dataset
stringclasses 1
value | id
stringlengths 1
5
| messages
listlengths 2
2
|
|---|---|---|
query-laysum
|
21936
|
[
{
"role": "user",
"content": "Abstract: Background\nIntimate partner abuse (including coercive control, physical, sexual, economic, emotional and economic abuse) is common worldwide. Advocacy may help women who are in, or have left, an abusive intimate relationship, to stop or reduce repeat victimisation and overcome consequences of the abuse. Advocacy primarily involves education, safety planning support and increasing access to different services. It may be stand-alone or part of other services and interventions, and may be provided within healthcare, criminal justice, social, government or specialist domestic violence services. We focus on the abuse of women, as interventions for abused men require different considerations.\nObjectives\nTo assess advocacy interventions for intimate partner abuse in women, in terms of which interventions work for whom, why and in what circumstances.\nSearch methods\nIn January 2019 we searched CENTRAL, MEDLINE, 12 other databases, two trials registers and two relevant websites. The search had three phases: scoping of articles to identify candidate theories; iterative recursive search for studies to explore and fill gaps in these theories; and systematic search for studies to test, confirm or refute our explanatory theory.\nSelection criteria\nEmpirical studies of any advocacy or multi-component intervention including advocacy, intended for women aged 15 years and over who were experiencing or had experienced any form of intimate partner abuse, or of advocates delivering such interventions, or experiences of women who were receiving or had received such an intervention. Partner abuse encompasses coercive control in the absence of physical abuse. For theory development, we included studies that did not strictly fit our original criteria but provided information useful for theory development.\nData collection and analysis\nFour review authors independently extracted data, with double assessment of 10% of the data, and assessed risk of bias and quality of the evidence. We adopted RAMESES (Realist and meta-narrative evidence syntheses: evolving standards) standards for reporting results. We applied a realist approach to the analysis.\nMain results\nWe included 98 studies (147 articles). There were 88 core studies: 37 focused on advocates (4 survey-based, 3 instrument development, 30 qualitative focus) and seven on abused women (6 qualitative studies, 1 survey); 44 were experimental intervention studies (some including qualitative evaluations). Ten further studies (3 randomised controlled trials (RCTs), 1 intervention process evaluation, 1 qualitative study, 2 mixed methods studies, 2 surveys of women, and 1 mixed methods study of women and staff) did not fit the original criteria but added useful information, as befitting a realist approach. Two studies are awaiting classification and three are ongoing.\nAdvocacy interventions varied considerably in contact hours, profession delivering and setting.\nWe constructed a conceptual model from six essential principles based on context-mechanism-outcome (CMO) patterns.\nWe have moderate and high confidence in evidence for the importance of considering both women's vulnerabilities and intersectionalities and the trade-offs of abuse-related decisions in the contexts of individual women's lives. Decisions should consider the risks to the woman's safety from the abuse. Whether actions resulting from advocacy increase or decrease abuse depends on contextual factors (e.g. severity and type of abuse), and the outcomes the particular advocacy intervention is designed to address (e.g. increasing successful court orders versus decreasing depression).\nWe have low confidence in evidence regarding the significance of physical dependencies, being pregnant or having children. There were links between setting (high confidence), and potentially also theoretical underpinnings of interventions, type, duration and intensity of advocacy, advocate discipline and outcomes (moderate and low confidence). A good therapeutic alliance was important (high confidence); this alliance might be improved when advocates are matched with abused women on ethnicity or abuse experience, exercise cultural humility, and remove structural barriers to resource access by marginalised women. We identified significant challenges for advocates in inter-organisational working, vicarious traumatisation, and lack of clarity on how much support to give a woman (moderate and high confidence). To work effectively, advocates need ongoing training, role clarity, access to resources, and peer and institutional support.\nOur provisional model highlights the complex way that factors combine and interact for effective advocacy. We confirmed the core ingredients of advocacy according to both women and advocates, supported by studies and theoretical considerations: education and information on abuse; rights and resources; active referral and liaising with other services; risk assessment and safety planning. We were unable to confirm the impact of complexity of the intervention (low confidence). Our low confidence in the evidence was driven mostly by a lack of relevant studies, rather than poor-quality studies, despite the size of the review.\nAuthors' conclusions\nResults confirm the core ingredients of advocacy and suggest its use rests on sound theoretical underpinnings. We determined the elements of a good therapeutic alliance and how it might be improved, with a need for particular considerations of the factors affecting marginalised women. Women's goals from advocacy should be considered in the contexts of their personal lives. Women's safety was not necessarily at greatest risk from staying with the abuser. Potentially, if undertaken for long enough, advocacy should benefit an abused woman in terms of at least one outcome providing the goals are matched to each woman's needs. Some outcomes may take months to be determined. Where abuse is severe, some interventions may increase abuse. Advocates have a challenging role and must be supported emotionally, through provision of resources and through professional training, by organisations and peers.\nFuture research should consider the different principles identified in this review, and study outcomes should be considered in relation to the mechanisms and contexts elucidated. More longitudinal evidence is needed. Single-subject research designs may help determine exactly when effect no longer increases, to determine the duration of longitudinal work, which will likely differ for vulnerable and marginalised women. Further work is needed to ascertain how to tailor advocacy interventions to cultural variations and rural and resource-poor settings. The methods used in the included studies may, in some cases, limit the applicability and completeness of the data reported. Economic analyses are required to ascertain if resources devoted to advocacy interventions are cost-effective in healthcare and community settings.\n\nGiven the provided abstract, please respond to the following query: \"Methods\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched scientific literature worldwide up to January 2019 for any relevant studies."
}
] |
query-laysum
|
21937
|
[
{
"role": "user",
"content": "Abstract: Background\nCOVID-19 infection poses a serious risk to patients and – due to its contagious nature – to those healthcare workers (HCWs) treating them. The risks of transmission of infection are greater when a patient is undergoing an aerosol-generating procedure (AGP). Not all those with COVID-19 infection are symptomatic, or suspected of harbouring the infection. If a patient who is not known to have or suspected of having COVID-19 infection is to undergo an AGP, it would nonetheless be sensible to minimise the risk to those HCWs treating them.\nIf the mouth and nose of an individual undergoing an AGP are irrigated with antimicrobial solutions, this may be a simple and safe method of reducing the risk of any covert infection being passed to HCWs through droplet transmission or direct contact. Alternatively, the use of antimicrobial solutions by the HCW may decrease the chance of them acquiring COVID-19 infection. However, the use of such antimicrobial solutions may be associated with harms related to the toxicity of the solutions themselves or alterations in the natural microbial flora of the mouth or nose.\nObjectives\nTo assess the benefits and harms of antimicrobial mouthwashes and nasal sprays administered to HCWs and/or patients when undertaking AGPs on patients without suspected or confirmed COVID-19 infection.\nSearch methods\nInformation Specialists from Cochrane ENT and Cochrane Oral Health searched the Central Register of Controlled Trials (CENTRAL 2020, Issue 6); Ovid MEDLINE; Ovid Embase and additional sources for published and unpublished trials. The date of the search was 1 June 2020.\nSelection criteria\nThis is a question that urgently requires evidence, however at the present time we did not anticipate finding many completed RCTs. We therefore planned to include the following types of studies: randomised controlled trials (RCTs); quasi-RCTs; non-randomised controlled trials; prospective cohort studies; retrospective cohort studies; cross-sectional studies; controlled before-and-after studies. We set no minimum duration for the studies.\nWe sought studies comparing any antimicrobial mouthwash and/or nasal spray (alone or in combination) at any concentration, delivered to the patient or HCW before and/or after an AGP.\nData collection and analysis\nWe used standard Cochrane methodological procedures. Our primary outcomes were: 1) incidence of symptomatic or test-positive COVID-19 infection in HCWs or patients; 2) significant adverse event: anosmia (or disturbance in sense of smell). Our secondary outcomes were: 3) COVID-19 viral content of aerosol (when present); 4) change in COVID-19 viral load at site(s) of irrigation; 5) other adverse events: changes in microbiome in oral cavity, nasal cavity, oro- or nasopharynx; 6) other adverse events: allergy, irritation/burning of nasal, oral or oropharyngeal mucosa (e.g. erosions, ulcers, bleeding), long-term staining of mucous membranes or teeth, accidental ingestion. We planned to use GRADE to assess the certainty of the evidence for each outcome.\nMain results\nWe found no completed studies to include in this review.\nAuthors' conclusions\nWe identified no studies for inclusion in this review, nor any ongoing studies. The absence of completed studies is not surprising given the relatively recent emergence of COVID-19 infection. However, we are disappointed that this important clinical question is not being addressed by ongoing studies.\n\nGiven the provided abstract, please respond to the following query: \"What does this mean?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "There is currently no evidence relating to the benefits and risks of healthcare workers' or patients' use of antimicrobial mouthwashes or nasal sprays to protect healthcare workers who undertake aerosol-generating procedures on patients without a known or suspected COVID-19 infection.\nWe need studies to be conducted so that we can answer this important clinical question."
}
] |
query-laysum
|
21938
|
[
{
"role": "user",
"content": "Abstract: Background\nBetween 4% and 25% of school-aged children at some stage complain of recurrent abdominal pain (RAP) of sufficient severity to interfere with their daily lives. When no clear organic cause is found, the children are managed with reassurance and simple measures; a large range of pharmacological interventions have been recommended for use in these children.\nObjectives\nTo determine the effectiveness of pharmacological interventions for RAP in children of school age.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE, Embase, and eight other electronic databases up to June 2016. We also searched two trials registers and contacted researchers of published studies.\nSelection criteria\nRandomised controlled trials involving children aged five to 18 years old with RAP or an abdominal pain-related functional gastrointestinal disorder, as defined by the Rome III criteria (Rasquin 2006). The interventions were any pharmacological intervention compared to placebo, no treatment, waiting list, or standard care. The primary outcome measures were pain intensity, pain duration or pain frequency, and improvement in pain. The secondary outcome measures were school performance, social or psychological functioning, and quality of daily life.\nData collection and analysis\nTwo review authors independently screened titles, abstracts, and potentially relevant full-text reports for eligible studies. Two review authors extracted data and performed a 'Risk of bias' assessment. We used the GRADE approach to rate the overall quality of the evidence. We deemed a meta-analysis to be not appropriate as the studies were significantly heterogeneous. We have consequently provided a narrative summary of the results.\nMain results\nThis review included 16 studies with a total of 1024 participants aged between five and 18 years, all of whom were recruited from paediatric outpatient clinics. Studies were conducted in seven countries: seven in the USA, four in Iran, and one each in the UK, Switzerland, Turkey, Sri Lanka, and India. Follow-up ranged from two weeks to four months. The studies examined the following interventions to treat RAP: tricyclic antidepressants, antibiotics, 5-HT4 receptor agonists, antispasmodics, antihistamines, H2 receptor antagonists, serotonin antagonists, selective serotonin re-uptake inhibitors, a dopamine receptor antagonist, and a hormone. Although some single studies reported that treatments were effective, all of these studies were either small or had key methodological weaknesses with a substantial risk of bias. None of these 'positive' results have been reproduced in subsequent studies. We judged the evidence of effectiveness to be of low quality. No adverse effects were reported in these studies.\nAuthors' conclusions\nThere is currently no convincing evidence to support the use of drugs to treat RAP in children. Well-conducted clinical trials are needed to evaluate any possible benefits and risks of pharmacological interventions. In practice, if a clinician chooses to use a drug as a 'therapeutic trial', they and the patient need to be aware that RAP is a fluctuating condition and any 'response' may reflect the natural history of the condition or a placebo effect, rather than drug efficacy.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Recurrent abdominal pain in childhood is a term used to describe unexplained episodes of tummy pain for which no cause can be found. The pain is often accompanied by other symptoms, such as diarrhoea or facial pallor. Some researchers have therefore classified different syndromes of unexplained pain according to these other associated symptoms. Recurrent abdominal pain is common in children. It is likely that the underlying cause or trigger differs among children."
}
] |
query-laysum
|
21939
|
[
{
"role": "user",
"content": "Abstract: Background\nNitric oxide (NO) is a prevalent molecule in humans that is responsible for many physiologic activities including pulmonary vasodilation. An exogenous, inhaled form (iNO) exists that mimics this action without affecting systemic blood pressure. This therapy has been implemented in the treatment of pulmonary hypertension. This review examines the efficacy of iNO in the postoperative management of infants and children with congenital heart disease (CHD). The original review was published in 2005, updated in 2008 and again in 2014.\nObjectives\nTo compare the effects of postoperative administration of iNO versus placebo or conventional management, or both, on infants and children with CHD and pulmonary hypertension. The primary outcome was mortality. Secondary outcomes included length of hospital stay; neurodevelopmental disability; number of pulmonary hypertensive crises (PHTC); changes in mean pulmonary arterial pressure (MPAP), mean arterial pressure (MAP), and heart rate (HR); changes in oxygenation measured as the ratio of arterial oxygen tension (PaO2) to fraction of inspired oxygen (FiO2); and measurement of maximum methaemoglobin level as a marker of toxicity.\nSearch methods\nIn this updated version we extended the CENTRAL search to 2013, Issue 12 of The Cochrane Library, and MEDLINE and EMBASE through to 1 December 2013. The original search was performed in July 2004 and again in November 2007. We included abstracts and all languages.\nSelection criteria\nWe included randomized and quasi-randomized controlled trials comparing iNO with placebo or conventional management, or both. Trials included only children with CHD requiring surgery complicated by pulmonary hypertension.\nData collection and analysis\nTwo authors extracted data. Data were collected on mortality; number of PHTC; changes in MPAP, MAP, HR, and PaO2:FiO2; and maximum methaemoglobin level. Data on long-term mortality, neurodevelopmental disability, and length of hospital stay were unavailable. We performed subgroup analysis by method of control (placebo or conventional management).\nMain results\nWe reran the searches to December 2013 and identified three new studies. These three studies did not fulfil our inclusion criteria. Therefore, no new studies were included in this updated review. In total four randomized trials involving 210 participants were included in this review. We observed no differences in mortality (OR 1.67, 95% CI 0.38 to 7.30; P = 0.50); PHTC (OR 0.80, 95% CI 0.15 to 4.18; P = 0.79); changes in MPAP (treatment effect -2.94 mm Hg, 95% CI -9.28 to 3.40; P = 0.36), MAP (treatment effect -3.55 mm Hg, 95% CI -11.86 to 4.76; P = 0.40), HR (treatment effect 0.02 bpm, 95% CI -8.13 to 8.18; P = 1.00), or PaO2:FiO2 (mean difference 17.18, 95% CI -28.21 to 62.57; P = 0.46). There was a significant increase in the methaemoglobin level (mean difference 0.30%, 95% CI 0.24 to 0.36; P < 0.00001) in patients treated with iNO, although levels did not reach toxicity levels. Data from long-term mortality, neurodevelopmental disability, and length of stay were not available. Two trials had a low risk of bias. Very low quality of the evidence was observed considering grading of the outcomes.\nAuthors' conclusions\nWe observed no differences with the use of iNO in the outcomes reviewed. No data were available for several clinical outcomes including long-term mortality and neurodevelopmental outcome. We found it difficult to draw valid conclusions given concerns regarding methodologic quality, sample size, and heterogeneity.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Two trials had a low risk of bias. The quality of the evidence was, however, very low due to the small number of participants and low event rates. All trials utilized different concentrations of iNO, different durations of administration initiated at different times after the operation, and included patients with diverse congenital heart defects necessitating repair."
}
] |
query-laysum
|
21940
|
[
{
"role": "user",
"content": "Abstract: Background\nRoot canal treatment (RoCT), or endodontic treatment, is a common procedure in dentistry. The main indications for RoCT are irreversible pulpitis and necrosis of the dental pulp caused by carious processes, coronal crack or fracture, or dental trauma. Successful RoCT is characterised by an absence of symptoms (i.e. pain) and clinical signs (i.e. swelling and sinus tract) in teeth without radiographic evidence of periodontal involvement (i.e. normal periodontal ligament). The success of RoCT depends on a number of variables related to the preoperative condition of the tooth, as well as the endodontic procedures. RoCT can be carried out with a single-visit approach, which involves root canal system obturation (filling and sealing) directly after instrumentation and irrigation, or with a multiple-visits approach, in which the treatment is completed in two or more sessions and obturation is performed in the last session. This review updates the previous versions published in 2007 and 2016.\nObjectives\nTo evaluate the benefits and harms of completion of root canal treatment (RoCT) in a single visit compared to RoCT over two or more visits, with or without medication, in people aged over 10 years.\nSearch methods\nWe used standard, extensive Cochrane search methods. The latest search date was 25 April 2022.\nSelection criteria\nWe included randomised controlled trials and quasi-randomised controlled trials in people needing RoCT comparing completion of RoCT in a single visit compared to RoCT over two or more visits.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were 1. tooth extraction and 2. radiological failure after at least one year (i.e. periapical radiolucency). Our secondary outcomes were 3. postoperative and postobturation pain; 4. swelling or flare-up; 5. analgesic use and 6. presence of sinus track or fistula after at least one month. We used GRADE to assess certainty of evidence for each outcome.\nWe excluded five studies that were included in the previous version of the review because they did not meet the current standard of care (i.e. rubber dam isolation and irrigation with sodium hypochlorite).\nMain results\nWe included 47 studies with 5805 participants and 5693 teeth analysed. We judged 10 studies at low risk of bias, 17 at high risk of bias and 20 at unclear risk of bias.\nOnly two studies reported data on tooth extraction. We found no evidence of a difference between treatment in one visit or treatment over multiple visits, but we had very low certainty about the findings (risk ratio (RR) 0.46, 95% confidence interval (CI) 0.09 to 2.50; I2 = 0%; 2 studies, 402 teeth). We found no evidence of a difference between single-visit and multiple-visit treatment in terms of radiological failure (RR 0.93, 95% CI 0.81 to 1.07; I2 = 0%; 13 studies, 1505 teeth; moderate-certainty evidence).\nWe found evidence of a higher proportion of participants reporting pain within one week in single-visit groups compared to multiple visit groups (RR 1.55, 95% CI 1.14 to 2.09; I2 = 18%; 5 studies, 638 teeth; moderate-certainty evidence).\nWe found no evidence of a difference in the proportion of participants reporting pain until 72 hours postobturation (RR 0.97, 95% CI 0.81 to 1.16; I2 = 70%; 12 studies, 1329 teeth; low-certainty evidence), pain intensity until 72 hours postobturation (mean difference (MD) 0.26, 95% CI −4.76 to 5.29; I2 = 98%; 12 studies, 1258 teeth; low-certainty evidence) or pain at one week postobturation (RR 1.05, 95% CI 0.67 to 1.67; I2 = 61%; 9 studies, 1139 teeth; very low-certainty evidence). We found no evidence of a difference in swelling or flare-up incidence (RR 0.56 95% CI 0.16 to 1.92; I2 = 0%; 6 studies; 605 teeth; very low-certainty evidence), analgesic use (RR 1.25 95% CI 0.75 to 2.09; I2 = 36%; 6 studies, 540 teeth; very low-certainty evidence) or sinus tract or fistula presence (RR 1.00, 95% CI 0.24 to 4.28; I2 = 0%; 5 studies, 650 teeth; very low-certainty evidence).\nSubgroup analysis found no differences between single-visit and multiple-visit RoCT for considered outcomes other than proportion of participants reporting post-treatment pain within one week, which was higher in the single-visit groups for vital teeth (RR 2.16, 95% CI 1.39 to 3.36; I2 = 0%; 2 studies, 316 teeth), and when instrumentation was mechanical (RR 1.80, 95% CI 1.10 to 2.92; I2 = 56%; 2 studies, 278 teeth).\nAuthors' conclusions\nAs in the previous two versions of the review, there is currently no evidence to suggest that one treatment regimen (single-visit or multiple-visit RoCT) is more effective than the other. Neither regimen can prevent pain and other complications in the 12-month postoperative period. There was moderate-certainty evidence of higher proportion of participants reporting pain within one week in single-visit groups compared to multiple-visit groups. In contrast to the results of the last version of the review, there was no difference in analgesic use.\n\nGiven the provided abstract, please respond to the following query: \"What did we do?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched for studies that investigated success and complications of single-visit versus multiple-visit root canal treatment in permanent (adult) teeth. We combined the results of relevant studies and rated our confidence in the evidence, based on factors such as study methods and number of people tested."
}
] |
query-laysum
|
21941
|
[
{
"role": "user",
"content": "Abstract: Background\nTraumatic hyphema is the entry of blood into the anterior chamber, the space between the cornea and iris, following significant injury to the eye. Hyphema may be associated with significant complications that uncommonly cause permanent vision loss. Complications include elevated intraocular pressure, corneal blood staining, anterior and posterior synechiae, and optic nerve atrophy. People with sickle cell trait or disease may be particularly susceptible to increases in intraocular pressure and optic atrophy. Rebleeding is associated with an increase in the rate and severity of complications.\nObjectives\nTo assess the effectiveness of various medical interventions in the management of traumatic hyphema.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2022, Issue 3); MEDLINE Ovid; Embase.com; PubMed (1948 to March 2022); the ISRCTN registry; ClinicalTrials.gov; and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). The last date of the search was 22 March 2022.\nSelection criteria\nTwo review authors independently assessed the titles and abstracts of all reports identified by the electronic and manual searches. We included randomized and quasi-randomized trials that compared various medical (non-surgical) interventions versus other medical interventions or control groups for the treatment of traumatic hyphema following closed-globe trauma. We applied no restrictions on age, gender, severity of the closed-globe trauma, or level of visual acuity at time of enrollment.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane and assessed the certainty of evidence using GRADE.\nMain results\nWe included 23 randomized and seven quasi-randomized studies with a total of 2969 participants. Interventions included antifibrinolytic agents (systemic and topical aminocaproic acid, tranexamic acid, and aminomethylbenzoic acid), corticosteroids (systemic and topical), cycloplegics, miotics, aspirin, conjugated estrogens, traditional Chinese medicine, monocular versus bilateral patching, elevation of the head, and bed rest.\nWe found no evidence of an effect on visual acuity for any intervention, whether measured within two weeks (short term) or for longer periods. In a meta-analysis of two trials, we found no evidence of an effect of aminocaproic acid on long-term visual acuity (RR 1.03, 95% confidence interval (CI) 0.82 to 1.29) or final visual acuity measured up to three years after the hyphema (RR 1.05, 95% CI 0.93 to 1.18). Oral tranexamic acid appeared to provide little to no benefit on visual acuity in four trials (RR 1.12, 95% CI 1.00 to 1.25). The remaining trials evaluated the effects of various interventions on short-term visual acuity; none of these interventions was measured in more than one trial. No intervention showed a statistically significant effect (RRs ranged from 0.75 to 1.10). Similarly, visual acuity measured for longer periods in four trials evaluating different interventions was also not statistically significant (RRs ranged from 0.82 to 1.02). The evidence supporting these findings was of low or very low certainty.\nSystemic aminocaproic acid reduced the rate of recurrent hemorrhage (RR 0.28, 95% CI 0.13 to 0.60), as assessed in six trials with 330 participants. A sensitivity analysis omitting two studies not using an intention-to-treat analysis reduced the strength of the evidence (RR 0.43, 95% CI 0.17 to 1.08). We obtained similar results for topical aminocaproic acid (RR 0.48, 95% CI 0.20 to 1.10) in two trials with 131 participants. We assessed the certainty of the evidence as low. Systemic tranexamic acid had a significant effect in reducing the rate of secondary hemorrhage (RR 0.33, 95% CI 0.21 to 0.53) in seven trials with 754 participants, as did aminomethylbenzoic acid (RR 0.10, 95% CI 0.02 to 0.41), as reported in one study. Evidence to support an associated reduction in risk of complications from secondary hemorrhage (i.e. corneal blood staining, peripheral anterior synechiae, elevated intraocular pressure, and development of optic atrophy) by antifibrinolytics was limited by the small number of these events. Use of aminocaproic acid was associated with increased nausea, vomiting, and other adverse events compared with placebo. We found no evidence of an effect on the number of adverse events with the use of systemic versus topical aminocaproic acid or with standard versus lower drug dose.\nThe number of days for the primary hyphema to resolve appeared to be longer with the use of systemic aminocaproic acid compared with no use, but this outcome was not altered by any other intervention.\nThe available evidence on usage of systemic or topical corticosteroids, cycloplegics, or aspirin in traumatic hyphema was limited due to the small numbers of participants and events in the trials.\nWe found no evidence of an effect between a single versus binocular patch on the risk of secondary hemorrhage or time to rebleed. We also found no evidence of an effect on the risk of secondary hemorrhage between ambulation and complete bed rest.\nAuthors' conclusions\nWe found no evidence of an effect on visual acuity of any of the interventions evaluated in this review. Although the evidence was limited, people with traumatic hyphema who receive aminocaproic acid or tranexamic acid are less likely to experience secondary hemorrhage. However, hyphema took longer to clear in people treated with systemic aminocaproic acid.\nThere is no good evidence to support the use of antifibrinolytic agents in the management of traumatic hyphema, other than possibly to reduce the rate of secondary hemorrhage. The potentially long-term deleterious effects of secondary hemorrhage are unknown. Similarly, there is no evidence to support the use of corticosteroids, cycloplegics, or non-drug interventions (such as patching, bed rest, or head elevation) in the management of traumatic hyphema. As these multiple interventions are rarely used in isolation, further research to assess the additive effect of these interventions might be of value.\n\nGiven the provided abstract, please respond to the following query: \"Main results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found no evidence that any medical treatment affected final vision, but we graded the evidence as generally of low certainty. Antifibrinolytic agents did appear to reduce the risk of new bleeding in the eye, but participants taking oral aminocaproic acid (an antifibrinolytic agent) appeared to have more nausea and vomiting compared with those in the comparison group. It was unclear whether antifibrinolytics reduced complications of secondary bleeding, as these events occurred infrequently in the studies. We found no evidence for the effectiveness of any other medical treatment in reducing the rate of fresh bleeding or the number of complications."
}
] |
query-laysum
|
21942
|
[
{
"role": "user",
"content": "Abstract: Background\nDepression is an important consequence of stroke that influences recovery yet often is not detected, or is inadequately treated. This is an update and expansion of a Cochrane Review first published in 2004 and previously updated in 2008.\nObjectives\nThe primary objective is to test the hypothesis that pharmacological, psychological therapy, non-invasive brain stimulation, or combinations of these interventions reduce the incidence of diagnosable depression after stroke. Secondary objectives are to test the hypothesis that pharmacological, psychological therapy, non-invasive brain stimulation or combinations of these interventions reduce levels of depressive symptoms and dependency, and improve physical functioning after stroke. We also aim to determine the safety of, and adherence to, the interventions.\nSearch methods\nWe searched the Specialised Register of Cochrane Stroke and the Cochrane Depression Anxiety and Neurosis (last searched August 2018). In addition, we searched the following databases; Cochrane Central Register of Controlled Trials, CENTRAL (the Cochrane Library, 2018, Issue 8), MEDLINE (1966 to August 2018), Embase (1980 to August 2018), PsycINFO (1967 to August 2018), CINAHL (1982 to August 2018) and three Web of Science indexes (2002 to August 2018). We also searched reference lists, clinical trial registers (World Health Organization International Clinical Trials Registry Platform (WHO ICTRP); to August 2018 and ClinicalTrials.gov; to August 2018), conference proceedings; we also contacted study authors.\nSelection criteria\nRandomised controlled trials (RCTs) comparing: 1) pharmacological interventions with placebo; 2) one of various forms of psychological therapy with usual care and/or attention control; 3) one of various forms of non-invasive brain stimulation with sham stimulation or usual care; 4) a pharmacological intervention and one of various forms of psychological therapy with a pharmacological intervention and usual care and/or attention control; 5) non-invasive brain stimulation and pharmacological intervention with a pharmacological intervention and sham stimulation or usual care; 6) pharmacological intervention and one of various forms of psychological therapy with placebo and psychological therapy; 7) pharmacological intervention and non-invasive brain stimulation with placebo plus non-invasive brain stimulation; 8) non-invasive brain stimulation and one of various forms of psychological therapy versus non-invasive brain stimulation plus usual care and/or attention control; and 9) non-invasive brain stimulation and one of various forms of psychological therapy versus sham brain stimulation or usual care plus psychological therapy, with the intention of preventing depression after stroke.\nData collection and analysis\nReview authors independently selected studies, assessed risk of bias, and extracted data from all included studies. We calculated mean difference (MD) or standardised mean difference (SMD) for continuous data and risk ratio (RR) for dichotomous data with 95% confidence intervals (CIs). We assessed heterogeneity using the I2 statistic and assessed the certainty of evidence using GRADE.\nMain results\nWe included 19 RCTs (21 interventions), with 1771 participants in the review. Data were available for 12 pharmacological trials (14 interventions) and seven psychological trials. There were no trials of non-invasive brain stimulation compared with sham stimulation or usual care, a combination of pharmacological intervention and one of various forms of psychological therapy with placebo and psychological therapy, or a combination of non-invasive brain stimulation and a pharmacological intervention with a pharmacological intervention and sham stimulation or usual care to prevent depression after stroke. Treatment effects were observed on the primary outcome of meeting the study criteria for depression at the end of treatment: there is very low-certainty evidence from eight trials (nine interventions) that pharmacological interventions decrease the number of people meeting the study criteria for depression (RR 0.50, 95% CI 0.37 to 0.68; 734 participants) compared to placebo. There is very low-certainty evidence from two trials that psychological interventions reduce the proportion of people meeting the study criteria for depression (RR 0.68, 95% CI 0.49 to 0.94, 607 participants) compared to usual care and/or attention control.\nEight trials (nine interventions) found no difference in death and other adverse events between pharmacological intervention and placebo groups (RR 1.25, 95% CI 0.32 to 4.91; 496 participants) based on very low-certainty evidence. Five trials found no difference in psychological intervention and usual care and/or attention control groups for death and other adverse events (RR 1.18, 95% CI 0.73 to 1.91; 975 participants) based on very low-certainty evidence.\nAuthors' conclusions\nThe available evidence suggests that pharmacological interventions and psychological therapy may prevent depression and improve mood after stroke. However, there is very low certainty in these conclusions because of the very low-certainty evidence. More trials are required before reliable recommendations can be made about the routine use of such treatments after stroke.\n\nGiven the provided abstract, please respond to the following query: \"Search date\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We identified trials using searches conducted on 13 August 2018."
}
] |
query-laysum
|
21943
|
[
{
"role": "user",
"content": "Abstract: Background\nAntisocial personality disorder (AsPD) is associated with poor mental health, criminality, substance use and relationship difficulties. This review updates Gibbon 2010 (previous version of the review).\nObjectives\nTo evaluate the potential benefits and adverse effects of psychological interventions for adults with AsPD.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, 13 other databases and two trials registers up to 5 September 2019. We also searched reference lists and contacted study authors to identify studies.\nSelection criteria\nRandomised controlled trials of adults, where participants with an AsPD or dissocial personality disorder diagnosis comprised at least 75% of the sample randomly allocated to receive a psychological intervention, treatment-as-usual (TAU), waiting list or no treatment. The primary outcomes were aggression, reconviction, global state/functioning, social functioning and adverse events.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nThis review includes 19 studies (eight new to this update), comparing a psychological intervention against TAU (also called 'standard Maintenance'(SM) in some studies). Eight of the 18 psychological interventions reported data on our primary outcomes.\nFour studies focussed exclusively on participants with AsPD, and 15 on subgroups of participants with AsPD. Data were available from only 10 studies involving 605 participants.\nEight studies were conducted in the UK and North America, and one each in Iran, Denmark and the Netherlands. Study duration ranged from 4 to 156 weeks (median = 26 weeks). Most participants (75%) were male; the mean age was 35.5 years. Eleven studies (58%) were funded by research councils. Risk of bias was high for 13% of criteria, unclear for 54% and low for 33%.\nCognitive behaviour therapy (CBT) + TAUversus TAU\nOne study (52 participants) found no evidence of a difference between CBT + TAU and TAU for physical aggression (odds ratio (OR) 0.92, 95% CI 0.28 to 3.07; low-certainty evidence) for outpatients at 12 months post-intervention.\nOne study (39 participants) found no evidence of a difference between CBT + TAU and TAU for social functioning (mean difference (MD) −1.60 points, 95% CI −5.21 to 2.01; very low-certainty evidence), measured by the Social Functioning Questionnaire (SFQ; range = 0-24), for outpatients at 12 months post-intervention.\nImpulsive lifestyle counselling (ILC) + TAU versus TAU\nOne study (118 participants) found no evidence of a difference between ILC + TAU and TAU for trait aggression (assessed with Buss-Perry Aggression Questionnaire-Short Form) for outpatients at nine months (MD 0.07, CI −0.35 to 0.49; very low-certainty evidence).\nOne study (142 participants) found no evidence of a difference between ILC + TAU and TAU alone for the adverse event of death (OR 0.40, 95% CI 0.04 to 4.54; very low-certainty evidence) or incarceration (OR 0.70, 95% CI 0.27 to 1.86; very low-certainty evidence) for outpatients between three and nine months follow-up.\nContingency management (CM) + SM versus SM\nOne study (83 participants) found evidence that, compared to SM alone, CM + SM may improve social functioning measured by family/social scores on the Addiction Severity Index (ASI; range = 0 (no problems) to 1 (severe problems); MD −0.08, 95% CI −0.14 to −0.02; low-certainty evidence) for outpatients at six months.\n‘Driving whilst intoxicated' programme (DWI) + incarcerationversus incarceration\nOne study (52 participants) found no evidence of a difference between DWI + incarceration and incarceration alone on reconviction rates (hazard ratio 0.56, CI −0.19 to 1.31; very low-certainty evidence) for prisoner participants at 24 months.\nSchema therapy (ST) versus TAU\nOne study (30 participants in a secure psychiatric hospital, 87% had AsPD diagnosis) found no evidence of a difference between ST and TAU for the number of participants who were reconvicted (OR 2.81, 95% CI 0.11 to 74.56, P = 0.54) at three years. The same study found that ST may be more likely to improve social functioning (assessed by the mean number of days until patients gain unsupervised leave (MD −137.33, 95% CI −271.31 to −3.35) compared to TAU, and no evidence of a difference between the groups for overall adverse events, classified as the number of people experiencing a global negative outcome over a three-year period (OR 0.42, 95% CI 0.08 to 2.19). The certainty of the evidence for all outcomes was very low.\nSocial problem-solving (SPS) + psychoeducation (PE) versus TAU\nOne study (17 participants) found no evidence of a difference between SPS + PE and TAU for participants’ level of social functioning (MD −1.60 points, 95% CI −5.43 to 2.23; very low-certainty evidence) assessed with the SFQ at six months post-intervention.\nDialectical behaviour therapy versus TAU\nOne study (skewed data, 14 participants) provided very low-certainty, narrative evidence that DBT may reduce the number of self-harm days for outpatients at two months post-intervention compared to TAU.\nPsychosocial risk management (PSRM; 'Resettle') versus TAU\nOne study (skewed data, 35 participants) found no evidence of a difference between PSRM and TAU for a number of officially recorded offences at one year after release from prison. It also found no evidence of difference between the PSRM and TAU for the adverse event of death during the study period (OR 0.89, 95% CI 0.05 to 14.83, P = 0.94, 72 participants (90% had AsPD), 1 study, very low-certainty evidence).\nAuthors' conclusions\nThere is very limited evidence available on psychological interventions for adults with AsPD. Few interventions addressed the primary outcomes of this review and, of the eight that did, only three (CM + SM, ST and DBT) showed evidence that the intervention may be more effective than the control condition. No intervention reported compelling evidence of change in antisocial behaviour. Overall, the certainty of the evidence was low or very low, meaning that we have little confidence in the effect estimates reported.\nThe conclusions of this update have not changed from those of the original review, despite the addition of eight new studies. This highlights the ongoing need for further methodologically rigorous studies to yield further data to guide the development and application of psychological interventions for AsPD and may suggest that a new approach is required.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "People with antisocial personality disorder (AsPD) may behave in a way that is harmful to themselves or others and is against the law. They can be dishonest and act aggressively without thinking. Many also misuse drugs and alcohol. Certain types of psychological treatment, such as talking or thinking therapies, may help people with AsPD. Such treatments aim to change the person’s behaviour, to change the person’s thinking, or to help the person manage feelings of anger, self-harm, drug and alcohol abuse or negative behaviour.\nThis review updates one published in 2010."
}
] |
query-laysum
|
21944
|
[
{
"role": "user",
"content": "Abstract: Background\nHigh altitude illness (HAI) is a term used to describe a group of mainly cerebral and pulmonary syndromes that can occur during travel to elevations above 2500 metres (˜ 8200 feet). Acute mountain sickness (AMS), high altitude cerebral oedema (HACE) and high altitude pulmonary oedema (HAPE) are reported as potential medical problems associated with high altitude ascent. In this second review, in a series of three about preventive strategies for HAI, we assessed the effectiveness of five of the less commonly used classes of pharmacological interventions.\nObjectives\nTo assess the clinical effectiveness and adverse events of five of the less commonly used pharmacological interventions for preventing acute HAI in participants who are at risk of developing high altitude illness in any setting.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, LILACS and the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) in May 2017. We adapted the MEDLINE strategy for searching the other databases. We used a combination of thesaurus-based and free-text search terms. We scanned the reference lists and citations of included trials and any relevant systematic reviews that we identified for further references to additional trials.\nSelection criteria\nWe included randomized controlled trials conducted in any setting where one of five classes of drugs was employed to prevent acute HAI: selective 5-hydroxytryptamine(1) receptor agonists; N-methyl-D-aspartate (NMDA) antagonist; endothelin-1 antagonist; anticonvulsant drugs; and spironolactone. We included trials involving participants who are at risk of developing high altitude illness (AMS or HACE, or HAPE, or both). We included participants with and without a history of high altitude illness. We applied no age or gender restrictions. We included trials where the relevant medication was administered before the beginning of ascent. We excluded trials using these drugs during ascent or after ascent.\nData collection and analysis\nWe used the standard methodological procedures employed by Cochrane.\nMain results\nWe included eight studies (334 participants, 9 references) in this review. Twelve studies are ongoing and will be considered in future versions of this review as appropriate. We have been unable to obtain full-text versions of a further 12 studies and have designated them as 'awaiting classification'. Four studies were at a low risk of bias for randomization; two at a low risk of bias for allocation concealment. Four studies were at a low risk of bias for blinding of participants and personnel. We considered three studies at a low risk of bias for blinding of outcome assessors. We considered most studies at a high risk of selective reporting bias.\nWe report results for the following four main comparisons.\nSumatriptan versus placebo (1 parallel study; 102 participants)\nData on sumatriptan showed a reduction of the risk of AMS when compared with a placebo (risk ratio (RR) = 0.43, CI 95% 0.21 to 0.84; 1 study, 102 participants; low quality of evidence). The one included study did not report events of HAPE, HACE or adverse events related to administrations of sumatriptan.\nMagnesium citrate versus placebo (1 parallel study; 70 participants)\nThe estimated RR for AMS, comparing magnesium citrate tablets versus placebo, was 1.09 (95% CI 0.55 to 2.13; 1 study; 70 participants; low quality of evidence). In addition, the estimated RR for loose stools was 3.25 (95% CI 1.17 to 8.99; 1 study; 70 participants; low quality of evidence). The one included study did not report events of HAPE or HACE.\nSpironolactone versus placebo (2 parallel studies; 205 participants)\nPooled estimation of RR for AMS was not performed due to considerable heterogeneity between the included studies (I² = 72%). RR from individual studies was 0.40 (95% CI 0.12 to 1.31) and 1.44 (95% CI 0.79 to 2.01; very low quality of evidence). No events of HAPE or HACE were reported. Adverse events were not evaluated.\nAcetazolamide versus spironolactone (1 parallel study; 232 participants)\nData on acetazolamide compared with spironolactone showed a reduction of the risk of AMS with the administration of acetazolamide (RR = 0.36, 95% CI 0.18 to 0.70; 232 participants; low quality of evidence). No events of HAPE or HACE were reported. Adverse events were not evaluated.\nAuthors' conclusions\nThis Cochrane Review is the second in a series of three providing relevant information to clinicians and other interested parties on how to prevent high altitude illness. The assessment of five of the less commonly used classes of drugs suggests that there is a scarcity of evidence related to these interventions. Clinical benefits and harms related to potential interventions such as sumatriptan are still unclear. Overall, the evidence is limited due to the low number of studies identified (for most of the comparison only one study was identified); limitations in the quality of the evidence (moderate to low); and the number of studies pending classification (24 studies awaiting classification or ongoing). We lack the large and methodologically sound studies required to establish or refute the efficacy and safety of most of the pharmacological agents evaluated in this review.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The quality of the evidence was rated from low to very low. Several studies had quality shortcomings such as only having small sample sizes and therefore generating uncertain results. For most of the medicines evaluated, additional research is required to clarify their effectiveness and safety."
}
] |
query-laysum
|
21945
|
[
{
"role": "user",
"content": "Abstract: Background\nA peripheral venous catheter (PVC) is typically used for short-term delivery of intravascular fluids and medications. It is an essential element of modern medicine and the most frequent invasive procedure performed in hospitals. However, PVCs often fail before intravenous treatment is completed: this can occur because the device is not adequately attached to the skin, allowing the PVC to fall out, leading to complications such as phlebitis (irritation or inflammation to the vein wall), infiltration (fluid leaking into surrounding tissues) or occlusion (blockage). An inadequately secured PVC also increases the risk of catheter-related bloodstream infection (CRBSI), as the pistoning action (moving back and forth in the vein) of the catheter can allow migration of organisms along the catheter and into the bloodstream. Despite the many dressings and securement devices available, the impact of different securement techniques for increasing PVC dwell time is still unclear; there is a need to provide guidance for clinicians by reviewing current studies systematically.\nObjectives\nTo assess the effects of PVC dressings and securement devices on the incidence of PVC failure.\nSearch methods\nWe searched the following electronic databases to identify reports of relevant randomised controlled trials (RCTs): the Cochrane Wounds Group Register (searched 08 April 2015): The Cochrane Central Register of Controlled Trials (CENTRAL; 2015, Issue 3), Ovid MEDLINE (1946 to March 7 2015); Ovid MEDLINE (In-Process & Other Non-Indexed Citations, March 7 2015); Ovid EMBASE (1974 to March 7 2015); and EBSCO CINAHL (1982 to March 8 2015).\nSelection criteria\nRCTs or cluster RCTs comparing different dressings or securement devices for the stabilisation of PVCs. Cross-over trials were ineligible for inclusion, unless data for the first treatment period could be obtained.\nData collection and analysis\nTwo review authors independently selected studies, assessed trial quality and extracted data. We contacted study authors for missing information. We used standard methodological procedures expected by Cochrane.\nMain results\nWe included six RCTs (1539 participants) in this review. Trial sizes ranged from 50 to 703 participants. These six trials made four comparisons, namely: transparent dressings versus gauze; bordered transparent dressings versus a securement device; bordered transparent dressings versus tape; and transparent dressing versus sticking plaster. There is very low quality evidence of fewer catheter dislodgements or accidental removals with transparent dressings compared with gauze (two studies, 278 participants, RR 0.40; 95% CI 0.17 to 0.92, P = 0.03%). The relative effects of transparent dressings and gauze on phlebitis (RR 0.89; 95% CI 0.47 to 1.68) and infiltration (RR 0.80; 95% CI 0.48 to 1.33) are unclear. The relative effects on PVC failure of a bordered transparent dressing and a securement device have been assessed in only one small study and these were unclear. There was very low quality evidence from the same single study of less frequent dislodgement or accidental catheter removal with bordered transparent dressings than securement devices (RR 0.14, 95% CI 0.03 to 0.63) but more phlebitis with bordered dressings (RR 8.11, 95% CI 1.03 to 64.02) (very low quality evidence). A small single study compared bordered transparent dressings with tape and found very low quality evidence of more PVC failure with the bordered dressing (RR 1.84, 95% CI 1.08 to 3.11) but the relative effects on dislodgement were not clear (very low quality evidence). The relative effects of transparent dressings and a sticking plaster have only been compared in one small study and are unclear. More high quality RCTs are required to determine the relative effects of alternative PVC dressings and securement devices.\nAuthors' conclusions\nIt is not clear if any one dressing or securement device is better than any other in securing peripheral venous catheters. There is a need for further, independent high quality trials to evaluate the many traditional as well as the newer, high use products. Given the large cost differences between some different dressings and securement devices, future trials should include a robust cost-effectiveness analysis.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Most people admitted to an acute/emergency hospital ward require the insertion of a peripheral venous catheter/cannula (PVC), often known as a 'drip' or 'IV'. A PVC is a flexible, hollow, plastic tube that is inserted in a peripheral vein, most commonly in the hand, or lower arm. Up to half of all PVCs stop working before treatment has finished and a new one has to be inserted. This is uncomfortable for the patient and costly for the healthcare system. One of the reasons PVCs fail, is that the products used to hold them in place are not fully effective, and allow the PVC to move around. This movement causes redness, inflammation and even blood infections. The PVC can become blocked, or leak into the surrounding tissues, or even fall out as a consequence of the movement. The function of PVC dressings and/or securement devices is to keep the PVC in the vein, and to cover the insertion site so that it is kept dry and clean and protected from infection."
}
] |
query-laysum
|
21946
|
[
{
"role": "user",
"content": "Abstract: Background\nVenous ulcers (also known as varicose or venous stasis ulcers) are a chronic, recurring and debilitating condition that affects up to 1% of the population. Best practice documents and expert opinion suggests that the removal of devitalised tissue from venous ulcers (debridement) by any one of six methods helps to promote healing. However, to date there has been no review of the evidence from randomised controlled trials (RCTs) to support this.\nObjectives\nTo determine the effects of different debriding methods or debridement versus no debridement, on the rate of debridement and wound healing in venous leg ulcers.\nSearch methods\nIn February 2015 we searched: The Cochrane Wounds Group Specialised Register; The Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid EMBASE and EBSCO CINAHL. There were no restrictions with respect to language, date of publication or study setting. In addition we handsearched conference proceedings, journals not cited in MEDLINE, and the bibliographies of all retrieved publications to identify potential studies. We made contact with the pharmaceutical industry to enquire about any completed studies.\nSelection criteria\nWe included RCTs, either published or unpublished, which compared two methods of debridement or compared debridement with no debridement. We presented study results in a narrative form, as meta-analysis was not possible.\nData collection and analysis\nIndependently, two review authors completed all study selection, data extraction and assessment of trial quality; resolution of disagreements was completed by a third review author.\nMain results\nWe identified 10 RCTs involving 715 participants. Eight RCTs evaluated autolytic debridement and included the following agents or dressings: biocellulose wound dressing (BWD), non-adherent dressing, honey gel, hydrogel (gel formula), hydrofibre dressing, hydrocolloid dressings, dextranomer beads, Edinburgh University Solution of Lime (EUSOL) and paraffin gauze. Two RCTs evaluated enzymatic preparations and one evaluated biosurgical debridement. No RCTs evaluated surgical, sharp or mechanical methods of debridement, or debridement versus no debridement. Most trials were at a high risk of bias.\nThree RCTs assessed the number of wounds completely debrided. All three of these trials compared two different methods of autolytic debridement (234 participants), with two studies reporting statistically significant results: one study (100 participants) reported that 40/50 (80%) ulcers treated with dextranomer beads and 7/50 (14%) treated with EUSOL achieved complete debridement (RR 5.71, 95% CI 2.84 to 11.52); while the other trial (86 participants) reported the number of ulcers completely debrided as 31/46 (76%) for hydrogel versus 18/40 (45%) for paraffin gauze (RR 0.67, 95% CI 0.45 to 0.99). One study (48 participants) reported that by 12 weeks, 15/18 (84%) ulcers treated with BWD had achieved a 75% to 100% clean, granulating wound bed versus 4/15 (26%) treated with non-adherent petrolatum emulsion-impregnated gauze.\nFour trials assessed the mean time to achieve debridement: one (86 participants) compared two autolytic debridement methods, two compared autolytic methods with enzymatic debridement (71 participants), and the last (12 participants) compared autolytic with biosurgical debridement; none of the results achieved statistical significance.\nTwo trials that assessed autolytic debridement methods reported the number of wounds healed at 12 weeks. One trial (108 participants) reported that 24/54 (44%) ulcers treated with honey healed versus 18/54 (33%) treated with hydrogel (RR (adjusted for baseline wound diameter) 1.38, 95% CI 1.02 to 1.88; P value 0.037). The second trial (48 participants) reported that 7/25 (28%) ulcers treated with BWD healed versus 7/23 (30%) treated with non-adherent dressing.\nReduction in wound size was assessed in five trials (444 participants) in which two autolytic methods were compared. Results were statistically significant in one three-armed trial (153 participants) when cadexomer iodine was compared to paraffin gauze (mean difference 24.9 cm², 95% CI 7.27 to 42.53, P value 0.006) and hydrocolloid compared to paraffin gauze (mean difference 23.8 cm², 95% CI 5.48 to 42.12, P value 0.01). A second trial that assessed reduction in wound size based its results on median differences and, at four weeks, produced a statistically significantly result that favoured honey over hydrogel (P value < 0.001). The other three trials reported no statistically significant results for reduction in wound size, although one trial reported that the mean percentage reduction in wound area was greater at six and 12 weeks for BWD versus a non-adherent dressing (44% versus 24% week 6; 74% versus 54% week 12).\nPain was assessed in six trials (544 participants) that compared two autolytic debridement methods, but the results were not statistically significant. No serious adverse events were reported in any trial.\nAuthors' conclusions\nThere is limited evidence to suggest that actively debriding a venous leg ulcer has a clinically significant impact on healing. The overall small number of participants, low number of studies and lack of meta-analysis in this review precludes any strong conclusions of benefit. Comparisons of different autolytic agents (hydrogel versus paraffin gauze; Dextranomer beads versus EUSOL and BWD versus non-adherent dressings) and Larvae versus hydrogel all showed statistically significant results for numbers of wounds debrided. Larger trials with follow up to healing are required.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Venous leg ulcers are a common type of leg wound. They can cause pain, stress, social isolation and depression. These ulcers take approximately 12 weeks to heal and the best and first treatment to try is compression bandages. In an attempt to improve the healing process it is thought that removing dead or dying tissue (debridement) from the surface of the wound can speed up healing. Six different methods can be used to achieve debridement: use of an instrument such as a scalpel (with or without anaesthesia - surgical debridement and sharp debridement, respectively); washing solutions and dressings (mechanical debridement); enzymes that break down the affected tissue (enzymatic debridement); moist dressings or natural agents, or both, to promote the wound's own healing processes (autolytic debridement); or maggots (biosurgical debridement)."
}
] |
query-laysum
|
21947
|
[
{
"role": "user",
"content": "Abstract: Background\nThis is an updated version of the original Cochrane review published in Issue 4, 2008.\nPeople suffering from epilepsy have an increased risk of experiencing psychotic symptoms. The psychotic syndromes associated with epilepsy have generally been classified as ictal, postictal, and interictal psychosis. Anticonvulsant drugs have been reported to precipitate psychosis. Moreover, all antipsychotic drugs have the propensity to cause paroxysmal electroencephalogram abnormalities and induce seizures.\nObjectives\nTo evaluate the benefits of interventions used to treat clinically significant psychotic symptoms occurring in people with epilepsy with regard to global improvement, changes in mental state, hospitalization, behavior, quality of life, effect on the frequency of seizures, and interaction with antiepileptic drugs.\nSearch methods\nWe searched the Cochrane Epilepsy Group's Specialized Register (23 March 2015), the Cochrane Central Register of Controlled Trials (CENTRAL via the Cochrane Register of Studies Online (CRSO), 23 March 2015), MEDLINE (Ovid, 1946 to 23 March 2015), PsycINFO (1887 to 23 March 2015), CINAHL (1937 to 23 March 2015), and BIOSIS Previews (1969 to 23 March 2015).\nTwo review authors (SF and AS) independently inspected the citations identified from the search. We identified potentially relevant abstracts and assessed full papers for inclusion and methodological quality.\nSelection criteria\nAll randomized controlled trials comparing drugs, behavior therapy, cognitive behavior therapy, or other non-pharmacological interventions used to relieve psychotic symptoms in people with epilepsy.\nData collection and analysis\nWe planned to extract and analyze the data from all relevant studies using standardized methods. As only one study met the inclusion criteria, we attempted no meta-analysis.\nMain results\nAfter independently assessing the abstracts and titles of 618 articles, we selected five relevant abstracts. Ultimately we found only one study meeting the inclusion criteria, which was available only as an abstract. This study compared the use of olanzapine (10 mg/day) with haloperidol (12 mg/day) in 16 people suffering from schizophrenia-like psychosis of epilepsy. Thirteen participants completed the study. Significant improvement was associated with use of olanzapine. We did not identify any study on psychosocial interventions in people suffering from epilepsy and psychosis.\nAuthors' conclusions\nWe found only one randomized controlled trial, which lacked the power to test the efficacy of antipsychotics in those suffering from psychosis concomitant with epilepsy.\nLimited evidence from this small randomized controlled trial suggests an improvement in psychotic symptoms, but not other outcome measures, with the use of an antipsychotic. The effects on seizure control are not well studied. Further trials are required to inform practice.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Only one small trial with a total of 16 participants met the inclusion criteria for this review. At present there is a lack of evidence to inform the treatment of psychosis in people with epilepsy, and further randomized controlled trials are needed.\nThe last search for trials was conducted in March 2015."
}
] |
query-laysum
|
21948
|
[
{
"role": "user",
"content": "Abstract: Background\nMénière's disease or syndrome is a chronic inner ear disorder that results in sporadic attacks of vertigo, sensorineural hearing loss, aural fullness and tinnitus.\nThere is no definitive treatment for Ménière's disease and treatment options range from dietary modification through medication to surgery.\nModification of diet, including restriction of salt, caffeine and alcohol intake, is a management option that is widely recommended to patients with Ménière's as a first-line treatment. There has not previously been a systematic review of this intervention.\nObjectives\nTo assess the effects of dietary restriction of salt, caffeine and alcohol intake in patients with Ménière's disease or syndrome.\nSearch methods\nThe Cochrane ENT Information Specialist searched the Cochrane ENT Trials Register; Central Register of Controlled Trials (CENTRAL); PubMed; Ovid Embase; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 28 March 2018.\nSelection criteria\nRandomised controlled trials of dietary modification, specifically salt, caffeine and alcohol restriction or substitution (or both), compared to no modification of these agents or a placebo intervention, in adult patients with Ménière's disease or syndrome.\nData collection and analysis\nWe used the standard methodological procedures expected by Cochrane. Our primary outcomes were control of vertigo or decrease in vertigo attacks, and adverse effects. Secondary outcomes included hearing (change in hearing loss or its progression), tinnitus (severity), perception of aural fullness, well-being and quality of life (overall changes), and other adverse effects. We planned to use GRADE to assess the quality of the evidence for each outcome.\nMain results\nWe did not identify any studies that met the inclusion criteria for the review.\nAuthors' conclusions\nThere is no evidence from randomised controlled trials to support or refute the restriction of salt, caffeine or alcohol intake in patients with Ménière's disease or syndrome.\nHigh-quality research in this field is warranted. The best evidence may come from a randomised controlled trial comparing dietary interventions (e.g. low salt versus general healthy diet advice), using rigorous methodology for patient selection, randomisation and blinding, and strictly adhering to the Bárány Society diagnostic criteria. However, this research question might be more pragmatically addressed by using information from carefully constructed patient registries that include information on dietary intake of substances of interest such as salt, caffeine and alcohol. It will be important to address the question of any possible harms or unwanted effects of dietary modification.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched for high-quality studies (randomised controlled trials) of dietary changes (salt, caffeine and alcohol restriction or substitution, or both) compared to no restriction in adult patients with Ménière's disease or syndrome. Our search is up to date to March 2018."
}
] |
query-laysum
|
21949
|
[
{
"role": "user",
"content": "Abstract: Background\nNephrolithiasis is a common urological disease worldwide. Extracorporeal shock wave lithotripsy (ESWL) has been used for the treatment of renal stones since the 1980s, while retrograde intrarenal surgery (RIRS) and percutaneous nephrolithotomy (PCNL) are newer, more invasive treatment modalities that may have higher stone-free rates. The complications of RIRS and PCNL have decreased owing to improvement in surgical techniques and instruments. We re-evaluated the best evidence on this topic in an update of a Cochrane Review first published in 2014.\nObjectives\nTo assess the effects of extracorporeal shock wave lithotripsy compared with percutaneous nephrolithotomy or retrograde intrarenal surgery for treating kidney stones.\nSearch methods\nWe performed a comprehensive search in CENTRAL, MEDLINE, Embase, and ClinicalTrials.gov with no restrictions on language or publication status. The latest search date was 6 December 2022.\nSelection criteria\nWe included randomized controlled trials (RCTs) and quasi-RCTs that compared ESWL with PCNL or RIRS for kidney stone treatment.\nData collection and analysis\nTwo review authors independently classified studies, extracted data, and assessed risk of bias. Our primary outcomes were treatment success rate at three months (defined as residual fragments smaller than 4 mm, or as defined by the study authors), quality of life (QoL), and complications. Our secondary outcomes were retreatment rate, auxiliary procedures rate, and duration of hospital stay. We performed statistical analyses using a random-effects model and independently rated the certainty of evidence using the GRADE approach.\nMain results\nWe included 31 trials involving 3361 participants (3060 participants completed follow-up). Four trials were only available as an abstract. Overall mean age was 46.6 years and overall mean stone size was 13.4 mm. Most participants (93.8%) had kidney stones measuring 20 mm or less, and 68.9% had lower pole stones.\nESWL versus PCNL\nESWL may have a lower three-month treatment success rate than PCNL (risk ratio [RR] 0.67, 95% confidence interval [CI] 0.57 to 0.79; I2 = 87%; 12 studies, 1303 participants; low-certainty evidence). This corresponds to 304 fewer participants per 1000 (397 fewer to 194 fewer) reporting treatment success with ESWL. ESWL may have little or no effect on QoL after treatment compared with PCNL (1 study, 78 participants; low-certainty evidence). ESWL probably leads to fewer complications than PCNL (RR 0.62, 95% CI 0.47 to 0.82; I2 = 18%; 13 studies, 1385 participants; moderate-certainty evidence). This corresponds to 82 fewer participants per 1000 (115 fewer to 39 fewer) having complications after ESWL.\nESWL versus RIRS\nESWL may have a lower three-month treatment success rate than RIRS (RR 0.85, 95% CI 0.78 to 0.93; I2 = 63%; 13 studies, 1349 participants; low-certainty evidence). This corresponds to 127 fewer participants per 1000 (186 fewer to 59 fewer) reporting treatment success with ESWL. We are very uncertain about QoL after treatment; the evidence is based on three studies (214 participants) that we were unable to pool. We are very uncertain about the difference in complication rates between ESWL and RIRS (RR 0.93, 95% CI 0.63 to 1.36; I2 = 32%; 13 studies, 1305 participants; very low-certainty evidence). This corresponds to nine fewer participants per 1000 (49 fewer to 48 more) having complications after ESWL.\nAuthors' conclusions\nESWL compared with PCNL may have lower three-month success rates, may have a similar effect on QoL, and probably leads to fewer complications. ESWL compared with RIRS may have lower three-month success rates, but the evidence on QoL outcomes and complication rates is very uncertain. These findings should provide valuable information to aid shared decision-making between clinicians and people with kidney stones who are undecided about these three options.\n\nGiven the provided abstract, please respond to the following query: \"What did we find?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found 31 studies that included 3361 people (1360 people were treated by ESWL, 786 by PCNL, and 925 by RIRS). The biggest study included 649 people and the smallest study included 30 people. The studies were conducted in countries around the world; most were set in Europe (12 studies). Medical device companies funded two of the studies. The average stone size was 13.4 mm."
}
] |
query-laysum
|
21950
|
[
{
"role": "user",
"content": "Abstract: Background\nDown's syndrome occurs when a person has three copies of chromosome 21, or the specific area of chromosome 21 implicated in causing Down's syndrome, rather than two. It is the commonest congenital cause of mental disability and also leads to numerous metabolic and structural problems. It can be life-threatening, or lead to considerable ill health, although some individuals have only mild problems and can lead relatively normal lives. Having a baby with Down's syndrome is likely to have a significant impact on family life. The risk of a Down's syndrome affected pregnancy increases with advancing maternal age.\nNoninvasive screening based on biochemical analysis of maternal serum or urine, or fetal ultrasound measurements, allows estimates of the risk of a pregnancy being affected and provides information to guide decisions about definitive testing. Before agreeing to screening tests, parents need to be fully informed about the risks, benefits and possible consequences of such a test. This includes subsequent choices for further tests they may face, and the implications of both false positive and false negative screening tests (i.e. invasive diagnostic testing, and the possibility that a miscarried fetus may be chromosomally normal). The decisions that may be faced by expectant parents inevitably engender a high level of anxiety at all stages of the screening process, and the outcomes of screening can be associated with considerable physical and psychological morbidity. No screening test can predict the severity of problems a person with Down's syndrome will have.\nObjectives\nTo estimate and compare the accuracy of first and second trimester urine markers for the detection of Down's syndrome.\nSearch methods\nWe carried out a sensitive and comprehensive literature search of MEDLINE (1980 to 25 August 2011), EMBASE (1980 to 25 August 2011), BIOSIS via EDINA (1985 to 25 August 2011), CINAHL via OVID (1982 to 25 August 2011), The Database of Abstracts of Reviews of Effectiveness (The Cochrane Library 2011, Issue 7), MEDION (25 August 2011), The Database of Systematic Reviews and Meta-Analyses in Laboratory Medicine (25 August 2011), The National Research Register (archived 2007), Health Services Research Projects in Progress database (25 August 2011). We studied reference lists and published review articles.\nSelection criteria\nStudies evaluating tests of maternal urine in women up to 24 weeks of gestation for Down's syndrome, compared with a reference standard, either chromosomal verification or macroscopic postnatal inspection.\nData collection and analysis\nWe extracted data as test positive or test negative results for Down's and non-Down's pregnancies allowing estimation of detection rates (sensitivity) and false positive rates (1-specificity). We performed quality assessment according to QUADAS (Quality Assessment of Diagnostic Accuracy Studies) criteria. We used hierarchical summary ROC (receiver operating characteristic) meta-analytical methods to analyse test performance and compare test accuracy. We performed analysis of studies allowing direct comparison between tests. We investigated the impact of maternal age on test performance in subgroup analyses.\nMain results\nWe included 19 studies involving 18,013 pregnancies (including 527 with Down's syndrome). Studies were generally of high quality, although differential verification was common with invasive testing of only high-risk pregnancies. Twenty-four test combinations were evaluated formed from combinations of the following seven different markers with and without maternal age: AFP (alpha-fetoprotein), ITA (invasive trophoblast antigen), ß-core fragment, free ßhCG (beta human chorionic gonadotrophin), total hCG, oestriol, gonadotropin peptide and various marker ratios. The strategies evaluated included three double tests and seven single tests in combination with maternal age, and one triple test, two double tests and 11 single tests without maternal age. Twelve of the 19 studies only evaluated the performance of a single test strategy while the remaining seven evaluated at least two test strategies. Two marker combinations were evaluated in more than four studies; second trimester ß-core fragment (six studies), and second trimester ß-core fragment with maternal age (five studies).\nIn direct test comparisons, for a 5% false positive rate (FPR), the diagnostic accuracy of the double marker second trimester ß-core fragment and oestriol with maternal age test combination was significantly better (ratio of diagnostic odds ratio (RDOR): 2.2 (95% confidence interval (CI) 1.1 to 4.5), P = 0.02) (summary sensitivity of 73% (CI 57 to 85) at a cut-point of 5% FPR) than that of the single marker test strategy of second trimester ß-core fragment and maternal age (summary sensitivity of 56% (CI 45 to 66) at a cut-point of 5% FPR), but was not significantly better (RDOR: 1.5 (0.8 to 2.8), P = 0.21) than that of the second trimester ß-core fragment to oestriol ratio and maternal age test strategy (summary sensitivity of 71% (CI 51 to 86) at a cut-point of 5% FPR).\nAuthors' conclusions\nTests involving second trimester ß-core fragment and oestriol with maternal age are significantly more sensitive than the single marker second trimester ß-core fragment and maternal age, however, there were few studies. There is a paucity of evidence available to support the use of urine testing for Down's syndrome screening in clinical practice where alternatives are available.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Down's syndrome (also known as Down's or Trisomy 21) is an incurable genetic disorder that causes significant physical and mental health problems, and disabilities. However, there is wide variation in how Down's affects people. Some individuals are severely affected whilst others have mild problems and are able to lead relatively normal lives. There is no way of predicting how badly a baby might be affected.\nExpectant parents are given the choice to be tested for Down’s during pregnancy to assist them in making decisions. If a mother is carrying a baby with Down’s, then there is the decision about whether to terminate or continue with the pregnancy. The information offers parents the opportunity to plan for life with a Down’s child.\nThe most accurate tests for Down’s involve testing fluid from around the baby (amniocentesis) or tissue from the placenta (chorionic villus sampling (CVS)) for the abnormal chromosomes associated with Down’s. Both these tests involve inserting needles through the mother's abdomen and are known to increase the risk of miscarriage. Thus, the tests are not suitable for offering to all pregnant women. Rather, tests that measure markers in the mother’s blood, urine or on ultrasound scans of the baby are used for screening. These screening tests are not perfect, they can miss cases of Down’s and also give a ‘high risk’ test results to a number of women whose babies are not affected by Down’s. Thus, pregnancies identified as ‘high risk’ using these screening tests require further testing using amniocentesis or CVS to confirm a diagnosis of Down’s."
}
] |
query-laysum
|
21951
|
[
{
"role": "user",
"content": "Abstract: Background\nRespiratory disease is the main cause of morbidity and mortality in cystic fibrosis (CF), and many different therapies are used by people with CF in the management of respiratory problems. Bronchodilator therapy is used to relieve symptoms of shortness of breath and to open the airways to allow clearance of mucus. Despite the widespread use of inhaled bronchodilators in CF, there is little objective evidence of their efficacy. A Cochrane Review looking at both short- and long-acting inhaled bronchodilators for CF was withdrawn from the Cochrane Library in 2016. That review has been replaced by two separate Cochrane Reviews: one on long-acting inhaled bronchodilators for CF, and this review on short-acting inhaled bronchodilators for CF. For this review 'inhaled' includes the use of pressurised metered dose inhalers (MDIs), with or without a spacer, dry powder devices and nebulisers.\nObjectives\nTo evaluate short-acting inhaled bronchodilators in children and adults with CF in terms of clinical outcomes and safety.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis Trials Register, compiled from electronic database searches and handsearching of journals and conference abstract books on 28 March 2022 and searched trial registries for any new or ongoing trials on 12 April 2022. We also searched the reference lists of relevant articles and reviews.\nSelection criteria\nWe searched for randomised controlled trials (RCTs) or quasi-RCTs that looked at the effect of any short-acting inhaled bronchodilator delivered by any device, at any dose, at any frequency and for any duration compared to either placebo or another short-acting inhaled bronchodilator in people with CF. We screened references as per standard Cochrane methodology.\nData collection and analysis\nTwo review authors extracted data and assessed risk of bias using the Cochrane RoB 1 tool. Where we were not able to enter data into our analyses we reported results directly from the papers. We assessed the certainty of evidence using GRADE.\nMain results\nWe included 11 trials from our systematic search, with 191 participants meeting our inclusion criteria; three of these trials had three treatment arms. Eight trials compared short-acting inhaled beta-2 agonists to placebo and four trials compared short-acting inhaled muscarinic antagonists to placebo. Three trials compared short-acting inhaled beta-2 agonists to short-acting inhaled muscarinic antagonists. All were cross-over trials with only small numbers of participants. We were only able to enter data into the analysis from three trials comparing short-acting inhaled beta-2 agonists to placebo.\nShort-acting inhaled beta-2 agonists versus placebo\nAll eight trials (six single-dose trials and two longer-term trials) reporting on this comparison reported on forced expiratory volume in 1 second (FEV1), either as per cent predicted (% predicted) or L. We were able to combine the data from two trials in a meta-analysis which showed a greater per cent change from baseline in FEV1 L after beta-2 agonists compared to placebo (mean difference (MD) 6.95%, 95% confidence interval (CI) 1.88 to 12.02; 2 trials, 82 participants). Only one of the longer-term trials reported on exacerbations, as measured by hospitalisations and courses of antibiotics. Only the second longer-term trial presented results for participant-reported outcomes. Three trials narratively reported adverse events, and these were all mild. Three single-dose trials and the two longer trials reported on forced vital capacity (FVC), and five trials reported on peak expiratory flow, i.e. forced expiratory flow between 25% and 75% (FEF25-75). One trial reported on airway clearance in terms of sputum weight. We judged the certainty of evidence for each of these outcomes to be very low, meaning we are very uncertain about the effect of short-acting inhaled beta-2 agonists on any of the outcomes we assessed.\nShort-acting inhaled muscarinic antagonists versus placebo\nAll four trials reporting on this comparison looked at the effects of ipratropium bromide, but in different doses and via different delivery methods. One trial reported FEV1 % predicted; three trials measured this in L. Two trials reported adverse events, but these were few and mild. One trial reported FVC and three trials reported FEF25-75. None of the trials reported on quality of life, exacerbations or airway clearance. We judged the certainty of evidence for each of these outcomes to be very low, meaning we are very uncertain about the effect of short-acting inhaled muscarinic antagonists on any of the outcomes we assessed.\nShort-acting inhaled beta-2 agonists versus short-acting inhaled muscarinic antagonists\nNone of the three single-dose trials reporting on this comparison provided data we could analyse. The original papers from three trials report that both treatments lead to an improvement in FEV1 L. Only one trial reported on adverse events; but none were experienced by any participant. No trial reported on any of our other outcomes. We judged the certainty of evidence to be very low, meaning we are very uncertain about the effect of short-acting inhaled beta-2 agonists compared to short-acting inhaled muscarinic antagonists on any of the outcomes we assessed.\nAuthors' conclusions\nAll included trials in this review are small and of a cross-over design. Most trials looked at very short-term effects of inhaled bronchodilators, and therefore did not measure longer-term outcomes. The certainty of evidence across all outcomes was very low, and therefore we have been unable to describe any effects with certainty.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "All trials looked at the effect of short-acting inhaled bronchodilators on lung function, measured as forced expiratory volume in one second (FEV1), but this was reported in different ways and at different time points.\nWe are uncertain whether any of the short-acting inhaled bronchodilators have an effect on FEV1 compared to placebo. The trials were too small and there were not enough data to show if there was an effect or not.\nOnly six of the 11 trials reported on harmful effects of treatment: one trial reported no harmful effects and five trials reported mild tremors, dry mouth and fatigue."
}
] |
query-laysum
|
21952
|
[
{
"role": "user",
"content": "Abstract: Background\nCarotid patch angioplasty may reduce the risk of acute occlusion or long-term restenosis of the carotid artery and subsequent ischaemic stroke in people undergoing carotid endarterectomy (CEA). This is an update of a Cochrane Review originally published in 1995 and updated in 2008.\nObjectives\nTo assess the safety and efficacy of routine or selective carotid patch angioplasty with either a venous patch or a synthetic patch compared with primary closure in people undergoing CEA. We wished to test the primary hypothesis that carotid patch angioplasty results in a lower rate of severe arterial restenosis and therefore fewer recurrent strokes and stroke-related deaths, without a considerable increase in perioperative complications.\nSearch methods\nWe searched the Cochrane Stroke Group trials register, CENTRAL, MEDLINE, Embase, two other databases, and two trial registries in September 2021.\nSelection criteria\nRandomised controlled trials and quasi-randomised trials comparing carotid patch angioplasty with primary closure in people undergoing CEA.\nData collection and analysis\nTwo review authors independently assessed eligibility and risk of bias; extracted data; and determined the certainty of evidence using the GRADE approach. Outcomes of interest included stroke, death, significant complications related to surgery, and artery restenosis or occlusion during the perioperative period (within 30 days of the operation) or during long-term follow-up.\nMain results\nWe included 11 trials involving 2100 participants undergoing 2304 CEA operations. The quality of trials was generally poor. Follow-up varied from hospital discharge to five years. Compared with primary closure, carotid patch angioplasty may make little or no difference to reduction in risk of any stroke during the perioperative period (odds ratio (OR) 0.57, 95% confidence interval (CI) 0.31 to 1.03; P = 0.063; 8 studies, 1769 participants; very low-certainty evidence), but may lower the risk of any stroke during long-term follow-up (OR 0.49, 95% CI 0.27 to 0.90; P = 0.022; 7 studies, 1332 participants; very low-certainty evidence). In the included studies, carotid patch angioplasty resulted in a lower risk of ipsilateral stroke during the perioperative period (OR 0.31, 95% CI 0.15 to 0.63; P = 0.001; 7 studies, 1201 participants; very low-certainty evidence), and during long-term follow-up (OR 0.32, 95% CI 0.16 to 0.63; P = 0.001; 6 studies, 1141 participants; very low-certainty evidence). The intervention was associated with a reduction in the risk of any stroke or death during long-term follow-up (OR 0.59, 95% CI 0.42 to 0.84; P = 0.003; 6 studies, 1019 participants; very low-certainty evidence). In addition, the included studies suggest that carotid patch angioplasty may reduce the risk of perioperative arterial occlusion (OR 0.18, 95% CI 0.08 to 0.41; P < 0.0001; 7 studies, 1435 participants; low-certainty evidence), and may reduce the risk of restenosis during long-term follow-up (OR 0.24, 95% CI 0.17 to 0.34; P < 0.00001; 8 studies, 1719 participants; low-certainty evidence). The studies recorded very few arterial complications, including haemorrhage, infection, cranial nerve palsies and pseudo-aneurysm formation, with either patch or primary closure. We found no correlation between the use of patch angioplasty and the risk of either perioperative or long-term stroke-related death or all-cause death rates.\nAuthors' conclusions\nCompared with primary closure, carotid patch angioplasty may reduce the risk of perioperative arterial occlusion and long-term restenosis of the operated artery. It would appear to reduce the risk of ipsilateral stroke during the perioperative and long-term period and reduce the risk of any stroke in the long-term when compared with primary closure. However, the evidence is uncertain due to the limited quality of included trials.\n\nGiven the provided abstract, please respond to the following query: \"What is primary closure, and what is patch angioplasty?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "After removing the plaques from the artery, the surgeon can simply bring the two edges of the hole together and sew it closed (primary closure), or can close the hole with a patch, sewing the edges of the hole to the edges of the patch to widen the artery further (patch angioplasty). This patch can be made of synthetic material or can be a piece of the patient's own vein."
}
] |
query-laysum
|
21953
|
[
{
"role": "user",
"content": "Abstract: Background\nVitiligo is a chronic skin disorder characterised by patchy loss of skin colour. Some people experience itching before the appearance of a new patch. It affects people of any age or ethnicity, more than half of whom develop it before the age of 20 years. There are two main types: generalised vitiligo, the common symmetrical form, and segmental, affecting only one side of the body. Around 1% of the world's population has vitiligo, a disease causing white patches on the skin. Several treatments are available. Some can restore pigment but none can cure the disease.\nObjectives\nTo assess the effects of all therapeutic interventions used in the management of vitiligo.\nSearch methods\nWe updated our searches of the following databases to October 2013: the Cochrane Skin Group Specialised Register, CENTRAL in The Cochrane Library (2013, Issue 10), MEDLINE, Embase, AMED, PsycINFO, CINAHL and LILACS. We also searched five trials databases, and checked the reference lists of included studies for further references to relevant randomised controlled trials (RCTs).\nSelection criteria\nRandomised controlled trials (RCTs) assessing the effects of treatments for vitiligo.\nData collection and analysis\nAt least two review authors independently assessed study eligibility and methodological quality, and extracted data.\nMain results\nThis update of the 2010 review includes 96 studies, 57 from the previous update and 39 new studies, totalling 4512 participants. Most of the studies, covering a wide range of interventions, had fewer than 50 participants. All of the studies assessed repigmentation, however only five reported on all of our three primary outcomes which were quality of life, > 75% repigmentation and adverse effects. Of our secondary outcomes, six studies measured cessation of spread but none assessed long-term permanence of repigmentation resulting from treatment at two years follow-up.\nMost of the studies assessed combination therapies which generally reported better results. New interventions include seven new surgical interventions.\nWe analysed the data from 25 studies which assessed our primary outcomes. We used the effect measures risk ratio (RR), and odds ratio (OR) with their 95% confidence intervals (CI) and where N is the number of participants in the study.\nWe were only able to analyse one of nine studies assessing quality of life and this showed no statistically significant improvement between the comparators.\nNine analyses from eight studies reported >75% repigmentation. In the following studies the repigmentation was better in the combination therapy group: calcipotriol plus PUVA (psoralen with UVA light) versus PUVA (paired OR 4.25, 95% CI 1.43 to 12.64, one study, N = 27); hydrocortisone-17-butyrate plus excimer laser versus excimer laser alone (RR 2.57, 95% CI 1.20 to 5.50, one study, N = 84); oral minipulse of prednisolone (OMP) plus NB-UVB (narrowband UVB) versus OMP alone (RR 7.41, 95% CI 1.03 to 53.26, one study, N = 47); azathioprine with PUVA versus PUVA alone (RR 17.77, 95% CI 1.08 to 291.82, one study, N = 58) and 8-Methoxypsoralen (8-MOP ) plus sunlight versus psoralen (RR 2.50, 95% CI 1.06 to 5.91, one study, N = 168). In these three studies ginkgo biloba was better than placebo (RR 4.40, 95% CI 1.08 to 17.95, one study, N = 47); clobetasol propionate was better than PUVAsol (PUVA with sunlight) (RR 4.70, 95% CI 1.14 to 19.39, one study, N = 45); split skin grafts with PUVAsol was better than minipunch grafts with PUVAsol (RR 1.89, 95% CI 1.25 to 2.85, one study, N = 64).\nWe performed one meta-analysis of three studies, in which we found a non-significant 60% increase in the proportion of participants achieving >75% repigmentation in favour of NB-UVB compared to PUVA (RR 1.60, 95% CI 0.74 to 3.45; I² = 0%).\nStudies assessing topical preparations, in particular topical corticosteroids, reported most adverse effects. However, in combination studies it was difficult to ascertain which treatment caused these effects. We performed two analyses from a pooled analysis of three studies on adverse effects. Where NB-UVB was compared to PUVA, the NB-UVB group reported less observations of nausea in three studies (RR 0.13, 95% CI 0.02 to 0.69; I² = 0% three studies, N = 156) and erythema in two studies (RR 0.73, 95% CI 0.55 to 0.98; I² = 0%, two studies, N = 106), but not itching in two studies (RR 0.57, 95% CI 0.20 to 1.60; I² = 0%, two studies, N = 106).\nVery few studies only assessed children or included segmental vitiligo. We found one study of psychological interventions but we could not include the outcomes in our statistical analyses. We found no studies evaluating micropigmentation, depigmentation, or cosmetic camouflage.\nAuthors' conclusions\nThis review has found some evidence from individual studies to support existing therapies for vitiligo, but the usefulness of the findings is limited by the different designs and outcome measurements and lack of quality of life measures. There is a need for follow-up studies to assess permanence of repigmentation as well as high-quality randomised trials using standardised measures and which also address quality of life.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "In this update search we found 39 new randomised controlled trials which, added to the 57 studies included previously, makes a total of 96 studies with 4512 participants."
}
] |
query-laysum
|
21954
|
[
{
"role": "user",
"content": "Abstract: Background\nPeople diagnosed with borderline personality disorder (BPD) frequently present to healthcare services in crisis, often with suicidal thoughts or actions. Despite this, little is known about what constitutes effective management of acute crises in this population and what type of interventions are helpful at times of crisis. In this review, we will examine the efficacy of crisis interventions, defined as an immediate response by one or more individuals to the acute distress experienced by another individual, designed to ensure safety and recovery and lasting no longer than one month. This review is an update of a previous Cochrane Review examining the evidence for the effects of crisis interventions in adults diagnosed with BPD.\nObjectives\nTo assess the effects of crisis interventions in adults diagnosed with BPD in any setting.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, nine other databases and three trials registers up to January 2022. We also checked reference lists, handsearched relevant journal archives and contacted experts in the field to identify any unpublished or ongoing studies.\nSelection criteria\nRandomised controlled trials (RCTs) comparing crisis interventions with usual care, no intervention or waiting list, in adults of any age diagnosed with BPD.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nWe included two studies with 213 participants.\nOne study (88 participants) was a feasibility RCT conducted in the UK that examined the effects of joint crisis plans (JCPs) plus treatment as usual (TAU) compared to TAU alone in people diagnosed with BPD. The primary outcome was self-harm. Participants had an average age of 36 years, and 81% were women. Government research councils funded the study. Risk of bias was unclear for blinding, but low in the other domains assessed. Evidence from this study suggested that there may be no difference between JCPs and TAU on deaths (risk ratio (RR) 0.91, 95% confidence interval (CI) 0.06 to 14.14; 88 participants; low-certainty evidence); mean number of self-harm episodes (mean difference (MD) 0.30, 95% CI −36.27 to 36.87; 72 participants; low-certainty evidence), number of inpatient mental health nights (MD 1.80, 95% CI −5.06 to 8.66; 73 participants; low-certainty evidence), or quality of life measured using the EuroQol five-dimension questionnaire (EQ-5D; MD −6.10, 95% CI −15.52 to 3.32; 72 participants; very low-certainty evidence). The study authors calculated an Incremental Cost Effectiveness Ratio of GBP −32,358 per quality-adjusted life year (QALY), favouring JCPs, but they described this result as \"hypothesis-generating only\" and we rated this as very low-certainty evidence.\nThe other study (125 participants) was an RCT conducted in Sweden of brief admission to psychiatric hospital by self-referral (BA) compared to TAU, in people with self-harm or suicidal behaviour and three or more diagnostic criteria for BPD. The primary outcome was use of inpatient mental health services. Participants had an average age of 32 years, and 85% were women. Government research councils and non-profit foundations funded the study. Risk of bias was unclear for blinding and baseline imbalances, but low in the other domains assessed. The evidence suggested that there is no clear difference between BA and TAU on deaths (RR 0.49, 95% CI 0.05 to 5.29; 125 participants; low-certainty evidence), mean number of self-harm episodes (MD −0.03, 95% CI −2.26 to 2.20; 125 participants; low-certainty evidence), violence perpetration (RR 2.95, 95% CI 0.12 to 71.13; 125 participants; low-certainty evidence), or days of inpatient mental health care (MD 0.70, 95% CI −14.32 to 15.72; 125 participants; low-certainty evidence). The study suggested that BA may have little or no effect on the mean number of suicide attempts (MD 0.00, 95% CI −0.06 to 0.06; 125 participants; very low-certainty evidence).\nWe also identified three ongoing RCTs that met our inclusion criteria. The results will be incorporated into future updates of this review.\nAuthors' conclusions\nA comprehensive search of the literature revealed very little RCT-based evidence to inform the management of acute crises in people diagnosed with BPD. We included two studies of two very different types of intervention (JCP and BA). We found no clear evidence of a benefit over TAU in any of our main outcomes. We are very uncertain about the true effects of either intervention, as the evidence was judged low- and very low-certainty, and there was only a single study of each intervention.\nThere is an urgent need for high-quality, large-scale, adequately powered RCTs on crisis interventions for people diagnosed with BPD, in addition to development of new crisis interventions.\n\nGiven the provided abstract, please respond to the following query: \"What is borderline personality disorder?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Borderline personality disorder (BPD) is a complex and severe mental disorder that affects about 2% of the general population. Many people diagnosed with BPD have unstable relationships and distressing and rapid changes in emotions, leading to frequent crises. These crises are critical periods, as they may lead to increased drug and alcohol use, fewer contacts with health professionals and self-harm, which may be life-threatening."
}
] |
query-laysum
|
21955
|
[
{
"role": "user",
"content": "Abstract: Background\nBibliographic databases provide access to an international body of scientific literature in health and medical sciences. Systematic reviews are an important source of evidence for clinicians, researchers, consumers, and policymakers as they address a specific health-related question and use explicit methods to identify, appraise and synthesize evidence from which conclusions can be drawn and decisions made.\nMethodological search filters help database end-users search the literature effectively with different levels of sensitivity and specificity. These filters have been developed for various study designs and have been found to be particularly useful for intervention studies. Other filters have been developed for finding systematic reviews. Considering the variety and number of available search filters for systematic reviews, there is a need for a review of them in order to provide evidence about their retrieval properties at the time they were developed.\nObjectives\nTo review systematically empirical studies that report the development, evaluation, or comparison of search filters to retrieve reports of systematic reviews in MEDLINE and Embase.\nSearch methods\nWe searched the following databases from inception to January 2023: MEDLINE, Embase, PsycINFO; Library, Information Science & Technology Abstracts (LISTA) and Science Citation Index (Web of Science).\nSelection criteria\nWe included studies if one of their primary objectives is the development, evaluation, or comparison of a search filter that could be used to retrieve systematic reviews on MEDLINE, Embase, or both.\nData collection and analysis\nTwo review authors independently extracted data using a pre-specified and piloted data extraction form using InterTASC Information Specialist Subgroup (ISSG) Search Filter Evaluation Checklist.\nMain results\nWe identified eight studies that developed filters for MEDLINE and three studies that developed filters for Embase. Most studies are very old and some were limited to systematic reviews in specific clinical areas. Six included studies reported the sensitivity of their developed filter. Seven studies reported precision and six studies reported specificity. Only one study reported the number needed to read and positive predictive value. None of the filters were designed to differentiate systematic reviews on the basis of their methodological quality. For MEDLINE, all filters showed similar sensitivity and precision, and one filter showed higher levels of specificity. For Embase, filters showed variable sensitivity and precision, with limited study reports that may affect accuracy assessments. The report of these studies had some limitations, and the assessments of their accuracy may suffer from indirectness, considering that they were mostly developed before the release of the PRISMA 2009 statement or due to their limited scope in the selection of systematic review topics.\nSearch filters for MEDLINE\nThree studies produced filters with sensitivity > 90% with variable degrees of precision, and only one of them was developed and validated in a gold-standard database, which allowed the calculation of specificity. The other two search filters had lower levels of sensitivity. One of these produced a filter with higher levels of specificity (> 90%). All filters showed similar sensitivity and precision in the external validation, except for one which was not externally validated and another one which was conceptually derived and only externally validated.\nSearch filters for Embase\nWe identified three studies that developed filters for this database. One of these studies developed filters with variable sensitivity and precision, including highly sensitive strategies (> 90%); however, it was not externally validated. The other study produced a filter with a lower sensitivity (72.7%) but high specificity (99.1%) with a similar performance in the external validation.\nAuthors' conclusions\nStudies reporting the development, evaluation, or comparison of search filters to retrieve reports of systematic reviews in MEDLINE showed similar sensitivity and precision, with one filter showing higher levels of specificity. For Embase, filters showed variable sensitivity and precision, with limited information about how the filter was produced, which leaves us uncertain about their performance assessments. Newer filters had limitations in their methods or scope, including very focused subject topics for their gold standards, limiting their applicability across other topics. Our findings highlight that consensus guidance on the conduct of search filters and standardized reporting of search filters are needed, as we found highly heterogeneous development methods, accuracy assessments and outcome selection. New strategies adaptable across interfaces could enhance their usability. Moreover, the performance of existing filters needs to be evaluated in light of the impact of reporting guidelines, including the PRISMA 2009, on how systematic reviews are reported. Finally, future filter developments should also consider comparing the filters against a common reference set to establish comparative performance and assess the quality of systematic reviews retrieved by strategies.\n\nGiven the provided abstract, please respond to the following query: \"What did we find?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "For MEDLINE, all filters showed similar sensitivity and precision, and one filter showed higher levels of specificity. For Embase, filters showed variable sensitivity and precision, with limited study reports that may affect accuracy assessments."
}
] |
query-laysum
|
21956
|
[
{
"role": "user",
"content": "Abstract: Background\nAbout 10% of women of reproductive age suffer from endometriosis. Endometriosis is a costly chronic disease that causes pelvic pain and subfertility. Laparoscopy, the gold standard diagnostic test for endometriosis, is expensive and carries surgical risks. Currently, no non-invasive tests that can be used to accurately diagnose endometriosis are available in clinical practice. This is the first review of diagnostic test accuracy of imaging tests for endometriosis that uses Cochrane methods to provide an update on the rapidly expanding literature in this field.\nObjectives\n• To provide estimates of the diagnostic accuracy of imaging modalities for the diagnosis of pelvic endometriosis, ovarian endometriosis and deeply infiltrating endometriosis (DIE) versus surgical diagnosis as a reference standard.\n• To describe performance of imaging tests for mapping of deep endometriotic lesions in the pelvis at specific anatomical sites.\nImaging tests were evaluated as replacement tests for diagnostic surgery and as triage tests that would assist decision making regarding diagnostic surgery for endometriosis.\nSearch methods\nWe searched the following databases to 20 April 2015: MEDLINE, CENTRAL, EMBASE, CINAHL, PsycINFO, Web of Science, LILACS, OAIster, TRIP, ClinicalTrials.gov, MEDION, DARE, and PubMed. Searches were not restricted to a particular study design or language nor to specific publication dates. The search strategy incorporated words in the title, abstracts, text words across the record and medical subject headings (MeSH).\nSelection criteria\nWe considered published peer-reviewed cross-sectional studies and randomised controlled trials of any size that included prospectively recruited women of reproductive age suspected of having one or more of the following target conditions: endometrioma, pelvic endometriosis, DIE or endometriotic lesions at specific intrapelvic anatomical locations. We included studies that compared the diagnostic test accuracy of one or more imaging modalities versus findings of surgical visualisation of endometriotic lesions.\nData collection and analysis\nTwo review authors independently collected and performed a quality assessment of data from each study. For each imaging test, data were classified as positive or negative for surgical detection of endometriosis, and sensitivity and specificity estimates were calculated. If two or more tests were evaluated in the same cohort, each was considered as a separate data set. We used the bivariate model to obtain pooled estimates of sensitivity and specificity when sufficient data sets were available. Predetermined criteria for a clinically useful imaging test to replace diagnostic surgery included sensitivity ≥ 94% and specificity ≥ 79%. Criteria for triage tests were set at sensitivity ≥ 95% and specificity ≥ 50%, ruling out the diagnosis with a negative result (SnNout test - if sensitivity is high, a negative test rules out pathology) or at sensitivity ≥ 50% with specificity ≥ 95%, ruling in the diagnosis with a positive result (SpPin test - if specificity is high, a positive test rules in pathology).\nMain results\nWe included 49 studies involving 4807 women: 13 studies evaluated pelvic endometriosis, 10 endometriomas and 15 DIE, and 33 studies addressed endometriosis at specific anatomical sites. Most studies were of poor methodological quality. The most studied modalities were transvaginal ultrasound (TVUS) and magnetic resonance imaging (MRI), with outcome measures commonly demonstrating diversity in diagnostic estimates; however, sources of heterogeneity could not be reliably determined. No imaging test met the criteria for a replacement or triage test for detecting pelvic endometriosis, albeit TVUS approached the criteria for a SpPin triage test. For endometrioma, TVUS (eight studies, 765 participants; sensitivity 0.93 (95% confidence interval (CI) 0.87, 0.99), specificity 0.96 (95% CI 0.92, 0.99)) qualified as a SpPin triage test and approached the criteria for a replacement and SnNout triage test, whereas MRI (three studies, 179 participants; sensitivity 0.95 (95% CI 0.90, 1.00), specificity 0.91 (95% CI 0.86, 0.97)) met the criteria for a replacement and SnNout triage test and approached the criteria for a SpPin test. For DIE, TVUS (nine studies, 12 data sets, 934 participants; sensitivity 0.79 (95% CI 0.69, 0.89) and specificity 0.94 (95% CI 0.88, 1.00)) approached the criteria for a SpPin triage test, and MRI (six studies, seven data sets, 266 participants; sensitivity 0.94 (95% CI 0.90, 0.97), specificity 0.77 (95% CI 0.44, 1.00)) approached the criteria for a replacement and SnNout triage test. Other imaging tests assessed in small individual studies could not be statistically evaluated.\nTVUS met the criteria for a SpPin triage test in mapping DIE to uterosacral ligaments, rectovaginal septum, vaginal wall, pouch of Douglas (POD) and rectosigmoid. MRI met the criteria for a SpPin triage test for POD and vaginal and rectosigmoid endometriosis. Transrectal ultrasonography (TRUS) might qualify as a SpPin triage test for rectosigmoid involvement but could not be adequately assessed for other anatomical sites because heterogeneous data were scant. Multi-detector computerised tomography enema (MDCT-e) displayed the highest diagnostic performance for rectosigmoid and other bowel endometriosis and met the criteria for both SpPin and SnNout triage tests, but studies were too few to provide meaningful results.\nDiagnostic accuracies were higher for TVUS with bowel preparation (TVUS-BP) and rectal water contrast (RWC-TVS) and for 3.0TMRI than for conventional methods, although the paucity of studies precluded statistical evaluation.\nAuthors' conclusions\nNone of the evaluated imaging modalities were able to detect overall pelvic endometriosis with enough accuracy that they would be suggested to replace surgery. Specifically for endometrioma, TVUS qualified as a SpPin triage test. MRI displayed sufficient accuracy to suggest utility as a replacement test, but the data were too scant to permit meaningful conclusions. TVUS could be used clinically to identify additional anatomical sites of DIE compared with MRI, thus facilitating preoperative planning. Rectosigmoid endometriosis was the only site that could be accurately mapped by using TVUS, TRUS, MRI or MDCT-e. Studies evaluating recent advances in imaging modalities such as TVUS-BP, RWC-TVS, 3.0TMRI and MDCT-e were observed to have high diagnostic accuracies but were too few to allow prudent evaluation of their diagnostic role. In view of the low quality of most of the included studies, the findings of this review should be interpreted with caution. Future well-designed diagnostic studies undertaken to compare imaging tests for diagnostic test accuracy and costs are recommended.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "None of the imaging methods was accurate enough to provide this information on overall pelvic endometriosis. Transvaginal ultrasound identified ovarian endometriosis with enough accuracy to help surgeons determine whether surgery was needed, and magnetic resonance imaging (MRI) was sufficiently accurate to replace surgery in diagnosing endometrioma but was evaluated in only a small number of studies. Other imaging tests were assessed in small individual studies and could not be evaluated in a meaningful way. Transvaginal ultrasound could be used to locate more anatomical sites of deep endometriosis when compared with MRI, helping surgeons better plan an operative procedure. Endometriosis in the lower bowel appears to be relatively accurately identified by both transvaginal and transrectal ultrasound, by MRI and by multi-detector computerised tomography enema. New types of ultrasound and MRI show a lot of promise in detecting endometriosis but studies are too few to clearly show their diagnostic value."
}
] |
query-laysum
|
21957
|
[
{
"role": "user",
"content": "Abstract: Background\nContractures, a common complication following immobility, lead to restricted joint range of motion. Passive movements (PMs) are widely used for the treatment and prevention of contractures; however, it is not clear whether they are effective.\nObjectives\nThe aim of this review was to determine the effects of PMs on persons with contractures or at risk of developing contractures. Specifically, the aim was to determine whether PMs increase joint mobility.\nSearch methods\nWe searched the Cochrane Injuries Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (Ovid SP), EMBASE (Ovid SP), ISI Web of Science (SCI-EXPANDED; SSCI; CPCI-S; CPCI-SSH), PEDro and PsycINFO (Ovid SP). The search was run on 21 November 2013.\nSelection criteria\nRandomised controlled trials of PMs administered for the treatment or prevention of contractures were included. Studies were included if they compared the effectiveness of PMs versus no intervention, sham intervention or placebo in people with or at risk of contracture. Studies that involved other co-interventions were included, provided the co-interventions were administered in the same way to all groups. Interventions administered through mechanical devices and interventions that involved sustained stretch were excluded.\nData collection and analysis\nThree independent review authors screened studies for inclusion. Two review authors then extracted data and assessed risk of bias. Primary outcomes were joint mobility and occurrence of adverse events such as joint subluxations or dislocations, heterotopic ossification, autonomic dysreflexia and fractures or muscle tears. Secondary outcomes were quality of life, pain, spasticity, activity limitations and participation restrictions. We used standard methodological procedures as advocated by the Cochrane Handbook for Systematic Reviews of Interventions.\nMain results\nTwo identified studies randomly assigned a total of 122 participants with neurological conditions comparing PMs versus no PMs. Data from 121 participants were available for analysis. Both studies had a low risk of bias. One within-participant study involving 20 participants (40 limbs) measured ankle joint mobility and reported a mean between-group difference of four degrees (95% confidence interval (CI), two to six degrees) favouring the experimental group. Both studies measured spasticity with the Modified Ashworth Scale, but the results were not pooled because of clinical heterogeneity. Neither study reported a clinically or statistically relevant reduction in spasticity with PMs. In one study, the mean difference on a tallied 48-point Modified Ashworth Scale for the upper limbs was one of 48 points (95% CI minus two to four points), and in the other study, the median difference on a six-point Modified Ashworth Scale for the ankle plantar flexor muscles was zero points (95% CI minus one to zero points). In both studies, a negative between-group difference indicated a reduction in spasticity in the experimental group compared with the control group. One study with a total of 102 participants investigated the short-term effects on pain. The mean difference on a zero to 24-point pain scale was -0.4 points in favour of the control group (95% CI -1.4 to 0.6 points). The GRADE level of evidence about the effects of PMs on joint mobility, spasticity and pain is very low. Neither study examined quality of life, activity limitations or participation restrictions or reported any adverse events.\nAuthors' conclusions\nIt is not clear whether PMs are effective for the treatment and prevention of contractures.\n\nGiven the provided abstract, please respond to the following query: \"What are contractures?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Contractures are characterised by stiffness around joints that restricts joint mobility. Contractures are common in people with paralysis such as those with stroke, spinal cord injury and cerebral palsy, and they lead to various other complications such as pain, pressure ulcers and deformities."
}
] |
query-laysum
|
21958
|
[
{
"role": "user",
"content": "Abstract: Background\nIncurable cancer, which often constitutes an enormous challenge for patients, their families, and medical professionals, profoundly affects the patient's physical and psychosocial well-being. In standard cancer care, palliative measures generally are initiated when it is evident that disease-modifying treatments have been unsuccessful, no treatments can be offered, or death is anticipated. In contrast, early palliative care is initiated much earlier in the disease trajectory and closer to the diagnosis of incurable cancer.\nObjectives\nTo compare effects of early palliative care interventions versus treatment as usual/standard cancer care on health-related quality of life, depression, symptom intensity, and survival among adults with a diagnosis of advanced cancer.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycINFO, OpenGrey (a database for grey literature), and three clinical trial registers to October 2016. We checked reference lists, searched citations, and contacted study authors to identify additional studies.\nSelection criteria\nRandomised controlled trials (RCTs) and cluster-randomised controlled trials (cRCTs) on professional palliative care services that provided or co-ordinated comprehensive care for adults at early advanced stages of cancer.\nData collection and analysis\nWe used standard methodological procedures as expected by Cochrane. We assessed risk of bias, extracted data, and collected information on adverse events. For quantitative synthesis, we combined respective results on our primary outcomes of health-related quality of life, survival (death hazard ratio), depression, and symptom intensity across studies in meta-analyses using an inverse variance random-effects model. We expressed pooled effects as standardised mean differences (SMDs, or Hedges' adjusted g). We assessed certainty of evidence at the outcome level using GRADE (Grading of Recommendations Assessment, Development, and Evaluation) and created a 'Summary of findings' table.\nMain results\nWe included seven randomised and cluster-randomised controlled trials that together recruited 1614 participants. Four studies evaluated interventions delivered by specialised palliative care teams, and the remaining studies assessed models of co-ordinated care. Overall, risk of bias at the study level was mostly low, apart from possible selection bias in three studies and attrition bias in one study, along with insufficient information on blinding of participants and outcome assessment in six studies.\nCompared with usual/standard cancer care alone, early palliative care significantly improved health-related quality of life at a small effect size (SMD 0.27, 95% confidence interval (CI) 0.15 to 0.38; participants analysed at post treatment = 1028; evidence of low certainty). As re-expressed in natural units (absolute change in Functional Assessment of Cancer Therapy-General (FACT-G) score), health-related quality of life scores increased on average by 4.59 (95% CI 2.55 to 6.46) points more among participants given early palliative care than among control participants. Data on survival, available from four studies enrolling a total of 800 participants, did not indicate differences in efficacy (death hazard ratio 0.85, 95% CI 0.56 to 1.28; evidence of very low certainty). Levels of depressive symptoms among those receiving early palliative care did not differ significantly from levels among those receiving usual/standard cancer care (five studies; SMD -0.11, 95% CI -0.26 to 0.03; participants analysed at post treatment = 762; evidence of very low certainty). Results from seven studies that analysed 1054 participants post treatment suggest a small effect for significantly lower symptom intensity in early palliative care compared with the control condition (SMD -0.23, 95% CI -0.35 to -0.10; evidence of low certainty). The type of model used to provide early palliative care did not affect study results. One RCT reported potential adverse events of early palliative care, such as a higher percentage of participants with severe scores for pain and poor appetite; the remaining six studies did not report adverse events in study publications. For these six studies, principal investigators stated upon request that they had not observed any adverse events.\nAuthors' conclusions\nThis systematic review of a small number of trials indicates that early palliative care interventions may have more beneficial effects on quality of life and symptom intensity among patients with advanced cancer than among those given usual/standard cancer care alone. Although we found only small effect sizes, these may be clinically relevant at an advanced disease stage with limited prognosis, at which time further decline in quality of life is very common. At this point, effects on mortality and depression are uncertain. We have to interpret current results with caution owing to very low to low certainty of current evidence and between-study differences regarding participant populations, interventions, and methods. Additional research now under way will present a clearer picture of the effect and specific indication of early palliative care. Upcoming results from several ongoing studies (N = 20) and studies awaiting assessment (N = 10) may increase the certainty of study results and may lead to improved decision making. In perspective, early palliative care is a newly emerging field, and well-conducted studies are needed to explicitly describe the components of early palliative care and control treatments, after blinding of participants and outcome assessors, and to report on possible adverse events.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "In October 2016, we searched for clinical trials on early palliative care in adults with advanced cancer. We included seven studies and found 20 ongoing studies. Most of the studies included participants older than 65 years of age on average, diagnosed with different tumour types and receiving treatment in tertiary care centres in North America. Most of these studies compared early palliative care with standard oncological (cancer) care. All studies were funded by government agencies."
}
] |
query-laysum
|
21959
|
[
{
"role": "user",
"content": "Abstract: Background\nComplex regional pain syndrome (CRPS) is a chronic pain condition that usually occurs in a limb following trauma or surgery. It is characterised by persisting pain that is disproportionate in magnitude or duration to the typical course of pain after similar injury. There is currently no consensus regarding the optimal management of CRPS, although a broad range of interventions have been described and are commonly used. This is the first update of the original Cochrane review published in Issue 4, 2013.\nObjectives\nTo summarise the evidence from Cochrane and non-Cochrane systematic reviews of the efficacy, effectiveness, and safety of any intervention used to reduce pain, disability, or both, in adults with CRPS.\nMethods\nWe identified Cochrane reviews and non-Cochrane reviews through a systematic search of Ovid MEDLINE, Ovid Embase, Cochrane Database of Systematic Reviews, CINAHL, PEDro, LILACS and Epistemonikos from inception to October 2022, with no language restrictions. We included systematic reviews of randomised controlled trials that included adults (≥18 years) diagnosed with CRPS, using any diagnostic criteria.\nTwo overview authors independently assessed eligibility, extracted data, and assessed the quality of the reviews and certainty of the evidence using the AMSTAR 2 and GRADE tools respectively. We extracted data for the primary outcomes pain, disability and adverse events, and the secondary outcomes quality of life, emotional well-being, and participants' ratings of satisfaction or improvement with treatment.\nMain results\nWe included six Cochrane and 13 non-Cochrane systematic reviews in the previous version of this overview and five Cochrane and 12 non-Cochrane reviews in the current version. Using the AMSTAR 2 tool, we judged Cochrane reviews to have higher methodological quality than non-Cochrane reviews. The studies in the included reviews were typically small and mostly at high risk of bias or of low methodological quality. We found no high-certainty evidence for any comparison.\nThere was low-certainty evidence that bisphosphonates may reduce pain intensity post-intervention (standardised mean difference (SMD) -2.6, 95% confidence interval (CI) −1.8 to −3.4, P = 0.001; I2 = 81%; 4 trials, n = 181) and moderate-certainty evidence that they are probably associated with increased adverse events of any nature (risk ratio (RR) 2.10, 95% CI 1.27 to 3.47; number needed to treat for an additional harmful outcome (NNTH) 4.6, 95% CI 2.4 to 168.0; 4 trials, n = 181).\nThere was moderate-certainty evidence that lidocaine local anaesthetic sympathetic blockade probably does not reduce pain intensity compared with placebo, and low-certainty evidence that it may not reduce pain intensity compared with ultrasound of the stellate ganglion. No effect size was reported for either comparison.\nThere was low-certainty evidence that topical dimethyl sulfoxide may not reduce pain intensity compared with oral N-acetylcysteine, but no effect size was reported.\nThere was low-certainty evidence that continuous bupivacaine brachial plexus block may reduce pain intensity compared with continuous bupivacaine stellate ganglion block, but no effect size was reported.\nFor a wide range of other commonly used interventions, the certainty in the evidence was very low and provides insufficient evidence to either support or refute their use. Comparisons with low- and very low-certainty evidence should be treated with substantial caution. We did not identify any RCT evidence for routinely used pharmacological interventions for CRPS such as tricyclic antidepressants or opioids.\nAuthors' conclusions\nDespite a considerable increase in included evidence compared with the previous version of this overview, we identified no high-certainty evidence for the effectiveness of any therapy for CRPS. Until larger, high-quality trials are undertaken, formulating an evidence-based approach to managing CRPS will remain difficult. Current non-Cochrane systematic reviews of interventions for CRPS are of low methodological quality and should not be relied upon to provide an accurate and comprehensive summary of the evidence.\n\nGiven the provided abstract, please respond to the following query: \"What did we do?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched for Cochrane and non-Cochrane reviews in the medical literature using online databases, from their beginning to October 2011, in the previous version of this overview, and between October 2011 and October 2022 in the current version. We included reviews that evaluated any treatment aiming to reduce pain intensity and disability in adults with CRPS. We judged the quality of the included reviews and summarised their results. We also rated our confidence in the evidence included in the reviews, based on factors such as study methods and size.\n"
}
] |
query-laysum
|
21960
|
[
{
"role": "user",
"content": "Abstract: Background\nPolycystic ovarian syndrome (PCOS) is characterised by the clinical signs of oligo-amenorrhoea, infertility and hirsutism. Conventional treatment of PCOS includes a range of oral pharmacological agents, lifestyle changes and surgical modalities. Beta-endorphin is present in the follicular fluid of both normal and polycystic ovaries. It was demonstrated that the beta-endorphin levels in ovarian follicular fluid of otherwise healthy women who were undergoing ovulation were much higher than the levels measured in plasma. Given that acupuncture impacts on beta-endorphin production, which may affect gonadotropin-releasing hormone (GnRH) secretion, it is postulated that acupuncture may have a role in ovulation induction via increased beta-endorphin production effecting GnRH secretion. This is an update of our previous review published in 2016.\nObjectives\nTo assess the effectiveness and safety of acupuncture treatment for oligo/anovulatory women with polycystic ovarian syndrome (PCOS) for both fertility and symptom control.\nSearch methods\nWe identified relevant studies from databases including the Gynaecology and Fertility Group Specialised Register, CENTRAL, MEDLINE, Embase, PsycINFO, CNKI, CBM and VIP. We also searched trial registries and reference lists from relevant papers. CENTRAL, MEDLINE, Embase, PsycINFO, CNKI and VIP searches are current to May 2018. CBM database search is to November 2015.\nSelection criteria\nWe included randomised controlled trials (RCTs) that studied the efficacy of acupuncture treatment for oligo/anovulatory women with PCOS. We excluded quasi- or pseudo-RCTs.\nData collection and analysis\nTwo review authors independently selected the studies, extracted data and assessed risk of bias. We calculated risk ratios (RR), mean difference (MD), standardised mean difference (SMD) and 95% confidence intervals (CIs). Primary outcomes were live birth rate, multiple pregnancy rate and ovulation rate, and secondary outcomes were clinical pregnancy rate, restored regular menstruation period, miscarriage rate and adverse events. We assessed the quality of the evidence using GRADE methods.\nMain results\nWe included eight RCTs with 1546 women. Five RCTs were included in our previous review and three new RCTs were added in this update of the review. They compared true acupuncture versus sham acupuncture (three RCTs), true acupuncture versus relaxation (one RCT), true acupuncture versus clomiphene (one RCT), low-frequency electroacupuncture versus physical exercise or no intervention (one RCT) and true acupuncture versus Diane-35 (two RCTs). Studies that compared true acupuncture versus Diane-35 did not measure fertility outcomes as they were focused on symptom control.\nSeven of the studies were at high risk of bias in at least one domain.\nFor true acupuncture versus sham acupuncture, we could not exclude clinically relevant differences in live birth (RR 0.97, 95% CI 0.76 to 1.24; 1 RCT, 926 women; low-quality evidence); multiple pregnancy rate (RR 0.89, 95% CI 0.33 to 2.45; 1 RCT, 926 women; low-quality evidence); ovulation rate (SMD 0.02, 95% CI –0.15 to 0.19, I2 = 0%; 2 RCTs, 1010 women; low-quality evidence); clinical pregnancy rate (RR 1.03, 95% CI 0.82 to 1.29; I2 = 0%; 3 RCTs, 1117 women; low-quality evidence) and miscarriage rate (RR 1.10, 95% CI 0.77 to 1.56; 1 RCT, 926 women; low-quality evidence).\nNumber of intermenstrual days may have improved in participants receiving true acupuncture compared to sham acupuncture (MD –312.09 days, 95% CI –344.59 to –279.59; 1 RCT, 141 women; low-quality evidence).\nTrue acupuncture probably worsens adverse events compared to sham acupuncture (RR 1.16, 95% CI 1.02 to 1.31; I2 = 0%; 3 RCTs, 1230 women; moderate-quality evidence).\nNo studies reported data on live birth rate and multiple pregnancy rate for the other comparisons: physical exercise or no intervention, relaxation and clomiphene. Studies including Diane-35 did not measure fertility outcomes.\nWe were uncertain whether acupuncture improved ovulation rate (measured by ultrasound three months post treatment) compared to relaxation (MD 0.35, 95% CI 0.14 to 0.56; 1 RCT, 28 women; very low-quality evidence) or Diane-35 (RR 1.45, 95% CI 0.87 to 2.42; 1 RCT, 58 women; very low-quality evidence).\nOverall evidence ranged from very low quality to moderate quality. The main limitations were failure to report important clinical outcomes and very serious imprecision.\nAuthors' conclusions\nFor true acupuncture versus sham acupuncture we cannot exclude clinically relevant differences in live birth rate, multiple pregnancy rate, ovulation rate, clinical pregnancy rate or miscarriage. Number of intermenstrual days may improve in participants receiving true acupuncture compared to sham acupuncture. True acupuncture probably worsens adverse events compared to sham acupuncture.\nNo studies reported data on live birth rate and multiple pregnancy rate for the other comparisons: physical exercise or no intervention, relaxation and clomiphene. Studies including Diane-35 did not measure fertility outcomes as the women in these trials did not seek fertility.\nWe are uncertain whether acupuncture improves ovulation rate (measured by ultrasound three months post treatment) compared to relaxation or Diane-35. The other comparisons did not report on this outcome.\nAdverse events were recorded in the acupuncture group for the comparisons physical exercise or no intervention, clomiphene and Diane-35. These included dizziness, nausea and subcutaneous haematoma. Evidence was very low quality with very wide CIs and very low event rates.\nThere are only a limited number of RCTs in this area, limiting our ability to determine effectiveness of acupuncture for PCOS.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched medical databases for clinical studies where people were randomly put into one of two or more treatment groups including acupuncture treatment for women with PCOS who were infrequently or never ovulating. Acupuncture was compared with pretend acupuncture (sham), no treatment, lifestyle changes (e.g. relaxation) and conventional treatment.\nWe included eight studies with 1546 women in this review. The studies compared true acupuncture versus sham acupuncture, clomiphene (medicines to induce ovulation), relaxation and Diane-35 (combined oral contraceptive pill); and low-frequency electroacupuncture (where small electrical currents are passed through the acupuncture needles) versus physical exercise. We included women who wanted to get pregnant and women who wanted regular ovulation and symptom control as our two main populations of interest."
}
] |
query-laysum
|
21961
|
[
{
"role": "user",
"content": "Abstract: Background\nCarnitine deficiency is common in patients with chronic kidney disease (CKD) who require dialysis. Several clinical studies have suggested that carnitine supplementation is beneficial for dialysis-related symptoms. However, the clinical effectiveness and potential adverse effects of carnitine supplementation in dialysis patients have not been determined.\nObjectives\nThis review aimed to evaluate the effectiveness and safety of carnitine supplementation for the treatment of dialysis-related complications in CKD patients requiring dialysis.\nSearch methods\nWe searched the Cochrane Kidney and Transplant Register of Studies up to 16 August 2022 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov.\nSelection criteria\nWe included all randomised controlled trials (RCTs) and quasi-RCTs (RCTs in which allocation to treatment was obtained by alternation, use of alternate medical records, date of birth, or other predictable methods) that compared carnitine supplements with placebo or standard care in people with CKD requiring dialysis.\nData collection and analysis\nTwo authors independently extracted study data and assessed study quality. We used a random-effects model to perform a quantitative synthesis of the data.\nWe used the I² statistic to measure heterogeneity amongst the studies in each analysis. We indicated summary estimates as a risk ratio (RR) for dichotomous outcomes, mean difference (MD) for continuous outcomes, or standardised mean differences (SMD) if different scales were used, with 95% confidence intervals (CI). We assessed the certainty of the evidence for each of the main outcomes using the GRADE (Grades of Recommendation, Assessment, Development, and Evaluation) approach.\nMain results\nWe included 52 studies (47 parallel RCTs and five cross-over RCTs) (3398 randomised participants). All studies compared L-carnitine with a placebo, other treatment, or no treatment. Standard care was continued as co-interventions in each group. Most studies were judged to have an unclear or high risk of bias.\nL-carnitine may have little or no effect on the quality of life (QoL) SF-36 physical component score (PCS) (4 studies, 134 participants: SMD 0.57, 95% CI -0.15 to 1.28; I² = 73%; low certainty of evidence), and the total QoL score (Kidney Disease Quality of Life (KDQOL), VAS (general well-being), or PedsQL) (3 studies, 230 participants: SMD -0.02, 95% CI -0.29 to 0.25; I² = 0%; low certainty of evidence). L-carnitine may improve SF-36 mental component score (MCS) (4 studies, 134 participants: SMD 0.70, 95% CI 0.22 to 1.18; I² = 42%; low certainty of evidence). L-carnitine may have little or no effect on fatigue score (2 studies, 353 participants: SMD 0.01, 95% CI -0.20 to 0.23; I² = 0%; low certainty of evidence), adverse events (12 studies, 1041 participants: RR, 1.14, 95% CI 0.86 to 1.51; I² = 0%; low certainty of evidence), muscle cramps (2 studies, 102 participants: RR, 0.44, 95% CI 0.18 to 1.09; I² = 23%; low certainty of evidence), and intradialytic hypotension (3 studies, 128 participants: RR, 0.76, 95% CI 0.34 to 1.69; I² = 0%; low certainty of evidence). L-carnitine may improve haemoglobin levels (26 studies, 1795 participants: MD 0.46 g/dL, 95% CI 0.18 to 0.74; I² = 86%; low certainty of evidence) and haematocrit values (14 studies, 950 participants: MD 1.78%, 95% CI 0.38 to 3.18; I² = 84%; low certainty of evidence).\nAuthors' conclusions\nThe available evidence does not currently support the use of carnitine supplementation in the treatment of dialysis-related carnitine deficiency. Although carnitine supplementation may slightly improve anaemia-related markers, carnitine supplementation makes little or no difference to adverse events. However, these conclusions are based on limited data and, therefore, should be interpreted with caution.\n\nGiven the provided abstract, please respond to the following query: \"What is the issue?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Carnitine deficiency is an important problem in chronic kidney disease (CKD) patients requiring dialysis. Dialysis-related carnitine deficiency can exacerbate intradialytic symptoms (e.g. muscle symptoms including muscle cramps and weakness, and hypotension) and chronic complications of kidney failure (e.g. anaemia). However, it is unknown whether carnitine supplementation can improve the symptoms of dialysis-related carnitine deficiency."
}
] |
query-laysum
|
21962
|
[
{
"role": "user",
"content": "Abstract: Background\nIn people with chronic obstructive pulmonary disease (COPD), the use of neuromuscular electrostimulation (NMES) either alone, or together with conventional exercise training, might improve the condition of the peripheral muscles, increase exercise capacity and functional performance, reduce symptoms and improve health-related quality of life (HRQoL).\nObjectives\nTo determine the effects of NMES, applied in isolation or concurrently with conventional exercise training to one or more peripheral muscles, on peripheral muscle force and endurance, muscle size, exercise capacity, functional performance, symptoms, HRQoL and adverse events in people with COPD.\nSearch methods\nWe searched the Cochrane Airways Group Specialised Register, the Physiotherapy Evidence Database, clinical trial registries and conference abstracts on 14 March 2018.\nSelection criteria\nRandomised controlled trials that recruited adults with COPD if they had compared outcomes between a group that received NMES and a group that received usual care or compared outcomes between a group that received NMES plus conventional exercise training and a group that participated in conventional exercise training alone.\nData collection and analysis\nTwo review authors independently extracted data and assessed risk of bias using the Cochrane 'Risk of bias' tool. We expressed continuous data as either the standardised mean difference (SMD) or mean difference (MD) with the corresponding 95% confidence interval (CI). We assessed the quality of evidence using the GRADE approach.\nMain results\nNineteen studies met the inclusion criteria of which 16 contributed data on 267 participants with COPD (mean age 56 to 76 years and 67% were men). Of these 16 studies, seven explored the effect of NMES versus usual care and nine explored the effect of NMES plus conventional exercise training versus conventional exercise training alone. Six studies utilised sham stimulation in the control group. When applied in isolation, NMES produced an increase in peripheral muscle force (SMD 0.34, 95% CI 0.02 to 0.65; low-quality evidence) and quadriceps endurance (SMD 1.36, 95% CI 0.59 to 2.12; low-quality evidence) but the effect on thigh muscle size was unclear (MD 0.25, 95% CI -0.11 to 0.61; low-quality evidence). There were increases in six-minute walk distance (6MWD) (MD 39.26 m, 95% CI 16.31 to 62.22; low-quality evidence) and time to symptom limitation exercising at a submaximal intensity (MD 3.62 minutes, 95% CI 2.33 to 4.91). There was a reduction in the severity of leg fatigue on completion of an exercise test (MD -1.12 units, 95% CI -1.81 to -0.43). The increase in peak rate of oxygen uptake (VO2peak) was of borderline significance (MD 0.10 L/minute, 95% CI 0.00 to 0.19).\nFor NMES with conventional exercise training, there was an uncertain effect on peripheral muscle force (SMD 0.47, 95% CI -0.10 to 1.04; very low-quality evidence) and there were insufficient studies to undertake a meta-analysis on the effect on quadriceps endurance or thigh muscle size. However, there was an increase in 6MWD in favour of NMES combined with conventional exercise training (MD 25.87 m, 95% CI 1.06 to 50.69; very low-quality evidence). In people admitted to either in an intensive care unit or a respiratory high dependency centre, NMES combined with conventional exercise reduced the time taken for participants to first sit out of bed by 4.98 days (95% CI -8.55 to -1.41; very low-quality evidence), although the statistical heterogeneity for this analysis was high (I2 = 60%). For both types of studies (i.e. NMES versus usual care and NMES with conventional exercise training versus conventional exercise training alone), there was no risk difference for mortality or minor adverse events in participants who received NMES.\nAuthors' conclusions\nNMES, when applied in isolation, increased quadriceps force and endurance, 6MWD and time to symptom limitation exercising at a submaximal intensity, and reduced the severity of leg fatigue on completion of exercise testing. It may increase VO2peak, but the true effect on this outcome measure could be trivial. However, the quality of evidence was low or very low due to risk of bias within the studies, imprecision of the estimates, small number of studies and inconsistency between the studies. Although there were no additional gains in quadriceps force with NMES plus conventional exercise training, there was evidence of an increase in 6MWD. Further, in people who were the most debilitated, the addition of NMES may have accelerated the achievement of a functional milestone, that is, the first time someone sits out of bed.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Nineteen studies met the inclusion criteria for the review, of which 16 had data on 267 participants that could be included in the analyses. The average age of people in each of the studies ranged from 56 to 76 years and 179 (67%) were men. Seven studies explored the effect of applying electrical stimulation alone and nine studies explored the effect of adding electrical stimulation to an exercise programme. Electrical stimulation was applied in a range of settings, such as at home, in an outpatient hospital department, on a hospital ward or in an intensive care unit. Most studies stimulated the thigh muscles once or twice a day for 30 to 60 minutes on four to seven days each week for four to eight weeks."
}
] |
query-laysum
|
21963
|
[
{
"role": "user",
"content": "Abstract: Background\nAccurate rapid diagnostic tests for SARS-CoV-2 infection would be a useful tool to help manage the COVID-19 pandemic. Testing strategies that use rapid antigen tests to detect current infection have the potential to increase access to testing, speed detection of infection, and inform clinical and public health management decisions to reduce transmission. This is the second update of this review, which was first published in 2020.\nObjectives\nTo assess the diagnostic accuracy of rapid, point-of-care antigen tests for diagnosis of SARS-CoV-2 infection. We consider accuracy separately in symptomatic and asymptomatic population groups. Sources of heterogeneity investigated included setting and indication for testing, assay format, sample site, viral load, age, timing of test, and study design.\nSearch methods\nWe searched the COVID-19 Open Access Project living evidence database from the University of Bern (which includes daily updates from PubMed and Embase and preprints from medRxiv and bioRxiv) on 08 March 2021. We included independent evaluations from national reference laboratories, FIND and the Diagnostics Global Health website. We did not apply language restrictions.\nSelection criteria\nWe included studies of people with either suspected SARS-CoV-2 infection, known SARS-CoV-2 infection or known absence of infection, or those who were being screened for infection. We included test accuracy studies of any design that evaluated commercially produced, rapid antigen tests. We included evaluations of single applications of a test (one test result reported per person) and evaluations of serial testing (repeated antigen testing over time). Reference standards for presence or absence of infection were any laboratory-based molecular test (primarily reverse transcription polymerase chain reaction (RT-PCR)) or pre-pandemic respiratory sample.\nData collection and analysis\nWe used standard screening procedures with three people. Two people independently carried out quality assessment (using the QUADAS-2 tool) and extracted study results. Other study characteristics were extracted by one review author and checked by a second. We present sensitivity and specificity with 95% confidence intervals (CIs) for each test, and pooled data using the bivariate model. We investigated heterogeneity by including indicator variables in the random-effects logistic regression models. We tabulated results by test manufacturer and compliance with manufacturer instructions for use and according to symptom status.\nMain results\nWe included 155 study cohorts (described in 166 study reports, with 24 as preprints). The main results relate to 152 evaluations of single test applications including 100,462 unique samples (16,822 with confirmed SARS-CoV-2). Studies were mainly conducted in Europe (101/152, 66%), and evaluated 49 different commercial antigen assays. Only 23 studies compared two or more brands of test.\nRisk of bias was high because of participant selection (40, 26%); interpretation of the index test (6, 4%); weaknesses in the reference standard for absence of infection (119, 78%); and participant flow and timing 41 (27%). Characteristics of participants (45, 30%) and index test delivery (47, 31%) differed from the way in which and in whom the test was intended to be used. Nearly all studies (91%) used a single RT-PCR result to define presence or absence of infection.\nThe 152 studies of single test applications reported 228 evaluations of antigen tests. Estimates of sensitivity varied considerably between studies, with consistently high specificities. Average sensitivity was higher in symptomatic (73.0%, 95% CI 69.3% to 76.4%; 109 evaluations; 50,574 samples, 11,662 cases) compared to asymptomatic participants (54.7%, 95% CI 47.7% to 61.6%; 50 evaluations; 40,956 samples, 2641 cases). Average sensitivity was higher in the first week after symptom onset (80.9%, 95% CI 76.9% to 84.4%; 30 evaluations, 2408 cases) than in the second week of symptoms (53.8%, 95% CI 48.0% to 59.6%; 40 evaluations, 1119 cases). For those who were asymptomatic at the time of testing, sensitivity was higher when an epidemiological exposure to SARS-CoV-2 was suspected (64.3%, 95% CI 54.6% to 73.0%; 16 evaluations; 7677 samples, 703 cases) compared to where COVID-19 testing was reported to be widely available to anyone on presentation for testing (49.6%, 95% CI 42.1% to 57.1%; 26 evaluations; 31,904 samples, 1758 cases). Average specificity was similarly high for symptomatic (99.1%) or asymptomatic (99.7%) participants.\nWe observed a steady decline in summary sensitivities as measures of sample viral load decreased.\nSensitivity varied between brands. When tests were used according to manufacturer instructions, average sensitivities by brand ranged from 34.3% to 91.3% in symptomatic participants (20 assays with eligible data) and from 28.6% to 77.8% for asymptomatic participants (12 assays). For symptomatic participants, summary sensitivities for seven assays were 80% or more (meeting acceptable criteria set by the World Health Organization (WHO)). The WHO acceptable performance criterion of 97% specificity was met by 17 of 20 assays when tests were used according to manufacturer instructions, 12 of which demonstrated specificities above 99%. For asymptomatic participants the sensitivities of only two assays approached but did not meet WHO acceptable performance standards in one study each; specificities for asymptomatic participants were in a similar range to those observed for symptomatic people.\nAt 5% prevalence using summary data in symptomatic people during the first week after symptom onset, the positive predictive value (PPV) of 89% means that 1 in 10 positive results will be a false positive, and around 1 in 5 cases will be missed. At 0.5% prevalence using summary data for asymptomatic people, where testing was widely available and where epidemiological exposure to COVID-19 was suspected, resulting PPVs would be 38% to 52%, meaning that between 2 in 5 and 1 in 2 positive results will be false positives, and between 1 in 2 and 1 in 3 cases will be missed.\nAuthors' conclusions\nAntigen tests vary in sensitivity. In people with signs and symptoms of COVID-19, sensitivities are highest in the first week of illness when viral loads are higher. Assays that meet appropriate performance standards, such as those set by WHO, could replace laboratory-based RT-PCR when immediate decisions about patient care must be made, or where RT-PCR cannot be delivered in a timely manner. However, they are more suitable for use as triage to RT-PCR testing. The variable sensitivity of antigen tests means that people who test negative may still be infected. Many commercially available rapid antigen tests have not been evaluated in independent validation studies.\nEvidence for testing in asymptomatic cohorts has increased, however sensitivity is lower and there is a paucity of evidence for testing in different settings. Questions remain about the use of antigen test-based repeat testing strategies. Further research is needed to evaluate the effectiveness of screening programmes at reducing transmission of infection, whether mass screening or targeted approaches including schools, healthcare setting and traveller screening.\n\nGiven the provided abstract, please respond to the following query: \"What did we find?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We included 155 studies in the review. The main results are based on 152 studies investigating a total of 100,462 nose or throat samples; COVID-19 was confirmed in 16,822 of these samples. Studies investigated 49 different antigen tests. Around 60% of studies took place in Europe."
}
] |
query-laysum
|
21964
|
[
{
"role": "user",
"content": "Abstract: Background\nA parastomal hernia is defined as an incisional hernia related to a stoma, and belongs to the most common stoma-related complications. Many factors, which are considered to influence the incidence of parastomal herniation, have been investigated. However, it remains unclear whether the enterostomy should be placed through, or lateral to the rectus abdominis muscle, in order to prevent parastomal herniation and other important stoma complications.\nObjectives\nTo assess if there is a difference regarding the incidence of parastomal herniation and other stoma complications, such as ileus and stenosis, in lateral pararectal versus transrectal stoma placement in people undergoing elective or emergency abdominal wall enterostomy.\nSearch methods\nFor this update, we searched for all types of published and unpublished randomized and non-randomized studies in four medical databases: CENTRAL, PubMed, LILACS, Science Ciation Index, and two trials registers: ICTRP Search Portal and ClinicalTrials.gov to 9 November 2018. We applied no language restrictions.\nSelection criteria\nRandomized and non-randomized studies comparing lateral pararectal versus transrectal stoma placement with regard to parastomal herniation and other stoma-related complications.\nData collection and analysis\nTwo authors independently assessed study quality and extracted data. We conducted data analyses according to the recommendations of Cochrane and the Cochrane Colorectal Cancer Group (CCCG). We rated quality of evidence according to the GRADE approach.\nMain results\nRandomized controlled trials (RCT)\nOnly one RCT met the inclusion criteria. The participants underwent enterostomy placement in the frame of an operation for: rectal cancer (37/60), ulcerative colitis (14/60), familial adenomatous polyposis (7/60), and other (2/60).\nThe results between the lateral pararectal and the transrectal approach groups were inconclusive for the incidence of parastomal herniation (risk ratio (RR) 1.34, 95% confidence interval (CI) 0.40 to 4.48; low-quality evidence); development of ileus or stenosis (RR 2.0, 95% CI 0.19 to 20.9; low-quality evidence); or skin irritation (RR 0.67, 95% CI 0.21 to 2.13; moderate-quality evidence). The results were also inconclusive for the subgroup analysis in which we compared the effect of ileostomy versus colostomy on parastomal herniation. The study did not measured other stoma-related morbidities, or stoma-related mortality, but did measure quality of life, which was not one of our outcomes of interest.\nNon-randomized studies (NRS)\nTen retrospective cohort studies, with a total of 864 participants, met the inclusion criteria. The indications for enterostomy placement and the baseline characteristics of the participants (age, co-morbidities, disease-severity) varied between studies. All included studies reported results for the primary outcome (parastomal herniation) and one study also reported data on one of the secondary outcomes (stomal prolapse).\nThe effects of different surgical approaches on parastomal herniation (RR 1.22, 95% CI 0.84 to 1.75; 10 studies, 864 participants; very low-quality evidence) and the occurrence of stomal prolapse (RR 1.23, 95% CI 0.39 to 3.85; 1 study, 145 participants; very low-quality evidence) are uncertain.\nNone of the included studies measured other stoma-related morbidity or stoma-related mortality.\nAuthors' conclusions\nThe present systematic review of randomized and non-randomized studies found inconsistent results between the two compared interventions regarding their potential to prevent parastomal herniation.\nIn conclusion, there is still a lack of high-quality evidence to support the ideal surgical technique of stoma formation. The available moderate-, low-, and very low-quality evidence, does not support or refute the superiority of one of the studied stoma formation techniques over the other.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The results found inconclusive results between the two techniques for the risk of parastomal herniation (11 studies, 924 participants), stomal prolapse (1 study, 145 participants), ileus or stenosis (1 study, 60 participants), and skin irritation (1 study, 60 participants).\nNeither technique was found to be better than the other for any of the stoma-related outcomes of interest.\nNone of the studies measured other stoma-related problems, or death."
}
] |
query-laysum
|
21965
|
[
{
"role": "user",
"content": "Abstract: Background\nAntipsychotic (neuroleptic) medication is used extensively to treat people with chronic mental illnesses. Its use, however, is associated with adverse effects, including movement disorders such as tardive dyskinesia (TD) – a problem often seen as repetitive involuntary movements around the mouth and face. Vitamin E has been proposed as a treatment to prevent or decrease TD.\nObjectives\nThe primary objective was to determine the clinical effects of vitamin E in people with schizophrenia or other chronic mental illness who had developed antipsychotic-induced TD.\nThe secondary objectives were:\n1. to examine whether the effect of vitamin E was maintained as duration of follow-up increased;\n2. to test the hypothesis that the use of vitamin E is most effective for those with early onset TD (less than five years)\nSearch methods\nWe searched the Cochrane Schizophrenia Group Trials Register (July 2015 and April 2017), inspected references of all identified studies for further trials and contacted authors of trials for additional information.\nSelection criteria\nWe included reports if they were controlled trials dealing with people with antipsychotic-induced TD and schizophrenia who remained on their antipsychotic medication and had been randomly allocated to either vitamin E or to a placebo, no intervention, or any other intervention.\nData collection and analysis\nWe independently extracted data from these trials and we estimated risk ratios (RR) or mean differences (MD), with 95% confidence intervals (CI). We assumed that people who left early had no improvement. We assessed risk of bias and created a 'Summary of findings' table using GRADE.\nMain results\nThe review now includes 13 poorly reported randomised trials (total 478 people), all participants were adults with chronic psychiatric disorders, mostly schizophrenia, and antipsychotic-induced TD. There was no clear difference between vitamin E and placebo for the outcome of TD: not improved to a clinically important extent (6 RCTs, N = 264, RR 0.95, 95% CI 0.89 to 1.01, low-quality evidence). However, people allocated to placebo may show more deterioration of their symptoms compared with those given vitamin E (5 RCTs, N = 85, RR 0.23, 95% CI 0.07 to 0.76, low-quality evidence). There was no evidence of a difference in the incidence of any adverse effects (9 RCTs, N = 205, RR 1.21, 95% CI 0.35 to 4.15, very low-quality evidence), extrapyramidal adverse effects (1 RCT, N = 104, MD 1.10, 95% CI -1.02 to 3.22, very low-quality evidence), or acceptability of treatment (measured by participants leaving the study early) (medium term, 8 RCTs, N = 232, RR 1.07, 95% CI 0.64 to 1.80, very low-quality evidence). No trials reported on social confidence, social inclusion, social networks, or personalised quality of life, outcomes designated important to patients. There is no trial-based information regarding the effect of vitamin E for those with early onset of TD.\nAuthors' conclusions\nSmall trials of limited quality suggest that vitamin E may protect against deterioration of TD. There is no evidence that vitamin E improves symptoms of this problematic and disfiguring condition once established. New and better trials are indicated in this under-researched area, and, of the many adjunctive treatments that have been given for TD, vitamin E would be a good choice for further evaluation.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Vitamin E may protect against tardive dyskinesia. However, there is no clear evidence that vitamin E improves this problematic and disfiguring condition."
}
] |
query-laysum
|
21966
|
[
{
"role": "user",
"content": "Abstract: Background\nPostoperative nausea and vomiting (PONV) is a common complication following general anaesthesia. It may be associated with patient dissatisfaction, increased costs of treatment, and unintended admission to hospital.\nSupplemental intravenous crystalloid administration in the perioperative period may be a simple intervention to prevent PONV.\nObjectives\nTo assess whether supplemental intravenous crystalloid administration prevents PONV in patients undergoing surgical procedures under general anaesthesia.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 7), MEDLINE (1946 to August 2018), Embase (1947 to August 2018), and the Cumulative Index of Nursing and Allied Health Literature (CINAHL; 1971 to August 2018). We searched clinical trials registers for ongoing or unpublished completed studies (August 2018), handsearched conference proceedings of anaesthesiology societies, as published in three major journals (British Journal of Anaesthesia, European Journal of Anaesthesiology, and Anesthesiology; August 2018), and conducted backward and forward citation searching of relevant articles.\nSelection criteria\nWe included randomized controlled trials of participants older than six months undergoing surgical procedures under general anaesthesia and given supplemental perioperative intravenous crystalloids, defined as a volume larger than that received by a comparator group, to prevent PONV.\nData collection and analysis\nWe used the standard methodological procedures described by Cochrane.\nMain results\nWe included 41 studies (4224 participants). Participants underwent ambulatory or short length of stay surgical procedures, and were predominantly American Society of Anesthesiology (ASA) class I or II. There is one study awaiting classification and three ongoing studies. All studies took place in surgical centres, and were conducted in geographically diverse settings. Risk of bias was generally unclear across all domains.\nSupplemental intravenous crystalloid administration probably reduces the cumulative risk of postoperative nausea (PON) (risk ratio (RR) 0.62, 95% confidence interval (CI) 0.51 to 0.75; 18 studies; 1766 participants; moderate-certainty evidence). When the postoperative period was divided into early (first six hours postoperatively) and late (at the time point closest to or including 24 hours postoperatively) time points, the intervention reduced the risk of early PON (RR 0.67, 95% CI 0.58 to 0.78; 20 studies; 2310 participants; moderate-certainty evidence) and late PON (RR 0.47, 95% CI 0.32 to 0.69; 17 studies; 1682 participants; moderate-certainty evidence).\nSupplemental intravenous crystalloid administration probably reduces the risk of postoperative vomiting (POV) (RR 0.50, 95% CI 0.40 to 0.63; 20 studies; 1970 participants; moderate-certainty evidence). The intervention specifically reduced both early POV (RR 0.56, 95% CI 0.41 to 0.76; 19 studies; 1998 participants; moderate-certainty evidence) and late POV (RR 0.48, 95% CI 0.29 to 0.79; 15 studies; 1403 participants; moderate-certainty evidence).\nSupplemental intravenous crystalloid administration probably reduces the need for pharmacologic treatment of PONV (RR 0.62, 95% CI 0.51 to 0.76; 23 studies; 2416 participants; moderate-certainty evidence).\nThe effect of supplemental intravenous crystalloid administration on the risk of unplanned postoperative admission to hospital is unclear (RR 1.05, 95% CI 0.77 to 1.43; 3 studies; 235 participants; low-certainty evidence).\nNo studies reported serious adverse events that may occur following supplemental perioperative intravenous crystalloid administration (i.e. admission to high-dependency unit, postoperative cardiac or respiratory complication, or death).\nAuthors' conclusions\nThere is moderate-certainty evidence that supplemental perioperative intravenous crystalloid administration reduces PON and POV, in ASA class I to II patients receiving general anaesthesia for ambulatory or short length of stay surgical procedures. The intervention probably also reduces the risk of pharmacologic treatment for PONV. The effect of the intervention on the risk of unintended postoperative admission to hospital is unclear. The risk of serious adverse events resulting from supplemental perioperative intravenous crystalloid administration is unknown as no studies reported this outcome. The one study awaiting classification may alter the conclusions of the review once assessed.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Nausea and vomiting is a common complication after having general anaesthetic for surgery. About 30% of people suffer from nausea and vomiting after surgery, even after receiving medication intended to prevent it.\nDuring surgery, a patient receives salt-containing fluid through an intravenous drip and the amount of fluid given may affect how they feel afterwards. Some complications, like nausea and vomiting, may be reduced after getting extra intravenous fluid during surgery. Some complications, like shortness of breath, may be worse with extra fluid."
}
] |
query-laysum
|
21967
|
[
{
"role": "user",
"content": "Abstract: Background\nDepression is common in young people. It has a marked negative impact and is associated with self-harm and suicide. Preventing its onset would be an important advance in public health. This is an update of a Cochrane review that was last updated in 2011.\nObjectives\nTo determine whether evidence-based psychological interventions (including cognitive behavioural therapy (CBT), interpersonal therapy (IPT) and third wave CBT)) are effective in preventing the onset of depressive disorder in children and adolescents.\nSearch methods\nWe searched the specialised register of the Cochrane Common Mental Disorders Group (CCMDCTR to 11 September 2015), which includes relevant randomised controlled trials from the following bibliographic databases: The Cochrane Library (all years), EMBASE (1974 to date), MEDLINE (1950 to date) and PsycINFO (1967 to date). We searched conference abstracts and reference lists of included trials and reviews, and contacted experts in the field.\nSelection criteria\nWe included randomised controlled trials of an evidence-based psychological prevention programme compared with any comparison control for young people aged 5 to 19 years, who did not currently meet diagnostic criteria for depression.\nData collection and analysis\nTwo authors independently assessed trials for inclusion and rated their risk of bias. We adjusted sample sizes to take account of cluster designs and multiple comparisons. We contacted trial authors for additional information where needed. We assessed the quality of evidence for the primary outcomes using GRADE.\nMain results\nWe included 83 trials in this review. The majority of trials (67) were carried out in school settings with eight in colleges or universities, four in clinical settings, three in the community and four in mixed settings. Twenty-nine trials were carried out in unselected populations and 53 in targeted populations.\nFor the primary outcome of depression diagnosis at medium-term follow-up (up to 12 months), there were 32 trials with 5965 participants and the risk of having a diagnosis of depression was reduced for participants receiving an intervention compared to those receiving no intervention (risk difference (RD) -0.03, 95% confidence interval (CI) -0.05 to -0.01; P value = 0.01). We rated this evidence as moderate quality according to the GRADE criteria. There were 70 trials (73 trial arms) with 13,829 participants that contributed to the analysis for the primary outcome of depression symptoms (self-rated) at the post-intervention time point, with results showing a small but statistically significant effect (standardised mean difference (SMD) -0.21, 95% CI -0.27 to -0.15; P value < 0.0001). This effect persisted to the short-term assessment point (up to three months) (SMD -0.31, 95% CI -0.45 to -0.17; P value < 0.0001; 16 studies; 1558 participants) and medium-term (4 to 12 months) assessment point (SMD -0.12, 95% CI -0.18 to -0.05; P value = 0.0002; 53 studies; 11,913 participants); however, the effect was no longer evident at the long-term follow-up. We rated this evidence as low to moderate quality according to the GRADE criteria.\nThe evidence from this review is unclear with regard to whether the type of population modified the overall effects; there was statistically significant moderation of the overall effect for depression symptoms (P value = 0.0002), but not for depressive disorder (P value = 0.08). For trials implemented in universal populations there was no effect for depression diagnosis (RD -0.01, 95% CI -0.03 to 0.01) and a small effect for depression symptoms (SMD -0.11, 95% CI -0.17 to -0.05). For trials implemented in targeted populations there was a statistically significantly beneficial effect of intervention (depression diagnosis RD -0.04, 95% CI -0.07 to -0.01; depression symptoms SMD -0.32, 95% CI -0.42 to -0.23). Of note were the lack of attention placebo-controlled trials in targeted populations (none for depression diagnosis and four for depression symptoms). Among trials implemented in universal populations a number used an attention placebo comparison in which the intervention consistently showed no effect.\nAuthors' conclusions\nOverall the results show small positive benefits of depression prevention, for both the primary outcomes of self-rated depressive symptoms post-intervention and depression diagnosis up to 12 months (but not beyond). Estimates of numbers needed to treat to benefit (NNTB = 11) compare well with other public health interventions. However, the evidence was of moderate to low quality using the GRADE framework and the results were heterogeneous. Prevention programmes delivered to universal populations showed a sobering lack of effect when compared with an attention placebo control. Interventions delivered to targeted populations, particularly those selected on the basis of depression symptoms, had larger effect sizes, but these seldom used an attention placebo comparison and there are practical difficulties inherent in the implementation of targeted programmes. We conclude that there is still not enough evidence to support the implementation of depression prevention programmes.\nFuture research should focus on current gaps in our knowledge. Given the relative lack of evidence for universal interventions compared with attention placebo controls and the poor results from well-conducted effectiveness trials of universal interventions, in our opinion any future such trials should test a depression prevention programme in an indicated targeted population using a credible attention placebo comparison group. Depressive disorder as the primary outcome should be measured over the longer term, as well as clinician-rated depression. Such a trial should consider scalability as well as the potential for the intervention to do harm.\n\nGiven the provided abstract, please respond to the following query: \"Who may be interested in this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "People involved in public health initiatives, school personnel and mental health clinicians."
}
] |
query-laysum
|
21968
|
[
{
"role": "user",
"content": "Abstract: Background\nChronic pulmonary infection is a hallmark of lung disease in cystic fibrosis. Infections dominated by organisms of the Burkholderia cepacia complex, a group of at least 18 closely-related species of gram-negative bacteria, are particularly difficult to treat. These infections may be associated with a fulminant necrotising pneumonia. Burkholderia cepacia complex bacteria are resistant to many common antibiotics and able to acquire resistance against many more. Following patient segregation in cystic fibrosis medical care, the more virulent epidemic strains are not as frequent, and new infections are more likely to be with less virulent environmentally-acquired strains. Although evidence-based guidelines exist for treating respiratory exacerbations involving Pseudomonas aeruginosa, these cannot be extended to Burkholderia cepacia complex infections. This review, which is an update of a previous review, aims to assess the available trial evidence for the choice and application of treatments for these infections.\nObjectives\nTo assess the effectiveness and safety of different antibiotic regimens in people with cystic fibrosis experiencing an exacerbation and chronically infected with organisms of the Burkholderia cepacia complex.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis Trials Register, compiled from electronic database searches and handsearching of journals and conference abstract books. We also searched the reference lists of relevant articles and reviews.\nDate of latest search: 29 May 2019.\nSelection criteria\nRandomised and quasi-randomised controlled trials of treatments for exacerbations of pulmonary symptoms in people with cystic fibrosis chronically infected with organisms of the Burkholderia cepacia complex.\nData collection and analysis\nNo relevant trials were identified.\nMain results\nNo trials were included in this review.\nAuthors' conclusions\nBurkholderia cepacia complex infections present a significant challenge for people with cystic fibrosis and their clinicians. The incidence is likely to increase as the cystic fibrosis population ages; and managing and treating these infections will become more important. There is a lack of trial evidence to guide decision making and no conclusions can be drawn from this review about the optimal antibiotic regimens for people with cystic fibrosis who have chronic Burkholderia cepacia complex infections. Clinicians must continue to assess each person individually, taking into account in vitro antibiotic susceptibility data, previous clinical responses and their own experience. Multicentre randomised clinical trials are needed to assess the effectiveness of different antibiotic regimens in people with cystic fibrosis infected with organisms of the Burkholderia cepacia complex.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We did not find any trials in people with exacerbations of cystic fibrosis who were infected with Burkholderia cepacia complex bacteria, where they were given different treatments at random."
}
] |
query-laysum
|
21969
|
[
{
"role": "user",
"content": "Abstract: Background\nThe most recent syncope guideline recommends that implantable loop recorders (ILRs) are implanted in the early phase of evaluation of people with recurrent syncope of uncertain origin in the absence of high-risk criteria, and in high-risk patients after a negative evaluation. Observational and case-control studies have shown that loop recorders lead to earlier diagnosis and reduce the rate of unexplained syncopes, justifying their use in clinical practice. However, only randomised clinical trials with an emphasis on a primary outcome of specific ILR-guided diagnosis and therapy, rather than simply electrocardiogram (ECG) diagnosis, might change clinical practice.\nObjectives\nTo assess the incidence of mortality, quality of life, adverse events and costs of ILRs versus conventional diagnostic workup in people with unexplained syncope.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL, Issue 3, 2015), MEDLINE, EMBASE, ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) Search Portal in April 2015. No language restriction was applied.\nSelection criteria\nWe included all randomised controlled trials of adult participants (i.e. ≥ 18 years old) with a diagnosis of unexplained syncope comparing ILR with standard diagnostic workup.\nData collection and analysis\nTwo independent review authors screened titles and abstracts of all potential studies we identified as a result of the literature search, extracted study characteristics and outcome data from included studies and assessed risk of bias for each study using the criteria outlined in the Cochrane Handbook for Systematic Reviews of Interventions. We contacted authors of trials for missing data. We analysed dichotomous data (all-cause mortality and aetiologic diagnosis) as risk ratios (RR) with 95% confidence intervals (CI). We used the Chi2 test to assess statistical heterogeneity (with P < 0.1) and the I² statistic to measure heterogeneity among the trials. We created a 'Summary of findings' table using the five GRADE considerations (study limitations, consistency of effect, imprecision, indirectness and publication bias) to assess the quality of a body of evidence as it relates to the studies which contribute data to the meta-analyses for the prespecified outcomes.\nMain results\nWe included four trials involving a total of 579 participants. With the limitation that only two studies reported data on mortality and none of them had considered death as a primary endpoint, the meta-analysis showed no evidence of a difference in the risk of long-term mortality between participants who received ILR and those who were managed conventionally at follow-up (RR 0.97, 95% CI 0.41 to 2.30; participants = 255; studies = 2; very low quality evidence) with no evidence of heterogeneity. No data on short term mortality were available. Two studies reported data on adverse events after ILR implant. Due to the lack of data on adverse events in one of the studies' arms, a formal meta-analysis was not performed for this outcome.\nData from two trials seemed to show no difference in quality of life, although this finding was not supported by a formal analysis due to the differences in both the scores used and the way the data were reported. Data from two studies seemed to show a trend towards a reduction in syncope relapses after diagnosis in participants implanted with ILR. Cost analyses from two studies showed higher overall mean costs in the ILR group, if the costs incurred by the ILR implant were counted. The mean cost per diagnosis and the mean cost per arrhythmic diagnosis were lower for participants randomised to ILR implant.\nParticipants who underwent ILR implantation experienced higher rates of diagnosis (RR (in favour of ILR) 0.61, 95% CI 0.54 to 0.68; participants = 579; studies = 4; moderate quality evidence), as compared to participants in the standard assessment group, with no evidence of heterogeneity.\nAuthors' conclusions\nOur systematic review shows that there is no evidence that an ILR-based diagnostic strategy reduces long-term mortality as compared to a standard diagnostic assessment (very low quality evidence). No data were available for short-term all-cause mortality. Moderate quality evidence shows that an ILR-based diagnostic strategy increases the rate of aetiologic diagnosis as compared to a standard diagnostic pathway. No conclusive data were available on the other end-points analysed.\nFurther trials evaluating the effect of ILRs in the diagnostic strategy of people with recurrent unexplained syncope are warranted. Future research should focus on the assessment of the ability of ILRs to change clinically relevant outcomes, such as quality of life, syncope relapse and costs.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The aim of this study was to assess the evidence about potential benefits and harms of implantable loop recorders (ILRs) compared to standard diagnostic assessment for people with unexplained recurrent faints or blackouts."
}
] |
query-laysum
|
21970
|
[
{
"role": "user",
"content": "Abstract: Background\nVitiligo is a chronic skin disorder characterised by patchy loss of skin colour. Some people experience itching before the appearance of a new patch. It affects people of any age or ethnicity, more than half of whom develop it before the age of 20 years. There are two main types: generalised vitiligo, the common symmetrical form, and segmental, affecting only one side of the body. Around 1% of the world's population has vitiligo, a disease causing white patches on the skin. Several treatments are available. Some can restore pigment but none can cure the disease.\nObjectives\nTo assess the effects of all therapeutic interventions used in the management of vitiligo.\nSearch methods\nWe updated our searches of the following databases to October 2013: the Cochrane Skin Group Specialised Register, CENTRAL in The Cochrane Library (2013, Issue 10), MEDLINE, Embase, AMED, PsycINFO, CINAHL and LILACS. We also searched five trials databases, and checked the reference lists of included studies for further references to relevant randomised controlled trials (RCTs).\nSelection criteria\nRandomised controlled trials (RCTs) assessing the effects of treatments for vitiligo.\nData collection and analysis\nAt least two review authors independently assessed study eligibility and methodological quality, and extracted data.\nMain results\nThis update of the 2010 review includes 96 studies, 57 from the previous update and 39 new studies, totalling 4512 participants. Most of the studies, covering a wide range of interventions, had fewer than 50 participants. All of the studies assessed repigmentation, however only five reported on all of our three primary outcomes which were quality of life, > 75% repigmentation and adverse effects. Of our secondary outcomes, six studies measured cessation of spread but none assessed long-term permanence of repigmentation resulting from treatment at two years follow-up.\nMost of the studies assessed combination therapies which generally reported better results. New interventions include seven new surgical interventions.\nWe analysed the data from 25 studies which assessed our primary outcomes. We used the effect measures risk ratio (RR), and odds ratio (OR) with their 95% confidence intervals (CI) and where N is the number of participants in the study.\nWe were only able to analyse one of nine studies assessing quality of life and this showed no statistically significant improvement between the comparators.\nNine analyses from eight studies reported >75% repigmentation. In the following studies the repigmentation was better in the combination therapy group: calcipotriol plus PUVA (psoralen with UVA light) versus PUVA (paired OR 4.25, 95% CI 1.43 to 12.64, one study, N = 27); hydrocortisone-17-butyrate plus excimer laser versus excimer laser alone (RR 2.57, 95% CI 1.20 to 5.50, one study, N = 84); oral minipulse of prednisolone (OMP) plus NB-UVB (narrowband UVB) versus OMP alone (RR 7.41, 95% CI 1.03 to 53.26, one study, N = 47); azathioprine with PUVA versus PUVA alone (RR 17.77, 95% CI 1.08 to 291.82, one study, N = 58) and 8-Methoxypsoralen (8-MOP ) plus sunlight versus psoralen (RR 2.50, 95% CI 1.06 to 5.91, one study, N = 168). In these three studies ginkgo biloba was better than placebo (RR 4.40, 95% CI 1.08 to 17.95, one study, N = 47); clobetasol propionate was better than PUVAsol (PUVA with sunlight) (RR 4.70, 95% CI 1.14 to 19.39, one study, N = 45); split skin grafts with PUVAsol was better than minipunch grafts with PUVAsol (RR 1.89, 95% CI 1.25 to 2.85, one study, N = 64).\nWe performed one meta-analysis of three studies, in which we found a non-significant 60% increase in the proportion of participants achieving >75% repigmentation in favour of NB-UVB compared to PUVA (RR 1.60, 95% CI 0.74 to 3.45; I² = 0%).\nStudies assessing topical preparations, in particular topical corticosteroids, reported most adverse effects. However, in combination studies it was difficult to ascertain which treatment caused these effects. We performed two analyses from a pooled analysis of three studies on adverse effects. Where NB-UVB was compared to PUVA, the NB-UVB group reported less observations of nausea in three studies (RR 0.13, 95% CI 0.02 to 0.69; I² = 0% three studies, N = 156) and erythema in two studies (RR 0.73, 95% CI 0.55 to 0.98; I² = 0%, two studies, N = 106), but not itching in two studies (RR 0.57, 95% CI 0.20 to 1.60; I² = 0%, two studies, N = 106).\nVery few studies only assessed children or included segmental vitiligo. We found one study of psychological interventions but we could not include the outcomes in our statistical analyses. We found no studies evaluating micropigmentation, depigmentation, or cosmetic camouflage.\nAuthors' conclusions\nThis review has found some evidence from individual studies to support existing therapies for vitiligo, but the usefulness of the findings is limited by the different designs and outcome measurements and lack of quality of life measures. There is a need for follow-up studies to assess permanence of repigmentation as well as high-quality randomised trials using standardised measures and which also address quality of life.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Vitiligo is a chronic skin disorder characterised by patchy loss of skin colour. Some people experience itching before the appearance of a new patch. It affects people of any age or ethnicity, more than half of whom develop it before the age of 20 years. There are two main types: generalised vitiligo, the common symmetrical form, and segmental, affecting only one side of the body. Recent genetic research suggests that generalised vitiligo is, at least in part, an autoimmune condition which destroys melanocytes (pigment cells). Although our understanding of vitiligo has increased, its causes are still poorly understood. Several treatments are available. Some can restore pigment but none can cure it or prevent its spread or recurrence. Vitiligo patches can have a major psychosocial impact, especially for people with dark or tanned skin or when the face or hands are affected. People with vitiligo can be stigmatised, often experiencing low self-esteem and a lack of self-confidence. Children with vitiligo may be teased and bullied at school. Despite this, we found only one study assessing psychological therapy for vitiligo."
}
] |
query-laysum
|
21971
|
[
{
"role": "user",
"content": "Abstract: Background\nWithin the context of heavy menstrual bleeding, pandemics impact upon women's assessment and treatment by healthcare providers.\nObjectives\nTo summarise the evidence from Cochrane Reviews evaluating interventions for heavy menstrual bleeding that are commonly available during pandemics.\nMethods\nWe sought published Cochrane Reviews, evaluating interventions that can continue during pandemics for women with heavy menstrual bleeding with no known underlying cause. We identified Cochrane Reviews by searching the Cochrane Database of Systematic Reviews in June 2020. The primary outcome was menstrual bleeding. Secondary outcomes included quality of life, patient satisfaction, side effects, and serious adverse events.\nWe undertook the selection of systematic reviews, data extraction, and quality assessment in duplicate. We resolved any disagreements by discussion. We assessed review quality using the Assessing the Methodological Quality of Systematic Reviews (AMSTAR) 2 tool, and the certainty of the evidence for each outcome using GRADE methods.\nMain results\nWe included four Cochrane Reviews, with 11 comparisons, data from 44 randomised controlled trials (RCTs), and 3196 women. We assessed all the reviews to be high quality.\nNon-steroidal anti-inflammatory drugs (NSAIDs)\nNSAIDs may be more effective in reducing heavy menstrual bleeding than placebo (mean difference (MD) -124 mL per cycle, 95% confidence interval (CI) -186 to -62 mL per cycle; 1 RCT, 11 women; low-certainty evidence). Mefenamic acid may be similar to naproxen (MD 21 mL per cycle, 95% CI -6 to 48 mL per cycle; 2 RCTs, 61 women; low-certainty evidence), and NSAIDs may be similar to combined hormonal contraceptives for heavy menstrual bleeding (MD 25 mL per cycle, 95% CI -22 to 73 mL per cycle; 1 RCT, 26 women; low-certainty evidence). NSAIDs may be be less effective in reducing menstrual bleeding than antifibrinolytics (relative risk (RR) 0.70, 95% CI 0.58 to 0.85; 2 RCTs, 161 women; low-certainty evidence). We are uncertain whether NSAIDs reduce menstrual blood loss more than short-cycle progestogens (RR 0.80, 95% CI 0.49 to 1.32; 1 RCT 32 women; very low-certainty evidence).\nAntifibrinolytics\nAntifibrinolytics appear to be more effective in reducing heavy menstrual bleeding than placebo (MD -53 mL per cycle, 95% CI -63 to -44 mL per cycle; 4 RCTs, 565 women; moderate-certainty evidence). Antifibrinolytics may be similar to placebo on the incidence of side effects (RR 1.05, 95% CI 0.93 to 1.18; 1 RCT, 297 women; low-certainty evidence), and they are probably similar on the incidence of serious adverse events (thrombotic events; RR 0.10, 95% CI 0.00 to 2.46; 2 RCT, 468 women; moderate-certainty evidence).\nAntifibrinolytics may be more effective in reducing heavy menstrual bleeding than short-cycle progestogen (MD -111 mL per cycle, 95% CI -178 mL to -44 mL per cycle; 1 RCT, 46 women; low-certainty evidence). We are uncertain whether antifibrinolytics are similar to short-cycle progestogens on quality of life (RR 1.67, 95% CI 0.76 to 3.64; 1 RCT, 44 women; very low-certainty evidence), patient satisfaction (RR 0.91, 95% CI 0.59 to 1.39; 1 RCT, 42 women; very low-certainty evidence), or side effects (RR 0.85, 95% CI 0.65 to 1.12; 3 RCTs, 211 women; very low-certainty evidence).\nWe are uncertain whether antifibrinolytics are more effective in reducing heavy menstrual bleeding when compared with long-cycle progestogen (MD -9 points per cycle, 95% CI -30 to 12 points per cycle; 2 RCTs, 184 women; low-certainty evidence). Antifibrinolytics may increase self-reported improvement in menstrual bleeding when compared with long-cycle medroxyprogesterone acetate (RR 1.32, 95% CI 1.08 to 1.61; 1 RCT, 94 women; low-certainty evidence). Antifibrinolytics may be similar to long-cycle progestogens on quality of life (MD 5, 95% CI -2.49 to 12.49; 1 RCT, 90 women; low-certainty evidence). We are uncertain whether antifibrinolytics are similar to long-cycle progestogens on side effects (RR 0.58, 95% CI 0.33 to 1.00; 2 RCTs, 184 women; very low-certainty evidence).\nThere were no trials comparing antifibrinolytics to combined hormonal contraceptives.\nCombined hormonal contraceptives\nCombined hormonal contraceptives appear to be more effective for heavy menstrual bleeding than placebo or no treatment (RR 13.25, 95% CI 2.94 to 59.64; 2 RCTs, 363 women; moderate-certainty evidence). Combined hormonal contraceptives are probably similar to placebo on the incidence of side effects (RR 1.53, 95% CI 0.90 to 2.60; 2 RCTs, 411 women; moderate-certainty evidence).\nProgestogens\nThere were no trials comparing progestogens to placebo.\nLimitations in the evidence included risk of bias in the primary RCTs, inconsistency between the primary RCTs, and imprecision in effect estimates.\nAuthors' conclusions\nThere is moderate-certainty evidence that antifibrinolytics and combined hormonal contraceptives reduce heavy menstrual bleeding compared with placebo. There is low-certainty evidence that NSAIDs reduce heavy menstrual bleeding compared with placebo. There is low-certainty evidence that antifibrinolytics are more effective in reducing heavy menstrual bleeding when compared with NSAIDs and short-cycle progestogens, but we are unable to draw conclusions about the effects of antifibrinolytics compared to long-cycle progestogens, on low-certainty evidence.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Antifibrinolytics and combined hormonal contraceptives are probably effective in reducing heavy menstrual bleeding when compared to placebo. Of 1000 women with heavy menstrual bleeding, 109 will report improvement with placebo, and 363 (range 200 to 662) with antifibrinolytics. Of 1000 women with heavy menstrual bleeding, 29 will perceive their menstrual bleeding is back to normal with placebo, and 401 (range 118 to 771) with combined oral contraceptive. NSAIDs may be effective in reducing heavy menstrual bleeding when compared to placebo. Of 1000 women with heavy menstrual bleeding, 200 will report improvement with placebo, and 766 (range 578 to 887) with NSAIDs. Antifibrinolytics may be more effective in reducing heavy menstrual bleeding when compared with NSAIDs and short-cycle progestogens, but we are unable to draw conclusions about the effects of antifibrinolytics compared to long-cycle progestogens.\nThere was poor reporting of secondary outcomes, including quality of life, and the women's satisfaction with treatment. These studies did not have enough women participating to detect serious adverse events. There is well known evidence that even though the risk of thromboembolic events is very low in the general population, it increases with oral contraceptives."
}
] |
query-laysum
|
21972
|
[
{
"role": "user",
"content": "Abstract: Background\nHealthcare professionals are important contributors to healthcare quality and patient safety, but their performance does not always follow recommended clinical practice. There are many approaches to influencing practice among healthcare professionals. These approaches include audit and feedback, reminders, educational materials, educational outreach visits, educational meetings or conferences, use of local opinion leaders, financial incentives, and organisational interventions. In this review, we evaluated the effectiveness of patient-mediated interventions. These interventions are aimed at changing the performance of healthcare professionals through interactions with patients, or through information provided by or to patients. Examples of patient-mediated interventions include 1) patient-reported health information, 2) patient information, 3) patient education, 4) patient feedback about clinical practice, 5) patient decision aids, 6) patients, or patient representatives, being members of a committee or board, and 7) patient-led training or education of healthcare professionals.\nObjectives\nTo assess the effectiveness of patient-mediated interventions on healthcare professionals' performance (adherence to clinical practice guidelines or recommendations for clinical practice).\nSearch methods\nWe searched MEDLINE, Ovid in March 2018, Cochrane Central Register of Controlled Trials (CENTRAL) in March 2017, and ClinicalTrials.gov and the International Clinical Trials Registry (ICTRP) in September 2017, and OpenGrey, the Grey Literature Report and Google Scholar in October 2017. We also screened the reference lists of included studies and conducted cited reference searches for all included studies in October 2017.\nSelection criteria\nRandomised studies comparing patient-mediated interventions to either usual care or other interventions to improve professional practice.\nData collection and analysis\nTwo review authors independently assessed studies for inclusion, extracted data and assessed risk of bias. We calculated the risk ratio (RR) for dichotomous outcomes using Mantel-Haenszel statistics and the random-effects model. For continuous outcomes, we calculated the mean difference (MD) using inverse variance statistics. Two review authors independently assessed the certainty of the evidence (GRADE).\nMain results\nWe included 25 studies with a total of 12,268 patients. The number of healthcare professionals included in the studies ranged from 12 to 167 where this was reported. The included studies evaluated four types of patient-mediated interventions: 1) patient-reported health information interventions (for instance information obtained from patients about patients' own health, concerns or needs before a clinical encounter), 2) patient information interventions (for instance, where patients are informed about, or reminded to attend recommended care), 3) patient education interventions (intended to increase patients' knowledge about their condition and options of care, for instance), and 4) patient decision aids (where the patient is provided with information about treatment options including risks and benefits). For each type of patient-mediated intervention a separate meta-analysis was produced.\nPatient-reported health information interventions probably improve healthcare professionals' adherence to recommended clinical practice (moderate-certainty evidence). We found that for every 100 patients consulted or treated, 26 (95% CI 23 to 30) are in accordance with recommended clinical practice compared to 17 per 100 in the comparison group (no intervention or usual care). We are uncertain about the effect of patient-reported health information interventions on desirable patient health outcomes and patient satisfaction (very low-certainty evidence). Undesirable patient health outcomes and adverse events were not reported in the included studies and resource use was poorly reported.\nPatient information interventions may improve healthcare professionals' adherence to recommended clinical practice (low-certainty evidence). We found that for every 100 patients consulted or treated, 32 (95% CI 24 to 42) are in accordance with recommended clinical practice compared to 20 per 100 in the comparison group (no intervention or usual care). Patient information interventions may have little or no effect on desirable patient health outcomes and patient satisfaction (low-certainty evidence). We are uncertain about the effect of patient information interventions on undesirable patient health outcomes because the certainty of the evidence is very low. Adverse events and resource use were not reported in the included studies.\nPatient education interventions probably improve healthcare professionals' adherence to recommended clinical practice (moderate-certainty evidence). We found that for every 100 patients consulted or treated, 46 (95% CI 39 to 54) are in accordance with recommended clinical practice compared to 35 per 100 in the comparison group (no intervention or usual care). Patient education interventions may slightly increase the number of patients with desirable health outcomes (low-certainty evidence). Undesirable patient health outcomes, patient satisfaction, adverse events and resource use were not reported in the included studies.\nPatient decision aid interventions may have little or no effect on healthcare professionals' adherence to recommended clinical practice (low-certainty evidence). We found that for every 100 patients consulted or treated, 32 (95% CI 24 to 43) are in accordance with recommended clinical practice compared to 37 per 100 in the comparison group (usual care). Patient health outcomes, patient satisfaction, adverse events and resource use were not reported in the included studies.\nAuthors' conclusions\nWe found that two types of patient-mediated interventions, patient-reported health information and patient education, probably improve professional practice by increasing healthcare professionals' adherence to recommended clinical practice (moderate-certainty evidence). We consider the effect to be small to moderate. Other patient-mediated interventions, such as patient information may also improve professional practice (low-certainty evidence). Patient decision aids may make little or no difference to the number of healthcare professionals' adhering to recommended clinical practice (low-certainty evidence).\nThe impact of these interventions on patient health and satisfaction, adverse events and resource use, is more uncertain mostly due to very low certainty evidence or lack of evidence.\n\nGiven the provided abstract, please respond to the following query: \"Patient education strategies\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "In these studies, patients took part in patient education such as self-management programmes, for instance to increase their knowledge about their condition. The review shows that these strategies:\n- probably improve the extent to which healthcare professionals follow recommended clinical practice (moderate-certainty evidence);\n- may slightly improve some patient health outcomes such as the number of patients who reach controlled blood pressure (low-certainty evidence). However, we are uncertain about the effect of these strategies on other patient health outcomes, patient satisfaction and resource use because these outcomes were not measured in the included studies."
}
] |
query-laysum
|
21973
|
[
{
"role": "user",
"content": "Abstract: Background\nDelayed motor development may occur in children with Down syndrome, cerebral palsy, general developmental delay or children born preterm. It limits the child's exploration of the environment and can hinder cognitive and social-emotional development. Literature suggests that task-specific training, such as locomotor treadmill training, facilitates motor development.\nObjectives\nTo assess the effectiveness of treadmill interventions on locomotor development in children with delayed ambulation or in pre-ambulatory children (or both), who are under six years of age and who are at risk for neuromotor delay.\nSearch methods\nIn May 2017, we searched CENTRAL, MEDLINE, Embase, six other databases and a number of trials registers. We also searched the reference lists of relevant studies and systematic reviews.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-RCTs that evaluated the effect of treadmill intervention in the target population.\nData collection and analysis\nFour authors independently extracted the data. Outcome parameters were structured according to the International Classification of Functioning, Disability and Health model.\nMain results\nThis is an update of a Cochrane review from 2011, which included five trials. This update includes seven studies on treadmill intervention in 175 children: 104 were allocated to treadmill groups, and 71 were controls. The studies varied in population (children with Down syndrome, cerebral palsy, developmental delay or at moderate risk for neuromotor delay); comparison type (treadmill versus no treadmill; treadmill with versus without orthoses; high- versus low-intensity training); study duration, and assessed outcomes. Due to the diversity of the studies, only data from five studies were used in meta-analyses for five outcomes: age of independent walking onset, overall gross motor function, gross motor function related to standing and walking, and gait velocity. GRADE assessments of quality of the evidence ranged from high to very low.\nThe effects of treadmill intervention on independent walking onset compared to no treadmill intervention was population dependent, but showed no overall effect (mean difference (MD) -2.08, 95% confidence intervals (CI) -5.38 to 1.22, 2 studies, 58 children; moderate-quality evidence): 30 children with Down syndrome benefited from treadmill training (MD -4.00, 95% CI -6.96 to -1.04), but 28 children at moderate risk of developmental delay did not (MD -0.60, 95% CI -2.34 to 1.14). We found no evidence regarding walking onset in two studies that compared treadmill intervention with and without orthotics in 17 children (MD 0.10, 95% CI -5.96 to 6.16), and high- versus low-intensity treadmill interventions in 30 children with Down syndrome (MD -2.13, 95% -4.96 to 0.70).\nTreadmill intervention did not improve overall gross motor function (MD 0.88, 95% CI -4.54 to 6.30, 2 studies, 36 children; moderate-quality evidence) or gross motor skills related to standing (MD 5.41, 95% CI -1.64 to 12.43, 2 studies, 32 children; low-quality evidence), and had a negligible improvement in gross motor skills related to walking (MD 4.51, 95% CI 0.29 to 8.73, 2 studies, 32 children; low-quality evidence). It led to improved walking skills in 20 ambulatory children with developmental delay (MD 7.60, 95% CI 0.88 to 14.32, 1 study) and favourable gross motor skills in 12 children with cerebral palsy (MD 8.00, 95% CI 3.18 to 12.82). A study which compared treadmill intervention with and without orthotics in 17 children with Down syndrome suggested that adding orthotics might hinder overall gross motor progress (MD -8.40, 95% CI -14.55 to -2.25).\nOverall, treadmill intervention showed a very small increase in walking speed compared to no treadmill intervention (MD 0.23, 95% CI 0.08 to 0.37, 2 studies, 32 children; high-quality evidence). Treadmill intervention increased walking speed in 20 ambulatory children with developmental delay (MD 0.25, 95% CI 0.08 to 0.42), but not in 12 children with cerebral palsy (MD 0.18, 95% CI -0.09 to 0.45).\nAuthors' conclusions\nThis update of the review from 2011 provides additional evidence of the efficacy of treadmill intervention for certain groups of children up to six years of age, but power to find significant results still remains limited. The current findings indicate that treadmill intervention may accelerate the development of independent walking in children with Down syndrome and may accelerate motor skill attainment in children with cerebral palsy and general developmental delay. Future research should first confirm these findings with larger and better designed studies, especially for infants with cerebral palsy and developmental delay. Once efficacy is established, research should examine the optimal dosage of treadmill intervention in these populations.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Standardized assessment for quality of evidence ranged from high to very low. Quality of evidence was determined by the number of children studied, completeness of the data, and random group assignment."
}
] |
query-laysum
|
21974
|
[
{
"role": "user",
"content": "Abstract: Background\nMobile health (mHealth), refers to healthcare practices supported by mobile devices, such as mobile phones and tablets. Within primary care, health workers often use mobile devices to register clients, track their health, and make decisions about care, as well as to communicate with clients and other health workers. An understanding of how health workers relate to, and experience mHealth, can help in its implementation.\nObjectives\nTo synthesise qualitative research evidence on health workers' perceptions and experiences of using mHealth technologies to deliver primary healthcare services, and to develop hypotheses about why some technologies are more effective than others.\nSearch methods\nWe searched MEDLINE, Embase, CINAHL, Science Citation Index and Social Sciences Citation Index in January 2018. We searched Global Health in December 2015. We screened the reference lists of included studies and key references and searched seven sources for grey literature (16 February to 5 March 2018). We re-ran the search strategies in February 2020. We screened these records and any studies that we identified as potentially relevant are awaiting classification.\nSelection criteria\nWe included studies that used qualitative data collection and analysis methods. We included studies of mHealth programmes that were part of primary healthcare services. These services could be implemented in public or private primary healthcare facilities, community and workplace, or the homes of clients. We included all categories of health workers, as well as those persons who supported the delivery and management of the mHealth programmes. We excluded participants identified as technical staff who developed and maintained the mHealth technology, without otherwise being involved in the programme delivery. We included studies conducted in any country.\nData collection and analysis\nWe assessed abstracts, titles and full-text papers according to the inclusion criteria. We found 53 studies that met the inclusion criteria and sampled 43 of these for our analysis. For the 43 sampled studies, we extracted information, such as country, health worker category, and the mHealth technology. We used a thematic analysis process. We used GRADE-CERQual to assess our confidence in the findings.\nMain results\nMost of the 43 included sample studies were from low- or middle-income countries. In many of the studies, the mobile devices had decision support software loaded onto them, which showed the steps the health workers had to follow when they provided health care. Other uses included in-person and/or text message communication, and recording clients' health information. Almost half of the studies looked at health workers' use of mobile devices for mother, child, and newborn health.\nWe have moderate or high confidence in the following findings.\nmHealth changed how health workers worked with each other : health workers appreciated being more connected to colleagues, and thought that this improved co-ordination and quality of care. However, some described problems when senior colleagues did not respond or responded in anger. Some preferred face-to-face connection with colleagues. Some believed that mHealth improved their reporting, while others compared it to \"big brother watching\".\nmHealth changed how health workers delivered care : health workers appreciated how mHealth let them take on new tasks, work flexibly, and reach clients in difficult-to-reach areas. They appreciated mHealth when it improved feedback, speed and workflow, but not when it was slow or time consuming. Some health workers found decision support software useful; others thought it threatened their clinical skills. Most health workers saw mHealth as better than paper, but some preferred paper. Some health workers saw mHealth as creating more work.\nmHealth led to new forms of engagement and relationships with clients and communities : health workers felt that communicating with clients by mobile phone improved care and their relationships with clients, but felt that some clients needed face-to-face contact. Health workers were aware of the importance of protecting confidential client information when using mobile devices. Some health workers did not mind being contacted by clients outside working hours, while others wanted boundaries. Health workers described how some community members trusted health workers that used mHealth while others were sceptical. Health workers pointed to problems when clients needed to own their own phones.\nHealth workers' use and perceptions of mHealth could be influenced by factors tied to costs, the health worker, the technology, the health system and society, poor network access, and poor access to electricity : some health workers did not mind covering extra costs. Others complained that phone credit was not delivered on time. Health workers who were accustomed to using mobile phones were sometimes more positive towards mHealth. Others with less experience, were sometimes embarrassed about making mistakes in front of clients or worried about job security. Health workers wanted training, technical support, user-friendly devices, and systems that were integrated into existing electronic health systems. The main challenges health workers experienced were poor network connections, access to electricity, and the cost of recharging phones. Other problems included damaged phones. Factors outside the health system also influenced how health workers experienced mHealth, including language, gender, and poverty issues. Health workers felt that their commitment to clients helped them cope with these challenges.\nAuthors' conclusions\nOur findings propose a nuanced view about mHealth programmes. The complexities of healthcare delivery and human interactions defy simplistic conclusions on how health workers will perceive and experience their use of mHealth. Perceptions reflect the interplay between the technology, contexts, and human attributes. Detailed descriptions of the programme, implementation processes and contexts, alongside effectiveness studies, will help to unravel this interplay to formulate hypotheses regarding the effectiveness of mHealth.\n\nGiven the provided abstract, please respond to the following query: \"How up-to-date is this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched for studies published up to January 2018."
}
] |
query-laysum
|
21975
|
[
{
"role": "user",
"content": "Abstract: Background\nOral nonsteroidal anti-inflammatory drugs (NSAIDs) are widely used in the treatment of pain in fibromyalgia, despite being considered not to be effective.\nObjectives\nTo assess the analgesic efficacy, tolerability (drop-out due to adverse events), and safety (serious adverse events) of oral nonsteroidal anti-inflammatory drugs for fibromyalgia in adults.\nSearch methods\nWe searched CENTRAL, MEDLINE, and Embase for randomised controlled trials from inception to January 2017. We also searched the reference lists of retrieved studies and reviews, and online clinical trial registries.\nSelection criteria\nWe included randomised, double-blind trials of two weeks' duration or longer, comparing any oral NSAID with placebo or another active treatment for relief of pain in fibromyalgia, with subjective pain assessment by the participant.\nData collection and analysis\nTwo review authors independently extracted data and assessed trial quality and potential bias. Primary outcomes were participants with substantial pain relief (at least 50% pain relief over baseline or very much improved on Patient Global Impression of Change scale (PGIC)) or moderate pain relief (at least 30% pain relief over baseline or much or very much improved on PGIC), serious adverse events, and withdrawals due to adverse events; secondary outcomes were adverse events, withdrawals due to lack of efficacy, and outcomes relating to sleep, fatigue, and quality of life. Where pooled analysis was possible, we used dichotomous data to calculate risk difference (RD) and number needed to treat for an additional beneficial outcome (NNT), using standard methods. We assessed the quality of the evidence using GRADE and created a 'Summary of findings' table.\nMain results\nOur searches identified six randomised, double-blind studies involving 292 participants in suitably characterised fibromyalgia. The mean age of participants was between 39 and 50 years, and 89% to 100% were women. The initial pain intensity was around 7/10 on a 0 to 10 pain scale, indicating severe pain. NSAIDs tested were etoricoxib 90 mg daily, ibuprofen 2400 mg daily, naproxen 1000 mg daily, and tenoxicam 20 mg daily; 146 participants received NSAID and 146 placebo. The duration of treatment in the double-blind phase varied between three and eight weeks.\nNot all studies reported all the outcomes of interest. Analyses consistently showed no significant difference between NSAID and placebo: substantial benefit (at least 50% pain intensity reduction) (risk difference (RD) -0.07 (95% confidence interval (CI) -0.18 to 0.04) 2 studies, 146 participants; moderate benefit (at least 30% pain intensity reduction) (RD -0.04 (95% CI -0.16 to 0.08) 3 studies, 192 participants; withdrawals due to adverse events (RD 0.04 (95% CI -0.02 to 0.09) 4 studies, 230 participants; participants experiencing any adverse event (RD 0.08 (95% CI -0.03 to 0.19) 4 studies, 230 participants; all-cause withdrawals (RD 0.03 (95% CI -0.07 to 0.14) 3 studies, 192 participants. There were no serious adverse events or deaths. Although most studies had some measures of health-related quality of life, fibromyalgia impact, or other outcomes, none reported the outcomes beyond saying that there was no or little difference between the treatment groups.\nWe downgraded evidence on all outcomes to very low quality, meaning that this research does not provide a reliable indication of the likely effect. The likelihood that the effect could be substantially different is very high. This is based on the small numbers of studies, participants, and events, as well as other deficiencies of reporting study quality allowing possible risks of bias.\nAuthors' conclusions\nThere is only a modest amount of very low-quality evidence about the use of NSAIDs in fibromyalgia, and that comes from small, largely inadequate studies with potential risk of bias. That bias would normally be to increase the apparent benefits of NSAIDs, but no such benefits were seen. Consequently, NSAIDs cannot be regarded as useful for treating fibromyalgia.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Fibromyalgia is characterised by persistent, widespread pain, sleep problems, and fatigue. NSAIDs are drugs with analgesic (pain-killing), antipyretic (fever-reducing) effects, and also with anti-inflammatory effects at higher doses. NSAIDs are frequently used to treat rheumatic diseases.\nOur definition of a good result was someone who had a high level of pain relief and was able to keep taking the medicine without side effects that made them want to stop."
}
] |
query-laysum
|
21976
|
[
{
"role": "user",
"content": "Abstract: Background\nPolycystic ovarian syndrome (PCOS) is characterised by the clinical signs of oligo-amenorrhoea, infertility and hirsutism. Conventional treatment of PCOS includes a range of oral pharmacological agents, lifestyle changes and surgical modalities. Beta-endorphin is present in the follicular fluid of both normal and polycystic ovaries. It was demonstrated that the beta-endorphin levels in ovarian follicular fluid of otherwise healthy women who were undergoing ovulation were much higher than the levels measured in plasma. Given that acupuncture impacts on beta-endorphin production, which may affect gonadotropin-releasing hormone (GnRH) secretion, it is postulated that acupuncture may have a role in ovulation induction via increased beta-endorphin production effecting GnRH secretion. This is an update of our previous review published in 2016.\nObjectives\nTo assess the effectiveness and safety of acupuncture treatment for oligo/anovulatory women with polycystic ovarian syndrome (PCOS) for both fertility and symptom control.\nSearch methods\nWe identified relevant studies from databases including the Gynaecology and Fertility Group Specialised Register, CENTRAL, MEDLINE, Embase, PsycINFO, CNKI, CBM and VIP. We also searched trial registries and reference lists from relevant papers. CENTRAL, MEDLINE, Embase, PsycINFO, CNKI and VIP searches are current to May 2018. CBM database search is to November 2015.\nSelection criteria\nWe included randomised controlled trials (RCTs) that studied the efficacy of acupuncture treatment for oligo/anovulatory women with PCOS. We excluded quasi- or pseudo-RCTs.\nData collection and analysis\nTwo review authors independently selected the studies, extracted data and assessed risk of bias. We calculated risk ratios (RR), mean difference (MD), standardised mean difference (SMD) and 95% confidence intervals (CIs). Primary outcomes were live birth rate, multiple pregnancy rate and ovulation rate, and secondary outcomes were clinical pregnancy rate, restored regular menstruation period, miscarriage rate and adverse events. We assessed the quality of the evidence using GRADE methods.\nMain results\nWe included eight RCTs with 1546 women. Five RCTs were included in our previous review and three new RCTs were added in this update of the review. They compared true acupuncture versus sham acupuncture (three RCTs), true acupuncture versus relaxation (one RCT), true acupuncture versus clomiphene (one RCT), low-frequency electroacupuncture versus physical exercise or no intervention (one RCT) and true acupuncture versus Diane-35 (two RCTs). Studies that compared true acupuncture versus Diane-35 did not measure fertility outcomes as they were focused on symptom control.\nSeven of the studies were at high risk of bias in at least one domain.\nFor true acupuncture versus sham acupuncture, we could not exclude clinically relevant differences in live birth (RR 0.97, 95% CI 0.76 to 1.24; 1 RCT, 926 women; low-quality evidence); multiple pregnancy rate (RR 0.89, 95% CI 0.33 to 2.45; 1 RCT, 926 women; low-quality evidence); ovulation rate (SMD 0.02, 95% CI –0.15 to 0.19, I2 = 0%; 2 RCTs, 1010 women; low-quality evidence); clinical pregnancy rate (RR 1.03, 95% CI 0.82 to 1.29; I2 = 0%; 3 RCTs, 1117 women; low-quality evidence) and miscarriage rate (RR 1.10, 95% CI 0.77 to 1.56; 1 RCT, 926 women; low-quality evidence).\nNumber of intermenstrual days may have improved in participants receiving true acupuncture compared to sham acupuncture (MD –312.09 days, 95% CI –344.59 to –279.59; 1 RCT, 141 women; low-quality evidence).\nTrue acupuncture probably worsens adverse events compared to sham acupuncture (RR 1.16, 95% CI 1.02 to 1.31; I2 = 0%; 3 RCTs, 1230 women; moderate-quality evidence).\nNo studies reported data on live birth rate and multiple pregnancy rate for the other comparisons: physical exercise or no intervention, relaxation and clomiphene. Studies including Diane-35 did not measure fertility outcomes.\nWe were uncertain whether acupuncture improved ovulation rate (measured by ultrasound three months post treatment) compared to relaxation (MD 0.35, 95% CI 0.14 to 0.56; 1 RCT, 28 women; very low-quality evidence) or Diane-35 (RR 1.45, 95% CI 0.87 to 2.42; 1 RCT, 58 women; very low-quality evidence).\nOverall evidence ranged from very low quality to moderate quality. The main limitations were failure to report important clinical outcomes and very serious imprecision.\nAuthors' conclusions\nFor true acupuncture versus sham acupuncture we cannot exclude clinically relevant differences in live birth rate, multiple pregnancy rate, ovulation rate, clinical pregnancy rate or miscarriage. Number of intermenstrual days may improve in participants receiving true acupuncture compared to sham acupuncture. True acupuncture probably worsens adverse events compared to sham acupuncture.\nNo studies reported data on live birth rate and multiple pregnancy rate for the other comparisons: physical exercise or no intervention, relaxation and clomiphene. Studies including Diane-35 did not measure fertility outcomes as the women in these trials did not seek fertility.\nWe are uncertain whether acupuncture improves ovulation rate (measured by ultrasound three months post treatment) compared to relaxation or Diane-35. The other comparisons did not report on this outcome.\nAdverse events were recorded in the acupuncture group for the comparisons physical exercise or no intervention, clomiphene and Diane-35. These included dizziness, nausea and subcutaneous haematoma. Evidence was very low quality with very wide CIs and very low event rates.\nThere are only a limited number of RCTs in this area, limiting our ability to determine effectiveness of acupuncture for PCOS.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "PCOS is where women have multiple cysts (fluid-filled sacs) on their ovaries (organs that produce eggs) and is characterised by the clinical signs of infrequent or very light menstruation (periods), failure to conceive (become pregnant) and excessive hair growth. Women may or may not have symptoms. The current standard western treatments for women with PCOS are prescription medicines, surgery and lifestyle changes. There has been evidence suggesting acupuncture may influence ovulation (release of the egg) by affecting levels of various hormones. Acupuncture is a Chinese therapy where fine needles are inserted into the skin in certain places. The exact mechanism of how acupuncture works for PCOS is not known and we aimed to explore the use of it for PCOS in this review."
}
] |
query-laysum
|
21977
|
[
{
"role": "user",
"content": "Abstract: Background\nComorbid depression and substance use disorders are common and have poorer outcomes than either disorder alone. While effective psychological treatments for depression or substance use disorders are available, relatively few randomised controlled trials (RCTs) have examined the efficacy of these treatments in people with these comorbid disorders.\nObjectives\nTo assess the efficacy of psychological interventions delivered alone or in combination with pharmacotherapy for people diagnosed with comorbid depression and substance use disorders.\nSearch methods\nWe searched the following databases up to February 2019: Cochrane Central Register of Controlled Trials, PubMed, Embase, CINAHL, Google Scholar and clinical trials registers. All systematic reviews identified, were handsearched for relevant articles.\nSelection criteria\nThe review includes data from RCTs of psychological treatments for people diagnosed with comorbid depression and substance use disorders, using structured clinical interviews. Studies were included if some of the sample were experiencing another mental health disorder (e.g. anxiety); however, studies which required a third disorder as part of their inclusion criteria were not included. Studies were included if psychological interventions (with or without pharmacotherapy) were compared with no treatment, delayed treatment, treatment as usual or other psychological treatments.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nSeven RCTs of psychological treatments with a total of 608 participants met inclusion criteria. All studies were published in the USA and predominately consisted of Caucasian samples. All studies compared different types of psychological treatments. Two studies compared Integrated Cognitive Behavioural Therapy (ICBT) with Twelve Step Facilitation (TSF), another two studies compared Interpersonal Psychotherapy for Depression (IPT-D) with other treatment (Brief Supportive Therapy (BST) or Psychoeducation). The other three studies compared different types or combinations of psychological treatments. No studies compared psychological interventions with no treatment or treatment as usual control conditions. The studies included a diverse range of participants (e.g. veterans, prisoners, community adults and adolescents).\nAll studies were at high risk of performance bias, other main sources were selection, outcome detection and attrition bias. Due to heterogeneity between studies only two meta-analyses were conducted. The first meta-analysis focused on two studies (296 participants) comparing ICBT to TSF. Very low-quality evidence revealed that while the TSF group had lower depression scores than the ICBT group at post-treatment (mean difference (MD) 4.05, 95% confidence interval (CI) 1.43 to 6.66; 212 participants), there was no difference between groups in depression symptoms (MD 1.53, 95% CI -1.73 to 4.79; 181 participants) at six- to 12-month follow-up. At post-treatment there was no difference between groups in proportion of days abstinent (MD -2.84, 95% CI -8.04 to 2.35; 220 participants), however, the ICBT group had a greater proportion of days abstinent than the TSF group at the six- to 12-month follow-up (MD 10.76, 95% CI 3.10 to 18.42; 189 participants). There were no differences between the groups in treatment attendance (MD -1.27, 95% CI -6.10 to 3.56; 270 participants) or treatment retention (RR 0.95, 95% CI 0.72 to 1.25; 296 participants).\nThe second meta-analysis was conducted with two studies (64 participants) comparing IPT-D with other treatment (Brief Supportive Psychotherapy/Psychoeducation). Very low-quality evidence indicated IPT-D resulted in significantly lower depressive symptoms at post-treatment (MD -0.54, 95% CI -1.04 to -0.04; 64 participants), but this effect was not maintained at three-month follow-up (MD 3.80, 95% CI -3.83 to 11.43) in the one study reporting follow-up outcomes (38 participants; IPT-D versus Psychoeducation). Substance use was examined separately in each study, due to heterogeneity in outcomes. Both studies found very low-quality evidence of no significant differences in substance use outcomes at post-treatment (percentage of days abstinent, IPD versus Brief Supportive Psychotherapy; MD -2.70, 95% CI -28.74 to 23.34; 26 participants) or at three-month follow-up (relative risk of relapse, IPT-D versus Psychoeducation; RR 0.67, 95% CI 0.30 to 1.50; 38 participants). There was also very low-quality evidence for no significant differences between groups in treatment retention (RR 1.00, 95% CI 0.81 to 1.23; 64 participants). No adverse events were reported in any study.\nAuthors' conclusions\nThe conclusions of this review are limited due to the low number and very poor quality of included studies. No conclusions can be made about the efficacy of psychological interventions (delivered alone or in combination with pharmacotherapy) for the treatment of comorbid depression and substance use disorders, as they are yet to be compared with no treatment or treatment as usual in this population. In terms of differences between psychotherapies, although some significant effects were found, the effects were too inconsistent and small, and the evidence of too poor quality, to be of relevance to practice.\n\nGiven the provided abstract, please respond to the following query: \"What is the aim of this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The aim of this Cochrane Review was to find out if psychological interventions (delivered with or without pharmacotherapy) are effective for the treatment of comorbid depression and substance use disorders. Cochrane researchers collected and analysed all relevant studies to answer this question."
}
] |
query-laysum
|
21978
|
[
{
"role": "user",
"content": "Abstract: Background\nGuillain-Barré syndrome (GBS) is an acute paralysing disease caused by peripheral nerve inflammation. This is an update of a review first published in 2001 and last updated in 2012.\nObjectives\nTo assess the effects of plasma exchange for treating GBS.\nSearch methods\nOn 18 January 2016 we searched the Cochrane Neuromuscular Specialised Register, CENTRAL, MEDLINE, and Embase. We also searched clinical trials registries.\nSelection criteria\nRandomised and quasi-randomised trials of plasma exchange versus sham exchange or supportive treatment, or comparing different regimens or techniques of plasma exchange.\nData collection and analysis\nWe followed standard Cochrane methodology.\nMain results\nIn the first version of this review there were six eligible trials concerning 649 participants comparing plasma exchange with supportive treatment. No new eligible trials have been identified in subsequent updates. Two other studies compared different numbers of plasma exchanges. Overall the included trials had a moderate risk of bias (in general, the studies were at low risk but all had a high risk of bias from lack of blinding).\nIn one trial with 220 severely affected participants, the median time to recover walking with aid was significantly shorter with plasma exchange (30 days) than without plasma exchange (44 days). In another trial with 91 mildly affected participants, the median time to onset of motor recovery was significantly shorter with plasma exchange (six days) than without plasma exchange (10 days). After four weeks, moderate-quality evidence from the combined data of three trials accounting for a total of 349 patients showed that plasma exchange significantly increased the proportion of patients who recovered the ability to walk with assistance (risk ratio (RR) 1.60, 95% confidence interval (CI) 1.19 to 2.15).\nIn five trials with 623 participants in total, moderate-quality evidence showed that the RR for improvement by one or more disability grades after four weeks was 1.64 (95% CI 1.37 to 1.96) times greater with plasma exchange. Participants treated with plasma exchange also fared better, according to moderate-quality evidence, in time to recover walking without aid (three trials with 349 participants; RR 1.72, 95% CI 1.06 to 2.79) and requirement for artificial ventilation (five trials with 623 participants; RR 0.53, 95% CI 0.39 to 0.74). More participants had relapses by the end of follow-up in the plasma exchange group than in the control group (six trials with 649 participants; RR 2.89, 95% CI 1.05 to 7.93; moderate-quality evidence). Despite this, according to moderate-quality evidence, the likelihood of full muscle strength recovery at one year was greater with plasma exchange than without plasma exchange (five trials with 404 participants; RR 1.24, 95% CI 1.07 to 1.45), and the likelihood of severe motor sequelae was less (six trials with 649 participants; RR 0.65, 95% CI 0.44 to 0.96). High-quality evidence from six trials with 649 participants could not confirm or refute a lower risk of death following plasma exchange compared to control (RR 0.86, 95% CI 0.45 to 1.65).\nThree trials (N = 556) provided details of serious adverse events during the hospital stay; combined analyses found no increase in serious infectious events compared to the control group (RR 0.91, 95% CI 0.73 to 1.13), nor were there clear differences in blood pressure instability, cardiac arrhythmias or pulmonary emboli.\nAuthors' conclusions\nModerate-quality evidence shows significantly more improvement with plasma exchange than with supportive care alone in adults with Guillain-Barré syndrome, without a significant increase in serious adverse events. According to moderate-quality evidence, there was a small but significant increase in the risk of relapse during the first six to 12 months after onset in people treated with plasma exchange compared with those who were not treated. Despite this, after one year, full recovery of muscle strength was more likely and severe residual weakness less likely with plasma exchange.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We carried out a wide search of medical databases for trials in which participants were randomly assigned to plasma exchange or no treatment except supportive care. We found six trials, which included 649 participants in total. All six trials compared plasma exchange with supportive treatment. All were at low risk of bias, except that participants and their carers were aware of the treatment given (they were not blinded). Two additional studies compared different numbers of plasma exchange and could not be included in the analysis but are discussed."
}
] |
query-laysum
|
21979
|
[
{
"role": "user",
"content": "Abstract: Background\nPre-eclampsia is a very frequent complication of pregnancy, and anticipation of birth is often necessary. However, the best mode of giving birth remains to be established, although observational studies suggest better maternal and perinatal outcomes with vaginal birth.\nObjectives\nTo assess the effects of a policy of planned caesarean section versus planned vaginal birth for women with severe pre-eclampsia on mortality and morbidity for mother and baby.\nSearch methods\nWe searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (6 September 2017) and reference lists of retrieved studies.\nSelection criteria\nWe planned to include all randomised trials of planned caesarean section versus planned vaginal birth for pregnant women with severe pre-eclampsia. Quasi-randomised and non-randomised studies are not eligible for inclusion in this review.\nThe focus of this review is severe pre-eclampsia; studies of planned caesarean section versus planned vaginal birth in pregnant women with eclampsia are not eligible for inclusion.\nData collection and analysis\nWe identified no studies that met the inclusion criteria. We excluded two studies.\nMain results\nThere are no included studies in this review.\nAuthors' conclusions\nThere is a lack of robust evidence from randomised controlled trials that can inform practice regarding planned caesarean section versus planned vaginal birth for women with severe pre-eclampsia. There is a need for high-quality randomised controlled trials to assess the short- and long-term effects of caesarean section and vaginal birth for these women and their babies.\n\nGiven the provided abstract, please respond to the following query: \"What does this mean?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We do not have any information from randomised clinical trials to assess whether caesarean section or vaginal birth is better for pregnant women with severe pre-eclampsia, and their babies. Until such time as we have good randomised clinical trials, pregnant women with severe pre-eclampsia need to talk with their doctors about their options for delivering their baby safely and with the best possible results. Doctors and pregnant women can then decide together if caesarean section or vaginal birth is best for the short- and long-term health of mother and baby."
}
] |
query-laysum
|
21980
|
[
{
"role": "user",
"content": "Abstract: Background\nCritical lower limb ischaemia (CLI) is a manifestation of peripheral arterial disease (PAD) that is seen in patients with typical chronic ischaemic rest pain or patients with ischaemic skin lesions - ulcers or gangrene - for longer than 2 weeks. Critical lower limb ischaemia is the most severe form of PAD, and interventions to improve arterial perfusion become necessary. Although surgical bypass has been the gold standard for revascularisation, the extent or the site of disease may be such that the artery cannot be reconstructed or bypassed. These patients require other modalities of treatment, for example, vasodilatation by drugs or lumbar sympathectomy to relieve pain at rest and to avoid amputations. A systematic review of randomised controlled trials is required to evaluate the effects of lumbar sympathectomy in treating patients with CLI due to non-reconstructable PAD.\nObjectives\nThe objective of this review is to assess the effects of lumbar sympathectomy by open, laparoscopic and percutaneous methods compared with no treatment or compared with any other method of lumbar sympathectomy in patients with CLI due to non-reconstructable PAD.\nSearch methods\nThe Cochrane Vascular Information Specialist (CIS) searched the Specialised Register (January 2016) and the Cochrane Central Register of Controlled Trials (CENTRAL; 2015, Issue 12). In addition, the CIS searched clinical trials databases for details of ongoing and unpublished studies.\nSelection criteria\nRandomised controlled trials (RCTs) comparing any of the treatment modalities of lumbar sympathectomy, such as open, laparoscopic and chemical percutaneous methods, with no treatment or with any other method of lumbar sympathectomy for CLI due to non-reconstructable PAD were eligible. To decrease the bias of including participants that may be incorrectly diagnosed with CLI, review authors defined CLI as persistently recurring ischaemic rest pain requiring regular analgesia for more than two weeks, or ulceration or gangrene of the foot or toes, attributable to objectively proven arterial occlusive disease by measurement of ankle pressure of < 50 mmHg or toe pressure < 30 mmHg. We defined non-reconstructable PAD as a resting ankle brachial index (ABI) < 0.9 when no reasonable open surgical or endovascular revascularisation treatment option is available, as determined by individual trial vascular specialists.\nData collection and analysis\nTwo review authors independently assessed studies identified for potential inclusion in the review. We planned to conduct data collection and analysis in accordance with the Cochrane Handbook for Systematic Review of Interventions.\nMain results\nWe identified no studies that met the predefined inclusion criteria. To decrease the bias of including participants who may be incorrectly diagnosed with CLI, we based our inclusion criteria on objective tests, as described above. The randomised trials identified by the literature search were performed before such objective criteria for selection were applied and therefore were not eligible for inclusion in the review.\nAuthors' conclusions\nWe identified no RCTs assessing effects of lumbar sympathectomy by open, laparoscopic and percutaneous methods compared with no treatment or compared with any other method of lumbar sympathectomy in patients with CLI due to non-reconstructable PAD. High-quality studies are needed.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Peripheral arterial disease (PAD) refers to a common condition of narrowing of the arteries of the lower limbs that restricts blood flow; in the most severe cases, PAD can cause pain at rest, ulcers and gangrene. Amputation may be required if resistant pain or sepsis ensues, unless an intervention is undertaken to improve arterial perfusion (delivery of blood to cells and tissues). One such intervention is lumbar sympathectomy, whereby nerves that stimulate constriction of arteries are destroyed. This is done mainly when other treatments such as reconstruction are not possible and when no treatment would result in amputation."
}
] |
query-laysum
|
21981
|
[
{
"role": "user",
"content": "Abstract: Background\nFixed prosthodontic treatment (crowns, fixed dental prostheses (FDPs), complete arch prostheses) involves the use of several different materials to replace missing tooth structure. Traditionally full metal or metal frameworks veneered with ceramic (metal-ceramic (MC)) have been used. In recent years several different metal-free systems have become available to clinicians and patients. In general, metal-free restorations should allow practitioners to better reproduce natural tooth colour, avoiding shortcomings of MC restorations. The comparative in service clinical performance of fixed prosthodontic treatments of different materials is unclear.\nObjectives\nTo assess the effects of metal-free materials for prosthodontic restorations compared to metal-ceramic or other conventional all-metal materials.\nSearch methods\nCochrane Oral Health's Information Specialist searched the following databases: Cochrane Oral Health's Trials Register (searched 3 May 2017), Cochrane Central Register of Controlled Trials (CENTRAL; 2017, Issue 4) in the Cochrane Library (searched 3 May 2017), MEDLINE Ovid (1946 to 3 May 2017), and Embase Ovid (1980 to 3 May 2017). The US National Institutes of Health Trials Registry (ClinicalTrials.gov) and the World Health Organization International Clinical Trials Registry Platform were searched for ongoing trials (searched 3 May 2017). No restrictions were placed on the language or date of publication when searching the electronic databases.\nSelection criteria\nRandomised controlled trials (RCTs) in which the clinical performance of metal-free fixed prosthodontic restorations was compared with metal-ceramic (MC) or other conventional restorations in adult patients requiring prosthodontic treatment. RCTs in which the clinical performance of different kinds of metal-free systems were compared among themselves were also considered.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. Screening of eligible studies, assessment of the methodological quality of the trials and data extraction were conducted independently and in duplicate. Trial authors were contacted for missing information. Available results for the outcomes of interest of the systematic review of the studies included were tabulated as they could not be included in a formal meta-analysis.\nMain results\nNine trials involving a total of 448 participants were included. We judged two trials to be at unclear risk of bias and seven to be at high risk of bias. The majority of items of risk of bias were evaluated to be at unclear or high risk level in more than 50% of the included trials. Each trial except two was addressing a different type of intervention. All evidence was rated as being of very low quality due to problems with risk of bias and imprecision of results, the latter being due to very small sample sizes, low event rates, 95% confidence intervals including the possibility of benefit for both the test and control groups, or combinations of these problems. This means that we are very uncertain about all of the results presented in this review.\nOne trial compared metal-free single crowns (full contour zirconia) to cast gold single crowns in 224 participants and found insufficient evidence of a difference in failure rate after one year, but after five years there was some evidence of a benefit for the gold crowns. There was insufficient evidence of a difference for crown complications at either time of assessment.\nOne trial compared three-unit metal-free FDPs (lithium disilicate) to three-unit metal-ceramic FDPs in 37 participants. There was insufficient evidence of a difference in bridge failure at one and six years, but some evidence of a benefit for the lithium disilicate group in terms of bridge complications at six years. One trial compared zirconia-ceramic FDPs to metal-ceramic FDPs in 34 participants but found insufficient evidence of a difference in bridge failures (i.e. no failures in either treatment group), bridge complications or patients' aesthetic evaluation at any time of assessment up to three years.\nOne trial compared metal-free cantilevered FDPs to metal-ceramic cantilevered FDPs in 21 participants. There was insufficient evidence of a difference for any primary outcome: bridge failures (i.e. no failures in either treatment group), bridge complications, or patients' aesthetic evaluation at any time of assessment up to three years.\nOne trial compared metal-free implant-supported screw retained single crowns (zirconia veneered with feldspathic ceramic) to metal-ceramic implant-supported screw-retained single crowns in 20 participants. There was insufficient evidence of a difference for any primary outcome: crown failures (i.e. no failures in either treatment group), crown complications, or satisfaction/aesthetic evaluation at any time of assessment up to two years.\nTwo trials compared metal-free implant abutments (zirconia) to metal implant abutments both supporting single crowns in 50 participants. There was insufficient evidence of a difference in abutment failure at one year.\nOne trial compared metal-free implant-supported FDPs made of two different types of zirconia ceramic in 18 participants. There was insufficient evidence of a difference in failures at any time of assessment up to 10 years (i.e. no failures in either treatment group). There was some evidence of a benefit for the zirconia-toughened alumina group in terms of complications (chipping).\nOne trial compared metal-free tooth-supported FDPs made with two different veneering techniques (pressed versus layered) in 40 participants. There was insufficient evidence of a difference for failures (i.e. no failures in either treatment group) or complications at any time of assessment up to three years.\nAuthors' conclusions\nThere is insufficient evidence to support or refute the effectiveness of metal-free materials for fixed prosthodontic treatment over metal-ceramic or other type of standard restorations. The overall quality of existing evidence was very low, therefore great caution should be exercised when generalising the results of the included trials. Until more evidence becomes available clinicians should continue to base decisions on which material to use for fixed prosthodontic treatment on their own clinical experience, whilst taking into consideration the individual circumstances and preferences of their patients. There is urgent need of properly designed RCTs.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "To compare the effects of metal-free materials to metal-ceramic or other conventional all-metal materials for prosthodontic treatments aimed to restore severely damaged teeth or to replace missing teeth."
}
] |
query-laysum
|
21982
|
[
{
"role": "user",
"content": "Abstract: Background\nKidney transplantation is the optimal treatment for end-stage kidney disease. Retrieval, transport and transplant of kidney grafts causes ischaemia reperfusion injury. The current accepted standard is static cold storage (SCS) whereby the kidney is stored on ice after removal from the donor and then removed from the ice box at the time of implantation. However, technology is now available to perfuse or \"pump\" the kidney during the transport phase or at the recipient centre. This can be done at a variety of temperatures and using different perfusates. The effectiveness of treatment is manifest clinically as delayed graft function (DGF), whereby the kidney fails to produce urine immediately after transplant.\nObjectives\nTo compare hypothermic machine perfusion (HMP) and (sub)normothermic machine perfusion (NMP) with standard SCS.\nSearch methods\nWe searched the Cochrane Kidney and Transplant Register of Studies to 18 October 2018 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov.\nSelection criteria\nAll randomised controlled trials (RCTs) and quasi-RCTs comparing HMP/NMP versus SCS for deceased donor kidney transplantation were eligible for inclusion. All donor types were included (donor after circulatory (DCD) and brainstem death (DBD), standard and extended/expanded criteria donors). Both paired and unpaired studies were eligible for inclusion.\nData collection and analysis\nThe results of the literature search were screened and a standard data extraction form was used to collect data. Both of these steps were performed by two independent authors. Dichotomous outcome results were expressed as risk ratio (RR) with 95% confidence intervals (CI). Continuous scales of measurement were expressed as a mean difference (MD). Random effects models were used for data analysis. The primary outcome was incidence of DGF. Secondary outcomes included: one-year graft survival, incidence of primary non-function (PNF), DGF duration, long term graft survival, economic implications, graft function, patient survival and incidence of acute rejection.\nMain results\nNo studies reported on NMP, however one ongoing study was identified.\nSixteen studies (2266 participants) comparing HMP with SCS were included; 15 studies could be meta-analysed. Fourteen studies reported on requirement for dialysis in the first week post-transplant (DGF incidence); there is high-certainty evidence that HMP reduces the risk of DGF when compared to SCS (RR 0.77; 95% CI 0.67 to 0.90; P = 0.0006). HMP reduces the risk of DGF in kidneys from DCD donors (7 studies, 772 participants: RR 0.75; 95% CI 0.64 to 0.87; P = 0.0002; high certainty evidence), as well as kidneys from DBD donors (4 studies, 971 participants: RR 0.78, 95% CI 0.65 to 0.93; P = 0.006; high certainty evidence). The number of perfusions required to prevent one episode of DGF (number needed to treat, NNT) was 7.26 and 13.60 in DCD and DBD kidneys respectively. Studies performed in the last decade all used the LifePort machine and confirmed that HMP reduces the incidence of DGF in the modern era (5 studies, 1355 participants: RR 0.77, 95% CI 0.66 to 0.91; P = 0.002; high certainty evidence). Reports of economic analysis suggest that HMP can lead to cost savings in both the North American and European settings.\nTwo studies reported HMP also improves graft survival however we were not able to meta-analyse these results. A reduction in incidence of PNF could not be demonstrated. The effect of HMP on our other outcomes (incidence of acute rejection, patient survival, hospital stay, long-term graft function, duration of DGF) remains uncertain.\nAuthors' conclusions\nHMP is superior to SCS in deceased donor kidney transplantation. This is true for both DBD and DCD kidneys, and remains true in the modern era (studies performed in the last decade). As kidneys from DCD donors have a higher overall DGF rate, fewer perfusions are needed to prevent one episode of DGF (7.26 versus 13.60 in DBD kidneys).\nFurther studies looking solely at the impact of HMP on DGF incidence are not required. Follow-up reports detailing long-term graft survival from participants of the studies already included in this review would be an efficient way to generate further long-term graft survival data.\nEconomic analysis, based on the results of this review, would help cement HMP as the standard preservation method in deceased donor kidney transplantation.\nRCTs investigating (sub)NMP are required.\n\nGiven the provided abstract, please respond to the following query: \"Conclusions\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Compared with standard static cold storage, hypothermic machine perfusion reduces the rate of DGF in kidneys from deceased donors, and likely results in increased survival of the transplanted kidney and overall cost savings. Studies looking at normothermic machine perfusion are required to assess if this results in superior outcomes."
}
] |
query-laysum
|
21983
|
[
{
"role": "user",
"content": "Abstract: Background\nLong-term physical conditions affect 10% to 12% of children and adolescents worldwide. These individuals are at greater risk of developing psychological problems, particularly anxiety and depression, sometimes directly related to their illness or medical care (e.g. health-related anxiety). There is limited evidence regarding the effectiveness of psychological therapies for treating anxiety and depression in this population. Therapies designed for children and adolescents without medical issues may or may not be appropriate for use with those who have long-term physical conditions.\nObjectives\nThis review was undertaken to assess the effectiveness and acceptability of psychological therapies in comparison with controls (treatment-as-usual, waiting list, attention placebo, psychological placebo, or non-psychological treatment) for treating anxiety and depression in children and adolescents with long-term physical conditions.\nSearch methods\nWe searched Ovid MEDLINE (1950- ), Embase (1974- ), PsycINFO (1967- ) and the Cochrane Central Register of Controlled Trials (CENTRAL) to 27 September 2018. An earlier search of these databases was conducted via the Cochrane Common Mental Disorders Controlled Trial Register (CCMD-CTR) (all years to May 2016). In addition, we searched the Web of Science (Core Collection) (12 October 2018) and conducted a cited reference search for reports of all included trials. We handsearched relevant conference proceedings, reference lists of included articles, and grey literature.\nSelection criteria\nRandomised controlled trials (RCTs), cluster-randomised trials and cross-over trials of psychological therapies for treating anxiety or depression in children with long-term physical conditions were included.\nData collection and analysis\nAbstracts and complete articles were independently reviewed by two authors. Discrepancies were addressed by a third author. Odds ratio (OR) was used for comparing dichotomous data and standardised mean differences (SMD) for comparing continuous data. Meta-analysis was undertaken when treatments, participants, and the underlying clinical question were similar. Otherwise, narrative analysis of data was undertaken.\nMain results\nTwenty-eight RCTs and one cross-over trial with 1349 participants were included in the review. Most participants were recruited from community settings and hospital clinics in high-income countries. For the primary outcome of treatment efficacy, short-term depression (versus any control), there was low-quality evidence from 16 trials involving 1121 participants suggesting that psychological therapies may be more effective than control therapies (SMD -0.31, 95% CI -0.59 to -0.03; I2 = 79%). For the primary outcome of treatment efficacy, short-term anxiety (versus any control), there was inadequate evidence of moderate-quality from 13 studies involving 578 participants to determine whether psychological therapies were more effective than control conditions (SMD -0.26, CI -0.59 to 0.07, I2 = 72%). Planned sensitivity analyses could not be undertaken for risk of bias due to the small number of trials that rated high for each domain. Additional sensitivity analysis demonstrated that psychological interventions specifically designed to reduce anxiety or depression were more effective than psychological therapies designed to improve other symptoms or general coping. There was some suggestion from subgroup analyses that they type of intervention (Chi² = 14.75, df = 5 (P = 0.01), I² = 66.1%), the severity of depression (Chi² = 23.29, df = 4 (P = 0.0001), I² = 82.8%) and the type of long-term physical condition (Chi² = 10.55, df = 4 (P = 0.03), I² = 62.1%) may have an impact on the overall treatment effect.There was qualitative (reported), but not quantitative evidence confirming the acceptability of selected psychological therapies for anxiety and depression. There was low-quality evidence that psychological therapies were more effective than control conditions in improving quality of life (SMD 1.13, CI 0.44 to 1.82, I2 = 89%) and symptoms of long-term physical conditions (SMD -0.34, CI -0.6 to -0.06, I2 = 70%), but only in the short term. There was inadequate low-quality evidence to determine whether psychological therapies were more effective than control conditions at improving functioning in either the short term or long term. No trials of therapies for addressing health-related anxiety were identified and only two trials reported adverse effects; these were unrelated to psychological therapies. Overall, the evidence was of low to moderate quality, results were heterogeneous, and only one trial had an available protocol.\nAuthors' conclusions\nA limited number of trials of variable quality have been undertaken to assess whether psychological therapies are effective for treating anxiety and depression in children and adolescents with long-term physical conditions. According to the available evidence, therapies specifically designed to treat anxiety or depression (especially those based on principles of cognitive behaviour therapy (CBT)) may be more likely to work in children and adolescents who have mild to moderate levels of symptoms of these disorders, at least in the short term. There is a dearth of therapies specifically designed to treat health-related anxiety in this age group.\n\nGiven the provided abstract, please respond to the following query: \"Who will be interested in this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This review will be of interest to mental and medical healthcare providers, service users, and service commissioners."
}
] |
query-laysum
|
21984
|
[
{
"role": "user",
"content": "Abstract: Background\nHead and neck cancer treatment has developed over the last decade, with improved mortality and survival rates, but the treatments often result in dysphagia (a difficulty in swallowing) as a side effect. This may be acute, resolving after treatment, or remain as a long-term negative sequela of head and neck cancer (HNC) treatment. Interventions to counteract the problems associated with dysphagia include swallowing exercises or modification of diet (bolus texture, size), or both.\nObjectives\nTo determine the effects of therapeutic exercises, undertaken before, during and/or immediately after HNC treatment, on swallowing, aspiration and adverse events such as chest infections, aspiration pneumonia and profound weight loss, in people treated curatively for advanced-stage (stage III, stage IV) squamous cell carcinoma of the head and neck.\nSearch methods\nThe Cochrane ENT Information Specialist searched the ENT Trials Register; Cochrane Central Register of Controlled Trials (CENTRAL 2016, Issue 6); MEDLINE; PubMed; Embase; CINAHL; LILACS; KoreaMed; IndMed; PakMediNet; Web of Science; ClinicalTrials.gov; ICTRP; speechBITE; Google Scholar; Google and additional sources for published and unpublished trials. The date of the search was 1 July 2016.\nSelection criteria\nWe selected randomised controlled trials (RCTs) of adults with head and neck cancer (stage III, stage IV) who underwent therapeutic exercises for swallowing before, during and/or immediately after HNC treatment to help produce safe and efficient swallowing. The main comparison was therapeutic exercises versus treatment as usual (TAU). Other possible comparison pairs included: therapeutic exercises versus sham exercises and therapeutic exercises plus TAU versus TAU. TAU consisted of reactive management of a patient's dysphagia, when this occurred. When severe, this included insertion of either a percutaneous endoscopic gastroscopy or nasogastric tube for non-oral feeding.\nData collection and analysis\nWe used the standard methodological procedures expected by Cochrane. Our primary outcomes were: safety and efficiency of oral swallowing, as measured by reduced/no aspiration; oropharyngeal swallowing efficiency (OPSE) measures, taken from videofluoroscopy swallowing studies; and adverse events, such as chest infections, aspiration pneumonia and profound weight loss. Secondary outcomes were time to return to function (swallowing); self-reported changes to quality of life; changes to psychological well-being - depression, anxiety and stress; patient satisfaction with the intervention; patient compliance with the intervention; and cost-effectiveness of the intervention.\nMain results\nWe included six studies (reported as seven papers) involving 326 participants whose ages ranged from 39 to 83 years, with a gender bias towards men (73% to 95% across studies), reflecting the characteristics of patients with HNC. The risk of bias in the studies was generally high.\nWe did not pool data from studies because of significant differences in the interventions and outcomes evaluated. We found a lack of standardisation and consistency in the outcomes measured and the endpoints at which they were evaluated.\nWe found no evidence that therapeutic exercises were better than TAU, or any other treatment, in improving the safety and efficiency of oral swallowing (our primary outcome) or in improving any of the secondary outcomes.\nUsing the GRADE system, we classified the overall quality of the evidence for each outcome as very low, due to the limited number of trials and their low quality. There were no adverse events reported that were directly attributable to the intervention (swallowing exercises).\nAuthors' conclusions\nWe found no evidence that undertaking therapeutic exercises before, during and/or immediately after HNC treatment leads to improvement in oral swallowing. This absence of evidence may be due to the small participant numbers in trials, resulting in insufficient power to detect any difference. Data from the identified trials could not be combined due to differences in the choice of primary outcomes and in the measurement tools used to assess them, and the differing baseline and endpoints across studies.\nDesigning and implementing studies with stronger methodological rigour is essential. There needs to be agreement about the key primary outcomes, the choice of validated assessment tools to measure them and the time points at which those measurements are made.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence is up to date to 1 July 2016.\nWe found no evidence that therapeutic exercises were better than TAU, or any other treatment, in improving the safety and efficiency of oral swallowing (our primary outcome) or in improving any of the secondary outcomes. However, there is insufficient evidence to draw any clear conclusion about the effects of undertaking therapeutic exercises before during and/or immediately after HNC treatment on preventing or reducing dysphagia. Studies had small participant numbers, used complex interventions and varied in the choice of outcomes measured, making it difficult to draw reliable conclusions. There were no reported adverse events directly attributable to the intervention (swallowing exercises)."
}
] |
query-laysum
|
21985
|
[
{
"role": "user",
"content": "Abstract: Background\nTinea infections are fungal infections of the skin caused by dermatophytes. It is estimated that 10% to 20% of the world population is affected by fungal skin infections. Sites of infection vary according to geographical location, the organism involved, and environmental and cultural differences. Both tinea corporis, also referred to as 'ringworm' and tinea cruris or 'jock itch' are conditions frequently seen by primary care doctors and dermatologists. The diagnosis can be made on clinical appearance and can be confirmed by microscopy or culture. A wide range of topical antifungal drugs are used to treat these superficial dermatomycoses, but it is unclear which are the most effective.\nObjectives\nTo assess the effects of topical antifungal treatments in tinea cruris and tinea corporis.\nSearch methods\nWe searched the following databases up to 13th August 2013: the Cochrane Skin Group Specialised Register, CENTRAL in The Cochrane Library (2013, Issue 7), MEDLINE (from 1946), EMBASE (from 1974), and LILACS (from 1982). We also searched five trials registers, and checked the reference lists of included and excluded studies for further references to relevant randomised controlled trials. We handsearched the journal Mycoses from 1957 to 1990.\nSelection criteria\nRandomised controlled trials in people with proven dermatophyte infection of the body (tinea corporis) or groin (tinea cruris).\nData collection and analysis\nTwo review authors independently carried out study selection, data extraction, assessment of risk of bias, and analyses.\nMain results\nOf the 364 records identified, 129 studies with 18,086 participants met the inclusion criteria. Half of the studies were judged at high risk of bias with the remainder judged at unclear risk. A wide range of different comparisons were evaluated across the 129 studies, 92 in total, with azoles accounting for the majority of the interventions. Treatment duration varied from one week to two months, but in most studies this was two to four weeks. The length of follow-up varied from one week to six months. Sixty-three studies contained no usable or retrievable data mainly due to the lack of separate data for different tinea infections. Mycological and clinical cure were assessed in the majority of studies, along with adverse effects. Less than half of the studies assessed disease relapse, and hardly any of them assessed duration until clinical cure, or participant-judged cure. The quality of the body of evidence was rated as low to very low for the different outcomes.\nData for several outcomes for two individual treatments were pooled. Across five studies, significantly higher clinical cure rates were seen in participants treated with terbinafine compared to placebo (risk ratio (RR) 4.51, 95% confidence interval (CI) 3.10 to 6.56, number needed to treat (NNT) 3, 95% CI 2 to 4). The quality of evidence for this outcome was rated as low. Data for mycological cure for terbinafine could not be pooled due to substantial heterogeneity.\nMycological cure rates favoured naftifine 1% compared to placebo across three studies (RR 2.38, 95% CI 1.80 to 3.14, NNT 3, 95% CI 2 to 4) with the quality of evidence rated as low. In one study, naftifine 1% was more effective than placebo in achieving clinical cure (RR 2.42, 95% CI 1.41 to 4.16, NNT 3, 95% CI 2 to 5) with the quality of evidence rated as low.\nAcross two studies, mycological cure rates favoured clotrimazole 1% compared to placebo (RR 2.87, 95% CI 2.28 to 3.62, NNT 2, 95% CI 2 to 3).\nData for several outcomes were pooled for three comparisons between different classes of treatment. There was no difference in mycological cure between azoles and benzylamines (RR 1.01, 95% CI 0.94 to 1.07). The quality of the evidence was rated as low for this comparison. Substantial heterogeneity precluded the pooling of data for mycological and clinical cure when comparing azoles and allylamines. Azoles were slightly less effective in achieving clinical cure compared to azole and steroid combination creams immediately at the end of treatment (RR 0.67, 95% CI 0.53 to 0.84, NNT 6, 95% CI 5 to 13), but there was no difference in mycological cure rate (RR 0.99, 95% CI 0.93 to 1.05). The quality of evidence for these two outcomes was rated as low for mycological cure and very low for clinical cure.\nAll of the treatments that were examined appeared to be effective, but most comparisons were evaluated in single studies. There was no evidence for a difference in cure rates between tinea cruris and tinea corporis. Adverse effects were minimal - mainly irritation and burning; results were generally imprecise between active interventions and placebo, and between different classes of treatment.\nAuthors' conclusions\nThe pooled data suggest that the individual treatments terbinafine and naftifine are effective. Adverse effects were generally mild and reported infrequently. A substantial number of the studies were more than 20 years old and of unclear or high risk of bias; there is however, some evidence that other topical antifungal treatments also provide similar clinical and mycological cure rates, particularly azoles although most were evaluated in single studies.There is insufficient evidence to determine if Whitfield’s ointment, a widely used agent is effective.\nAlthough combinations of topical steroids and antifungals are not currently recommended in any clinical guidelines, relevant studies included in this review reported higher clinical cure rates with similar mycological cure rates at the end of treatment, but the quality of evidence for these outcomes was rated very low due to imprecision, indirectness and risk of bias. There was insufficient evidence to confidently assess relapse rates in the individual or combination treatments.\nAlthough there was little difference between different classes of treatment in achieving cure, some interventions may be more appealing as they require fewer applications and a shorter duration of treatment. Further, high quality, adequately powered trials focusing on patient-centred outcomes, such as patient satisfaction with treatment should be considered.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Which topical treatments work best for 'jock' itch and ringworm?"
}
] |
query-laysum
|
21986
|
[
{
"role": "user",
"content": "Abstract: Background\nCaries is one of the most prevalent and preventable conditions worldwide. If identified early enough then non-invasive techniques can be applied, and therefore this review focusses on early caries involving the enamel surface of the tooth. The cornerstone of caries detection is a visual and tactile dental examination, however alternative methods of detection are available, and these include fluorescence-based devices. There are three categories of fluorescence-based device each primarily defined by the different wavelengths they exploit; we have labelled these groups as red, blue, and green fluorescence. These devices could support the visual examination for the detection and diagnosis of caries at an early stage of decay.\nObjectives\nOur primary objectives were to estimate the diagnostic test accuracy of fluorescence-based devices for the detection and diagnosis of enamel caries in children or adults. We planned to investigate the following potential sources of heterogeneity: tooth surface (occlusal, proximal, smooth surface or adjacent to a restoration); single point measurement devices versus imaging or surface assessment devices; and the prevalence of more severe disease in each study sample, at the level of caries into dentine.\nSearch methods\nCochrane Oral Health's Information Specialist undertook a search of the following databases: MEDLINE Ovid (1946 to 30 May 2019); Embase Ovid (1980 to 30 May 2019); US National Institutes of Health Ongoing Trials Register (ClinicalTrials.gov, to 30 May 2019); and the World Health Organization International Clinical Trials Registry Platform (to 30 May 2019). We studied reference lists as well as published systematic review articles.\nSelection criteria\nWe included diagnostic accuracy study designs that compared a fluorescence-based device with a reference standard. This included prospective studies that evaluated the diagnostic accuracy of single index tests and studies that directly compared two or more index tests. Studies that explicitly recruited participants with caries into dentine or frank cavitation were excluded.\nData collection and analysis\nTwo review authors extracted data independently using a piloted study data extraction form based on the Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2). Sensitivity and specificity with 95% confidence intervals (CIs) were reported for each study. This information has been displayed as coupled forest plots and summary receiver operating characteristic (SROC) plots, displaying the sensitivity-specificity points for each study. We estimated diagnostic accuracy using hierarchical summary receiver operating characteristic (HSROC) methods. We reported sensitivities at fixed values of specificity (median 0.78, upper quartile 0.90).\nMain results\nWe included a total of 133 studies, 55 did not report data in the 2 x 2 format and could not be included in the meta-analysis. 79 studies which provided 114 datasets and evaluated 21,283 tooth surfaces were included in the meta-analysis. There was a high risk of bias for the participant selection domain. The index test, reference standard, and flow and timing domains all showed a high proportion of studies to be at low risk of bias. Concerns regarding the applicability of the evidence were high or unclear for all domains, the highest proportion being seen in participant selection. Selective participant recruitment, poorly defined diagnostic thresholds, and in vitro studies being non-generalisable to the clinical scenario of a routine dental examination were the main reasons for these findings. The dominance of in vitro studies also means that the information on how the results of these devices are used to support diagnosis, as opposed to pure detection, was extremely limited. There was substantial variability in the results which could not be explained by the different devices or dentition or other sources of heterogeneity that we investigated. The diagnostic odds ratio (DOR) was 14.12 (95% CI 11.17 to 17.84).\nThe estimated sensitivity, at a fixed median specificity of 0.78, was 0.70 (95% CI 0.64 to 0.75). In a hypothetical cohort of 1000 tooth sites or surfaces, with a prevalence of enamel caries of 57%, obtained from the included studies, the estimated sensitivity of 0.70 and specificity of 0.78 would result in 171 missed tooth sites or surfaces with enamel caries (false negatives) and 95 incorrectly classed as having early caries (false positives).\nWe used meta-regression to compare the accuracy of the different devices for red fluorescence (84 datasets, 14,514 tooth sites), blue fluorescence (21 datasets, 3429 tooth sites), and green fluorescence (9 datasets, 3340 tooth sites) devices. Initially, we allowed threshold, shape, and accuracy to vary according to device type by including covariates in the model. Allowing consistency of shape, removal of the covariates for accuracy had only a negligible effect (Chi2 = 3.91, degrees of freedom (df) = 2, P = 0.14).\nDespite the relatively large volume of evidence we rated the certainty of the evidence as low, downgraded two levels in total, for risk of bias due to limitations in the design and conduct of the included studies, indirectness arising from the high number of in vitro studies, and inconsistency due to the substantial variability of results.\nAuthors' conclusions\nThere is considerable variation in the performance of these fluorescence-based devices that could not be explained by the different wavelengths of the devices assessed, participant, or study characteristics. Blue and green fluorescence-based devices appeared to outperform red fluorescence-based devices but this difference was not supported by the results of a formal statistical comparison. The evidence base was considerable, but we were only able to include 79 studies out of 133 in the meta-analysis as estimates of sensitivity or specificity values or both could not be extracted or derived. In terms of applicability, any future studies should be carried out in a clinical setting, where difficulties of caries assessment within the oral cavity include plaque, staining, and restorations. Other considerations include the potential of fluorescence devices to be used in combination with other technologies and comparative diagnostic accuracy studies.\n\nGiven the provided abstract, please respond to the following query: \"What is the aim of this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This Cochrane Review aimed to find out how accurate fluorescence devices (non-invasive devices that shine a light on the surface of the tooth) are for detecting and diagnosing early tooth decay as part of the dental 'check-up' for children and adults who visit their general dentist. Researchers included 133 studies to answer this question."
}
] |
query-laysum
|
21987
|
[
{
"role": "user",
"content": "Abstract: Background\nGoal setting is considered a key component of rehabilitation for adults with acquired disability, yet there is little consensus regarding the best strategies for undertaking goal setting and in which clinical contexts. It has also been unclear what effect, if any, goal setting has on health outcomes after rehabilitation.\nObjectives\nTo assess the effects of goal setting and strategies to enhance the pursuit of goals (i.e. how goals and progress towards goals are communicated, used, or shared) on improving health outcomes in adults with acquired disability participating in rehabilitation.\nSearch methods\nWe searched CENTRAL, MEDLINE, EMBASE, four other databases and three trials registers to December 2013, together with reference checking, citation searching and contact with study authors to identify additional studies. We did not impose any language or date restrictions.\nSelection criteria\nRandomised controlled trials (RCTs), cluster-RCTs and quasi-RCTs evaluating the effects of goal setting or strategies to enhance goal pursuit in the context of adult rehabilitation for acquired disability.\nData collection and analysis\nTwo authors independently reviewed search results for inclusion. Grey literature searches were conducted and reviewed by a single author. Two authors independently extracted data and assessed risk of bias for included studies. We contacted study authors for additional information.\nMain results\nWe included 39 studies (27 RCTs, 6 cluster-RCTs, and 6 quasi-RCTs) involving 2846 participants in total. Studies ranged widely regarding clinical context and participants' primary health conditions. The most common health conditions included musculoskeletal disorders, brain injury, chronic pain, mental health conditions, and cardiovascular disease.\nEighteen studies compared goal setting, with or without strategies to enhance goal pursuit, to no goal setting. These studies provide very low quality evidence that including any type of goal setting in the practice of adult rehabilitation is better than no goal setting for health-related quality of life or self-reported emotional status (8 studies; 446 participants; standardised mean difference (SMD) 0.53, 95% confidence interval (CI) 0.17 to 0.88, indicative of a moderate effect size) and self-efficacy (3 studies; 108 participants; SMD 1.07, 95% CI 0.64 to 1.49, indicative of a moderate to large effect size). The evidence is inconclusive regarding whether goal setting results in improvements in social participation or activity levels, body structure or function, or levels of patient engagement in the rehabilitation process. Insufficient data are available to determine whether or not goal setting is associated with more or fewer adverse events compared to no goal setting.\nFourteen studies compared structured goal setting approaches, with or without strategies to enhance goal pursuit, to 'usual care' that may have involved some goal setting but where no structured approach was followed. These studies provide very low quality evidence that more structured goal setting results in higher patient self-efficacy (2 studies; 134 participants; SMD 0.37, 95% CI 0.02 to 0.71, indicative of a small effect size) and low quality evidence for greater satisfaction with service delivery (5 studies; 309 participants; SMD 0.33, 95% CI 0.10 to 0.56, indicative of a small effect size). The evidence was inconclusive regarding whether more structured goal setting approaches result in higher health-related quality of life or self-reported emotional status, social participation, activity levels, or improvements in body structure or function. Three studies in this group reported on adverse events (death, re-hospitalisation, or worsening symptoms), but insufficient data are available to determine whether structured goal setting is associated with more or fewer adverse events than usual care.\nA moderate degree of heterogeneity was observed in outcomes across all studies, but an insufficient number of studies was available to permit subgroup analysis to explore the reasons for this heterogeneity. The review also considers studies which investigate the effects of different approaches to enhancing goal pursuit, and studies which investigate different structured goal setting approaches. It also reports on secondary outcomes including goal attainment and healthcare utilisation.\nAuthors' conclusions\nThere is some very low quality evidence that goal setting may improve some outcomes for adults receiving rehabilitation for acquired disability. The best of this evidence appears to favour positive effects for psychosocial outcomes (i.e. health-related quality of life, emotional status, and self-efficacy) rather than physical ones. Due to study limitations, there is considerable uncertainty regarding these effects however, and further research is highly likely to change reported estimates of effect.\n\nGiven the provided abstract, please respond to the following query: \"Results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This review found 39 studies published before December 2013, involving a total of 2846 participants receiving rehabilitation in a variety of countries and clinical situations. The studies used a wide range of different approaches to goal setting and tested the effectiveness of these approaches in a number of different ways. Overall these studies provide very low quality evidence that goal setting helps patients achieve a higher quality of life or sense of well-being and a higher belief in their own ability to achieve goals that they choose to pursue. There is currently no consistent evidence that goal setting improves people's functional abilities after rehabilitation or how hard they try with therapeutic interventions during rehabilitation.\nInsufficient information exists to say whether goal setting increases or reduces the risk of adverse events (such as death or re-hospitalisation) for people involved in rehabilitation. Because of the variety of approaches to studying goal setting in rehabilitation and because of limitations in the design of many studies completed to date, it is very possible that future studies could change the conclusions of this review. We also need more research to improve our understanding of how components of the goal setting process (such as how difficult goals are, how goals of therapy should be selected and prioritised, how goals are used in clinical practice, and how feedback on progress towards goals should be provided) contribute or do not contribute to better health outcomes."
}
] |
query-laysum
|
21988
|
[
{
"role": "user",
"content": "Abstract: Background\nOvereating and harmful alcohol and tobacco use have been linked to the aetiology of various non-communicable diseases, which are among the leading global causes of morbidity and premature mortality. As people are repeatedly exposed to varying sizes and shapes of food, alcohol and tobacco products in environments such as shops, restaurants, bars and homes, this has stimulated public health policy interest in product size and shape as potential targets for intervention.\nObjectives\n1) To assess the effects of interventions involving exposure to different sizes or sets of physical dimensions of a portion, package, individual unit or item of tableware on unregulated selection or consumption of food, alcohol or tobacco products in adults and children.\n2) To assess the extent to which these effects may be modified by study, intervention and participant characteristics.\nSearch methods\nWe searched CENTRAL, MEDLINE, EMBASE, PsycINFO, eight other published or grey literature databases, trial registries and key websites up to November 2012, followed by citation searches and contacts with study authors. This original search identified eligible studies published up to July 2013, which are fully incorporated into the review. We conducted an updated search up to 30 January 2015 but further eligible studies are not yet fully incorporated due to their minimal potential to change the conclusions.\nSelection criteria\nRandomised controlled trials with between-subjects (parallel-group) or within-subjects (cross-over) designs, conducted in laboratory or field settings, in adults or children. Eligible studies compared at least two groups of participants, each exposed to a different size or shape of a portion of a food (including non-alcoholic beverages), alcohol or tobacco product, its package or individual unit size, or of an item of tableware used to consume it, and included a measure of unregulated selection or consumption of food, alcohol or tobacco.\nData collection and analysis\nWe applied standard Cochrane methods to select eligible studies for inclusion and to collect data and assess risk of bias. We calculated study-level effect sizes as standardised mean differences (SMDs) between comparison groups, measured as quantities selected or consumed. We combined these results using random-effects meta-analysis models to estimate summary effect sizes (SMDs with 95% confidence intervals (CIs)) for each outcome for size and shape comparisons. We rated the overall quality of evidence using the GRADE system. Finally, we used meta-regression analysis to investigate statistical associations between summary effect sizes and variant study, intervention or participant characteristics.\nMain results\nThe current version of this review includes 72 studies, published between 1978 and July 2013, assessed as being at overall unclear or high risk of bias with respect to selection and consumption outcomes. Ninety-six per cent of included studies (69/72) manipulated food products and 4% (3/72) manipulated cigarettes. No included studies manipulated alcohol products. Forty-nine per cent (35/72) manipulated portion size, 14% (10/72) package size and 21% (15/72) tableware size or shape. More studies investigated effects among adults (76% (55/72)) than children and all studies were conducted in high-income countries - predominantly in the USA (81% (58/72)). Sources of funding were reported for the majority of studies, with no evidence of funding by agencies with possible commercial interests in their results.\nA meta-analysis of 86 independent comparisons from 58 studies (6603 participants) found a small to moderate effect of portion, package, individual unit or tableware size on consumption of food (SMD 0.38, 95% CI 0.29 to 0.46), providing moderate quality evidence that exposure to larger sizes increased quantities of food consumed among children (SMD 0.21, 95% CI 0.10 to 0.31) and adults (SMD 0.46, 95% CI 0.40 to 0.52). The size of this effect suggests that, if sustained reductions in exposure to larger-sized food portions, packages and tableware could be achieved across the whole diet, this could reduce average daily energy consumed from food by between 144 and 228 kcal (8.5% to 13.5% from a baseline of 1689 kcal) among UK children and adults. A meta-analysis of six independent comparisons from three studies (108 participants) found low quality evidence for no difference in the effect of cigarette length on consumption (SMD 0.25, 95% CI -0.14 to 0.65).\nOne included study (50 participants) estimated a large effect on consumption of exposure to differently shaped tableware (SMD 1.17, 95% CI 0.57 to 1.78), rated as very low quality evidence that exposure to shorter, wider bottles (versus taller, narrower bottles) increased quantities of water consumed by young adult participants.\nA meta-analysis of 13 independent comparisons from 10 studies (1164 participants) found a small to moderate effect of portion or tableware size on selection of food (SMD 0.42, 95% CI 0.24 to 0.59), rated as moderate quality evidence that exposure to larger sizes increased the quantities of food people selected for subsequent consumption. This effect was present among adults (SMD 0.55, 95% CI 0.35 to 0.75) but not children (SMD 0.14, 95% CI -0.06 to 0.34).\nIn addition, a meta-analysis of three independent comparisons from three studies (232 participants) found a very large effect of exposure to differently shaped tableware on selection of non-alcoholic beverages (SMD 1.47, 95% CI 0.52 to 2.43), rated as low quality evidence that exposure to shorter, wider (versus taller, narrower) glasses or bottles increased the quantities selected for subsequent consumption among adults (SMD 2.31, 95% CI 1.79 to 2.83) and children (SMD 1.03, 95% CI 0.41 to 1.65).\nAuthors' conclusions\nThis review found that people consistently consume more food and drink when offered larger-sized portions, packages or tableware than when offered smaller-sized versions. This suggests that policies and practices that successfully reduce the size, availability and appeal of larger-sized portions, packages, individual units and tableware can contribute to meaningful reductions in the quantities of food (including non-alcoholic beverages) people select and consume in the immediate and short term. However, it is uncertain whether reducing portions at the smaller end of the size range can be as effective in reducing food consumption as reductions at the larger end of the range. We are unable to highlight clear implications for tobacco or alcohol policy due to identified gaps in the current evidence base.\n\nGiven the provided abstract, please respond to the following query: \"Conclusions\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Overall, this review provides the most conclusive evidence to date that acting to reduce the size, availability and appeal of larger-sized portions, packages and tableware has potential to reduce the quantities of food that people select and consume by meaningful amounts. However, it is uncertain whether reducing portions at the smaller end of the size range can be as effective in reducing food consumption as reductions at the larger end of the range. Our findings highlight the need for further research that aims to reduce uncertainties about these effects and address identified gaps in the evidence base, including not having enough evidence for longer-term effects and the absence of evidence about alcohol products."
}
] |
query-laysum
|
21989
|
[
{
"role": "user",
"content": "Abstract: Background\nGroin dissection is commonly performed for the treatment of a variety of cancers, including melanoma, and squamous cell carcinoma of the skin, penis or vulva. It is uncertain whether insertion of a drain reduces complication rates, and, if used, the optimum time for drain removal after surgery is also unknown.\nObjectives\nTo assess the current level of evidence to determine whether placement of a drain is beneficial after groin dissection in terms of reducing seroma, haematoma, wound dehiscence and wound infection rates, and to determine the optimal type and duration of drainage following groin dissection if it is shown to be beneficial.\nSearch methods\nIn September 2014 we searched the following electronic databases using a pre-designed search strategy: the Cochrane Wounds Group Specialised Register; The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library). In November 2013 we searched Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid EMBASE and EBSCO CINAHL. We did not restrict the search and study selection with respect to language, date of publication or study setting.\nSelection criteria\nWe considered all randomised controlled trials (RCTs) comparing wound drainage with no wound drainage in individuals undergoing groin dissection, where the most superior node excised was Cloquet's node (the most superior inguinal lymph node). No limits were applied to language of publication or trial location. Two review authors independently determined the eligibility of each trial.\nData collection and analysis\nTwo review authors, working independently, screened studies identified from the search; there were no disagreements.\nMain results\nWe did not identify any RCTs that met the inclusion criteria for the review.\nAuthors' conclusions\nThere is a need for high quality RCTs to guide clinical practice in this under-researched area.\n\nGiven the provided abstract, please respond to the following query: \"What are lymph glands?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Lymph glands are part of the body's immune system and swell or enlarge when the body is fighting an infection. They are located in a number of places in the body, including the neck, armpits, and groin."
}
] |
query-laysum
|
21990
|
[
{
"role": "user",
"content": "Abstract: Background\nThe main complications of elevated systemic blood pressure (BP), coronary heart disease, ischaemic stroke, and peripheral vascular disease, are related to thrombosis rather than haemorrhage. Therefore, it is important to investigate if antithrombotic therapy may be useful in preventing thrombosis-related complications in patients with elevated BP.\nObjectives\nTo conduct a systematic review of the role of antiplatelet therapy and anticoagulation in patients with elevated BP, including elevations in systolic or diastolic BP alone or together.\nTo assess the effects of antiplatelet agents on total deaths or major thrombotic events or both in these patients versus placebo or other active treatment.\nTo assess the effects of oral anticoagulants on total deaths or major thromboembolic events or both in these patients versus placebo or other active treatment.\nSearch methods\nThe Cochrane Hypertension Information Specialist searched the following databases for randomised controlled trials (RCTs) up to January 2021: the Cochrane Hypertension Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL; 2020, Issue 12), Ovid MEDLINE (from 1946), and Ovid Embase (from 1974). The World Health Organization International Clinical Trials Registry Platform and the US National Institutes of Health Ongoing Trials Register (ClinicalTrials.gov) were searched for ongoing trials.\nSelection criteria\nRCTs in patients with elevated BP were included if they were ≥ 3 months in duration and compared antithrombotic therapy with control or other active treatment.\nData collection and analysis\nTwo review authors independently extracted data for inclusion criteria, our prespecified outcomes, and sources of bias. They assessed the risks and benefits of antiplatelet agents and anticoagulants by calculating odds ratios (OR), accompanied by the 95% confidence intervals (CI). They assessed risks of bias and applied GRADE criteria.\nMain results\nSix trials (61,015 patients) met the inclusion criteria and were included in this review.\nFour trials were primary prevention (41,695 patients; HOT, JPAD, JPPP, and TPT), and two secondary prevention (19,320 patients, CAPRIE and Huynh). Four trials (HOT, JPAD, JPPP, and TPT) were placebo-controlled and two studies (CAPRIE and Huynh) included active comparators.\nFour studies compared acetylsalicylic acid (ASA) versus placebo and found no evidence of a difference for all-cause mortality (OR 0.97, 95% CI 0.87 to 1.08; 3 studies, 35,794 participants; low-certainty evidence). We found no evidence of a difference for cardiovascular mortality (OR 0.98, 95% CI 0.82 to 1.17; 3 studies, 35,794 participants; low-certainty evidence). ASA reduced the risk of all non-fatal cardiovascular events (OR 0.63, 95% CI 0.45 to 0.87; 1 study (missing data in 3 studies), 2540 participants; low-certainty evidence) and the risk of all cardiovascular events (OR 0.86, 95% CI 0.77 to 0.96; 3 studies, 35,794 participants; low-certainty evidence). ASA increased the risk of major bleeding events (OR 1.77, 95% CI 1.34 to 2.32; 2 studies, 21,330 participants; high-certainty evidence).\nOne study (CAPRIE; ASA versus clopidogrel) included patients diagnosed with hypertension (mean age 62.5 years, 72% males, 95% Caucasians, mean follow-up: 1.91 years). It showed no evidence of a difference for all-cause mortality (OR 1.02, 95% CI 0.91 to 1.15; 1 study, 19,143 participants; high-certainty evidence) and for cardiovascular mortality (OR 1.08, 95% CI 0.94 to 1.26; 1 study, 19,143 participants; high-certainty evidence). ASA probably reduced the risk of non-fatal cardiovascular events (OR 1.10, 95% CI 1.00 to 1.22; 1 study, 19,143 participants; high-certainty evidence) and the risk of all cardiovascular events (OR 1.08, 95% CI 1.00 to 1.17; 1 study, 19,143 participants; high-certainty evidence) when compared to clopidogrel. Clopidogrel increased the risk of major bleeding events when compared to ASA (OR 1.35, 95% CI 1.14 to 1.61; 1 study, 19,143 participants; high-certainty evidence).\nIn one study (Huynh; ASA verus warfarin) patients with unstable angina or non–ST-segment elevation myocardial infarction, with prior coronary artery bypass grafting (CABG) were included (mean age 68 years, 79.8% males, mean follow-up: 1.1 year). There was no evidence of a difference for all-cause mortality (OR 0.98, 95% CI 0.06 to 16.12; 1 study, 91 participants; low-certainty evidence). Cardiovascular mortality, non-fatal cardiovascular events, and all cardiovascular events were not available. There was no evidence of a difference for major bleeding events (OR 0.13, 95% CI 0.01 to 2.60; 1 study, 91 participants; low-certainty evidence).\nAuthors' conclusions\nThere is no evidence that antiplatelet therapy modifies mortality in patients with elevated BP for primary prevention. ASA reduced the risk of cardiovascular events and increased the risk of major bleeding events.\nAntiplatelet therapy with ASA probably reduces the risk of non-fatal and all cardiovascular events when compared to clopidogrel. Clopidogrel increases the risk of major bleeding events compared to ASA in patients with elevated BP for secondary prevention.\nThere is no evidence that warfarin modifies mortality in patients with elevated BP for secondary prevention.\nThe benefits and harms of the newer drugs glycoprotein IIb/IIIa inhibitors, clopidogrel, prasugrel, ticagrelor, and non-vitamin K antagonist oral anticoagulants for patients with high BP have not been studied in clinical trials.\nFurther RCTs of antithrombotic therapy including newer agents and complete documentation of all benefits and harms are required in patients with elevated BP.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We reviewed the evidence that examined whether antiplatelet agents reduced total deaths or major thrombotic events or both in patients with elevated blood pressure (BP) when compared to placebo or other active treatment. We also assessed whether oral anticoagulants reduced total deaths or major thrombotic events or both in these patients when compared to placebo or other active treatment."
}
] |
query-laysum
|
21991
|
[
{
"role": "user",
"content": "Abstract: Background\nIt is common for people not to take antidepressant medication as prescribed, with around 50% of people likely to prematurely discontinue taking their medication after six months. Community pharmacists may be well placed to have a role in antidepressant management because of their unique pharmacotherapeutic knowledge and ease of access for people. Pharmacists are in an ideal position to offer proactive interventions to people with depression or depressive symptoms. However, the effectiveness and acceptability of existing pharmacist-based interventions is not yet well understood. The degree to which a pharmacy-based management approach might be beneficial, acceptable to people, and effective as part of the overall management for those with depression is, to date, unclear. A systematic review of randomised controlled trials (RCTs) will help answer these questions and add important knowledge to the currently sparse evidence base.\nObjectives\nTo examine the effects of pharmacy-based management interventions compared with active control (e.g. patient information materials or any other active intervention delivered by someone other than the pharmacist or the pharmacy team), waiting list, or treatment as usual (e.g. standard pharmacist advice or antidepressant education, signposting to support available in primary care services, brief medication counselling, and/or (self-)monitoring of medication adherence offered by a healthcare professional outside the pharmacy team) at improving depression outcomes in adults.\nSearch methods\nWe searched the Cochrane Common Mental Disorders Controlled Trials Register (CCMD-CTR) to June 2016; the Cochrane Library (Issue 11, 2018); and Ovid MEDLINE, Embase, and PsycINFO to December 2018. We searched theses and dissertation databases and international trial registers for unpublished/ongoing trials. We applied no restrictions on date, language, or publication status to the searches.\nSelection criteria\nWe included all RCTs and cluster-RCTs where a pharmacy-based intervention was compared with treatment as usual, waiting list, or an alternative intervention in the management of depression in adults over 16 years of age. Eligible studies had to report at least one of the following outcomes at any time point: depression symptom change, acceptability of the intervention, diagnosis of depression, non-adherence to medication, frequency of primary care appointments, quality of life, social functioning, or adverse events.\nData collection and analysis\nTwo authors independently, and in duplicate, conducted all stages of study selection, data extraction, and quality assessment (including GRADE). We discussed disagreements within the team until we reached consensus. Where data did not allow meta-analyses, we synthesised results narratively.\nMain results\nTwelve studies (2215 participants) met the inclusion criteria and compared pharmacy-based management with treatment as usual. Two studies (291 participants) also included an active control (both used patient information leaflets providing information about the prescribed antidepressant). Neither of these studies reported depression symptom change. A narrative synthesis of results on acceptability of the intervention was inconclusive, with one study reporting better acceptability of pharmacy-based management and the other better acceptability of the active control. One study reported that participants in the pharmacy-based management group had better medication adherence than the control participants. One study reported adverse events with no difference between groups. The studies reported no other outcomes.\nMeta-analyses comparing pharmacy-based management with treatment as usual showed no evidence of a difference in the effect of the intervention on depression symptom change (dichotomous data; improvement in symptoms yes/no: risk ratio (RR), 0.95, 95% confidence interval (CI) 0.86 to 1.05; 4 RCTs, 475 participants; moderate-quality evidence; continuous data: standard mean difference (SMD) -0.04, 95% CI -0.19 to 0.10; 5 RCTs, 718 participants; high-certainty evidence), or acceptability of the intervention (RR 1.09, 95% CI 0.81 to 1.45; 12 RCTs, 2072 participants; moderate-certainty evidence). The risk of non-adherence was reduced in participants receiving pharmacy-based management (RR 0.73, 95% CI 0.61 to 0.87; 6 RCTs, 911 participants; high-certainty evidence). We were unable to meta-analyse data on diagnosis of depression, frequency of primary care appointments, quality of life, or social functioning.\nAuthors' conclusions\nWe found no evidence of a difference between pharmacy-based management for depression in adults compared with treatment as usual in facilitating depression symptom change. Based on numbers of participants leaving the trials early, there may be no difference in acceptability between pharmacy-based management and controls. However, there was uncertainty due to the low-certainty evidence.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched medical databases for well-designed studies that compared a group of adults with depression who received additional help with their depression medicines from their pharmacy with a group of adults with depression who received their treatment as usual.\nThe evidence is current to 14 December 2018."
}
] |
query-laysum
|
21992
|
[
{
"role": "user",
"content": "Abstract: Background\nPain management is a high priority for patients with rheumatoid arthritis (RA). Despite deficiencies in research data, neuromodulators have gained widespread clinical acceptance as adjuvants in the management of patients with chronic musculoskeletal pain.\nObjectives\nThe aim of this review was to determine the efficacy and safety of neuromodulators in pain management in patients with RA. Neuromodulators included in this review were anticonvulsants (gabapentin, pregabalin, phenytoin, sodium valproate, lamotrigine, carbamazepine, levetiracetam, oxcarbazepine, tiagabine and topiramate), ketamine, bupropion, methylphenidate, nefopam, capsaicin and the cannabinoids.\nSearch methods\nWe performed a computer-assisted search of the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2010, 4th quarter), MEDLINE (1950 to week 1 November 2010), EMBASE (Week 44, 2010) and PsycINFO (1806 to week 2 November 2010). We also searched the 2008 and 2009 American College of Rheumatology (ACR) and European League against Rheumatism (EULAR) conference abstracts and performed a handsearch of reference lists of articles.\nSelection criteria\nWe included randomised controlled trials which compared any neuromodulator to another therapy (active or placebo, including non-pharmacological therapies) in adult patients with RA that had at least one clinically relevant outcome measure.\nData collection and analysis\nTwo blinded review authors independently extracted data and assessed the risk of bias in the trials. Meta-analyses were used to examine the efficacy of a neuromodulator on pain, depression and function as well as their safety.\nMain results\nFour trials with high risk of bias were included in this review. Two trials evaluated oral nefopam (52 participants) and one trial each evaluated topical capsaicin (31 participants) and oromucosal cannabis (58 participants).\nThe pooled analyses identified a significant reduction in pain levels favouring nefopam over placebo (weighted mean difference (WMD) -21.16, 95% CI -35.61 to -6.71; number needed to treat (NNT) 2, 95% CI 1.4 to 9.5) after two weeks. There were insufficient data to assess withdrawals due to adverse events. Nefopam was associated with significantly more adverse events (RR 4.11, 95% CI 1.58 to 10.69; NNTH 9, 95% CI 2 to 367), which were predominantly nausea and sweating.\nIn a mixed population trial, qualitative analysis of patients with RA showed a significantly greater reduction in pain favouring topical capsaicin over placebo at one and two weeks (MD -23.80, 95% CI -44.81 to -2.79; NNT 3, 95% CI 2 to 47; MD -34.40, 95% CI -54.66 to -14.14; NNT 2, 95% CI 1.4 to 6 respectively). No separate safety data were available for patients with RA, however 44% of patients developed burning at the site of application and 2% withdrew because of this.\nOne small, low quality trial assessed oromucosal cannabis against placebo and found a small, significant difference favouring cannabis in the verbal rating score 'pain at present' (MD -0.72, 95% CI -1.31 to -0.13) after five weeks. Patients receiving cannabis were significantly more likely to suffer an adverse event (risk ratio (RR) 1.82, 95% CI 1.10 to 3.00; NNTH 3, 95% CI 3 to 13). These were most commonly dizziness (26%), dry mouth (13%) and light headedness (10%).\nAuthors' conclusions\nThere is currently weak evidence that oral nefopam, topical capsaicin and oromucosal cannabis are all superior to placebo in reducing pain in patients with RA. However, each agent is associated with a significant side effect profile. The confidence in our estimates is not strong given the difficulties with blinding, the small numbers of participants evaluated and the lack of adverse event data. In some patients, however, even a small degree of pain relief may be considered worthwhile. Until further research is available, given the relatively mild nature of the adverse events, capsaicin could be considered as an add-on therapy for patients with persistent local pain and inadequate response or intolerance to other treatments. Oral nefopam and oromucosal cannabis have more significant side effect profiles however and the potential harms seem to outweigh any modest benefit achieved.\n\nGiven the provided abstract, please respond to the following query: \"Topical capsaicin\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Pain (higher scores mean worse or more severe pain)\n- People who took capsaicin rated their pain 34 points lower on a scale of 0 to 100 after 2 weeks treatment (34% absolute improvement)\n- People who took capsaicin rated their pain as 14 on a scale of 0 to 100 after 2 weeks\n- People who took a placebo rated their pain as 48 on a scale of 0 to 100\nAdverse events\nNo data"
}
] |
query-laysum
|
21993
|
[
{
"role": "user",
"content": "Abstract: Background\nThis is the second update of the review first published in the Cochrane Library (2010, Issue 2) and later updated (2014, Issue 9).\nDespite advances in chemotherapy, the prognosis of ovarian cancer remains poor. Antigen-specific active immunotherapy aims to induce tumour antigen-specific anti-tumour immune responses as an alternative treatment for ovarian cancer.\nObjectives\nPrimary objective \n• To assess the clinical efficacy of antigen-specific active immunotherapy for the treatment of ovarian cancer as evaluated by tumour response measured by Response Evaluation Criteria In Solid Tumors (RECIST) and/or cancer antigen (CA)-125 levels, response to post-immunotherapy treatment, and survival differences\n◦ In addition, we recorded the numbers of observed antigen-specific humoral and cellular responses\nSecondary objective \n• To establish which combinations of immunotherapeutic strategies with tumour antigens provide the best immunological and clinical results\nSearch methods\nFor the previous version of this review, we performed a systematic search of the Cochrane Central Register of Controlled Trials (CENTRAL; 2009, Issue 3), in the Cochrane Library, the Cochrane Gynaecological Cancer Group Specialised Register, MEDLINE and Embase databases, and clinicaltrials.gov (1966 to July 2009). We also conducted handsearches of the proceedings of relevant annual meetings (1996 to July 2009).\nFor the first update of this review, we extended the searches to October 2013, and for this update, we extended the searches to July 2017.\nSelection criteria\nWe searched for randomised controlled trials (RCTs), as well as non-randomised studies (NRSs), that included participants with epithelial ovarian cancer, irrespective of disease stage, who were treated with antigen-specific active immunotherapy, irrespective of type of vaccine, antigen used, adjuvant used, route of vaccination, treatment schedule, and reported clinical or immunological outcomes.\nData collection and analysis\nTwo reviews authors independently extracted the data. We evaluated the risk of bias for RCTs according to standard methodological procedures expected by Cochrane, and for NRSs by using a selection of quality domains deemed best applicable to the NRS.\nMain results\nWe included 67 studies (representing 3632 women with epithelial ovarian cancer). The most striking observations of this review address the lack of uniformity in conduct and reporting of early-phase immunotherapy studies. Response definitions show substantial variation between trials, which makes comparison of trial results unreliable. Information on adverse events is frequently limited. Furthermore, reports of both RCTs and NRSs frequently lack the relevant information necessary for risk of bias assessment. Therefore, we cannot rule out serious biases in most of the included trials. However, selection, attrition, and selective reporting biases are likely to have affected the studies included in this review. GRADE ratings were high only for survival; for other primary outcomes, GRADE ratings were very low.\nThe largest body of evidence is currently available for CA-125-targeted antibody therapy (17 studies, 2347 participants; very low-certainty evidence). Non-randomised studies of CA-125-targeted antibody therapy suggest improved survival among humoral and/or cellular responders, with only moderate adverse events. However, four large randomised placebo-controlled trials did not show any clinical benefit, despite induction of immune responses in approximately 60% of participants. Time to relapse with CA-125 monoclonal antibody versus placebo, respectively, ranged from 10.3 to 18.9 months versus 10.3 to 13 months (six RCTs, 1882 participants; high-certainty evidence). Only one RCT provided data on overall survival, reporting rates of 80% in both treatment and placebo groups (three RCTs, 1062 participants; high-certainty evidence). Other small studies targeting many different tumour antigens have presented promising immunological results. As these strategies have not yet been tested in RCTs, no reliable inferences about clinical efficacy can be made. Given the promising immunological results and the limited side effects and toxicity reported, exploration of clinical efficacy in large well-designed RCTs may be worthwhile.\nAuthors' conclusions\nWe conclude that despite promising immunological responses, no clinically effective antigen-specific active immunotherapy is yet available for ovarian cancer. Results should be interpreted cautiously, as review authors found a significant dearth of relevant information for assessment of risk of bias in both RCTs and NRSs.\n\nGiven the provided abstract, please respond to the following query: \"Certainty of the evidence and conclusions\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Because no high-certainty evidence of clinical benefit is currently available, antibody therapy targeting CA-125 should not be incorporated into standard treatment in its current form.\nBased on lack of uniformity in included studies, we strongly advocate universal adoption of response definitions, guidelines for adverse events reporting, and directives for trial conduct and reporting. Furthermore, results from ongoing randomised controlled trials (RCTs) are awaited, and further RCTs should be conducted."
}
] |
query-laysum
|
21994
|
[
{
"role": "user",
"content": "Abstract: Background\nDeep vein thrombosis (DVT) occurs when a blood clot blocks blood flow through a vein, which can occur after surgery, after trauma, or when a person has been immobile for a long time. Clots can dislodge and block blood flow to the lungs (pulmonary embolism (PE)), causing death. DVT and PE are known by the term venous thromboembolism (VTE). Heparin (in the form of unfractionated heparin (UFH)) is a blood-thinning drug used during the first three to five days of DVT treatment. Low molecular weight heparins (LMWHs) allow people with DVT to receive their initial treatment at home instead of in hospital. This is an update of a review first published in 2001 and updated in 2007.\nObjectives\nTo compare the incidence and complications of venous thromboembolism (VTE) in patients treated at home versus patients treated with standard in-patient hospital regimens. Secondary objectives included assessment of patient satisfaction and cost-effectiveness of treatment.\nSearch methods\nFor this update, the Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register (last searched 16 March 2017), the Cochrane Central Register of Controlled Trials (CENTRAL; 2017, Issue 2), and trials registries. We also checked the reference lists of relevant publications.\nSelection criteria\nRandomised controlled trials (RCTs) examining home versus hospital treatment for DVT, in which DVT was clinically confirmed and was treated with LMWHs or UFH.\nData collection and analysis\nOne review author selected material for inclusion, and another reviewed the selection of trials. Two review authors independently extracted data and assessed included studies for risk of bias. Primary outcomes included combined VTE events (PE and recurrent DVT), gangrene, heparin complications, and death. Secondary outcomes were patient satisfaction and cost implications. We performed meta-analysis using fixed-effect models with risk ratios (RRs) and 95% confidence intervals (CIs) for dichotomous data.\nMain results\nWe included in this review seven RCTs involving 1839 randomised participants with comparable treatment arms. All seven had fundamental problems including high exclusion rates, partial hospital treatment of many in the home treatment arms, and comparison of UFH in hospital versus LMWH at home. These trials showed that patients treated at home with LMWH were less likely to have recurrence of VTE events than those given hospital treatment with UFH or LMWH (fixed-effect risk ratio (RR) 0.58, 95% confidence interval (CI) 0.39 to 0.86; 6 studies; 1708 participants; P = 0.007; low-quality evidence). No clear difference was seen between groups for major bleeding (RR 0.67, 95% CI 0.33 to 1.36; 6 studies; 1708 participants; P = 0.27; low-quality evidence), minor bleeding (RR 1.29, 95% CI 0.94 to 1.78; 6 studies; 1708 participants; P = 0.11; low-quality evidence), or mortality (RR 0.69, 95% CI 0.44 to 1.09; 6 studies; 1708 participants; P = 0.11; low-quality evidence). The included studies reported no cases of venous gangrene. We could not combine patient satisfaction and quality of life outcomes in meta-analysis owing to heterogeneity of reporting, but two of three studies found evidence that home treatment led to greater improvement in quality of life compared with in-patient treatment at some point during follow-up, and the third study reported that a large number of participants chose to switch from in-patient care to home-based care for social and personal reasons, suggesting it is the patient's preferred option (very low-quality evidence). None of the studies included in this review carried out a full cost-effectiveness analysis. However, a small randomised economic evaluation of the two alternative treatment settings involving 131 participants found that direct costs were higher for those in the in-patient group. These findings were supported by three other studies that reported on their costs (very low-quality evidence).\nQuality of evidence for data from meta-analyses was low to very low. This was due to risk of bias, as many of the included studies used unclear randomisation techniques, and blinding was a concern for many. Also, indirectness was a concern, as most studies included a large number of participants randomised to the home (LMWH) treatment group who were treated in hospital for some or all of the treatment period. A further issue for some outcomes was heterogeneity that was evident in measurement and reporting of outcomes.\nAuthors' conclusions\nLow-quality evidence suggests that patients treated at home with LMWH are less likely to have recurrence of VTE than those treated in hospital. However, data show no clear differences in major or minor bleeding, nor in mortality (low-quality evidence), indicating that home treatment is no worse than in-patient treatment for these outcomes. Because most healthcare systems are moving towards more LMWH usage in the home setting it is unlikely that additional large trials will be undertaken to compare these treatments. Therefore, home treatment is likely to become the norm, and further research will be directed towards resolving practical issues by devising local guidelines that include clinical prediction rules, developing biomarkers and imaging that can be used to tailor therapy to disease severity, and providing training for community healthcare workers who administer treatment and monitor treatment progress.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Deep vein thrombosis (DVT) occurs when a blood clot blocks the flow of blood through a vein, generally in the legs. This can happen after surgery, after trauma, when a person is immobile for a long time, or for no obvious reason. Clots can dislodge and block blood flow to the lungs (pulmonary embolism (PE)), which can be fatal. DVT and PE are known as venous thromboembolism (VTE). Heparin is a blood-thinning drug that is used to treat DVT during the first three to five days. Unfractionated heparin (UFH) is administered intravenously in hospital with laboratory monitoring. Low molecular weight heparins (LMWHs) are given by subcutaneous injection once a day and can be given at home. Oral anticoagulants are then continued for three to six months. After recovery from the acute episode, people may develop post-thrombotic syndrome with leg swelling, varicose veins, and ulceration."
}
] |
query-laysum
|
21995
|
[
{
"role": "user",
"content": "Abstract: Background\nLow back pain (LBP) is responsible for considerable personal suffering worldwide. Those with persistent disabling symptoms also contribute to substantial costs to society via healthcare expenditure and reduced work productivity. While there are many treatment options, none are universally endorsed. The idea that chronic LBP is a condition best understood with reference to an interaction of physical, psychological and social influences, the 'biopsychosocial model', has received increasing acceptance. This has led to the development of multidisciplinary biopsychosocial rehabilitation (MBR) programs that target factors from the different domains, administered by healthcare professionals from different backgrounds.\nObjectives\nTo review the evidence on the effectiveness of MBR for patients with chronic LBP. The focus was on comparisons with usual care and with physical treatments measuring outcomes of pain, disability and work status, particularly in the long term.\nSearch methods\nWe searched the CENTRAL, MEDLINE, EMBASE, PsycINFO and CINAHL databases in January and March 2014 together with carrying out handsearches of the reference lists of included and related studies, forward citation tracking of included studies and screening of studies excluded in the previous version of this review.\nSelection criteria\nAll studies identified in the searches were screened independently by two review authors; disagreements regarding inclusion were resolved by consensus. The inclusion criteria were published randomised controlled trials (RCTs) that included adults with non-specific LBP of longer than 12 weeks duration; the index intervention targeted at least two of physical, psychological and social or work-related factors; and the index intervention was delivered by clinicians from at least two different professional backgrounds.\nData collection and analysis\nTwo review authors extracted and checked information to describe the included studies, assessed risk of bias and performed the analyses. We used the Cochrane risk of bias tool to describe the methodological quality. The primary outcomes were pain, disability and work status, divided into the short, medium and long term. Secondary outcomes were psychological functioning (for example depression, anxiety, catastrophising), healthcare service utilisation, quality of life and adverse events. We categorised the control interventions as usual care, physical treatment, surgery, or wait list for surgery in separate meta-analyses. The first two comparisons formed our primary focus. We performed meta-analyses using random-effects models and assessed the quality of evidence using the GRADE method. We performed sensitivity analyses to assess the influence of the methodological quality, and subgroup analyses to investigate the influence of baseline symptom severity and intervention intensity.\nMain results\nFrom 6168 studies identified in the searches, 41 RCTs with a total of 6858 participants were included. Methodological quality ratings ranged from 1 to 9 out 12, and 13 of the 41 included studies were assessed as low risk of bias. Pooled estimates from 16 RCTs provided moderate to low quality evidence that MBR is more effective than usual care in reducing pain and disability, with standardised mean differences (SMDs) in the long term of 0.21 (95% CI 0.04 to 0.37) and 0.23 (95% CI 0.06 to 0.4) respectively. The range across all time points equated to approximately 0.5 to 1.4 units on a 0 to 10 numerical rating scale for pain and 1.4 to 2.5 points on the Roland Morris disability scale (0 to 24). There was moderate to low quality evidence of no difference on work outcomes (odds ratio (OR) at long term 1.04, 95% CI 0.73 to 1.47). Pooled estimates from 19 RCTs provided moderate to low quality evidence that MBR was more effective than physical treatment for pain and disability with SMDs in the long term of 0.51 (95% CI -0.01 to 1.04) and 0.68 (95% CI 0.16 to 1.19) respectively. Across all time points this translated to approximately 0.6 to 1.2 units on the pain scale and 1.2 to 4.0 points on the Roland Morris scale. There was moderate to low quality evidence of an effect on work outcomes (OR at long term 1.87, 95% CI 1.39 to 2.53). There was insufficient evidence to assess whether MBR interventions were associated with more adverse events than usual care or physical interventions.\nSensitivity analyses did not suggest that the pooled estimates were unduly influenced by the results from low quality studies. Subgroup analyses were inconclusive regarding the influence of baseline symptom severity and intervention intensity.\nAuthors' conclusions\nPatients with chronic LBP receiving MBR are likely to experience less pain and disability than those receiving usual care or a physical treatment. MBR also has a positive influence on work status compared to physical treatment. Effects are of a modest magnitude and should be balanced against the time and resource requirements of MBR programs. More intensive interventions were not responsible for effects that were substantially different to those of less intensive interventions. While we were not able to determine if symptom intensity at presentation influenced the likelihood of success, it seems appropriate that only those people with indicators of significant psychosocial impact are referred to MBR.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Low back pain (LBP) is a condition that causes a great deal of pain and suffering across the world and also accounts for large costs to society due to healthcare spending and missed work. Previous research has shown that LBP that has persisted for several months or years is often associated with psychological and social problems. Multidisciplinary treatments target physical as well as psychological and social aspects of LBP and involve a team of healthcare providers with different professional backgrounds and training."
}
] |
query-laysum
|
21996
|
[
{
"role": "user",
"content": "Abstract: Background\nWorldwide, pneumonia is the leading cause of death amongst children under five years of age, and accounts for approximately two million deaths annually.\nPneumonia can be classified according to the World Health Organization (WHO) guidelines. Classification includes assessment of certain clinical signs and symptoms, and the severity of the disease. Treatment is then tailored according to the classification. For non-severe pneumonia, the WHO recommends treatment with oral antibiotics. We used the 2014 WHO definition of non-severe pneumonia for this review: an acute episode of cough, or difficulty in breathing, combined with fast breathing and chest indrawing.\nThe WHO recommends treating non-severe pneumonia with oral antibiotics. Pneumonia is more commonly caused by viruses that do not require antibiotic treatment, but pneumonia caused by bacteria needs management with antibiotics to avoid complications. There is no clear way to quickly distinguish between viral and bacterial pneumonia. It is considered safe to give antibiotics, however, this may lead to the development of antibiotic resistance, and thus, limit their use in future infections. Therefore, it is essential to explore the efficacy of antibiotics for children with WHO-defined non-severe pneumonia and wheeze.\nObjectives\nTo evaluate the efficacy of antibiotic therapy versus no antibiotic therapy for children aged 2 to 59 months with WHO-defined non-severe pneumonia and wheeze.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, four other databases, and two trial registers (December 2020).\nSelection criteria\nWe included randomised controlled trials (RCTs) evaluating the efficacy of antibiotic therapy versus no antibiotic therapy for children, aged 2 to 59 months, with non-severe pneumonia and wheeze. We defined non-severe pneumonia as 'a cough or difficulty in breathing, with rapid breathing (a respiratory rate of 50 breaths per minute or more for children aged 2 to 12 months, or a respiratory rate of 40 breaths per minute or more for children aged 12 to 59 months), chest indrawing and wheeze'. We excluded trials involving children with severe or very severe pneumonia, and non-RCTs.\nData collection and analysis\nOur primary outcomes were clinical cure and treatment failure; secondary outcomes were relapse, mortality, and treatment harms. We used standard methodological procedures expected by Cochrane. We used GRADE to assess the certainty of the evidence. Two review authors independently assessed the search results, extracted data, assessed risk of bias and the certainty of the evidence. We contacted the authors of two included trials and the author of the trial awaiting classification to obtain missing numerical outcome data.\nMain results\nWe included three trials involving 3256 children aged between 2 to 59 months, who exhibited features of non-severe pneumonia with wheeze. The included trials were multi-centre, double-blind, randomised, placebo-controlled trials carried out in Malawi, Pakistan, and India. The children were treated with a three-day course of amoxicillin or placebo, and were followed up for a total of two weeks. We assessed the included trials at overall low risk of bias for random sequence generation, allocation concealment, blinding, attrition bias, and selective reporting. Only one trial was assessed to be at high risk for blinding of outcome assessors. One trial is awaiting classification\nAntibiotic therapy may result in a reduction of treatment failure by 20% (risk ratio (RR) 0.80, 95% confidence interval (CI) 0.68 to 0.94; three trials; 3222 participants; low-certainty evidence).\nAntibiotic therapy probably results in little or no difference to clinical cure (RR 1.02, 95% CI 0.96 to 1.08; one trial; 456 participants; moderate-certainty evidence), and in little or no difference to relapse (RR 1.00, 95% CI 0.74 to 1.34; three trials; 2795 participants; low-certainty evidence), and treatment harms (RR 0.81, 95% CI 0.60 to 1.09; three trials, 3253 participants; low-certainty evidence). Two trials (2112 participants ) reported on mortality; no deaths occurred in either group.\nOne trial reported cases of hospitalisation, diarrhoea (with and without dehydration), rash (without itch), tremors, mild nausea and vomiting.\nAuthors' conclusions\nWe do not currently have enough evidence to support or challenge the continued use of antibiotics for the treatment of non-severe pneumonia. There is a clear need for RCTs to address this question in children aged 2 to 59 months with 2014 WHO-defined non-severe pneumonia and wheeze.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We tried to identify whether there was a difference in the outcomes for children aged 2 to 59 months with non-severe pneumonia and wheeze, treated with or without antibiotics."
}
] |
query-laysum
|
21997
|
[
{
"role": "user",
"content": "Abstract: Background\nAvailable evidence on the effects of a high fraction of inspired oxygen (FIO2) of 60% to 90% compared with a routine fraction of inspired oxygen of 30% to 40%, during anaesthesia and surgery, on mortality and surgical site infection has been inconclusive. Previous trials and meta-analyses have led to different conclusions on whether a high fraction of supplemental inspired oxygen during anaesthesia may decrease or increase mortality and surgical site infections in surgical patients.\nObjectives\nTo assess the benefits and harms of an FIO2 equal to or greater than 60% compared with a control FIO2 at or below 40% in the perioperative setting in terms of mortality, surgical site infection, respiratory insufficiency, serious adverse events and length of stay during the index admission for adult surgical patients.\nWe looked at various outcomes, conducted subgroup and sensitivity analyses, examined the role of bias and applied trial sequential analysis (TSA) to examine the level of evidence supporting or refuting a high FIO2 during surgery, anaesthesia and recovery.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, BIOSIS, International Web of Science, the Latin American and Caribbean Health Science Information Database (LILACS), advanced Google and the Cumulative Index to Nursing and Allied Health Literature (CINAHL) up to February 2014. We checked the references of included trials and reviews for unidentified relevant trials and reran the searches in March 2015. We will consider two studies of interest when we update the review.\nSelection criteria\nWe included randomized clinical trials that compared a high fraction of inspired oxygen with a routine fraction of inspired oxygen during anaesthesia, surgery and recovery in individuals 18 years of age or older.\nData collection and analysis\nTwo review authors extracted data independently. We conducted random-effects and fixed-effect meta-analyses, and for dichotomous outcomes, we calculated risk ratios (RRs). We used published data and data obtained by contacting trial authors.\nTo minimize the risk of systematic error, we assessed the risk of bias of the included trials. To reduce the risk of random errors caused by sparse data and repetitive updating of cumulative meta-analyses, we applied trial sequential analyses. We used Grades of Recommendation, Assessment, Development and Evaluation (GRADE) to assess the quality of the evidence.\nMain results\nWe included 28 randomized clinical trials (9330 participants); in the 21 trials reporting relevant outcomes for this review, 7597 participants were randomly assigned to a high fraction of inspired oxygen versus a routine fraction of inspired oxygen.\nIn trials with an overall low risk of bias, a high fraction of inspired oxygen compared with a routine fraction of inspired oxygen was not associated with all-cause mortality (random-effects model: RR 1.12, 95% confidence interval (CI) 0.93 to 1.36; GRADE: low quality) within the longest follow-up and within 30 days of follow-up (Peto odds ratio (OR) 0.99, 95% CI 0.61 to 1.60; GRADE: low quality). In a trial sequential analysis, the required information size was not reached and the analysis could not refute a 20% increase in mortality. Similarly, when all trials were included, a high fraction of inspired oxygen was not associated with all-cause mortality to the longest follow-up (RR 1.07, 95% CI 0.87 to 1.33) or within 30 days of follow-up (Peto OR 0.83, 95% CI 0.54 to 1.29), both of very low quality according to GRADE. Neither was a high fraction of inspired oxygen associated with the risk of surgical site infection in trials with low risk of bias (RR 0.86, 95% CI 0.63 to 1.17; GRADE: low quality) or in all trials (RR 0.87, 95% CI 0.71 to 1.07; GRADE: low quality). A high fraction of inspired oxygen was not associated with respiratory insufficiency (RR 1.25, 95% CI 0.79 to 1.99), serious adverse events (RR 0.96, 95% CI 0.65 to 1.43) or length of stay (mean difference -0.06 days, 95% CI -0.44 to 0.32 days).\nIn subgroup analyses of nine trials using preoperative antibiotics, a high fraction of inspired oxygen was associated with a decrease in surgical site infections (RR 0.76, 95% CI 0.60 to 0.97; GRADE: very low quality); a similar effect was noted in the five trials adequately blinded for the outcome assessment (RR 0.79, 95% CI 0.66 to 0.96; GRADE: very low quality). We did not observe an effect of a high fraction of inspired oxygen on surgical site infections in any other subgroup analyses.\nAuthors' conclusions\nAs the risk of adverse events, including mortality, may be increased by a fraction of inspired oxygen of 60% or higher, and as robust evidence is lacking for a beneficial effect of a fraction of inspired oxygen of 60% or higher on surgical site infection, our overall results suggest that evidence is insufficient to support the routine use of a high fraction of inspired oxygen during anaesthesia and surgery. Given the risk of attrition and outcome reporting bias, as well as other weaknesses in the available evidence, further randomized clinical trials with low risk of bias in all bias domains, including a large sample size and long-term follow-up, are warranted.\n\nGiven the provided abstract, please respond to the following query: \"Quality and quantity of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Only five of the included trials had low risk of bias. The trials randomly assigned 9330 participants, of whom only 7537 participants provided data for this review. The number of participants required to detect or reject a 20% relative risk reduction in deaths was not reached; therefore the observed results were uncertain."
}
] |
query-laysum
|
21998
|
[
{
"role": "user",
"content": "Abstract: Background\nA giant retinal tear (GRT) is a full-thickness neurosensory retinal break extending for 90° or more in the presence of a posterior vitreous detachment.\nObjectives\nTo evaluate the effectiveness and safety of pars plana vitrectomy combined with scleral buckle versus pars plana vitrectomy alone for eyes with giant retinal tear.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 8), which contains the Cochrane Eyes and Vision Trials Register; Ovid MEDLINE; Embase.com; PubMed; Latin American and Caribbean Literature on Health Sciences (LILACS); ClinicalTrials.gov; and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). We did not use any date or language restrictions in our electronic search. We last searched the electronic databases on 16 August 2018.\nSelection criteria\nWe included only randomized controlled trials (RCTs) comparing pars plana vitrectomy combined with scleral buckle versus pars plana vitrectomy alone for giant retinal tear regardless of age, gender, lens status (e.g. phakic or pseudophakic eyes) of the affected eye(s), or etiology of GRT among participants enrolled in these trials.\nData collection and analysis\nTwo review authors independently assessed titles and abstracts, then full-text articles, using Covidence. Any differences in classification between the two review authors were resolved through discussion. Two review authors independently abstracted data and assessed risk of bias of included trials.\nMain results\nWe found two RCTs in abstract format (105 participants randomized). Neither RCT was published in full. Based on the data presented in the abstracts, scleral buckling might be beneficial (relative risk of re-attachement ranged from 3.0 to 4.4), but the findings are inconclusive due to a lack of peer reviewed publication and insufficient information for assessing risk of bias.\nAuthors' conclusions\nWe found no conclusive evidence from RCTs on which to base clinical recommendations for scleral buckle combined with pars plana vitrectomy for giant retinal tear. RCTs are clearly needed to address this evidence gap. Such trials should be randomized, and patients should be classified by giant retinal tear characteristics (extension (90º, 90º to 180º, > 180º), location (oral, anterior, posterior to equator)), proliferative vitreoretinopathy stage, and endotamponade. Analysis should include both short-term (three months and six months) and long-term (one year to two years) outcomes for primary retinal reattachment, mean change in best corrected visual acuity, study eyes that required second surgery for retinal reattachment, and adverse events such as elevation of intraocular pressure above 21 mmHg, choroidal detachment, cystoid macular edema, macular pucker, proliferative vitreoretinopathy, and progression of cataract in initially phakic eyes.\n\nGiven the provided abstract, please respond to the following query: \"What are the main results of the review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Cochrane researchers searched for all relevant studies to answer this question and found only two conference abstracts, neither of which was published in full. Cochrane researchers also reached out to the investigators of these two studies but did not receive additional information.\nPeople affected by giant retinal tears and retinal surgeons treating them need evidence to show whether it is useful to combine scleral buckle with vitrectomy. They need more information about the surgical procedure associated with a higher rate of retinal reattachment and reduced surgical risk. Future studies need to obtain information on outcomes for people affected by this condition, such as eye and systemic medical history, eye and retinal tear findings, vision gained from surgery, and adverse events associated with surgery."
}
] |
query-laysum
|
21999
|
[
{
"role": "user",
"content": "Abstract: Background\nThis is an updated version of the original review, published in Issue 1, 2011, of The Cochrane Library. Acute lower abdominal pain is common, and making a diagnosis is particularly challenging in premenopausal women, as ovulation and menstruation symptoms overlap with symptoms of appendicitis, early pregnancy complications and pelvic infection. A management strategy involving early laparoscopy could potentially provide a more accurate diagnosis, earlier treatment and reduced risk of complications.\nObjectives\nTo evaluate the effectiveness and harms of laparoscopy for the management of acute lower abdominal pain in women of childbearing age.\nSearch methods\nThe Menstrual Disorders and Subfertility Group (MDSG) Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library), MEDLINE, EMBASE, PsycINFO, LILACS and CINAHL were searched (October 2013). The International Clinical Trials Registry Platform (ICTRP) was also searched. No new studies were included in this updated version.\nSelection criteria\nRandomised controlled trials (RCTs) that included women of childbearing age who presented with acute lower abdominal pain, non-specific lower abdominal pain or suspected appendicitis were included. Trials were included if they evaluated laparoscopy with open appendicectomy, or laparoscopy with a wait and see strategy. Study selection was carried out by two review authors independently.\nData collection and analysis\nData from studies that met the inclusion criteria were independently extracted by two review authors and the risk of bias assessed. We used standard methodological procedures as expected by The Cochrane Collaboration. A summary of findings table was prepared using GRADE criteria.\nMain results\nA total of 12 studies including 1020 participants were incorporated into the review. These studies had low to moderate risk of bias, mainly because allocation concealment or methods of sequence generation were not adequately reported. In addition, it was not clear whether follow-up was similar for the treatment groups. The index test was incorporated as a reference standard in the laparoscopy group, and differential verification or partial verification bias may have occurred in most RCTs. Overall the quality of the evidence was low to moderate for most outcomes, as per the GRADE approach.\nLaparoscopy was compared with open appendicectomy in eight RCTs. Laparoscopy was associated with an increased rate of specific diagnoses (seven RCTs, 561 participants; odds ratio (OR) 4.10, 95% confidence interval (CI) 2.50 to 6.71; I2 = 18%), but no evidence was found of reduced rates for any adverse events (eight RCTs, 623 participants; OR 0.46, 95% CI 0.19 to 1.10; I2 = 0%). A meta-analysis of seven studies found a significant difference favouring the laparoscopic procedure in the rate of removal of normal appendix (seven RCTs, 475 participants; OR 0.13, 95% CI 0.07 to 0.24; I2 = 0%).\nLaparoscopic diagnosis versus a 'wait and see' strategy was investigated in four RCTs. A significant difference favoured laparoscopy in terms of rate of specific diagnoses (four RCTs, 395 participants; OR 6.07, 95% CI 1.85 to 29.88; I2 = 79%), but no evidence suggested a difference in rates of adverse events (OR 0.87, 95% CI 0.45 to 1.67; I2 = 0%).\nAuthors' conclusions\nWe found that laparoscopy in women with acute lower abdominal pain, non-specific lower abdominal pain or suspected appendicitis led to a higher rate of specific diagnoses being made and a lower rate of removal of normal appendices compared with open appendicectomy only. Hospital stays were shorter. No evidence showed an increase in adverse events when any of these strategies were used.\n\nGiven the provided abstract, please respond to the following query: \"Key result\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "In this review of randomised controlled trials, laparoscopy was found to be superior to both open appendicectomy alone and a wait and see strategy, as more specific diagnoses were made before discharge, and shorter hospital stays and earlier return to work (when compared with open appendicectomy only) were reported. No evidence was found of an increase in adverse events when any of these strategies was applied. The rate of removal of normal appendices was reduced with the laparoscopic approach compared with open appendicectomy but was greater when a laparoscopic approach was compared with a wait and see strategy."
}
] |
query-laysum
|
22000
|
[
{
"role": "user",
"content": "Abstract: Background\nExcess dietary sodium consumption is a risk factor for high blood pressure, stroke and cardiovascular disease. Currently, dietary sodium consumption in almost every country is too high. Excess sodium intake is associated with high blood pressure, which is common and costly and accounts for significant burden of disease. A large number of jurisdictions worldwide have implemented population-level dietary sodium reduction initiatives. No systematic review has examined the impact of these initiatives.\nObjectives\n• To assess the impact of population-level interventions for dietary sodium reduction in government jurisdictions worldwide.\n• To assess the differential impact of those initiatives by social and economic indicators.\nSearch methods\nWe searched the following electronic databases from their start date to 5 January 2015: the Cochrane Central Register of Controlled Trials (CENTRAL); Cochrane Public Health Group Specialised Register; MEDLINE; MEDLINE In Process & Other Non-Indexed Citations; EMBASE; Effective Public Health Practice Project Database; Web of Science; Trials Register of Promoting Health Interventions (TRoPHI) databases; and Latin American Caribbean Health Sciences Literature (LILACS). We also searched grey literature, other national sources and references of included studies.\nThis review was conducted in parallel with a comprehensive review of national sodium reduction efforts under way worldwide (Trieu 2015), through which we gained additional information directly from country contacts.\nWe imposed no restrictions on language or publication status.\nSelection criteria\nWe included population-level initiatives (i.e. interventions that target whole populations, in this case, government jurisdictions, worldwide) for dietary sodium reduction, with at least one pre-intervention data point and at least one post-intervention data point of comparable jurisdiction. We included populations of all ages and the following types of study designs: cluster-randomised, controlled pre-post, interrupted time series and uncontrolled pre-post. We contacted study authors at different points in the review to ask for missing information.\nData collection and analysis\nTwo review authors extracted data, and two review authors assessed risk of bias for each included initiative.\nWe analysed the impact of initiatives by using estimates of sodium consumption from dietary surveys or urine samples. All estimates were converted to a common metric: salt intake in grams per day. We analysed impact by computing the mean change in salt intake (grams per day) from pre-intervention to post-intervention.\nMain results\nWe reviewed a total of 881 full-text documents. From these, we identified 15 national initiatives, including more than 260,000 people, that met the inclusion criteria. None of the initiatives were provided in lower-middle-income or low-income countries. All initiatives except one used an uncontrolled pre-post study design.\nBecause of high levels of study heterogeneity (I2 > 90%), we focused on individual initiatives rather than on pooled results.\nTen initiatives provided sufficient data for quantitative analysis of impact (64,798 participants). As required by the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) method, we graded the evidence as very low due to the risk of bias of the included studies, as well as variation in the direction and size of effect across the studies. Five of these showed mean decreases in average daily salt intake per person from pre-intervention to post-intervention, ranging from 1.15 grams/day less (Finland) to 0.35 grams/day less (Ireland). Two initiatives showed mean increase in salt intake from pre-intervention to post-intervention: Canada (1.66) and Switzerland (0.80 grams/day more per person); however in both countries the pre-intervention data point was from several years prior to the initiation of the intervention. The remaining initiatives did not show a statistically significant mean change.\nSeven of the 10 initiatives were multi-component and incorporated intervention activities of a structural nature (e.g. food product reformulation, food procurement policy in specific settings). Of those seven initiatives, four showed a statistically significant mean decrease in salt intake from pre-intervention to post-intervention, ranging from Finland to Ireland (see above), and one showed a statistically significant mean increase in salt intake from pre-intervention to post-intervention (Switzerland; see above).\nNine initiatives permitted quantitative analysis of differential impact by sex (men and women separately). For women, three initiatives (China, Finland, France) showed a statistically significant mean decrease, four (Austria, Netherlands, Switzerland, United Kingdom) showed no significant change and two (Canada, United States) showed a statistically significant mean increase in salt intake from pre-intervention to post-intervention. For men, five initiatives (Austria, China, Finland, France, United Kingdom) showed a statistically significant mean decrease, three (Netherlands, Switzerland, United States) showed no significant change and one (Canada) showed a statistically significant mean increase in salt intake from pre-intervention to post-intervention.\nInformation was insufficient to indicate whether a differential change in mean salt intake occurred from pre-intervention to post-intervention by other axes of equity included in the PROGRESS framework (e.g. education, place of residence).\nWe identified no adverse effects of these initiatives.\nThe number of initiatives was insufficient to permit other subgroup analyses, including stratification by intervention type, economic status of country and duration (or start year) of the initiative.\nMany studies had methodological strengths, including large, nationally representative samples of the population and rigorous measurement of dietary sodium intake. However, all studies were scored as having high risk of bias, reflecting the observational nature of the research and the use of an uncontrolled study design. The quality of evidence for the main outcome was low. We could perform a sensitivity analysis only for impact.\nAuthors' conclusions\nPopulation-level interventions in government jurisdictions for dietary sodium reduction have the potential to result in population-wide reductions in salt intake from pre-intervention to post-intervention, particularly if they are multi-component (more than one intervention activity) and incorporate intervention activities of a structural nature (e.g. food product reformulation), and particularly amongst men. Heterogeneity across studies was significant, reflecting different contexts (population and setting) and initiative characteristics. Implementation of future initiatives should embed more effective means of evaluation to help us better understand the variation in the effects.\n\nGiven the provided abstract, please respond to the following query: \"The review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Our aim was to examine whether national salt reduction initiatives have been effective in reducing the amount of salt consumed in those populations."
}
] |
query-laysum
|
22001
|
[
{
"role": "user",
"content": "Abstract: Background\nWhen human milk is not available for feeding preterm infants, protein hydrolysate, rather than standard cow's milk formulas (with intact proteins), is often used because it is perceived as being tolerated better and less likely to lead to complications. However, protein hydrolysate formulas are more expensive than standard formulas, and concern exists that their use in practice is not supported by high-quality evidence.\nObjectives\nTo assess the effects of feeding preterm infants hydrolysed formula (vs standard cow's milk formula) on risk of feed intolerance, necrotising enterocolitis, and other morbidity and mortality.\nSearch methods\nWe used the standard Cochrane Neonatal search strategy including electronic searches of the Cochrane Central Register of Controlled Trials (CENTRAL; 2019, Issue 1), in the Cochrane Library; Ovid MEDLINE (1966 to 28 January 2019); Ovid Embase (1980 to 28 January 2019); and the Cumulative Index to Nursing and Allied Health Literature (CINAHL) (28 January 2019), as well as conference proceedings and previous reviews.\nSelection criteria\nRandomised and quasi-randomised controlled trials that compared feeding preterm infants protein hydrolysate versus standard (non-hydrolysed) cow's milk formula.\nData collection and analysis\nTwo review authors assessed trial eligibility and risk of bias and extracted data independently. We analysed treatment effects as described in the individual trials and reported risk ratios and risk differences for dichotomous data, and mean differences for continuous data, with respective 95% confidence intervals (CIs). We used a fixed-effect model in meta-analyses and explored potential causes of heterogeneity in sensitivity analyses. We assessed quality of evidence at the outcome level using the GRADE approach.\nMain results\nWe identified 11 trials for inclusion in the review. All trials were small (total participants 665) and had various methodological limitations including uncertainty about methods to ensure allocation concealment and blinding. Most participants were clinically stable preterm infants of less than about 34 weeks' gestational age or with birth weight less than about 1750 g. Fewer participants were extremely preterm, extremely low birth weight, or growth restricted. Most trials found no effects on feed intolerance, assessed variously as mean pre-feed gastric residual volume, incidence of abdominal distension or other gastrointestinal signs of concern, or time taken to achieve full enteral feeds (meta-analysis was limited because studies used different measures). Meta-analysis showed no effect on the risk of necrotising enterocolitis (typical risk ratio 1.10, 95% CI 0.36 to 3.34; risk difference 0.00, 95% CI -0.03 to 0.04; 5 trials, 385 infants) (low-certainty evidence; downgraded for imprecision and design weaknesses).\nAuthors' conclusions\nThe identified trials provide only low-certainty evidence about the effects of feeding preterm infants protein hydrolysate versus standard formula. Existing data do not support conclusions that feeding protein hydrolysate affects the risk of feed intolerance or necrotising enterocolitis. Additional large, pragmatic trials are needed to provide more reliable and precise estimates of effectiveness and cost-effectiveness.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Currently available evidence suggests that feeding preterm infants hydrolysed formula (rather than standard formula) during their initial hospital admission has no important benefits or harms. However, this finding is not yet conclusive, and larger trials of better quality are needed to provide evidence to help clinicians and families make informed choices about this issue."
}
] |
query-laysum
|
22002
|
[
{
"role": "user",
"content": "Abstract: Background\nEndotracheal intubation is a commonly performed procedure in neonates, the risks of which are well-described. Some endotracheal tubes (ETT) are equipped with a cuff that can be inflated after insertion of the ETT in the airway to limit leak or aspiration. Cuffed ETTs have been shown in larger children and adults to reduce gas leak around the ETT, ETT exchange, accidental extubation, and exposure of healthcare workers to anesthetic gas during surgery. With improved understanding of neonatal airway anatomy and the widespread use of cuffed ETTs by anesthesiologists, the use of cuffed tubes is increasing in neonates.\nObjectives\nTo assess the benefits and harms of cuffed ETTs (inflated or non-inflated) compared to uncuffed ETTs for respiratory support in neonates.\nSearch methods\nWe searched CENTRAL, PubMed, and CINAHL on 20 August 2021; we also searched trial registers and checked reference lists to identify additional studies.\nSelection criteria\nWe included randomized controlled trials (RCTs), quasi-RCTs, and cluster-randomized trials comparing cuffed (inflated and non-inflated) versus uncuffed ETTs in newborns. We sought to compare 1. inflated, cuffed versus uncuffed ETT; 2. non-inflated, cuffed versus uncuffed ETT; and 3. inflated, cuffed versus non-inflated, cuffed ETT.\nData collection and analysis\nWe used the standard methods of Cochrane Neonatal. Two review authors independently assessed studies identified by the search strategy for inclusion, extracted data, and assessed risk of bias. We used the GRADE approach to assess the certainty of evidence.\nMain results\nWe identified one eligible RCT for inclusion that compared the use of cuffed (inflated if ETT leak greater than 20% with cuff pressure 20 cm H2O or less) versus uncuffed ETT. The author provided a spreadsheet with individual data. Among 76 infants in the original manuscript, 69 met the inclusion and exclusion criteria for this Cochrane Review. We found possible bias due to lack of blinding and other bias.\nWe are very uncertain about frequency of postextubation stridor, because the confidence intervals (CI) of the risk ratio (RR) were very wide (RR 1.36, 95% CI 0.35 to 5.25; risk difference (RD) 0.03, −0.11 to 0.18; 1 study, 69 participants; very low-certainty evidence).\nNo neonate was diagnosed with postextubation subglottic stenosis; however, endoscopy was not available to confirm the clinical diagnosis.\nWe are very uncertain about reintubation for stridor or subglottic stenosis because the CIs of the RR were very wide (RR 0.27, 95% CI 0.01 to 6.49; RD −0.03, 95% CI −0.11 to 0.05; 1 study, 69 participants; very low-certainty evidence).\nNo neonate had surgical intervention (e.g. endoscopic balloon dilation, cricoid split, tracheostomy) for stridor or subglottic stenosis (1 study, 69 participants).\nNeonates randomized to cuffed ETT may be less likely to have a reintubation for any reason (RR 0.06, 95% CI 0.01 to 0.45; RD −0.39, 95% CI −0.57 to −0.21; number needed to treat for an additional beneficial outcome 3, 95% CI 2 to 5; 1 study, 69 participants; very low-certainty evidence).\nWe are very uncertain about accidental extubation because the CIs of the RR were wide (RR 0.82, 95% CI 0.12 to 5.46; RD −0.01, 95% CI −0.12 to 0.10; 1 study, 69 participants; very low-certainty evidence).\nWe are very uncertain about all-cause mortality during initial hospitalization because the CIs of the RR were extremely wide (RR 2.46, 95% CI 0.10 to 58.39; RD 0.03, 95% CI −0.05 to 0.10; 1 study, 69 participants; very low-certainty evidence).\nThere is one ongoing trial. We classified two studies as awaiting classification because outcome data were not reported separately for newborns and older infants.\nAuthors' conclusions\nEvidence for comparing cuffed versus uncuffed ETTs in neonates is limited by a small number of babies in a single RCT with possible bias. There is very low certainty evidence for all outcomes of this review. CIs of the estimate for postextubation stridor were wide. No neonate had clinical evidence for subglottic stenosis; however, endoscopy results were not available to assess the anatomy.\nAdditional RCTs are necessary to evaluate the benefits and harms of cuffed ETTs (inflated and non-inflated) in the neonatal population. These studies must include neonates and be conducted both for short-term use (in the setting of the operating room) and chronic use (in the setting of chronic lung disease) of cuffed ETTs.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "newborn babies rarely need a tube placed in the windpipe; however, this may occur before a procedure or to help with breathing. The tube may or may not have a cuff. The standard of care in newborn babies is a tube without a cuff. Cuffed tubes are used more frequently in older babies and children to reduce leaks of gas around the tube, the risk of aspiration (breathing food, saliva, or stomach contents into the airways or lungs), the need to change the tube, or the tube coming out."
}
] |
query-laysum
|
22003
|
[
{
"role": "user",
"content": "Abstract: Background\nPosterior capsule opacification (PCO) is a clouding of the posterior part of the lens capsule, a skin-like transparent structure, which surrounds the crystalline lens in the human eye. PCO is the most common postoperative complication following modern cataract surgery with implantation of a posterior chamber intraocular lens (IOL). The main symptoms of PCO are a decrease in visual acuity, 'cloudy', blurred vision and reduced contrast sensitivity. PCO is treated with a neodymium:YAG (Nd:YAG) laser to create a small opening in the opaque capsule and regain a clear central visual axis. This capsulotomy might cause further ocular complications, such as raised intraocular pressure or swelling of the central retina (macular oedema). This procedure is also a significant financial burden for health care systems worldwide. In recent decades, there have been advances in the selection of IOL materials and optimisation of IOL designs to help prevent PCO formation after cataract surgery. These include changes to the side structures holding the lens in the centre of the lens capsule bag, called IOL haptics, and IOL optic edge designs.\nObjectives\nTo compare the effects of different IOL optic edge designs on PCO after cataract surgery.\nSearch methods\nWe searched CENTRAL, Ovid MEDLINE, Ovid Embase, Latin American and Caribbean Health Sciences Literature Database (LILACS), the ISRCTN registry, ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) up to 17 November 2020.\nSelection criteria\nWe included randomised controlled trials (RCTs) that compared different types of IOL optic edge design. Our prespecified primary outcome was the proportion of eyes with Nd:YAG capsulotomy one year after surgery. Secondary outcomes included PCO score, best-corrected distance visual acuity (BCDVA) and quality of life score at one year. Due to availability of important long-term data, we also presented data at longer-term follow-up which is a post hoc change to our protocol.\nData collection and analysis\nWe used standard methods expected by Cochrane and the GRADE approach to assess the certainty of the evidence.\nMain results\nWe included 10 studies (1065 people, 1834 eyes) that compared sharp- and round-edged IOLs. Eight of these studies were within-person studies whereby one eye received a sharp-edged IOL and the fellow eye a round-edged IOL. The IOL materials were acrylic (2 studies), silicone (4 studies), polymethyl methacrylate (PMMA, 3 studies) and different materials (1 study). The studies were conducted in Austria, Germany, India, Japan, Sweden and the UK. Five studies were at high risk of bias in at least one domain. We judged two studies to be at low risk of bias in all domains.\nThere were few cases of Nd:YAG capsulotomy at one year (primary outcome): 1/371 in sharp-edged and 4/371 in round-edged groups. The effect estimate was in favour of sharp-edged IOLs but the confidence intervals were very wide and compatible with higher or lower chance of Nd:YAG capsulotomy in sharp-edged compared with round-edged lenses (Peto odds ratio (OR) 0.30, 95% CI 0.05 to 1.74; I2 = 0%; 6 studies, 742 eyes). This corresponds to seven fewer cases of Nd:YAG capsulotomy per 1000 sharp-edged IOLs inserted compared with round-edged IOLs (95% CI 9 fewer to 7 more). We judged this as low-certainty evidence, downgrading for imprecision and risk of bias.\nA similar reduced risk of Nd:YAG capsulotomy in sharp-edge compared with round-edge IOLs was seen at two, three and five years but as the number of Nd:YAG capsulotomy events increased with longer follow-up this effect was more precisely measured at longer follow-up: two years, risk ratio (RR) 0.35 (0.16 to 0.80); 703 eyes (6 studies); 89 fewer cases per 1000; three years, RR 0.21 (0.11 to 0.41); 538 eyes (6 studies); 170 fewer cases per 1000; five years, RR 0.21 (0.10 to 0.45); 306 eyes (4 studies); 331 fewer cases per 1000. Data at 9 years and 12 years were only available from one study.\nAll studies reported a PCO score. Four studies reported the AQUA (Automated Quantification of After-Cataract) score, four studies reported the EPCO (Evaluation of PCO) score and two studies reported another method of quantifying PCO. It was not possible to pool these data due to the way they were reported, but all studies consistently reported a statistically significant lower average PCO score (of the order of 0.5 to 3 units) with sharp-edged IOLs compared with round-edged IOLs. We judged this to be moderate-certainty evidence downgrading for risk of bias.\nThe logMAR visual acuity score was lower (better) in eyes that received a sharp-edged IOL but the difference was small and likely to be clinically unimportant at one year (mean difference (MD) -0.06 logMAR, 95% CI -0.12 to 0; 2 studies, 153 eyes; low-certainty evidence). Similar effects were seen at longer follow-up periods but non-statistically significant data were less fully reported: two years MD -0.01 logMAR (-0.05 to 0.02); 2 studies, 311 eyes; three years MD -0.09 logMAR (-0.22 to 0.03); 2 studies, 117 eyes; data at five years only available from one study.\nNone of the studies reported quality of life. Very low-certainty evidence on adverse events did not suggest any important differences between the groups.\nAuthors' conclusions\nThis review provides evidence that sharp-edged IOLs are likely to be associated with less PCO formation than round-edged IOLs, with less Nd:YAG capsulotomy. The effects on visual acuity were less certain. The impact of these lenses on quality of life has not been assessed and there are only very low-certainty comparative data on adverse events.\n\nGiven the provided abstract, please respond to the following query: \"What we found\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found 10 studies involving 1065 people with age-related cataracts who had surgery to replace the lens in 1834 eyes. The studies took place in Austria, Germany, India, Japan, Sweden and the UK. The studies lasted for at least one year. Some studies followed participants for up to 12 years after their surgery.\nThe studies compared replacement lenses with rounded edges against replacement lenses with sharp edges.\nA pharmaceutical company funded one study and partly funded another study."
}
] |
query-laysum
|
22004
|
[
{
"role": "user",
"content": "Abstract: Background\nEndocrine therapy is effective at preventing or treating breast cancer. Some forms of endocrine therapy have been shown to reduce mammographic density. Reduced mammographic density for women receiving endocrine therapy could be used to estimate the chance of breast cancer returning or developing breast cancer in the first instance (a prognostic biomarker). In addition, changes in mammographic density might be able to predict how well a woman responds to endocrine therapy (a predictive biomarker). The role of breast density as a prognostic or predictive biomarker could help improve the management of breast cancer.\nObjectives\nTo assess the evidence that a reduction in mammographic density following endocrine therapy for breast cancer prevention in women without previous breast cancer, or for treatment in women with early-stage hormone receptor-positive breast cancer, is a prognostic or predictive biomarker.\nSearch methods\nWe searched the Cochrane Breast Cancer Group Specialised Register, CENTRAL, MEDLINE, Embase, and two trials registers on 3 August 2020 along with reference checking, bibliographic searching, and contact with study authors to obtain further data.\nSelection criteria\nWe included randomised, cohort and case-control studies of adult women with or without breast cancer receiving endocrine therapy. Endocrine therapy agents included were selective oestrogen receptor modulators and aromatase inhibitors. We required breast density before start of endocrine therapy and at follow-up. We included studies published in English.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. Two review authors independently extracted data and assessed risk of bias using adapted Quality in Prognostic Studies (QUIPS) and Risk Of Bias In Non-randomised Studies - of Interventions (ROBINS-I) tools. We used the GRADE approach to evaluate the certainty of the evidence. We did not perform a quantitative meta-analysis due to substantial heterogeneity across studies.\nMain results\nEight studies met our inclusion criteria, of which seven provided data on outcomes listed in the protocol (5786 women). There was substantial heterogeneity across studies in design, sample size (349 to 1066 women), participant characteristics, follow-up (5 to 14 years), and endocrine therapy agent. There were five breast density measures and six density change definitions. All studies had at least one domain as at moderate or high risk of bias. Common concerns were whether the study sample reflected the review target population, and likely post hoc definitions of breast density change.\nMost studies on prognosis for women receiving endocrine therapy reported a reduced risk associated with breast density reduction. Across endpoints, settings, and agents, risk ratio point estimates (most likely value) were between 0.1 and 1.5, but with substantial uncertainty. There was greatest consistency in the direction and magnitude of the effect for tamoxifen (across endpoints and settings, risk ratio point estimates were between 0.3 and 0.7). The findings are summarised as follows.\nPrognostic biomarker findings:\nTreatment\nBreast cancer mortality\nTwo studies of 823 women on tamoxifen (172 breast cancer deaths) reported risk ratio point estimates of ~0.4 and ~0.5 associated with a density reduction. The certainty of the evidence was low.\nRecurrence\nTwo studies of 1956 women on tamoxifen reported risk ratio point estimates of ~0.4 and ~0.7 associated with a density reduction. There was risk of bias in methodology for design and analysis of the studies and considerable uncertainty over the size of the effect.\nOne study of 175 women receiving an aromatase inhibitor reported a risk ratio point estimate of ~0.1 associated with a density reduction. There was considerable uncertainty about the effect size and a moderate or high risk of bias in all domains.\nOne study of 284 women receiving exemestane or tamoxifen as part of a randomised controlled trial reported risk ratio point estimates of ~1.5 (loco-regional recurrence) and ~1.3 (distance recurrence) associated with a density reduction. There was risk of bias in reporting and study confounding, and uncertainty over the size of the effects.\nThe certainty of the evidence for all recurrence endpoints was very low.\nIncidence of a secondary primary breast cancer\nTwo studies of 451 women on exemestane, tamoxifen, or unknown endocrine therapy reported risk ratio point estimates of ~0.5 and ~0.6 associated with a density reduction. There was risk of bias in reporting and study confounding, and uncertainty over the effect size. The certainty of the evidence was very low.\nWe were unable to find data regarding the remaining nine outcomes prespecified in the review protocol.\nPrevention\nIncidence of invasive breast cancer and ductal carcinoma in situ (DCIS)\nOne study of 507 women without breast cancer who were receiving preventive tamoxifen as part of a randomised controlled trial (51 subsequent breast cancers) reported a risk ratio point estimate of ~0.3 associated with a density reduction. The certainty of the evidence was low.\nPredictive biomarker findings:\nOne study of a subset of 1065 women from a randomised controlled trial assessed how much the effect of endocrine therapy could be explained by breast density declines in those receiving endocrine therapy. This study evaluated the prevention of invasive breast cancer and DCIS. We found some evidence to support the hypothesis, with a risk ratio interaction point estimate ~0.5. However, the 95% confidence interval included unity, and data were based on 51 women with subsequent breast cancer in the tamoxifen group. The certainty of the evidence was low.\nAuthors' conclusions\nThere is low-/very low-certainty evidence to support the hypothesis that breast density change following endocrine therapy is a prognostic biomarker for treatment or prevention. Studies suggested a potentially large effect size with tamoxifen, but the evidence was limited. There was less evidence that breast density change following tamoxifen preventive therapy is a predictive biomarker than prognostic biomarker. Evidence for breast density change as a prognostic treatment biomarker was stronger for tamoxifen than aromatase inhibitors. There were no studies reporting mammographic density change following endocrine therapy as a predictive biomarker in the treatment setting, nor aromatase inhibitor therapy as a prognostic or predictive biomarker in the preventive setting. Further research is warranted to assess mammographic density as a biomarker for all classes of endocrine therapy and review endpoints.\n\nGiven the provided abstract, please respond to the following query: \"What is the issue?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Breast cancer is a common cancer and cause of death in women worldwide. Treatment options for breast cancer include endocrine therapy. Endocrine therapy can also be used to prevent breast cancer for women who have not been diagnosed with breast cancer. It would help doctors and their patients to understand whether some patients are likely to have greater benefit from endocrine therapy than others. The structure of the breast is likely to change following endocrine therapy. These structural changes are seen when women have a mammogram (breast x-ray). They appear as a decrease in the area of white tissue (breast density) on the mammogram. We wanted to find out whether reductions in breast density after endocrine therapy can help to determine how well endocrine therapy works."
}
] |
query-laysum
|
22005
|
[
{
"role": "user",
"content": "Abstract: Background\nTuberculosis (TB) is an important cause of illness and death in HIV-positive children living in areas of high TB prevalence. We know that isoniazid prophylaxis prevents TB in HIV-negative children following TB exposure, but there is uncertainty related to its role in TB preventive treatment in HIV-positive children.\nObjectives\nTo summarise the effects of TB preventive treatment versus placebo in HIV-positive children with no known TB contact on active TB, death, and reported adverse events.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE/PubMed, Embase and two trial registers up to February 2017.\nSelection criteria\nWe included trials of HIV-positive children with and without known TB exposure, randomized to receive TB preventive treatment or placebo.\nData collection and analysis\nTwo review authors independently used the study selection criteria, assessed risk of bias, and extracted data. We assessed effects using risk, incidence rate and hazard ratios and assessed the certainty of evidence using GRADE.\nMain results\nWe included three trials, involving 991 participants, below the age of 13 years, from South Africa and Botswana. Children were randomized to isoniazid prophylaxis or placebo, given daily or three times weekly. The median length of follow-up ranged from 5.7 to 34 months; some were on antiretroviral therapy (ART).\nIn HIV-positive children not on ART, isoniazid prophylaxis may reduce the risk of active TB (hazard ratio (HR) 0.31, 95% confidence interval (CI) 0.11 to 0.87; 1 trial, 240 participants, low certainty evidence), and death (HR 0.46, 95% CI 0.22 to 0.95; 1 trial, 240 participants, low certainty evidence). One trial (182 participants) reported number of children with laboratory adverse events, which was similar between the isoniazid prophylaxis and placebo groups. No clinical adverse events were reported.\nIn HIV-positive children on ART, we do not know if isoniazid prophylaxis reduces the risk of active TB (risk ratio (RR) 0.76, 95% CI 0.50 to 1.14; 3 trials, 737 participants, very low certainty evidence) or death (RR 1.45, 95% CI 0.78 to 2.72; 3 trials, 737 participants, very low certainty evidence). Two trials (714 participants) reported number of clinical adverse events and three trials (795 participants) reported number of laboratory adverse events; for both categories, the number of adverse events were similar between the isoniazid prophylaxis and placebo groups.\nAuthors' conclusions\nIsoniazid prophylaxis given to all children diagnosed with HIV may reduce the risk of active TB and death in HIV-positive children not on ART in studies from Africa. For children on ART, no clear benefit was detected. .\n\nGiven the provided abstract, please respond to the following query: \"What was the aim of this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "To summarise the effects of isoniazid prophylaxis on TB, death, and adverse effects in HIV-positive children."
}
] |
query-laysum
|
22006
|
[
{
"role": "user",
"content": "Abstract: Background\nThe increased birth rate of twins during recent decades and the improved prognosis of preterm infants have resulted in the need to explore measures that could optimize their growth and neurodevelopmental outcomes. It has been postulated that co-bedding simulates twins' intrauterine experiences in which co-regulatory behaviors between them are observed. These behaviors are proposed to benefit twins by reducing their stress, which may promote growth and development. However, in practice, uncertainty surrounds the benefit-risk profile of co-bedding.\nObjectives\nWe aimed to assess the effectiveness of co-bedding compared with separate (individual) care for stable preterm twins in the neonatal nursery in promoting growth and neurodevelopment and reducing short- and long-term morbidities, and to determine whether co-bedding is associated with significant adverse effects.\nAs secondary objectives, we sought to evaluate effects of co-bedding via the following subgroup analyses: twin pairs with different weight ranges (very low birth weight [VLBW] < 1500 grams vs non-VLBW), twins with versus without significant growth discordance at birth, preterm versus borderline preterm twins, twins co-bedded in incubator versus cot at study entry, and twins randomized by twin pair versus neonatal unit.\nSearch methods\nWe used the standard search strategy of the Cochrane Neonatal Review Group (CNRG). We used keywords and medical subject headings (MeSH) to search the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 2), MEDLINE (via PubMed), EMBASE (hosted by EBSCOHOST), the Cumulative Index to Nursing and Allied Health Literature (CINAHL), and references cited in our short-listed articles, up to February 29, 2016.\nSelection criteria\nWe included randomized controlled trials with randomization by twin pair and/or by neonatal unit. We excluded cross-over studies.\nData collection and analysis\nWe extracted data using standard methods of the CNRG. Two review authors independently assessed the relevance and risk of bias of retrieved records. We contacted the authors of included studies to request important information missing from their published papers. We expressed our results using risk ratios (RRs) and mean differences (MDs) when appropriate, along with 95% confidence intervals (95% CIs). We adjusted the unit of analysis from individual infants to twin pairs by averaging measurements for each twin pair (continuous outcomes) or by counting outcomes as positive if developed by either twin (dichotomous outcomes).\nMain results\nSix studies met the inclusion criteria; however, only five studies provided data for analysis. Four of the six included studies were small and had significant limitations in design. As each study reported outcomes differently, data for most outcomes were effectively contributed by a single study. Study authors reported no differences between co-bedded twins and twins receiving separate care in terms of rate of weight gain (MD 0.20 grams/kg/d, 95% CI -1.60 to 2.00; one study; 18 pairs of twins; evidence of low quality); apnea, bradycardia, and desaturation (A/B/D) episodes (RR 0.85, 95% CI 0.18 to 4.05; one study; 62 pairs of twins; evidence of low quality); episodes in co-regulated states (MD 0.96, 95% CI -3.44 to 5.36; one study; three pairs of twins; evidence of very low quality); suspected or proven infection (RR 0.84, 95% CI 0.30 to 2.31; three studies; 65 pairs of twins; evidence of very low quality); length of hospital stay (MD -4.90 days, 95% CI -35.23 to 25.43; one study; three pairs of twins; evidence of very low quality); and parental satisfaction measured on a scale of 0 to 55 (MD -0.38, 95% CI -4.49 to 3.73; one study; nine pairs of twins; evidence of moderate quality). Although co-bedded twins appeared to have lower pain scores 30 seconds after heel lance on a scale of 0 to 21 (MD -0.96, 95% CI -1.68 to -0.23; two studies; 117 pairs of twins; I2 = 75%; evidence of low quality), they had higher pain scores 90 seconds after the procedure (MD 1.00, 95% CI 0.14 to 1.86; one study; 62 pairs of twins). Substantial heterogeneity in the outcome of infant pain response after heel prick at 30 seconds post procedure and conflicting results at 30 and 90 seconds post procedure precluded clear conclusions.\nAuthors' conclusions\nEvidence on the benefits and harms of co-bedding for stable preterm twins was insufficient to permit recommendations for practice. Future studies must be adequately powered to detect clinically important differences in growth and neurodevelopment. Researchers should assess harms such as infection, along with medication errors and caregiver satisfaction.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Preterm twins are at high risk for problems in growth and development. Co-bedding (placement of twins in the same cot or incubator) has been proposed to benefit twins because it simulates the environment that they shared before birth, in which twins have been seen to support each other through a series of observed activities, termed \"co-regulation.\" These activities have been proposed to promote growth and brain development when they are allowed to continue after birth. Risks of placing twins in the same incubator or cot include caregiver error and infection."
}
] |
query-laysum
|
22007
|
[
{
"role": "user",
"content": "Abstract: Background\nAppendicitis remains a difficult disease to diagnose, and imaging adjuncts are commonly employed. Magnetic resonance imaging (MRI) is an imaging test that can be used to diagnose appendicitis. It is not commonly regarded as a first-line imaging test for appendicitis, but the reported diagnostic accuracy in some studies is equivalent to computed tomography (CT) scans. As it does not expose patients to radiation, it is an attractive imaging modality, particularly in women and children.\nObjectives\nThe primary objective was to determine the diagnostic accuracy of MRI for detecting appendicitis in all patients.\nSecondary objectives:\nTo investigate the accuracy of MRI in subgroups of pregnant women, children, and adults.\nTo investigate the potential influence of MRI scanning variables such as sequences, slice thickness, or field of view.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and Embase until February 2021. We searched the references of included studies and other systematic reviews to identify further studies. We did not exclude studies that were unpublished, published in another language, or retrospective.\nSelection criteria\nWe included studies that compared the outcome of an MRI scan for suspected appendicitis with a reference standard of histology, intraoperative findings, or clinical follow-up. Three study team members independently filtered search results for eligible studies.\nData collection and analysis\nWe independently extracted study data and assessed study quality using the Quality Assessment of Studies of Diagnostic Accuracy - Revised (QUADAS-2) tool. We used the bivariate model to calculate pooled estimates of sensitivity and specificity.\nMain results\nWe identified 58 studies with sufficient data for meta-analysis including a total of 7462 participants (1980 with and 5482 without acute appendicitis). Estimates of sensitivity ranged from 0.18 to 1.0; estimates of specificity ranged from 0.4 to 1.0. Summary sensitivity was 0.95 (95% confidence interval (CI) 0.94 to 0.97); summary specificity was 0.96 (95% CI 0.95 to 0.97). Sensitivity and specificity remained high on subgroup analysis for pregnant women (sensitivity 0.96 (95% CI 0.88 to 0.99); specificity 0.97 (95% CI 0.95 to 0.98); 21 studies, 2282 women); children (sensitivity 0.96 (95% CI 0.95 to 0.97); specificity 0.96 (95% CI 0.92 to 0.98); 17 studies, 2794 children); and adults (sensitivity 0.96 (95% CI 0.93 to 0.97); specificity 0.93 (95% CI 0.80 to 0.98); 9 studies, 1088 participants), as well as different scanning techniques. In a hypothetical cohort of 1000 patients, there would be 12 false-positive results and 30 false-negative results. Methodological quality of the included studies was poor, and the risk of bias was high or unclear in 53% to 83% of the QUADAS-2 domains.\nAuthors' conclusions\nMRI appears to be highly accurate in confirming and excluding acute appendicitis in adults, children, and pregnant women regardless of protocol. The methodological quality of the included studies was generally low due to incomplete and low standards of follow-up, so summary estimates of sensitivity and specificity may be biased. We could not assess the impact and direction of potential bias given the very low number of high-quality studies. Studies comparing MRI protocols were few, and although we found no influence of MRI protocol variables on the summary estimates of accuracy, our results do not rule out that some MRI protocols are more accurate than others.\n\nGiven the provided abstract, please respond to the following query: \"What was studied in this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We studied the accuracy of MRI for appendicitis in all patients."
}
] |
query-laysum
|
22008
|
[
{
"role": "user",
"content": "Abstract: Background\nParenteral nutrition solutions, artificial formulas, and human breast milk contain insufficient iodine to meet recommended intakes for preterm infants. Iodine deficiency may exacerbate transient hypothyroxinaemia in preterm infants and this may be associated with adverse neonatal and longer-term outcomes.\nObjectives\nTo assess the evidence from randomised controlled trials that dietary supplementation with iodine reduces mortality and morbidity in preterm infants.\nSearch methods\nWe used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL 2018, Issue 1), Ovid MEDLINE, Ovid Embase, Ovid Maternity & Infant Care Database, and CINAHL to February 2018. We searched clinical trials databases, conference proceedings, and the reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials.\nSelection criteria\nRandomised or quasi-randomised controlled trials that compared supplementing enteral or parenteral feeds with iodine (as iodide salt) versus placebo or no supplementation in preterm infants.\nData collection and analysis\nTwo review authors independently assessed trial eligibility and risk of bias, and extracted data. We analysed treatment effects as described in the individual trials and reported risk ratios (RR) and risk differences for dichotomous data, and mean differences (MD) for continuous data, with 95% confidence intervals (CI). We used a fixed-effect model in meta-analyses and planned to explore potential causes of heterogeneity in sensitivity analyses. We used the GRADE approach to assess the quality of evidence.\nMain results\nTwo randomised controlled trials fulfilled the eligibility criteria. Both trials used methods to limit bias including allocation concealment and blinding of clinicians and investigators to the allocated intervention. The trials enrolled 1394 infants. One trial recruited 1273 participants. Most participants were born very preterm (less than 32 weeks' gestation) and about one-third were extremely preterm (less than 28 weeks' gestation). Analyses found no effect of iodine supplementation on mortality before hospital discharge (typical RR 1.01, 95% CI 0.72 to 1.42; typical RD 0.00, 95% CI -0.03 to 0.03; 2 studies, 1380 infants) or on neurodevelopmental assessments at two years post-term (Bayley Scales of Infant and Toddler Development, Third Edition main domain composite scores: cognitive: MD –0.30, 95% CI –2.44 to 1.84; motor: MD 0.20, 95% CI –2.15 to 2.55; language: MD –0.10, 95% CI –2.50 to 2.30; 1 study, 1259 infants). There were no differences in the proportion of infants who died or had a composite score less than 85 in any main Bayley domain (RR 1.05, 95% CI 0.94 to 1.17; RD 0.02 95% CI -0.03 to 0.08; 1 study, 1259 infants), or had visual impairment (RR 0.63, 95% CI 0.28 to 1.45; RD -0.01 95% CI -0.03 to 0.01; 1 study, 1092 infants) or auditory impairment (RR 1.05, 95% CI 0.51 to 2.16; RD 0.00 95% CI -0.02 to 0.02 1 study, 1093 infants). Using GRADE methods, we assessed the evidence for the effects on mortality and neurodevelopment outcomes as high-certainty.\nAuthors' conclusions\nThe available trial data, predominantly from one large, high-quality multicentre study published in 2017, do not show any evidence of beneficial effects of iodine supplementation for preterm infants. Given the high certainty of these estimates of effect, further trials of this intervention in this population are unlikely to be considered research priorities.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Infants born preterm (several weeks early) may not receive the recommended amounts of iodine in their diet, as both preterm human breast milk and nutrition given via a drip in hospitals do not contain enough iodine to meet their heightened needs. Deficiency of iodine may affect the production of thyroid hormones that are important for brain and lung development in newborn infants. Given concerns that iodine deficiency may be harmful, we reviewed all the available evidence from clinical trials that assessed the effects of giving preterm infants iodine supplements."
}
] |
query-laysum
|
22009
|
[
{
"role": "user",
"content": "Abstract: Background\nAnaesthetic drugs during general anaesthesia are titrated according to sympathetic or somatic responses to surgical stimuli. It is now possible to measure depth of anaesthesia using electroencephalography (EEG). Entropy, an EEG-based monitor can be used to assess the depth of anaesthesia using a strip of electrodes applied to the forehead, and this can guide intraoperative anaesthetic drug administration.\nObjectives\nThe primary objective of this review was to assess the effectiveness of entropy monitoring in facilitating faster recovery from general anaesthesia. We also wanted to assess mortality at 24 hours, 30 days, and one year following general anaesthesia with entropy monitoring.\nThe secondary objectives were to assess the effectiveness of the entropy monitor in: preventing postoperative recall of intraoperative events (awareness) following general anaesthesia; reducing the amount of anaesthetic drugs used; reducing cost of the anaesthetic as well as in reducing time to readiness to leave the postanaesthesia care unit (PACU).\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2014, Issue 10), MEDLINE via Ovid SP (1990 to September 2014) and EMBASE via Ovid SP (1990 to September 2014). We reran the search in CENTRAL, MEDLINE via Ovid SP and EMBASE via Ovid SP in January 2016. We added one potential new study of interest to the list of ‘Studies awaiting Classification' and we will incorporate this study into the formal review findings during the review update.\nSelection criteria\nWe included randomized controlled trials (RCTs) conducted in adults and children (aged greater than two years of age), where in one arm entropy monitoring was used for titrating anaesthesia, and in the other standard practice (increase in heart rate, mean arterial pressure, lacrimation, movement in response to noxious surgical stimuli) was used for titrating anaesthetic drug administration. We also included trials with an additional third arm, wherein another EEG monitor, the Bispectral index (BIS) monitor was used to assess anaesthetic depth.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. Two review authors independently extracted details of trial methodology and outcome data from trials considered eligible for inclusion. All analyses were made on an intention-to-treat basis. We used a random-effect model where there was heterogeneity. For assessments of the overall quality of evidence for each outcome that included pooled data from RCTs, we downgraded evidence from 'high quality' by one level for serious (or by two for very serious) study limitations (risk of bias, indirectness of evidence, serious inconsistency, imprecision of effect or potential publication bias).\nMain results\nWe included 11 RCTs (962 participants). Eight RCTs (762 participants) were carried out on adults (18 to 80 years of age), two (128 participants) involved children (two to 16 years) and one RCT (72 participants) included patients aged 60 to 75 years. Of the 11 included studies, we judged three to be at low risk of bias, and the remaining eight RCTs at unclear or high risk of bias.\nSix RCTs (383 participants) estimated the primary outcome, time to awakening after stopping general anaesthesia, which was reduced in the entropy as compared to the standard practice group (mean difference (MD) -5.42 minutes, 95% confidence interval (CI) -8.77 to -2.08; moderate quality of evidence). We noted heterogeneity for this outcome; on performing subgroup analysis this was found to be due to studies that included participants undergoing major, long duration surgeries (off-pump coronary artery bypass grafting, major urological surgery). The MD for time to awakening with four studies on ambulatory procedures was -3.20 minutes (95% CI -3.94 to -2.45). No trial reported the second primary outcome, mortality at 24 hours, 30 days, and one year with the use of entropy monitoring.\nEight trials (797 participants) compared the secondary outcome, postoperative recall of intraoperative events (awareness) in the entropy and standard practice groups. Awareness was reported by only one patient in the standard practice group, making meaningful estimation of benefit of entropy monitoring difficult; moderate quality of evidence.\nAll 11 RCTs compared the amount of anaesthetic agent used between the entropy and standard practice groups. Six RCTs compared the amount of propofol, four compared the amount of sevoflurane and one the amount of isoflurane used between the groups. Analysis of three studies (166 participants) revealed that the MD of propofol consumption between the entropy group and control group was -11.56 mcg/kg/min (95% CI -24.05 to 0.92); low quality of evidence. Analysis of another two studies (156 participants) showed that the MD in sevoflurane consumption in the entropy group compared to the control group was -3.42 mL (95% CI -6.49 to -0.35); moderate quality of evidence.\nNo trial reported on the secondary outcome of the cost of general anaesthesia.\nThree trials (170 participants) estimated MD in time to readiness to leave the PACU of the entropy group as compared to the control group (MD -5.94 minutes, 95% CI -16.08 to 4.20; low quality of evidence). Heterogeneity was noted, which was due to the difference in anaesthetic technique (propofol-based general anaesthesia) in one study. The remaining two studies had used volatile-based general anaesthesia. The MD in time to readiness to leave the PACU was -4.17 minutes (95% CI -6.84 to -1.51) with these two studies.\nAuthors' conclusions\nThe evidence as regards time to awakening, recall of intraoperative awareness and reduction in inhalational anaesthetic agent use was of moderate quality. The quality of evidence of as regards reduction in intravenous anaesthetic agent (propofol) use, as well as time to readiness to leave the PACU was found to be of low quality. As the data are limited, further studies consisting of more participants will be required for ascertaining benefits of entropy monitoring.\nFurther studies are needed to assess the effect of entropy monitoring on focal issues such as short-term and long-term mortality, as well as cost of general anaesthesia.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "General anaesthesia is a reversible state of unconsciousness produced by administering anaesthetic medicines that enable patients to undergo surgery without pain or recollection of intraoperative events. Electroencephalography (EEG) is a method whereby sensors attached on the scalp are used to pick up and record electrical activity of the brain. The entropy monitor measures the irregularity of the processed EEG signals and displays it as a numerical value, denoting level of anaesthesia.\nToo little anaesthesia can cause the patient to awaken during surgery, feel pain, hear conversations and realize that they are paralysed. Recollection of these experiences after awakening can lead to severe mental distress, anxiety and inability to function normally. Excessive anaesthesia can lead to delayed awakening and increased anaesthetic costs, as well as contribute to an increase in incidence of death within 24 hours, or up to a year after surgery.\nAn entropy monitor, by displaying values indicating adequate level of anaesthesia, can guide anaesthetic medicine administration, without increasing chances of awakening during surgery. Further, it can facilitate faster awakening at the end of surgery, reduce costs and decrease chances of death."
}
] |
query-laysum
|
22010
|
[
{
"role": "user",
"content": "Abstract: Background\nHip fracture is a major cause of morbidity and mortality in older people, and its impact on society is substantial. After surgery, people require rehabilitation to help them recover. Multidisciplinary rehabilitation is where rehabilitation is delivered by a multidisciplinary team, supervised by a geriatrician, rehabilitation physician or other appropriate physician. This is an update of a Cochrane Review first published in 2009.\nObjectives\nTo assess the effects of multidisciplinary rehabilitation, in either inpatient or ambulatory care settings, for older people with hip fracture.\nSearch methods\nWe searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register, CENTRAL, MEDLINE and Embase (October 2020), and two trials registers (November 2019).\nSelection criteria\nWe included randomised and quasi-randomised trials of post-surgical care using multidisciplinary rehabilitation of older people (aged 65 years or over) with hip fracture. The primary outcome – 'poor outcome' – was a composite of mortality and decline in residential status at long-term (generally one year) follow-up. The other 'critical' outcomes were health-related quality of life, mortality, dependency in activities of daily living, mobility, and related pain.\nData collection and analysis\nPairs of review authors independently performed study selection, assessed risk of bias and extracted data. We pooled data where appropriate and used GRADE for assessing the certainty of evidence for each outcome.\nMain results\nThe 28 included trials involved 5351 older (mean ages ranged from 76.5 to 87 years), usually female, participants who had undergone hip fracture surgery. There was substantial clinical heterogeneity in the trial interventions and populations. Most trials had unclear or high risk of bias for one or more items, such as blinding-related performance and detection biases. We summarise the findings for three comparisons below.\nInpatient rehabilitation: multidisciplinary rehabilitation versus 'usual care'\nMultidisciplinary rehabilitation was provided primarily in an inpatient setting in 20 trials.\nMultidisciplinary rehabilitation probably results in fewer cases of 'poor outcome' (death or deterioration in residential status, generally requiring institutional care) at 6 to 12 months' follow-up (risk ratio (RR) 0.88, 95% confidence interval (CI) 0.80 to 0.98; 13 studies, 3036 participants; moderate-certainty evidence). Based on an illustrative risk of 347 people with hip fracture with poor outcome in 1000 people followed up between 6 and 12 months, this equates to 41 (95% CI 7 to 69) fewer people with poor outcome after multidisciplinary rehabilitation. Expressed in terms of numbers needed to treat for an additional harmful outcome (NNTH), 25 patients (95% CI 15 to 100) would need to be treated to avoid one 'poor outcome'. Subgroup analysis by type of multidisciplinary rehabilitation intervention showed no evidence of subgroup differences.\nMultidisciplinary rehabilitation may result in fewer deaths in hospital but the confidence interval does not exclude a small increase in the number of deaths (RR 0.77, 95% CI 0.58 to 1.04; 11 studies, 2455 participants; low-certainty evidence). A similar finding applies at 4 to 12 months' follow-up (RR 0.91, 95% CI 0.80 to 1.05; 18 studies, 3973 participants; low-certainty evidence). Multidisciplinary rehabilitation may result in fewer people with poorer mobility at 6 to 12 months' follow-up (RR 0.83, 95% CI 0.71 to 0.98; 5 studies, 1085 participants; low-certainty evidence).\nDue to very low-certainty evidence, we have little confidence in the findings for marginally better quality of life after multidisciplinary rehabilitation (1 study). The same applies to the mixed findings of some or no difference from multidisciplinary rehabilitation on dependence in activities of daily living at 1 to 4 months' follow-up (measured in various ways by 11 studies), or at 6 to 12 months' follow-up (13 studies). Long-term hip-related pain was not reported.\nAmbulatory setting: supported discharge and multidisciplinary home rehabilitation versus 'usual care'\nThree trials tested this comparison in 377 people mainly living at home. Due to very low-certainty evidence, we have very little confidence in the findings of little to no between-group difference in poor outcome (death or move to a higher level of care or inability to walk) at one year (3 studies); quality of life at one year (1 study); in mortality at 4 or 12 months (2 studies); in independence in personal activities of daily living (1 study); in moving permanently to a higher level of care (2 studies) or being unable to walk (2 studies). Long-term hip-related pain was not reported.\nOne trial tested this comparison in 240 nursing home residents. There is low-certainty evidence that there may be no or minimal between-group differences at 12 months in 'poor outcome' defined as dead or unable to walk; or in mortality at 4 months or 12 months. Due to very low-certainty evidence, we have very little confidence in the findings of no between-group differences in dependency at 4 weeks or at 12 months, or in quality of life, inability to walk or pain at 12 months.\nAuthors' conclusions\nIn a hospital inpatient setting, there is moderate-certainty evidence that rehabilitation after hip fracture surgery, when delivered by a multidisciplinary team and supervised by an appropriate medical specialist, results in fewer cases of 'poor outcome' (death or deterioration in residential status). There is low-certainty evidence that multidisciplinary rehabilitation may result in fewer deaths in hospital and at 4 to 12 months; however, it may also result in slightly more. There is low-certainty evidence that multidisciplinary rehabilitation may reduce the numbers of people with poorer mobility at 12 months. No conclusions can be drawn on other outcomes, for which the evidence is of very low certainty.\nThe generally very low-certainty evidence available for supported discharge and multidisciplinary home rehabilitation means that we are very uncertain whether the findings of little or no difference for all outcomes between the intervention and usual care is true.\nGiven the prevalent clinical emphasis on early discharge, we suggest that research is best orientated towards early supported discharge and identifying the components of multidisciplinary inpatient rehabilitation to optimise patient recovery within hospital and the components of multidisciplinary rehabilitation, including social care, subsequent to hospital discharge.\n\nGiven the provided abstract, please respond to the following query: \"What did we want to find out?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We wanted to know if multidisciplinary rehabilitation helps people recover better from hip fracture than usual care. We were particularly interested in how many people had a ‘poor outcome’ at up to a year after surgery; that is, whether they died or were more dependent such that they needed to be cared for in a nursing home. We also looked at:\n- health-related quality of life;\n- deaths;\n- need for help with daily activities;\n- mobility; and\n- pain."
}
] |
query-laysum
|
22011
|
[
{
"role": "user",
"content": "Abstract: Background\nRaised intraocular pressure is a risk factor for glaucoma. One treatment option is glaucoma drainage surgery (trabeculectomy). Antimetabolites are used during surgery to reduce postoperative scarring during wound healing. Two agents in common use are mitomycin C (MMC) and 5-Fluorouracil (5-FU).\nObjectives\nTo assess the effects of MMC compared to 5-FU as an antimetabolite adjunct in trabeculectomy surgery.\nSearch methods\nWe searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (2015 Issue 9), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to October 2015), EMBASE (January 1980 to October 2015), Latin American and Caribbean Health Sciences Literature Database (LILACS) (January 1982 to October 2015), the ISRCTN registry (www.isrctn.com/editAdvancedSearch), ClinicalTrials.gov (www.clinicaltrials.gov) and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 2 October 2015.\nSelection criteria\nWe included randomised controlled trials where wound healing had been modified with MMC compared to 5-FU.\nData collection and analysis\nTwo review authors independently selected trials and collected data. The primary outcome was failure of a functioning trabeculectomy one year after surgery. Secondary outcomes included mean intraocular pressure at one year. We considered three subgroups: high risk of trabeculectomy failure (people with previous glaucoma surgery, extracapsular cataract surgery, African origin and people with secondary glaucoma or congenital glaucoma); medium risk of trabeculectomy failure (people undergoing trabeculectomy with extracapsular cataract surgery) and low risk of trabeculectomy failure (people who have received no previous surgical eye intervention).\nMain results\nWe identified 11 trials that enrolled 687 eyes of 679 participants. The studies were conducted in the United States, Europe, Asia and Africa. Five studies enrolled participants at low risk of trabeculectomy failure, five studies enrolled participants at high risk of failure, and one study enrolled people with both high and low risk of failure. None of the included trials enrolled participants with combined trabeculectomy/cataract surgery.\nWe considered one study to be at low risk of bias in all domains, six studies to be at high risk of bias in one or more domains, and the remaining four studies to be at an unclear risk of bias in all domains.\nThe risk of failure of trabeculectomy at one year after surgery was less in those participants who received MMC compared to those who received 5-FU, however the confidence intervals were wide and are compatible with no effect (risk ratio (RR) 0.54, 95% confidence interval (CI) 0.30 to 1.00; studies = 11; I2 = 40%). There was no evidence for any difference between groups at high and low risk of failure (test for subgroup differences P = 0.69).\nOn average, people treated with MMC had lower intraocular pressure at one year (mean difference (MD) -3.05 mmHg, 95% CI -4.60 to -1.50), but the studies were inconsistent (I2 = 52%). The size of the effect was greater in the high-risk group (MD -4.18 mmHg, 95% CI -6.73 to -1.64) compared to the low-risk group (MD -1.72 mmHg, 95% CI -3.28 to -0.16), but again the test for interaction was not statistically significant (P = 0.11).\nSimilar proportions of eyes treated with MMC lost 2 or more lines of visual acuity one year after surgery compared to 5-FU, but the confidence intervals were wide (RR 1.05, 95% CI 0.54 to 2.06).\nAdverse events occurred relatively rarely, and estimates of effect were generally imprecise. There was some evidence for less epitheliopathy in the MMC group (RR 0.23, 95% CI 0.11 to 0.47) and less hyphaema in the MMC group (RR 0.62, 95% CI 0.42 to 0.91).\nNone of the studies reported quality of life.\nOverall, we graded the quality of the evidence as low largely because of risk of bias in the included studies and imprecision in the estimate of effect.\nAuthors' conclusions\nWe found low-quality evidence that MMC may be more effective in achieving long-term lower intraocular pressure than 5-FU. Further comparative research on MMC and 5-FU is needed to enhance reliability and validity of the results shown in this review. Furthermore, the development of new agents that control postoperative scar tissue formation without side effects would be valuable and is justified by the results of this review.\n\nGiven the provided abstract, please respond to the following query: \"Quality of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We graded the quality of the evidence as low, mostly due to the risk of bias in the included studies. One bias we commonly encountered came from the different techniques of antimetabolite administration, making it difficult to conceal which medicine was being used. Furthermore, most studies only had a few complications to report, which meant that there were low numbers overall to include in the analysis of complications."
}
] |
query-laysum
|
22012
|
[
{
"role": "user",
"content": "Abstract: Background\nVenous leg ulcers (VLUs) are a serious manifestation of chronic venous disease affecting up to 3% of the adult population. This typically recalcitrant and recurring condition significantly impairs quality of life, and its treatment places a heavy financial burden upon healthcare systems. The longstanding mainstay treatment for VLUs is compression therapy. Surgical removal of incompetent veins reduces the risk of ulcer recurrence. However, open surgery is an unpopular option amongst people with VLU, and many people are unsuitable for it. The efficacy of the newer, minimally-invasive endovenous techniques has been established in uncomplicated superficial venous disease, and these techniques can also be used in the management of VLU. When used with compression, endovenous ablation aims to further reduce pressure in the veins of the leg, which may impact ulcer healing.\nObjectives\nTo determine the effects of superficial endovenous ablation on the healing and recurrence of venous leg ulcers and the quality of life of people with venous ulcer disease.\nSearch methods\nIn April 2022 we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations); Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and scrutinised reference lists of relevant included studies as well as reviews, meta-analyses and health technology reports to identify additional studies. There were no restrictions on the language of publication, but there was a restriction on publication year from 1998 to April 2022 as superficial endovenous ablation is a comparatively new technology.\nSelection criteria\nRandomised controlled trials (RCTs) comparing endovenous ablative techniques with compression versus compression therapy alone for the treatment of VLU were eligible for inclusion. Studies needed to have assessed at least one of the following primary review outcomes related to objective measures of ulcer healing such as: proportion of ulcers healed at a given time point; time to complete healing; change in ulcer size; proportion of ulcers recurring over a given time period or at a specific point; or ulcer-free days. Secondary outcomes of interest were patient-reported quality of life, economic data and adverse events.\nData collection and analysis\nTwo reviewers independently assessed studies for eligibility, extracted data, carried out risk of bias assessment using the Cochrane RoB 1 tool, and assessed GRADE certainty of evidence.\nMain results\nThe previous version of this review found no RCTs meeting the inclusion criteria. In this update, we identified two eligible RCTs and included them in a meta-analysis. There was a total of 506 participants with an active VLU, with mean durations of 3.1 months ± 1.1 months in the EVRA trial and 60.5 months ± 96.4 months in the VUERT trial. Both trials randomised participants to endovenous treatment and compression or compression alone, however the compression alone group in the EVRA trial received deferred endovenous treatment (after ulcer healing or from six months).\nThere is high-certainty evidence that combined endovenous ablation and compression compared with compression therapy alone, or compression with deferred endovenous treatment, improves time to complete ulcer healing (pooled hazard ratio (HR) 1.41, 95% CI 1.36 to 1.47; I2 = 0%; 2 studies, 466 participants). There is moderate-certainty evidence that the proportion of ulcers healed at 90 days is probably higher with combined endovenous ablation and compression compared with compression therapy alone or compression with deferred endovenous treatment (risk ratio (RR) 1.14, 95% CI 1.00 to 1.30; I2 = 0%; 2 studies, 466 participants). There is low-certainty evidence showing an unclear effect on ulcer recurrence at one year in people with healed ulcers with combined endovenous treatment and compression when compared with compression alone or compression with deferred endovenous treatment (RR 0.29, 95% CI 0.03 to 2.48; I2 = 78%; 2 studies, 460 participants). There is also low-certainty evidence that the median number of ulcer-free days at one year may not differ (306 (interquartile range (IQR) 240 to 328) days versus 278 (IQR 175 to 324) days) following combined endovenous treatment and compression when compared with compression and deferred endovenous treatment; (1 study, 450 participants).\nThere is low-certainty evidence of an unclear effect in rates of thromboembolism between groups (RR 2.02, 95% CI 0.51 to 7.97; I2 = 78%, 2 studies, 506 participants). The addition of endovenous ablation to compression is probably cost-effective at one year (99% probability at GBP 20,000/QALY; 1 study; moderate-certainty evidence).\nAuthors' conclusions\nEndovenous ablation of superficial venous incompetence in combination with compression improves leg ulcer healing when compared with compression alone. This conclusion is based on high-certainty evidence. There is moderate-certainty evidence to suggest that it is probably cost-effective at one year and low certainty evidence of unclear effects on recurrence and complications. Further research is needed to explore the additional benefit of endovenous ablation in ulcers of greater than six months duration and the optimal modality of endovenous ablation.\n\nGiven the provided abstract, please respond to the following query: \"What did we do?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched for studies that looked at endovenous ablation with compression therapy versus compression therapy alone for treating VLUs. There were no restrictions on the publication language.\nWe compared and summarised the studies’ results and rated our confidence in the evidence, based on factors such as study methods and sizes."
}
] |
query-laysum
|
22013
|
[
{
"role": "user",
"content": "Abstract: Background\nThe uptake of clinical practice guidelines (CPGs) is inconsistent, despite their potential to improve the quality of health care and patient outcomes. Some guideline producers have addressed this problem by developing tools to encourage faster adoption of new guidelines. This review focuses on the effectiveness of tools developed and disseminated by guideline producers to improve the uptake of their CPGs.\nObjectives\nTo evaluate the effectiveness of implementation tools developed and disseminated by guideline producers, which accompany or follow the publication of a CPG, to promote uptake. A secondary objective is to determine which approaches to guideline implementation are most effective.\nSearch methods\nWe searched the Cochrane Effective Practice and Organisation of Care (EPOC) Group Specialised Register, Cochrane Central Register of Controlled Trials (CENTRAL); NHS Economic Evaluation Database, HTA Database; MEDLINE and MEDLINE In-Process and other non-indexed citations; Embase; PsycINFO; CINAHL; Dissertations and Theses, ProQuest; Index to Theses; Science Citation Index Expanded, ISI Web of Knowledge; Conference Proceedings Citation Index - Science, ISI Web of Knowledge; Health Management Information Consortium (HMIC), and NHS Evidence up to February 2016. We also searched trials registers, reference lists of included studies and relevant websites.\nSelection criteria\nWe included randomised controlled trials (RCTs) and cluster-RCTs, controlled before-and-after studies (CBAs) and interrupted time series (ITS) studies evaluating the effects of guideline implementation tools developed by recognised guideline producers to improve the uptake of their own guidelines. The guideline could target any clinical area.\nData collection and analysis\nTwo review authors independently extracted data and assessed the risk of bias of each included study using the Cochrane 'Risk of bias' criteria. We graded our confidence in the evidence using the approach recommended by the GRADE working group. The clinical conditions targeted and the implementation tools used were too heterogenous to combine data for meta-analysis. We report the median absolute risk difference (ARD) and interquartile range (IQR) for the main outcome of adherence to guidelines.\nMain results\nWe included four cluster-RCTs that were conducted in the Netherlands, France, the USA and Canada. These studies evaluated the effects of tools developed by national guideline producers to implement their CPGs. The implementation tools evaluated targeted healthcare professionals; none targeted healthcare organisations or patients.\nOne study used two short educational workshops tailored to barriers. In three studies the intervention consisted of the provision of paper-based educational materials, order forms or reminders, or both. The clinical condition, type of healthcare professional, and behaviour targeted by the CPG varied across studies.\nTwo of the four included studies reported data on healthcare professionals' adherence to guidelines. A guideline tool developed by the producers of a guideline probably leads to increased adherence to the guidelines; median ARD (IQR) was 0.135 (0.115 and 0.159 for the two studies respectively) at an average four-week follow-up (moderate certainty evidence), which indicates a median 13.5% greater adherence to guidelines in the intervention group. Providing healthcare professionals with a tool to improve implementation of a guideline may lead to little or no difference in costs to the health service.\nAuthors' conclusions\nImplementation tools developed by recognised guideline producers probably lead to improved healthcare professionals' adherence to guidelines in the management of non-specific low back pain and ordering thyroid-function tests. There are limited data on the relative costs of implementing these interventions.There are no studies evaluating the effectiveness of interventions targeting the organisation of care (e.g. benchmarking tools, costing templates, etc.), or for mass media interventions. We could not draw any conclusions about our second objective, the comparative effectiveness of implementation tools, due to the small number of studies, the heterogeneity between interventions, and the clinical conditions that were targeted.\n\nGiven the provided abstract, please respond to the following query: \"Certainty of the included evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The included evidence was from randomised controlled trials, which is considered the highest level of evidence. However, due to high risk of bias in the included studies our confidence in the effect on observing guideline recommendations was moderate. Our confidence in the evidence for cost effectiveness was low, since only a single study provided evidence for this comparison."
}
] |
query-laysum
|
22014
|
[
{
"role": "user",
"content": "Abstract: Background\nA well-functioning routine health information system (RHIS) can provide the information needed for health system management, for governance, accountability, planning, policy making, surveillance and quality improvement, but poor information support has been identified as a major obstacle for improving health system management.\nObjectives\nTo assess the effects of interventions to improve routine health information systems in terms of RHIS performance, and also, in terms of improved health system management performance, and improved patient and population health outcomes.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library, MEDLINE Ovid and Embase Ovid in May 2019. We searched Global Health, Ovid and PsycInfo in April 2016. In January 2020 we searched for grey literature in the Grey Literature Report and in OpenGrey, and for ongoing trials using the International Clinical Trials Registry Platform (ICTRP) and ClinicalTrials.gov. In October 2019 we also did a cited reference search using Web of Science, and a ‘similar articles’ search in PubMed.\nSelection criteria\nRandomised and non-randomised trials, controlled before-after studies and time-series studies comparing routine health information system interventions, with controls, in primary, hospital or community health care settings. Participants included clinical staff and management, district management and community health workers using routine information systems.\nData collection and analysis\nTwo authors independently reviewed records to identify studies for inclusion, extracted data from the included studies and assessed the risk of bias. Interventions and outcomes were too varied across studies to allow for pooled risk analysis. We present a 'Summary of findings' table for each intervention comparisons broadly categorised into Technical and Organisational (or a combination), and report outcomes on data quality and service quality. We used the GRADE approach to assess the certainty of the evidence.\nMain results\nWe included six studies: four cluster randomised trials and two controlled before-after studies, from Africa and South America. Three studies evaluated technical interventions, one study evaluated an organisational intervention, and two studies evaluated a combination of technical and organisational interventions. Four studies reported on data quality and six studies reported on service quality.\nIn terms of data quality, a web-based electronic TB laboratory information system probably reduces the length of time to reporting of TB test results, and probably reduces the overall rate of recording errors of TB test results, compared to a paper-based system (moderate certainty evidence). We are uncertain about the effect of the electronic laboratory information system on the recording rate of serious (misidentification) errors for TB test results compared to a paper-based system (very low certainty evidence). Misidentification errors are inaccuracies in transferring test results between an electronic register and patients' clinical charts. We are also uncertain about the effect of the intervention on service quality (timeliness of starting or changing a patient's TB treatment) (very low certainty evidence).\nA hand-held electronic device probably improves the length of time to report TB test results, and probably reduces the total frequency of recording errors in TB test results between the laboratory notebook and the electronic information record system, compared to a paper-based system (moderate-certainty evidence). We are, however, uncertain about the effect of the intervention on the frequency of serious (misidentification) errors in recording between the laboratory notebook and the electronic information record, compared to a paper-based system (very low certainty evidence).\nWe are uncertain about the effect of a hospital electronic health information system on service quality (length of time outpatients spend at hospital, length of hospital stay, and hospital revenue collection), compared to a paper-based system (very low certainty evidence).\nHigh-intensity brief text messaging (SMS) may make little or no difference to data quality (in terms of completeness of documentation of pregnancy outcomes), compared to low-intensity brief text messaging (low-certainty evidence).\nWe are uncertain about the effect of electronic drug stock notification (with either data management support or product transfer support) on service quality (in terms of transporting stock and stock levels), compared to paper-based stock notification (very low certainty evidence).\nWe are uncertain about the effect of health information strengthening (where it is part of comprehensive service quality improvement intervention) on service quality (health worker motivation, receipt of training by health workers, health information index scores, quality of clinical observation of children and adults) (very low certainty evidence).\nAuthors' conclusions\nThe review indicates mixed effects of mainly technical interventions to improve data quality, with gaps in evidence on interventions aimed at enhancing data-informed health system management. There is a gap in interventions studying information support beyond clinical management, such as for human resources, finances, drug supply and governance. We need to have a better understanding of the causal mechanisms by which information support may affect change in management decision-making, to inform robust intervention design and evaluation methods.\n\nGiven the provided abstract, please respond to the following query: \"Key messages\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Moving from paper-based information systems to electronic and digital systems probably allows staff at healthcare facilities to collect some types of routine health information faster and with fewer mistakes. But there are many evidence gaps, and we still need to know more about the effect of different approaches on information quality and use and on the quality of healthcare services and the broader health system."
}
] |
query-laysum
|
22015
|
[
{
"role": "user",
"content": "Abstract: Background\nInfantile colic is a common disorder in the first months of life, affecting somewhere between 4% and 28% of infants worldwide, depending on geography and definitions used. Although it is self limiting and resolves by four months of age, colic is perceived by parents as a problem that requires action. Pain-relieving agents, such as drugs, sugars and herbal remedies, have been suggested as interventions to reduce crying episodes and severity of symptoms.\nObjectives\nTo assess the effectiveness and safety of pain-relieving agents for reducing colic in infants younger than four months of age.\nSearch methods\nWe searched the following databases in March 2015 and again in May 2016: CENTRAL, Ovid MEDLINE, Embase and PsycINFO, along with 11 other databases. We also searched two trial registers, four thesis repositories and the reference lists of relevant studies to identify unpublished and ongoing studies.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-RCTs evaluating the effects of pain-relieving agents given to infants with colic.\nData collection and analysis\nWe used the standard methodological procedures of The Cochrane Collaboration.\nMain results\nWe included 18 RCTs involving 1014 infants. All studies were small and at high risk of bias, often presenting major shortcomings across multiple design factors (e.g. selection, performance, attrition, lack of washout period).\nThree studies compared simethicone with placebo, and one with Mentha piperita; four studies compared herbal agents with placebo; two compared sucrose or glucose with placebo; five compared dicyclomine with placebo; and two compared cimetropium - one against placebo and the other at two different dosages. One multiple-arm study compared sucrose and herbal tea versus no treatment.\nSimethicone. Comparison with placebo revealed no difference in daily hours of crying reported for simethicone at the end of treatment in one small, low-quality study involving 27 infants. A meta-analysis of data from two cross-over studies comparing simethicone with placebo showed no difference in the number of of infants who responded positively to treatment (risk ratio (RR) 0.95, 95% confidence interval (CI) 0.73 to 1.23; 110 infants, low-quality evidence).\nOne small study (30 participants) compared simethicone with Mentha piperita and found no difference in crying duration, number of crying episodes or number of responders.\nHerbal agents. We found low-quality evidence suggesting that herbal agents reduce the duration of crying compared with placebo (mean difference (MD) 1.33, 95% CI 0.71 to 1.96; three studies, 279 infants), with different magnitude of benefit noted across studies (I² = 96%). We found moderate-quality evidence indicating that herbal agents increase response over placebo (RR 2.05, 95% CI 1.56 to 2.70; three studies, 277 infants).\nSucrose. One very low-quality study involving 35 infants reported that sucrose reduced hours spent crying compared with placebo (MD 1.72, 95% CI 1.38 to 2.06).\nDicyclomine. We could consider only one of the five studies of dicyclomine (48 infants) for the primary comparison. In this study, more of the infants given dicyclomine responded than than those given placebo (RR 2.50, 95% CI 1.17 to 5.34).\nCimetropium bromide. Data from one very low-quality study comparing cimetropium bromide with placebo showed reduced crying duration among infants treated with cimetropium bromide (MD -30.20 minutes per crisis, 95% CI -39.51 to -20.89; 86 infants). The same study reported that cimetropium increased the number of responders (RR 2.29, 95% CI 1.44 to 3.64).\nNo serious adverse events were reported for all of the agents considered, with the exception of dicyclomine, for which two of five studies reported relevant adverse effects (longer sleep 4%, wide-eyed state 4%, drowsiness 13%).\nAuthors' conclusions\nAt the present time, evidence of the effectiveness of pain-relieving agents for the treatment of infantile colic is sparse and prone to bias. The few available studies included small sample sizes, and most had serious limitations. Benefits, when reported, were inconsistent.\nWe found no evidence to support the use of simethicone as a pain-relieving agent for infantile colic.\nAvailable evidence shows that herbal agents, sugar, dicyclomine and cimetropium bromide cannot be recommended for infants with colic.\nInvestigators must conduct RCTs using standardised measures that allow comparisons among pain-relieving agents and pooling of results across studies. Parents, who most often provide the intervention and assess the outcome, should always be blinded.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Do infants who have colic during the first four months of life benefit from pain-relieving agents (substances to alleviate/prevent pain) when compared with infants who are given no substance or a placebo (a substance that is identical to the drug but has no active ingredient)?"
}
] |
query-laysum
|
22016
|
[
{
"role": "user",
"content": "Abstract: Background\nPeriorbital and orbital cellulitis are infections of the tissue anterior and posterior to the orbital septum, respectively, and can be difficult to differentiate clinically. Periorbital cellulitis can also progress to become orbital cellulitis.\nOrbital cellulitis has a relatively high incidence in children and adults, and potentially serious consequences including vision loss, meningitis, and death. Complications occur in part due to inflammatory swelling from the infection creating a compartment syndrome within the bony orbit, leading to elevated ocular pressure and compression of vasculature and the optic nerve. Corticosteroids are used in other infections to reduce this inflammation and edema, but they can lead to immune suppression and worsening infection.\nObjectives\nTo assess the effectiveness and safety of adjunctive corticosteroids for periorbital and orbital cellulitis, and to assess their effectiveness and safety in children and in adults separately.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2020, Issue 3); Ovid MEDLINE; Embase.com; PubMed; Latin American and Caribbean Health Sciences Literature Database (LILACS); ClinicalTrials.gov, and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). We did not use any date or language restrictions in the electronic search for trials. We last searched the electronic databases on 2 March 2020.\nSelection criteria\nWe included studies of participants diagnosed with periorbital or orbital cellulitis. We excluded studies that focused exclusively on participants who were undergoing elective endoscopic surgery, including management of infections postsurgery as well as studies conducted solely on trauma patients. Randomized and quasi-randomized controlled trials were eligible for inclusion. Any study that administered corticosteroids was eligible regardless of type of steroid, route of administration, length of therapy, or timing of treatment. Comparators could include placebo, another corticosteroid, no treatment control, or another intervention.\nData collection and analysis\nWe used standard methodological procedures recommended by Cochrane.\nMain results\nThe search yielded 7998 records, of which 13 were selected for full-text screening. We identified one trial for inclusion. No other eligible ongoing or completed trials were identified. The included study compared the use of corticosteroids in addition to antibiotics to the use of antibiotics alone for the treatment of orbital cellulitis. The study included a total of 21 participants aged 10 years and older, of which 14 participants were randomized to corticosteroids and antibiotics and 7 participants to antibiotics alone. Participants randomized to corticosteroids and antibiotics received adjunctive corticosteroids after initial antibiotic response (mean 5.13 days), at an initial dose of 1.5 mg/kg for three days followed by 1 mg/kg for another three days before being tapered over a one- to two-week period.\nWe assessed the included study as having an unclear risk of bias for allocation concealment, masking (blinding), selective outcome reporting, and other sources of bias. Risk of bias from sequence generation and incomplete outcome data were low.\nThe certainty of evidence for all outcomes was very low, downgraded for risk of bias (-1) and imprecision (-2). Length of hospital stay was compared between the group receiving antibiotics alone compared to the group receiving antibiotics and corticosteroids (mean difference (MD) 4.30, 95% confidence interval (CI) −0.48 to 9.08; 21 participants). There was no observed difference in duration of antibiotics between treatment groups (MD 3.00, 95% CI −0.48 to 6.48; 21 participants). Likewise, preservation of visual acuity at 12 weeks of follow-up between group was also assessed (RR 1.00, 95% CI 0.82 to 1.22; 21 participants). Pain scores were compared between groups on day 3 (MD −0.20, 95% CI −1.02 to 0.62; 22 eyes) along with the need for surgical intervention (RR 1.00, 95% CI 0.11 to 9.23; 21 participants). Exposure keratopathy was reported in five participants who received corticosteroids and antibiotics and three participants who received antibiotic alone (RR 1.20, 95% CI 0.40 to 3.63; 21 participants). No major complications of orbital cellulitis were seen in either the intervention or the control group. No side effects of corticosteroids were reported, although it is unclear which side effects were assessed.\nAuthors' conclusions\nThere is insufficient evidence to draw conclusions about the use of corticosteroids in the treatment of periorbital and orbital cellulitis. Since there is significant variation in how corticosteroids are used in clinical practice, additional high-quality evidence from randomized controlled trials is needed to inform decision making. Future studies should explore the effects of corticosteroids in children and adults separately, and evaluate different dosing and timing of corticosteroid therapy.\n\nGiven the provided abstract, please respond to the following query: \"What is the aim of this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We aimed to find out if steroids are useful in treating serious infections of the area around the eye known as periorbital and orbital cellulitis. These infections can lead to complications like blindness, brain infection, or death. We also wanted to see if steroids worked the same or differently in children and adults."
}
] |
query-laysum
|
22017
|
[
{
"role": "user",
"content": "Abstract: Background\nThe term anchorage in orthodontic treatment refers to methods of controlling unwanted tooth movement. This is provided either by anchor sites within the mouth, such as the teeth and the palate, or from outside the mouth (headgear). Recently, new methods of providing anchorage have been developed using orthodontic implants which are surgically inserted into the bone in the mouth. This is termed surgical anchorage. This is an update of a Cochrane review first published in 2007.\nObjectives\nTo assess the effects of surgical anchorage techniques compared to conventional anchorage in the prevention of unwanted tooth movement in patients undergoing orthodontic treatment by evaluating the mesiodistal movement of upper first molar teeth. A secondary objective was to compare the effects of one type of surgical anchorage with another.\nSearch methods\nWe searched the Cochrane Oral Health Group's Trials Register (to 28 October 2013), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2013, Issue 9), MEDLINE via OVID (1946 to 28 October 2013) and EMBASE via OVID (1980 to 28 October 2013). We handsearched key international orthodontic and dental journals, and searched the trial database ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform for ongoing and unpublished studies.\nSelection criteria\nRandomised controlled trials comparing surgical anchorage with conventional anchorage in orthodontic patients. Trials comparing two types of surgical anchorage were also included.\nData collection and analysis\nAt least two review authors independently and in duplicate extracted data and carried out risk of bias assessments. We contacted study authors to clarify aspects of study design and conduct, and to obtain unreported data.\nMain results\nFourteen new studies were added in this update resulting in a total of 15 studies reporting data from 561 randomised patients. The studies were conducted in Europe, India, China, South Korea and the USA. The age range of patients was commonly restricted to adolescents or young adults, however the participants of two studies were from a much wider age range (12 to 54 years). The distribution of males and females was similar in eight of the studies, with a predominance of female patients in seven studies.\nEight studies were assessed to be at high overall risk of bias; six studies at unclear risk of bias; one study at low risk of bias.\nTen studies with 407 randomised and 390 analysed patients compared surgical anchorage with conventional anchorage for the primary outcome of mesiodistal movement of upper first molars. We carried out a random-effects model meta-analysis for the seven studies that fully reported this outcome. There was strong evidence of an effect of surgical anchorage on this outcome. Compared with conventional anchorage, surgical anchorage was more effective in the reinforcement of anchorage by 1.68 mm (95% confidence interval (CI) -2.27 mm to -1.09 mm; seven studies, 308 participants analysed) with moderate quality of evidence (one study at high overall risk of bias, five studies at unclear risk of bias, one study at low risk of bias). This result should be interpreted with some caution, however, as there was a substantial degree of heterogeneity for this comparison. There was no evidence of a difference in overall duration of treatment between surgical and conventional anchorage (-0.15 years; 95% CI -0.37 years to 0.07 years; three studies, 111 analysed patients) with low quality of evidence (one study at high overall risk of bias and two studies at unclear risk of bias). Information on patient-reported outcomes such as pain and acceptability was limited and inconclusive.\nWhen direct comparisons were made between two types of surgical anchorage, there was a lack of evidence to suggest that any one technique was better than another.\nNo included studies reported adverse effects.\nAuthors' conclusions\nThere is moderate quality evidence that reinforcement of anchorage is more effective with surgical anchorage than conventional anchorage, and that results from mini-screw implants are particularly promising. While surgical anchorage is not associated with the inherent risks and compliance issues related to extraoral headgear, none of the included studies reported on harms of surgical or conventional anchorage.\n\nGiven the provided abstract, please respond to the following query: \"Review question\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This review, produced by the Cochrane Oral Health Group, seeks to assess the effects of using implants surgically placed in bone in the mouth in order to stabilise (anchor) teeth during treatment with orthodontic braces and compares implants with the use of conventional methods. It also assesses the effects of different surgical anchorage techniques."
}
] |
query-laysum
|
22018
|
[
{
"role": "user",
"content": "Abstract: Background\nCystic fibrosis (CF) is the most common, life-limiting, genetically inherited disease. It affects multiple organs, particularly the respiratory system. However, gastrointestinal problems such as constipation and distal intestinal obstruction syndrome (DIOS) are also important and well-recognised complications in CF. They share similar symptoms e.g. bloating, abdominal pain, but are distinct conditions. Constipation occurs when there is gradual faecal impaction of the colon, but DIOS occurs when there is an accumulation of faeces and sticky mucus, forming a mass in the distal part of the small intestine. The mass may partially block the intestine (incomplete DIOS) or completely block the intestine (complete DIOS). Symptoms of DIOS can affect quality of life and other aspects of CF health, such as airway clearance, exercise, sleep and nutritional status. Treatment of constipation and prevention of complete bowel obstruction are required for gastrointestinal management in CF. However, many different strategies are used in clinical practice and there is a lack of consensus. The importance of this topic was highlighted in a recent research priority setting exercise by the James Lind Alliance.\nObjectives\nTo evaluate the effectiveness and safety of laxative agents of differing types for preventing DIOS (complete and incomplete) in children and adults with CF.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register comprising references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings. Date of search: 09 September 2021.\nWe also searched online trial registries. Date of last search: 12 October 2021.\nSelection criteria\nRandomised and quasi-randomised controlled parallel trials comparing laxative therapy for preventing DIOS (including osmotic agents, stimulants, mucolytics and substances with more than one action) at any dose to placebo, no treatment or an alternative laxative therapy, in people of any age with pancreatic sufficient or insufficient CF and any stage of lung disease. Randomised cross-over trials were judged on an individual basis.\nData collection and analysis\nTwo authors independently assessed trials for inclusion, extracted outcome data and performed a risk of bias assessment for the included data. We judged the certainty of the evidence using GRADE criteria.\nMain results\nWe included one cross-over trial (17 participants) with a duration of 12 months, in which participants were randomly allocated to either cisapride (a gastro-prokinetic agent) or placebo for six months each. The trial had an unclear risk of bias for most domains but had a high risk of reporting bias.\nRadiograph scores revealed no difference in occurrence of DIOS between cisapride and placebo (narrative report, no data provided). There were no adverse effects. Symptom scores were the only secondary outcome within the review that were reported. Total gastrointestinal symptom scores favoured cisapride with a statistically significant mean difference (MD) of -7.60 (95% confidence interval (CI) -14.73 to -0.47). There was no significant difference at six months between cisapride and placebo for abdominal distension, MD -0.90 (95% CI -2.39 to 0.59) or abdominal pain, MD -0.4 (95% CI -2.05 to 1.25). The global symptom scores (whether individuals felt better or worse) were reported in the paper to favour cisapride and be statistically significant (P < 0.05).\nWe assessed the available data to be very low certainty. There was a great deal of missing data from the included trial and the investigators failed to report numerical data for many outcomes. The overall risk of bias of the trial was unclear and it had a high risk for reporting bias. There was also indirectness; the trial drug (cisapride) has since been removed from the market in several countries due to adverse effects, thus it has no current applicability for preventing DIOS. The included trial also had very few participants, which downgraded the certainty a further level for precision.\nAuthors' conclusions\nThere is an absence of evidence for interventions for the prevention of DIOS. As there was only one included trial, we could not perform a meta-analysis of the data. Furthermore, the included trial compared a prokinetic agent (cisapride) that is no longer licensed for use in a number of countries due to the risk of serious cardiac events, a finding that came to light after the trial was conducted. Therefore, the limited findings from the trial are not applicable in current clinical practice.\nOverall, a great deal more research needs to be undertaken on gastrointestinal complications in CF, as this is a very poorly studied area compared to respiratory complications in CF.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The trial used radiography to diagnose DIOS, but did not provide any data and only stated that there was no difference between cisapride and placebo. The trial also stated that there were no adverse effects from the cisapride. The trial assessed participant-reported total and individual gastrointestinal symptom scores. People in the cisapride group reported an improvement in total gastrointestinal symptom scores compared to those in the placebo group. However, there were no differences reported between groups for the individual symptom scores of abdominal pain and abdominal distension (swelling). Participants also reported global symptom scores, which showed that most people felt better taking cisapride compared to placebo."
}
] |
query-laysum
|
22019
|
[
{
"role": "user",
"content": "Abstract: Background\nOmega-3 polyunsaturated fatty acids (omega-3 PUFAs) from fish and plant sources are commonly considered as a promising non-medical alternative to improve brain functions and slow down the progression of dementia. This assumption is mostly based on findings of preclinical studies and epidemiological research. Resulting explanatory models aim at the role omega-3 PUFAs play in the development and integrity of the brain's neurons, their protective antioxidative effect on cell membranes and potential neurochemical mechanisms directly related to Alzheimer-specific pathology. Epidemiological research also found evidence of malnutrition in people with dementia. Considering this and the fact that omega-3 PUFA cannot be synthesised by humans, omega-3 PUFAs might be a promising treatment option for dementia.\nObjectives\nTo assess the efficacy and safety of omega-3 polyunsaturated fatty acid (PUFA) supplementation for the treatment of people with dementia.\nSearch methods\nWe searched the Specialized Register of the Cochrane Dementia and Cognitive Improvement Group (ALOIS), MEDLINE, EMBASE, PsycINFO, CINAHL, ClinicalTrials.gov and the World Health Organization (WHO) portal/ICTRP on 10 December 2015. We contacted manufacturers of omega-3 supplements and scanned reference lists of landmark papers and included articles.\nSelection criteria\nWe included randomised controlled trials (RCTs) in which omega-3 PUFA in the form of supplements or enriched diets were administered to people with Alzheimer's disease (AD), vascular dementia (VaD), dementia with Lewy bodies (DLB), Parkinson's disease dementia (PDD) or frontotemporal dementia (FTD).\nData collection and analysis\nThe primary outcome measures of interest were changes in global and specific cognitive functions, functional performance, dementia severity and adverse effects. Two review authors independently selected studies, extracted data and assessed the quality of trials according to the Cochrane Handbook for Systematic Reviews of Interventions. We rated the quality of the evidence using the GRADE approach. We received unpublished data from the trial authors and collected adverse effects information from the published articles. We conducted meta-analyses for available outcome measures at six months.\nMain results\nWe included three comparable randomised, placebo-controlled trials investigating omega-3 PUFA supplements in 632 participants with mild to moderate AD over six, 12 and 18 months. We found no studies investigating other types of dementia. All trials were of high methodological quality. The overall quality of evidence for most of the outcomes was high.\nThere was no evidence of a benefit from omega-3 PUFAs on cognitive function when measured at six months with the Alzheimer's Disease Assessment Scale - Cognitive subscale (standardised mean difference (SMD) -0.02, 95% confidence interval (CI) -0.19 to 0.15; 566 participants; 3 studies; high quality evidence) or Mini-Mental State Examination (mean difference (MD) 0.18, 95% CI -1.05 to 1.41; 202 participants; 2 studies; high quality evidence) or on activities of daily living (SMD -0.02, 95% CI -0.19 to 0.16; 544 participants; 2 studies; high quality evidence). There was also no effect at six months of treatment on severity of dementia measured with the Clinical Dementia Rating - Sum of Boxes (MD -0.00, 95% CI -0.58 to 0.57; 542 participants; 2 studies; high quality evidence) or on quality of life measured with the Quality of Life Alzheimer's Disease scale (MD -0.10, 95% CI -1.28 to 1.08; 322 participants; 1 study; high quality evidence). There was no difference at six months on mental health measured with the Montgomery-Åsberg Depression Rating Scale (MD -0.10, 95% CI -0.74 to 0.54; 178 participants: 1 study; high quality of evidence) or the Neuropsychiatric Inventory (SMD 0.10, 95% CI -0.07 to 0.27; 543 participants; 2 studies; high quality of evidence). One very small study showed a benefit for omega-3 PUFAs in instrumental activities of daily living after 12 months of treatment (MD -3.50, 95% CI -4.30 to -2.70; 22 participants; moderate quality evidence). The included studies did not measure specific cognitive function. The studies did not report adverse events well. Two studies stated that all adverse events were mild and that they did not differ in overall frequency between omega-3 PUFA and placebo groups. Data from one study showed no difference between groups in frequency of any adverse event (risk ratio (RR) 1.02, 95% CI 0.95 to 1.10; 402 participants; 1 study; moderate quality evidence) or any serious adverse event (RR 1.05, 95% CI 0.78 to 1.41; 402 participants; 1 study; high quality evidence) at 18 months of treatment.\nAuthors' conclusions\nWe found no convincing evidence for the efficacy of omega-3 PUFA supplements in the treatment of mild to moderate AD. This result was consistent for all outcomes relevant for people with dementia. Adverse effects of omega-3 PUFAs seemed to be low, but based on the evidence synthesised in this review, we cannot make a final statement on tolerability. The effects on other populations remain unclear.\n\nGiven the provided abstract, please respond to the following query: \"Included trials\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We included three trials that investigated 632 people with Alzheimer's disease of mild to moderate severity. We found no trials on other types of dementia. In all trials participants took either placebo or omega-3 PUFA supplements. The quality of the trials was good. The participants were allocated to the groups randomly. The participants and most of the investigators did not know which treatment was given."
}
] |
query-laysum
|
22020
|
[
{
"role": "user",
"content": "Abstract: Background\nThe World Health Organization (WHO) guidelines for safe abortion recommend medical abortion with mifepristone and misoprostol or surgical abortion with vacuum aspiration or dilation and evacuation as safe and effective options for women. However, no specific clinical considerations are stipulated within these guidelines for women living with HIV. Concerns have been raised that women living with HIV may be at greater risk of adverse abortion outcomes compared to HIV-uninfected women due to immunosuppression, high rates of co-infection with other sexually transmitted infections, and possible contraindications between medications used for medical abortion and antiretroviral therapy regimens.\nObjectives\nOur primary objective was to assess the effectiveness and safety of medical versus surgical abortion among women living with HIV. Our secondary objectives were to: (1) compare outcomes of medical and surgical abortion between women living with HIV and women without HIV and (2) describe outcomes of medical and surgical abortion among women living with HIV.\nSearch methods\nWe conducted our search on 17 April 2018. We searched for all published and unpublished trials and observational studies of medical and surgical abortion among women living with HIV. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, PsycINFO, CINAHL, ClinicalTrials.gov, and the WHO International Clinical Trials Registry Platform using a combination of terms for abortion and HIV. We searched conference websites for relevant abstracts. We also sought unpublished data stratified by HIV status that could be newly analyzed.\nSelection criteria\nWe considered randomized controlled trials (RCTs), non-RCTs, and observational studies. We considered: (1) studies on the effectiveness and safety of medical versus surgical abortion among women living with HIV; (2) studies comparing outcomes of abortion for both methods between women living with HIV and women without HIV; and (3) studies that described outcomes of abortion among women living with HIV.\nData collection and analysis\nOne review author screened the titles, abstracts, citation information, and descriptor terms for citations initially identified by the search. We obtained the full-text articles of all potentially eligible studies when these were available. Two review authors independently examined the full-text articles for compliance with the inclusion criteria and determination of final study selection. We planned to conduct meta-analysis if a sufficient number of studies (at least three) addressed the same research question and presented data on sufficiently comparable outcomes.\nMain results\nOf 3840 records screened, we identified just one conference abstract that met our inclusion criteria. This prospective cohort study assessed the efficacy and acceptability of home administration of misoprostol for early medical abortion among women living with HIV who were of less than 63 days amenorrhea in Ukraine. Medical abortion was effective in 65 of 68 cases (96%) examined. The small number of failures included incomplete abortion (n = 1), heavy bleeding (n = 1), and ongoing pregnancy (n = 1). There were no serious infections.\nAuthors' conclusions\nDue to the paucity of studies, we were unable to determine if outcome differences exist between women living with HIV and women without HIV who undergo medical or surgical abortion. We found no evidence suggesting that medical or surgical abortions are unsafe for women living with HIV. While additional research would strengthen the evidence base, healthcare providers should not be deterred from providing access to safe abortion to their patients living with HIV.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The quality of evidence was low, but found that medical abortion was successful with no major complications experienced among women living with HIV."
}
] |
query-laysum
|
22021
|
[
{
"role": "user",
"content": "Abstract: Background\nPreoperative anaemia is common and occurs in 5% to 76% of patients preoperatively. It is associated with an increased risk of perioperative allogeneic blood transfusion, longer hospital stay, and increased morbidity and mortality. Iron deficiency is one of the most common causes of anaemia. Oral and intravenous iron therapy can be used to treat anaemia. Parenteral iron preparations have been shown to be more effective in conditions such as inflammatory bowel disease, chronic heart failure and postpartum haemorrhage due to rapid correction of iron stores. A limited number of studies has investigated iron therapy for the treatment of preoperative anaemia. The aim of this Cochrane Review is to summarise the evidence for iron supplementation, both enteral and parenteral, for the management of preoperative anaemia.\nObjectives\nTo evaluate the effects of preoperative iron therapy (enteral or parenteral) in reducing the need for allogeneic blood transfusions in anaemic patients undergoing surgery.\nSearch methods\nWe ran the search on 30 July 2018. We searched the Cochrane Injuries Group's Specialised Register, Cochrane Central Register of Controlled Trials (CENTRAL, the Cochrane Library), Ovid MEDLINE(R), Ovid MEDLINE(R) In-Process & Other Non-Indexed Citations, Ovid MEDLINE(R) Daily and Ovid OLDMEDLINE(R), Embase Classic and Embase (Ovid), CINAHL Plus (EBSCO), PubMed, and clinical trials registries, and we screened reference lists. We ran a top-up search on 28 November 2019; one study is now awaiting classification.\nSelection criteria\nWe included all randomised controlled trials (RCTs) that compared preoperative iron monotherapy to placebo, no treatment, standard care or another form of iron therapy for anaemic adults undergoing surgery. We defined anaemia as haemoglobin values less than 13 g/dL for males and 12 g/dL for non-pregnant females.\nData collection and analysis\nTwo review authors collected data and a third review author checked all collected data. Data were collected on the proportion of patients who receive a blood transfusion, the amount of blood transfused per patient (units), quality of life, ferritin levels and haemoglobin levels, measured as continuous variables at the following predetermined time points: pretreatment (baseline), preoperatively but postintervention, and postoperatively. We performed statistical analysis using the Cochrane software, Review Manager 5. We summarised outcome data in tables and forest plots. We used the GRADE approach to describe the quality of the body of evidence.\nMain results\nSix RCTs, with a total of 372 participants, evaluated preoperative iron therapy to correct anaemia before planned surgery. Four studies compared iron therapy (either oral (one study) or intravenous (three studies)) with no treatment, placebo or usual care, and two studies compared intravenous iron therapy with oral iron therapy. Iron therapy was delivered over a range of periods that varied from 48 hours to three weeks prior to surgery. The 372 participants in our analysis fall far short of the 819 required - as calculated by our information size calculation - to detect a 30% reduction in blood transfusions. Five trials, involving 310 people, reported the proportion of participants who received allogeneic blood transfusions.\nMeta-analysis of iron therapy versus placebo or standard care showed no difference in the proportion of participants who received a blood transfusion (risk ratio (RR) 1.21, 95% confidence interval (CI) 0.87 to 1.70; 4 studies, 200 participants; moderate-quality evidence). Only one study that compared oral versus intravenous iron therapy measured this outcome, and reported no difference in risk of transfusion between groups.\nThere was no difference between the iron therapy and placebo/standard care groups for haemoglobin level preoperatively at the end of the intervention (mean difference (MD) 0.63 g/dL, 95% CI -0.07 to 1.34; 2 studies, 83 participants; low-quality evidence). However, intravenous iron therapy produced an increase in preoperative postintervention haemoglobin levels compared with oral iron (MD 1.23 g/dL, 95% CI 0.80 to 1.65; 2 studies, 172 participants; low-quality evidence). Ferritin levels were increased by intravenous iron, both when compared to standard care ((MD 149.00, 95% CI 25.84 to 272.16; 1 study, 63 participants; low-quality evidence) or to oral iron (MD 395.03 ng/mL, 95% CI 227.72 to 562.35; 2 studies, 151 participants; low-quality evidence).\nNot all studies measured quality of life, short-term mortality or postoperative morbidity. Some measured the outcomes, but did not report the data, and the studies which did report the data were underpowered. Therefore, uncertainty remains regarding these outcomes. The inclusion of new research in the future is very likely to change these results.\nAuthors' conclusions\nThe use of iron therapy for preoperative anaemia does not show a clinically significant reduction in the proportion of trial participants who received an allogeneic blood transfusion compared to no iron therapy. Results for intravenous iron are consistent with a greater increase in haemoglobin and ferritin when compared to oral iron, but do not provide reliable evidence. These conclusions are drawn from six studies, three of which included very small numbers of participants. Further, well-designed, adequately powered, RCTs are required to determine the true effectiveness of iron therapy for preoperative anaemia. Two studies are currently in progress, and will include 1500 randomised participants.\n\nGiven the provided abstract, please respond to the following query: \"Study characteristics\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "we looked at adults with anaemia who were due to have an operation, who received iron treatment or usual care, or a 'pretend' iron treatment (placebo) prior to their surgery. We also compared different forms of iron therapy with each other. We included six studies and a total of 372 participants."
}
] |
query-laysum
|
22022
|
[
{
"role": "user",
"content": "Abstract: Background\nAlpha-glucosidase inhibitors (AGI) reduce blood glucose levels and may thus prevent or delay type 2 diabetes mellitus (T2DM) and its associated complications in people at risk of developing of T2DM.\nObjectives\nTo assess the effects of AGI in people with impaired glucose tolerance (IGT), impaired fasting blood glucose (IFG), moderately elevated glycosylated haemoglobin A1c (HbA1c) or any combination of these.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, ClinicalTrials.gov, the World Health Organization International Clinical Trials Registry Platform, and the reference lists of systematic reviews, articles and health technology assessment reports. The date of the last search of all databases was December 2017.\nSelection criteria\nWe included randomised controlled trials (RCTs), with a duration of one year or more, comparing AGI with any pharmacological glucose-lowering intervention, behaviour-changing intervention, placebo or no intervention in people with IFG, IGT, moderately elevated HbA1c or combinations of these.\nData collection and analysis\nTwo review authors read all abstracts and full-text articles or records, assessed quality and extracted outcome data independently. One review author extracted data, which were checked by a second review author. We resolved discrepancies by consensus or involvement of a third review author. For meta-analyses we used a random-effects model with assessment of risk ratios (RRs) for dichotomous outcomes and mean differences (MDs) for continuous outcomes, using 95% confidence intervals (CIs) for effect estimates. We assessed the overall quality of the evidence by using the GRADE instrument.\nMain results\nFor this update of the Cochrane Review (first published 2006, Issue 4) we included 10 RCTs (11,814 participants), eight investigating acarbose and two investigating voglibose, that included people with IGT or people \"at increased risk for diabetes\". The trial duration ranged from one to six years. Most trials compared AGI with placebo (N = 4) or no intervention (N = 4).\nAcarbose reduced the incidence of T2DM compared to placebo: 670 out of 4014 people (16.7%) in the acarbose groups developed T2DM, compared to 812 out of 3994 people (20.3%) in the placebo groups (RR 0.82, 95% CI 0.75 to 0.89; P < 0.0001; 3 trials; 8008 participants; moderate-certainty evidence). One trial including participants with coronary heart disease and IGT contributed 64% of cases for this outcome. Acarbose reduced the risk of T2DM compared to no intervention: 7 out 75 people (9.3%) in the acarbose groups developed T2DM, compared to 18 out of 65 people (27.7%) in the no-intervention groups (RR 0.31, 95% CI 0.14 to 0.69; P = 0.004; 2 trials; 140 participants; very low-certainty evidence).\nAcarbose compared to placebo did not reduce or increase the risk of all-cause mortality (RR 0.98, 95% CI 0.82 to 1.18; P = 0.86; 3 trials; 8069 participants; very low-certainty evidence), cardiovascular mortality (RR 0.88; 95% CI 0.71 to 1.10; P = 0.26; 3 trials; 8069 participants; very low-certainty evidence), serious adverse events (RR 1.12, 95% CI 0.97 to 1.29; P = 0.13; 2 trials; 6625 participants; low-certainty evidence), non-fatal stroke (RR 0.50, 95% CI 0.09 to 2.74; P = 0.43; 1 trial; 1368 participants; very low-certainty evidence) or congestive heart failure (RR of 0.87; 95% CI 0.63 to 1.12; P = 0.40; 2 trials; 7890 participants; low-certainty evidence). Acarbose compared to placebo reduced non-fatal myocardial infarction: one out of 742 participants (0.1%) in the acarbose groups had a non-fatal myocardial infarction compared to 15 out of 744 participants (2%) in the placebo groups (RR 0.10, 95% CI 0.02 to 0.53; P = 0.007; 2 trials; 1486 participants; very low-certainty evidence). Acarbose treatment showed an increased risk of non-serious adverse events (mainly gastro-intestinal events), compared to placebo: 751 of 775 people (96.9%) in the acarbose groups experienced an event, compared to 723 of 775 people (93.3%) in the placebo groups (RR 1.04; 95% CI 1.01 to 1.06; P = 0.0008; 2 trials; 1550 participants). Acarbose compared to no intervention showed no advantage or disadvantage for any of these outcome measures (very low-certainty evidence).\nOne trial each compared voglibose with placebo (1780 participants) or diet and exercise (870 participants). Voglibose compared to placebo reduced the incidence of T2DM: 50 out of 897 participants (5.6%) developed T2DM, compared to 106 out of 881 participants (12%) in the placebo group (RR 0.46, 95% CI 0.34 to 0.64; P < 0.0001; 1 trial; 1778 participants; low-certainty evidence). For all other reported outcome measures there were no clear differences between voglibose and comparator groups. One trial with 90 participants compared acarbose with diet and exercise and another trial with 98 participants reported data on acarbose versus metformin. There were no clear differences for any outcome measure between these two acarbose interventions and the associated comparator groups.\nNone of the trials reported amputation of lower extremity, blindness or severe vision loss, end-stage renal disease, health-related quality of life, time to progression to T2DM, or socioeconomic effects.\nAuthors' conclusions\nAGI may prevent or delay the development of T2DM in people with IGT. There is no firm evidence that AGI have a beneficial effect on cardiovascular mortality or cardiovascular events.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "People with moderately elevated glucose levels are often said to be at an increased risk of developing type 2 diabetes. Therefore, these people are frequently recommended to increase exercise and lower calorie intake to prevent type 2 diabetes. Alpha-glucosidase inhibitors (acarbose, miglitol, voglibose), are used to lower blood glucose in people with type 2 diabetes mellitus. It is currently not known whether alpha-glucosidase inhibitors should be prescribed for people with moderately raised blood glucose levels. We wanted to find out whether alpha-glucosidase inhibitors could prevent or delay type 2 diabetes mellitus in people with moderately elevated glucose levels. We searched medical literature for randomised controlled trials (clinical trials where people are randomly put into one of two or more treatment groups), of at least one year's duration, investigating alpha-glucosidase inhibitors in participants with glucose levels higher than considered normal, but below the diagnostic criteria for type 2 diabetes mellitus."
}
] |
query-laysum
|
22023
|
[
{
"role": "user",
"content": "Abstract: Background\nNeonates who have undergone gastrointestinal surgery are particularly susceptible to infectious complications in the postoperative period. This may be due in part to disruption of the integrity of the gut and its altered intestinal microflora. Lactoferrin is a whey protein found in milk and is an important innate mammalian defence mechanism. Lactoferrin has been reported to have antimicrobial and anti-inflammatory properties. It has also been reported to help establish a healthy gut microflora and aid in the intestinal immune system. Lactoferrin supplementation has been reported to decrease sepsis in preterm infants. There may be a role for lactoferrin to reduce the incidence of sepsis, thus reducing morbidity and mortality and improving enteral feeding in postoperative term neonates.\nObjectives\nThe primary objective of this review was to evaluate the efficacy of administering lactoferrin on the incidence of sepsis and mortality in term neonates after gastrointestinal surgery.\nThe secondary objective was to assess the impact of administering lactoferrin on time to full enteral feeds, the intestinal microflora, duration of hospital stay, and mortality before discharge in the same population.\nSearch methods\nThe Cochrane Neonatal Information Specialist searched the Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE, Embase Ovid, CINAHL, the WHO ICTRP and ClinicalTrials.gov trials registries. The date of the last search was February 2023. There were no restrictions to language, publication year or publication type. We checked references of potentially relevant studies and systematic reviews.\nSelection criteria\nWe planned to include randomised controlled trials that studied infants born at 37 or more weeks of gestation who had one or more episodes of gastrointestinal surgery within 28 days of birth, and compared administration of lactoferrin with a placebo.\nData collection and analysis\nWe used standard Cochrane methodological procedures. We planned to use the GRADE approach to assess the certainty of evidence for each outcome.\nMain results\nWe identified no published randomised controlled studies that assessed the efficacy of lactoferrin for the postoperative management of term neonates following gastrointestinal surgery.\nAuthors' conclusions\nThere is currently no evidence available from randomised controlled trials to show whether lactoferrin is effective or ineffective for the postoperative management of term neonates after gastrointestinal surgery. There is a need for randomised controlled trials to be performed to assess the role of lactoferrin in this setting.\n\nGiven the provided abstract, please respond to the following query: \"What are some of the risks of digestive tract surgery in babies?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Surgery of the digestive tract increases the risk of infection. Infections can increase the length of stay in hospital. Treatment with antibiotics (medicines that fight bacterial infections) and stress from surgery can disrupt good bacteria in the digestive tract."
}
] |
query-laysum
|
22024
|
[
{
"role": "user",
"content": "Abstract: Background\nChordoma is a rare primary bone tumour with a high propensity for local recurrence. Surgical resection is the mainstay of treatment, but complete resection is often morbid due to tumour location. Similarly, the dose of radiotherapy (RT) that surrounding healthy organs can tolerate is frequently below that required to provide effective tumour control. Therefore, clinicians have investigated different radiation delivery techniques, often in combination with surgery, aimed to improve the therapeutic ratio.\nObjectives\nTo assess the effects and toxicity of proton and photon adjuvant radiotherapy (RT) in people with biopsy-confirmed chordoma.\nSearch methods\nWe searched CENTRAL (2021, Issue 4); MEDLINE Ovid (1946 to April 2021); Embase Ovid (1980 to April 2021) and online registers of clinical trials, and abstracts of scientific meetings up until April 2021.\nSelection criteria\nWe included adults with pathologically confirmed primary chordoma, who were irradiated with curative intent, with protons or photons in the form of fractionated RT, SRS (stereotactic radiosurgery), SBRT (stereotactic body radiotherapy), or IMRT (intensity modulated radiation therapy). We limited analysis to studies that included outcomes of participants treated with both protons and photons.\nData collection and analysis\nThe primary outcomes were local control, mortality, recurrence, and treatment-related toxicity. We followed current standard Cochrane methodological procedures for data extraction, management, and analysis. We used the ROBINS-I tool to assess risk of bias, and GRADE to assess the certainty of the evidence.\nMain results\nWe included six observational studies with 187 adult participants. We judged all studies to be at high risk of bias. Four studies were included in meta-analysis.\nWe are uncertain if proton compared to photon therapy worsens or has no effect on local control (hazard ratio (HR) 5.34, 95% confidence interval (CI) 0.66 to 43.43; 2 observational studies, 39 participants; very low-certainty evidence).\nMedian survival time ranged between 45.5 months and 66 months. We are uncertain if proton compared to photon therapy reduces or has no effect on mortality (HR 0.44, 95% CI 0.13 to 1.57; 4 observational studies, 65 participants; very low-certainty evidence).\nMedian recurrence-free survival ranged between 3 and 10 years. We are uncertain whether proton compared to photon therapy reduces or has no effect on recurrence (HR 0.34, 95% CI 0.10 to 1.17; 4 observational studies, 94 participants; very low-certainty evidence).\nOne study assessed treatment-related toxicity and reported that four participants on proton therapy developed radiation-induced necrosis in the temporal bone, radiation-induced damage to the brainstem, and chronic mastoiditis; one participant on photon therapy developed hearing loss, worsening of the seventh cranial nerve paresis, and ulcerative keratitis (risk ratio (RR) 1.28, 95% CI 0.17 to 9.86; 1 observational study, 33 participants; very low-certainty evidence). There is no evidence that protons led to reduced toxicity.\nThere is very low-certainty evidence to show an advantage for proton therapy in comparison to photon therapy with respect to local control, mortality, recurrence, and treatment related toxicity.\nAuthors' conclusions\nThere is a lack of published evidence to confirm a clinical difference in effect with either proton or photon therapy for the treatment of chordoma. As radiation techniques evolve, multi-institutional data should be collected prospectively and published, to help identify persons that would most benefit from the available radiation treatment techniques.\n\nGiven the provided abstract, please respond to the following query: \"Why is this review important?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "At the time of this review, there is a lack of evidence to confirm a benefit with proton therapy compared to conventional photon radiation treatment. However, it is important to note that this review found a number of delivery techniques for both proton and photon therapy. As evidence comparing the latest techniques for proton and photon therapy emerges, we will update this review."
}
] |
query-laysum
|
22025
|
[
{
"role": "user",
"content": "Abstract: Background\nCannulation techniques have been recognized as being important in causing post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). However, considerable controversy exists about the usefulness of the guidewire-assisted cannulation technique for the prevention of PEP.\nObjectives\nTo assess the effectiveness and safety of the guidewire-assisted cannulation technique compared to the conventional contrast-assisted cannulation technique for the prevention of PEP in people undergoing diagnostic or therapeutic ERCP for biliary or pancreatic diseases.\nSearch methods\nFor the previous version of this review, we searched CENTRAL (the Cochrane Library), MEDLINE, Embase, CINAHL and major conference proceedings, up to February 2012, with no language restrictions. An updated search was performed on 26 February 2021 for the current version of this review. Two clinical trial registries, clinicaltrials.gov and WHO ICTRP, were also searched in this update.\nSelection criteria\nRandomized controlled trials (RCTs) comparing the guidewire-assisted cannulation technique versus the contrast-assisted cannulation technique in people undergoing ERCP.\nData collection and analysis\nTwo review authors conducted study selection, data extraction, and methodological quality assessment independently. Using intention-to-treat analysis with random-effects models, we combined dichotomous data to obtain risk ratios (RR) with 95% confidence intervals (CI). We assessed heterogeneity using the Chi² test (P < 0.10) and I² statistic (> 50%). To explore sources of heterogeneity, we conducted a priori subgroup analyses according to trial design, publication type, risk of bias, use of precut sphincterotomy, inadvertent guidewire insertion or contrast injection of the pancreatic duct (PD), use of a PD stent, cannulation device, and trainee involvement in cannulation. To assess the robustness of our results, we carried out sensitivity analyses using different summary statistics (RR versus odds ratio (OR)) and meta-analytic models (fixed-effect versus random-effects) and per-protocol analysis.\nMain results\n15 RCTs comprising 4426 participants were included. There was moderate heterogeneity among trials for the outcome of PEP (P = 0.08, I² = 36%). Meta-analyses suggest that the guidewire-assisted cannulation technique probably reduces the risk of PEP compared to the contrast-assisted cannulation technique (RR 0.51, 95% CI 0.36 to 0.72, 15 studies, moderate-certainty evidence). In addition, the guidewire-assisted cannulation technique may result in an increase in primary cannulation success (RR 1.06, 95% CI 1.01 to 1.12, 13 studies, low-certainty evidence), and probably reduces the need for precut sphincterotomy (RR 0.79, 95% CI 0.64 to 0.96, 10 studies, moderate-certainty evidence). Compared to the contrast-assisted cannulation technique, the guidewire-assisted cannulation technique may result in little to no difference in the risk of post-sphincterotomy bleeding (RR 0.87, 95% CI 0.49 to 1.54, 7 studies, low-certainty evidence) and perforation (RR 0.93, 95% CI 0.11 to 8.23, 8 studies, very low-certainty evidence). Procedure-related mortality was reported by eight studies, and there were no cases of deaths in both arms (moderate-certainty evidence). Subgroup analyses suggest that the heterogeneity for the outcome of PEP could be explained by differences in trial design. The results were robust in sensitivity analyses.\nAuthors' conclusions\nThere is moderate-certainty evidence that the guidewire-assisted cannulation technique probably reduces the risk of PEP compared to the contrast-assisted cannulation technique. There is low-certainty evidence that the guidewire-assisted cannulation technique may result in an increase in primary cannulation success. There is low- and very low-certainty evidence that the guidewire-assisted cannulation technique may result in little to no difference in the risk of bleeding and perforation. No procedure-related deaths were reported. Therefore, the guidewire-assisted cannulation technique appears to be superior to the contrast-assisted cannulation technique considering the certainty of evidence and the balance of benefits and harms. However, the routine use of guidewires in biliary cannulation will be dependent on local expertise, availability, and cost. Future research should assess the effectiveness and safety of the guidewire-assisted cannulation technique in the context of other pharmacologic or non-pharmacologic interventions for the prevention of PEP.\n\nGiven the provided abstract, please respond to the following query: \"What is post-ERCP pancreatitis (PEP)?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "ERCP combines endoscopy (examination inside the body using a medical instrument called an endoscope) and x-ray to diagnose and treat problems of the bile and pancreatic ducts (structures that support the process of digestion). With the patient under sedation, an endoscope is passed down the oesophagus (windpipe) and into the small bowel, where the opening of the bile and pancreatic ducts (papilla) is located. A catheter is inserted through the endoscope and papilla into the bile duct. Contrast dye is injected into the bile duct, and x-rays are taken to look for gallstones or blockage. However, the major risk of ERCP is the development of pancreatitis (inflammation of the pancreas) due to irritation of the pancreatic duct by the contrast material or catheter, which can occur in 5% to 10% of all procedures. This may be self-limited and mild, but can also be severe and require hospitalisation. Rarely, it may be life-threatening. There are also small risks of bleeding or making a hole in the bowel wall."
}
] |
query-laysum
|
22026
|
[
{
"role": "user",
"content": "Abstract: Background\nGreat saphenous vein (GSV) incompetence, causing varicose veins and venous insufficiency, makes up the majority of lower-limb superficial venous diseases. Treatment options for GSV incompetence include surgery (also known as high ligation and stripping), laser and radiofrequency ablation, and ultrasound-guided foam sclerotherapy. Newer treatments include cyanoacrylate glue, mechanochemical ablation, and endovenous steam ablation. These techniques avoid the need for a general anaesthetic, and may result in fewer complications and improved quality of life (QoL). These treatments should be compared to inform decisions on treatment for varicosities in the GSV. This is an update of a Cochrane Review first published in 2011.\nObjectives\nTo assess the effects of endovenous laser ablation (EVLA), radiofrequency ablation (RFA), endovenous steam ablation (EVSA), ultrasound-guided foam sclerotherapy (UGFS), cyanoacrylate glue, mechanochemical ablation (MOCA) and high ligation and stripping (HL/S) for the treatment of varicosities of the great saphenous vein (GSV).\nSearch methods\nThe Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL, and AMED databases, and World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 2 November 2020. We undertook reference checking to identify additional studies.\nSelection criteria\nWe included randomised controlled trials (RCTs) treating participants for varicosities of the GSV using EVLA, RFA, EVSA, UGFS, cyanoacrylate glue, MOCA or HL/S. Key outcomes of interest are technical success, recurrence, complications and QoL.\nData collection and analysis\nTwo review authors independently selected trials, applied Cochrane's risk of bias tool, and extracted data. We calculated odds ratios (ORs) with 95% confidence intervals (CIs) and assessed the certainty of evidence using GRADE.\nMain results\nWe identified 11 new RCTs for this update. Therefore, we included 24 RCTs with 5135 participants. Duration of follow-up ranged from five weeks to eight years. Five comparisons included single trials. For comparisons with more than one trial, we could only pool data for 'technical success' and 'recurrence' due to heterogeneity in outcome definitions and time points reported. All trials had some risk of bias concerns. Here we report the clinically most relevant comparisons.\nEVLA versus RFA\nTechnical success was comparable up to five years (OR 0.98, 95% CI 0.41 to 2.38; 5 studies, 780 participants; moderate-certainty evidence); over five years, there was no evidence of a difference (OR 0.85, 95% CI 0.30 to 2.41; 1 study, 291 participants; low-certainty evidence). One study reported recurrence, showing no clear difference at three years (OR 1.53, 95% CI 0.78 to 2.99; 291 participants; low-certainty evidence), but a benefit for RFA may be seen at five years (OR 2.77, 95% CI 1.52 to 5.06; 291 participants; low-certainty evidence).\nEVLA versus UGFS\nTechnical success may be better in EVLA participants up to five years (OR 6.13, 95% CI 0.98 to 38.27; 3 studies, 588 participants; low-certainty evidence), and over five years (OR 6.47, 95% CI 2.60 to 16.10; 3 studies, 534 participants; low-certainty evidence). There was no clear difference in recurrence up to three years and at five years (OR 0.68, 95% CI 0.20 to 2.36; 2 studies, 443 participants; and OR 1.08, 95% CI 0.40 to 2.87; 2 studies, 418 participants; very low-certainty evidence, respectively).\nEVLA versus HL/S\nTechnical success may be better in EVLA participants up to five years (OR 2.31, 95% CI 1.27 to 4.23; 6 studies, 1051 participants; low-certainty evidence). No clear difference in technical success was seen at five years and beyond (OR 0.93, 95% CI 0.57 to 1.50; 5 studies, 874 participants; low-certainty evidence). Recurrence was comparable within three years and at 5 years (OR 0.78, 95% CI 0.47 to 1.29; 7 studies, 1459 participants; and OR 1.09, 95% CI 0.68 to 1.76; 7 studies, 1267 participants; moderate-certainty evidence, respectively).\nRFA versus MOCA\nThere was no clear difference in technical success (OR 1.76, 95% CI 0.06 to 54.15; 3 studies, 435 participants; low-certainty evidence), or recurrence (OR 1.00, 95% CI 0.21 to 4.81; 3 studies, 389 participants; low-certainty evidence). Long-term data are not available.\nRFA versus HL/S\nNo clear difference in technical success was detected up to five years (OR 5.71, 95% CI 0.64 to 50.81; 2 studies, 318 participants; low-certainty evidence); over five years, there was no evidence of a difference (OR 0.88, 95% CI 0.29 to 2.69; 1 study, 289 participants; low-certainty evidence). No clear difference in recurrence was detected up to three years (OR 0.93, 95% CI 0.58 to 1.51; 4 studies, 546 participants; moderate-certainty evidence); but a possible long-term benefit for RFA was seen (OR 0.41, 95% CI 0.22 to 0.75; 1 study, 289 participants; low-certainty evidence).\nUGFS versus HL/S\nMeta-analysis showed a possible benefit for HL/S compared with UGFS in technical success up to five years (OR 0.32, 95% CI 0.11 to 0.94; 4 studies, 954 participants; low-certainty evidence), and over five years (OR 0.09, 95% CI 0.03 to 0.30; 3 studies, 525 participants; moderate-certainty evidence). No clear difference was detected in recurrence up to three years (OR 1.81, 95% CI 0.87 to 3.77; 3 studies, 822 participants; low-certainty evidence), and after five years (OR 1.24, 95% CI 0.57 to 2.71; 3 studies, 639 participants; low-certainty evidence).\nComplications were generally low for all interventions, but due to different definitions and time points, we were unable to draw conclusions (very-low certainty evidence). Similarly, most studies evaluated QoL but used different questionnaires at variable time points. Rates of QoL improvement were comparable between interventions at follow-up (moderate-certainty evidence).\nAuthors' conclusions\nOur conclusions are limited due to the relatively small number of studies for each comparison and differences in outcome definitions and time points reported. Technical success was comparable between most modalities. EVLA may offer improved technical success compared to UGFS or HL/S. HL/S may have improved technical success compared to UGFS. No evidence of a difference was detected in recurrence, except for a possible long-term benefit for RFA compared to EVLA or HL/S. Studies which provide more evidence on the breadth of treatments are needed. Future trials should seek to standardise clinical terminology of outcome measures and the time points at which they are measured.\n\nGiven the provided abstract, please respond to the following query: \"Key messages\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We are uncertain about which treatments are best for varicose veins because we found only a small number of studies that compared the different types of treatment, and because studies differed in how they measured results.\n- All currently available varicose vein treatments are similar in terms of whether the treatment fully destroys the vein, or stops blood from pooling in the legs, or both (technical success).\n- We need studies that provide more evidence on all the available treatments."
}
] |
query-laysum
|
22027
|
[
{
"role": "user",
"content": "Abstract: Background\nAlopecia areata is an autoimmune disease leading to nonscarring hair loss on the scalp or body. There are different treatments including immunosuppressants, hair growth stimulants, and contact immunotherapy.\nObjectives\nTo assess the benefits and harms of the treatments for alopecia areata (AA), alopecia totalis (AT), and alopecia universalis (AU) in children and adults.\nSearch methods\nThe Cochrane Skin Specialised Register, CENTRAL, MEDLINE, Embase, ClinicalTrials.gov and WHO ICTRP were searched up to July 2022.\nSelection criteria\nWe included randomised controlled trials (RCTs) that evaluated classical immunosuppressants, biologics, small molecule inhibitors, contact immunotherapy, hair growth stimulants, and other therapies in paediatric and adult populations with AA.\nData collection and analysis\nWe used the standard procedures expected by Cochrane including assessment of risks of bias using RoB2 and the certainty of the evidence using GRADE. The primary outcomes were short-term hair regrowth ≥ 75% (between 12 and 26 weeks of follow-up), and incidence of serious adverse events. The secondary outcomes were long-term hair regrowth ≥ 75% (greater than 26 weeks of follow-up) and health-related quality of life. We could not perform a network meta-analysis as very few trials compared the same treatments. We presented direct comparisons and made a narrative description of the findings.\nMain results\nWe included 63 studies that tested 47 different treatments in 4817 randomised participants. All trials used a parallel-group design except one that used a cross-over design. The mean sample size was 78 participants. All trials recruited outpatients from dermatology clinics. Participants were between 2 and 74 years old. The trials included patients with AA (n = 25), AT (n = 1), AU (n = 1), mixed cases (n = 31), and unclear types of alopecia (n = 4).\nThirty-three out of 63 studies (52.3%) reported the proportion of participants achieving short-term hair regrowth ≥ 75% (between 12 and 26 weeks). Forty-seven studies (74.6%) reported serious adverse events and only one study (1.5%) reported health-related quality of life. Five studies (7.9%) reported the proportion of participants with long-term hair regrowth ≥ 75% (greater than 26 weeks).\nAmongst the variety of interventions found, we prioritised some groups of interventions for their relevance to clinical practice: systemic therapies (classical immunosuppressants, biologics, and small molecule inhibitors), and local therapies (intralesional corticosteroids, topical small molecule inhibitors, contact immunotherapy, hair growth stimulants and cryotherapy).\nConsidering only the prioritised interventions, 14 studies from 12 comparisons reported short-term hair regrowth ≥ 75% and 22 studies from 10 comparisons reported serious adverse events (18 reported zero events and 4 reported at least one). One study (1 comparison) reported quality of life, and two studies (1 comparison) reported long-term hair regrowth ≥ 75%.\nFor the main outcome of short-term hair regrowth ≥ 75%, the evidence is very uncertain about the effect of oral prednisolone or cyclosporine versus placebo (RR 4.68, 95% CI 0.57 to 38.27; 79 participants; 2 studies; very low-certainty evidence), intralesional betamethasone or triamcinolone versus placebo (RR 13.84, 95% CI 0.87 to 219.76; 231 participants; 1 study; very low-certainty evidence), oral ruxolitinib versus oral tofacitinib (RR 1.08, 95% CI 0.77 to 1.52; 80 participants; 1 study; very low-certainty evidence), diphencyprone or squaric acid dibutil ester versus placebo (RR 1.16, 95% CI 0.79 to 1.71; 99 participants; 1 study; very-low-certainty evidence), diphencyprone or squaric acid dibutyl ester versus topical minoxidil (RR 1.16, 95% CI 0.79 to 1.71; 99 participants; 1 study; very low-certainty evidence), diphencyprone plus topical minoxidil versus diphencyprone (RR 0.67, 95% CI 0.13 to 3.44; 30 participants; 1 study; very low-certainty evidence), topical minoxidil 1% and 2% versus placebo (RR 2.31, 95% CI 1.34 to 3.96; 202 participants; 2 studies; very low-certainty evidence) and cryotherapy versus fractional CO2 laser (RR 0.31, 95% CI 0.11 to 0.86; 80 participants; 1 study; very low-certainty evidence). The evidence suggests oral betamethasone may increase short-term hair regrowth ≥ 75% compared to prednisolone or azathioprine (RR 1.67, 95% CI 0.96 to 2.88; 80 participants; 2 studies; low-certainty evidence). There may be little to no difference between subcutaneous dupilumab and placebo in short-term hair regrowth ≥ 75% (RR 3.59, 95% CI 0.19 to 66.22; 60 participants; 1 study; low-certainty evidence) as well as between topical ruxolitinib and placebo (RR 5.00, 95% CI 0.25 to 100.89; 78 participants; 1 study; low-certainty evidence). However, baricitinib results in an increase in short-term hair regrowth ≥ 75% when compared to placebo (RR 7.54, 95% CI 3.90 to 14.58; 1200 participants; 2 studies; high-certainty evidence).\nFor the incidence of serious adverse events, the evidence is very uncertain about the effect of topical ruxolitinib versus placebo (RR 0.33, 95% CI 0.01 to 7.94; 78 participants; 1 study; very low-certainty evidence). Baricitinib and apremilast may result in little to no difference in the incidence of serious adverse events versus placebo (RR 1.47, 95% CI 0.60 to 3.60; 1224 participants; 3 studies; low-certainty evidence). The same result is observed for subcutaneous dupilumab compared to placebo (RR 1.54, 95% CI 0.07 to 36.11; 60 participants; 1 study; low-certainty evidence).\nFor health-related quality of life, the evidence is very uncertain about the effect of oral cyclosporine compared to placebo (MD 0.01, 95% CI -0.04 to 0.07; very low-certainty evidence).\nBaricitinib results in an increase in long-term hair regrowth ≥ 75% compared to placebo (RR 8.49, 95% CI 4.70 to 15.34; 1200 participants; 2 studies; high-certainty evidence).\nRegarding the risk of bias, the most relevant issues were the lack of details about randomisation and allocation concealment, the limited efforts to keep patients and assessors unaware of the assigned intervention, and losses to follow-up.\nAuthors' conclusions\nWe found that treatment with baricitinib results in an increase in short- and long-term hair regrowth compared to placebo. Although we found inconclusive results for the risk of serious adverse effects with baricitinib, the reported small incidence of serious adverse events in the baricitinib arm should be balanced with the expected benefits. We also found that the impact of other treatments on hair regrowth is very uncertain. Evidence for health-related quality of life is still scant.\n\nGiven the provided abstract, please respond to the following query: \"What did we find?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found 63 studies that tested 47 different therapies in 4817 people with AA, AT or AU (participants were between 2 and 74 years old).\nWithin the 12 comparisons (one comparison means one treatment compared to another) considered more relevant to clinical practice, short-term hair regrowth ≥ 75% (from 12 to 26 weeks of follow-up) was evaluated in 14 studies and long-term regrowth ≥ 75% (after 26 weeks of follow-up) was evaluated in two studies. Only one study assessed well-being (quality of life) and 22 studies assessed serious adverse events (although only four of them reported at least one serious adverse event)."
}
] |
query-laysum
|
22028
|
[
{
"role": "user",
"content": "Abstract: Background\nEndometrial cancer is one of the most common gynaecological cancers in developed countries. Treatment of advanced endometrial cancer usually involves radiotherapy, chemotherapy, endocrine therapy or a combination of these. However, survival outcomes are poor in advanced or metastatic disease. Better systemic treatment options are needed to improve survival and safety outcomes for these women. The PI3K/AKT/mTOR pathway is a frequently altered signalling pathway in endometrial cancer. Single-arm studies have reported some encouraging results of the PI3K/AKT/mTOR inhibition in advanced or recurrent endometrial cancer.\nObjectives\nTo assess the efficacy and safety of PI3K/AKT/mTOR inhibitor-containing regimens in women with locally-advanced, metastatic or recurrent endometrial cancer.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials, MEDLINE and Embase to 16 January 2019; and the World Health Organization's International Clinical Trials Registry Platform (WHO ICTRP) and ClinicalTrials.gov in July 2018. We also reviewed reference lists from included studies and endometrial cancer guidelines.\nSelection criteria\nWe included randomised controlled trials (RCTs) comparing a regimen with a PI3K/AKT/mTOR inhibitor (either alone or in combination with other treatments, such as chemotherapy or hormonal therapy) versus a comparator regimen without a PI3K/AKT/mTOR inhibitor. There were no restrictions on which comparator(s) were included.\nData collection and analysis\nWe extracted data independently, and assessed risks of bias and the certainty of the evidence. The primary outcome measures were progression-free survival and toxicity (grade 3/4 where available). We derived hazard ratios (HRs) for time-to-event outcomes and risk ratios (RRs) for dichotomous outcomes. Secondary outcomes included overall survival, objective tumour response rate, quality of life and treatment-related death. We used GRADEproGDT to assess the certainty of the evidence for the most important outcomes (by first-line and second/third-line therapy for progression-free survival and overall survival).\nMain results\nWe included two RCTs involving 361 women. One study assessed the effects of the mTOR inhibitor temsirolimus, in combination with carboplatin/paclitaxel versus carboplatin/paclitaxel and bevacizumab in treatment-naïve women with advanced or recurrent endometrial cancer. The second study compared the mTOR inhibitor ridaforolimus alone versus progestin or investigator choice of chemotherapy in women who had received prior treatment for metastatic or recurrent endometrial cancer. We identified five ongoing studies on the effects of PI3K and AKT inhibitors, metformin and dual mTOR inhibitors.\nFor first-line therapy, an mTOR inhibitor-containing regimen may worsen progression-free survival (HR 1.43, 95% CI 1.06 to 1.93; 1 study, 231 participants; low-certainty evidence), while for second/third-line therapy, an mTOR inhibitor probably improves progression-free survival compared to chemotherapy or endocrine therapy (HR 0.53, 95% CI 0.31 to 0.91; 1 study, 95 participants; moderate-certainty evidence). Data on toxicity were available from both studies: administering an mTOR inhibitor regimen may increase the risk of grade 3/4 mucositis (RR 10.42, 95% CI 1.34 to 80.74; 2 studies, 357 participants; low-certainty evidence), but may result in little to no difference in risk of anaemia or interstitial pneumonitis (low-certainty evidence for both toxicities). Overall, event rates were low. For first-line therapy, an mTOR inhibitor-containing regimen may result in little to no difference in overall survival compared to chemotherapy (HR 1.32, 95% CI 0.98 to 1.781 study, 231 participants; low-certainty evidence). The finding was similar for second/third-line therapy (HR 1.06, 95% CI 0.70 to 1.61; 1 study, 130 participants; low-certainty evidence). Administering mTOR inhibitor-containing regimens may result in little to no difference in tumour response compared to chemotherapy or hormonal therapy in first-line or second/third-line therapy (first line: RR 0.93, 95% CI 0.75 to 1.17; 1 study, 231 participants; second/third line: RR 0.22, 95% CI 0.01 to 4.40; 1 study, 61 participants; low-certainty evidence).\nNeither study collected or reported quality-of-life data.\nAuthors' conclusions\nTwo RCTs have been reported to date, with low certainty of evidence. In a recurrent disease setting, mTOR inhibitors may result in improved progression-free survival, but we found no clear benefit in overall survival or tumour response rate. We await the publication of at least five ongoing studies investigating the role of PI3K/AKT/mTOR inhibitors in advanced or recurrent endometrial cancer before any conclusions can be drawn on their use.\n\nGiven the provided abstract, please respond to the following query: \"Key messages\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "There is a low certainty of evidence from two clinical trials about the use of drugs targeting PI3K/AKT/mTOR pathway in women with locally-advanced, metastatic or recurrent endometrial cancer. Based on the small number of completed studies, women who have received prior treatment for advanced or recurrent endometrial cancer and received an mTOR inhibitor may have a lower risk of their cancer progressing compared to those who received chemotherapy/hormonal therapy alone. However, in women who received mTOR inhibitor-containing chemotherapy as part of their treatment when first diagnosed with advanced disease, mTOR inhibitor-containing treatment may result in their disease progressing more quickly and probably with increased complications compared to chemotherapy or hormonal therapy alone. Although mTOR inhibitors may change how long it takes for their cancer to progress, there may be little or no difference in how long women lived after treatment (known as overall survival). We await the publication of at least five studies examining the role of PI3K, AKT and mTOR inhibitors in advanced or recurrent endometrial cancer."
}
] |
query-laysum
|
22029
|
[
{
"role": "user",
"content": "Abstract: Background\nReference standard indices of iron deficiency and iron overload are generally invasive, expensive, and can be unpleasant or occasionally risky. Ferritin is an iron storage protein and its concentration in the plasma or serum reflects iron stores; low ferritin indicates iron deficiency, while elevated ferritin reflects risk of iron overload. However, ferritin is also an acute-phase protein and its levels are elevated in inflammation and infection. The use of ferritin as a diagnostic test of iron deficiency and overload is a common clinical practice.\nObjectives\nTo determine the diagnostic accuracy of ferritin concentrations (serum or plasma) for detecting iron deficiency and risk of iron overload in primary and secondary iron-loading syndromes.\nSearch methods\nWe searched the following databases (10 June 2020): DARE (Cochrane Library) Issue 2 of 4 2015, HTA (Cochrane Library) Issue 4 of 4 2016, CENTRAL (Cochrane Library) Issue 6 of 12 2020, MEDLINE (OVID) 1946 to 9 June 2020, Embase (OVID) 1947 to week 23 2020, CINAHL (Ebsco) 1982 to June 2020, Web of Science (ISI) SCI, SSCI, CPCI-exp & CPCI-SSH to June 2020, POPLINE 16/8/18, Open Grey (10/6/20), TRoPHI (10/6/20), Bibliomap (10/6/20), IBECS (10/6/20), SCIELO (10/6/20), Global Index Medicus (10/6/20) AIM, IMSEAR, WPRIM, IMEMR, LILACS (10/6/20), PAHO (10/6/20), WHOLIS 10/6/20, IndMED (16/8/18) and Native Health Research Database (10/6/20). We also searched two trials registers and contacted relevant organisations for unpublished studies.\nSelection criteria\nWe included all study designs seeking to evaluate serum or plasma ferritin concentrations measured by any current or previously available quantitative assay as an index of iron status in individuals of any age, sex, clinical and physiological status from any country.\nData collection and analysis\nWe followed standard Cochrane methods. We designed the data extraction form to record results for ferritin concentration as the index test, and bone marrow iron content for iron deficiency and liver iron content for iron overload as the reference standards. Two other authors further extracted and validated the number of true positive, true negative, false positive, false negative cases, and extracted or derived the sensitivity, specificity, positive and negative predictive values for each threshold presented for iron deficiency and iron overload in included studies.\nWe assessed risk of bias and applicability using the Quality Assessment of Diagnostic Accuracy Studies (QUADAS)-2 tool. We used GRADE assessment to enable the quality of evidence and hence strength of evidence for our conclusions.\nMain results\nOur search was conducted initially in 2014 and updated in 2017, 2018 and 2020 (10 June). We identified 21,217 records and screened 14,244 records after duplicates were removed. We assessed 316 records in full text. We excluded 190 studies (193 records) with reasons and included 108 studies (111 records) in the qualitative and quantitative analysis. There were 11 studies (12 records) that we screened from the last search update and appeared eligible for a future analysis. We decided to enter these as awaiting classification.\nWe stratified the analysis first by participant clinical status: apparently healthy and non-healthy populations. We then stratified by age and pregnancy status as: infants and children, adolescents, pregnant women, and adults.\nIron deficiency\nWe included 72 studies (75 records) involving 6059 participants.\nApparently healthy populations\nFive studies screened for iron deficiency in people without apparent illness. In the general adult population, three studies reported sensitivities of 63% to 100% at the optimum cutoff for ferritin, with corresponding specificities of 92% to 98%, but the ferritin cutoffs varied between studies. One study in healthy children reported a sensitivity of 74% and a specificity of 77%. One study in pregnant women reported a sensitivity of 88% and a specificity of 100%. Overall confidence in these estimates was very low because of potential bias, indirectness, and sparse and heterogenous evidence. No studies screened for iron overload in apparently healthy people.\nPeople presenting for medical care\nThere were 63 studies among adults presenting for medical care (5042 participants). For a sample of 1000 subjects with a 35% prevalence of iron deficiency (of the included studies in this category) and supposing a 85% specificity, there would be 315 iron-deficient subjects correctly classified as having iron deficiency and 35 iron-deficient subjects incorrectly classified as not having iron deficiency, leading to a 90% sensitivity. Thresholds proposed by the authors of the included studies ranged between 12 to 200 µg/L. The estimated diagnostic odds ratio was 50.\nAmong non-healthy adults using a fixed threshold of 30 μg/L (nine studies, 512 participants, low-certainty evidence), the pooled estimate for sensitivity was 79% with a 95% confidence interval of (58%, 91%) and specificity of 98%, with a 95% confidence interval of (91%, 100%). The estimated diagnostic odds ratio was 140, a relatively highly informative test.\nIron overload\nWe included 36 studies (36 records) involving 1927 participants. All studies concerned non-healthy populations. There were no studies targeting either infants, children, or pregnant women.\nAmong all populations (one threshold for males and females; 36 studies, 1927 participants, very low-certainty evidence): for a sample of 1000 subjects with a 42% prevalence of iron overload (of the included studies in this category) and supposing a 65% specificity, there would be 332 iron-overloaded subjects correctly classified as having iron overload and 85 iron-overloaded subjects incorrectly classified as not having iron overload, leading to a 80% sensitivity. The estimated diagnostic odds ratio was 8.\nAuthors' conclusions\nAt a threshold of 30 micrograms/L, there is low-certainty evidence that blood ferritin concentration is reasonably sensitive and a very specific test for iron deficiency in people presenting for medical care. There is very low certainty that high concentrations of ferritin provide a sensitive test for iron overload in people where this condition is suspected. There is insufficient evidence to know whether ferritin concentration performs similarly when screening asymptomatic people for iron deficiency or overload.\n\nGiven the provided abstract, please respond to the following query: \"What did we do?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched for studies that compared ferritin blood tests against:\n- tests of iron levels in the bone marrow, to diagnose iron deficiency; and\n- tests of iron levels in the liver, to diagnose iron overload.\nWe compared and summarised the results of the studies and rated our confidence in the evidence, based on factors like study methods and sizes."
}
] |
query-laysum
|
22030
|
[
{
"role": "user",
"content": "Abstract: Background\nOur March 2021 edition of this review showed thoracic imaging computed tomography (CT) to be sensitive and moderately specific in diagnosing COVID-19 pneumonia. This new edition is an update of the review.\nObjectives\nOur objectives were to evaluate the diagnostic accuracy of thoracic imaging in people with suspected COVID-19; assess the rate of positive imaging in people who had an initial reverse transcriptase polymerase chain reaction (RT-PCR) negative result and a positive RT-PCR result on follow-up; and evaluate the accuracy of thoracic imaging for screening COVID-19 in asymptomatic individuals. The secondary objective was to assess threshold effects of index test positivity on accuracy.\nSearch methods\nWe searched the COVID-19 Living Evidence Database from the University of Bern, the Cochrane COVID-19 Study Register, The Stephen B. Thacker CDC Library, and repositories of COVID-19 publications through to 17 February 2021. We did not apply any language restrictions.\nSelection criteria\nWe included diagnostic accuracy studies of all designs, except for case-control, that recruited participants of any age group suspected to have COVID-19. Studies had to assess chest CT, chest X-ray, or ultrasound of the lungs for the diagnosis of COVID-19, use a reference standard that included RT-PCR, and report estimates of test accuracy or provide data from which we could compute estimates. We excluded studies that used imaging as part of the reference standard and studies that excluded participants with normal index test results.\nData collection and analysis\nThe review authors independently and in duplicate screened articles, extracted data and assessed risk of bias and applicability concerns using QUADAS-2. We presented sensitivity and specificity per study on paired forest plots, and summarized pooled estimates in tables. We used a bivariate meta-analysis model where appropriate.\nMain results\nWe included 98 studies in this review. Of these, 94 were included for evaluating the diagnostic accuracy of thoracic imaging in the evaluation of people with suspected COVID-19. Eight studies were included for assessing the rate of positive imaging in individuals with initial RT-PCR negative results and positive RT-PCR results on follow-up, and 10 studies were included for evaluating the accuracy of thoracic imaging for imagining asymptomatic individuals.\nFor all 98 included studies, risk of bias was high or unclear in 52 (53%) studies with respect to participant selection, in 64 (65%) studies with respect to reference standard, in 46 (47%) studies with respect to index test, and in 48 (49%) studies with respect to flow and timing. Concerns about the applicability of the evidence to: participants were high or unclear in eight (8%) studies; index test were high or unclear in seven (7%) studies; and reference standard were high or unclear in seven (7%) studies.\nImaging in people with suspected COVID-19\nWe included 94 studies. Eighty-seven studies evaluated one imaging modality, and seven studies evaluated two imaging modalities. All studies used RT-PCR alone or in combination with other criteria (for example, clinical signs and symptoms, positive contacts) as the reference standard for the diagnosis of COVID-19.\nFor chest CT (69 studies, 28285 participants, 14,342 (51%) cases), sensitivities ranged from 45% to 100%, and specificities from 10% to 99%. The pooled sensitivity of chest CT was 86.9% (95% confidence interval (CI) 83.6 to 89.6), and pooled specificity was 78.3% (95% CI 73.7 to 82.3). Definition for index test positivity was a source of heterogeneity for sensitivity, but not specificity. Reference standard was not a source of heterogeneity.\nFor chest X-ray (17 studies, 8529 participants, 5303 (62%) cases), the sensitivity ranged from 44% to 94% and specificity from 24 to 93%. The pooled sensitivity of chest X-ray was 73.1% (95% CI 64.1 to 80.5), and pooled specificity was 73.3% (95% CI 61.9 to 82.2). Definition for index test positivity was not found to be a source of heterogeneity. Definition for index test positivity and reference standard were not found to be sources of heterogeneity.\nFor ultrasound of the lungs (15 studies, 2410 participants, 1158 (48%) cases), the sensitivity ranged from 73% to 94% and the specificity ranged from 21% to 98%. The pooled sensitivity of ultrasound was 88.9% (95% CI 84.9 to 92.0), and the pooled specificity was 72.2% (95% CI 58.8 to 82.5). Definition for index test positivity and reference standard were not found to be sources of heterogeneity.\nIndirect comparisons of modalities evaluated across all 94 studies indicated that chest CT and ultrasound gave higher sensitivity estimates than X-ray (P = 0.0003 and P = 0.001, respectively). Chest CT and ultrasound gave similar sensitivities (P = 0.42). All modalities had similar specificities (CT versus X-ray P = 0.36; CT versus ultrasound P = 0.32; X-ray versus ultrasound P = 0.89).\nImaging in PCR-negative people who subsequently became positive\nFor rate of positive imaging in individuals with initial RT-PCR negative results, we included 8 studies (7 CT, 1 ultrasound) with a total of 198 participants suspected of having COVID-19, all of whom had a final diagnosis of COVID-19. Most studies (7/8) evaluated CT. Of 177 participants with initially negative RT-PCR who had positive RT-PCR results on follow-up testing, 75.8% (95% CI 45.3 to 92.2) had positive CT findings.\nImaging in asymptomatic PCR-positive people\nFor imaging asymptomatic individuals, we included 10 studies (7 CT, 1 X-ray, 2 ultrasound) with a total of 3548 asymptomatic participants, of whom 364 (10%) had a final diagnosis of COVID-19. For chest CT (7 studies, 3134 participants, 315 (10%) cases), the pooled sensitivity was 55.7% (95% CI 35.4 to 74.3) and the pooled specificity was 91.1% (95% CI 82.6 to 95.7).\nAuthors' conclusions\nChest CT and ultrasound of the lungs are sensitive and moderately specific in diagnosing COVID-19. Chest X-ray is moderately sensitive and moderately specific in diagnosing COVID-19. Thus, chest CT and ultrasound may have more utility for ruling out COVID-19 than for differentiating SARS-CoV-2 infection from other causes of respiratory illness. The uncertainty resulting from high or unclear risk of bias and the heterogeneity of included studies limit our ability to confidently draw conclusions based on our results.\n\nGiven the provided abstract, please respond to the following query: \"What are chest imaging tests?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "X-rays or scans produce an image of the organs and structures in the chest.\n- X-rays (radiography) use radiation to produce a 2-D image. Usually done in hospitals, using fixed equipment by a radiographer; they can also be done on portable machines.\n- Computed tomography (CT) scans use a computer to merge 2-D X-ray images and convert them to a 3-D image. They require highly-specialized equipment and are done in hospital by a specialist radiographer.\n- Ultrasound scans use high-frequency sound waves to produce an image. They can be done in hospitals or other healthcare settings, such as a doctor’s office."
}
] |
query-laysum
|
22032
|
[
{
"role": "user",
"content": "Abstract: Background\nResults of randomised controlled trials (RCTs) of vitamin D supplementation to improve bone density in children are inconsistent.\nObjectives\nTo determine the effectiveness of vitamin D supplementation for improving bone mineral density in children, whether any effect varies by sex, age or pubertal stage, the type or dose of vitamin D given or baseline vitamin D status, and if effects persist after cessation of supplementation.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL Issue 3, 2009), MEDLINE (1966 to present), EMBASE (1980 to present), CINAHL (1982 to present), AMED (1985 to present) and ISI Web of Science (1945 to present) on 9 August 2009, and we handsearched key journal conference abstracts.\nSelection criteria\nPlacebo-controlled RCTs of vitamin D supplementation for at least three months in healthy children and adolescents (aged from one month to < 20 years) with bone density outcomes.\nData collection and analysis\nTwo authors screened references for inclusion, assessed risk of bias, and extracted data. We conducted meta-analyses and calculated standardised mean differences (SMD) of the percent change from baseline in outcomes in treatment and control groups. We performed subgroup analyses by sex, pubertal stage, dose of vitamin D and baseline serum vitamin D and considered these as well as compliance and allocation concealment as possible sources of heterogeneity.\nMain results\nWe included six RCTs (343 participants receiving placebo and 541 receiving vitamin D) for meta-analyses. Vitamin D supplementation had no statistically significant effects on total body bone mineral content (BMC), hip bone mineral density (BMD) or forearm BMD. There was a trend to a small effect on lumbar spine BMD (SMD 0.15, 95% CI -0.01 to 0.31, P = 0.07). There were no differences in effects between high and low serum vitamin D studies at any site though there was a trend towards a larger effect with low vitamin D for total body BMC (P = 0.09 for difference). In low serum vitamin D studies, significant effects on total body BMC and lumbar spine BMD were approximately equivalent to a 2.6% and 1.7 % percentage point greater change from baseline in the supplemented group.\nAuthors' conclusions\nThese results do not support vitamin D supplementation to improve bone density in healthy children with normal vitamin D levels, but suggest that supplementation of deficient children may be clinically useful. Further RCTs in deficient children are needed to confirm this.\n\nGiven the provided abstract, please respond to the following query: \"What is osteoporosis and what is vitamin D?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Osteoporosis is a condition where bones are weak, brittle and break easily. The risk of osteoporosis and fractures (breaks) in later life depends on how much bone is built when a child and how much bone is lost when an adult. One way to prevent osteoporosis and fractures in later life is to build stronger bones when young. Vitamin D plays an important role in improving the body’s absorption of calcium from food, reducing losses of calcium from the body and getting calcium deposited into to bone to improve the quantity of bone developed. Therefore it is thought that if vitamin D levels in the body are low in childhood, less bone will be developed and that improving vitamin D levels by supplements would result in more bone being developed. Bone density is a major measure of bone strength and the amount of bone mineral present at different sites and so is used to measure the effects of interventions, like vitamin D supplementation, to improve bone health."
}
] |
query-laysum
|
22033
|
[
{
"role": "user",
"content": "Abstract: Background\nDespite advances in perioperative care, elective major vascular surgical procedures still carry a significant risk of morbidity and mortality. Remote ischaemic preconditioning (RIPC) is the temporary blocking of blood flow to vascular beds remote from those targeted by surgery. It has the potential to provide local tissue protection from further prolonged periods of ischaemia. However, the efficacy and safety of RIPC in people undergoing major vascular surgery remain unknown. This is an update of a review published in 2011.\nObjectives\nTo assess the benefits and harms of RIPC versus no RIPC in people undergoing elective major vascular and endovascular surgery.\nSearch methods\nThe Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, and CINAHL databases and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov to 1 April 2022.\nSelection criteria\nWe included all randomised controlled trials that evaluated the role of RIPC in reducing perioperative mortality and morbidities in people undergoing elective major vascular or endovascular surgery.\nData collection and analysis\nWe collected data on the characteristics of the trial, methodological quality, and the remote ischaemic preconditioning stimulus used. Our primary outcome was perioperative mortality, and secondary outcomes included myocardial infarction, renal impairment, stroke, hospital stay, limb loss, and operating time or total anaesthetic time. We analysed the data using random-effects models. For each outcome, we calculated the risk ratio (RR) or mean difference (MD) with a 95% confidence interval (CI) based on an intention-to-treat analysis. In addition, we used GRADE to assess the certainty of the evidence for each outcome.\nMain results\nWe included 14 trials which randomised a total of 1295 participants (age range: 64.5 to 76 years; 84% male; study periods ranged from 2003 to 2019). In general, the included studies were at low to unclear risk of bias for most risk of bias domains. The certainty of evidence of main outcomes was moderate due to imprecision of results, moderate heterogeneity, or possible publication bias.\nWe found that RIPC made no clear difference in perioperative mortality compared with no RIPC (RR 1.41, 95% CI 0.59 to 3.40; I2 = 0%; 10 studies, 965 participants; moderate-certainty evidence). Similarly, we found no clear difference between the two groups for myocardial infarction (RR 0.82, 95% CI 0.49 to 1.40; I2 = 7%; 11 studies, 1001 participants; moderate-certainty evidence), renal impairment (RR 1.07, 95% CI 0.62 to 1.86; I2 = 40%; 12 studies, 1054 participants; moderate-certainty evidence), stroke (RR 0.33, 95% CI 0.04 to 3.15; I2 = 0%; 4 studies, 392 participants; moderate-certainty evidence), limb loss (RR 0.74, 95% CI 0.05 to 10.61; I2 = 32%; 3 studies, 322 participants; low-certainty evidence), hospital stay (MD −0.94 day, 95% CI −1.95 to 0.07; I2 = 17%; 7 studies, 569 participants; moderate-certainty evidence), and operating time or total anaesthetic time (MD 5.76 minutes, 95% CI −3.25 to 14.76; I2 = 44%; 10 studies, 803 participants; moderate-certainty evidence).\nAuthors' conclusions\nOverall, compared with no RIPC, RIPC probably leads to little or no difference in perioperative mortality, myocardial infarction, renal impairment, stroke, hospital stay, and operating time, and may lead to little or no difference in limb loss in people undergoing elective major vascular and endovascular surgery. Adequately powered and designed randomised studies are needed, focusing in particular on the clinical endpoints and patient-centred outcomes.\n\nGiven the provided abstract, please respond to the following query: \"What did we want to find out?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We wanted to find out whether RIPC versus no RIPC can reduce death and organ injury in people undergoing vascular surgery, and if it may cause any harm."
}
] |
query-laysum
|
22034
|
[
{
"role": "user",
"content": "Abstract: Background\nThe early postpartum period is an important time in which to identify the risk of diabetes in women with a history of gestational diabetes mellitus (GDM). Oral glucose tolerance and other tests can help guide lifestyle management and monitoring to reduce the future risk of type 2 diabetes mellitus.\nObjectives\nTo assess whether reminder systems increase the uptake of testing for type 2 diabetes or impaired glucose tolerance in women with a history of GDM.\nSearch methods\nWe searched MEDLINE and EMBASE (last searched 1 June 2013) and The Cochrane Library (last searched April 2013).\nSelection criteria\nWe included randomised trials of women who had experienced GDM in the index pregnancy and who were then sent any modality of reminder (or control) to complete a test for type 2 diabetes after giving birth.\nData collection and analysis\nTwo authors independently screened titles and abstracts for relevance. One author extracted the data, carried out 'Risk of bias' assessments and evaluated the overall study quality according to GRADE (Grading of Recommendations Assessment, Development and Evaluation) criteria; the other author double-checked these procedures. Meta-analysis was not possible as only one study was eligible for inclusion.\nMain results\nOnly one trial with an unclear risk of bias in the majority of domains was included in the study; the overall study quality was judged to be low. This factorial trial of 256 women compared three types of postal reminder strategies (in a total of 213 women) with usual care (no postal reminder, 43 women) and reported on the uptake of four possible types of glucose tests. The three strategies investigated were: reminders sent to both the woman and the physician; reminder sent to the woman only; and reminder sent to the physician only, all issued approximately three months after the woman had given birth.\nThere was low-quality evidence that all three reminder interventions increased uptake of oral glucose tolerance tests compared with usual care (no reminder system): reminders to the woman and the physician (uptake 60% versus 14%): risk ratio 4.23 (95% confidence interval (CI) 1.85 to 9.71); 116 participants); reminder to the woman only (uptake 55% versus 14%): RR 3.87 (95% CI 1.68 to 8.93); 111 participants); reminder to the physician only (uptake 52% versus 14%): RR 3.61 (95% CI 1.50 to 8.71); 66 participants). This represented an increase in uptake from 14% in the no reminder group to 57% across the three reminder groups. There was also an increase in uptake of fasting glucose tests in the reminder group compared with the usual care group: reminders to the woman and the physician versus no reminder (uptake 63% versus 40%): RR 1.57 (95% CI 1.01 to 2.44); reminder to the woman only (uptake 71% versus 40%): RR 1.78 (95% CI 1.16 to 2.73); reminder to the physician only (uptake 68% versus 40%): RR 1.69 (95% CI 1.06 to 2.72). Uptake of random glucose and glycated haemoglobin A1c tests was low, and no statistically significant differences were seen between the reminder and no reminder groups for these tests. Uptake of any test was higher in each of the reminder groups compared with the no reminder group (RR 1.65 (95% CI 1.12 to 2.41); 1.73 (95% CI 1.18 to 2.52); and 1.55 (95% CI 1.01 to 2.38) in the respective reminder groups.\nThe trial did not report this review's other primary outcomes (proportion of women diagnosed with type 2 diabetes or showing impaired glucose tolerance or impaired fasting glucose after giving birth; or health-related quality of life). Nor did it report any secondary review outcomes such as diabetes-associated morbidity, lifestyle changes, need for insulin, recurrence of GDM or women's and/or health professionals' views of the intervention. No adverse events of the intervention were reported.\nSubgroup interaction tests gave no indication that dual reminders (to both women and physicians) were more successful than single reminders to either women or physicians alone. It was also not clear if test uptakes between women in the reminder and no reminder groups differed by type of glucose test undertaken.\nAuthors' conclusions\nResults from the only trial that fulfilled our inclusion criteria showed low-quality evidence for a marked increase in the uptake of testing for type 2 diabetes in women with previous GDM following the issue of postal reminders. The effects of other forms of reminder systems need to be assessed to see whether test uptake also increases when email and telephone reminders are deployed. We also need a better understanding of why some women fail to take opportunities to be screened postpartum. As the ultimate aim of increasing postpartum testing is to prevent the subsequent development of type 2 diabetes, it is important to determine whether increased test uptake rates also increase women's use of preventive strategies such as lifestyle modifications.\n\nGiven the provided abstract, please respond to the following query: \"Key results\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This study showed that, compared with no reminder, a postal reminder was around two to four times (depending on the blood glucose test concerned) more likely to encourage women who had experienced GDM to take a blood glucose test three months after having their baby. It did not seem to make a difference if the reminder was sent to the woman only, the physician only or to both the woman and the physician.\nThe trial did not assess women's quality of life, or how many women were subsequently diagnosed with type 2 diabetes or impaired glucose results after giving birth.\nOther kinds of reminders such as email and telephone need to be assessed in studies as they might be easier and more convenient for women than posted reminders. We need to know more about women's preferences and attitudes, and also to find out whether increasing the chances of a woman being tested helps to reduce her risk of developing type 2 diabetes in the future, for example by encouraging a healthier diet and more exercise."
}
] |
query-laysum
|
22035
|
[
{
"role": "user",
"content": "Abstract: Background\nA wide variety of grafts have been introduced with the aim of improving the outcomes of traditional native tissue repair (colporrhaphy) for vaginal prolapse.\nObjectives\nTo determine the safety and effectiveness of transvaginal mesh or biological grafts compared to native tissue repair for vaginal prolapse.\nSearch methods\nWe searched the Cochrane Incontinence Group Specialised Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, ongoing trials registers, and handsearching of journals and conference proceedings (6 July 2015). We also contacted researchers in the field.\nSelection criteria\nRandomised controlled trials (RCTs) comparing different types of vaginal repair (mesh, biological graft, or native tissue).\nData collection and analysis\nTwo review authors independently selected trials, assessed risk of bias, and extracted data. The primary outcomes were awareness of prolapse, repeat surgery, and recurrent prolapse on examination.\nMain results\nWe included 37 RCTs (4023 women). The quality of the evidence ranged from very low to moderate. The main limitations were poor reporting of study methods, inconsistency, and imprecision.\nPermanent mesh versus native tissue repair\nAwareness of prolapse at one to three years was less likely after mesh repair (risk ratio (RR) 0.66, 95% confidence interval (CI) 0.54 to 0.81, 12 RCTs, n = 1614, I2 = 3%, moderate-quality evidence). This suggests that if 19% of women are aware of prolapse after native tissue repair, between 10% and 15% will be aware of prolapse after permanent mesh repair.\nRates of repeat surgery for prolapse were lower in the mesh group (RR 0.53, 95% CI 0.31 to 0.88, 12 RCTs, n = 1675, I2 = 0%, moderate-quality evidence). There was no evidence of a difference between the groups in rates of repeat surgery for continence (RR 1.07, 95% CI 0.62 to 1.83, 9 RCTs, n = 1284, I2 = 21%, low-quality evidence). More women in the mesh group required repeat surgery for the combined outcome of prolapse, stress incontinence, or mesh exposure (RR 2.40, 95% CI 1.51 to 3.81, 7 RCTs, n = 867, I2 = 0%, moderate-quality evidence). This suggests that if 5% of women require repeat surgery after native tissue repair, between 7% and 18% in the permanent mesh group will do so. Eight per cent of women in the mesh group required repeat surgery for mesh exposure.\nRecurrent prolapse on examination was less likely after mesh repair (RR 0.40, 95% CI 0.30 to 0.53, 21 RCTs, n = 2494, I2 = 73%, low-quality evidence). This suggests that if 38% of women have recurrent prolapse after native tissue repair, between 11% and 20% will do so after mesh repair.\nPermanent mesh was associated with higher rates of de novo stress incontinence (RR 1.39, 95% CI 1.06 to 1.82, 12 RCTs, 1512 women, I2 = 0%, low-quality evidence) and bladder injury (RR 3.92, 95% CI 1.62 to 9.50, 11 RCTs, n = 1514, I2 = 0%, moderate-quality evidence). There was no evidence of a difference between the groups in rates of de novo dyspareunia (RR 0.92, 95% CI 0.58 to 1.47, 11 RCTs, n = 764, I2 = 21%, low-quality evidence). Effects on quality of life were uncertain due to the very low-quality evidence.\nAbsorbable mesh versus native tissue repair\nThere was very low-quality evidence for the effectiveness of either form of repair at two years on the rate of awareness of prolapse (RR 1.05, 95% CI 0.77 to 1.44, 1 RCT, n = 54).\nThere was very low-quality evidence for the effectiveness of either form of repair on the rate of repeat surgery for prolapse (RR 0.47, 95% CI 0.09 to 2.40, 1 RCT, n = 66).\nRecurrent prolapse on examination was less likely in the mesh group (RR 0.71, 95% CI 0.52 to 0.96, 3 RCTs, n = 292, I2 = 21%, low-quality evidence)\nThe effect of either form of repair was uncertain for urinary outcomes, dyspareunia, and quality of life.\nBiological graft versus native tissue repair\nThere was no evidence of a difference between the groups at one to three years for the outcome awareness of prolapse (RR 0.97, 95% CI 0.65 to 1.43, 7 RCTs, n = 777, low-quality evidence).\nThere was no evidence of a difference between the groups for the outcome repeat surgery for prolapse (RR 1.22, 95% CI 0.61 to 2.44, 5 RCTs, n = 306, I2 = 8%, low-quality evidence).\nThe effect of either approach was very uncertain for recurrent prolapse (RR 0.94, 95% CI 0.60 to 1.47, 7 RCTs, n = 587, I2 = 59%, very low-quality evidence).\nThere was no evidence of a difference between the groups for dyspareunia or quality of life outcomes (very low-quality evidence).\nAuthors' conclusions\nWhile transvaginal permanent mesh is associated with lower rates of awareness of prolapse, repeat surgery for prolapse, and prolapse on examination than native tissue repair, it is also associated with higher rates of repeat surgery for prolapse or stress urinary incontinence or mesh exposure (as a composite outcome), and with higher rates of bladder injury at surgery and de novo stress urinary incontinence. The risk-benefit profile means that transvaginal mesh has limited utility in primary surgery. While it is possible that in women with higher risk of recurrence the benefits may outweigh the risks, there is currently no evidence to support this position.\nLimited evidence suggests that absorbable mesh may reduce rates of recurrent prolapse on examination compared to native tissue repair, but there was insufficient evidence on absorbable mesh for us to draw any conclusions for other outcomes. There was also insufficient evidence for us to draw any conclusions regarding biological grafts compared to native tissue repair.\nIn 2011, many transvaginal permanent meshes were voluntarily withdrawn from the market, and the newer, lightweight transvaginal permanent meshes still available have not been evaluated within a RCT. In the meantime, these newer transvaginal meshes should be utilised under the discretion of the ethics committee.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Pelvic organ prolapse is common, affecting as many as 50% of women who have had children. The traditional method of repairing vaginal prolapse using native tissue is associated with high rates of recurrence. It is thought that transvaginal grafts made of absorbable or permanent mesh or biological material may improve the outcomes of prolapse surgery."
}
] |
query-laysum
|
22036
|
[
{
"role": "user",
"content": "Abstract: Background\nPeople with thrombocytopenia due to bone marrow failure are vulnerable to bleeding. Platelet transfusions have limited efficacy in this setting and alternative agents that could replace, or reduce platelet transfusion, and are effective at reducing bleeding are needed.\nObjectives\nTo compare the relative efficacy of different interventions for patients with thrombocytopenia due to chronic bone marrow failure and to derive a hierarchy of potential alternative treatments to platelet transfusions.\nSearch methods\nWe searched for randomised controlled trials (RCTs) in the Cochrane Central Register of Controlled Trials (the Cochrane Library 2016, Issue 3), MEDLINE (from 1946), Embase (from 1974), CINAHL (from 1937), the Transfusion Evidence Library (from 1980) and ongoing trial databases to 27 April 2016.\nSelection criteria\nWe included randomised controlled trials in people with thrombocytopenia due to chronic bone marrow failure who were allocated to either an alternative to platelet transfusion (artificial platelet substitutes, platelet-poor plasma, fibrinogen concentrate, recombinant activated factor VII (rFVIIa), desmopressin (DDAVP), recombinant factor XIII (rFXIII), recombinant interleukin (rIL)6 or rIL11, or thrombopoietin (TPO) mimetics) or a comparator (placebo, standard of care or platelet transfusion). We excluded people undergoing intensive chemotherapy or stem cell transfusion.\nData collection and analysis\nTwo review authors independently screened search results, extracted data and assessed trial quality. We estimated summary risk ratios (RR) for dichotomous outcomes. We planned to use summary mean differences (MD) for continuous outcomes. All summary measures are presented with 95% confidence intervals (CI).\nWe could not perform a network meta-analysis because the included studies had important differences in the baseline severity of disease for the participants and in the number of participants undergoing chemotherapy. This raised important concerns about the plausibility of the transitivity assumption in the final dataset and we could not evaluate transitivity statistically because of the small number of trials per comparison. Therefore, we could only perform direct pairwise meta-analyses of included interventions.\nWe employed a random-effects model for all analyses. We assessed statistical heterogeneity using the I2 statistic and its 95% CI. The risk of bias of each study included was assessed using the Cochrane 'Risk of bias' tool. The quality of the evidence was assessed using GRADE methods.\nMain results\nWe identified seven completed trials (472 participants), and four ongoing trials (recruiting 837 participants) which are due to be completed by December 2020. Of the seven completed trials, five trials (456 participants) compared a TPO mimetic versus placebo (four romiplostim trials, and one eltrombopag trial), one trial (eight participants) compared DDAVP with placebo and one trial (eight participants) compared tranexamic acid with placebo. In the DDAVP trial, the only outcome reported was the bleeding time. In the tranexamic acid trial there were methodological flaws and bleeding definitions were subject to significant bias. Consequently, these trials could not be incorporated into the quantitative synthesis. No randomised trial of artificial platelet substitutes, platelet-poor plasma, fibrinogen concentrate, rFVIIa, rFXIII, rIL6 or rIL11 was identified.\nWe assessed all five trials of TPO mimetics included in this review to be at high risk of bias because the trials were funded by the manufacturers of the TPO mimetics and the authors had financial stakes in the sponsoring companies.\nThe GRADE quality of the evidence was very low to moderate across the different outcomes.\nThere was insufficient evidence to detect a difference in the number of participants with at least one bleeding episode between TPO mimetics and placebo (RR 0.86, 95% CI 0.56 to 1.31, four trials, 206 participants, low-quality evidence).\nThere was insufficient evidence to detect a difference in the risk of a life-threatening bleed between those treated with a TPO mimetic and placebo (RR 0.31, 95% CI 0.04 to 2.26, one trial, 39 participants, low-quality evidence).\nThere was insufficient evidence to detect a difference in the risk of all-cause mortality between those treated with a TPO mimetic and placebo (RR 0.74, 95%CI 0.52 to 1.05, five trials, 456 participants, very low-quality evidence).\nThere was a significant reduction in the number of participants receiving any platelet transfusion between those treated with TPO mimetics and placebo (RR 0.76, 95% CI 0.61 to 0.95, four trials, 206 participants, moderate-quality evidence).\nThere was no evidence for a difference in the incidence of transfusion reactions between those treated with TPO mimetics and placebo (pOR 0.06, 95% CI 0.00 to 3.44, one trial, 98 participants, very low-quality evidence).\nThere was no evidence for a difference in thromboembolic events between TPO mimetics and placebo (RR 1.41, 95%CI 0.39 to 5.01, five trials, 456 participants, very-low quality evidence).\nThere was no evidence for a difference in drug reactions between TPO mimetics and placebo (RR 1.12, 95% CI 0.83 to 1.51, five trials, 455 participants, low-quality evidence).\nNo trial reported the number of days of bleeding per participant, platelet transfusion episodes, mean red cell transfusions per participant, red cell transfusion episodes, transfusion-transmitted infections, formation of antiplatelet antibodies or platelet refractoriness.\nIn order to demonstrate a reduction in bleeding events from 26 in 100 to 16 in 100 participants, a study would need to recruit 514 participants (80% power, 5% significance).\nAuthors' conclusions\nThere is insufficient evidence at present for thrombopoietin (TPO) mimetics for the prevention of bleeding for people with thrombocytopenia due to chronic bone marrow failure. There is no randomised controlled trial evidence for artificial platelet substitutes, platelet-poor plasma, fibrinogen concentrate, rFVIIa, rFXIII or rIL6 or rIL11, antifibrinolytics or DDAVP in this setting.\n\nGiven the provided abstract, please respond to the following query: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "People with low platelet counts due to bone marrow disorders are vulnerable to bleeding which may be severe or life-threatening. In order to treat, or prevent bleeding, they are often given platelet transfusions. However, platelet transfusions are associated with risks such as infection and transfusion reactions. Consequently, there is interest in whether it is possible to use alternative treatments to prevent bleeding. These treatments include: man-made platelets (artificial platelets); stimulating the person's body to produce more platelets (recombinant interleukin (rIL)6, rIL11, TPO mimetics); increasing the levels of proteins in the blood that help the body to form a clot (platelet-poor plasma, fibrinogen concentrate, recombinant activated factor VII (rFVIIa), recombinant factor XIII (rFXIII)); and preventing a blood clot from breaking down (antifibrinolytics) There may be risks associated with agents that prevent bleeding; the most important being an increased risk of forming unwanted blood clots, which could be potentially life-threatening."
}
] |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.