of an effect of sexual counselling on reported rate of return to sexual activity (yes/no) at four months after completion of the intervention (relative risk (RR) 1.71, 95% confidence interval (CI) 1.26 to 2.32; one trial, 92 participants, very low quality of evidence). Two trials found no evidence of an effect of sexual counselling on rate of return to sexual activity at 12 week (RR 1.01, 95% CI 0.94 to 1.09; one trial, 127 participants, very low quality of evidence) and three month follow-up (RR 0.98, 95% CI 0.88 to 1.10; one trial, 115 participants, very low quality of evidence).Two trials reported psychological well-being. In one trial, no scores were reported, but the trial authors stated: "No treatment effects were observed on state anxiety as measured in three points in time". In the other trial no scores were reported but, based on results of a repeated measures ANCOVA to compare intervention and control groups, the trial authors stated: "The experimental group had significantly greater anxiety at one month post MI". They also reported: "There were no significant differences between the two groups [for anxiety] at any other time points".One trial reporting relationship satisfaction and one trial reporting quality of life found no differences between intervention and control.No trial reported on satisfaction in how sexual issues were addressed in cardiac rehabilitation services.AUTHORS' CONCLUSIONS: We found no high quality evidence to support the effectiveness of sexual counselling for sexual problems in patients with cardiovascular disease. There is a clear need for robust, methodologically rigorous, adequately powered RCTs to test the effectiveness of sexual counselling interventions for people with cardiovascular disease and their partners.
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  • Bäcke, Pyrola, et al. (författare)
  • Pharmacological interventions for pain and sedation management in newborn infants undergoing therapeutic hypothermia
  • 2022
  • Ingår i: Cochrane Database of Systematic Reviews. - : John Wiley & Sons. - 1469-493X. ; 2022:11
  • Forskningsöversikt (refereegranskat)abstract
    • BACKGROUND: Newborn infants affected by hypoxic-ischemic encephalopathy (HIE) undergo therapeutic hypothermia. As this treatment seems to be associated with pain, and intensive and invasive care is needed, pharmacological interventions are often used. Moreover, painful procedures in the newborn period can affect pain responses later in life, impair brain development, and possibly have a long-term negative impact on neurodevelopment and quality of life.OBJECTIVES: To determine the effects of pharmacological interventions for pain and sedation management in newborn infants undergoing therapeutic hypothermia. Primary outcomes were analgesia and sedation, and all-cause mortality to discharge.SEARCH METHODS: We searched CENTRAL, PubMed, CINAHL (Cumulative Index to Nursing and Allied Health Literature), and the trial register ISRCTN in August 2021. We also checked the reference lists of relevant articles to identify additional studies.SELECTION CRITERIA: We included randomized controlled trials (RCT), quasi-RCTs and cluster-randomized trials comparing drugs used for the management of pain or sedation, or both, during therapeutic hypothermia: any opioids (e.g. morphine, fentanyl), alpha-2 agonists (e.g. clonidine, dexmedetomidine), N-Methyl-D-aspartate (NMDA) receptor antagonist (e.g. ketamine), other analgesics (e.g. paracetamol), and sedatives (e.g. benzodiazepines such as midazolam) versus another drug, placebo, no intervention, or non-pharmacological interventions.  Primary outcomes were analgesia and sedation, and all-cause mortality to discharge.DATA COLLECTION AND ANALYSIS: Two review authors independently assessed studies identified by the search strategy for inclusion. We planned to use the GRADE approach to assess the certainty of evidence. We planned to assess the methodological quality of included trials using Cochrane Effective Practice and Organisation of Care Group (EPOC) criteria (assessing randomization, blinding, loss to follow-up, and handling of outcome data). We planned to evaluate treatment effects using a fixed-effect model with risk ratio (RR) for categorical data and mean, standard deviation (SD), and mean difference (MD) for continuous data.  MAIN RESULTS: We did not find any completed studies for inclusion. Amongst the four excluded studies, topiramate and atropine were used in two and one trial, respectively; one study used dexmedetomidine and was initially reported in 2019 to be a randomized trial. However, it was an observational study (correction in 2021). We identified one ongoing study comparing dexmedetomidine to morphine.AUTHORS' CONCLUSIONS: We found no studies that met our inclusion criteria and hence there is no evidence to recommend or refute the use of pharmacological interventions for pain and sedation management in newborn infants undergoing therapeutic hypothermia.
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  • Carrwik, Christian, et al. (författare)
  • Potential harms of interventions for spinal metastatic disease
  • 2017
  • Ingår i: Cochrane Database of Systematic Reviews. - : John Wiley and Sons Ltd. - 1469-493X. ; :7
  • Tidskriftsartikel (refereegranskat)abstract
    • This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:The primary objective of this review is to compare the potential harms of treatment for spinal metastatic disease for the following treatments:1. Surgical intervention.2. Surgical intervention with radiation therapy.3. Radiation therapy alone.Our secondary objectives are:1. comparing the harms of different surgical methods;2. comparing the harms between different radiation protocols.
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  • Cooper, Tess E, et al. (författare)
  • Non-steroidal anti-inflammatory drugs (NSAIDs) for cancer-related pain in children and adolescents
  • 2017
  • Ingår i: Cochrane Database of Systematic Reviews. - 1469-493X. ; 7
  • Forskningsöversikt (refereegranskat)abstract
    • BACKGROUND: Pain is a common feature of childhood and adolescence around the world, and for many young people, that pain is chronic. The World Health Organization (WHO) guidelines for pharmacological treatments for persisting pain in children acknowledge that pain in children is a major public health concern of high significance in most parts of the world. Views on children's pain have changed over time and relief of pain is now seen as important. In the past, pain was largely dismissed and was frequently left untreated, and it was assumed that children quickly forgot about painful experiences.We designed a suite of seven reviews in chronic non-cancer pain and cancer pain (looking at antidepressants, antiepileptic drugs, non-steroidal anti-inflammatory drugs, opioids, and paracetamol as priority areas) to review the evidence for children's pain using pharmacological interventions.As one of the leading causes of mortality and morbidity for children and adolescents in the world today, childhood cancer (and its associated pain) is a major health concern. Specific mortality and morbidity data relating to children are not currently identified. All childhood cancer rates are on the rise; for example, in the USA approximately 10,380 children aged under 15 years were expected to be diagnosed with cancer by the end of 2016. However, with survival rates also increasing, over 80% of paediatric cancer patients are expected to survive for five years or more, thus identifying the need to address pain management in this population.Cancer pain in infants, children, and adolescents is primarily nociceptive pain with negative long term effects. Cancer-related pain is generally caused directly by the tumour itself such as compressing on the nerve or inflammation of the organs. Cancer-related pain generally occurs as a result of perioperative procedures, nerve damage caused by radiation or chemotherapy treatments, or mucositis. However, this review focused on pain caused directly by the tumour itself such as nerve infiltration, external nerve compression, and other inflammatory events.Non-steroidal anti-inflammatory drugs (NSAIDs) are used to treat pain, reduce fever, and for their anti-inflammatory properties. They are commonly used within paediatric pain management. NSAIDs are currently licensed for use in western countries, however not approved for infants aged under three months. Primary adverse effects include gastrointestinal issues and possible renal impairment with long term use. Other adverse effects in children include diarrhoea, headache, nausea, constipation, rash, dizziness, and abdominal pain.OBJECTIVES: To assess the analgesic efficacy, and adverse events, of non-steroidal anti-inflammatory drugs (NSAIDs) used to treat cancer-related pain in children and adolescents aged from birth and 17 years, in any setting.SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) via the Cochrane Register of Studies Online, MEDLINE via Ovid, and Embase via Ovid from inception to 21 February 2017. We also searched the reference lists of retrieved studies and reviews, and searched online clinical trial registries.SELECTION CRITERIA: Randomised, double-blind trials of any dose, and any route, treating cancer-related pain in children and adolescents, comparing NSAIDs with placebo or an active comparator.DATA COLLECTION AND ANALYSIS: Two review authors independently assessed studies for eligibility. We planned to use dichotomous data to calculate risk ratio and number needed to treat for one additional event, using standard methods. We assessed GRADE (Grading of Recommendations Assessment, Development and Evaluation) and planned to create a 'Summary of findings' table.MAIN RESULTS: No studies were eligible for inclusion in this review (very low quality evidence). We downgraded the quality of evidence by three levels due to the lack of data reported for any outcome.AUTHORS' CONCLUSIONS: There is no evidence from randomised controlled trials that non-steroidal anti-inflammatory drugs (NSAIDs) reduce cancer-related pain in children and adolescents. This means that no reliance or conclusions can be made about efficacy or harm in the use of NSAIDs to treat chronic cancer-related pain in children and adolescents.
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  • Coren, Esther, et al. (författare)
  • Parent training support for intellectually disabled parents
  • 2010
  • Ingår i: Cochrane Database of Systematic Reviews. - 1469-493X. ; :6, s. CD007987-
  • Forskningsöversikt (refereegranskat)abstract
    • BACKGROUND: Intellectual disability may impact on an individual's capacity to parent a child effectively. Research suggests that the number of intellectually disabled people with children is increasing. Children of parents with intellectual disabilities may be at increased risk of neglectful care which could lead to health, developmental and behavioural problems, or increased risk of intellectual disability.However, there is some indication that some parents with intellectual disabilities are able to provide adequate child care if they are given appropriate training and support to do so. OBJECTIVES: To assess the effectiveness of parent training interventions to support the parenting of parents with intellectual disabilities SEARCH STRATEGY: We searched the following databases: Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library), MEDLINE, EMBASE, CINAHL, PsycINFO, ASSIA, Sociological Abstracts, Dissertation Abstracts International, MetaRegister of Controlled Trials, and ZETOC. SELECTION CRITERIA: Randomised controlled trials comparing parent training interventions for parents with intellectual disabilities with usual care or with a control group. Outcomes of interest were: the attainment of parenting skills specific to the intervention, safe home practices and the understanding of child health. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed risk of bias and undertook data extraction. MAIN RESULTS: Three trials met the inclusion criteria for this review but no meta-analysis was possible. One study reported improved maternal-child interaction following group parent training compared with the control group. The second study reported some improvements in parents knowledge of life threatening emergencies, ability to recognise dangers and identify precautions and smaller improvements in their ability to implement precautions, use medicines safely and recognise child illness and symptoms. The third study reported improvement in child care and safety skills following the intervention. AUTHORS' CONCLUSIONS: There is some risk of bias in the included studies, with limited information available to assess possible bias and to fully assess the findings of one included study. Whilst the evidence presented here does seem promising with regard to the ability of such interventions to improve parenting knowledge and skill in this population, there is a need for larger RCTs of interventions before conclusions can be drawn about the effectiveness of parent training for this group of parents.
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  • Ekström, Magnus, et al. (författare)
  • Oxygen for breathlessness in patients with chronic obstructive pulmonary disease who do not qualify for home oxygen therapy
  • 2016
  • Ingår i: Cochrane Database of Systematic Reviews. - 1469-493X. ; :11
  • Forskningsöversikt (refereegranskat)abstract
    • Background: Breathlessness is a cardinal symptom of chronic obstructive pulmonary disease (COPD). Long-term oxygen therapy (LTOT) is given to improve survival time in people with COPD and severe chronic hypoxaemia at rest. The efficacy of oxygen therapy for breathlessness and health-related quality of life (HRQOL) in people with COPD and mild or no hypoxaemia who do not meet the criteria for LTOT has not been established. Objectives: To determine the efficacy of oxygen versus air in mildly hypoxaemic or non-hypoxaemic patients with COPD in terms of (1) breathlessness; (2) HRQOL; (3) patient preference whether to continue therapy; and (4) oxygen-related adverse events. Search methods: We searched the Cochrane Airways Group Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and Embase, to 12 July 2016, for randomised controlled trials (RCTs). We handsearched the reference lists of included articles. Selection criteria: We included RCTs of the effects of non-invasive oxygen versus air on breathlessness, HRQOL or patient preference to continue therapy among people with COPD and mild or no hypoxaemia (partial pressure of oxygen (PaO2) >7.3 kPa) who were not already receiving LTOT. Two review authors independently assessed articles for inclusion in the review. Data collection and analysis: Two review authors independently collected and analysed data. We assessed risk of bias by using the Cochrane 'Risk of bias tool'. We pooled effects recorded on different scales as standardised mean differences (SMDs) with 95% confidence intervals (CIs) using random-effects models. Lower SMDs indicated decreased breathlessness and reduced HRQOL. We performed subanalyses and sensitivity analyses and assessed the quality of evidence according to the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach. Main results: Compared with the previous review, which was published in 2011, we included 14 additional studies (493 participants), excluded one study and included data for meta-analysis of HRQOL. In total, we included in this review 44 studies including 1195 participants, and we included 33 of these (901 participants) in the meta-analysis. We found that breathlessness during exercise or daily activities was reduced by oxygen compared with air (32 studies; 865 participants; SMD -0.34, 95% CI -0.48 to -0.21; I-2 = 37%; low-quality evidence). This translates to a decrease in breathlessness of about 0.7 points on a 0 to 10 numerical rating scale. In contrast, we found no effect of short-burst oxygen given before exercise (four studies; 90 participants; SMD 0.01, 95% CI -0.26 to 0.28; I-2 = 0%; low-quality evidence). Oxygen reduced breathlessness measured during exercise tests (25 studies; 442 participants; SMD-0.34, 95% CI -0.46 to -0.22; I-2 = 29%; moderate-quality evidence), whereas evidence of an effect on breathlessness measured in daily life was limited (two studies; 274 participants; SMD -0.13, 95% CI, -0.37 to 0.11; I-2 = 0%; low-quality evidence). Oxygen did not clearly affectHRQOL (five studies; 267 participants; SMD 0.10, 95% CI -0.06 to 0.26; I-2 = 0%; low-quality evidence). Patient preference and adverse events could not be analysed owing to insufficient data. Authors' conclusions: We are moderately confident that oxygen can relieve breathlessness when given during exercise to mildly hypoxaemic and non-hypoxaemic people with chronic obstructive pulmonary disease who would not otherwise qualify for home oxygen therapy. Most evidence pertains to acute effects during exercise tests, and no evidence indicates that oxygen decreases breathlessness in the daily life setting. Findings show that oxygen does not affect health-related quality of life.
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32.
  • Ezzo, Jeanette, et al. (författare)
  • Manual lymphatic drainage for lymphedema following breast cancer treatment
  • 2015
  • Ingår i: Cochrane Database of Systematic Reviews. - 1469-493X. ; :5, s. 003475-003475
  • Forskningsöversikt (refereegranskat)abstract
    • Background More than one in five patients who undergo treatment for breast cancer will develop breast cancer-related lymphedema (BCRL). BCRL can occur as a result of breast cancer surgery and/or radiation therapy. BCRL can negatively impact comfort, function, and quality of life (QoL). Manual lymphatic drainage (MLD), a type of hands-on therapy, is frequently used for BCRL and often as part of complex decongestive therapy (CDT). CDT is a fourfold conservative treatment which includes MLD, compression therapy (consisting of compression bandages, compression sleeves, or other types of compression garments), skin care, and lymph-reducing exercises (LREs). Phase 1 of CDT is to reduce swelling; Phase 2 is to maintain the reduced swelling. Objectives To assess the efficacy and safety of MLD in treating BCRL. Search methods We searched Medline, EMBASE, CENTRAL, WHO ICTRP (World Health Organization's International Clinical Trial Registry Platform), and Cochrane Breast Cancer Group's Specialised Register from root to 24May 2013. No language restrictions were applied. Selection criteria We included randomized controlled trials (RCTs) or quasi-RCTs of women with BCRL. The intervention was MLD. The primary outcomes were (1) volumetric changes, (2) adverse events. Secondary outcomes were (1) function, (2) subjective sensations, (3) QoL, (4) cost of care. Data collection and analysis We collected data on three volumetric outcomes. (1) LE (lymphedema) volume was defined as the amount of excess fluid left in the arm after treatment, calculated as volume in mL of affected arm post-treatment minus unaffected arm post-treatment. (2) Volume reduction was defined as the amount of fluid reduction in mL from before to after treatment calculated as the pretreatment LE volume of the affected arm minus the post-treatment LE volume of the affected arm. (3) Per cent reduction was defined as the proportion of fluid reduced relative to the baseline excess volume, calculated as volume reduction divided by baseline LE volume multiplied by 100. We entered trial data into ReviewManger 5.2 (RevMan), pooled data using a fixed-effect model, and analyzed continuous data as mean differences (MDs) with 95% confidence intervals (CIs). We also explored subgroups to determine whether mild BCRL compared to moderate or severe BCRL, and BCRL less than a year compared to more than a year was associated with a better response to MLD. Main results Six trials were included. Based on similar designs, trials clustered in three categories. (1) MLD + standard physiotherapy versus standard physiotherapy (one trial) showed significant improvements in both groups from baseline but no significant between-groups differences for per cent reduction. (2) MLD + compression bandaging versus compression bandaging (two trials) showed significant per cent reductions of 30% to 38.6% for compression bandaging alone, and an additional 7.11% reduction forMLD (MD7.11%, 95% CI 1.75% to 12.47%; two RCTs; 83 participants). Volume reduction was borderline significant (P = 0.06). LE volume was not significant. Subgroup analyses was significant showing that participants with mild-to-moderate BCRL were better responders to MLD than were moderate-to-severe participants. (3) MLD+ compression therapy versus nonMLDtreatment + compression therapy (three trials) were too varied to pool. One of the trials compared compression sleeve plus MLD to compression sleeve plus pneumatic pump. Volume reduction was statistically significant favoringMLD (MD 47.00 mL, 95% CI 15.25 mL to 78.75 mL; 1 RCT; 24 participants), per cent reduction was borderline significant (P= 0.07), and LE volume was not significant. A second trial compared compression sleeve plus MLD to compression sleeve plus selfadministered simple lymphatic drainage (SLD), and was significant forMLD for LE volume (MD -230.00 mL, 95% CI -450.84 mL to -9.16 mL; 1 RCT; 31 participants) but not for volume reduction or per cent reduction. A third trial of MLD + compression bandaging versus SLD + compression bandaging was not significant (P = 0.10) for per cent reduction, the only outcome measured (MD 11.80%, 95% CI -2.47% to 26.07%, 28 participants). MLD was well tolerated and safe in all trials. Two trials measured function as range of motion with conflicting results. One trial reported significant within-groups gains for both groups, but no between-groups differences. The other trial reported there were no significant within-groups gains and did not report between-groups results. One trial measured strength and reported no significant changes in either group. Two trials measured QoL, but results were not usable because one trial did not report any results, and the other trial did not report between-groups results. Four trials measured sensations such as pain and heaviness. Overall, the sensations were significantly reduced in both groups over baseline, but with no between-groups differences. No trials reported cost of care. Trials were small ranging from 24 to 45 participants. Most trials appeared to randomize participants adequately. However, in four trials the person measuring the swelling knew what treatment the participants were receiving, and this could have biased results. Authors' conclusions MLD is safe and may offer additional benefit to compression bandaging for swelling reduction. Compared to individuals with moderate to-severe BCRL, those with mild-to-moderate BCRL may be the ones who benefit from adding MLD to an intensive course of treatment with compression bandaging. This finding, however, needs to be confirmed by randomized data. In trials where MLD and sleeve were compared with a nonMLD treatment and sleeve, volumetric outcomes were inconsistent within the same trial. Research is needed to identify themost clinically meaningful volumetric measurement, to incorporate newer technologies in LE assessment, and to assess other clinically relevant outcomes such as fibrotic tissue formation. Findings were contradictory for function (range of motion), and inconclusive for quality of life. For symptoms such as pain and heaviness, 60% to 80% of participants reported feeling better regardless of which treatment they received. One-year follow-up suggests that once swelling had been reduced, participants were likely to keep their swelling down if they continued to use a custom-made sleeve.
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  • Gaitonde, Rakhal, et al. (författare)
  • Interventions to reduce corruption in the health sector
  • 2016
  • Ingår i: Cochrane Database of Systematic Reviews. - : Wiley-Blackwell. - 1469-493X. ; :8
  • Forskningsöversikt (refereegranskat)abstract
    • Background: Corruption is the abuse or complicity in abuse, of public or private position, power or authority to benefit oneself, a group, an organisation or others close to oneself; where the benefits may be financial, material or non-material. It is wide-spread in the health sector and represents a major problem.Objectives: Our primary objective was to systematically summarise empirical evidence of the effects of strategies to reduce corruption in the health sector. Our secondary objective was to describe the range of strategies that have been tried and to guide future evaluations of promising strategies for which there is insufficient evidence.Search methods: We searched 14 electronic databases up to January 2014, including: CENTRAL; MEDLINE; EMBASE; sociological, economic, political and other health databases; Human Resources Abstracts up to November 2010; Euroethics up to August 2015; and PubMed alerts from January 2014 to June 2016. We searched another 23 websites and online databases for grey literature up to August 2015, including the World Bank, the International Monetary Fund, the U4 Anti-Corruption Resource Centre, Transparency International, healthcare anti-fraud association websites and trial registries. We conducted citation searches in Science Citation Index and Google Scholar, and searched PubMed for related articles up to August 2015. We contacted corruption researchers in December 2015, and screened reference lists of articles up to May 2016.Selection criteria: For the primary analysis, we included randomised trials, non-randomised trials, interrupted time series studies and controlled before-after studies that evaluated the effects of an intervention to reduce corruption in the health sector. For the secondary analysis, we included case studies that clearly described an intervention to reduce corruption in the health sector, addressed either our primary or secondary objective, and stated the methods that the study authors used to collect and analyse data.Data collection and analysis: One review author extracted data from the included studies and a second review author checked the extracted data against the reports of the included studies. We undertook a structured synthesis of the findings. We constructed a results table and 'Summaries of findings' tables. We used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to assess the certainty of the evidence.Main results: No studies met the inclusion criteria of the primary analysis. We included nine studies that met the inclusion criteria for the secondary analysis. One study found that a package of interventions coordinated by the US Department of Health and Human Services and Department of Justice recovered a large amount of money and resulted in hundreds of new cases and convictions each year (high certainty of the evidence). Another study from the USA found that establishment of an independent agency to investigate and enforce efforts against overbilling might lead to a small reduction in overbilling, but the certainty of this evidence was very low. A third study from India suggested that the impacts of coordinated efforts to reduce corruption through increased detection and enforcement are dependent on continued political support and that they can be limited by a dysfunctional judicial system (very low certainty of the evidence). One study in South Korea and two in the USA evaluated increased efforts to investigate and punish corruption in clinics and hospitals without establishing an independent agency to coordinate these efforts. It is unclear whether these were effective because the evidence is of very low certainty. One study from Kyrgyzstan suggested that increased transparency and accountability for co-payments together with reduction of incentives for demanding informal payments may reduce informal payments (low certainty of the evidence). One study from Germany suggested that guidelines that prohibit hospital doctors from accepting any form of benefits from the pharmaceutical industry may improve doctors' attitudes about the influence of pharmaceutical companies on their choice of medicines (low certainty of the evidence). A study in the USA, evaluated the effects of introducing a law that required pharmaceutical companies to report the gifts they gave to healthcare workers. Another study in the USA evaluated the effects of a variety of internal control mechanisms used by community health centres to stop corruption. The effects of these strategies is unclear because the evidence was of very low certainty.Authors' conclusions: There is a paucity of evidence regarding how best to reduce corruption. Promising interventions include improvements in the detection and punishment of corruption, especially efforts that are coordinated by an independent agency. Other promising interventions include guidelines that prohibit doctors from accepting benefits from the pharmaceutical industry, internal control practices in community health centres, and increased transparency and accountability for co-payments combined with reduced incentives for informal payments. The extent to which increased transparency alone reduces corruption is uncertain. There is a need to monitor and evaluate the impacts of all interventions to reduce corruption, including their potential adverse effects.
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35.
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36.
  • Gendron, Louis McCusky, et al. (författare)
  • Active mind‐body movement therapies as an adjunct to or in comparison with pulmonary rehabilitation for people with chronic obstructive pulmonary disease
  • 2018
  • Ingår i: Cochrane Database of Systematic Reviews. - : John Wiley & Sons. - 1469-493X. ; :10
  • Forskningsöversikt (refereegranskat)abstract
    • Background: Active mind‐body movement therapies (AMBMTs), including but not limited to yoga, tai chi, and qigong, have been applied as exercise modalities for people with chronic obstructive pulmonary disease (COPD). AMBMT strategies have been found to be more effective than usual care; however, whether AMBMT is inferior, equivalent, or superior to pulmonary rehabilitation (PR) in people with COPD remains to be determined.Objectives: To assess the effects of AMBMTs compared with, or in addition to, PR in the management of COPD.Search methods: We searched the Cochrane Airways Group Specialised Register of trials and major Chinese databases, as well as trial registries from inception to July 2017. In addition, we searched references of primary studies and review articles. We updated this search in July 2018 but have not yet incorporated these results.Selection criteria: We included (1) randomised controlled trials (RCTs) comparing AMBMT (i.e. controlled breathing and/or focused meditation/attention interventions for which patients must actively move their joints and muscles for at least four weeks with no minimum intervention frequency) versus PR (any inpatient or outpatient, community‐based or home‐based rehabilitation programme lasting at least four weeks, with no minimum intervention frequency, that included conventional exercise training with or without education or psychological support) and (2) RCTs comparing AMBMT + PR versus PR alone in people with COPD. Two independent review authors screened and selected studies for inclusion.Data collection and analysis: Two review authors independently selected trials for inclusion, extracted outcome data, and assessed risk of bias. We contacted study authors if necessary to ask them to provide missing data. We calculated mean differences (MDs) using a random‐effects model.Main results: We included in the meta‐analysis 10 studies with 762 participants across one or more comparisons. The sample size of included studies ranged from 11 to 206 participants. Nine out of 10 studies involving all levels of COPD severity were conducted in China with adults from 55 to 88 years of age, a higher proportion of whom were male (78%). Nine out of 10 studies provided tai chi and/or qigong programmes as AMBMT, and one study provided yoga. Overall, the term 'PR' has been uncritically applied in the vast majority of studies, which limits comparison of AMBMT and PR. For example, eight out of 10 studies considered walking training as equal to PR and used this as conventional exercise training within PR. Overall study quality for main comparisons was moderate to very low mainly owing to imprecision, indirectness (exercise component inconsistent with recommendations), and risk of bias issues. The primary outcomes for our review were quality of life, dyspnoea, and serious adverse events.When researchers compared AMBMT versus PR alone (mainly unstructured walking training), statistically significant improvements in disease‐specific quality of life (QoL) (St. George's Respiratory Questionnaire (SGRQ) total score) favoured AMBMT: mean difference (MD) ‐5.83, 95% confidence interval (CI) ‐8.75 to ‐2.92; three trials; 249 participants; low‐quality evidence. The common effect size, but not the 95% CI around the pooled treatment effect, exceeded the minimal clinically important difference (MCID) of minus four. The COPD Assessment Test (CAT) also revealed statistically significant improvements favouring AMBMT over PR, with scores exceeding the MCID of three, with an MD of 6.58 units (95% CI ‐9.16 to – 4.00 units; one trial; 74 participants; low‐quality evidence). Results show no between‐group differences with regard to dyspnoea measured by the modified Medical Research Council Scale (MD 0.00 units, 95% CI ‐0.37 to 0.37; two trials; 127 participants; low‐quality evidence), the Borg Scale (MD 0.44 units, 95% CI ‐0.88 to 0.00; one trial; 139 participants; low‐quality evidence), or the Chronic Respiratory Questionnaire (CRQ) Dyspnoea Scale (MD ‐0.21, 95% CI ‐2.81 to 2.38; one trial; 11 participants; low‐quality evidence). Comparisons of AMBMT versus PR alone did not include assessments of generic quality of life, adverse events, limb muscle function, exacerbations, or adherence.Comparisons of AMBMT added to PR versus PR alone (mainly unstructured walking training) revealed significant improvements in generic QoL as measured by Short Form (SF)‐36 for both the SF‐36 general health summary score (MD 5.42, 95% CI 3.82 to 7.02; one trial; 80 participants; very low‐quality evidence) and the SF‐36 mental health summary score (MD 3.29, 95% CI 1.45 to 4.95; one trial; 80 participants; very low‐quality evidence). With regard to disease‐specific QoL, investigators noted no significant improvement with addition of AMBMT to PR versus PR alone (SGRQ total score: MD ‐2.57, 95% CI ‐7.76 to 2.62 units; one trial; 192 participants; moderate‐quality evidence; CRQ Dyspnoea Scale score: MD 0.04, 95% CI ‐2.18 to 2.26 units; one trial; 80 participants; very low‐quality evidence). Comparisons of AMBMT + PR versus PR alone did not include assessments of dyspnoea, adverse events, limb muscle function, exacerbations, or adherence.Authors' conclusions: Given the quality of available evidence, the effects of AMBMT versus PR or of AMBMT added to PR versus PR alone in people with stable COPD remain inconclusive. Evidence of low quality suggests better disease‐specific QoL with AMBMT versus PR in people with stable COPD, and evidence of very low quality suggests no differences in dyspnoea between AMBMT and PR. Evidence of moderate quality shows that AMBMT added to PR does not result in improved disease‐specific QoL, and evidence of very low quality suggests that AMBMT added to PR may lead to better generic QoL versus PR alone. Future studies with adequate descriptions of conventional exercise training (i.e. information on duration, intensity, and progression) delivered by trained professionals with a comprehensive understanding of respiratory physiology, exercise science, and the pathology of COPD are needed before definitive conclusions can be drawn regarding treatment outcomes with AMBMT versus PR or AMBMT added to PR versus PR alone for patients with COPD.
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37.
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38.
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39.
  • Hofmann, Fabian, et al. (författare)
  • Targeted therapy for metastatic renal cell carcinoma
  • 2020
  • Ingår i: Cochrane Database of Systematic Reviews. - : John Wiley & Sons. - 1469-493X. ; :10
  • Forskningsöversikt (refereegranskat)abstract
    • Background: Several comparative randomised controlled trials (RCTs) have been performed including combinations of tyrosine kinase inhibitors (TKIs) and immune checkpoint inhibitors since the publication of a Cochrane Review on targeted therapy for metastatic renal cell carcinoma (mRCC) in 2008. This review represents an update of that original review.Objectives: To assess the effects of targeted therapies for clear cell mRCC in patients naïve to systemic therapy.Search methods: We performed a comprehensive search with no restrictions on language or publication status. The date of the latest search was 18 June 2020.Selection criteria: We included randomised controlled trials, recruiting patients with clear cell mRCC naïve to previous systemic treatment. The index intervention was any TKI‐based targeted therapy.Data collection and analysis: Two review authors independently assessed the included studies and extracted data for the primary outcomes: progression‐free survival (PFS), overall survival (OS) and serious adverse events (SAEs); and the secondary outcomes: health‐related quality of life (QoL), response rate and minor adverse events (AEs). We performed statistical analyses using a random‐effects model and rated the certainty of evidence according to the GRADE approach.Main results: We included 18 RCTs reporting on 11,590 participants randomised across 18 comparisons. This abstract focuses on the primary outcomes of select comparisons.
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40.
  • Hofmann, Fabian, et al. (författare)
  • Targeted therapy for metastatic renal cell carcinoma
  • 2017
  • Ingår i: Cochrane Database of Systematic Reviews. - : John Wiley & Sons. - 1469-493X. ; 2017:9
  • Tidskriftsartikel (refereegranskat)abstract
    • This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: To compare the effects of targeted agents in the systemic therapy of people with metastatic renal cell carcinoma.
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41.
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42.
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43.
  • Hultcrantz, Monica, et al. (författare)
  • From evidence to policy on a national level : supporting the government’s role in a learning healthcare system
  • 2020
  • Ingår i: Cochrane Database of Systematic Reviews. - 1469-493X. ; 9, s. 190-190
  • Tidskriftsartikel (refereegranskat)abstract
    • Background: In August 2018, the Swedish government appointed a special investigator to support a national ecosystem for evidence-based healthcare. In November 2019, the inquiry received an additional task now focusing on follow-up to enable a more strategic, evidence-based and long-term sustainable management of health care on a national level. Since healthcare systems around the world face similar challenges, we believe the results of the investigation are highly relevant for a broader audience.Objectives: To analyze how governmental agencies can better support a comprehensive follow-up of health care and thereby create a learning system on a national level. This includes following the effects of the government’s initiatives and reforms and analyzing where future governmental interventions are needed.Methods: The investigator and her team have worked with an expert committee including representatives of governmental agencies, healthcare professions and healthcare providers, as well as a reference group of patient representatives. Additional information has been collected through questionnaires, workshops and meetings with stakeholders and other governmental inquiries working on related topics. Background information was collected from published research, governmental reports, existing regulations etc.Results: Although roughly estimated more than 1000 full-time government employees work with followup in Sweden, the quality, effectiveness and equity in health care is not improving at the anticipated rate. Our findings suggest that a co-ordination of the different initiatives is a prerequisite for creating a learning system on a national level. Key challenges arise in the interface between evidence and policy. At the Colloquium, we will present possible solutions to these challenges using the Swedish healthcare system as an example.Conclusions: Although a lot of efforts are made in conducting and developing methods for evidence generation, implementation and follow-up, it is apparent that the full value for patients is not reached. Facilitators are needed for a learning system on a national level, where the government’s initiatives efficiently contribute to an increased quality, effectiveness and equity in health care. Sharing experiences from national efforts can be one way of increasing the understanding of what these facilitators are. Patient or healthcare consumer involvement: We have received valuable input through regular meetings with a reference group of six representatives from different patient organizations throughout the work. The expert committee linked to the investigation also included a patient representative adding important perspectives to the discussions.
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44.
  • Johnson, Nick, et al. (författare)
  • Adjuvant chemotherapy for endometrial cancer after hysterectomy
  • 2011
  • Ingår i: Cochrane Database of Systematic Reviews. - 1469-493X. ; :10, s. 003175-003175
  • Forskningsöversikt (refereegranskat)abstract
    • Background Endometrial adenocarcinoma (womb cancer) is a malignant growth of the lining (endometrium) of the womb (uterus). It is distinct from sarcomas (tumours of the uterine muscle). Survival depends the risk of microscopic metastases after surgery. Adjuvant (postoperative) chemotherapy improves survival from some other adenocarcinomas, and there is evidence that endometrial cancer is sensitive to cytotoxic therapy. This systematic review examines the effect of chemotherapy on survival after hysterectomy for endometrial cancer. Objectives To assess efficacy of adjuvant (postoperative) chemotherapy for endometrial cancer. Search strategy We searched the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library 2010, Issue 3), MEDLINE and EMBASE up to August 2010, registers of clinical trials, abstracts of scientific meetings, reference lists of included studies and contacted experts in the field. Selection criteria Randomised controlled trials (RCTs) comparing adjuvant chemotherapy with any other adjuvant treatment or no other treatment. Data collection and analysis We used a random-effects meta-analysis to assess hazard ratios (HR) for overall and progression-free survival and risk ratios (RR) to compare death rates and site of initial relapse. Main results Five RCTs compared no additional treatment with additional chemotherapy after hysterectomy and radiotherapy. Four trials compared platinum based combination chemotherapy directly with radiotherapy. Indiscriminate pooling of survival data from 2197 women shows a significant overall survival advantage from adjuvant chemotherapy (RR (95% CI) = 0.88 (0.79 to 0.99)). Sensitivity analysis focused on trials of modern platinum based chemotherapy regimens and found the relative risk of death to be 0.85 ((0.76 to 0.96); number needed to treat for an additional beneficial outcome (NNT) = 25; absolute risk reduction = 4% (1% to 8%)). The HR for overall survival is 0.74 (0.64 to 0.89), significantly favouring the addition of postoperative platinum based chemotherapy. The HR for progression-free survival is 0.75 (0.64 to 0.89). This means that chemotherapy reduces the risk of being dead at any censorship by a quarter. Chemotherapy reduces the risk of developing the first recurrence outside the pelvis (RR = 0.79 (0.68 to 0.92), 5% absolute risk reduction; NNT = 20). The analysis of pelvic recurrence rates is underpowered but the trend suggests that chemotherapy may be less effective than radiotherapy in a direct comparison (RR = 1.28 (0.97 to 1.68)) but it may have added value when used with radiotherapy (RR = 0.48 (0.20 to 1.18)). Authors' conclusions Postoperative platinum based chemotherapy is associated with a small benefit in progression-free survival and overall survival irrespective of radiotherapy treatment. It reduces the risk of developing a metastasis, could be an alternative to radiotherapy and has added value when used with radiotherapy.
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45.
  • Johnson, Neil, et al. (författare)
  • Surgical treatment for tubal disease in women due to undergo in vitro fertilisation.
  • 2010
  • Ingår i: Cochrane database of systematic reviews. - 1469-493X. ; :1
  • Tidskriftsartikel (refereegranskat)abstract
    • Tubal disease, and particularly hydrosalpinx, has a detrimental effect on the outcome of in-vitro fertilisation (IVF). Performing a surgical intervention such as salpingectomy, tubal occlusion, aspiration of the hydrosalpinx fluid, or salpingostomy, prior to the IVF procedure in women with hydrosalpinges is thought improve the likelihood of successful outcome.
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46.
  • Karjalainen, Teemu V., et al. (författare)
  • Subacromial decompression surgery for rotator cuff disease
  • 2019
  • Ingår i: Cochrane Database of Systematic Reviews. - : WILEY. - 1469-493X. ; :1
  • Forskningsöversikt (refereegranskat)abstract
    • Background Surgery for rotator cuff disease is usually used after non-operative interventions have failed, although our Cochrane Review, first published in 2007, found that there was uncertain clinical benefit following subacromial decompression surgery. Objectives To synthesise the available evidence of the benefits and harms of subacromial decompression surgery compared with placebo, no intervention or non-surgical interventions in people with rotator cuff disease (excluding full thickness rotator cuff tears). Search methods We searched CENTRAL, MEDLINE, Embase, Clinicaltrials. gov and WHO ICRTP registry from 2006 until 22 October 2018, unrestricted by language. Selection criteria We included randomised and quasi-randomised controlled trials (RCTs) of adults with rotator cuff disease (excluding full-thickness tears), that compared subacromial decompression surgery with placebo, no treatment, or any other non-surgical interventions. As it is least prone to bias, subacromial decompression compared with placebo was the primary comparison. Other comparisons were subacromial decompression versus exercises or non-operative treatment. Major outcomes were mean pain scores, shoulder function, quality of life, participant global assessment of success, adverse events and serious adverse events. The primary endpoint for this review was one year. For serious adverse events, we also included data from prospective cohort studies designed to record harms that evaluated subacromial decompression surgery or shoulder arthroscopy. Data collection and analysis We used standard methodologic procedures expected by Cochrane. Main results We included eight trials, with a total of 1062 randomised participants with rotator cuff disease, all with subacromial impingement. Two trials (506 participants) compared arthroscopic subacromial decompression with arthroscopy only (placebo surgery), with all groups receiving postoperative exercises. These trials included a third treatment group: no treatment (active monitoring) in one and exercises in the other. Six trials (556 participants) compared arthroscopic subacromial decompression followed by exercises with exercises alone. Two of these trials included a third arm: sham laser in one and open subacromial decompression in the other. Trial size varied from 42 to 313 participants. Participant mean age ranged between 42 and 65 years. Only two trials reported mean symptom duration (18 to 22 months in one trial and 30 to 31 months in the other), two did not report duration and four reported it categorically. Both placebo-controlled trials were at low risk of bias for the comparison of surgery versus placebo surgery. The other trials were at high risk of bias for several criteria, most notably at risk of performance or detection bias due to lack of participant and personnel blinding. We have restricted the reporting of results of benefits in the Abstract to the placebo-controlled trials. Compared with placebo, high-certainty evidence indicates that subacromial decompression provides no improvement in pain, shoulder function, or health-related quality of life up to one year, and probably no improvement in global success (moderate-certainty evidence, downgraded due to imprecision). At one year, mean pain (on a scale zero to 10, higher scores indicate more pain), was 2.9 points after placebo surgery and 0.26 better (0.84 better to 0.33 worse), after subacromial decompression (284 participants), an absolute difference of 3%(8% better to 3% worse), and relative difference of 4% (12% better to 5% worse). At one year, mean function (on a scale 0 to 100, higher score indicating better outcome), was 69 points after placebo surgery and 2.8 better (1.4 worse to 6.9 better), after surgery (274 participants), an absolute difference of 3% (7% better to 1% worse), and relative difference of 9% (22% better to 4% worse). Global success rate was 97/148 (or 655 per 1000), after placebo and 101/142 (or 708 per 1000) after surgery corresponding to RR 1.08 (95% CI 0.93 to 1.27). Healthrelated quality of life was 0.73 units (European Quality of Life EQ-5D, -0.59 to 1, higher score indicating better quality of life), after placebo and 0.03 units worse (0.011 units worse to 0.06 units better), after subacromial decompression (285 participants), an absolute difference of 1.3% (5% worse to 2.5% better), and relative difference of 4% (15% worse to 7% better). Adverse events including frozen shoulder or transientminor complications of surgery were reported in approximately 3% of participants across treatment groups in two randomised controlled trials, but due to low event rates we are uncertain if the risks differ between groups: 5/165 (37 per 1000) reported adverse events with subacromial decompression and 9/241 (34 per 1000) with placebo or nonoperative treatment, RR 0.91 (95% CI 0.31 to 2.65) (moderate-certainty evidence, downgraded due to imprecision). The trials did not report serious adverse events. Based upon moderate-certainty evidence from two observational trials from the same prospective surgery registry, which also included other shoulder arthroscopic procedures (downgraded for indirectness), the incidence proportion of serious adverse events within 30 days following surgery was 0.5% (0.4% to 0.7%; data collected 2006 to 2011), or 0.6% (0.5 % to 0.7%; data collected 2011 to 2013). Serious adverse events such as deep infection, pulmonary embolism, nerve injury, and death have been observed in participants following shoulder surgery. Authors conclusions The data in this review do not support the use of subacromial decompression in the treatment of rotator cuff disease manifest as painful shoulder impingement. High-certainty evidence shows that subacromial decompression does not provide clinically important benefits over placebo in pain, function or health-related quality of life. Including results from open-label trials (with high risk of bias) did not change the estimates considerably. Due to imprecision, we downgraded the certainty of the evidence to moderate for global assessment of treatment success; there was probably no clinically important benefit in this outcome either compared with placebo, exercises or non-operative treatment. Adverse event rates were low, 3% or less across treatment groups in the trials, which is consistent with adverse event rates reported in the two observational studies. Although precise estimates are unknown, the risk of serious adverse events is likely less than 1%.
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47.
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48.
  • Kew, KM, et al. (författare)
  • Macrolides for chronic asthma
  • 2015
  • Ingår i: The Cochrane database of systematic reviews. - 1469-493X. ; :9, s. CD002997-
  • Tidskriftsartikel (refereegranskat)
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49.
  • Kinoshita, Mari, et al. (författare)
  • Opioids for procedural pain in neonates
  • 2021
  • Ingår i: Cochrane Database of Systematic Reviews. - : John Wiley & Sons. - 1469-493X .- 1465-1858. ; :12
  • Tidskriftsartikel (refereegranskat)abstract
    • ObjectivesThis is a protocol for a Cochrane Review (intervention). The objectives are as follows:To determine the effects of opioid analgesics in term or preterm neonates exposed to procedural pain, compared to placebo or no drug, non-pharmacological intervention, other analgesics or sedatives, other opioids, or the same opioid administered by a different route.
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50.
  • Kinoshita, Mari, et al. (författare)
  • Opioids for procedural pain in neonates
  • 2023
  • Ingår i: Cochrane Database of Systematic Reviews. - : John Wiley & Sons. - 1469-493X. ; 2023:4
  • Forskningsöversikt (refereegranskat)abstract
    • BACKGROUND: Neonates might be exposed to numerous painful procedures due to diagnostic reasons, therapeutic interventions, or surgical procedures. Options for pain management include opioids, non-pharmacological interventions, and other drugs. Morphine, fentanyl, and remifentanil are the opioids most often used in neonates. However, negative impact of opioids on the structure and function of the developing brain has been reported.OBJECTIVES: To evaluate the benefits and harms of opioids in term or preterm neonates exposed to procedural pain, compared to placebo or no drug, non-pharmacological intervention, other analgesics or sedatives, other opioids, or the same opioid administered by a different route.SEARCH METHODS: We used standard, extensive Cochrane search methods. The latest search date was December 2021.SELECTION CRITERIA: We included randomized controlled trials conducted in preterm and term infants of a postmenstrual age (PMA) up to 46 weeks and 0 days exposed to procedural pain where opioids were compared to 1) placebo or no drug; 2) non-pharmacological intervention; 3) other analgesics or sedatives; 4) other opioids; or 5) the same opioid administered by a different route.DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our primary outcomes were pain assessed with validated methods and any harms. We used a fixed-effect model with risk ratio (RR) for dichotomous data and mean difference (MD) for continuous data, and their confidence intervals (CI). We used GRADE to assess the certainty of the evidence for each outcome.MAIN RESULTS: We included 13 independent studies (enrolling 823 newborn infants): seven studies compared opioids to no treatment or placebo (the main comparison in this review), two studies to oral sweet solution or non-pharmacological intervention, and five studies (of which two were part of the same study) to other analgesics and sedatives. All studies were performed in a hospital setting.Opioids compared to placebo or no drug Compared to placebo, opioids probably reduce pain score assessed with the Premature Infant Pain Profile (PIPP)/PIPP-Revised (PIPP-R) scale during the procedure (MD -2.58, 95% CI -3.12 to -2.03; 199 participants, 3 studies; moderate-certainty evidence); may reduce Neonatal Infant Pain Scale (NIPS) during the procedure (MD -1.97, 95% CI -2.46 to -1.48; 102 participants, 2 studies; low-certainty evidence); and may result in little to no difference in pain score assessed with the Douleur Aiguë du Nouveau-né (DAN) scale one to two hours after the procedure (MD -0.20, 95% CI -2.21 to 1.81; 42 participants, 1 study; low-certainty evidence). The evidence is very uncertain about the effect of opioids on pain score assessed with the PIPP/PIPP-R scale up to 30 minutes after the procedure (MD 0.14, 95% CI -0.17 to 0.45; 123 participants, 2 studies; very low-certainty evidence) or one to two hours after the procedure (MD -0.83, 95% CI -2.42 to 0.75; 54 participants, 2 studies; very low-certainty evidence). No studies reported any harms. The evidence is very uncertain about the effect of opioids on episodes of bradycardia (RR 3.19, 95% CI 0.14 to 72.69; 172 participants, 3 studies; very low-certainty evidence). Opioids may result in an increase in episodes of apnea compared to placebo (RR 3.15, 95% CI 1.08 to 9.16; 199 participants, 3 studies; low-certainty evidence). The evidence is very uncertain about the effect of opioids on episodes of hypotension (RR not estimable, risk difference 0.00, 95% CI -0.06 to 0.06; 88 participants, 2 studies; very low-certainty evidence). No studies reported parent satisfaction with care provided in the neonatal intensive care unit (NICU). Opioids compared to non-pharmacological intervention The evidence is very uncertain about the effect of opioids on pain score assessed with the Crying Requires oxygen Increased vital signs Expression Sleep (CRIES) scale during the procedure when compared to facilitated tucking (MD -4.62, 95% CI -6.38 to -2.86; 100 participants, 1 study; very low-certainty evidence) or sensorial stimulation (MD 0.32, 95% CI -1.13 to 1.77; 100 participants, 1 study; very low-certainty evidence). The other main outcomes were not reported.Opioids compared to other analgesics or sedatives The evidence is very uncertain about the effect of opioids on pain score assessed with the PIPP/PIPP-R during the procedure (MD -0.29, 95% CI -1.58 to 1.01; 124 participants, 2 studies; very low-certainty evidence); up to 30 minutes after the procedure (MD -1.10, 95% CI -2.82 to 0.62; 12 participants, 1 study; very low-certainty evidence); and one to two hours after the procedure (MD -0.17, 95% CI -2.22 to 1.88; 12 participants, 1 study; very low-certainty evidence). No studies reported any harms. The evidence is very uncertain about the effect of opioids on episodes of apnea during (RR 3.27, 95% CI 0.85 to 12.58; 124 participants, 2 studies; very low-certainty evidence) and after the procedure (RR 2.71, 95% CI 0.11 to 64.96; 124 participants, 2 studies; very low-certainty evidence) and on hypotension (RR 1.34, 95% CI 0.32 to 5.59; 204 participants, 3 studies; very low-certainty evidence). The other main outcomes were not reported. We identified no studies comparing different opioids (e.g. morphine versus fentanyl) or different routes for administration of the same opioid (e.g. morphine enterally versus morphine intravenously).AUTHORS' CONCLUSIONS: Compared to placebo, opioids probably reduce pain score assessed with PIPP/PIPP-R scale during the procedure; may reduce NIPS during the procedure; and may result in little to no difference in DAN one to two hours after the procedure. The evidence is very uncertain about the effect of opioids on pain assessed with other pain scores or at different time points. No studies reported if any harms occurred. The evidence is very uncertain about the effect of opioids on episodes of bradycardia or hypotension. Opioids may result in an increase in episodes of apnea. No studies reported parent satisfaction with care provided in the NICU. The evidence is very uncertain about the effect of opioids on any outcome when compared to non-pharmacological interventions or to other analgesics. We identified no studies comparing opioids to other opioids or comparing different routes of administration of the same opioid.
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