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query-laysum
|
23752
|
[
{
"role": "user",
"content": "Abstract: Background\nTrachoma is the leading infectious cause of blindness. The World Health Organization (WHO) recommends eliminating trachomatous blindness through the SAFE strategy: Surgery for trichiasis, Antibiotic treatment, Facial cleanliness and Environmental hygiene. This is an update of a Cochrane review first published in 2003, and previously updated in 2006.\nObjectives\nTo assess the effects of interventions for trachomatous trichiasis for people living in endemic settings.\nSearch methods\nWe searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (2015, Issue 4), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to May 2015), EMBASE (January 1980 to May 2015), the ISRCTN registry (www.isrctn.com/editAdvancedSearch), ClinicalTrials.gov (www.clinicaltrials.gov) and the 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 7 May 2015. We searched the reference lists of included studies to identify further potentially relevant studies. We also contacted authors for details of other relevant studies.\nSelection criteria\nWe included randomised trials of any intervention intended to treat trachomatous trichiasis.\nData collection and analysis\nThree review authors independently selected and assessed the trials, including the risk of bias. We contacted trial authors for missing data when necessary. Our primary outcome was post-operative trichiasis which was defined as any lash touching the globe at three months, one year or two years after surgery.\nMain results\nThirteen studies met the inclusion criteria with 8586 participants. Most of the studies were conducted in sub-Saharan Africa. The majority of the studies were of a low or unclear risk of bias.\nFive studies compared different surgical interventions. Most surgical interventions were performed by non-physician technicians. These trials suggest the most effective surgery is full-thickness incision of the tarsal plate and rotation of the terminal tarsal strip. Pooled data from two studies suggested that the bilamellar rotation was more effective than unilamellar rotation (OR 0.29, 95% CI 0.16 to 0.50). Use of a lid clamp reduced lid contour abnormalities (OR 0.65, 95% CI 0.44 to 0.98) and granuloma formation (OR 0.67, 95% CI 0.46 to 0.97). Absorbable sutures gave comparable outcomes to silk sutures (OR 0.90, 95% CI 0.68 to 1.20) and were associated with less frequent granuloma formation (OR 0.63, 95% CI 0.40 to 0.99). Epilation was less effective at preventing eyelashes from touching the globe than surgery for mild trichiasis, but had comparable results for vision and corneal change. Peri-operative azithromycin reduced post-operative trichiasis; however, the estimate of effect was imprecise and compatible with no effect or increased trichiasis (OR 0.85, 95% CI 0.63 to 1.14; 1954 eyes; 3 studies). Community-based surgery when compared to health centres increased uptake with comparable outcomes. Surgery performed by ophthalmologists and integrated eye care workers was comparable. Adverse events were typically infrequent or mild and included rare postoperative infections, eyelid contour abnormalities and conjunctival granulomas.\nAuthors' conclusions\nNo trials were designed to evaluate whether the interventions for trichiasis prevent blindness as an outcome; however, several found modest improvement in vision following intervention. Certain interventions have been shown to be more effective at eliminating trichiasis. Full-thickness incision of the tarsal plate and rotation of the lash-bearing lid margin was found to be the best technique and is preferably delivered in the community. Surgery may be carried out by an ophthalmologist or a trained ophthalmic assistant. Surgery performed with silk or absorbable sutures gave comparable results. Post-operative azithromycin was found to improve outcomes where overall recurrence was low.\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": "Trachoma is the commonest infectious cause of blindness in the world. It is caused by a bacterium calledChlamydia trachomatis.This infection causes inflammation and scarring of the surface of the eye, which results in the eyelid turning in (entropion) so that the eyelashes touch the eyeball. This is known as trachomatous trichiasis. The lashes can scratch the corneal surface, leading directly or indirectly (from secondary infections) to corneal opacity. Surgery to correct the eyelid deformity is the main treatment for the late stages of the disease. Most cases of trachomatous trichiasis occur in sub-Saharan Africa. They are generally treated by nurses with limited surgical training. Unfortunately the results of the surgery can be quite variable, with frequent post-operative trichiasis reported. Therefore, we wanted to find out what types of surgery and other interventions give the best results in treating this condition."
}
] |
query-laysum
|
23753
|
[
{
"role": "user",
"content": "Abstract: Background\nPostoperative delirium (POD) and postoperative cognitive dysfunction (POCD) may complicate a patient's postoperative recovery in several ways. Monitoring of processed electroencephalogram (EEG) or evoked potential (EP) indices may prevent or minimize POD and POCD, probably through optimization of anaesthetic doses.\nObjectives\nTo assess whether the use of processed EEG or auditory evoked potential (AEP) indices (bispectral index (BIS), narcotrend index, cerebral state index, state entropy and response entropy, patient state index, index of consciousness, A-line autoregressive index, and auditory evoked potentials (AEP index)) as guides to anaesthetic delivery can reduce the risk of POD and POCD in non-cardiac surgical or non-neurosurgical adult patients undergoing general anaesthesia compared with standard practice where only clinical signs are used.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase and clinical trial registry databases up to 28 March 2017. We updated this search in February 2018, but these results have not been incorporated in the review.\nSelection criteria\nWe included randomized or quasi-randomized controlled trials comparing any method of processed EEG or evoked potential techniques (entropy, BIS, AEP etc.) against a control group where clinical signs were used to guide doses of anaesthetics in adults aged 18 years or over undergoing general anaesthesia for non-cardiac or non-neurosurgical elective operations.\nData collection and analysis\nWe used the standard methodological procedures expected by Cochrane. Our primary outcomes were: occurrence of POD; and occurrence of POCD. Secondary outcomes included: all-cause mortality; any postoperative complications; and postoperative length of stay. We used GRADE to assess the quality of evidence for each outcome.\nMain results\nWe included six randomized controlled trials (RCTs) with 2929 participants comparing processed EEG or EP indices-guided anaesthesia with clinical signs-guided anaesthesia. There are five ongoing studies and one study awaiting classification.\nAnaesthesia administration guided by the indices from a processed EEG (bispectral index) probably reduces the risk of POD within seven days after surgery with risk ratio (RR) of 0.71 (95% CI 0.59 to 0.85; number needed to treat for an additional beneficial outcome (NNTB) of 17, 95% CI 11 to 34; 2197 participants; 3 RCTs; moderate quality of evidence). Three trials also showed the lower rate of POCD at 12 weeks after surgery (RR 0.71, 95% CI 0.53 to 0.96; NNTB 38, 95% CI 21 to 289; 2051 participants; moderate-quality evidence), but it is uncertain whether processed EEG indices reduce POCD at one week (RR 0.84, 95% CI 0.69 to 1.02; 3 trials; 1989 participants; moderate-quality evidence), and at 52 weeks (RR 0.30, 95% CI 0.05 to 1.80; 1 trial; 59 participants; very low quality of evidence). There may be little or no effect on all-cause mortality (RR 1.01, 95% CI 0.62 to 1.64; 1 trial; 1155 participants; low-quality evidence). One trial suggested a lower risk of any postoperative complications with processed EEG (RR 0.51, 95% CI 0.37 to 0.71; 902 participants, moderate-quality evidence). There may be little or no effect on reduced postoperative length of stay (mean difference −0.2 days, 95% CI −2.02 to 1.62; 1155 participants; low-quality evidence).\nAuthors' conclusions\nThere is moderate-quality evidence that optimized anaesthesia guided by processed EEG indices could reduce the risk of postoperative delirium in patients aged 60 years or over undergoing non-cardiac surgical and non-neurosurgical procedures. We found moderate-quality evidence that postoperative cognitive dysfunction at three months could be reduced in these patients. The effect on POCD at one week and over one year after surgery is uncertain. There are no data available for patients under 60 years. Further blinded randomized controlled trials are needed to elucidate strategies for the amelioration of postoperative delirium and postoperative cognitive dysfunction, and their consequences such as dementia (including Alzheimer's disease (AD)) in both non-elderly (below 60 years) and elderly (60 years or over) adult patients. The one study awaiting classification and five ongoing studies may alter the conclusions of the review once assessed.\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": "Our review provides moderate-quality evidence that anaesthesia guided by processed EEG indices could reduce the risk of postoperative delirium in patients aged 60 years or over undergoing non-cardiac and non-neurological surgical procedures. We found some moderate-quality evidence that postoperative cognitive dysfunction at three months could be reduced in these participants. There is insufficient evidence supporting the effect on POCD at one week and over one year after surgery or in younger patients."
}
] |
query-laysum
|
23754
|
[
{
"role": "user",
"content": "Abstract: Background\nResting or immobilizing a joint to enhance outcomes following intra-articular (IA) steroid injection is generally advocated. This systematic review aimed to determine the efficacy of IA steroid injections and the influence of post-injection rest.\nObjectives\n1. Compare IA steroid injections versus no treatment or placebo. \n2. Determine the effects of rest following IA steroid injection in rheumatoid or juvenile idiopathic arthritis.\nSearch methods\nThe Cochrane Central Register of Controlled Trials (CENTRAL- Issue 4, 2003), Cochrane Database of Systematic Reviews (CDSR - Issue 4, 2003), Database of Abstracts of Reviews of Effectiveness (DARE - searched 8.1.04), MEDLINE (1966 to August Week 2 2004), EMBASE (1980 to August Week 2 2004) , CINAHL (1982 to December Week 2 2003), Clinical Trials site of the National Institute of Health, (USA - searched 8.1.04), OTseeker (Occupational Therapy Systematic Evaluation of Evidence - searched 8.1.04) and PEDro (Physiotherapy Evidence Database - searched 8.1.04) were searched. Journals and reference lists were hand searched.\nSelection criteria\nEligible were randomised controlled trials of IA steroid injections or of rest following IA steroid injections in rheumatoid or juvenile idiopathic arthritis.\nData collection and analysis\nPotentially relevant references were evaluated and all data extracted by two independent reviewers.\nMain results\nFive trials (n=346) examining IA steroid injection in the knee joint were included. It was not possible to pool data as outcome measures, timing of follow up and the methods of data reporting differed between trials. There was inconclusive conflicting evidence from two trials that walking time was reduced. There was evidence from one moderate quality trial that pain was reduced at 1-day post-injection (0-100 VAS from 28.33 to 13.46; McGill Pain Scale from 8.89 to 3.96) but not at 1 week or 7-12 weeks post-injection. There is some evidence that IA injections improved knee flexion (by 14 degrees) and reduced knee extension lag (by 20 degrees), knee circumference (median reduction = 0.3 cm) and morning stiffness (reduced from 60 mins to 7.6 mins). One trial (n=91) examined the effects of rest following injection in the knee. The rested group achieved significant improvement in pain, stiffness, knee circumference, and walking time when compared with the non-rested group (no point estimates provided). One trial evaluated rest following injection of the wrist (n=117). Relapse rate was higher in the rested group (rest relapse rate = 24/58, no-rest group = 14/59); but there were no differences between the rested and non-rested groups on pain, joint circumference, wrist function, grip strength or ROM.\nAuthors' conclusions\nThere is some evidence to support the use of IA steroid injections and resting a knee following injections but that wrists should not be rested following injections. The included studies involved adult participants so any conclusions can only cautiously applied to children. Further research is required to examine the use and type of rest and the differential responses of different joints following injections.\n\nGiven the provided abstract, please respond to the following query: \"What is the bottom line?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The level of quality of the evidence is 'silver'. Intra-articular steroid injections can improve pain, movement, stiffness and swelling and are safe in adults with rheumatoid arthritis. There is no evidence to say whether this is true for children.\nKnees should be rested after a steroid injection, but wrists should not."
}
] |
query-laysum
|
23755
|
[
{
"role": "user",
"content": "Abstract: Background\nPost-dural puncture headache (PDPH) is one of the most common complications of diagnostic and therapeutic lumbar punctures. PDPH is defined as any headache occurring after a lumbar puncture that worsens within 15 minutes of sitting or standing and is relieved within 15 minutes of the patient lying down. Researchers have suggested many types of interventions to help prevent PDPH. It has been suggested that aspects such as needle tip and gauge can be modified to decrease the incidence of PDPH.\nObjectives\nTo assess the effects of needle tip design (traumatic versus atraumatic) and diameter (gauge) on the prevention of PDPH in participants who have undergone dural puncture for diagnostic or therapeutic causes.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, CINAHL and LILACS, as well as trial registries via the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) search portal in September 2016. We adopted the MEDLINE strategy for searching the other databases. The search terms we used were a combination of thesaurus-based and free-text terms for both interventions (lumbar puncture in neurological, anaesthesia or myelography settings) and headache.\nSelection criteria\nWe included randomized controlled trials (RCTs) conducted in any clinical/research setting where dural puncture had been used in participants of all ages and both genders, which compared different tip designs or diameters for prevention of PDPH\nData collection and analysis\nWe used the standard methodological procedures expected by Cochrane.\nMain results\nWe included 70 studies in the review; 66 studies with 17,067 participants were included in the quantitative analysis. An additional 18 studies are awaiting classification and 12 are ongoing. Fifteen of the 18 studies awaiting classification mainly correspond to congress summaries published before 2010, in which the available information does not allow the complete evaluation of all their risks of bias and characteristics. Our main outcome was prevention of PDPH, but we also assessed the onset of severe PDPH, headache in general and adverse events. The quality of evidence was moderate for most of the outcomes mainly due to risk of bias issues. For the analysis, we undertook three main comparisons: 1) traumatic needles versus atraumatic needles; 2) larger gauge traumatic needles versus smaller gauge traumatic needles; and 3) larger gauge atraumatic needles versus smaller gauge atraumatic needles. For each main comparison, if data were available, we performed a subgroup analysis evaluating lumbar puncture indication, age and posture.\nFor the first comparison, the use of traumatic needles showed a higher risk of onset of PDPH compared to atraumatic needles (36 studies, 9378 participants, risk ratio (RR) 2.14, 95% confidence interval (CI) 1.72 to 2.67, I2 = 9%).\nIn the second comparison of traumatic needles, studies comparing various sizes of large and small gauges showed no significant difference in effects in terms of risk of PDPH, with the exception of one study comparing 26 and 27 gauge needles (one study, 658 participants, RR 6.47, 95% CI 2.55 to 16.43).\nIn the third comparison of atraumatic needles, studies comparing various sizes of large and small gauges showed no significant difference in effects in terms of risk of PDPH.\nWe observed no significant difference in the risk of paraesthesia, backache, severe PDPH and any headache between traumatic and atraumatic needles. Sensitivity analyses of PDPH results between traumatic and atraumatic needles omitting high risk of bias studies showed similar results regarding the benefit of atraumatic needles in the prevention of PDPH (three studies, RR 2.78, 95% CI 1.26 to 6.15; I2 = 51%).\nAuthors' conclusions\nThere is moderate-quality evidence that atraumatic needles reduce the risk of post-dural puncture headache (PDPH) without increasing adverse events such as paraesthesia or backache. The studies did not report very clearly on aspects related to randomization, such as random sequence generation and allocation concealment, making it difficult to interpret the risk of bias in the included studies. The moderate quality of the evidence for traumatic versus atraumatic needles suggests that further research is likely to have an important impact on our confidence in the estimate of effect.\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": "A lumbar puncture is a needle inserted into the lower part of the spine to draw fluid, to test for conditions affecting the brain and spinal cord. It can also be used for treatment (for instance, for the management of pain in caesarean section).\nIn general, lumbar punctures are considered safe; however, a number of adverse effects such as backache, tickling sensations (paraesthesia) or even post-dural puncture headache (PDPH) have been reported. These conditions are not life-threatening, but can impair the person's physical activity and can be very painful. Several different needle tips (classified as traumatic or atraumatic) and gauges (size/diameter) are used to perform a lumbar puncture. We compared different types of needles to assess the effects of the needle tip and its thickness on the prevention of post-dural puncture headache."
}
] |
query-laysum
|
23757
|
[
{
"role": "user",
"content": "Abstract: Background\nGestational diabetes mellitus (GDM) is associated with adverse health outcomes for mothers and their infants both perinatally and long term. Women with a history of GDM are at risk of recurrence in subsequent pregnancies and may benefit from intervention in the interconception period to improve maternal and infant health outcomes.\nObjectives\nTo assess the effects of interconception care for women with a history of GDM on maternal and infant health outcomes.\nSearch methods\nWe searched Cochrane Pregnancy and Childbirth's Trials Register (7 April 2017) and reference lists of retrieved studies.\nSelection criteria\nRandomised controlled trials, including quasi-randomised controlled trials and cluster-randomised trials evaluating any protocol of interconception care with standard care or other forms of interconception care for women with a history of GDM on maternal and infant health outcomes.\nData collection and analysis\nTwo review authors independently assessed study eligibility. In future updates of this review, at least two review authors will extract data and assess the risk of bias of included studies; the quality of the evidence will be assessed using the GRADE approach.\nMain results\nNo eligible published trials were identified. We identified a completed randomised controlled trial that was designed to evaluate the effects of a diet and exercise intervention compared with standard care in women with a history of GDM, however to date, it has only published results on women who were pregnant at randomisation (and not women in the interconception period). We also identified an ongoing trial, in obese women with a history of GDM planning a subsequent pregnancy, which is assessing the effects of an intensive lifestyle intervention, supported with liraglutide treatment, compared with usual care. We also identified a trial that was designed to evaluate the effects of a weight loss and exercise intervention compared with lifestyle education also in obese women with a history of GDM planning a subsequent pregnancy, however it has not yet been published. These trials will be re-considered for inclusion in the next review update.\nAuthors' conclusions\nThe role of interconception care for women with a history of GDM remains unclear. Randomised controlled trials are required evaluating different forms and protocols of interconception care for these women on perinatal and long-term maternal and infant health outcomes, acceptability of such interventions and cost-effectiveness.\n\nGiven the provided abstract, please respond to the following query: \"What evidence did we find?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We searched for trials which looked at the health outcomes for women and babies after specific interconception care, and compared the outcomes for standard care (with no interconception care of this type). Our search identified one trial which has yet to issue a full set of results, plus two further trials; one of these is still underway and the other has yet to be published."
}
] |
query-laysum
|
23758
|
[
{
"role": "user",
"content": "Abstract: Background\nThe optimal haemoglobin threshold for use of red blood cell (RBC) transfusions in anaemic patients remains an active field of research. Blood is a scarce resource, and in some countries, transfusions are less safe than in others because of inadequate testing for viral pathogens. If a liberal transfusion policy does not improve clinical outcomes, or if it is equivalent, then adopting a more restrictive approach could be recognised as the standard of care.\nObjectives\nThe aim of this review update was to compare 30-day mortality and other clinical outcomes for participants randomised to restrictive versus liberal red blood cell (RBC) transfusion thresholds (triggers) for all clinical conditions. The restrictive transfusion threshold uses a lower haemoglobin concentration as a threshold for transfusion (most commonly, 7.0 g/dL to 8.0 g/dL), and the liberal transfusion threshold uses a higher haemoglobin concentration as a threshold for transfusion (most commonly, 9.0 g/dL to 10.0 g/dL).\nSearch methods\nWe identified trials through updated searches: CENTRAL (2020, Issue 11), MEDLINE (1946 to November 2020), Embase (1974 to November 2020), Transfusion Evidence Library (1950 to November 2020), Web of Science Conference Proceedings Citation Index (1990 to November 2020), and trial registries (November 2020). We checked the reference lists of other published reviews and relevant papers to identify additional trials. We were aware of one trial identified in earlier searching that was in the process of being published (in February 2021), and we were able to include it before this review was finalised.\nSelection criteria\nWe included randomised trials of surgical or medical participants that recruited adults or children, or both. We excluded studies that focused on neonates.\nEligible trials assigned intervention groups on the basis of different transfusion schedules or thresholds or 'triggers'. These thresholds would be defined by a haemoglobin (Hb) or haematocrit (Hct) concentration below which an RBC transfusion would be administered; the haemoglobin concentration remains the most commonly applied marker of the need for RBC transfusion in clinical practice. We included trials in which investigators had allocated participants to higher thresholds or more liberal transfusion strategies compared to more restrictive ones, which might include no transfusion. As in previous versions of this review, we did not exclude unregistered trials published after 2010 (as per the policy of the Cochrane Injuries Group, 2015), however, we did conduct analyses to consider the differential impact of results of trials for which prospective registration could not be confirmed.\nData collection and analysis\nWe identified trials for inclusion and extracted data using Cochrane methods. We pooled risk ratios of clinical outcomes across trials using a random-effects model. Two review authors independently extracted data and assessed risk of bias. We conducted predefined analyses by clinical subgroups. We defined participants randomly allocated to the lower transfusion threshold as being in the 'restrictive transfusion' group and those randomly allocated to the higher transfusion threshold as being in the 'liberal transfusion' group.\nMain results\nA total of 48 trials, involving data from 21,433 participants (at baseline), across a range of clinical contexts (e.g. orthopaedic, cardiac, or vascular surgery; critical care; acute blood loss (including gastrointestinal bleeding); acute coronary syndrome; cancer; leukaemia; haematological malignancies), met the eligibility criteria. The haemoglobin concentration used to define the restrictive transfusion group in most trials (36) was between 7.0 g/dL and 8.0 g/dL. Most trials included only adults; three trials focused on children.\nThe included studies were generally at low risk of bias for key domains including allocation concealment and incomplete outcome data.\nRestrictive transfusion strategies reduced the risk of receiving at least one RBC transfusion by 41% across a broad range of clinical contexts (risk ratio (RR) 0.59, 95% confidence interval (CI) 0.53 to 0.66; 42 studies, 20,057 participants; high-quality evidence), with a large amount of heterogeneity between trials (I² = 96%).\nOverall, restrictive transfusion strategies did not increase or decrease the risk of 30-day mortality compared with liberal transfusion strategies (RR 0.99, 95% CI 0.86 to 1.15; 31 studies, 16,729 participants; I² = 30%; moderate-quality evidence) or any of the other outcomes assessed (i.e. cardiac events (low-quality evidence), myocardial infarction, stroke, thromboembolism (all high-quality evidence)). High-quality evidence shows that the liberal transfusion threshold did not affect the risk of infection (pneumonia, wound infection, or bacteraemia). Transfusion-specific reactions are uncommon and were inconsistently reported within trials.\nWe noted less certainty in the strength of evidence to support the safety of restrictive transfusion thresholds for the following predefined clinical subgroups: myocardial infarction, vascular surgery, haematological malignancies, and chronic bone-marrow disorders.\nAuthors' conclusions\nTransfusion at a restrictive haemoglobin concentration decreased the proportion of people exposed to RBC transfusion by 41% across a broad range of clinical contexts. Across all trials, no evidence suggests that a restrictive transfusion strategy impacted 30-day mortality, mortality at other time points, or morbidity (i.e. cardiac events, myocardial infarction, stroke, pneumonia, thromboembolism, infection) compared with a liberal transfusion strategy.\nDespite including 17 more randomised trials (and 8846 participants), data remain insufficient to inform the safety of transfusion policies in important and selected clinical contexts, such as myocardial infarction, chronic cardiovascular disease, neurological injury or traumatic brain injury, stroke, thrombocytopenia, and cancer or haematological malignancies, including chronic bone marrow failure.\nFurther work is needed to improve our understanding of outcomes other than mortality. Most trials compared only two separate thresholds for haemoglobin concentration, which may not identify the actual optimal threshold for transfusion in a particular patient. Haemoglobin concentration may not be the most informative marker of the need for transfusion in individual patients with different degrees of physiological adaptation to anaemia. Notwithstanding these issues, overall findings provide good evidence that transfusions with allogeneic RBCs can be avoided in most patients with haemoglobin thresholds between the range of 7.0 g/dL and 8.0 g/dL. Some patient subgroups might benefit from RBCs to maintain higher haemoglobin concentrations; research efforts should focus on these clinical contexts.\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 examined the results of studies that allocated patients to one of two groups by chance (for example, by flipping a coin). In one group, the patients only received blood transfusions if their blood count fell below a higher threshold (typically, 9.0 g/dL to 10.0 g/dL). In the other group, the patients only received blood transfusions if their blood counts fell below a lower threshold (typically, 7.0 g/dL to 8.0 g/dL)."
}
] |
query-laysum
|
23759
|
[
{
"role": "user",
"content": "Abstract: Background\nTrabeculectomy is performed as a treatment for glaucoma to lower intraocular pressure (IOP). The surgical procedure involves creating a channel through the wall of the eye. However scarring during wound healing can block this channel which will lead to the operation failing. Anti-vascular endothelial growth factor (VEGF) agents have been proposed to slow down healing response and scar formation.\nObjectives\nTo assess the effectiveness of anti-VEGF therapies administered by subconjunctival injection for the outcome of trabeculectomy at 12 months follow-up and to examine the balance of benefit and harms when compared to any other anti-scarring agents or no additional anti-scarring agents.\nSearch methods\nWe searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register) (2015, Issue 10), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to November 2015), EMBASE (January 1980 to November 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 12 November 2015.\nSelection criteria\nWe included randomised controlled trials (RCTs) of anti-VEGF therapies administered by subconjunctival injection compared to any other anti-scarring agents or no additional anti-scarring agents (no treatment or placebo) in trabeculectomy surgery.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. Our primary outcome was successful trabeculectomy at 12 months after surgery which was defined as achieving a target IOP (usually no more than 21 mm Hg) without any additional intervention. Other outcomes included: qualified success (achieving target IOP with or without additional intervention), mean IOP and adverse events.\nMain results\nWe included five RCTs (175 participants, 177 eyes) that met the inclusion criteria in this review.\nOne trial conducted in Iran (37 participants, 37 eyes) compared anti-VEGF (bevacizumab 0.2 mg) versus control (sham injection) in people with refractory glaucoma. We judged this study to be at low risk of bias.The primary outcome of this review was not reported; mean IOP at three months was 15.1 mm Hg (standard deviation 1.0) in both anti-VEGF and control groups.\nFour trials compared anti-VEGF to mitomycin C (MMC) (138 particpants, 140 eyes). These studies were conducted in India, Iran, Turkey and the USA. The anti-VEGF agent used in these four trials was bevacizumab 2.5 mg (two trials), bevacizumab 1.25 mg three times and ranibizumab 0.5 mg. Two trials were at high risk of bias in two domains and one trial was at high risk of bias in four domains.\nOnly one of these trials reported the primary outcome of this review (42 participants, 42 eyes). Low quality evidence from this trial showed that people receiving bevacizumab 2.5 mg during primary trabeculectomy were less likely to achieve complete success at 12 months compared to people receiving MMC but the confidence interval (CI) was wide and compatible with increased chance of complete success for anti-VEGF (risk ratio (RR) 0.71, 95% CI 0.46 to 1.08), Assuming that approximately 81% of people receiving MMC achieve complete success, the anticipated success using anti-VEGF agents would be between 37.2% and 87.4%. The same trial suggested no evidence for any difference in qualified success between bevacizumab and MMC (RR 1.00, 95% CI 0.87 to 1.14, moderate quality evidence). Two trials of primary trabeculectomy provided data on mean IOP at 12 months; one trial of bevacizumab 2.5 mg and one trial of ranibizumab 0.5 mg. Mean IOP was 1.86 mm Hg higher (95% CI 0.15 to 3.57) in the anti-VEGF groups compared to the MMC groups (66 people, low quality evidence). Data were reported on wound leak, hypotony, shallow anterior chamber and endophthalmitis, but these events occurred rarely and currently there are not enough data available to detect any differences, if any, between the two treatments.\nAuthors' conclusions\nThe evidence is currently of low quality which is insufficient to refute or support anti-VEGF subconjunctival injection for control of wound healing in glaucoma surgery. The effect on IOP control of anti-VEGF agents in glaucoma patients undergoing trabeculectomy is still uncertain, compared to MMC.\nFurther RCTs of anti-VEGF subconjunctival injection in glaucoma surgery are required, particularly compared to sham treatment with at least 12 months follow-up.\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": "Glaucoma filtration surgery, an eye operation in which a drainage fistula is created in the wall of the eye to reduce intraocular pressure (IOP), is usually reserved for glaucoma patients whose IOP cannot be sufficiently managed by medical and/or laser intervention. Scarring during wound healing can lead to failure of the operation, therefore, drugs are used to modify wound healing. Anti-VEGF agents have been proposed to decrease scar formation. This review asks whether there is evidence that the use of anti-VEGF drugs reduces the risk of failure of glaucoma surgery. We searched the medical literature for studies that evaluated the benefit and harms of anti-VEGF subconjunctival injection during trabeculectomy for control of wound healing, compared to control or MMC."
}
] |
query-laysum
|
23760
|
[
{
"role": "user",
"content": "Abstract: Background\nCurrent international treatment guidelines recommending therapeutic exercise for people with symptomatic hip osteoarthritis (OA) report are based on limited evidence.\nObjectives\nTo determine whether land-based therapeutic exercise is beneficial for people with hip OA in terms of reduced joint pain and improved physical function and quality of life.\nSearch methods\nWe searched five databases from inception up to February 2013.\nSelection criteria\nAll randomised controlled trials (RCTs) recruiting people with hip OA and comparing some form of land-based therapeutic exercise (as opposed to exercises conducted in water) with a non-exercise group.\nData collection and analysis\nFour review authors independently selected studies for inclusion. We resolved disagreements through consensus. Two review authors independently extracted data, assessed risk of bias and the quality of the body of evidence for each outcome using the GRADE approach. We conducted analyses on continuous outcomes (pain, physical function and quality of life) and dichotomous outcomes (proportion of study withdrawals).\nMain results\nWe considered that seven of the 10 included RCTs had a low risk of bias. However, the results may be vulnerable to performance and detection bias as none of the RCTs were able to blind participants to treatment allocation and, while most RCTs reported blinded outcome assessment, pain, physical function and quality of life were participant self reported. One of the 10 RCTs was only reported as a conference abstract and did not provide sufficient data for the evaluation of bias risk.\nHigh-quality evidence from nine trials (549 participants) indicated that exercise reduced pain (standardised mean difference (SMD) -0.38, 95% confidence interval (CI) -0.55 to -0.20) and improved physical function (SMD -0.38, 95% CI -0.54 to -0.05) immediately after treatment. Pain and physical function were estimated to be 29 points on a 0- to 100-point scale (0 was no pain or loss of physical function) in the control group; exercise reduced pain by an equivalent of 8 points (95% CI 4 to 11 points; number needed to treat for an additional beneficial outcome (NNTB) 6) and improved physical function by an equivalent of 7 points (95% CI 1 to 12 points; NNTB 6). Only three small studies (183 participants) evaluated quality of life, with overall low quality evidence, with no benefit of exercise demonstrated (SMD -0.07, 95% CI -0.23 to 0.36). Quality of life was estimated to be 50 points on a norm-based mean (standard deviation (SD)) score of 50 (10) in the general population in the control group; exercise improved quality of life by 0 points. Moderate-quality evidence from seven trials (715 participants) indicated an increased likelihood of withdrawal from the exercise allocation (event rate 6%) compared with the control group (event rate 3%), but this difference was not significant (risk difference 1%; 95% CI -1% to 4%). Of the five studies reporting adverse events, each study reported only one or two events and all were related to increased pain attributed to the exercise programme.\nThe reduction in pain was sustained at least three to six months after ceasing monitored treatment (five RCTs, 391 participants): pain (SMD -0.38, 95% CI -0.58 to -0.18). Pain was estimated to be 29 points on a 0- to 100-point scale (0 was no pain) in the control group, the improvement in pain translated to a sustained reduction in pain intensity of 8 points (95% CI 4 to 12 points) compared with the control group (0 to 100 scale). The improvement in physical function was also sustained (five RCTs, 367 participants): physical function (SMD -0.37, 95% CI -0.57 to -0.16). Physical function was estimated to be 24 points on a 0- to 100-point scale (0 was no loss of physical function) in the control group, the improvement translated to a mean of 7 points (95% CI 4 to 13) compared with the control group.\nOnly five of the 10 RCTs exclusively recruited people with symptomatic hip OA (419 participants). There was no significant difference in pain or physical function outcomes compared with five studies recruiting participants with hip or knee OA (130 participants).\nAuthors' conclusions\nPooling the results of these 10 RCTs demonstrated that land-based therapeutic exercise programmes can reduce pain and improve physical function among people with symptomatic hip OA.\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": "Pain on a scale of 0 to 100 points (lower scores mean reduced pain):\n- People who completed an exercise programme rated their pain to be 8 points lower (4 to 11 points lower) at end of treatment (8% absolute improvement) compared with people who did not exercise.\n- People who completed an exercise programme rated their pain as 21 points.\n- People who did not exercise rated their pain as 29 points.\nPhysical function on a scale of 0 to 100 points (lower score means better physical function):\n- People who completed an exercise programme rated their physical function to be 7 points lower (1 to 12 points lower) at end of treatment (7% absolute improvement) compared with people who did not exercise.\n- People who completed an exercise programme rated their physical function as 22 points.\n- People who did not exercise rated their physical function as 29 points.\nQuality of life (higher score means better quality of life):\n- Overall, people with hip OA participating in the studies had a similar quality of life compared with the general population (normative scores of average 50 points), and quality of life was not further improved by participation in an exercise programme: 0 points higher.\n- People who completed an exercise programme rated their quality of life as 50 points on a population norm-based scale.\n- People who did not exercise rated their quality of life as 50 points on a population norm-based scale.\nWithdrawals\n- three more people out of 100 dropped out of the exercise programme (1% absolute increase).\n- Six out of 100 people in exercise programmes dropped out.\n- Three out of 100 people who did not exercise dropped out."
}
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query-laysum
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23761
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[
{
"role": "user",
"content": "Abstract: Background\nTopical analgesic drugs are used for a variety of painful conditions. Some are acute, typically strains or sprains, tendinopathy, or muscle aches. Others are chronic, typically osteoarthritis of hand or knee, or neuropathic pain.\nObjectives\nTo provide an overview of the analgesic efficacy and associated adverse events of topical analgesics (primarily nonsteroidal anti-inflammatory drugs (NSAIDs), salicylate rubefacients, capsaicin, and lidocaine) applied to intact skin for the treatment of acute and chronic pain in adults.\nMethods\nWe identified systematic reviews in acute and chronic pain published to February 2017 in the Cochrane Database of Systematic Reviews (the Cochrane Library). The primary outcome was at least 50% pain relief (participant-reported) at an appropriate duration. We extracted the number needed to treat for one additional beneficial outcome (NNT) for efficacy outcomes for each topical analgesic or formulation, and the number needed to treat for one additional harmful outcome (NNH) for adverse events. We also extracted information on withdrawals due to lack of efficacy or adverse events, systemic and local adverse events, and serious adverse events. We required information from at least 200 participants, in at least two studies. We judged that there was potential for publication bias if the addition of four studies of typical size (400 participants) with zero effect increased NNT compared with placebo to 10 (minimal clinical utility). We extracted GRADE assessment in the original papers, and made our own GRADE assessment.\nMain results\nThirteen Cochrane Reviews (206 studies with around 30,700 participants) assessed the efficacy and harms from a range of topical analgesics applied to intact skin in a number of acute and chronic painful conditions. Reviews were overseen by several Review Groups, and concentrated on evidence comparing topical analgesic with topical placebo; comparisons of topical and oral analgesics were rare.\nFor at least 50% pain relief, we considered evidence was moderate or high quality for several therapies, based on the underlying quality of studies and susceptibility to publication bias.\nIn acute musculoskeletal pain (strains and sprains) with assessment at about seven days, therapies were diclofenac Emulgel (78% Emulgel, 20% placebo; 2 studies, 314 participants, NNT 1.8 (95% confidence interval 1.5 to 2.1)), ketoprofen gel (72% ketoprofen, 33% placebo, 5 studies, 348 participants, NNT 2.5 (2.0 to 3.4)), piroxicam gel (70% piroxicam, 47% placebo, 3 studies, 522 participants, NNT 4.4 (3.2 to 6.9)), diclofenac Flector plaster (63% Flector, 41% placebo, 4 studies, 1030 participants, NNT 4.7 (3.7 to 6.5)), and diclofenac other plaster (88% diclofenac plaster, 57% placebo, 3 studies, 474 participants, NNT 3.2 (2.6 to 4.2)).\nIn chronic musculoskeletal pain (mainly hand and knee osteoarthritis) therapies were topical diclofenac preparations for less than six weeks (43% diclofenac, 23% placebo, 5 studies, 732 participants, NNT 5.0 (3.7 to 7.4)), ketoprofen over 6 to 12 weeks (63% ketoprofen, 48% placebo, 4 studies, 2573 participants, NNT 6.9 (5.4 to 9.3)), and topical diclofenac preparations over 6 to 12 weeks (60% diclofenac, 50% placebo, 4 studies, 2343 participants, NNT 9.8 (7.1 to 16)). In postherpetic neuralgia, topical high-concentration capsaicin had moderate-quality evidence of limited efficacy (33% capsaicin, 24% placebo, 2 studies, 571 participants, NNT 11 (6.1 to 62)).\nWe judged evidence of efficacy for other therapies as low or very low quality. Limited evidence of efficacy, potentially subject to publication bias, existed for topical preparations of ibuprofen gels and creams, unspecified diclofenac formulations and diclofenac gel other than Emulgel, indomethacin, and ketoprofen plaster in acute pain conditions, and for salicylate rubefacients for chronic pain conditions. Evidence for other interventions (other topical NSAIDs, topical salicylate in acute pain conditions, low concentration capsaicin, lidocaine, clonidine for neuropathic pain, and herbal remedies for any condition) was very low quality and typically limited to single studies or comparisons with sparse data.\nWe assessed the evidence on withdrawals as moderate or very low quality, because of small numbers of events. In chronic pain conditions lack of efficacy withdrawals were lower with topical diclofenac (6%) than placebo (9%) (11 studies, 3455 participants, number needed to treat to prevent (NNTp) 26, moderate-quality evidence), and topical salicylate (2% vs 7% for placebo) (5 studies, 501 participants, NNTp 21, very low-quality evidence). Adverse event withdrawals were higher with topical capsaicin low-concentration (15%) than placebo (3%) (4 studies, 477 participants, NNH 8, very low-quality evidence), topical salicylate (5% vs 1% for placebo) (7 studies, 735 participants, NNH 26, very low-quality evidence), and topical diclofenac (5% vs 4% for placebo) (12 studies, 3552 participants, NNH 51, very low-quality evidence).\nIn acute pain, systemic or local adverse event rates with topical NSAIDs (4.3%) were no greater than with topical placebo (4.6%) (42 studies, 6740 participants, high quality evidence). In chronic pain local adverse events with topical capsaicin low concentration (63%) were higher than topical placebo (5 studies, 557 participants, number needed to treat for harm (NNH) 2.6), high quality evidence. Moderate-quality evidence indicated more local adverse events than placebo in chronic pain conditions with topical diclofenac (NNH 16) and local pain with topical capsaicin high-concentration (NNH 16). There was moderate-quality evidence of no additional local adverse events with topical ketoprofen over topical placebo in chronic pain. Serious adverse events were rare (very low-quality evidence).\nGRADE assessments of moderate or low quality in some of the reviews were considered by us to be very low because of small numbers of participants and events.\nAuthors' conclusions\nThere is good evidence that some formulations of topical diclofenac and ketoprofen are useful in acute pain conditions such as sprains or strains, with low (good) NNT values. There is a strong message that the exact formulation used is critically important in acute conditions, and that might also apply to other pain conditions. In chronic musculoskeletal conditions with assessments over 6 to 12 weeks, topical diclofenac and ketoprofen had limited efficacy in hand and knee osteoarthritis, as did topical high-concentration capsaicin in postherpetic neuralgia. Though NNTs were higher, this still indicates that a small proportion of people had good pain relief.\nUse of GRADE in Cochrane Reviews with small numbers of participants and events requires attention.\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": "Painkillers rubbed onto the skin are called topical (local) painkillers (analgesics). There has been considerable debate over whether, how, and in what painful condition, they work."
}
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query-laysum
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23762
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[
{
"role": "user",
"content": "Abstract: Background\nThis is the first update of a review published in 2015, Issue 1. Chronic pain is common during childhood and adolescence and is associated with negative outcomes, such as increased severity of pain, reduced function, and low mood. Psychological therapies, traditionally delivered face-to-face with a therapist, are efficacious at reducing pain intensity and disability. To address barriers to treatment access, such as distance and cost of treatment, technology is being used to deliver these psychological therapies remotely. Therapies delivered remotely, such as via the Internet, computer-based programmes, and smartphone applications, can be used to deliver treatment to children and adolescents with chronic pain.\nObjectives\nTo determine the efficacy of psychological therapies delivered remotely compared to waiting list, treatment as usual, or active control treatments, for the management of chronic pain in children and adolescents.\nSearch methods\nWe searched four databases (CENTRAL, MEDLINE, Embase, and PsycINFO) from inception to May 2018 for randomised controlled trials (RCTs) of remotely-delivered psychological interventions for children and adolescents with chronic pain. We searched for chronic pain conditions including, but not exclusive to, headache, recurrent abdominal pain, musculoskeletal pain, and neuropathic pain. We also searched online trial registries, reference sections, and citations of included studies for potential trials.\nSelection criteria\nWe included RCTs that investigated the efficacy of a psychological therapy delivered remotely via technology in comparison to an active, treatment as usual, or waiting-list control. We considered blended treatments, which used a combination of technology and up to 30% face-to-face interaction. Interventions had to be delivered primarily via technology to be included, and we excluded interventions delivered via telephone. We included studies that delivered interventions to children and adolescents (up to 18 years of age) with a chronic pain condition or where chronic pain was a primary symptom of their condition (e.g. juvenile arthritis). We included studies that reported 10 or more participants in each comparator arm, at each extraction point.\nData collection and analysis\nWe combined all psychological therapies in the analyses. We split pain conditions into headache and mixed (non-headache) pain and analysed them separately. We extracted pain severity/intensity, disability, depression, anxiety, and adverse events as primary outcomes, and satisfaction with treatment as a secondary outcome. We considered outcomes at two time points: first immediately following the end of treatment (known as 'post-treatment'), and second, any follow-up time point post-treatment between three and 12 months (known as 'follow-up'). We assessed risk of bias and all outcomes for quality using the GRADE assessment.\nMain results\nWe found 10 studies with 697 participants (an additional 4 studies with 326 participants since the previous review) that delivered treatment remotely; four studies investigated children with headache conditions, one study was with children with juvenile idiopathic arthritis, one included children with sickle cell disease, one included children with irritable bowel syndrome, and three studies included children with different chronic pain conditions (i.e. headache, recurrent abdominal pain, musculoskeletal pain). The average age of children receiving treatment was 13.17 years.\nWe judged selection, detection, and reporting biases to be mostly low risk. However, we judged performance and attrition biases to be mostly unclear. Out of the 16 planned analyses, we were able to conduct 13 meta-analyses. We downgraded outcomes for imprecision, indirectness of evidence, inconsistency of results, or because the analysis only included one study.\nHeadache conditions\nFor headache pain conditions, we found headache severity was reduced post-treatment (risk ratio (RR) 2.02, 95% confidence interval (CI) 1.35 to 3.01); P < 0.001, number needed to treat to benefit (NNTB) = 5.36, 7 studies, 379 participants; very low-quality evidence). No effect was found at follow-up (very low-quality evidence). There were no effects of psychological therapies delivered remotely for disability post-treatment (standardised mean difference (SMD) -0.16, 95% CI -0.46 to 0.13; P = 0.28, 5 studies, 440 participants) or follow-up (both very low-quality evidence). Similarly, no effect was found for the outcomes of depression (SMD -0.04, 95% CI -0.15 to 0.23, P = 0.69, 4 studies, 422 participants) or anxiety (SMD -0.08, 95% CI -0.28 to 0.12; P = 0.45, 3 studies, 380 participants) at post-treatment, or follow-up (both very low-quality evidence).\nMixed chronic pain conditions\nWe did not find any beneficial effects of psychological therapies for reducing pain intensity post-treatment for mixed chronic pain conditions (SMD -0.90, 95% CI -1.95 to 0.16; P = 0.10, 5 studies, 501 participants) or at follow-up. There were no beneficial effects of psychological therapies delivered remotely for disability post-treatment (SMD -0.28, 95% CI -0.74 to 0.18; P = 0.24, 3 studies, 363 participants) and a lack of data at follow-up meant no analysis could be run. We found no beneficial effects for the outcomes of depression (SMD 0.04, 95% CI -0.18 to 0.26; P = 0.73, 2 studies, 317 participants) and anxiety (SMD 0.53, 95% CI -0.63 to 1.68; P = 0.37, 2 studies, 370 participants) post-treatment, however, we are cautious of our findings as we could only include two studies in the analyses. We could not conduct analyses at follow-up. We judged the evidence for all outcomes to be very low quality.\nAll conditions\nAcross all chronic pain conditions, six studies reported minor adverse events which were not attributed to the psychological therapies. Satisfaction with treatment is described qualitatively and was overall positive. However, we judged both these outcomes as very low quality.\nAuthors' conclusions\nThere are currently a small number of trials investigating psychological therapies delivered remotely, primarily via the Internet. We are cautious in our interpretations of analyses. We found one beneficial effect of therapies to reduce headache severity post-treatment. For the remaining outcomes there was either no beneficial effect at post-treatment or follow-up, or lack of evidence to determine an effect. Overall, participant satisfaction with treatment was positive. We judged the quality of the evidence to be very low, meaning we are very uncertain about the estimate. Further studies are needed to increase our confidence in this potentially promising field.\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"
},
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"role": "assistant",
"content": "We split the painful conditions into two groups and looked at them separately. The first group included children with headache. The second group included children with other painful conditions (e.g. frequent stomach pain, musculoskeletal pain), known as 'mixed chronic pain'. Psychological therapies delivered remotely (primarily via the Internet) were helpful at reducing pain for children and adolescents with headache when assessed immediately following treatment. However, we did not find a beneficial effect for these children at follow-up. We found no beneficial effect of therapies for reducing pain intensity for children with other types of pain. Further, we did not find beneficial effects of remotely-delivered therapies on physical functioning, depression, or anxiety post-treatment for headache and mixed chronic pain conditions. However, there were limited data for mixed chronic pain conditions to draw conclusions from these outcomes, particularly at follow-up. Satisfaction with treatment was described in the trials and was generally positive. Six trials described side effects which were not linked to receiving psychological therapies.\nCurrently, there are very few studies investigating this treatment. Caution should be taken when interpreting these results as they are based on a small number of studies with few children. Further studies in this area are likely to change our findings and may show this to be a useful treatment for reducing pain and improving functioning in children with long-term pain."
}
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query-laysum
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23763
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[
{
"role": "user",
"content": "Abstract: Background\nOtomycosis is a fungal infection of the outer ear, which may be treated with topical antifungal medications. There are many types, with compounds belonging to the azole group ('azoles') being among the most widely used.\nObjectives\nTo evaluate the benefits and harms of topical azole treatments for otomycosis.\nSearch methods\nThe Cochrane ENT Information Specialist searched the Cochrane ENT Register; Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE; Ovid Embase; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The search date was 11 November 2020.\nSelection criteria\nWe included randomised controlled trials (RCTs) in adults and children with otomycosis comparing any topical azole antifungal with: placebo, no treatment, another type of topical azole or the same type of azole but applied in different forms. A minimum follow-up of two weeks was required.\nData collection and analysis\nWe used standard Cochrane methods. Our primary outcomes were: 1) clinical resolution as measured by the proportion of participants with complete resolution at between two and four weeks after treatment (however defined by the authors of the studies) and 2) significant adverse events. Secondary outcomes were 3) mycological resolution and 4) other less serious adverse effects. We used GRADE to assess the certainty of evidence for each outcome.\nMain results\nWe included four studies with 559 participants from Spain, Mexico and India. Three studies included children and adults; one included only adults. The duration of symptoms was not always explicitly stated. Mycological resolution results were only reported in one study. The studies assessed two comparisons: one type of topical azole versus another and the same azole but administered in different forms (cream versus solution).\nA. Topical azoles versus placebo\nNone of the studies assessed this comparison.\nB. Topical azoles versus no treatment\nNone of the studies assessed this comparison.\nC. One type of topical azole versus another type of topical azole\ni) Clotrimazole versus other types of azoles (eberconazole, fluconazole, miconazole)\nThree studies examined clotrimazole versus other types of azoles. The evidence is very uncertain about the difference between clotrimazole and other types of azole in achieving complete clinical resolution at four weeks (risk ratio (RR) 0.80, 95% confidence interval (CI) 0.59 to 1.07; 3 studies; 439 participants; very low-certainty evidence). The anticipated absolute effects are 668 per 1000 for clotrimazole versus 835 per 1000 for other azoles.\nOne study planned a safety analysis and reported no significant adverse events in either group. The evidence is therefore very uncertain about any differences between clotrimazole and other types of azole (no events in either group; 1 study; 174 participants; very low-certainty evidence).\nClotrimazole may result in little or no difference in mycological resolution at two weeks follow-up (RR 1.01, 95% CI 0.96 to 1.06; 1 study; 174 participants; low-certainty evidence) or in other (less serious) adverse events at two weeks follow-up (36 per 1000, compared to 45 per 1000, RR 0.79, 95% CI 0.18 to 3.41; 1 study; 174 participants; very low-certainty evidence).\nii) Bifonazole cream versus bifonazole solution\nOne study compared bifonazole 1% cream with solution. Bifonazole cream may have little or no effect on clinical resolution at two weeks follow-up when compared to solution, but the evidence is very uncertain (RR 1.07, 95% CI 0.73 to 1.57; 1 study; 40 ears; very low-certainty evidence). Bifonazole cream may achieve less mycological resolution compared to solution at two weeks after the end of therapy, but the evidence for this is also very uncertain (RR 0.53, 95% CI 0.29 to 0.96; 1 study; 40 ears; very low-certainty evidence). Five out of 35 patients sustained severe itching and burning from the bifonazole solution but none with the bifonazole cream (very low-certainty evidence).\nAuthors' conclusions\nWe found no studies that evaluated topical azoles compared to placebo or no treatment. The evidence is very uncertain about the effect of clotrimazole on clinical resolution of otomycosis, on significant adverse events or other (non-serious) adverse events when compared with other topical azoles (eberconazole, fluconazole, miconazole). There may be little or no difference between clotrimazole and other azoles in terms of mycological resolution. It may be difficult to generalise these results because the range of ethnic backgrounds of the participants in the studies is limited.\n\nGiven the provided abstract, please respond to the following query: \"How up to date is this evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "The evidence is up to date to November 2020."
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query-laysum
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23764
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[
{
"role": "user",
"content": "Abstract: Background\nAbout 10% of women of reproductive age suffer from endometriosis, a costly chronic disease causing pelvic pain and subfertility. Laparoscopy is the gold standard diagnostic test for endometriosis, but is expensive and carries surgical risks. Currently, there are no non-invasive tests available in clinical practice to accurately diagnose endometriosis. This review assessed the diagnostic accuracy of combinations of different non-invasive testing modalities for endometriosis and provided a summary of all the reviews in the non-invasive tests for endometriosis series.\nObjectives\nTo estimate the diagnostic accuracy of any combination of non-invasive tests for the diagnosis of pelvic endometriosis (peritoneal and/or ovarian or deep infiltrating) compared to surgical diagnosis as a reference standard. The combined tests were evaluated as replacement tests for diagnostic surgery and triage tests to assist decision-making to undertake diagnostic surgery for endometriosis.\nSearch methods\nWe did not restrict the searches to particular study designs, language or publication dates. We searched CENTRAL to July 2015, MEDLINE and EMBASE to May 2015, as well as the following databases to April 2015: CINAHL, PsycINFO, Web of Science, LILACS, OAIster, TRIP, ClinicalTrials.gov, DARE and PubMed.\nSelection criteria\nWe considered published, peer-reviewed, randomised controlled or cross-sectional studies of any size, including prospectively collected samples from any population of women of reproductive age suspected of having one or more of the following target conditions: ovarian, peritoneal or deep infiltrating endometriosis (DIE). We included studies comparing the diagnostic test accuracy of a combination of several testing modalities with the findings of surgical visualisation of endometriotic lesions.\nData collection and analysis\nThree review authors independently collected and performed a quality assessment of the data from each study by using the QUADAS-2 tool. For each test, the data were classified as positive or negative for the surgical detection of endometriosis and sensitivity and specificity estimates were calculated. The bivariate model was planned to obtain pooled estimates of sensitivity and specificity whenever sufficient data were available. The predetermined criteria for a clinically useful test to replace diagnostic surgery were a sensitivity of 0.94 and a specificity of 0.79 to detect endometriosis. We set the criteria for triage tests at a sensitivity of 0.95 and above and a specificity of 0.50 and above, which 'rules out' the diagnosis with high accuracy if there is a negative test result (SnOUT test), or a sensitivity of 0.50 and above and a specificity of 0.95 and above, which 'rules in' the diagnosis with high accuracy if there is a positive result (SpIN test).\nMain results\nEleven eligible studies included 1339 participants. All the studies were of poor methodological quality. Seven studies evaluated pelvic endometriosis, one study considered DIE and/or ovarian endometrioma, two studies differentiated endometrioma from other ovarian cysts and one study addressed mapping DIE at specific anatomical sites. Fifteen different diagnostic combinations were assessed, including blood, urinary or endometrial biomarkers, transvaginal ultrasound (TVUS) and clinical history or examination. We did not pool estimates of sensitivity and specificity, as each study analysed independent combinations of the non-invasive tests.\nTests that met the criteria for a replacement test were: a combination of serum IL-6 (cut-off >15.4 pg/ml) and endometrial PGP 9.5 for pelvic endometriosis (sensitivity 1.00 (95% confidence interval (CI) 0.91 to 1.00), specificity 0.93 (95% CI, 0.80, 0.98) and the combination of vaginal examination and transvaginal ultrasound (TVUS) for rectal endometriosis (sensitivity 0.96 (95% CI 0.86 to 0.99), specificity 0.98 (95% CI 0.94 to 1.00)). Tests that met the criteria for SpIN triage tests for pelvic endometriosis were: 1. a multiplication of urine vitamin-D-binding protein (VDBP) and serum CA-125 (cut-off >2755) (sensitivity 0.74 (95% CI 0.60 to 0.84), specificity 0.97 (95% CI 0.86 to 1.00)) and 2. a combination of history (length of menses), serum CA-125 (cut-off >35 U/ml) and endometrial leukocytes (sensitivity 0.61 (95% CI 0.54 to 0.69), specificity 0.95 (95% CI 0.91 to 0.98)). For endometrioma, the following combinations qualified as SpIN test: 1. TVUS and either serum CA-125 (cut-off ≥25 U/ml) or CA 19.9 (cut-off ≥12 U/ml) (sensitivity 0.79 (95% CI 0.64 to 0.91), specificity 0.97 (95% CI 0.91 to 1.00)); 2. TVUS and serum CA 19.9 (cut-off ≥12 U/ml) (sensitivity 0.54 (95% CI 0.37 to 0.70), specificity 0.97 (95% CI 0.91 to 1.0)); 3-4. TVUS and serum CA-125 (cut-off ≥20 U/ml or cut-off ≥25 U/ml) (sensitivity 0.69 (95% CI 0.49 to 0.85), specificity 0.96 (95% CI 0.88 to 0.99)); 5. TVUS and serum CA-125 (cut-off ≥35 U/ml) (sensitivity 0.52 (95% CI 0.33 to 0.71), specificity 0.97 (95% CI 0.90 to 1.00)). A combination of vaginal examination and TVUS reached the threshold for a SpIN test for obliterated pouch of Douglas (sensitivity 0.87 (95% CI 0.69 to 0.96), specificity 0.98 (95% CI 0.95 to 1.00)), vaginal wall endometriosis (sensitivity 0.82 (95% CI 0.60 to 0.95), specificity 0.99 (95% CI 0.97 to 1.0)) and rectovaginal septum endometriosis (sensitivity 0.88 (95% CI 0.47 to 1.00), specificity 0.99 (95% CI 0.96 to 1.00)).\nAll the tests were evaluated in individual studies and displayed wide CIs. Due to the heterogeneity and high risk of bias of the included studies, the clinical utility of the studied combination diagnostic tests for endometriosis remains unclear.\nAuthors' conclusions\nNone of the biomarkers evaluated in this review could be evaluated in a meaningful way and there was insufficient or poor-quality evidence. Laparoscopy remains the gold standard for the diagnosis of endometriosis and using any non-invasive tests should only be undertaken in a research setting.\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": "Can any combination of non-invasive tests be accurate enough to replace or reduce the need for surgery in the diagnosis of endometriosis?"
}
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query-laysum
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23765
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[
{
"role": "user",
"content": "Abstract: Background\nRates of major depression among people living with HIV (PLWH) are substantially higher than those seen in the general population and this may adversely affect antiretroviral treatment outcomes. Several unique clinical and psychosocial factors may contribute to the development and persistence of depression in PLWH. Given these influences, it is unclear if antidepressant therapy is as effective for PLWH as the general population.\nObjectives\nTo assess the efficacy of antidepressant therapy for treatment of depression in PLWH.\nSearch methods\nWe searched The Cochrane Common Mental Disorders Group's specialised register (CCMD-CTR), the Cochrane Library, PubMed, Embase and ran a cited reference search on the Web of Science for reports of all included studies. We conducted additional searches of the international trial registers including; ClinicalTrials.gov, World Health Organization Trials Portal (ICTRP), and the HIV and AIDS - Clinical trials register. We searched grey literature and reference lists to identify additional studies and contacted authors to obtain missing data. We applied no restrictions on date, language or publication status to the searches, which included studies conducted between 1 January 1980 and 18 April 2017.\nSelection criteria\nWe included randomized controlled trials of antidepressant drug therapy compared to placebo or another antidepressant drug class. Participants eligible for inclusion had to be aged 18 years and older, from any setting, and have both HIV and depression. Depression was defined according to Diagnostic and Statistical Manual of Mental Disorders or International Statistical Classification of Diseases criteria.\nData collection and analysis\nTwo review authors independently applied the inclusion criteria and extracted data. We presented categorical outcomes as risk ratios (RR) with 95% confidence intervals (CIs). Continuous outcomes were presented mean (MD) or standardized mean differences (SMD) with standard deviations (SD). We assessed quality of evidence using the GRADE approach.\nMain results\nWe included 10 studies with 709 participants in this review. Of the 10 studies, eight were conducted in high income countries (USA and Italy), seven were conducted prior to 2000 and seven had predominantly men. Seven studies assessed antidepressants versus placebo, two compared different antidepressant classes and one had three arms comparing two antidepressant classes with placebo.\nAntidepressant therapy may result in a greater improvement in depression compared to placebo. There was a moderate improvement in depression when assessed with the Hamilton Depression Rating Scale (HAM-D) score as a continuous outcome (SMD 0.59, 95% CI 0.21 to 0.96; participants = 357; studies = 6; I2 = 62%, low quality evidence). However, there was no evidence of improvement when this was assessed with HAM-D score as a dichotomized outcome (RR 1.10, 95% CI 0.89 to 1.35; participants = 434; studies = 5; I2 = 0%, low quality evidence) or Clinical Global Impression of Improvement (CGI-I) score (RR 1.28, 95% CI 0.93 to 1.77; participants = 346; studies = 4; I2 = 29%, low quality evidence). There was little to no difference in the proportion of study dropouts between study arms (RR 1.28, 95% CI 0.91 to 1.80; participants = 306; studies = 4; I2 = 0%, moderate quality evidence).\nThe methods of reporting adverse events varied substantially between studies, this resulted in very low quality evidence contributing to a pooled estimate (RR 0.88, 95% CI 0.64 to 1.21; participants = 167; studies = 2; I2 = 34%; very low quality evidence). Based on this, we were unable to determine if there was a difference in the proportion of participants experiencing adverse events in the antidepressant versus placebo arms. However, sexual dysfunction was reported commonly in people receiving selective serotonin reuptake inhibitors (SSRIs). People receiving tricyclic antidepressants (TCAs) frequently reported anticholinergic adverse effects such as dry mouth and constipation. There were no reported grade 3 or 4 adverse events in any study group.\nThere was no evidence of a difference in follow-up CD4 count at study termination (MD -6.31 cells/mm3, 95% CI -72.76 to 60.14; participants = 176; studies = 3; I2 = 0%; low quality evidence). Only one study evaluated quality of life score (MD 3.60, 95% CI -0.38 to 7.58; participants = 87; studies = 1; very low quality evidence), due to the poor quality evidence we could not draw conclusions for this outcome.\nThere were few studies comparing different antidepressant classes. We are uncertain if SSRIs differ from TCAs with regard to improvement in depression as evaluated by HAM-D score (MD -3.20, 95% CI -10.87 to 4.47; participants = 14; studies = 1; very low quality evidence). There was some evidence that mirtazapine resulted in a greater improvement in depression compared to an SSRI (MD 9.00, 95% CI 3.61 to 14.39; participants = 70; studies = 1; low quality evidence); however, this finding was not consistent for all measures of improvement in depression for this comparison.\nNo studies reported on virological suppression or any other HIV specific outcomes.\nThe studies included in this review had an overall unclear or high risk of bias due to under-reporting of study methods, high risk of attrition bias and inadequate sequence generation methods. Heterogeneity between studies and the limited number of participants, and events lead to downgrading of the quality of the evidence for several outcomes.\nAuthors' conclusions\nThis review demonstrates that antidepressant therapy may be more beneficial than placebo for the treatment of depression in PLWH. The low quality of the evidence contributing to this assessment and the lack of studies representing PLWH from generalized epidemics in low- to middle-income countries make the relevance of these finding in today's context limited. Future studies that evaluate the effectiveness of antidepressant therapy should be designed and conducted rigorously. Such studies should incorporate evaluation of stepped care models and health system strengthening interventions in the study design. In addition, outcomes related to HIV care and antiretroviral therapy should be reported.\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": "PLWH, general practitioners, HIV clinicians and professionals working in mental health services."
}
] |
query-laysum
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23766
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[
{
"role": "user",
"content": "Abstract: Background\nTotal knee replacement (TKR) is a common intervention for people with end-stage symptomatic knee osteoarthritis, resulting in significant improvements in pain, function and quality of life within three to six months. It is, however, acutely associated with pain, local oedema and blood loss. Post-operative management may include cryotherapy. This is the application of low temperatures to the skin surrounding the surgical site, through ice or cooled water, often delivered using specialised devices. This is an update of a review published in 2012.\nObjectives\nTo evaluate the effect of cryotherapy in the acute phase after TKR (within 48 hours after surgery) on blood loss, pain, transfusion rate, range of motion, knee function, adverse events and withdrawals due to adverse events.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, six other databases and two trials registers, as well as reference lists, related links and conference proceedings on 27 May 2022.\nSelection criteria\nWe included randomised controlled trials or controlled clinical trials comparing cryotherapy with or without other treatments (such as compression, regional nerve block or continuous passive motion) to no treatment, or the other treatment alone, following TKR for osteoarthritis.\nData collection and analysis\nTwo review authors independently selected studies for inclusion, extracted data and assessed risk of bias and certainty of evidence using GRADE. We discussed any disagreements and consulted another review author to resolve them, if required. Major outcomes were blood loss, pain, transfusion rate, knee range of motion, knee function, total adverse events and withdrawals from adverse events. Minor outcomes were analgesia use, knee swelling, length of stay, quality of life, activity level and participant-reported global assessment of success.\nMain results\nWe included 22 trials (20 randomised trials and two controlled clinical trials), with 1839 total participants. The mean ages reflected the TKR population, ranging from 64 to 74 years.\nCryotherapy with compression was compared to no treatment in four studies, and to compression alone in nine studies. Cryotherapy without compression was compared to no treatment in eight studies. One study compared cryotherapy without compression to control with compression alone. We combined all control interventions in the primary analysis.\nCertainty of evidence was low for blood loss (downgraded for bias and inconsistency), pain (downgraded twice for bias) and range of motion (downgraded for bias and indirectness). It was very low for transfusion rate (downgraded for bias, inconsistency and imprecision), function (downgraded twice for bias and once for inconsistency), total adverse events (downgraded for bias, indirectness and imprecision) and withdrawals from adverse events (downgraded for bias, indirectness and imprecision). The nature of cryotherapy made blinding difficult and most studies had a high risk of performance and detection bias.\nLow-certainty evidence from 12 trials (956 participants) shows that cryotherapy may reduce blood loss at one to 13 days after surgery. Blood loss was 825 mL with no cryotherapy and 561 mL with cryotherapy: mean difference (MD) 264 mL less (95% confidence interval (CI) 7 mL less to 516 mL less).\nLow-certainty evidence from six trials (530 participants) shows that cryotherapy may slightly improve pain at 48 hours on a 0- to 10-point visual analogue scale (lower scores indicate less pain). Pain was 4.8 points with no cryotherapy and 3.16 points with cryotherapy: MD 1.6 points lower (95% CI 2.3 lower to 1.0 lower).\nWe are uncertain whether cryotherapy improves transfusion rate at zero to 13 days after surgery. The transfusion rate was 37% with no cryotherapy and 79% with cryotherapy (risk ratio (RR) 2.13, 95% CI 0.04 to 109.63; 2 trials, 91 participants; very low-certainty evidence).\nLow-certainty evidence from three trials (174 participants) indicates cryotherapy may improve range of motion at discharge: it was 62.9 degrees with no cryotherapy and 71.2 degrees with cryotherapy: MD 8.3 degrees greater (95% CI 3.6 degrees more to 13.1 degrees more).\nWe are uncertain whether cryotherapy improves function two weeks after surgery. Function was 75.4 points on the 0- to 100-point Dutch Western Ontario and McMaster Universities Arthritis Index (WOMAC) scale (lower score indicates worse function) in the control group and 88.6 points with cryotherapy (MD 13.2 points better, 95% CI 0.5 worse to 27.1 improved; 4 trials, 296 participants; very low-certainty evidence).\nWe are uncertain whether cryotherapy reduces total adverse events: the risk ratio was 1.30 (95% CI 0.53 to 3.20; 16 trials, 1199 participants; very low-certainty evidence). Adverse events included discomfort, local skin reactions, superficial infections, cold-induced injuries and thrombolytic events.\nWe are uncertain whether cryotherapy reduces withdrawals from adverse events (RR 2.71, 95% CI 0.42 to 17.38; 19 trials, 1347 participants; very low-certainty evidence).\nNo significant benefit was found for secondary outcomes of analgesia use, length of stay, activity level or quality of life. Evidence from seven studies (403 participants) showed improved mid-patella swelling between two and six days after surgery (MD 7.32 mm less, 95% CI 11.79 to 2.84 lower), though not at six weeks and three months after surgery. The included studies did not assess participant-reported global assessment of success.\nAuthors' conclusions\nThe certainty of evidence was low for blood loss, pain and range of motion, and very low for transfusion rate, function, total adverse events and withdrawals from adverse events. We are uncertain whether cryotherapy improves transfusion rate, function, total adverse events or withdrawals from adverse events. We downgraded evidence for bias, indirectness, imprecision and inconsistency. Hence, the potential benefits of cryotherapy on blood loss, pain and range of motion may be too small to justify its use. More well-designed randomised controlled trials focusing especially on clinically meaningful outcomes, such as blood transfusion, and patient-reported outcomes, such as knee function, quality of life, activity level and participant-reported global assessment of success, are required.\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 cryotherapy compared with placebo in people after TKR. We compared and summarised the results of the studies and rated our confidence in the evidence, based on factors such as study methods and sizes."
}
] |
query-laysum
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23767
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[
{
"role": "user",
"content": "Abstract: Background\nFluoride mouthrinses have been used extensively as a caries-preventive intervention in school-based programmes and by individuals at home. This is an update of the Cochrane review of fluoride mouthrinses for preventing dental caries in children and adolescents that was first published in 2003.\nObjectives\nThe primary objective is to determine the effectiveness and safety of fluoride mouthrinses in preventing dental caries in the child and adolescent population.\nThe secondary objective is to examine whether the effect of fluoride rinses is influenced by:\n• initial level of caries severity;\n• background exposure to fluoride in water (or salt), toothpastes or reported fluoride sources other than the study option(s); or\n• fluoride concentration (ppm F) or frequency of use (times per year).\nSearch methods\nWe searched the following electronic databases: Cochrane Oral Health's Trials Register (whole database, to 22 April 2016), the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library, 2016, Issue 3), MEDLINE Ovid (1946 to 22 April 2016), Embase Ovid (1980 to 22 April 2016), CINAHL EBSCO (the Cumulative Index to Nursing and Allied Health Literature, 1937 to 22 April 2016), LILACS BIREME (Latin American and Caribbean Health Science Information Database, 1982 to 22 April 2016), BBO BIREME (Bibliografia Brasileira de Odontologia; from 1986 to 22 April 2016), Proquest Dissertations and Theses (1861 to 22 April 2016) and Web of Science Conference Proceedings (1990 to 22 April 2016). We undertook a search for ongoing trials on the US National Institutes of Health Trials Register (http://clinicaltrials.gov) and the World Health Organization International Clinical Trials Registry Platform. We placed no restrictions on language or date of publication when searching electronic databases. We also searched reference lists of articles and contacted selected authors and manufacturers.\nSelection criteria\nRandomised or quasi-randomised controlled trials where blind outcome assessment was stated or indicated, comparing fluoride mouthrinse with placebo or no treatment in children up to 16 years of age. Study duration had to be at least one year. The main outcome was caries increment measured by the change in decayed, missing and filled tooth surfaces in permanent teeth (D(M)FS).\nData collection and analysis\nAt least two review authors independently performed study selection, data extraction and risk of bias assessment. We contacted study authors for additional information when required. The primary measure of effect was the prevented fraction (PF), that is, the difference in mean caries increments between treatment and control groups expressed as a percentage of the mean increment in the control group. We conducted random-effects meta-analyses where data could be pooled. We examined potential sources of heterogeneity in random-effects metaregression analyses. We collected adverse effects information from the included trials.\nMain results\nIn this review, we included 37 trials involving 15,813 children and adolescents. All trials tested supervised use of fluoride mouthrinse in schools, with two studies also including home use. Almost all children received a fluoride rinse formulated with sodium fluoride (NaF), mostly on either a daily or weekly/fortnightly basis and at two main strengths, 230 or 900 ppm F, respectively. Most studies (28) were at high risk of bias, and nine were at unclear risk of bias.\nFrom the 35 trials (15,305 participants) that contributed data on permanent tooth surface for meta-analysis, the D(M)FS pooled PF was 27% (95% confidence interval (CI), 23% to 30%; I2 = 42%) (moderate quality evidence). We found no significant association between estimates of D(M)FS prevented fractions and baseline caries severity, background exposure to fluorides, rinsing frequency or fluoride concentration in metaregression analyses. A funnel plot of the 35 studies in the D(M)FS PF meta-analysis indicated no relationship between prevented fraction and study precision (no evidence of reporting bias). The pooled estimate of D(M)FT PF was 23% (95% CI, 18% to 29%; I² = 54%), from the 13 trials that contributed data for the permanent teeth meta-analysis (moderate quality evidence).\nWe found limited information concerning possible adverse effects or acceptability of the treatment regimen in the included trials. Three trials incompletely reported data on tooth staining, and one trial incompletely reported information on mucosal irritation/allergic reaction. None of the trials reported on acute adverse symptoms during treatment.\nAuthors' conclusions\nThis review found that supervised regular use of fluoride mouthrinse by children and adolescents is associated with a large reduction in caries increment in permanent teeth. We are moderately certain of the size of the effect. Most of the evidence evaluated use of fluoride mouthrinse supervised in a school setting, but the findings may be applicable to children in other settings with supervised or unsupervised rinsing, although the size of the caries-preventive effect is less clear. Any future research on fluoride mouthrinses should focus on head-to-head comparisons between different fluoride rinse features or fluoride rinses against other preventive strategies, and should evaluate adverse effects and acceptability.\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 review update confirmed that supervised regular use of fluoride mouthrinse can reduce tooth decay in children and adolescents. Combined results of 35 trials showed that, on average, there is a 27% reduction in decayed, missing and filled tooth surfaces in permanent teeth with fluoride mouthrinse compared with placebo or no mouthrinse. This benefit is likely to be present even if children use fluoride toothpaste or live in water-fluoridated areas. Combined results of 13 trials found an average 23% reduction in decayed, missing and filled teeth (rather than tooth surfaces) in permanent teeth with fluoride mouthrinse compared with placebo or no mouthrinse. No trials have looked at the effect of fluoride rinse on baby teeth. We found little information about unwanted side effects or about how well children were able to cope with the use of mouthrinses."
}
] |
query-laysum
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23768
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[
{
"role": "user",
"content": "Abstract: Background\nLong-acting bronchodilators such as long-acting β-agonist (LABA), long-acting muscarinic antagonist (LAMA), and LABA/inhaled corticosteroid (ICS) combinations have been used in people with moderate to severe chronic obstructive pulmonary disease (COPD) to control symptoms such as dyspnoea and cough, and prevent exacerbations. A number of LABA/LAMA combinations are now available for clinical use in COPD. However, it is not clear which group of above mentioned inhalers is most effective or if any specific formulation works better than the others within the same group or class.\nObjectives\nTo compare the efficacy and safety of available formulations from four different groups of inhalers (i.e. LABA/LAMA combination, LABA/ICS combination, LAMA and LABA) in people with moderate to severe COPD. The review will update previous systematic reviews on dual combination inhalers and long-acting bronchodilators to answer the questions described above using the strength of a network meta-analysis (NMA).\nSearch methods\nWe identified studies from the Cochrane Airways Specialised Register, which contains several databases. We also conducted a search of ClinicalTrials.gov and manufacturers’ websites. The most recent searches were conducted on 6 April 2018.\nSelection criteria\nWe included randomised controlled trials (RCTs) that recruited people aged 35 years or older with a diagnosis of COPD and a baseline forced expiratory volume in one second (FEV1) of less than 80% of predicted. We included studies of at least 12 weeks' duration including at least two active comparators from one of the four inhaler groups.\nData collection and analysis\nWe conducted NMAs using a Bayesian Markov chain Monte Carlo method. We considered a study as high risk if recruited participants had at least one COPD exacerbation within the 12 months before study entry and as low risk otherwise. Primary outcomes were COPD exacerbations (moderate to severe and severe), and secondary outcomes included symptom and quality-of-life scores, safety outcomes, and lung function. We collected data only for active comparators and did not consider placebo was not considered. We assumed a class/group effect when a fixed-class model fitted well. Otherwise we used a random-class model to assess intraclass/group differences. We supplemented the NMAs with pairwise meta-analyses.\nMain results\nWe included a total of 101,311 participants from 99 studies (26 studies with 32,265 participants in the high-risk population and 73 studies with 69,046 participants in the low-risk population) in our systematic review. The median duration of studies was 52 weeks in the high-risk population and 26 weeks in the low-risk population (range 12 to 156 for both populations). We considered the quality of included studies generally to be good.\nThe NMAs suggested that the LABA/LAMA combination was the highest ranked treatment group to reduce COPD exacerbations followed by LAMA in the both populations.\nThere is evidence that the LABA/LAMA combination decreases moderate to severe exacerbations compared to LABA/ICS combination, LAMA, and LABA in the high-risk population (network hazard ratios (HRs) 0.86 (95% credible interval (CrI) 0.76 to 0.99), 0.87 (95% CrI 0.78 to 0.99), and 0.70 (95% CrI 0.61 to 0.8) respectively), and that LAMA decreases moderate to severe exacerbations compared to LABA in the high- and low-risk populations (network HR 0.80 (95% CrI 0.71 to 0.88) and 0.87 (95% CrI 0.78 to 0.97), respectively). There is evidence that the LABA/LAMA combination reduces severe exacerbations compared to LABA/ICS combination and LABA in the high-risk population (network HR 0.78 (95% CrI 0.64 to 0.93) and 0.64 (95% CrI 0.51 to 0.81), respectively).\nThere was a general trend towards a greater improvement in symptom and quality-of-life scores with the combination therapies compared to monotherapies, and the combination therapies were generally ranked higher than monotherapies.\nThe LABA/ICS combination was the lowest ranked in pneumonia serious adverse events (SAEs) in both populations. There is evidence that the LABA/ICS combination increases the odds of pneumonia compared to LAMA/LABA combination, LAMA and LABA (network ORs: 1.69 (95% CrI 1.20 to 2.44), 1.78 (95% CrI 1.33 to 2.39), and 1.50 (95% CrI 1.17 to 1.92) in the high-risk population and network or pairwise OR: 2.33 (95% CI 1.03 to 5.26), 2.02 (95% CrI 1.16 to 3.72), and 1.93 (95% CrI 1.29 to 3.22) in the low-risk population respectively). There were significant overlaps in the rank statistics in the other safety outcomes including mortality, total, COPD, and cardiac SAEs, and dropouts due to adverse events.\nNone of the differences in lung function met a minimal clinically important difference criterion except for LABA/LAMA combination versus LABA in the high-risk population (network mean difference 0.13 L (95% CrI 0.10 to 0.15). The results of pairwise meta-analyses generally agreed with those of the NMAs. There is no evidence to suggest intraclass/group differences except for lung function at 12 months in the high-risk population.\nAuthors' conclusions\nThe LABA/LAMA combination was the highest ranked treatment group to reduce COPD exacerbations although there was some uncertainty in the results. LAMA containing inhalers may have an advantage over those without a LAMA for preventing COPD exacerbations based on the rank statistics. Combination therapies appear more effective than monotherapies for improving symptom and quality-of-life scores. ICS-containing inhalers are associated with an increased risk of pneumonia.\nOur most comprehensive review including intraclass/group comparisons, free combination therapies, 99 studies, and 20 outcomes for each high- and low-risk population summarises the current literature and could help with updating existing COPD guidelines.\n\nGiven the provided abstract, please respond to the following query: \"How did we answer the question?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We collected and analysed data from 99 studies, including a total of 101,311 participants with advanced COPD, using a special method called network meta-analysis, which enabled us to simultaneously compare the four inhaler groups and 28 individual inhalers (4 LABAs, 5 LAMAs, 9 LABA/ICS combinations, and 10 LABA/LAMA combinations)."
}
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query-laysum
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23769
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[
{
"role": "user",
"content": "Abstract: Background\nProminent upper front teeth are a common problem affecting about a quarter of 12-year-old children in the UK. The condition develops when permanent teeth erupt. These teeth are more likely to be injured and their appearance can cause significant distress. Children are often referred to an orthodontist for treatment with dental braces to reduce the prominence of their teeth. If a child is referred at a young age, the orthodontist is faced with the dilemma of whether to treat the patient early or to wait and provide treatment in adolescence.\nObjectives\nTo assess the effects of orthodontic treatment for prominent upper front teeth initiated when children are seven to 11 years old ('early treatment' in two phases) compared to in adolescence at around 12 to 16 years old ('late treatment' in one phase); to assess the effects of late treatment compared to no treatment; and to assess the effects of different types of orthodontic braces.\nSearch methods\nCochrane Oral Health’s Information Specialist searched the following databases: Cochrane Oral Health’s Trials Register (to 27 September 2017), the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library, 2017, Issue 8), MEDLINE Ovid (1946 to 27 September 2017), and Embase Ovid (1980 to 27 September 2017). The US National Institutes of Health Ongoing Trials Registry (ClinicalTrials.gov) and the World Health Organization International Clinical Trials Registry Platform were searched for ongoing trials. No restrictions were placed on the language or date of publication when searching the electronic databases.\nSelection criteria\nRandomised controlled trials of orthodontic treatments to correct prominent upper front teeth (Class II malocclusion) in children and adolescents. We included trials that compared early treatment in children (two-phase) with any type of orthodontic braces (removable, fixed, functional) or head-braces versus late treatment in adolescents (one-phase) with any type of orthodontic braces or head-braces, and trials that compared any type of orthodontic braces or head-braces versus no treatment or another type of orthodontic brace or appliance (where treatment started at a similar age in the intervention groups).\nWe excluded trials involving participants with a cleft lip or palate, or other craniofacial deformity/syndrome, and trials that recruited patients who had previously received surgical treatment for their Class II malocclusion.\nData collection and analysis\nReview authors screened the search results, extracted data and assessed risk of bias independently. We used odds ratios (ORs) and 95% confidence intervals (CIs) for dichotomous outcomes, and mean differences (MDs) and 95% CIs for continuous outcomes. We used the fixed-effect model for meta-analyses including two or three studies and the random-effects model for more than three studies.\nMain results\nWe included 27 RCTs based on data from 1251 participants.\nThree trials compared early treatment with a functional appliance versus late treatment for overjet, ANB and incisal trauma. After phase one of early treatment (i.e. before the other group had received any intervention), there was a reduction in overjet and ANB reduction favouring treatment with a functional appliance; however, when both groups had completed treatment, there was no difference between groups in final overjet (MD 0.21, 95% CI −0.10 to 0.51, P = 0.18; 343 participants) (low-quality evidence) or ANB (MD −0.02, 95% CI −0.47 to 0.43; 347 participants) (moderate-quality evidence). Early treatment with functional appliances reduced the incidence of incisal trauma compared to late treatment (OR 0.56, 95% CI 0.33 to 0.95; 332 participants) (moderate-quality evidence). The difference in the incidence of incisal trauma was clinically important with 30% (51/171) of participants reporting new trauma in the late treatment group compared to only 19% (31/161) of participants who had received early treatment.\nTwo trials compared early treatment using headgear versus late treatment. After phase one of early treatment, headgear had reduced overjet and ANB; however, when both groups had completed treatment, there was no evidence of a difference between groups in overjet (MD −0.22, 95% CI −0.56 to 0.12; 238 participants) (low-quality evidence) or ANB (MD −0.27, 95% CI −0.80 to 0.26; 231 participants) (low-quality evidence). Early (two-phase) treatment with headgear reduced the incidence of incisal trauma (OR 0.45, 95% CI 0.25 to 0.80; 237 participants) (low-quality evidence), with almost half the incidence of new incisal trauma (24/117) compared to the late treatment group (44/120).\nSeven trials compared late treatment with functional appliances versus no treatment. There was a reduction in final overjet with both fixed functional appliances (MD −5.46 mm, 95% CI −6.63 to −4.28; 2 trials, 61 participants) and removable functional appliances (MD −4.62, 95% CI -5.33 to -3.92; 3 trials, 122 participants) (low-quality evidence). There was no evidence of a difference in final ANB between fixed functional appliances and no treatment (MD −0.53°, 95% CI −1.27 to −0.22; 3 trials, 89 participants) (low-quality evidence), but removable functional appliances seemed to reduce ANB compared to no treatment (MD −2.37°, 95% CI -3.01 to -1.74; 2 trials, 99 participants) (low-quality evidence).\nSix trials compared orthodontic treatment for adolescents with Twin Block versus other appliances and found no difference in overjet (0.08 mm, 95% CI −0.60 to 0.76; 4 trials, 259 participants) (low-quality evidence). The reduction in ANB favoured treatment with a Twin Block (−0.56°, 95% CI −0.96 to −0.16; 6 trials, 320 participants) (low-quality evidence).\nThree trials compared orthodontic treatment for adolescents with removable functional appliances versus fixed functional appliances and found a reduction in overjet in favour of fixed appliances (0.74, 95% CI 0.15 to 1.33; two trials, 154 participants) (low-quality evidence), and a reduction in ANB in favour of removable appliances (−1.04°, 95% CI −1.60 to −0.49; 3 trials, 185 participants) (low-quality evidence).\nAuthors' conclusions\nEvidence of low to moderate quality suggests that providing early orthodontic treatment for children with prominent upper front teeth is more effective for reducing the incidence of incisal trauma than providing one course of orthodontic treatment in adolescence. There appear to be no other advantages of providing early treatment when compared to late treatment. Low-quality evidence suggests that, compared to no treatment, late treatment in adolescence with functional appliances, is effective for reducing the prominence of upper front teeth.\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 suggests that providing orthodontic early treatment to children with prominent upper front teeth reduces the incidence of damage to upper incisor teeth significantly (middle four teeth at the top) as compared to treatment that is provided in one phase in adolescence. There are no other advantages of providing a two-phase treatment (i.e. between age seven to 11 years and again in adolescence) compared to treatment in one phase in adolescence.\nThe evidence also suggests that providing treatment with functional appliances for adolescents with prominent upper front teeth, significantly reduces their prominence when compared to adolescents who did not receive any treatment. The studies did not suggest that any particular appliance was better than any other for reducing teeth prominence."
}
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query-laysum
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23770
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[
{
"role": "user",
"content": "Abstract: Background\nPostpartum haemorrhage (PPH) is the single leading cause of maternal mortality worldwide. Most of the deaths associated with PPH occur in resource-poor settings where effective methods of prevention and treatment - such as oxytocin - are not accessible because many births still occur at home, or in community settings, far from a health facility. Likewise, most of the evidence supporting oxytocin effectiveness comes from hospital settings in high-income countries, mainly because of the need of well-organised care for its administration and monitoring. Easier methods for oxytocin administration have been developed for use in resource-poor settings, but as far as we know, its effectiveness has not been assessed in a systematic review.\nObjectives\nTo assess the effectiveness and safety of oxytocin provided in non-facility birth settings by any way in the third stage of labour to prevent PPH.\nSearch methods\nWe searched the Cochrane Pregnancy and Childbirth Group's Trials Register, the WHO International Clinical Trials Registry Platform (ICTRP), ClinicalTrials.gov (12 November 2015), and reference lists of retrieved reports.\nSelection criteria\nAll published, unpublished or ongoing randomised or quasi-randomised controlled trials comparing the administration of oxytocin with no intervention, or usual/standard care for the management of the third stage of labour in non-facility birth settings were considered for inclusion.\nQuasi-randomised controlled trials and randomised controlled trials published in abstract form only were eligible for inclusion but none were identified. Cross-over trials were not eligible for inclusion in this review.\nData collection and analysis\nTwo review authors independently assessed studies for eligibility, assessed risk of bias and extracted the data using an agreed data extraction form. Data were checked for accuracy.\nMain results\nWe included one cluster-randomised trial conducted in four rural districts in Ghana that randomised 28 community health officers (CHOs) (serving 2404 potentially eligible pregnant women) to the intervention group and 26 CHOs (serving 3515 potentially eligible pregnant women) to the control group. Overall, the trial had a high risk of bias. CHOs delivered the intervention in the experimental group (injection of 10 IU (international units) of oxytocin in the thigh one minute following birth using a prefilled, auto-disposable syringe). In the control group, CHOs did not provide this prophylactic injection to the women they observed. CHOs had no midwifery skills and did not in any way manage the birth. All other CHO activities (outcome measurement, data collection, and early treatment and referral when necessary) were identical across the control and oxytocin CHOs.\nAlthough only one of the nine cases of severe PPH (blood loss greater or equal to 1000 mL) occurred in the oxytocin group, the effect estimate for this outcome was very imprecise and it is uncertain whether the intervention prevents severe PPH (risk ratio (RR) 0.16, 95% confidence interval (CI) 0.02 to 1.30; 1570 women (very low-quality evidence)). Similarly, because of the lack of cases of severe maternal morbidity (e.g. uterine rupture) and maternal deaths, it was not possible to obtain effect estimates for those outcomes (both very low-quality evidence).\nOxytocin compared with the control group decreased the incidence of PPH (> 500 mL) in both our unadjusted (RR 0.48, 95% CI 0.28 to 0.81; 1569 women) and adjusted (RR 0.49, 95% CI 0.27 to 0.90; 1174 women (both low-quality evidence)) analyses. There was little or no difference between the oxytocin and control groups on the rates of transfer or referral of the mother to a healthcare facility (RR 0.72, 95% CI 0.34 to 1.56; 1586 women (low-quality evidence)), stillbirths (RR 1.27, 95% CI 0.67 to 2.40; 2006 infants (low-quality evidence)); andearly infant deaths (0 to three days) (RR 1.03, 95% CI 0.35 to 3.07; 1969 infants (low-quality evidence)). There were no cases of needle-stick injury or any other maternal major or minor adverse event or unanticipated harmful event. There were no cases of oxytocin use during labour.\nThere were no data reported for some of this review's secondary outcomes: manual removal of placenta, maternal anaemia, neonatal death within 28 days, neonatal transfer to health facility for advanced care, breastfeeding rates. Similarly, the women's or the provider's satisfaction with the intervention was not reported.\nAuthors' conclusions\nIt is uncertain if oxytocin administered by CHO in non-facility settings compared with a control group reduces the incidence of severe PPH (>1000 mL), severe maternal morbidity or maternal deaths. However, the intervention probably decreases the incidence of PPH (> 500 mL).\nThe quality of the one trial included in this review was limited because of the risk of attrition and recruitment biases related to limitations in the follow-up of pregnant women in both arms of the trials and some baseline imbalance on the size of babies at birth. Additionally, there was serious imprecision of the effect estimates for most of the primary outcomes mainly because of the size of the trial, very few or no events and CIs around both relative and absolute estimates of effect that include both appreciable benefit and appreciable harm.\nAlthough the trial presented data both for primary and secondary outcomes, it seemed to be underpowered to detect differences in the primary outcomes that are the ones more relevant for making judgments about the potential applicability of the intervention in other settings (especially severe PPH).\nTherefore, taking into account the extreme setting where the intervention was implemented, the limited role of the CHO in the trial and the lack of power for detecting effects on primary (relevant) outcomes, the applicability of the evidence found seems to be rather limited.\nFurther well-executed and adequately-powered randomised controlled trials assessing the effects of using oxytocin in pre-filled injection devices or other new delivery systems (spray-dried ultrafine formulation of oxytocin) on severe PPH are urgently needed. Likewise, other important outcomes like possible adverse events and acceptability of the intervention by mothers and other community stakeholders should also be assessed.\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": "Postpartum haemorrhage (PPH) - excessive blood loss (of more than half a litre) following a vaginal birth - is the single leading cause of maternal mortality worldwide. Most of the deaths associated with PPH occur in low-income settings where effective methods of prevention and treatment are not easily accessible."
}
] |
query-laysum
|
23771
|
[
{
"role": "user",
"content": "Abstract: Background\nExtravasation injury, a complication commonly seen in the neonatal intensive care unit, can result in scarring with cosmetic and functional sequelae. A wide variety of treatments are available, including subcutaneous irrigation with saline (with or without hyaluronidase), liposuction, use of specific antidotes, topical applications, and normal wound care with dry or wet dressings. All such treatments aim to prevent or reduce the severity of complications.\nObjectives\nPrimary objective\nTo compare the efficacy and safety of saline irrigation or saline irrigation with prior hyaluronidase infiltration versus no intervention or normal wound care for tissue healing in neonates with extravasation injury.\nSecondary objectives\nTo evaluate by subgroup analysis of controlled trials the influence of type of extravasate, timing of irrigation following extravasation, and postmenstrual age (PMA) of the neonate at the time of injury on outcomes and adverse effects.\nSpecifically, we planned to perform subgroup analysis for the primary outcome, if appropriate, by examining:\n1. time to irrigation from identified extravasation injury (< 1 hour or ≥ 1 hour);\n2. type of extravasate (parenteral nutrition fluid or other fluids or medications);\n3. amount of saline used (< 500 mL or ≥ 500 mL); and\n4. PMA at injury (< 37 completed weeks or ≥ 37 completed weeks).\nSearch methods\nWe used the standard search strategy of the Cochrane Neonatal Review Group to search the Cochrane Central Register of Controlled Trials (CENTRAL; 2017, Issue 1), MEDLINE via PubMed (1966 to 2 February 2017), Embase (1980 to 2 February 2017), and the Cumulative Index to Nursing and Allied Health Literature (CINAHL; 1982 to 2 February 2017). We also searched clinical trial databases, conference proceedings, and reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials. We used the Google Scholar search tool for reverse citations of relevant articles.\nSelection criteria\nRandomised controlled trials (RCTs) and quasi-randomised controlled trials comparing saline irrigation with or without hyaluronidase infiltration versus no intervention or normal wound care for the management of extravasation injury in neonates.\nData collection and analysis\nThree review authors independently reviewed and identified articles for possible inclusion in this review. We used the GRADE approach to assess the quality of evidence.\nMain results\nWe found no eligible studies. Our search revealed 10 case reports or case series describing successful outcomes with different interventions for this condition.\nAuthors' conclusions\nTo date, no RCTs have examined the effects of saline irrigation with or without prior hyaluronidase infiltration for management of extravasation injury in neonates. Saline irrigation is frequently reported in the literature as an intervention for management of extravasation injury in neonates. Research should focus first on evaluating the efficacy and safety of this intervention through RCTs. It will also be important for investigators to determine effect size by examining the timing of the intervention, the nature of the infusate, and severity of injury at the time of intervention.\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": "To date, no randomised controlled trials have examined the effects of saline irrigation with or without prior hyaluronidase infiltration on the management of extravasation injury in neonates. Frequent reports in the literature indicate that saline irrigation is used for the management of extravasation injury in neonates. Research should be directed first toward evaluating the efficacy and safety of this intervention through randomised controlled trials. It will also be important to determine effect size by examining the timing of the intervention, the nature of the infusate, and severity of injury at the time of intervention."
}
] |
query-laysum
|
23772
|
[
{
"role": "user",
"content": "Abstract: Background\nNecrotizing soft tissue infections (NSTIs) are severe and rapidly spreading soft tissue infections of the subcutaneous tissue, fascia, or muscle, which are mostly caused by bacteria. Associated rates of mortality and morbidity are high, with the former estimated at around 23%, and disability, sequelae, and limb loss occurring in 15% of patients. Standard management includes intravenous empiric antimicrobial therapy, early surgical debridement of necrotic tissues, intensive care support, and adjuvant therapies such as intravenous immunoglobulin (IVIG).\nObjectives\nTo assess the effects of medical and surgical treatments for necrotizing soft tissue infections (NSTIs) in adults in hospital settings.\nSearch methods\nWe searched the following databases up to April 2018: the Cochrane Skin Group Specialised Register, CENTRAL, MEDLINE, Embase, and LILACS. We also searched five trials registers, pharmaceutical company trial results databases, and the US Food and Drug Administration and the European Medicines Agency websites. We checked the reference lists of included studies and reviews for further references to relevant randomised controlled trials (RCTs).\nSelection criteria\nRCTs conducted in hospital settings, that evaluated any medical or surgical treatment for adults with NSTI were eligible for inclusion. Eligible medical treatments included 1) comparisons between different antimicrobials or with placebo; 2) adjuvant therapies such as intravenous immunoglobulin (IGIV) therapy compared with placebo; no treatment; or other adjuvant therapies. Eligible surgical treatments included surgical debridement compared with amputation, immediate versus delayed intervention, or comparisons of number of interventions.\nRCTs of hyperbaric oxygen (HBO) therapy for NSTI were ineligible because HBO is the focus of another Cochrane Review.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. The primary outcome measures were 1) mortality within 30 days, and 2) proportion of participants who experience a serious adverse event. Secondary outcomes were 1) survival time, and 2) assessment of long-term morbidity. We used GRADE to assess the quality of the evidence for each outcome.\nMain results\nWe included three trials randomising 197 participants (62% men) who had a mean age of 55 years. One trial compared two antibiotic treatments, and two trials compared adjuvant therapies with placebo. In all trials, participants concomitantly received standard interventions, such as intravenous empiric antimicrobial therapy, surgical debridement of necrotic tissues, intensive care support, and adjuvant therapies. All trials were at risk of attrition bias and one trial was not blinded.\nMoxifloxacin versus amoxicillin-clavulanate\nOne trial included 54 participants who had a NSTI; it compared a third-generation quinolone, moxifloxacin, at a dose of 400 mg given once daily, against a penicillin, amoxicillin-clavulanate, at a dose of 3 g given three times daily for at least three days, followed by 1.5 g three times daily. Duration of treatment varied from 7 to 21 days. We are uncertain of the effects of these treatments on mortality within 30 days (risk ratio (RR) 3.00, 95% confidence interval (CI) 0.39 to 23.07) and serious adverse events at 28 days (RR 0.63, 95% CI 0.30 to 1.31) because the quality of the evidence is very low.\nAB103 versus placebo\nOne trial of 43 randomised participants compared two doses, 0.5 mg/kg and 0.25 mg/kg, of an adjuvant drug, a CD28 antagonist receptor (AB103), with placebo. Treatment was given via infusion pump for 10 minutes before, after, or during surgery within six hours after the diagnosis of NSTI. We are uncertain of the effects of AB103 on mortality rate within 30 days (RR of 0.34, 95% CI 0.05 to 2.16) and serious adverse events measured at 28 days (RR 1.49, 95% CI 0.52 to 4.27) because the quality of the evidence is very low.\nIntravenous immunoglobulin (IVIG) versus placebo\nOne trial of 100 randomised participants assessed IVIG as an adjuvant drug, given at a dose of 25 g/day, compared with placebo, given for three consecutive days. There may be no clear difference between IVIG and placebo in terms of mortality within 30 days (RR 1.17, 95% CI 0.42 to 3.23) (low-certainty evidence), nor serious adverse events experienced in the intensive care unit (ICU) (RR 0.73 CI 95% 0.32 to 1.65) (low-certainty evidence).\nSerious adverse events were only described in one RCT (the IVIG versus placebo trial) and included acute kidney injury, allergic reactions, aseptic meningitis syndrome, haemolytic anaemia, thrombi, and transmissible agents.\nOnly one trial reported assessment of long-term morbidity, but the outcome was not defined in the way we prespecified in our protocol. The trial used the Short Form Health Survey (SF36). Data on survival time were provided upon request for the trials comparing amoxicillin-clavulanate versus moxifloxacin and IVIG versus placebo. However, even with data provided, it was not possible to perform survival analysis.\nAuthors' conclusions\nWe found very little evidence on the effects of medical and surgical treatments for NSTI. We cannot draw conclusions regarding the relative effects of any of the interventions on 30-day mortality or serious adverse events due to the very low quality of the evidence.\nThe quality of the evidence is limited by the very small number of trials, the small sample sizes, and the risks of bias in the included trials. It is important for future trials to clearly define their inclusion criteria, which will help with the applicability of future trial results to a real-life population.\nManagement of NSTI participants (critically-ill participants) is complex, involving multiple interventions; thus, observational studies and prospective registries might be a better foundation for future research, which should assess empiric antimicrobial therapy, as well as surgical debridement, along with the placebo-controlled comparison of adjuvant therapy. Key outcomes to assess include mortality (in the acute phase of the condition) and long-term functional outcomes, e.g. quality of life (in the chronic phase).\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": "The available evidence from three studies is not strong enough to enable us to draw definite conclusions about the effectiveness and safety of the different treatments for NSTI assessed in this review. All studies assessed number of deaths and risk of serious side effects.\nFactors affecting our confidence in the results included the following:\n- the small number of trials and participants;\n- weaknesses in the trial methodologies which affect the reliability of results; and\n- poor definition of the participants’ condition.\nWe found no evidence that assessed antimicrobial therapy (which targets a wide range of disease-causing bacteria and fungi) or surgical removal of damaged tissue.\nIn future studies, risk of death should be a key outcome in the short term (i.e. within 30 days) phase of the condition, and outcomes such as loss of work and quality of life should be assessed in the long-term phase (after 30 days)."
}
] |
query-laysum
|
23773
|
[
{
"role": "user",
"content": "Abstract: Background\nAlcohol dependence is a major public health problem that is characterised by recidivism and a host of medical and psychosocial complications. Besides psychosocial interventions, different pharmacological interventions have been or currently are under investigation through Cochrane systematic reviews.\nObjectives\nThe primary aim of the review is to assess the benefits/risks of anticonvulsants for the treatment of alcohol dependence.\nSearch methods\nWe searched the Cochrane Drugs and Alcohol Group Trials Register (October 2013), PubMed (1966 to October 2013), EMBASE (1974 to October 2013) and CINAHL (1982 to October 2013).\nSelection criteria\nRandomised controlled trials (RCTs) and controlled clinical trials (CCTs) comparing anticonvulsants alone or in association with other drugs and/or psychosocial interventions versus placebo, no treatment and other pharmacological or psychosocial interventions.\nData collection and analysis\nWe used standard methodological procedures as expected by The Cochrane Collaboration.\nMain results\nA total of 25 studies were included in the review (2641 participants). Most participants were male, with an average age of 44 years. Anticonvulsants were compared with placebo (17 studies), other medications (seven studies) and no medication (two studies). The mean duration of the trials was 17 weeks (range four to 52 weeks). The studies took place in the USA, Europe, South America, India and Thailand. Variation was reported in the characteristics of the studies, including their design and the rating instruments used. For many key outcomes, the risk of bias associated with unclear or unconcealed allocation and lack of blinding affected the quality of the evidence.\nAnticonvulsants versus placebo: For dropouts (16 studies, 1675 participants, risk ratio (RR) 0.94, 95% confidence interval (Cl) 0.74 to 1.19, moderate-quality evidence) and continuous abstinence (eight studies, 634 participants, RR 1.21, 95% Cl 95% 0.97 to 1.52, moderate-quality evidence), results showed no evidence of differences. Moderate-quality evidence suggested that anticonvulsants reduced drinks/drinking days (11 studies, 1126 participants, mean difference (MD) -1.49, 95% Cl -2.32 to -0.65) and heavy drinking (12 studies, 1129 participants, standardised mean difference (SMD) -0.35, 95% Cl -0.51 to -0.19). Moreover, withdrawal for medical reasons (12 studies, 1410 participants, RR 1.22, 95% Cl 0.58 to 2.56, moderate-quality evidence) showed no evidence of difference, but for specific adverse effects (nine studies, 1164 participants), two of 18 adverse event outcomes favoured placebo. The direction of results was confirmed by subgroup analyses for topiramate and partially for gabapentin and valproate.\nAnticonvulsants versus naltrexone: No evidence of difference was shown in dropout rates (five studies, 528 participants, RR 0.74, 95% CI 0.52 to 1.06), severe relapse rates (four studies, 427 participants, RR 0.69, 95% Cl 0.44 to 1.07) and continuous abstinence rates (five studies, 528 participants, RR 1.21, 95% Cl 0.99 to 1.49); anticonvulsants were associated with fewer heavy drinking days (three studies, 308 participants, MD -5.21, 95% Cl -8.58 to -1.83), more days to severe relapse (three studies, 244 participants, MD 11.88, 95% Cl 3.29 to 20.46) and lower withdrawal for medical reasons (three studies, 245 participants, RR 0.13, 95% Cl 0.03 to 0.58).\nAuthors' conclusions\nAt the current stage of research, randomised evidence supporting the clinical use of anticonvulsants to treat alcohol dependence is insufficient. Results are conditioned by heterogeneity and by the low number and quality of studies comparing anticonvulsants with other medications. The uncertainty associated with these results leaves to clinicians the need to balance possible benefits/risks of treatment with anticonvulsants versus other medications as supported by evidence of efficacy.\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 2013, we used electronic medical databases to find all published and unpublished medical trials that compared anticonvulsants with placebo or other interventions. We also used other sources, such as conference proceedings, likely to contain trials relevant to the review. To be included in the review, medical trials had to have a randomised design and had to include adult participants (older than 18 years of age) with a diagnosis of alcohol dependence.\nWe identified 25 medical trials involving a total of 2641 participants. 80% of participants in these trials were male; mean age was 44 years. Most studies compared anticonvulsants versus placebo (17 studies), but some researchers compared anticonvulsants versus other medications (seven studies) or no medication (two studies). The mean duration of the trials was 17 weeks (range four to 52 weeks). Half of the trials took place in the USA, the other half in Spain, Brasil, Germany, Greece, Italy, India and Thailand. The anticonvulsant included in most of the trials was topiramate; other medications were gabapentin, valproate, levetiracetam, oxcarbazepine, zonisamide, carbamazepine, pregabalin and tiagabine. Included studies used 73 different rating instruments and differed in design, quality, characteristics of patients, tested medications, services provided and treatments delivered."
}
] |
query-laysum
|
23774
|
[
{
"role": "user",
"content": "Abstract: Background\nFor people with physical, sensory and cognitive limitations due to stroke, the routine practice of oral health care (OHC) may become a challenge. Evidence-based supported oral care intervention is essential for this patient group.\nObjectives\nTo compare the effectiveness of OHC interventions with usual care or other treatment options for ensuring oral health in people after a stroke.\nSearch methods\nWe searched the Cochrane Stroke Group and Cochrane Oral Health Group trials registers, CENTRAL, MEDLINE, Embase, and six other databases in February 2019. We scanned reference lists from relevant papers and contacted authors and researchers in the field. We handsearched the reference lists of relevant articles and contacted other researchers. There were no language restrictions.\nSelection criteria\nWe included randomised controlled trials (RCTs) that evaluated one or more interventions designed to improve the cleanliness and health of the mouth, tongue and teeth in people with a stroke who received assisted OHC led by healthcare staff. We included trials with a mixed population provided we could extract the stroke-specific data. The primary outcomes were dental plaque or denture plaque. Secondary outcomes included presence of oral disease, presence of related infection and oral opportunistic pathogens related to OHC and pneumonia, stroke survivor and providers' knowledge and attitudes to OHC, and patient satisfaction and quality of life.\nData collection and analysis\nTwo review authors independently screened abstracts and full-text articles according to prespecified selection criteria, extracted data and assessed the methodological quality using the Cochrane 'Risk of bias' tool. We sought clarification from investigators when required. Where suitable statistical data were available, we combined the selected outcome data in pooled meta-analyses. We used GRADE to assess the quality of evidence for each outcome.\nMain results\nFifteen RCTs (22 randomised comparisons) involving 3631 participants with data for 1546 people with stroke met the selection criteria.\nOHC interventions compared with usual care\nSeven trials (2865 participants, with data for 903 participants with stroke, 1028 healthcare providers, 94 informal carers) investigated OHC interventions compared with usual care.\nMulti-component OHC interventions showed no evidence of a difference in the mean score (DMS) of dental plaque one month after the intervention was delivered (DMS –0.66, 95% CI –1.40 to 0.09; 2 trials, 83 participants; I2 = 83%; P = 0.08; very low-quality evidence).\nStroke survivors had less plaque on their dentures when staff had access to the multi-component OHC intervention (DMS –1.31, 95% CI –1.96 to –0.66; 1 trial, 38 participants; P < 0.0001; low-quality evidence).\nThere was no evidence of a difference in gingivitis (DMS –0.60, 95% CI –1.66 to 0.45; 2 trials, 83 participants; I2 = 93%; P = 0.26: very low-quality evidence) or denture-induced stomatitis (DMS –0.33, 95% CI –0.92 to 0.26; 1 trial, 38 participants; P = 0.69; low-quality evidence) among participants receiving the multi-component OHC protocol compared with usual care one month after the intervention. There was no difference in the incidence of pneumonia in participants receiving a multi-component OHC intervention (99 participants; 5 incidents of pneumonia) compared with those receiving usual care (105 participants; 1 incident of pneumonia) (OR 4.17, CI 95% 0.82 to 21.11; 1 trial, 204 participants; P = 0.08; low-quality evidence).\nOHC training for stroke survivors and healthcare providers significantly improved their OHC knowledge at one month after training (SMD 0.70, 95% CI 0.06 to 1.35; 3 trials, 728 participants; I2 = 94%; P = 0.03; very low-quality evidence). Pooled data one month after training also showed evidence of a difference between stroke survivor and providers' oral health attitudes (SMD 0.28, 95% CI 0.01 to 0.54; 3 trials, 728 participants; I2 = 65%; P = 0.06; very low-quality evidence).\nOHC interventions compared with placebo\nThree trials (394 participants, with data for 271 participants with stroke) compared an OHC intervention with placebo. There were no data for primary outcomes. There was no evidence of a difference in the incidence of pneumonia in participants receiving an OHC intervention compared with placebo (OR 0.39, CI 95% 0.14 to 1.09; 2 trials, 242 participants; I2 = 42%; P = 0.07; low-quality evidence). However, decontamination gel reduced the incidence of pneumonia among the intervention group compared with placebo gel group (OR 0.20, 95% CI 0.05 to 0.84; 1 trial, 203 participants; P = 0.028). There was no difference in the incidence of pneumonia in participants treated with povidone-iodine compared with a placebo (OR 0.81, 95% CI 0.18 to 3.51; 1 trial, 39 participants; P = 0.77).\nOne OHC intervention compared with another OHC intervention\nTwelve trials (372 participants with stroke) compared one OHC intervention with another OHC intervention. There was no difference in dental plaque scores between those participants that received an enhanced multi-component OHC intervention compared with conventional OHC interventions at three months (MD –0.04, 95% CI –0.33 to 0.25; 1 trial, 61 participants; P = 0.78; low-quality evidence). There were no data for denture plaque.\nAuthors' conclusions\nWe found low- to very low-quality evidence suggesting that OHC interventions can improve the cleanliness of patient's dentures and stroke survivor and providers' knowledge and attitudes. There is limited low-quality evidence that selective decontamination gel may be more beneficial than placebo at reducing the incidence of pneumonia. Improvements in the cleanliness of a patient's own teeth was limited. We judged the quality of the evidence included within meta-analyses to be low or very low quality, and this limits our confidence in the results. We still lack high-quality evidence of the optimal approach to providing OHC to people 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": "The evidence is current to February 2019."
}
] |
query-laysum
|
23775
|
[
{
"role": "user",
"content": "Abstract: Background\nStroke is caused by the interruption of blood flow to the brain (ischemic stroke) or the rupture of blood vessels within the brain (hemorrhagic stroke) and may lead to changes in perception, cognition, mood, speech, health-related quality of life, and function, such as difficulty walking and using the arm. Activity limitations (decreased function) of the upper extremity are a common finding for individuals living with stroke. Mental practice (MP) is a training method that uses cognitive rehearsal of activities to improve performance of those activities.\nObjectives\nTo determine whether MP improves outcomes of upper extremity rehabilitation for individuals living with the effects of stroke.\nIn particular, we sought to (1) determine the effects of MP on upper extremity activity, upper extremity impairment, activities of daily living, health-related quality of life, economic costs, and adverse effects; and (2) explore whether effects differed according to (a) the time post stroke at which MP was delivered, (b) the dose of MP provided, or (c) the type of comparison performed.\nSearch methods\nWe last searched the Cochrane Stroke Group Trials Register on September 17, 2019. On September 3, 2019, we searched the Cochrane Central Register of Controlled Trials (the Cochrane Library), MEDLINE, Embase, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycINFO, Scopus, Web of Science, the Physiotherapy Evidence Database (PEDro), and REHABDATA. On October 2, 2019, we searched ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform. We reviewed the reference lists of included studies.\nSelection criteria\nWe included randomized controlled trials (RCTs) of adult participants with stroke who had deficits in upper extremity function (called upper extremity activity).\nData collection and analysis\nTwo review authors screened titles and abstracts of the citations produced by the literature search and excluded obviously irrelevant studies. We obtained the full text of all remaining studies, and both review authors then independently selected trials for inclusion. We combined studies when the review produced a minimum of two trials employing a particular intervention strategy and a common outcome. We considered the primary outcome to be the ability of the arm to be used for appropriate tasks, called upper extremity activity. Secondary outcomes included upper extremity impairment (such as quality of movement, range of motion, tone, presence of synergistic movement), activities of daily living (ADLs), health-related quality of life (HRQL), economic costs, and adverse events. We assessed risk of bias in the included studies and applied GRADE to assess the certainty of the evidence. We completed subgroup analyses for time since stroke, dosage of MP, type of comparison, and type of arm activity outcome measure.\nMain results\nWe included 25 studies involving 676 participants from nine countries. For the comparison of MP in addition to other treatment versus the other treatment, MP in combination with other treatment appears more effective in improving upper extremity activity than the other treatment without MP (standardized mean difference [SMD] 0.66, 95% confidence interval [CI] 0.39 to 0.94; I² = 39%; 15 studies; 397 participants); the GRADE certainty of evidence score was moderate based on risk of bias for the upper extremity activity outcome. For upper extremity impairment, results were as follows: SMD 0.59, 95% CI 0.30 to 0.87; I² = 43%; 15 studies; 397 participants, with a GRADE score of moderate, based on risk of bias. For ADLs, results were as follows: SMD 0.08, 95% CI -0.24 to 0.39; I² = 0%; 4 studies; 157 participants; the GRADE score was low due to risk of bias and small sample size. For the comparison of MP versus conventional treatment, the only outcome with available data to combine (3 studies; 50 participants) was upper extremity impairment (SMD 0.34, 95% CI -0.33 to 1.00; I² = 21%); GRADE for the impairment outcome in this comparison was low due to risk of bias and small sample size. Subgroup analyses of time post stroke, dosage of MP, or comparison type for the MP in combination with other rehabilitation treatment versus the other treatment comparison showed no differences. The secondary outcome of health-related quality of life was reported in only one study, and no study noted the outcomes of economic costs and adverse events.\nAuthors' conclusions\nModerate-certainty evidence shows that MP in addition to other treatment versus the other treatment appears to be beneficial in improving upper extremity activity. Moderate-certainty evidence also shows that MP in addition to other treatment versus the other treatment appears to be beneficial in improving upper extremity impairment after stroke. Low-certainty evidence suggests that ADLs may not be improved with MP in addition to other treatment versus the other treatment. Low-certainty evidence also suggests that MP versus conventional treatment may not improve upper extremity impairment. Further study is required to evaluate effects of MP on time post stroke, the volume of MP required to affect outcomes, and whether improvement is maintained over the long term.\n\nGiven the provided abstract, please respond to the following query: \"Certainty of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "For mental practice added to other physical rehabilitation treatment compared to use of the other rehabilitation treatment alone, the certainty of evidence was moderate for arm function and arm movement outcomes based on some challenges in study design. The certainty of evidence was low for the activities of daily living outcome based on study design and the small number of participants included. For the mental practice compared to conventional treatment comparison, the certainty of evidence for the arm movement outcome was determined to be low for the same reasons."
}
] |
query-laysum
|
23776
|
[
{
"role": "user",
"content": "Abstract: Background\nPeroxisome proliferator-activated receptor gamma (PPAR-γ) agonists are insulin-sensitising drugs used for the treatment of insulin resistance. In addition to lowering glucose in diabetes, these drugs may also protect against hyperlipidaemia and arteriosclerosis, which are risk factors for stroke. This is an update of a review first published in January 2014 and subsequently updated in December 2017 and October 2019.\nObjectives\nTo assess the efficacy and safety of PPAR-γ agonists in the secondary prevention of stroke and related vascular events for people with stroke or transient ischaemic attack (TIA).\nSearch methods\nWe searched the Cochrane Stroke Group Trials Register (1 January 2022), the Cochrane Central Register of Controlled Trials (CENTRAL; 2021, Issue 12), MEDLINE (1949 to 1 January 2022), Embase (1980 to 1 January 2022), CINAHL (1982 to 1 January 2022), AMED (1985 to 1 January 2022), and 11 Chinese databases (1 January 2022). In an effort to identify further published, unpublished, and ongoing trials, we searched ongoing trials registers, reference lists, and relevant conference proceedings, and contacted authors and pharmaceutical companies. We did not impose any language restrictions.\nSelection criteria\nWe included randomised controlled trials (RCTs) evaluating PPAR-γ agonists versus placebo for the secondary prevention of stroke and related vascular events in people with stroke or TIA, with the outcomes of recurrent stroke, vascular events, and adverse events.\nData collection and analysis\nTwo review authors independently screened the titles and abstracts of identified records, selected studies for inclusion, extracted eligible data, cross-checked the data for accuracy, and assessed methodological quality and risk of bias. We evaluated the certainty of evidence for each outcome using the GRADE approach.\nMain results\nWe identified five RCTs with 5039 participants; two studies had a low risk of bias for all domains. Four studies evaluated the drug pioglitazone, and one study evaluated rosiglitazone. The participants in different studies were heterogeneous.\nRecurrent stroke\nThree studies evaluated the number of participants with recurrent stroke (4979 participants, a single study contributing 3876 of these). Peroxisome proliferator-activated receptor gamma agonists probably reduce the recurrence of stroke compared with placebo (risk ratio (RR) 0.66, 95% confidence interval (CI) 0.44 to 0.99; moderate-certainty evidence).\nAdverse events\nEvidence that adverse events occurred more frequently in participants treated with PPAR-γ agonists when compared with placebo was uncertain due to wide confidence intervals and high levels of statistical heterogeneity: risk difference 10%, 95% CI -8% to 28%; low-certainty evidence).\nData were available on additional composite outcomes reflecting serious vascular events (all-cause death and other major vascular events; all-cause mortality, non-fatal myocardial infarction or non-fatal stroke) from one study in 984 people. This study provided low-certainty evidence that PPAR-γ agonists led to fewer events (data not meta-analysed).\nVascular events\nPeroxisome proliferator-activated receptor gamma agonists given over a mean duration of 34.5 months in a single trial of 984 participants may reduce serious vascular events expressed as a composite outcome of total events of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke (RR 0.73, 95% CI 0.54 to 0.99; low-certainty evidence).\nOther outcomes\nOne study in 20 people measured insulin sensitivity, and one study in 40 people measured the ubiquitin-proteasome activity in carotid plaques. Our confidence in the improvements observed with PPAR-γ agonists were limited by small sample sizes and risk of bias. None of the studies reported the number of participants with disability due to vascular events or improvement in quality of life.\nAuthors' conclusions\nPeroxisome proliferator-activated receptor gamma agonists probably reduce recurrent stroke and total events of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke, and may improve insulin sensitivity and the stabilisation of carotid plaques. Their effects on adverse events are uncertain. Our conclusions should be interpreted with caution considering the small number and the quality of the included studies. Further well-designed, double-blind RCTs with large samples are required to assess the efficacy and safety of PPAR-γ agonists in the secondary prevention of stroke and related vascular events in people with stroke or TIA.\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": "Peroxisome proliferator-activated receptor gamma agonists are drugs that improve the way insulin works in the human body. They are widely used in the treatment of adult type diabetes (type 2 diabetes). Moreover, they may also protect against the presence of excess fats in the blood and disease of the artery walls, which are both risk factors for stroke."
}
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query-laysum
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23777
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[
{
"role": "user",
"content": "Abstract: Background\nPhysical activity, a balanced diet, avoidance of tobacco exposure, and limited alcohol consumption may reduce morbidity and mortality from non-communicable diseases (NCDs). Mass media interventions are commonly used to encourage healthier behaviours in population groups. It is unclear whether targeted mass media interventions for ethnic minority groups are more or less effective in changing behaviours than those developed for the general population.\nObjectives\nTo determine the effects of mass media interventions targeting adult ethnic minorities with messages about physical activity, dietary patterns, tobacco use or alcohol consumption to reduce the risk of NCDs.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, ERIC, SweMed+, and ISI Web of Science until August 2016. We also searched for grey literature in OpenGrey, Grey Literature Report, Eldis, and two relevant websites until October 2016. The searches were not restricted by language.\nSelection criteria\nWe searched for individual and cluster-randomised controlled trials, controlled before-and-after studies (CBA) and interrupted time series studies (ITS). Relevant interventions promoted healthier behaviours related to physical activity, dietary patterns, tobacco use or alcohol consumption; were disseminated via mass media channels; and targeted ethnic minority groups. The population of interest comprised adults (≥ 18 years) from ethnic minority groups in the focal countries. Primary outcomes included indicators of behavioural change, self-reported behavioural change and knowledge and attitudes towards change. Secondary outcomes were the use of health promotion services and costs related to the project.\nData collection and analysis\nTwo authors independently reviewed the references to identify studies for inclusion. We extracted data and assessed the risk of bias in all included studies. We did not pool the results due to heterogeneity in comparisons made, outcomes, and study designs. We describe the results narratively and present them in 'Summary of findings' tables. We judged the quality of the evidence using the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) methodology.\nMain results\nSix studies met the inclusion criteria, including three RCTs, two cluster-RCTs and one ITS. All were conducted in the USA and comprised targeted mass media interventions for people of African descent (four studies), Spanish-language dominant Latino immigrants (one study), and Chinese immigrants (one study). The two latter studies offered the intervention in the participants’ first language (Spanish, Cantonese, or Mandarin). Three interventions targeted towards women only, one pregnant women specifically. We judged all studies as being at unclear risk of bias in at least one domain and three studies as being at high risk of bias in at least one domain.\nWe categorised the findings into three comparisons. The first comparison examined mass media interventions targeted at ethnic minorities versus an equivalent mass media intervention intended for the general population. The one study in this category (255 participants of African decent) found little or no difference in effect on self-reported behavioural change for smoking and only small differences in attitudes to change between participants who were given a culturally specific smoking cessation booklet versus a booklet intended for the general population. We are uncertain about the effect estimates, as assessed by the GRADE methodology (very low quality evidence of effect). No study provided data for indicators of behavioural change or adverse effects.\nThe second comparison assessed targeted mass media interventions versus no intervention. One study (154 participants of African decent) reported effects for our primary outcomes. Participants in the intervention group had access to 12 one-hour live programmes on cable TV and received print material over three months regarding nutrition and physical activity to improve health and weight control. Change in body mass index (BMI) was comparable between groups 12 months after the baseline (low quality evidence). Scores on a food habits (fat behaviours) and total leisure activity scores changed favourably for the intervention group (very low quality evidence). Two other studies exposed entire populations in geographical areas to radio advertisements targeted towards African American communities. Authors presented effects on two of our secondary outcomes, use of health promotion services and project costs. The campaign message was to call smoking quit lines. The outcome was the number of calls received. After one year, one study reported 18 calls per estimated 10,000 targeted smokers from the intervention communities (estimated target population 310,500 persons), compared to 0.2 calls per estimated 10,000 targeted smokers from the control communities (estimated target population 331,400 persons) (moderate quality evidence). The ITS study also reported an increase in the number of calls from the target population during campaigns (low quality evidence). The proportion of African American callers increased in both studies (low to very low quality evidence). No study provided data on knowledge and attitudes for change and adverse effects. Information on costs were sparse.\nThe third comparison assessed targeted mass media interventions versus a mass media intervention plus personalised content. Findings are based on three studies (1361 participants). Participants in these comparison groups received personal feedback. Two of the studies recorded weight changes over time. Neither found significant differences between the groups (low quality evidence). Evidence on behavioural changes, and knowledge and attitudes typically found some effects in favour of receiving personalised content or no significant differences between groups (very low quality evidence). No study provided data on adverse effects. Information on costs were sparse.\nAuthors' conclusions\nThe available evidence is inadequate for understanding whether mass media interventions targeted toward ethnic minority populations are more effective in changing health behaviours than mass media interventions intended for the population at large. When compared to no intervention, a targeted mass media intervention may increase the number of calls to smoking quit line, but the effect on health behaviours is unclear. These studies could not distinguish the impact of different components, for instance the effect of hearing a message regarding behavioural change, the cultural adaptation to the ethnic minority group, or increase reach to the target group through more appropriate mass media channels. New studies should explore targeted interventions for ethnic minorities with a first language other than the dominant language in their resident country, as well as directly compare targeted versus general population mass media interventions.\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": "Our confidence in the evidence of effect on all main outcomes is low to very low. This means that the true effect may be different or substantially different from the results presented in this review. We have moderate confidence in the estimated increase in the number of calls to smoking quit lines."
}
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query-laysum
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23778
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[
{
"role": "user",
"content": "Abstract: Background\nPanic disorder is characterised by the presence of recurrent unexpected panic attacks, discrete periods of fear or anxiety that have a rapid onset and include symptoms such as racing heart, chest pain, sweating and shaking. Panic disorder is common in the general population, with a lifetime prevalence of 1% to 4%. A previous Cochrane meta-analysis suggested that psychological therapy (either alone or combined with pharmacotherapy) can be chosen as a first-line treatment for panic disorder with or without agoraphobia. However, it is not yet clear whether certain psychological therapies can be considered superior to others. In order to answer this question, in this review we performed a network meta-analysis (NMA), in which we compared eight different forms of psychological therapy and three forms of a control condition.\nObjectives\nTo assess the comparative efficacy and acceptability of different psychological therapies and different control conditions for panic disorder, with or without agoraphobia, in adults.\nSearch methods\nWe conducted the main searches in the CCDANCTR electronic databases (studies and references registers), all years to 16 March 2015. We conducted complementary searches in PubMed and trials registries. Supplementary searches included reference lists of included studies, citation indexes, personal communication to the authors of all included studies and grey literature searches in OpenSIGLE. We applied no restrictions on date, language or publication status.\nSelection criteria\nWe included all relevant randomised controlled trials (RCTs) focusing on adults with a formal diagnosis of panic disorder with or without agoraphobia. We considered the following psychological therapies: psychoeducation (PE), supportive psychotherapy (SP), physiological therapies (PT), behaviour therapy (BT), cognitive therapy (CT), cognitive behaviour therapy (CBT), third-wave CBT (3W) and psychodynamic therapies (PD). We included both individual and group formats. Therapies had to be administered face-to-face. The comparator interventions considered for this review were: no treatment (NT), wait list (WL) and attention/psychological placebo (APP). For this review we considered four short-term (ST) outcomes (ST-remission, ST-response, ST-dropouts, ST-improvement on a continuous scale) and one long-term (LT) outcome (LT-remission/response).\nData collection and analysis\nAs a first step, we conducted a systematic search of all relevant papers according to the inclusion criteria. For each outcome, we then constructed a treatment network in order to clarify the extent to which each type of therapy and each comparison had been investigated in the available literature. Then, for each available comparison, we conducted a random-effects meta-analysis. Subsequently, we performed a network meta-analysis in order to synthesise the available direct evidence with indirect evidence, and to obtain an overall effect size estimate for each possible pair of therapies in the network. Finally, we calculated a probabilistic ranking of the different psychological therapies and control conditions for each outcome.\nMain results\nWe identified 1432 references; after screening, we included 60 studies in the final qualitative analyses. Among these, 54 (including 3021 patients) were also included in the quantitative analyses. With respect to the analyses for the first of our primary outcomes, (short-term remission), the most studied of the included psychological therapies was CBT (32 studies), followed by BT (12 studies), PT (10 studies), CT (three studies), SP (three studies) and PD (two studies).\nThe quality of the evidence for the entire network was found to be low for all outcomes. The quality of the evidence for CBT vs NT, CBT vs SP and CBT vs PD was low to very low, depending on the outcome. The majority of the included studies were at unclear risk of bias with regard to the randomisation process. We found almost half of the included studies to be at high risk of attrition bias and detection bias. We also found selective outcome reporting bias to be present and we strongly suspected publication bias. Finally, we found almost half of the included studies to be at high risk of researcher allegiance bias.\nOverall the networks appeared to be well connected, but were generally underpowered to detect any important disagreement between direct and indirect evidence. The results showed the superiority of psychological therapies over the WL condition, although this finding was amplified by evident small study effects (SSE). The NMAs for ST-remission, ST-response and ST-improvement on a continuous scale showed well-replicated evidence in favour of CBT, as well as some sparse but relevant evidence in favour of PD and SP, over other therapies. In terms of ST-dropouts, PD and 3W showed better tolerability over other psychological therapies in the short term. In the long term, CBT and PD showed the highest level of remission/response, suggesting that the effects of these two treatments may be more stable with respect to other psychological therapies. However, all the mentioned differences among active treatments must be interpreted while taking into account that in most cases the effect sizes were small and/or results were imprecise.\nAuthors' conclusions\nThere is no high-quality, unequivocal evidence to support one psychological therapy over the others for the treatment of panic disorder with or without agoraphobia in adults. However, the results show that CBT - the most extensively studied among the included psychological therapies - was often superior to other therapies, although the effect size was small and the level of precision was often insufficient or clinically irrelevant. In the only two studies available that explored PD, this treatment showed promising results, although further research is needed in order to better explore the relative efficacy of PD with respect to CBT. Furthermore, PD appeared to be the best tolerated (in terms of ST-dropouts) among psychological treatments. Unexpectedly, we found some evidence in support of the possible viability of non-specific supportive psychotherapy for the treatment of panic disorder; however, the results concerning SP should be interpreted cautiously because of the sparsity of evidence regarding this treatment and, as in the case of PD, further research is needed to explore this issue. Behaviour therapy did not appear to be a valid alternative to CBT as a first-line treatment for patients with panic disorder with or without agoraphobia.\n\nGiven the provided abstract, please respond to the following query: \"What does the evidence from the review tell us?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The results of the review show that in general talking therapies are more effective than no treatment. There was no strong evidence to support one talking therapy over the others for the treatment of panic disorder with or without agoraphobia in adults. However, there was some low-quality evidence in favour of cognitive behaviour therapy (CBT), psychodynamic therapy and supportive psychotherapy over other talking therapies for short-term remission and short-term reduction in symptoms. The results concerning supportive psychotherapy should, however, be treated with caution because of the small amount of evidence available about this treatment. On the other hand, beyond the evidence regarding its efficacy, psychodynamic therapy also showed promising results in terms of tolerability: as a way of assessing how well people tolerated the talking therapies, we assessed short-term dropout rates. We found that there were fewer dropouts in psychodynamic therapy and third-wave CBT, suggesting that people tolerate these therapies better than other therapies."
}
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query-laysum
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23779
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[
{
"role": "user",
"content": "Abstract: Background\nDespite evidence of the long-term implications of unrelieved pain during infancy, it is evident that infant pain is still under-managed and unmanaged. Inadequately managed pain in infancy, a period of exponential development, can have implications across the lifespan. Therefore, a comprehensive and systematic review of pain management strategies is integral to appropriate infant pain management. This is an update of a previously published review update in the Cochrane Database of Systematic Reviews (2015, Issue 12) of the same title.\nObjectives\nTo assess the efficacy and adverse events of non-pharmacological interventions for infant and child (aged up to three years) acute pain, excluding kangaroo care, sucrose, breastfeeding/breast milk, and music.\nSearch methods\nFor this update, we searched CENTRAL, MEDLINE-Ovid platform, EMBASE-OVID platform, PsycINFO-OVID platform, CINAHL-EBSCO platform and trial registration websites (ClinicalTrials.gov; International Clinical Trials Registry Platform) (March 2015 to October 2020). An update search was completed in July 2022, but studies identified at this point were added to 'Awaiting classification' for a future update.\nWe also searched reference lists and contacted researchers via electronic list-serves.\nWe incorporated 76 new studies into the review.\nSelection criteria\nParticipants included infants from birth to three years in randomised controlled trials (RCTs) or cross-over RCTs that had a no-treatment control comparison. Studies were eligible for inclusion in the analysis if they compared a non-pharmacological pain management strategy to a no-treatment control group (15 different strategies). In addition, we also analysed studies when the unique effect of adding a non-pharmacological pain management strategy onto another pain management strategy could be assessed (i.e. additive effects on a sweet solution, non-nutritive sucking, or swaddling) (three strategies). The eligible control groups for these additive studies were sweet solution only, non-nutritive sucking only, or swaddling only, respectively. Finally, we qualitatively described six interventions that met the eligibility criteria for inclusion in the review, but not in the analysis.\nData collection and analysis\nThe outcomes assessed in the review were pain response (reactivity and regulation) and adverse events. The level of certainty in the evidence and risk of bias were based on the Cochrane risk of bias tool and the GRADE approach. We analysed the standardised mean difference (SMD) using the generic inverse variance method to determine effect sizes.\nMain results\nWe included total of 138 studies (11,058 participants), which includes an additional 76 new studies for this update. Of these 138 studies, we analysed 115 (9048 participants) and described 23 (2010 participants) qualitatively. We described qualitatively studies that could not be meta-analysed due to being the only studies in their category or statistical reporting issues. We report the results of the 138 included studies here. An SMD effect size of 0.2 represents a small effect, 0.5 a moderate effect, and 0.8 a large effect. The thresholds for the I2 interpretation were established as follows: not important (0% to 40%); moderate heterogeneity (30% to 60%); substantial heterogeneity (50% to 90%); considerable heterogeneity (75% to 100%). The most commonly studied acute procedures were heel sticks (63 studies) and needlestick procedures for the purposes of vaccines/vitamins (35 studies). We judged most studies to have high risk of bias (103 out of 138), with the most common methodological concerns relating to blinding of personnel and outcome assessors. Pain responses were examined during two separate pain phases: pain reactivity (within the first 30 seconds after the acutely painful stimulus) and immediate pain regulation (after the first 30 seconds following the acutely painful stimulus). We report below the strategies with the strongest evidence base for each age group.\nIn preterm born neonates, non-nutritive sucking may reduce pain reactivity (SMD -0.57, 95% confidence interval (CI) -1.03 to -0.11, moderate effect; I2 = 93%, considerable heterogeneity) and improve immediate pain regulation (SMD -0.61, 95% CI -0.95 to -0.27, moderate effect; I2 = 81%, considerable heterogeneity), based on very low-certainty evidence. Facilitated tucking may also reduce pain reactivity (SMD -1.01, 95% CI -1.44 to -0.58, large effect; I2 = 93%, considerable heterogeneity) and improve immediate pain regulation (SMD -0.59, 95% CI -0.92 to -0.26, moderate effect; I2 = 87%, considerable heterogeneity); however, this is also based on very low-certainty evidence. While swaddling likely does not reduce pain reactivity in preterm neonates (SMD -0.60, 95% CI -1.23 to 0.04, no effect; I2 = 91%, considerable heterogeneity), it has been shown to possibly improve immediate pain regulation (SMD -1.21, 95% CI -2.05 to -0.38, large effect; I2 = 89%, considerable heterogeneity), based on very low-certainty evidence.\nIn full-term born neonates, non-nutritive sucking may reduce pain reactivity (SMD -1.13, 95% CI -1.57 to -0.68, large effect; I2 = 82%, considerable heterogeneity) and improve immediate pain regulation (SMD -1.49, 95% CI -2.20 to -0.78, large effect; I2 = 92%, considerable heterogeneity), based on very low-certainty evidence.\nIn full-term born older infants, structured parent involvement was the intervention most studied. Results showed that this intervention has little to no effect in reducing pain reactivity (SMD -0.18, 95% CI -0.40 to 0.03, no effect; I2 = 46%, moderate heterogeneity) or improving immediate pain regulation (SMD -0.09, 95% CI -0.40 to 0.21, no effect; I2 = 74%, substantial heterogeneity), based on low- to moderate-certainty evidence.\nOf these five interventions most studied, only two studies observed adverse events, specifically vomiting (one preterm neonate) and desaturation (one full-term neonate hospitalised in the NICU) following the non-nutritive sucking intervention. The presence of considerable heterogeneity limited our confidence in the findings for certain analyses, as did the preponderance of evidence of very low to low certainty based on GRADE judgements.\nAuthors' conclusions\nOverall, non-nutritive sucking, facilitated tucking, and swaddling may reduce pain behaviours in preterm born neonates. Non-nutritive sucking may also reduce pain behaviours in full-term neonates. No interventions based on a substantial body of evidence showed promise in reducing pain behaviours in older infants. Most analyses were based on very low- or low-certainty grades of evidence and none were based on high-certainty evidence. Therefore, the lack of confidence in the evidence would require further research before we could draw a definitive conclusion.\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": "Non-nutritive sucking (an object, such as pacifier, being placed in an infant's mouth to stimulate sucking behaviours), facilitated tucking (containing the infant using a care-giver's hands on both head and lower limbs to maintain a 'folded-in' position), and swaddling (wrapping the infant tightly in a blanket to prevent excessive limb movement) are among the most promising strategies that may reduce pain behaviours in preterm newborns. Non-nutritive sucking may reduce pain behaviours in full-term newborns. None of the strategies analysed reduced pain behaviours in older infants with sufficient evidence. Structured parent involvement (parents instructed on using strategies, such as shushing, rocking, tickling, or distraction, without being given any materials to aid them) did have a more substantial evidence base but did not have an effect on reducing pain behaviours."
}
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query-laysum
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23780
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[
{
"role": "user",
"content": "Abstract: Background\nBreathing exercises have been widely used worldwide as a non-pharmacological therapy to treat people with asthma. Breathing exercises aim to control the symptoms of asthma and can be performed as the Papworth Method, the Buteyko breathing technique, yogic breathing, deep diaphragmatic breathing or any other similar intervention that manipulates the breathing pattern. The training of breathing usually focuses on tidal and minute volume and encourages relaxation, exercise at home, the modification of breathing pattern, nasal breathing, holding of breath, lower rib cage and abdominal breathing.\nObjectives\nTo evaluate the evidence for the efficacy of breathing exercises in the management of people with asthma.\nSearch methods\nTo identify relevant studies we searched The Cochrane Library, MEDLINE, Embase, PsycINFO, CINAHL and AMED and performed handsearching of respiratory journals and meeting abstracts. We also consulted trials registers and reference lists of included articles.\nThe most recent literature search was on 4 April 2019.\nSelection criteria\nWe included randomised controlled trials of breathing exercises in adults with asthma compared with a control group receiving asthma education or, alternatively, with no active control group.\nData collection and analysis\nTwo review authors independently assessed study quality and extracted data. We used Review Manager 5 software for data analysis based on the random-effects model. We expressed continuous outcomes as mean differences (MDs) with confidence intervals (CIs) of 95%. We assessed heterogeneity by inspecting the forest plots. We applied the Chi2 test, with a P value of 0.10 indicating statistical significance, and the I2 statistic, with a value greater than 50% representing a substantial level of heterogeneity. The primary outcome was quality of life.\nMain results\nWe included nine new studies (1910 participants) in this update, resulting in a total of 22 studies involving 2880 participants in the review. Fourteen studies used Yoga as the intervention, four studies involved breathing retraining, one the Buteyko method, one the Buteyko method and pranayama, one the Papworth method and one deep diaphragmatic breathing. The studies were different from one another in terms of type of breathing exercise performed, number of participants enrolled, number of sessions completed, period of follow-up, outcomes reported and statistical presentation of data. Asthma severity in participants from the included studies ranged from mild to moderate, and the samples consisted solely of outpatients. Twenty studies compared breathing exercise with inactive control, and two with asthma education control groups. Meta-analysis was possible for the primary outcome quality of life and the secondary outcomes asthma symptoms, hyperventilation symptoms, and some lung function variables. Assessment of risk of bias was impaired by incomplete reporting of methodological aspects of most of the included studies. We did not include adverse effects as an outcome in the review.\nBreathing exercises versus inactive control\nFor quality of life, measured by the Asthma Quality of Life Questionnaire (AQLQ), meta-analysis showed improvement favouring the breathing exercises group at three months (MD 0.42, 95% CI 0.17 to 0.68; 4 studies, 974 participants; moderate-certainty evidence), and at six months the OR was 1.34 for the proportion of people with at least 0.5 unit improvement in AQLQ, (95% CI 0.97 to 1.86; 1 study, 655 participants). For asthma symptoms, measured by the Asthma Control Questionnaire (ACQ), meta-analysis at up to three months was inconclusive, MD of -0.15 units (95% CI −2.32 to 2.02; 1 study, 115 participants; low-certainty evidence), and was similar over six months (MD −0.08 units, 95% CI −0.22 to 0.07; 1 study, 449 participants). For hyperventilation symptoms, measured by the Nijmegen Questionnaire (from four to six months), meta-analysis showed less symptoms with breathing exercises (MD −3.22, 95% CI −6.31 to −0.13; 2 studies, 118 participants; moderate-certainty evidence), but this was not shown at six months (MD 0.63, 95% CI −0.90 to 2.17; 2 studies, 521 participants). Meta-analyses for forced expiratory volume in 1 second (FEV1) measured at up to three months was inconclusive, MD −0.10 L, (95% CI −0.32 to 0.12; 4 studies, 252 participants; very low-certainty evidence). However, for FEV1 % of predicted, an improvement was observed in favour of the breathing exercise group (MD 6.88%, 95% CI 5.03 to 8.73; five studies, 618 participants).\nBreathing exercises versus asthma education\nFor quality of life, one study measuring AQLQ was inconclusive up to three months (MD 0.04, 95% CI -0.26 to 0.34; 1 study, 183 participants). When assessed from four to six months, the results favoured breathing exercises (MD 0.38, 95% CI 0.08 to 0.68; 1 study, 183 participants). Hyperventilation symptoms measured by the Nijmegen Questionnaire were inconclusive up to three months (MD −1.24, 95% CI −3.23 to 0.75; 1 study, 183 participants), but favoured breathing exercises from four to six months (MD −3.16, 95% CI −5.35 to −0.97; 1 study, 183 participants).\nAuthors' conclusions\nBreathing exercises may have some positive effects on quality of life, hyperventilation symptoms, and lung function. Due to some methodological differences among included studies and studies with poor methodology, the quality of evidence for the measured outcomes ranged from moderate to very low certainty according to GRADE criteria. In addition, further studies including full descriptions of treatment methods and outcome measurements 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": "Asthma is a lung disease. Asthma works in two ways. It that causes the airways to become inflamed (the body's response to injury and infection) and it causes the small tubes of the airways to tighten (called airway obstruction). The tightening of the tubes can happen in response to asthma triggers, such as animal fur or feathers, dust or pollen.\nAsthma is very common worldwide and is a major public health problem due to the high healthcare costs associated with hospitalisation and medication. Breathing exercises have been used to treat people with asthma as a way of controlling the symptoms of asthma without medication. People use various breathing techniques to change their breathing pattern."
}
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query-laysum
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23781
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[
{
"role": "user",
"content": "Abstract: Background\nNicotine replacement therapy (NRT) aims to temporarily replace much of the nicotine from cigarettes to reduce motivation to smoke and nicotine withdrawal symptoms, thus easing the transition from cigarette smoking to complete abstinence.\nObjectives\nTo determine the effectiveness and safety of nicotine replacement therapy (NRT), including gum, transdermal patch, intranasal spray and inhaled and oral preparations, for achieving long-term smoking cessation, compared to placebo or 'no NRT' interventions.\nSearch methods\nWe searched the Cochrane Tobacco Addiction Group trials register for papers mentioning 'NRT' or any type of nicotine replacement therapy in the title, abstract or keywords. Date of most recent search is July 2017.\nSelection criteria\nRandomized trials in people motivated to quit which compared NRT to placebo or to no treatment. We excluded trials that did not report cessation rates, and those with follow-up of less than six months. We recorded adverse events from included and excluded studies that compared NRT with placebo. Studies comparing different types, durations, and doses of NRT, and studies comparing NRT to other pharmacotherapies, are covered in separate reviews.\nData collection and analysis\nScreening, data extraction and 'Risk of bias' assessment followed standard Cochrane methods. The main outcome measure was abstinence from smoking after at least six months of follow-up. We used the most rigorous definition of abstinence for each trial, and biochemically validated rates if available. We calculated the risk ratio (RR) for each study. Where appropriate, we performed meta-analysis using a Mantel-Haenszel fixed-effect model.\nMain results\nWe identified 136 studies; 133 with 64,640 participants contributed to the primary comparison between any type of NRT and a placebo or non-NRT control group. The majority of studies were conducted in adults and had similar numbers of men and women. People enrolled in the studies typically smoked at least 15 cigarettes a day at the start of the studies. We judged the evidence to be of high quality; we judged most studies to be at high or unclear risk of bias but restricting the analysis to only those studies at low risk of bias did not significantly alter the result. The RR of abstinence for any form of NRT relative to control was 1.55 (95% confidence interval (CI) 1.49 to 1.61). The pooled RRs for each type were 1.49 (95% CI 1.40 to 1.60, 56 trials, 22,581 participants) for nicotine gum; 1.64 (95% CI 1.53 to 1.75, 51 trials, 25,754 participants) for nicotine patch; 1.52 (95% CI 1.32 to 1.74, 8 trials, 4439 participants) for oral tablets/lozenges; 1.90 (95% CI 1.36 to 2.67, 4 trials, 976 participants) for nicotine inhalator; and 2.02 (95% CI 1.49 to 2.73, 4 trials, 887 participants) for nicotine nasal spray. The effects were largely independent of the definition of abstinence, the intensity of additional support provided or the setting in which the NRT was offered. Adverse events from using NRT were related to the type of product, and include skin irritation from patches and irritation to the inside of the mouth from gum and tablets. Attempts to quantitatively synthesize the incidence of various adverse effects were hindered by extensive variation in reporting the nature, timing and duration of symptoms. The odds ratio (OR) of chest pains or palpitations for any form of NRT relative to control was 1.88 (95% CI 1.37 to 2.57, 15 included and excluded trials, 11,074 participants). However, chest pains and palpitations were rare in both groups and serious adverse events were extremely rare.\nAuthors' conclusions\nThere is high-quality evidence that all of the licensed forms of NRT (gum, transdermal patch, nasal spray, inhalator and sublingual tablets/lozenges) can help people who make a quit attempt to increase their chances of successfully stopping smoking. NRTs increase the rate of quitting by 50% to 60%, regardless of setting, and further research is very unlikely to change our confidence in the estimate of the effect. The relative effectiveness of NRT appears to be largely independent of the intensity of additional support provided to the individual. Provision of more intense levels of support, although beneficial in facilitating the likelihood of quitting, is not essential to the success of NRT. NRT often causes minor irritation of the site through which it is administered, and in rare cases can cause non-ischaemic chest pain and palpitations.\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": "We found evidence that all forms of NRT made it more likely that a person's attempt to quit smoking would succeed. The chances of stopping smoking were increased by 50% to 60%. NRT works with or without additional counselling, and does not need to be prescribed by a doctor. Side effects from using NRT are related to the type of product, and include skin irritation from patches and irritation to the inside of the mouth from gum and tablets. There is no evidence that NRT increases the risk of heart attacks."
}
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query-laysum
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23782
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[
{
"role": "user",
"content": "Abstract: Background\nDespite the widely documented risks of not breastfeeding, initiation rates remain relatively low in many high-income countries, particularly among women in lower-income groups. In low- and middle-income countries, many women do not follow World Health Organization (WHO) recommendations to initiate breastfeeding within the first hour after birth. This is an update of a Cochrane Review, first published in 2005.\nObjectives\nTo identify and describe health promotion activities intended to increase the initiation rate of breastfeeding.\nTo evaluate the effectiveness of different types of breastfeeding promotion activities, in terms of changing the number of women who initiate breastfeeding.\nTo evaluate the effectiveness of different types of breastfeeding promotion activities, in terms of changing the number of women who initiate breastfeeding early (within one hour after birth).\nSearch methods\nWe searched Cochrane Pregnancy and Childbirth's Trials Register (29 February 2016) and scanned reference lists of all articles obtained.\nSelection criteria\nRandomised controlled trials (RCTs), with or without blinding, of any breastfeeding promotion intervention in any population group, except women and infants with a specific health problem.\nData collection and analysis\nTwo review authors independently assessed trial reports for inclusion, extracted data and assessed trial quality. Discrepancies were resolved through discussion and a third review author was involved when necessary. We contacted investigators to obtain missing information.\nMain results\nTwenty-eight trials involving 107,362 women in seven countries are included in this updated review. Five studies involving 3,124 women did not contribute outcome data and we excluded them from the analyses. The methodological quality of the included trials was mixed, with significant numbers of studies at high or unclear risk of bias due to: inadequate allocation concealment (N = 20); lack of blinding of outcome assessment (N = 20); incomplete outcome data (N = 19); selective reporting (N = 22) and bias from other potential sources (N = 17).\nHealthcare professional-led breastfeeding education and support versus standard care\nThe studies pooled here compare professional health workers delivering breastfeeding education and support during the prenatal and postpartum periods with standard care. Interventions included promotion campaigns and counselling, and all took place in a formal setting. There was evidence from five trials involving 564 women for improved rates ofbreastfeeding initiation among women who received healthcare professional-led breastfeeding education and support (average risk ratio (RR) 1.43, 95% confidence interval (CI) 1.07 to 1.92; Tau² = 0.07, I² = 62%, low-quality evidence) compared to those women who received standard care. We downgraded evidence due to design limitations and heterogeneity. The outcome of early initiation of breastfeeding was not reported in the studies under this comparison.\nNon-healthcare professional-led breastfeeding education and support versus standard care\nThere was evidence from eight trials of 5712 women for improved rates of breastfeeding initiation among women who received interventions from non-healthcare professional counsellors and support groups (average RR 1.22, 95% CI 1.06 to 1.40; Tau² = 0.02, I² = 86%, low-quality evidence) compared to women who received standard care. In three trials of 76,373 women, there was no clear difference between groups in terms of the number of women practicing early initiation of breastfeeding (average RR 1.70, 95% CI 0.98 to 2.95; Tau² = 0.18, I² = 78%, very low-quality evidence). We downgraded the evidence for a combination of design limitations, heterogeneity and imprecision (wide confidence intervals crossing the line of no effect).\nOther comparisons\nOther comparisons in this review also looked at the rates of initiation of breastfeeding and there were no clear differences between groups for the following comparisons of combined healthcare professional-led education with peer support or community educator versus standard care (2 studies, 1371 women) or attention control (1 study, 237 women), breastfeeding education using multimedia (a self-help manual or a video) versus routine care (2 studies, 497 women); early mother-infant contact versus standard care (2 studies, 309 women); and community-based breastfeeding groups versus no breastfeeding groups (1 study, 18,603 women). None of these comparisons reported data on early initiation of breastfeeding.\nAuthors' conclusions\nThis review found low-quality evidence that healthcare professional-led breastfeeding education and non-healthcare professional-led counselling and peer support interventions can result in some improvements in the number of women beginning to breastfeed. The majority of the trials were conducted in the USA, among women on low incomes and who varied in ethnicity and feeding intention, thus limiting the generalisability of these results to other settings.\nFuture studies would ideally be conducted in a range of low- and high-income settings, with data on breastfeeding rates over various timeframes, and explore the effectiveness of interventions that are initiated prior to conception or during pregnancy. These might include well-described interventions, including health education, early and continuing mother-infant contact, and initiatives to help mothers overcome societal barriers to breastfeeding, all with clearly defined outcome measures.\n\nGiven the provided abstract, please respond to the following query: \"Why is this important?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We want to have a better understanding of what works to promote breastfeeding, for women, their families, the health system and society. Women face many barriers to breastfeeding, including lack of public spaces where women can breastfeed without feeling embarrassment; lack of flexible working days for breastfeeding women at work; widespread advertising of breast milk substitutes; and public policy that ignores the needs of breastfeeding women. New ways to promote breastfeeding are needed."
}
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query-laysum
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23783
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[
{
"role": "user",
"content": "Abstract: Background\nSurgery is the cornerstone in curative treatment of colorectal cancer. Unfortunately, surgery itself can adversely affect patient health. 'Enhanced Recovery After Surgery' programmes, which include multimodal interventions, have improved patient outcomes substantially. However, these are mainly applied peri- and postoperatively. Multimodal prehabilitation includes multiple preoperative interventions to prepare patients for surgery with the aim of increasing resilience, thereby improving postoperative outcomes.\nObjectives\nTo determine the effects of multimodal prehabilitation programmes on functional capacity, postoperative complications, and quality of life in adult patients undergoing surgery for colorectal cancer.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase and PsycINFO in January 2021. We also searched trial registries up to March 2021.\nSelection criteria\nWe included randomised controlled trials (RCTs) in adult patients with non-metastatic colorectal cancer, scheduled for surgery, comparing multimodal prehabilitation programmes (defined as comprising at least two preoperative interventions) with no prehabilitation. We focused on the following outcomes: functional capacity (i.e. 6-minute walk test, VO2peak, handgrip strength), postoperative outcomes (i.e. complications, mortality, length of hospital stay, emergency department visits, re-admissions), health-related quality of life, compliance, safety of prehabilitation, and return to normal activities.\nData collection and analysis\nTwo authors independently selected studies, extracted data, assessed risk of bias and used GRADE to assess the certainty of the evidence. Any disagreements were solved with discussion and consensus. We pooled data to perform meta-analyses, where possible.\nMain results\nWe included three RCTs that enrolled 250 participants with non-metastatic colorectal cancer, scheduled for elective (mainly laparoscopic) surgery. Included trials were conducted in tertiary care centres and recruited patients during periods ranging from 17 months to 45 months. A total of 130 participants enrolled in a preoperative four-week trimodal prehabilitation programme consisting of exercise, nutritional intervention, and anxiety reduction techniques. Outcomes of these participants were compared to those of 120 participants who started an identical but postoperative programme.\nPostoperatively, prehabilitation may improve functional capacity, determined with the 6-minute walk test at four and eight weeks (mean difference (MD) 26.02, 95% confidence interval (CI) -13.81 to 65.85; 2 studies; n = 131; and MD 26.58, 95% CI -8.88 to 62.04; 2 studies; n = 140); however, the certainty of evidence is low and very low, respectively, due to serious risk of bias, imprecision, and inconsistency. After prehabilitation, the functional capacity before surgery improved, with a clinically relevant mean difference of 24.91 metres (95% CI 11.24 to 38.57; 3 studies; n = 225). The certainty of evidence was moderate due to downgrading for serious risk of bias. The effects of prehabilitation on the number of complications (RR 0.95, 95% CI 0.70 to 1.29; 3 studies; n = 250), emergency department visits (RR 0.72, 95% CI 0.39 to 1.32; 3 studies; n = 250) and re-admissions (RR 1.20, 95% CI 0.54 to 2.65; 3 studies; n = 250) were small or even trivial. The certainty of evidence was low due to downgrading for serious risk of bias and imprecision. The effects on VO2peak, handgrip strength, length of hospital stay, mortality rate, health-related quality of life, return to normal activities, safety of the programme, and compliance rate could not be analysed quantitatively due to missing or insufficient data. The included studies did not report a difference between groups for health-related quality of life and length of hospital stay. Data on remaining outcomes were not reported or were reported inadequately in the included studies.\nAuthors' conclusions\nPrehabilitation may result in an improved functional capacity, determined with the 6-minute walk test both preoperatively and postoperatively. A solid effect on the number of complications, postoperative emergency department visits and re-admissions could not be established. The certainty of evidence ranges from moderate to very low, due to downgrading for serious risk of bias, imprecision and inconsistency. In addition, only three heterogeneous studies were included in this review. Therefore, the findings of this review should be interpreted with caution. Numerous relevant RCTs are ongoing and will be included in a future update of this review.\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": "The review authors searched for studies that had been published up to January 2021 and also looked for unpublished, ongoing studies up to March 2021. In a future update of this review, many ongoing studies will likely have been completed, which can be included to collect more evidence on this subject."
}
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query-laysum
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23784
|
[
{
"role": "user",
"content": "Abstract: Background\nSalvage systemic therapy has become the new standard of care in patients with advanced gastric and oesophago-gastric junction (OGJ) adenocarcinoma, following disease progression on first-line fluoropyrimidine and platinum-containing chemotherapy. Pharmacological agents proven to be effective in this setting include both chemotherapy and biological therapy, however, the consensus on the best salvage systemic therapy has not been reached.\nObjectives\nTo assess the effects of systemic chemotherapy and biological therapy, either alone or in combination, on overall survival (OS) and progression-free survival (PFS) in patients with advanced gastric and OGJ adenocarcinoma, whose disease has progressed on, or relapsed after first-line fluoropyrimidine and platinum-containing chemotherapy. Adverse events (AEs), tumour response rate (TRR) and quality of life (QoL) associated with systemic chemotherapy and/or biological therapy were additionally assessed.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, trial registries and proceedings of the major oncology conferences up to October 2020. We additionally handsearched the reference lists of studies. No language restriction was applied.\nSelection criteria\nWe included randomised controlled trials (RCTs) comparing salvage systemic therapy (chemotherapy and/or biological therapy) and either another type of salvage systemic therapy, placebo, best supportive care (BSC) or no treatment in patients with gastric and OGJ adenocarcinoma refractory to first-line fluoropyrimidine and platinum-containing chemotherapy.\nData collection and analysis\nTwo review authors independently performed selection of eligible studies and the primary author extracted study characteristics and outcome data from included studies. We assessed the quality and risk of bias of eligible studies according to the Cochrane Handbook for Systematic Reviews of Interventions. We expressed pooled estimates of effect using hazard ratio (HR) calculated using an inverse variance random-effects model for time-to-event data, and risk ratio (RR) calculated using Mantel-Haenszel random-effects model for binary data. The certainty of evidence was graded using GRADEpro.\nMain results\nWe identified 17 RCTs with 5110 participants for inclusion in this review. Tweenty-nine studies are ongoing and twenty studies are awaiting classification. No studies examined the following comparisons: chemotherapy combined with biological therapy versus placebo, BSC or no treatment, chemotherapy combined with biological therapy versus biological therapy, biological therapy versus biological therapy and chemotherapy combined with biological therapy versus chemotherapy combined with biological therapy.\nChemotherapy versus placebo, best supportive care or no treatment\nChemotherapy probably improves OS (HR = 0.66, 95% CI 0.52 to 0.83, moderate-certainty evidence) based on two studies involving 547 participants and improves PFS (HR = 0.57, 95% CI 0.47 to 0.69, high-certainty evidence) based on one study involving 507 participants over placebo and BSC. Chemotherapy probably increases serious AEs (SAEs) (RR = 1.38, 95% CI 1.20 to 1.59, moderate-certainty evidence) based on one study involving 503 participants.\nBiological therapy versus placebo, best supportive care or no treatment\nBiological therapy improves OS (HR = 0.55, 95% CI 0.41 to 0.73, high-certainty evidence) and probably improves PFS (HR = 0.33, 95% CI 0.19 to 0.57, moderate-certainty evidence) over placebo based on three studies involving 781 participants. There is currently insufficient evidence for increased SAEs from biological therapy (RR = 1.14, 95% CI 0.95 to 1.37, low-certainty evidence) based on two studies involving 638 participants.\nChemotherapy versus biological therapy\nThis comparison only considered immunotherapy. There is probably no evidence of a difference for OS (HR = 0.82, 95% CI 0.66 to 1.02, moderate-certainty evidence) between chemotherapy and immunotherapy, and immunotherapy probably reduces PFS (HR = 1.27, 95% CI 1.03 to 1.57, moderate-certainty evidence) based on one study involving 395 participants. SAEs may be less frequent with immunotherapy compared to chemotherapy (RR = 0.41, 95% CI 0.30 to 0.57, low-certainty evidence).\nChemotherapy combined with biological therapy versus chemotherapy\nAddition of biological therapy to chemotherapy probably does not improve OS (HR = 0.93, 95% CI 0.83 to 1.04, moderate-certainty evidence) and we are uncertain whether it improves PFS (HR = 0.87, 95% CI 0.74 to 1.02, very low-certainty evidence) based on seven studies involving 2743 participants. We are similarly uncertain whether combined chemotherapy and biological therapy increases SAEs (RR = 1.17, 95% CI 0.95 to 1.44, very low-certainty evidence) based on four studies involving 1618 participants.\nChemotherapy versus chemotherapy\nThere is no evidence of a difference for OS and PFS between irinotecan and paclitaxel (HR = 1.13, 95% CI 0.86 to 1.48, low-certainty evidence for OS; HR = 1.14, 95% CI 0.88 to 1.48, low-certainty evidence for PFS) based on one study involving 219 participants. Similarly, there is no evidence to indicate improved OS and PFS from addition of another chemotherapy to docetaxel (HR = 1.05, 95% CI 0.72 to 1.54, low-certainty evidence for OS; HR = 0.75, 95% CI 0.52 to 1.09, low-certainty evidence for PFS) based on two studies involving 121 participants. Grade ≥ 3 neutropenia occurred commonly with both mono- and poly-chemotherapy except for docetaxel-S1 and EOX chemotherapy.\nAuthors' conclusions\nSurvival outcome of patients with advanced gastric and OGJ adenocarcinoma whose disease progressed on first-line fluoropyrimidine and platinum-containing chemotherapy can be improved by chemotherapy and biological therapy. Biological therapy, in particular, achieves this without clear increase in SAEs or QoL impairment. Whether biological therapy is preferred over chemotherapy is still unclear and there is no evidence of a difference for OS outcome, although immunotherapy may be associated with less SAEs. Addition of biological therapy to chemotherapy and poly-chemotherapy are associated with frequent treatment-related toxicity without clear survival benefit.\n\nGiven the provided abstract, please respond to the following query: \"What are the results of our review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "People probably live longer after further chemotherapy (irinotecan or trifluridine plus tipiracil) than with placebo treatment or best supportive care. But chemotherapy probably increases serious unwanted effects, including diarrhoea, fever, and lower numbers of red and white blood cells.\nPeople may live as long after irinotecan chemotherapy as after paclitaxel chemotherapy. Adding another chemotherapy (oxaliplatin or cisplatin) to docetaxel may not affect how long people live.\nPeople live longer after biological therapy (nivolumab, apatinib or regorafenib) than with placebo treatment. We did not find enough evidence about whether biological therapy increases unwanted effects.\nPeople given immunotherapy (pembrolizumab) probably live as long as people given chemotherapy (paclitaxel), but may not have as many unwanted effects as with chemotherapy.\nCombining chemotherapy with biological therapy probably does not help people live longer than chemotherapy alone, and we are uncertain whether it increases unwanted effects."
}
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query-laysum
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23785
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[
{
"role": "user",
"content": "Abstract: Background\nAcquired brain injury can cause eye movement disorders which may include: strabismus, gaze deficits and nystagmus, causing visual symptoms of double, blurred or 'juddery' vision and reading difficulties. A wide range of interventions exist that have potential to alleviate or ameliorate these symptoms. There is a need to evaluate the effectiveness of these interventions and the timing of their implementation.\nObjectives\nWe aimed to assess the effectiveness of any intervention and determine the effect of timing of intervention in the treatment of strabismus, gaze deficits and nystagmus due to acquired brain injury. We considered restitutive, substitutive, compensatory or pharmacological interventions separately and compared them to control, placebo, alternative treatment or no treatment for improving ocular alignment or motility (or both).\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (containing the Cochrane Eyes and Vision Trials Register) (2017, Issue 5), MEDLINE Ovid, Embase Ovid, CINAHL EBSCO, AMED Ovid, PsycINFO Ovid, Dissertations & Theses (PQDT) database, PsycBITE (Psychological Database for Brain Impairment Treatment Efficacy), ISRCTN registry, ClinicalTrials.gov, Health Services Research Projects in Progress (HSRProj), National Eye Institute Clinical Studies Database and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). The databases were last searched on 26 June 2017. No date or language restrictions were used in the electronic searches for trials. We manually searched the Australian Orthoptic Journal, British and Irish Orthoptic Journal, and ESA, ISA and IOA conference proceedings. We contacted researchers active in this field for information about further published or unpublished studies.\nSelection criteria\nWe included randomised controlled trials (RCTs) of any intervention for ocular alignment or motility deficits (or both) due to acquired brain injury.\nData collection and analysis\nTwo review authors independently selected studies and extracted data. We used standard methods expected by Cochrane. We employed the GRADE approach to interpret findings and assess the quality of the evidence.\nMain results\nWe found five RCTs (116 participants) that were eligible for inclusion. These trials included conditions of acquired nystagmus, sixth cranial nerve palsy and traumatic brain injury-induced ocular motility defects. We did not identify any relevant studies of restitutive interventions.\nWe identified one UK-based trial of a substitutive intervention, in which botulinum toxin was compared with observation in 47 people with acute sixth nerve palsy. At four months after entry into the trial, people given botulinum toxin were more likely to make a full recovery (reduction in angle of deviation within 10 prism dioptres), compared with observation (risk ratio 1.19, 95% CI 0.96 to 1.48; low-certainty evidence). These same participants also achieved binocular single vision. In the injection group only, there were 2 cases of transient ptosis out of 22 participants (9%), and 4 participants out of 22 (18%) with transient vertical deviation; a total complication rate of 24% per injection and 27% per participant. All adverse events recovered. We judged the certainty of evidence as low, downgrading for risk of bias and imprecision. It was not possible to mask investigators or participants to allocation, and the follow-up between groups varied.\nWe identified one USA-based cross-over trial of a compensatory intervention. Oculomotor rehabilitation was compared with sham training in 12 people with mild traumatic brain injury, at least one year after the injury. We judged the evidence from this study to be very low-certainty. The study was small, data for the sham training group were not fully reported, and it was unclear if a cross-over study design was appropriate as this is an intervention with potential to have a permanent effect.\nWe identified three cross-over studies of pharmacological interventions for acquired nystagmus, which took place in Germany and the USA. These studies investigated two classes of pharmacological interventions: GABAergic drugs (gabapentin, baclofen) and aminopyridines (4-aminopyridines (AP), 3,4-diaminopyridine (DAP)). We judged the evidence from all three studies as very low-certainty because of small numbers of participants (which led to imprecision) and risk of bias (they were cross-over studies which did not report data in a way that permitted estimation of effect size).\nOne study compared gabapentin (up to 900 mg/day) with baclofen (up to 30 mg/day) in 21 people with pendular and jerk nystagmus. The follow-up period was two weeks. This study provides very low-certainty evidence that gabapentin may work better than baclofen in improving ocular motility and reducing participant-reported symptoms (oscillopsia). These effects may be different in pendular and jerk nystagmus, but without formal subgroup analysis it is unclear if the difference between the two types of nystagmus was chance finding. Quality of life was not reported. Ten participants with pendular nystagmus chose to continue treatment with gabapentin, and one with baclofen. Two participants with jerk nystagmus chose to continue treatment with gabapentin, and one with baclofen. Drug intolerance was reported in one person receiving gabapentin and in four participants receiving baclofen. Increased ataxia was reported in three participants receiving gabapentin and two participants receiving baclofen.\nOne study compared a single dose of 3,4-DAP (20 mg) with placebo in 17 people with downbeat nystagmus. Assessments were made 30 minutes after taking the drug. This study provides very low-certainty evidence that 3,4-DAP may reduce the mean peak slow-phase velocity, with less oscillopsia, in people with downbeat nystagmus. Three participants reported transient side effects of minor perioral/distal paraesthesia.\nOne study compared a single dose of 4-AP with a single dose of 3,4-DAP (both 10 mg doses) in eight people with downbeat nystagmus. Assessments were made 45 and 90 minutes after drug administration. This study provides very low-certainty evidence that both 3,4-DAP and 4-AP may reduce the mean slow-phase velocity in people with downbeat nystagmus. This effect may be stronger with 4-AP.\nAuthors' conclusions\nThe included studies provide insufficient evidence to inform decisions about treatments specifically for eye movement disorders that occur following acquired brain injury. No information was obtained on the cost of treatment or measures of participant satisfaction relating to treatment options and effectiveness. It was possible to describe the outcome of treatment in each trial and ascertain the occurrence of adverse events.\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"
},
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"role": "assistant",
"content": "Acquired brain injury is any injury that occurs after birth and causes damage to the brain's function. Strabismus is a condition in which the eyes are out of alignment, with one or both eyes turned in, out, up or down. Ocular motility (eye movement) disorders are defects that prevent normal movement of the eyes. Nystagmus is a condition where the eye movements are not steady and, instead, the eyes wobble. Treatment options include eye therapy, glasses, prisms, occlusion, botulinum toxin or surgery, to reduce the deviation or movement of the eyes. Currently there are no clear recommendations on when is best to provide these treatments, how much these treatments cost and whether treatments are of benefit to people with eye alignment and movement disorders occurring after acquired brain injury."
}
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query-laysum
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23786
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[
{
"role": "user",
"content": "Abstract: Background\nMailuoning is widely used in the treatment of acute ischaemic stroke in China. Animal experimental studies and clinical pharmacological research indicate that mailuoning might improve blood circulation, prevent ischaemic injury, and protect heart and brain tissue. This review was last published in 2009. As new data have become available, it is necessary to reassess the evidence from randomised controlled trials.\nObjectives\nTo determine the effects and safety of mailuoning agents (injection or oral liquid) in the treatment of people with acute ischaemic stroke.\nSearch methods\nWe searched the Cochrane Stroke Group Trials Register (May 2014), the Cochrane Central Register of Controlled Trials (CENTRAL;2014, Issue 4), MEDLINE (1966 to May 2014), Embase (1980 to May 2014), AMED (1985 to May 2014), the Chinese Stroke Trials Register (June 2014), the China Biological Medicine Database (CBM-disc; 1979 to June 2014), China Science and Technology Journal database (CSTJ; 1979 to June 2014), Wanfang Data Chinese databases (1979 to June 2014), and the China National Knowledge Infrastructure (1979 to June 2014). We searched clinical trials and research registers, handsearched 10 Chinese journals including relevant conference proceedings, scanned reference lists, and contacted the pharmaceutical company that manufactures mailuoning. We also attempted to contact trial authors to obtain further data.\nSelection criteria\nRandomised controlled trials comparing mailuoning with placebo or mailuoning plus other treatment compared with that other treatment in people with acute ischaemic stroke.\nData collection and analysis\nTwo review authors independently selected trials for inclusion, assessed trial quality, and extracted data.\nMain results\nWe included 21 trials, involving 1746 participants, in this update; six trials were new. The included trials did not report the numbers of dead and dependent participants at the end of at least three months' follow-up. Of the 12 trials that reported adverse events, five events occurred in two trials. There was no significant difference between the treatment group and the control group. We assessed 20 trials to be of a poor quality: When analysing these trials together, mailuoning was associated with a significant increase in the number of participants with an improved neurological deficit (risk ratio (RR) 0.31, 95% confidence interval (CI) 0.23 to 0.42) and showed a significant improvement of neurological deficit with the European Stroke Scale (ESS) (mean difference (MD) (fixed) 8.29, 95% CI 3.44 to 13.15). One placebo-controlled trial, assessed to be of a better methodological quality, failed to show a significant improvement of neurological deficit at the end of three months' follow-up (MD (fixed) 2.49, 95% CI -1.45 to 6.43) or in quality of life. One trial, which reported cognitive function using the Montreal Cognitive Assessment as a continuous scale, showed a significant improvement of cognitive function (MD (fixed) 2.68, 95% CI 1.82 to 3.54). Two trials assessed activities of daily life: One trial showed a significant improvement, but the other did not.\nAuthors' conclusions\nThis review did not provide sufficient evidence to support the routine use of mailuoning for the treatment of people with acute ischaemic stroke. High-quality large-scale randomised controlled trials are needed to confirm the efficacy of mailuoning.\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": "Mailuoning, a type of Chinese traditional medicine, is widely used in the treatment of acute ischaemic stroke in China even though its effect is still uncertain. Animal experimental studies and clinical pharmacological research indicate that mailuoning might improve blood circulation, prevent ischaemic injury, and protect heart and brain tissue. We therefore sought to undertake a review to discover whether using mailuoning therapy was better or worse than placebo or no additional treatment for people with acute ischaemic stroke."
}
] |
query-laysum
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23787
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[
{
"role": "user",
"content": "Abstract: Background\nCongenital ptosis is a drooping of one or both eyelids at birth, often due to poor development of the levator palpebrae superioris muscle. This can result in amblyopia, astigmatism, and ocular torticollis and therefore may necessitate surgical intervention in early childhood if visual development is compromised. Patients may have varied levels of levator function. Those with moderate to good function may elect to first attempt ptosis repair with external levator advancement or mullerectomy/Fasanella–Servat procedures. For those with poor function, those procedures are less likely to be effective, so they may undergo frontalis sling surgery, in which the tarsal plate is coupled to the frontalis muscle, so that movement of the brow and forehead result in movement of the eyelid. The optimal material to use in this surgery is unknown.\nObjectives\nTo evaluate the comparative effectiveness and safety of various materials used in frontalis sling surgery for congenital ptosis.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (June 2018), Ovid MEDLINE, Ovid MEDLINE E-pub Ahead of Print, Ovid Medline In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily (January 1946 to 20 June 2018), Embase (January 1947 to 20 June 2018), PubMed (1948 to 20 June 2018), Latin American and Caribbean Health Sciences Literature Database (LILACS) (1982 to 20 June 2018), 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 search for trials. We last searched the electronic databases on 20 June 2018.\nSelection criteria\nWe included randomized trials that compared one material to another for the treatment of congenital ptosis.\nData collection and analysis\nTwo review authors independently completed eligibility screening, data abstraction, 'Risk of bias' assessment, and grading of the evidence.\nMain results\nWe identified three randomized trials that had compared four different materials, two materials in each trial. The studies included a total of 160 participants. The surgical procedures compared were polytetrafluoroethylene (Gore-Tex), Ethibond suture, Mersilene mesh, and autogenous fascia lata.\nWe judged all studies to be at unclear risk of bias due to incomplete reporting of methods and other methodological deficiencies.\nBecause the three included studies compared different types of implants, we were unable to combine data in a meta-analysis. The limited data preclude any conclusion regarding the optimal implant for frontalis sling surgery.\nIn terms of the primary outcome of functional success, this was defined as widening of the opening between eyelids, assessed either by grade or by millimeter measurement. Bajaj 2004 showed that 93% of the Gore-Tex group and 83% of the Ethibond group had a good or satisfactory outcome (as defined by investigators). Elsamkary 2016 reported that 78.1% of the autogenous fascia group and 61.8% of the Gore-Tex group had a very good or good outcome. Salour 2008 did not include this type of grading system; they showed that the lid fissure increased 4.0 mm ± 1.46 mm in the Mersilene group and 3.13 mm ± 1.72 mm in the fascia lata group.\nIn terms of adverse events, Bajaj 2004, which included 15 patients per group, showed no recurrence in the Gore-Tex group and 1 in the Ethibond group; no need for removal in the Gore-Tex group and 1 in the Ethibond group; and no infections in the Gore-Tex group and 1 in the Ethibond group. Elsamkary 2016, which included 55 patients per group, had 3 recurrences in the fascia group and 6 in the Gore-Tex group; no need for removal in either group; and 1 infection in the fascia group and 2 in the Gore-Tex group. Salour 2008, which included 10 patients per group, had no recurrence, removals, or infections in either the Mersilene or the fascia group.\nAuthors' conclusions\nThe three trials included in this review evaluated four materials for frontalis sling surgery. Assessment of these three studies does not allow us to identify the optimal material. Future randomized trials should be rigorously designed so as to identify the best treatment for this condition.\n\nGiven the provided abstract, please respond to the following query: \"What were the main results of this review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We included three randomized controlled trials which compared frontalis sling materials. Among the three trials, four included materials were evaluated: Gore-Tex, Ethibond suture, Mersilene mesh, and autogenous fascia lata. Two trials included both eyes from the same participant, while the other trial included people with ptosis in one or both eyes. Data from the three studies could not be combined because the materials were different. It remains unclear which type of frontalis sling material has the highest success rate."
}
] |
query-laysum
|
23788
|
[
{
"role": "user",
"content": "Abstract: Background\nCommunication is a common element in all medical consultations, affecting a range of outcomes for doctors and patients. The increasing demand for medical students to be trained to communicate effectively has seen the emergence of interpersonal communication skills as core graduate competencies in medical training around the world. Medical schools have adopted a range of approaches to develop and evaluate these competencies.\nObjectives\nTo assess the effects of interventions for medical students that aim to improve interpersonal communication in medical consultations.\nSearch methods\nWe searched five electronic databases: Cochrane Central Register of Controlled Trials, MEDLINE, Embase, PsycINFO, and ERIC (Educational Resource Information Centre) in September 2020, with no language, date, or publication status restrictions. We also screened reference lists of relevant articles and contacted authors of included studies.\nSelection criteria\nWe included randomised controlled trials (RCTs), cluster-RCTs (C-RCTs), and non-randomised controlled trials (quasi-RCTs) evaluating the effectiveness of interventions delivered to students in undergraduate or graduate-entry medical programmes. We included studies of interventions aiming to improve medical students’ interpersonal communication during medical consultations. Included interventions targeted communication skills associated with empathy, relationship building, gathering information, and explanation and planning, as well as specific communication tasks such as listening, appropriate structure, and question style.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. Two review authors independently reviewed all search results, extracted data, assessed the risk of bias of included studies, and rated the quality of evidence using GRADE.\nMain results\nWe found 91 publications relating to 76 separate studies (involving 10,124 students): 55 RCTs, 9 quasi-RCTs, 7 C-RCTs, and 5 quasi-C-RCTs. We performed meta-analysis according to comparison and outcome. Among both effectiveness and comparative effectiveness analyses, we separated outcomes reporting on overall communication skills, empathy, rapport or relationship building, patient perceptions/satisfaction, information gathering, and explanation and planning. Overall communication skills and empathy were further divided as examiner- or simulated patient-assessed. The overall quality of evidence ranged from moderate to very low, and there was high, unexplained heterogeneity.\nOverall, interventions had positive effects on most outcomes, but generally small effect sizes and evidence quality limit the conclusions that can be drawn. Communication skills interventions in comparison to usual curricula or control may improve both overall communication skills (standardised mean difference (SMD) 0.92, 95% confidence interval (CI) 0.53 to 1.31; 18 studies, 1356 participants; I² = 90%; low-quality evidence) and empathy (SMD 0.64, 95% CI 0.23 to 1.05; 6 studies, 831 participants; I² = 86%; low-quality evidence) when assessed by experts, but not by simulated patients. Students’ skills in information gathering probably also improve with educational intervention (SMD 1.07, 95% CI 0.61 to 1.54; 5 studies, 405 participants; I² = 78%; moderate-quality evidence), but there may be little to no effect on students' rapport (SMD 0.18, 95% CI -0.15 to 0.51; 9 studies, 834 participants; I² = 81%; low-quality evidence), and effects on information giving skills are uncertain (very low-quality evidence).\nWe are uncertain whether experiential interventions improve overall communication skills in comparison to didactic approaches (SMD 0.08, 95% CI -0.02 to 0.19; 4 studies, 1578 participants; I² = 4%; very low-quality evidence). Electronic learning approaches may have little to no effect on students’ empathy scores (SMD -0.13, 95% CI -0.68 to 0.43; 3 studies, 421 participants; I² = 82%; low-quality evidence) or on rapport (SMD 0.02, 95% CI -0.33 to 0.38; 3 studies, 176 participants; I² = 19%; moderate-quality evidence) compared to face-to-face approaches. There may be small negative effects of electronic interventions on information giving skills (low-quality evidence), and effects on information gathering skills are uncertain (very low-quality evidence).\nPersonalised/specific feedback probably improves overall communication skills to a small degree in comparison to generic or no feedback (SMD 0.58, 95% CI 0.29 to 0.87; 6 studies, 502 participants; I² = 56%; moderate-quality evidence). There may be small positive effects of personalised feedback on empathy and information gathering skills (low quality), but effects on rapport are uncertain (very low quality), and we found no evidence on information giving skills.\nWe are uncertain whether role-play with simulated patients outperforms peer role-play in improving students’ overall communication skills (SMD 0.17, 95% CI -0.33 to 0.67; 4 studies, 637 participants; I² = 87%; very low-quality evidence). There may be little to no difference between effects of simulated patient and peer role-play on students' empathy (low-quality evidence) with no evidence on other outcomes for this comparison.\nDescriptive syntheses of results that could not be included in meta-analyses across outcomes and comparisons were mixed, as were effects of different interventions and comparisons on specific communication skills assessed by the included trials. Quality of evidence was downgraded due to methodological limitations across several risk of bias domains, high unexplained heterogeneity, and imprecision of results.\nIn general, results remain consistent in sensitivity analysis based on risk of bias and adjustment for clustering. No adverse effects were reported.\nAuthors' conclusions\nThis review represents a substantial body of evidence from which to draw, but further research is needed to strengthen the quality of the evidence base, to consider the long-term effects of interventions on students’ behaviour as they progress through training and into practice, and to assess effects of interventions on patient outcomes. Efforts to standardise assessment and evaluation of interpersonal skills will strengthen future research efforts.\n\nGiven the provided abstract, please respond to the following query: \"What are the best ways to teach medical students how to talk to patients?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": ""
}
] |
query-laysum
|
23789
|
[
{
"role": "user",
"content": "Abstract: Background\nCrohn's disease (CD) is a chronic immune-mediated condition of transmural inflammation in the gastrointestinal tract, associated with significant morbidity and decreased quality of life. The endocannabinoid system provides a potential therapeutic target for cannabis and cannabinoids and animal models have shown benefit in decreasing inflammation. However, there is also evidence to suggest transient adverse events such as weakness, dizziness and diarrhea, and an increased risk of surgery in people with CD who use cannabis.\nObjectives\nThe objectives were to assess the efficacy and safety of cannabis and cannabinoids for induction and maintenance of remission in people with CD.\nSearch methods\nWe searched MEDLINE, Embase, AMED, PsychINFO, the Cochrane IBD Group Specialized Register, CENTRAL, ClinicalTrials.Gov, and the European Clinical Trials Register up to 17 October 2018. We searched conference abstracts, references and we also contacted researchers in this field for upcoming publications.\nSelection criteria\nRandomized controlled trials comparing any form of cannabis or its cannabinoid derivatives (natural or synthetic) to placebo or an active therapy for adults with Crohn’s disease were included.\nData collection and analysis\nTwo authors independently screened search results, extracted data and assessed bias using the Cochrane risk of bias tool. The primary outcomes were clinical remission and relapse. Remission is commonly defined as a Crohn's disease activity index (CDAI) of < 150. Relapse is defined as a CDAI > 150. Secondary outcomes included clinical response, endoscopic remission, endoscopic improvement, histological improvement, quality of life, C-reactive protein (CRP) and fecal calprotectin measurements, adverse events (AEs), serious AEs, withdrawal due to AEs, and cannabis dependence and withdrawal effects. We calculated the risk ratio (RR) and corresponding 95% confidence interval (95% CI) for dichotomous outcomes. For continuous outcomes, we calculated the mean difference (MD) and 95% CI. Data were combined for analysis when the interventions, patient groups and outcomes were sufficiently similar (determined by consensus). Data were analyzed on an intention-to-treat basis and the overall certainty of the evidence supporting the outcomes was evaluated using the GRADE criteria.\nMain results\nThree studies (93 participants) that assessed cannabis in people with active CD met the inclusion criteria. One ongoing study was also identified. Participants in two of the studies were adults with active Crohn's disease who had failed at least one medical treatment. The inclusion criteria for the third study were unclear. No studies that assessed cannabis therapy in quiescent CD were identified. The studies were not pooled due to differences in the interventional drug.\nOne small study (N = 21) compared eight weeks of treatment with cannabis cigarettes containing 115 mg of D9-tetrahydrocannabinol (THC) to placebo cigarettes containing cannabis with the THC removed in participants with active CD. This study was rated as high risk of bias for blinding and other bias (cannabis participants were older than placebo). The effects of cannabis on clinical remission were unclear. Forty-five per cent (5/11) of the cannabis group achieved clinical remission compared with 10% (1/10) of the placebo group (RR 4.55, 95% CI 0.63 to 32.56; very low certainty evidence). A difference was observed in clinical response (decrease in CDAI score of >100 points) rates. Ninety-one per cent (10/11) of the cannabis group achieved a clinical response compared to 40% (4/10) of the placebo group (RR 2.27, 95% CI 1.04 to 4.97; very low certainty evidence). More AEs were observed in the cannabis cigarette group compared to placebo (RR 4.09, 95% CI 1.15 to 14.57; very low certainty evidence). These AEs were considered to be mild in nature and included sleepiness, nausea, difficulty with concentration, memory loss, confusion and dizziness. This study did not report on serious AEs or withdrawal due to AEs.\nOne small study (N = 22) compared cannabis oil (5% cannabidiol) to placebo oil in people with active CD. This study was rated as high risk of bias for other bias (cannabis participants were more likely than placebo participants to be smokers). There was no difference in clinical remission rates. Forty per cent (4/10) of cannabis oil participants achieved remission at 8 weeks compared to 33% (3/9) of the placebo participants (RR 1.20, 95% CI 0.36 to 3.97; very low certainty evidence). There was no difference in the proportion of participants who had a serious adverse event. Ten per cent (1/10) of participants in the cannabis oil group had a serious adverse event compared to 11% (1/9) of placebo participants (RR 0.90, 95% CI 0.07 to 12.38, very low certainty evidence). Both serious AEs were worsening Crohn's disease that required rescue intervention. This study did not report on clinical response, CRP, quality of life or withdrawal due to AEs.\nOne small study (N= 50) compared cannabis oil (15% cannabidiol and 4% THC) to placebo in participants with active CD. This study was rated as low risk of bias. Differences in CDAI and quality of life scores measured by the SF-36 instrument were observed. The mean quality of life score after 8 weeks of treatment was 96.3 in the cannabis oil group compared to 79.9 in the placebo group (MD 16.40, 95% CI 5.72 to 27.08, low certainty evidence). After 8 weeks of treatment, the mean CDAI score was118.6 in the cannabis oil group compared to 212.6 in the placebo group (MD -94.00, 95%CI -148.86 to -39.14, low certainty evidence). This study did not report on clinical remission, clinical response, CRP or AEs.\nAuthors' conclusions\nThe effects of cannabis and cannabis oil on Crohn's disease are uncertain. Thus no firm conclusions regarding the efficacy and safety of cannabis and cannabis oil in adults with active Crohn's disease can be drawn. The effects of cannabis or cannabis oil in quiescent Crohn's disease have not been investigated. Further studies with larger numbers of participants are required to assess the potential benefits and harms of cannabis in Crohn's disease. Future studies should assess the effects of cannabis in people with active and quiescent Crohn's disease. Different doses of cannabis and delivery modalities should be investigated.\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": "The effects of cannabis and cannabis oil on Crohn's disease are uncertain. No firm conclusions regarding the benefits and harms (e.g. side effects) of cannabis and cannabis oil in adults with Crohn's disease can be drawn. The effects of cannabis and cannabis oil in people with Crohn's disease in remission have not been investigated. Further studies with larger numbers of participants are required to assess the potential benefits and harms of cannabis in Crohn's disease. Future studies should assess the effects of cannabis in people with active and inactive Crohn's disease. Different doses of cannabis and formulations (e.g. cannabis oil or pills) should be investigated."
}
] |
query-laysum
|
23790
|
[
{
"role": "user",
"content": "Abstract: Background\nSocial networking platforms offer a wide reach for public health interventions allowing communication with broad audiences using tools that are generally free and straightforward to use and may be combined with other components, such as public health policies. We define interactive social media as activities, practices, or behaviours among communities of people who have gathered online to interactively share information, knowledge, and opinions.\nObjectives\nWe aimed to assess the effectiveness of interactive social media interventions, in which adults are able to communicate directly with each other, on changing health behaviours, body functions, psychological health, well-being, and adverse effects.\nOur secondary objective was to assess the effects of these interventions on the health of populations who experience health inequity as defined by PROGRESS-Plus. We assessed whether there is evidence about PROGRESS-Plus populations being included in studies and whether results are analysed across any of these characteristics.\nSearch methods\nWe searched CENTRAL, CINAHL, Embase, MEDLINE (including trial registries) and PsycINFO. We used Google, Web of Science, and relevant web sites to identify additional studies and searched reference lists of included studies. We searched for published and unpublished studies from 2001 until June 1, 2020. We did not limit results by language.\nSelection criteria\nWe included randomised controlled trials (RCTs), controlled before-and-after (CBAs) and interrupted time series studies (ITSs). We included studies in which the intervention website, app, or social media platform described a goal of changing a health behaviour, or included a behaviour change technique. The social media intervention had to be delivered to adults via a commonly-used social media platform or one that mimicked a commonly-used platform. We included studies comparing an interactive social media intervention alone or as a component of a multi-component intervention with either a non-interactive social media control or an active but less-interactive social media comparator (e.g. a moderated versus an unmoderated discussion group).\nOur main outcomes were health behaviours (e.g. physical activity), body function outcomes (e.g. blood glucose), psychological health outcomes (e.g. depression), well-being, and adverse events. Our secondary outcomes were process outcomes important for behaviour change and included knowledge, attitudes, intention and motivation, perceived susceptibility, self-efficacy, and social support.\nData collection and analysis\nWe used a pre-tested data extraction form and collected data independently, in duplicate. Because we aimed to assess broad outcomes, we extracted only one outcome per main and secondary outcome categories prioritised by those that were the primary outcome as reported by the study authors, used in a sample size calculation, and patient-important.\nMain results\nWe included 88 studies (871,378 participants), of which 84 were RCTs, three were CBAs and one was an ITS. The majority of the studies were conducted in the USA (54%). In total, 86% were conducted in high-income countries and the remaining 14% in upper middle-income countries. The most commonly used social media platform was Facebook (39%) with few studies utilising other platforms such as WeChat, Twitter, WhatsApp, and Google Hangouts. Many studies (48%) used web-based communities or apps that mimic functions of these well-known social media platforms.\nWe compared studies assessing interactive social media interventions with non-interactive social media interventions, which included paper-based or in-person interventions or no intervention. We only reported the RCT results in our 'Summary of findings' table. We found a range of effects on health behaviours, such as breastfeeding, condom use, diet quality, medication adherence, medical screening and testing, physical activity, tobacco use, and vaccination. For example, these interventions may increase physical activity and medical screening tests but there was little to no effect for other health behaviours, such as improved diet or reduced tobacco use (20,139 participants in 54 RCTs). For body function outcomes, interactive social media interventions may result in small but important positive effects, such as a small but important positive effect on weight loss and a small but important reduction in resting heart rate (4521 participants in 30 RCTs). Interactive social media may improve overall well-being (standardised mean difference (SMD) 0.46, 95% confidence interval (CI) 0.14 to 0.79, moderate effect, low-certainty evidence) demonstrated by an increase of 3.77 points on a general well-being scale (from 1.15 to 6.48 points higher) where scores range from 14 to 70 (3792 participants in 16 studies). We found no difference in effect on psychological outcomes (depression and distress) representing a difference of 0.1 points on a standard scale in which scores range from 0 to 63 points (SMD -0.01, 95% CI -0.14 to 0.12, low-certainty evidence, 2070 participants in 12 RCTs).\nWe also compared studies assessing interactive social media interventions with those with an active but less interactive social media control (11 studies). Four RCTs (1523 participants) that reported on physical activity found an improvement demonstrated by an increase of 28 minutes of moderate-to-vigorous physical activity per week (from 10 to 47 minutes more, SMD 0.35, 95% CI 0.12 to 0.59, small effect, very low-certainty evidence). Two studies found little to no difference in well-being for those in the intervention and control groups (SMD 0.02, 95% CI -0.08 to 0.13, small effect, low-certainty evidence), demonstrated by a mean change of 0.4 points on a scale with a range of 0 to 100.\nAdverse events related to the social media component of the interventions, such as privacy issues, were not reported in any of our included studies.\nWe were unable to conduct planned subgroup analyses related to health equity as only four studies reported relevant data.\nAuthors' conclusions\nThis review combined data for a variety of outcomes and found that social media interventions that aim to increase physical activity may be effective and social media interventions may improve well-being. While we assessed many other outcomes, there were too few studies to compare or, where there were studies, the evidence was uncertain. None of our included studies reported adverse effects related to the social media component of the intervention. Future studies should assess adverse events related to the interactive social media component and should report on population characteristics to increase our understanding of the potential effect of these interventions on reducing health inequities.\n\nGiven the provided abstract, please respond to the following query: \"What is social media?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Social media are computer-based technologies that help people to share ideas, thoughts and information by building virtual networks and communities on the Internet; examples include, Facebook, Twitter or WhatsApp. Social media networks are 'interactive': the user communicates directly with a computer, or other device, to share and receive information."
}
] |
query-laysum
|
23791
|
[
{
"role": "user",
"content": "Abstract: Background\nBrain radionecrosis (tissue death caused by radiation) can occur following high-dose radiotherapy to brain tissue and can have a significant impact on a person's quality of life (QoL) and function. The underlying pathophysiological mechanism remains unclear for this condition, which makes establishing effective treatments challenging.\nObjectives\nTo assess the effectiveness of interventions used for the treatment of brain radionecrosis in adults over 18 years old.\nSearch methods\nIn October 2017, we searched the Cochrane Register of Controlled Trials (CENTRAL), MEDLINE, Embase and the Cumulative Index to Nursing and Allied Health Literature (CINAHL) for eligible studies. We also searched unpublished data through Physicians Data Query, www.controlled-trials.com/rct, www.clinicaltrials.gov, and www.cancer.gov/clinicaltrials for ongoing trials and handsearched relevant conference material.\nSelection criteria\nWe included randomised controlled trials (RCTs) of any intervention directed to treat brain radionecrosis in adults over 18 years old previously treated with radiation therapy to the brain. We anticipated a limited number of RCTs, so we also planned to include all comparative prospective intervention trials and quasi-randomised trials of interventions for brain radionecrosis in adults as long as these studies had a comparison group that reflects the standard of care (i.e. placebo or corticosteroids). Selection bias was likely to be an issue in all the included non-randomised studies therefore results are interpreted with caution.\nData collection and analysis\nTwo review authors (CC, PB) independently extracted data from selected studies and completed a 'Risk of bias' assessment. For dichotomous outcomes, the odds ratio (OR) for the outcome of interest was reported. For continuous outcomes, treatment effect was reported as mean difference (MD) between treatment arms with 95% confidence intervals (CIs).\nMain results\nTwo RCTs and one prospective non-randomised study evaluating pharmacological interventions met the inclusion criteria for this review. As each study evaluated a different drug or intervention using different endpoints, a meta-analysis was not possible. There were no trials of non-pharmacological interventions that met the inclusion criteria.\nA very small randomised, double-blind, placebo-controlled trial of bevacizumab versus placebo reported that 100% (7/7) of participants on bevacizumab had reduction in brain oedema by at least 25% and reduction in post-gadolinium enhancement, whereas all those receiving placebo had clinical or radiological worsening or both. This was an encouraging finding but due to the small sample size we did not report a relative effect. The authors also failed to provide adequate details regarding the randomisation and blinding procedures Therefore, the certainty of this evidence is low and a larger RCT adhering to reporting standards is needed.\nAn open-label RCT demonstrated a greater reduction in brain oedema (T2 hyperintensity) in the edaravone plus corticosteroid group than in the corticosteroid alone group (MD was 3.03 (95% CI 0.14 to 5.92; low-certainty evidence due to high risk of bias and imprecision); although the result approached borderline significance, there was no evidence of any important difference in the reduction in post-gadolinium enhancement between arms (MD = 0.47, 95% CI - 0.80 to 1.74; low-certainty evidence due to high risk of bias and imprecision).\nIn the RCT of bevacizumab versus placebo, all seven participants receiving bevacizumab were reported to have neurological improvement, whereas five of seven participants on placebo had neurological worsening (very low-certainty evidence due to small sample size and concerns over validity of analyses). While no adverse events were noted with placebo, three severe adverse events were noted with bevacizumab, which included aspiration pneumonia, pulmonary embolus and superior sagittal sinus thrombosis. In the RCT of corticosteroids with or without edaravone, the participants who received the combination treatment were noted to have significantly greater clinical improvement than corticosteroids alone based on LENT/SOMA scale (OR = 2.51, 95% CI 1.26 to 5.01; low-certainty evidence due to open-label design). No differences in treatment toxicities were observed between arms.\nOne included prospective non-randomised study of alpha-tocopherol (vitamin E) versus no active treatment was found but it did not include any radiological assessment. As only one included study was a double-blinded randomised controlled trial, the other studies were prone to selection and detection biases.\nNone of the included studies reported quality of life outcomes or adequately reported details about corticosteroid requirements.\nA limited number of prospective studies were identified but subsequently excluded as these studies had a limited number of participants evaluating different pharmacological interventions using variable endpoints.\nAuthors' conclusions\nThere is a lack of good certainty evidence to help quantify the risks and benefits of interventions for the treatment of brain radionecrosis after radiotherapy or radiosurgery. In an RCT of 14 patients, bevacizumab showed radiological response which was associated with minimal improvement in cognition or symptom severity. Although it was a randomised trial by design, the small sample size limits the quality of data. A trial of edaravone plus corticosteroids versus corticosteroids alone reported greater reduction in the surrounding oedema with combination treatment but no effect on the enhancing radionecrosis lesion. Due to the open-label design and wide confidence intervals in the results, the quality of this data was also low. There was no evidence to support any non-pharmacological interventions for the treatment of radionecrosis. Further prospective randomised studies of pharmacological and non-pharmacological interventions are needed to generate stronger evidence. Two ongoing RCTs, one evaluating bevacizumab and one evaluating hyperbaric oxygen therapy were identified.\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": "When brain tissue dies due to a reaction to radiotherapy it is calledbrain radionecrosis.Brain radionecrosis can cause damage to the patient’s ability function. What this looks like depends where the radionecrosis has happened in the brain and it can impact on a patient’s quality of life. There are currently limited available treatments for brain radionecrosis. Patients are commonly given powerful anti-inflammatory drugs (called corticosteroids) and some patients may require surgery to remove the area of brain that has radionecrosis. More effective treatments for this condition are needed."
}
] |
query-laysum
|
23792
|
[
{
"role": "user",
"content": "Abstract: Background\nUveitis is a term used to describe a group of intraocular inflammatory diseases. Uveitis is the fifth most common cause of vision loss in high-income countries, with the highest incidence of disease in the working-age population. Corticosteroids are the mainstay of treatment for all subtypes of non-infectious uveitis. They can be administered orally, topically with drops, by periocular (around the eye) or intravitreal (inside the eye) injection, or by surgical implantation.\nObjectives\nTo determine the efficacy and safety of steroid implants in people with chronic non-infectious posterior uveitis, intermediate uveitis, and panuveitis.\nSearch methods\nWe searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register), MEDLINE Ovid, Embase, PubMed, LILACS, and three trials registries to November 2021.\nSelection criteria\nWe included randomized controlled trials comparing either fluocinolone acetonide (FA) or dexamethasone (DEX) intravitreal implants with standard-of-care therapy or sham procedures, with at least six months of follow-up after treatment. We included studies that enrolled participants of all ages, who had chronic non-infectious posterior uveitis, intermediate uveitis, or panuveitis with vision that was better than hand-motion.\nData collection and analysis\nWe applied standard Cochrane methodology.\nMain results\nWe included data from four trials (683 participants, 907 eyes) that compared corticosteroid implants with either sham or standard-of-care therapy.\nStudy characteristics and risk of bias\nOf the two trials that compared corticosteroid implants with sham procedure, one examined a 0.18 mg FA implant, and the other, a 0.7 mg DEX implant. The other two trials compared a 0.59 mg FA implant with standard-of-care therapy, which included systemic corticosteroids and immunosuppressive medications, if needed. Considering improvement in visual acuity, we assessed the four trials to be at either low risk, or with some concerns of risk of bias across all domains.\nFindings\nUsing sham procedure as control, combined results at the six-month primary time point suggested that corticosteroid implants may decrease the risk of uveitis recurrence by 60% (relative risk [RR] 0.40, 95% confidence interval [CI] 0.30 to 0.54; 2 trials, 282 participants; low-certainty evidence); and lead to a greater improvement in best-corrected visual acuity (BCVA; mean difference [MD] 0.15 logMAR, 95% CI 0.06 to 0.24; 1 trial, 153 participants; low-certainty evidence). Evidence based on a single-study report (146 participants) suggested that steroid implants may have no effects on visual functioning quality of life, measured on the National Eye Institute 25-Item Visual Function Questionnaire (MD 2.85, 95%CI -3.64 to 9.34; 1 trial, 146 participants; moderate-certainty evidence).\nUsing standard-of care therapy as control, combined estimates at the 24-month primary time point suggested that corticosteroid implants were likely to decrease the risk of recurrence of uveitis by 54% (RR 0.46, 95% CI 0.35 to 0.60; 2 trials, 619 eyes). Combined estimates at 24 months also suggested that steroid implants may have little to no effects on improving BCVA (MD 0.05 logMAR, 95% CI -0.02 to 0.12; 2 trials, 619 eyes; low-certainty evidence). Evidence based on a single-study report (232 participants) suggested that steroid implants may have minimal clinical effects on visual functioning (MD 4.64, 95% CI 0.13 to 9.15; 1 trial, 232 participants; moderate-certainty evidence); physical functioning (SF-36 physical subscale MD 2.95, 95% CI 0.55 to 5.35; 1 trial, 232 participants; moderate-certainty evidence); or mental health (SF-36 mental subscale MD 3.65, 95% CI 0.52 to 6.78; 1 trial, 232 participants; moderate-certainty evidence); but not on EuroQoL (MD 6.17, 95% CI 1.87 to 10.47; 1 trial, 232 participants; moderate-certainty evidence); or EuroQoL-5D scale (MD 0.02, 95% CI -0.04 to 0.08; 1 trial, 232 participants; moderate-certainty evidence).\nAdverse effects\nCompared with sham procedures, corticosteroid implants may slightly increase the risk of cataract formation (RR 2.69, 95% CI 1.17 to 6.18; 1 trial, 90 eyes; low-certainty evidence), but not the risk of cataract progression (RR 2.00, 95% CI 0.65 to 6.12; 1 trial, 117 eyes; low-certainty evidence); or the need for surgery (RR 2.98, 95% CI 0.82 to 10.81; 1 trial, 180 eyes; low-certainty evidence), during up to 12 months of follow-up. These implants may increase the risk of elevated intraocular pressure ([IOP] RR 2.81, 95% CI 1.42 to 5.56; 2 trials, 282 participants; moderate-certainty evidence); and the need for IOP-lowering eyedrops (RR 1.85, 95% CI 1.05 to 3.25; 2 trials, 282 participants; moderate-certainty evidence); but not the need for IOP-lowering surgery (RR 0.72, 95% CI 0.13 to 4.17; 2 trials, 282 participants; moderate-certainty evidence).\nEvidence comparing the 0.59 mg FA implant with standard-of-care suggested that the implant may increase the risk of cataract progression (RR 2.71, 95% CI 2.06 to 3.56; 2 trials, 210 eyes; low-certainty evidence); and the need for surgery (RR 2.98, 95% CI 2.33 to 3.79; 2 trials, 371 eyes; low-certainty evidence); along with the risk of elevated IOP (RR 3.64, 95% CI 2.71 to 4.87; 2 trials, 605 eyes; moderate-certainty evidence); and the need for medical (RR 3.04, 95% CI 2.36 to 3.91; 2 trials, 544 eyes; moderate-certainty evidence); or surgical interventions (RR 5.43, 95% CI 3.12 to 9.45; 2 trials, 599 eyes; moderate-certainty evidence).\nIn either comparison, these implants did not increase the risk for endophthalmitis, retinal tear, or retinal detachment (moderate-certainty evidence).\nAuthors' conclusions\nOur confidence is limited that local corticosteroid implants are superior to sham therapy or standard-of-care therapy in reducing the risk of uveitis recurrence. We demonstrated different effectiveness on BCVA relative to comparators in people with non-infectious uveitis. Nevertheless, the evidence suggests that these implants may increase the risk of cataract progression and IOP elevation, which will require interventions over time.\nTo better understand the efficacy and safety profiles of corticosteroid implants, we need future trials that examine implants of different doses, used for different durations. The trials should measure core standard outcomes that are universally defined, and measured at comparable follow-up time points.\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 two studies (282 participants) that compared surgically-placed implants that released fluocinolone acetonide into the eye with a sham procedure. The type and amount of medicine released was different in both studies. The steroid-containing implants appeared to reduce the risk of uveitis coming back, and lead to better vision and quality of life.\nWe found two studies (683 participants) that compared surgically-placed implants that released fluocinolone acetonide into the eye with standard treatment. Both studies used the same implant. The results did not show that the steroid-containing implants reduced the risk of uveitis coming back, or improved much vision, but the participants appeared to have a better quality of life.\nSteroid-containing implants seemed to increase the risk for developing cataracts (clouding of the lens of the eye), and for increasing the pressure in the eye. All four studies included participants from multiple countries."
}
] |
query-laysum
|
23793
|
[
{
"role": "user",
"content": "Abstract: Background\nHeart failure is associated with high mortality and hospital readmissions. Beta-adrenergic blocking agents, angiotensin converting enzyme inhibitors (ACEIs), and angiotensin receptor blockers (ARBs) can improve survival and reduce hospital readmissions and are recommended as first-line therapy in the treatment of heart failure. Evidence has also shown that there is a dose-dependent relationship of these medications with patient outcomes. Despite this evidence, primary care physicians are reluctant to up-titrate these medications. New strategies aimed at facilitating this up-titration are warranted. Nurse-led titration (NLT) is one such strategy.\nObjectives\nTo assess the effects of NLT of beta-adrenergic blocking agents, ACEIs, and ARBs in patients with heart failure with reduced ejection fraction (HFrEF) in terms of safety and patient outcomes.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials in the Cochrane Library (CENTRAL Issue 11 of 12, 19/12/2014), MEDLINE OVID (1946 to November week 3 2014), and EMBASE Classic and EMBASE OVID (1947 to 2014 week 50). We also searched reference lists of relevant primary studies, systematic reviews, clinical trial registries, and unpublished theses sources. We used no language restrictions.\nSelection criteria\nRandomised controlled trials (RCTs) comparing NLT of beta-adrenergic blocking agents, ACEIs, and/or ARBs comparing the optimisation of these medications by a nurse to optimisation by another health professional in patients with HFrEF.\nData collection and analysis\nTwo review authors (AD & JC) independently assessed studies for eligibility and risk of bias. We contacted primary authors if we required additional information. We examined quality of evidence using the GRADE rating tool for RCTs. We analysed extracted data by risk ratio (RR) with 95% confidence interval (CI) for dichotomous data to measure effect sizes of intervention group compared with usual-care group. Meta-analyses used the fixed-effect Mantel-Haenszel method. We assessed heterogeneity between studies by Chi2 and I2.\nMain results\nWe included seven studies (1684 participants) in the review. One study enrolled participants from a residential care facility, and the other six studies from primary care and outpatient clinics. All-cause hospital admission data was available in four studies (556 participants). Participants in the NLT group experienced a lower rate of all-cause hospital admissions (RR 0.80, 95% CI 0.72 to 0.88, high-quality evidence) and fewer hospital admissions related to heart failure (RR 0.51, 95% CI 0.36 to 0.72, moderate-quality evidence) compared to the usual-care group. Six studies (902 participants) examined all-cause mortality. All-cause mortality was also lower in the NLT group (RR 0.66, 95% CI 0.48 to 0.92, moderate-quality evidence) compared to usual care. Approximately 27 deaths could be avoided for every 1000 people receiving NLT of beta-adrenergic blocking agents, ACEIs, and ARBs. Only three studies (370 participants) reported outcomes on all-cause and heart failure-related event-free survival. Participants in the NLT group were more likely to remain event free compared to participants in the usual-care group (RR 0.60, 95% CI 0.46 to 0.77, moderate-quality evidence). Five studies (966 participants) reported on the number of participants reaching target dose of beta-adrenergic blocking agents. This was also higher in the NLT group compared to usual care (RR 1.99, 95% CI 1.61 to 2.47, low-quality evidence). However, there was a substantial degree of heterogeneity in this pooled analysis. We rated the risk of bias in these studies as high mainly due to a lack of clarity regarding incomplete outcome data, lack of reporting on adverse events associated with the intervention, and the inability to blind participants and personnel. Participants in the NLT group reached maximal dose of beta-adrenergic blocking agents in half the time compared with participants in usual care. Two studies reported on adverse events; one of these studies stated there were no adverse events, and the other study found one adverse event but did not specify the type or severity of the adverse event.\nAuthors' conclusions\nParticipants in the NLT group experienced fewer hospital admissions for any cause and an increase in survival and number of participants reaching target dose within a shorter time period. However, the quality of evidence regarding the proportion of participants reaching target dose was low and should be interpreted with caution. We found high-quality evidence supporting NLT as one strategy that may improve the optimisation of beta-adrenergic blocking agents resulting in a reduction in hospital admissions. Despite evidence of a dose-dependent relationship of beta-adrenergic blocking agents, ACEIs, and ARBs with improving outcomes in patients with HFrEF, the translation of this evidence into clinical practice is poor. NLT is one strategy that facilitates the implementation of this evidence into practice.\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": "Heart failure has a high rate of hospitalisations and mortality. Large clinical trials have shown that the presence of beta-adrenergic blocking agents, ACEIs, and ARBs will improve these outcomes. Also, there is a dose response, so the higher the dose of these medications, the greater the improvement in patient outcomes. However, primary care physicians are often reluctant to up-titrate these medications. New ways of up-titration of these medications is needed. Optimisation of these medications can be done by nurse practitioners or advanced practice nurses under medical supervision."
}
] |
query-laysum
|
23794
|
[
{
"role": "user",
"content": "Abstract: Background\nThere is presently no certainty about the ideal feeding intervals for preterm infants. Shorter feeding intervals of, for example, two hours, have the theoretical advantage of allowing smaller volumes of milk. This may have the potential to reduce the incidence and severity of gastro-oesophageal reflux. Longer feeding intervals have the theoretical advantage of allowing more gastric emptying between two feeds. This potentially provides periods of rest (and thus less hyperaemia) for an immature digestive tract.\nObjectives\nTo determine the safety of shorter feeding intervals (two hours or shorter) versus longer feeding intervals (three hours or more) and to compare the effects in terms of days taken to regain birth weight and to achieve full feeding.\nSearch methods\nWe used the standard search strategy of Cochrane Neonatal to run comprehensive searches in CENTRAL (2020, Issue 6) and Ovid MEDLINE and Epub Ahead of Print, In-Process & Other Non-Indexed Citations, Daily and Versions, and CINAHL on 25 June 2020. We searched clinical trials databases and the reference lists of retrieved articles for randomised controlled trials (RCTs) and quasi-RCTs.\nSelection criteria\nWe included RCTs and quasi-RCTs comparing short (e.g. one or two hours) versus long (e.g. three or four hours) feeding intervals in preterm infants of any birth weight, all or most of whom were less than 32 weeks' gestation. Infants could be of any postnatal age at trial entry, but eligible infants should not have received feeds before study entry, with the exception of minimal enteral feeding. We included studies of nasogastric or orogastric bolus feeding, breast milk or formula, in which the feeding interval is the intervention.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. We used the GRADE approach to assess the certainty of evidence. Our primary outcomes were days taken to achieve full enteral feeding and days to regain birth weight. Our other outcomes were duration of hospital stay, episodes of necrotising enterocolitis (NEC) and growth during hospital stay (weight, length and head circumference).\nMain results\nWe included four RCTs, involving 417 infants in the review. One study involving 350 infants is awaiting classification. All studies compared two-hourly versus three-hourly feeding interval. The risk of bias of the included studies was generally low, but all studies had high risk of performance bias due to lack of blinding of the intervention.\nThree studies were included in meta-analysis for the number of days taken to achieve full enteral feeding (351 participants). The mean days to achieve full feeds was between eight and 11 days. There was little or no difference in days taken to achieve full enteral feeding between two-hourly and three-hourly feeding, but this finding was of low certainty (mean difference (MD) ‒0.62, 95% confidence interval (CI) ‒1.60 to 0.36).\nThere was low-certainty evidence that the days taken to regain birth weight may be slightly longer in infants receiving two-hourly feeding than in those receiving three-hourly feeding (MD 1.15, 95% CI 0.11 to 2.20; 3 studies, 350 participants).\nWe are uncertain whether shorter feeding intervals have any effect on any of our secondary outcomes including the duration of hospital stay (MD ‒3.36, 95% CI ‒9.18 to 2.46; 2 studies, 207 participants; very low-certainty evidence) and the risk of NEC (typical risk ratio 1.07, 95% CI 0.54 to 2.11; 4 studies, 417 participants; low-certainty evidence).\nNo study reported growth during hospital stay.\nAuthors' conclusions\nThe low-certainty evidence we found in this review suggests that there may be no clinically important differences between two- and three-hourly feeding intervals. There is insufficient information about potential feeding complications and in particular NEC. No studies have looked at the effect of other feeding intervals and there is no long-term data on neurodevelopment or growth.\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": "Feeding very preterm infants, less than 32 weeks' gestation at birth, is a major challenge. They have an immature gut which may lead to problems, varying from mild (feeding intolerance) to moderate (regurgitation of milk from the stomach) to severe (such as necrotising enterocolitis; NEC). NEC is an infectious complication leading to irreparable loss of parts of the bowel. The feeding interval, that is, the time interval between each feed, might matter but determining the appropriate feeding interval is a major challenge. Both short intervals, typically less than three hours, and longer intervals of three or more hours have their own risks. When the interval is short, a smaller volume of milk can be given more frequently. The infant might tolerate smaller volumes better, but their gut might not have sufficient time to rest between each feeding."
}
] |
query-laysum
|
23795
|
[
{
"role": "user",
"content": "Abstract: Background\nNasal continuous positive airway pressure (NCPAP) is a strategy to maintain positive airway pressure throughout the respiratory cycle through the application of a bias flow of respiratory gas to an apparatus attached to the nose. Early treatment with NCPAP is associated with decreased risk of mechanical ventilation exposure and might reduce chronic lung disease. Nasal intermittent positive pressure ventilation (NIPPV) is a form of noninvasive ventilation delivered through the same nasal interface during which patients are exposed to short inflations, along with background end-expiratory pressure.\nObjectives\nTo examine the risks and benefits of early (within the first six hours after birth) NIPPV versus early NCPAP for preterm infants at risk of or with respiratory distress syndrome (RDS).\nPrimary endpoints are respiratory failure and the need for intubated ventilatory support during the first week of life. Secondary endpoints include the incidence of mortality, chronic lung disease (CLD) (oxygen therapy at 36 weeks' postmenstrual age), pneumothorax, duration of respiratory support, duration of oxygen therapy, and intraventricular hemorrhage (IVH).\nSearch methods\nSearches were conducted in January 2023 in CENTRAL, MEDLINE, Embase, Web of Science, and Dissertation Abstracts. The reference lists of related systematic reviews and of studies selected for inclusion were also searched.\nSelection criteria\nWe considered all randomized and quasi-randomized controlled trials. Eligible studies compared NIPPV versus NCPAP treatment, starting within six hours after birth in preterm infants (< 37 weeks' gestational age (GA)).\nData collection and analysis\nWe collected and analyzed data using the recommendations of the Cochrane Neonatal Review Group.\nMain results\nWe included 17 trials, enrolling 1958 infants in this review. NIPPV likely reduces the rate of respiratory failure (risk ratio (RR) 0.65, 95% confidence interval (CI) 0.54 to 0.78; risk difference (RD) -0.08, 95% CI -0.12 to -0.05; 17 RCTs, 1958 infants; moderate-certainty evidence) and needing endotracheal tube ventilation (RR 0.67, 95% CI 0.56 to 0.81; RD -0.07, 95% CI -0.11 to -0.04; 16 RCTs; 1848 infants; moderate-certainty evidence) amongst infants treated with early NIPPV compared with early NCPAP.\nThe meta-analysis demonstrated that NIPPV may reduce the risk of developing CLD compared to CPAP (RR 0.70, 95% CI 0.52 to 0.92; 12 RCTs, 1284 infants; low-certainty evidence) slightly. NIPPV may result in little to no difference in mortality (RR 0.82, 95% CI 0.62 to 1.10; 17 RCTs; 1958 infants; I2 of 0%; low-certainty evidence), the incidence of pneumothorax (RR 0.92, 95% CI 0.60 to 1.41; 16 RCTs; 1674 infants; I2 of 0%; low-certainty evidence), and rates of severe IVH (RR 0.98, 95% CI 0.53 to 1.79; 8 RCTs; 977 infants; I2 of 0%; low-certainty evidence).\nAuthors' conclusions\nWhen applied within six hours after birth, NIPPV likely reduces the risk of respiratory failure and the need for intubation and endotracheal tube ventilation in very preterm infants (GA 28 weeks and above) with respiratory distress syndrome or at risk for RDS. It may also decrease the rate of CLD slightly. However, most trials enrolled infants with a gestational age of approximately 28 to 32 weeks with an overall mean gestational age of around 30 weeks. As such, the results of this review may not apply to extremely preterm infants that are most at risk of needing mechanical ventilation or developing CLD. Additional studies are needed to confirm these results and to assess the safety of NIPPV compared with NCPAP alone in a larger patient population.\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": "We found 17 trials (enrolling 1958 infants) comparing NCPAP with NIPPV. When applied within six hours after birth, NIPPV likely reduces the risk of respiratory failure and the need for intubation and endotracheal tube ventilation in very preterm infants (gestational age of 28 weeks and above) with respiratory distress syndrome (RDS) or at risk for RDS. It may also decrease the rate of chronic lung disease slightly. Compared to NCPAP, NIPPV may result in little to no difference on the risk of dying, developing an air leak in the thoracic cage, or a severe brain bleed. However, there was a lack of data for the most premature infants that are born at less than 28 weeks of gestational age. Additional studies are needed to determine how NIPPV can be best delivered to infants. The evidence is up-to-date to January 2023."
}
] |
query-laysum
|
23796
|
[
{
"role": "user",
"content": "Abstract: Background\nThis is an update of the Cochrane Review first published in 2010; it includes one additional study.\nPrimary generalised tonic-clonic seizures are a type of generalised seizure. Other types of seizures include: absence, myoclonic, and atonic seizures. Effective control of tonic-clonic seizures reduces the risk of injury and death, and improves quality of life. While most people achieve seizure control with one antiepileptic drug, around 30% do not, and require a combination of antiepileptic drugs.\nObjectives\nTo assess the effectiveness and tolerability of add-on lamotrigine for drug-resistant primary generalised tonic-clonic seizures.\nSearch methods\nFor the latest update, we searched these databases on 19 March 2019: Cochrane Register of Studies (CRS) Web, MEDLINE Ovid, and the WHO International Clinical Trials Registry Platform (ICTRP). The CRS includes records from the Cochrane Epilepsy Group Specialized Register, CENTRAL, Embase, and ClinicalTrials.gov. We imposed no language restrictions. We also contacted GlaxoSmithKline, manufacturers of lamotrigine.\nSelection criteria\nRandomised controlled parallel or cross-over trials of add-on lamotrigine for people of any age with drug-resistant primary generalised tonic-clonic seizures.\nData collection and analysis\nWe followed standard Cochrane methodology; two review authors independently assessed trials for inclusion, evaluated risk of bias, extracted relevant data, and GRADE-assessed evidence. We investigated these outcomes: (1) 50% or greater reduction in primary generalised tonic-clonic seizure frequency; (2) seizure freedom; (3) treatment withdrawal; (4) adverse effects; (5) cognitive effects; and (6) quality of life. We used an intention-to-treat (ITT) population for all analyses, and presented results as risk ratios (RRs) with 95% confidence intervals (CIs); for adverse effects, we used 99% CIs to compensate for multiple hypothesis testing.\nMain results\nWe included three studies (total 300 participants): two parallel-group studies and one cross-over study. We assessed varied risks of bias across studies; most limitations arose from the poor reporting of methodological details. We meta-analysed data extracted from the two parallel-group studies, and conducted a narrative synthesis for data from the cross-over study.\nBoth parallel-group studies (270 participants) reported all dichotomous outcomes. Participants taking lamotrigine were almost twice as likely to attain a 50% or greater reduction in primary generalised tonic-clonic seizure frequency than those taking a placebo (RR 1.88, 95% CI 1.43 to 2.45; low-certainty evidence). The results between groups were inconclusive for the likelihood of seizure freedom (RR 1.55, 95% CI 0.89 to 2.72; very low-certainty evidence); treatment withdrawal (RR 1.20, 95% CI 0.72 to 1.99; very low-certainty evidence); and individual adverse effects: ataxia (RR 3.05, 99% CI 0.05 to 199.36); dizziness (RR 0.91, 99% CI 0.29 to 2.86; very low-certainty evidence); fatigue (RR 1.02, 99% CI 0.13 to 8.14; very low-certainty evidence); nausea (RR 1.60, 99% CI 0.48 to 5.32; very low-certainty evidence); and somnolence (RR 3.73, 99% CI 0.36 to 38.90; low-certainty evidence).\nThe cross-over trial (26 participants) reported that 7/14 participants with generalised tonic-clonic seizures experienced a 50% or greater reduction in seizure frequency with add-on lamotrigine compared to placebo. The authors reported four treatment withdrawals, but did not specify during which treatment allocation they occurred. Rash (seven lamotrigine participants; zero placebo participants) and fatigue (five lamotrigine participants; zero placebo participants) were the most frequently reported adverse effects.\nNone of the included studies measured cognition. One parallel-group study (N = 153) evaluated quality of life. They reported inconclusive results for the overall quality of life score between groups (P = 0.74).\nAuthors' conclusions\nThis review provides insufficient information to inform clinical practice.\nLow-certainty evidence suggests that lamotrigine reduces the rate of generalised tonic-clonic seizures by 50% or more. Very low-certainty evidence found inconclusive results between groups for all other outcomes. Therefore, we are uncertain to very uncertain that the results reported are accurate, and suggest that the true effect could be grossly different.\nMore trials, recruiting larger populations, over longer periods, are necessary to determine lamotrigine's clinical use.\n\nGiven the provided abstract, please respond to the following query: \"Aim of review\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This review studied whether lamotrigine was effective and tolerable when used as add-on treatment, alongside other antiepileptic medicines, for people with drug-resistant generalised epilepsy (affecting the entire brain from onset) with tonic clonic-seizures (seizures where people lose consciousness and jerk quickly and rhythmically)."
}
] |
query-laysum
|
23797
|
[
{
"role": "user",
"content": "Abstract: Background\nThe prevalence of musculoskeletal symptoms among sedentary workers is high. Interventions that promote occupational standing or walking have been found to reduce occupational sedentary time, but it is unclear whether these interventions ameliorate musculoskeletal symptoms in sedentary workers.\nObjectives\nTo investigate the effectiveness of workplace interventions to increase standing or walking for decreasing musculoskeletal symptoms in sedentary workers.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, OSH UPDATE, PEDro, ClinicalTrials.gov, and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) search portal up to January 2019. We also screened reference lists of primary studies and contacted experts to identify additional studies.\nSelection criteria\nWe included randomised controlled trials (RCTs), cluster-randomised controlled trials (cluster-RCTs), quasi RCTs, and controlled before-and-after (CBA) studies of interventions to reduce or break up workplace sitting by encouraging standing or walking in the workplace among workers with musculoskeletal symptoms. The primary outcome was self-reported intensity or presence of musculoskeletal symptoms by body region and the impact of musculoskeletal symptoms such as pain-related disability. We considered work performance and productivity, sickness absenteeism, and adverse events such as venous disorders or perinatal complications as secondary outcomes.\nData collection and analysis\nTwo review authors independently screened titles, abstracts, and full-text articles for study eligibility. These review authors independently extracted data and assessed risk of bias. We contacted study authors to request additional data when required. We used GRADE considerations to assess the quality of evidence provided by studies that contributed to the meta-analyses.\nMain results\nWe found ten studies including three RCTs, five cluster RCTs, and two CBA studies with a total of 955 participants, all from high-income countries. Interventions targeted changes to the physical work environment such as provision of sit-stand or treadmill workstations (four studies), an activity tracker (two studies) for use in individual approaches, and multi-component interventions (five studies). We did not find any studies that specifically targeted only the organisational level components. Two studies assessed pain-related disability.\nPhysical work environment\nThere was no significant difference in the intensity of low back symptoms (standardised mean difference (SMD) -0.35, 95% confidence interval (CI) -0.80 to 0.10; 2 RCTs; low-quality evidence) nor in the intensity of upper back symptoms (SMD -0.48, 95% CI -.96 to 0.00; 2 RCTs; low-quality evidence) in the short term (less than six months) for interventions using sit-stand workstations compared to no intervention. No studies examined discomfort outcomes at medium (six to less than 12 months) or long term (12 months and more). No significant reduction in pain-related disability was noted when a sit-stand workstation was used compared to when no intervention was provided in the medium term (mean difference (MD) -0.4, 95% CI -2.70 to 1.90; 1 RCT; low-quality evidence).\nIndividual approach\nThere was no significant difference in the intensity or presence of low back symptoms (SMD -0.05, 95% CI -0.87 to 0.77; 2 RCTs; low-quality evidence), upper back symptoms (SMD -0.04, 95% CI -0.92 to 0.84; 2 RCTs; low-quality evidence), neck symptoms (SMD -0.05, 95% CI -0.68 to 0.78; 2 RCTs; low-quality evidence), shoulder symptoms (SMD -0.14, 95% CI -0.63 to 0.90; 2 RCTs; low-quality evidence), or elbow/wrist and hand symptoms (SMD -0.30, 95% CI -0.63 to 0.90; 2 RCTs; low-quality evidence) for interventions involving an activity tracker compared to an alternative intervention or no intervention in the short term. No studies provided outcomes at medium term, and only one study examined outcomes at long term.\nOrganisational level\nNo studies evaluated the effects of interventions solely targeted at the organisational level.\nMulti-component approach\nThere was no significant difference in the proportion of participants reporting low back symptoms (risk ratio (RR) 0.93, 95% CI 0.69 to 1.27; 3 RCTs; low-quality evidence), neck symptoms (RR 1.00, 95% CI 0.76 to 1.32; 3 RCTs; low-quality evidence), shoulder symptoms (RR 0.83, 95% CI 0.12 to 5.80; 2 RCTs; very low-quality evidence), and upper back symptoms (RR 0.88, 95% CI 0.76 to 1.32; 3 RCTs; low-quality evidence) for interventions using a multi-component approach compared to no intervention in the short term. Only one RCT examined outcomes at medium term and found no significant difference in low back symptoms (MD -0.40, 95% CI -1.95 to 1.15; 1 RCT; low-quality evidence), upper back symptoms (MD -0.70, 95% CI -2.12 to 0.72; low-quality evidence), and leg symptoms (MD -0.80, 95% CI -2.49 to 0.89; low-quality evidence). There was no significant difference in the proportion of participants reporting low back symptoms (RR 0.89, 95% CI 0.57 to 1.40; 2 RCTs; low-quality evidence), neck symptoms (RR 0.67, 95% CI 0.41 to 1.08; two RCTs; low-quality evidence), and upper back symptoms (RR 0.52, 95% CI 0.08 to 3.29; 2 RCTs; low-quality evidence) for interventions using a multi-component approach compared to no intervention in the long term. There was a statistically significant reduction in pain-related disability following a multi-component intervention compared to no intervention in the medium term (MD -8.80, 95% CI -17.46 to -0.14; 1 RCT; low-quality evidence).\nAuthors' conclusions\nCurrently available limited evidence does not show that interventions to increase standing or walking in the workplace reduced musculoskeletal symptoms among sedentary workers at short-, medium-, or long-term follow up. The quality of evidence is low or very low, largely due to study design and small sample sizes. Although the results of this review are not statistically significant, some interventions targeting the physical work environment are suggestive of an intervention effect. Therefore, in the future, larger cluster-RCTs recruiting participants with baseline musculoskeletal symptoms and long-term outcomes are needed to determine whether interventions to increase standing or walking can reduce musculoskeletal symptoms among sedentary workers and can be sustained over time.\n\nGiven the provided abstract, please respond to the following query: \"Effects of changes to the physical work environment\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The available evidence is insufficient to show the effectiveness of sit-stand desk or treadmill workstations in reducing the intensity of low back and upper back symptoms."
}
] |
query-laysum
|
23798
|
[
{
"role": "user",
"content": "Abstract: Background\nPain is a common symptom with cancer, and 30% to 50% of all people with cancer will experience moderate to severe pain that can have a major negative impact on their quality of life. Non-opioid drugs are commonly used to treat cancer pain, and are recommended for this purpose in the World Health Organization (WHO) cancer pain treatment ladder, either alone or in combination with opioids.\nA previous Cochrane review that examined the evidence for nonsteroidal anti-inflammatory drugs (NSAIDs) or paracetamol, alone or combined with opioids, for cancer pain was withdrawn in 2015 because it was out of date; the date of the last search was 2005. This review, and another on paracetamol, updates the evidence.\nObjectives\nTo assess the efficacy of oral NSAIDs for cancer pain in adults, and the adverse events reported during their use in clinical trials.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and Embase from inception to April 2017, together with reference lists of retrieved papers and reviews, and two online study registries.\nSelection criteria\nWe included randomised, double-blind, single-blind, or open-label studies of five days' duration or longer, comparing any oral NSAID alone with placebo or another NSAID, or a combination of NSAID plus opioid with the same dose of the opioid alone, for cancer pain of any pain intensity. The minimum study size was 25 participants per treatment arm at the initial randomisation.\nData collection and analysis\nTwo review authors independently searched for studies, extracted efficacy and adverse event data, and examined issues of study quality and potential bias. We did not carry out any pooled analyses. We assessed the quality of the evidence using GRADE and created a 'Summary of findings' table.\nMain results\nEleven studies satisfied inclusion criteria, lasting one week or longer; 949 participants with mostly moderate or severe pain were randomised initially, but fewer completed treatment or had results of treatment. Eight studies were double-blind, two single-blind, and one open-label. None had a placebo only control; eight compared different NSAIDs, three an NSAID with opioid or opioid combination, and one both. None compared an NSAID plus opioid with the same dose of opioid alone. Most studies were at high risk of bias for blinding, incomplete outcome data, or small size; none was unequivocally at low risk of bias.\nIt was not possible to compare NSAIDs as a group with another treatment, or one NSAID with another NSAID. Results for all NSAIDs are reported as a randomised cohort. We judged results for all outcomes as very low-quality evidence.\nNone of the studies reported our primary outcomes of participants with pain reduction of at least 50%, and at least 30%, from baseline; participants with Patient Global Impression of Change (PGIC) of much improved or very much improved (or equivalent wording). With NSAID, initially moderate or severe pain was reduced to no worse than mild pain after one or two weeks in four studies (415 participants in total), with a range of estimates between 26% and 51% in individual studies.\nAdverse event and withdrawal reporting was inconsistent. Two serious adverse events were reported with NSAIDs, and 22 deaths, but these were not clearly related to any pain treatment. Common adverse events were thirst/dry mouth (15%), loss of appetite (14%), somnolence (11%), and dyspepsia (11%). Withdrawals were common, mostly because of lack of efficacy (24%) or adverse events (5%).\nAuthors' conclusions\nThere is no high-quality evidence to support or refute the use of NSAIDs alone or in combination with opioids for the three steps of the three-step WHO cancer pain ladder. There is very low-quality evidence that some people with moderate or severe cancer pain can obtain substantial levels of benefit within one or two weeks.\n\nGiven the provided abstract, please respond to the following query: \"Key findings\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "With an NSAID, initially moderate or severe cancer pain was reduced to no worse than mild pain after one or two weeks in 1 in 4 (26%) to 1 in 2 (51%) people in four studies.\nSide-effect reporting was poor. Two serious side effects were reported with NSAIDs, and 22 deaths, but these were not related to pain treatment. Common side effects were thirst/dry mouth (1 in 7; 15%), loss of appetite (1 in 7; 14%), sleepiness (1 in 10; 11%), and heartburn (1 in 10; 11%). One in four people stopped taking NSAIDs because the drug did not work, and 1 in 20 stopped because of side effects."
}
] |
query-laysum
|
23799
|
[
{
"role": "user",
"content": "Abstract: Background\nMeningococcal disease can lead to death or disability within hours after onset. Pre-admission antibiotics aim to reduce the risk of serious disease and death by preventing delays in starting therapy before confirmation of the diagnosis.\nObjectives\nTo study the effectiveness and safety of pre-admission antibiotics versus no pre-admission antibiotics or placebo, and different pre-admission antibiotic regimens in decreasing mortality, clinical failure, and morbidity in people suspected of meningococcal disease.\nSearch methods\nWe searched CENTRAL (6 January 2017), MEDLINE (1966 to 6 January 2017), Embase (1980 to 6 January 2017), Web of Science (1985 to 6 January 2017), LILACS (1982 to 6 January 2017), and prospective trial registries to January 2017. We previously searched CAB Abstracts from 1985 to June 2015, but did not update this search in January 2017.\nSelection criteria\nRandomised controlled trials (RCTs) or quasi-RCTs comparing antibiotics versus placebo or no intervention, in people with suspected meningococcal infection, or different antibiotics administered before admission to hospital or confirmation of the diagnosis.\nData collection and analysis\nTwo review authors independently assessed trial quality and extracted data from the search results. We calculated the risk ratio (RR) and 95% confidence interval (CI) for dichotomous data. We included only one trial and so did not perform data synthesis. We assessed the overall quality of the evidence using the GRADE approach.\nMain results\nWe found no RCTs comparing pre-admission antibiotics versus no pre-admission antibiotics or placebo. We included one open-label, non-inferiority RCT with 510 participants, conducted during an epidemic in Niger, evaluating a single dose of intramuscular ceftriaxone versus a single dose of intramuscular long-acting (oily) chloramphenicol. Ceftriaxone was not inferior to chloramphenicol in reducing mortality (RR 1.21, 95% CI 0.57 to 2.56; N = 503; 308 confirmed meningococcal meningitis; 26 deaths; moderate-quality evidence), clinical failures (RR 0.83, 95% CI 0.32 to 2.15; N = 477; 18 clinical failures; moderate-quality evidence), or neurological sequelae (RR 1.29, 95% CI 0.63 to 2.62; N = 477; 29 with sequelae; low-quality evidence). No adverse effects of treatment were reported. Estimated treatment costs were similar. No data were available on disease burden due to sequelae.\nAuthors' conclusions\nWe found no reliable evidence to support the use pre-admission antibiotics for suspected cases of non-severe meningococcal disease. Moderate-quality evidence from one RCT indicated that single intramuscular injections of ceftriaxone and long-acting chloramphenicol were equally effective, safe, and economical in reducing serious outcomes. The choice between these antibiotics should be based on affordability, availability, and patterns of antibiotic resistance.\nFurther RCTs comparing different pre-admission antibiotics, accompanied by intensive supportive measures, are ethically justified in people with less severe illness, and are needed to provide reliable evidence in different clinical settings.\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": "Although the study was well conducted, the overall quality of the evidence was only moderate for death and treatment failures because the study excluded children less than two months old, pregnant women, and the severely ill. The quality of evidence was lower for neurological disabilities because of the shortness of follow-up.\nSince meningococcal disease has serious consequences, not giving antibiotics empirically would be unethical. However, future research comparing different antibiotics in people of all ages and illness severity is required to provide reliable evidence in different clinical settings."
}
] |
query-laysum
|
23800
|
[
{
"role": "user",
"content": "Abstract: Background\nTopical analgesic drugs are used for a variety of painful conditions. Some are acute, typically strains or sprains, tendinopathy, or muscle aches. Others are chronic, typically osteoarthritis of hand or knee, or neuropathic pain.\nObjectives\nTo provide an overview of the analgesic efficacy and associated adverse events of topical analgesics (primarily nonsteroidal anti-inflammatory drugs (NSAIDs), salicylate rubefacients, capsaicin, and lidocaine) applied to intact skin for the treatment of acute and chronic pain in adults.\nMethods\nWe identified systematic reviews in acute and chronic pain published to February 2017 in the Cochrane Database of Systematic Reviews (the Cochrane Library). The primary outcome was at least 50% pain relief (participant-reported) at an appropriate duration. We extracted the number needed to treat for one additional beneficial outcome (NNT) for efficacy outcomes for each topical analgesic or formulation, and the number needed to treat for one additional harmful outcome (NNH) for adverse events. We also extracted information on withdrawals due to lack of efficacy or adverse events, systemic and local adverse events, and serious adverse events. We required information from at least 200 participants, in at least two studies. We judged that there was potential for publication bias if the addition of four studies of typical size (400 participants) with zero effect increased NNT compared with placebo to 10 (minimal clinical utility). We extracted GRADE assessment in the original papers, and made our own GRADE assessment.\nMain results\nThirteen Cochrane Reviews (206 studies with around 30,700 participants) assessed the efficacy and harms from a range of topical analgesics applied to intact skin in a number of acute and chronic painful conditions. Reviews were overseen by several Review Groups, and concentrated on evidence comparing topical analgesic with topical placebo; comparisons of topical and oral analgesics were rare.\nFor at least 50% pain relief, we considered evidence was moderate or high quality for several therapies, based on the underlying quality of studies and susceptibility to publication bias.\nIn acute musculoskeletal pain (strains and sprains) with assessment at about seven days, therapies were diclofenac Emulgel (78% Emulgel, 20% placebo; 2 studies, 314 participants, NNT 1.8 (95% confidence interval 1.5 to 2.1)), ketoprofen gel (72% ketoprofen, 33% placebo, 5 studies, 348 participants, NNT 2.5 (2.0 to 3.4)), piroxicam gel (70% piroxicam, 47% placebo, 3 studies, 522 participants, NNT 4.4 (3.2 to 6.9)), diclofenac Flector plaster (63% Flector, 41% placebo, 4 studies, 1030 participants, NNT 4.7 (3.7 to 6.5)), and diclofenac other plaster (88% diclofenac plaster, 57% placebo, 3 studies, 474 participants, NNT 3.2 (2.6 to 4.2)).\nIn chronic musculoskeletal pain (mainly hand and knee osteoarthritis) therapies were topical diclofenac preparations for less than six weeks (43% diclofenac, 23% placebo, 5 studies, 732 participants, NNT 5.0 (3.7 to 7.4)), ketoprofen over 6 to 12 weeks (63% ketoprofen, 48% placebo, 4 studies, 2573 participants, NNT 6.9 (5.4 to 9.3)), and topical diclofenac preparations over 6 to 12 weeks (60% diclofenac, 50% placebo, 4 studies, 2343 participants, NNT 9.8 (7.1 to 16)). In postherpetic neuralgia, topical high-concentration capsaicin had moderate-quality evidence of limited efficacy (33% capsaicin, 24% placebo, 2 studies, 571 participants, NNT 11 (6.1 to 62)).\nWe judged evidence of efficacy for other therapies as low or very low quality. Limited evidence of efficacy, potentially subject to publication bias, existed for topical preparations of ibuprofen gels and creams, unspecified diclofenac formulations and diclofenac gel other than Emulgel, indomethacin, and ketoprofen plaster in acute pain conditions, and for salicylate rubefacients for chronic pain conditions. Evidence for other interventions (other topical NSAIDs, topical salicylate in acute pain conditions, low concentration capsaicin, lidocaine, clonidine for neuropathic pain, and herbal remedies for any condition) was very low quality and typically limited to single studies or comparisons with sparse data.\nWe assessed the evidence on withdrawals as moderate or very low quality, because of small numbers of events. In chronic pain conditions lack of efficacy withdrawals were lower with topical diclofenac (6%) than placebo (9%) (11 studies, 3455 participants, number needed to treat to prevent (NNTp) 26, moderate-quality evidence), and topical salicylate (2% vs 7% for placebo) (5 studies, 501 participants, NNTp 21, very low-quality evidence). Adverse event withdrawals were higher with topical capsaicin low-concentration (15%) than placebo (3%) (4 studies, 477 participants, NNH 8, very low-quality evidence), topical salicylate (5% vs 1% for placebo) (7 studies, 735 participants, NNH 26, very low-quality evidence), and topical diclofenac (5% vs 4% for placebo) (12 studies, 3552 participants, NNH 51, very low-quality evidence).\nIn acute pain, systemic or local adverse event rates with topical NSAIDs (4.3%) were no greater than with topical placebo (4.6%) (42 studies, 6740 participants, high quality evidence). In chronic pain local adverse events with topical capsaicin low concentration (63%) were higher than topical placebo (5 studies, 557 participants, number needed to treat for harm (NNH) 2.6), high quality evidence. Moderate-quality evidence indicated more local adverse events than placebo in chronic pain conditions with topical diclofenac (NNH 16) and local pain with topical capsaicin high-concentration (NNH 16). There was moderate-quality evidence of no additional local adverse events with topical ketoprofen over topical placebo in chronic pain. Serious adverse events were rare (very low-quality evidence).\nGRADE assessments of moderate or low quality in some of the reviews were considered by us to be very low because of small numbers of participants and events.\nAuthors' conclusions\nThere is good evidence that some formulations of topical diclofenac and ketoprofen are useful in acute pain conditions such as sprains or strains, with low (good) NNT values. There is a strong message that the exact formulation used is critically important in acute conditions, and that might also apply to other pain conditions. In chronic musculoskeletal conditions with assessments over 6 to 12 weeks, topical diclofenac and ketoprofen had limited efficacy in hand and knee osteoarthritis, as did topical high-concentration capsaicin in postherpetic neuralgia. Though NNTs were higher, this still indicates that a small proportion of people had good pain relief.\nUse of GRADE in Cochrane Reviews with small numbers of participants and events requires attention.\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 ranged from high to very low. The main reason for evidence being very low quality was the small number of participants in some studies, which make it impossible (or unsafe) to estimate benefit or harm."
}
] |
query-laysum
|
23801
|
[
{
"role": "user",
"content": "Abstract: Background\nUrinary incontinence is common after radical prostatectomy and can also occur in some circumstances after transurethral resection of the prostate (TURP). Conservative management includes pelvic floor muscle training with or without biofeedback, electrical stimulation, extra-corporeal magnetic innervation (ExMI), compression devices (penile clamps), lifestyle changes, or a combination of methods.\nObjectives\nTo determine the effectiveness of conservative management for urinary incontinence up to 12 months after transurethral, suprapubic, laparoscopic, radical retropubic or perineal prostatectomy, including any single conservative therapy or any combination of conservative therapies.\nSearch methods\nWe searched the Cochrane Incontinence Group Specialised Register (5 February 2014), CENTRAL (2014, Issue 1), EMBASE (January 2010 to Week 3 2014), CINAHL (January 1982 to 18 January 2014), ClinicalTrials.gov and World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (both searched 29 January 2014), and the reference lists of relevant articles.\nSelection criteria\nRandomised or quasi-randomised controlled trials evaluating conservative interventions for urinary continence in men after prostatectomy.\nData collection and analysis\nTwo or more review authors assessed the methodological quality of the trials and abstracted data. We tried to contact several authors of included studies to obtain extra information.\nMain results\nFifty trials met the inclusion criteria, 45 in men after radical prostatectomy, four trials after TURP and one trial after either operation. The trials included 4717 men of whom 2736 had an active conservative intervention. There was considerable variation in the interventions, populations and outcome measures. Data were not available for many of the pre-stated outcomes. Men's symptoms improved over time irrespective of management.\nThere was no evidence from eight trials that pelvic floor muscle training with or without biofeedback was better than control for men who had urinary incontinence up to 12 months after radical prostatectomy; the quality of the evidence was judged to be moderate (for example 57% with urinary incontinence in the intervention group versus 62% in the control group, risk ratio (RR) for incontinence after 12 months 0.85, 95% confidence interval (CI) 0.60 to 1.22). One large multi-centre trial of one-to-one therapy showed no difference in any urinary or quality of life outcome measures and had narrow CIs. It seems unlikely that men benefit from one-to-one PFMT therapy after TURP. Individual small trials provided data to suggest that electrical stimulation, external magnetic innervation, or combinations of treatments might be beneficial but the evidence was limited.\nAmongst trials of conservative treatment for all men after radical prostatectomy, aimed at both treatment and prevention, there was moderate evidence of an overall benefit from pelvic floor muscle training versus control management in terms of reduction of urinary incontinence (for example 10% with urinary incontinence after one year in the intervention groups versus 32% in the control groups, RR for urinary incontinence 0.32, 95% CI 0.20 to 0.51). However, this finding was not supported by other data from pad tests. The findings should be treated with caution because the risk of bias assessment showed methodological limitations.\nMen in one trial were more satisfied with one type of external compression device, which had the lowest urine loss, compared to two others or no treatment. The effect of other conservative interventions such as lifestyle changes remained undetermined as no trials involving these interventions were identified.\nAuthors' conclusions\nThe value of the various approaches to conservative management of postprostatectomy incontinence after radical prostatectomy remains uncertain. The evidence is conflicting and therefore rigorous, adequately powered randomised controlled trials (RCTs) which abide by the principles and recommendations of the CONSORT statement are still needed to obtain a definitive answer. The trials should be robustly designed to answer specific well constructed research questions and include outcomes which are important from the patient's perspective in decision making and are also relevant to the healthcare professionals. Long-term incontinence may be managed by an external penile clamp, but there are safety problems.\n\nGiven the provided abstract, please respond to the following query: \"Adverse effects\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "This one penile clamp needed to be used cautiously because of safety risks."
}
] |
query-laysum
|
23802
|
[
{
"role": "user",
"content": "Abstract: Background\nRespiratory syncytial virus infection causes acute lung infection in infants and young children worldwide, resulting in considerable morbidity and mortality. Children with cystic fibrosis are prone to recurrent lung inflammation, bacterial colonisation and subsequent chronic airway disease, putting them at risk for severe respiratory syncytial virus infections requiring intensive care and respiratory support. No treatment currently exists, hence prevention is important. Palivizumab is effective in reducing respiratory syncytial virus hospitalisation rates and is recommended for prophylaxis in high-risk children with other conditions. It is unclear if palivizumab can prevent respiratory syncytial virus hospitalisations and intensive care unit admissions in children with cystic fibrosis. This is an update of a previously published review.\nObjectives\nTo determine the efficacy and safety of palivizumab (Synagis®) compared with placebo, no prophylaxis or other prophylaxis, in preventing hospitalisation and mortality from respiratory syncytial virus infection in children with cystic fibrosis.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register and scanned references of the eligible study and related reviews.\nDate of last search: 05 May 2016.\nSelection criteria\nRandomised and quasi-randomised studies.\nData collection and analysis\nThe authors independently extracted data and assessed risk of bias.\nMain results\nOne study (186 infants up to two years old) comparing five monthly doses of palivizumab (N = 92) to placebo (N = 94) over one respiratory syncytial virus season was identified and met our inclusion criteria. We judged there to be a low risk of bias with respect to the concealment of the randomization schedule (although it was not clear how this was generated) and to blinding of participants and study personnel. There is also a low risk of bias with regards to incomplete outcome data. However, we judged there to be a high risk of bias from selective reporting (summary statements presented but no data) and the fact that this industry-supported study has not been published as a full report in a peer-reviewed journal.\nAt six months follow-up, one participant in each group was hospitalised due to respiratory syncytial virus; there were no deaths in either group. In the palivizumab and placebo groups, 86 and 90 children experienced any adverse event, while five and four children had related adverse events respectively. Nineteeen children receiving palivizumab and 16 receiving placebo suffered serious adverse events; one participant receiving palivizumab discontinued due to this. At 12 months follow-up, there were no significant differences between groups in number of Pseudomonas bacterial colonisations or change in weight-to-height ratio.\nAuthors' conclusions\nWe identified one randomised controlled trial comparing five monthly doses of palivizumab to placebo in infants up to two years old with cystic fibrosis. While the overall incidence of adverse events was similar in both groups, it is not possible to draw firm conclusions on the safety and tolerability of respiratory syncytial virus prophylaxis with palivizumab in infants with cystic fibrosis. Six months after treatment, the authors reported no clinically meaningful differences in outcomes. Additional randomised studies are needed to establish the safety and efficacy of palivizumab in children with cystic fibrosis.\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 about the effects of vaccinating children with cystic fibrosis with palivizumab to prevent respiratory syncytial virus."
}
] |
query-laysum
|
23803
|
[
{
"role": "user",
"content": "Abstract: Background\nRadial head fracture is the most common fracture of the elbow. It usually results from a fall onto an outstretched arm. In 1954, Mason classified these fractures into type 1 (undisplaced), type 2 (simple displaced), and type 3 (comminuted fractures). Aspiration of the elbow joint aims to relieve pressure in the elbow joint and has been used as an initial treatment option for radial head fractures. However, it is an invasive technique with the potential for complications such as infection and injury to nerves and vessels.\nObjectives\nTo assess the effects (benefits and harms) of elbow joint aspiration for treating radial head fracture in adults.\nSearch methods\nWe searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (14 April 2014), the Cochrane Central Register of Controlled Trials (CENTRAL) (14 April 2014), MEDLINE (1946 to April Week 1 2014) and EMBASE (1980 to 2014 Week 15), trial registries, bibliographies and conference proceedings.\nSelection criteria\nRandomised and quasi-randomised controlled clinical trials comparing aspiration versus no aspiration for treating radial head fractures in adults.\nData collection and analysis\nTwo review authors independently selected articles, assessed risk of bias and extracted data. Disagreements were resolved by discussion. Where appropriate, we pooled results of comparable studies using fixed-effect meta-analysis.\nMain results\nWe included two trials that involved 126 participants but provided results for only 108 participants. Most participants were adults, typically over 30 years of age. Both trials were at high risk of selection, performance, detection and reporting bias. Reflecting this high risk of bias, we downgraded the quality of evidence two levels for study limitations and a further level for imprecision. Thus we judged the evidence for all outcomes to be 'very low' quality, meaning that we are very uncertain about these estimates.\nOne trial included participants with Mason type 1, 2 or 3 radial head fractures and also a few cases of traumatic elbow hemarthrosis without fracture. The other trial included participants with Mason type 1 and 2 fractures. All participants were managed non-surgically.\nNeither trial reported functional outcome based on validated patient-reported outcome measures of function or pain using validated measures such as a visual analogue scale. Very low quality evidence (108 participants, two trials) indicates little difference between aspiration and no aspiration in impaired function (unable to carry heavy loads; discomfort when carrying loads) at 12 months (9/51 in aspiration group versus 7/57 in the no aspiration group; risk ratio 1.43 favouring no aspiration, 95% confidence interval (CI) 0.57 to 3.58). Very low quality evidence (two trials) suggests a beneficial effect of aspiration on pain relief immediately after aspiration. Very low quality evidence (one trial, 28 participants) shows less pain after aspiration at three weeks, but it is unclear whether this applies subsequently. Neither trial reported on adverse events (for example, nerve and vascular injuries; deep or superficial infection) from the procedure, but aspiration was reported as being unsuccessful in three participants (7.9%) in one trial. Very low quality evidence indicates little difference in range of motion (based on elbow extension) between the two groups at six weeks (28 participants, one trial) or 12 months (108 participants, two trials). The report of adverse events was incomplete, but one trial (80 participants) reported the absence of three specific complications: myositis ossificans, joint instability or late displacement of the fracture.\nAuthors' conclusions\nThere is insufficient evidence to determine the effectiveness of joint aspiration for the initial treatment of radial head fracture in terms of function, pain and range of motion or to determine the safety of the procedure. An examination of current aspiration use, the prospective collection of adverse events and consultation with patients as to their preferences and values would be helpful in guiding decisions about the future design of a multicentre randomised trial aiming to obtain definitive evidence on the use of aspiration for treating radial head fractures.\n\nGiven the provided abstract, please respond to the following query: \"Summary of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Very low quality evidence showed little difference between those who had joint aspiration and those who did not in being unable to carry heavy loads or having discomfort when carrying loads using their previously injured arm at one year after injury. Very low quality evidence shows that aspiration often provides immediate pain relief and may still provide pain relief at three weeks. Neither trial reported on adverse events from the procedure, but aspiration was reported as being unsuccessful in three participants of one study. Very low quality evidence shows little effect of aspiration on being able to extend the elbow at either six weeks or one year. The reporting of adverse events was incomplete, but one trial reported the absence of three common complications of radial head fractures."
}
] |
query-laysum
|
23804
|
[
{
"role": "user",
"content": "Abstract: Background\nPlatelet transfusions are used in modern clinical practice to prevent and treat bleeding in people who are thrombocytopenic due to bone marrow failure. Although considerable advances have been made in platelet transfusion therapy in the last 40 years, some areas continue to provoke debate, especially concerning the use of prophylactic platelet transfusions for the prevention of thrombocytopenic bleeding.\nThis is an update of a Cochrane review first published in 2004, and previously updated in 2012 that addressed four separate questions: prophylactic versus therapeutic-only platelet transfusion policy; prophylactic platelet transfusion threshold; prophylactic platelet transfusion dose; and platelet transfusions compared to alternative treatments. This review has now been split into four smaller reviews looking at these questions individually; this review compares prophylactic platelet transfusion thresholds.\nObjectives\nTo determine whether different platelet transfusion thresholds for administration of prophylactic platelet transfusions (platelet transfusions given to prevent bleeding) affect the efficacy and safety of prophylactic platelet transfusions in preventing bleeding in people with haematological disorders undergoing myelosuppressive chemotherapy or haematopoietic stem cell transplantation (HSCT).\nSearch methods\nWe searched for randomised controlled trials (RCTs) in the Cochrane Central Register of Controlled Trials (CENTRAL) (Cochrane Library 2015, Issue 6, 23 July 2015), MEDLINE (from 1946), Embase (from 1974), CINAHL (from 1937), the Transfusion Evidence Library (from 1950), and ongoing trial databases to 23 July 2015.\nSelection criteria\nWe included RCTs involving transfusions of platelet concentrates, prepared either from individual units of whole blood or by apheresis, and given to prevent bleeding in people with haematological disorders (receiving myelosuppressive chemotherapy or undergoing HSCT) that compared different thresholds for administration of prophylactic platelet transfusions (low trigger (5 x 109/L); standard trigger (10 x 109/L); higher trigger (20 x 109/L, 30 x 109/L, 50 x 109/L); or alternative platelet trigger (for example platelet mass)).\nData collection and analysis\nWe used the standard methodological procedures expected by Cochrane.\nMain results\nThree trials met our predefined inclusion criteria and were included for analysis in the review (499 participants). All three trials compared a standard trigger (10 x 109/L) versus a higher trigger (20 x 109/L or 30 x 109/L). None of the trials compared a low trigger versus a standard trigger or an alternative platelet trigger. The trials were conducted between 1991 and 2001 and enrolled participants from fairly comparable patient populations.\nThe original review contained four trials (658 participants); in the previous update of this review we excluded one trial (159 participants) because fewer than 80% of participants had a haematological disorder. We identified no new trials in this update of the review.\nOverall, the methodological quality of the studies was low across different outcomes according to GRADE methodology. None of the included studies were at low risk of bias in every domain, and all the included studies had some threats to validity.\nThree studies reported the number of participants with at least one clinically significant bleeding episode within 30 days from the start of the study. There was no evidence of a difference in the number of participants with a clinically significant bleeding episode between the standard and higher trigger groups (three studies; 499 participants; risk ratio (RR) 1.35, 95% confidence interval (CI) 0.95 to 1.90; low-quality evidence).\nOne study reported the number of days with a clinically significant bleeding event (adjusted for repeated measures). There was no evidence of a difference in the number of days of bleeding per participant between the standard and higher trigger groups (one study; 255 participants; relative proportion of days with World Health Organization Grade 2 or worse bleeding (RR 1.71, 95% CI 0.84 to 3.48, P = 0.162; authors' own results; low-quality evidence).\nTwo studies reported the number of participants with severe or life-threatening bleeding. There was no evidence of any difference in the number of participants with severe or life-threatening bleeding between a standard trigger level and a higher trigger level (two studies; 421 participants; RR 0.99, 95% CI 0.52 to 1.88; low-quality evidence).\nOnly one study reported the time to first bleeding episode. There was no evidence of any difference in the time to the first bleeding episode between a standard trigger level and a higher trigger level (one study; 255 participants; hazard ratio 1.11, 95% CI 0.64 to 1.91; low-quality evidence).\nOnly one study reported on all-cause mortality within 30 days from the start of the study. There was no evidence of any difference in all-cause mortality between standard and higher trigger groups (one study; 255 participants; RR 1.78, 95% CI 0.83 to 3.81; low-quality evidence).\nThree studies reported on the number of platelet transfusions per participant. Two studies reported on the mean number of platelet transfusions per participant. There was a significant reduction in the number of platelet transfusions per participant in the standard trigger group (two studies, mean difference -2.09, 95% CI -3.20 to -0.99; low-quality evidence).\nOne study reported on the number of transfusion reactions. There was no evidence to demonstrate any difference in transfusion reactions between the standard and higher trigger groups (one study; 79 participants; RR 0.07, 95% CI 0.00 to 1.09).\nNone of the studies reported on quality of life.\nAuthors' conclusions\nIn people with haematological disorders who are thrombocytopenic due to myelosuppressive chemotherapy or HSCT, we found low-quality evidence that a standard trigger level (10 x 109/L) is associated with no increase in the risk of bleeding when compared to a higher trigger level (20 x 109/L or 30 x 109/L). There was low-quality evidence that a standard trigger level is associated with a decreased number of transfusion episodes when compared to a higher trigger level (20 x 109/L or 30 x 109/L).\nFindings from this review were based on three studies and 499 participants. Without further evidence, it is reasonable to continue with the current practice of administering prophylactic platelet transfusions using the standard trigger level (10 x 109/L) in the absence of other risk factors for bleeding.\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 evaluated the evidence about whether platelet transfusions given to prevent bleeding in people with lower platelet counts (for example 5 x 109/L or below) were as effective and safe as the current standard (10 x 109/L or below), or whether higher platelet count levels (20 x 109/L or below, 30 x 109/L or below, or 50 x 109/L or below) were safer than the current standard (10 x 109/L or below). Our target population was people with blood cancers (for example leukaemia, lymphoma, myeloma) who were receiving intensive (myelosuppressive) chemotherapy treatments or stem cell transplantation."
}
] |
query-laysum
|
23805
|
[
{
"role": "user",
"content": "Abstract: Background\nDietary supplements are frequently used for the treatment of several medical conditions, both prescribed by physicians or self administered. However, evidence of benefit and safety of these supplements is usually limited or absent.\nObjectives\nTo assess the efficacy and safety of dietary supplementation for people with chronic gout.\nSearch methods\nWe updated the original search by searching CENTRAL, MEDLINE, Embase, CINAHL, and four trials registers (August 2020). We applied no date or language restrictions. We also handsearched the abstracts from the 2010 to 2019 American College of Rheumatology and European League against Rheumatism conferences, and checked the references of all included studies.\nSelection criteria\nWe considered all published randomised controlled trials (RCTs) or quasi-RCTs that compared dietary supplements with no supplements, placebo, another supplement, or pharmacological agents for adults with chronic gout for inclusion. Dietary supplements included, but were not limited to, amino acids, antioxidants, essential minerals, polyunsaturated fatty acids, prebiotic agents, probiotic agents, and vitamins. The major outcomes were acute gout flares, study withdrawal due to adverse events (AEs), serum uric acid (sUA) reduction, joint pain reduction, participant global assessment, total number of AEs, and tophus regression.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nTwo previously included RCTs (160 participants) met our inclusion criteria; we did not identify any new trials for this update. As these two trials evaluated different diet supplements (enriched skim milk powder (SMP) and vitamin C) with different outcomes (gout flare prevention for enriched SMP, and sUA reduction for vitamin C), we reported the results separately.\nOne trial (120 participants), at unclear risk of selection and detection bias, compared SMP enriched with glycomacropeptides (GMP) with un-enriched SMP, and with lactose, over three months. Participants were predominantly men, aged in their 50s, who had severe gout. The results for all major outcomes were imprecise, except for pain. None of the results were clinically significant.\nThe frequency of acute gout attacks, measured as the number of flares per month, decreased in all three groups over the three-month study period. The effects of enriched SMP (SMP/GMP/G600) compared with the combined control groups (SMP and lactose powder) at three months in terms of mean number of gout flares per month were not clinically significant (mean (standard deviation (SD)) flares per month: 0.49 (1.52) in SMP/GMP/G600 group versus 0.70 (1.28) in the control groups; absolute risk difference: mean difference (MD) -0.21 flares per month, 95% confidence interval (CI) -0.76 to 0.34; low-quality evidence).\nThe number of withdrawals due to adverse effects was similar between groups (7/40 in SMP/GMP/G600 group versus 11/80 in control groups; (risk ratio (RR) 1.27, 95% CI 0.53 to 3.03); there were 4% more withdrawals in the SMP/lactose groups (10% fewer to 18% more; low-quality evidence).\nSerum uric acid reduction was similar across groups (mean (SD) -0.025 (0.067) mmol/L in SMP/GMP/G600 group versus -0.010 (0.069) in control groups; MD -0.01, 95% CI -0.04 to 0.01; low-quality evidence).\nPain from self-reported gout flares (measured on a 10-point Likert scale) improved slightly more in the GMP/G600 SMP group compared with controls (mean (SD) -1.97 (2.28) in SMP/GMP/G600 group versus -0.94 (2.25) in control groups; MD -1.03, 95% CI -1.89 to -0.17). This was an absolute reduction of 10% (95% CI 20% to 1% reduction; low-quality evidence), which may not be of clinical relevance.\nThe risk of adverse events was similar between groups (19/40 in SMP/GMP/G600 group versus 39/80 in control groups; RR 0.97, 95% CI 0.66 to 1.45); the absolute risk difference was 1% fewer adverse events (1% fewer to 2% more), low-quality evidence). Gastrointestinal events such as nausea, flatulence and diarrhoea were the most commonly reported adverse effects.\nData for participant global assessment were not available for analysis; the study did not report tophus regression.\nOne trial (40 participants), at high risk of selection, performance, and detection bias, compared vitamin C alone with allopurinol, and with allopurinol plus vitamin C, in a three-arm study. We only included data from the vitamin C versus allopurinol comparison in this review. Participants were predominantly middle-aged men, and their severity of gout was representative of gout in general.\nAllopurinol reduced sUA levels more than vitamin C (MD 0.10 mmol/L, 95% CI 0.06 to 0.15), low-quality evidence. The study reported no adverse events; none of the participants withdrew due to adverse events.\nThe study did not assess the rate of gout attacks, joint pain reduction, participant global assessment, or tophus regression.\nAuthors' conclusions\nWhile dietary supplements may be widely used for gout, this review found no high-quality that supported or refuted the use of glycomacropeptide-enriched skim milk powder or vitamin C for adults with chronic gout.\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": "Overall, we found low-quality evidence in both trials. We reduced the quality of the evidence because the trials were poorly conducted and reported, the sample sizes were small, and the results suggested both benefits and harms for most outcomes. Low-quality evidence from one study indicated that enriched skim milk, compared with standard skim milk or lactose powder, may not reduce the frequency of gout attacks or improve uric acid levels, but may reduce pain. Further research is likely to change these estimates. We do not have precise information about side effects and complications, but possible side effects may include nausea, bloating or diarrhoea.\nCompared with the commonly used medicine, allopurinol, low-quality evidence from one study showed that vitamin C reduced serum uric acid levels less; the difference was probably clinically unimportant. Other possible benefits of vitamin C are uncertain, as they were not evaluated in the study. No side effects were reported. Further research is likely to change these estimates."
}
] |
query-laysum
|
23806
|
[
{
"role": "user",
"content": "Abstract: Background\nThis is an update of the original Cochrane Review published in Cochrane Library, Issue 10, 2012.\nHydatidiform mole (HM), also called a molar pregnancy, is characterised by an overgrowth of foetal chorionic tissue within the uterus. HMs may be partial (PM) or complete (CM) depending on their gross appearance, histopathology and karyotype. PMs usually have a triploid karyotype, derived from maternal and paternal origins, whereas CMs are diploid and have paternal origins only. Most women with HM can be cured by evacuation of retained products of conception (ERPC) and their fertility preserved. However, in some women the growth persists and develops into gestational trophoblastic neoplasia (GTN), a malignant form of the disease that requires treatment with chemotherapy. CMs have a higher rate of malignant transformation than PMs. It may be possible to reduce the risk of GTN in women with HM by administering prophylactic chemotherapy (P-Chem). However, P-Chem given before or after evacuation of HM to prevent malignant sequelae remains controversial, as the risks and benefits of this practice are unclear.\nObjectives\nTo evaluate the effectiveness and safety of P-Chem to prevent GTN in women with a molar pregnancy. To investigate whether any subgroup of women with HM may benefit more from P-Chem than others.\nSearch methods\nFor the original review we performed electronic searches in the Cochrane Gynaecological Cancer Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL, Issue 2, 2012), MEDLINE (1946 to February week 4, 2012) and Embase (1980 to 2012, week 9). We developed the search strategy using free text and MeSH. For this update we searched the Cochrane Central Register of Controlled Trials (CENTRAL, Issue 5, 2017), MEDLINE (February 2012 to June week 1, 2017) and Embase (February 2012 to 2017, week 23). We also handsearched reference lists of relevant literature to identify additional studies and searched trial registries.\nSelection criteria\nWe included randomised controlled trials (RCTs) of P-Chem for HM.\nData collection and analysis\nTwo review authors independently assessed studies for inclusion in the review and extracted data using a specifically designed data collection form. Meta-analyses were performed by pooling data from individual trials using Review Manager 5 (RevMan 5) software in line with standard methodological procedures expected by Cochrane methodology.\nMain results\nThe searches identified 161 records; after de-duplication and title and abstract screening 90 full-text articles were retrieved. From these we included three RCTs with a combined total of 613 participants. One study compared prophylactic dactinomycin to no prophylaxis (60 participants); the other two studies compared prophylactic methotrexate to no prophylaxis (420 and 133 participants). All participants were diagnosed with CMs. We considered the latter two studies to be of poor methodological quality.\nP-Chem reduced the risk of GTN occurring in women following a CM (3 studies, 550 participants; risk ratio (RR) 0.37, 95% confidence interval (CI) 0.24 to 0.57; I² = 0%; P < 0.00001; low-quality evidence). However, owing to the poor quality (high risk of bias) of two of the included studies, we performed sensitivity analyses excluding these two studies. This left only one small study of high-risk women to contribute data for this primary outcome (59 participants; RR 0.28, 95% CI 0.10 to 0.73; P = 0.01); therefore we consider this evidence to be of low quality.\nThe time to diagnosis was longer in the P-Chem group than the control group (2 studies, 33 participants; mean difference (MD) 28.72, 95% CI 13.19 to 44.24; P = 0.0003; low-quality evidence); and the P-Chem group required more courses to cure subsequent GTN (1 poor-quality study, 14 participants; MD 1.10, 95% CI 0.52 to 1.68; P = 0.0002; very low quality evidence).\nThere were insufficient data to perform meta-analyses for toxicity, overall survival, drug resistance and reproductive outcomes.\nAuthors' conclusions\nP-Chem may reduce the risk of progression to GTN in women with CMs who are at a high risk of malignant transformation; however, current evidence in favour of P-Chem is limited by the poor methodological quality and small size of the included studies. As P-Chem may increase drug resistance, delays treatment of GTN and may expose women toxic side effects, this practice cannot currently be recommended.\n\nGiven the provided abstract, please respond to the following query: \"The aim of the review\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "By doing this review, we tried to assess the benefits and risks of giving anti-cancer drugs (P-Chem) to women with molar pregnancies, before or after ERPC."
}
] |
query-laysum
|
23807
|
[
{
"role": "user",
"content": "Abstract: Background\nHip fractures are a major healthcare problem, presenting a considerable challenge and burden to individuals and healthcare systems. The number of hip fractures globally is rising rapidly. The majority of intracapsular hip fractures are treated surgically.\nObjectives\nTo assess the relative effects (benefits and harms) of all surgical treatments used in the management of intracapsular hip fractures in older adults, using a network meta-analysis of randomised trials, and to generate a hierarchy of interventions according to their outcomes.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, Web of Science, and five other databases in July 2020. We also searched clinical trials databases, conference proceedings, reference lists of retrieved articles and conducted backward-citation searches.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-RCTs comparing different treatments for fragility intracapsular hip fractures in older adults. We included total hip arthroplasties (THAs), hemiarthroplasties (HAs), internal fixation, and non-operative treatments. We excluded studies of people with hip fracture with specific pathologies other than osteoporosis or resulting from high-energy trauma.\nData collection and analysis\nTwo review authors independently assessed studies for inclusion. One review author completed data extraction which was checked by a second review author. We collected data for three outcomes at different time points: mortality and health-related quality of life (HRQoL) - both reported within 4 months, at 12 months, and after 24 months of surgery, and unplanned return to theatre (at end of study follow-up).\nWe performed a network meta-analysis (NMA) with Stata software, using frequentist methods, and calculated the differences between treatments using risk ratios (RRs) and standardised mean differences (SMDs) and their corresponding 95% confidence intervals (CIs). We also performed direct comparisons using the same codes.\nMain results\nWe included 119 studies (102 RCTS, 17 quasi-RCTs) with 17,653 participants with 17,669 intracapsular fractures in the review; 83% of fractures were displaced. The mean participant age ranged from 60 to 87 years and 73% were women.\nAfter discussion with clinical experts, we selected 12 nodes that represented the best balance between clinical plausibility and efficiency of the networks: cemented modern unipolar HA, dynamic fixed angle plate, uncemented first-generation bipolar HA, uncemented modern bipolar HA, cemented modern bipolar HA, uncemented first-generation unipolar HA, uncemented modern unipolar HA, THA with single articulation, dual-mobility THA, pins, screws, and non-operative treatment. Seventy-five studies (with 11,855 participants) with data for at least two of these treatments contributed to the NMA.\nWe selected cemented modern unipolar HA as a reference treatment against which other treatments were compared. This was a common treatment in the networks, providing a clinically appropriate comparison. In order to provide a concise summary of the results, we report only network estimates when there was evidence of difference between treatments.\nWe downgraded the certainty of the evidence for serious and very serious risks of bias and when estimates included possible transitivity, particularly for internal fixation which included more undisplaced fractures. We also downgraded for incoherence, or inconsistency in indirect estimates, although this affected few estimates. Most estimates included the possibility of benefits and harms, and we downgraded the evidence for these treatments for imprecision.\nWe found that cemented modern unipolar HA, dynamic fixed angle plate and pins seemed to have the greatest likelihood of reducing mortality at 12 months. Overall, 23.5% of participants who received the reference treatment died within 12 months of surgery. Uncemented modern bipolar HA had higher mortality than the reference treatment (RR 1.37, 95% CI 1.02 to 1.85; derived only from indirect evidence; low-certainty evidence), and THA with single articulation also had higher mortality (network estimate RR 1.62, 95% CI 1.13 to 2.32; derived from direct evidence from 2 studies with 225 participants, and indirect evidence; very low-certainty evidence). In the remaining treatments, the certainty of the evidence ranged from low to very low, and we noted no evidence of any differences in mortality at 12 months.\nWe found that THA (single articulation), cemented modern bipolar HA and uncemented modern bipolar HA seemed to have the greatest likelihood of improving HRQoL at 12 months. This network was comparatively sparse compared to other outcomes and the certainty of the evidence of differences between treatments was very low. We noted no evidence of any differences in HRQoL at 12 months, although estimates were imprecise.\nWe found that arthroplasty treatments seemed to have a greater likelihood of reducing unplanned return to theatre than internal fixation and non-operative treatment. We estimated that 4.3% of participants who received the reference treatment returned to theatre during the study follow-up. Compared to this treatment, we found low-certainty evidence that more participants returned to theatre if they were treated with a dynamic fixed angle plate (network estimate RR 4.63, 95% CI 2.94 to 7.30; from direct evidence from 1 study with 190 participants, and indirect evidence). We found very low-certainty evidence that more participants returned to theatre when treated with pins (RR 4.16, 95% CI 2.53 to 6.84; only from indirect evidence), screws (network estimate RR 5.04, 95% CI 3.25 to 7.82; from direct evidence from 2 studies with 278 participants, and indirect evidence), and non-operative treatment (RR 5.41, 95% CI 1.80 to 16.26; only from indirect evidence). There was very low-certainty evidence of a tendency for an increased risk of unplanned return to theatre for all of the arthroplasty treatments, and in particular for THA, compared with cemented modern unipolar HA, with little evidence to suggest the size of this difference varied strongly between the arthroplasty treatments.\nAuthors' conclusions\nThere was considerable variability in the ranking of each treatment such that there was no one outstanding, or subset of outstanding, superior treatments. However, cemented modern arthroplasties tended to more often yield better outcomes than alternative treatments and may be a more successful approach than internal fixation. There is no evidence of a difference between THA (single articulation) and cemented modern unipolar HA in the outcomes measured in this review. THA may be an appropriate treatment for a subset of people with intracapsular fracture but we have not explored this further.\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 ran our search in July 2020."
}
] |
query-laysum
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23808
|
[
{
"role": "user",
"content": "Abstract: Background\nSelf-harm (SH; intentional self-poisoning or self-injury regardless of degree of suicidal intent or other types of motivation) is a growing problem in most counties, often repeated, and associated with suicide. There has been a substantial increase in both the number of trials and therapeutic approaches of psychosocial interventions for SH in adults. This review therefore updates a previous Cochrane Review (last published in 2016) on the role of psychosocial interventions in the treatment of SH in adults.\nObjectives\nTo assess the effects of psychosocial interventions for self-harm (SH) compared to comparison types of care (e.g. treatment-as-usual, routine psychiatric care, enhanced usual care, active comparator) for adults (aged 18 years or older) who engage in SH.\nSearch methods\nWe searched the Cochrane Common Mental Disorders Specialised Register, the Cochrane Library (Central Register of Controlled Trials [CENTRAL] and Cochrane Database of Systematic reviews [CDSR]), together with MEDLINE, Ovid Embase, and PsycINFO (to 4 July 2020).\nSelection criteria\nWe included all randomised controlled trials (RCTs) comparing interventions of specific psychosocial treatments versus treatment-as-usual (TAU), routine psychiatric care, enhanced usual care (EUC), active comparator, or a combination of these, in the treatment of adults with a recent (within six months of trial entry) episode of SH resulting in presentation to hospital or clinical services. The primary outcome was the occurrence of a repeated episode of SH over a maximum follow-up period of two years. Secondary outcomes included treatment adherence, depression, hopelessness, general functioning, social functioning, suicidal ideation, and suicide.\nData collection and analysis\nWe independently selected trials, extracted data, and appraised trial quality. For binary outcomes, we calculated odds ratio (ORs) and their 95% confidence intervals (CIs). For continuous outcomes, we calculated mean differences (MDs) or standardised mean differences (SMDs) and 95% CIs. The overall quality of evidence for the primary outcome (i.e. repetition of SH at post-intervention) was appraised for each intervention using the GRADE approach.\nMain results\nWe included data from 76 trials with a total of 21,414 participants. Participants in these trials were predominately female (61.9%) with a mean age of 31.8 years (standard deviation [SD] 11.7 years). On the basis of data from four trials, individual cognitive behavioural therapy (CBT)-based psychotherapy may reduce repetition of SH as compared to TAU or another comparator by the end of the intervention (OR 0.35, 95% CI 0.12 to 1.02; N = 238; k = 4; GRADE: low certainty evidence), although there was imprecision in the effect estimate. At longer follow-up time points (e.g., 6- and 12-months) there was some evidence that individual CBT-based psychotherapy may reduce SH repetition. Whilst there may be a slightly lower rate of SH repetition for dialectical behaviour therapy (DBT) (66.0%) as compared to TAU or alternative psychotherapy (68.2%), the evidence remains uncertain as to whether DBT reduces absolute repetition of SH by the post-intervention assessment. On the basis of data from a single trial, mentalisation-based therapy (MBT) reduces repetition of SH and frequency of SH by the post-intervention assessment (OR 0.35, 95% CI 0.17 to 0.73; N = 134; k = 1; GRADE: high-certainty evidence). A group-based emotion-regulation psychotherapy may also reduce repetition of SH by the post-intervention assessment based on evidence from two trials by the same author group (OR 0.34, 95% CI 0.13 to 0.88; N = 83; k = 2; moderate-certainty evidence). There is probably little to no effect for different variants of DBT on absolute repetition of SH, including DBT group-based skills training, DBT individual skills training, or an experimental form of DBT in which participants were given significantly longer cognitive exposure to stressful events. The evidence remains uncertain as to whether provision of information and support, based on the Suicide Trends in At-Risk Territories (START) and the SUicide-PREvention Multisite Intervention Study on Suicidal behaviors (SUPRE-MISS) models, have any effect on repetition of SH by the post-intervention assessment. There was no evidence of a difference for psychodynamic psychotherapy, case management, general practitioner (GP) management, remote contact interventions, and other multimodal interventions, or a variety of brief emergency department-based interventions.\nAuthors' conclusions\nOverall, there were significant methodological limitations across the trials included in this review. Given the moderate or very low quality of the available evidence, there is only uncertain evidence regarding a number of psychosocial interventions for adults who engage in SH. Psychosocial therapy based on CBT approaches may result in fewer individuals repeating SH at longer follow-up time points, although no such effect was found at the post-intervention assessment and the quality of evidence, according to the GRADE criteria, was low. Given findings in single trials, or trials by the same author group, both MBT and group-based emotion regulation therapy should be further developed and evaluated in adults. DBT may also lead to a reduction in frequency of SH. Other interventions were mostly evaluated in single trials of moderate to very low quality such that the evidence relating to the use of these interventions is inconclusive at present.\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": "Self-harm (SH), which includes intentional self-poisoning/overdose and self-injury, is a major problem in many countries and is strongly linked with suicide. It is therefore important that effective treatments are developed for people who engage in SH. There has been an increase in both the number of trials and the diversity of therapeutic approaches for SH in adults in recent years. It is therefore important to assess the evidence for their effectiveness."
}
] |
query-laysum
|
23809
|
[
{
"role": "user",
"content": "Abstract: Background\nAcute asthma is a common cause of presentations to acute care centres, such as the emergency department (ED), and while the majority of patients can be discharged, relapse requiring additional medical care is common. Systemic corticosteroids are a major part in the treatment of moderate to severe acute asthma; however, there is no clear evidence regarding the most effective route of administration for improving outcomes in patients discharged from acute care.\nObjectives\nTo examine the effectiveness and safety of a single dose of intramuscular (IM) corticosteroids provided prior to discharge compared to a short course of oral corticosteroids in the treatment of acute asthma patients discharged from an ED or equivalent acute care setting.\nSearch methods\nThe Cochrane Airways Group conducted searches of the Cochrane Airways Group Register of Trials, most recently on 14 March 2018. In addition in April 2017 we completed an extensive search of nine electronic databases including Medline, Embase, EBM ALL, Global Health, International Pharmaceutical Abstracts, CINAHL, SCOPUS, Proquest Dissertations and Theses Global, and LILACS. Furthermore, we searched the grey literature to identify any additional studies.\nSelection criteria\nWe included randomized controlled trials or controlled clinical trials if they compared the effectiveness of intramuscular (IM) versus oral corticosteroids to treat paediatric or adult patients presenting with acute asthma to an ED or equivalent acute care setting. Two independent reviewers assessed study eligibility and study quality. We resolved disagreements via a third party and assessed risk of bias using the Cochrane 'Risk of bias' tool. We assessed the quality of the evidence using GRADE.\nData collection and analysis\nFor dichotomous outcomes, we calculated individual and pooled statistics as risk ratios (RRs) with 95% confidence intervals (CIs) using a random-effects model. We reported continuous outcomes using mean difference (MD) or standardised mean difference (SMD) with 95% CIs using a random-effects model. We reported heterogeneity using I² and Cochran Q statistics. We used standard procedures recommended by Cochrane.\nMain results\nNine studies involving 804 participants (IM = 402 participants; oral = 402 participants) met our review inclusion criteria. Four studies enrolled children (n = 245 participants), while five studies enrolled adults (n = 559 participants). All of the studies recruited participants presenting to an ED, except one study which recruited participants attending a primary care clinic. All of the paediatric studies compared intramuscular (IM) dexamethasone to oral prednisone/prednisolone. In the adult studies, the IM corticosteroid provided ranged from methylprednisolone, betamethasone, dexamethasone, or triamcinolone, while the regimen of oral corticosteroids provided consisted of prednisone, methylprednisolone, or dexamethasone. Only five studies were placebo controlled. For the purposes of this review, we did not take corticosteroid dose equivalency into account in the analysis. The most common co-intervention provided to participants during the acute care visit included short-acting beta₂-agonists (SABA), methylxanthines, and ipratropium bromide. In some instances, some studies reported providing some participants with supplemental oral or IV corticosteroids during their stay in the ED. Co-interventions provided to participants at discharge consisted primarily of SABA, methylxanthine, long-acting beta₂-agonists (LABA), and ipratropium bromide. The risk of bias of the included studies ranged from unclear to high across various domains. The primary outcome of interest was relapse to additional care defined as an unscheduled visit to a health practitioner for worsening asthma symptoms, or requiring subsequent treatment with corticosteroids which may have occurred at any time point after discharge from the ED.\nWe found intramuscular and oral corticosteroids to be similarly effective in reducing the risk for relapse (RR 0.94, 95% CI 0.72 to 1.24; 9 studies, 804 participants; I² = 0%; low-quality evidence). We found no subgroup differences in relapse rates between paediatric and adult participants (P = 0.71), relapse occurring within or after 10 days post-discharge (P = 0.22), or participants with mild/moderate or severe exacerbations (P = 0.35). While we found no statistical difference between participants receiving IM versus oral corticosteroids regarding the risk for adverse events (RR 0.83, 95% CI 0.64 to 1.07; 5 studies, 404 participants; I² = 0%; moderate-quality evidence), an estimated 50 fewer patients per 1000 receiving IM corticosteroids reported experiencing adverse events (95% from 106 fewer to 21 more). We found inconsistent reporting of specific adverse events across the studies. There were no differences in the frequency of specific adverse events including nausea and vomiting, pain, swelling, redness, insomnia, or personality changes. We did not seek additional adverse events data.\nParticipants receiving IM corticosteroids or oral corticosteroids both reported decreases in peak expiratory flow (MD −7.78 L/min, 95% CI −38.83 L/min to 23.28 L/min; 4 studies, 272 participants; I² = 33%; moderate-quality evidence), similar symptom persistence (RR 0.41, 95% CI 0.14 to 1.20; 3 studies, 80 participants; I² = 44%; low-quality evidence), and 24-hour beta-agonist use (RR 0.54, 95% CI 0.21 to 1.37; 2 studies, 48 participants; I² = 0%; low-quality evidence).\nAuthors' conclusions\nThere is insufficient evidence to identify whether IM corticosteroids are more effective in reducing relapse compared to oral corticosteroids among children or adults discharged from an ED or equivalent acute care setting for acute asthma. While we found no statistical differences, patients receiving IM corticosteroids reported fewer adverse events. Additional studies comparing the effectiveness of IM versus oral corticosteroids could provide further evidence clarity. Furthermore, there is a need for studies comparing different IM corticosteroids (e.g. IM dexamethasone versus IM methylprednisone) and different oral corticosteroids (e.g. oral dexamethasone versus oral prednisone), with consideration for dosing and pharmacokinetic properties, to better identify the optimal IM or oral corticosteroid regimens to improve patient outcomes. Other factors, such as patient preference and potential issues with adherence, may dictate practitioner prescribing.\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": "Asthma attacks result from airway passages to the lungs becoming constricted due to inflammation, resulting in wheezing, coughing and difficulty breathing. People experiencing asthma attacks often go to emergency departments. Corticosteroids, which are powerful anti-inflammatory agents, are the treatment cornerstone of asthma exacerbations, and have been shown to be effective in improving lung function and reducing hospitalisations in patients with asthma. At discharge, patients are commonly provided with corticosteroids to reduce the chance of returning to the emergency department due to worsening asthma symptoms. Corticosteroids may be provided via a single injection under the skin into the muscle ('intramuscular') or as tablets to take home, and it is currently unclear which regimen of corticosteroids is more effective at improving outcomes for patients following discharge from the emergency department."
}
] |
query-laysum
|
23810
|
[
{
"role": "user",
"content": "Abstract: Background\nBlepharokeratoconjunctivitis (BKC) is a type of inflammation of the surface of the eye and eyelids that involves changes of the eyelids, dysfunction of the meibomian glands, and inflammation of the conjunctiva and cornea. Chronic inflammation of the cornea can lead to scarring, vascularisation and opacity. BKC in children can cause significant symptoms including irritation, watering, photophobia and loss of vision from corneal opacity, refractive error or amblyopia.\nTreatment of BKC is directed towards modification of meibomian gland disease and the bacterial flora of lid margin and conjunctiva, and control of ocular surface inflammation. Although both topical and systemic treatments are used to treat people with BKC, this Cochrane review focuses on topical treatments.\nObjectives\nTo assess and compare data on the efficacy and safety of topical treatments (including antibiotics, steroids, immunosuppressants and lubricants), alone or in combination, for BKC in children from birth to 16 years.\nSearch methods\nWe searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register) (2016, Issue 6), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE ( January 1946 to 11 July 2016), Embase (January 1980 to 11 July 2016), 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 11 July 2016. We searched the reference lists of identified reports and the Science Citation Index to identify any additional reports of studies that met the inclusion criteria.\nSelection criteria\nWe searched for randomised controlled trials that involved topical treatments in children up to 16 years of age with a clinical diagnosis of BKC. We planned to include studies that evaluated a single topical medication versus placebo, a combination of treatments versus placebo, and those that compared two or multiple active treatments. We planned to include studies in which participants received additional treatments, such as oral antibiotics, oral anti-inflammatories, warm lid compresses and lid margin cleaning.\nData collection and analysis\nTwo review authors independently screened the results of the literature search (titles and abstracts) to identify studies that met the inclusion criteria of the review and applied standards as expected for Cochrane reviews. We graded the certainty of the evidence using GRADE.\nMain results\nWe included one study from the USA that met the inclusion criteria. In the study, 137 children aged zero to six years old with blepharoconjunctivitis were randomised to treatment in one of four trial arms (loteprednol etabonate/tobramycin combination, loteprednol etabonate alone, tobramycin alone or placebo) for 15 days, with assessments on days 1, 3, 7 and 15. We judged the study to be at high risk of attrition bias and bias due to selective outcome reporting. The study did not report the number of children with improvement in symptoms nor with total or partial success as measured by changes in clinical symptoms.\nAll children showed a reduction in blepharoconjunctivitis grade score, but there was no evidence of important differences between groups. Visual acuity was not fully reported but the authors stated that there was no change in visual acuity in any of the treatment groups. The study reported ocular and non ocular adverse events but was underpowered to detect differences between the groups. Ocular adverse events were as follows: loteprednol/tobramycin 1/34 (eye pain); loteprednol 4/35 (eye pain, conjunctivitis, eye discharge, eye inflammation); tobramycin 0/34; placebo (vehicle) 0/34. The evidence was limited for all these outcomes and we judged it to be very low certainty.\nThere was no information on clinical signs (aside from grade score), disease progression or quality of life.\nAuthors' conclusions\nThere is no high-quality evidence of the safety and efficacy of topical treatments for BKC, which resulted in uncertainty about the indications and effectiveness of topical treatment. Clinical trials are required to test efficacy and safety of current and any future treatments. Outcome measures need to be developed which can capture both objective clinical and patient-reported aspects of the condition and treatments.\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 found one study that looked at the effects of a combination of steroids and antibiotics in treatment of BKC in children. The study did not report the effects of this treatment clearly and was too small to provide a good assessment of safety."
}
] |
query-laysum
|
23811
|
[
{
"role": "user",
"content": "Abstract: Background\nTo support patient-centred care, healthcare organisations increasingly offer patients access to data stored in the institutional electronic health record (EHR).\nObjectives\nPrimary objective\n1. To assess the effects of providing adult patients with access to electronic health records (EHRs) alone or with additional functionalities on a range of patient, patient-provider, and health resource consumption outcomes, including patient knowledge and understanding, patient empowerment, patient adherence, patient satisfaction with care, adverse events, health-related quality of life, health-related outcomes, psychosocial health outcomes, health resource consumption, and patient-provider communication.\nSecondary objective\n1. To assess whether effects of providing adult patients with EHR access alone versus EHR access with additional functionalities differ among patient groups according to age, educational level, or different status of disease (chronic or acute).\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, and Scopus in June 2017 and in April 2020.\nSelection criteria\nRandomised controlled trials and cluster-randomised trials of EHR access with or without additional functionalities for adults with any medical condition.\nData collection and analysis\nWe used standard Cochrane methodological procedures.\nMain results\nWe included 10 studies with 78 to 4500 participants and follow-up from 3 to 24 months. Nine studies assessed the effects of EHR with additional functionalities, each addressing a subset of outcomes sought by this review. Five studies focused on patients with diabetes mellitus, four on patients with specific diseases, and one on all patients. All studies compared EHR access alone or with additional functionalities plus usual care versus usual care only. No studies assessing the effects of EHR access alone versus EHR access with additional functionalities were identified. Interventions required a variety of data within the EHR, such as patient history, problem list, medication, allergies, and lab results. In addition to EHR access, eight studies allowed patients to share self-documented data, seven offered individualised disease management functions, seven offered educational disease-related information, six supported secure communication, and one offered preventive reminders.\nOnly two studies were at low or unclear risk of bias across domains. Meta-analysis could not be performed, as participants, interventions, and outcomes were too heterogeneous, and most studies presented results based on different adjustment methods or variables. The quality of evidence was rated as low or very low across outcomes. Overall differences between intervention and control groups, if any, were small. The relevance of any small effects remains unclear for most outcomes because in most cases, trial authors did not define a minimal clinically important difference. Overall, results suggest that the effects of EHR access alone and with additional functionalities are mostly uncertain when compared with usual care.\nPatient knowledge and understanding: very low-quality evidence is available from one study, so we are uncertain about effects of the intervention on patient knowledge about diabetes and blood glucose testing.\nPatient empowerment: low-quality evidence from three studies suggests that the intervention may have little or no effect on patient empowerment measures.\nPatient adherence: low-quality evidence from two studies suggests that the intervention may slightly improve adherence to the process of monitoring risk factors and preventive services. Effects on medication adherence are conflicting in two studies; this may or may not improve to a clinically relevant degree.\nPatient satisfaction with care: low-quality evidence from three studies suggests that the intervention may have little or no effect on patient satisfaction, with conflicting results.\nAdverse events: two small studies reported on mortality; one of these also reported on serious and other adverse events, but sample sizes were too small for small differences to be detected. Therefore, low-quality evidence suggests that the intervention may have little to no effect on mortality and other adverse events.\nHealth-related quality of life: only very low-quality evidence from one study is available. We are uncertain whether the intervention improves disease-specific quality of life of patients with asthma.\nHealth-related outcomes: low-quality evidence from eight studies suggests that the intervention may have little to no effect on asthma control, glycosylated haemoglobin (HbA1c) levels, blood pressure, low-density lipoprotein or total cholesterol levels, body mass index or weight, or 10-year Framingham risk scores. Low-quality evidence from one study suggests that the composite scores of risk factors for diabetes mellitus may improve slightly with the intervention, but there is uncertainty about effects on ophthalmic medications or intraocular pressure.\nPsychosocial health outcomes: no study investigated psychosocial health outcomes in a more than anecdotal way.\nHealth resource consumption: low-quality evidence for adult patients in three studies suggests that there may be little to no effect of the intervention on different measures of healthcare use.\nPatient-provider communication: very low-quality evidence is available from a single small study, and we are uncertain whether the intervention improves communication measures, such as the number of messages sent.\nAuthors' conclusions\nThe effects of EHR access with additional functionalities in comparison with usual care for the most part are uncertain. Only adherence to the process of monitoring risk factors and providing preventive services as well as a composite score of risk factors for diabetes mellitus may improve slightly with EHR access with additional functionalities. Due to inconsistent terminology in this area, our search may have missed relevant studies.\nAs the overall quality of evidence is very low to low, future research is likely to change these results. Further trials should investigate the impact of EHR access in a broader range of countries and clinical settings, including more patients over a longer period of follow-up, as this may increase the likelihood of detecting effects of the intervention, should these exist. More studies should focus on assessing outcomes such as patient empowerment and behavioural outcomes, rather than concentrating on health-related outcomes alone. Future studies should distinguish between effects of EHR access only and effects of additional functionalities, and investigate the impact of mobile EHR tools. Future studies should include information on usage patterns, and consider the potential for widening health inequalities with implementation of EHR access. A taxonomy for EHR access and additional functionalities should be developed to promote consistency and comparability of outcome measures, and facilitate future reviews by better enabling cross-study comparisons.\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 patients’ access to electronic health records. We also looked for studies where access came with extra services. We were interested in changes in:\n1. how much patients knew, and understood, about their healthcare;\n2. whether patients felt more in control of their care (empowerment);\n3. taking medicines, or keeping up with monitoring (prevention) programmes;\n4. patients' satisfaction with their care;\n5. how patients rated their well-being (quality of life);\n6. patients' health;\n7. patients' levels of anxiety, worry, or depression;\n8. how often patients used healthcare services (numbers of phone calls or visits);\n9. communication between patients and their healthcare providers; and\n10. whether patients experienced any unwanted effects."
}
] |
query-laysum
|
23812
|
[
{
"role": "user",
"content": "Abstract: Background\nRespiratory support is a central component of the management of critically ill children. It can be delivered invasively via an endotracheal tube or non-invasively via face mask, nasal mask, nasal cannula or oxygen hood/tent. Invasive ventilation can be damaging to the lungs, and the tendency to use non-invasive forms is growing. However, non-invasive delivery is often poorly tolerated by children. High-flow nasal cannula (HFNC) oxygen delivery is a relatively new therapy that shows the potential to reduce the need for intubation and be better tolerated by children than other non-invasive forms of support. HFNC therapy differs from other non-invasive forms of treatment in that it delivers heated, humidified and blended air/oxygen via nasal cannula at rates > 2 L/kg/min. This allows the user to deliver high concentrations of oxygen and to potentially deliver continuous distending pressure; this treatment often is better tolerated by the child.\nObjectives\nTo determine whether HFNC therapy is more effective than other forms of non-invasive therapy in paediatric patients who require respiratory support.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (2013, Issue 4); MEDLINE via PubMed (January 1966 to April 2013); EMBASE (January 1980 to April 2013); CINAHL (1982 to April 2013); and LILACS (1982 to April 2013). Abstracts from conference proceedings, theses and dissertations and bibliographical references to relevant studies were also searched. We applied no restriction on language.\nSelection criteria\nWe planned to included randomized controlled trials (RCTs) and quas-randomized trials comparing HFNC therapy with other forms of non-invasive respiratory support for children. Non-invasive support encompassed cot, hood or tent oxygen; low-flow nasal cannulae (flow rates ≤ 2 L/min); and continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP) delivered via facial or nasal mask/cannula. Treatment failure was defined by the need for additional respiratory support. We excluded children with a diagnosis of bronchiolitis.\nData collection and analysis\nTwo review authors independently assessed all studies for selection and data extraction. We used standard methodological procedures expected by The Cochrane Collaboration.\nMain results\nOur search yielded 922 records. A total of 109 relevant records were retrieved with reference to our search criteria. After duplicates and irrelevant studies were removed, 69 studies were further scrutinized. Of these, 11 studies involved children. No study matched our inclusion criteria.\nAuthors' conclusions\nBased on the results of this review, no evidence is available to allow determination of the safety or effectiveness of HFNC as a form of respiratory support in children.\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": "We found 11 studies involving children; however none matched our criteria."
}
] |
query-laysum
|
23813
|
[
{
"role": "user",
"content": "Abstract: Background\nThis is the third update of this review, first published in July 2009. All major guidelines on treatment of hypertension recommend weight loss; anti-obesity drugs may be able to help in this respect.\nObjectives\nPrimary objectives:\nTo assess the long-term effects of pharmacologically-induced reduction in body weight in adults with essential hypertension on all-cause mortality, cardiovascular morbidity, and adverse events (including total serious adverse events, withdrawal due to adverse events, and total non-serious adverse events)..\nSecondary objectives:\nTo assess the long-term effects of pharmacologically-induced reduction in body weight in adults with essential hypertension on change from baseline in systolic and diastolic blood pressure, and on body weight reduction.\nSearch methods\nFor this updated review, the Cochrane Hypertension Information Specialist searched the following databases for randomised controlled trials up to March 2020: the Cochrane Hypertension Specialised Register, CENTRAL, MEDLINE (from 1946), Embase (from 1974), the World Health Organization International Clinical Trials Registry Platform, and ClinicalTrials.gov. The searches had no language restrictions. We contacted authors of relevant papers about further published and unpublished work.\nSelection criteria\nRandomised controlled trials of at least 24 weeks' duration in adults with hypertension that compared approved long-term weight-loss medications to placebo.\nData collection and analysis\nTwo review authors independently selected studies, assessed risks of bias, and extracted data. Where appropriate and in the absence of significant heterogeneity between studies (P > 0.1), we pooled studies using a fixed-effect meta-analysis. When heterogeneity was present, we used the random-effects method and investigated the cause of the heterogeneity.\nMain results\nThis third update of the review added one new trial, investigating the combination of naltrexone/bupropion versus placebo. Two medications, which were included in the previous versions of this review (rimonabant and sibutramine) are no longer considered relevant for this update, since their marketing approval was withdrawn in 2010 and 2009, respectively. The number of included studies in this review update is therefore six (12,724 participants in total): four RCTs comparing orlistat to placebo, involving a total of 3132 participants with high blood pressure and a mean age of 46 to 55 years; one trial comparing phentermine/topiramate to placebo, involving 1305 participants with high blood pressure and a mean age of 53 years; and one trial comparing naltrexone/bupropion to placebo, involving 8283 participants with hypertension and a mean age of 62 years. We judged the risks of bias to be unclear for the trials investigating orlistat or naltrexone/bupropion. and low for the trial investigating phentermine/topiramate. Only the study of naltrexone/bupropion included cardiovascular mortality and morbidity as predefined outcomes.\nThere were no differences in the rates of all-cause or cardiovascular mortality, major cardiovascular events, or serious adverse events between naltrexone/bupropion and placebo. The incidence of overall adverse events was significantly higher in participants treated with naltrexone/bupropion. For orlistat, the incidence of gastrointestinal side effects was consistently higher compared to placebo. The most frequent side effects with phentermine/topiramate were dry mouth and paraesthesia. After six to 12 months, orlistat reduced systolic blood pressure compared to placebo by mean difference (MD) −2.6 mm Hg (95% confidence interval (CI) −3.8 to −1.4 mm Hg; 4 trials, 2058 participants) and diastolic blood pressure by MD −2.0 mm Hg (95% CI −2.7 to −1.2 mm Hg; 4 trials, 2058 participants). After 13 months of follow-up, phentermine/topiramate decreased systolic blood pressure compared to placebo by −2.0 to −4.2 mm Hg (1 trial, 1030 participants) (depending on drug dosage), and diastolic blood pressure by −1.3 to −1.9 mm Hg (1 trial, 1030 participants) (depending on drug dosage). There was no difference in the change in systolic or diastolic blood pressure between naltrexone/bupropion and placebo (1 trial, 8283 participants). We identified no relevant studies investigating liraglutide or lorcaserin in people with hypertension.\nAuthors' conclusions\nIn people with elevated blood pressure, orlistat, phentermine/topiramate and naltrexone/bupropion reduced body weight; the magnitude of the effect was greatest with phentermine/topiramate. In the same trials, orlistat and phentermine/topiramate, but not naltrexone/bupropion, reduced blood pressure. One RCT of naltrexone/bupropion versus placebo showed no differences in all-cause mortality or cardiovascular mortality or morbidity after two years. The European Medicines Agency refused marketing authorisation for phentermine/topiramate due to safety concerns, while for lorcaserin the application for European marketing authorisation was withdrawn due to a negative overall benefit/risk balance. In 2020 lorcaserin was also withdrawn from the US market. Two other medications (rimonabant and sibutramine) had already been withdrawn from the market in 2009 and 2010, respectively.\n\nGiven the provided abstract, please respond to the following query: \"How reliable are these results?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Results are from a small number of studies. In some studies, there were few events for some measures we were interested in.\nWe are moderately confident about how orlistat and naltrexone plus bupropion affected weight loss and blood pressure. However, results might change if more evidence becomes available.\nWe are less confident about the effects of phentermine plus topiramate; the unwanted effects of orlistat, and the risk of unwanted cardiovascular events associated with naltrexone plus bupropion. Results are likely to change if more evidence becomes available."
}
] |
query-laysum
|
23814
|
[
{
"role": "user",
"content": "Abstract: Background\nThe projected rise in the incidence of type 2 diabetes mellitus (T2DM) could develop into a substantial health problem worldwide. Whether dipeptidyl-peptidase (DPP)-4 inhibitors or glucagon-like peptide (GLP)-1 analogues are able to prevent or delay T2DM and its associated complications in people at risk for the development of T2DM is unknown.\nObjectives\nTo assess the effects of DPP-4 inhibitors and GLP-1 analogues on the prevention or delay of T2DM and its associated complications in people with impaired glucose tolerance, impaired fasting blood glucose, moderately elevated glycosylated haemoglobin A1c (HbA1c) or any combination of these.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials; MEDLINE; PubMed; Embase; ClinicalTrials.gov; the World Health Organization (WHO) International Clinical Trials Registry Platform; and the reference lists of systematic reviews, articles and health technology assessment reports. We asked investigators of the included trials for information about additional trials. The date of the last search of all databases was January 2017.\nSelection criteria\nWe included randomised controlled trials (RCTs) with a duration of 12 weeks or more comparing DPP-4 inhibitors and GLP-1 analogues with any pharmacological glucose-lowering intervention, behaviour-changing intervention, placebo or no intervention in people with impaired fasting glucose, impaired glucose tolerance, moderately elevated HbA1c or combinations of these.\nData collection and analysis\nTwo review authors read all abstracts and full-text articles and 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 the involvement of a third review author. For meta-analyses, we planned to use a random-effects model with investigation 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 using the GRADE instrument.\nMain results\nWe included seven completed RCTs; about 98 participants were randomised to a DPP-4 inhibitor as monotherapy and 1620 participants were randomised to a GLP-1 analogue as monotherapy. Two trials investigated a DPP-4 inhibitor and five trials investigated a GLP-1 analogue. A total of 924 participants with data on allocation to control groups were randomised to a comparator group; 889 participants were randomised to placebo and 33 participants to metformin monotherapy. One RCT of liraglutide contributed 85% of all participants. The duration of the intervention varied from 12 weeks to 160 weeks. We judged none of the included trials at low risk of bias for all 'Risk of bias' domains and did not perform meta-analyses because there were not enough trials.\nOne trial comparing the DPP-4 inhibitor vildagliptin with placebo reported no deaths (very low-quality evidence). The incidence of T2DM by means of WHO diagnostic criteria in this trial was 3/90 participants randomised to vildagliptin versus 1/89 participants randomised to placebo (very low-quality evidence). Also, 1/90 participants on vildagliptin versus 2/89 participants on placebo experienced a serious adverse event (very low-quality evidence). One out of 90 participants experienced congestive heart failure in the vildagliptin group versus none in the placebo group (very low-quality evidence). There were no data on non-fatal myocardial infarction, stroke, health-related quality of life or socioeconomic effects reported.\nAll-cause and cardiovascular mortality following treatment with GLP-1 analogues were rarely reported; one trial of exenatide reported that no participant died. Another trial of liraglutide 3.0 mg showed that 2/1501 in the liraglutide group versus 2/747 in the placebo group died after 160 weeks of treatment (very low-quality evidence).\nThe incidence of T2DM following treatment with liraglutide 3.0 mg compared to placebo after 160 weeks was 26/1472 (1.8%) participants randomised to liraglutide versus 46/738 (6.2%) participants randomised to placebo (very low-quality evidence). The trial established the risk for (diagnosis of) T2DM as HbA1c 5.7% to 6.4% (6.5% or greater), fasting plasma glucose 5.6 mmol/L or greater to 6.9 mmol/L or less (7.0 mmol/L or greater) or two-hour post-load plasma glucose 7.8 mmol/L or greater to 11.0 mmol/L (11.1 mmol/L). Altogether, 70/1472 (66%) participants regressed from intermediate hyperglycaemia to normoglycaemia compared with 268/738 (36%) participants in the placebo group. The incidence of T2DM after the 12-week off-treatment extension period (i.e. after 172 weeks) showed that five additional participants were diagnosed T2DM in the liraglutide group, compared with one participant in the placebo group. After 12-week treatment cessation, 740/1472 (50%) participants in the liraglutide group compared with 263/738 (36%) participants in the placebo group had normoglycaemia.\nOne trial used exenatide and 2/17 participants randomised to exenatide versus 1/16 participants randomised to placebo developed T2DM (very low-quality evidence). This trial did not provide a definition of T2DM. One trial reported serious adverse events in 230/1524 (15.1%) participants in the liraglutide 3.0 mg arm versus 96/755 (12.7%) participants in the placebo arm (very low quality evidence). There were no serious adverse events in the trial using exenatide. Non-fatal myocardial infarction was reported in 1/1524 participants in the liraglutide arm and in 0/55 participants in the placebo arm at 172 weeks (very low-quality evidence). One trial reported congestive heart failure in 1/1524 participants in the liraglutide arm and in 1/755 participants in the placebo arm (very low-quality evidence). Participants receiving liraglutide compared with placebo had a small mean improvement in the physical component of the 36-item Short Form scale showing a difference of 0.87 points (95% CI 0.17 to 1.58; P = 0.02; 1 trial; 1791 participants; very low-quality evidence). No trial evaluating GLP-1-analogues reported data on stroke, microvascular complications or socioeconomic effects.\nAuthors' conclusions\nThere is no firm evidence that DPP-4 inhibitors or GLP-1 analogues compared mainly with placebo substantially influence the risk of T2DM and especially its associated complications in people at increased risk for the development of T2DM. Most trials did not investigate patient-important outcomes.\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": "DPP-4 inhibitors and GLP-1 analogues are widely used to treat people with type 2 diabetes. People with moderately elevated blood glucose are said to be at an increased risk for developing type 2 diabetes (often referred to as 'prediabetes'). It is currently not known whether DPP-4 inhibitors or GLP-1 analogues should be prescribed for people with raised blood glucose levels who do not have type 2 diabetes. We wanted to find out whether these medicines could prevent or delay type 2 diabetes in people at increased risk. We also wanted to know the effects on patient-important outcomes such as complications of diabetes (e.g. kidney and eye disease, heart attacks, strokes), death from any cause, health-related quality of life (a measure of a person's satisfaction with their life and health) and side effects of the medicines."
}
] |
query-laysum
|
23815
|
[
{
"role": "user",
"content": "Abstract: Background\nPancreatic cancer is the fourth-leading cause of cancer death for both, men and women. The standard treatment for resectable tumours consists of a classic Whipple (CW) operation or a pylorus-preserving pancreaticoduodenectomy (PPW). It is unclear which of these procedures is more favourable in terms of survival, postoperative mortality, complications, and quality of life.\nObjectives\nThe objective of this systematic review was to compare the effectiveness of CW and PPW techniques for surgical treatment of cancer of the pancreatic head and the periampullary region.\nSearch methods\nWe conducted searches on 28 March 2006, 11 January 2011, 9 January 2014, and 18 August 2015 to identify all randomised controlled trials (RCTs), while applying no language restrictions. We searched the following electronic databases on 18 August 2015: the Cochrane Central Register of Controlled Trials (CENTRAL), the Cochrane Database of Systematic Reviews (CDSR) and the Database of Abstracts of Reviews of Effects (DARE) from the Cochrane Library (2015, Issue 8); MEDLINE (1946 to August 2015); and EMBASE (1980 to August 2015). We also searched abstracts from Digestive Disease Week and United European Gastroenterology Week (1995 to 2010); we did not update this part of the search for the 2014 and 2015 updates because the prior searches did not contribute any additional information. We identified two additional trials through the updated search in 2015.\nSelection criteria\nRCTs comparing CW versus PPW including participants with periampullary or pancreatic carcinoma.\nData collection and analysis\nTwo review authors independently extracted data from the included trials. We used a random-effects model for pooling data. We compared binary outcomes using odds ratios (ORs), pooled continuous outcomes using mean differences (MDs), and used hazard ratios (HRs) for meta-analysis of survival. Two review authors independently evaluated the methodological quality and risk of bias of included trials according to the standards of The Cochrane Collaboration.\nMain results\nWe included eight RCTs with a total of 512 participants. Our critical appraisal revealed vast heterogeneity with respect to methodological quality and outcome parameters. Postoperative mortality (OR 0.64, 95% confidence interval (CI) 0.26 to 1.54; P = 0.32), overall survival (HR 0.84, 95% CI 0.61 to 1.16; P = 0.29), and morbidity showed no significant differences, except of delayed gastric emptying, which significantly favoured CW (OR 3.03, 95% CI 1.05 to 8.70; P = 0.04). Furthermore, we noted that operating time (MD -45.22 minutes, 95% CI -74.67 to -15.78; P = 0.003), intraoperative blood loss (MD -0.32 L, 95% CI -0.62 to -0.03; P = 0.03), and red blood cell transfusion (MD -0.47 units, 95% CI -0.86 to -0.07; P = 0.02) were significantly reduced in the PPW group. All significant results were associated with low-quality evidence based on GRADE (Grades of Recommendation, Assessment, Development and Evaluation) criteria.\nAuthors' conclusions\nCurrent evidence suggests no relevant differences in mortality, morbidity, and survival between the two operations. However, some perioperative outcome measures significantly favour the PPW procedure. Given obvious clinical and methodological heterogeneity, future high-quality RCTs of complex surgical interventions based on well-defined outcome parameters 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": "Pancreatic cancer is a leading cause of cancer death. Two surgical procedures can lead to a cure: the classic Whipple operation, in which part of the pancreas, the gallbladder, the duodenum, the pylorus (outlet of the stomach), and the distal (lower) part of the stomach are removed, and the so-called pylorus-preserving pancreaticoduodenectomy, or pylorus-preserving Whipple operation, in which the stomach and the pylorus are not removed."
}
] |
query-laysum
|
23816
|
[
{
"role": "user",
"content": "Abstract: Background\nSchizophrenia is a serious chronic mental illness affecting an estimated 21 million people worldwide and there is increasing evidence linking inflammation in the brain to the pathophysiology of schizophrenia. Antipsychotic drugs are the conventional treatment for people with schizophrenia but are not always fully effective. Acetylsalicylic acid (aspirin) is a non-steroidal anti-inflammatory drug (NSAID) with properties that inhibit the proinflammatory status of the brain. Using aspirin as an adjunct (add-on) treatment to antipsychotics or as a stand-alone treatment could be a novel, relatively inexpensive option for people with schizophrenia.\nObjectives\nTo review the effects of acetylsalicylic acid (aspirin) as adjunct (add-on) or as stand-alone treatment for people with schizophrenia.\nSearch methods\nWe searched the Cochrane Schizophrenia Group's Trials Register (last search 8 March 2018) which is based on regular searches of MEDLINE, Embase, PubMed, CINAHL, BIOSIS, AMED, PsycINFO and registries of Clinical Trials. There are no language, date, document type, or publication status limitations for inclusion of records in the register.\nSelection criteria\nRandomised clinical trials focusing on aspirin for people with schizophrenia.\nData collection and analysis\nWe extracted data independently. For binary outcomes, we calculated risk ratio (RR) and its 95% confidence interval (CI), on an intention-to-treat (ITT) basis. For continuous data, we estimated the mean difference (MD) between groups and its 95% CI. We employed a fixed-effect model for analyses. We assessed risk of bias for included studies and created a 'Summary of findings' table using GRADE.\nMain results\nWe included two studies, both comparing the effects of adding aspirin to standard antipsychotic treatment with adding placebo to standard antipsychotic treatment. We were hoping to find high-quality data for seven main outcomes of importance: clinically important change in global state, mental state, cognitive functioning and quality of life, numbers leaving the study early, incidence of gastrointestinal adverse events and hospital admission. Clinically important change data were not reported. Global state data were reported by one study as 'unspecified problem necessitating change in dose or type of antipsychotics'; there was no clear difference between treatment groups for this outcome (RR 0.75, 95% CI 0.30 to 1.88; studies = 1; participants = 70; very low-quality evidence). Both trials measured mental state using the Positive and Negative Symptom Scale (PANSS), and mean total PANSS endpoint scores favoured the adjunct aspirin group in the medium term (MD –6.56, 95% CI –12.04 to –1.08; studies = 2; participants = 130; very low-quality evidence). Less than 10% of each group's participants left the studies early (for any reason) and by around three months there was no clear difference between numbers leaving early from the aspirin group compared to numbers leaving early from the placebo group suggesting aspirin is acceptable (RR 1.12, 95% CI 0.40 to 3.14; studies = 2; participants = 130; very low-quality evidence). There was some gastric upset in both groups but rates were not clearly different between the treatment groups (RR 1.03, 95% CI 0.55 to 1.94; studies = 1; participants = 70; very low-quality evidence). We are unclear if 'change in hospital status' is an unfavourable outcome or not as one study reported equivocal data (RR 0.56, 95% CI 0.05 to 5.90; studies = 1; participants = 70; very low-quality evidence). It should be noted that all the above results were based on data of very low-quality and were difficult to interpret for clinicians or patients, and that the two studies, completed in the last decade, failed to report any usable outcomes on cognitive functioning or quality of life.\nAuthors' conclusions\nWe highlighted the evidence that some pioneering researchers feel this question is important enough to merit testing in randomised trials. However, we also highlighted that the evidence produced from these trials was weak and inconclusive. It was impossible to draw clear conclusions on the therapeutic value of aspirin for schizophrenia from these short, small and limited trials.\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": "This review was based on results from only two small trials, which made it impossible to say whether aspirin would be a good treatment option for people with schizophrenia. More information from the trials that are underway could strengthen the results of this analysis."
}
] |
query-laysum
|
23817
|
[
{
"role": "user",
"content": "Abstract: Background\nAcceptable, effective and feasible support strategies (interventions) for parents experiencing complex post-traumatic stress disorder (CPTSD) symptoms or with a history of childhood maltreatment may offer an opportunity to support parental recovery, reduce the risk of intergenerational transmission of trauma and improve life-course trajectories for children and future generations. However, evidence relating to the effect of interventions has not been synthesised to provide a comprehensive review of available support strategies. This evidence synthesis is critical to inform further research, practice and policy approaches in this emerging area.\nObjectives\nTo assess the effects of interventions provided to support parents who were experiencing CPTSD symptoms or who had experienced childhood maltreatment (or both), on parenting capacity and parental psychological or socio-emotional wellbeing.\nSearch methods\nIn October 2021 we searched CENTRAL, MEDLINE, Embase, six other databases and two trials registers, together with checking references and contacting experts to identify additional studies.\nSelection criteria\nAll variants of randomised controlled trials (RCTs) comparing any intervention delivered in the perinatal period designed to support parents experiencing CPTSD symptoms or with a history of childhood maltreatment (or both), to any active or inactive control. Primary outcomes were parental psychological or socio-emotional wellbeing and parenting capacity between pregnancy and up to two years postpartum.\nData collection and analysis\nTwo review authors independently assessed the eligibility of trials for inclusion, extracted data using a pre-designed data extraction form, and assessed risk of bias and certainty of evidence. We contacted study authors for additional information as required. We analysed continuous data using mean difference (MD) for outcomes using a single measure, and standardised mean difference (SMD) for outcomes using multiple measures, and risk ratios (RR) for dichotomous data. All data are presented with 95% confidence intervals (CIs). We undertook meta-analyses using random-effects models.\nMain results\nWe included evidence from 1925 participants in 15 RCTs that investigated the effect of 17 interventions. All included studies were published after 2005. Interventions included seven parenting interventions, eight psychological interventions and two service system approaches. The studies were funded by major research councils, government departments and philanthropic/charitable organisations. All evidence was of low or very low certainty.\nParenting interventions\nEvidence was very uncertain from a study (33 participants) assessing the effects of a parenting intervention compared to attention control on trauma-related symptoms, and psychological wellbeing symptoms (postpartum depression), in mothers who had experienced childhood maltreatment and were experiencing current parenting risk factors. Evidence suggested that parenting interventions may improve parent-child relationships slightly compared to usual service provision (SMD 0.45, 95% CI -0.06 to 0.96; I2 = 60%; 2 studies, 153 participants; low-certainty evidence). There may be little or no difference between parenting interventions and usual perinatal service in parenting skills including nurturance, supportive presence and reciprocity (SMD 0.25, 95% CI -0.07 to 0.58; I2 = 0%; 4 studies, 149 participants; low-certainty evidence). No studies assessed the effects of parenting interventions on parents' substance use, relationship quality or self-harm.\nPsychological interventions\nPsychological interventions may result in little or no difference in trauma-related symptoms compared to usual care (SMD -0.05, 95% CI -0.40 to 0.31; I2 = 39%; 4 studies, 247 participants; low-certainty evidence). Psychological interventions may make little or no difference compared to usual care to depression symptom severity (8 studies, 507 participants, low-certainty evidence, SMD -0.34, 95% CI -0.66 to -0.03; I2 = 63%). An interpersonally focused cognitive behavioural analysis system of psychotherapy may slightly increase the number of pregnant women who quit smoking compared to usual smoking cessation therapy and prenatal care (189 participants, low-certainty evidence). A psychological intervention may slightly improve parents' relationship quality compared to usual care (1 study, 67 participants, low-certainty evidence). Benefits for parent-child relationships were very uncertain (26 participants, very low-certainty evidence), while there may be a slight improvement in parenting skills compared to usual care (66 participants, low-certainty evidence). No studies assessed the effects of psychological interventions on parents' self-harm.\nService system approaches\nOne service system approach assessed the effect of a financial empowerment education programme, with and without trauma-informed peer support, compared to usual care for parents with low incomes. The interventions increased depression slightly (52 participants, low-certainty evidence). No studies assessed the effects of service system interventions on parents' trauma-related symptoms, substance use, relationship quality, self-harm, parent-child relationships or parenting skills.\nAuthors' conclusions\nThere is currently a lack of high-quality evidence regarding the effectiveness of interventions to improve parenting capacity or parental psychological or socio-emotional wellbeing in parents experiencing CPTSD symptoms or who have experienced childhood maltreatment (or both). This lack of methodological rigour and high risk of bias made it difficult to interpret the findings of this review. Overall, results suggest that parenting interventions may slightly improve parent-child relationships but have a small, unimportant effect on parenting skills. Psychological interventions may help some women stop smoking in pregnancy, and may have small benefits on parents' relationships and parenting skills. A financial empowerment programme may slightly worsen depression symptoms. While potential beneficial effects were small, the importance of a positive effect in a small number of parents must be considered when making treatment and care decisions. There is a need for further high-quality research into effective strategies for this population.\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 15 studies that involved 1925 parents who had experienced childhood maltreatment and/or who had CPTSD or PTSD symptoms. About half of the studies included people who had experienced moderate-severe childhood maltreatment, while the others experienced lower levels of childhood maltreatment.\nMost studies looked at how well parenting or psychological interventions worked, and these were mostly compared to usual prenatal or postnatal care. We found no studies that looked at mind-body, biomedical or pharmacological approaches to improving parenting capacity or parent wellbeing. Most studies reported changes in wellbeing or parenting outcomes immediately after finishing the intervention. The interventions ranged from a single session to 12 months of weekly sessions. All but one study took place in the USA, and almost all people who took part were mothers. Most studies were funded by major research councils, government departments and philanthropic/charitable organisations."
}
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query-laysum
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23818
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[
{
"role": "user",
"content": "Abstract: Background\nThe optimal glycaemic control target in pregnant women with pre-existing diabetes is unclear, although there is a clear link between high glucose concentrations and adverse birth outcomes.\nObjectives\nTo assess the effects of different intensities of glycaemic control in pregnant women with pre-existing type 1 or type 2 diabetes.\nSearch methods\nWe searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 January 2016) and planned to search reference lists of retrieved studies.\nSelection criteria\nWe included randomised controlled trials comparing different glycaemic control targets in pregnant women with pre-existing diabetes.\nData collection and analysis\nTwo review authors independently assessed trials for inclusion, conducted data extraction, assessed risk of bias and checked for accuracy. We assessed the quality of the evidence using the GRADE approach.\nMain results\nWe included three trials, all in women with type 1 diabetes (223 women and babies). All three trials were at high risk of bias due to lack of blinding, unclear methods of randomisation and selective reporting of outcomes. Two trials compared very tight (3.33 to 5.0 mmol/L fasting blood glucose (FBG)) with tight-moderate (4.45 to 6.38 mmol/L) glycaemic control targets, with one trial of 22 babies reporting no perinatal deaths orserious perinatal morbidity (evidence graded low for both outcomes). In the same trial, there were two congenital anomalies in the very tight, and none in the tight-moderate group, with no significant differences in caesarean section between groups (risk ratio (RR) 0.92, 95% confidence interval (CI) 0.49 to 1.73; evidence graded very low). In these two trials, glycaemic control was not significantly different between the very tight and tight-moderate groups by the third trimester, although one trial of 22 women found significantly less maternal hypoglycaemia in the tight-moderate group.\nIn a trial of 60 women and babies comparing tight (≤ 5.6 mmol/L FBG); moderate (5.6 to 6.7 mmol/L); and loose (6.7 to 8.9 mmol/L) glycaemic control targets, there were two neonatal deaths in the loose and none in the tight or moderate groups (evidence graded very low). There were significantly fewer women with pre-eclampsia (evidence graded low), fewer caesarean sections (evidence graded low) and fewer babies with birthweights greater than 90th centile (evidence graded low) in the combined tight-moderate compared with the loose group.\nThe quality of the evidence was graded low or very low for important outcomes, because of design limitations to the studies, the small numbers of women included, and wide confidence intervals crossing the line of no effect. Many of the important outcomes were not reported in these studies.\nAuthors' conclusions\nIn a very limited body of evidence, few differences in outcomes were seen between very tight and tight-moderate glycaemic control targets in pregnant women with pre-existing type 1 diabetes, including actual glycaemic control achieved. There is evidence of harm (increased pre-eclampsia, caesareans and birthweights greater than 90th centile) for 'loose' control (FBG above 7 mmol/L). Future trials comparing interventions, rather than glycaemic control targets, may be more feasible. Trials in pregnant women with pre-existing type 2 diabetes are required.\n\nGiven the provided abstract, please respond to the following query: \"Why is this important?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Women who have either type 1 or type 2 diabetes before they become pregnant have an increased risk of pregnancy loss, large babies, and babies dying. When a pregnant woman has high blood glucose and insulin resistance this can affect the development of the baby's heart and other organs. Babies born to diabetic mothers may also have a higher risk of developing obesity and type 2 diabetes.\nMonitoring a diabetic pregnant woman's blood glucose level and staying within a target range may help to reduce these risks. We wanted to find out what the best blood glucose target is for pregnant women who had type 1 or type 2 diabetes before becoming pregnant."
}
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query-laysum
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23819
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[
{
"role": "user",
"content": "Abstract: Background\nSurgical site infection is more frequent in liver transplantation than in other types of solid organ transplantation with different antibiotics. Studies have shown that the rate of surgical site infection varies from 8.8% to 37.5% after liver transplantation. Therefore, antimicrobial prophylaxis is likely an essential tool for reducing these infections. However, the literature lacks evidence indicating the best prophylactic antibiotic regimen that can be used for liver transplantation.\nObjectives\nTo assess the benefits and harms of antibiotic prophylactic regimens for surgical site infection in people undergoing liver transplantation.\nSearch methods\nWe searched the Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, Science Citation Index Expanded and Latin American Caribbean Health Sciences Literature (LILACS). The most recent search was performed on 11 September 2015.\nSelection criteria\nAll eligible randomised clinical trials comparing any antibiotic regimen versus placebo, versus no intervention or versus another antibiotic regimen for surgical site infection in liver transplant recipients, regardless of age, sex and reason for transplantation. Quasi-randomised studies and other observational studies were considered for data on harm if retrieved with search results for randomised clinical trials.\nData collection and analysis\nTwo review authors selected relevant trials, assessed risk of bias of studies and extracted data.\nMain results\nThe electronic search identified 786 publications after removal of duplicates. From this search, only one seemingly randomised clinical trial, published in abstract form, fulfilled the inclusion criteria of this review. This trial was conducted at Shiraz Transplant Centre, Shiraz, Iran, where investigators randomly assigned a total of 180 consecutive liver transplant recipients. We judged the overall risk of bias of the trial published in abstract form as high. Researchers reported no numerical data but mentioned that 163 participants met the inclusion criteria after randomisation, and hence were included in the analyses. Most probably, the 17 excluded participants were high-risk liver transplant recipients. Trial authors concluded that they could find no differences between the two antibiotic regimens - ceftriaxone plus metronidazole versus ampicillin-sulbactam plus ceftizoxime - when given to liver transplant recipients. Review authors could not reconfirm the analyses because, as it has been mentioned, trial authors provided no trial data for analyses.\nAuthors' conclusions\nBenefits and harms of antibiotic prophylactic regimens for surgical site infection in liver transplantation remain unclear. Additional well-conducted randomised clinical trials adhering to SPIRIT (Spirit Protocol Items: Recommendations for Interventional Trials) and CONSORT (Consolidated Standards of Reporting Trials) guidelines are needed to determine the exact role of antibiotic prophylactic regimens in patients undergoing liver transplantation.\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 randomised clinical trial, which was conducted at Shiraz Transplant Centre, Shiraz, Iran, randomly assigned a total of 180 participants; of these, 163 participants met the inclusion criteria after randomisation. The trial reported no other numerical data and was considered at high risk of bias; the quality of the evidence was low, hence we cannot be sure of the conclusions presented by trial authors. This trial assessed ceftriaxone plus metronidazole versus ampicillin-sulbactam plus ceftizoxime. Trial authors have not responded to three email requests sent by review authors to request detailed information, but they mention that they found no differences between the two antibiotic regimens when used for prophylaxis for bacterial infection among liver transplant recipients."
}
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query-laysum
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23820
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[
{
"role": "user",
"content": "Abstract: Background\nThe effective control of moisture and microbes is necessary for the success of restoration procedures. The rubber dam, as an isolation method, has been widely used in dental restorative treatments. The effects of rubber dam usage on the longevity and quality of dental restorations still require evidence-based discussion. This review compares the effects of rubber dam with other isolation methods in dental restorative treatments. This is an update of the Cochrane Review first published in 2016.\nObjectives\nTo assess the effects of rubber dam isolation compared with other types of isolation used for direct and indirect restorative treatments in dental patients.\nSearch methods\nCochrane Oral Health's Information specialist searched the following electronic databases: Cochrane Oral Health's Trials Register (searched 13 January 2021), Cochrane Central Register of Controlled Trials (CENTRAL; 2020, Issue 12) in the Cochrane Library (searched 13 January 2021), MEDLINE Ovid (1946 to 13 January 2021), Embase Ovid (1980 to 13 January 2021), LILACS BIREME Virtual Health Library (Latin American and Caribbean Health Science Information database; 1982 to 13 January 2021), and SciELO BIREME Virtual Health Library (1998 to 13 January 2021). We also searched Chinese BioMedical Literature Database (CBM, in Chinese) (1978 to 13 January 2021), VIP database (in Chinese) (1989 to 13 January 2021), and China National Knowledge Infrastructure (CNKI, in Chinese) (1994 to 13 January 2021). We searched ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform, OpenGrey, and Sciencepaper Online (in Chinese) for ongoing trials. There were no restrictions on the language or date of publication when searching the electronic databases.\nSelection criteria\nWe included randomised controlled trials (including split-mouth trials) over one month in length assessing the effects of rubber dam compared with alternative isolation methods for dental restorative treatments.\nData collection and analysis\nTwo review authors independently screened the results of the electronic searches, extracted data, and assessed the risk of bias of the included studies. Disagreement was resolved by discussion. We strictly followed Cochrane's statistical guidelines and assessed the certainty of the evidence using GRADE.\nMain results\nWe included six studies conducted worldwide between 2010 and 2015 involving a total of 1342 participants (of which 233 participants were lost to follow-up). All the included studies were at high risk of bias.\nFive studies compared rubber dam with traditional cotton rolls isolation. One study was excluded from the analysis due to inconsistencies in the presented data. Of the four remaining trials, three reported survival rates of the restorations with a minimum follow-up of six months. Pooled results from two studies involving 192 participants indicated that the use of rubber dam isolation may increase the survival rates of direct composite restorations of non-carious cervical lesions (NCCLs) at six months (odds ratio (OR) 2.29, 95% confidence interval (CI) 1.05 to 4.99; low-certainty evidence). However, the use of rubber dam in NCCLs composite restorations may have little to no effect on the survival rates of the restorations compared to cotton rolls at 12 months (OR 1.38, 95% CI 0.45 to 4.28; 1 study, 30 participants; very low-certainty evidence) and at 18 months (OR 1.00, 95% CI 0.45 to 2.25; 1 study, 30 participants; very low-certainty evidence) but the evidence is very uncertain. At 24 months, the use of rubber dam may decrease the risk of failure of the restorations in children undergoing proximal atraumatic restorative treatment in primary molars but the evidence is very uncertain (hazard ratio (HR) 0.80, 95% CI 0.66 to 0.97; 1 study, 559 participants; very low-certainty evidence).\nNone of the included studies mentioned adverse effects or reported the direct cost of the treatment.\nAuthors' conclusions\nThis review found some low-certainty evidence that the use of rubber dam in dental direct restorative treatments may lead to a lower failure rate of the restorations compared with cotton roll usage after six months. At other time points, the evidence is very uncertain. Further high-quality research evaluating the effects of rubber dam usage on different types of restorative treatments is required.\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 if rubber dams improve the success of tooth repairs when compared against other methods for isolating teeth. We also wanted to know if they are associated with unwanted (adverse) effects."
}
] |
query-laysum
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23821
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[
{
"role": "user",
"content": "Abstract: Background\nMany people with schizophrenia do not achieve satisfactory improvements in their mental state, particularly the symptom of hearing voices (hallucinations), with medical treatment.\nObjectives\nTo examine the effects of Avatar Therapy for people with schizophrenia or related disorders.\nSearch methods\nIn December 2016, November 2018 and April 2019, the Cochrane Schizophrenia Group's Study-Based Register of Trials (including registries of clinical trials) was searched, review authors checked references of all identified relevant reports to identify more studies and contacted authors of trials for additional information.\nSelection criteria\nAll randomised clinical trials focusing on Avatar Therapy for people with schizophrenia or related disorders.\nData collection and analysis\nWe extracted data independently. For binary outcomes, we calculated risk ratio (RR) and 95% confidence intervals (CI), on an intention-to-treat basis. For continuous data, we estimated the mean difference (MD) between groups and 95% CIs. We employed a fixed-effect model for analyses. We assessed risk of bias for included studies and created 'Summary of findings' tables using GRADE. Our main outcomes of interest were clinically important change in; mental state, insight, global state, quality of life and functioning as well as adverse effects and leaving the study early.\nMain results\nWe found 14 potentially relevant references for three studies (participants = 195) comparing Avatar Therapy with two other interventions; treatment as usual or supportive counselling. Both Avatar Therapy and supportive counselling were given in addition (add-on) to the participants' normal care. All of the studies had high risk of bias across one or more domains for methodology and, for other risks of bias, authors from one of the studies were involved in the development of the avatar systems on trial and in another trial, authors had patents on the avatar system pending.\n1. Avatar Therapy compared with treatment as usual\nWhen Avatar Therapy was compared with treatment as usual average endpoint Positive and Negative Syndrome Scale – Positive (PANSS-P) scores were not different between treatment groups (MD –1.93, 95% CI –5.10 to 1.24; studies = 1, participants = 19; very low-certainty evidence). A measure of insight (Revised Beliefs about Voices Questionnaire; BAVQ-R) showed an effect in favour of Avatar Therapy (MD –5.97, 95% CI –10.98 to –0.96; studies = 1, participants = 19; very low-certainty evidence). No one was rehospitalised in either group in the short term (risk difference (RD) 0.00, 95% CI –0.20 to 0.20; studies = 1, participants = 19; low-certainty evidence). Numbers leaving the study early from each group were not clearly different – although more did leave from the Avatar Therapy group (6/14 versus 0/12; RR 11.27, 95% CI 0.70 to 181.41; studies = 1, participants = 26; low-certainty evidence). There was no clear difference in anxiety between treatment groups (RR 5.54, 95% CI 0.34 to 89.80; studies = 1, participants = 19; low-certainty evidence). For quality of life, average Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (QLESQ-SF) scores favoured Avatar Therapy (MD 9.99, 95% CI 3.89 to 16.09; studies = 1, participants = 19; very low-certainty evidence). No study reported data for functioning.\n2. Avatar Therapy compared with supportive counselling\nWhen Avatar Therapy was compared with supportive counselling (all short-term), general mental state (Psychotic Symptom Rating Scale (PSYRATS)) scores favoured the Avatar Therapy group (MD –4.74, 95% CI –8.01 to –1.47; studies = 1, participants = 124; low-certainty evidence). For insight (BAVQ-R), there was a small effect in favour of Avatar Therapy (MD –8.39, 95% CI –14.31 to –2.47; studies = 1, participants = 124; low-certainty evidence). Around 20% of each group left the study early (risk ratio (RR) 1.06, 95% CI 0.59 to 1.89; studies = 1, participants = 150; moderate-certainty evidence). Analysis of quality of life scores (Manchester Short Assessment of Quality of Life (MANSA)) showed no clear difference between groups (MD 2.69, 95% CI –1.48 to 6.86; studies = 1, participants = 120; low-certainty evidence). No data were available for rehospitalisation rates, adverse events or functioning.\nAuthors' conclusions\nOur analyses of available data shows few, if any, consistent effects of Avatar Therapy for people living with schizophrenia who experience auditory hallucinations. Where there are effects, or suggestions of effects, we are uncertain because of their risk of bias and their unclear clinical meaning. The theory behind Avatar Therapy is compelling but the practice needs testing in large, long, well-designed, well-reported randomised trials undertaken with help from – but not under the direction of – Avatar Therapy pioneers.\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": "Auditory hallucination is perceiving voices when there is no external stimulus. Around 70% of people with schizophrenia experience these. Medication may help cause these to decrease or disappear. However, some people do not want to take medication and, in a proportion of people, it has little meaningful effect. Avatar Therapy is an experimental technology that uses a visualised avatar face, voice and other sensory input to create an interactive computerised environment. We investigated the effects of Avatar Therapy for improving auditory hallucinations for people with schizophrenia."
}
] |
query-laysum
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23822
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[
{
"role": "user",
"content": "Abstract: Background\nTumour necrosis factor (TNF)-alpha inhibitors are beneficial for the treatment of rheumatoid arthritis (RA) for reducing the risk of joint damage, improving physical function and improving the quality of life. This review is an update of the 2014 Cochrane Review of the treatment of RA with certolizumab pegol.\nObjectives\nTo assess the clinical benefits and harms of certolizumab pegol (CZP) in people with RA who have not responded well to conventional disease-modifying anti-rheumatic drugs (DMARDs).\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL: Cochrane Library 2016, Issue 9), MEDLINE, Embase, Web of Knowledge, reference lists of articles, clinicaltrials.gov and ICTRP of WHO. The searches were updated from 2014 (date of the last search for the previous version) to 26 September 2016.\nSelection criteria\nRandomised controlled trials that compared certolizumab pegol with any other agent, including placebo or methotrexate (MTX), in adults with active RA, regardless of current or prior treatment with conventional disease-modifying anti-rheumatic drugs (DMARDs), such as MTX.\nData collection and analysis\nTwo review authors independently checked search results, extracted data and assessed trial quality. We resolved disagreements by discussion or referral to a third review author.\nMain results\nWe included 14 trials in this update, three more than previously. Twelve trials (5422 participants) included measures of benefit. We pooled 11 of them, two more than previously. Thirteen trials included information on harms, (5273 participants). The duration of follow-up varied from 12 to 52 weeks and the range of doses of certolizumab pegol varied from 50 to 400 mg given subcutaneously. In Phase III trials, the comparator was placebo plus MTX in seven trials and placebo in five. In the two Phase II trials the comparator was only placebo.\nThe approved dose of certolizumab pegol, 200 mg every other week, produced clinically important improvements at 24 weeks for the following outcomes:\n- American College of Rheumatology (ACR) 50% improvement (pain, function and other symptoms of RA): 25% absolute improvement (95% confidence interval (CI) 20% to 33%); number need to treat for an additional beneficial outcome (NNTB) of 4 (95% CI 3 to 5); risk ratio (RR) 3.80 (95% CI 2.42 to 5.95), 1445 participants, 5 studies.\n- The Health Assessment Questionnaire (HAQ): -12% absolute improvement (95% CI -9% to -14%); NNTB of 8 (95% CI 7 to 11); mean difference (MD) - 0.35 (95% CI -0.43 to -0.26; 1268 participants, 4 studies) (scale 0 to 3; lower scores mean better function).\n- Proportion of participants achieving remission (Disease Activity Score (DAS) < 2.6) absolute improvement 10% (95% CI 8% to 16%); NNTB of 8 (95% CI 6 to 12); risk ratio (RR) 2.94 (95% CI 1.64 to 5.28), 2420 participants, six studies.\n- Radiological changes: erosion score (ES) absolute improvement -0.29% (95% CI -0.42% to -0.17%); NNTB of 6 (95% CI 4 to 10); MD -0.67 (95% CI -0.96 to -0.38); 714 participants, two studies (scale 0 to 230), but not a clinically important difference.\n-Serious adverse events (SAEs) were statistically but not clinically significantly more frequent for certolizumab pegol (200 mg every other week) with an absolute rate difference of 3% (95% CI 1% to 4%); number needed to treat for an additional harmful outcome (NNTH) of 33 (95% CI 25 to 100); Peto odds ratio (OR) 1.47 (95% CI 1.13 to 1.91); 3927 participants, nine studies.\nThere was a clinically significant increase in all withdrawals in the placebo groups (for all doses and at all follow-ups) with an absolute rate difference of -29% (95% CI -16% to -42%), NNTH of 3 (95% CI 2 to 6), RR 0.47 (95% CI 0.39 to 0.56); and there was a clinically significant increase in withdrawals due to adverse events in the certolizumab groups (for all doses and at all follow-ups) with an absolute rate difference of 2% (95% CI 0% to 3%); NNTH of 58 (95% CI 28 to 329); Peto OR 1.45 (95% CI 1.09 to 1.94) 5236 participants Twelve studies.\nWe judged the quality of evidence to be high for ACR50, DAS remission, SAEs and withdrawals due to adverse events, and moderate for HAQ and radiological changes, due to concerns about attrition bias. For all withdrawals we judged the quality of evidence to be moderate, due to inconsistency.\nAuthors' conclusions\nThe results and conclusions did not change from the previous review. There is a moderate to high certainty of evidence from randomised controlled trials that certolizumab pegol, alone or combined with methotrexate, is beneficial in the treatment of RA for improved ACR50 and health-related quality of life, an increased chance of remission of RA, and reduced joint damage as seen on x-ray. Fewer people stopped taking their treatment, but most of these who did stopped due to serious adverse events. Adverse events were more frequent with active treatment. We found a clinically but not statistically significant risk of serious adverse events.\n\nGiven the provided abstract, please respond to the following query: \"What is rheumatoid arthritis and what is certolizumab pegol?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "When you have RA, your immune system becomes overactive and attacks the lining of your joints. This makes your joints swollen, stiff and painful.\nCertolizumab pegol is a biologic medication for the treatment of RA. It works by blocking a substance produced by the body known as tumour necrosis factor alpha (TNFα). Certolizumab pegol is given by injections under the skin. The approved dose is 200 mg."
}
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query-laysum
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23823
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[
{
"role": "user",
"content": "Abstract: Background\nUlcerative colitis is an inflammatory condition affecting the colon, with an annual incidence of approximately 10 to 20 per 100,000 people. The majority of people with ulcerative colitis can be put into remission, leaving a group who do not respond to first- or second-line therapies. There is a significant proportion of people who experience adverse effects with current therapies. Consequently, new alternatives for the treatment of ulcerative colitis are constantly being sought. Probiotics are live microbial feed supplements that may beneficially affect the host by improving intestinal microbial balance, enhancing gut barrier function and improving local immune response.\nObjectives\nThe primary objective was to determine the efficacy of probiotics compared to placebo, no treatment, or any other intervention for the maintenance of remission in people with ulcerative colitis. The secondary objective was to assess the occurrence of adverse events associated with the use of probiotics.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, and two other databases on 31 October 2019. We contacted authors of relevant studies and manufacturers of probiotics regarding ongoing or unpublished trials that may be relevant to the review, and we searched ClinicalTrials.gov. We also searched references of trials for any additional trials.\nSelection criteria\nRandomised controlled trials (RCTs) that compared probiotics against placebo or any other intervention, in both adults and children, for the maintenance of remission in ulcerative colitis were eligible for inclusion. Maintenance therapy had to be for a minimum of three months when remission has been established by any clinical, endoscopic,histological or radiological relapse as defined by study authors.\nData collection and analysis\nTwo review authors independently conducted data extraction and 'Risk of bias' assessment of included studies. We analysed data using Review Manager 5. We expressed dichotomous and continuous outcomes as risk ratios (RRs) and mean differences (MDs) with 95% confidence intervals (CIs). We assessed the certainty of the evidence using the GRADE methodology.\nMain results\nIn this review, we included 12 studies (1473 randomised participants) that met the inclusion criteria. Participants were mostly adults. The studies compared probiotics to placebo, probiotics to 5-aminosalicylic acid (5-ASA) and a combination of probiotics and 5-ASA to 5-ASA. The studies ranged in length from 12 to 52 weeks. The average age of participants was between 32 and 51, with a range between 18 and 88 years. Seven studies investigated a single bacterial strain, and five studies considered mixed preparations of multiple strains. The risk of bias was high in all except three studies due to selective reporting, incomplete outcome data and lack of blinding. This resulted in low- to very low-certainty of evidence.\nIt is uncertain if there is any difference in occurrence of clinical relapse when probiotics are compared with placebo (RR 0.87, 95% CI 0.63 to 1.18; 4 studies, 361 participants; very low-certainty evidence (downgraded for risk of bias, imbalance in baseline characteristics and imprecision)). It is also uncertain whether probiotics lead to a difference in the number of people who maintain clinical remission compared with placebo (RR 1.16, 95% CI 0.98 to 1.37; 2 studies, 141 participants; very low-certainty evidence (downgraded for risk of bias, imbalance in baseline characteristics and imprecision)).\nWhen probiotics are compared with 5-ASA, there may be little or no difference in clinical relapse (RR 1.01, 95% CI 0.84 to 1.22; 2 studies, 452 participants; low-certainty evidence) and maintenance of clinical remission (RR 1.06, 95% CI 0.90 to 1.25; 1 study, 125 participants; low-certainty evidence). It is uncertain if there is any difference in clinical relapse when probiotics, combined with 5-ASA are compared with 5-ASA alone (RR 1.11, 95% CI 0.66 to 1.87; 2 studies, 242 participants; very low-certainty evidence (downgraded due to risk of bias and imprecision)). There may be little or no difference in maintenance of remission when probiotics, combined with 5-ASA, are compared with 5-ASA alone (RR 1.05, 95% CI 0.89 to 1.24; 1 study, 122 participants; low-certainty evidence).\nWhere reported, most of the studies which compared probiotics with placebo recorded no serious adverse events or withdrawals due to adverse events. For the comparison of probiotics and 5-ASA, one trial reported 11/110 withdrawals due to adverse events with probiotics and 11/112 with 5-ASA (RR 1.02, 95% CI 0.46 to 2.25; 222 participants; very low-certainty evidence). Discontinuation of therapy was due to gastrointestinal symptoms. One study (24 participants) comparing probiotics combined with 5-ASA with 5-ASA alone, reported no withdrawals due to adverse events; and two studies reported two withdrawals in the probiotic arm, due to avascular necrosis of bilateral femoral head and pulmonary thromboembolism (RR 5.29, 95% CI 0.26 to 107.63; 127 participants; very low-certainty evidence).\nHealth-related quality of life and need for additional therapy were reported infrequently.\nAuthors' conclusions\nThe effectiveness of probiotics for the maintenance of remission in ulcerative colitis remains unclear. This is due to low- to very low-certainty evidence from poorly conducted studies, which contribute limited amounts of data from a small number of participants. Future trials comparing probiotics with 5-ASA rather than placebo will better reflect conventional care given to people with ulcerative colitis. Appropriately powered studies with a minimum length of 12 months are needed.\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 whether probiotics can maintain remission in people with ulcerative colitis. We collected and analysed data from 12 studies with a total of 1473 people to answer this question."
}
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query-laysum
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23824
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[
{
"role": "user",
"content": "Abstract: Background\nVarious rehabilitation treatments may be offered following surgery for flexor tendon injuries of the hand. Rehabilitation often includes a combination of an exercise regimen and an orthosis, plus other rehabilitation treatments, usually delivered together. The effectiveness of these interventions remains unclear.\nObjectives\nTo assess the effects (benefits and harms) of different rehabilitation interventions after surgery for flexor tendon injuries of the hand.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials, the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register, MEDLINE, Embase, two additional databases and two international trials registries, unrestricted by language. The last date of searches was 11 August 2020. We checked the reference lists of included studies and relevant systematic reviews.\nSelection criteria\nWe included randomised controlled trials (RCTs) and quasi-RCTs that compared any postoperative rehabilitation intervention with no intervention, control, placebo, or another postoperative rehabilitation intervention in individuals who have had surgery for flexor tendon injuries of the hand. Trials comparing different mobilisation regimens either with another mobilisation regimen or with a control were the main comparisons of interest. Our main outcomes of interest were patient-reported function, active range of motion of the fingers, and number of participants experiencing an adverse event.\nData collection and analysis\nTwo review authors independently selected trials for inclusion, extracted data, assessed risk of bias and assessed the quality of the body of evidence for primary outcomes using the GRADE approach, according to standard Cochrane methodology.\nMain results\nWe included 16 RCTs and one quasi-RCT, with a total of 1108 participants, mainly adults. Overall, the participants were aged between 7 and 72 years, and 74% were male. Studies mainly focused on flexor tendon injuries in zone II.\nThe 17 studies were heterogeneous with respect to the types of rehabilitation treatments provided, intensity, duration of treatment and the treatment setting. Each trial tested one of 14 comparisons, eight of which were of different exercise regimens. The other trials examined the timing of return to unrestricted functional activities after surgery (one study); the use of external devices applied to the participant to facilitate mobilisation, such as an exoskeleton (one study) or continuous passive motion device (one study); modalities such as laser therapy (two studies) or ultrasound therapy (one study); and a motor imagery treatment (one study). No trials tested different types of orthoses; different orthosis wearing regimens, including duration; different timings for commencing mobilisation; different types of scar management; or different timings for commencing strengthening.\nTrials were generally at high risk of bias for one or more domains, including lack of blinding, incomplete outcome data and selective outcome reporting. Data pooling was limited to tendon rupture data in a three trial comparison. We rated the evidence available for all reported outcomes of all comparisons as very low-certainty evidence, which means that we have very little confidence in the estimates of effect.\nWe present the findings from three exercise regimen comparisons, as these are commonly used in clinical current practice.\nEarly active flexion plus controlled passive exercise regimen versus early controlled passive exercise regimen (modified Kleinert protocol) was compared in one trial of 53 participants with mainly zone II flexor tendon repairs. There is very low-certainty evidence of no clinically important difference between the two groups in patient-rated function or active finger range of motion at 6 or 12 months follow-up. There is very low-certainty evidence of little between-group difference in adverse events: there were 15 overall. All three tendon ruptures underwent secondary surgery.\nAn active exercise regimen versus an immobilisation regimen for three weeks was compared in one trial reporting data for 84 participants with zone II flexor tendon repairs. The trial did not report on self-rated function, on range of movement during three to six months or numbers of participants experiencing adverse events. The very low-certainty evidence for poor (under one-quarter that of normal) range of finger movement at one to three years follow-up means we are uncertain of the finding of zero cases in the active group versus seven cases in the immobilisation regimen. The same uncertainty applies to the finding of little difference between the two groups in adverse events (5 tendon ruptures in the active group versus 10 probable scar adhesion in the immobilisation group) indicated for surgery.\nPlace and hold exercise regimen performed within an orthosis versus a controlled passive regimen using rubber band traction was compared in three heterogeneous trials, which reported data for a maximum of 194 participants, with mainly zone II flexor tendon repairs. The trials did not report on range of movement during three to six months, or numbers of participants experiencing adverse events. There was very low-certainty evidence of no difference in self-rated function using the Disability of the Arm, Shoulder and Hand (DASH) functional assessment between the two groups at six months (one trial) or at 12 months (one trial). There is very low-certainty evidence from one trial of greater active finger range of motion at 12 months after place and hold. Secondary surgery data were not available; however, all seven recorded tendon ruptures would have required surgery.\nAll the evidence for the other five exercise comparisons as well as those of the other six comparisons made by the included studies was incomplete and, where available, of very low-certainty.\nAuthors' conclusions\nThere is a lack of evidence from RCTs on most of the rehabilitation interventions used following surgery for flexor tendon injuries of the hand. The limited and very low-certainty evidence for all 14 comparisons examined in the 17 included studies means that we have very little confidence in the estimates of effect for all outcomes for which data were available for these comparisons.\nThe dearth of evidence identified in this review points to the urgent need for sufficiently powered RCTs that examine key questions relating to the rehabilitation of these injuries. A consensus approach identifying these and establishing minimum study conduct and reporting criteria will be valuable. Our suggestions for future research are detailed in the review.\n\nGiven the provided abstract, please respond to the following query: \"How did we identify and evaluate the evidence?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "First, we searched for studies in the medical literature that compared any rehabilitation approach after flexor tendon surgery against:\n- no treatment;\n- a placebo (dummy) treatment (in which, for example, someone thinks they may be receiving laser therapy but the machine is switched off); or\n- another rehabilitation approach.\nWe then compared the results, and summarised the evidence from all the studies. Finally, we rated our confidence in the evidence, based on factors such as study methods and sizes, and the consistency of findings across studies that tested the same comparison."
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query-laysum
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23826
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[
{
"role": "user",
"content": "Abstract: Background\nA septic abortion refers to any abortion (spontaneous or induced) complicated by upper genital tract infection including endometritis or parametritis. The mainstay of treatment of septic abortion is antibiotic therapy alone or in combination with evacuation of retained products of conception. Regimens including broad-spectrum antibiotics are routinely recommended for treatment. However, there is no consensus on the most effective antibiotics alone or in combination to treat septic abortion. This review aimed to bridge this gap in knowledge to inform policy and practice.\nObjectives\nTo review the effectiveness of various individual antibiotics or antibiotic regimens in the treatment of septic abortion.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, LILACS, and POPLINE using the following keywords: 'Abortion', 'septic abortion', 'Antibiotics', 'Infected abortion', 'postabortion infection'. We also searched the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) and ClinicalTrials.gov for ongoing trials on 19 April, 2016.\nSelection criteria\nWe considered for inclusion randomised controlled trials (RCTs) and non-RCTs that compared antibiotic(s) to another antibiotic(s), irrespective of route of administration, dosage, and duration as well as studies comparing antibiotics alone with antibiotics in combination with other interventions such as dilation and curettage (D&C).\nData collection and analysis\nTwo review authors independently extracted data from included trials. We resolved disagreements through consultation with a third author. One review author entered extracted data into Review Manager 5.3, and a second review author cross-checked the entry for accuracy.\nMain results\nWe included 3 small RCTs involving 233 women that were conducted over 3 decades ago.\nClindamycin did not differ significantly from penicillin plus chloramphenicol in reducing fever in all women (mean difference (MD) -12.30, 95% confidence interval (CI) -25.12 to 0.52; women = 77; studies = 1). The evidence for this was of moderate quality. \"Response to treatment was evaluated by the patient's 'fever index' expressed in degree-hour and defined as the total quantity of fever under the daily temperature curve with 99°F (37.2°C) as the baseline\".\nThere was no difference in duration of hospitalisation between clindamycin and penicillin plus chloramphenicol. The mean duration of hospital stay for women in each group was 5 days (MD 0.00, 95% CI -0.54 to 0.54; women = 77; studies = 1).\nOne study evaluated the effect of penicillin plus chloramphenicol versus cephalothin plus kanamycin before and after D&C. Response to therapy was evaluated by \"the time from start of antibiotics until fever lysis and time from D&C until patients become afebrile\". Low-quality evidence suggested that the effect of penicillin plus chloramphenicol on fever did not differ from that of cephalothin plus kanamycin (MD -2.30, 95% CI -17.31 to 12.71; women = 56; studies = 1). There was no significant difference between penicillin plus chloramphenicol versus cephalothin plus kanamycin when D&C was performed during antibiotic therapy (MD -1.00, 95% CI -13.84 to 11.84; women = 56; studies = 1). The quality of evidence was low.\nA study with unclear risk of bias showed that the time for fever resolution (MD -5.03, 95% CI -5.77 to -4.29; women = 100; studies = 1) as well as time for resolution of leukocytosis (MD -4.88, 95% CI -5.98 to -3.78; women = 100; studies = 1) was significantly lower with tetracycline plus enzymes compared with intravenous penicillin G.\nTreatment failure and adverse events occurred infrequently, and the difference between groups was not statistically significant.\nAuthors' conclusions\nWe found no strong evidence that intravenous clindamycin alone was better than penicillin plus chloramphenicol for treating women with septic abortion. Similarly, available evidence did not suggest that penicillin plus chloramphenicol was better than cephalothin plus kanamycin for the treatment of women with septic abortion. Tetracyline enzyme antibiotic appeared to be more effective than intravenous penicillin G in reducing the time to fever defervescence, but this evidence was provided by only one study at low risk of bias.\nThere is a need for high-quality RCTs providing reliable evidence for treatments of septic abortion with antibiotics that are currently in use. The three included studies were carried out over 30 years ago. There is also a need to include institutions in low-resource settings, such as sub-Saharan Africa, Latin America and the Caribbean, and South Asia, with a high burden of abortion and health systems challenges.\n\nGiven the provided abstract, please respond to the following query: \"Conclusion\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
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"role": "assistant",
"content": "The available evidence from three small trials, which involved some antibiotics not currently in use, is insufficient to advocate for a change in existing treatment recommendations for septic abortion. In spite of this, combinations of antibiotics may be administered to women with septic abortion because they are more likely to reduce fever faster, including in women with bacteria in the blood, than single antibiotic treatment. Only one study reported harm experienced by women: two women given clindamycin had treatment failure, and one woman had an adverse drug reaction. In addition, two women in the clindamycin group had pelvic abscess compared to one in the penicillin plus chloramphenicol group, although the difference was not significant. The limitation of this review is the inclusion of three small studies conducted over 30 years ago."
}
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query-laysum
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23827
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[
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"role": "user",
"content": "Abstract: Background\nAntibodies against hepatitis B surface antigen (HBsAg) wane over time following hepatitis B immunisation; hence, it is unclear whether people vaccinated in three-dose or four-dose schedules of the hepatitis B vaccine are still immune when the hepatitis B surface antibody (anti-HBs) level in their body is undetectable, or lower than the level usually considered protective. This question may potentially be answered indirectly by measuring the anamnestic immune response to a booster dose of vaccine. The term 'booster' (or revaccination) refers to an additional dose of hepatitis B vaccine (HBV) given some time post-primary vaccination to induce immune memory and improve protection against hepatitis B virus (HBV) infection.\nObjectives\nTo assess the benefits and harms of booster dose hepatitis B vaccination, more than five years after the primary vaccination, for preventing HBV infection in healthy individuals previously vaccinated with the hepatitis B vaccine, and with hepatitis B surface antibody (anti-HBs) levels below 10 mIU/mL.\nSearch methods\nWe searched the Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, Science Citation Index Expanded, conference databases, and reference lists of articles to January 2016. We also contacted authors of articles. In addition, we searched ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform for ongoing trials (May 2016).\nSelection criteria\nRandomised clinical trials addressing anamnestic immune response to a booster dose of hepatitis B vaccine, more than five years after the primary vaccination, in apparently healthy participants, vaccinated in a three-dose or four-dose schedule of the hepatitis B vaccine during the primary vaccination, without receiving an additional dose or immunoglobulin.\nData collection and analysis\nBoth review authors decided if the identified studies met the inclusion criteria or not. Primary outcomes included the proportion of participants with anamnestic immune response in non-protected participants and signs of HBV infection. Secondary outcomes were the proportion of participants that developed local and systemic adverse events following a booster dose injection. We planned to report the weighted proportion with 95% confidence intervals (CIs).\nMain results\nThere were no eligible randomised clinical trials fulfilling the inclusion criteria of this review.\nAuthors' conclusions\nWe were unable to include any randomised clinical trials on the topic; only randomised clinical trials will be able to provide an answer as to whether a booster dose vaccination is able to protect against hepatitis B infection.\n\nGiven the provided abstract, please respond to the following query: \"Selection criteria\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Randomised clinical trials addressing immune response (i.e., the way your body recognises and defends itself against bacteria, viruses, and substances that appear foreign and harmful to the body) to a booster dose of hepatitis B vaccine, more than five years after the primary vaccination in apparently healthy participants, vaccinated in a three-dose or four-dose schedule of hepatitis B vaccine during their primary vaccination, without receiving an additional dose of the hepatitis B vaccine or immunoglobulin."
}
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query-laysum
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23828
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[
{
"role": "user",
"content": "Abstract: Background\nSeveral agents are used to clear secretions from the airways of people with cystic fibrosis. Mannitol increases mucociliary clearance, but its exact mechanism of action is unknown. The dry powder formulation of mannitol may be more convenient and easier to use compared with established agents which require delivery via a nebuliser. Phase III trials of inhaled dry powder mannitol for the treatment of cystic fibrosis have been completed and it is now available in Australia and some countries in Europe. This is an update of a previous review.\nObjectives\nTo assess whether inhaled dry powder mannitol is well tolerated, whether it improves the quality of life and respiratory function in people with cystic fibrosis and which adverse events are associated with the treatment.\nSearch methods\nWe searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register which comprises references identified from comprehensive electronic databases, handsearching relevant journals and abstracts from conferences.\nDate of last search: 12 December 2019.\nSelection criteria\nAll randomised controlled studies comparing mannitol with placebo, active inhaled comparators (for example, hypertonic saline or dornase alfa) or with no treatment.\nData collection and analysis\nAuthors independently assessed studies for inclusion, carried out data extraction and assessed the risk of bias in included studies. The quality of the evidence was assessed using GRADE.\nMain results\nSix studies (reported in 36 unique publications) were included with a total of 784 participants.\nDuration of treatment in the included studies ranged from 12 days to six months, with open-label treatment for an additional six months in two of the studies. Five studies compared mannitol with control (a very low dose of mannitol or non-respirable mannitol) and the final study compared mannitol to dornase alfa alone and to mannitol plus dornase alfa. Two large studies had a similar parallel design and provided data for 600 participants, which could be pooled where data for a particular outcome and time point were available. The remaining studies had much smaller sample sizes (ranging from 22 to 95) and data could not be pooled due to differences in design, interventions and population.\nPooled evidence from the two large parallel studies was judged to be of low to moderate quality and from the smaller studies was judged to be of low to very low quality. In all studies, there was an initial test to see if participants tolerated mannitol, with only those who could tolerate the drug being randomised; therefore, the study results are not applicable to the cystic fibrosis population as a whole.\nWhile the published papers did not provide all the data required for our analysis, additional unpublished data were provided by the drug's manufacturer and the author of one of the studies.\nPooling the large parallel studies comparing mannitol to control, up to and including six months, lung function (forced expiratory volume at one second) measured in both mL and % predicted was significantly improved in the mannitol group compared to the control group (moderate-quality evidence). Beneficial results were observed in these studies in adults and in both concomitant dornase alfa users and non-users in these studies. In the smaller studies, statistically significant improvements in lung function were also observed in the mannitol groups compared to the non-respirable mannitol groups; however, we judged this evidence to be of low to very low quality.\nFor the comparisons of mannitol and control, we found no consistent differences in health-related quality of life in any of the domains except for burden of treatment, which was less for mannitol up to four months in the two pooled studies of a similar design; this difference was not maintained at six months. It should be noted that the tool used to measure health-related quality of life was not designed to assess mucolytics and pooling of the age-appropriate tools (as done in some of the included studies) may not be valid so results were judged to be low to very low quality and should be interpreted with caution. Cough, haemoptysis, bronchospasm, pharyngolaryngeal pain and post-tussive vomiting were the most commonly reported side effects in both treatment groups. Where rates of adverse events could be compared, statistically no significant differences were found between mannitol and control groups; although some of these events may have clinical relevance for people with CF.\nFor the comparisons of mannitol to dornase alfa alone and to mannitol plus dornase alfa, very low-quality evidence from a 12-week cross-over study of 28 participants showed no statistically significant differences in the recorded domains of health-related quality of life or measures of lung function. Cough was the most common side effect in the mannitol alone arm but there was no occurrence of cough in the dornase alfa alone arm and the most commonly reported reason of withdrawal from the mannitol plus dornase alfa arm was pulmonary exacerbations.\nIn terms of secondary outcomes of the review (pulmonary exacerbations, hospitalisations, symptoms, sputum microbiology), evidence provided by the included studies was more limited. For all comparisons, no consistent statistically significant and clinically meaningful differences were observed between mannitol and control treatments (including dornase alfa).\nAuthors' conclusions\nThere is moderate-quality evidence to show that treatment with mannitol over a six-month period is associated with an improvement in some measures of lung function in people with cystic fibrosis compared to control. There is low to very low-quality evidence suggesting no difference in quality of life for participants taking mannitol compared to control. This review provides very low-quality evidence suggesting no difference in lung function or quality of life comparing mannitol to dornase alfa alone and to mannitol plus dornase alfa.\nThe clinical implications from this review suggest that mannitol could be considered as a treatment in cystic fibrosis; but further research is required in order to establish who may benefit most and whether this benefit is sustained in the longer term. Furthermore, studies comparing its efficacy against other (established) mucolytic therapies need to be undertaken before it can be considered for mainstream 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": "We included six studies (with a total of 784 adults and children) in this review. Five studies compared a standard dose of mannitol with control (a very low dose of mannitol or a version of mannitol which did not allow the active drug to reach the lungs) and the sixth study compared mannitol with nebulised recombinant human deoxyribonuclease (dornase alfa), both alone and taken together. Participants could continue using dornase alfa and other standard therapies, but were excluded from the five of the six studies if they were using hypertonic saline. Treatment in these studies lasted from 12 days to six months. Five studies provided the treatments to people as outpatients and in one study, the children treated were in hospital due to pulmonary exacerbations (flare ups of disease)."
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query-laysum
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23829
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[
{
"role": "user",
"content": "Abstract: Background\nColorectal cancer is the third most commonly diagnosed cancer worldwide. A diagnosis of colorectal cancer and subsequent treatment can adversely affect an individuals physical and mental health. Benefits of physical activity interventions in alleviating treatment side effects have been demonstrated in other cancer populations. Given that regular physical activity can decrease the risk of colorectal cancer, and cardiovascular fitness is a strong predictor of all-cause and cancer mortality risk, physical activity interventions may have a role to play in the colorectal cancer control continuum. Evidence of the efficacy of physical activity interventions in this population remains unclear.\nObjectives\nTo assess the effectiveness and safety of physical activity interventions on the disease-related physical and mental health of individuals diagnosed with non-advanced colorectal cancer, staged as T1-4 N0-2 M0, treated surgically or with neoadjuvant or adjuvant therapy (i.e. chemotherapy, radiotherapy or chemoradiotherapy), or both.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2019, Issue 6), along with OVID MEDLINE, six other databases and four trial registries with no language or date restrictions. We screened reference lists of relevant publications and handsearched meeting abstracts and conference proceedings of relevant organisations for additional relevant studies. All searches were completed between 6 June and 14 June 2019.\nSelection criteria\nWe included randomised control trials (RCTs) and cluster-RCTs comparing physical activity interventions, to usual care or no physical activity intervention in adults with non-advanced colorectal cancer.\nData collection and analysis\nTwo review authors independently selected studies, performed the data extraction, assessed the risk of bias and rated the quality of the studies using GRADE criteria. We pooled data for meta-analyses by length of follow-up, reported as mean differences (MDs) or standardised mean differences (SMDs) using random-effects wherever possible, or the fixed-effect model, where appropriate. If a meta-analysis was not possible, we synthesised studies narratively.\nMain results\nWe identified 16 RCTs, involving 992 participants; 524 were allocated to a physical activity intervention group and 468 to a usual care control group. The mean age of participants ranged between 51 and 69 years. Ten studies included participants who had finished active treatment, two studies included participants who were receiving active treatment, two studies included both those receiving and finished active treatment. It was unclear whether participants were receiving or finished treatment in two studies. Type, setting and duration of physical activity intervention varied between trials. Three studies opted for supervised interventions, five for home-based self-directed interventions and seven studies opted for a combination of supervised and self-directed programmes. One study did not report the intervention setting. The most common intervention duration was 12 weeks (7 studies). Type of physical activity included walking, cycling, resistance exercise, yoga and core stabilisation exercise.\nMost of the uncertainty in judging study bias came from a lack of clarity around allocation concealment and blinding of outcome assessors. Blinding of participants and personnel was not possible. The quality of the evidence ranged from very low to moderate overall. We did not pool physical function results at immediate-term follow-up due to considerable variation in results and inconsistency of direction of effect. We are uncertain whether physical activity interventions improve physical function compared with usual care. We found no evidence of effect of physical activity interventions compared to usual care on disease-related mental health (anxiety: SMD -0.11, 95% confidence interval (CI) -0.40 to 0.18; 4 studies, 198 participants; I2 = 0%; and depression: SMD -0.21, 95% CI -0.50 to 0.08; 4 studies, 198 participants; I2 = 0%; moderate-quality evidence) at short- or medium-term follow-up. Seven studies reported on adverse events. We did not pool adverse events due to inconsistency in reporting and measurement. We found no evidence of serious adverse events in the intervention or usual care groups. Minor adverse events, such as neck, back and muscle pain were most commonly reported. No studies reported on overall survival or recurrence-free survival and no studies assessed outcomes at long-term follow-up\nWe found evidence of positive effects of physical activity interventions on the aerobic fitness component of physical fitness (SMD 0.82, 95% CI 0.34 to 1.29; 7 studies, 295; I2 = 68%; low-quality evidence), cancer-related fatigue (MD 2.16, 95% CI 0.18 to 4.15; 6 studies, 230 participants; I2 = 18%; low-quality evidence) and health-related quality of life (SMD 0.36, 95% CI 0.10 to 0.62; 6 studies, 230 participants; I2 = 0%; moderate-quality evidence) at immediate-term follow-up. These positive effects were also observed at short-term follow-up but not medium-term follow-up. Only three studies reported medium-term follow-up for cancer-related fatigue and health-related quality of life.\nAuthors' conclusions\nThe findings of this review should be interpreted with caution due to the low number of studies included and the quality of the evidence. We are uncertain whether physical activity interventions improve physical function. Physical activity interventions may have no effect on disease-related mental health. Physical activity interventions may be beneficial for aerobic fitness, cancer-related fatigue and health-related quality of life up to six months follow-up. Where reported, adverse events were generally minor. Adequately powered RCTs of high methodological quality with longer-term follow-up are required to assess the effect of physical activity interventions on the disease-related physical and mental health and on survival of people with non-advanced colorectal cancer. Adverse events should be adequately reported.\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"
},
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"role": "assistant",
"content": "We found 16 studies that included 992 participants, our evidence is current to June 2019. Participants were randomly assigned to receive a physical activity programme or usual care (no physical activity programme). In the included studies, we are unsure whether physical activity programmes improve physical function and we found no effect of physical activity programmes compared to usual care on disease-related mental health. No serious adverse events occurred in the eight studies that looked at adverse events. There was inconsistency in reporting and measurement of adverse events. We do not know whether physical activity improves survival at any time point as no studies looked at this. The included studies suggest physical activity programmes may increase aerobic fitness, health-related quality of life (general well-being) and reduce fatigue (tiredness) in the short term. We are unsure of the long-term effects of physical activity interventions on physical function, disease-related mental health, adverse events, physical fitness, fatigue (tiredness), weight, health-related quality of life (general well-being) and physical activity levels because no studies assessed this."
}
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query-laysum
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23830
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[
{
"role": "user",
"content": "Abstract: Background\nDespite modern antimicrobials and supportive therapy, bacterial and fungal infections are still major complications in people with prolonged disease-related or therapy-related neutropenia. Since the late 1990s there has been increasing demand for donated granulocyte transfusions to treat or prevent severe infections in people who lack their own functional granulocytes. This is an update of a Cochrane review first published in 2009.\nObjectives\nTo determine the effectiveness and safety of prophylactic granulocyte transfusions compared with a control population not receiving this intervention for preventing all-cause mortality, mortality due to infection, and evidence of infection due to infection or due to any other cause in people with neutropenia or disorders of neutrophil function.\nSearch methods\nWe searched for randomised controlled trials (RCTs) and quasi-RCTs in the Cochrane Central Register of Controlled Trials (Cochrane Library 2015, Issue 3), MEDLINE (from 1946), EMBASE (from 1974), CINAHL (from 1937), theTransfusion Evidence Library (from 1980) and ongoing trial databases to April 20 2015.\nSelection criteria\nRandomised controlled trials (RCTs) and quasi-RCTs comparing people receiving granulocyte transfusions to prevent the development of infection with a control group receiving no granulocyte transfusions. Neonates are the subject of another Cochrane review and were excluded from this review. There was no restriction by outcomes examined, but this review focuses on mortality, mortality due to infection and adverse events.\nData collection and analysis\nWe used standard methodological procedures expected by The Cochrane Collaboration.\nMain results\nTwelve trials met the inclusion criteria. One trial is still ongoing, leaving a total of 11 trials eligible involving 653 participants. These trials were conducted between 1978 and 2006 and enrolled participants from fairly comparable patient populations. None of the studies included people with neutrophil dysfunction. Ten studies included only adults, and two studies included children and adults. Ten of these studies contained separate data for each arm and were able to be critically appraised. One study re-randomised people and therefore quantitative analysis was unable to be performed.\nOverall, the quality of the evidence was very low to low across different outcomes according to GRADE methodology. This was due to many of the studies being at high risk of bias, and many of the outcome estimates being imprecise.\nAll-cause mortality was reported for nine studies (609 participants). There was no difference in all-cause mortality over 30 days between people receiving prophylactic granulocyte transfusions and those that did not (seven studies; 437 participants; RR 0.92, 95% CI 0.63 to 1.36, very low-quality evidence).\nMortality due to infection was reported for seven studies (398 participants). There was no difference in mortality due to infection over 30 days between people receiving prophylactic granulocyte transfusions and those that did not (six studies; 286 participants; RR 0.69, 95% CI 0.33 to 1.44, very low-quality evidence).\nThe number of people with localised or systemic bacterial or fungal infections was reported for nine studies (609 participants). There were differences between the granulocyte dose subgroups (test for subgroup differences P = 0.01). There was no difference in the number of people with infections over 30 days between people receiving prophylactic granulocyte transfusions and those that did not in the low-dose granulocyte group (< 1.0 x 1010 granulocytes per day) (four studies, 204 participants; RR 0.84, 95% CI 0.58 to 1.20; very low-quality evidence). There was a decreased number of people with infections over 30 days in the people receiving prophylactic granulocyte transfusions in the intermediate-dose granulocyte group (1.0 x 1010 to 4.0 x 1010 granulocytes per day) (4 studies; 293 participants; RR 0.40, 95% CI 0.26 to 0.63, low-quality evidence).\nThere was a decreased number of participants with bacteraemia and fungaemia in the participants receiving prophylactic granulocyte transfusions (nine studies; 609 participants; RR 0.45, 95% CI 0.30 to 0.65, low-quality evidence).\nThere was no difference in the number of participants with localised bacterial or fungal infection in the participants receiving prophylactic granulocyte transfusions (six studies; 296 participants; RR 0.75, 95% CI 0.50 to 1.14; very low-quality evidence).\nSerious adverse events were only reported for participants receiving granulocyte transfusions and donors of granulocyte transfusions.\nAuthors' conclusions\nIn people who are neutropenic due to myelosuppressive chemotherapy or a haematopoietic stem cell transplant, there is low-grade evidence that prophylactic granulocyte transfusions decrease the risk of bacteraemia or fungaemia. There is low-grade evidence that the effect of prophylactic granulocyte transfusions may be dose-dependent, a dose of at least 1.0 x 1010 per day being more effective at decreasing the risk of infection. There is insufficient evidence to determine any difference in mortality rates due to infection, all-cause mortality, or serious adverse events.\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"
},
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"role": "assistant",
"content": "We evaluated the evidence about whether granulocyte transfusions given to prevent infection are safe and decrease the risk of infection. Our target population was people with neutropenia (a very low count of a type of white blood cell (neutrophil), or white blood cells that did not function properly (neutrophil dysfunction)."
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query-laysum
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23831
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[
{
"role": "user",
"content": "Abstract: Background\nAcute limb ischaemia (ALI), the sudden and significant reduction of blood flow to the limb, is considered a vascular emergency. In the general population, the incidence is estimated as 14 per 100,000. Prognosis depends on the time it takes to diagnose the condition and begin appropriate treatment. Standard initial interventional treatments include conventional open surgery and endovascular interventions such as catheter-directed thrombolysis (CDT). Percutaneous interventions, such as percutaneous thrombectomy (PT, including mechanical thrombectomy or pharmomechanical thrombectomy) and ultrasound-accelerated thrombolysis (USAT), are also performed as alternative endovascular techniques. The proposed advantages of PT and USAT include reduced time to revascularisation and when combined with catheter-directed thrombolysis, a reduction in dose of thrombolytic agents and infusion time. The benefits of PT or USAT versus open surgery or thrombolysis alone are still uncertain. In this review, we compared PT or USAT against standard treatment for ALI, in an attempt to determine if any technique is comparatively safer and more effective.\nObjectives\nTo assess the safety and effectiveness of percutaneous thrombectomy or ultrasound-accelerated thrombolysis for the initial management of acute limb ischaemia in adults.\nSearch methods\nThe Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL, the World Health Organization (WHO) International Clinical Trials Registry Platform, and ClinicalTrials.gov to 3 March 2021. We searched reference lists of relevant studies and papers.\nSelection criteria\nWe included randomised controlled trials (RCTs) that compared PT (any modality, including mechanical thrombectomy (aspiration, rheolysis, rotation) or pharmomechanical thrombectomy) or USAT with open surgery, thrombolysis alone, no treatment, or another PT modality for the treatment of ALI.\nData collection and analysis\nTwo review authors independently selected the studies, assessed risk of bias, extracted data, performed data analysis, and assessed the certainty of evidence according to GRADE. Outcomes of interest were primary patency, amputation rate, major bleeding, clinical success, secondary patency, and adverse effects.\nMain results\nWe included one RCT in this review. This study had a total of 60 participants and compared USAT with standard treatment (CDT). The study included 32 participants in the CDT group and 28 participants in the USAT group.\nWe found no evidence of a difference between USAT and CDT alone for the following evaluated outcomes: amputation rate (risk ratio (RR) 1.14, 95% confidence interval (CI) 0.17 to 7.59); major bleeding (RR 1.71, 95% CI 0.31 to 9.53); clinical success (RR 1.00, 95% CI 0.94 to 1.07); and adverse effects (RR 5.69, 95% CI 0.28 to 113.72). We rated the certainty of the evidence as very low for these outcomes. We downgraded the certainty of the evidence for amputation rate, major bleeding, clinical success, and adverse effects by two levels due to serious limitations in the design (there was a high risk of bias in critical domains) and by two further levels due to imprecision (a small number of participants and only one study included). The study authors reported 30-day patency, but did not report primary and secondary patency separately. The patency rate in the successfully lysed participants was 71% (15/21) in the USAT group and 82% (22/27) in the CDT group. The study authors did not directly report secondary patency, which is patency after secondary procedures, but they did report on secondary procedures. Secondary procedures were subdivided into embolectomy and bypass grafting. Embolectomy was performed on 14% (4/28) of participants in the USAT group versus 3% (1/32) of participants in the CDT group. Bypass grafting was performed on 4% (1/28) of participants in the USAT group versus 0% in the CDT group. As we did not have access to the specific participant data, it was not possible to assess these outcomes further.\nWe did not identify studies comparing the other planned interventions.\nAuthors' conclusions\nThere is insufficient evidence to assess the safety and effectiveness of USAT versus CDT alone for ALI for our evaluated outcomes: amputation rate, major bleeding, clinical success, and adverse effects. Primary and secondary patency were not reported separately. There was no RCT evidence for PT. Limitations of this systematic review derive from the single included study, small sample size, short clinical follow-up period, and high risk of bias in critical domains. For this reason, the applicability of the results is limited. There is a need for high-quality studies to compare PT or USAT against open surgery, thrombolysis alone, no treatment, or other PT modalities for ALI. Future trials should assess outcomes, such as primary patency, amputation rate, major bleeding, clinical success, secondary patency, and adverse effects.\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 if percutaneous thrombectomy or ultrasound-accelerated thrombolysis are better than catheter-directed thrombolysis or open surgery at improving blood flow and reducing amputation, bleeding, and other risks."
}
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query-laysum
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23832
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[
{
"role": "user",
"content": "Abstract: Background\nWorldwide, hormonal contraceptives are among the most popular reversible contraceptives. Despite high perfect-use effectiveness rates, typical-use effectiveness rates for shorter-term methods such as oral and injectable contraceptives are much lower. In large part, this disparity reflects difficulties in ongoing adherence to the contraceptive regimen and low continuation rates. Correct use of contraceptives to ensure effectiveness is vital to reducing unintended pregnancy.\nObjectives\nTo determine the effectiveness of strategies aiming to improve adherence to, and continuation of, shorter-term hormonal methods of contraception compared with usual family planning care.\nSearch methods\nWe searched to July 2018 in the following databases (without language restrictions): The Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 7), PubMed via MEDLINE, POPLINE, Web of Science, ClinicalTrials.gov, and the International Clinical Trials Registry Platform (ICTRP).\nSelection criteria\nWe included randomized controlled trials (RCTs) comparing strategies aimed to facilitate adherence and continuation of shorter-term hormonal methods of contraception (such as oral contraceptives (OCs), injectable depot medroxyprogesterone acetate (DMPA or Depo-Provera), intravaginal ring, or transdermal patch) with usual family planning care in reproductive age women seeking to avoid pregnancy.\nData collection and analysis\nWe used standard methodological procedures recommended by Cochrane. Primary outcomes were continuation or discontinuation of contraceptive method, rates of discontinuation due to adverse events (menstrual disturbances and all other adverse events), and adherence to method use as indicated by missed pills and on-time/late injections. Pregnancy was a secondary outcome.\nMain results\nWe included 10 RCTs involving 6242 women. Six trials provided direct in-person counseling using either multiple counseling contacts or multiple components during one visit. Four trials provided intensive reminders of appointments or next dosing, of which two provided additional educational health information as well as reminders. All trials stated 'usual care' as the comparison.\nThe certainty of the evidence ranged from very low to moderate. Main limitations were risk of bias (associated with poor reporting of methodological detail, lack of blinding, and incomplete outcome data), inconsistency, indirectness, and imprecision.\nContinuation of hormonal contraceptive methods\nIt is uncertain whether intensive counseling improves continuation of hormonal contraceptive methods compared with usual care (OR 1.28, 95% CI 1.07 to 1.54; 2624 participants; 6 studies; I2 = 79%; very low certainty evidence). The evidence suggested: if the chance of continuation with usual care is 39%, the chance of continuation with intensive counseling would be between 41% and 50%. The overall pooled OR suggested continuation of improvement, however, when stratified by contraceptive method type, the positive results were restricted to DMPA.\nIt is uncertain whether reminders (+/- educational information) improve continuation of hormonal contraceptive methods compared with usual care (OR 1.33, 95% CI 1.03 to 1.73; 933 participants; 2 studies; I2 = 69%; very low certainty evidence).The evidence suggested: if the chance of continuation with usual care is 52%, the chance of continuation with reminders would be between 52% and 65%.\nDiscontinuation due to adverse events\nThe evidence suggested that counseling may be associated with a decreased rate of discontinuation due to adverse events compared with usual care, with a lower rate of discontinuation due to menstrual disturbances (OR 0.20, 95% CI 0.11 to 0.37; 350 participants; 1 study; low certainty evidence), but may make little or no difference to all other adverse events (OR 0.73, 95% CI 0.36 to 1.47; 350 participants; 1 study; low certainty evidence). The evidence suggested: if the chance of discontinuation with usual care due to menstrual disturbances is 32%, the chance of discontinuation with intensive counseling would be between 5% and 15%; and that if the chance of discontinuation with usual care due to other adverse events is 55%, the chance of discontinuation with intensive counseling would be between 30% and 64%.\nDiscontinuation was not reported among trials that investigated the use of reminders (+/- educational information).\nAdherence\nAdherence was not reported among trials that investigated the use of intensive counseling.\nAmong trials that investigated reminders (+/- educational information), there was no conclusive evidence of a difference in adherence as indicated by missed pills (MD 0.80, 95% CI -1.22 to 2.82; 73 participants; 1 study; moderate certainty evidence) or by on-time injections (OR 0.84, 95% CI 0.54 to 1.29; 350 participants; 2 studies; I2 = 0%; low certainty evidence). The evidence suggested: if the chance of adherence to method use as indicated by on-time injections with usual care is 50%, the chance of adherence with method use as indicated by on-time injections with reminders would be between 35% and 56%.\nPregnancy\nThere was no conclusive evidence of a difference in rates of pregnancy between intensive counseling and usual care (OR 1.24, 95% CI 0.98 to 1.57; 1985 participants; 3 studies; I2 = 0%, very low certainty evidence). The evidence suggested: if the chance of pregnancy with usual care is 18%, the chance of pregnancy with counseling would be between 18% and 25%.\nPregnancy was not reported among trials that investigated the use of reminders (+/- educational information).\nAuthors' conclusions\nDespite the importance of this topic, studies have not been published since the last review in 2013 (nine studies) with only one study added in 2019 that neither changed the results nor improved the certainty of evidence.\nOverall, the certainty of evidence for strategies to improve adherence and continuation of contraceptives is low. Intensive counseling and reminders (with or without educational information) may be associated with improved continuation of shorter-term hormonal contraceptive methods when compared with usual family planning care. However, this should be interpreted with caution due to the low certainty of the evidence. Included trials used a variety of shorter-term hormonal contraceptive methods which may account for the high heterogeneity. It is possible that the effectiveness of strategies for improving adherence and continuation are contingent on the contraceptive method targeted. There was limited reporting of objectively measurable outcomes (e.g. electronic monitoring device) among included studies. Future trials would benefit from standardized definitions and measurements of adherence, and consistent terminology for describing interventions and comparisons. Further research requires larger studies, follow-up of at least one year, and improved reporting of trial methodology.\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"
},
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"role": "assistant",
"content": "We searched for evidence from randomized controlled trials (RCTs) through July 2018. This updated review now includes 10 RCTs involving 6242 women. Six studies focused on counseling and four studies involved reminders of next dose or appointments (+/- educational health information). All studies were conducted either in the USA or Mexico. The one study that was added neither changed the results nor improved the certainty of evidence."
}
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query-laysum
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23833
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[
{
"role": "user",
"content": "Abstract: Background\nThere has been renewal of interest in the use of prophylactic antibiotics to reduce the frequency of exacerbations and improve quality of life in chronic obstructive pulmonary disease (COPD).\nObjectives\nTo determine whether or not regular (continuous, intermittent or pulsed) treatment of COPD patients with prophylactic antibiotics reduces exacerbations or affects quality of life.\nSearch methods\nWe searched the Cochrane Airways Group Trials Register and bibliographies of relevant studies. The latest literature search was performed on 27 July 2018.\nSelection criteria\nRandomised controlled trials (RCTs) that compared prophylactic antibiotics with placebo in patients with COPD.\nData collection and analysis\nWe used the standard Cochrane methods. Two independent review authors selected studies for inclusion, extracted data, and assessed risk of bias. We resolved discrepancies by involving a third review author.\nMain results\nWe included 14 studies involving 3932 participants in this review. We identified two further studies meeting inclusion criteria but both were terminated early without providing results. All studies were published between 2001 and 2015. Nine studies were of continuous macrolide antibiotics, two studies were of intermittent antibiotic prophylaxis (three times per week) and two were of pulsed antibiotic regimens (e.g. five days every eight weeks). The final study included one continuous, one intermittent and one pulsed arm. The antibiotics investigated were azithromycin, erythromycin, clarithromycin, doxycyline, roxithromycin and moxifloxacin. The study duration varied from three months to 36 months and all used intention-to-treat analysis. Most of the pooled results were of moderate quality. The risk of bias of the included studies was generally low.\nThe studies recruited participants with a mean age between 65 and 72 years and mostly at least moderate-severity COPD. Five studies only included participants with frequent exacerbations and two studies recruited participants requiring systemic steroids or antibiotics or both, or who were at the end stage of their disease and required oxygen. One study recruited participants with pulmonary hypertension secondary to COPD and a further study was specifically designed to asses whether eradication of Chlamydia pneumoniae reduced exacerbation rates.\nThe co-primary outcomes for this review were the number of exacerbations and quality of life.\nWith use of prophylactic antibiotics, the number of participants experiencing one or more exacerbations was reduced (odds ratio (OR) 0.57, 95% CI 0.42 to 0.78; participants = 2716; studies = 8; moderate-quality evidence). This represented a reduction from 61% of participants in the control group compared to 47% in the treatment group (95% CI 39% to 55%). The number needed to treat for an additional beneficial outcome with prophylactic antibiotics given for three to 12 months to prevent one person from experiencing an exacerbation (NNTB) was 8 (95% CI 5 to 17). The test for subgroup difference suggested that continuous and intermittent antibiotics may be more effective than pulsed antibiotics (P = 0.02, I² = 73.3%).\nThe frequency of exacerbations per patient per year was also reduced with prophylactic antibiotic treatment (rate ratio 0.67; 95% CI 0.54 to 0.83; participants = 1384; studies = 5; moderate-quality evidence). Although we were unable to pool the result, six of the seven studies reporting time to first exacerbation identified an increase (i.e. benefit) with antibiotics, which was reported as statistically significant in four studies.\nThere was a statistically significant improvement in quality of life as measured by the St George's Respiratory Questionnaire (SGRQ) with prophylactic antibiotic treatment, but this was smaller than the four unit improvement that is regarded as being clinically significant (mean difference (MD) -1.94, 95% CI -3.13 to -0.75; participants = 2237; studies = 7, high-quality evidence).\nProphylactic antibiotics showed no significant effect on the secondary outcomes of frequency of hospital admissions, change in forced expiratory volume in one second (FEV1), serious adverse events or all-cause mortality (moderate-quality evidence). There was some evidence of benefit in exercise tolerance, but this was driven by a single study of lower methodological quality.\nThe adverse events that were recorded varied among the studies depending on the antibiotics used. Azithromycin was associated with significant hearing loss in the treatment group, which was in many cases reversible or partially reversible. The moxifloxacin pulsed study reported a significantly higher number of adverse events in the treatment arm due to the marked increase in gastrointestinal adverse events (P < 0.001). Some adverse events that led to drug discontinuation, such as development of long QTc or tinnitus, were not significantly more frequent in the treatment group than the placebo group but pose important considerations in clinical practice.\nThe development of antibiotic resistance in the community is of major concern. Six studies reported on this, but we were unable to combine results. One study found newly colonised participants to have higher rates of antibiotic resistance. Participants colonised with moxifloxacin-sensitive pseudomonas at initiation of therapy rapidly became resistant with the quinolone treatment. A further study with three active treatment arms found an increase in the degree of antibiotic resistance of isolates in all three arms after 13 weeks treatment.\nAuthors' conclusions\nUse of continuous and intermittent prophylactic antibiotics results in a clinically significant benefit in reducing exacerbations in COPD patients. All studies of continuous and intermittent antibiotics used macrolides, hence the noted benefit applies only to the use of macrolide antibiotics prescribed at least three times per week. The impact of pulsed antibiotics remains uncertain and requires further research.\nThe studies in this review included mostly participants who were frequent exacerbators with at least moderate-severity COPD. There were also older individuals with a mean age over 65 years. The results of these studies apply only to the group of participants who were studied in these studies and may not be generalisable to other groups.\nBecause of concerns about antibiotic resistance and specific adverse effects, consideration of prophylactic antibiotic use should be mindful of the balance between benefits to individual patients and the potential harms to society created by antibiotic overuse. Monitoring of significant side effects including hearing loss, tinnitus, and long QTc in the community in this elderly patient group may require extra health resources.\n\nGiven the provided abstract, please respond to the following query: \"Results and conclusions\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We found that, with the use of antibiotics, the number of participants who developed an exacerbation reduced markedly. For every eight participants treated, one person would be prevented from suffering an exacerbation. However, not all the antibiotic regimens had the same impact on exacerbations. The results suggested that antibiotics given at least three times per week may be more effective than antibiotics given daily for a few days followed by a break of several weeks. We also found there may have been a benefit on patient-reported quality of life with the antibiotics. On the other hand, use of antibiotics did not significantly affect the number of deaths due to any cause, the frequency of hospitalisation, or the loss of lung function during the study period.\nEven though there may be fewer exacerbations with antibiotics, there are considerable drawbacks of taking antibiotics. First, there were specific adverse events associated with the antibiotics, which differed according to the antibiotic used; second, patients have to take antibiotics regularly for months or years; finally, the resulting increase in antibiotic resistance will have implications for both individual patients and the wider community through reducing the effectiveness of currently available antibiotics.\nBecause of concerns about antibiotic resistance and specific adverse effects, consideration of prophylactic antibiotic use should be mindful of the balance between benefits to individual patients and the potential harms to society created by antibiotic overuse."
}
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query-laysum
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23834
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[
{
"role": "user",
"content": "Abstract: Background\nUnemployment is associated with decreased health which may be a reason or a consequence of becoming unemployed. Decreased health can inhibit re-employment.\nObjectives\nTo assess the effectiveness of health-improving interventions for obtaining employment in unemployed job seekers.\nSearch methods\nWe searched (3 May 2018, updated 13 August 2019) the Cochrane Central Register of Controlled Trials, MEDLINE, Scopus, PsycINFO, CINAHL, SocINDEX, OSH Update, ClinicalTrials.gov, the WHO trials portal, and also reference lists of included studies and selected reviews.\nSelection criteria\nWe included randomised controlled trials (RCTs) of the effectiveness of health-improving interventions for obtaining employment in unemployed job seekers. The primary outcome was re-employment reported as the number or percentage of participants who obtained employment. Our secondary outcomes were health and work ability.\nData collection and analysis\nTwo authors independently screened studies, extracted outcome data, and assessed risk of bias. We pooled study results with random-effect models and reported risk ratios (RRs) with 95% confidence intervals (CIs) and assessed the overall quality of the evidence for each comparison using the GRADE approach.\nMain results\nWe included 15 randomised controlled trials (16 interventions) with a total of 6397 unemployed participants. Eight studies evaluated therapeutic interventions such as cognitive behavioural therapy, physical exercise, and health-related advice and counselling and, in seven studies, interventions were combined using therapeutic methods and job-search training.\nTherapeutic interventions\nTherapeutic interventions compared to no intervention may increase employment at an average of 11 months follow-up but the evidence is very uncertain (RR = 1.41, 95% CI 1.07 to 1.87, n = 1142, 8 studies with 9 interventions, I² = 52%, very low-quality evidence). There is probably no difference in the effects of therapeutic interventions compared to no intervention on mental health (SMD 0.12, 95% CI -0.06 to 0.29, n = 530, 2 studies, low-quality evidence) and on general health (SMD 0.19, 95% CI -0.04 to 0.41, n = 318, 1 study, moderate-quality evidence).\nCombined interventions\nCombined interventions probably increase employment slightly compared to no intervention at an average of 10 months follow-up (RR 1.12, 95% CI 1.06 to 1.20, n = 4101, 6 studies, I² = 7%).\nThere were no studies that measured work-ability, adverse events, or cost-effectiveness.\nAuthors' conclusions\nInterventions combining therapeutic methods and job-search training probably have a small beneficial effect in increasing employment. Therapeutic interventions may have an effect on re-employment, but we are very uncertain. Therapeutic interventions may not improve health in unemployed job seekers. Large high-quality RCTs targeting short-term or long-term unemployed people are needed to increase the quality of the evidence. A cost-effectiveness assessment is needed of the small beneficial effects.\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 it is possible to help unemployed people to get a job by improving their health.\nDecreased health and declined work ability may be reasons for becoming unemployed. Also, unemployment, and especially prolonged unemployment, may in turn cause poor health and well-being. It is not known if unemployed people could be helped to get a job by interventions that improve health."
}
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query-laysum
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23835
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[
{
"role": "user",
"content": "Abstract: Background\nThis is an update of a review last published by Cochrane in June 2012 entitled \"Cromolyn sodium for the prevention of chronic lung disease in preterm infants\", which included two studies. This 2016 update identified no further studies.\nChronic lung disease (CLD) frequently occurs in preterm infants and has a multifactorial aetiology including inflammation. Cromolyn sodium is a mast cell stabiliser that inhibits neutrophil activation and neutrophil chemotaxis and therefore may have a role in the prevention of CLD.\nObjectives\nTo determine the effect of prophylactic administration of cromolyn sodium on the incidence of CLD at 28 days or 36 weeks' postmenstrual age (PMA), mortality, or the combined outcome of mortality and CLD at 28 days or 36 weeks' PMA in preterm infants.\nSearch methods\nWe used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL 2016, Issue 4), MEDLINE via PubMed (1966 to 12 May 2016), Embase (1980 to 12 May 2016), and CINAHL (1982 to 12 May 2016). We searched clinical trials databases, conference proceedings, and the reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials.\nSelection criteria\nWe included randomised or quasi-randomised controlled clinical trials involving preterm infants. Initiation of cromolyn sodium administration was during the first two weeks of life. The intervention had to include administration of cromolyn sodium by nebuliser or metered dose inhaler with or without spacer device versus placebo or no intervention. Eligible studies had to include at least one of the following outcomes: overall mortality, CLD at 28 days, CLD at 36 weeks' PMA, or the combined outcome mortality and CLD at 28 days.\nData collection and analysis\nWe used the standard method for Cochrane as described in the Cochrane Handbook for Systematic Reviews of Interventions. We reported risk ratio (RR) and risk difference (RD) with 95% confidence intervals (CI) for dichotomous outcomes and mean difference (MD) with 95% CI for continuous data. The meta-analysis used a fixed-effect model. We examined heterogeneity using the I2 statistic. We assessed the quality of evidence for the main comparison at the outcome level using the GRADE approach.\nMain results\nWe identified two eligible studies with small numbers of infants enrolled (64 infants). Prophylaxis with cromolyn sodium did not result in a statistically significant effect on the combined outcome of mortality and CLD at 28 days (typical RR 1.05, 95% CI 0.73 to 1.52; typical RD 0.03, 95% CI -0.20 to 0.27; 2 trials, 64 infants; I2 = 0% for both RR and RD); mortality at 28 days (typical RR 1.31, 95% CI 0.52 to 3.29; I2 = 73% typical RD 0.06, 95% CI -0.13 to 0.26; I2 = 87%; 2 trials, 64 infants) (very low quality evidence); CLD at 28 days (typical RR 0.93, 95% CI 0.53 to 1.64; I2 = 40%; typical RD -0.03, 95% CI -0.27 to 0.20; I2 = 38%; 2 trials, 64 infants) or at 36 weeks' PMA (RR 1.25, 95% CI 0.43 to 3.63; RD 0.08, 95% CI -0.29 to 0.44; 1 trial, 26 infants). There was no significant difference in CLD in survivors at 28 days (typical RR 0.97, 95% CI 0.58 to 1.63; typical RD -0.02, 95% CI -0.29 to 0.26; I2 = 0% for both RR and RD; 2 trials, 50 infants) or at 36 weeks' PMA (RR 1.04, 95% CI 0.38 to 2.87; RD 0.02, 95% CI -0.40 to 0.43; 1 trial, 22 infants). Prophylaxis with cromolyn sodium did not show a statistically significant difference in overall neonatal mortality, incidence of air leaks, necrotising enterocolitis, intraventricular haemorrhage, sepsis, and days of mechanical ventilation. There were no adverse effects noted. The quality of evidence according to GRADE was very low for one outcome (mortality to 28 days) and low for all other outcomes. The reasons for downgrading the evidence was due to design (risk of bias in one study), inconsistency between the two studies (high I2 values for mortality at 28 days for both RR and RD), and lack of precision of estimates (small sample sizes). Further research does not seem to be justified.\nAuthors' conclusions\nThere is currently no evidence from randomised trials that cromolyn sodium has a role in the prevention of CLD. Cromolyn sodium cannot be recommended for the prevention of CLD in preterm infants.\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": "Prophylaxis with cromolyn sodium did not result in an important effect on the combined outcome of mortality or chronic lung disease at 28 days of age, chronic lung disease at 28 days; chronic lung disease at 28 days or at 36 weeks' PMA; or chronic lung disease in survivors at 28 days or at 36 weeks' PMA. This review of trials found no strong evidence that cromolyn sodium can prevent or reduce chronic lung disease and further research does not seem to be justified."
}
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query-laysum
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23836
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[
{
"role": "user",
"content": "Abstract: Background\nHysterosalpingography (HSG) is a method of testing for tubal patency. However, women struggle to tolerate the procedure, as it is associated with some discomfort. Various pharmacological strategies are available that may reduce pain during the procedure, though there is no consensus as to the best method.\nObjectives\nTo compare the effectiveness of different types of pharmacological interventions for pain relief in women undergoing HSG for investigation of subfertility.\nSearch methods\nThis review has drawn on the search strategy developed for the Cochrane Menstrual Disorders and Subfertility Group (MDSG). We searched the following databases to 15 April 2015: MDSG Specialised Register, CENTRAL, MEDLINE, EMBASE, CINAHL and PsycINFO.\nSelection criteria\nAll identified randomised controlled trials investigating pharmacological interventions for pain relief during HSG were investigated for selection.\nData collection and analysis\nFour review authors independently extracted data. We combined data to calculate mean differences (MDs) with 95% confidence intervals (CIs). Statistical heterogeneity was assessed using the I² statistic. We assessed the overall quality of the evidence for the main comparisons using GRADE methods.\nMain results\nThe search identified 23 trials (1272 women) that were eligible for inclusion into the study.\nOral opioid analgesia versus placebo/no treatment\nThere was no evidence of effect for oral opioid analgesia in reducing pain during the procedure (MD −0.91, 95% CI −1.88 to 0.06, 1 study, n = 128, low quality evidence) or more than 30 minutes after the procedure (MD −0.99, 95% CI −1.75 to −0.23, 1 study, n = 128, moderate quality evidence)\nNo studies reported on the effect of oral opioid analgesia, when taken prior to the procedure, in reducing pain within 30 minutes after the procedure\nThere was insufficient evidence to reach conclusions regarding adverse effects.\nIntravenous opioid analgesia versus placebo/no treatment\nThere was evidence that intravenous opioids may improve pain relief during the procedure compared to no treatment (MD −3.53, 95% CI −4.29 to −2.77, 1 study, n = 62, moderate quality evidence)\nNo studies reported on the effect of intravenous opioid analgesia, when taken prior to the procedure, in reducing pain within 30 minutes and more than 30 minutes after the procedure\nIn terms of adverse effects, one trial reported 1/32 participants had apnoea with intravenous remifentanil. Recovery time was nearly 4 minutes longer in the remifentanil group compared to the control.\nOral non-opioid analgesia versus placebo/no treatment\nThere was no evidence of effect for oral non-opioid analgesia in reducing pain during the procedure (MD −0.13, 95% CI −0.48 to 0.23, 3 studies, n = 133, I² = 61%, low quality evidence), less than 30 minutes after the procedure (MD −0.30, 95% CI −1.03 to 0.43, 2 studies, n = 45, I² = 97%, very low quality evidence), or more than 30 minutes after the procedure (MD −0.36, 95% CI −1.06 to 0.34, 3 studies, n = 133, I² = 58%, low quality evidence).\nThere was insufficient evidence to reach conclusions regarding adverse effects.\nTopical anaesthesia versus placebo/no treatment\nThere was evidence that topical anaesthetics may reduce pain during the procedure (MD −0.63, 95% CI −1.06 to −0.19, 9 studies, n = 613, I² = 66%, low quality evidence).\nThere was no evidence of effect for topical anaesthesia, when applied prior to the procedure, in reducing pain less than 30 minutes after the procedure (MD 0.42, 95% CI -0.03 to 0.86, 5 studies, n = 373, I² = 59%, very low quality evidence).\nThere was evidence of effect for topical anaesthesia, when applied prior to the procedure, in reducing pain more than 30 minutes after the procedure (MD −1.38, 95% CI -3.44 to −0.68, 2 studies, n = 166, I² = 92%, very low quality evidence).\nThere was insufficient evidence to reach conclusions regarding adverse effects.\nLocally injected anaesthesia versus placebo/no treatment\nThere was evidence of effect that locally injected anaesthetic can reduce pain during the procedure (MD −1.31, 95% CI −1.55 to −1.07, 2 studies, n = 125, I² = 0%, very low quality evidence).\nThere was no evidence of effect for locally injected anaesthesia, when applied prior to the procedure, in reducing pain less than 30 minutes after the procedure (MD −1.31, 95% CI −2.14 to −0.49, 2 studies, n = 125, I² = 46%, low quality evidence).\nNo studies were included into the analysis of the effect of locally injected anaesthesia, when injected prior to the procedure, in reducing pain more than 30 minutes after the procedure.\nThere was insufficient evidence to reach conclusions regarding adverse effects.\nAny analgesic versus any other analgesic\nThere was no evidence of a difference between the groups when oral non-opioid analgesia was compared to opioid analgesia for pain relief during the procedure (MD 1.10, 95% CI −0.26 to 2.46, 1 study, n = 91, low quality evidence); less than 30 minutes following the procedure (MD −0.30, 95% CI −1.00 to 0.40, 1 study, n = 91, low quality evidence); and more than 30 minutes following the procedure (MD −0.60, 95% CI −1.56 to 0.36, 1 study, n = 91, low quality evidence). Topical anaesthetics were found to be more effective than paracervical block for pain relief during HSG (MD −2.73, 95% CI −3.86 to −1.60, 1 study, n = 20, moderate quality evidence). This benefit did not extend to within 30 minutes following HSG (MD −1.03, 95% CI −2.52 to 0.46, 1 study, n = 20, low quality evidence); or 30 minutes or more after HSG (MD 0.31, 95% CI −0.87 to 1.49, 1 study, n = 20, low quality evidence).\nThere was insufficient evidence to reach conclusions regarding adverse effects.\nAuthors' conclusions\nTopical anaesthetic applied before the procedure may be associated with effective pain relief during HSG, though the quality of this evidence is low. Intravenous opioids may also be effective in pain relief, though this must be weighed against their side effects and their effects on the recovery time. There is insufficient evidence to draw conclusions on the efficacy of other analgesics for HSG, or to reach any other conclusions regarding adverse effects.\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 identified 19 randomised controlled trials that compared a specific drug treatment to a placebo/no treatment. Four trials compared two different drug treatments to establish if one was better. All studies took place in a clinical setting. Age of participants ranged from 18 to 42 years. Studies took place in India, Australia, United Kingdom, United States of America, Turkey, Israel, Netherlands, Italy, Iran, Nigeria, Spain, Brazil, and Belgium (1272 women in total).\nWe included 15 of these trials in a meta-analysis. The remaining eight trials, while eligible for inclusion, did not have data in a format that could be entered into meta-analysis (seven compared a specific drug to a placebo/no treatment, one compared two different drug treatments). The evidence is current to April 2015."
}
] |
query-laysum
|
23837
|
[
{
"role": "user",
"content": "Abstract: Background\nThere is growing interest in paying for performance (P4P) as a means to align the incentives of healthcare providers with public health goals. Rigorous evidence on the effectiveness of these strategies in improving health care and health in low- and middle-income countries (LMICs) is lacking; this is an update of the 2012 review on this topic.\nObjectives\nTo assess the effects of paying for performance on the provision of health care and health outcomes in low- and middle-income countries.\nSearch methods\nWe searched CENTRAL, MEDLINE, Embase, and 10 other databases between April and June 2018. We also searched two trial registries, websites, online resources of international agencies, organizations and universities, and contacted experts in the field. Studies identified from rerunning searches in 2020 are under 'Studies awaiting classification.'\nSelection criteria\nWe included randomized or non-randomized trials, controlled before-after studies, or interrupted time series studies conducted in LMICs (as defined by the World Bank in 2018). P4P refers to the transfer of money or material goods conditional on taking a measurable action or achieving a predetermined performance target. To be included, a study had to report at least one of the following outcomes: patient health outcomes, changes in targeted measures of provider performance (such as the delivery of healthcare services), unintended effects, or changes in resource use.\nData collection and analysis\nWe extracted data as per original review protocol and narratively synthesised findings. We used standard methodological procedures expected by Cochrane. Given diversity and variability in intervention types, patient populations, analyses and outcome reporting, we deemed meta-analysis inappropriate. We noted the range of effects associated with P4P against each outcome of interest. Based on intervention descriptions provided in documents, we classified design schemes and explored variation in effect by scheme design.\nMain results\nWe included 59 studies: controlled before-after studies (19), non-randomized (16) or cluster randomized trials (14); and interrupted time-series studies (9). One study included both an interrupted time series and a controlled before-after study.\nStudies focused on a wide range of P4P interventions, including target payments and payment for outputs as modified by quality (or quality and equity assessments). Only one study assessed results-based aid. Many schemes were funded by national governments (23 studies) with the World Bank funding most externally funded schemes (11 studies). Targeted services varied; however, most interventions focused on reproductive, maternal and child health indicators. Participants were predominantly located in public or in a mix of public, non-governmental and faith-based facilities (54 studies). P4P was assessed predominantly at health facility level, though districts and other levels were also involved.\nMost studies assessed the effects of P4P against a status quo control (49 studies); however, some studies assessed effects against comparator interventions (predominantly enhanced financing intended to match P4P funds (17 studies)). Four studies reported intervention effects against both comparator and status quo.\nControlled before-after studies were at higher risk of bias than other study designs. However, some randomised trials were also downgraded due to risk of bias. The interrupted time-series studies provided insufficient information on other concurrent changes in the study context.\nP4P compared to a status quo control\nFor health services that are specifically targeted, P4P may slightly improve health outcomes (low certainty evidence), but few studies assessed this. P4P may also improve service quality overall (low certainty evidence); and probably increases the availability of health workers, medicines and well-functioning infrastructure and equipment (moderate certainty evidence). P4P may have mixed effects on the delivery and use of services (low certainty evidence) and may have few or no distorting unintended effects on outcomes that were not targeted (low-certainty evidence), but few studies assessed these. For secondary outcomes, P4P may make little or no difference to provider absenteeism, motivation or satisfaction (low certainty evidence); but may improve patient satisfaction and acceptability (low certainty evidence); and may positively affect facility managerial autonomy (low certainty evidence). P4P probably makes little to no difference to management quality or facility governance (low certainty evidence). Impacts on equity were mixed (low certainty evidence).\nFor health services that are untargeted, P4P probably improves some health outcomes (moderate certainty evidence); may improve the delivery, use and quality of some health services but may make little or no difference to others (low certainty evidence); and may have few or no distorting unintended effects (low certainty evidence). The effects of P4P on the availability of medicines and other resources are uncertain (very low certainty evidence).\nP4P compared to other strategies\nFor health outcomes and services that are specifically targeted, P4P may make little or no difference to health outcomes (low certainty evidence), but few studies assessed this. P4P may improve service quality (low certainty evidence); and may have mixed effects on the delivery and use of health services and on the availability of equipment and medicines (low certainty evidence).\nFor health outcomes and services that are untargeted, P4P may make little or no difference to health outcomes and to the delivery and use of health services (low certainty evidence). The effects of P4P on service quality, resource availability and unintended effects are uncertain (very low certainty evidence).\nFindings of subgroup analyses\nResults-based aid, and schemes using payment per output adjusted for service quality, appeared to yield the greatest positive effects on outcomes. However, only one study evaluated results-based aid, so the effects may be spurious. Overall, schemes adjusting both for quality of service and rewarding equitable delivery of services appeared to perform best in relation to service utilization outcomes.\nAuthors' conclusions\nThe evidence base on the impacts of P4P schemes has grown considerably, with study quality gradually increasing. P4P schemes may have mixed effects on outcomes of interest, and there is high heterogeneity in the types of schemes implemented and evaluations conducted. P4P is not a uniform intervention, but rather a range of approaches. Its effects depend on the interaction of several variables, including the design of the intervention (e.g., who receives payments ), the amount of additional funding, ancillary components (such as technical support) and contextual factors (including organizational context).\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": "The review authors included studies that had been published up to April 2018."
}
] |
query-laysum
|
23838
|
[
{
"role": "user",
"content": "Abstract: Background\nThe para-aortic lymph nodes (located along the major vessels in the mid and upper abdomen) are a common place for disease recurrence after treatment for locally advanced cervical cancer. The para-aortic area is not covered by standard pelvic radiotherapy fields and so treatment to the pelvis alone is inadequate for women at a high risk of occult cancer within para-aortic lymph nodes. Extended-field radiotherapy (RT) widens the pelvic RT field to include the para-aortic lymph node area. Extended-field RT may improve outcomes in women with locally advanced cervical cancer by treating occult disease in para-aortic nodes not identified at pretreatment imaging. However, RT treatment of the para-aortic area can cause severe adverse effects, so may increase harms.\nStudies of pelvic chemoradiotherapy (CRT) demonstrated improved survival rates compared to pelvic RT alone. CRT is now the standard of care in the treatment of locally advanced cervical cancer. Studies comparing pelvic RT alone (without concurrent chemotherapy) with extended-field RT should therefore be viewed with caution, since they compare treatments against what is now substandard treatment (pelvic RT alone). This review should therefore be read with this in mind and comparisons with pelvic RT cannot be extrapolated to pelvic CRT.\nObjectives\nTo evaluate the effectiveness and toxicity of extended-field radiotherapy in women undergoing first-line treatment for locally advanced cervical cancer.\nSearch methods\nWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 7), MEDLINE via Ovid (1946 to August week 4, 2018), and Embase via Ovid (1980 to 2018, week 35). We checked registers of clinical trials, grey literature, conference reports, and citation lists of included studies to August 2018.\nSelection criteria\nWe included randomised controlled trials (RCTs) evaluating the effectiveness and toxicity of extended-field RT for locally advanced cervical cancer.\nData collection and analysis\nTwo review authors independently selected potentially relevant RCTs, extracted data, assessed risk of bias, compared results, and made judgements on the quality and certainty of the evidence for each outcome. Any disagreements were resolved by discussion or consultation with a third review author.\nMain results\nFive studies met the inclusion criteria. Three included studies compared extended-field RT versus pelvic RT, one included study compared extended-field RT with pelvic CRT, and one study compared extended-field CRT versus pelvic CRT.\nExtended-field radiotherapy versus pelvic radiotherapy alone\nCompared to pelvic RT, extended-field RT probably reduces the risk of death (hazard ratio (HR) 0.67, 95% confidence interval (CI) 0.48 to 0.94; 1 study; 337 participants; moderate-certainty evidence) and para-aortic lymph node recurrence (risk ratio (RR) 0.36, 95% CI 0.18 to 0.70; 2 studies; 477 participants; moderate-certainty evidence), although there may or may not have been improvement in the risk of disease progression (HR 0.92, 95% CI 0.69 to 1.22; 1 study; 337 participants; moderate-certainty evidence) and severe adverse events (RR 1.05, 95% CI 0.79 to 1.41; 2 studies; 776 participants; moderate-certainty evidence).\nExtended-field radiotherapy versus pelvic chemoradiotherapy\nIn a comparison of extended-field RT versus pelvic CRT, women given pelvic CRT probably had a lower risk of death (HR 0.50, 95% CI 0.39 to 0.64; 1 study; 389 participants; moderate-certainty evidence) and disease progression (HR 0.52, 95% CI 0.37 to 0.72; 1 study; 389 participants; moderate-certainty evidence). Participants given extended-field RT may or may not have had a lower risk of para-aortic lymph node recurrence (HR 0.44, 95% CI 0.20 to 0.99; 1 study; 389 participants; low-certainty evidence) and acute severe adverse events (RR 0.05, 95% CI 0.02 to 0.11; 1 study; 388 participants; moderate-certainty evidence). There were no clear differences in terms of late severe adverse events among the comparison groups (RR 1.06, 95% CI 0.69 to 1.62; 1 study; 386 participants; moderate-certainty evidence).\nExtended-field chemoradiotherapy versus pelvic chemoradiotherapy\nVery low-certainty evidence obtained from one small study (74 participants) showed that, compared to pelvic CRT, extended-field CRT may or may not have reduced risk of death (HR 0.37, 95% CI 0.14 to 0.96) and disease progression (HR 0.25, 95% CI 0.07 to 0.87). There were no clear differences between the groups in the risks of para-aortic lymph node recurrence (RR 0.19, 95% CI 0.02 to 1.54; very low-certainty evidence) and severe adverse events (acute: RR 0.95, 95% CI 0.20 to 4.39; late: RR 0.95, 95% CI 0.06 to 14.59; very low-certainty evidence).\nAuthors' conclusions\nModerate-certainty evidence shows that, compared with pelvic RT alone, extended-field RT probably improves overall survival and reduces risk of para-aortic lymph node recurrence. However, pelvic RT alone would now be considered substandard treatment, so this result cannot be extrapolated to modern standards of care. Low- to moderate-certainty evidence suggests that pelvic CRT may increase overall and progression-free survival compared to extended-field RT, although there may or may not be a higher rate of para-aortic recurrence and acute adverse events. Extended-field CRT versus pelvic CRT may improve overall or progression-free survival, but these findings should be interpreted with caution due to very low-certainty evidence.\nHigh-quality RCTs, comparing modern treatment techniques in CRT, are needed to more fully inform treatment for locally advanced cervical cancer without obvious para-aortic node involvement.\n\nGiven the provided abstract, please respond to the following query: \"Certainty of the evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence for outcomes in the comparison of extended-field RT alone versus pelvic RT alone were of moderate certainty. In the comparison of extended-field RT versus pelvic CRT, the evidence regarding the survival and side effects were of moderate certainty. The evidence for para-aortic recurrence was of low certainty. The evidence for all outcomes in a comparison of extended-field CRT versus pelvic CRT were of very-low certainty because of concerns regarding the high risk of bias and results coming from a single trial of very few women."
}
] |
query-laysum
|
23839
|
[
{
"role": "user",
"content": "Abstract: Background\nSupplementary feeding may help food insecure and vulnerable people by optimising the nutritional value and adequacy of the diet, improving quality of life and improving various health parameters of disadvantaged families. In low- and middle-income countries (LMIC), the problems supplementary feeding aims to address are entangled with poverty and deprivation, the programmes are expensive and delivery is complicated.\nObjectives\n1. To summarise the evidence from systematic reviews of supplementary feeding for food insecure, vulnerable and malnourished populations, including children under five years of age, school-aged children, pregnant and lactating women, people with HIV or tuberculosis (or both), and older populations.\n2. To describe and explore the effects of supplementary feeding given to people in these groups, and to describe the range of outcomes between reviews and range of effects in the different groups.\nMethods\nIn January 2017, we searched the Cochrane Database of Systematic Reviews, MEDLINE, Embase and nine other databases. We included systematic reviews evaluating community-based supplementary feeding, and concerning food insecure, vulnerable and malnourished populations. Two review authors independently undertook selection of systematic reviews, data extraction and 'Risk of bias' assessment. We assessed review quality using the AMSTAR tool, and used GRADEpro 'Summary of findings' tables from each review to indicate the certainty of the evidence for the main comparisons. We summarised review findings in the text and reported the data for each outcome in additional tables. We also used forest plots to display results graphically.\nMain results\nThis overview included eight systematic reviews (with last search dates between May 2006 and February 2016). Seven were Cochrane Reviews evaluating interventions in pregnant women; children (aged from birth to five years) from LMIC; disadvantaged infants and young children (aged three months to five years); children with moderate acute malnutrition (MAM); disadvantaged school children; adults and children who were HIV positive or with active tuberculosis (with or without HIV). One was a non-Cochrane systematic review in older people with Alzheimer's disease. These reviews included 95 trials relevant to this overview, with the majority (74%) of participants from LMIC.\nThe number of included participants varied between 91 and 7940 adults, and 271 and more than 12,595 children. Trials included a wide array of nutritional interventions that varied in duration, frequency and format, with micronutrients often reported as cointerventions. Follow-up ranged from six weeks to two years; three trials investigated outcomes at four to 17 years of age. All reviews were rated as high quality (AMSTAR score between eight and 11). The GRADE certainty ratings ranged from very low to moderate for individual comparisons, with the evidence often comprising only one or two small trials, thereby resulting in many underpowered analyses (too small to detect small but important differences). The main outcome categories reported across reviews were death, anthropometry (adults and children) and other markers of nutritional status, disease-related outcomes, neurocognitive development and psychosocial outcomes, and adverse events.\nMortality data were limited and underpowered in meta-analysis in all populations (children with MAM, in children with HIV, and in adults with tuberculosis) with the exception of balanced energy and protein supplementation in pregnancy, which may have reduced the risk of stillbirth (risk ratio (RR) 0.60, 95% confidence interval (CI) 0.39 to 0.94; 5 trials, 3408 women). Supplementation in pregnancy also improved infant birth weight (mean difference (MD) 40.96 g, 95% CI 4.66 to 77.26; 11 trials, 5385 participants) and reduced risk of infants born small-for-gestational age (RR 0.79, 95% CI 0.69 to 0.90; 7 trials, 4408 participants). These effects did not translate into demonstrable long-term benefits for children in terms of growth and neurocognitive development in the one to two trials reporting on longer-term outcomes. In one study (505 participants), high-protein supplementation was associated with increased risk of small-for-gestational age babies.\nEffects on growth in children were mixed. In children under five years of age from LMIC, one review found that supplementary feeding had a little or no effect on child growth; however, a more recent review in a similar population found that those who received food supplementation gained an average of 0.12 kg more in weight (MD 0.12 kg, 95% CI 0.05 to 0.18; 9 trials, 1057 participants) and 0.27 cm more in height (MD 0.27 cm, 95% CI 0.07 to 0.48; 9 trials, 1463 participants) than those who were not supplemented. Supplementary food was generally more effective for younger children (younger than two years of age) and for those who were poorer or less well-nourished. In children with MAM, the provision of specially formulated food improved their weight, weight-for-height z scores and other key outcomes such as recovery rate (by 29%), as well as reducing the number of participants dropping out (by 70%). In LMIC, school meals seemed to lead to small benefits for children, including improvements in weight z scores, especially in children from lower-income countries, height z scores, cognition or intelligence quotient tests, and maths and spelling performance.\nSupplementary feeding in adults who were HIV positive increased the daily energy and protein intake compared to nutritional counselling alone. Supplementation led to an initial improvement in weight gain or body mass index but did not seem to confer long-term benefit.\nIn adults with tuberculosis, one small trial found a significant benefit on treatment completion and sputum conversion rate. There were also significant but modest benefits in terms of weight gain (up to 2.60 kg) during active tuberculosis.\nThe one study included in the Alzheimer's disease review found that three months of daily oral nutritional supplements improved nutritional outcomes in the intervention group.\nThere was little or no evidence regarding people's quality of life, adherence to treatment, attendance at clinic or the costs of supplementary feeding programmes.\nAuthors' conclusions\nConsidering the current evidence base included, supplementary food effects are modest at best, with inconsistent and limited mortality evidence. The trials reflected in the reviews mostly reported on short-term outcomes and across the whole of the supplementation trial literature it appears important outcomes, such as quality of life and cost of programmes, are not systematically reported or summarised.\n\nGiven the provided abstract, please respond to the following query: \"What was studied in the review?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Supplementary feeding means providing extra food to people or families over and above their home diet and has been used in populations that are food insecure (limited access to adequate and nutritious food) and vulnerable (including women and young children; school-aged children; people living with diseases such as tuberculosis, HIV, and Alzheimer's disease; and older people) to improve their health and quality of life."
}
] |
query-laysum
|
23840
|
[
{
"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: \"Background\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Up to 20% of the world's population is affected by fungal skin infections of the groin ('jock' itch, or tinea cruris) or of the body (ringworm, or tinea corporis), which generally appear as red and itchy areas on the skin. Many topical (directly applied to the skin) treatments are available."
}
] |
query-laysum
|
23841
|
[
{
"role": "user",
"content": "Abstract: Background\nPhototherapy is a widely accepted, effective first-line therapy for neonatal jaundice. It is traditionally used continuously but intermittent phototherapy has been proposed as an equally effective alternative with practical advantages of improved maternal feeding and bonding. The effectiveness of intermittent phototherapy compared with continuous phototherapy is unknown.\nObjectives\nTo assess the safety and effectiveness of intermittent phototherapy compared with continuous phototherapy.\nSearch methods\nSearches were conducted on 31 January 2022 in the following databases: CENTRAL via CRS Web, MEDLINE and Embase via Ovid. We also searched clinical trials databases and the reference lists of retrieved articles for randomised controlled trials (RCTs) and quasi-randomised trials.\nSelection criteria\nWe included RCTs, cluster-RCTs and quasi-RCTs comparing intermittent phototherapy with continuous phototherapy in jaundiced infants (both term and preterm) up to the age of 30 days. We compared intermittent phototherapy with continuous phototherapy by any method and at any dose and duration as defined by the authors.\nData collection and analysis\nThree review authors independently selected trials, assessed trial quality and extracted data from included studies. We performed fixed-effect analyses and expressed treatment effects as mean difference (MD), risk ratio (RR) and risk difference (RD) with 95% confidence intervals (CIs). Our primary outcomes of interest were rate of decline of serum bilirubin, and kernicterus. We used the GRADE approach to assess the certainty of evidence.\nMain results\nWe included 12 RCTs (1600 infants) in the review. There is one ongoing study and four awaiting classification. There was little or no difference between intermittent phototherapy and continuous phototherapy with respect to rate of decline of bilirubin in jaundiced newborn infants (MD -0.09 micromol/L/hr, 95% CI -0.21 to 0.03; I² = 61%; 10 studies; 1225 infants; low-certainty evidence). One study involving 60 infants reported no incidence of bilirubin induced brain dysfunction (BIND). It is uncertain whether either intermittent or continuous phototherapy reduces BIND because the certainty of this evidence is very low. There was little or no difference in treatment failure (RD 0.03, 95% CI 0.08 to 0.15; RR 1.63, 95% CI 0.29 to 9.17; 1 study; 75 infants; very low-certainty evidence) or infant mortality (RD -0.01, 95% CI -0.03 to 0.01; RR 0.69, 95% CI 0.37 to 1.31 I² = 0%; 10 studies, 1470 infants; low-certainty evidence).\nAuthors' conclusions\nThe available evidence detected little or no difference between intermittent and continuous phototherapy with respect to rate of decline of bilirubin. Continuous phototherapy appears to be more effective in preterm infants, however, the risks of continuous phototherapy and the potential benefits of a slightly lower bilirubin level are unknown. Intermittent phototherapy is associated with a decrease in the total number of hours of phototherapy exposure. There are theoretical benefits to intermittent regimens but there are important safety outcomes that were inadequately addressed. Large, well designed, prospective trials are needed in both preterm and term infants before it can be concluded that intermittent and continuous phototherapy regimens are equally effective.\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": "In jaundiced newborn infants, is intermittent phototherapy compared with continuous phototherapy effective in reducing bilirubin levels."
}
] |
query-laysum
|
23842
|
[
{
"role": "user",
"content": "Abstract: Background\nHand eczema is an inflammation of the skin of the hands that tends to run a chronic, relapsing course. This common condition is often associated with itch, social stigma, and impairment in employment. Many different interventions of unknown effectiveness are used to treat hand eczema.\nObjectives\nTo assess the effects of topical and systemic interventions for hand eczema in adults and children.\nSearch methods\nWe searched the following up to April 2018: Cochrane Skin Group Specialised Register, CENTRAL, MEDLINE, Embase, AMED, LILACS, GREAT, and four trials registries. We checked the reference lists of included studies for further references to relevant trials.\nSelection criteria\nWe included randomised controlled trials (RCTs) that compared interventions for hand eczema, regardless of hand eczema type and other affected sites, versus no treatment, placebo, vehicle, or active treatments.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane. Primary outcomes were participant- and investigator-rated good/excellent control of symptoms, and adverse events.\nMain results\nWe included 60 RCTs, conducted in secondary care (5469 participants with mild to severe chronic hand eczema). Most participants were over 18 years old. The duration of treatment was short, generally up to four months. Only 24 studies included a follow-up period. Clinical heterogeneity in treatments and outcome measures was evident. Few studies performed head-to-head comparisons of different interventions. Risk of bias varied considerably, with only five studies at low risk in all domains. Twenty-two studies were industry-funded.\nEighteen trials studied topical corticosteroids or calcineurin inhibitors; 10 studies, phototherapy; three studies, systemic immunosuppressives; and five studies, oral retinoids. Most studies compared an active intervention against no treatment, variants of the same medication, or placebo (or vehicle). Below, we present results from the main comparisons.\nCorticosteroid creams/ointments: when assessed 15 days after the start of treatment, clobetasol propionate 0.05% foam probably improves participant-rated control of symptoms compared to vehicle (risk ratio (RR) 2.32, 95% confidence interval (CI) 1.38 to 3.91; number needed to treat for an additional beneficial outcome (NNTB) 3, 95% CI 2 to 8; 1 study, 125 participants); the effect of clobetasol compared to vehicle for investigator-rated improvement is less clear (RR 1.43, 95% CI 0.86 to 2.40). More participants had at least one adverse event with clobetasol (11/62 versus 5/63; RR 2.24, 95% CI 0.82 to 6.06), including application site burning/pruritus. This evidence was rated as moderate certainty.\nWhen assessed 36 weeks after the start of treatment, mometasone furoate cream used thrice weekly may slightly improve investigator-rated symptom control compared to twice weekly (RR 1.23, 95% CI 0.94 to 1.61; 1 study, 72 participants) after remission is reached. Participant-rated symptoms were not measured. Some mild atrophy was reported in both groups (RR 1.76, 95% CI 0.45 to 6.83; 5/35 versus 3/37). This evidence was rated as low certainty.\nIrradiation with ultraviolet (UV) light: local combination ultraviolet light therapy (PUVA) may lead to improvement in investigator-rated symptom control when compared to local narrow-band UVB after 12 weeks of treatment (RR 0.50, 95% CI 0.22 to 1.16; 1 study, 60 participants). However, the 95% CI indicates that PUVA might make little or no difference. Participant-rated symptoms were not measured. Adverse events (mainly erythema) were reported by 9/30 participants in the narrow-band UVB group versus none in the PUVA group. This evidence was rated as moderate certainty.\nTopical calcineurin inhibitors: tacrolimus 0.1% over two weeks probably improves investigator-rated symptom control measured after three weeks compared to vehicle (14/14 tacrolimus versus 0/14 vehicle; 1 study). Participant-rated symptoms were not measured. Four of 14 people in the tacrolimus group versus zero in the vehicle group had well-tolerated application site burning/itching.\nA within-participant study in 16 participants compared 0.1% tacrolimus to 0.1% mometasone furoate but did not measure investigator- or participant-rated symptoms. Both treatments were well tolerated when assessed at two weeks during four weeks of treatment.\nEvidence from these studies was rated as moderate certainty.\nOral interventions: oral cyclosporin 3 mg/kg/d probably slightly improves investigator-rated (RR 1.88, 95% CI 0.88 to 3.99; 1 study, 34 participants) or participant-rated (RR 1.25, 95% CI 0.69 to 2.27) control of symptoms compared to topical betamethasone dipropionate 0.05% after six weeks of treatment. The risk of adverse events such as dizziness was similar between groups (up to 36 weeks; RR 1.22, 95% CI 0.80 to 1.86, n = 55; 15/27 betamethasone versus 19/28 cyclosporin). The evidence was rated as moderate certainty.\nAlitretinoin 10 mg improves investigator-rated symptom control compared with placebo (RR 1.58, 95% CI 1.20 to 2.07; NNTB 11, 95% CI 6.3 to 26.5; 2 studies, n = 781) and alitretinoin 30 mg also improves this outcome compared with placebo (RR 2.75, 95% CI 2.20 to 3.43; NNTB 4, 95% CI 3 to 5; 2 studies, n = 1210). Similar results were found for participant-rated symptom control: alitretinoin 10 mg RR 1.73 (95% CI 1.25 to 2.40) and 30 mg RR 2.75 (95% CI 2.18 to 3.48). Evidence was rated as high certainty. The number of adverse events (including headache) probably did not differ between alitretinoin 10 mg and placebo (RR 1.01, 95% CI 0.66 to 1.55; 1 study, n = 158; moderate-certainty evidence), but the risk of headache increased with alitretinoin 30 mg (RR 3.43, 95% CI 2.45 to 4.81; 2 studies, n = 1210; high-certainty evidence). Outcomes were assessed between 48 and 72 weeks.\nAuthors' conclusions\nMost findings were from single studies with low precision, so they should be interpreted with caution. Topical corticosteroids and UV phototherapy were two of the major standard treatments, but evidence is insufficient to support one specific treatment over another. The effect of topical calcineurin inhibitors is not certain. Alitretinoin is more effective than placebo in controlling symptoms, but advantages over other treatments need evaluating.\nWell-designed and well-reported, long-term (more than three months), head-to-head studies comparing different treatments are needed. Consensus is required regarding the definition of hand eczema and its subtypes, and a standard severity scale should be established.\nThe main limitation was heterogeneity between studies. Small sample size impacted our ability to detect differences between treatments.\n\nGiven the provided abstract, please respond to the following query: \"Topical calcineurin inhibitors\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "people receiving tacrolimus are probably more likely to achieve improved investigator-rated good/excellent symptom control compared to those given vehicle (14/14 participants with tacrolimus compared to none with vehicle), but participant-rated control of symptoms was not measured. Four of 14 people in the tacrolimus group versus zero in the vehicle group had well-tolerated application site burning/itching. One small study compared tacrolimus to mometasone furoate, which were both well tolerated, but did not measure investigator- or participant-rated control (all based on moderate-certainty evidence)."
}
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query-laysum
|
23843
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[
{
"role": "user",
"content": "Abstract: Background\nPilonidal sinus disease is a common condition that mainly affects young adults. This condition can cause significant pain and impairment of normal activities. No consensus currently exists on the optimum treatment for pilonidal sinus and current therapies have various advantages and disadvantages. Fibrin glue has emerged as a potential treatment as both monotherapy and an adjunct to surgery.\nObjectives\nTo assess the effects of fibrin glue alone or in combination with surgery compared with surgery alone in the treatment of pilonidal sinus disease.\nSearch methods\nIn December 2016 we searched: the Cochrane Wounds Specialised Register; CENTRAL; MEDLINE; Embase and CINAHL Plus. We also searched clinical trials registries and conference proceedings for ongoing and unpublished studies and scanned reference lists to identify additional studies. There were no restrictions with respect to language, date of publication or study setting.\nSelection criteria\nWe included randomised controlled trials (RCTs) only. We included studies involving participants of all ages and studies conducted in any setting. We considered studies involving people with both new and recurrent pilonidal sinus. We included studies which evaluated fibrin glue monotherapy or as an adjunct to surgery.\nData collection and analysis\nTwo study authors independently extracted data and assessed risk of bias. We used standard methods expected by Cochrane.\nMain results\nWe included four RCTs with 253 participants, all were at risk of bias. One unpublished study evaluated fibrin glue monotherapy compared with Bascom's procedure, two studies evaluated fibrin glue as an adjunct to Limberg flap and one study evaluated fibrin glue as an adjunct to Karydakis flap.\nFor fibrin glue monotherapy compared with Bascom's procedure, there were no data available for the primary outcomes of time to healing and adverse events. There was low-quality evidence of less pain on day one after the procedure with fibrin glue monotherapy compared with Bascom's procedure (mean difference (MD) -2.50, 95% confidence interval (CI) -4.03 to -0.97) (evidence downgraded twice for risk of performance and detection bias). Fibrin glue may reduce the time taken to return to normal activities compared with Bascom's procedure (mean time 42 days with surgery and 7 days with glue, MD -34.80 days, 95% CI -66.82 days to -2.78 days) (very low-quality evidence, downgraded as above and for imprecision).\nFibrin glue as an adjunct to the Limberg flap may reduce the healing time from 22 to 8 days compared with the Limberg flap alone (MD -13.95 days, 95% CI -16.76 days to -11.14 days) (very low-quality evidence, downgraded twice for risk of selection, performance and detection bias and imprecision). It is uncertain whether use of fibrin glue affects the incidence of postoperative seroma (an adverse event) (risk ratio (RR) 0.27, 95% CI 0.05 to 1.61; very low-quality evidence, downgraded twice for risk of selection, performance and detection bias and imprecision). There was low-quality evidence that fibrin glue, as an adjunct to Limberg flap, may reduce postoperative pain (median 2 versus 4; P < 0.001) and time to return to normal activities (median 8 days versus 17 days; P < 0.001). The addition of fibrin glue to the Limberg flap may reduce the length of hospital stay (MD -1.69 days, 95% CI -2.08 days to -1.29 days) (very low-quality evidence, downgraded twice for risk of selection, performance and detection bias and for unexplained heterogeneity).\nA single RCT evaluating fibrin glue as an adjunct to the Karydakis flap did not report data for the primary outcome of time to healing. It is uncertain whether fibrin glue with the Karydakis flap affects the incidence of postoperative seroma (adverse event) (RR 3.00, 95% CI 0.67 to 13.46) (very low-quality evidence, downgraded twice for risk of selection, performance and detection bias and for imprecision). Fibrin glue as an adjunct to Karydakis flap may reduce length of stay but this is highly uncertain (mean 2 days versus 3.7 days; P < 0.001, low-quality evidence downgraded twice for risk of selection, performance and detection bias).\nAuthors' conclusions\nCurrent evidence is uncertain regarding any benefits associated with fibrin glue either as monotherapy or as an adjunct to surgery for people with pilonidal sinus disease. We identified only four RCTs and each was small and at risk of bias resulting in very low-quality evidence for the primary outcomes of time to healing and adverse events. Future studies should enrol many more participants, ensure adequate randomisation and blinding, whilst measuring clinically relevant outcomes.\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 evidence for all outcomes was low or very low, mainly due to problems with the ways the studies were conducted and also the uncertainty in the results because of the small numbers of participants in the studies. This means we cannot be confident of the effects of fibrin glue on any of these outcomes and more, better quality and larger studies are required.\nThis plain language summary is up to date as of December 2016."
}
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query-laysum
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23844
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[
{
"role": "user",
"content": "Abstract: Background\nEnuresis (bedwetting) affects up to 20% of five-year-olds and can have considerable social, emotional and psychological effects. Treatments include alarms (activated by urination), behavioural interventions and drugs.\nObjectives\nTo assess the effects of enuresis alarms for treating enuresis in children.\nSearch methods\nWe searched the Cochrane Incontinence Specialised Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, ClinicalTrials.gov, WHO ICTRP, and handsearching of journals and conference proceedings (searched 25 June 2018), and reference lists of relevant articles.\nSelection criteria\nWe included randomised or quasi-randomised trials of enuresis alarms or alarms combined with another intervention for treating nocturnal enuresis in children between 5 and 16 years old.\nData collection and analysis\nTwo review authors independently assessed risk of bias and extracted data.\nMain results\nWe included 74 trials (5983 children).\nAt treatment completion, alarms may reduce the number of wet nights a week compared to control or no treatment (mean difference (MD) −2.68, 95% confidence interval (CI) −4.59 to −0.78; 4 trials, 127 children; low-quality evidence). Low-quality evidence suggests more children may achieve complete response (14 consecutive dry nights) with alarms compared to control or no treatment (RR 7.23, 95% CI 1.40 to 37.33; 18 trials, 827 children) and that more children may remain dry post-treatment (RR 9.67, 95% CI 4.74 to 19.76; 10 trials, 366 children; low-quality evidence).\nAt treatment completion, we are uncertain whether there is any difference between alarms and placebo drugs in the number of wet nights a week (MD −0.96, 95% CI −2.32 to 0.41; 1 trial, 47 children; very low-quality evidence). Alarms may result in more children achieving complete response than with placebo drugs (RR 1.59, 95% CI 1.16 to 2.17; 2 trials, 181 children; low-quality evidence). No trials comparing alarms to placebo reported the number of children remaining dry post-treatment.\nCompared with control alarms, code-word alarms probably slightly increase the number of children achieving complete response at treatment completion (RR 1.11, 95% CI 0.97 to 1.27; 1 trial, 353 children; moderate-quality evidence) but there is probably little to no difference in the number of children remaining dry post-treatment (RR 0.91, 95% CI 0.79 to 1.05; moderate-quality evidence). Very low-quality evidence means we are uncertain if there are any differences in effectiveness between the other different types of alarm.\nAt treatment completion, alarms may reduce the number of wet nights a week compared with behavioural interventions (waking, bladder training, dry-bed training, and star chart plus rewards) (MD -0.81, 95% CI -2.01 to 0.38; low-quality evidence) and may increase the number of children achieving complete response (RR 1.77, 95% CI 0.98 to 3.19; low-quality evidence) and may slightly increase the number of children remaining dry post-treatment (RR 1.39, 95% CI 0.81 to 2.41; low-quality evidence).\nThe evidence relating to alarms compared with desmopressin in the number of wet nights a week (MD −0.64, 95% CI −1.77 to 0.49; 4 trials, 285 children) and the number of children achieving complete response at treatment completion (RR 1.12, 95% CI 0.93 to 1.36; 12 trials, 1168 children) is low-quality, spanning possible harms and possible benefits. Alarms probably slightly increase the number of children remaining dry post-treatment compared with desmopressin (RR 1.30, 95% CI 0.92 to 1.84; 5 trials, 565 children; moderate-quality evidence).\nAt treatment completion, we are uncertain if there is any difference between alarms and tricyclics in the number of wet nights a week, the number of children achieving complete response or the number of children remaining dry post-treatment, because the quality of evidence is very low.\nDue to very low-quality evidence we are uncertain about any differences in effectiveness between alarms and cognitive behavioural therapy, psychotherapy, hypnotherapy and restricted diet.\nAlarm plus desmopressin may reduce the number of wet nights a week compared with desmopressin monotherapy (MD −0.88, 95% CI −0.38 to −1.38; 2 trials, 156 children; low-quality evidence). Alarm plus desmopressin may increase the number of children achieving complete response (RR 1.32, 95% CI 1.08 to 1.62; 5 trials, 359 children; low-quality evidence) and the number of children remaining dry post-treatment (RR 2.33, 95% CI 1.26 to 4.29; 2 trials, 161 children; low-quality evidence) compared with desmopressin alone.\nAlarm plus dry-bed training may increase the number of children achieving a complete response compared to dry-bed training alone (RR 3.79, 95% CI 1.85 to 7.77; 1 trial, 80 children; low-quality evidence). It is unclear if there is any difference in the number of children remaining dry post-treatment because of the wide confidence interval (RR 0.56, 95% CI 0.15 to 2.12; low-quality evidence). Due to very low-quality evidence, we are uncertain about any differences in effectiveness between alarm plus bladder training versus bladder training alone.\nOf the 74 included trials, 17 reported one or more adverse events, nine reported no adverse events and 48 did not mention adverse events. Adverse events attributed to alarms included failure to wake the child, ringing without urination, waking others, causing discomfort, frightening the child and being too difficult to use. Adverse events of comparator interventions included nose bleeds, headaches and abdominal pain.\nThere is probably a slight increase in adverse events between code-word alarm and standard alarm (RR 1.34, 95% CI 0.75 to 2.38; moderate-quality evidence), although we are uncertain because of the wide confidence interval. Alarms probably reduce the number of children experiencing adverse events compared with desmopressin (RR 0.38, 95% CI 0.20 to 0.71; 5 trials, 565 children; moderate-quality evidence). Very low-quality evidence means we cannot be certain whether the adverse event rate for alarms is lower than for other treatments.\nAuthors' conclusions\nAlarm therapy may be more effective than no treatment in reducing enuresis in children. We are uncertain if alarm therapy is more effective than desmopressin but there is probably a lower risk of adverse events with alarms than with desmopressin. Despite the large number of trials included in this review, further adequately-powered trials with robust randomisation are still needed to determine the full effect of alarm therapy.\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": "This review includes 74 trials involving 5983 children."
}
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query-laysum
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23845
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[
{
"role": "user",
"content": "Abstract: Background\nProbiotics are live micro-organisms that may give a beneficial physiological effect when administered in adequate amounts. Some trials show that probiotic strains can prevent respiratory infections. Even though our previously published review showed the benefits of probiotics for acute upper respiratory tract infections (URTIs), several new studies have been published. This is an update of a review first published in 2011 and updated in 2015.\nObjectives\nTo assess the effectiveness and safety of probiotics (any specified strain or dose), compared with placebo or no treatment, in the prevention of acute URTIs in people of all ages, at risk of acute URTIs.\nSearch methods\nWe searched CENTRAL (2022, Issue 6), MEDLINE (1950 to May week 2, 2022), Embase (1974 to 10 May 2022), Web of Science (1900 to 10 May 2022), the Chinese Biomedical Literature Database, which includes the China Biological Medicine Database (from 1978 to 10 May 2022), the Chinese Medicine Popular Science Literature Database (from 2000 to 10 May 2022), and the Master's Degree Dissertation of Beijing Union Medical College Database (from 1981 to 10 May 2022). We searched the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov for completed and ongoing trials on 10 May 2022.\nSelection criteria\nWe included individual randomised controlled trials (RCTs) and cluster-RCTs comparing probiotics with placebo or no treatment to prevent acute URTIs. The participants were children, adults, or the elderly in the community, care facilities, schools, or hospitals. Our main outcomes were the number of participants diagnosed with URTIs (at least one event and at least three events), the incidence rate (number of cases/person year) of acute URTIs, and the mean duration of an episode of URTIs. Our secondary outcomes were the number of participants who were absent from childcare centre, school, or work due to acute URTIs; the number of participants who used prescribed antibiotics for acute URTIs; and the number of participants who experienced at least one adverse event from probiotics. We excluded studies if they did not specify acute respiratory infections as 'upper'; studies with more than 50% of participants vaccinated against influenza or other acute URTIs within the last 12 months; and studies with significantly different proportions of vaccinated participants between the probiotics arm and the placebo or no treatment arm.\nData collection and analysis\nTwo review authors independently assessed the eligibility of trials and extracted data using standard Cochrane methodological procedures. We analysed both intention-to-treat and per-protocol data and used a random-effects model. We expressed results as risk ratios (RRs) for dichotomous outcomes and mean differences (MDs) for continuous outcomes, both with 95% confidence intervals (CIs). We assessed the certainty of the evidence using the GRADE approach.\nMain results\nWe included 23 individual RCTs and one cluster-RCT. As one of the individual RCTs did not report outcomes in a usable way, we could only meta-analyse data from 23 trials, involving a total of 6950 participants including children (aged from one month to 11 years old), adults (mean age 37.3), and older people (mean age 84.6 years). One trial reported 22.5% flu-vaccine participants within the last 12 months, and 25.4% flu-vaccine participants during the intervention. Probiotics were more likely to be given with milk-based food in children; administered in powder form in adults; and given with milk-based food or in capsules in the elderly. Most of the studies used one or two strains (e.g. Lactobacillus plantarum HEAL9, Lactobacillus paracasei (8700:2 or N1115)) and 109 or 1011 colony-forming units (CFU)/day of probiotics for more than three months.\nWe found that probiotics may reduce the number of participants diagnosed with URTIs (at least one event) (RR 0.76, 95% CI 0.67 to 0.87; P < 0.001; 16 studies, 4798 participants; low-certainty evidence); likely reduce the number of participants diagnosed with URTIs (at least three events) (RR 0.59, 95% CI 0.38 to 0.91; P = 0.02; 4 studies, 763 participants; moderate-certainty evidence); may reduce the incidence rate (number of cases/person year) of URTIs (rate ratio 0.82, 95% CI 0.73 to 0.92, P = 0.001; 12 studies, 4364 participants; low-certainty evidence); may reduce the mean duration of an episode of acute URTIs (MD −1.22 days, 95% CI −2.12 to −0.33; P = 0.007; 6 studies, 2406 participants; low-certainty evidence); likely reduce the number of participants who used prescribed antibiotics for acute URTIs (RR 0.58, 95% CI 0.42 to 0.81; P = 0.001; 6 studies, 1548 participants; moderate-certainty evidence); and may not increase the number of participants who experienced at least one adverse event (RR 1.02, 95% CI 0.90 to 1.15; P = 0.79; 8 studies, 2456 participants; low-certainty evidence). Evidence showing a decrease in the number of people absent from childcare centre, school, or work due to acute URTIs with probiotics is very uncertain (RR 0.14, 95% CI 0.03 to 0.59; 1 study, 80 participants; very low-certainty evidence). Adverse events from probiotics were minor, and most commonly gastrointestinal symptoms, such as vomiting, flatulence, diarrhoea, and bowel pain.\nAuthors' conclusions\nOverall, we found that probiotics were better than placebo or no treatment in preventing acute URTIs.\n\nGiven the provided abstract, please respond to the following query: \"What are probiotics?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "A common description of probiotics is live micro-organisms that give a beneficial effect to the body when consumed in adequate amounts. Lactic acid bacteria and bifidobacteria are the most common types and are commonly consumed in fermented foods, such as yoghurt and soy yoghurt, or as dietary supplements."
}
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query-laysum
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23846
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[
{
"role": "user",
"content": "Abstract: Background\nEpilepsy is a common neurological condition in which abnormal electrical discharges from the brain cause recurrent unprovoked seizures. It is believed that with effective drug treatment up to 70% of individuals with active epilepsy have the potential to become seizure-free, and to go into long-term remission shortly after starting drug therapy with a single antiepileptic drug in monotherapy.\nWorldwide, sodium valproate and phenytoin are commonly used antiepileptic drugs for monotherapy treatment. It is generally believed that phenytoin is more effective for focal onset seizures, and that sodium pvalproate is more effective for generalised onset tonic-clonic seizures (with or without other generalised seizure types). This review is one in a series of Cochrane Reviews investigating pair-wise monotherapy comparisons. This is the latest updated version of the review first published in 2001, and updated in 2013 and 2016.\nObjectives\nTo review the time to treatment failure, remission and first seizure of sodium valproate compared to phenytoin when used as monotherapy in people with focal onset seizures or generalised tonic-clonic seizures (with or without other generalised seizure types).\nSearch methods\nWe searched the Cochrane Epilepsy Group's Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform ICTRP on 19 February 2018. We handsearched relevant journals, contacted pharmaceutical companies, original trial investigators and experts in the field.\nSelection criteria\nRandomised controlled trials (RCTs) comparing monotherapy with either sodium valproate or phenytoin in children or adults with focal onset seizures or generalised onset tonic-clonic seizures\nData collection and analysis\nThis was an individual participant data (IPD) review. Our primary outcome was time to treatment failure and our secondary outcomes were time to first seizure post-randomisation, time to six-month, and 12-month remission, and incidence of adverse events. We used Cox proportional hazards regression models to obtain trial-specific estimates of hazard ratios (HRs) with 95% confidence intervals (CIs), using the generic inverse variance method to obtain the overall pooled HR and 95% CI.\nMain results\nWe included 11 trials in this review and IPD were available for 669 individuals out of 1119 eligible individuals from five out of 11 trials, 60% of the potential data. Results apply to focal onset seizures (simple, complex and secondary generalised tonic-clonic seizures), and generalised tonic-clonic seizures, but not other generalised seizure types (absence or myoclonus seizure types). For remission outcomes, a HR of less than 1 indicates an advantage for phenytoin, and for first seizure and treatment failure outcomes a HR of less than 1 indicates an advantage for sodium valproate.\nThe main overall results were: time to treatment failure for any reason related to treatment (pooled HR adjusted for seizure type 0.88, 95% CI 0.61 to 1.27; 5 studies; 528 participants; moderate-quality evidence), time to treatment failure due to adverse events (pooled HR adjusted for seizure type 0.77, 95% CI 0.44 to 1.37; 4 studies; 418 participants; moderate-quality evidence), time to treatment failure due to lack of efficacy (pooled HR for all participants 1.16 (95% CI 0.71 to 1.89; 5 studies; 451 participants; moderate-quality evidence). These results suggest that treatment failure for any reason related to treatment and treatment failure due to adverse events may occur earlier on phenytoin compared to sodium valproate, while treatment failure due to lack of efficacy may occur earlier on sodium valproate than phenytoin; however none of these results were statistically significant.\nResults for time to first seizure (pooled HR adjusted for seizure type 1.08, 95% CI 0.88 to 1.33; 5 studies; 639 participants; low-quality evidence) suggest that first seizure recurrence may occur slightly earlier on sodium valproate compared to phenytoin. There were no clear differences between drugs in terms of time to 12-month remission (pooled HR adjusted for seizure type 1.02, 95% CI 0.81 to 1.28; 4 studies; 514 participants; moderate-quality evidence) and time to six-month remission (pooled HR adjusted for seizure type 1.05, 95% CI 0.86 to 1.27; 5 studies; 639 participants; moderate-quality evidence).\nLimited information was available regarding adverse events in the trials and we could not make comparisons between the rates of adverse events on sodium valproate and phenytoin. Some adverse events reported with both drugs were drowsiness, rash, dizziness, nausea and gastrointestinal problems. Weight gain was also reported with sodium valproate and gingival hypertrophy/hyperplasia was reported on phenytoin.\nThe methodological quality of the included trials was generally good, however four out of the five trials providing IPD for analysis were of an open-label design, therefore all results were at risk of detection bias. There was also evidence that misclassification of seizure type may have confounded the results of this review, particularly for the outcome 'time to first seizure' and heterogeneity was present in analysis of treatment failure outcomes which could not be explained by subgroup analysis by epilepsy type or by sensitivity analysis for misclassification of seizure type. Therefore, for treatment failure outcomes we judged the quality of the evidence to be moderate to low, for 'time to first seizure' we judged the quality of the evidence to be low, and for remission outcomes we judged the quality of the evidence to be moderate.\nAuthors' conclusions\nWe have not found evidence that a significant difference exists between valproate and phenytoin for any of the outcomes examined in this review. However detection bias, classification bias and heterogeneity may have impacted on the results of this review. We did not find any outright evidence to support or refute current treatment policies. We recommend that future trials be designed to the highest quality possible with consideration of masking, choice of population, classification of seizure type, duration of follow-up, choice of outcomes and analysis, and presentation of results.\n\nGiven the provided abstract, please respond to the following query: \"Objective\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Sodium valproate and phenytoin are commonly used treatments for individuals with epilepsy. The aim of this review was to compare how effective these drugs are at controlling seizures and whether individuals choose to stop taking these treatments (treatment failure), to inform a choice between these drugs."
}
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query-laysum
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23847
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[
{
"role": "user",
"content": "Abstract: Background\nEditor's note: The anti-inflammatory drug rofecoxib (Vioxx) was withdrawn from the market at the end of September 2004 after it was shown that long-term use (greater than 18 months) could increase the risk of heart attack and stroke. Further information is available at www.vioxx.com.\nOsteoarthritis is a chronic disease of the joints, characterised by joint pain, stiffness and loss of physical function. Its onset is age-related and occurs usually between the ages of 50 and 60. It is the commonest cause of disability in those aged over 65, with OA of the knee and/or hip affecting over 20 per cent of the elderly population.\nObjectives\nTo establish the efficacy and safety of rofecoxib in the management of OA by systematic review of available evidence.\nSearch methods\nWe searched the following databases up to August 2004: MEDLINE, EMBASE, Cochrane Database of Systematic Reviews, Cochrane Controlled Trials Register, National Research Register, NHS Economic Evaluation Database, Health Technology Assessment Database. The bibliographies of retrieved papers and content experts were consulted for additional references.\nSelection criteria\nAll eligible randomised controlled trials (RCTs) were included. No unpublished RCTs were included in this edition of the review.\nData collection and analysis\nData were abstracted independently by two reviewers. A validated checklist was used to score the quality of the RCTs. Comparable trials were pooled using fixed effects model.\nMain results\nTwenty-six RCTs were included. The comparators were placebo, diclofenac, ibuprofen, naproxen, nimesulide, nabumetone, paracetamol, celecoxib and Arthrotec. The evidence reviewed indicated that rofecoxib was more effective than placebo (patient global response RR 1.75 95% CI: 1.35, 2.26) but was associated with more adverse events (RR 1.32 95% CI 1.11, 1.56). There were no consistent differences in efficacy between rofecoxib and any of the active comparators at equivalent doses. Endoscopic studies indicated that compared to ibuprofen 800mg three times a day, rofecoxib caused fewer erosions and gastric ulcers at doses of 25mg and 50mg; the difference in duodenal ulcers was evident only at a dose of 25mg. Rofecoxib 50mg also caused more endoscopically observed ulcers greater than rofecoxib 25mg (RR 2.48 CI: 1.21, 5.11). Very few of the trials reported overall rates of GI adverse events although rofecoxib was found to cause fewer GI events than naproxen. Only one of the nine trials comparing rofecoxib to celecoxib reported on the overall rates of GI events and this was a comparison of the higher recommended dose of rofecoxib with the lower recommended dose of celecoxib. Similarly, the three trials in older hypertensive patients that examined the cardiovascular safety of rofecoxib and celecoxib used non-comparable doses; the results of these studies indicated that rofecoxib caused more patients to have oedema and a clinically significant increase in systolic blood pressure. This difference between rofecoxib and celecoxib was not evident in studies conducted in more general populations.\nAuthors' conclusions\nRofecoxib was voluntarily withdrawn from global markets in October 2004 therefore there are no implications for practice concerning its use. There remains a number of questions over both the benefits and risks associated with Cox II selective agents and further work is ongoing.\n\nGiven the provided abstract, please respond to the following query: \"What is osteoarthritis and how could rofecoxib help?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "Osteoarthritis (OA) is the most common form of arthritis that can affect the hands, hips, shoulders and knees. In OA, the cartilage that protects the ends of the bones breaks down and causes pain and swelling. Rofecoxib is often referred to as a 'COX II inhibitor' and is one of the new non-steroidal anti-inflammatory drugs (NSAIDs) prescribed to decrease pain and inflammation. Other NSAIDS, such as naproxen (Naprosyn) are also prescribed but they come with warnings that they may cause stomach problems such as ulcers, bleeds and sores that can be serious. Rofecoxib is thought to be safer on the stomach than other NSAIDS.\nRofecoxib was taken off the market in October 2004. A study had shown that people taking rofecoxib to prevent colon cancer had more heart attacks and strokes than people taking a sugar pill."
}
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query-laysum
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23848
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[
{
"role": "user",
"content": "Abstract: Background\nA large subgroup of people with interstitial lung disease (ILD) are normoxic at rest, but rapidly desaturate on exertion. This can limit exercise capacity and worsen dyspnoea. The use of ambulatory or short-burst oxygen when mobilising or during other activities, may improve exercise capacity and relieve dyspnoea.\nObjectives\nTo determine the effects of ambulatory and short-burst oxygen therapy, separately, on exercise capacity, dyspnoea and quality of life in people who have interstitial lung disease (ILD), particularly those with idiopathic pulmonary fibrosis (IPF).\nSearch methods\nWe conducted searches in the Cochrane Airways Group Specialised Register (all years to May 2016), Cochrane Central Register of Controlled Trials (CENTRAL) (all years to May 2016), MEDLINE (Ovid) (1950 to 4th May 2016) and EMBASE (Ovid) (1974 to 4th May 2016). We also searched the reference lists of relevant studies, international clinical trial registries and respiratory conference abstracts for studies.\nSelection criteria\nWe included randomised controlled trials (RCTs) or quasi-RCTs that compared ambulatory or short-burst oxygen with a control group in people with ILD of any origin.\nData collection and analysis\nTwo review authors independently selected studies for inclusion and assessed risk of bias in the included studies. We extracted data from included studies using a prepared checklist, including study characteristics and results. We used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) criteria to assess the quality of the included studies.\nMain results\nThree studies (including 98 participants, all of whom had IPF) met the inclusion criteria of this review. These studies were conducted in hospital respiratory physiology laboratories. Two studies did not demonstrate any beneficial effect of supplemental oxygen on exercise capacity or exertional dyspnoea. Neither of these studies titrated oxygen requirements to prevent ongoing exertional desaturation. One study showed an increase in exercise capacity as assessed by endurance time with supplemental oxygen. We did not identify any studies that examined the effect of ambulatory oxygen on health-related quality of life, survival, costs or time to exacerbation or hospitalisation. No study reported any adverse events. The quality of evidence for all three studies, as assessed by GRADE criteria, was low.\nAuthors' conclusions\nThis review found no evidence to support or refute the use of ambulatory or short burst oxygen in ILD due to the limited number of included studies and data. Further research is needed to examine the role of this treatment.\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": "Many people with ILD have a drop in their oxygen levels when they are moving about. This is because of their lung scarring. Oxygen can be given, to be used only when people are moving about, to prevent this drop. This is called ambulatory oxygen. This may help to improve symptoms of breathlessness and their ability to exercise. It may also improve their quality of life. This Cochrane review examined the evidence for any effect of ambulatory oxygen on the ability to exercise, breathlessness and quality of life. Cochrane researchers searched the available evidence up to 4th May 2016."
}
] |
query-laysum
|
23849
|
[
{
"role": "user",
"content": "Abstract: Background\nThe admission cardiotocograph (CTG) is a commonly used screening test consisting of a short (usually 20 minutes) recording of the fetal heart rate (FHR) and uterine activity performed on the mother's admission to the labour ward. This is an update of a review published in 2012.\nObjectives\nTo compare the effects of admission cardiotocography with intermittent auscultation of the FHR on maternal and infant outcomes for pregnant women without risk factors on their admission to the labour ward.\nSearch methods\nWe searched the Cochrane Pregnancy and Childbirth Group's Trials Register to 30 November 2016 and we planned to review the reference list of retrieved papers.\nSelection criteria\nAll randomised and quasi-randomised trials comparing admission CTG with intermittent auscultation of the FHR for pregnant women between 37 and 42 completed weeks of pregnancy and considered to be at low risk of intrapartum fetal hypoxia and of developing complications during labour.\nData collection and analysis\nTwo authors independently assessed trial eligibility and quality, and extracted data. Data were checked for accuracy.\nMain results\nWe included no new trials in this update. We included four trials involving more than 13,000 women which were conducted in the UK and Ireland and included women in labour. Three trials were funded by the hospitals where the trials took place and one trial was funded by the Scottish government. No declarations of interest were made in two trials; the remaining two trials did not mention declarations of interest. Overall, the studies were assessed as low risk of bias. Results reported in the 2012 review remain unchanged.\nAlthough not statistically significant using a strict P < 0.05 criterion, data were consistent with women allocated to admission CTG having, on average, a higher probability of an increase in incidence of caesarean section than women allocated to intermittent auscultation (risk ratio (RR) 1.20, 95% confidence interval (CI) 1.00 to 1.44, 4 trials, 11,338 women, I² = 0%, moderate quality evidence). There was no clear difference in the average treatment effect across included trials between women allocated to admission CTG and women allocated to intermittent auscultation in instrumental vaginal birth (RR 1.10, 95% CI 0.95 to 1.27, 4 trials, 11,338 women, I² = 38%, low quality evidence) and perinatal mortality rate (RR 1.01, 95% CI 0.30 to 3.47, 4 trials, 11,339 infants, I² = 0%, moderate quality evidence).\nWomen allocated to admission CTG had, on average, higher rates of continuous electronic fetal monitoring during labour (RR 1.30, 95% CI 1.14 to 1.48, 3 trials, 10,753 women, I² = 79%, low quality evidence) and fetal blood sampling (RR 1.28, 95% CI 1.13 to 1.45, 3 trials, 10,757 women, I² = 0%) than women allocated to intermittent auscultation. There were no differences between groups in other secondary outcome measures including incidence and severity of hypoxic ischaemic encephalopathy (incidence only reported) (RR 1.19, 95% CI 0.37 to 3.90; 2367 infants; 1 trial; very low quality evidence) and incidence of seizures in the neonatal period (RR 0.72, 95% CI 0.32 to 1.61; 8056 infants; 1 trial; low quality evidence). There were no data reported for severe neurodevelopmental disability assessed at greater than, or equal to, 12 months of age.\nAuthors' conclusions\nContrary to continued use in some clinical areas, we found no evidence of benefit for the use of the admission CTG for low-risk women on admission in labour.\nFurthermore, the probability is that admission CTG increases the caesarean section rate by approximately 20%. The data lacked power to detect possible important differences in perinatal mortality. However, it is unlikely that any trial, or meta-analysis, will be adequately powered to detect such differences. The findings of this review support recommendations that the admission CTG not be used for women who are low risk on admission in labour. Women should be informed that admission CTG is likely associated with an increase in the incidence of caesarean section without evidence of benefit.\nEvidence quality ranged from moderate to very low, with downgrading decisions based on imprecision, inconsistency and a lack of blinding for participants and personnel. All four included trials were conducted in developed Western European countries. One additional study is ongoing.\nThe usefulness of the findings of this review for developing countries will depend on FHR monitoring practices. However, an absence of benefit and likely harm associated with admission CTG will have relevance for countries where questions are being asked about the role of the admission CTG.\nFuture studies evaluating the effects of the admission CTG should consider including women admitted with signs of labour and before a formal diagnosis of labour. This would include a cohort of women currently having admission CTGs and not included in current trials.\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": "When healthy women with low-risk pregnancies are admitted to labour wards, does a cardiotocograph (CTG) or listening to the fetal heart rate (FHR) for one minute following a contraction lead to better outcomes for mothers and their babies?"
}
] |
query-laysum
|
23850
|
[
{
"role": "user",
"content": "Abstract: Background\nSore throat is a common condition associated with a high rate of antibiotic prescriptions, despite limited evidence for the effectiveness of antibiotics. Corticosteroids may improve symptoms of sore throat by reducing inflammation of the upper respiratory tract. This review is an update to our review published in 2012.\nObjectives\nTo assess the clinical benefit and safety of corticosteroids in reducing the symptoms of sore throat in adults and children.\nSearch methods\nWe searched CENTRAL (Issue 4, 2019), MEDLINE (1966 to 14 May 2019), Embase (1974 to 14 May 2019), the Database of Abstracts of Reviews of Effects (DARE, 2002 to 2015), and the NHS Economic Evaluation Database (inception to 2015). We also searched the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) and ClinicalTrials.gov.\nSelection criteria\nWe included randomised controlled trials (RCTs) that compared steroids to either placebo or standard care in adults and children (aged over three years) with sore throat. We excluded studies of hospitalised participants, those with infectious mononucleosis (glandular fever), sore throat following tonsillectomy or intubation, or peritonsillar abscess.\nData collection and analysis\nWe used standard methodological procedures expected by Cochrane.\nMain results\nWe included one new RCT in this update, for a total of nine trials involving 1319 participants (369 children and 950 adults). In eight trials, participants in both corticosteroid and placebo groups received antibiotics; one trial offered delayed prescription of antibiotics based on clinical assessment. Only two trials reported funding sources (government and a university foundation).\nIn addition to any effect of antibiotics and analgesia, corticosteroids increased the likelihood of complete resolution of pain at 24 hours by 2.40 times (risk ratio (RR) 2.4, 95% confidence interval (CI) 1.29 to 4.47; P = 0.006; I² = 67%; high-certainty evidence) and at 48 hours by 1.5 times (RR 1.50, 95% CI 1.27 to 1.76; P < 0.001; I² = 0%; high-certainty evidence). Five people need to be treated to prevent one person continuing to experience pain at 24 hours. Corticosteroids also reduced the mean time to onset of pain relief and the mean time to complete resolution of pain by 6 and 11.6 hours, respectively, although significant heterogeneity was present (moderate-certainty evidence). At 24 hours, pain (assessed by visual analogue scales) was reduced by an additional 10.6% by corticosteroids (moderate-certainty evidence). No differences were reported in recurrence/relapse rates, days missed from work or school, or adverse events for participants taking corticosteroids compared to placebo. However, the reporting of adverse events was poor, and only two trials included children or reported days missed from work or school. The included studies were assessed as moderate quality evidence, but the small number of included studies has the potential to increase the uncertainty, particularly in terms of applying these results to children.\nAuthors' conclusions\nOral or intramuscular corticosteroids, in addition to antibiotics, moderately increased the likelihood of both resolution and improvement of pain in participants with sore throat. Given the limited benefit, further research into the harms and benefits of short courses of steroids is needed to permit informed decision-making.\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 assessed the certainty of the evidence as high for complete resolution of pain at 24 and 48 hours, and moderate for mean time to onset of pain relief, mean time to complete resolution of pain, absolute reduction in pain measured by visual analogue scales, adverse events, recurrence/relapse rates, and days missed from work or school."
}
] |
query-laysum
|
23851
|
[
{
"role": "user",
"content": "Abstract: Background\nHigh blood pressure is an important risk factor for cardiovascular disease, contributing to about 50% of cardiovascular events worldwide and 37% of cardiovascular-related deaths in Western populations. Epidemiological studies suggest that cocoa-rich products reduce the risk of cardiovascular disease. Flavanols found in cocoa have been shown to increase the formation of endothelial nitric oxide which promotes vasodilation and therefore blood pressure reduction. Here we update previous meta-analyses on the effect of cocoa on blood pressure.\nObjectives\nTo assess the effects on blood pressure of chocolate or cocoa products versus low-flavanol products or placebo in adults with or without hypertension when consumed for two weeks or longer.\nSearch methods\nThis is an updated version of the review initially published in 2012. In this updated version, we searched the following electronic databases from inception to November 2016: Cochrane Hypertension Group Specialised Register, CENTRAL, MEDLINE and Embase. We also searched international trial registries, and the reference lists of review articles and included trials.\nSelection criteria\nRandomised controlled trials (RCTs) investigating the effects of chocolate or cocoa products on systolic and diastolic blood pressure in adults for a minimum of two weeks duration.\nData collection and analysis\nTwo review authors independently extracted data and assessed the risks of bias in each trial. We conducted random-effects meta-analyses on the included studies using Review Manager 5. We explored heterogeneity with subgroup analyses by baseline blood pressure, flavanol content of control group, blinding, age and duration. Sensitivity analyses explored the influence of unusual study design.\nMain results\nThirty-five trials (including 40 treatment comparisons) met the inclusion criteria. Of these, we added 17 trials (20 treatment comparisons) to the 18 trials (20 treatment comparisons) in the previous version of this updated review.\nTrials provided participants with 30 to 1218 mg of flavanols (mean = 670 mg) in 1.4 to 105 grams of cocoa products per day in the active intervention group. The control group received either a flavanol-free product (n = 26 treatment comparisons) or a low-flavanol-containing cocoa powder (range 6.4 to 88 mg flavanols (mean = 55 mg, 13 treatment comparisons; 259 mg, 1 trial).\nMeta-analyses of the 40 treatment comparisons involving 1804 mainly healthy participants revealed a small but statistically significant blood pressure-reducing effect of flavanol-rich cocoa products compared with control in trials of two to 18 weeks duration (mean nine weeks):\nMean difference systolic blood pressure (SBP) (95% confidence interval (CI): -1.76 (-3.09 to -0.43) mmHg, P = 0.009, n = 40 treatment comparisons, 1804 participants;\nMean difference diastolic blood pressure (DBP) (95% CI): -1.76 (-2.57 to -0.94) mmHg, P < 0.001, n = 39 treatment comparisons, 1772 participants.\nBaseline blood pressure may play a role in the effect of cocoa on blood pressure. While systolic blood pressure was reduced significantly by 4 mmHg in hypertensive people (n = 9 treatment comparisons, 401 participants), and tended to be lowered in prehypertensive people (n= 8 treatment comparisons, 340 participants), there was no significant difference in normotensive people (n = 23 treatment comparisons, 1063 participants); however, the test for subgroup differences was of borderline significance (P = 0.08; I2 = 60%), requiring further research to confirm the findings.\nSubgroup meta-analysis by blinding suggested a trend towards greater blood pressure reduction in unblinded trials compared to double-blinded trials, albeit statistically not significant. Further research is needed to confirm whether participant expectation may influence blood pressure results. Subgroup analysis by type of control (flavanol-free versus low-flavanol control) did not reveal a significant difference.\nWhether the age of participants plays a role in the effect of cocoa on blood pressure, with younger participants responding with greater blood pressure reduction, needs to be further investigated.\nSensitivity analysis excluding trials with authors employed by trials sponsoring industry (33 trials, 1482 participants) revealed a small reduction in effect size, indicating some reporting bias.\nDue to the remaining heterogeneity, which we could not explain in terms of blinding, flavanol content of the control groups, age of participants, or study duration, we downgraded the quality of the evidence from high to moderate.\nResults of subgroup analyses should be interpreted with caution and need to be confirmed or refuted in trials using direct randomised comparisons.\nGenerally, cocoa products were highly tolerable, with adverse effects including gastrointestinal complaints and nausea being reported by 1% of participants in the active cocoa intervention group and 0.4% of participants in the control groups (moderate-quality evidence).\nAuthors' conclusions\nThis review provides moderate-quality evidence that flavanol-rich chocolate and cocoa products cause a small (2 mmHg) blood pressure-lowering effect in mainly healthy adults in the short term.\nThese findings are limited by the heterogeneity between trials, which could not be explained by prespecified subgroup analyses, including blinding, flavanol content of the control groups, age of participants, or study duration. However, baseline blood pressure may play a role in the effect of cocoa on blood pressure; subgroup analysis of trials with (pre)hypertensive participants revealed a greater blood pressure-reducing effect of cocoa compared to normotensive participants with borderline significance.\nLong-term trials investigating the effect of cocoa on clinical outcomes are also needed to assess whether cocoa has an effect on cardiovascular events and to assess potential adverse effects associated with chronic ingestion of cocoa products.\n\nGiven the provided abstract, please respond to the following query: \"Quality of evidence\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "The evidence is of moderate quality. We were unable to identify any randomised controlled trials that tested the effect of long-term daily use of cocoa products on blood pressure, and there were no trials that measured the health consequences of high blood pressure, such as heart attacks or strokes."
}
] |
query-laysum
|
23852
|
[
{
"role": "user",
"content": "Abstract: Background\nPseudomonas aeruginosa is the most common bacterial pathogen causing lung infections in people with cystic fibrosis and appropriate antibiotic therapy is vital. Antibiotics for pulmonary exacerbations are usually given intravenously, and for long-term treatment, via a nebuliser. Oral anti-pseudomonal antibiotics with the same efficacy and safety as intravenous or nebulised antibiotics would benefit people with cystic fibrosis due to ease of treatment and avoidance of hospitalisation. This is an update of a previous review.\nObjectives\nTo determine the benefit or harm of oral anti-pseudomonal antibiotic therapy for people with cystic fibrosis, colonised with Pseudomonas aeruginosa, in the:\n1. treatment of a pulmonary exacerbation; and\n2. long-term treatment of chronic infection.\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.\nWe contacted pharmaceutical companies and checked reference lists of identified trials.\nDate of last search: 08 July 2016.\nSelection criteria\nRandomised or quasi-randomised controlled trials comparing any dose of oral anti-pseudomonal antibiotics, to other combinations of inhaled, oral or intravenous antibiotics, or to placebo or usual treatment for pulmonary exacerbations and long-term treatment.\nData collection and analysis\nTwo authors independently selected the trials, extracted data and assessed quality. We contacted trial authors to obtain missing information.\nMain results\nWe included three trials examining pulmonary exacerbations (171 participants) and two trials examining long-term therapy (85 participants). We regarded the most important outcomes as quality of life and lung function. The analysis did not identify any statistically significant difference between oral anti-pseudomonal antibiotics and other treatments for these outcome measures for either pulmonary exacerbations or long-term treatment. One of the included trials reported significantly better lung function when treating a pulmonary exacerbation with ciprofloxacin when compared with intravenous treatment; however, our analysis did not confirm this finding. We found no evidence of difference between oral anti-pseudomonal antibiotics and other treatments regarding adverse events or development of antibiotic resistance, but trials were not adequately powered to detect this. None of the studies had a low risk of bias from blinding which may have an impact particularly on subjective outcomes such as quality of life. The risk of bias for other criteria could not be clearly stated across the studies.\nAuthors' conclusions\nWe found no conclusive evidence that an oral anti-pseudomonal antibiotic regimen is more or less effective than an alternative treatment for either pulmonary exacerbations or long-term treatment of chronic infection with P. aeruginosa. Until results of adequately-powered future trials are available, treatment needs to be selected on a pragmatic basis, based upon any available non-randomised evidence, the clinical circumstances of the individual, the known effectiveness of drugs against local strains and upon individual preference.\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 included five trials with 256 participants. Three trials included people experiencing a flare up of disease (171 participants) and two trials looked at long-term therapy (85 participants)."
}
] |
query-laysum
|
23853
|
[
{
"role": "user",
"content": "Abstract: Background\nDiffuse large B-cell lymphoma (DLBCL) is an aggressive cancer of the lymphatic system. About 30% to 40% of people with DLBCL experience relapse and 10% are refractory to first-line treatment usually consisting of R-CHOP chemotherapy. Of those eligible for second-line treatment, commonly consisting of salvage chemotherapy followed by autologous stem-cell transplantation (ASCT), around 50% experience relapse. With a median overall survival of less than six to 12 months, the prognosis of individuals who relapse or are refractory (r/r) to advanced lines of treatment or of those who are ineligible for ASCT, is very poor. With the introduction of chimeric antigen receptor (CAR) T-cell therapy, a novel treatment option for these people is available.\nObjectives\nTo assess the benefits and harms of chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory (r/r) DLBCL.\nSearch methods\nAn experienced information specialist performed a systematic database search for relevant articles on CENTRAL, MEDLINE and Embase until September 11th, 2020. We also searched trial registries and reference lists of identified studies up to this date. All search results were screened by two authors independently and a third author was involved in case of discrepancies.\nSelection criteria\nWe included prospectively planned trials evaluating CAR T-cell therapy for people with r/r DLBCL. We had planned to include randomised controlled trials (RCTs) and we flexibly adapted eligibility criteria to the most reliable study designs available. We excluded studies involving fewer than 10 participants with r/r DLBCL and studies with a proportion of participants with r/r DLBCL below 70%, unless data were reported separately for this subgroup.\nData collection and analysis\nTwo review authors extracted data and performed risk of bias ratings independently. A third author was involved in case of disagreements. As our search did not yield any completed RCTs, prospective controlled non-randomised studies of interventions (NRSIs) or prospective observational studies with a control group, we did not meta-analyse data and reported all results narratively. We adopted the GRADE approach to assess the certainty of the evidence for prioritised outcomes.\nMain results\nWe identified 13 eligible uncontrolled studies evaluating a single or multiple arms of CAR T-cell therapies. We also identified 38 ongoing studies, including three RCTs. Ten studies are awaiting classification due to completion with no retrievable results data or insufficient data to justify inclusion. The mean number of participants enrolled, treated with CAR T-cell therapy and evaluated in the included studies were 79 (range 12 to 344; data unavailable for two studies), 61 (range 12 to 294; data unavailable for one study) and 52 (range 11 to 256), respectively.\nMost studies included people with r/r DLBCL among people with other haematological B-cell malignancies. Participants had received at least a median of three prior treatment lines (data unavailable for four studies), 5% to 50% had undergone ASCT (data unavailable for five studies) and, except for two studies, 3% to 18% had undergone allogenic stem-cell transplantation (data unavailable for eight studies).\nThe overall risk of bias was high for all studies, in particular, due to incomplete follow-up and the absence of blinding. None of the included studies had a control group so that no adequate comparative effect measures could be calculated. The duration of follow-up varied substantially between studies, in particular, for harms. Our certainty in the evidence is very low for all outcomes.\nOverall survival was reported by eight studies (567 participants). Four studies reported survival rates at 12 months which ranged between 48% and 59%, and one study reported an overall survival rate of 50.5% at 24 months. The evidence is very uncertain about the effect of CAR T-cell therapy on overall survival.\nTwo studies including 294 participants at baseline and 59 participants at the longest follow-up (12 months or 18 months) described improvements of quality of life measured with the EuroQol 5-Dimension 5-Level visual analogue scale (EQ-5D-5L VAS) or Function Assessment of Cancer Therapy-Lymphoma (FACT-Lym). The evidence is very uncertain about the effect of CAR T-cell therapy on quality of life.\nNone of the studies reported treatment-related mortality.\nFive studies (550 participants) reported the occurrence of adverse events among participants, ranging between 99% and 100% for any grade adverse events and 68% to 98% for adverse events grade ≥ 3. In three studies (253 participants), 56% to 68% of participants experienced serious adverse events, while in one study (28 participants), no serious adverse events occurred. CAR T-cell therapy may increase the risk of adverse events and serious adverse events but the evidence is very uncertain about the exact risk.\nThe occurrence of cytokine release syndrome (CRS) was reported in 11 studies (675 participants) under use of various grading criteria. Five studies reported between 42% and 100% of participants experiencing CRS according to criteria described in Lee 2014. CAR T-cell therapy may increase the risk of CRS but the evidence is very uncertain about the exact risk.\nNine studies (575 participants) reported results on progression-free survival, disease-free survival or relapse-free survival. Twelve-month progression-free survival rates were reported by four studies and ranged between 44% and 75%. In one study, relapse-free survival remained at a rate of 64% at both 12 and 18 months. The evidence is very uncertain about the effect of CAR T-cell therapy on progression-free survival.\nThirteen studies (620 participants) provided data on complete response rates. At six months, three studies reported complete response rates between 40% and 45%. The evidence is very uncertain about the effect of CAR T-cell therapy on complete response rates.\nAuthors' conclusions\nThe available evidence on the benefits and harms of CAR T-cell therapy for people with r/r DLBCL is limited, mainly because of the absence of comparative clinical trials. The results we present should be regarded in light of this limitation and conclusions should be drawn very carefully. Due to the uncertainty in the current evidence, a large number of ongoing investigations and a risk of substantial and potentially life-threatening complications requiring supplementary treatment, it is critical to continue evaluating the evidence on this new therapy.\n\nGiven the provided abstract, please respond to the following query: \"What was our aim?\". Use language that can be easily comprehended by individuals without domain knowledge:\n"
},
{
"role": "assistant",
"content": "We wanted to explore whether CAR T-cells are an effective treatment for people with DLBCL that returns after treatment (relapses) or no longer responds to treatment (is refractory). We also wanted to explore the frequency of unwanted effects associated with CAR T-cell therapy."
}
] |
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